chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had Covid 19 until they pcr the entire crew.; After about 35 days upon arrival I contracted Covid 19.; mild soar throat; mild case of sinus infection; This is a spontaneous report from a contactable consumer (patient). A patient of un-specified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that I have had both does of Covid 19 vaccination. I do have other health issues. Anyway I returned to work. After about 35 days upon arrival I contracted Covid 19. I just want you to know I never knew I had Covid 19 until they PCR the entire crew. We actually had a total of 40 cases. I was still jogging 2 miles a day with Covid 19. The only symptoms I had was a mild soar throat and mild case of sinus infection due to the great vaccination you created in your lab. Lab test included had Covid 19 until they PCR the entire crew: result had Covid 19 (I never knew I had Covid 19 until they PCR the entire crew) on unspecified date. The outcome of the events was as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a licensed practical nurse concerning a 46 year old female employee who on 09-Oct-2006, 06-Nov-2006 and 06-Apr-2007 was vaccinated IM with a first, second and third 10 mcg dose of RECOMBIVAX HB. It was reported that the patient received the 3 vaccine doses and failed to seroconvert. A hepatitis B antibody titer was negative. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. No product quality complaint was involved. Additional information has been requested.
Pt received 2 doses of COVID19 vaccine in summer 2021 (but pt can't recall which vaccine and when exactly he received the two doses). Admitted for RLE cellulitis, incidentally covid positive with mild cough symptoms.
Patient experienced a sncope episode after receiving vaccines. The patient was on the floor of the exam room, his legs were elevated and after symptoms improved he was given some juice to drink. The physician assessed him and found no injuries, after resting for 15 minutes, patient walked out of clinic with his mother.
administered a dose of Kinrix on 08May2023, which had an expiration date of 07May2023.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 08-MAY-2023, the patient received Kinrix. On 08-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Kinrix on 08May2023, which had an expiration date of 07May2023.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-MAY-2023. GSK Representative reported a healthcare provided had emailed him requesting information on an expired dose of Kinrix that was administered to the patient.   Medical Information contacted the healthcare provider, who was the vaccine program coordinator.   The reporter stated that a patient was administered a dose of Kinrix on 08 May 2023, which had an expiration date of 07 May 2023 which led to expired vaccine used.   At the time of reporting, the dose had not been repeated. The reporter consented to follow up.
Extreme dizziness, lightheadedness, nausea, vomiting, fever and chills lasting through Sunday morning, 07/20/2014.
Tinnitus. Previously had very little mild tinnitus. Became much worse after vaccine. Worse in left ear.
Presented to ED w/ chief complaint COVID; reports dx w/COVID 1/13 & seen at ER and sent home; admitted for COVID-19 pna & AKI; tx w/abx & Vit C; pt was not hypoxic; pt dc'd home
Upper left arm, originating from vaccination site, initially became severely reddened and painful and patches of bruising occurred approximately 48hrs later.  Affected area included entire medial bicep, ultimately extending to medial forearm just below elbow.  Treatment with ibuprofen and diphenhydramine were ineffective.  Medical treatment was sought on July 12, 2016.  Seven week course of Cephalexin & Sulfamethoxazole/Trimethoprim were prescribed.
Pt was taken to emergency room after full arrest at home. Dad reported that he woke up to family dog laying on child.
Sore Muscles (around injection site and neck); Sore Muscles (around injection site and neck); Mild Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 13:15 (Lot number: EL 3247) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Migraines (unfortunately, with similar symptoms" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Avocados" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE; PROPRANOLOL; CAMBIA. The following information was reported: MYALGIA (non-serious), NECK PAIN (non-serious) all with onset 10Mar2021 15:00, outcome "recovering" and all described as "Sore Muscles (around injection site and neck)"; HEADACHE (non-serious) with onset 10Mar2021 15:00, outcome "recovering", described as "Mild Headache"; FATIGUE (non-serious) with onset 10Mar2021 15:00, outcome "recovering", described as "Fatigue". Therapeutic measures were not taken as a result of myalgia, neck pain, headache, fatigue.  Additional information: About 2-3 hours after vaccination (10Mar2021), patient noticed the symptoms. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior to vaccination and was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous prospective pregnancy report as received from a physician refers to a 34 year old female patient. The patient's medical history included abortion spontaneous. The patient became pregnant with last menstrual period (LMP) of 24-AUG-2014 and estimated date of conception (EDC) of 06-SEP-2014. On 10-NOV-2014, an ultrasound test was performed and the result was reported as 10-6. On 09-MAR-2015, the patient was vaccinated with first dose of GARDASIL (lot number: K006117 with unknown expiry date). Other suspect therapies included levothyroxine sodium (manufacturer unknown) (strength: 25 microgram, frequency: once a day) for hypothyroidism. Concomitant medications were not reported. Initial exposure to GARDASIL was at 28 weeks. The estimated date of delivery (EDD) was reported as 31-MAY-2015. Action taken with levothyroxine sodium was unknown. The pregnancy outcome was outcome pending. The outcome of exposure during pregnancy was unknown. The causality of the event with suspect therapies was unknown. Additional information has been requested.
This child had a fever by touch, generalized tonic / clonic jerking for 2 -3 minutes, lethargy.
L thigh began to swell after vaccine and had fever x 2 days, but over last week has increase swelling and redness, very itchy in same area. In process of recovery.  Follow-up information received 1-12-10.  Hours after vaccinated developed induration and mild redness that became worse 2 weeks later.
Information has been received from a physician concerning a 2-month-old female with no medical history or allergies who on 31-AUG-2006 was vaccinated PO with the first 2.0 mL dose of ROTATEQ. There was no concomitant therapy. The physician reported that on approximately 01-NOV-2006 the patient developed a rash around her mouth. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. In November 2006 the patient's rash resolved. Additional information has been requested.
1/2 DOLLAR SIZE RED RAISED,HOT TO THE TOUCH  ,SWOLLEN AREA ON LEFT  THIGH .CHILD HAD NO OTHER SYMPTOMS TO NOTE , NORMAL TEMPERMENT .
Presented to ED on 7/27/21 with shortness of breath and non-productive cough. POC PCR positive on 7/27/21. Previous recent hospitalization 7/7-7/11 for acute metabolic encephalopathy, acute kidney injury, theophylline toxicity. Palliative care in place. Died 8/3/21 Hospitalized 8 days at Health care
Fever, Chills, muscle aches, swelling and redness at point of vaccine, weakness, dizziness, sick at my stomach.
On 1/10/2022, I had an excruciating headache, a runny nose, and extreme fatigue. I work at a facility, so I went to the nurse, who did a rapid COVID-19 test, and the result was negative. As the day progressed, I became more tired. I took 2 Advil for my headache, which helped. After work, I took a PCR test at the community lab. On 1/11/2022, I called in sick to my workplace. That day, I had a runny nose, sore throat, extreme sinus pressure, and extreme fatigue. I slept for most of that day. On 1/14/2022, I finally got my PCR results back, and they were positive. My doctor recommended that I take Mucinex-D, DayQuil, and NyQuil. She also recommended another OTC medicine, but I don't remember the name. She then provided me with a sick note for work and instructed me to stay at home and recuperate. I then returned to work on 1/17/2022.
SWELLING OF TESTICLES AND PENIS  THAT LASTED ABOUT 4 DAYS AFTER FIRST DOSE OF VACCINATION.
PATIENT CALLED TO INFORM US THAT HIS VISION IS BLURRY AND DOUBLED AS OF 03/21/21. HE IS NOT SURE IF IT HAS ANYTHING TO DO WITH THE VACCINE, AND IS GOING TO FOLLOW UP WITH A DOCTOR, BUT THINKS HIS DOCTOR HAS MOVED AND UNSURE OF WHERE SHE IS BUT WAS INTRUCTED TO MAKE SURE HE GETS INTO A DOCTOR AS SOON AS POSSIBLE.
expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 77-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd February 2023, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The caller consented to follow-up from safety. The caller consented to follow-up via email. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Had Fatigue, chills, & dull headache @ 7:30pm.  Went to bed early.  Woke up @ 4:20 am for work and had fatigue, headache, and sweats on forehead.  Took 2 Ibuprofen and went back to bed.  woke up at 9:15 am and still had slight fatigue & headache.  Effects seemed manageable, so didn?t go  see a doctor.  It?s about 11am & I still have a dull headache,.
After my 1st vaccine I ovulated much earlier in my cycle then I usually do. I ovulated about 15 days earlier than my normal cycles. I have been tracking my cycles very closely for a long time. I have now been having irregular periods and what I believe to be anovulatory cycles where I am not ovulating but getting my period more frequently. For example, this month I started to bleed on day 15 of my cycle after not ovulating yet.
Initial report was received 03 November 2010 from a health care professional. A 66-year-old female patient who had a history of a penicillin allergy, had received a first dose left deltoid intramuscular injection of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number U3609A on 17 October 2010 and two days later, she developed shortness of breath, itchy eyes and itchy ears. Laboratory and diagnostic testing had not been performed and the event did not require a doctor's visit. Corrective treatments were not reported. The reporter further noted that a 1 inch 25 gauge needle had been used for vaccine administration and the patient had no concurrent illness at the time of vaccination. According to the reporter, medical notes on 01 November 2010 did not indicate if shortness of breath or itching was present at that time. At the time of the report, the patient's outcome was unknown. Documents held by sender: None
Patient was sitting in observation area after vaccine. Approximately 5 minutes (1050) after administration the patient reports feeling a 'head rush', like he was going to pass out, and nausea. Patient taken to exam room via W/C. Skin pale, cool, moist. BP taken with feet elevated. Denies SOB, itching.  1115 patient reports nausea has resolved. Denies dizzy, lightheaded, SOB, nausea, itching. Patient not as pale. Transitioned to sitting with feet down. 1125 patient denies dizzy, lightheaded, SOB, itching, nausea. Color natural. Blood pressure WDL. Patient standing and walking in exam room with no symptoms. Patient dismissed to home.  12/21/20 no symptoms reported.
Swelling and significant redness on left arm at site of injections. area extends down to the elbow.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. On 26-NOV-2014 the patient was vaccinated with a dose of expired MMR II (lot # was not reported) expiration date 20-SEP-2014, dose 0.5 ml, given intramuscular. No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
pt recv vax 6DEC95 & 22DEC95 pt devel a rash which was described by Md as non-vesicular, 2cm fleshy papules on an erythematous base;MD concluded that rash was not related to the vax;
Janssen COVID-19 Vaccine EUA Chills- morning of 3/10 Aches- all day Fever- afternoon of 3/10 High Heart Rate- 130-150 resting Headache- all day  Fatigue- all day
threw-up; she is unsure if the patient received any of the medication; This spontaneous report was received from a physician referring to a 2-month-old female patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.       On 28-APR-2021, the patient was administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, dose, lot number and expiration date were not reported) and then the patient immediately threw-up (vomiting). The physician was unsure if the patient received any of the medication (underdose). This was the infant's first dose. The physician reported the infant was doing well and fully recovered.    The causal relationship between the reported events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
SORE ARM; SEVERE FATIGUE/FATIGUE; HEADACHES; This spontaneous report received from a consumer concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, severe fatigue/fatigue, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe fatigue/fatigue, and headaches, and the outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211110917.
Severe swelling of entire anterior aspect of thigh.  Red-purple in color, pruritic, firm, warm.  Improving, but unresolved as of 11/19/2013.
4/9/19 - woke up with headache, chills, lethargy, nausea, loss of appetite, left arm was extremely sore where vaccination was administered. Took ZOFRAN and ibuprofen, left work early, had only a cup of chicken soup that day, tried to rest/sleep. 4/10/19 - same signs as 4/9/19 without chills, continued ZOFRAN, ibuprofen, still no appetite, tried to rest, sleep. 4/11/19 - headache gone, still some nausea and lethargy, sore arm, but was able to eat a little more than the previous 2 days. Took ZOFRAN and rested. 4/12/19 - felt pretty much fully recovered, able to go back to work but constipated. 4/13/19 - still dealing with constipation. 4/14/19 - constipation resolved, fully recovered.
The morning after he received his vaccine he started feeling sick and then started to run a temperature. By evening his temperature was 102.9.  Then the seizures started, first his "left" hand up his arm and down his left side. His right hand and arm was shaking rapidly. His left leg stiffened and his toes pointed down and then the seizure traveled to his right side. He remained conscious but somewhat dazed. This went on all night. By 10:00 the next day, Thursday the seizures stopped. His temperature went back to normal Friday morning.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 09-AUG-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, lot#, expiration date and route of administration were not reported). There was no adverse effect reported.  Administered doses of vaccines experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 11 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007465: US-009507513-1708USA007464: US-009507513-1708USA005855: US-009507513-1708USA007463:
Information has been received from a registered nurse concerning a 79 year old patient who on 20-APR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included COUMADIN. On 23-APR-2007 the patient had an elevated INR. The INR elevation was descried as a "panic value." Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
rt leg red, swollen, hard, size of an orange-mom called our office @ 320PM on 16APR98 of these c/o;tx motrin & compresses to area;
suspected vaccination failure; breakout on back; itchiness; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: breakout on back) and pruritus (Verbatim: itchiness). The outcome of the vaccination failure, shingles and pruritus were not reported.   It was not reported if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-Feb-2023 The reporter reported the case via interactive digital media. The patient was caught and cured Quick In 2011. The patient got Shingles In 2011, 2 weeks to recover.  The reporter asked took the new. The patient received vaccine in 2022.  The patient had the break out on his/ her back, itchiness.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Pericarditis; Severe chest pain; A spontaneous report was received from a 56 year-old, female consumer, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pericarditis and severe chest pain.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 Dec 2020, approximately five days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 0011JZ0A) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient went to the emergency room due to severe chest pain.   On 05 Jan 2021, the patient went to see the cardiologist and was diagnosed with pericarditis. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, pericarditis and severe chest pain, was unknown.; Reporter's Comments: This case concerns a 56 year old, female patient. The patient's medical history was not provided. The patient experienced a serious, unexpected event of pericarditis and severe chest pain. The event of severe chest pain occurred 5 days and the event of pericarditis occurred after 6 days after first dose of mRNA-1273 (Lot number: 0011JZ0A). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the mRNA-1273 and the start date of the event, a causal relationship cannot be excluded.
Ear infection; Spontaneous report received on 28FEB2020.   A caregiver (consumer's mother) reported that her 12-year-old daughter was diagnosed with an ear infection (PT: Ear infection) while being on Vivotif for immunisation. The consumer took her first of Vivotif on 27FEB2020. On 28FEB2020, she was diagnosed with an ear infection. Thus, she was prescribed amoxicillin of unknown strength (12 ml; twice a day for 10 days). She was not planning to take remaining doses of Vivotif until the end of her antibiotics course. Action taken with Vivotif with respect to the reported event was vaccine withdrawn. The outcome of the reported event was unknown at the time of report.  Company Comment: A consumer was diagnosed with ear infection a day after taking first dose of Vivotif. In response to the event, she was prescribed with amoxicillin and consumer did not plan to take the remaining Vivotif doses. Considering the infectious pathogenesis of ear infection, the causality of ear infection is assessed as not related to Vivotif.; Sender's Comments: A consumer was diagnosed with ear infection a day after taking first dose of Vivotif. In response to the event, she was prescribed with amoxicillin and consumer did not plan to take the remaining Vivotif doses. Considering the infectious pathogenesis of ear infection, the causality of ear infection is assessed as not related to Vivotif.