chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness; Warmth; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced localized erythema, feeling of warmth and local swelling. The patient was treated with antibiotics nos. On an unknown date, the outcome of the localized erythema, feeling of warmth and local swelling were recovered/resolved.   It was unknown if the reporter considered the localized erythema, feeling of warmth and local swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported the patient received the Shingrix dose at a different location and had a pretty severe reaction.  The patient reported severe redness, warmth, and swelling, 4 to 6 inches from the actual injection site.  The patient reported going to the physician and received an antibiotic, which seemed to resolve the issue. The physician felt the reaction was local.  The reporter did not give consent to follow up. The outcome reported for all AES in the structured field of XML is " RECOVERED/RESOLVED WITH SEQUEL" instead of " Recovered/Resolved" (outcome uploaded in database)
Patient called one day after "booster" dose of pfizer to state that her glucose meter was reading "high" and would not give a numerical result.  I instructed the patient to seek treatment at an urgent care facility.  Patient's blood glucose at the facility was 653 mg/dl.  Patient had not altered her medication nor changed her diet to precipitate this reading. The only thing added was her booster dose.  Patient stated that after 3 hours at the facility her blood glucose was brought down to around 350 mg/dl.  As of 4pm on 01/13/2022 patient blood glucose was around 180 mg/dl.
The patient called the pharmacy the day after he received his flu vaccination, 9-8-17 around 9:30 am. The patient said he was experiencing itching, tingling in his limbs, and dizziness. The patient said the itching on his limbs started the day of the vaccination on 9-7-17 but that the tingling in his limbs and dizziness did not start until the morning after the vaccination, 9-8-17. The patient mentioned that he has atrial fibrillation and is taking potassium, so he was not sure if his health issues were the cause or if they contributed to the possible reaction. I, RPh encouraged the patient to call his primary care physician right away due to concern for the signs and symptoms described. I left a voicemail message with the patient on 9-8-17 in the evening for him to call us for follow-up, but I did not hear back from the patient as of 9 pm close on 9-8-17.
pain, warmness, swelling, itching, redness at injection site and below site, bad headache, bad muscle aches and joint pain, mild fever, mild nausea,  mild fatigue. The headache and muscle aches were the worst of all the symptoms. Symptoms lasted for 36 hours and then  stopped.  The swelling on arm lasted 3 days.
21month old patient was admitted for bronchiolitis due to influzenza virus on 12/16/22.  On 12/17/22, patient inadvertently received Pfizer bivalent booster for 12+year old patients.  Spoke with mother on 12/22/22 through interpreter that patient experienced stronger side effects post vaccination but is doing better now with only a lingering cough.
Pain in legs causing him to not be able to walk; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in legs causing him to not be able to walk) and MYALGIA (Muscle pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in legs causing him to not be able to walk) and MYALGIA (Muscle pain). At the time of the report, PAIN IN EXTREMITY (Pain in legs causing him to not be able to walk) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.
Pt was given vaccines 2/20/12 & started with a rash a few hours after administration. Rash was on arms & legs. Rash was for two days.
RECEIVED VACCINE AT APPROXIMATELY 1PM. FINISHED WORK DAY AND WENT HOME. ARM WAS EXCESSIVELY SORE AT THIS TIME, MUCH WORSE THAN THE OTHER 3 DOSES. ARM ALSO NOTED TO HAVE A LARGE 10CM ROUND AREA OF INDURATION. PATIENT WENT TO BED THAT NIGHT AND WOKE UP WITH A TERRIBLE HEADACHE AND NAUSEA. THERE WAS REDNESS AND HEAT NOTED AT THE INJECTION SITE WHICH CONTINUED WITH REDNESS AND INDERATION. THE PATIENT NOTED SEVERAL IRREGULAR HEAT BEATS, SAYING SHE COULD FEEL HER HEART FLUTTERING.
no adverse effect; the 12 month old patient was inadvertently administered a dose of VARIVAX and PROQUAD on the same day; the 12 month old patient was inadvertently administered a dose of VARIVAX and PROQUAD on the same day; This spontaneous report was received from a licensed practical nurse regarding a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported.   On 06-NOV-2019, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, therapy type: rHa (lot number S003862, expiration date: 08-AUG-2020) (dose, frequency and route of administration were not reported) and with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number S002393, expiration date: 23-JAN-2021) (dose, frequency and route of administration were not reported) both for prophylaxis.
who experienced fever; flu; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a patient that, A patient of unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, post vaccination the patient experienced fever and flu. The reporter wants to know if it's contagious. The outcome of the events was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained.
Client received 3rd dose on 09/07/2021 and saw a lump on left side of the chest on 09/08/2021. Client was seen in Urgent Care and a biopsy was recommended. Client came to notify us in case issues with vaccine. Client schedule to see primary MD next week.
Chills, headache, flu like aches, fever up to 101.5 degrees F even when treating with Tylenol.  Lasted less than 24 hours.
Extreme vertigo/dizziness from day 2-day 16 after first dose. Same timeline for swollen lymph nodes in neck, jaw and teeth pain and headaches.
My symptoms started in the evening of the vaccine.  I started with a headache.  I was in so much pain, my joints were so swollen and felt like they were "on fire".  My doctor admitted me to the hospital I spent 5 days in the hospital and then I spend 2 weeks in rehab.  The doctors diagnosed it a multi system immune inflammatory response.   Everything is inflamed my muscles and my joints.  I had a headache that would not go away.  I went to rehab. Dr.  was the doctor I worked with.
same day patient devloped sever shoulder pain in vaccinated arm, chills, fatigue and cough, She was unable to work the follwoing 2 days due to severity oif her symptoms. She also reports a mild rash at injection site.
The patient received ZOSTAVAX injection on 11/26/12 by 12/1/12 patient began to have symptoms of facial zoster by 12/6/12 this included the right side of her face affecting all 3 trigeminal nerve branches with possible ocular and otic involvement.
Information has been received from a pharmacist concerning a 60 year old female patient with no drug allergies or pertinent medical history who on 21-SEP-2010 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number 664673/0150Z, expiration date 01-APR-2010) in the left arm. There was no concomitant medication. The pharmacist reported that a few days after vaccination, the patient presented with redness and numbness at the injection site. The patient went to the emergency room where she was given an IV of unknown origin and was sent home. No laboratory tests were performed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Shingles-type pain on head; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 10:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, vestibular issues, fibromyalgia. The patient had known allergies to sulfa. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) of 5 mg, mirtazapine (MANUFACTURER UNKNOWN) of 10 mg and cyclobenzaprine (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Apr2021 at 21:30, the patient experienced shingles-type pain on head. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported event. The clinical outcome of the event shingles-type pain on head was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 10-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 18-JAN-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
I woke up unable to breathe, wheezing, throat, swollen, lips, nose and nasal cavity was swollen, hives on face,  stomach and back. My eyes was swollen and itchy, symptoms subsided same day after emergency room visit. I was treated at hospital for side effect and had more adverse effect. Following ER visit I had severe headaches, body pain, disoriented, difficulty articulating. I was having severe anxiety and depression and concerned about my well being.
pt recv vax 24JAN97 & 31JAN97 pt exp a classic case of chicken pox consisting of 100 to 200 pruritic vesicular lesions over body, fever & malaise;subsequently pt recovered;
Vomiting, diarrhea, body aches, fever as high as 102...used a digital ear thermometer and fever was only in left ear, same side of body where I had the shot.  Feeling better today, controlling symptoms with Tylenol.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On or about 12-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On or about 29-AUG-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
fever (no temp taken) 4PM-5PM;chills;stiff joints;tender, sore skin;no pain or redness @ inj site;
Suspected vaccination failure; shingles / No good; have had three shingles vaccine / No good; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingle's vaccine).    Co-suspect products included Herpes zoster (Shingle's vaccine) and Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingle's vaccine, Shingle's vaccine and Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved, and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine, Shingle's vaccine and Shingle's vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided but was captured as adult as per vaccine indication. The patient received 3 doses of Shingles vaccine and experienced shingles a year ago and stated they would not go away. The patient received 3rd dose of Shingle's vaccine, which led to extra dose of administered. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
04/08/21- Sporadically distributed petechial and purpuric rash with recent areas of large macular erythemic confluence on both legs.2nd dose-Pfizer on O4/15/21; Pronounced purpura on 4-23-21 on both lower legs. 3rd dose-Pfizer 1O/14/21, marked increase of rash about 11/03/21. Rash with purpuric confluent patches on both inner thighs with petechiae on both legs, thigh to ankles. On 12/6/21. through 12/31/21; most recent development, left leg extensive macular rash (bright red) on left inner thigh 3'x 8" varigated, also left popliteal area with macular rash. Additional: 1) 2 month period of intermittant pain under left rib area, lasting 30 minutes to 1 hour.  2) Bruise easily 3)lethargy  01/6/22- large confluent patch
Dizziness, Headache, Myalgia, CoughWheeze, Night chills Narrative:
Body aches, chills, fever of 102,  severe headache, stomach  and gastrointestinal cramping. From approximately 9:30 PM on March 24, 2021 until approximately 4 AM March 25, 2021. Took 1000 mg of acetaminophen p.m. at approximately 9:30 PM on March  24 2021. Adverse event symptoms we?re better on the morning of March 25, 2021 with the exception of headache. Took an additional thousand milligram of Tylenol extra strength rapid release at approximately 7:00 AM on March 25, 2021. At the time of submitting this report at 11:30 AM on March 25, 2021 simply have a sore left arm from the injection
pt recvd vax & w/in 30mins post vax exp dizziness;sx persists
Severe headaches ongoing, had chills, little dizzy, sore arm and swelling , very tired and sleepy still, & now left arm has welt like rash  & very red that started today and very itchy-
symptoms after the second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (symptoms after the second dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced VACCINATION COMPLICATION (symptoms after the second dose of the vaccine). At the time of the report, VACCINATION COMPLICATION (symptoms after the second dose of the vaccine) outcome was unknown. Not Provided          relevant concomitant products usage were not reported by the reporter. Treatment details not included.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: No specific follow-up information recorded.
This spontaneous report was received from a physician who referred to multiple patients of unknown demographics. There was no information about the patients concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005552: US-009507513-1709USA005524.
Hives on bilateral legs about 48 hours after vaccination. Fever and "puffy face" 4 days after vaccination. Seen in office the next day. Fever 100.7 unmedicated. Hives upper thighs, anterior trunk, left side of face, and bilateral arms, possible targetoid rash right arm. Possible erythema multiforme vs urticaria. Also some mild viral symptoms including nasal congestion. Rash possibly vaccine related, more likely viral.
He believes he has a history of COVID-19 which occurred from 02Jan2022-15Jan2022; He believes he has a history of COVID-19 which occurred from 02Jan2022-15Jan2022; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): MOD22-029370 (Moderna).  A 78-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 06Jan2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "He believes he has a history of COVID-19 which occurred from 02Jan2022-15Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2020) Positive, notes: He later received an antibody test in Dec2020 which showed strongly positive for covid-19 vaccine antibodies; (unspecified date) Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included, reporter received an antibody test on an unspecified date in Dec2020 which showed strongly positive for covid-19 vaccine antibodies. Reporter believed that he had a history of covid-19 which occurred from 02Jan2022 to 15Jan2022. He took robitussin DM (dextromethorphan-guaifenesin) by day and whiskey by night for his symptoms. But there were no lab tests available at that time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events-Vaccination Failure and COVID-19
Injection sight swelling, redness, itching, burning, hot to touch. Bruising. Swelling area 3x4 inch on upper arm. Head ache and joint aches.
very ill; Initial information received on 06-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves an unknown demographic patient who experienced very ill (illness) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious very ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Flu Shot Fridays the only and ONLY time I ever got the flu jab was around 15 years ago. I became very ill, I think I am all set. P.s. the numbers for flu cases were down to nearly 0 last year across the country. Everything but c 19 just disappeared."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
Pt. came in w/redness and warm to the touch area around injection site. About 6" long 3" W 48 hours after inj. Pt. began to notice redness 24 hour after. Area gets larger each day.
Dizziness, Headache, Myalgia, Tachypnea, CoughWheeze, NauseaVomiting, Palpitations & Tachycardia & Narrative: Patient stated that after receiving injection on 01/06/2021, tasted metal in her mouth. No reaction noted in clinic after vaccine administered. Patient states that after returning home, she began to have chills, headache, and muscle aches. Could not sleep. On 01/07/2021. Patient continued to experience above symptoms. Approx. 13:50 on 01/07/2021. Patient presented with respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was tachycardic. Epi-pen administered via left lateral thigh. Patient administered 50mg of PO Benadryl, and 2 puffs of albuterol inhaler. Continuous V/S initiated. Patient began to experience relief of symptoms. HR and blood pressure remained elevated, but this was expected side effect of epi. SpO2 stabilized around 99% on room air. Patient was monitored for 60 minutes. Transportation home was arranged and family was present to observe overnight.