chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight dizziness; sore arm at vaccine location; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (slight dizziness) and VACCINATION SITE PAIN (sore arm at vaccine location) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 DIZZINESS (slight dizziness) and VACCINATION SITE PAIN (sore arm at vaccine location). At the time of the report, DIZZINESS (slight dizziness) and VACCINATION SITE PAIN (sore arm at vaccine location) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No Relevant concomitant medications was reported.  Treatment information was not provided.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients received unspecified doses of GARDASIL (lot # K006117, expiry date: 14-JAN-2017) immunization series that were improperly stored. Nurse stated that the dates of administration was presently unknown. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. The case is also related to 1509USA009766, 1509USA009767, 1509USA009768 and 1509USA009769 (same reporter link). Additional information has been requested.
Pain where shot was given, redness & swelling where shot was given, fever over 101F, headache, chills, body aches, weakness, dizziness.
This spontaneous report was received from a consumer (the patient's parent) and refers to a non- pregnant female patient of unknown age. The patient's mother had a cervical cancer. The patient's concurrent condition included anxiety and depression. The reporter stated none drug reactions/allergies. No concomitant therapies were reported. On an unknown date, the patient was vaccinated with a third dose of GARDASIL (exact dose and route were not reported) for prophylaxis or with a dose of GARDASIL 9 (exact dose and route were not reported) for prophylaxis (exact type of human papillomavirus (HPV) vaccine was not specified)). On an unknown date, after the third dose of her vaccine series, the patient experienced unresponsive migraines, unexplained medical problems, gastrointestinal problems, anxiety, depression, she was fatigued and had a muscle and joint pain. The reporter stated, that the patient's anxiety and depression had worsened. She also experienced dizzy spells and panic attacks (on unknown dates), mainly in the previous two weeks, and 3 times in the previous 2 days. The patient was given a treatment for the events. No laboratory test were performed. The patient was not hospitalized . The outcome of the events was reported as not recovered. Causality assessment was not provided.
Injection site pain, bumpy skin/muscle and redness 3 inch across injection site the following day after vaccination.
Information has been received from a physician concerning an 8 yr old male who on 02Oct1997 was vaccinated with a dose of varicella virus vaccine live. On 24Mar05 the pt presented with less than 30 lesions on the trunk and was diagnosed with breakthrough varicella. No treatment was required. It was reported that the pt recovered (date unspecified). No product quality complaint was involved. The physician also reported that the pt's older brother had breakthrough varicella after prior vaccination (associated WAES0504USA00522) and the unvaccinated sister also developed the same varicella rash (associated WAES0504USA00523). Additional information has been requested.
"I" believe the second dose of the vaccine had an interaction with "my" Vyvanse prescription. The next morning, "I" woke up extremely nauseous; Vomited for 8 hours, vomited on at least 20 different occasions during this time period and ran out of stomach contents before puking bile; Then eventually ran out of that in "my" system before dry heaving; Even just drinking water made me vomit again, so "I" could not eat anything.; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 15:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) 20mg for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 15:00 (at the age of 19-years-old), as a single dose for COVID-19 immunisation. On 25Apr2021 at 10:00, the next morning after vaccination, the patient woke up extremely nauseous and vomited for 8 hours until patient took some anti-nausea medications. The patient vomited on at least 20 different occasions during that time period and ran out of stomach contents before puking bile, then eventually ran out of that in her system before dry heaving. Even drinking water made the patient vomit again, so could not eat anything. The patient believed the second dose of the vaccine had an interaction with her vyvanse prescription. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events nauseous and vomited for 8 hours, vomited on at least 20 different occasions, puking bile, dry heaving and included treatment with unspecified anti-nausea medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely nauseous, vomited for 8 hours, vomited on at least 20 different occasions during this time period and ran out of stomach contents before puking bile, then eventually ran out of that in her system before dry heaving, so that could not eat anything were resolved on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Itchy, red, hot, and tender rash from injection site in left arm began 8 days after vaccination.  Redness extended to bisep.  I could fit my hand around the rash.
Left sided weakness, fatigue for 3 days post immunization. Patient was seen by health care provider on 12/30/2020. Provider transferred patient to Hospital ER for further evaluation.
Burning for about 90 sec after injection. Lump at injection site now, slight burning following morning with redness surrounding lump.
This spontaneous report as received from a pharmacist via company representative refers to an unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route, strength not reported). The pharmacist reported that an unspecified patient called into the pharmacy to report that they developed redness at the injection site after receiving ZOSTAVAX. The outcome of the event was unknown. Additional information is not expected since the reporter didn't want to be contacted.
Fever 1.5 degrees higher than normal begining approx 6.5 hours after injection and lasting for several hours. Chills begining approx 6.5 hours after injection and lasting for several hours. Headache beginning approximately 20 hours after injection and lasting several hours
This spontaneous report was received from a licensed practical nurse (L.P.N.) referring to unspecified number of patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with doses of PROQUAD (Merck) (dose and route of administration were not reported) (Lot # K021548, expiration date: 06-MAY-2016; Lot# K022447, expiration date: 13-MAY-2016; Lot# L016395, expiration date: 8-NOV-2016; Lot # L023112, expiration date: 24-DEC-2016; Lot # L030591, expiration date: 10-FEB-2017; Lot# L034931, expiration date: 03-MAR-2017), which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Based on additional information received on 25 September 2015 this case was considered as medically confirmed. Initial unsolicited pregnancy report received from a Consumer (patient) on 02 Feb 2015. A 28 year old female patient (age not reported), had received an intramuscular first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) vaccine (lot number: unknown) in left deltoid on 30 Jan 2015. The patient illness at the time of vaccination was not reported. The last menstrual period was 27 Dec 2014 and estimated date of delivery was 03 Oct 2015. The patient was 5 weeks pregnant at the time of vaccination. On 31 Jan 2015 i.e. one day after vaccination patient had developed redness at injection site with a hard lump and soreness right below the injection site. Corrective treatments were not reported and no laboratory details. At the time of this report, outcome of the events was unknown. Documents held by sender: None. Follow up information received from a physician on 25 September 2015. Patient illness at the time of vaccination was reported as unknown. It was reported that patient had no maternal/paternal/relative history. Previous pregnancies was reported as none. Patient had received prenatal vitamins and Pitocin (during labour) as concomitant medications and other medications was reported as unknown. On 21 May 2015, Prenatal testing included alpha fetal protein test and sequential screen test were performed. Corrective treatment was not reported. Mode of delivery was reported as vaginal and it was reported that there was no complications during delivery. Pregnancy outcome was reported as live birth (normal baby) (male, Apgar score 9/9). it was reported that baby has no congenital anomaly. Additional information about the newborn conditions included breast feeding was reported as yes and baby has no neonate illness, no need for resuscitation, not received any corrective treatment and not transferred to intensive care unit or pediatric department.
Felt hot,  burning sensation across chest, palpitations,  dizziness,  having sensation of everything smelling sweet,  tingling in hands and feet,  hands shaking, slight nausea.  Evaluated by  EMS. Had not eaten  given water and  tea.  Ate protein bar.   Feeling better,  symptoms resolved.  Discharged home at 9:45am.
On February 11, 2 days after my vaccination, I woke up with pain and swelling under my left eye.  Over the next 2 days, the left side of my face under the eye experienced redness and swelling then subsided and localized into a large stye on the lower left eyelid.  Now,  a week later, the stye is still red and pus filled but has improved and is slowly resolving.   I would not normally think that this affliction had anything to do with getting a vaccine but it does seem strange that something like this could occur in someone who is very healthy and and does not experience any side effects from vaccines.   The last time I had a stye was in my 20's and it wasn't nearly as bad as the one I am now experiencing.   Since the Covid vaccine is so new and however unrelated this coincidental affliction seems, I thought I should report it regardless.
stroke; developed neurological symptoms; developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor.; developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor.; developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor.; This is a spontaneous report from a non-contactable consumer. An elderly female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stroke, developed neurological symptoms and developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor. It was reported that the events resulted in hospitalization. It was reported that the patient developed neurological symptoms following the first dose of the Pfizer vaccine. Thereafter she was hospitalized and diagnosed with a stroke and is now home. She received the shot in her right arm and later developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor. She saw her doctor who thought she had had a stroke and send her for an MRI and to see a neurologist who confirmed after the image she had a stroke. The patient underwent lab tests and procedures which included magnetic resonance imaging: stroke on an unspecified date (neurologist who confirmed after the image she had a stroke). Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2022 as dose 4 (booster), single (Lot number: FJ5682), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: NSAIDs" (unspecified if ongoing). Concomitant medication(s) included: SILDENAFIL oral, start date: Dec2017. Past drug history included: Sudafed, reaction(s): "Known allergies: sudafed". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
This spontaneous report as received from a healthcare worker refers to approximately 15 year old patient of unknown gender. On 09-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008840, 1312USA008941, 1312USA008942, 1312USA008943, 1312USA008944, 1312USA008945 (Same reporter link). Additional information has been requested.
15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fever that climbed to 102.7  and lasted 24 hours.  Took acetaminophen. Fever back to normal on 3/16/2021, four days after the vaccination.
Immediately after vaccine was given, she lost consciousness. Arms and legs stiffened, eyes rolled back she had urinary incontinence and made gurgling sounds for a few seconds. Whole episode resolved after a few seconds. Felt fatigued afterward.
Developed Redness at site gradually extending down arm. 1/27/21 10 inches x 6 inches. Mild heat, mild tenderness. No Fever, chills. Benadryl no help. Treated with Augmentin 875 bid x 7d, loratidine
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX, 0.5 ml once, subcutaneous, lot number L006386, expiration date 25-FEB-2017. There was no concomitant medication reported. No adverse events were reported after (Oka/Merck) VARIVAX was administered. This is one of several reports from the same source. Additional information has been requested.
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 30-year-old male patient received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "n/a" (unspecified if ongoing). Concomitant medication(s) included: ESOMEPRAZOLE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive; (23Jul2022) Negative; (26Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that. Patient received Paxlovid for treatment of covid-19,start date 18Jul2022, Paxlovid End Date 22Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 30SEP96 & 6 hr p/vax pt exp t105;6OCT96 pt devel mild rash consisting of 102 papules in a red, indurated area @ inj site;
MILD SWELLING OF TONGUE Narrative: 39 yo female with PMH of headache, GERD, colitis, endometriosis, depression, mixed hyperlipidemia, chronic pain syndrome, low back pain reported mild swelling of tongue during the observation period of her first COVID19 VACCINE and was referred to urgent care. Per urgent care notes, patient had some tongue swelling and has a hx of swelling of tongue in the past and takes OTC Benadryl 50mg for this with improvement. Pt reported fullness to the right side of tongue, no difficulty swallowing or speaking. Pt was given IM diphenhydramine 50mg, symptom improved and patient was discharged. Provider recommended that patient follows up with her allergist to see if the next dose of covid19 vaccine would be appropriate for her. Pt carries an EpiPen and an EpiPen was not required to treat the mild tongue swelling.
Day after vaccine developed fever and URI symptoms. Since then has urticaria and dermatographia.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 07-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Large swollen lymph node on right side of the neck. Noticed about 5-6 days after 2nd shot. As of today, there is no change in the lymph node one way or the other.  Not a major deal, just thought you might need the data! I heard this was a side effect you were learning about. Will continue to monitor and will see the doctor if it doesn't change in a few weeks.
Had stomach ache.  Ended up in the hospital with appendicitis.  Had it removed in surgery. Went home the next day.
Patient received both doses of Moderna Vaccine, last dose on 3/9/21.  On 3/22 patient was admitted to our hospital for dyspnea and hypoxia.  Patient tested positive for COVID.  Xray revealed infilitrates consistent with infectious pneumonia.  Patient received treatment with steroids, remdesivir and antibiotics.  Patient's breathing improved and was discharged on 3/26.  Patient had recovered back to baseline.
Injection site red swollen painful. Hurt to have my arm touching the surface if the bed. By Thursday AM 12/18/2014 woke with very bad headache. Arm painful more swollen and red. Soreness and swelling spreading further down my arm. Nausea body aches  chills. Took 600 MG Motrin and went back to bed around 12:30 pm. Friday felt better but rash/redness still getting larger. Started to itch. Today Saturday 12/20/14 soreness, redness, swelling, itching continues to spread down into the for arm. Can't really scratch because it hurts to touch just rub it. It alternates between pain, tingling, and itching. Sight and the red swollen area is her dish to touch.
Information has been received from a registered nurse concerning a 42-year-old female with no medical history or allergies who on 23-APR-2007 at 10:00 am was vaccinated subcutaneously in the right upper arm with the first dose of VARIVAX (lot# 652725/0249F).  There was no illness at the time of vaccination.  There were no concomitant medications.  On 17-MAY-2007 the patient experienced a rash on her belly and back that was itchy.  Unspecified medical attention was sought.  No diagnostic/laboratory tests were performed.  Also reported by the nurse that in 1993 the patient was immune to varicella, then in 2002 was negative for varicella.  The patient never had the chicken pox and never received the varicella virus vaccine in the past.  No product quality complaint was involved.  Information was received from the registered nurse who reported that on 17-May-2007 the patient's rash was on her stomach and back with 10 vesicles noted.  The patient recovered 21-May-2007.  Additional information is not expected.
Confirmed Breakthrough Case COVID-19 (Janssen) 1 84 Years 6 Months 05/13/2021  Health Department Janssen 1805025
A non-serious spontaneous report of inadvertently administered a dose of H1N1 to 56 year old woman was received from a physician concerning a 56-year-old female. The relevant medical history was not reported for this patient. On 11-Nov-2009, the patient inadvertently received a dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.