chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 20-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
The decedent had significant medical conditions. The wife stated, the appointment for the vaccine shot was made on-line.  Dept. of Health visited their home on 3/16. The shot was administered into the decedent's left arm at 0930hrs. The decedent expressed no health complaints and had no visible indications of adverse affects. The decedent was found not breathing supine in bed at 2347hrs 3/16 (same day as vaccine shot).
Rashes on arm and chest; have rash all across chest and down opposite arm that I got the vaccine; This is a spontaneous report from a contactable female consumer (patient) via Pfizer-sponsored program Support.   A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EW0185, expiry date: unknown), via unspecified route of administration, administered in left arm on 13May2021 at 15:00 (at the age of 24-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. It was unknown that the patient was pregnant at time of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0170, expiry date: unknown), via unspecified route of administration, on 22Apr2021 as a dose 1, single for covid-19 immunization. On 13May2021, the patient experienced rashes on arm and chest; have rash all across chest and down opposite arm that patient got the vaccine. The rashes were coming with the second dose and she was experiencing rashes on her arm and chest. She just got the second dose today around 15.00. The patient did not receive any treatment for the reported event. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected
Right side of body (leg foot hand arm cheek neck torso ear, etc.) experienced tingling sensations, numbness, some burning sensations, mostly cold feeling, weakness ( like moving through water) sensations have lessened in two days, but minor sensations and weakness persist.  monday (12/21/2020) visited the  E.R. for exam and testing.  E.R. doctor reported current testing normal. 12/23/2020 visited normal  MD to go over results from previous testing and get checkup.
local reaction at injection sight. Some redness, swelling, soreness; local reaction at injection sight. Some redness, swelling, soreness; local reaction at injection sight. Some redness, swelling, soreness; local reaction at injection sight. Some redness, swelling, soreness; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer (patient) and transmitted to Sanofi on 15-Dec-2020.  This case involved a patient who experienced local reaction at injection sight, some redness, swelling, soreness (vaccination site reaction), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, past vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced local reaction at injection sight, some redness, swelling, soreness (vaccination site reaction, vaccination site erythema, vaccination site swelling and vaccination site pain), unknown latency following the administration of INFLUENZA VACCINE.  It was reported that it usually resolves in day or two. No big deal.  Relevant laboratory test was not reported.  Final diagnosis was vaccination site reaction with symptoms such as vaccination site erythema, vaccination site swelling and vaccination site pain.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient was recovering from the reported events.  There would be no information available on batch number for this case.
Mother of child reports s/s of anaphylactic reaction to H1N1 immunization received at school clinic on 1/25/2010 - "he came home from school with "wheezing, whelp w/2 red streaks near site of injection, larger area of erythema over left shoulder, hives on chest, pulse 02 87%, temp 99.5. Mother administered inj w/epi pen and 12.5 mg Benadryl, repeated epi and benadryl in 3 hours and started breathing tx per pvt Dr's Rx with Xopenex (1.25 mg/3 ml vial X 2 via nebulizer. Started child on prednisone dose pack.
pt recv vax 10OCT95 or 12OCT95 & exp pain @ inj site;health care professional also reported several other pt who exp pain @ inj site following vax WAES96040713;
Joint pain; Fatigue; headache; Muscle pain; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle pain) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle pain), NAUSEA (Nausea) and PYREXIA (Low grade fever). At the time of the report, ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle pain), NAUSEA (Nausea) and PYREXIA (Low grade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient was taking insulin. Patient treatment information was not provided.
A report received from a health professional concerning a neonate, female patient, height: 18.5 centimeters; weight: 8.0 pounds. No information regarding relevant history and concomitant disease was provided. Concomitant medications included ascorbic acid, biotin, minerals nos., nicotinic acid, retinol, tocopherol, vitamin B nos., vitamin D nos. The patient received transplacental FLUMIST QUADRIVALENT when the mother received FLUMIST QUADRIVALENT (intranasal) on 17-Nov-2014. The patient experienced newborn pneumonia of maternal abruption which occurred on 06-Aug-2015. The outcome of the event of newborn pneumonia of maternal abruption was unknown. The outcome of the pregnancy was reported to be a non-healthy baby. The AZ physician identified the event newborn pneumonia of maternal abruption from the source document and assessed as serious due to hospitalization.
sore arm at point of injection immediately  afterwards belly pain and light nausea beginning the afternoon of the second day post injection severe nausea  third  night post injection including dry heaves chills accompany nausea diarrhea  and lethargy
Information has been received from a 75 year old female consumer with cancer, heart problems, cholesterol, high blood pressure and diabetes, who on 31-DEC-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # unknown). Concomitant therapy included bisoprolol, allopurinol, WELCHOL, LOVAZA, losartan potassium-HCTZ (MSD), metformin, sitagliptin phosphate (MSD), warfarin, PREVACID, TRANXENE, ARIMIDEX, K-LYTE, ZAROXOLYN, "lezodipan" and "poorsimide". The consumer reported she had a half dollar size circle on the right arm, and the dot where the vaccine was administered was red and irritated. She also mentioned she thought the vaccine was administered in the wrong place. She mentioned it was administered four inches up from the elbow. There were no lab diagnostics studies performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Pt recvd 1st dose of Hep B on 26FEB91 & 24 hrs following vax pt devel severe h/a, nausea, vomiting, & diarrhea; h/a was severe for the next 18 hrs; pt treated self w/6-8 extra-strength acetaminophen; 36 hrs later sx resolved; cont fatigue;
pt recvd vax; GBS starting w/ numbness & tingling fingers; progressed to inability to walk;
Information has been received from a physician concerning a female who on 14-JAN-2008 was vaccinated "by injection" with Gardasil (lot # not reported). Subsequently the patient developed a knot at injection site. The patient sought unspecified medical attention. Therapy with Gardasil vaccine was discontinued. The knot at the injection site persisted. Additional information has been requested.
Had COVID; Had COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had COVID".  Clinical course: That I had my COVID shots and subsequently had COVID but a relatively mild case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Basically: It seems relatively likely there is some neuropathy that may be piriformis/IT related but I cant assess it fully w the PE burden, weight, and his knee safety (and even if I could be cant do the stretches right now) but I would guess its neuropathy w some piriformis tightness worsening it. Then large burden PEs, many, days later, negative covid x2, up to date cancer screenings, no fhx PE/lupus/hypercoag/cancer.  56yo morbid obesity and R knee fx, presented here w SOB and found to have multiple large Pes. Story as follows: recieved second dose moderna 9/1, 9/2 he had tingling in his R knee w some swelling and joint pains more diffuse. He has baselie chronic R knee pain after accident at six flags w acl tear, meniscus tear, and fx after the boat ride accident in 2016 and he uses a L handed cane since. This progressed and by 9/3 there was R hip pain, and tingling, by 9/5 tingling in both LE b/l and weakness, the toes felt numb and the R hip pain was worse. He went to an ED and was palced on muscle relaxant steroid injection and po steroid, no benefit, came to our ed and had ct a few days after negative again steroid injection given. 2 days ago sob worsened and he had xray at medstop, sent home. Presented here elevated DD and significant PE burden. He has some LE swelling at baseline but this is more than usual and he is easy out of breath more than usual. Normal colonscopy 6 months ago anf no fhx of cancers or blood clots.
cant' taste; loss of smell/I have hard time in smelling/cant' smell; low-grade fever/fever; body aches; fatigue; This is a spontaneous report from a contactable consumer (patient).     A 23-years-old male patient received first dose of bnt162b2 (BNT162B2; Batch/Lot Number: FA7484), via an unspecified route of administration, administered in Arm Right on 27Jul2021 17:00 (at the age of 23-year-old) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient experienced cant' taste (ageusia) (medically significant) on 30Jul2021 with outcome of not recovered, body aches (non-serious) on 28Jul2021 with outcome of recovered, low-grade fever (non-serious) on 29Jul2021 with outcome of recovered, loss of smell (anosmia) (non-serious) on 30Jul2021 with outcome of not recovered , fatigue (non-serious) on Jul2021 with outcome of recovered.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 23Jul2021, sars-cov-2 test: negative on 26Jul2021.
DID NOT CONTINUE VIVOTIF ON TIME AFTER TAKING TWO DOSES; This spontaneous case report (PVX2019-2694) was received from a non-healthcare professional on 29-Oct-2019. It described a male consumer who "did not continue Vivotif on time after taking two doses" (PT: Incomplete course of vaccination), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took only first and second dose of Vivotif on 14-Oct-2019 and 16-Oct-2019 respectively. Later, he did not take the remaining doses.  Action taken with Vivotif with respect to event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not continue Vivotif on time after taking two doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not continue Vivotif on time after taking two doses" was considered as not applicable.
no other AE; an expired adult V AQTA given to 12 yo; an expired adult V AQTA given to 12 yo; This spontaneous report as received from a medical assistant refers to a 12-years-old patient of unknown gender. The patient's medical history and concurrent condition were not reported. On 04-SEP-2020, the patient was vaccinated with a dose of 1 ml of adult hepatitis a vaccine, inactivated (VAQTA) (pre-filled syringe, lot # S007265, expiry date: 07-JUL-2020, route of administration not reported). No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S007265; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Positive rapid antigen test rebound on Day +4 after finishing the 5-day course of Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive rapid antigen test rebound on Day +4 after finishing the 5-day course of Paxlovid) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced COVID-19 (Positive rapid antigen test rebound on Day +4 after finishing the 5-day course of Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive rapid antigen test rebound on Day +4 after finishing the 5-day course of Paxlovid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative on day 5 of Paxlovid treatment and positive (Positive) Positive rapid antigen test rebound on Day 4 after finishing the 5 day course of Paxlovid treatment..         No concomitant medication information provided. No treatment medication information provided.  On 08-Dec-2021, the patient received booster dose of Moderna COVID-19 Vaccine.  Patient tested positive for COVID-19 on day 4th of Paxlovid treatment. After finishing the 5 days course symptoms were cough and congestion which was persisted steadily during that time. Rapid antigen test returned negative on the day 5 of paxlovid treatment.  Company Comment: This spontaneous case concerns a 26-year-old female patient, with Co-suspect drug Paxlovid, who experienced the unexpected ADR of COVID-19. The event occurred approximately 5 months after receiving the third dose of mRNA-1273 Vaccine. The patient was treated with PAXLOVID for COVID-19, however the patient had persistent symptoms of cough and congestion and tested positive again after 4 days of treatment. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 26-year-old female patient, with Co-suspect drug Paxlovid, who experienced the unexpected ADR of COVID-19. The event occurred approximately 5 months after receiving the third dose of mRNA-1273 Vaccine. The patient was treated with PAXLOVID for COVID-19, however the patient had persistent symptoms of cough and congestion and tested positive again after 4 days of treatment. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Began with large baseball sized red area at site 24 hours after, then fatigue, flu like symptoms, Blood Pressure uncontrolled ,  then 3-7-21  squaded for tremor/seizure like episodes and high BP,  Hyponatremia/Sodium low 135.  Tremors/seizures continued, squaded on 3-14 for seizure/tremor episode, Hyponatremia Sodium 129, NS IV given.   3-17-21 Squaded again for seizure/tremor episode, admitted to hospital, Sodium 129. Calcium 8.2.  Diagnosis r/o focal seizures/myoclonic episodes, Hyponatremia, r/o Moderna.  Following up with Nephrology and Neurology currently.  Still symptomatic.
Patient stated that eight days after receiving the vaccine got vertigo. He became very dizzy and had stomach nausea.
Information has been received from a registered nurse concerning a female over 50 years with no drug allergies/reactions who on 25-MAY-2010 was vaccinated SC with a first 0.5mL dose of VARIVAX (Merck) (lot number not reported). The registered nurse stated that recently (in approximately May 2010), the patient called the office to report she had some isolated blisters with some crusting, fever and headache. She had contacted her doctor and was taking antihistamines and oatmeal baths. At the time of the report, the patient had not recovered from the events. No lab studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Left arm was sore when received the vaccine which she expected.  Then it started traveling and now it is completely up to the shoulder area and she is in extreme pain.  Her doctor told her to call local DOH to report adverse effects.
Mild tightness in chest, coldness in fingers bilaterally. No SOB. No numbness and tingling in hands  Vital Signs: B/P: 140/88 HR:63 Resp.: 20 O2Sat:99 Skin Signs: Warm and Dry Circulation: Cap Refill <2Sec Resp.: Breath Sounds Clear Bilaterally  Treatment: 11:40  symptoms subsiding, improvement noted.  Reassessment @11:45 Vitals: 132/84 HR:60 Resp.: 20 O2Sat: 99 Skin Signs: Warm and dry Circulation: Cap refill <2sec  Resp.: Breath sounds clear bilaterally Treatment: Advised patient to call 911 if symptoms return or notify PCP. Symptoms resolved  at 11:45, encouraged to monitor symptoms, encourage hydration throughout the day. D/C home by self
This spontaneous report as received from a health professional refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date approximately in September 2041, reported as "the past week and a half", the patients were vaccinated with improperly stored ROTATEQ oral, (dose, lot number and expiration date not reported). No adverse effects were reported. Co-suspect and concomitant therapies were not reported. This is one of several reports from the same source. Additional information is not expected, since the reporter did not want to be contacted.
8cc induration, (+) erythema L arm. Seen by PCR local care to arm and NSaids given.
Loss of taste on left side of the tongue started on Sunday 04/04. This was followed by slight muscle spasms on the left side of the face (cheek and eyelid) on 04/05. On 04/06, loss of control of left side of the face started. I cannot blink fully with the left eye, and I cannot contract my left cheek fully. My smile is asymmetric and I cannot fully lift my left eyebrow. The loss of taste on left side of the tongue persists as of today 04/08. I was prescribed prednisone 20mg twice daily by my primary physician, which I started yesterday, 04/07. No alleviation of symptoms so far.
pt devel herpes zoster lesions rt chest, axilla, back 3 days p/flu vax given;
COVID-19; This spontaneous report received from a patient via a company representative concerned multiple patients. The patients' height and weight were not reported.  No past medical histories or concurrent conditions were reported. The patients previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination.  It was unknown whether patients had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patients received additional dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patients experienced covid-19 (Dose number in series 2). It was reported as "that people who are getting booster are getting it".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of multiple patients with covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000229796. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this report indicates medical adverse events, there is no product quality issue described in the information reported and this does not meet the criteria for lack of effect for the vaccine) based on the PQC evaluation/investigation performed.
Received flu shot on Thursday 11/21/13.  Shortly afterward felt soreness in arm where shot was given and then in lower back.  Skin felt unusually sensitive over the weekend and back was unusually sore.  On Monday 11/25/13, a rash appeared on my abdomen and lower back.  Went to the doctor and was diagnosed with shingles.  Never had shingles before.
Received COVID vaccine on Friday afternoon, 1/22, developed some slight abdominal cramping 1/24 and 1/25, had severe abdominal and back pain resulting in miscarriage evening of 1/25.  Estimated date of delivery: August 27, 2020 Also had known subchorionic hematoma, diagnosed on 1/19 via ultrasound at physician's (OBGYN) office