chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have not yet received 2nd dose; This non-serious case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first Shingrix vaccine about 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Have not yet received 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-Mar-2023 Lot number was unavailable. The health care professional was not provided. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 22 year old female with no pertinent medical history and no known drug allergies who on 20-MAY-2008 and 01-AUG-2008, was vaccinated intramuscularly with her first and second 0.5 ml doses, respectively, of GARDASIL (Lot # of the two doses 658490/0802U).  There was no concomitant medication.  On 01-AUG-2008, after receiving her second dose of GARDASIL, the patient fainted and experienced two small seizures.  The patient's symptoms resolved in 20 minutes.  The patient had a full meal prior to administration of GARDASIL.  The adverse events happened during office visit.  Follow-up information was received on 15-AUG-2008 from the L.P.N. via phone call.  The nurse refused to provide the patient's name.  It was reported that the patient only had fruit prior to receiving the second dose of GARDASIL.  The nurse stated that when the patient "came to" she was fine.  It was reported that the patient was scheduled for her third dose of GARDASIL in October 2008.  Upon internal review, seizures were determined to be an other important medical event.  This is one of several reports from the same source.  Additional information has been requested.
Per pt's mother pt started to run 102-103 fever on 5/28/15. 5/30/15 rash on whole body. Rash worsen 5/31/15. 6/01/15 rash improved, 6/02/15 rash faded almost completely, no treatment recommend but advised if rash persist or worsen. Pt needs to be seen for further evaluation.
Patient laid down on floor almost immediately following injection, reportedly pale/dizzy/light-headed. Patient was treated by EMS and was assisted onto gurney and gradually raised head to sitting up. Color returned and patient began feeling better - noted she also experiences syncopal episodes when giving blood. Patient's BP 137/76 immediately following incident, 124/70 at clinic discharge at 2:59pm. No other treatment administered.
Patient had flu shot around 9 am this morning. Throat/tongue swelling around 3pm. Never had reaction to flu shots previously, but never had HD version.
This case was reported by a physician and described the occurrence of hepatitis B antigen positive in an infant subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). One day after vaccination with ENGERIX B, the subject was tested for hepatitis B antigen and the result was positive. At the time of reporting the outcome of the event was unspecified. No further details were provided. It was reported that this event occurred in 4 infant subjects from different hospital facilities. Linked cases include A0942894A, A0942899A and A0942900A.
TINGLING AND NUMBNESS BILATERAL LOWER EXTREMITIES, RIGHT LEG IS WORSE. DENIES SHORTNESS OF BREATH OR ITCHING,. 1647 CLAIMS TO FELL BETTER. WAS ANXIOUS ALL DAY, AMBULATED SOME, FLUIDS TOLERATED BY MOUTH. 1710 FEELS BETTER, LEFT THE SITE, INSTRUCTED TO CALL PRIMARY CARE PROVIDER, 911, OR GO TO THE EMERGENCY DEPARTMENT IF SYMPTOMS PERSIST OR GETS WORSE
Intention was for patient to receive separate MMR and varicella vaccines. Clinic staff administered combination MMRV vaccine instead.  No harm to patient, but not intended vaccine.
L upper arm and shoulder pain.  No weakness, muscle atrophy, numbness.  Pt currently on meloxicam 7.5 mg, increased to 15 mg and given home exercises.
FLUSHED, HIGH FEVER (103 F, RECTAL), FEBRILE SEIZURE LASTED 20+ MINUTES.
Body aches and chills the following morning after receiving the vaccination.  I was very sluggish and remained in bed for the majority of the day.    I also had a lot of pain at the injection site and couldn't lift my arm.  Tylenol resolved the issues for the most part but it was only effective for about three hours prompting me to wait an additional 2-3 hours with the symptoms.   This lasted 24 hours and I felt good as new the following day with minor pain at the injection site.
first dose of Shingrix 2 years ago; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 2 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if the patient needs to restart or just give the second dose at the moment of reporting. The follow-up would not possible as no contact details were available.
By history, patient seemd to have a hypotonic, hyporesponsive episode.  Patient received 4 immunizations (listed below) at approximately 4 pm on 3/13/2003.  Patient then slept from 7-10pm.  He awakend, screaming.  He then became pale and blue.  Mom reports he was lethargic and not arousable.  He then had a second similar episode and parents started driving to the hospital.  On the way, patient had a third, similar episode and parents stopped a policeman who then called an ambulance.  Child was transported to the ER without incident. Discharge Summary received on 3/10/2004 states apnea.
Her arm is red and warm feeling today where it was done; Her arm is red and warm feeling today where it was done; A spontaneous report was received from a consumer ms concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events her arm is red and warm feeling today where it was done.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.   on unknown date the patient experienced the event Her arm is red and warm feeling today where it was done.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), her arm is red and warm feeling today where it was done,  was unknown.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 14-JUN-2013 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. No concomitant medications were reported. on 15-AUG-2013 the patient was vaccinated with GARDASIL dose 2 and 3 weeks early on 21-NOV-2013 the patient was vaccinated with GARDASIL dose 3. No adverse effect was reported. Additional information has been requested.
sores in her mouth; absolutely no energy; Feels very fatigued; arm is swollen; arm was swollen and tender; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), TENDERNESS (arm was swollen and tender), STOMATITIS (sores in her mouth), ASTHENIA (absolutely no energy) and FATIGUE (Feels very fatigued) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen) and TENDERNESS (arm was swollen and tender). On 02-Feb-2021, the patient experienced STOMATITIS (sores in her mouth), ASTHENIA (absolutely no energy) and FATIGUE (Feels very fatigued). At the time of the report, PERIPHERAL SWELLING (arm is swollen), TENDERNESS (arm was swollen and tender), STOMATITIS (sores in her mouth), ASTHENIA (absolutely no energy) and FATIGUE (Feels very fatigued) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included allergy pill and arrhythmia medication (not specified)
Patient reported tongue tingling. Then advised that she was feeling light headed. Patient then began slurring words and stuttering. Patient was given 25 mg of Benadryl IM. Then transported via ambulance to the local ER.
Fever of 103, headache, body aches, vomiting, tiredness lasting for 5 days
Rash to arms and legs 4-20-2014. Went to ER 4-22-2014 12.5mg BENADRYL given PO.
A large "knot" developed on the patient's neck on the same side as the shot also her arm is still sore after several days "knot" is not painful, but soft to touch, pt calling MD for follow up.
Redness, swelling day after flu shot. Hot to touch, sore. Swelling gone now 10/14/13. Healed bruise noticed now only.
FLUBLOK was mistakenly administered to an underage patient with no adverse event; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via consumer via physician via phone (Inquiry Number: 00804698).  This case involves a 15-years old female patient who was mistakenly administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with no adverse event (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 25-Sep-2021, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number: UJ723AA and expiry date: 30-Jun-2022 via intramuscular route in the right deltoid for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "FLUBLOK was mistakenly administered to an underage patient, caller would like to know safety and how to proceed."  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 the 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.
Fever, chills, swollen at injection site, weak, slept 24 hr, rash on arm
Rash R upper outer arm 24 hours after immunization given on 9/11 - Dizziness 9/14 in AM that went away. Some light headedness yesterday and today. BENADRYL 25 mg Q4h Rx today.
It started with body aches and flu like symptoms. Then, I developed a cough. I did not have a fever, but I was fatigued. I tested positive for COVID-19 on Thursday, August 25, 2022. I had a video visit with my doctor the next day. He prescribed PAXLOVID. I started the medication the same day and took it for five days. The symptoms never got worse. I quarantined for 10 days. I was never in any real discomfort from my symptoms, but the cough has lingered. It's more bothersome than anything.
Patient experienced numbness in arm vaccine was given in.  Numb feeling also went into upper back and right side of face.  Numbness was gone when patient left store.
Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil. Subsequently the patient was at the front desk to make another appointment when she fainted. Medical attention was sought. Additional information has been requested. Information has been received from a physician concerning a 14 year old female student who was vaccinated with a first dose of GARDASIL. On 11-APR-2007, the patient fainted a few minutes after receiving the vaccine. The physician had her lie down and took her blood pressure which was 98/60. The patient was watched for 10 to 15 minutes and then she went home. It was reported that there was no nausea or vomiting. On 11-APR-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Ist night  2/24 am, t, work up at around 2am with muscle aches (neck, back, arms,etc.) this subsided with tylenol.  Sunday morning woke up slighly dizzy ( 5:30am) but this dizziness has worsened as the days has progresses and turned into very unpleasant vertigo.At 8:55 pm, veritgo stil present, and feeling chills.
This is a spontaneous report from a contactable other HCP. A currently 91-year-old female patient of an unspecified ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration from an unspecified date to an unspecified date at a single dose for immunization. The patient started to receive atenolol, acetylsalicylic acid (ASPIRIN), omeprazole, hydrochlorothiazide, triamterene (DYAZIDE) and lisinopril: all via unspecified routes of administration from unspecified dates of therapy at unspecified doses and for unspecified indications. The patient's medical history and concomitant medications were not reported.  The patient had allergies with aspirin, atenolol, omeprazole, dyazide (triamterene-hydrochlorothiazide), lisinopril and pneumococcal vaccine on an unspecified date. The action taken in response to the event for pneumococcal 13-val conj vac (dipht crm197 protein) was not applicable while unknown for atenolol, acetylsalicylic acid, omeprazole, hydrochlorothiazide, triamterene and lisinopril. Outcome of the event was unknown. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) and atenolol in the reporter's country. This may be duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) and atenolol has submitted the same report to the regulatory authority.
can't sleep; he's not even resting because of the pain irradiating from the neck and back, to ribs and chest; chest pain; pain went to the ribs; Neck pain; Shoulder pain; pain was from the injection site/the pain was excrutiating; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (pain went to the ribs), CHEST PAIN (chest pain), INSOMNIA (can't sleep), RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest) and NECK PAIN (Neck pain) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain was from the injection site/the pain was excrutiating). On 12-Aug-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (pain went to the ribs). On 13-Aug-2021, the patient experienced CHEST PAIN (chest pain). On an unknown date, the patient experienced INSOMNIA (can't sleep) and RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL CHEST PAIN (pain went to the ribs), CHEST PAIN (chest pain), INSOMNIA (can't sleep), RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain was from the injection site/the pain was excrutiating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter.; Sender'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.
PATIENT HAD ITCHING, REDNESS IN A LARGE PATCH, POSSIBLE SLIGHT FEVER.
throwing up/vomiting; her body was jerking when she was badly throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "throwing up/vomiting"; DYSKINESIA (non-serious), outcome "unknown", described as "her body was jerking when she was badly throwing up". Therapeutic measures were taken as a result of vomiting, dyskinesia. Additional Information: It was reported that out of nowhere the patient started throwing up in school. The reporter was called upon and had to pick the patient from school. It was further reported that the only thing that was different was the shot. The patient had been home and the reporter have given the patient little pills. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fainted; Diarrhoea; Feels weak; bone pain from falling; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Fainted) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Fainted) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea), ASTHENIA (Feels weak), BONE PAIN (bone pain from falling) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 19-Mar-2021, LOSS OF CONSCIOUSNESS (Fainted), DIARRHOEA (Diarrhoea), ASTHENIA (Feels weak), BONE PAIN (bone pain from falling) and VOMITING (Vomiting) had resolved.            Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 was not applicable.  Company Comment: This case concerns a 77-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected diarrhoea, asthenia, bone pain and expected vomiting. Event latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 77-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected diarrhoea, asthenia, bone pain and expected vomiting. Event latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a 70 year old female patient concerning herself with no pertinent medical history. The patient had drug reaction/allergies to SEPTRA/sulfer drugs. In roughly around 2008 or 2009, the patient was vaccinated with one dose of ZOSTAVAX (lot # was not reported). Concomitant therapies included ibuprofen and GABAPIN. The patient got shingles right after ZOSTAVAX administration. The patient explained the shingles lasted 3 months. In that time the patient was experiencing severe pain on her right side collarbone, the right side of her scalp real bad and her right ear. She reported she still had pain from time to time. The patient sought unspecified medical attention. Blood work was performed on unknown date, and it was found that the cholesterol was high. Anti-viral medicine was given for treatment of the adverse event. At the time of reporting, the outcomes of pain and cholesterol high were unknown. The relationship between shingles, pains and cholesterol high and ZOSTAVAX was not reported. Additional information has been requested.
Left arm swelling, redness, pain, low grade fever, body ache, arm hot to touch.
3JAN97 mom reports cry more-like scream, high pitched lasting 30min, pt slept 1hr, same cry for 20-30min;mom contacted MD & was told rxn to DTP;has never heard cry like a/or since;
HOSPITALIZATION 1/22/22 DUE TO BREAKTHROUGH COVID-19 CASE. ONGOING HOSPITALIZATION.
Pt with a history of menigitis at 10 yrs old. Vaccinated with MENOMUNE prior to college entrance. Contracted meningitis and passed away at age 19 on 11/20/08. MD stated he will fill out VAERS himself and fax to agency. No further info provided.  1/27/09 Death certificate states COD as disseminated intravascular coagulation w/meningococcemia as contributing factor. DOD corrected to 11/17/2008.  12/31/08 Reviewed hospital medical records of 11/13-11/14/2008. FINAL DX: septic shock w/multiorgan failure, DIC, respiratory failure, acute renal failure, lactic acidosis, metabolic acidosis & suspected meningococcemia Records reveal patient experienced myalgia, malaise, generalized aching, nausea, vomiting, diarrhea, fever, petechial rash, sweating, photophobia, neck stiffness, SOB, abdominal pain, back pain.  Taken to hospital.  Intubated in ER & admitted to ICU in isolation.  Exam revealed tachycardia, hypotension(on pressors), anasarca, fever, thrombocytopenia, coagulopathy.  Renal, ID, pulmonary consults done.  Tx w/IV antibiotics, pressors, steroids, blood product transfusions & hemodialysis. Transferred to higher level of care.  01/14/09 Reviewed hospital medical records of 11/14-11/17/2008. FINAL DX: meningococcemia; purpura fulminans; multiorgan system failure. Records reveal patient experienced purpura fulminans.  Had been transferred from outlying hospital.  Noted to have had HA in addition to other presenting symptoms as noted in prior records.  Tx w/CVVHD, antibiotics & pressors.  Developed atrial fib/flutter & was cardioverted.  Developed ARDS, acites & anasarca.
Localized redness, warm to the touch, induration at injection site patient placed on KEFLEX due to history of cellulitis and being immunosuppressed.
Patient has ulnar artery aneurysm, developed occlusive emboli of proper (radial) digital arteries in digits 2, 3