chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 24 month old female, with no pertinent medical history, drug reactions or allergies, who on 18-MAY-2006 was vaccinated subcutaneously with 0.5 ml dose of MMRV (Lot # 653203/1138R). There was no concomitant medication. Ten months post vaccination with MMR, in approximately MAR2007, the patient developed a widespread outbreak of chickenpox. The patient was examined on 16 MAR 2007, and was found to have widespread vesicular lesions on bilateral hands, bilateral legs and the trunk. The patient was afebrile. A follow up exam is scheduled for 30 MAR 2007. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.  01/04/08 This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a registered nurse concerning a 22 month old female with no medical history or pre existing allergies who on 18-MAY-2006 was vaccinated subcutaneously into the right arm with a first dose of PROQUAD (Oka/Merck upgrade process) (Lot # 653203/1138R). Concomitant vaccine therapy that same day included a second dose intramuscularly, into the left leg of FLUZONE (Lot #U1788BA), a fourth dose intramuscularly into the right leg with ACTHIB (Lot # UE778AA) and a third dose, intramuscularly into the left leg of PREVNAR (Lot # B0863AF). There was no illness at the time of vaccination. On 16-MAR-2007 the patient presented at the walk in clinic with blister like lesions on the hands, legs, and trunk, and was subsequently diagnosed with varicella. The patient was afebrile. On 30-MAR-2007 the patient presented for a follow up doctor visit with scattered papular lesions on the legs, thighs, belly, and arms with scratch marks. The doctor's impression at that time was scabies. Treatment was permethrin cream. On 07 APR 2007 the patient presented to the walk in clinic with a complaint of a rash, which was diagnosed as allergic dermatitis. On 12 Mary 2007 the patient presented to a dermatologist, with erythematous papules on the right arm and right leg with excoriation. It was the impression of the physician that the patient had probable insect bites. A topical cream (unspecified) was prescribed, along with diphenhydramine hydrochloride elixir for pruritus, as well as calamine lotion. On 13 JUL 2007 a well child visit was conducted, at which time it was reported that the child was recovered. No lab diagnostic studies were performed. There was no product quality complaint. There were no adverse events reported with prior vaccinations: ACTHIB 30-Jun-2005, 16-Aug-2005, 05-Oct-2005, and PREVNAR 30-Jun-2005, 16-Aug-2005, 05-Oct-2005 and FLUZONE 15-Feb-2006.
Patient had swelling and pain, then developed body aches and a low grade fever. Went to urgent care 4 days later pain in lower back-thought had kidney stone. Given antibiotic. Two days later Monday, Oct 16, 2017) "went to urologist & had a CT, & x-rays. It turns out the customer had no infection, so took customer off antibiotic. Then customer went to her doctor and told him she couldn't sleep and still had severe pain everywhere. They did a complete blood work & customers white count was down, so was put on steroids.
itching of palms and neck followed by itchy, swollen hands, hives on her arms, runny nose, watery eyes and redness on neck
This case was reported by a nurse via call center representative and described the occurrence of herpes simplex in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced herpes simplex and vaginal lesion. On an unknown date, the outcome of the herpes simplex and vaginal lesion were unknown. It was unknown if the reporter considered the herpes simplex and vaginal lesion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and about a week after appeared to the office with vaginal lesions which tested positive for Herpes simplex virus - 2. The healthcare professional did not felt that this was directly related to the vaccine itself. This case has been linked with case US2018GSK072794, reported by same reporter.
On Thursday, Feb. 18, 2021, I had my second dose.  About 6 hours after injection, my left arm became sore, just as it did with the initial dose.  However, unlike the first dose, on the next day,  the muscle soreness was accompanied by a  large red rash and swelling  just below the injection site.   Today, the third day, the  muscle soreness is gone, but the rash is still there.   It is tender and warm to the touch, and itches.   I have no fever or other symptoms.
Patient felt dizzy and lightheaded, had brief, 30 sec syncopal episode.  After patient revived, he was observed and given juice.  He felt well enough to leave after about 30 minutes.  Dr. did check the patient, but patient did not need formal doctor visit.
Initial unsolicited report received from health care professional via other company (Pfizer) (Manufacturer Report Number: 2017360783) on 12-Oct-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient experienced allergy to vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
The day after the first shot, my mother had bad knee pain in her left knee. It went on for days/week. After the second dose, days out she started feel very tired and bad pain in her feet that went to her hands and she couldn't get out of bed or urinate properly. Her facility doctor gave her Gabepentin for the pain but it did not help. She declined over a week or so and then She was admitted into the hospital for dehydration (March 19, 2021). The put a catheter in her to get urine out and bring her kidney function back to her normal (she does have kidney disease). Gave her more Gabepentin (which does not help pain in feet an hands) and released her to rehab. and she is now on oxygen.  Rehab was bad so I got her out and released to her facility so she could receive rehab there. She declined again with the same reaction: extreme fatigue, can't walk and now urinates and defecates in an adult diaper and now breathing is very labored.  She was admitted to the hospital and they can't find out why she is in this way. They did blood work, tests, scan and X-rays without any answers. They switched up meds on her and then released her to rehab since she hasn't walked in weeks/month at this point. She is regaining strength but now on oxygen even when sitting. She is 86 and walked with a walker all around her facility and when going to doctor appointments. Now she is in a wheelchair for doctor appointments since she has no strength and needs oxygen to walk. Her facility saw her decline after the second shot and my mom is very vocal and each day told them how she felt awful and it is because of the shot. She still has neuropathy in her feet and hands but it is not as painful as it originally was and it peaked and now just painful about a 5-6 on a scale of 0-10.
Information has been received from a licensed nurse practitioner concerning a 41 year old female who on 17-JAN-2011 was inadvertently vaccinated with PROQUAD (Lot# 666370/0194Z) SC (therapy site unknown), instead of MMR II. The patient was receiving the MMR II as a booster after low titers to one of the disease components were confirmed. Also the vaccine was found to have been stored inappropriately at the time it was given. It had been in the refrigerator for one week. No adverse effects reported. The patient sought unspecified medical attention. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right 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: "Hypothyroid" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: tested negative on days 5, 6 and 7; (2022) Positive, notes: on day 11 and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: If vaccine received: Yes, Other medication in 2 weeks: No. Anti-viral details: Product= COVID 19 Treatment, Brand= Pfizer, Treatment start date= 09Jul2022. Treatment stop date= 13Jul2022, Lot number= Don't know, Indication= Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 2 weeks s/p influenza vaccine, pt developed weakness and myalgia. Symptoms: Myalgia(M791), Weakness (R531).
Pt. is more aggressive and impulsive than pre-injection condition. He also has less cognitive focus as compared to pre-injection condition. Additionally, Item 21 Response is for current 72 hours only. Item 21 Response is subject to change.
Swelling, redness, & warmness at vaccine administration site. On right upper arm were reaction occurred patient's skin is swollen & filled with water.
started w/rash on face;then rash & spots over entire body;fever between 103.5 & 104.5 x 5 days; rash lasted 10 days; baby ASA, cal lotion for rash;baking soda baths
Skin raised with blister like bumps by nose; Very acidy nasal drip/area was sore for a couple of days; Sore area by nose; Small scab by; I got a cold it lasted two days; Lymph nodes achy; Painful swelling by nose; Fatigue; Fever of 101 F; Headache/excrutiating headache between her eyes; Muscle aches after 2nd dose/Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Painful swelling by nose), RASH VESICULAR (Skin raised with blister like bumps by nose), NASAL INFLAMMATION (Very acidy nasal drip/area was sore for a couple of days), NASAL DISCOMFORT (Sore area by nose) and SCAB (Small scab by ) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (right side 10 years ago.).   On 01-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 02-Apr-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever of 101 F), HEADACHE (Headache/excrutiating headache between her eyes), MYALGIA (Muscle aches after 2nd dose/Body aches) and CHILLS (Chills). On 04-Apr-2021, the patient experienced SWELLING FACE (Painful swelling by nose). On an unknown date, the patient experienced RASH VESICULAR (Skin raised with blister like bumps by nose), NASAL INFLAMMATION (Very acidy nasal drip/area was sore for a couple of days), NASAL DISCOMFORT (Sore area by nose), SCAB (Small scab by ), NASOPHARYNGITIS (I got a cold it lasted two days) and LYMPH NODE PAIN (Lymph nodes achy). At the time of the report, SWELLING FACE (Painful swelling by nose), RASH VESICULAR (Skin raised with blister like bumps by nose), NASAL INFLAMMATION (Very acidy nasal drip/area was sore for a couple of days), SCAB (Small scab by ), LYMPH NODE PAIN (Lymph nodes achy), FATIGUE (Fatigue), PYREXIA (Fever of 101 F), HEADACHE (Headache/excrutiating headache between her eyes), MYALGIA (Muscle aches after 2nd dose/Body aches) and CHILLS (Chills) outcome was unknown, NASAL DISCOMFORT (Sore area by nose) was resolving and NASOPHARYNGITIS (I got a cold it lasted two days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101 (abnormal) Fever of 101 F.         Concomitant product use was not provided by the reporter.   ?No treatment information was provided.   This case was linked to MOD-2021-073362 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: New event Cold was added. On 21-Jul-2021: Non-Significant Follow Up Appended
pt recvd vax; pt devel serum sickness-like illness w/ 1st dose of vax; pt devel also migratory polyarthralgia w/ 2nd dose;
lymph node in the right arm that has been swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node in the right arm that has been swollen) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph node in the right arm that has been swollen). At the time of the report, LYMPHADENOPATHY (lymph node in the right arm that has been swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         Concomitant medication not provided.  Treatment information not provided.
Chest pain; Dizzy-headed; Runny nose; Slight headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), DIZZINESS (Dizzy-headed), RHINORRHOEA (Runny nose) and HEADACHE (Slight headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome and Heart disorder (slight heart condition.). Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), DIZZINESS (Dizzy-headed) (seriousness criterion hospitalization), RHINORRHOEA (Runny nose) (seriousness criterion hospitalization) and HEADACHE (Slight headache) (seriousness criterion hospitalization). The patient was hospitalized on sometime in February 2021 due to CHEST PAIN, DIZZINESS, HEADACHE and RHINORRHOEA. At the time of the report, CHEST PAIN (Chest pain), DIZZINESS (Dizzy-headed), RHINORRHOEA (Runny nose) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-060612 (Patient Link).
Patient received the vaccine on 3-20-21 at the clinic and was admitted to Hospital on 4-6-21 with Covid-19 with Acute Respiratory Failure, Pneumonia, and right femoral DVT. She was intubated on 4-7-21 thru 4-21-21. She is in our facility receiving therapies to recover from illness.
mouth,throat and eyes feltweird; slightly itchy in eyes andmouth.; slightly itchy in eyes andmouth.; headache; low-grade fever; not feeling well; mouth swelled; lip swelled; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old non-pregnant female patient 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 01Apr2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have a history of allergies to food, medications, or other products. The patient did not receive any medication within two weeks of COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 16:00, the patient experienced usual headache, low-grade fever and she was not feeling well. On 03Apr2021 (reported as last night at the time of report), left side of her mouth and lip swelled up which was hold up all night. The patient woke up in the next morning, it was swollen. Her mouth, throat felt weird and her eyes felt a little weird on 04Apr2021. Like she was going to have an allergic reaction. The patient felt slightly itchy in her eyes and mouth on 04Apr2021. She was worried about getting her second dose. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events headache, low-grade fever, not feeling well, mouth swelled, lip swelled, mouth, throat and eyes felt weird and slightly itchy in eyes and mouth was not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received a flu vaccine beginning of September. I did not realize until after she got her second flu vaccine. Patient was called and notified.
Client in clinic 4/21/10 for Shingles vaccine. Received ZOSTAVAX live vac. sq (LA) by RD. Given vaccination sheet/shingles. Noticed redness/scalp and itching, rash, enlarged lymph node cheek, 2 wks after vaccination 5/7/10. Went to see PCP 5/12/10 Dx Breakthrough Shingles. Placed on Valtrex tid x 7days. Ibuprofen prn-pain, f/u PCP as needed.
Herpes Zoster diagnosis on 9/30/2014 by Dermatologist at the Hospital. Painful rash in one dermatome. Treated with Valtrex x7 days.
Flu vaccine caused severe bursitis in shoulder as diagnosed by primary care physician more than three weeks after vaccination. Symptoms presented within three hours of vaccine and are still very severe after five weeks. Primary care physician clearly indicated that vaccine was given much too high in the arm.
Patient is a 84 y.o. male with history of dementia, CAD, CHF, Afib, HTN transferred from Psych facility to with chest pain radiating to left arm, work-up unremarkable. Hospital course complicated by COVID and prolonged due to placement issues.   Presumed Dementia with behavioral disturbances Toxic metabolic encephalopathy - (Resolved) Approximately 4-5 months of disorientation, marked paranoia resulting in psychiatric admission.  Family does admit to some memory changes prior  Has had several changes in setting from home, jail, medical hospital, psych hospital, son's house BH consulted: unlikely primary psychological disorder given age, no need for inpatient psych Workup generally unrevealing  Old strokes/microvascular changes on MRI, at risk for vascular dementia  Remains no AMA, Wife is surrogate decision maker but currently in SNF Patient is not able to consistently name a POA Continue donepezil, memantine, nightly olanzapine  Patient needs outpatient neurocognitive evaluation  Discharging to the Facility on Tuesday 2/14 at 11 am    Falls Twice this admit Fall precautions, E companion in place  PT/OT-- AM-PAC 19 Recommend out of bed TID with nursing B12 and folate normal    Vitamin D insufficiency Vitamin D: 29, started replacement   Insomnia  Scheduled melatonin nightly  PRN trazodone    Stable/Chronic or Resolved Medical Conditions Covid 19 infection with Hypoxia (Resolved) -- Required 2L NC, weaned to RA (12/14); treated with Decadron 6 mg (12/12 - 12/22). Isolation ended 12/19 Chest pain -- Troponin negative; EKG a.fib. Cardio c/s, no ischemic testing recommended  CAD S/p CABG (2005) subsequent PCI 2015 Chronic HFpEF -- euvolemic. TTE (10/2022): EF 60%, diastolic dysfunction. Continue Toprol, Cardura, Lisinopril. Lasix stopped d/t AKI, resumed at 20 mg (12/29). Check weekly weights Bradycardia (Resolved) -- HR down ~30's while sleeping / soft pressures  Toprol reduced, stopped clonidine Essential HTN -- Continue home cardura, lisinopril and Toprol w/ hold parameters. Dose of lisinopril reduced (parameters added) for soft pressures  Chronic A. Fib -- Continue home Toprol and Xarelto Abdominal Distention (Resolved) -- KUB no acute, PVR WNL (12/21)  Leukocytosis (Resolved)   AKI and Hyperkalemia - (Resolved) -- Baseline Cr ~1.0; Renal/bladder US (12/25): without obstruction. Follow RFP intermittently. Hypophosphatemia-- (Resolved) --  supplement given Pleural Calcifications  CXR (12/22/22): Extensive bilateral calcified pleural plaquing consistent with asbestos related pleural disease Currently stable on RA  Can follow with PCP OP for PFTs and referral to pulmonology as needed  Constipation Continue bowel regimen
Facial numbness, tingling in the nose, right ear hearing affected. Consulted with doctor's office over the phone daily on 03/03, 03/04, 03/05.
Information has been received from a physician concerning a 66 year old female patient who in September 2009, was vaccinated with a SC dose of ZOSTAVAX (Merck). On 03-JUN-2010, the patient experienced shingles. No lab diagnostics studies were performed. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Was supposed to begin menstrual cycle 1 to 2 days following the date of my vaccination. Menstrual cycle was delayed for 8 weeks. During this time, I did not test positive for pregnancy. There were no other variables, no other medication changes, diet or exercise changes. After several tests, my doctors decided this was most likely a side effect of the vaccination I had received.
Patient came into pharmacy asking about new covid vaccine, stating her last dose was over 6 months ago. She did not have her card on her but was on break (Employee) and stated she would bring card in from car after her shift. Clinical services had host error, RPh did not re-try. STC was not checked due to busniess/help ratio at time of request. Verbal account is considered "acceptable" as current health information from patient, so proceeded with vaccination as patient did not appear confused or hesitant in answering last injeciton date. When patient brought back card; she had her last dose 09/23/2022 and was the bivalent pfizer; currently CDC guidelines only indicate 1 bivalent booster dose at this time. Educated patient that she received TWO doses of bivalent pfizer; and she is only indicated to have one bivalent at this time. Educated her on reporting adverse effects to us following vaccine administration. Was not upset, actually stated she was 79 and diabetic so happy to have an additional dose. Re-educated it was still not indicated for her to have two bivalent doses regardless of age or comorbidities. Will recheck profile not just clin services file folder to avoid this in the future
Information has been received from a physician concerning a 68 year old female patient ("one of the physician's patient's") who on 14-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 15-APR-2011 the patient developed a rash. The rash was unremarkable to start, but at the time of reporting the patient had developed vesicles, consistent with varicella on her left ear. The patient sought medical attention via calling a doctor. The physician had not yet started any kind of treatment and was sending the patient to a specialist for a consult. At the time of reporting, the outcome of the events was not reported. Additional information has been requested.