chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TOOK VIVOTIF WITH FOOD; A spontaneous case report was received from a nurse on 10-Jan-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX2019-089 (PVX201901-000027; husband) and PVX2019-090 (PVX201901-000028, wife) were created and cross-linked in the database.  This case report describes an adult male consumer who "took Vivotif with food". The consumer was receiving Vivotif for unknown indication.  It was reported that the consumer took the three out of four doses of Vivotif with food.  The action taken with Vivotif with respect to event "took Vivotif with food" was not applicable.  The clinical outcome of the event "took Vivotif with food" was unknown.  Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000028:
W/in 1 hr of receiving immunizations, PT developed fussiness, mild facial urticaria and local redness and swelling of her right deltoid area. She was seen in the office and given Benadryl.
As per death summary, Pt. succumbed to complications of contracting COVID-19 virus.
Suspected vaccination failure; Shingles/ I got 2 vaccines and still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/ I got 2 vaccines and still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 09-Jul-2023 This case was reported the patient via interactive digital media. The patient got the 2 vaccines and still got it. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Patient is a 75 y.o. female patient of MD with history of essential hypertension, hx of  gastric ulcer, remote leukemia in remission presented to local Hospital with complaints of nausea/vomiting. She was followed by surgery and s/p EGD with no acute finding. She got 2 units PRBCs transfusions and Hb 8.4 at discharge. When she progressed, she was discharged home with advice for OP f/u with her physicians as instructed   Nausea and vomiting-resolved Hx of peptic ulcer and NSAID use at home Etiology likely COVID19 infection COVID-19 test as positive  s/p IV fluids, antiemetics S/p negative EGD on 2/28 avoid NSAIDs Tolerating diet OP PCP f/u as instructed   Symptomatic anemia Iron deficiency anemia  Hemoglobin on admission 6.9, negative stool studies No history of melena, hematochezia or hematemesis MCV strikingly low consistent with IDA S/p 2 unit PRBC and Hb 8.4 at discharge S/p venofer IVPB x1 and oral iron sulfate S/p negative EGD on 2/28 Last C-scope over 10 yrs back C/w iron on discharge Appreciate general surgery input and management OP f/u with surgery for C-scope as instructed   Acute urinary tract infection Positive nitrates and leukocyte esterase Started on ceftriaxone, changed to keflex on discharge      Covid-19 Virus Infection Date of onset of symptoms: 48 hours Symptoms present on admission: Nausea vomiting Date of covid positive test: 2/20/2023 Vaccination status: vaccinated Imaging: Chest x-ray showed no acute pathology Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not a candidate Consultants following: None Anticipated special isolation end date: 3/10/2023 Elevated LFTs- improving Likely secondary to underlying viral infection History of cholecystectomy CT without evidence of acute pathology Supportive care, IV fluids     Hypokalemia K 3 >3.9 today Replaced  SIRS due to COVID 19 infection, POA-resolved Sepsis ruled out Suspect combination of viral infection, and nausea/vomiting Not in sepsis, normal lactic acid   Essential hypertension Resume home losartan Blood pressure fairly controlled monitor     Generalized weakness Physical deconditioning PT/OT followed here
5:45p: patient made a noise and got stiff for about 60 seconds (no longer than 2 minutes). Arms, legs, and hands stiff. No shaking. Mother rolled him on his side and he started crying when stiffness ended. No postictal period. Told mom he felt like he got "hit in the head" and his legs hurt. Mother took him to urgent care - no fever noted.
Woke up morning after vaccine with under left arm in armpit area swollen and painful. Swelling and pain have been present for two days as of now.
Headache, Sedation, Fever, NauseaVomiting, CHILLS AND PAIN, SORE THROAT Narrative:
Fully vaccinated with CV19 positive via PCR test; Fully vaccinated with CV19 positive via PCR test; This is a spontaneous report from a contactable healthcare professional.  A 28-year-old (also the age at time of vaccination) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 27Mar2021 (Batch/Lot Number: EP6955) as DOSE 1, SINGLE then on 17Apr2021 (Batch/Lot Number: EP6955) as DOSE 2, SINGLE both given intramuscularly administered on arm left for COVID-19 immunization at workplace clinic. Medical history and concomitant medications were not reported. On 27Aug2021, the fully vaccinated patient with COVID-19 vaccine was noted to be positive via Nasal Swab (PCR test) on that same day of 27Aug2021.  The event requires doctor or other healthcare professional office/clinic visit. The patient was recovering from the events.
14 year old patient with pulmonary disease was supposed to receive Pneumovax 23 but in error was given Prevnar 20; This spontaneous report was received from a nurse and refers to a 14-year-old patient of unknown gender. The patient's concurrent conditions included lung disorder. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated in error with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, vaccination schedule, lot #, expiry date, site and route of administration were not provided) instead of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (strength, dose, vaccination schedule, formulation, lot #, expiry date, route of administration, and indication were not provided) (Wrong product administered).
Pt reports R shoulder pain like strain from 1/20/05, progressive pain to restricted motion by 2/5/05, required ED eval/treatment. Since then had neurologic orthopedics work up, have led to acute brachial neuritis. Report by Peripheral nerve surgeon: Shoulder pain after shoveling and fishing. Intense pain seen in ER and given narcotics. Slept with arm over head because it was the only way he could get any pain relief. 2/17/05 cannot lift arm. Secondary shoulder instability secondary to deltoid weakness. EMG right axillary nerve damage. Absent lateral and antebrachial response. CT/Mylogram- no significant impingement. Wing of left scapula. Right FLP 5/5. Only long head is palpable. With exertion active vesiculation of supraspinatus, right external rotation 05, exertion 5/5, wrist and finger 5/5. Prognosis: Acute onset right axillary and supra scapular nerve palsy with motor involvement. With EMG appears brachial plexus level. History of related palsy on the other side. Differential diagnosis: Parsonage Turner Syndrome, Motor Neuritis Multiplex, HNPP, Presence of Tineal Sign right supraclavicular fossa suggest some nerve regeneration. This is a challenging problem that may not be amenable to surgery.
rash all over hands and forearms. no itching present. still persisting 10 days later. patient advised to take antihistamine until clear.
I got up at 06:00 and sat up and I felt body aches and headache. As the morning went on, I took a couple of Tylenol and went back to sleep. I felt dizzy and nauseous when I woke up - with body aches. That went on the whole day. I stayed in bed all day. I felt like I had been drugged. By 05:00 pm, I decided to go downstairs and I felt really hot and went out to patio and sat down. I had laid my head back and I guess I had passed out - eyes had rolled back into my head. My daughter called Paramedics - they did some tests and then helped me back to my bed. My daughter gave me another Tylenol - I still felt achy, nauseous and headache. The next morning, I felt a little better. The third day - was still really tired and weak. I finally came downstairs to work on Thursday. I still felt like my energy was drained but the achiness, headache and nausea were going away on Wednesday and Thursday. But I was still tired. By the weekend, I started getting better. I didn't go anywhere but I was feeling much better than I had.
Vaccinated arm was a bit sore; feel a bit tired; This is a spontaneous report from a contactable consumer. A female patient of an unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 09Apr2021 the patient experienced vaccinated arm was a bit sore and felt a bit tired. It was unknown if the patient received treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccinated arm was a bit sore and felt a bit tired was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moaning while sleeping woke her up very high fever over 103.5. Taken to ER, given 2mg Motrin. Fever decreased to 102.9. Gave alternating doses Tylenol/ Motrin every 4 hours. Fever went completely away 24 hrs later.
pt recv vax & devel an inj site rxn characterized redness & induration;pt was seen by MD & recovered;
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. Medical history included asthma from an unknown date and ongoing,  cholesterol. Concomitant medications were not reported. Long time ago prescribed for cholesterol, had pain all over body (patient does not remember name of medication). Two hours after having the vaccination (on unknown date), the patient experienced heart palpitations lasting about 1 hour with outcome of recovered, aches and pains all over with outcome of recovering, felt like she was getting flu with outcome of unknown, difficulty breathing, like pneumonia or worsening of my asthma with outcome of unknown. Therapeutic measures were taken as a result of difficulty breathing, like pneumonia or worsening of my asthma included VENTOLIN 10 times a day. The information on the lot number has been requested.
Blurry area in center of visual field. Sudden onset. Vision changed to "2D". Had to move head to side and read out of corner of eyes to make out words. Denied headache, nausea, vomiting, no change to speech, hand grips equal bilaterally. Denied sudden changes of movement prior to symptoms. Nothing new or unusual for lunch 2 hrs prior. Sat down to rest, drank bottle of water. Symptoms resolved within an hour. For rest of work day stated could not concentrate, made silly mistakes. Developed slight headache after other symptoms resolved. No obvious symptoms later in evening or morning after.
Severe heart palpitations; Fever; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Severe heart palpitations) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 03-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) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tired). On 14-Apr-2021, the patient experienced PALPITATIONS (Severe heart palpitations) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 14-Apr-2021 due to PALPITATIONS. At the time of the report, PALPITATIONS (Severe heart palpitations) outcome was unknown and PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Angiogram: normal (normal) Normal. On 04-Mar-2021, Blood pressure measurement: (High) Increased. On 04-Mar-2021, Cardiac stress test: normal (normal) Normal. On 04-Mar-2021, Electrocardiogram: normal (normal) Normal. On 04-Mar-2021, Heart rate: elevated and (High) Increased. On 04-Mar-2021, Magnetic resonance imaging: normal (normal) Normal. In April 2021, Blood pressure measurement: (High) Elevated. In April 2021, Heart rate: elevated High.         Comments from  the patient: Yesterday 14APR2021 I had severe Heart Palpitations and I was taken to the Hospital. I called an ambulance and they brought me to the Emergency Room. The Doctor performed an EKG and my heart was in normal condition.  I received my second Moderna Covid-19 vaccination on 3MAR2021.By 5PM on 3MAR2021 I had a Fever, Chills, was tired, I woke up at 6AM on 4MAR2021 with an elevated Heart Rate and elevated Blood Pressure. I went to go see my Cardiologist that day and he sent me right to the Hospital. I spent 2 days and 1 night in the Hospital. MRI, MRA, Stress Test, EKG were performed and all tests were normal. I was discharged from the Hospital on 6MAR2021. Then I came home and was fine until early April when my elevated heart beat, elevated blood pressure, and heart palpitations started again. My Cardiologist started me on Diltiazem 30mg three times per day.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Crossinked with First dose case
Fever 102.0 R in office; no crying or syncope; In evening @ home reported temp inc to 106;
At 0958 AM, the patient felt light-headed in the observation room. The patient was taken to the EMS. Water and icepack given @1013 AM. @1035 AM, the patient felt okay and lightheadedness subsided. The patient left @1037 AM without issues.
Muscle spasms, pain, and weakness throughout body, beginning the day after the shot and exacerbating exactly one week after reception of the shot-- doctor prescribed muscle relaxer and painkiller to treat; sciatica-- beginning exactly one week after reception of the shot, likely brought on by the muscle spasms-- doctor prescribed the above medications and physical therapy
This spontaneous report was received from a pharmacist refers to a patient of unknown age. Patient's pertinent medical history and drug reactions were not reported. On 30-JAN-2015 the patient was administered with an expired dose of ZOSTAVAX (lot # J011338, expiration date: 19-DEC-2014). Concomitant medications were not reported. On the same day patient experienced expired product administered. The patient who received the ZOSTAVAX did not reported any adverse effects. No product quality complaint (PQC) was involved. Reporter considered the event, expired product administered to be not related to ZOSTAVAX. Additional information has been requested.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative and from a contactable nurse. A 17-year-old male patient received the first dose of TRUMENBA (Lot M74090, expiry date 30Jun2017, NDC number 0005-0100-10), intramuscular at 0.5 ml, single in the left arm on 31Aug2016 at 11 AM for immunisation. Administration of any antipyretics prior to vaccination: no. Illness at time of vaccination: generalized abdominal pain. Medical history included gall bladder issues. Concomitant medications were not reported. The patient experienced facial swelling on 31Aug2016 and swollen eyes, puffiness under his eyes on 01Sep2016, all with outcome of recovering. The events were described as follows: at 20:00 on 31Aug2016 the patient developed facial swelling, no other symptoms, no respiratory problems, and then the next day when he woke up (about 20 hours after vaccination) he still had swollen eyes, puffiness under his eyes. The events did not require an emergency room, physician visit, or treatment. Probably the patient will not receive the 2nd vaccine dose. Cultures and other diagnostic tests: no. The reporting nurse considered the vaccine had a causal effect to the adverse events. Follow-up (12Oct2016): New information from a contactable nurse includes: illness at time of vaccination, events onset time and details, reporter causality assessment.  Follow-up attempts completed. No further information expected.
dose number: 1, brand other: Janssen ; dose number: 2, brand: Pfizer / BioNTech; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 30Dec2021 at 15:15 as dose 2 (booster), single (Lot number: FL3197) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 21Mar2021 as dose 1, single (Lot number: 1808609), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Known allergies: Sulfa quinolones (antibiotics)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "dose number: 1, brand other: Janssen ; dose number: 2, brand: Pfizer / BioNTech"; 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 19Aug2023 to 22Aug2023.
5 min after vaccine administration the entire right arm tingled.  That faded within 2 min, at which point the tongue started tingling on both sides.  At 18 min post-vaccine, patient spoke to pharmacist and was advised the tongue tingling was not an expected or documented side effect; the pharmacist requested that the patient stay an additional 5 min for monitoring.  During that 5 min, a mild rash appeared on both forearms and tops of both hands.  Pharmacist advised patient to take bendaryl and monitor for any further adverse symptoms.  When patient reached vehicle, she noticed that her face was bright red and rash had appeared on part of neck and chest.  Benadryl was taken at roughly 55 min post-vaccine. 1.5 hrs post vaccine, patient noted some of the rash had disappeared, the face tingling had stopped, and the tongue was less tingly.
postherpetic neuralgia; hearing loss; balance problems; multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the vaccine, the pt suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, hearing loss and balance problems. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the pt 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), the pt had 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. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant. The lawyer considered all the events to be disabling.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age. From 21-JUL-2017 to 07-AUG-2017 the patients were vaccinated with improperly stored doses of VAQTA lot # N005796 for prophylaxis. Sender's Comments: US-009507513-1708USA012473.
Approximately one hour after injection, she developed hives and itching generalized across body; next day they ulcerated and opened up; lasted 5 days; 10 days later she developed fever to 103 with cervical adenopathy, generalized myalgias and torticollis that lasted 3 days
Last Thursday I woke up with a little bit of a sore throat and a mild headache. As the day progressed, I got a runny nose and the next day I started to have a small cough. I felt like I had a cold. On Monday I started to feel better but by Wednesday I feel like I have a head cold and a small cough. I test on Friday, and it was negative. I tested again on Monday. I called my doctor and he wanted to prescribe Paxlovid and I declined. I am taking Claritin once a day and I have taken 1 Advil when I get a headache. I am still in the process of recovery.