chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (did not have this type of reaction to the first dose). On an unknown date, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, injection site swelling, induration, skin warm and skin discoloration. On an unknown date, the outcome of the erythema of extremities, injection site swelling, induration, skin warm and skin discoloration were unknown. It was unknown if the reporter considered the erythema of extremities, injection site swelling, induration, skin warm and skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of SHINGRIX on Monday and their arm was red, hard, swollen, purple in the middle and warm to the touch. The swelling goes from the site to the arm pit.
She received her second dose today, and she is 6 weeks pregnant.; No additional AE/No PQC; This spontaneous report was received from consumer and refers to a 30-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-FEB-2023, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, lot #, expiry date, and route of administration were not provided) administration for prophylaxis. On 03-MAY-2023 (also reported as today), she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (strength, lot #, expiry date, and route of administration were not provided) administration for prophylaxis. Consumer stated she informed the healthcare proffesyinal (HCP) on her intake form that she was pregnant, and she was vaccined anyway (exposure during pregnancy). The date of last menstrual period (LMP), date of conception and due date is not reported. No additional adverse event was reported.
Patient experienced swelling and redness approximately 2 hours after the vaccination. Later experienced chills and sweats and pain in the arm and chest. Redness and swelling lasted approximately 2 days after the vaccine. On 10/03/2018 reports feeling fine.
Child c/o itching several hours after receiving vaccine later in the evening, enrolled in a basketball game. Become hot & developed a fine rash in face & chin. Parent reports no difficulty breathing or hives rash still faint but improving.
Injection site pain; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 12:45 (Lot number: EL3247) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "CT scan dye allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY; CALCIUM CITRATE; VIT D; CENTRUM SILVER +50. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021 17:00, outcome "recovering", described as "Injection site pain"; PAIN IN EXTREMITY (non-serious) with onset 03Mar2021 17:00, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Narrative: Patient refused second injection and reported he had developed chest pain following the initial vaccination. Unfortunately there was no report made to the medical center around the time of the vaccination. Patient was positive for COVID-19 on 12/8/2021. EKS in February 2022 showed no abnormalities.
No additional AE reported; HBP stated an adult patient was administered a pediatric dose of VAQTA by mistake.; This spontaneous report was received from a healthcare business professional and refers to an adult patient of unknown gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 02-MAR-2022, the patient was by mistake vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 ml (dose number, route of administration, anatomical location, lot # and expiration date were not provided) or prophylaxis (Accidental underdose). No additional adverse event was reported (No adverse event).
This spontaneous report as received from a registered nurse, refers to an unspecified number of patient of unknown age and gender, who on an unknown date were vaccinated with improperly stored dose PEDVAXHIB (lot # L038502, expiry date 16-AUG-2018) (dose and route were not reported). No adverse effects were reported. No further information was provided. This is one of the three reports received from the same reporter. Additional information has been requested.
pt recvd vax;next day p/ the dose had fine red rash & itched;pt was not tx for sxs; sxs resolved 1 day p/ onset;
Left arm was sore and is like some body hit with a base ball; Light headed; Feeling as if he had flu; Feeling weak; Very cold; Entire body aches; Teeth shattering; Feeling tired; Headache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm was sore and is like some body hit with a base ball), DIZZINESS (Light headed), INFLUENZA LIKE ILLNESS (Feeling as if he had flu), ASTHENIA (Feeling weak) and FEELING COLD (Very cold) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Apr-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) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm was sore and is like some body hit with a base ball), DIZZINESS (Light headed), INFLUENZA LIKE ILLNESS (Feeling as if he had flu), ASTHENIA (Feeling weak), FEELING COLD (Very cold), MYALGIA (Entire body aches), CHILLS (Teeth shattering), FATIGUE (Feeling tired), HEADACHE (Headache) and NAUSEA (Nauseous). At the time of the report, PAIN IN EXTREMITY (Left arm was sore and is like some body hit with a base ball), DIZZINESS (Light headed), INFLUENZA LIKE ILLNESS (Feeling as if he had flu), ASTHENIA (Feeling weak), FEELING COLD (Very cold), MYALGIA (Entire body aches), CHILLS (Teeth shattering), FATIGUE (Feeling tired), HEADACHE (Headache) and NAUSEA (Nauseous) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment information were not provided.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome updated,2nd dose information updated
SHINGLES ON STOMACH; DIZZY; DOUBLE VISION; VERY WEAK; MILD HEADACHE; PAINFUL SHOT; This spontaneous report received from a patient concerned a 79 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2021, the subject experienced painful shot. On 29-JUL-2021, the subject experienced shingles on stomach. On 29-JUL-2021, the subject experienced dizzy. On 29-JUL-2021, the subject experienced double vision. On 29-JUL-2021, the subject experienced very weak. On 29-JUL-2021, the subject experienced mild headache. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shingles on stomach, very weak, dizzy, double vision, mild headache and painful shot was not reported. This report was non-serious.
Seen blurry; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Seen blurry) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included CALCIUM for Osteoporosis, SIMVASTATIN for an unknown indication.   On 26-Apr-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 26-Apr-2021, the patient experienced VISION BLURRED (Seen blurry). On 26-Apr-2021, VISION BLURRED (Seen blurry) had resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided.
Information has been received from a female concerning her 13 year old granddaughter with no pertinent medical history and no history of drug reactions or allergies who on unspecified dates was vaccinated with the complete series of GARDASIL. There was no concomitant medication. Subsequently, in April 2008, the patient experienced severe pain on the bottom of her stomach on both sides and she was having blood clots. Because of these symptoms, the patient was hospitalized for 4 days. The patient also developed cyst. Ultrasound was performed (results not reported). As of 16-JUL-2008, the patient was at home but still complaining about severe pain in the lower part of her stomach and still has blood clots. This is one of three reports from the same source. (WAES: 0807USA03551 and 0807USA03552). Additional information has been requested. 8/21/08-ER records for DOS 4/2-4/4/08-presented with C/O abdominal pain and cramping. Menses began 3-4 days prior. Pale diaphoretic. Impression: abdominal pain, syncope. Temperature elevated. Urine culture E. coli. Seen in OB/GYN office 4/8/08-C/O continuous bleeding and abdominal pain. Follicular cyst of ovary. 6/4/08-continues to have heavy bleeding with cramps. Prescribed Ortho Novum 1/35. Seen on 7/15/08-last period without problems no longer taking birth control pills. Office did not administer Gadasil to client.
Approximately three hours after receiving the AFLURIA flu vaccine, employee was at home and developed an acute onset of upper respiratory symptoms of nasal congestion, throat irritation, watery eyes and cough with high fever. She denied any episode of SOB, wheezing or stridor. She also developed generalized body aches. She treated at home with oral antihistamines and antipyretics and did not seek emergency medical treatment. Her symptoms resolved within 24 hours except for residual fatigue.
shortness of breathe; Itchiness of throat; weakness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breathe), THROAT IRRITATION (Itchiness of throat) and ASTHENIA (weakness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    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 DYSPNOEA (shortness of breathe), THROAT IRRITATION (Itchiness of throat) and ASTHENIA (weakness). At the time of the report, DYSPNOEA (shortness of breathe), THROAT IRRITATION (Itchiness of throat) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I was tired, the first vaccine seems to be worst for me; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EN6202), via an unspecified route of administration, on 25Feb2021 (at the age of 50-year-old) as second dose , single dose, for covid-19 immunization. The patient did not have any prior vaccination within 4 weeks and was not sure if she had COVID-19 in the past. She also mentioned that she was part of the clinical trial for the Pfizer COVID-19 vaccine. The patient's medical history included blood pressure high. The patient's concomitant medication included metoprolol taken for blood pressure high, at dose of 25mg, twice a day. On an unknown date in Feb-2021, the patient said that "I was tired, the first vaccine seems to be worst for me". The patient mentioned that she had taken both vaccines and she did not consider it a bad reaction. The patient mentioned that "I was in clinical trials. The outcome of the event was unknown.  Follow-up attempts needed. Additional information has been requested.
pt recvd flu vax & the following vax exp a local reaction consisting of erythema, swelling, & warmth @ the inject site; also arthritic-like sx (fingers red & swollen) & fever; redness @ inject site & sl swelling of fingers;
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported. The date of vaccine refrigeration was reported as 07-May-2021
Patient reported dizziness, inability to stand due to disorientation, sweating, sensation near syncope, & shakiness lasting about 25 minutes.
No adverse effect; 2 month old patient inadvertently received a dose of GARDASIL 9; This spontaneous report was received from a nurse practitioner referring to a 2-month-old infant patient. His concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On 29-OCT-2019, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (batch/lot # R025729 and expiration date: 18-JUN-2021) for prophylaxis (strength, dose, unit, route and anatomical location were not reported) (wrong vaccine administered). No adverse effects were reported. The outcome of wrong product administered was unknown.
Fever 101 degrees F from 3AM (1-9-13) to 3 PM (1-9-13) weakness - resolved after 48 hours.
bleed on her brain; the infection had spread to her heart valves; she could not walk; legs went numb; sepsis; fever / fever went up over 103 F; chills; diarrhea; This is a spontaneous report received from a contactable consumer. A 61 years old female received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 30Mar2021 (at 61 years of age), in right arm, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 09Mar2021 (lot EN6202), at 61 years of age, in right arm. No other vaccines were given within 4 weeks prior to the COVID vaccine. Medical history included connective tissue disorder - scleroderma. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included methotrexate. On 30Mar2021, within a few hours of receiving the second vaccination, she had fever, chills and diarrhea. By 4:30 AM on 31Mar2021 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to hospital where they started treating with antibiotics her for an infection but her fever went up over 103 F, so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did Magnetic Resonance Imaging (MRIs) as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. She died on 14Apr2021 after 15 days of hospital care and Intensive Care Unit (ICU) care. The events were reported with a fatal outcome. It was unknown if autopsy was performed. Since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: chills; diarrhea; she could not walk; legs went numb; sepsis; bleed on her brain; the infection had spread to her heart valves; fever / fever went up over 103 F
very sore arm at the injection site; very sore arm at the injection site; This is a spontaneous report from a non-contactable consumer(patient). This 61-year-old male patient reported that he received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 17Jan2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient (frontline worker), received his first dose of the Pfizer COVID vaccine on 17Jan2021. On an unspecified date the patient had a very sore arm at the injection site which he was never had with a vaccine before, and the patient had no side effects except these. The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch cannot be obtained. No further information is expected.
Day 1 -- Chills, fever, headache, body aches Day 2-4 -- those plus diarrhea, abdominal pain, inability to tolerate drinking Day 5 -- plus dehydration, vomiting.  Received saline IV, CT scan, injection of zofran, prescription for bentyl. Day 6 -- provided stool sample.  Received injection of morphine, prescription for viocidin,  Day 7-8 -- symptoms continued. Possible to drink fluids. Day 9 -- prescribed cipro for salmonella. Day 10-12 -- symptoms begin to abate
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit ; 32 to 35 degrees Fahrenheit for 64 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012527: US-009507513-1703USA012528: US-009507513-1703USA010513:
Started with sore arm where I could not raise it. (12pm) Headache, fever, chills (2pm) Light headed, fatigued, swollen joints in fingers (I have arthritis), could make a fist (6pm) called off from work at 8pm Had very vivid weird dreams, breathing somewhat labored, woke up every hour. I took Excedrine Severe Headache every 4 to 6 hours, drank lots of fluids Woke up in a pool of sweat, showered, changed went back to bed. Friday same thing, I pretty much stayed in bed all day. I did not start to feel better until late Saturday afternoon around 2pm and then I developed a rash on my left inside of arm and left side of my waist. It is very itchy and I have been putting hydrocortisone on as needed. I still have the rash, and feel pretty good. Will be contacting my Drs. office today.
Runny nose; My sinus screwed up but when I blew my nose it was; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 79-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Medical history included Hip replacement and pain from an unknown date and unknown if ongoing. On an unspecified date, the patient experienced runny nose and my sinus screwed up but when i blew my nose it was. The patient did not receive treatment for events. Reporter seriousness for Runny nose and My sinus screwed up but when I blew my nose it was orange and it was blood was reported as unspecified. It was reported that the patient got first shot on the 26th and that evening the patients nose was runny, so just, you know, just crazy weather and the patient sinus were all screwed up but anyway, the patient blew nose and when the patient, when to throw the paper towel away, the patient had when the patient blew nose it was orange and on Friday was week day the patient had shot and the patient was in the evening. The patient blew nose again and it was blood and it was quite a bit, a couple times the patient blew up and it was still bloody but the patient never had anything ever since, everything is been good but those are the two side effects that the patient had and I the patient didn't and couldn't call the pharmacy here because it was after hours, so the patient got paper out today and see that number there, so that's why the patient was calling. The patient will go for next one on the 16th. The patient don't know what to do about it, they said if the patient had side effects to call it in. It was reported that the patient said right now the patient was 79 but in July the patient will be 80. About the treatment for the event, the patient said, no, it just went away, it never came back. About concomitant medication, the patient said the patient took 9 pills a day. About the lot number the patient said, the patient can't read it says ET7534 and then there is another number RAO4407. About the laboratory test, the patient stated, yes, in November, the patient fell and I broke the hip and had to have a hip replacement, so the patient don't know what the patient had or what because it was a lot of pain (hence, captured in history). The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.