chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with Acute Myloid Leukemia on 06May2022. Blood work in Nov2021 was normal. AML symptoms started in Mar2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FH8927) at the age of 60 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE; Lot Number: EW0153, Vaccine location: Right arm), administration date: 16Apr2021, when the patient was 59-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, 0.3 ML SINGLE; Lot Number: EW0173, Vaccine location: Right arm), administration date: 07May2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: ACUTE MYELOID LEUKAEMIA (hospitalization, medically significant, life threatening) with onset 01Mar2022, outcome "recovered with sequelae", described as "Diagnosed with Acute Myloid Leukemia on 06May2022. Blood work in Nov2021 was normal. AML symptoms started in Mar2022.". The patient was hospitalized for acute myeloid leukaemia (hospitalization duration: 30 day(s)). The patient underwent the following laboratory tests and procedures: Blood work: (Nov2021) Normal, notes: Blood work in Nov2021 was normal. Therapeutic measures were taken as a result of acute myeloid leukaemia.  Clinical course: Patient had no other vaccine in four weeks. No covid prior vaccination and covid not tested post vaccination. Patient had no known allergies. Facility type vaccine administered was Other. Diagnosed with Acute Myloid Leukemia on 06May2022. AML symptoms started in Mar2022, Treatment with Chemotherapy.
This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Body was heavy (After the Second Shot)), FEELING ABNORMAL (Felt out of it (After the Second Shot)), FEELING DRUNK (Felt like Drunk (After the Second Shot)), ASTHENIA (Felt Weakness Coming (After the Second Shot)) and GAIT DISTURBANCE (Trouble Walking (After the Second Shot)) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DISCOMFORT (Body was heavy (After the Second Shot)), FEELING ABNORMAL (Felt out of it (After the Second Shot)), FEELING DRUNK (Felt like Drunk (After the Second Shot)), ASTHENIA (Felt Weakness Coming (After the Second Shot)), GAIT DISTURBANCE (Trouble Walking (After the Second Shot)), HYPOAESTHESIA ORAL (Numbness in the Mouth and Lip (After the Second Shot)), HEART RATE INCREASED (Elevated Heart Rate (After the Second Shot)) and ANXIETY (Anxiety Attack per MD). At the time of the report, DISCOMFORT (Body was heavy (After the Second Shot)), FEELING ABNORMAL (Felt out of it (After the Second Shot)), FEELING DRUNK (Felt like Drunk (After the Second Shot)), ASTHENIA (Felt Weakness Coming (After the Second Shot)), GAIT DISTURBANCE (Trouble Walking (After the Second Shot)), HYPOAESTHESIA ORAL (Numbness in the Mouth and Lip (After the Second Shot)), HEART RATE INCREASED (Elevated Heart Rate (After the Second Shot)) and ANXIETY (Anxiety Attack per MD) outcome was unknown.            This case was linked to MOD-2021-071289 (E2B Linked Report).; Sender's Comments:  MOD-2021-071289:First Dose
pt recvd MMR vax 16NOV92 & exp flu-like sx; 24NOV92 pt devel swelling in rt inguinal lymph nodes one of which was 2-3cm & tender & induration @ inject site of 5x3 cm,fever, chills & skin erythema of 2-3cm; lab eval revealed inc WBC;
Pain and impaired range of motion in left shoulder. Advised patient to use Advil or Aleve for pain management. Advised patient to seek medical attention if symptoms worsen or do not improve by tomorrow morning.
Crohn's disease flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4309603-00.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Daily dose: 1) First Dose (1 in 1 Once), Route of administration : Intramuscular), administration date: 02Nov2020, when the patient was 30-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 2, SINGLE, Daily dose: 2)Second Dose (1 in 1 Once), Route of administration : Intramuscular), administration date: 20Dec2020, when the patient was 30-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's disease flare up". The action taken for adalimumab was unknown.  Clinical Information: In 2021, the patient experienced COVID. Causality as per reporter (Humira): The reporter's causality for the event Crohn's Disease Flare up was not provided. Causality as per reporter (BNT162B2): The reporter's causality for the event Crohn's Disease Flare up was Not Reported.  The reporter's assessment of the causal relationship of "Crohn's disease flare up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and the event crohn's disease cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Temp 101 - 102 after vaccine, chills, usually hyperactive, but sleepy exhibiting malaise. Father administered 200 mg liquid gel MOTRIN. Hx of increased fever prior to vaccines listed below. Stayed home for one week during last week of September. Second call from father reporting child continuation with fever often as high as 103. Does come down with MOTRIN gel - not eating, congestion extreme coughing- sore stomach due to coughing.
Super tired; Kind of dizzy, had dizzy spells ringing in my ears; There is still ringing in my ear so it makes you kind of nauseous; There is still ringing in my ear so it makes you kind of nauseous; I am off balance; Headache; I still don't feel right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EP7534) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Unspecified allergies" (unspecified if ongoing); "Feel like there was fluid or something in my ear" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity, ear discomfort (ongoing). The following information was reported: MALAISE (non-serious) with onset 19Mar2021, outcome "unknown", described as "I still don't feel right"; FATIGUE (non-serious) with onset 20Mar2021, outcome "recovering", described as "Super tired"; DIZZINESS (non-serious) with onset 20Mar2021, outcome "not recovered", described as "Kind of dizzy, had dizzy spells ringing in my ears"; TINNITUS (non-serious), NAUSEA (non-serious) all with onset 20Mar2021, outcome "recovering" and all described as "There is still ringing in my ear so it makes you kind of nauseous"; BALANCE DISORDER (non-serious) with onset 20Mar2021, outcome "unknown", described as "I am off balance"; HEADACHE (non-serious) with onset 20Mar2021, outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient went to a chiropractor hoping that will help a bit for the dizziness part and it did help a little. The patient took TYLENOL for headache.   No follow-up attempts are possible. No further information is expected.
muscle ache, body chills, no fever, stuffy nose, sinus headaches, coughing, fatigue, skin rash
pt recv vax; has large red area to lt thigh about size of orange; area sl swollen; no hard place to area;
Patient seen in office for well child check, normal healthy child with viral symptoms. Immunizations performed, child tolerated well. Following morning found deceased.
Information has been received from a physician and a woman in the physician's office concerning a 10 yr old black male student who on 03Mar97, at 18 months of age, was vaccinated SC with the first 0.5mL dose of varicella virus vaccine live (lot617913/0778D). Concomitant vaccinations on that same day included an IM fourth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lot438-064). Illness at the time of vaccination included respiratory allergies. Other comcomitant therapy included chlorpheniramine maleate (+) phenylephrine HC1 (+) phenylpropanolamine HC1 (+) phenyltoloxamine citrate (Naldecon Pediatric Syrup). The physician reported that on 13Sep05, the pt developed breakthrough chickenpox. It was noted that by 14Sep05, the pt had multiple box described as alot of small bumps. In Sept 2005, the pt recovered from breakthrough chickenpox. No further information is available.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. Upon information and belief, a physician recommended the ZOSTAVAX to the patient for the intended purpose of the long-term prevention of shingles and zoster-related injuries. On or about 17-SEP-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or approximately 24-JUL-2016, the patient was treated for his zoster-related symptoms. In or around July 2016 and August 2016, the patient was treated by two physicians for shingles and zoster-related injuries. The outcome of the events is unknown. The patient suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
The patient's wife came in on 10/24/18 and reported that her husband was experiencing neck pain that he felt may be related to the flu vaccine he received on 10/21/18. I spoke with the patient and he stated that after he received the vaccine, his shoulder was hurting, which he said he knew could happen with a flu shot. He said that shortly after, he had pain in his neck that spread to his shoulders and back. When I spoke to the patient on 10/24/18, he said he continues to have pain and body aches and that the tendons in the front of his neck are sore to the touch.
Mop states that child received varicella vaccine on the 24th of march 2014, and at first it was ok, but yesterday the spot started to look like it was swelling, and turned red. Child does not appear to be bothered, by the spot, and does not poke at it or scratch at it.  No fevers. Brother with cellulitis of his arm after this vaccination requiring recent hospitalization for IV antibiotics
Left deltoid red and swollen (mild redness to deltoid) TX Augmentin 400mg BID x 10 Days.
Strong Metallic taste in mouth immediately after injection. Fatigue, muscle aches, headache, low grade fever.
After receiving the vaccine patient was taken to the waiting area where he sat down.  a few minutes later the technician reported that he needed help.  The patient had fainted but came to by the time we made it out to check on him.  He reported that he had not eaten that day at all, and he was provided with water with electrolytes.  he reported that he was feeling fine and was released to his own care with instructions to contact medical provider if not feeling better or anything worsens.
nausea, dizzy, faint, BP 90/50, 100/70 cold rag applied to forehead & back of neck, sitting head low, monitored BP, offered fluids-juice; left work;
Pneumomediastinum diagnosed by x-ray after shortness of breath and chest tightness
Patient was given a Pfizer monovalent vaccine instead of the Bivalent Pfizer vaccine. Patient reports no problems or issues at this time.
Pain in injection site, headache, fatigue, body aches, chills, nausea, and fever.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history included completed serie of GARDASIL approximately in 2014 (reported as "two years ago", it was unknown if the series previously administered was GARDASIL quadrivalent or GARDASIL 9). Drugs reactions/allergies and concomitant medication were not reported. On 22-NOV-2016, the patient was vaccinated with dose number 4 of GARDASIL 9 lot # M023169 with expiration date: 13-JUN-2018 (route and dosage were not reported) for prophylaxis. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Pt exp dizziness/lightheadedness, flushing, general malaise, nausea following vax; Given APAP & DPH; supine several hrs; f/u ER if not better 2-3 hrs;
Patient to ED 9/4 for altered mental status. Patient has cough noted, febrile 102.9. COVID+ 9/5, RX remdesivir for 3 days. 9/7 patient left without finishing remdesivir course.
: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and fatigue following the vaccination. Those symptoms lasted a few days and resolved. On 1/17 she noticed a sore area under her left arm. she has a small firm painful lymph node under the left arm. She also noticed that she has a slight " fullness" in the neck area. She feels like her thyroid gland is more pronounced. than it was prior to the vaccine. She denies any dysphagia or odynophagia. No SOB or tachypnea. No fever or chills. No hx of thyroid dysfunction.
Breakthrough case admission after 3 vaccines Pfizer 2/17/1 Lot# EL9267;  Pfizer 3/6/21 Lot# EN6202;  Pfizer 11/30/21 Lot# FH8027
This spontaneous report has been received from a registered nurse referring to a 2 year old patient of unknown gender with no concurrent condition or medical history reported. On 15-DEC-2015, the patient was vaccinated with a dose of PROQUAD (Merck) (subcutaneous injection, lot # I011080) and VARIVAX (Merck) (subcutaneous injection, lot# I002868) (overdose). No concomitant therapy was reported. The nurse did not have access to the expiration dates of the doses at the time of the call. The patient had not experienced an adverse effect. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II  lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
From initial information received on 30Jul03 from manufacturer, by a registered nurse, regarding an adverse event occurring in the US, it was reported that a 42 year old female pt received, on an unspecified date, a dose of Tetanus Toxoid (manufacturer Aventis Pasteur, lot number and route/site were not reported), MMR II vaccine, manufacturer, lot number and route/site were not reported and second dose of Twinrix, manufacturer, lot number not reported, given in the right deltoid. On the same unspecified date, the pt experienced chest tightness, aches all over her body and fatigue. Along with developing a rash on the arm where the MMR was injected. Reportedly, the pt has an allergy to yeast. The events resolved after seven days. From additional information received on 06Oct03, no record was kept for this event per the reporter. No further information is anticipated, this case is considered closed.
There was no adverse reaction by the patient and he has not contacted the clinic regarding any reactions, post-vaccination. He left the clinic in stable condition. The discovery of the incorrect route was made by the immunization program, after reading my nursing notes, where I charted that Jynneos 0.5mL was administered intradermally instate of subcutaneously. If the dose was 0.1mL, then it would have been given intradermally.
Miscarriage / pregnancy loss; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report.  A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 30-years-old), administered in Arm Left on 23Apr2021 10:00 (Lot Number: ER8735) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included Nature Made Pre-Natal Vitamin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:00 (Lot Number: EL9263) as 1st dose, single for COVID-19 immunization. Confirmed pregnancy on 22Apr2021 at OBGYN via blood test, urine test, and ultrasound. Pfizer 2nd dose COVID vaccine administered on 23Apr2021. Began miscarriage on 28Apr2021. On 28Apr2021, OGBYN medical professionals detected NO GROWTH since 22Apr2021 ultrasound. Identical imagining in size. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient experienced miscarriage / pregnancy loss on 28Apr2021 15:30.No treatment received for the event. The mother reported she became pregnant while taking bnt162b2. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 20Dec2021. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovering. The event was considered as serious (disability, congenital anomaly).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021497434 fetal case
pt recv vax & 20min p/vax devel pain & numbness in rt arm;
PT STARTED XOLAIR OVER A YEAR AGO & STARTED WORKING WELL FOR HER W/IN 2 DOSES & WAS CONTROLLING HIVES UNTIL ABOUT NOV/DEC 2020. AT THAT TIME SHE STARTED NOTICING VERY MINIMAL HIVES COMING BACK. PT RECEIVED 1ST PFIZER COVID VACCINE ON 3/11. NO CHANGES TO HIVES, STILL MINIMIAL. RECEIVED 2ND DOSE OF VACCINE ON 4/1. THAT DAY/EVENING SHE HAD ARM PAIN & FATIGUE (EXPECTED OF VACCINE). SHE WOKE UP OVERNIGHT W/ SEVERE ITCHING. FRIDAY AM HIVEALL ALL OVER BODY & SEVERE ITCHING. SAT/SUN THE HIVES STARTED RAISING & STILL ITCHING. MONDAY THE SX WERE SO SEVERE SHE WAS NAUSEOUS. MD STARTED HER ON TOPICAL CORTISONE & 5 DIFFERENT ANTIHISTAMINES. CORTISONE HELPS FOR ABOUT 15 MINUTES & ANTI-HISTAMINES DON'T SEE TO RESOLVE ITCHING. PATIENT IS TO FOLLOW-UP WITH MD FOR TREATMENT OF HIVES & POTENTIAL OF COVID VACCINE CAUSING SUCH AN IMMUNE RESPONSE THAT IT OVERWHELMED THE XOLAIR'S EFFECTS AND CAUSED THE HIVES TO OUTBREAK SEVERELY.
Patient was given an expired Moderna dose that expired 10/12/2021 Patient has not had any symptoms to our knowledge
Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced swollen arms. The patient would not be finishing the series. The patient had made phone calls for medical attention. The outcome of the patient's swollen arms was not reported. Additional information has been requested. This is one of several reports received from the same source.
rash all over her body; hives on the upper torso of her body; This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On 28th August 2019, the patient received the 1st dose of Shingrix. On 29th August 2019, 1 days after receiving Shingrix, the patient experienced generalized rash and hives. On an unknown date, the outcome of the generalized rash and hives were resolved with sequelae.   It was unknown if the reporter considered the generalized rash and hives to be related to Shingrix.  Additional details were received as follows: Approximately 24 hours after receiving Shingrix, the patient experienced rash all over her body, with hives on the upper torso of her body. The reporter consented to follow up.
*No serious adverse reactions - patient remained healthy.  Exactly one week after receiving first COVID vaccine shot (Moderna) - patient (3yr) developed redness / slightly swollen marks at the injection site. The rash grew quickly to form one large area around the injection site. She commented early during onset that the area was itchy and tender, but it wasn't painful. The large, slightly swollen, red rash remained for about 24 hours and then began to dissipate and slowly loose redness until completely going away. Based on comparison images online - it seems to match "covid arm" or "modern arm" similar to the reactions had by other adult modern vaccine recipients.