chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has an immediate hypersensitive reaction to Hemagglutinin reaction from the  Pfizer Covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (medically significant), outcome "unknown", described as "Patient has an immediate hypersensitive reaction to Hemagglutinin reaction from the  Pfizer Covid-19 Vaccine".  Clinical course: The reporter stated that he was just calling to ask more information or if we have literature that they can find all the this specifically, so basically they said that they are saying that the patient had an immediate hypersensitive reaction to Hemagglutinin reaction from the Pfizer Covid-19 Vaccine and again they are just finding a literature that can find on this specifically, so there Doctor said many hypersensitivity reaction include Nano (further not clarified) components of the current (Pfizer) Covid-19 Vaccine and he mentioned that he don't believe that there was hemagglutinin on the Covid-19 Vaccine, so basically he just want to getting some information or if you have literature that can prove that.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Headache, Palpitations, Tachycardia, numbness/tingling bil feet, chills, night sweats Narrative:
np reaction did not report receiving 1st dose outside of pharmacy in job training and got 2 shots for a total of 3
I received the rash within 3-4 hours of receiving the vaccine and a gold ball size bump.  On day 8 I was on my way home and I was on my way home and I reached behind me and had a sharp, needle like sensation, pain like when I first got the shot, my arm was on fire and itching. I got home and examined the spot and it was also peeling of the skin and hot  to the touch. I ended up going to an urgent care where I was put on antibiotics for cellulitis and prednisone for possible allergic reaction. I was told to come back in after 24-48 if I still had the symptoms. I will note that I am not 100% sure if the initial rash ever went away or if I have had the rash for   8 days.
first Engerix-B in 2019, second in January of 2022.; second and last in January of 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for an unknown indication and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix-B (received 1st dose on an unknown date in 2019).   In January 2022, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. In January 2022, not applicable after receiving Engerix B and unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long and drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient did not gave permission to use her date of birth (DOB) in the report, but did confirm she was well over 21 years old. The patient received her first Engerix-B vaccine in 2019 and received the second and last dose in January of 2022.  The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule The patient also received 3rd dose of Engerix-B within a month after 2nd dose, earlier than recommended interval, which led to shortening of vaccination schedule The patient was not sure if she should restart the series or take a titer.  The patient's health care professional (HCP) would call medical information(MI). The patient did not gave permission to contact HCP, but GlaxoSmithKline could contact patient by email provided. The reporter did not consent to follow-up.
The evening on the day of my vaccination, I started having fever 101 F, chills and myalgia. This happened after the 1st dose of the vaccine. Fever lasted 3 days (up until 1/2/2021) at noon and was ranging between 100.9 and 101. Fever responded well to Advil.
Colon stenosis; Unspecified disorder of intestine; Post-procedural pain; Surgical scar; Laceration; Wound healing delayed; Bruise; Nighmare; Chills; Muscle aches; Fever; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LARGE INTESTINAL STENOSIS (Colon stenosis) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (Colon stenosis) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), PROCEDURAL PAIN (Post-procedural pain), SCAR (Surgical scar), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (Bruise), NIGHTMARE (Nighmare), CHILLS (Chills), MYALGIA (Muscle aches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, LARGE INTESTINAL STENOSIS (Colon stenosis), GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), PROCEDURAL PAIN (Post-procedural pain), SCAR (Surgical scar), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed) and CONTUSION (Bruise) had not resolved and NIGHTMARE (Nighmare), CHILLS (Chills), MYALGIA (Muscle aches), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment information were reported.   Action taken with the drug in response to events was not applicable.  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fatigue, chills, pyrexia, and myalgia.   This case was linked to (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fatigue, chills, pyrexia, and myalgia.
I had extreme muscle and joint pain, it continued until I couldn't move. Turned into bursitis in left hip.
PATIENT WAS ANXIOUS ABOUT GETTING SHOT  SHOT WAS FINISHED. PATIENT WAS TALKING. A COUPLE OF MINUTES LATER THE PATIENT SAID SHE FELT LIGHT HEADED AND SHE TURNED WHITE. SHE PASSED OUT. SHE STARTED JERKING IN A SEIZURE TYPE MOVEMENT.  (PHARMACIST) OPENED SMELLING SALTS AND SHE RESPONDED AND CAME TO.   CALLED 911. PARAMEDICS ARRIVED AND STABILIZED THE PATIENT. PATIENT HAS LOW BLOOD SUGAR. BLOOD PRESSURE SUPINE WAS NORMAL. WHEN THE PATIENT LEFT HER BLOOD PRESSURE WAS 147/90.  PATIENT STAYED IN THE PHARMACY FOR AN ADDITIONAL 20-30 MINUTES RECOVERING AFTER THE PARAMEDICS LEFT.
Patient presented to the ED and was subsequently hospitalized for pneumothorax and respiratory failure within 6 weeks of receiving COVID vaccination.
Pt was admitted to Meritus for pyelonephritis on 6/23 after receiving first dose of Pfizer vaccine on 6/9. Per guidelines, all hospitalizations are reported.
10 days after shot patient developed a rash that itched and swelled. It was red.
Itchy throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: THROAT IRRITATION (non-serious) with onset 28Mar2023, outcome "unknown", described as "Itchy throat". Additional information: Reporter was calling in reference to reporter's daughter. The daughter got a vaccination shot booster shot, and she stayed there for the 15 minutes like they ask she to, but she came home and she was saying she have itchy throat is that a side effect from it. The daughter had a booster and she waited 15 minutes like they are supposed to.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe body aches and fatigue as of 72 hours post injection. Having to continually take ibuprofen and It does not take all the ache away.   Injection site pain has rendered my left arm unable to lift.; Severe body aches and fatigue as of 72 hours post injection. Having to continually take ibuprofen and It does not take all the ache away.   Injection site pain has rendered my left arm unable to lift.; Severe body aches and fatigue as of 72 hours post injection. Having to continually take ibuprofen and It does not take all the ache away.   Injection site pain has rendered my left arm unable to lift.; Severe body aches and fatigue as of 72 hours post injection. Having to continually take ibuprofen and It does not take all the ache away.   Injection site pain has rendered my left arm unable to lift.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 39-year-old female patient received first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 26Jul2021 at 01:00 PM (age at vaccination: 39 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included seizure and allergic to Bactrim. Concomitant medication included levetiracetam (KEPPRA). The patient was diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not received any other vaccine in four weeks. On 26Jul2021, the patient experienced severe body aches and fatigue as of 72 hours post injection. Having to continually take ibuprofen and It does not take all the ache away. Injection site pain has rendered my left arm unable to lift. The patient underwent lab test and procedure included covid-19 with positive result on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.
No adverse event; Dose 3 was administered on 05-Mar-2022 and Dose 4 was administered on 03-Jul-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 3 was administered on 05-Mar-2022 and Dose 4 was administered on 03-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 026L21B, 050E214 and 088D21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 3 was administered on 05-Mar-2022 and Dose 4 was administered on 03-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 3 was administered on 05-Mar-2022 and Dose 4 was administered on 03-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant drugs were not reported. No additional medications or treatments.   This case was linked to MOD-2022-661803 (Patient Link).
new muscle pain and increased old pain. neck pain. flu-like systems. fever chills, tired for two days.
THE PATIENT RECEIVED THE FLU SHOT AND APPROXIMATELY 10 MINUTES AFTER RECEIVING THE VACCINE HE BEGAN TO FEEL LIGHTHEADED. THE PATIENT STATED HE FELT DIZZY AND BEGAN TO LOOK PALE. HE WAS BROUGHT A WHEELCHAIR TO SIT IN AND AN AMBULANCE WAS CALLED. WHEN THE AMBULANCE CAME AND CHECKED HIS BLOOD PRESSURE, IT WAS 80/50. OXYGEN SATURATION WAS AT 100%. HE WAS FEELING BETTER BEFORE THE AMBULANCE TOOK HIM AWAY.
Information has been received from a healthcare worker concerning a 13-month-old female who about one month ago, on approximately 28-JUN-2006, was vaccinated with a dose of Varivax. Secondary suspect vaccination given on the same day included a dose of MMR. About one month ago, on approximately 28-JUN-2006, the patient experienced erythema and rash at the injection site. Unspecified medical attention was sought. It was reported that the patient was recovering. No product quality complaint was involved. Additional information has been requested.
8cm area erythema, blanchable-no diff breathing, no pruritus, no pain;
Patient presented today with pain/soreness in her left arm claiming it has been sore and hard to use since receiving an PREVNAR and a FLUZONE HIGH DOSE shots on 12/29/17. She stopped in to ask if this was normal, since it is almost 4 weeks out she was informed that it is usually not still sore this far from the immunization date. She also claimed it had a "bump" on her arm. She claims she has had flu shots before so it would not be from the flu shot, and assumed it was from the PREVNAR. She has not gone to the dr as she has no insurance. Patient said she may have to be seen by a doctor since soreness from the immunizations is not "typical" for this length of time.
Daughter passed out completed immediately when shot was administered; fell to floor; hit head; had to be brought to emergency room; diagnosed as a concussion.
In addition to the normal side effects that lasted for several days for me, I also had significant increase in hair loss that began in the days after the vaccine and has continued to the present day (almost 5 weeks post injection); increased fatigue; joint pain and the feeling of swelling in joints and in particular hands and feet.  This was a problem in the past with lupus but has not been an issue for many years and it just started again after the vaccine.  I have not received the second injection yet due to these lingering symptoms
shivering and shaking; Trembling uncontrollably; Glucose at 154; Oxygen at 94%; Temperature 97.6; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Trembling uncontrollably), BLOOD GLUCOSE INCREASED (Glucose at 154), OXYGEN SATURATION DECREASED (Oxygen at 94%), BODY TEMPERATURE (Temperature 97.6) and CHILLS (shivering and shaking) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017BZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetic. Concomitant products included INSULIN for an unknown indication.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced TREMOR (Trembling uncontrollably), BLOOD GLUCOSE INCREASED (Glucose at 154), OXYGEN SATURATION DECREASED (Oxygen at 94%) and BODY TEMPERATURE (Temperature 97.6). On an unknown date, the patient experienced CHILLS (shivering and shaking). At the time of the report, TREMOR (Trembling uncontrollably), BLOOD GLUCOSE INCREASED (Glucose at 154), OXYGEN SATURATION DECREASED (Oxygen at 94%), BODY TEMPERATURE (Temperature 97.6) and CHILLS (shivering and shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood glucose: 154 (Inconclusive) 154. On 25-Mar-2021, Body temperature: 97.6 degrees fahrenheit (Inconclusive) 97.6 degrees Fahrenheit. On 25-Mar-2021, Oxygen saturation: 94% (Inconclusive) 94%.         Concomitant product use was provided by the reporter Oral medication for Diabetes and Hypertension. Treatment information was not provided.
pt had very tender erthematous, hot area - 8 cm over inject site. does not remember date of previous td
Tired; The initial case was missing the following minimum criteria: identifiable Event. Upon receipt of follow-up information on 4Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 87-years-old female patient (Age at Time of Vaccination in 87Years) received bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0175, Expiration date: unknown)), dose 1 via an unspecified route of administration, administered in Arm Left as 1st dose, single dose for covid-19 immunisation in a church. Medical history included ongoing hypertension (diagnosed with high blood pressure 10 years ago or something like that), ongoing anxiety (diagnosed with anxiety about 2 years ago as she had to be in isolation for 2 weeks and that her problem with anxiety began afterwards), ongoing atrial fibrillation, hip surgery few years ago. Adverse event following prior vaccinations includes sort of bothered her face after Flu shot reported that the event occurred 40-50 years ago and she never got another flu shot. No prior vaccinations within 4 weeks. Concomitant medication included warfarin (WARFARIN) taken for atrial fibrillation (3 mg of Warfarin daily Tuesday, Thursday, Saturday, Sunday, and 1.5 mg daily on Monday, Wednesday, Friday, she has been taking Warfarin for at least 6 years), olmesartan medoxomil (BENICAR) taken for blood pressure abnormal (taking for about 3 years); nebivolol hydrochloride (BYSTOLIC) taken for blood pressure abnormal (taking for about 3 years); diltiazem hydrochloride (DILTIAZEM CD) taken for blood pressure abnormal (taking for about 3 years); clonazepam (CLONAZEPAM) taking for about 2 years. The patient began feeling tired about 4-5 days (In May2021) after she received her first dose of the Covid-19 vaccine. No Emergency Room or Physician Office visit required. Tiredness lasted for 3-4 days and then she was fine. Did not performed any relevant Tests. Caller declined to provide her email address, her physicians information. The outcome of the event was recovered.
Approximately 1 week later, the patient reported a raised red area around where she thought she had the vaccination. She reported a mild redness the day after the shot that resolved, then a more severe reaction occurred a week later.
A physician reported, via a company representative, that a 4 year old male received Prevnar vaccine and subsequently developed persistent crying, that evening, for 2 hours. He also was requesting medication because he did not feel right. His behavior was noted to be unusual. The child recovered. No additional information was available as of the date of this report.
10/7/03 received Varicella and MMR. 10/9/03 104 temp. Febrile seizure, to ER, though may be a virus. 10/15/03: rash on trunk, T 99 with children's Tylenol.
This case was reported by a physician via call center representative and described the occurrence of intussusception in a 3-month-old female patient who received ROTARIX (batch number A41CB508A, expiry date 4th February 2017). On 20th October 2015, the patient received the 1st dose of ROTARIX (oral). On 6th December 2015, 47 days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant). The patient was treated with Enema (Nos). On an unknown date, the outcome of the intussusception was recovered/resolved. It was unknown if the reporter considered the intussusception to be related to ROTARIX. Additional details were received as follows: On 6th December 2015, the patient was hospitalized for intussusception and was treated with an air enema. On 8th December 2015, the patient recovered and was discharged. On 10th December 2015, the patient received 2nd dose of ROTARIX (batch number A41CB524A, expiry date 13th February 2017) and the symptoms which occurred after the 1st dose, did not return.
Received the vaccine at 9:30 am and experienced symptoms around 2 pm. Experienced rapid heartbeat, shakiness, and numbness throughout the entire body which is NOT normal for me. Lasted 10-15 minutes and subsided. Did not eat or drink anything different that day. Had lunch around noon. I was at work when this happened. I went to my boss's office to have her check my pulse as I was too shaky to do so. By the time I got there, the episode started to subside.
17 years old patient received the moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient received the moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient received the moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient received the moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.                   No treatment medication was reported.
Pt recvd DTP/OPV 25Mar91 @ 10am,Approx 30 hrs later developed T of 101-102(R).Approx 40 hrs /p vaxs pt T peaked @ 105(R)/w shaking for few mins.T came down /w APAP&sponge bath.T was 101-102 X few days.Cried inconsolably"for days"vomited X2