chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Renal Failure; This is a spontaneous report from a contactable consumer.  A 94-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 15:00 (Batch/Lot number was not reported) (at the age of  94-year-old, not pregnant) as single dose for COVID-19 immunisation.  Medical history: none, she was just old. Concomitant medications included temazepam; ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER); ascorbic acid, betacarotene, copper, tocofersolan, zinc (OCUVITE).  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 on 23Feb2021 at 12:00 PM in left arm at the age of 94-year-old for COVID-19 immunization and experienced Renal Failure.  No covid prior vaccination.  No other vaccine in four weeks.  No covid tested post vaccination.  No known allergies.  The patient experienced periodic uncontrollable shaking renal failure.  AE resulted in: Doctor or other healthcare professional office/clinic visit.  No treatment.  The patient died on 18May2021.  An autopsy was not performed.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101102004 same reporter, patient, product, event, different doses and potential; Reported Cause(s) of Death: Renal Failure
Patient reported a rash on her arm around the vaccine site about 10 days after administration.  She stated it itched slightly, was not painful and resolved within one day.
This case was reported by a healthcare professional and described the occurrence of positive influenza B cultures in a female subject aged between 80 and 89 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2007 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 26 February 2008, several months after vaccination with FLULAVAL, the subject experienced positive B influenza cultures. A nasal culture was done. The subject was diagnosed with influenza B. The strain of the B was not known. At the time of reporting the outcome of the events was unspecified. This event occurred in two different subjects with the master case being case number A0713041A.
Has chickenpox with clusters of erythema round lesions, some with vesicular sites emerging over 2 days. Had varicella given on 6/5/06.
Covid -19 6 month-4 year vaccine drawn up from vial without diliting. Medical assistant drwe up 0.3 ml and gave injection to patient. Error was discovered on 10-24-23 8 AM. Did covid vial count and discovered 2 vial were used on 10-23-24 , but only 2 doses for this age group were administered. Bothe vials used on 10-23-23 available to view. One appeared to be the 2 diluted wasted doses, the other vial has a few drops of fluid.  Contacted the MA who states she did not dilute vial before drawing up the 0.3 ml dose. Vial comes as 0.48 ml vial that needs to be diluted with 1.1 ml normal saline. Vial then mixed and ready for use, 3 doses per vial.  Contacted manager and clinical educators. Pfizer was contacted regarding overdose of vaccine. Pfizer informed us no additional testing is needed and that he may have increased local or systemic reaction. Dr called parent and informed of vaccine error and pfizer's response. Mother reports no adverse reaction. Mother was instructed she can bring child to office for evaluation if concerned. No appointment requested at this time. Added additional sighnage for Covid vaccines in refrigerator and in delegated area used to draw up thsi age group vaccine. Re-trained, in person all staff who give vaccines, including process of preparing and drawing up each Covid vaccine, and timng of vaccinations.
Swelling on left arm. Swollen area is red and 1/4" enlarged. Size is 3" x 2" in oval shape.
Son walked out of shot area. Sat in chair in observation area. Within 30 seconds eyes rolled to back of head, body was jerking and shaking and his arms a d legs went very tight. I grabbed him before he hit the floor. Pharmacist got a cold compress and put on neck. He was very foggy and without color for about 15 minutes . We called 911. It took them 20+ minutes to arrive. They ran a few tests and recommended home observation vs hospital,  due to crowding and lots of Covid, etc. He was running fever around 99.8. Gave Motrin, appears to be better. He was very scary and nervous to sleep given the incident and stories on internet. He is nervous now about his heart and impact to his health.
Headache, body & muscle aches, chills, extreme fatigue, nausea (one day)- resolved with fluids & rest the next day Neck pain, neck stiffness (loss of ROM), posterior neck swelling (2 days)- went to urgent care, resolve after a few days of Tylenol & ibuprofen Total time of reaction: started the day after the vaccine, mostly resolved within 4 days.
Initial report received on 25 November 2009 from a health care professional. A 63 year old female patient with an allergy to sulfa, reaction to anesthetic, REGLAN, ZANTAC, iodine, gadolimine, "several surgeries", gastritis, and hyperlipidemia reported feeling light headed to her doctor's office during the afternoon after receiving ADACEL (lot number C3087) intramuscularly in the left deltoid on the morning of 23 November 2009. The following day she went to an appointment at 8 AM and then went to volunteer. In the afternoon she could not remember if she went to her 8 AM appointment. She seemed to have a 2-3 hour period where where she could not remember, a period of amnesia. The symptoms have cleared and the patient was reported as recovered. Concomitant therapy included "PROVICOL", AMBIEN CR, CLARINEX, "ACIFEX", vitamins, NASONEX, MAALOX, DIZOZIDE, acidophilus, MAALOX, monthly allergy shots. List of Documents held by Sender: none.
Pt had syncopal episode x3 seconds, emesis x1. BP to 80/25 from 100/63 baseline. Episode lasted 10 minutes
pale, clammy, sweating, lightheadness, possible absence seizure after 2nd shot. He waited his 15 minutes, and was waiting on his wife's 15 minutes, when he started to feel badly. Ambulance came to make sure he didnt have a seizure and his vitals were okay. patient said he had not eaten before shot and walked to a nearby restaurant to eat.
A 55-year-old male patient had received a first dose, intramuscular injection of Adacel, lot number not known, on 09 August 2007. Nineteen days post-vaccination, the patient developed Guillain Barre Syndrome requiring hospitalization for ten days. Past medical history, other medications, and whether there was illness at the time of vaccination were not known. Per the reporter, the patient's chart was not available, and there was no information on the patient's current condition. At the time of this report, the patient had not recovered.  9/28/07 Reviewed medical records received from pcp which consist of hospital d/c summary, H&P  & neuro consult.  Admitted 9/5-9/10/2007.  Records reveal patient experienced low back pain, tingling of LEs x 8 days.  No illness prior to s/s.  Initially thought to be radicular pain due to prior history.  Numbness progressed although pain subsided.  Seen in ER x 3 prior to admit/diagnosis.  Had difficulty walking, dysuria & mild SOB.  Seen by neuro 9/4 & dx w/GBS.  Admitted to ICU & tx w/IVIG.   FINAL DX: Guillain Barre syndrome. Linked w/290735 & 291191. 10/26/07 Reviewed hospital medical records which reveal patient experienced low back pain x 8 days w/tingling in LEs.  Seen by pcp & dx w/LBP w/radiculopathy & paresthesia.  Symptoms progressed but pain subsided.  Numbness & weakness extended from feet up to abdomen & hands.  Difficulty voiding.  Seen in ER several times & d/c to home.  Neuro consult done 9/4/07 & dx w/GBS.  Admitted to ICU for IVIG x 6.  Improved & was d/c to home to continue outpatient PT & pcp/neuro f/u. FINAL DX: Guillain Barre syndrome, uncertain etiology.
No additional AE; HBP called to report inadvertent administration of expired MMR-II; This spontaneous report has been received from an office manager, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical conditions, and concomitant therapies were not reported.  On 18-OCT-2017, the patient was inadvertently vaccinated with an expired dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, expiration date: 17-OCT-2017, administered as prophylaxis (exact dose, lot number, route of administration, and anatomical location were not provided) (Expired product administered).  No additional adverse event (AE) was reported.
Swollen spleen, blood clot in spleen,  splenal infarct.
Muscle soreness.  Fatigue.  Fever 12 hours after injection.  Highest temp 101.0  by 8:00 pm Saturday, 2/13.    Fever broke midnight on 2/14.
Date of start of drug: 06Jun2021, Dose Number: 1; Date of start of drug: 25Apr2021, Dose Number: 2; It got worse after 2nd dose of Pfizer. The stiffness is worse inthe mornings and slowly getts litter better by the evening. The pain is worse on bending.; I have developed low back pain and stiffness.; It got worse after 2nd dose of Pfizer. The stiffness is worse inthe mornings and slowly getts litter better by the evening. The pain is worse on bending.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Apr2021 (Lot number: ew0217) at the age of 39 years as dose 2, single and administration date 06Jun2021 (Lot number: ew0171) 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: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Date of start of drug: 06Jun2021, Dose Number: 1; Date of start of drug: 25Apr2021, Dose Number: 2"; MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious) all with onset May2021, outcome "not recovered" and all described as "It got worse after 2nd dose of Pfizer. The stiffness is worse inthe mornings and slowly getts litter better by the evening. The pain is worse on bending."; BACK PAIN (non-serious) with onset May2021, outcome "not recovered", described as "I have developed low back pain and stiffness.". Therapeutic measures were not taken as a result of musculoskeletal stiffness, back pain, pain.  Additional information:  No other vaccine in four weeks. No other medications in two weeks. covid prior vaccination used. No covid tested post vaccination. No allergies and other medical history  Follow-up attempts are completed. No further information is expected.
Information has been received from a consumer concerning his approximately 2 year old daughter who in approximately 1998 was vaccinated with MMR and experienced a high fever and rash. Medical attention was sought. No further information is available.
ALMOST PASSED OUT; SKIN LOOKED WHITE AND PALE; MILD PAIN IN  STOMACH; LEG HURTS; CHILLS (FEELING COLD AND SHIVERING); FEELING UNWELL; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included nose bleed, and other pre-existing medical conditions included patient had no other health condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced almost passed out. On 02-JUN-2021, the subject experienced skin looked  and pale. On 02-JUN-2021, the subject experienced mild pain in stomach. On 02-JUN-2021, the subject experienced leg hurts. On 02-JUN-2021, the subject experienced chills (feeling cold and shivering). On 02-JUN-2021, the subject experienced feeling unwell. Laboratory data (dates unspecified) included: Blood test (NR: not provided) low platelet count. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from almost passed out, had not recovered from skin looked white and pale, leg hurts, and chills (feeling cold and shivering), and the outcome of mild pain in stomach and feeling unwell was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Patient experienced covid like symptoms after receiving 1st dose; cold; face ache; Stomach ache; Next day, she started with headaches; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), FACIAL PAIN (face ache), ABDOMINAL PAIN UPPER (Stomach ache), HEADACHE (Next day, she started with headaches) and MYALGIA (body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history information was provided.  Concomitant products included TERBINAFINE for Fungal infection, ESCITALOPRAM for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced NASOPHARYNGITIS (cold), FACIAL PAIN (face ache), ABDOMINAL PAIN UPPER (Stomach ache), HEADACHE (Next day, she started with headaches), MYALGIA (body aches) and CHILLS (chills). On an unknown date, the patient experienced COVID-19 (Patient experienced covid like symptoms after receiving 1st dose). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold), FACIAL PAIN (face ache), ABDOMINAL PAIN UPPER (Stomach ache), HEADACHE (Next day, she started with headaches), MYALGIA (body aches), CHILLS (chills) and COVID-19 (Patient experienced covid like symptoms after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also include supplements.
chills  Narrative:  She relates experiencing chills, headache and nausea after the initial  injection: *Chills/nausea: started about 45 minutes after the vaccination. Chills  persisted for about 4-5x days and nausea ~4xdays. She remained afebrile during  that time and did not experience vomiting, abodminal cramping, or diarrhea. Her appetite was decreased, but she was still able to eat and drink. *Headache: started  about 45 minutes after the vaccination and persisted for ~7x days. Described as  different from past typical HA and more splitting in character. She did not obtain relief from the HA with acetaminophen. Patient otherwise denied pruritus, urticaria/hives, flushing, angioedema/swelling, confusion/disorientation, dizziness/lightheadedness, weakness, SOB/palpitations.
Mom states that pt started with a rash that she describes as hives on bilateral upper extremities, back and torso.
This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unspecified date, the patient received GARDASIL (dose, route of administration, lot# and expiration date were not reported) as the first dose in the HPV series. Seven months later, the patient recieved GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) as the second dose in the HPV series. No concomitant therapies were reported. No adverse event was reported. The outcome of the event and the relatedness between the event and the vaccines were not reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1607USA011966.
Hacking cough; Hot; I could feel the heat radiate off my forehead; Pretty good headache; Last night , fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Hacking cough), FEELING HOT (Hot), HEAD DISCOMFORT (I could feel the heat radiate off my forehead), HEADACHE (Pretty good headache) and PYREXIA (Last night , fever) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced PYREXIA (Last night , fever). On an unknown date, the patient experienced COUGH (Hacking cough), FEELING HOT (Hot), HEAD DISCOMFORT (I could feel the heat radiate off my forehead) and HEADACHE (Pretty good headache). On 11-Nov-2021, PYREXIA (Last night , fever) was resolving. At the time of the report, COUGH (Hacking cough), FEELING HOT (Hot), HEAD DISCOMFORT (I could feel the heat radiate off my forehead) and HEADACHE (Pretty good headache) outcome was unknown.     Concomitant medications were not provided.  Treatment information was not provided.
About 1-1 1/2 hours, post vax, mother was feeding the infant and his head and his left arm began to tremble. It was over quickly. Temperature was 99.1F. This has happened about 6 times since 5/2/01, usually when infant is falling asleep or waking up. Saw MD and is getting an appointment with a neurologist for further tests.
Pt seen 3 days after the injection.  Had increasing headache, backache and skin hypersensitive following the vaccination.  She also felt hot and cold.  She has had several episodes of nausea and vomiting.  She does not feel that her s/s have improved.  She has been able to eat and drink today( 9/6/19).  She was feeling poorly enough she did not go to classes today.  No visual changes, no neck pain or stiffness.  Fever99.4
Complaints of itching redness and mild swelling app. 3 inches below injection site on right arm.  Redness, swelling and itching lasted app. 72 hours.
pt recvd vax 5JUL95 & 12JUL95 pt devel a papular rash on scalp, face, & legs;pt reported daughter had one lesion on 12JUL95, 4 lesions on 14JUL95 when presented to MD & 25 lesions on 15JUL95;
Itchy Rash/Urticaria on wrist; grew over several hours.  Treatment with antihistamine.
This spontaneous report as received from a pharmacist refers to an over 60 years old female patient. In November 2013 (approximately 2 months ago) the patient was vaccinated with ZOSTAVAX (dose and route unknown). On an unknown date the patient experienced redness at the injection site. The patient was feeling better now. Causality was not reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Patient received first dose of the Pfizer COVID vaccination series.  After administration by nurse, there was concern that the injection site was away from the deltoid muscle and that a portion of the injection leaked out of the body and was present on the skin surface.  Concern for incomplete administration of the first dose of the Pfizer COVID vaccination series.
Extremely red and itchy hives that are often raised up like a mosquito bite. They often look like long scratch marks on my skin but sometimes can be large patches of red skin on my body. They move all along my body and face, including the inside of my ears and on my genitals throughout the day. They both me enough to interrupt my daily functions. No wheezing, coughing or swollen throat
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 17-JUN-2013, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # H0108796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 Since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same source. Additional information has been requested.
Pfizer Dose 1 5/11/21 (lot NA) Pfizer Dose 2 6/1/21 (lot NA) COVID Positive 1/2/22  1/2/22: A 55-year-old gentleman presented to the emergency room with complaint of progressive worsening shortness of breath for a week.  The patient reports nonproductive cough, shortness of breath worse with activities.  In the emergency room, he was noted to be desaturating to 86% on room air and currently is on 3 L of oxygen via nasal cannula.  The patient has tested positive for COVID, although he was vaccinated and completed 2 vaccines for COVID but not yet boosted.  1/15/22: This patient with obstructive sleep apnea on BiPAP at night, was tested positive for COVID 19 on 01/02, then admitted to the hospital for hypoxemia pulse ox 86%.  He initially required only 3 L of oxygen, but this became progressively worse, pulmonary was consulted and the patient did not require intubation.  He did receive IV dexamethasone and Baricitinib.  He has been improving the past few days and his recent oxygen walk was doing well on 3.5 L at rest and 8 L with activity.  He will go home with his BiPAP and home oxygen.  The dexamethasone will be tapered over next 10 days.  He is finished with his antibiotics and antiviral medications.
The pt experienced an area of redness and induration at the site which was 4 x 3 inches in size and has increased approximately 1 inch on all sides. The pt was advised to apply ice and contact PMD if symptoms worsen.
Redness and pain at site of injection. Redness about 4 inches diameter. Pt took Benadryl. Results unknown as of now.
Vaccine administered 2 days after beyond use date; Vaccine administered 2 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date) and PRODUCT STORAGE ERROR (Vaccine administered 2 days after beyond use date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination.     Patient had been never diagnosed or tested positive for Covid-19. Non acute illness at the time of vaccination and upto one month before. No other vaccines given on the same day as moderna covid-19 vaccine. No other vaccines received within one month prior to any dose of moderna covid-19 vaccine.  Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and AZELASTINE for Asthma.    On 28-Jun-2022 at 8:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Jun-2022 at 8:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered 2 days after beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date) and PRODUCT STORAGE ERROR (Vaccine administered 2 days after beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patients had reported no side effects. Number of doses or vails were reported as 7. The vial was initially stored in the refrigerator on 26-May-2022. The vial did not undergo any temperature excursion. Treatment details were not reported by the reporter.
7/23/09 father called H.D. stating "poisoning type" rash noted on child's thigh in approximate area where a vaccine was given - right thigh. Suspect VARIVAX. 7/26/09 rash resolved without any treatment.