chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 11-OCT-2016, the patient was treated by a physician's assistant for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, 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 vaccine, 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 including 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report was received from a medical assistant, refers to a 23 year old female patient. There were not pertinent medical history or drug reactions. On 05-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, in the left deltoid, lot # K023435, expiration date: 05-NOV-2016. There were not concomitant therapies. The medical assistant informed that on an unspecified date in June 2015, (reported as within 2-3 days), the patient experienced migraines with aura, nausea and vomiting. Also informed that the patient sought medical attention by visiting her primary care physician, who ran a blood work and urinalysis and the results were negative. Subsequently the physician suggested patient take unspecified "pain medication", at the moment of this report the patient was continuing with migraines but they are not at the severity that they first presented. The outcome of the migraine with aura was recovering. The outcome of migraine with aura was reported as recovering. Additional information has been requested.
patient has tingling in her throat. had her stay in the pharmacy for 30 minutes. She took some Benadryl over the counter.  She felt better and went home. Called the patient again 1 hour later and she has no symptoms. Told her to go to the ER is she experiences any other symptoms.
Swelling, redness, warmth, pain at yellow fever injection site diagnosed as cellulitis. Expansion of affected area noted on 3/30/15, borders marked and area markedly increased on 03/31/2015. Augmentin started on 03/30/2015 3 doses completed, discontinued 4/1/2015. Bactrim started 4/1/2015 for 10 days, improvement noted after 4 doses, plan to continue for 10 days.
product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 90-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EK4176), on 05Feb2021 as dose 2, single (Lot number: EL9264) and on 27Sep2021 as dose 3 (booster), single (Lot number: EW0170) at the age of 89 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 03May2022 as dose 4 (booster), single (Lot number: 057M21A) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "adhesive capsulitis of the shoulder" (unspecified if ongoing); "carotid stenosis" (unspecified if ongoing); "cervical radiculitis" (unspecified if ongoing); "chronic sinusitis" (unspecified if ongoing); "HTN" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "idiopathic progressive polyneuropathy" (unspecified if ongoing); "lumbar radiculopathy" (unspecified if ongoing); "peripheral arterial occlusive disease" (unspecified if ongoing); "lumbar radi" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER oral, start date: 28Feb2020; METOPROLOL oral, start date: 29Jan2018; OMEPRAZOLE, start date: 06Mar2018; ROSUVASTATIN oral, start date: 20Feb2020; ZOLPIDEM, start date: 23Jan2018; OXYCODONE, start date: 29Aug2018. Past drug history included: Amitriptyline, reaction(s): "Allergy"; Bactrim, reaction(s): "Allergy"; Cymbalta, reaction(s): "Allergy"; Gabapentin, reaction(s): "Allergy"; Lisinopril, reaction(s): "Allergy"; Mybetric, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "not recovered" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive; (08Jun2022) Negative; (13Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received other medication in 2 weeks. Rebound Covid 19 after treatment with Paxlovid, tested positive for covid and start of sx on 31May2022; treated with Paxlovid starting evening of 31May2022; completed 5 day series on morning of 06Jun2022; felt better tested negative for Covid 19 by OTC method on 08Jun then Friday 10Jun patient redeveloped fever, congestion and cough, retested with OTC Covid test 13Jun2022 and again positive for Covid. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure and COVID-19 cannot be ruled out.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO. On 12th June 2017, the patient received the 1st dose of BEXSERO .5 ml. On 13th June 2017, 1 days after receiving BEXSERO, the patient experienced injection site erythema, injection site lump, injection site induration and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the injection site lump and injection site induration were not recovered/not resolved. The reporter considered the injection site erythema, injection site lump, injection site induration and injection site pain to be related to BEXSERO. Additional details were reported as follows: This case was reported by the patient's mother. The mother reported that the patient experienced a red ring around the injection site and it was very sore with a hard knot.
odd mental changes; 5/1/19, 5/23/19, 7/1/19, 7/30/19; 5/1/19, 5/23/19, 7/1/19, 7/30/19; 5/1/19, 5/23/19, 7/1/19, 7/30/19; This case was reported by a pharmacist and described the occurrence of mental status changes in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st May 2019).   On 23rd May 2019, the patient received the 2nd dose of Shingrix. On 1st July 2019, the patient received the 3rd dose of Shingrix. On 30th July 2019, the patient received the 4th dose of Shingrix. On 1st July 2019, not applicable after receiving Shingrix and Shingrix, unknown after receiving Shingrix and not applicable after receiving Shingrix and Shingrix, the patient experienced extra dose administered. On 30th July 2019, the patient experienced extra dose administered. On an unknown date, the patient experienced mental status changes and drug dose administration interval too short. On an unknown date, the outcome of the mental status changes, drug dose administration interval too short, extra dose administered and extra dose administered were unknown.   It was unknown if the reporter considered the mental status changes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called in to report that the patient received Shingrix and experienced odd mental changes. The patient then went to the doctor and doctor mentioned may be due to patient receiving more than the recommended dosing of Shingrix. The patient received 2nd dose early, which led to shortening of vaccination schedule. The patient received 3rd and 4th Shingrix, which led to extra dose administration. The pharmacist did not know how accurate the state vaccine registry was. The pharmacist unable to provide vaccine lot, expiration date and patients details. The reporter did not consent to follow up.
Subject received a Janssen Covid-19 vaccination at the Education Center vaccination site. After administration of the vaccine, the patient was required to ubdergo medical observation for fifteen minutes. At the end of the observation period, the patient had no medical complaint and left the observation.  Approximately five minutes after leaving the observation area, the patient returned with a complaint of chest pain. The patient was assessed and treated , a Paramedic assigned to the vaccination site. EMS was requested through the 911 system and the Fire Department responded (Incident # 2021-019703). The patient was subsequently transported to a loca
Tingling hands, Lungs diminishing, rash, congestion, throat swollen, cough, flushed appearance, dilated pupils, burning sensation at the site
pt recv vax 15OCT98 & 16OCT98 arm became red & swollen @ the  inj site;this extended into the elbow;fever 101.3;recv PCN IM & PR;wife reported husband had pneumonia vax 1998 prior to 15OCT98;
flu like symptoms; slight increase with heart beat; slight fever; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEART RATE INCREASED (slight increase with heart beat), PYREXIA (slight fever) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HEART RATE INCREASED (slight increase with heart beat), PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HEART RATE INCREASED (slight increase with heart beat), PYREXIA (slight fever) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided. Patient received her first dose, had minimal side effects, flu like symptoms but only lasted for a day or so.  had slight fever, headache, slight increase with heart beat but didn't take anything and side effects went away pretty quickly.   This case was linked to MOD-2021-303896 (Patient Link).
(1) leg/injection site swollen and painful - o/v 24 hrs later. (2) glomerulonephritis (post strep) Dx'd 4/21/09.
The only side effect I had with my arm was sore at the injection site; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program US COVID-19 Vaccine Online Consumer Community. An 53 year-old female patient received bnt162b2 (COMIRNATY) (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "The only side effect I had with my arm was sore at the injection site".  Additional information: The only side effect I had with my arm was sore at the injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around 2 and a half hours after injection, onset of headache. Around 4 hours after injection feverish, and continued headache. From around 4 hours fatigue. Fatigue and headache are still continuing. Around 24 hours after injection, nausea.
This spontaneous report as received from a pharmacist refers to a currently 24 year old female patient. On an unknown date the patient was vaccinated one dose of GARDASIL (lot# not reported) (dose, route, indication not reported). Concomitant therapies included IMPLANON. On an unknown date the patient was positive for an unspecified HPV type. It was unsure if the patient was diagnosed with a positive unspecified HPV type prior to receiving the GARDASIL or after. The outcome of the event was unknown. Additional information has been requested.
Pulmonary Embolism. Treated with anti-coagulation for three months.
warm to the touch; raised then flattens out; larger, now smaller; sore arm; redness at injection site; swollen at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm to the touch), FEELING HOT (raised then flattens out), VACCINATION SITE REACTION (larger, now smaller), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swollen at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swollen at injection site). On 27-Mar-2021, the patient experienced FEELING HOT (warm to the touch), FEELING HOT (raised then flattens out), VACCINATION SITE REACTION (larger, now smaller) and VACCINATION SITE PAIN (sore arm). On 21-Mar-2021, VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swollen at injection site) had resolved. At the time of the report, FEELING HOT (warm to the touch), FEELING HOT (raised then flattens out), VACCINATION SITE REACTION (larger, now smaller) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
I am fine now, and this adverse event resolved, but I worked in a pharmaceutical company and know that you need to know about adverse events.  I had the vaccine on Friday morning and was fine all day. In the middle of the night, I felt like ice water was rushing through my veins, and it was actually somewhat pleasant.  Then I got out of bed and realized something was wrong, and I felt dehydrated. I took my temperature, and it was 102.8. I drank seven glasses of water and took two Tylenol and could tell after a little while that the temperature was not as high, but I still had it. I had a fever that night and all day Saturday of 101 degrees and was continuing to  take two tylenol every six hours.  I had no aches (my husband immediately had aches and chills after getting his second vaccine, but his fever was not as high. We have not filled out a form for him, yet). On Sunday, I think my fever was not as high, getting better, but I still felt too out of it to even watch a tv show.  I slowly started getting back to normal on Monday and by Tuesday was fine.  Thank you. I'm grateful for the vaccine.  We knew that people had difficulties after the second dose, so we were prepared for it. But only when I saw an article about reporting adverse events today did I remember that this is data that needs to be known. I am sure that most people where I live have no idea that they should report a fever after getting the vaccine.
Information has been received from a nurse referring to a male patient of unknown age. On 21-SEP-2015, the patient was vaccinated with one improperly stored dose of GARDASIL 9 (lot # L016428, expiration date 04-SEP-2016, dose and route unknown). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
My entire upper arm is swollen /Each day the swelling is more than the previous day; My entire upper arm is red; My entire upper arm is hot; Im having difficulty waking since the shot; I wake up but have to fight to open my eyes; I wake up but have to fight to move; This case was reported by a consumer and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, extremities hot feeling of, walking difficulty, eye discomfort and mobility decreased. On an unknown date, the outcome of the swelling arm, erythema of extremities, extremities hot feeling of, walking difficulty, eye discomfort and mobility decreased were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, extremities hot feeling of, walking difficulty, eye discomfort and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient's entire upper arm was swollen, red and hot.  On day by day the swelling was increased. The patient had difficulty in waking since the shot.  After wake up the patient had to fight to open eyes and to move the patient never had this before this could not be normal.  The patient was afraid to go to sleep.
3 days of fever starting 3/18. Followed by full body morbiliform rash that started on 3/19 and progressed from trunk to extremities and face.
Angioimmunoblastic T-cell lymphoma and underwent chemotherapy; This spontaneous case was reported by a consumer and describes the occurrence of T-CELL LYMPHOMA (Angioimmunoblastic T-cell lymphoma and underwent chemotherapy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced T-CELL LYMPHOMA (Angioimmunoblastic T-cell lymphoma and underwent chemotherapy) (seriousness criteria death and medically significant). The reported cause of death was angioimmunoblastic t-cell lymphoma and underwent chemotherapy and Rash. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant and treatment medications were reported. Date of death was reported as 09-Aug-2022. After five months of horrific, nightmarish ordeal, our beloved husband, father, and brother died of this aggressive, vaccine-induced cancer. It is unknown if the patient experienced any additional symptoms/events. Patient has 1st dose of Moderna vaccine (received both shots a month apart).  Additionally reported events vaccine-induced cancer, rash over the legs and body, pain sensation/Swollen neck with pain developed, facial numbness, tingling and enlarged lymph nodes were considered as signs and symptoms of the final diagnosis Angioimmunoblastic T-cell lymphoma.  Company Comment: This is a Spontaneous case concerning a 59-year-old male patient with no medical history reported, who experienced the fatal unexpected event of T-cell lymphoma (Angioimmunoblastic T-cell lymphoma) (medically significant) which occurred on the same day after a dose of mRNA-1273 received as the first dose for COVID-19 Vaccination. It was reported that after vaccination the patient experienced events of rash over the legs and body, pain sensation/Swollen neck with pain developed, facial numbness, tingling and enlarged lymph nodes which were considered as signs and symptoms of the final diagnosis Angioimmunoblastic T-cell lymphoma. It was also reported as a vaccine-induced cancer. The patient received chemotherapy (not specified) and died after 5 months. The reported cause of death was angioimmunoblastic t-cell lymphoma and underwent chemotherapy and Rash. It was unknown if an autopsy was performed. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Angioimmunoblastic T-cell lymphoma and underwent chemotherapy; Rash
I been having some women's health issues. I am bleeding a lot and been bleeding since June. 4 days before I got the 4th shot I got an IUD to help with the bleeding, but it did not help and I am still bleeding. In July I got COVID. I have sore throat, headache, sinus congestion, nasal congestion, nausea, cough, lost of taste, loss of smell, brain fog, fatigue, and muscle body aches.
20 hours after the injection, I developed hives on my neck, trunk, arms and legs. Two tablets of Benadryl taken. The next morning, hives still present and bothersome. Two more tablets of Benadryl taken.
This spontaneous report as received from a pharmacist refers to a 79 years old patient of unknown gender. On 19-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, strength not reported, lot # 003597, exp. date: 12-MAR-2015). No adverse effect reported (also reported that the patient did not report shingles symptoms). It was reported that the freezer temperature -15 degrees C prior receiving the ZOSTAVAX. On 11-JUL-2014 the ZOSTAVAX was received. The temperature of the freezer was not recorded through 25-SEP-2014, when it was -9.2 degrees C. There were no power outages. The patient did not report shingles symptoms. The reporter asked what she should do. This is one of four reports from the same source. Additional information has been requested.
Neurological Lyme symptoms returned with a vengeance. Encephalomyelitis; extremely stiff, painful neck; Bilateral facial palsy; Meningial burning and pain; vasculitis in brain worsened; blurry vision returned.
LOCALIZED ERYTHEMA/EDEMA/TTP AT INJECTION SITE APPROX 3IN IN DIAMETER. REPORTED OROPHARYNGEAL PARESTHESIA/TINGLING/ITCHING.