chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician's nurse concerning a 14 year old female who on 10-MAR-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast) (Lot # 659435/1265U). There was no concomitant medication. The reporter heard that the patient was very sick and had an autoimmune disorder. It was unclear if the patient was hospitalized. The physician in the case had not been contacted by the patient's mother at the time of the report. The patient's autoimmune disorder persisted. The patient sought unspecified medical attention. Additional information has been requested. In follow-up a physician reported that the patient had several months pf heaby periods, developed rectal bleeding and bruising. The patient was diagnosed with idiopathic thrombocytopenic purpura and ulcerative colitis. It was also reported the patient developed an unspecified auto-immune disease. She received two units of packed red blood cells and multiple treatments with REMICADE and globulin, immune. The patient required emergency room visit and was hospitalized for 3 days. It was unknown if the patient recovered. It was noted that the patient continued on "aspirin cd" and oral conctraceptives. In follow-up a physician reported that the patient was diagnosed with autoimmune disorder. The specialist that the patient was seeing and the reporting physician did not feel that GARDASIL vaccine had anything to did the patient's condition. No further information is available since the physician stated that he already completed the forms and doesn't wish to receive anymore forms.  10/20/08-records received-4/30/08-C/O irregular and excessive menstruation. Pt got her period for first time in December and skipped 3 months until April. Presented to ED on 5/10-5/13/08- DC DX: ITP and GI bleed. C/O feeling tired, weak, fever spiked to 102.2 nasal congestion, cough, sore throat. Petechial rash. Bloody stool 2 days ago. Weight loss.
Pneumovax and DT Mon July 2, 2006 had DT several times past that July 3-4-5-6,2006. Fever 102, myalgias, arthralgias, unwell, pain lt arm site of Pneumovax.
Severe body aches, generalized weakness, fatigue, chills, fluid flushing, looking sick, sleepiness, poor appetite (could not eat) drank for (24 h), + redness, swelling at the injection site.  Treated with Tylenol, Motrin, fluids after 48-72 hours.
Fever 101-102 degrees F, vomit x 1, left upper arm warm, erythematous 6 cm area with injectioin pinpoint in middle (DTaP given 04/03/2002.
28 hours following flu vaccine, she developed irregular heart beat, palpitations, then dizziness, nausea vomiting, sweating episode.  Had to lay down.
Lack of taste/taste buds have not came back like they used to; Her voice is changed; Tastes different; Had the flu; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lack of taste/taste buds have not came back like they used to), DYSPHONIA (Her voice is changed), TASTE DISORDER (Tastes different) and INFLUENZA (Had the flu) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 029A21) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced AGEUSIA (Lack of taste/taste buds have not came back like they used to), DYSPHONIA (Her voice is changed), TASTE DISORDER (Tastes different) and INFLUENZA (Had the flu). At the time of the report, AGEUSIA (Lack of taste/taste buds have not came back like they used to), DYSPHONIA (Her voice is changed) and TASTE DISORDER (Tastes different) had not resolved and INFLUENZA (Had the flu) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported. This case concerns a 62-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected, AESI event of ageusia. The event occurred  on unknown date after second dose of mRNA 1273 vaccine. The patient felt that she has lack of taste, her taste is different, and her voice changed ever since she received the vaccine, she also had the flu. Events are still on going and she is hesitant to get the booster. The rechallenge is not applicable as events are not resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-392343 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains no new information.; Sender's Comments: This case concerns a 62-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected, AESI event of ageusia. The event occurred  on unknown date after second dose of mRNA 1273 vaccine. The patient felt that she has lack of taste, her taste is different, and her voice changed ever since she received the vaccine, she also had the flu. Events are still on going and she is hesitant to get the booster. The rechallenge is not applicable as events are not resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Information has been received from a 58 year old female physician concerning herself with history of shingles while in her 20's who following her husband's vaccination on 02-APR-2009 with a dose of ZOSTAVAX (Merck) experienced zoster sine herpete associated sith S1 which began on 12-APR-2009. It was reported that she was fatigued and had loss of appetite. The patient had a zoster titer on 17-APR-2009 which came back with an IGG of 3.04. It was reported that the patient had not any treatment at the time of the report. The outcome of the patient was unknown. Follow up information was received from the physician who reported who reported that she definitely had involvement of L3 bilaterally and several adjacent thoracic dermatomes bilaterally. It was reported that she saw a transient rash in those dermatomes that only lasted about an hour that looked like generalized erythema with some 1 cm whit areas with central papules. It was reported that she saw about 10 clustered vesicles that were only about 1 mm in diameter on one leg. It was reported that everything was gone on an unspecified date. It was also reported that she had Chronic fatigue syndrome. The patient reported that she had been "ill" and has had worsening fatigue, which she initially thought was relapse of her chronic fatigue syndrome. It was reported that she believed that she may have "zoster sine herpete" and that her signs/symptoms were similar to those she experienced with her initial bout of shingles. She confirmed that she had not any treatment. That suggested that maybe "sine herpete" was really just  transient rash. It was reported that the patient had something like this the first time she had shingles. But she discounted the rash because it was so transient, and it was a lot less impressive than this time. It was reported that she was still trying to get to her physician to get this treated. Follow up information was received from the physician who stated what she continued to express concern regarding the "atypical" nature of her symptoms, and was seeking additional information. It was reported that she was alright, but that "some days, she just did not feel well". she reported that she has not had any new lesions. She also stated that she was seeing as Infectious Disease physician the following day on May 6th. This is one of several cases from the same source. Additional information has been requested.
INCREASE IN HEART RATE; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies to medications. The patient was previously treated with diphenhydramine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-MAR-2021 at around noon for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced increase in heart rate. On MAR-2021 at about 22:00, the subject experienced chills. Laboratory data included: Heart rate (NR: not provided) increased heart rate, by about 30 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and the outcome of increase in heart rate was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
In the evening I got very weak and achy, then had severe chills (very scary, never had this before). I got into bed with electric blanket turned to the highest level. I continued to shake badly for over an hour later. Got a headache and didn't sleep. The next day still felt bad, headache, tired and achy. Layed around. It took until the following morning before I felt better. I don't have reactions to medication and this one scared me.
Respiratory  tightness in chest for five days. Took Benadryl   three times a day for five days.  It eased the tightness in chest.
About a month after receiving the Pfizer Bivalent vaccine, I suffered a stroke. I was out walking my dog and when we got back home, I dropped the leash and when I bent down to pick it up, I noticed that my right arm was completely paralyzed. I went in the house and told my wife that I was having a stroke and she drove me to the emergency room. At the ER, they confirmed that I was having a stroke. I was admitted into the hospital for about 2 1/2 days. They stopped all medications I was taking and put me on PLAVIX, atorvastatin and a low dose aspirin. I have followed up with my PCP, to go over my medications that I can take with my new medications. I have an appointment with a cardiologist 12/02/2022 and we are going to put me on a Holter monitor for two weeks. After having my stroke, I also ended up testing positive for Covid-19. My symptoms for Covid were minimal. I also tested positive for COVID back in 02/2022.
My grand daughter woke me up and told me she was taking me to the bank. I got up and started to get dressed, and it was very difficult for me and it normally isn't. I finally got dressed and I felt off.  I grabbed my coat and purse and started heading outside to her in the car and I just stood in the porch, confused. She yelled at me, and got me to move. It was pouring rain, and I was taking baby steps I noticed which was harder for me. I put my handle on the door and I couldn't open it. My grand daughter was confused and yelling at me and after I opened it 4 minutes later, I just stood there confused. My granddaughter grabbed me and dragged me into the car. She is a medic with ambulatory services and knew something was wrong. She called her mother who is a nurse, and both of them were shaking me and they were speaking to me but I could not respond. But all I could do was try to go to sleep. They called an ambulance and a first responder came in first, and took my pulse and blood pressure. They put me a gurney and decided it was a bylateral stroke. They kept me in the hospital and there was a night nurse who worked with me to get me to move and speak again. I was in the hospital until I could do it more (I was in there for 2 weeks). The doctor wanted me to go to a nursing home but I said no.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 4 months old female patient who received 0.25 ml pre-filled syringe dose today in left thigh, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.25 ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6315PA, expiry date- 30-Jun-2019 via unknown route in the left thigh. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
At 11:14 am on the morning of Saturday, March 20, 2021, I received my first COVID vaccination in my right arm. Overnight Sunday to Monday, the lymph node in my armpit of the same arm became swollen and tender. I sent a note to my PCP through the Patient Portal so he was aware and could note it in my medical chart.   I know from researching this that a small percentage of people experience this side effect after receiving their COVID vaccination. While I will continue to monitor it, it should most likely resolve on its own over time (days to months).
Raspatory issues Muscle pain fatigue Tested For congestive heart failure Severe diaheara
This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced itchy rash. The patient was treated with hydrocortisone. On an unknown date, the outcome of the itchy rash was recovered/resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient experienced an itchy rash after SHINGRIX. The first dose was given at the end of June 2018 and the rash began about a week later on the left arm. During the daytime, the rash was tolerable but it worsens after showering in the evening. Hydrocortisone cream was being used with success but symptoms have not fully abated. The patient visited dermatologist after the first dose who confirmed it was not herpes zoster. The reporter consented to follow up. The member of public adverse event collected by medical affairs contact center (MACC). For tolerance after 2nd dose refer case US2018GSK221233.
pt recvd vax & exp fever, crying, loose stools unable to contact pt due to phone being disconnected;
Patient came into pharmacy on October 25th and complained that her arm hurt after receiving flu shot October 4th. Complained of arm pain that radiated to both shoulders. No medical attention received. Patient commented "it was hard to turnover in bed." Patient says it still slightly hurts across her shoulders.
Received Moderna booster after two doses of Pfizer. Noticed inflammation in left should and swollen left arm pit. Developed low fever and body aches.
Patient can't move arm at shoulder level. Can't lift arm up over her head without pain. Will be seeing a neurologist on 9/24/14.
pt had itchy throat and tingly lips , pt offered Benadryl im and refused. symptom's did not worsen over 30 min observation and pt left clinic for home with no treatment.
Had redness at injection site about size of baseball not warm. Patient denies itching. Patient informed by PCP to apply BENADRYL cream to area.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapy were not reported. On an unspecified date in July 2012 and in August 2013, the patient was vaccinated with the first and second doses of GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported) (reported as the patient received the series outside of the prescirbing information schedule). Then, in May 2015, the patient was vaccinated with an unidentified hpv vaccine (GARDASIL 9) (dose, frequency, route of administration, lot # and expiration date were not reported) or (GARDASIL) (dose, frequency, route of administration, lot # and expiration date were not reported)). Subsequently, in October 2016, the reporting pharmacist also reported that a fourth dose of GARDASIL 9 was administered. No adverse effects and no product quality complaints were reported. Additional information has been requested.
Two days post vax, the pt developed an injection site reaction characterized by swelling, redness, and a rash. This is one of three employees from this facility who experienced this event following receipt of vax.
No adverse reaction from the vaccine.  Recipient was given the Moderna vaccine instead of the Pfizer vaccine.  Moderna not yet approved for under the age of 18.
Night chills, night sweats (approximately 12:00, night after injection through 6:00am) pain/discomfort at injection site, sore to touch (for 24 hrs, following injection) migraine (approximately 12:00pm to 6:00pm the day after)
Lymphadenopathy after the second dose of vaccine; This is a spontaneous report received from a contactable nurse (the patient) via a company representative. A patient of an unspecified gender and age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included COVID-19 several months ago. Concomitant medications were not reported. The patient experienced lymphadenopathy after the second dose of vaccine. The outcome of lymphadenopathy was unknown.    No follow-up attempts possible; information about batch/lot number cannot be obtained.
BRAIN TUMOR; This spontaneous report received from a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of administration was not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, patient had a brain tumor since got shot.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain tumor. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211220778-Covid-19 vaccine ad26.cov2.s-Brain tumor. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
covid vaccine breakthrough case  All Moderna dose 1 3/31/21  047A21A dose 2 4/28/21  040B21A dose 3 10/13/21  017F21A dose 4 8/17/22  013B22A
develop a rash on her upper stomach under her breast. Since then the rash is "coming and going" and will appear in different places all over her body; has been breaking out in red blotches; it is red and itchy; This is a spontaneous report from a contactable (patient). A 59-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 04Feb2021 (at the age of 59-years-old) (Batch/Lot Number: EK9231) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient was diagnosed when she was 8 years old. There were no concomitant medications. Patient states that about a week (unspecified date in 2021) after receiving the second dose she started to develop a rash on her upper stomach under her breast. Since then the rash was coming and going and will appear in different places all over her body. She also mentioned having the rash on her upper thigh by hear butt and also under her arm. She describes the rash as neither improving nor getting worse, but rather, staying the same except it is intermittent. She states that it will start out as really itchy, then it becomes red and the rash is also accompanied by bumps when it appears. She denies having any rash with the first dose of the Pfizer COVID-19 vaccine. patient states that she was a Type 1 Diabetic and she had a routine virtual appointment with her doctor. She told her doctor about the rash and her doctor told her to keep a close eye on it. Caller wants to know if this has been reported before and if she should see her regular doctor or Dermatologist. The caller states that she has been in quarantine since March and she was told that she wanted to know if she should still be cautious regarding wearing a mask, etc. even though she has received both doses of the Pfizer COVID-19 vaccine. Patient also states that she started breaking out in the red blotches about a week after getting the second dose of the product. Caller states that some of them will start, and then they disappear and reappear in other places on her body, it like switches spots. Caller states that it is red and itchy. The outcome of the event red and itchy was unknown. The outcome of all the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
8-19-14 clt stated taking oral typhoid on 8-12-14. That evening clt experienced slight stomach upset. With 2nd dose clt stated he had more stomach cramping and nausea. With 3rd dose clt stated he had severe cramping and nausea. Went to the ER. Had bloodwork done which was within normal limits. Clt took 4th dose and stated he did better with last dose - only slight stomach upset. Comparable to the first dose. Clt says he felt fine today no Sx. Advised clt to take injectable typhoid in future if needed.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            Concomitant medications were not reported.  Treatment medication information was not provided.
injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site was sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site was sore). At the time of the report, VACCINATION SITE PAIN (injection site was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.