chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) in 2 weeks included: ZOLOFT, start date: 01May2022; ORTHO MICRONOR, start date: 01Apr2022. The patient was not pregnant at the time of vaccination. 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) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 27Aug2022 and treatment stopped on 01Sep2022, 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.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
7 patients (4 students & 3 adults) recvd PNU-IMUNE intradermally instead of Mantoux, all have least 10mm of erythema & 2cm of induration; 1 adult w/lupus erythematosis had a sl larger rxn;
Pain in my left ovary which is chronic and getting worse; Itchy arm for a week; Fatigue for a month; This spontaneous case was reported by a consumer and describes the occurrence of ADNEXA UTERI PAIN (Pain in my left ovary which is chronic and getting worse), PRURITUS (Itchy arm for a week) and FATIGUE (Fatigue for a month) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADNEXA UTERI PAIN (Pain in my left ovary which is chronic and getting worse), PRURITUS (Itchy arm for a week) and FATIGUE (Fatigue for a month). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form. At the time of the report, ADNEXA UTERI PAIN (Pain in my left ovary which is chronic and getting worse) had not resolved and PRURITUS (Itchy arm for a week) and FATIGUE (Fatigue for a month) outcome was unknown.            No concomitant medication information was provided.
dizziness; itching/small hives on forearm (same side as injection but not at injection site); hives on chin/upper lip; This is a spontaneous report from a contactable pharmacist (patient). A 50-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number:  EK9231), via an unspecified route of administration (arm right) on 02Jan2021 08:15 at single dose for Covid-19 immunization. Medical history included asthma, hypothyroidism, and migraines. Concomitant medications included cetirizine hydrochloride (ZYRTEC), famotidine, salbutamol (ALBUTEROL), fluticasone propionate (FLOVENT), and fluticasone propionate (FLONASE). The patient previously took Keflex [cefalexin] and experienced drug allergies: hives, angioedema. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 30 minutes after the injection on 02Jan2021 (08:45 AM), the patient experienced dizziness and itching/small hives on forearm (same side as injection but not at injection site). Vital signs were measured, all was normal. It was also reported that 36 hours after the injection, the patient got hives on chin/upper lip. The patient was treated with Benadryl, Pepcid, and Zyrtec to stop itching and resolve the hives. Benadryl was taken at home, upon advice from nurse. The outcome of events was recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
pt seen 06jan97 @ around 11:30 am for routine will child visit; recv routine vax; presented to Emergency dept 18 hr after vax w/ apparent SIDS
Act-hib was mixed with sterile water instead of diluent and was administered to 2 patients/ NO AE; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves two patients of an unknown demographics who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] (batch number: UJ138AAA, expiry date: 01-Mar-2021, route and site of administration, dosing detains not reported) which was mixed with sterile water instead of diluent and administered (product preparation error) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient reports having afib lasting several hours, did not seek medical attention. After afib, she reports she started puking, does not recall the amount of times she puked but said it was more than once. After the puking she reports perfuse sweating. The previously mentioned symptoms all occurred and disappeared within about a 12 hour window. After these symptoms, patient reports she was fatigued and had to miss a day of work. Patient states she mostly feels better now.
Information has been received from a nurse concerning a female pt over 70 years old who in approximately the end of March or the beginning of April 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The nurse indicated that a physician had reported that the pt experienced inflammation (area unknown) and was admitted to the hospital. At the hospital, it was determined that the pt had cellulitis. At the time of the report, the pt was still in the hospital and had not recovered. It was noted that therapy with pneumococcal 23v polysaccharide vaccine was "discontinued". It was also noted that the vaccine was not linked directly to the outcome of cellulitis but "it occurred about the same time". A product quality complaint was not involved. Additional information has been requested. The reporter also indicated that the physician had seen "two or three other cases" with similar experiences after therapy with pneumococcal 23v polysaccharide vaccine (WAES # 0404USA00807).
Runny nose; Nasal Congestion; Cough; This spontaneous case was reported by a physician and describes the occurrence of RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal Congestion) and COUGH (Cough) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal Congestion) and COUGH (Cough). At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal Congestion) and COUGH (Cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, SARS-CoV-2 test: positiive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.
Patient became diaphoretic 10 minutes into observation after getting vaccinated. She remained alert and oriented x3. She denied chest pain,  difficulty breathing, itching. Vital signs taken : BP 130/69, HR 89, RR 16, SPO2 99%
It is uncomfortable, but not horrible; Very warm to touch; It was itchy to touch; Appeared a big circular rush in the shoulder area, where the vaccine was administered; Painful at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (It is uncomfortable, but not horrible), VACCINATION SITE WARMTH (Very warm to touch), VACCINATION SITE PRURITUS (It was itchy to touch), VACCINATION SITE PAIN (Painful at the injection site) and VACCINATION SITE RASH (Appeared a big circular rush in the shoulder area, where the vaccine was administered) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Painful at the injection site). On 31-Jan-2021, the patient experienced DISCOMFORT (It is uncomfortable, but not horrible), VACCINATION SITE WARMTH (Very warm to touch), VACCINATION SITE PRURITUS (It was itchy to touch) and VACCINATION SITE RASH (Appeared a big circular rush in the shoulder area, where the vaccine was administered). At the time of the report, DISCOMFORT (It is uncomfortable, but not horrible), VACCINATION SITE WARMTH (Very warm to touch), VACCINATION SITE PRURITUS (It was itchy to touch), VACCINATION SITE PAIN (Painful at the injection site) and VACCINATION SITE RASH (Appeared a big circular rush in the shoulder area, where the vaccine was administered) had resolved.            Concomitant product use was not provided. No treatment was received by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Updated reporter information, patient demographics. Added second dose details  and newevent. The outcome of the event(s)  changed from uknown to recovered.
Died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID:   A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: The patient (boy) got the vaccine and died afterwards.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died
I noticed two days later while I was bathing that my left breast was larger and was feeling sore. I had already spoken to my doctor about my breast after my second shot because it got bigger after that one. However, I noticed it was much worse after the 3rd shot. I have a mammogram scheduled for 11/12/2021. I am currently not experiencing any tenderness in my left breast anymore, but it is still enlarged. I also had slight pulsating headaches after the vaccine, but it may have been caused by the Atorvastatin that I take.
Patient felt dizzy and her left arm, shoulder an part of her neck felt heavy and could not move it.
A little sore arm after the vaccine. He reports it was just where the injection was; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included Allergic to penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On unspecified date of 2021 When providing experience of wife with the Covid 19 vaccine patient reports he also had a little sore arm after the vaccine. Patient reports it was just where the injection was. It was a little soreness, nothing, barely noticeable. Patient did exactly what the pharmacist said took a lot of fluids, drank Gatorade for electrolytes. Patient probably didn't even need to take the Tylenol. The outcome of the event was recovered on unspecified date of 2021.   Information related to batch/Lot no. was requested.
Patient presented to the ED and was subsequently hospitalized for MVA, closed fracture of multiple ribs within 6 weeks of receiving covid vaccination.
This spontaneous report as received from a health care worker refers to a 15 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PROQUAD (Merck). Dose, route, lot number and expiration date were not reported. No adverse effects were reported. Additional information has been requested.
Vaccine received on02/12/2021 Next morning at 8 am pain noted at injection site. 02/13/2021. By 7 pm  site is swollen,  painful and red.
Initially, had swelling and pain at injection site. The next day, the pain turned to an itch. On the third day arm was fine. 4 days after the vaccine, I started experiencing intense acidic reflux (but not sure if related to the vaccine). The reflux has lasted for a week now. Two days ago (Saturday, ie 8 days after the vaccine), the area around the injection site got very swollen, red and hot, with pain and itchiness. It was more itchy than during the first period of the vaccine. Also experiencing, on and off, exhaustion, headaches, light-headedness. According to my watch, my blood oxygen level is at 93%. Today (Monday, 13 days after the vaccine, the injection site is a little swollen, the pain and itchiness comes and goes, still a little hot; also still have acidic reflux, lightheadedness and metallic taste in my mouth.  Some of these symptoms may be related to my IBS.
Within 12 hours of vaccine, developed body aches, nausea, fatigue, fever of 101.0. Fever for 48 hours and nausea and body aches for total of 4 days.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the second 0.5ml dose of GARDASIL. The patient developed hives about 1 day after vaccination. The patient sought unspecified medical attention. The patient recovered on an unspecified date. Additional information has been requested.
Within 10 minutes of receiving the vaccine the patient became hot and sweating and passed out. He was given water, gatorade and crackers and remained seated for about 45 minutes before leaving the pharmacy.
Noticed widespread redness and swelling along the bicep of the arm along the back of the arm. The area was warm to touch. No immediate swelling around the injection site.  Today is day 2 and it is still red and swollen and slightly itchy.
Intense pain to R foot within 12 hours; This is a spontaneous report from a contactable other HCP (patient). A 62-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), via an unspecified route of administration on 29Dec2020 10:30 at SINGLE DOSE for covid-19 immunisation.  Medical history included hypertension, type 2 diabetes mellitus, cerebrovascular accident, Penicillin allergy.  The patient experienced intense pain to R foot within 12 hours on 30Dec2020 01:30 with outcome of recovered with sequelae. Treatment received for the adverse event included: MRI, Ultrasound, Interventional radiology. The patient was hospitalized for intense pain to R foot within 12 hours for 9 days.  The patient underwent lab tests and procedures which included Interventional radiology, magnetic resonance imaging, Nasal Swab test: negative, ultrasound scan.; Sender's Comments: The 62-year-old male patient had medical history included hypertension, type 2 diabetes mellitus and cerebrovascular accident.  The reported intense pain to R foot was more likely due to intercurrent condition/disease, and less likely causally related to the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information, including MRI and Ultrasound findings and Interventional radiology details, become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
PATIENT CALLED THE CLINIC AT APPROXIMATELY 2:30 TO STATE THAT HER FACE WAS RED AND HER TONGUE FELT SWOLLEN. PATIENT WAS ADVISED TO SEEK IMMEDIATE MEDICAL ATTENTION FOR EVALUATION AND TREATMENT. PATIENT WAS SEEN AND TREATED IN URGENT CARE.
Immediately following the shot, my daughter felt dizzy (after the first dose two months ago she fainted) and nauseated. Within 30 minutes she was drowsy. She began to have severe stomach pains and extreme tiredness. She has been sleeping since 5:00 PM. She is extremely tired and lethargic.
BACK PAIN; BURNING SENSATION ON  HEAD, FACE, CHEEKS, NECK, ELBOW, STOMACH, THIGHS AND  HANDS; REDNESS ON   HEAD, FACE, CHEEKS, NECK, ELBOW, STOMACH, THIGHS AND  HANDS; ITCHING ON  HEAD, FACE, CHEEKS, NECK, ELBOW, STOMACH, THIGHS AND  HANDS; BODY ACHES; CHILLS; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced tiredness. On 06-APR-2021, the subject experienced redness on head, face, cheeks, neck, elbow, stomach, thighs and hands. On 06-APR-2021, the subject experienced itching on head, face, cheeks, neck, elbow, stomach, thighs and hands. On 09-APR-2021, the subject experienced burning sensation on head, face, cheeks, neck, elbow, stomach, thighs and hands. On an unspecified date, the subject experienced back pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and tiredness on 05-APR-2021, and back pain, and had not recovered from redness on head, face, cheeks, neck, elbow, stomach, thighs and hands, itching on head, face, cheeks, neck, elbow, stomach, thighs and hands, and burning sensation on head, face, cheeks, neck, elbow, stomach, thighs and hands. This report was non-serious.
tachycardia, papitations lasting 3-4 hours, took extra 25 mg metoprolol
I hadn't been feeling well. Called my Doctor the day after receiving the shot and made an appointment for the first available time (Friday April 2). On Thursday morning I was having vision problems, high blood pressure, weakness on left side. I was rushed to the hospital administered tPA and was diagnosed with a stroke.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown patient demographics. The patients medical history and current conditions is not reported. It was reported that approximately on an unknown date in 2014 (reported as between 5-FEB-2014 and 9-JUN-2014) the patients were vaccinated with GARDASIL of unknown dose and route of administration (Lot # and batch # was not reported) that had been improperly stored. No adverse effects reported. The outcome is unknown. No product quality issue was reported. Additional information has been requested.
Booster dose; Diffuse myalgias to bilateral lower extremities; Urinary frequency; This is a spontaneous report from a contactable other healthcare professional. A 67-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient receive other vaccines within four weeks prior to the COVID vaccine. The patient received multiple unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced diffuse myalgias to bilateral lower extremities and urinary frequency. The adverse events resulted in doctor/other health care professional office/clinic visit. The patient received unspecified treatment for the reported events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events diffuse myalgias to bilateral lower extremities and urinary frequency were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Lymphadenopathy: left lump on left clavicle area, tender touch at injection site, slight redness for 1 day, still has small hardened area under skin at injection site.