chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had all her left arm (from shoulder to fingers) difficulty to move after a week.; localized reaction; she had another issue but did not mention what it was; This spontaneous report was received from an unknown female patient concerning herself. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unknown dates, the patient was vaccinated with vaccinated with a first and second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (route of administration, lot number and expiration date were not reported).  It was reported after the first dose of vaccination the patient experienced a localized reaction, on an unspecified date. The patient stated that after received the second dose she had all her left arm (from shoulder to fingers) difficulty to move after a week (mobility decreased). She said that she had another issue but did not mention what it was (Ill-defined disorder). She wanted to know if she would have another reaction if she gets another shot like exempt in limp swelling. The outcome of local reaction, ill-defined disorder  and mobility decreased  was unknown. The causal relationship between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  was unknown.
5 minutes post vax, pt felt tingling in right arm. School nurse checked and found redness at injection site. One day post vax, the pt complained of numbness 2 inches above right elbow to fingertips. Has full use of arm and hand.
This spontaneous report as received from a nurse to a 9 month old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. It was reported that on 08-AUG-2018, a 9 month old patient was vaccinated with GARDASIL 9 (dose, frequency, lot # and expiry date were not reported) intramuscularly for prophylaxis (drug administered to patient of inappropriate age). No known adverse effects reported. No product quality compliant was involved.
Day of injection (10/17/2018): Increasing pain at the site of the shot, spreading to shoulder and neck. Very painful upper arm; sore stiff neck; and headache prevented sleep that night. Did not respond to Ibuprofen. One day later (10/18/2018): Fatigue and mild pain in upper left arm. Two Days later (10/19/2018): Less pain in upper arm. Beginning ca. 11:00 am pain in and around lower left ear. Touching that area or turning the head excruciatingly painful. Duller pain radiated down jaw into neck. Pain persisted for 9 hours.
Changes in menstrual cycle. I was spotting when I received the first shot. I do not recall my cycles in May or June, but it was off in June. I started tracking in July because June was off. I only spotted for 5 days July 24-28, and 4 days Aug 31-Sep 3. Normal cycles for me are spot for 2-5 days, then bleed 4-6 days, then spot 1-3 days. This is every 23-26 days.
Slight fever for first day with dizziness. Dizziness has last for three day so far and is not listed as a possible side effect.
Large red rash at injection site, itchy, warm, firm. Approx. 4" circle.
Information has been received from a physician concerning a 64 year old female who on 16-JUN-2008 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 659487/1960U). On 18-JUN-2008 the patient experienced an injection site reaction after vaccination. She experienced redness, swelling and soreness at the site of injection. It was also noted that the swollen area was warm to touch. The patient sought medical attention at the office. At the time of the report, the outcomes of the injection site redness, swelling and swollen area was warm to touch were unknown. Additional information has been requested.
Hive like rash on all parts of my body.  Starting the Sunday afternoon after vaccination on scalp.  Showing up where my body parts rest against my torso.
right deltoid and upper arm redness, itching, pain started about 5 days after dose #1 into that arm
Shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 2P9XB, expiry date 31st January 2023) for prophylaxis.   The patient's past medical history included covid-19 (the patient was tested positive for Covid on 22nd September 2021, prior of receiving Shingrix vaccine).   On 15th October 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 20th October 2021, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The physician reported that patient received Shingrix on her left deltoid and developed shingles and the shingles symptoms started on 20th October 2021.
Can Shingrix cause a rash?; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had rash. The reporter asked could Shingrix cause a rash.
Sexual dysfunction; This case was reported by a consumer via call center representative and described the occurrence of sexual dysfunction in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sexual dysfunction. On an unknown date, the outcome of the sexual dysfunction was unknown.   It was unknown if the reporter considered the sexual dysfunction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient did not know it was a side effect but when the patient laying with a woman and could not keep it up got to wonder.
Systemic: Nausea-Mild, Additional Details: gave water and asked to sit still and was ok. Patients mom said he is fine
Moderna COVID-19 vaccine 0.5ml given as a booster dose instead of 0.25ml
This spontaneous report as received from a nurse refers to an adolescent patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not specified. In June 2016 (at 13 years of age), the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On 20-OCT-2017, the patient visited an office to be vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. The patient did not experience any adverse events. The outcome of the event was unknown.
Very fatigued; Low grade fever 100.5F; Chills; Upset stomach; This is a spontaneous report from a contactable consumer. A 13-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6207), via intramuscular route of administration in the left arm on 16Jun2021 at 09:30 (at the age of 13-years-old), as a single dose for COVID-19 immunisation. Medical history included ADHD. The patient did not have any allergies to medications, food or other products. Concomitant medications included methylphenidate hydrochloride (RITALIN) and levocetirizine dihydrochloride (XYZAL); both from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6207), via intramuscular route of administration in the left arm on an unknown date in May2021 at 15:00 (at the age of 13-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Jun2021 at 01:30, the patient experienced very fatigued, low-grade fever 100.5F, chills and upset stomach. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 17Jun2021 at 01:30, the patient underwent lab test and procedure which included body temperature and the result was shown as 100.5 F. The clinical outcome of the events very fatigued, low-grade fever 100.5F, chills and upset stomach were resolving at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Hives (urticaria), left arm edema after vaccines administered approx 48 hours after.  Site of symptoms is left deltoid.  Also site of KINRIX.
1/9 - headache, fatigue, chills, low grade fever lasting 12 hours 1/10 - headache and neck pain - still experiencing. Tylenol/ibuprofen not helping. 1/14- contacted clinic to report side effects, they recommended I get tested for COVID 1/15 - COVID test negative. Saw PCP, prescribed meds to help headache, provides slight relief. 1/22- still experiencing headache and neck pain
On 8/28/02 mom states "feels warm no thermometer, low grade temp." Has varicella like rash on back (first area noticed), face (2nd), head, frontal genital area. Circular red spots that blister then crust over and itch. Also has rash on lip and front legs.
I took the shot at 8:30am and took two Tylenol at 9:30 am for headache. At 3:45pm, I started getting a headache that started at the base of my skull and worked upward. I took two Tylenol at that time and it dulled it. At 7:30pm that evening, I got the chills, I covered up with four blankets and finally went to sleep. I woke up the next morning at 5:30am and felt fine except for a sore arm where the injection was given. The sore arm lasted about two days.
Tinnitus both ears -  After receiving the second dose of vaccine, I experience a headache and "ringing in my ears."  The headache subsided the following day but the tinnitus persisted.  It was mild but now is worsening.
felt like when I had the flu; Dark urine/Red urine; Tired; Fever; headache; right lymphedema arm also swelled up; arm pain.; delirious; Kidney pains; wheezy; hot and cold feeling; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (delirious) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Lymphedema. Concurrent medical conditions included COPD and Immunocompromised. Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), TAMOXIFEN, OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and ALPRAZOLAM (XANAX) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced DELIRIUM (delirious) (seriousness criterion medically significant), RENAL PAIN (Kidney pains), WHEEZING (wheezy), FEELING OF BODY TEMPERATURE CHANGE (hot and cold feeling), CHROMATURIA (Dark urine/Red urine), FATIGUE (Tired), PYREXIA (Fever), HEADACHE (headache), LYMPHADENOPATHY (right lymphedema arm also swelled up) and VACCINATION SITE PAIN (arm pain.). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like when I had the flu). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, DELIRIUM (delirious), RENAL PAIN (Kidney pains), WHEEZING (wheezy), FEELING OF BODY TEMPERATURE CHANGE (hot and cold feeling), INFLUENZA LIKE ILLNESS (felt like when I had the flu), FATIGUE (Tired), PYREXIA (Fever), HEADACHE (headache), LYMPHADENOPATHY (right lymphedema arm also swelled up) and VACCINATION SITE PAIN (arm pain.) outcome was unknown and CHROMATURIA (Dark urine/Red urine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Significant follow up received by safety 19-Aug-2021 includes added concomitant medications, treatment medications, added new events, outcome of event red urine changed from unknown to recovered.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Developed Small patch of eczema at throat (nickel sized) when I have never had this condition prior.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 01-MAR-2016 the patient was vaccinated with improperly stored ROTATEQ (lot # L023870, expiration date 20-APR-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm; This is a spontaneous report from a non-contactable pharmacist (patient) through a Pfizer-sponsored program. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Feb2021 as dose 2, single, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Feb2021, the patient had sore arm. The patient had a blood test on an unspecified date (results were not provided). The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Red rash, sore muscle on left arm, flu like symptoms, aches and pains for couple of days with headache and some chills at night, lack of appetite, stayed home and rested about 48 hrs and practically all symptoms gone.
Immediately following injection, patient developed pain at site and described tingling sensation extending down her left arm Two fingers. Within a few minutes, similar sensation extending in left leg to toes.   Speech normal, patient calm, blood pressure 132/89, heart rate 90, 18 respiratory rate. No rash, hives, swelling of face, Lips, tongue, extremities. Patient denied shortness of breath, respiratory difficulty, lightheadedness. Motor strength equivalent bilaterally, ambulate's normally, no deficit reported.    No recent viral infection or previous Covid infection. Client observed for 30 minutes. Recheck at 12:25, blood pressure 127/80, heart rate 90, respiratory rate 19.  Cold pack had been applied to upper arm. Client took her own Tylenol, 400 mg.  Patient stated had to return to work, agreed to check in by text and 15 minutes.
Generalized tonic-clonic seizure. No adverse outcomes. Lasted less than 5 minutes. Evaluated in the ER following the seizure and no abnormalities on exam. She had no other symptoms prior to or after the seizure and remained afebrile throughout.
11-30-2017 developed redness the size of fingertip to wrist. Mother circled the redness with a pen and it went beyond the line, denies fever, pain or vomiting. Mother spoke with a hospital resident on the day that she worked and was advised to just watch the area. 12-4-2017 the area is still warm to touch but the redness has went down and has no other complaints.
difficulty breathing or wheezing, Diagnosed with Asthma, Bronchitis and COPD, given antibiotic and  prednisone swelling of the tongue or throat, or, took Benadryl  a generalized rash or hives, which may include mucus membranes. still dealing with this issue, diagnosed as eczema  Sore Muscles in legs, given cortisone Thrombosis/verrucous veins in legs, swollen feet and ankles, still dealing with no diagnosis
the injection site is red; The injection site is hot; The injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (the injection site is red), INJECTION SITE WARMTH (The injection site is hot) and INJECTION SITE SWELLING (The injection site is swollen) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for an unknown indication.     The patient's past medical history included No adverse event.   On 11-Mar-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 12-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (the injection site is red), INJECTION SITE WARMTH (The injection site is hot) and INJECTION SITE SWELLING (The injection site is swollen). At the time of the report, INJECTION SITE ERYTHEMA (the injection site is red), INJECTION SITE WARMTH (The injection site is hot) and INJECTION SITE SWELLING (The injection site is swollen) outcome was unknown.            Concomitant medication provided was blood thinner. No treatment medications Tylenol and ice pack.
Patient received PENTACEL, PREVNAR 13, ENGERIX and Rotavirus on 1/31/11 and again on 2/18/11 - This was spaced too closely. No adverse response noted. Parents informed. Clinic physician examined patient, prolonged observation period of 20+ minutes.
Presented to the ED with shortness of breath and hypoxia with estimated onset 1/12/22.
COVID ARM-  day 8 after injection, a mild rash appeared at injection site. i am currently on the second day of the rash.  its hot to the touch and slightly itchy, but nothing too major.  about a 1 or 2 out of 10. rash is about 6" by 2.5"
VESICULAR RASH NOTICED BY MOTHER ON CHILD'S TRUNK. 5 VESICLES.
Starting at 15:00 on 2/8/2021, my right shoulder  in the joint area started hurting. Throughout the night it got worse. Pain and numbness up into my neck and tingling in my fingers. Also developed a bad headache with this joint pain.
then 3days after he was tested positive for Covid 19; This is a spontaneous report from contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A male patient of an unspecified age received bnt162b2 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 06Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Mar2021 patient had COVID-19. The patient had his 1st dose on 06Mar2021 then 3days after he was tested positive for Covid-19 and then wanted to reschedule his 2nd dose that was supposedly on the 27Mar2021 because he just got out of the hospital now and they would not let him get the 2nd dose on that day. The patient underwent lab tests and procedures which included tested for COVID-19: positive on 09Mar2021. There were no unaddressed medical questions referred or forwarded to Medical Information. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 74 years old male patient and reported that the vaccine seemed to leak at the bottom where the needle attaches and the suspect vaccine was FLUZONE HIGH DOSE. Concomitant medications included PREVENAR 13. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ023AA) (expiry date, dose in series, route and site of administration was not reported). It was a case of actual medication error due to underdose. No adverse event was reported. 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.
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 04-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
got sick for 2 weeks; Initial information was received on 08-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves patient age and gender unspecified] who got sick for 2 weeks (illness), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, 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 got sick for 2 weeks (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.