chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of muscle atrophy in a 14-year-old subject of unspecified gender who was vaccinated with HPV vaccine (manufacturer unspecified). Concurrent medical conditions included delayed early gross motor. On an unspecified date, the subject received unspecified dose of HPV vaccine (administration site and route unknown, batch number not provided). 90 days after vaccination with HPV vaccine, the subject experienced primary muscular atrophy and autoimmune polyneuropathy. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author considered the events were unlikely to be related to vaccination with HPV vaccine. This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review additional  cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion. AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a two-months-old male patient who was vaccinated DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ100AA via unknown route in the left thigh, on 27-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ, PREVNAR 13 and HEPATITIS B VACCINE. It was an actual medication case error due Inappropriate reconstitution technique. It was reported that the patient only received the diluent portion of the PENTACEL vaccine without the ACTHIB (lypholized powder). No side effects were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Initial report received from a consumer (the patient) on 19 NOVEMBER 2014. A male patient had received a dose of INFLUENZA, (batch number, dose number, route and site of vaccination not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was not feeling well. Corrective treatment and laboratory test was not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In 2017 (reported as "on or after 05-JUL-2017"), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M040423 with expiration date 03-JUL-2019; an improperly stored dose of ROTATEQ per oral, lot # M044396 with expiration date 19-JUN-2018; or an improperly stored dose of VAQTA lot # N005274 with expiration date 03-APR-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the vaccine was exposed to a temperature of 32 to 35 Fahrenheit degrees with a time frame of 1 hour. No previous temperature excursion was reported. The reporter did not know which vaccine was administered to the patient. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1710USA015406: US-009507513-1711USA008229: US-009507513-1711USA008231: US-009507513-1711USA008232: US-009507513-1711USA008233: US-009507513-1711USA008234:
BURNING ON BACK OF HEAD; STINGING ON BACK OF HEAD; TINGLING ON BACK OF HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced burning on back of head. On 10-APR-2021, the patient experienced stinging on back of head. On 10-APR-2021, the patient experienced tingling on back of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning on back of head, stinging on back of head, and tingling on back of head on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210810364.
Left deltoid area at injection swollen and red.  Pt complained of itching an hurting at site.  Swelling and itching started on 09/30/03.  No vesicles or cousate noted advised Benadryl cream to area for itching; cold compresses for swelling and comfort, and to see MD if no improvement.
I have got a aneurysm on the valve of my heart and I have got diabetes; I have got a aneurysm on the valve of my heart and I have got diabetes; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 26Jul2021 (Batch/Lot Number: FG7484) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that "I have got a aneurysm on the valve of my heart and I have got diabetes. I took the first dose and now I am kind of little skeptic about taking the second. The patient added that he is thinking if he can take the second dose of the vaccine and he is currently on a medication for the diabetes. The patient may not take the second dose. The outcome of the events was unknown.
earache; stuffy nose; sneezing; hoarseness; This non-serious case was reported by a consumer via call center representative and described the occurrence of ear pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAY-2023, the patient received the 1st dose of Shingrix. On 05-MAY-2023, 4 days after receiving Shingrix, the patient experienced ear pain (Verbatim: earache), nasal stuffiness (Verbatim: stuffy nose), sneezing (Verbatim: sneezing) and hoarseness (Verbatim: hoarseness). The outcome of the ear pain, nasal stuffiness, sneezing and hoarseness were unknown.   It was unknown if the reporter considered the ear pain, nasal stuffiness, sneezing and hoarseness to be related to Shingrix.     It was unknown if the company considered the ear pain, nasal stuffiness, sneezing and hoarseness to be related to Shingrix.   Additional Information: GSK receipt date: 05-MAY-2023 The reporter reported that on the day of reporting, the patient woke up with an earache, stuffy nose, sneezing and hoarseness. The reporter did not consent to follow up.
Administered vaccine 10/5 @ 11:16am. Injection site red and swollen- noted 10/6 at 8am
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot  number FD0809. The Public Health District, per guidance from the Regulatory Authority, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the  dose of vaccine that you received is valid.
Patient faint about 3 minutes after vaccine. Had patient lay down. Checked B/P, pulse, ox. Had patient remaining laying down. Doctor evaluated her after 15 minutes.
could not bend fingers; body aches; swollen armpit under the arm that was injected; chills; fatigue; fever; Had a hard time sleeping that night because she had hot and cold flashes; hot and cold flashes; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Had a hard time sleeping that night because she had hot and cold flashes), HOT FLUSH (hot and cold flashes), JOINT RANGE OF MOTION DECREASED (could not bend fingers), PAIN (body aches) and SWELLING (swollen armpit under the arm that was injected) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Which lasted a month and still not feeling quite back to normal.) in November 2020.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced INSOMNIA (Had a hard time sleeping that night because she had hot and cold flashes) and HOT FLUSH (hot and cold flashes). On 11-Apr-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (could not bend fingers), PAIN (body aches), SWELLING (swollen armpit under the arm that was injected), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever). At the time of the report, INSOMNIA (Had a hard time sleeping that night because she had hot and cold flashes), HOT FLUSH (hot and cold flashes), JOINT RANGE OF MOTION DECREASED (could not bend fingers), PAIN (body aches), SWELLING (swollen armpit under the arm that was injected), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       These symptoms started 24 to 26 hours after the vaccine. concomitant product include covid medications patient used prior suspect vaccine.
Started with a fever of 102.9, diarrhea and refusing to eat.  Fever was not controlled with repeated doses of ibuprofen and acetaminophen, tepid baths and exposure.  Had to take him to the emergency room for fever control and treatment of dehydration, followed by follow up appointment to our pediatrician for re-evaluation for dehydration.  On 09/16/2010, a rash appeared all over his trunk, neck and face.
On 9/21/2021, 4 days after receiving the shot I had  chest pressure and pain.  I went to the emergency room where my EKG showed abnormal and my Troponin levels were elevated.  I was transported to a surgical hospital and spent 2 days there after being diagnosed with Myocarditis
I was very ill after the Moderna vaccine shot #1 (and #2- appears I must make a separate report for that?); I could not get out of bed for two days.   I felt light headed, sick, headache, body aches, was exhausted.
Mother called to report that her child had been running a fever of 99.3 since having the 2nd COVID vaccine.  Today she was feeling bad and she was called by school to come and get her because she had vomitted.  This according to the mother is unusual for her in that she does not vomit and generally has no problems with vaccines.
La niña subio las escaleras de la casa y estaba observando, su boca en el espejo y poco a poco se acosto en el suelo. Al hablarle por su nombre no respondia tenia una baja respiracion, la boca morada y su cuerpo estaba flacido al cargarla, la llevamos a urgencias y tardo 30 minutos en estar consiente. La valoraron heciendole estudios de sangre, electrocardigrama, entre otros, Al Preguntarle a ella que sucedio dice o relata que sintio su cabeza y pies duros y sus ojos se cerraron porque le delian mucho que escuchaba su nombre pero no podia abrir sus ojos. The girl went up the stairs at her house and was observing her mouth in a mirror, then slowly she laid on the floor. When called by her name she didn't respond, breathing was shallow, her lips were blue, and her body was flaccid when picking her up, we took her to urgent care and it took 30min before she recovered consciousness. They did a blood work up, electrocardiogram and other lab tests. When the girl was asked what happened she says she felt her head and feet very heavy and her eyes closed because they were hurting so bad, she could hear someone calling her name but couldn't open her eyes.
1412 Shots given PENTACEL, MMR, PREVNAR, Hep A, Hep B, Varicella. 1915 parent stated child, limp, rash, convulsions, low temperature. 2000 child taken to ER, admitted to hospital. 9/25/09 Medical records received DOS 9/2/09 to 9/3/09: ER visit presenting SX: unable to walk, became limp in bath. Taken to ER had myoclonic movents/episodes, developed rash. Admit for observation. Admit DX: 780.79   D/C DX: Adverse reaction to immunizations.
Feel sick, don?t want to eat, extreme chills, headache, sharp pain in left under arm, heart palpitations fatigue  Has continued since day after injections
Patient had an erythematous area on the right deltoid where MCV 4 was placed.
Headache, chills, body ache, severe fatigue,  nausea. Symptoms were most severe about 16 hours after vaccine
A month after my last vaccine, I started getting sick. I tested positive for Covid on a home test. As I have issues with my lungs already, I didn't want to take any chances. I went to an urgent care, they gave me a PCR test and they prescribed Paxlovid. Starting to slowly get better, I'm still tired and coughing but not near as much.
EXTREME PAIN THE LEFT SHOULDER SOMETIME RADIATING  DOWN THE ARM . CANT LIFT ARM  UP PAST BREAST OR REACH IN THE BACK. SOMETIMES ARM GOES NUMB FEELING . IT ALSO CAUSED A PSORIATIC  FLARE UP ON DAY  5 AFTER THE SHOT .
This spontaneous report as received from a registered nurse refers to a 27 years old patient of unknown gender. On 26-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K003422, expiration date 06-MAR-2016 (dose, dose number, route and frequency were not reported) that was exposed to 19.5 for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Approximately three hour after receiving the vaccine the patient began to hallucinate. This is not normal for the patient. Per patient caregiver; the patient is hallucinating almost constantly. He is not resting currently due to the issues. He is also having extreme weakness in the arm which he received the vaccine and has unexplained bruising on the same side of his body on his trunk. Currently he has not pursued treatment. I advised he be taken to the ER or other clinic to be checked out as this may or may not be due to the vaccine.
my daughters and husband contacted covid-19 in spite having their vaccination; my daughters and husband contacted covid-19 in spite having their vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 5 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 5 years as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Jan2022, outcome "unknown" and all described as "my daughters and husband contacted covid-19 in spite having their vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive, notes: they had PCR test this morning but we don not have those results. The antigen test were positive."; (27Jan2022) unknown results, notes: they had PCR test this morning but we don not have those results. The antigen test were positive.". Therapeutic measures were taken as a result of covid-19.  Additional information: Tylenol was taken as treatment. NDC number, UPC number, expiry date were reported as unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a physician concerning a 27 year old female with a history of seasonal allergies who on 14-FEB-2008 was vaccinated IM, in the right deltoid with her third dose of GARDASIL (lot# 659655/1486U). On 17-FEB-2008 the patient experienced puffiness at injection site, swelling in the right arm and eye puffiness. It is unknown if the patient had this same reaction with the first and second doses of the vaccine. The patient sought unspecified medical attention. The patient took BENADRYL and subsequently recovered from puffiness at injection site, right arm swelling and eye puffiness on 19-FEB-2008. Additional information has been requested.
even to the point of near blindness; suddenly begin to sweat profusely; feeling weak/felt weak; nauseous; my vision becomes extremely blurry; spent much of that time in the bathroom with diarrhea; This is a spontaneous report from a contactable consumer. A 33-year-old male patient received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 13:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Seasonal allergies (trees, grass) and related fruits (apples/cherries/peaches). Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient reported "Received the shot and waited in the parking lot for the 15 minutes. No negative effects whatsoever during the 15 minutes, and I was cleared to leave. As I am driving out of the parking lot, suddenly begin to sweat profusely, feeling weak/nauseous, and my vision becomes extremely blurry, even to the point of near blindness. I stopped the car and sat for about 30 seconds/1 minute until my vision returned sufficiently to drive back to the waiting area where I requested water. I immediately felt better with the water, and the staff also gave me benadryl although I don't think it had any impact. I felt weak for an additional 30 minutes or so and spent much of that time in the bathroom with diarrhea. I felt fine to drive after this 30 minutes and have had no side effects since." Therapeutic measures were taken as a result of even to the point of near blindness, suddenly begin to sweat profusely, feeling weak/felt weak, nauseous and my vision becomes extremely blurry. No treatment was reported for the event spent much of that time in the bathroom with diarrhea. Outcome of the events was recovered on 31Mar2021.
experienced tired and diarrhea; experienced tired and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (experienced tired and diarrhea) and DIARRHOEA (experienced tired and diarrhea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FATIGUE (experienced tired and diarrhea) and DIARRHOEA (experienced tired and diarrhea). At the time of the report, FATIGUE (experienced tired and diarrhea) and DIARRHOEA (experienced tired and diarrhea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: X-ray showed that in the left AC joint there is degeneration.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Doctor recommended physical therapy  and cortisone shots   This case was linked to MOD-2021-035210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received and added concomitant medication. Adverse events, added outcome of the events On 03-Aug-2021: Non significant follow up
Had a sore arm after receiving Pfizer's Covid 19 vaccine; This is a spontaneous report from contactable consumer received via a sales representative.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced sore arm after receiving Pfizer's COVID-19 VACCINE. The patient outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
02/14/22 presents to ED for "abdominal pain". PMHx of "HTN, HLD, cholelithiasis s/p cholecystectomy, ventral hernia"