chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the shots; shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shots) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient had the shots and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Left arm red/swollen/hot from shoulder to elbow - first noted 6 hours after injection, resolving (mild redness only) when seen 70 hours after.
little tired the day (after the shot); red spot; swollen at spot; warm spot; sore arm; temperature elevated; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little tired the day (after the shot)), INJECTION SITE ERYTHEMA (red spot), INJECTION SITE SWELLING (swollen at spot), INJECTION SITE WARMTH (warm spot) and INJECTION SITE PAIN (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (little tired the day (after the shot)), INJECTION SITE ERYTHEMA (red spot), INJECTION SITE SWELLING (swollen at spot), INJECTION SITE WARMTH (warm spot), INJECTION SITE PAIN (sore arm) and BODY TEMPERATURE INCREASED (temperature elevated). At the time of the report, FATIGUE (little tired the day (after the shot)), INJECTION SITE ERYTHEMA (red spot), INJECTION SITE SWELLING (swollen at spot), INJECTION SITE WARMTH (warm spot), INJECTION SITE PAIN (sore arm) and BODY TEMPERATURE INCREASED (temperature elevated) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications are not reported.   Treatment: Ice.
use by date 1/18/23 admin date 1/20/23; no adverse event reported
Swelling at injection site. Some discomfort but otherwise patient feels normal. No fever or exudate.
Patient's arm was sore and continued to hurt to the extent it was difficult to raise above her head.  On 6/7/21, she experienced high blood pressure of >200 systolic and sought care at the ED since she was also having left arm pain.  EKG, bloodwork and heart monitoring all indicated no cardiac issues.  ED provider recommended acetaminophen for the pain.  Blood pressure continued to stay somewhat elevated on 6/8/21 but had returned to baseline by 6/9/21 and patient was feeling better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient has not received any other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Initial report received from healthcare professional on 21 November 2013. A 40-year-old female patient whose medical history and concomitant medications were not reported, received YF Vax (lot number UH671AA, expiration date 11-Feb-2013 and site of administration subcutaneous) at left arm (dose number not reported) on 16 October 2013. On 16 October 2013, the patient developed small bumps on various areas of her body resembling a pimple began day of vaccination. Reporter stated on initial evaluation on 21-Oct-2013 the bumps that appeared to be bigger than a mosquito bite, did not have a head like a pimple but would pop and ooze liquid of unknown description. Patient was evaluated by cardiovascular employee physician on 04-Nov-2013 and it the physician diagnosed skin condition as an allergic reaction. Laboratory investigation unknown and corrective treatment included BENADRYL, cortisone creme and OTC oatmeal baths. As of this report, outcome of the events was unknown. Documents held by sender: none.
Pain at the injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), MONTELUKAST SODIUM (SINGULAIR) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Fatigue). In March 2021, VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were provided.  With the first dose, patient experienced pain at the injection site and fatigue. But, it went away in 2 to 5 days.   This case was linked to MOD-2021-376981 (Patient Link).
4 Y.O. Female inadvertently administered Pfizer 5-11 y.o. covid vaccine when she was to young to qualify for it.
Vesicular rash started that is all over the patient body, on her entire legs, back, stomach adn arms; Vesicular rash started that is all over the patient body, on her entire legs, back, stomach adn arms; Information has been downloaded from Agency (US-CHIRONMA-PHHY2017US030236).  This spontaneous report was received from a other health professional referring to a 59 years old female patient. The patient's concomitant therapy included levothyroxine sodium (SYNTHROID). The patient's concurrent condition and medical history were not reported.      On 23-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), 1 dosage form, subcutaneously (lot # M019646, expiration date was not reported, but upon internal validation established as 18-JUL-2017) for immunisation. On the same date, the patient was also vaccinated with influenza virus sag 3v vaccine inactivated (FLUVIRIN) 1 dosage form, intramusculary (lot# 1618621, expiration date was not reported) for immunisation.    On 30-OCT-2016, vesicular rash started that was all over the patient body, on her entire legs, back, stomach and arms. The outcome of the events was recovering. The causality between the events and all the suspect therapies was not provided.    The reporter considered vesicular rash started that was all over the patient body, on her entire legs, back, stomach and arms to be serious for the following reason: medically significant.
Rash on neck/chest/back 1 day after starting oral Typhoid vaccine, pin-point bumps in reddened area, very itchy, resolve with cortisone cream.  Rash resolved. Pt seen 1/17/06 no rash seen, BENADRYL OTC, CLARITIN OTC prescribed.
Information has been received on 05-MAR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 25-NOV-2008, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 12-OCT-2011, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Information has been received from a RN concerning a 4th grade student who was vaccinated with a dose of varicella virus vacciene live ; It was reproted that  in mid December of 2004. According to the school nurse 58 other elementary school students who developed chicken pox and 34 of them had previously been vaccinated with a dose of varicella virus vaccine live. Unspecified medical attention was sought. There was no information regarding the present status of the student. No product quality complaint was involved.  Addition information    has been requested.
the shot doesn't keep you from getting shingles, I still get them/Suspected vaccination failure; still get them; 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 were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received the Shingles vaccine and still gets shingles. The patient mentioned that did not take the shot, it did not keep you from getting shingles, the breakouts would not be bad.  The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Horrible migraine headache; Headache is killing me, very bad headache; Nausea; Chills; Acid reflux; Sweat; Earache; Pain in feet, Pain in legs; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), HYPERHIDROSIS (Sweat), EAR PAIN (Earache), PAIN IN EXTREMITY (Pain in feet, Pain in legs) and MIGRAINE (Horrible migraine headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine NOS (had regular migraine attacks).    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), HYPERHIDROSIS (Sweat), EAR PAIN (Earache), PAIN IN EXTREMITY (Pain in feet, Pain in legs), NAUSEA (Nausea) and CHILLS (Chills). On 26-Mar-2021, the patient experienced MIGRAINE (Horrible migraine headache) and HEADACHE (Headache is killing me, very bad headache). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), HYPERHIDROSIS (Sweat), EAR PAIN (Earache), PAIN IN EXTREMITY (Pain in feet, Pain in legs), MIGRAINE (Horrible migraine headache), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache is killing me, very bad headache) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up information received on 22-Jun-2021 contains non significant information.
High fever Headache Weakness Chills Body aches Rapid heartbeat   All lasted about 12 hours
got one flu shot in my life and never been so sick.; Initial information was received on 07-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).   This case involves patient who got one flu shot in life and never been so sick (illness), after receiving vaccine INFLUENZA VACCINE  Relevant medical history, concomitant medications and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.   On an unknown date, the patient developed a non-serious got one flu shot in life and never been so sick (illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
patient states that after the vaccine she got a rash on her chest, arms, and her legs. She also stated that her hair has begun to thin.
Headache since getting the vaccine , been taking 2 Tylenol?s every day but doesn?t help
High fever up to 103.2 lasting approx 36 hours, responsive to Acetaminophen and Ibuprofen.
Information has been received from a pharmacist concerning an approximately 60 year old female who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient developed cold sores in and around the mouth. Unspecified medical attention was sought. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
He also said that he received all the Pfizer Covid 19 shots, but even though he was tested positive from COVID 19 a week ago.; He also said that he received all the Pfizer Covid 19 shots, but even though he was tested positive from COVID 19 a week ago.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "He also said that he received all the Pfizer Covid 19 shots, but even though he was tested positive from COVID 19 a week ago.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested positive from COVID 19 a week ago. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient said that he received all the Pfizer Covid 19 shots, but even though he was tested positive from COVID 19 a week ago. After that, he mentioned that he started to feel congested after finishing his treatment with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Covid-19 prior to Paxlovid treatment.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 prior to Paxlovid treatment.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient do not have any allergies. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Concurrent medical conditions included Drug allergy (Unspecified drug). Concomitant products included IBUPROFEN for an unknown indication.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19 prior to Paxlovid treatment.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19 prior to Paxlovid treatment.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Covid starting immediately after 5 days of Paxlovid..         Patient previously receive a COVID-19 Vaccine. Patient stated that Rebound COVID started immediately after 5 days of Paxlovid. Lasting another week. Still have shortness of breath and intermittent cough & sneezing. Device Date : 05Jun2022  Company Comment: This spontaneous case concerns a patient (age and gender not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 16 th to 20 th May 2022 for Covid-19 and had a rebound covid 5 days after the Paxlovid which lasted a week with shortness of breath and intermittent cough & sneezing. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient (age and gender not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 16 th to 20 th May 2022 for Covid-19 and had a rebound covid 5 days after the Paxlovid which lasted a week with shortness of breath and intermittent cough & sneezing. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
infertility; early menopause; soreness in her arm; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of INFERTILITY (infertility), PREMATURE MENOPAUSE (early menopause), PAIN IN EXTREMITY (soreness in her arm) and NAUSEA (nauseous) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFERTILITY (infertility), PREMATURE MENOPAUSE (early menopause), PAIN IN EXTREMITY (soreness in her arm) and NAUSEA (nauseous). At the time of the report, INFERTILITY (infertility), PREMATURE MENOPAUSE (early menopause), PAIN IN EXTREMITY (soreness in her arm) and NAUSEA (nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The dosage text was reported as unknown. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745838 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745838:Same Reporter Patient 1
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 14Oct2023 to 18Oct2023. Patient had no known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
1135 - (L) ear ringing it migrate to (L) neck. V/S BP-116/70, HR-76, O2Sat-97% on RA, R-18 1142 - Diziness and middle back pain start hurting. V/S BP-110/68, HR-75, O2Sat-96%, R-15 1150 - pt. continue to have symptoms, escort to ER.
Adverse Event: Mother and Provider were both under the impression that patient was receiving dose #2 in a year of the influenza. Order was placed by Dr.. While RN was entering the vaccines and noticed that patient chart had documented that he had received his 1st dose on 9/19/2022 and 2nd does on 10/31/2022. Patient did receive dose #3 on 02/17/2023. Mother wrote on Vaccine paper work that this was dose #2. Treatment: informed provider, mother and supervisor. Mother was also informed that if patient is to experience abnormal responses to vaccine to call or seek evaluation. Mother stated that "this is miscommunication due to paper work being faxed from previous provider". Mother also stated that "she was under the impression that this was only patients second influenza vaccine" Outcome: When informing Dr. she stated "Patient will be extra protected."
waking up and not being able to breath coughing diizziness diarea weakness, hight high rate, shortness of breath, dehydration, chills, soreness, unable to sleep
Right lower extremity edema (3 t pitting) developing within 12 hours of influenza vaccine. No redness or pain. Slowly resolved over course of several weeks.
Felt dizzy and light headed. Watch indicated heart rate climbing up to 172bpm momentarily and dropped back down to 120bpm.