chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals.We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods: ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the Health System, an integrated healthcare system. We queried the VAERS database to determine Health's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results: In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable pre-implementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involves patient (age and gender not reported), who was vaccinated with a dose of Tdap (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient had experienced local immunization reaction. Laboratory tests and corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.
Headache, body ache, fever, chills, weakness  10 days later mouth sores, cotton feeling. White tongue, burning when brushing teeth, taste buds swollen. Still having mouth symptoms 05/24/2021. Saw PC physician, dentist and tele-a-doc no one can give me any answers. Have tried home remedies but not clearing up
Post vax, the pt developed cellulitis at injection site. Area was red, hot, and hard for 48 hours.
chills; throwing up; This case was reported by a consumer via call center representative and described the occurrence of chills in a 17-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 22nd September 2020 09:30, the patient received Influenza vaccine Quadrivalent unspecified season and Meningococcal B vaccine. On 22nd September 2020, less than a day after receiving Influenza vaccine Quadrivalent unspecified season and Meningococcal B vaccine, the patient experienced chills and vomiting. On an unknown date, the outcome of the chills and vomiting were unknown.   The reporter considered the chills and vomiting to be related to Influenza vaccine Quadrivalent unspecified season and Meningococcal B vaccine.  Additional detaails were provided as follows: The reporter was patients mother. The patient was vaccinated with Meningitis B and Flu vaccine morning around 9:30. The patient was throwing up and had chills at time of reporting. The reporter did not known the brand name of products. The reporter did not consent to follow up.
About 30 to 45 days later,  I started to notice increased hip pain in the morning.  I consulted my rheumatologist Dr. who indicated that it may be vaccine related. I also started getting pain in my left shoulder.  I have not exerted or done anything physical to cause the pain. A week later, I also notice pain in my left thumb.  At this time, the pain did not resolve.  I consulted with Dr. and he instructed me to take prednisone 5mg-10mg for 10 days and start  tapering off. This did help resolve my hip pain and my thumb pain did improve.  I also increased my methotrexate dose to help with my pain.  Overall, I have noticed an increased in arthritic pain flare up  following the vaccine.
patient received an expired ActHib vaccine, no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 months old female patient who received a 0.5 ml dose (fourth dose in series) of expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (box lot UI900AAA, expiry date 17-Sep-2019, vial for powder lot UI900AA, expiry date 08-Oct-2019, diluent lot U6018AA, expiry date 17-Sep-2019) via intramuscular route in the right thigh on 29-Oct-2019.  The patient's medical history and concomitant medications were not reported.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At a time of reporting No adverse reaction 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.
I was finally diagnosed at Hospital. on 1/5/2020 with Guillain-Barre Syndrome.  Lost ability to speak, walk, hard time breathing - lost bowel movements for 12 days - had extremely HIGH blood pressure which now has resulted in a high dose of both Lisinopril, and Labetalol 2x a day.
I've noticed fatigue and I was really aware of it the last 3 months. I'm realizing that I have been having this fatigue where it's hard to go to bed, hard to wake up in the morning. I don't notice other symptoms that would indicate anything like a mental health incident. I mentioned this to my psychiatrist. We switched my medications to the evening, but I haven't noticed any difference with doing that. I'm still actively working through what seems like unusual amounts of sleep that I need to feel rested. I used to maintain myself at about 7 hours of sleep, but it seems like I would need about 9 hours to maintain myself now. I can even easily make that up to 12 hours.
Developed generalized aches, malaise 3 days after administration; fever up to 102 degrees 7 days after administration, PCP diagnosed "serum sickness".
MISSED DOSE; arm was so incredibly sore; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (MISSED DOSE), VACCINATION SITE PAIN (arm was so incredibly sore), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     The patient's past medical history included Surgery on 30-Jul-2021. Concurrent medical conditions included Thyroid therapy, Asthma and Allergy.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced VACCINATION SITE PAIN (arm was so incredibly sore), PYREXIA (fever) and CHILLS (chills). On 20-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (MISSED DOSE). On 20-Jul-2021, PRODUCT DOSE OMISSION ISSUE (MISSED DOSE) had resolved. At the time of the report, VACCINATION SITE PAIN (arm was so incredibly sore), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported
Fully vaccinated with Moderna vaccine x 3. Tested positive for Covid on 02/01/2022. Admitted to Medical Center on 02/15/2022. Expired on 02/18/2022 while still hospitalized.
A report received on 25Oct02 concerning a 33 year old vaccinee and approx 15 clinic staff members (demography unk) who were administered a Fluvirin injection by inappropriate route in error in Oct02. On an unk date in Oct02, the vaccinee and approx 15 staff members were administered Fluvirin with 1/2 inch needles. The reporter suspected that the staff members may have received the vaccine via a SC and not an IM route. No adverse events were reported.  The reporter has assessed the relationship of the vaccines to the event unclassifiable. Update 1 13Dec02: An update report was received received from a health care professional on 13Dec02 concerning a 40 year old female vaccine who was administered Fluvirin SC on 08Oct02. On 08Oct02, the vaccinee was inadvertently administered Fluvirin SC. The outcome of the event was unk. Ref: PJP200200657, PJP200200882, PJP200200883, PJP200200884, PJP200200885, PJP200200890.
Fatigue, myalgias, nausea, tachycardia, fever to 102.8, intense left arm erythema, pain, and edema.
I'm describing it as a colon spasm. I passed out and threw up. A trillion times worse than labor pains, 2 minutes after I ate. It lasted a very long time. Then I started passing blood and this was at 5pm in the evening. The next morning, I had my husband take me to the ER.
Information has been received from a registered nurse concerning a 21 week old infant who was vaccinated on 19-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Right After the vaccine I developed alot of post nasal drip and a metallic taste in my mouth. About 1 hour later I developed an cough which lasted for a few hours. The cough was very bothersome but eventually subsided by the next day. Since then I feel fine with no other symptoms. Lot # UP016AA Exp. 03/30/2011
Chills, Fever, Rapid Heart Rate, Nausea, very sore, tender arm.
Per hospital case manager report: Pt presented to Hospital ED on Apr 1 with c/o fever, sweats, chest pain, and hypertension. Admitted for hospital observation overnight and discharged home on Apr 2 with dx of "adverse vaccine response."
Per Dr.  patient has been complaining of arm pain since she has received the vaccine. He said he scheduled for patient to go get an MRI/scan done to see what is going on. Dr.  requested that the pharmacy complete a VAERS report for patient.
At around 11 Pm 10 hours after I took the vaccine, I experienced chills, then a fever, and extreme fatigue. The chills lasted for around 4 hours, and eventually my fever went away with it. I shook so hard my back, and my joints started to ache. I couldn't sleep because I was having hallucinations from the fever and the pain would wake me up every hour, I also had a headache. The next day my back still hurts, my head still hurts despite medication, the shaking has subsided. Yet I'm sweating, I'm still very weak, I can't stand up without getting super dizzy or experiencing extreme fatigue. If I think of food I feel as if I'm going to vomit just drinking too much water can make me ill.
Information has been received from a registered nurse concerning a 24 year old female who was vaccinated with 2 doses of of VARIVAX (Oka/Merck) and 3 doses of RECOMBIVAX HB on unspecified dates. Now the patient had low antibody titers to both varicella and hepatitis B. No further information available. Additional information is not expected.
On 11/09/2000 the patient presented at an after hours clinic with a cough that started 2 or 3 weeks prior, a fever of 102F that started 11/07/2000, a scattered rash on the trunk and extremities, mixed macular papular and some possible vesicular. The patient was diagnosed with chickenpox. The patient recovered. No further information is expected.
Could not function correctly; Headache; body aches; Chills; swelling pain; This is a spontaneous report from a contactable consumer or other non hcp. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 19Apr2021 11:30 as dose 1, single for COVID-19 immunization (at the age of 44-year-old). The patient's medical history and concomitant medications were not reported. Family medical history relevant to AE(s) was none. Prior vaccinations within 4 weeks and AE(s) following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer Suspect was none. The patient could not function correctly, headache, body aches, chills and swelling pain on an unspecified date. Event could not function correctly, body aches, swelling, pain was reported as worsened. Patient explained that her headache came and went when she was in pain. Her body aches and was swollen. Pain was all over the body on the right side. Adverse events did not require visit to emergency room and required physician office visit. Patient went to first care where she was given an antibiotic and nerve pain medicine. These were Diclofenac 75 mg, Prednisone 20mg, Valacyclovir 1gm and Gabapentin 300mg as a treatment for events. The outcome of the events was not recovered.  Follow up needed, further information has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Information has been received from a nurse concerning an 18-week-old female who on 12-FEB-2007 was vaccinated with the Second 2.0 ml dose of Rotateq (Lot #653661/0146F). The nurse reported that on 12-FEB-2007, the patient developed a high fever of 102.7. Unspecified medical attention was sought. At the time of this report the patient's high fever persisted. Additional information has been requested.
pt recvd vax;devel severe h/a 12 hrs post inject x 2 days despite advil post inject;
Within 36 to 48 hours, the pt developed fever of 102 degrees and an injection site reaction characterized by a 10 cm to 20 cm area of swelling and redness of his right arm. He was prescribed an oral antibiotic.
1st and 2nd Dose Pfizer COVID vaccine given as the Pfizer BIValent Booster
LEFT THIGH (LEG) SWELLING (OVAL SHAPED) WITH WARMTH TO TOUCH. COLD COMPRESS AND BENADRYL AS NEEDED AND FOLLOW UP WITH DOCTOR IF NOT IMPROVED. SEEN BY DR 8/13/2010.
Psoriasis breakout on hands; Became sick right after; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis breakout on hands) and IMMUNISATION REACTION (Became sick right after) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PSORIASIS (Psoriasis breakout on hands) and IMMUNISATION REACTION (Became sick right after). At the time of the report, PSORIASIS (Psoriasis breakout on hands) had not resolved and IMMUNISATION REACTION (Became sick right after) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Patient reported non-serious events psoriasis breakout on hands and had took both moderna covid vaccines and became sick right after with HUMIRA (ADALIMUMAB).  On unknown dates, the patient experienced psoriasis breakout on hands and had took both moderna covid vaccines and became sick right after.  On an unknown date, had took both moderna covid vaccines and became sick right after resolved.  MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient did not receive the full amount in the syringe; A spontaneous report  was received from a healthcare professional concerning a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the event, did not receive the full amount of dose in the syringe.  The patient's medical history was not provided by the reporter. Concomitant medications were not reported.  On an unspecified date, one day prior to the onset of event, the patient received their first two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. The patient did not receive the full amount of dose in the syringe.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event, did not receive the full amount of dose in the syringe, was considered resolved on unspecified date.; Reporter's Comments: This case concerns a female patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered.
Received vaccine on 10/12/00. Pt complained of redness, swelling burning sensation and tenderness at injection site. States approx. 3-4cm in size. Symptoms first noted on 10/13/00. Treated at hospital on Sunday, 10/15/00 with Keflex.
Pt found to have dysphagia/confusion. Exact time of onset of s/s are unknown. Pt admitted to ED where stroke was ruled out. Pt continued to have changes in mental status/hallucinations. Pt also with lesions consistent with shingles. Pt diagnosed with encephalitis. Started on IV Acyclovir. Encephalopathy resolving after starting Acyclovir. Pt with possible VZV encephalitis that has markedly improved with continuing 14 days of IV Acyclovir. 1/28/08-records received-for DOS 4/6-4/18/07 and 4/29-5/4/07-DX: probable varicella zoster viurs encephalitis. E. coli urinary tract infection. Neurogenic bladder. Polymicrobial sepsis, resolving. Presented to ED with confusion and global aphasia. Shingles. Pruritus. Fever chills and abdominal pain.
Patient presented to the ED and was subsequently hospitalized for chronic kidney disease within 6 weeks of receiving COVID vaccination.
Started itching Friday night - Itches off and on. If doesn't scratch, won't pop up. Started taking Benadryl 11/23/02. Continuing - States has hives - Denies any allergies to eggs or other components.
nose bleeds in his right nostril; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleeds in his right nostril) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (nose bleeds in his right nostril). At the time of the report, EPISTAXIS (nose bleeds in his right nostril) outcome was unknown.            No concomitant medication and treatment information was reported. Reporter stated that the patient experienced nose bleeds in his right nostril since getting the second dose of vaccine, which happened twice in one day but usually the patient experienced a couple of times in a week. Though the reporter also stated that the patient has no history of nose bleed.
pain getting worse; This case was reported by a consumer via interactive digital media and described the occurrence of exacerbation of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles during the 2 weeks to flatten the curve). Concurrent medical conditions included pain (still had).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced exacerbation of pain. On an unknown date, the outcome of the exacerbation of pain was not recovered/not resolved.   It was unknown if the reporter considered the exacerbation of pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had been vaccinated for shingles now, but he/she was starting to feel like the pain was getting worse.  The patient stated that, hope shingles was not coming back. Additional Supportive Information: The follow up would not possible as no contact details were available.
Started feeling dizzy, nauseous and had heavy brain fog consistently for 10 days. The brain fog abated after taking turmeric supplements. My period was 25 days late and was clotty.  The dizziness continues to persist although I have figured out that certain things trigger it to be worse (alcohol, flourescent lights). I am currently 8 days late for my period.  Had blood work done and confirmed that I'm not pregnant. All other things on blood work came back normal.
Dose 1: Minimal site discomfort, low grade fever, slight headache, muscle pains Dose 2: Site discomfort, low grade fever, slight Headache, moderate muscle pains.
I developed a form of dissecting cellulitus, after recieving the anthrax vaccination i got large bumps on the back of my head, and it was very irritated and red in color. Doctor tried numerous antibiotics, and ended up giving me the strongest one, Accutane. The bumps have somewhat gotten better, however my hair has not grown back.
02/16/2021- 7:00 AM - ITCHING AT THE INJECTION SITE. SLIGHT SWELLING .REDNESS OCCURRING AND SKIN IS VERY WARM.  THIS IS FISRT AND ONLY REACTIONS SO FAR.
On 2/11, I awoke feeling some pain in my lower abdomen and left groin when I walked. I had no pain when sitting or lying down. As the day progressed, the pain worsened. On 2/12, I began to be concerned that I had somehow damaged the repair of my left side hernia. So that afternoon I went to urgent care to have it checked. The hernia repairs on both sides were totally intact and the doctor did not speculate on what else it could be but said to watch it and if it worsened, to go to the ER. Into that evening, the pain shifted to the right groin. By the morning of 2/13 the pain had greatly diminished but had shifted again to the left groin. On the morning of 2/14, the pain disappeared.