chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 828 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Had the shot and had small case of shingles/ suspected vaccination failure; Shingles; 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: Had the shot and had small case of shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced small case of shingles and it was very painful and they are horrible. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Loss of consciousness, involuntary muscle movement, eye twitching lasting 15 seconds with immediate response and consciousness after.
Severe rash with swelling and wanting itch it badly.  Red splotches all over body, face, arms.
Patient's arm is sore when raised in a certain position or putting her arm back while putting on clothes.
red rash on lower arm. advised to use Benadryl or hydrocortisone for itchiness. Contact MD if worsening or no improvement
Chills, headache, dizzy, muscle aches, cloudy mind, fatigue,
8APR92 recvd Engerix-B 2 dasy later devel nausea, "mid abd soreness, & stomach cramps-subsequently recovered; sore, nausea, mid abd soreness, stomach cramps;
90-year-old male history of AFib, on anticoagulation with Eliquis, HTN, dementia, DM type 2, BPH presents with increasing shortness of breath. Previously lived in an assisted living facility, was admitted on 08/23 with confusion and generalized weakness, decreased heart rate. He was treated with IVF hydration, empiric antibiotics with ceftriaxone azithromycin, 2D echocardiogram was performed that demonstrated a preserved EF, he was transferred to a local SNF. He fell upon arrival to the sniff within 24 hours, with a subsequent left proximal humerus fracture, and is pending outpatient orthopedic evaluation. Unfortunately patient tested positive for COVID-19 on 08/31. He is fully vaccinated since January '21. Felt in ED profoundly hypoxic, proBNP elevated >39k, troponin T 262, CXR with bilateral multifocal infiltrates. Initiated on treatment with dexamethasone, Remdesivir, IV diuresis, and supplemental O2. Patient was seen by Cardiology and Pulmonary during hospitalization. They recommended continuing present management as above and reiterated patient has very poor overall prognosis given his multiple  comorbidities and frail state. Unfortunately, despite aggressive treatment, at 3:55 a.m. On 09/12/2021,  patient passed away. His family was notified of death by nursing staff.
Had Flu Shot on 10/25/08, symptoms presented within two hours.  Injection site swelled to 5 inches across raised and very hot to touch.  Have taken Benadryl for past two days and the swelling and redness has decreased, however itching and heat remains, however heat is much less.
This case was reported by a physician and described the occurrence of high fever in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (unknown). Seven hours after vaccination with FLULAVAL, the subject experienced high fever. At the time of reporting the outcome of the event was unspecified.
Spiked fever 12 hours after injection. For the next 48 hours had chills and was achy.
2 days p/DT in rt arm pt devel tenderness, induration, redness 8-10 cm in diameter around inject site; tx DPH ATB;
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 08-OCT-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 24 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
No additional adverse events were reported; Patient received an expired Proquad; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapy were not reported.    On 17-FEB-2022, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), lot # T028298, expiration date 16-FEB-2022 (route not reported) for prophylaxis (expired product administered). No additional adverse events or product quality complain were reported.
Hives occurred about one hour after flu vaccine administered. No shortness of breath. Treated with Benadryl.
onset 0230 of abd cramping & diarrhea took pepto bismol;noticed lower lip tingly-swollen w/blisters on inside;seen in ER eyelids swollen, tongue thick w/blisters (underside on lt);sl nausea given DPH in ER:
I did not feel much pain during the shot or imemediately after. However, the next morning, I woke with a sharp pain in my shoulder and bicep and couldn?t lift my 1-year-old child.  I had little range of motion without intense pain. The shot was administered very high on my arm and almost on top of my shoulder. The pain increased daily. I contacted my primary care physician via phone who recommended that if the pain continued to increase to visit an orthopedic urgent care. The pain continued for another day and by today (10/20/17) it has subsided some after heat and NSAIDs. It has not gone away and there is still a major loss of range in motion, especially moving my arm straight out from my side. I have had difficulty lifting or holding anything in my left arm. I have numbness or tingling from time to time. My left hand was very numb 3 days after the shot. My arm felt as if were very warm in the muscle for 4 days and is less intense the 5th day. If the pain does not subside fully by 1 week after the intial shot, I plan to follow the advice of my doctor and visit an orthopedic urgent care office. I was advised to contact the provider and alert them to the reaction to the shot which I did.
Pt exp high fever last evening around 8PM & then 10PM still fussy; APAP given; 2MAR94 vomitting in early AM x 2; still fussy touch temp first time on 2MAR93 103 ax called MD;
pain in his right leg and lower back hurts; rash then he had blisters; rash then he had blisters; pain in his right leg and lower back hurts; This is a spontaneous report from a contactable consumer. This consumer (patient's girlfriend) reported for a male patient that,  A 56-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8733) (at the age of 57 years old), dose 1 via an unspecified route of administration on 25Mar2021 as dose 1, single, dose 2 via an unspecified route of administration on 16Apr2021 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0151) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that on an unspecified date, caller stated her boyfriend was the same way, got his Pfizer Vaccines for the first and second dose and he also had pain in his right leg and lower back hurts; had really severe reaction and thought he had poison ivy two days after he had a rash then he had blisters and put Calamine lotion on it and waited till the blisters popped before they went away. She also stated that his rash had kept getting worse and three days ago his lower back was killing him, he could not sleep, sit or lay down and was in the emergency room with back pain and his right leg was kind of like hers but worse and he was kicking it and the leg would not wake up and looked like he was giving birth and went to the emergency room where they did blood work, CT scan and everything and she thought they said he may be having a back spasm and they could not find anything and gave him Lidocaine patches, Flexeril, and Naproxen and he took all of those at the same time but none of them are helping the pain and the pain was only easing away. She also stated that she had no dosages, lot numbers, expiry dates, or NDC numbers for the Lidocaine patches, Calamine lotion, Flexeril patches or Naproxen to provide at that time. The patient underwent lab tests and procedures which included blood test: unknown, computerised tomogram: normal, x-ray: normal on an unspecified date. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the pfizer suspect. Patient did not have prior vaccination within four weeks. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
SICKNESS  2 HOURS  AFTER VACCINATION; BODY SHAKING; SEVERE CHILLS; EVERY MUSCLE IN MY BODY ACHED; SPIKED A TEMPERATURE; SEVERE HEADACHE FOR DAYS; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included severe case of covid quite a while ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced sickness 2 hours after vaccination. On MAR-2021, the subject experienced body shaking. On MAR-2021, the subject experienced severe chills. On MAR-2021, the subject experienced every muscle in my body ached. On MAR-2021, the subject experienced spiked a temperature. On MAR-2021, the subject experienced severe headache for days. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe chills, sickness 2 hours after vaccination, body shaking, every muscle in my body ached, spiked a temperature, severe headache for days and nausea was not reported. This report was non-serious.
I had the 2nd Moderna vaccine injection for Covid-19 on 1/31/2021. On 2/1/2021, I started to have severe side effects that included very bad chills, spiking fever, confusion, over-all body weakness, and acute pain at the injection site on my arm. These symptoms lasted 48 hrs+. In fact, even today, 2/5/2021, I still have bad arm pain.
Broke out on back and legs. Patient stated that it looks as if he has been whooped with a bat. The bruises were red and now they are turning into a scab and itching. The ER prescribed prednisone. After medication was used spots went back to stage one.
DIZZY, NO OTHER SYMPTOMS.  TALKED WITH PARAMEDICS AND LEFT ON HIS OWN
Started period 10 days earlier then expected & heavier flow then normal. Currently on day 2.
Patient received Influenza and Pneumococcal vaccinations in left shoulder at 9am. At 5pm he developed weakness, dizziness and fever to 102F. He had terrible pain in the shoulder not so much at the injection site but in the joint itself. He had shakes and chills. He continued to feel faint after lying down and continued to have fever. He had pain in the left shoulder and also in both knees. Paramedics were called. Blood pressure in the field was as low as 52/40 but improved with fluid bolus to 118/58. He was brought to the ED and given Tylenol, Motrin, Stress-dose steroids, Morphine and Dilaudid.He became hypotensive again in the hospital and was transferred to intermediate care on dopamine. All symptoms improved within 48 hours. Sepsis was ruled out.  Hospital MR received revealing  70 yr old male admitted to the hospital for sudden onset of fever, weakness, dizziness, and shoulder pain approximately 8 hours after his Pneumovax and Flu vax.  PE: Febrile with rectal temp. up to 104'F.  Initially hypotensive then improved with bolus IV fluids.  Decreased ROM in left shoulder.  Pain in left shoulder and knees. Otherwise normal exam.  Treated with dopamine for BP support, Rocephin, Zosyn,and stress dose steroids. Discharged feeling well and asymptomatic after 48 hours. Impression: Resolved hypotension, arthralgias, fever 2' to AE from pneumococcal/influenza immunizations (serum-sickness like).
Day 8 after my injection I formed a bump under the skin that was extremely itchy. By the end of day 8 it was bumped up and red. The bump only last 2 days. The redness continued for 3 more days. the itching just at the site of injection lasted day 8 to 13. The only other symptom I had was increase in mucus drainage.
Blood pressure went up; Light headed; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 26Apr2021 at 13:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included Barrett's esophagus and allergy to sulfa drugs (sulfonamide allergy). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included potassium chloride (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN) and chlortalidone (CHLORTHALIDONE); for unknown indications from an unknown date and unknown if ongoing. The patient previously received lisinopril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 26Apr2021 at 14:00, within 2 hours of getting the second dose the patient's blood pressure went up and felt light headed. For the next 2 days the pressure stayed up and on the 3 days after it came down. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events blood pressure went up was recovered on 29Apr2021; while that of the event felt light headed was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
woke up sick; sore throat; This is a spontaneous report from a Pfizer sponsored program COVAX SUPPORT received from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer/BioNTech COVID-19 Vaccine), via an unspecified route of administration on 27Mar2021 (Lot number: not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Apr2021, the patient woke up sick with sore throat and thus could not go to have the 2nd dose of the vaccine and she was scheduled to have the 2nd dose of vaccine on 17Apr2021. The reporter was asking what they should do and wanted to cancel the appointment. The reporter was referred back to the facility and provided with PMI's (reported) phone number. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 HOURS later went to urgent care for heart palpitations. and the medical staff gave one dose of potassium . and discharged him
muscle aches, fever, rigors. Treatment - ibuprofen & APAP. improved temp to 99.7 F. Symptoms improved within 24 hours
injection site is still pretty red; injection site is still swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site is still pretty red) and VACCINATION SITE SWELLING (injection site is still swollen) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary hypertension. Concomitant products included INSULIN for an unknown indication.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site is still pretty red) and VACCINATION SITE SWELLING (injection site is still swollen). At the time of the report, VACCINATION SITE ERYTHEMA (injection site is still pretty red) and VACCINATION SITE SWELLING (injection site is still swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient also takes other unspecified concomitant medications. Treatment information was not reported.
having a biopsy done on some moles that recently changed look and size; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A report received from contactable female consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in 2021, the patient had some moles that recently changed look and size. It was reported that on 26Feb2021 patient was having a biopsy done on some moles that recently changed look and size and would have a local anesthetic at that appointment and wanted to make sure if she can still get the second dose on 9Mar2021.The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After receiving H1N1 Flumist client complained of Left Nostril pain and complained of eyes hurting and stomach pain. Course of treatment included observation for 20 minutes, client recovered fully, stated that she had no pain, but felt hungry and wanted to go home.
1. Left arm numb. No feeling for 28 hours.  2. Hives and rash from torso to forehead.
This spontaneous report as received from a consumer refers to a 63 year old female patient. Concurrent conditions included high cholesterol and sulfa allergy. On 21-MAY-2013 the patient was vaccinated with ZOSTAVAX. Lot number, dose, route and frequency were not provided. Concomitant therapies included Simvastatin (manufacturer unknown). On 28-MAY-2013, reported as one week after administration, the patient experienced zoster like rash on her head, waist, arms, and back welts on her head, redness at the injections site and itchiness. The patient visited medical offices on unspecified dates. The patient stated she was prescribed Prednisone (manufacturer unknown), Betamethasone Valerate foam (manufacturer unknown), Locoid lipocream (manufacturer unknown), Hydroxizine hcl 25 mg (manufacturer unknown), Trimacinolone (manufacturer unknown) and Clobetasol (manufacturer unknown). The outcome of itchiness, redness at the injections site, zoster like rash on her head, waist, arms, and back and welts on her head was reported as not recovered/not resolved. The reporter causality was unknown. Additional information has been requested.
Initial misuse report received from a healthcare professional on 15 January 2013. A patient (no information was provided regarding the patient) had received first dose of MENACTRA in July 2012 at an age of 16 years and then received the second dose in December 2012. No adverse event was reported. List of documents held by sender: none.
Rash and itchy arm one week following  first dose of Moderna  COVID-19 vaccine.
Initial report received from a nurse on 18 Mar 2010: This patient inadvertently administered FLUVIRIN (expiry date: Feb 2010) (Batch no.:1009234P), intramuscular, expired vaccine on 18 Mar 2010. No adverse effects were reported after administration. The outcome of the event was not reported.
This spontaneous report was received from a nurse practitioner referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 lot #: L014458, expiration date on 11-FEB-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
a 87-year-old male received a dose of Fluzone High-Dose and some of the medication leaked from the site/No AE; while removing the needle from arm, some of the medication ran down his arm/No AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 87 years old male patient who received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ251AD, expiry date: 01-May-2020) via intramuscular route in the left arm on 11-Oct-2019, some of the medication leaked from the site and ran down his arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine underdose and exposure via skin contact.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.