chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gillian bar syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: Gillian bar syndrome) (serious criteria GSK medically significant and life threatening). The outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient's friend via interactive digital media. The patient almost died from Gillian Bar Syndrome and was still not right. Follow-up would not possible as no contact details were available.
Headache; A bigger exacerbation in his photophobia; A bigger exacerbation in his photophobia; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (A bigger exacerbation in his photophobia), CONDITION AGGRAVATED (A bigger exacerbation in his photophobia) and HEADACHE (Headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 048B21A) for COVID-19 vaccination.     The patient's past medical history included Trauma. Concurrent medical conditions included Photophobia. Concomitant products included METFORMIN, GLIMEPIRIDE, ALOGLIPTIN, CELECOXIB, CETIRIZINE, MULTI VIT and MINERALS for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced PHOTOPHOBIA (A bigger exacerbation in his photophobia) and CONDITION AGGRAVATED (A bigger exacerbation in his photophobia). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, PHOTOPHOBIA (A bigger exacerbation in his photophobia), CONDITION AGGRAVATED (A bigger exacerbation in his photophobia) and HEADACHE (Headache) had not resolved.            No treatment medication information was provided.   This case was linked to MOD-2021-261758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow-up received: Outcome changed from unknown to not recovered
Fever of 102.5 orally, fever and chills, uncontrolled shaking, several muscle pain for appx 24 hours.
prolonged apnea episode 3 mins; parents gave CPR & called 911 & were transported to hosp;
Day after my booster on Saturday had fatigue and low grade fever . Had the same symptoms previously after my second dose .  Sunday 1/16/22 I  noticed a few small bumps on my right upper buttock.  By Monday morning that area had several painful and itchy  fluid filled blisters ,  and also had them on my right lower leg. A virtual visit was completed and I uploaded pictures for review . I was diagnosed with shingles and was prescribed Valcyclovir 1000 mg TID for 7 days .  The vaccine may have precipitated a shingles out break
arm swelling; red arm; arm hot; welt; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, skin warm and welts. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin warm and welts were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and welts to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller stated that 3 other people she spoke with had the same reaction as her. Following Shingrix the patients arm was swollen, red and very hot. The welt was 6 to 7 inches long. The caller did not provide any additional information, though she still wants to be reimbursed for the vaccine. This case has been linked to US2019AMR068938, US2019AMR068949, US2019AMR068954 reported by same reporter.
woke up with fever to 102F; rigors; body aches; headache; R arm pain and redness at injection site; R arm pain and redness at injection site; R arm pain and redness at injection site; the 1st dose on 22Dec2020, the 2nd dose on 08Jan2021; This is a spontaneous report from a contactable Physician (patient). This 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the 1st dose on 22Dec2020, the 2nd dose (lot number: EL0142) on 08Jan2021; both at right arm via an unspecified route of administration at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. 12 hours after vaccine, the patient woke up with fever to 102F, rigors, body aches, and headache on 09Jan2021. Severe symptoms until around 24 hrs, then continued mild body aches and chills up to 50 hours after shot. Continued R arm pain and redness at injection site currently, at 72 hours after vaccine. No treatment was received for events. The patient had no COVID prior vaccination, no COVID tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of all events was recovered.   No follow-up attempts are possible. No further information is expected.
A couple days after it started with earache down my neck, chills, lymph node on my left breast
Pt received flu shot 0.25ml to LAT mom left and went to store was in line and pt began acting really drowsy. Took pt to car stuck her in car seat and noticed that she threw her head back. Mom called pt name and pt was unresponsive says her eyes had rolled back in her head. Called us and was seen in Drs office.  11/28/06 Received medical records from hospital which reveal patient seen in PCP office on 10/16/06 for routine check up & flu shot.  Had cough, slight wheeze & head congestion symptoms for approx 1 day at time of visit w/temp 100.7.  Became very sleepy then unresponsive later same day & went to ER.  Neuro improved in ER but respiratory status worsened & was kept overnight for continued observation & management of asthma. MEDS: singulair & pulmicort for asthma & propanolol for SVT. Xopenex PRN.  GIven Rx for orapred during 10/16/ visit./ss Information received from annual follow up indicates causal relationship unclear.
Both doses on 9/15/19 and 6/08/20; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th September 2019).   On 8th June 2020, the patient received the 2nd dose of Shingrix. On 8th June 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter enquired if the patient should get a 3rd dose. The reporter disconnected before call center representative was able to gather additional information about the patient or obtain permission for follow up.  Email address was provided.
Information has been received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's medical history was not reported. Concurrent conditions and concomitant medications included treatment with interferon (manufacturer unknown) weekly for multiple sclerosis (diagnosed on an unknown date). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis. No adverse symptoms reported. No product quality complaint (PQC) was involved. Additional information has been requested.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 03-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Increase in: face gets hot; my body feels shaky on the inside (spine and stomach area); overall not good feeling that comes and goes. Slightly elevated fever a couple times of month, runs about 99.5-99.9. These symptoms occur on average of about once a week or maybe more and sometimes less. And in addition to that, I experience body pain and joint pain all over, knees and hips and back, it's increased a great deal since the vaccines and that happens all the time. No treatment as of yet because they don't know what is going on. Nothing scheduled for follow up as of yet.
Severe joint pain in the shoulder of the injection site. Sharp burning and deep pain similar to a torn muscle. Pain is still severe and has actually become worse since onset.
I started getting symptoms of fever, headache, lethargic, and sore throat. I took an at home COVID-19 test that was positive. My coughing progressed and was severe. I contacted my doctor after 10 days. It took me over 3 weeks to recover. I was off of work for 3 weeks as well.
Day after started to experience fatigue that still continues and with occasional low grade fever.  .Also experienced bloody nose and sniffles.  One week later developed swelling and rash at injection site and had some muscle aches, occasional low grade fever.  Feels like a case of the flu that just drags on.
11/19/2022 Slight sore throat in the morning. Tested positive on an at home rapid COVID-19 test. Had a tele visit with doctor. Doctor prescribed PAXLOVID. Sore throat lasted 24 hours. Fever spiked at 99.9, lasting about 48 hours.
6.5cm X 6cm red indurated area on right medial thigh with warmth and tender. Afebrile. Prescribed Keflex.
Patient broke out into rash. Parents did not notify agency until May 28, 2010.
expired PNEUMOVAX was administered to a patient; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown gender and age (age reported as 7 (age units not provided)). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On 21-AUG-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (expiration date: June 2020; lot#, route of administration and anatomical location were not reported); dose/frequency reported as 1 (not specified); for prophylaxis. Pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) had no previous temperature excursion.
Per nursing note 6/15/11... "Noted large blister, approximately size of a dime to left forearm ppd site with redness around blister. admits to some itching. no shortness of breath, no other rashes noted."  Treated via Medrol Dosepak & OTC Benadryl
patient bled profusely and complained of pain. Injection site bled enough to soak band-aid and drip down patient's arm. Patient has noticeable bruise on upper left arm where vaccine was administered.; patient bled profusely and complained of pain. Injection site bled enough to soak band-aid and drip down patient's arm. Patient has noticeable bruise on upper left arm where vaccine was administered.; patient bled profusely and complained of pain. Injection site bled enough to soak band-aid and drip down patient's arm. Patient has noticeable bruise on upper left arm where vaccine was administered.; This is a spontaneous report from a contactable consumer (patient's wife) reported for a patient. A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: ER2613), via an unknown route, administration in upper left arm on 20Apr2021 at 10:30 (at the age of 37-years-old) as dose 2, single for COVID-19 immunization at workplace clinic. No COVID prior vaccination. The patient had no medical history and no known allergies. Concomitant medication was not reported. No other vaccine in four weeks. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: EJ1685), via an unknown route, administration in left arm on 30Mar2021 at 10:30 (at the age of 37-years-old) as historical vaccine as dose 1, single for COVID-19 immunization at workplace clinic. On 20Apr2021 at 10:30, after vaccination immediately after needle was removed, the patient bled profusely and complained of pain. Injection site bled enough to soak band-aid and drip down patient's arm. Patient has noticeable bruise on upper left arm where vaccine was administered. Adverse event was not resulted to visit emergency room and physician office. No COVID tested post vaccination. No treatment received. The outcome of events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts completed. No further information expected.
Client has died on 3/19/2022 as written in an obituary for her.
1) fever up to 100.0 degrees mother states 2) red swollen area warm to touch on RUA about 5x5 and 1/2 cm in size.
Child at 11 months old would get stomach pain, vomiting & rash.  Pediatric allergist diagnosed egg & peanut allergies.  No one else in family has these allergies.  Mother has tired to eliminate all eggs from diet since 5/2006.  Child awakened 4-14-10 12 hrs after shots with wheezing, cough, vomiting and fever.  Redness on right upper arm.  Mother called to see if vaccine insert warned of egg protein allergies.  Insert read to mother.  Mother did not notify nurses of egg & peanut allergies prior to shots given.  VIS no longer lists egg allergy as a caution.
R shoulder, posterolateral aspect, pain, particularly with lateral and posterior abduction that began immediately after getting injection on 10/5/2020. Patient reported this 2 weeks later on 10/19/2020 to Occupational Health office.
This spontaneous report was received from medical assistant and refers to a 3 month old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No adverse symptoms reported.
two roommates that have previously tested positive; two roommates that have previously tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, 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. The patient underwent the following laboratory tests and procedures sars-cov-2 test positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial unsolicited report received from a consumer (patient) on 29 August 2016. This case involves a 55-year-old female (reported as 56 year old) patients who was vaccinated with a dose of ADACEL (batch number- U5279AA, expiry date: 18 March 2018) intramuscularly in the right deltoid on 10 June 2016. Patient's illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions included: no known allergies, none. Concomitant medications were not reported. On 11 June 2016, one day following the vaccination, the patient experienced vision in right eye became blurry and 48 hours later, patient could not see from right eye. The patient received IV steroids for 3 days as corrective treatment and vision returned partially, then one week later began to diminish, treated with oral prednisone, with partial return of vision, on prednisone until last month in july 2016. The patient was seen by neurologist and referred to opthalmal neurologist for late September. The patient was seen by ophthalmologist (ophtlamologist) MRI and eye exam. The outcome of the events was reported as not recovered. Upon internal review the case was considered as serious because of important medical event: could not see from right eye. List of documents held by sender: none.; Sender's Comments: Could not see from right eye is unlisted with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Time to onset is compatible with the role of the vaccine. This is poorly documented case. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Vomiting (3 times in 3 hours). Crying for over 3 hours (never in her life has she cried for so long).
Mother reports vaccine site (right upper thigh) red and swollen the following day, no fever. On Saturday am patient awoke with red facial rash and swelling. Mother took to urgent care. Dr. at urgent care encouraged Benadryl and sent client home. Mother called health dept in am on 11/17 and spoke with me. No fever, facial rash has improved now just dry red and blotchy, not itchy. No vesicles. Site swelling and redness is decreasing but still present. Client has complained of itching at site so mother covered with a bandaid.
Reports soreness at site of Tdap (L) deltoid within 1-2 days post administration. Reports itching on (L) arm w/discoloration approx. 10-14 days post injection. Continues on day of reporting. Applied warm compresses for soreness.
Patient came into the clinic, providing his name, and that he was on his first dose. After verifying in database with the name provided, no record of COVID-19 vaccine was found so a 1st dose of Moderna was given. When filling out the incentive form, which requires a signature, he signed his real name. We verified with database to see if that name had a vaccine record. It was found that he had two records. Both records had a history of COVID-19 vaccination. He had previously received Pfizer doses on 01/25/2022, 02/16/2022 and 03/01/2022, making his dose today, his 4th mRNA vaccine. No signs and symptoms were noted during his 15 minutes of monitoring and he left the clinic without any complaints.
Fatigue, fever (measured at 102 deg), pain and redness at injection site and general pain. Took Tylenol every 4hrs for 18 hrs. When condition did not improve, went to urgent care center (01/09/2016 @4:00 pm). Received prescription for antibiotics, which resolved fever and body aches but not injection site arm pain. Arm pain worsened over next 12 hours. Went to ED on 01/10/2016 for further treatment. Diagnosed with cellulitis and treated for infection (WBC was 18) with IV antibiotics and treated for pain with morphine. Received prescription for a course of a different antibiotic.  Symptoms have largely resolved since Sunday night. Pain in arm at injection site has improved. Redness decreasing but still present.
MOM OF PATIENT BROUGHT CHILD IN RA  IM.  WARM TO TOUCH AND TENDER TO TOUCH. CHILD AFEBRILE 98.2. MOM STATES THAT SHE IS TAKING CHILD TO PHYSICIAN FOR FOLLOW UP. INSTRUCTED MOTHER CONTINUE APPLY COOL TOWELS TO ARM. 9-30-11 MOM STATES "SHE I FINE, THE DOCTOR GAVE ME SOME CREAM TO PUT ON IT AND ITS GONE."
I63.512 ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 4/14/2023 HX OF ISCHEMIC STROKE W UNSPECIFIED RESIDUAL DEFICITS R29.810 LEFT FACIAL MUSCLE WEAKNESS 4/6/2023 HX OF ISCHEMIC STROKE W UNSPECIFIED RESIDUAL DEFICITS
Information has been received from a physician concerning himself, in 1995 he was vaccinated with two doses of Varivax. In approximately July 2006, he broke out with a mild form of herpes zoster virus. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Exactly twelve hours following injections acute, excruciating, debilitating abdominal pain progressing to loss of consciousness and transport to ER via 911.  Ten hours in ER with severe pain , nausea, and bloody diarrhea.  Loss of work two days.  Recovery lasting ten days.
SECONDARY ALLERGIC REACTION IN THE WHOLE BODY, RASH ON THE SKIN, TINY BUMPS AND RED SPOTS, AND A LOT OF ITCHING, LARGE BRUSE IN THE AREA OF THE INJECTION
mom states pt recvd vax 31OCT & by the next day lt arm was red, inflammed & swollen from shoulder to elbow; no one was notified @ that time on 2NOV MD saw pt arm improved but still a little red & swollen;
This spontaneous case reported by a consumer, describes the occurrence of bad headaches in a 68-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, the patient experienced bad headaches. At the time of the report, bad headaches outcome: unknown. No concomitant medication or treatment information provided.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength, dose and route of administration were not provided) (lot #L029073 expiration date 19-APR-2017). The registered nurse stated that PNEUMOVAX 23 was exposed to the following temperature conditions: 34 F degrees for an unknown period of time. Previous temperature excursion was unspecified. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
Pt stopped by the office today to report redness at the injection site from her immunization yesterday. She also noted she had a fever last night and c/o nausea last night.
pt recv vax & devel an inj site rxn characterized by a 12-cm area of redness & swelling;pt was seen by MD who prescribed warm compresses & E-Mycin 333;