chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Shingles; sick; very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), sickness (Verbatim: sick) and pain (Verbatim: very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles, sickness and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, sickness and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, sickness and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the patient via interactive digital media. The patient reported that he/she was so sick and bedbound with shingles a few years ago even though he/she had previously had the shingles vaccine. The patient reported that very painful more than anyone who had not had them could not imagine. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
Pediatric patient given Arexvy (Adult) vaccine. Unknown if there was an adverse reaction. Provider notified
I woke up several times during the night with very numb and tingling arms. This should have concerned me more than it did, the body aches and fatigue which were excepted were severe enough for me to just fall back to sleep. In the morning the tingling was gone and again the fatigue and body aches kept me asleep most of the day. This morning I woke up with numbness in my left arm  mild enough that I would not have noticed over yesterdays symptoms  so don't know if it is still or again, as the day has progressed there has been some numbness in the right arm as well. As it is the weekend I have not seen a health care provider yet if symptoms continue I will
she will take medication for her Sinus/she is having some sinus problems; This is a spontaneous report from a Pfizer-sponsored program. A 72-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (at the age of 72-years-old), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization.  Medical history included sinus problems "this time of year and takes Mucinex DM for it." Concomitant medications were not reported. On an unspecified date, she experienced some sinus problems. The clinical outcome of the event sinus problems was unknown.  Information about batch/lot number has been requested.
fevers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing), notes: takes an unspecified thyroid medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot Number: FK9895/EP6955), administration date: 18Mar2021, when the patient was 63-year-old, for Covid-19 Immunization, reaction(s): "Fever"; BNT162b2 (Dose 2, Lot Number: Reported by the caller as being either CRM29 or LRM29), administration date: 15Apr2021, when the patient was 63-year-old, for Covid-19 Immunization, reaction(s): "Fever"; BNT162b2 (Dose 3, Lot Number: 32030BD), administration date: 02Nov2021, when the patient was 63-year-old, for Covid-19 Immunization, reaction(s): "Fever". The following information was reported: PYREXIA (non-serious) with onset 03Apr2022, outcome "unknown", described as "fevers". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: For all four earlier Pfizer COVID vaccines, the patient had fevers the next day. They ranged from 100 to 101 degrees. Patient denied any other medications, medical conditions, labs, testing, or treatments relevant to these events. She was just taking an unspecified thyroid medication; did not think it was relevant. No vaccines administered on same date of the Pfizer suspect. No AE required a visit to emergency room/physician office.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224743 Same patient/vaccine/event, different dose number;
chills, headache, fatigue, shortness of breath, heaviness on chest for 2-3 days and shortness of breath and heaviness on chest is ongoing
4/8/21 approx. 3:00 am experienced nausea vomiting pain in left arm could not sleep due to body ache, intense stomach pain felt like menstruation pain in my left ovary but I was not demonstration I was shivering cold I had back pain and a headache. 4/9/21: headache body and Bone ache I felt cold and shivers. 4/9/21: headache dizziness arm pain. 4/10-4/13- felt better just pain in left indexing finger 4/14/21 approx. 12:15 pm: nausea, radiating headache from front right side to the back, and felt cold. Approx 12:20  pm took medicine Ondansetron for nausea and 2 ibuprofen. Approx. 2 pm piercing stomach ache in my left side upper torso it came out of nowhere did not last long. Approx. 4 pm left side headache gone, little headaches come and go. They are felt in different areas of head like top right side and left front temple area.
4 days post vax, the pt developed a rash which spread from arms to legs, which lasted for a week or so and was pruritic. After the rash resolved a hyperpigmented area remained which were still evident at 2 1/2 months later. The event was reported 2 1/2 months after it occurred, but photos were taken which appeared to be consistent with erythema multiforme.
Information has been received from a registered nurse concerning a 67 year old male with coronary artery disease, hyperthyroidism, colon polyps, benign prostatic hyperplasia and electrocardiogram abnormal on 08-DEC-2006, who was vaccinated SQ in the right arm with a 0.5 mL dose of Pneumovax 23 (Lot# 654981/0674F).  Concomitant therapy included NAPROSYN, aspirin, multivitamins and SYNTHROID.  The patient reported to the nurse on 14-FEB-2007, that on 08-DEC-2006, his reaction "felt like a near death experience".  Two months after his reaction, the patient reported that on 08-DEC-2006, he experienced severe pain in the right arm (injection site arm) that began at 4 pm.  At 6:30 PM on 08-DEC-2006, he "felt every bone in the body ached".  He pain was reported "10 out of 10" and "pain prevented him from sleeping until midnight".  On arising the morning of 09-DEC-2006, the patient still had severe pain in the right arm that was a "4 out of 10".  His tricep area hurt (approximately 09-DEC-2006).  The patient also mentioned that he had nasal congestion and sneezing that persisted, originally starting on 08-DEC-2006.  On 10-DEC-2006, he was extremely tired and had severe congestion.  His nasal congestion subsided but was still reported a nuisance.  The right arm pain was 4 out of 10 when flexed.  There was no account of the patient's experiences on 11-DEC-2006.  On 12-DEC-2006, when the patient flexed the right arm, there was no pain.  The patient pressed on the injection site and there was no pain and the patient felt his condition was good to normal.  The nurse felt that "the patient may have had a reaction because of a viral infection and the patient had localized pain to the right arm due to normal injection site reactions that are known for (Pneumovax 23)."  The patient felt that his reactions were life threatening however the nurse reported that they did not feel the event was serious in nature since the patient did not report his experiences until two months later and he did not seek medical care.  The patient had also reported that he did not go to the emergency room for his experiences.  The nurse also noted in the patient's chart in the allergy section, that no further shots should be given due to his reported experiences.  She clarified that they do not feel the patient had an allergic reaction but this was where she noted the information for future health providers.  Additional information has been requested.
I took my blood pressure, it was 78/51, heart rate of 128, next it dropped to 73/51, heart rate 151; I took my blood pressure, it was 78/51, heart rate of 128, next it dropped to 73/51, heart rate 151; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9364), via an unspecified route of administration, administered in Left arm on 12Feb2021 11:00 (age at the time of vaccination 72-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EUAEL9262), via an unspecified route of administration, administered in Left arm on 23Jan2021 14:00 (age at the time of vaccination 72-years-old), as a single dose for COVID-19 immunization. The patient's medical history included 3 surgeries for aortic aneurysms, fibromyalgia, hernias, Celiac, COPD, sleep apnea, and had known allergies to Tramadol, Amlodipine, Gabapentin, Loratadine, Metoprolol, Augmenting, Carvedilol, Sulfites, glutens(celiac), milk and egg protein, yeast, latex, surgical tape. The patient's concomitant medications included Armour Thyroid, Bumetanide, and Stiolto Respimat. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 13Feb2021 08:00, the patient experienced I took my blood pressure, it was 78/51, heart rate of 128, next it dropped to 73/51, heart rate 151. On an unspecified date, the patient underwent lab tests and procedures which included Blood pressure measurement: 78/57; 73/51; 150/80, and Heart rate: 128; 151. Patient stated that, I have many allergies and recently discovered that polyethylene glycol can cause that reaction. I am worried about the boosters that will come out. No treatment received for the adverse event. The outcome of the events was recovered on an unspecified date.  No follow up attempts are possible. No further information is expected.
This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-000002979 (RA). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic reaction". Additional information: It was reported the patient had an allergic reaction following the first dose of the Pfizer vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Almost completely over stroke; Affecting left side; Blood clot in lower left leg; After shots balance worsened; Pressure on left side of face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Almost completely over stroke"; HEMIPLEGIA (medically significant), outcome "unknown", described as "Affecting left side"; THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot in lower left leg"; BALANCE DISORDER (non-serious), outcome "unknown", described as "After shots balance worsened"; FACIAL PAIN (non-serious), outcome "unknown", described as "Pressure on left side of face". The events "almost completely over stroke", "affecting left side", "blood clot in lower left leg", "after shots balance worsened" and "pressure on left side of face" required emergency room visit.  Clinical course: Had reaction to shots (2 + 1 booster). Almost completely over stroke 10Dec2 (as reported), affecting left side, & after shots balance worsened (98% later 80%) & at the time of report need a cane, blood clot in lower left leg & pressure on left side of face. All of these things occurring after shots. Patient was mystified whether to go lawyer or clinic. ER many times from COVID shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300049900 Same patient/event, same drug in different dose;US-PFIZER INC-PV202300018058 Same patient/event, same drug in different dose;
This spontaneous report was received from a registered nurse from a pediatricians office (phone call) via PDC (Rocky Mountain Poison and Drug Center) and refers to a 6 month old male patient. The registered nurse reported that the male patient received a 0.5ml dose of VAQTA (Lot number reported as N005273, expiration date reported as 03-APR-2017) (route: intramuscular, frequency: once) on 27-JUN-2017 as the result of an unintended exposure (The indication for the vaccine was reported as unintentional exposure.) as the patient is less than 12 months old. The patients medical history includes being a term infant whose primary care provider was ordering routine immunizations.  The patient has not relevant concomitant medications or laboratory data.  The nurse reported that the patient has not experienced an adverse reaction and no treatments have been provided.  As of 27-JUN-2017, it is unknown if the patient will continue to receive VAQTA and the outcome of the unintended exposure was unknown. Additional information has been requested.
Patient had a viral infection earlier that week.  Received her HPV Vaccine on Friday 11/30/07 at 4:25 p.m. Pt was feeling fine ,until 8:30p.m.. Complained of hip pain. By 9:30, pt was in horrible bilateral hip pain over the greater trochanters. Given motrin 400mg by mother and a warm bath,  no relief. Called pediatrian,  no noted side effects.  Wnt to the emergency department.  Temperature 102,  WBC 17 sed rate 5 & C-reactive protein 1.5. Pt.  also developed bilteral knee pain.  Pt was given torodolwhich brought the pain down from 10/10 to 5/10. Pt the was given a percocet for the pain bring the pain down to a 2/10.  Sent home.  Called back for + blood culture on Sunday .  Back to the emergency department for I.V. antibiotics.  WBC 9,C- reactive protein was 41.5. Pt. was admitted to the hospital.  Diagnosis: acute tendonitis of the hips & knees. 2/7/08-records received for DOS 12/2-12/5/07-DC DX: Polyarticular arthritis. Presented with bilateral knee and hip pain times 3 days after symptoms of viral syndrome. Six days prior to admission developed sore throat, headache, vomiting and abdominal pain that lasted 3 days. On 11/30/07 febrile to 102,  Post infectious arthritis.  Developed red man syndrome to vancomycin.
PATIENT'S FACE BECAME EXTREMELY FLUSHED ABOUT 1 MINUTE AFTER ADMINISTRATION OF SHINGRIX. WE HAD PATIENT SIT DOWN AND GOT HIM SOME WATER. PATIENT SEEMED TO IMPROVE MOMENTARILY, AND ABOUT ANOTHER 1 TO 2 MINUTES LATER BECAME EXTREMELY FLUSHED AGAIN. I THEN TOLD PATIENT I WANTED TO CALL 911 AND HE AGREED. I ADMINISTERED CONTENTS OF 1 PREFILLED EPINEPHRINE PEN WHILE MY TECHNICIAN WAS ON THE PHONE WITH 911.
The individual was given the dose without the vaccine being diluted.  The patient has been informed and will watch for any adverse reactions
This spontaneous report was received from a registered nurse, via company representative and refers to a 18 year old male patient. Concomitant therapies included meningococcal vaccine (manufacturer unknown) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP). No information was provided regarding the patient's concurrent conditions or medical history. On 14-AUG-2018, the patient was vaccinated with GARDASIL 9, intramuscular for prophylaxis (dose, lot number and expiration date were not reported). Within 7 minutes of injection, the patient lost consciousness and was treated with ammonia inhalant, cold water compress and cold water. Then, the patient regained consciousness and vomited. No lab diagnostics or studies were performed. The events loss of consciousness and vomiting resolved within 20 minutes of starting, on 04-AUG-2018. The causal relationship between the aforementioned events and therapy with GARDASIL 9 were not reported. Upon internal review, the event loss of consciousness was considered to be medically significant.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency and route were not reported). No adverse events were reported. Additional information has been requested.
Vaccines from 05/21/02: DTaP, IPV, MMR, HAV. On 05/25 patient had focal seizure without fever. Normal exam within 10 hours negative work up. The follow up received on 7/18/02 states, "also developed large "bump" and bruise at injection site left deltoid which resolved."
Product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date when vial placed in refrigerator was 04 Nov 2021. No concomitant product reported by reporter. No treatment medication reported by reporter.
no symptoms were yet reported; Nurse calling to report accidental administration of GARDASIL-9 to a 9 month old infant.; This spontaneous report was received from a nurse referring to a 9-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On 05-MAY-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliters once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  The nurse reported an accidental administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to a 9 month old infant.  The reporter stated no symptoms were yet reported (product administered to patient of inappropriate age).
About five to six days after the vaccine, extremely itchy hives broke out across various parts of my body, after having no side effects (not even a sore arm) following the vaccine. It went away with no treatment in about 48 hours. I know that is not one of the common side effects and it occurred long after the shot, so I wanted to report it in case anyone else does as well. Of course, it may have been caused by something else, but I have never in my life had anything similar occur; nor had taken any new medications or eaten new foods.
04/01/04: Left thigh with redness and slight swelling and warm to touch.  Deferred to MD to evaluate.
Patient had no dates of Shingrix series in chart and  unable to find dates in system,   patient received a Shingrix dose in office.  Next day upper arm swollen, sore and red per patient.  She went to urgent care to be evaluated.   Afterwards patient  found at home she had completed the series somewhere else.   She contacted the office with the dates of her 2-dose series.  Records were updated.
red, hot, swollen area on my arm about 3" by 6" in size that started about 2 days after injection and started to get better 5 days after injection. Treated with ice. Outcome unknown at this time.
Narrative:  82yoM admitted to the floor from nursing home on 10/26/2022 due to testing positive for COVID. Upon presentation, only symptom was a slight cough. Developed mild temp of 100.3 overnight, which has since improved. Baseline inflammatory markers continue to be unremarkable. Currently only receiving supportive care. This includes guaifenesin PRN. Plan is to repeat BINAX test in 5 days.
About 4 days ago, around July 9, 2022 I did not feel well. It felt like I had COVID- 19. I did 2 at home tests and they were negative. I went to the clinic and to get another COVID- 19 test and it was negative. I just left the doctor's office today and was told it was something viral. My symptoms are getting worse, I have a sore throat and greenish stuff. I did test positive for COVID-19 before on February 1, 2022. I also had a sinus infection. Also, 3 days after receiving the vaccine, I had a bad headache in the back of my head and chest pain.
A report was received from a health professional on 16Oct02, concerning 13 month old male vaccinee who was inadvertently administered Fluvirin on 16Oct02. On 16Oct02 a 13 month old male vaccinee was inadvertently administered 0.25ml of Fluvirin vaccine in the right anterior thigh. The vaccinee has not received a previous influenza vaccination. The vaccinee has not exhibited any signs of symptoms of an adverse event and will be closely monitored by the vaccinees mother for adverse reactions. There was insufficient information to determine the reporters causality assessment. Update 1 31Dec02: A report was received from a health care professional which indicated that the vaccinee experienced no adverse event and the physician felt that no treatment was necessary.
joint pain in every joint from hips to shoulders.  (hips, back, wrists, elbows shoulders)  Each day the pain would move from one joint to another.  Never the same joint twice in a row plus muscle pain in both upper arms  this lasted for a total of 8 weeks exactly from date of injection
red ness size of a quarter and has grown to about 3 inches around and is hot to touch.lump about size of a quarter has left after 7-10 days.redness has lightened but remains to date. Terrible bilateral leg pain from hips to feet  on a scale of 1-10 it is a nine . Took OTC tylenol  without relief. stomach pains  for 5 days but resolved.
24 hours after vaccination I developed the chills and a high fever of 101?. The fever lasted for 10 hours.