chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 6 month old patient. On 27-JUN-2017, the patient was vaccinated with improperly stored doses of PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766.
Day of rabies #2 vaccine, experienced flu-like sx progressing to SOB, fever of 100 degrees. Sought emergency medical care for "asthma " event & pt. denies anaphylaxis. Rx'd with prednisone, BENADRYL, Albuterol. Sx lasted 3 days & pt. recovering, working, has not resumed running. Pt. will not receive rabies #3 as relation to sx unclear. Cont to use Albuterol prn & usual medications.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 13Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing), notes: known allergies No. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Anti viral details, product=COVID 19 Treatment, brand=Paxlovid, treatment start date=01Jun2022, treatment stop date=05Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
now testing serologically negative for MMRII protection; This spontaneous report was received from office manager and refers to a 20-year-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 31-AUG-2023, the patient experienced serologically negative test for MMRII protection. At the time of reporting, the outcome of the event was not known.   The causal relationship between adverse event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
pt recvd vax on 15OCT95 & came down w/flu;came down w/bad sore throat the next morning;4 days later lung congestion-had to go to MD & take ATB lasted 2 1/2wks;
Pain in left arm, swollen underneath arm, unable to sleep due to pain, head aches, tiredness, left arm feels limp, dizziness and stomach pains
Site: Pain at Injection Site-Medium, Additional Details: Right arm tingling & shaking all the way down to patient's hand making it difficult to perform day-to-day activities
Tremors in her legs; This spontaneous report was received from a pharmacist thecnician concerning a 75 year-old female patient. The patient's concurrent conditions included allergy to codeine (reported as "codine") and quinolones (reported as "quinolonds"). The patient's concomitant therapies included unspecified influenza medication and other unspecified medications.     On 17-SEP-2020, the patient was vaccinated with 1 shot in the right arm with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot# and expiration date were not provided) according to doctor's recommendation because of her age for prophylaxis.      On 24-SEP-2020, the patient experienced tremors in her legs. No treatment was prescribed for the event. At the time of the report, the outcome of the event was not recovered.  The causal relationship between the event and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.
About 1 hour after vaccine was administered, employee started itching on scalp, palms of hands and soles of feet. At 6:00PM that night he continued to have symptoms so he showered and took Benadryl 25mg PO. During the night itching continued and he developed a red splotchy rash on palms of hands, soles of feet, under arms and groin area. He took another Benadryl 25mg PO. 11/6/15 - Symptoms were not relieved with previous medications and began a Medrol dose pack. By day 3 all symptoms were resolved.
Inadvertently gave the third booster dose at 3 months instead of the 6 months/patient got a booster dose before 6 months had past after their second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently gave the third booster dose at 3 months instead of the 6 months/patient got a booster dose before 6 months had past after their second dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently gave the third booster dose at 3 months instead of the 6 months/patient got a booster dose before 6 months had past after their second dose). On 01-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently gave the third booster dose at 3 months instead of the 6 months/patient got a booster dose before 6 months had past after their second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given.  Patient received third booster dose at 3 months instead of the 6 months that is indicated.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received: Added reporter city, state, postal code, phone number, patient gender, suspect dose (started month of 1st, 2nd and booster dose) details and indication. On 08-Nov-2021: Follow-up received: Added patient demographics (initials, age and date of birth), suspect dose start dates (1st, 2nd and booster dose), dose (booster) and batch numbers. On 10-Nov-2021: Follow-up received contains no new information (NNI).
c/o fever, headaches, chills, and arm pain from yesterday's immunizations. pt received Menectra and Trumenba yesterday, today he woke up not feeling well with body aches, fever and chill; pt denies sore throat, cough, shortness of breath or difficulty swallowing. Temperature on 6-20-18 @ clinic: 100.8F
Several hrs p/inject was given, pt reported had some swelling & tenderness 24 hrs p/inject also inc inflammation & was having some numbness in the lt arm;
titers were negative fot measles, mumps, rubella and varicella; titers were negative fot measles, mumps, rubella and varicella; titers were negative fot measles, mumps, rubella and varicella; titers were negative fot measles, mumps, rubella and varicella; This spontaneous report as received from a nurse refers to a 21-year-old female patient. The patient had no pertinent medical history, no concomitant medications and no drug reactions or allergies.     On unknown dateS, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date and dose were not provided) subcutaneously and with varicella virus vaccine live (oka/merck) (VARIVAX) (lot #, expiration date and dose were not provided) subcutaneously, both for prophylaxis. The nurse reported that the patient finished the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) series on an unspecified date, 16 years ago. It was unspecified how many doses of suspect vaccines were administered to the patient.  On 12-AUG-2019, the patient had titers drawn and it showed that titers were negative for measles, mumps, rubella and varicella. No treatment was given for the event. The patient did not seek medical attention. The outcome of the event was reported as recovered/resolved on an unspecified date in August 2019.  The relatedness between the event and the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) vaccines was not provided.
4-13-90 pt vax dtp/opv/mmr.  pt devel pain, swelling at inject site, neurologic sx and hypotonia.  4-21 pt had fever 105.4 degF, rash on chest/back and possible convulsion-staring, jaw moving & no response.4/23 rash face,head,buttocks,legs.
Pt recvd 1st dose of Hep B vax on 27MAR92 & 2 wks following devel serum sickness-like sx w/h/a, muscle weakness, malaise, mascular-type non pruritic rash, & myalgia;
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were administered doses of GARDASIL 9 lot# L001312, expiration date 24-FEB-2017 and lot# K026246, expiration date 28-JAN-2017 (dose and route of administration were not reported) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Headache Neck Pain Subtle tingling in hands and feet Muscle weakness  Facial Droop
pt reported enlarged lymph nodes under lt arm, breast & to ripple area;pt denied muscle soreness;seen by MD who felt it wa snot vaccine r/by prescribed course of ATB for poss mastitis;
Tingling /Paresthesia hands, feet, face, mouth.  stabbing nerve pain in chest, crawling sensation in back, muscle spams and cramping in hands and feet, muscle weakness lower arms and legs, overall weakness, fatigue and lethargy.  Also developed UTI feelings, however tests show I do not have a UTI.
After the 8th day of the vaccine I have a rash on my arm that is hot to touch.
Few days after 2nd vaccine started having sever itching on torso has been lasting for about a week so far; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old, non-pregnant, female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 23Feb2021, at 67 years of age, (Batch/Lot Number: EN6203) as single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included hypothyroidism and hypertension, both from an unknown date. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 after vaccination. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 03Feb2021 01:00 PM, at 67 years of age, (Batch/Lot Number: El3246) as single dose for COVID-19 immunization. The patient didn't receive any other vaccine in the previous 4 weeks. Concomitant medications included levothyroxine, amlodipine besilate (NORVASC) and hydrochlorothiazide and "TINIMOL", all taken for an unspecified indication since an unknown date. The patient reported that on 26Feb2021, few days after the 2nd vaccine dose, she started having severe itching on torso, which has been lasting for about a week so far. The patient was treated with topical ointments as a result of the event. At the time of the report the event had not resolved yet.  No follow-up attempts are needed. No further information is expected.
Joint and muscle pain in knees, left ankle and foot (cramping severely at night and while walking), right hand joint pain and right jaw pain. Also have muscle twitching in both legs at night waking me up (calves and thighs). None of this occured before my vaccination.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored PEDVAXHIB injection (lot # L014426, expiry date: 18-MAR-2018: strength, dose, site and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Rashes are itchy; A rash on her legs (from the knee down), a rash on the lower part of her arm, wrist, and on the back of both hands; Feet swelled up; Feet are red; when she itches the rash it hurts; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rashes are itchy), RASH (A rash on her legs (from the knee down), a rash on the lower part of her arm, wrist, and on the back of both hands), PERIPHERAL SWELLING (Feet swelled up), ERYTHEMA (Feet are red) and PAIN (when she itches the rash it hurts) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Thyroid disorder NOS, ADHD and Depression. Concomitant products included VITAMIN B NOS for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rashes are itchy), RASH (A rash on her legs (from the knee down), a rash on the lower part of her arm, wrist, and on the back of both hands), PERIPHERAL SWELLING (Feet swelled up), ERYTHEMA (Feet are red) and PAIN (when she itches the rash it hurts). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Rashes are itchy), RASH (A rash on her legs (from the knee down), a rash on the lower part of her arm, wrist, and on the back of both hands), PERIPHERAL SWELLING (Feet swelled up), ERYTHEMA (Feet are red) and PAIN (when she itches the rash it hurts) outcome was unknown.            Concomitant product information includes Atrial Fibrillation medication,Blood Pressure Medication,Thyroid Medication,Reflux medications,Prodiotic,Antidepressants,ADHD medications,Vitamins Treatment information includes Ice pack on hand and got a cortisone injection in her lower back since it was hurting really bad. Patient stated that discontinued taking glucosamine and another oil. Action taken with mRNA-1273 in response to the events is not applicable   This case was linked to MOD-2021-116468 (Patient Link).
fever gone down to 100-101F/low grade fever of 99F/temperature remained 99-100; fatigue; soreness at the injection site (couldn't lift arm); metallic taste in their mouth that lasted the entire day; soreness at the injection site (couldn't lift arm); chills; muscle pain/body aches; joint pain; bad headache/massive headache; Fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (soreness at the injection site (couldn't lift arm)), DYSGEUSIA (metallic taste in their mouth that lasted the entire day), VACCINATION SITE PAIN (soreness at the injection site (couldn't lift arm)), CHILLS (chills) and MYALGIA (muscle pain/body aches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (soreness at the injection site (couldn't lift arm)), DYSGEUSIA (metallic taste in their mouth that lasted the entire day), VACCINATION SITE PAIN (soreness at the injection site (couldn't lift arm)), CHILLS (chills), MYALGIA (muscle pain/body aches), ARTHRALGIA (joint pain), HEADACHE (bad headache/massive headache) and PYREXIA (Fever of 102). On 20-Mar-2021, the patient experienced PYREXIA (fever gone down to 100-101F/low grade fever of 99F/temperature remained 99-100) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and ASA at a dose of 325 milligram. On 19-Mar-2021, DYSGEUSIA (metallic taste in their mouth that lasted the entire day) had resolved. On 20-Mar-2021, CHILLS (chills), MYALGIA (muscle pain/body aches) and ARTHRALGIA (joint pain) had resolved. On 21-Mar-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (soreness at the injection site (couldn't lift arm)), VACCINATION SITE PAIN (soreness at the injection site (couldn't lift arm)), HEADACHE (bad headache/massive headache), PYREXIA (Fever of 102), PYREXIA (fever gone down to 100-101F/low grade fever of 99F/temperature remained 99-100) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 102 (High) high. On 20-Mar-2021, Body temperature: 101 (High) 100-101.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-081737 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: follow up was received on 18th may 2021 additional events for second dose was updated.duration for the first dose events were updated
Initial flu-like symptoms.  Achy, fever, light-headed, progressing to soreness in torso and arm.  Arm and torso felt heavy like a stone.
that he decided not to take the second dose/ second dose administered more than 35 days after first dose; shoulder hurts; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (that he decided not to take the second dose/ second dose administered more than 35 days after first dose) and ARTHRALGIA (shoulder hurts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.    On 14-Sep-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (that he decided not to take the second dose/ second dose administered more than 35 days after first dose) and ARTHRALGIA (shoulder hurts). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (that he decided not to take the second dose/ second dose administered more than 35 days after first dose) had resolved and ARTHRALGIA (shoulder hurts) outcome was unknown.            Concomitant and treatment medications were not provided.   This case was linked to MOD-2021-320758 (Patient Link).   Reporter did not allow further contact
pt recvd vax & devel rash over entire body; treated w/DPH, Medrol pack & hydrocortisone cream;
Pt recvd vax & exp an unspecified adverse event which was treated w/Lotrimin & hydrocortisone;
Date and time of vaccination: (list both if they received both shots): 12/31/20 (first dose)- 01/19/21 (second dose)  Date and time adverse event started: 02/08/21- Patient complaining of headaches. She states that she the headaches typical are worse in the morning. She rates them a 8/10 with 10 being the most painful.
He had a new onset of tic starting 9 hours after vaccination. This required overnight admission to the hospital for evaluation for secondary causes of acute onset tic.
On 11/23/2022, roughly 3 hours after injection, injection site began to swell. With in 5 hours of injection, extreme pain in right arm in vicinity of injection site (front deltoid).  This was followed by  skin pain along spine and ribs and extreme muscle tightness in arms and upper back.  Experienced. Pain treated with 75mg  diclofenac and 1 mg tizanidine.  Joint swelling, extreme soreness and muscle tightness continued on 11/24 through 11/25  and managed with diclofenac (75 mg every 12 hours).  On  11/26/2022, joint swelling occurred in wrists, left hip, right foot, right shoulder.  Painful swelling in right  foot  occurred to point where I could not drive (site of sprain in June 2022) . Managed with  75 mg diclofenac, vitamin B, magnesium, 1 mg tizanidine.  As of  11/27, right arm injection still painful, still experiencing inflammation, though to much lesser extent than previous days. Contacted primary care virtually.
Narrative:  91yo male patient was admitted into hospice services on Saturday, Dec 18,2021 for renal cancer and uncontrolled pain. Pt died on 12/29/2021 from cancer at hospice house. Pt received one dose of covid vaccine - Moderna on 2/10/2021 from another source. Death is not related to covid vaccine.