chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neuralgic Amyotrophy; Brachial Neuritis; Parsonage-Turner Syndrome in left shoulder/arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 10Jan2022 at 11:30 as dose 2, single (Lot number: FJ683) at the age of 33 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADDERALL. Vaccination history included: pfizer-biontech (Dose Number: 1, Batch/Lot No: 330308D, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 14Dec2021, when the patient was 33-year-old, for COVID-19 immunization. The following information was reported: RADICULITIS BRACHIAL (disability, medically significant) with onset 11Jan2022 at 10:00, outcome "not recovered", described as "Brachial Neuritis"; NEURALGIC AMYOTROPHY (disability, medically significant) with onset 11Jan2022 at 10:00, outcome "not recovered"; NEURALGIC AMYOTROPHY (disability, medically significant) with onset 11Jan2022 at 10:00, outcome "not recovered", described as "Parsonage-Turner Syndrome in left shoulder/arm". The events "neuralgic amyotrophy", "brachial neuritis" and "parsonage-turner syndrome in left shoulder/arm" required physician office visit. Therapeutic measures were taken as a result of neuralgic amyotrophy, radiculitis brachial, neuralgic amyotrophy.  Clinical course as reported: 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. Treatment was Prescribed Amitriptyline. Physical Therapy. Patient had no known allergies. Patient received other medications in two weeks: Adderall. Device timestamp: 14Jul2022.No allergies.
24 hours after flu shot got chills and 96.5ºF body temp.  Slept for 4 hours. Awoke with 101.3º body temp.  Spent rest of day and most next day in bed with fever around 101º.  Fever subsided in evening.  Following day body temp back to normal.  Feel fine today...4 days later.
Patient is a 62 y.o. male patient of Physician with history of COPD, GAD, T2DM, GERD, PAF, HTN who presented with dyspnea, found to have worsening respiratory failure, COPD exacerbation and COVID-19 infection. He improved with steroids, COPD care and was weaned back to his home 2L NC and discharged home.    Acute on Chronic hypoxic/hypercarbic respiratory failure COPD with acute exacerbation Multifactorial, including COVID, volume overload, OSA/OHS Requiring 4L NC on admission, baseline O2 requirement: 2L  CXR w/bilateral interstitial infiltrates, no focal consolidation Resume home Advair; add Spiriva and continue levalbuterol nebs Aggressive pulm toilet   Covid-19 Virus Infection Date of onset of symptoms: 1/15 Symptoms present on admission: Dyspnea, hypoxia, cough Date of covid positive test: 1/16 Vaccination status: vaccinated, booster x1 (11/2021) Imaging: CXR w/bilateral interstitial infiltrates, no focal consolidation Oxygen requirements on admission: 4L NC Current oxygen requirements: 2L NC (baseline 2L at home) Medical therapy: remdesivir and steroids Consultants following: None Anticipated special isolation end date: 1/26   Uncontrolled Hypertension  Secondary to medication non-compliance BP 220/110 on admission Improved on home regimen -- resumed on discharge   Permanent AF Chronic, rate-controlled Resumed home PO Amiodarone, BB, Eliquis   T2DM, non-insulin dependent A1c 6.0  Resume home metformin    Morbid Obesity OSA/OHS
On 4/13/00, had fever X 48 hours. On 4/14/00, dx'd with otitis media and treated Amoxil. On 4/17/00, had ataxia (persistent), also, had viral exanthem on trunk, extremities and face. On 4/20/00, seen by Neurologist and dx'd with encephalitis with ataxia being persistent.
pt recv vax NOV96 & 3 days p/vax pt devel hepatitis w/an AST level of 65, an ALT level of 230, an alkaline phos level of 250, joint aches, & a fever;
Approx 10 minutes after vaccination, she felt very dizzy with elevated heart rate and BP.  Was given Benadryl 50mg po.  Vital signs monitored.  Laid on floor for approx. 30 minutes.  After she returned to work post vaccination (she is a nurse), she again started feeling bad and was monitored there also.
09/06/2023: RN administered 0.5 ML Moderna Bivalent COVID-19 Vaccine to patient during scheduled Nurse Visit today @ 2:05 PM. Patient is 7Y 10M old and per CDC Guidelines should have received 0.25 ML dose of Moderna Bivalent COVID-19. Dr. notified of error. Medical Manager notified of error.   Attempted to contact patient's Mother to inform her of administration dosage error. No answer. Unable to leave message as voicemail not set up. Will attempt to contact Mother again at later time.  09/07/2023 09:21:13 AM MDT >  Spoke to patient's mother. Informed her of COVID-19 Bivalent dosage error. Asked mother if patient experiencing any side effects from vaccination. Mother reports that the only thing patient complained of was that his arm was sore where he received his vaccination. Mother denies patient having any redness, swelling, or rash to injection sites. Mother denies patient having any other side effects from vaccination.  Mother states that patient went to school today. Reviewed with Mother that patient could experience increased general side effects of COVID vaccination as a result of higher dose administered including: soreness, redness & swelling at injection site, muscle/joint pain, headache, fever, nausea, vomiting, rash, loss of appetite. Reviewed signs & symptoms of severe allergic reaction with Mother. Advised Mother to contact Clinic if patient experiences any concerning side effects. Reviewed emergency precautions with Mother and advised if patient experiences any emergent symptoms or severe allergic response to go to ER immediately for evaluation. No further questions or concerns.
Case number PHEH2014US018228, is an initial spontaneous report from the health care professional (medical assistant) received on 08 Sep 2014. This report refers to a male patient of an unknown age. Past medical history and concomitant medication were not provided. He was vaccinated with 0.5 ml of MENVEO (batch number: unknown) intramuscularly on 05 Sep 2014. It was reported that the MENVEO received by the patient had been at 47 Fahrenheit (F) for 10 minutes on 29 Aug 2014. No adverse event reported following this medication error.
baby had generalized rashes on face, legs, body 2hrs after the IM administration by RN, baby also had nasal flaring with pulse ox of 100% in room air as repoted by RN. Most of the rashes resolve by itself the following day but still has some rashes on BLE, chest and some on face prior to discharge on 10/30/2021 and was snorty but pulse ox was 99% in room air, no retractions or nasal flariing noted. instructed to follow up with Dr on 11/1/2021. Baby's parents speak a different language.
Received at 1 year old check up, DTP, MMR, Varivax, PPD test. Noted maculopapular and vesicular rash on back of right leg. 1 week after immunization treatment. Benadryl PO
This spontaneous report as received from a pharmacist refers to a 63 years old female patient. The patient had no pertinent medical history or drug reactions/allergies. The patient was vaccinated with 0.5 ml of PNEUMOVAX23 (lot # 1947AA, expire date 20-OCT-2013) intramuscular on 19-SEP-2012. Patient did not have any concomitant medication. On 19-SEP-2012 the patient developed pain, redness, and swelling at the injection site after receiving PNEUMOVAX23. No treatment was given. No lab diagnostics study was performed. The outcome was reported as not recovered/not resolved. The patient sought medical attention via called to the pharmacist. Additional information is not expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-DEC-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 224, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Temp 103.7. Generalized rash, 7 days after MMR, Varicella IPV given- Could not get temp to go down with Tylenol/Motrin alternation.
COVID 19 BREAKTHROUGH: 91 Y/O FEMAIL PRESENTS TO THE ED WITH THE CC OF HYPOXIC AND INCREASED SECRETIONS X1 DAY. PATIENT WITH PMH OF DEMENTIA, CVA, WITH RESIDUAL R SIDED PAPALYSIS AND NONVERBAL, RECENT COVID, HTN, RECURRENT UTI'S MOST RECENT ENTEROCOCCUS FAECALIS, H/OESBL, GI BLEEDS, NPO AND USES PEG TUBE, HYPOTHYROIDISM, COPD, IDA, PULTIPLE. BROUGHT IN BY EMS FROM (SNF) DUE TO HYPOXIA, OX SATS IN THE 70-80S AND THICKCOPIOUS SECRETIONS. PT WAS PLACED ON 66L AND ONCE BROUGHT TO THE ED TITRATED DOWN TO 3L AFTER SUCTION. UPON MY EXAM, PT IS OBTUNDED. PT DOES NOT TRETRACT TO PAINFUL PHYSICAL.BOOSTER: 3RD DOSE 11/10/21
Developed Cardiac Tampanade and Pulmonary CNusion both lungs Treated at Hospital I was hospitalized for 8 days, I improved, but still have CHF UPDATED JUNE 13, 2021 GREATLY IMPROVED
pneumonia; vitreous floaters; blepharitis; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-APR-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date not provided) as recommended for routine adult health maintenance and for the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered a rash and visual impairment and was diagnosed with shingles, vitreous floaters and blepharitis. In the weeks following these diagnoses, patient additionally suffered and was diagnosed with pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. Causality assessment between the events and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, pneumonia was considered to be medically significant.
Rash under her arms/eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Rash under her arms/eczema) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Eczema.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Rash under her arms/eczema). At the time of the report, ECZEMA (Rash under her arms/eczema) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product  was not provided by the reporter. Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: event was updated as eczema ( previously reported as rash under skin).Patient reported that the event rash under the arms was due to eczema not the vaccine.
have arthritis in her knee on 08Apr2021; This is a spontaneous report from the COVAX US Support. A contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she was scheduled to receive the second dose of the PFIZER-BIONTECH COVID-19 VACCINE on 14Apr2021. She was also scheduled to get a cortisone shot because she have arthritis in her knee on 08Apr2021. The patient asked if it was ok to get her cortisone shot. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
High fever, body aches, nausea, vomiting, headache, and chest pains the fever caused her to start having seizures which she has had under control for over 2 years with her meds
Patient stated she received the flu vaccine one week prior to ED visit.  Unknown which vaccine and the location of administration. Patient presented to the ED with left arm numbness which is the same arm she received the flu vaccine in.
This medically confirmed spontaneous report (initial receipt: 18-Sep-2014) concerns 45-year-old female patient. No vaccine was given concomitantly. The patient received a Flu vaccine last year (identity unknown) without complaints. On 16-Sep-2014, the patient received intramuscular AFLURIA, (batch number not provided) at 0.5 ml. On 16-Sep-2014, the patient had an allergic reaction AFLURIA. She developed redness at the injection site and swollen arm on the arm of AFLURIA injection. The outcome was reported as unknown. Reporter comments: The reporter stated that the events were due to AFLURIA.
Received TD booster  and 24 hours later developed adverse reaction fever max of 104*significant erythema, warmth and tenderness in anterior upper arm, bicep region. min edema, tenderness extends into anterior axillary region as well no local lymphadenopahy. provider informed she could use Tylenol cool compress/ ice to area
Burning sensation on the heels of feet; itching; blisters on different parts of body/blisters are still popping out here & there; rash & blisters on different parts of body; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation on the heels of feet), PRURITUS (itching), BLISTER (blisters on different parts of body/blisters are still popping out here & there) and RASH (rash & blisters on different parts of body) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F20A, 022M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning sensation on the heels of feet), PRURITUS (itching), BLISTER (blisters on different parts of body/blisters are still popping out here & there) and RASH (rash & blisters on different parts of body). The patient was treated with BETAMETHASONE DIPROPIONATE (BETAMETHASONE DIPROPRIONATE) for Adverse event, at a dose of 0.05 percent; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Adverse event, at a dose of 1 dosage form; GABAPENTIN for Adverse event, at a dose of 600 mg and CANNABIDIOL for Adverse event, at a dose of 1 dosage form. At the time of the report, BURNING SENSATION (Burning sensation on the heels of feet) and PRURITUS (itching) was resolving, BLISTER (blisters on different parts of body/blisters are still popping out here & there) had not resolved and RASH (rash & blisters on different parts of body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient's burning and itching was very intense and hence patient soaked feet in ice water. On 05-Oct-2021 after using CBD cream, patient slept four hours for the first time since 22-Sep-2021 as the cream worked well for her. Patient had no reaction to the first and second dose.  No concomitant medications were provided.
Patient developed rash, swelling, itching in vaccinated arm. It lasted 3-4 days then resolved. Patient is currently having no reaction.
Swollen, red deltoid, tenderness at the injection site. Student ran temp from 99.0 to 100.2.
This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. No pertinent medical history and concurrent condition reported. On 25-JUN-2013, 12-MAY-2013 and 07-JUN-2014 the patient was vaccinated with GARDASIL dose 1, dose 2 and dose 3  (dose not reported). No other concomitant therapies reported. No known adverse effects reported. The outcome of the events was unknown. The causality of the events was unspecified. No PQC reported. Additional information has been requested.
Patient received a dose of Moderna COVID-19 vaccine mistakenly for the first dose and he is 14 years old.
Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experience (WAES #'s 0610USA04384, 0610USA04385 and 0610USA04386). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experience (WAES #'s 0610USA04384, 0610USA04385 and 0610USA04386). Additional information is not expected.
Patient passed out while on her 15 minutes of observation after the vaccine , she woke up quickly and  threw up ,she was conscious , her dad was with her all the time, we offered her the  first aids  , she was feeling  well after approximately 20 minutes.
Patient seen 11/23/09 with urticarial rash. As per patient rash appeared 11/5/09 after vaccines were given. Vaccines given 11/509. Td, IPV, Hep B, Flu vaccine H1N1 virus. No previous reactions to vaccines. Patient denies egg or latex allergies.
This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient did not have any preexisting physician-diagnosed allergies, birth defects or other medical conditions..The patient's concomitant medications included atorvastatin. The patient's pertinent medical history and drug reactions or allergies were not provided. On 15-SEP-2017, the patient was administered 1 dose of expired ZOSTAVAX, 19400 plaque-forming units (PFU) vial, lot # M042503 with expiration date on 17-AUG-2017, first dose, subcutaneously (exact dose and anatomical location were not reported). The expiration date was not checked by the pharmacist before administration of ZOSTAVAX and the expiration date in a computer was not updated (was wrong). It was reported that the medication error occurred also at the point of administration and preparation for administration. The lot number of the sterile diluent used for reconstitution was M024765 with expiration date on 20-FEB-2019. The patient was not given any other vaccines within 4 weeks prior the date of vaccination with ZOSTAVAX. No adverse effects or reactions occurred, the patient had no bad experience. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA008191:
Afib; PVCs; atrial flutter; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant), VENTRICULAR EXTRASYSTOLES (PVCs) and ATRIAL FLUTTER (atrial flutter). At the time of the report, ATRIAL FIBRILLATION (Afib), VENTRICULAR EXTRASYSTOLES (PVCs) and ATRIAL FLUTTER (atrial flutter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  Company Comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Pain at the site of where she had Tdap injection . Pain started the day after she got the injection and has persisted without relief.  Pain is worse with lifting up her arm  No swelling or redness  Has never had this reaction before She has put ibuprofen and ice on it without relief. MD Assessment on 2/28/23:  Full ROM right shoulder, TTP over the biceps at injection site, Mild local reaction likely to Band-Aid, No obvious bruising