chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 12/09/2022, I was trying to stand up and could not breathe. I couldn't breathe and my face was sweating. At that point in time, I finally had enough air in my system and I was able to breathe. I went to the doctor and they looked at me. They ran a few tests and said I had bronchitis. They provided me with a bronchitis inhaler and medication. They sent me home that day. On 12/12/2022, I was continuing to have symptoms and they decided to do additional tests. At that point, they noticed that my thrombosis levels were way out of line which would signify an embolism. I went to the hospital and did additional tests, x-rays etc. They saw that there was a blood clot in the saddle of my lungs which was restricting any kind of air going into my lungs. They ran some tubes through my veins and through my heart, they had an ultrasound where my blood clot was in my vein and dissolved it. It was a very successful procedure.
Patient received Pfizer Covid-19 5-11 yo vaccine in office for Boosters. After investigation, the covid vaccine vial was not properly diluted. Provider on site made aware.
Pt given DTP/OPV approx 2-3 min p/inject; pt collapsed & fell to floor in waiting area; pt pale, unconscious, aroused when hit floor has laceration on chin; dazed-warm to touch;
Major headache starting about 6 hours after the flu shot. Thought it was congestion so I took Sudafed but it did not help at all. Then took 600 mg of ibuprofen and it helped a bit
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.    This case was linked to MOD-2021-395985 (Patient Link).
pt recv vax 16AUG95 & 28DEC96 pt devel chickenpox consisting of approx 50 to 75 lesions & a low grade fever;20JAN97 pt recovered from exp;
My doctor told me to get the Prevnar 20 injection .5 ML and a flu shot which is 65+ Quad PF 2022-2023 .5. The next day I had terrible Side effects, feeling dizzy, extremely tired and weak, bad headaches, muscle And joint pain, a fever of 101.1. I was pretty sick for two days. The third day was a little better, but still tired and had bad headaches. I had gotten these two shots at a pharmacy store.
Fever around 101.7 for a few days.  Seizure like symptoms (Muscles clinching, eyes twitching and moving back in her head.
1st vaccine on 02/03/2021 left arm, had no side affects.  2nd vaccine on 02/24/2021, on second day, injection site got red, swollen, had hard knot, and deep itch at injection site right arm. On third day started getting brain fog, had hard time concentrating and felt extremely tired.  Redness, swelling, hard knot, and deep itching has gone away.  Still have a bit of brain fog but getting better.  Knee joints are hurting. I got most of my energy back.  It took 9 days for redness and swelling to go down.  I did not seek treatment for symptoms.
arm from second dose still has a mark; smell of pin burning sensation; hair loss; seven days later, redness in area, not as bad as the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR (arm from second dose still has a mark), PAROSMIA (smell of pin burning sensation), ALOPECIA (hair loss) and VACCINATION SITE ERYTHEMA (seven days later, redness in area, not as bad as the first dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SCAR (arm from second dose still has a mark), PAROSMIA (smell of pin burning sensation), ALOPECIA (hair loss) and VACCINATION SITE ERYTHEMA (seven days later, redness in area, not as bad as the first dose). At the time of the report, VACCINATION SITE SCAR (arm from second dose still has a mark), PAROSMIA (smell of pin burning sensation), ALOPECIA (hair loss) and VACCINATION SITE ERYTHEMA (seven days later, redness in area, not as bad as the first dose) outcome was unknown.            This case was linked to MOD-2021-034899 (Patient Link).
08/29/22 presents to ED for "nausea and vomiting as well as abdominal pain". PMHx of "Crohn's disease, CKD stage III, aortic sclerosis, mitral valve regurgitation, and diastolic dysfunction"
red itching blisters in body; red itching blisters in body; red itching blisters in body; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number A725Y, expiry date 20th May 2023) for prophylaxis.   On 28th March 2022, the patient received the 2nd dose of Shingrix. On 29th March 2022, 1 days after receiving Shingrix, the patient experienced blister, erythema and pruritus. On an unknown date, the outcome of the blister, erythema and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the blister, erythema and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 4-APR-2022 Reporter's Comment: Registered pharmacist reported that the patient received dose of Shingrix vaccine and one day after the patient noticed red itching blisters in different parts of the body not only near the injection site but in different places. The reporter stated that one day appeared one blister and the other day another 2 blisters and so on.  The patient still had presents some of those red blisters. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022028969:Same reporter
Patient experienced unexplained episodes of petechiae (bleeding under his skin) for starting two days after the vaccine (and continuing since then).
Initial report received from literature on 10 May 2014. Abstract: Yellow fever (YF) is an important public health concern in areas where the disease is endemic. For more than 60 years a highly effective live attenuated vaccine has been available, its widespread use resulting in a dramatic decrease in the number of cases. On rare occasions, YF vaccine can cause mild to severe disease and rare adverse vaccine-associated events have been reported. Additionally, an average viremia of 3-5 days after administration of the YF vaccine has been published. Here we present a case where YF vaccine was isolated in cell culture from a respiratory swab collected from a patient presenting with influenza-like illness. To the best of our knowledge, this is the first report finding replicating YF vaccine in the respiratory sample of a post inoculated individual. A 19-year-old female patient had received a dose of Yellow Fever Vaccine (manufacturer unknown, batch number, dose number, route and site of vaccination not reported) on an unspecified date. On an unspecified date, the patient presented with fever of 103 degree F (39 degree Celsius) for 3 days, nausea, vomiting, cough and myalgia. The patient history did not note any recent travel, vaccination, animal contact or insect bites. ILI was the initial diagnosis and a respiratory swab was sent for influenza testing. CPE was observed at 9 days in the Caco-2 cells and all other cell lines exhibited no viral changes after a total of 14 days incubation. Further, the ResPlex II assay and all of the real-time (RT)-PCR assays were negative. Since replicating YF vaccine was isolated and propagated in cell culture, and in the absence of detection of other known infectious agents, the potential cause of the ILI was the YF vaccine the patient received 8 days previously. The testing algorithm included both molecular assays and conventional cell culture. The respiratory swab was inoculated into primary Rhesus monkey kidney cells, human lung adenocarcinoma cells (A549), human embryonic lung cells (HEL) and epithelial colorectal adenocarcinoma (Caco-2) cells. All inoculated cell lines were examined for cytopathic effect (CPE) three times a week for 2 weeks. In parallel, the primary sample was extracted using the bioMerieux easyMAG, tested for influenza A and B using the Centers for Disease Control and Prevention (CDC) Human Influenza Virus Real-time RT-PCR Diagnostic Panel (unpublished protocol, details are available from the CDC on request), and for Influenza A and B, respiratory syncytial virus A and B, human metapneumovirus, rhinovirus, enterovirus, parainfluenza viruses 1-4, and human coronaviruses OC43, 229E, NL63 and HKU1 with the ResPlex II kit. Multiple real-time (RT)-PCR assays were used for the detection of cytomegalovirus, Epstein-Barr virus, human herpes virus 6, adenovirus, enterovirus, herpes simplex virus 1, herpes simplex virus 2, varicella zoster virus [3], rhinovirus [4], Mycoplasma pneumonia [5], Legionella pneumophila [6], and Chlamydia pneumonia. At the time of this report, the outcome was unknown. Documents held by sender: None.
Left arm very sore throughout the day.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 18-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 at 11:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 18 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose:3 (Booster) Single Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Dec2022, outcome "recovering", described as "Left arm very sore throughout the day.". Additional information: Left arm very sore throughout the day. Complaint arose because he didn't feel he could lift weights/exercise until this resolved. Known allergies: No, If COVID prior vaccination No, If COVID tested post vaccination: No, Other medical history: None. If other vaccine in four weeks: No, If other vaccine in two weeks: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details provided were as follows: The age at vaccination was not reported. The patient had shingles and the vaccine, the patient had prior did help in making shingles less severe. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Infant developed fever and loose watery stools on 8/16/2018, 2 days after vaccine. Fever only one day but Diarrhea persisted for a week with up to 12 stools per day. No blood in stool. No emesis. Diaper rash developed due to diarrhea. Mother states older sibling of this infant died from intussuception.
Patient's husband reported to the pharmacy that the night she received the vaccine she developed a fever and started to shake violently during the night while in bed.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Missing menstrual cycle; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration, in the left arm, on 25Jun2021 17:00 (at the age of 48-years-old), as dose number unknown, single for COVID-19 immunisation. The patient has no relevant medical history and concomitant medications were not reported. Patient has no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced missing menstrual cycle on 07Jul2021. Event did not result to either physician office visit nor to emergency room visit. No treatment was given as a result of the event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm itchiness; arm pain on the injection site; arm was swollen; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site arm pain, increasing swelling and itchiness.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 6 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly (batch unknown) in the arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, after the vaccine was administered, the patient reports experiencing arm pain at the injection site (not too painful) and swelling.   On 7 Jan 2021, the patient reports increasing swelling and arm itchiness. The patient noticed that it was swollen and started getting bigger, she drew a circle around it and it was as big as her index finger. No treatment information was provided.    Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events of injection site arm pain, increasing swelling and itchiness was not recovered.; 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. Further information has been requested
went into shock; infection; This is a spontaneous report from a Pfizer-Sponsored Program. A contactable male consumer (Patient) reported for himself. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The caller had first vaccine and then was admitted into the hospital and went into shock and had infection on an unspecified date. He was not able to get second vaccine. He wanted to know if he should get second vaccine or start over. The outcome of events was unknown.  Information about lot/batch number has been requested.
Developed marked itching at and around the vaccination site on the first day after vaccination. This also happened in October, 2021, when I received the Pfizer booster. The first two vaccinations (both Moderna) caused only injection site pain and tenderness.
Bad taste in mouth, headache, exhaustion at first. Symptoms increased over night to include join pain, hot flashes, fullness in ears and watering eyes.  Also experienced slowed motor skills. Next day all Symptoms increased with addition of back pain around kidneys.  Headache turned into migraine that lasted 12+ hours with dizziness and swelling in face. Symptoms started to subside during afternoon on 12/1/21.
Headache fatigue, chills, slight sore throat; next day, also felt flushed, headache worse
Vaccination site pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (fever) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (fever). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (fever) outcome was unknown. Not Provided          Concomitant information use was not reported.  Treatment information was not provided.
WARMTH AT INJECTION SITE Narrative:  60 yo female reported at her second vaccination appt (on 2/24/2021) for covid that the injection site felt hot for 2 days after her first vaccine. Patient received her first dose of covid19 Pfizer vaccine on 2/3/2021. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. Vaccine administered without complications.
Pt received vaccine and reported red blotches on arms and started feeling faint. Pt reported dizziness and headache as well as difficulty breathing. Vitals: 1156 112/71, HR 62; 1208 116/72, HR 62. Pt observed for 30 minutes on stretcher. At 30 minutes, pt reported feeling ok to leave and was wheeled out of facility and ambulated to car.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 10th August 2018, the patient received the 1st dose of SHINGRIX. On 11th August 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, injection site itching, facial pain, headache, fatigue, appetite lost, injection site erythema and injection site swelling. On an unknown date, the outcome of the pain in arm, injection site itching, facial pain, headache, fatigue, appetite lost, injection site erythema and injection site swelling were recovering/resolving. It was unknown if the reporter considered the pain in arm, injection site itching, facial pain, headache, fatigue, appetite lost, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the niece of the patient. The patient received SHINGRIX on right arm. The patient experienced experienced arm soreness, itching, redness, and swelling at the injection site, loss of appetite and her face hurt. The patient reported that the events began to resolve after 2 days. This is 1 of the 3 linked cases reported by the same reporter.
3 days after 2nd shot both legs knee on down front and back started to swell up. Feet and ankles as well.; 3 days after 2nd shot both legs knee on down front and back started to swell up. Feet and ankles as well.; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 17May2021 at 12:00 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. Concomitant medication included VITAMINS NOS Other medications in two weeks. Historical Vaccine included bnt162b2 as 1st dose for covid-19 immunization (at the age of 59 years-old).  The patient received no other vaccine in four weeks. On an unspecified date, the patient experienced 3 days after 2nd shot both legs knee on down front and back started to swell up. feet and ankles as well. Facility type vaccine was public Health Clinic/Veterans Administration facility. It was reported that 3 days after 2nd shot both legs knee on down front and back started to swell up. Feet and ankles as well. Continue to be swollen for up to two weeks and 4 days. The patient was going for an appointment to see his doctor. The patient reported it was is outrageous as it was known about this issue. Ae resulted in Doctor or other healthcare professional office/clinic visit. treatment was received Unknown. Patient was not covid prior vaccination. Patient did not test for covid post vaccination. Outcome of the events were not recovered.   Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
Severe lethargy and unable to use muscles to get out of bed for 3 days. Slept for 1 week with periods of brief awakennings. Felt as though my muscles were crawling. I am a very energetic individual and usually sleep 5-6 hours a night. Since my 2nd shot I am not able to stay awake and feel like I have Narclepsy. Afraid to drive so I have been having friends and family drive me. Started to use cafiene to try and stay awake but doess not help. I continue to feel as though my muscles are twitching and crawling even at rest. Feel funny in my head and have a head ache all the time that seems to move around with severe scalp tenderness. I feel as though my chest/breast muscles are burning and sore. Feelsevere muscle weakness.