chrisvoncsefalvay/vaers-outcomes huggingface dataset:
multiple doses of improperly stored GARDASIL 9 were administered to multiple unspecified patients on unspecified dates; No additional adverse event reported; This spontaneous report has been received from a nurse concerning an unspecified number of patients of unknown age and gender.  Their past medical history, concurrent conditions, concomitant medications and drug allergy/reactions were not reported.  On an unknown date, the patients were vaccinated with improperly stored with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number 1602284 has been verified to be a valid lot number, expiration date reported and validated as 26-SEP-2021) as prophylaxis (product storage error) (concentration, dose, dose description, frequency of vaccination scheme and anatomical location of vaccination were not reported).   The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) underwent a temperature excursion of 9.26 degrees Celsius for 42 minutes, as recorded by the data logger. There was a previous temperature excursion of 17.5 degrees Celsius for a time frame of 7 hours and 28 minutes from the same data logger.   No adverse effects were reported for the patients.    This is a non-valid case due to lack of patient's identifier.
mild expected side effects of slight headache; mild malaise; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8727) via unspecified route of administration in the right arm on 19Mar2021 at 13:30 (at the age of 66-year-old) as a single dose for Covid-19 immunisation. The patient's medical history included mild asthma, osteopenia, mild arthritis, long-lasting periods of fatigue and malaise following a brief viral illness with fever. Concomitant medication included estradiol cipionate (MANUFACTURER UNKNOWN) and ulmus rubra bark (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient had allergies to sulfa drugs (sulfonamide allergy). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203), via an unspecified route of administration in the right arm on 25Feb2021 at 14:00 as a single dose for COVID-19 immunisation. . The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, it was reported that, after the 2nd shot, 22 hours later had mild expected side effects of slight headache, mild malaise and fatigue. Past after 36 hours, the patient felt fine for a day, then malaise and fatigue returned and have continued for 10 days up to 30Mar2021. The malaise had lessened in past couple of days or so, but moderate fatigue continued. The patient had felt worse after napping and in the morning. No treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of slight headache, mild malaise, and fatigue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Large (3"x6") red swollen patch beneath injection site with extreme sensitivity to touch and pain diminishing gradually over 5 days; general malaise with headache and upset stomach lasting now 6 days although diminishing somewhat each day.  Injection site and upper left arm still feels some trauma after 6 days.
Mom reports in February, infant started having diarrhea 3-5x/day (none prior). This continued for several weeks but decreased to 1-2x/day. Dr initially thought maybe virus then considered several other possibilities. In early to mid April, infant started throwing up and clearly in pain. Surgery done 4-17-13 for intussusception and a cyst in the intestine per mom. Infant doing fine now.
Immediate pain in arm, swelling, stiffness followed by slowly increasing pain and swelling.  Exhaustion for 48 hours.  Increased joint pain in knees and hands.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 19-JUN-2015 the patient received a dose of GARDASIL 9 (lot number expiration date, route and dose were unknown). On 24-AUG-2015, the patient received a dose of GARDASIL (lot number, expiration date, route and dose were unknown). No adverse experienced were reported. Additional information has been requested.
a lot of nausea; Very dizzy; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and  concomitant medications were not reported.  She received the Pfizer Covid Vaccine 10 days ago and felt consumer had a reaction. Consumer reported a lot of nausea and was very dizzy. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Guillain-Barre syndrome; slowly feeling something in her legs; ill; This is a spontaneous report from pharmacist via Pfizer sponsored program. A 61-year-old female patient received unspecified dose of bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Guillain-Barre syndrome, slowly feeling something in her legs and ill on an unspecified date in Jul2021. The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the limited information available the causal association between the event Guillain-Barre syndrome and the vaccine BNT162B2 can neither be meaningfully assessed nor excluded. The case will be reassessed once detailed information is regarding vaccination details, medical history are 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 RAs, Ethics Committees, and Investigators, as appropriate.
Hot arm as site injection 101 temperature; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Sore arm) and INJECTION SITE PAIN (Hot arm as site injection 101 temperature) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Ceftin), Anxiety and Cholesterol. Concomitant products included LORAZEPAM and CITALOPRAM for Anxiety, ATORVASTATIN for Cholesterol, TEMAZEPAM for Sleepy.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2021 at 7:00 AM, the patient experienced MYALGIA (Sore arm). On 31-Jan-2021 at 10:00 AM, the patient experienced INJECTION SITE PAIN (Hot arm as site injection 101 temperature). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Jan-2021, MYALGIA (Sore arm) had resolved. On 01-Feb-2021, INJECTION SITE PAIN (Hot arm as site injection 101 temperature) had resolved. Not Provided          Concomitant medication includes Multivitamin adult 50+ daily. Patient was told take Tylenol and  cold compressors. And the temperature was gone and so the hotness by injection site. next day patient felt tired and relaxed.  Action taken with mRNA-1273 in response to the events were not applicable.
extreme body and joint aches, congestion Narrative: Took Tylenol and Mucinex
On 01/12/2021 the evening of my vaccination, very hot at the injection site, swollen and pain and that lasted for like 5 days. The next day, I had headache, diarrhea, and fatigue and the fatigue lasted for like 2 weeks, and I still have problems with the diarrhea. I called my Dr., she advised me to get rest, stay hydrated and follow up if it didn't past after 10 days. But I had fatigue for months after that. The doctor just told me to get a lot of rest and try not to be so active. Till this day, I still have the fatigue and the diarrhea.
Chills/shakes, nausea, dry mouth and headache that night. Next day into the next, sensitive skin (had to put hair up off my neck), muscle aches, joint pain, weakness and pain at the injection site up the left-side of my neck with pinching feeling.
Swelling & erythema of left thigh at sight of injection with fussiness & fever to 103.
About 6-9 months after second vaccine- tingling in left arm, lips turning black and cracks around mouth, then tingling right arm and legs; pressure all around head. Needed to pull hair to relieve pressure swollen feeling on a regular basis; sore neck, shoulders and down spine; swelling in legs; needed compression stocking to control ankle swelling.
Lethargic; Injection site was very inflamed; Itchy; Sore; injection site hot; injection site redness/ and the size of small ball; Rock hard (injection site); This spontaneous case was reported by a consumer and describes the occurrence of LIPOHYPERTROPHY (Rock hard (injection site)), LETHARGY (Lethargic), INJECTION SITE INFLAMMATION (Injection site was very inflamed), PRURITUS (Itchy) and MYALGIA (Sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB) for an unknown indication.    The patient's past medical history included No adverse event (No relevant medical history provided. ). Concomitant products included MULTIVITAMINS;MINERALS for an unknown indication.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB) (unknown route) at an unspecified dose. On 08-Apr-2021, the patient experienced LIPOHYPERTROPHY (Rock hard (injection site)), INJECTION SITE INFLAMMATION (Injection site was very inflamed), PRURITUS (Itchy), INJECTION SITE WARMTH (injection site hot) and INJECTION SITE ERYTHEMA (injection site redness/ and the size of small ball). On 09-Apr-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced MYALGIA (Sore). At the time of the report, LIPOHYPERTROPHY (Rock hard (injection site)), LETHARGY (Lethargic), INJECTION SITE INFLAMMATION (Injection site was very inflamed), PRURITUS (Itchy), INJECTION SITE WARMTH (injection site hot) and INJECTION SITE ERYTHEMA (injection site redness/ and the size of small ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pain in arm and within 30 minutes pain become intense and unbearable.  Range of motion dramatically decreased. Pain and decreased range of motion lasted approx. 20 hours.
Induration (7 - 8mm in diameter) and erythema adjacent to injection site on R thigh.
Patient has a swollen knuckle on her hand. Patient has elbow pain in the joint., as well as pain throughout the whole arm. All of this is occurring in the same arm the patient received her vaccine in.
This initial spontaneous case, was received on 26-Oct-2017, from a pharmacist concerning a male patient of unspecified age. This case refers to 03 out of 3 reports. On 05-Oct-2017, the patient was administered with FLUVIRIN (batch number: 179705P, dose: 0.5ml, route of administration; intramuscular, anatomical location: left deltoid). On 07-Oct-2017 after 3 days of vaccination, he had soreness in his arm. At the time of this report, the patient had not recovered from the event. It was reported that, the symptoms were persisting, even worsened. The reporter assessed the case as non-serious. Follow up information was received on 28-Nov-2017: The patient initials was updated. Event onset date was added (07-Oct-2017). Narrative was amended.
Presented to ED with AHRF d/t COVID19 PNA, was subsequently intubated and transferred to higher level of care.
Sore arm with moderate pain, shivering, feel hot but no fever.  Tired. Symptoms occurred about 4 hours after vaccination.
exposed to 1.8 C for 1 hour 54 minutes and 1.9 C; Based on additional information received on 27-AUG-2019, case was upgraded to Valid from Non-Valid because patient was involved.  Initial information received on 06-Aug-2019 regarding an unsolicited non-valid non-serious case received from a nurse.  It was reported that vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] exposed to 1.8 c for 1 hour 54 minutes and 1.9 c. It was reported that a patient received Act-Hib but did not produce any adverse event.  Patient's  medical history and concomitant therapies were not reported.  It was of actual medication error due to incorrect product storage..  It was reported that no adverse event was noticed post vaccination with Act-Hib.  Information on the batch number was requested  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.  Follow-up information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  Case was upgraded to valid. Significant information in Case was updated.  Information on the batch number was requested
pt recv vax APR95 & reported that there was blood in syringe on completion of vax;nurse suspects that all or some of the pt was administered IV;pt vomited noc of vax & felt lethargic for approx 5 days later;
ABOUT 8 HOURS AFTER MY FIRST SHOT I FELT VERY FATIGUED AND MY BONES AND JOINTS FROM MY WAIST DOWN TO MY TOES ACHED. WHEN I LAYED DOWN TO SLEEP AT 9:30PM THE BONE AND JOINT ACHES WENT UP MY BACK AND OUT MY SHOULDERS TO MY ARMS AND HANDS. I WAS THROBBING WITH BONE PAIN THE ENTIRE NIGHT.  THE MORNING AT 7AM I HAD TO TAKE IT EASY BUT THE BONE PAIN SUBSIDED BY 5PM THE NEXT DAY AFTER A HOT SHOWER AND AN ALVEVE. I HAD NO HEAD ACHE .
t102 x 4 days;large area of erythema @ site (2-3");
From approx 10 pm to 9:00 pm 2/24/21 I experienced the following:  Severe headache, nauseousness, vomiting, heart palptations, Chills and body ache, so much that all my teeth hurt.  All symptons left as fast as they came on.
My knees hurt.  They were swollen and aching so badly for a while it was very difficult to walk.  I went to Clinic.  I'm not very happy with their assessment.  I was in and out very quickly.  The doc said it is arthritis but I have never ever had issues with my knees like this. To this day I have pain and difficulty sleeping and working due to it.  I have lost flexibility and both knees ache constantly.  I have been in good shape and exercised most of my adult life and have never experienced anything like this before.  Of course the doctor went on to say that it's age, arthritis and could eventually lead to surgery.  My point is that It did not happen until the second shot.  I have also read that some vaccines can trigger arthritis events.  I believe my condition is due to the vaccine and I am not happy about it .  I have an appointment next Tuesday to get a steroid shot in my left knee which is the worse at this point.  I wish I never got the shot.
I have had mild tinnitus for 4 Years. About a week following my first dose of the Pfizer vaccine, my tinnitus has gotten extremely bad. It is much louder and higher pitched than it ever has been. After my second dose the tinnitus got even worse and is almost unbearable. Now I am almost 2 months post second vaccine and there has been no improvement what's so ever.
a painful outbreak of shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 05-FEB-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to the zoster vaccine live (ZOSTAVAX) vaccine being administered, in 2014 (reported as within weeks), the pt developed a painful outbreak of shingles.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presenting prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of the zoster vaccine live (ZOSTAVAX) product that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the pt. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered a painful outbreak of shingles to be disability.
Case number PHEH2014US025343 is an initial spontaneous report received from a consumer on 15 Dec 2014. This report refers to a 56 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 11 Dec 2014. On same day post vaccination, she experienced swelling on the left side of the face. It was reported that there was no swelling in any other part of the body and there was no associated neurological damage. Consumer explained that the swelling has significantly reduced. The outcome of the event was reported as condition improving. Reporter did not assess the seriousness of the event but the seriousness of the event (facial swelling) was upgraded as medically significant based on the information available in source document. The causality of the event was not reported.
L arm swollen, red, hard, hot and painful to touch, radiating up the shoulder, beginning 24 hours after injection. Pt had low grade fever 99.5 for 24 hours,
Induration/swelling redness & tenderness around the injection site. Increased warmth over the area of redness occurred day after injection to now (last 3 days). Will try TYLENOL, NSAID & ice.
46 yo female with h/o food allergy here for second covid vaccination c/o sensation of tightness in throat 20 min after the vaccination similar to throat tightness experienced with food allergies which is relieved with OTC benadryl. patient did not have any reaction after the first covid vaccination. patient denies shortness of breath or wheezing or stridor or change in voice or rash/hives or cor vasc sx  heent wnl; no lingular or uvular swelling neck without edema chest clr p and a cor rrr skin clear, no flushing. patient observed and symptoms resolved 30 min after 25 mg oral benadryl. pt called spouse to pick up rather drive home and instructed to repeat with OTC benadryl in 8 hours
Family noticed brain fog within a few weeks of getting the vaccine; DOSE 1: 11Sep2021 and DOSE 2: 23Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 at 10:00 as dose 2, single (Lot number: 30135ba) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Anatomical location: Left arm, Vaccine administration time: 11:30 AM), administration date: 11Sep2021, when the patient was 36-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 23Oct2021 at 10:00, outcome "unknown", described as "DOSE 1: 11Sep2021 and DOSE 2: 23Oct2021"; FEELING ABNORMAL (non-serious) with onset 01Nov2021, outcome "recovered with sequelae", described as "Family noticed brain fog within a few weeks of getting the vaccine". Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Family noticed brain fog within a few weeks of getting the vaccine. The event recovered with lasting effects. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.