chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 6 month old female who on 09-NOV-2007 and 10-JAN-2008 was vaccinated with her first and second doses of Rotateq (lot# 656841/1168U, 657673/0904U). In March 2008 (date unknown) the patient experienced intussusception and was hospitalized (length of stay unknown). Therapy with Rotateq was discontinued. There was no product quality complaint. Follow-up information from the reporting physician indicated that the 6 month old female with no current conditions or medical history who on 10-JAN-2008 was vaccinated with her second dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of Comvax (OMPC) (MSD), a dose of DTaP, a dose of poliovirus vaccine inactivated (unspecified) and a dose of PREVNAR. On 03-MAR-2008 the patient started with symptoms of vomiting which was the only symptom. There was no diarrhea. The patient was hospitalized for three or four days and had no stool in the hospital. An upper GI was performed questioning reflux but no reflux was noted. A barium enema was performed and the patient was diagnosed with intussusception. The event was not life-threatening. The patient was due back in the office this month and the physician was unsure if she was going to give the third dose of Rotateq. Subsequently, the patient recovered. The physician stated that there was no way she'll know if Rotateq caused the intussusception. Additional information has been requested.  4/28/08-records received-for DOS 3/3-3/5/08-DX DC: Intussusception. Presented with 5 episodes vomiting bilious. Decreased urine output. No diarrhea. Mildly dehydrated.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 4th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:
Severe shaking after feeling cold. Nothing like chills, nothing I have ever experienced before. Shaking so bad I had trouble walking. Couldn?t open Tylenol bottle, kept dropping it from shaking. Felt like a seizure. Went back to bed and covered up with blankets. Slowly went away. Episode lasted 20 minutes or so. Shook me up as I live alone. Was ready to dial 911...
ABOUT 5 MINUTES AFTER THE INJECTION THE PATIENT BECAME DIZZY AND LIGHTHEADED , ALMOST FAINTED. SHE WAS HELPED TO A  IMMUNICATION AREA  WHERE SHE STATED THAT HER HEARING AND VISION WERE FADING. AFTER 5-10 MINUTES SHE STARTED TO FEEL BETTER , AND THEN THE SYMPTOMS RETURNED AGAIN FOR ANOTHER 15 MINUTES. THE PATIENT'S TEMP, BLOOD PRESSURE, AND PULSE WERE CHECKED FLUIDS WERE GIVEN AFTER ANOTHER 15-20 MINUTES THE BEGAN TO FEEL BETTER AND CALLED HER HUSBAND TO PICK HER UP
lost consciousness; fever; chills; cold / hot sweat; cold / hot sweat; body aches; diarrhea; vomiting; vertigo; fell on the bathroom floor; had a little pain in the arm; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 at 08:15 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Mar2021 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced fever, chills, body aches, left arm pain, and diarrhea. Relevant medical history included COVID-19 infection on an unspecified date, lyme disease, seasonal allergies and penicillin allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm. The events resulted in an emergency room visit, however, the patient did not receive any treatment for these events. The outcome of the events lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm was unknown. Since the vaccination, the patient had not been tested for COVID-19.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) :  same  patient/reporter, different AE/first dose.
initial onset w/in days of vax: severe h/a, severe joint & muscle pain, noc sweats, rash, numbness in limbs, eye problems, abd pain; Per follow-up dated 9/18/00, the pt states he developed a autoimmune disorder as a result of the vaccine. The same symptoms that were recorded earlier continue to wax and wane in severity. He also developed cancer that the doctors suspect is related to this vaccine induced illness.Annual follow-up received on 09/18/00 provides no additional data.
According to the ER dr my 2nd dose of the vaccine awakened the chicken pox virus and I now have shingles.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 02-APR-2018, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M041184, expiry date: 31-MAY-2018) orally for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (59.6 degree Fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Developed hives on day 14 after Moderna booster dose. still on going (now day 29 post dose). Rash got worse at night. Can be resolved with Claritin.   With 1st dose on 12/31/2020, I had pain at injection site (left arm) and lymphadenopathy on the left.  with 2nd shot on 1/28/2021, I had fever, chills, nausea, headache for days, and fatigue, body ache for weeks. Also had COVID arm (rash at injection site on day 7 of 2nd shot).
Admit 7/2. Vaccine 3/5, 3/26. Admit for abdominal pain w N/D and chronic cough. H/O COPD. Acute on chronic resp fx.  Treated w/abx, remdesivir, tocluzemab. Still in hospital 7/27 at time of review requiring 3-4L FiO2 (norm at home is 2L).
June 22, 2022:  scratchy throat, fatigue, slight fever June 23, 2022:  same symptoms, negative rapid antigen test for COVID19, telehealth consult, negative strep and influenza tests June 24, 2022:  same symptoms, positive COVID19 rapid antigen test.  Visited urgent care/obtained Paxlovid and began treatment June25--28, 2022:  symptoms improved.  Paxlovid caused constant HORRIBLE taste in mouth! June 26, 2022:  Tested negative
Patient reports numbness in fingertips starting the day after receiving Tdap vaccine. Continuing as of 8/30/2012. Medical evaluation recommended.
My employer gave myself and large number of other employees the 2nd dose of the vaccine on day 16, 5 days earlier than is recommended by the manufacturer. This is concerning as a large scale medication administration error and that it may result in suboptimal immunity for those of us who were given the 2nd dose too soon.
body ache; fever; nausea; This is a spontaneous report from a contactable other HCP. A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: not reported) via an unspecified route of administration in Mar2021 (a week ago) as dose 2, single for COVID-19 immunization. The patient medical history included weight loss (reports intentional weight loss for "last several months" feels better) and concomitant medications were not reported. On an unspecified date, the patient had symptoms of fever, body aches, nausea, was able to restart XELJANZ on 04Mar2021. She reported no adverse events from missed doses of XELJANZ from 13Jan2021 to 04Mar2021 as last reported on 20Jan2021. On an unspecified date the patient underwent lab tests which included weight loss on unspecified date (reports intentional weight loss for "last several months" feels better), MD aware. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash on torso - mid section; This case was reported by a physician via sales rep and described the occurrence of rash in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was approximately 70 to 75 years old at the time of reporting. The patient received dose of shingrix 2 to 3 weeks before the date of reporting. The patient experienced rash on torso-mid section. The reporter consented to follow up.
vaccine recipient scheduled to receive second Moderna COVID vaccine received Janssen/J&J vaccine in error.
Typical allergic reaction, my eye lids and surrounding area swell up and are full of fluid.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 24Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no relevant medical history. No known allergies. No other medical history. Concomitant medication(s) included: METFORMIN; COQ 10; VITAMIN D [VITAMIN D NOS]; WELLBUTRIN; SERTRALINE HCL.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Relapse infection after 5day course of Paxlovid. Patient received COVID 19 treatment with Paxlovid from 30May2022 to 03Jun2022. Relapse infection after 5day course of Paxlovid. Tested negative days 6-10. Positive again starting day 11. Currently still sick (and testing positive) 13 days after starting Paxlovid. Also had the terrible taste in mouth while taking, but it went away as soon as she stopped the meds.  Treatment of COVID-19; (04Jun2022) Negative, notes: Tested negative days 6-10; (05Jun2022) Negative, notes: Tested negative days 6-10; (06Jun2022) Negative, notes: Tested negative days 6-10; (07Jun2022) Negative, notes: Tested negative days 6-10; (08Jun2022) Negative, notes: Tested negative days 6-10; (09Jun2022) Positive, notes: Positive again starting day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection given in R Deltoid, pt. developed an eythematous papular rash at site, swelling of R arm, pain R arm
Right arm was sensitive to touch/warm, hard and sollen like a giant bug bite and red, itchy.  Very sore for 3 days and had to ice and keep moving.  A week later, still have a reddish/purple bruise that is the size of a quarter and itchy.
The patient was given the Moderna vaccine at the age of 17. No adverse signs or symptoms have been reported.
6:00 pm the evening of the vaccine admin. started running a fever around 102 deg-off and on thru the night- then 4/15/08 in the aft. around 1:00 pm-temp- 103- and then 104.3 around 4:00 pm-also more fussy-irritable- and decreased appetite
The patient experienced no symptoms; a patient was administered an improperly stored dose ofROTATEQ; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 09-APR-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# S028771, expiration date 09-APR-2021, oral; dose was unknown) for prophylaxis (product storage error).  Temperature excursion of this vaccine was 55.7degree Fahrenheit for 2 hours and 45 minutes. There was no previous temperature excursion. The patient experienced no symptoms. Data logger was involved.
swollen lymph node on collarbone area; collarbone on the right side started hurting; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and ethinylestradiol, norgestimate (TRI-SPRINTEC) all from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the right arm on 06Mar2021 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient did not have a history of allergies to medications, food or other products. The patient had not received other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 23:00, the patient experienced collarbone hurting on the right side and after 2 days on 29Mar2021, the patient had a swollen lymph node on collarbone area, it was currently still swollen. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcomes for the events collarbone hurting and swollen lymph nodes on collarbone area was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
?COVID Arm? appeared about a week after injection and continues to increase outward in size. Area is warm, itchy, with a pinkish inner area surrounded by a darker red  outline area.  Prescribed TRIAMCINOLONE 0.1% CREAM 3 times daily.  In addition,cold packs, massage and Benedryl for itching as needed
This spontaneous report as received from a certified medical assistant refers to 2 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates in 2016 (reported as after excursion on 24-FEB-2016), the patients were vaccinated with the doses of improperly stored PROQUAD (lot # L005295, expiration date 17-AUG-2016; dose and route were not reported). No adverse effects were reported. The vaccines were stored in cumulative maximum temperature of 14.1F for total of 3 hours and 20 minutes, reported on 24-FEB-2016 with Data Logger. Also PROQUAD with lot L031602 with expiration date 18-FEB-2017, with lot # L034930 with expiration date 03-MAR-2017 and with lot # L005295 with expiration date 17-AUG_2016 were improperly stored, but they were not administered to the patients at the time of this report. This is one of several reports received from the same reporter. Additional information has been requested.
arm in that area go very red and itchy; arm in that area got very red and itchy; A spontaneous report was received from a female consumer, age unknown. The patient stated on 05-Jan-2021 which was a week after receiving the vaccine her arm in that area got very red and itchy.  The patient's medical history was not provided. Concomitant product use was not provided.   The patient received their first of two planned doses of mRNA-1273 (lot # 011J20A) on 28-Dec-2020 for prophylaxis of Covid-19 infection. The patient reported experiencing the events described in the paragraph above and below about a week after receiving the vaccine.   On 05-Jan-2021 a voice mail was received from the patient, a consumer who reported the following events after receiving the first dose of mRNA-1273 1273 on 28-Dec-2020. The patient stated that on 05-Jan-2021 her arm in that area got very red and itchy. She stated she hadn't had any symptoms since the 2nd day until that point. She did not describe any previous symptoms. She further stated that she thought that seemed strange, so she talked to employee health who told her" they didn't think it was a big deal and that the vaccine was most likely injected into the subcutaneous tissue instead of the muscle". The patient was told to call and report her symptoms and stated we could call her back if we want.  Attempted to contact the patient on 07-Jan-2021 at 9:05 am with no answer. Left voicemail for patient.  Action taken with the second dose of mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. She was reporting that the patient received the first two doses of GARDASIL (lot # unspecified) on 10-OCT-2007 and 11-DEC-2007. The patient was in the office to get the third dose on 25-MAR-2013. No adverse effect reported. Additional information has been requested.
Information has been received from a physician's assistant through a  pregnancy registry concerning a 21 year old female who on 08-AUG-2007 was vaccinated with the first dose of GARDASIL. The physician's assistant reported that the patient became pregnant after receiving the first dose of GARDASIL. At the time of the report, the patient had a gestational age of 16 weeks, and no adverse reactions were reported. The patient's last menstrual period was approximately 16-SEP-2007 with an estimated due date of 24-JUN-2008. Follow up information received from the physician's assistant stated that on an unspecified dates during the patient's pregnancy she developed pain (NOS) which was treated with TYLENOL 325 mg, PO, PRN and insomnia which was treated with BENADRYL 25 mg, PO, PRN. The patient's unspecified pain and insomnia were considered to be nonserious events. On 22-JUN-2008 at 40 wk 2 days gestation the patient gave birth to a normal female infant. The baby weighed 7 lbs. 6 oz and had a 9/10 Apgar score. It was also reported that there were no complications with the delivery. Additional information has been requested.
Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: 33130BA) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "CTCL" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: bee venom" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF2590), administration date: 13Oct2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955), administration date: 25Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6198), administration date: 04Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus. Clinical course: Evaluated by ENT and audiologist. Event treated with diagnostic MRI, no treatment available (as reported). The patient had no covid prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient/AE, different drug dose;