chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious initial spontaneous case, was received from a Pharmacist, on 25-Sep-2017, concerning an adult female patient in her mid-20's (as reported). On 23-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 178503, expiry date: Apr-2018). It was reported that FLUAD was suggested for age 65 years and over (explicitly coded to Inappropriate age at vaccine administration). The patient slept for 16 hours a few hours after receiving the vaccine (sleep excessive). The outcome of the event sleep excessive was recovered. The reporter did not provided the seriousness criteria of the event. Follow-up report received from the reporter on 05-Oct-2017: Suspect product details (route of administration, anatomical location, batch number, expiry date) were updated. Event onset date was added. Outcome of the events was updated from not reported to recovered. Amended narrative accordingly. Significant case correction received 05-Oct-2017: The outcome of event Inappropriate age at vaccine administration was changed from recovered to unknown and outcome of the event sleep excessive was changed from not reported to recovered. The narrative was amended accordingly.
COVID-19 infection just after the first dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19 infection just after the first dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced COVID-19 (COVID-19 infection just after the first dose). At the time of the report, COVID-19 (COVID-19 infection just after the first dose) outcome was unknown. Not Provided      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.   Based on the current available information, the mRNA-1723 does not contain a virus and with the occurrence of Covid-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information, the mRNA-1723 does not contain a virus and with the occurrence of Covid-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.
Took first Pfizer Covid 19 vaccine on March 5, 2021, second dose on March 19, 2022. Suffered stroke from blood clot on April 2, 2021.
I can't remember stuff like I had the memory of an elephant before I received my second dose.; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8731), dose 1 via an unspecified route of administration, administered in Arm Left on 22Apr2021 (at the age of 28-year-old) as dose 1, single for covid-19 immunisation. Medical history included bipolar 1/PTSD, post-traumatic stress disorder (PTSD). There is no known allergies. The patient's concomitant medications were not reported. There is no covid prior vaccination, the patient did not test covid post vaccination. The patient stated he can't remember stuff like he had the memory of an elephant before he received his second dose in 2021. There is no treatment for AE. The event resulted in disability or permanent damage. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent. On 21-FEB-2019, the patient was vaccinated with improperly stored VARIVAX (lot# R021098, expiration date was 23-JUL-2010; lot# R023502, expiration date: 16-AUG-2020; dose, route and frequency were unknown) for prophylaxis. The administered VARIVAX was stored under the temperature ranging from 6 Fahrenheit degrees to 14 Fahrenheit degrees (5.53 Fahrenheit degrees) for 15 minutes. The temperature excursion occurred as a result of a reading from a digital data logger. Moreover, there was no occurrence of previous temperature excursion. The sterile diluent used to reconstitute VARIVAX was stored appropriately. No adverse effects reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA009810.
About 5 hours after injection patient experienced racing heart rate chills and extreme fatigue she reported resolution not until 48 hours post vaccination.
Cough, nausea, vomiting and weakness, increase in confusion and disorientation,
Swelling of temples and cheeks where filler had been injected in February 2020.
This case involves a 50-year-old female patient who received TUBERCULIN TEST [TUBERSOL] instated of TETANUS TOXOID (wrong product administered) which was given via intramuscular route (incorrect route of product administration). The patients medical history included Dog bite. The patients medical treatments, vaccinations, concomitant medication and family history were not provided. On 23-Nov-2021, the patient received a dose of suspect TUBERSOL (TUBERCULIN TEST) (solution for injection, lot number and expiry date not reported) via an intramuscular at an unknown administration site instated of TETANUS TOXOID (lot number and expiry date not reported) for prophylactic vaccination. It was an actual medication error case due to wrong vaccine administered and wrong route of administration (latency: same day). It was reported "The Pharmacist reported that due to the consume receiving Tubersol in error there has not been any reported adverse effects. A Pharmacist reporting a medication error with TUBERSOL described as a female being given TUBERSOL and not the prescribed Tetanus vaccine and the TUBERSOL was given via intramuscular route. The Pharmacist reported that the consumer was due to get a Tetanus vaccine due to having a dog bite; that the caller does not have any more information on the consumer or the event; that they are a regional poison control center looking up the information on behalf of a providers office that the event took place." 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. There will be no information available on the batch number for this case.
Refrigerator date 03 Nov 2021 and administration date was 12 Nov 2021 Exp date is 03 Oct 2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Refrigerator date 03 Nov 2021 and administration date was 12 Nov 2021 Exp date is 03 Oct 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Refrigerator date 03 Nov 2021 and administration date was 12 Nov 2021 Exp date is 03 Oct 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Refrigerator date 03 Nov 2021 and administration date was 12 Nov 2021 Exp date is 03 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. No temperature expiration was happened. No adverse event occurred On 03-Nov-2021 vaccine was placed in refrigerator Treatment information was not reported
UPPER RESPIRATORY SYMPTOMS SORE THROAT, SINUS CONGESTION, SINUS DRAINAGE, PRODUCTIVE COUGH (GREEN MUCUS).
Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 17-MAR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Patient states a few hours after vaccine her eyes began burning and really red and feeling like she had been crying for hours. Her eyes remained red, burning, extremely sensitive to light, and painful for about 18 hours.
Received vacc on 10/23/2002.  On 10/25/2002 went to hospital- developed hives, weakness, vomiting, chest pain, swelling of face, feet and toes.
Patient's injection site swell and went to hospital for treatment. Hospital scan the injection site and treat the patient. Patient has upcoming follow up in 3 weeks
had 2 sets of shots and backside was breaking out/ suspected vaccination failure; Pneumonia; Backside was breaking out with shingles; Fever; Upset stomach; Sick; Upset , like you're into the MRI Machine Head first; Covid; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had first time in 1954 patient was 6 years old). Additional patient notes included for 56 years patient had been got hysterical shingles below the waist on his or her Sciatica.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had 2 sets of shots and backside was breaking out/ suspected vaccination failure) (serious criteria GSK medically significant), pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant), shingles (Verbatim: Backside was breaking out with shingles), fever (Verbatim: Fever), upset stomach (Verbatim: Upset stomach), sickness (Verbatim: Sick), emotional distress (Verbatim: Upset , like you're into the MRI Machine Head first) and covid-19 (Verbatim: Covid). The outcome of the vaccination failure was unknown and the outcome of the pneumonia, shingles, fever, upset stomach, sickness, emotional distress and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, pneumonia, shingles, fever, upset stomach, sickness, emotional distress and covid-19 to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, pneumonia, shingles, fever, upset stomach, sickness, emotional distress and covid-19 to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two doses of Shingles vaccine and slowed shingles down but he or she experienced fever, upset stomach sick and felt upset like he or she is in the MRI machine as head first. The patient stated that at the time he or she got home his or her backside was breaking out. The patient was bad at last summer when he or she experienced Covid followed by Pneumonia. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient came into the clinic to get her flu shot after explaining she was waiting to get it elsewhere and them being out. When I went to document the administration it said patient had already received their yearly flu shot. So patient has received 2 high dose flu shots a month apart.
positive rapid COVID testing positive/COVID-19 PCR test positive; positive rapid COVID testing positive/COVID-19 PCR test positive; This is a spontaneous report from a contactable nurse (patient herself). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, Expiration date: Mar2021), intramuscularly at site of right deltoid at 08:00 on 16Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. The patient received a flu shot in Oct2020. The patient's concomitant medications were not reported. The patient was tested positive for rapid COVID-19 testing on 21Dec2020 and was also positive for COVID-19 PCR test on 22Dec2020. No treatments after positive testing and patient was not hospitalized. The outcome of events was not recovered.; Sender's Comments: The reported  "tested positive for rapid COVID-19 testing" after 4 days of immunization with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) is considered related to BNT162B2 administration.
Myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: MYOCARDITIS (medically significant), outcome "unknown". Clinical course: The caller is inquiring if we have any claims set up for individuals who suffered myocarditis after receiving the Pfizer vaccine. He mentioned that he experienced this after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt minimal redness & no swelling @ inject site states inject was painful & arm cont to throb p/inject; difficult to use lt arm w/in  hrs of the vax; swelling in fingers;
Systemic: Chills-Severe, Systemic: Chills/numbness lead to hyperventilating, felt better after taking benadryl and is back to normal-Severe; symptoms lasted 0 days
Body Pain, Fever, Muscle Stiffness & Pain, Redness, Swelling & Itching, Patterns of Red areas spreading and shifting in different patterns, raised rash, weakness, nausea, dizziness, loss of appetite, lethargy. As the redness reduced in several days the areas of red changed to a dark tan color, eventually the skin started to peel.
2/6 I had the 2nd Moderna vaccine. On 2/7-2/8 I had body aches, chills, and 99.4F temp. On 2/9 those symptoms subsided, but I started to get right-sided flank pain with pain on inhalation. I took acetaminophen and ibuprofen around the clock, used a heating pad on 2/9 and 2/10, but pain progressed.  Mid-day on 2/10 the pain was so severe, I went to urgent care. They said it was gastritis and released me. I went back 2 hours later and saw a different doctor. He diagnosed me with a pulmonary embolism, pulmonary infarction, and pleural effusion. I was sent by ambulance to the hospital and admitted. I was treated for pain and started on Eliquis. I was discharged the evening of 2/12. The morning of 2/13, I woke up with 100.6 F Temp and 85% O2 at. I went to urgent care again, they thought I had pneumonia and referred me to the hospital. I was admitted to a different hospital on 2/12 and continue to antibiotic s and a heparin drip
An hour after receiving the shot my pinky and ring fingers of my left arm started going numb as if I'd hit my funny bone, which I had not.  This pins and needles feeling last only about an hour.  Other than injection site soreness I had no other arm issues and the injection site soreness only last about 48 hours.  Then two days after the vaccine I had a bad dizzy spell at work, requiring a trip to the ER.  All ER tests (imaging and blood work) came back normal,  so I can't really say that this was related to the vaccine.
A 68 year old female with a past history of hypertension and hypercholesterolemia but no prior cardiac history. She had a documented allergy to PCN. She had also received flu vaccine in my office in 2001 and in 2002. She received her Fluvirin dose on 10/02/03. The pt was found dead at home of a presumed sudden cardiac death on 10/20/03. The death certificate received on 12/3/03 states cardiac arrhythmia and cardiac arrest.
Expired Kinrix administered; This 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 YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th August 2022, unknown after receiving Kinrix and Kinrix 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: 29-AUG-2022 Reporter's Comment:  The reporter stated that the Kinrix was administered on 29AUG2022 and expired on 26AUG2022. No reactions reported. The reporter gave consent to follow up. Additional Supportive Information: The patient received expire Kinrix dose, which led to expired vaccine used.
Extremly fatigued; Right arm also feels swollen where injected.; Swollen right armpit with lumps. Not sure if they are swollen lymph nodes. Very tender and sore.; Swollen right armpit with lumps. Not sure if they are swollen lymph nodes. Very tender and sore.; Swollen right armpit with lumps. Not sure if they are swollen lymph nodes. Very tender and sore.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 05Apr2021 at 12:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN) and levothyroxine sodium (LEVOXYL); both from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 22Mar2021 at 12:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation and took Codeine and Vicodin; both on unknown date for unspecified indication and experienced drug allergy Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 15:00 within three hours of vaccination, the patient experienced swollen right armpit with lumps and not sure if they are swollen lymph nodes, very tender and sore, right arm also feels swollen where injected and extremely fatigued. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events swollen lymph node, lymph node tenderness, armpit pain, fatigue and vaccination site swelling were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling (hardening) of left arm right below injection site as big as my palm, red in color and hot to touch. Arm and shoulder pain that travels to neck and behind arm, shoulder and back. Aches in left side of body making me feel nauseous. Feeling tired and unable to focus. Symptoms started at 230 am throughout the day and still occurring.  Swelling of arm is spreading through the rest of my upper arm towards bicep, still red and hot to touch.   Been taking 400mg ibuprofen every 4 hours but only dulls aches, pain.
This medically confirmed spontaneous report (initial receipt 27-Oct-2014) concerns a 51-year-old male patient. The patient had no known allergies. He had concurrent conditions of high blood pressure for the past 17 years and high cholesterol. His concomitant medications included lisinopril/hydrochlorothiazide (for high blood pressure), rosuvastatin (for high cholesterol) and acetylsalicylic acid (for cardioprotection). The patient received flu vaccines (unknown brand) every year at the same facility for the past 10 years from the same immunizer without any complaint. On 13-Oct-2014, the patient received intramuscular AFLURIA (batch number T58106) at 0.5 ml. On 13-Oct-2014, after the vaccination at his place of work, the patient started to feel "really bad" with muscle aches, malaise, slight headache, nausea, and was diagnosed with herpes infection of the eye. He saw a ophthalmologist for the eye infection that he had experienced after AFLURIA administration and was instructed to apply ciprofloxacin eye drops in the affected eye for five days. The patient saw a second ophthalmologist who suspected the eye infection was caused by an adenovirus and prescribed antiviral lubricant eye drops. On 26-Oct-2014, the patient complained to the second ophthalmologist of severe eye pain (10/10 on pain scale) with severe vision impairment. On the same day, a diagnostic examination identified that the dendritic reaction was positive for herpes simplex virus. The patient was instructed to take oral acyclovir five times daily. The patient was never hospitalised and was still recovering from eye infection, his vision was less blurry but still impaired with reduction in eye pain. The outcome was reported as not yet recovered. However, the events of headache, muscle aches, malaise and nausea did not persist (recovered). Reporter's comments: The reporter assessed the case as serious. The reporter was absolutely certain that the herpes eye infection was caused directly by AFLURIA. Reporter suspected that herpes virus was dormant in the patient's system and became manifested as the eye infection after the proteins from AFLURIA activated the herpes virus by interacting with his immune system. Follow-up (28-Oct-2014): Reporter seriousness.
Headache, body aches, fatigue starting evening after receiving shot, peak for 24 hours (8/17/2021) then gradually better over 4 days.
I started out with a sore throat Sunday evening, it didn't go away, it felt full irritated a little scratchy. I was extremely tired for one day.  I still have a sore throat it has never gone away and i have had two negative test since.
Pt recvd 2nd dose of Hep B vax & w/in 24 hrs pt devel hives; tx DPH & steroids & the rxn resolved;
pt recv vax & started screaming-high pitch cry cont until 8PM (9hr);did not sleep & did not take formula until p/sleeping a few hr;mom states seemed to take another full day to fully recover;