chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre Syndrome; Malaise; Flu syndrome; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th January 2019, 1 days after receiving Shingrix, the patient experienced malaise and flu syndrome. On 11th January 2019, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome, malaise and flu syndrome were unknown.   It was unknown if the reporter considered the guillain barre syndrome, malaise and flu syndrome to be related to Shingrix.  Initial information received via legal complaint on 27 May 2021.The patient received 1st dose of Shingrix on 7 January 2019. The patient experienced malaise and flue syndrome on 8 January 2019 and guillain barre syndrome on 11 January 2019.
This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown age and unknown gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, starting on or after 01-SEP-2015, the unspecified patients were vaccinated with improperly stored doses of GARDASIL 9, Lot # L018499, expiration date 16-JUN-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received the SHINGRIX subcutaneously, which led to incorrect route of vaccine administration. No specific details were provided. For tolerance after 2nd dose refer case US2019GSK059447.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 31 year old female subject who was vaccinated with Hepatitis B virus vaccine (manufacturer unspecified). On unspecified dates, the subject received two series of Hepatitis B virus vaccine (unknown) and experienced not responding to therapy. The nurse reported that a subject had previously completed the Hepatitis B series twice. The subject still had not converted to show immunity.
Covid Arm: very itchy and a little red at injection site, 7 days after injection.  Before this, 48 hours after injection everything was normal until this, the 7th day.
Pt reports fatigue and wheezing beginning four hours post vaccination. Pt describes wheezing as "daily cyclical" Pt states fatigue lasted up to two weeks. Pt states wheezing lasted up to one week.
Patient had syncope symptoms and gave ice pack and asked him to put his head between his legs to help with the dizziness, took BP and was normal and found out he was pre-diabetic so I gave a coke in case it was low sugar, he felt better 30-45 mins post-vaccine and returned to work, he came back after 5 minutes feeling cold and spinning, so we called EMS and asked him to lay down with feet elevated and covered him to try to keep him warm. EMS arrived and conversed with patient, took vitals, and recommended him to go home and rest as he was finally feeling better; overall, it took roughly 3 hours for symptoms to completely fade.
This case was reported by a healthcare professional via a sales representative and described the occurrence of unspecified adverse event in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown) from lot number AFLL032AA. The sales representative reported the lot number to be AFL1A032AA but reported that he was unsure if the fourth character was a 1 or L. At an unspecified time after vaccination with FLULAVAL, the subject experienced unspecified adverse event and pharmaceutical product complaint. At the time of reporting the outcome of the event unspecified adverse event was unspecified. Per the source document it was reported that the nurse questioned if "there were any hot lots." The nurse reported that this event occurred in two other subjects. See GSK manufacturer case number A0705222A and A0705244A for details.
I had had my period when I got my first shot, around 2/27/21.  I thought it was weird when two weeks later, I started to get "another" period, when I'm on birth control and my period is always normal.  It started early in the morning on 3/9/21 which was my birthday.  I started having such horrific cramps, that they felt worse than contractions.  Eventually, I was losing so much blood, that I was worried if I stood up from the toilet, that I would pass out.  I waited until my Dad came home around 4 p.m., and had him drive me to the emergency room.  I was in horrific pain, losing a lot of blood, etc.  Eventually, I went to the bathroom, and passed what was a fist size piece of tissue.  It looked almost like a clear/bluish flesh, the size of an old rubber coin purse, with a thick and malleable consistency.  The doctor at the emergency room never did an ultrasound, vaginal exam, etc., but said that I had a "dysfunctional uterus".  This had never happened to me before, and I had never passed this type of tissue.  The fact that it happened exactly 2 weeks after getting my first shot was weird.  Then, 2 weeks after my 2nd shot, it happened again.  The same thing.  I had a period that I was not expecting, and ended up passing a fist size piece of tissue.  I had contractions all day, almost passed out from the pain, until that was passed.  I'm not sure what is going on, but it definitely seems related.
Large red and swollen area, painful surrounding injection site, approximately two inches in diameter- upped thigh.
Fever of 101.1, chills and body aches. Took 2 doses of 800 mg ibuprofen over period of 6 hours, symptoms went away within 24 hours
Shortly after receiving his influenza vaccination pt reported that his right ankle and foot felt like they were asleep, at the time he was driving. Once he got to where he was going, he went for a walk to see if that would help, it did not. He came back to the vaccination clinic. His gait was off and he was dragging his right foot. Denied injury or previous history. Pt had difficulty raising his right foot and complained of decreased sensation to his right ankle. Otherwise, assessment was unremarkable. Due to the acute onset, pt was sent to the ED via ambulance.
Patient was admitted for myocarditis on 8/29/21 with diffuse ST changes on EKG and elevated inflammatory markers. It is unclear if this event was related to vaccination as it was several months removed from the second shot it the series. there was significant heart dysfunction on echo with EF of 38%. Heart function quickly recovered to normal EF of 63% 3 days later after having support with milrinone and enalapril. Patient also received IVIG. the quick improvement of function fits more with vaccine related myocarditis as opposed to viral myocarditis. Infectious workup negative to date. Possible viral trigger with symptoms of headache and body aches for 3 days before presentation. Unclear at this time whether vaccine related or from an unknown viral etiology.
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates in JULY 2016 (reported as "starting on or after 11-JUL-2016"), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date 28-SEP-2017; lot # M019706, expiration date 24-OCT-2017, dose not reported) orally. The vaccine was improperly stored in 49.1 degree Fahrenheit for 1 hour 15 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. Additional information has been requested.
Itching; Redness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Redness on the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Redness on the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) (topical) at a dose of UNK dosage form. On 03-Feb-2021, PRURITUS (Itching) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Additional information received, provides outcome of the event and second dosage information was updated.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 2nd dose of Shingles vaccine. On 10th December 2018, less than a day after receiving Shingles vaccine, the patient experienced injection site pain. On 11th December 2018, the patient experienced generalized aching. In December 2018, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the injection site pain, generalized aching and influenza-like symptoms were unknown. It was unknown if the reporter considered the injection site pain, generalized aching and influenza-like symptoms to be related to Shingles vaccine. Additional details were reported as follows: The patient had a question about the Shingles vaccine. The patient received the 2nd dose the day before reporting. The patient had pain at the site. The patient asked was it possible to have generalized aches which started on the day of reporting in the morning in his legs and were radiating to his back. The patient felt like flu symptoms which he was praying was not the case.
the patient was given the covid vaccine. when mixing the diluent 2.2ml was used instead of the new protocol that indicates to use 1.1ml diluent to be used to mix.
Patient developed chest pain and feelings of bronchial constriction 2 days after receiving the vaccine.; Patient developed chest pain and feelings of bronchial constriction 2 days after receiving the vaccine.; This is a spontaneous report from a non-contactable physician. A 17-years-old (non-pregnant) female patient received first dose of bnt162b2 (BNT162B2), Formulation: Solution for injection, Batch/Lot number was not reported), via an intramuscular, administered in Arm Left on 09Apr2021 at 12:00 (at the age of 17-years-old) as DOSE 1, SINGLE for covid-19 immunisation. No, covid prior vaccination. No, known allergies. Vaccine facility type was unknown. No, other vaccine in four weeks. Other medications in two weeks was focalin, sertraline, hydroxyzine and nortriptyline. The patient medical history included postural orthostatic tachycardia syndrome, depression, anxiety, attention deficit hyperactivity. The patient concomitant medication(s) included dexamethasone, ofloxacin hydrochloride (FOCALIN [DEXAMETHASONE;OFLOXACIN HYDROCHLORIDE]) taken for an unspecified indication; sertraline taken for an unspecified indication; hydroxyzine taken for an unspecified indication; nortriptyline taken for an unspecified indication. It was reported that on 11Apr2021 at 07:00, the patient experienced patient developed chest pain and feelings of bronchial constriction 2 days after receiving the vaccine. Adverse event country was US. AE resulted to visit, Doctor or other healthcare professional office/clinic. No, treatment for AE. The outcome of event was unknown.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Pt states had a fever of 102F on 12/14/00 with vomiting and diarrhea, muscle ache and shooting pain in right arm (per phone conversation). Did not report for follow-up.
didn't know who her fiancee was and didn't recognize the house; panic attack; wasn't feeling well; confused; This is a spontaneous report from a contactable consumer (reporters fiancee).   A 42 years old female patient received the second dose  bnt162b2 (PFIZER-BIONTECH COVID 19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 28Apr2021 at 17:32 (at the age of 42 years old)  (Batch/Lot number was not reported) as SINGLE DOSE for covid 19 immunization. Medical history included hypertension( high blood pressure; had it for more than 10 years).  The patient concomitant medications includes blood pressure medication taken daily (details not provided). Historical Vaccine BNT162B2 was received on 07Apr2021 Dose 1, first dose was received 21 days before second dose.  The patient experienced panic attack, wasnt feeling well, confused on 29Apr2021, didnt know who her fiance was and didnt recognize the house on 29Apr2021 at 10:30. The clinical outcome of the events was unknown. The clinical course was as follows His fiancee went to get second vaccine shot yesterday. Today she woke up and said she wasn't feeling well. She had a bad reaction. She didn't know who her fiancee was and didnt recognize the house. The ambulance came and she had a panic attack. She did not  want to be touched by anyone. Patient didn't recognize caller or her daughter. The ambulance only checked her vitals. They did not take her to the hospital. The adverse events did not require an emergency room visit or physician office visit. She is home right now and is laying down, so reporter is not sure if she is still confused. He states that she didn't have any memory issues prior to the application of the vaccines second dose. He would like to know if this reaction was caused by the product. The clinical outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shingles 4 years ago, i was vaccinated/Suspected vaccination failure; Shingles 4 years ago; I was exausted, many test,x rays,suspicious cancer; Damage nerves; Pain treatments, killed nerves, and still in such a pain; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, exhaustion, nerve damage and pain. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the vaccination failure, shingles, exhaustion and nerve damage were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, exhaustion, nerve damage and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was vaccinated with shingles vaccine.  The patient stated that, after many years test, x-rays, suspicious cancer test etc. the patient went to a neurologist because he/she was exhausted. The doctor told him/her that, it was shingles 4 years ago, but rash never came out damage nerves, he/she went to pain treatments, killed nerves and still in such a pain that he/she really dealing every day. The patient was working and doing the best he/she could. The medication was not enough to calm it down. The patient was praying for the people who had it and did not know. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
On the evening of the vaccination, 01/29/2021 I started feeling pain on my left arm which was not the arm I received my vaccination at and chest pain and heart palpitations and that's what ultimately took me to the Emergency Department.  On 04/08/2021 I went to the Emergency Department. They did a  D-dimer test which came out positive. On 04/12/2021 I was diagnosed with Pulmonary Embolism in both my right and left lungs. They did a CT scan which found the blood clots visually. They prescribed the Lovenox  -an injection - blood thinner, I took from 04/08-04/12. Then I  started on the Eliquis 5 mg, twice daily,  on 04/12 and I am currently still on it.
The pt was immunized and within a number of hours he sustained a VFib cardiac arrest and was transported to  Hospital .  He had a negative heart cath, he survived a prolonged cardiac arrest with some anoxic encephalopathy.  MRI of his heart reveals an EF of approximately 39% and an area of myocarditis measuring 14X30mm.  Study was done 5 days post arrest on 8/9/2021
Began falling more about time of vaccine or within 7-10 days. Progressed to foot drop and 6th nerve palsy. Eventually R hemiparesis and unable to walk at all. Also bilat. ptosis. 11/01/02 Added per review of hospital discharge summaries: decreased energy, decreased appetite, ataxia, R arm intention & resing tremors, left 3rd nerve palsy, and constipation. Per 60 day follow up: Pt did not recover. Pt has mid brain lesion of uncertain etiology. Followed at hospital with a 2nd opinion at hospital. Seems to have progressive deterioration neurologically, but lesion is in too dangerous an are for biopsy. They do not feel it's cancer but are not sure. An homeopath suggested it was related to MMR vaccine. Though symptoms most likely predated the vaccine by about a week. An annual report received 11/13/2003 adds: Has a midbrain lesion causing severe neurologic deficit. Unable to Dx due to its location but felt to be post-infectious (not cancer).
pain in arm that got vaccinated; This is a spontaneous report from a non-contactable consumer (patient) from vacinne. This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 18Jan2021 at single dose for COVID-19 immunization. Patient wanted to know if she could take Advil since she was experiencing pain in her arm that got vaccinated with the Covid-19 vaccine on 18Jan2021. Outcome of event was unknown.  No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
No adverse event; patient was administered an expired dose of VAQTA; This spontaneous report was received from a nurse referring to a 12 month old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 10-SEP-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated( VAQTA) lot # R027431 (verified to be a valid lot number), expiration date reported and established as 08-SEP-2019, for prophylaxis. No adverse event was reported.
Wrong vaccine was given. Patient was supposed to receive meningococcal (Menveo) but recieved HIB (Pedvax HIB)
my brother-in-law had Pfizer vaccine also and is sick with Covid; my brother-in-law had Pfizer vaccine also and is sick with Covid; sick with Covid; This is a spontaneous report from a contactable consumer. A male patient (reporter's brother-in-law) of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route in the left arm on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On unspecified date, the patient experienced sick with Covid and has required ER visits at the same hospital. Reporter presented in ICU on a ventilator with Covid 19. reporter stated her patient had Pfizer vaccine also and is sick with Covid. The patient underwent lab tests and procedures which included Covid-19 test was positive on unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Developed subjective fever, sore throat, red eye, myalgias 11/17/19. Then developed rash 2-3 days following this that started on his face and evolved caudally to neck, chest, and upper abdomen.  No exposure to wild-type measles.
Pt reports she developed a rash and a fever (2 days with Tylenol use) 2-3 weeks after she received the varicella vaccine. She reports the rash started in the area she received the varicella vaccine and spread to her scalp but has improved since then. She denies experiencing and red flag symptoms such as SOB or difficulty breathing.
Experienced headache, weakness, fatigue, and fever evening of vax. Admitted to hospital 3 days later due to acute asthma attack. 60 day follow-up dated 7/21/00 provided no additional data.
booster; cardiac arrest; heart attacks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: IMMUNISATION (Death, medically significant), outcome "unknown", described as "booster"; CARDIAC ARREST (death, Medically significant), outcome "fatal", described as "cardiac arrest"; MYOCARDIAL INFARCTION (death, Medically significant), outcome "fatal", described as "heart attacks". The patient date of death was unknown. The reported cause of death was cardiac arrest, myocardial infarction. It was not reported if an autopsy was performed. Clinical course: Reporter friend after he received the booster shot he has passed away now. No heart complications, he had no heart issues at all, perfectly healthy and died of cardiac arrest after suffering multiple heart attacks in the hospital (further clarification unknown) with no heart history at all, young and healthy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: cardiac arrest; heart attacks
NO ADVERSE REACTION WHILE PATIENT WAS WAITING. PATIENT WAS GIVEN A CONCENTRATED DOSE DUE TO IMPROPER MIXING WITH THE 0.9% SODIUM CHLORIDE SOLUTION. PATIENT WAS INSTRUCTED TO TREAT SYMPTOMS AS THEY ARISE AND TO CONTACT PCP IF SYMPTOMS WORSEN OR CAN'T BE CONTROLLED WITH OTC MEDICATION.