chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a consumer who experienced received vaccine  FLUZONE QUADRIVALENT which did not have a working thermometer for three months 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  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. It was unknown whether adverse event was experienced. 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.
Fever; nausea; Achiness,so much pain; Whole body hurts; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (nausea), PAIN (Achiness,so much pain) and MYALGIA (Whole body hurts) 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 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (Fever), NAUSEA (nausea), PAIN (Achiness,so much pain) and MYALGIA (Whole body hurts). At the time of the report, PYREXIA (Fever), NAUSEA (nausea), PAIN (Achiness,so much pain) and MYALGIA (Whole body hurts) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
itching, primarily arms and trunk; more noticeable in the evening; from 1/25 through today, 1/28
Rash and pain at injection site. Also warm to the touch.  Started today. 14 days after first vaccine.
Information has been received from a physician concerning a female who in August 2007, was vaccinated with a single dose of zoster vaccine live (Oka/Merck). In October 2007 (about 11 weeks post vaccination), the patient developed a chick pox like rash. The patient sought medical attention thru a physician. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Appendicitis; Almost died; I'm now scared out of my mind; sick; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    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 APPENDICITIS (Appendicitis) (seriousness criterion medically significant), ILLNESS (sick), FEELING ABNORMAL (Almost died) and FEAR (I'm now scared out of my mind). At the time of the report, APPENDICITIS (Appendicitis), ILLNESS (sick), FEELING ABNORMAL (Almost died) and FEAR (I'm now scared out of my mind) outcome was unknown.            Concomitant medication were not reported Treatment medication were not reported The patient had sick for 5 days  Company Comment: This case concerns a female patient of an unknown age, with relevant medical history of COVID-19, who experienced the unexpected events of Appendicitis (AESI), Illness Feeling abnormal and Fear. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The patient's medical history of COVID-19 remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up received on 21-Dec-2021 as live follow up with medical history updated.; Sender's Comments: This case concerns a female patient of an unknown age, with relevant medical history of COVID-19, who experienced the unexpected events of Appendicitis (AESI), Illness Feeling abnormal and Fear. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The patient's medical history of COVID-19 remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient states"on 5-23-08 at 10:00 AM received shot. Two hours later began to feel pain,nausea,and light headed.Not feel like eating at all.The same night i ran a fever and was under a lot of pain.Took Motrin as directed.on morning of 5-24-08 woke up with redness underneath the shot site and did not feel good,wanted to sleep all the time with no strenght." continued that night eith pain at injection site and aches in joints that prevented sloeep.On 5-25-08 "redness spread further down my arm,wanted to sleep,continued taking Motrin and using cold packs" On 5-26-08 continued with lack of appetite,pain and fatigue.continued motrin and cold packs to left arm. On 5-27-08 reported to immunization clinic.Had beneath the injection site two areas of erthema measuring 7cm long by4cm wide.Instructed to try an antihistamine, use moist warm packs and continue with the motrin and move arm.
Initial report received from healthcare professional on 22 July 2013 and follow-up information received on 23 July 2013. This case is invalid as individual patient identifiable were not reported. The three patients (gender, date of birth and age at the time of administration was not reported), whose medical history and concomitant medications were not reported, had received a dose of MENACTRA, batch number U4414AA (dose number and route of administration were not reported) having expiry date 18 April 2014 in arm on an unspecified date. It was reported that on an unspecified date, after receiving MENACTRA, the patients experienced numbness, weakness in arm at which vaccine was administered and dizziness which was lasted for either 1 or 1 and half days for each patient. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was recovered. Documents held by sender: none.
I WOKE UP IN THE NIGHT AND MY RIGHT ARM FELT SORE AND PAIN WENT UP INTO MY SHOULDER AND NECK. THE NEXT MORNING I AWOKE WITH MY HAND TIGHT AND FELT LIKE I HAD SLEPT ON AND IT WOULD NOT WAKE UP. THE DAY WENT BY AND IT GOT BETTER AND WAS GONE BY THE NEXT DAY.
chills and night sweats and fever, cellulitis with lymphangitis, lymphadenopathy (worsening) and return of purulent drainage at site of vaccinia vaccination; Levaquin x 5 days
Redover elbow of arm of injection site; itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and VACCINATION SITE ERYTHEMA (Redover elbow of arm of injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (itching). On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redover elbow of arm of injection site). At the time of the report, PRURITUS (itching) and VACCINATION SITE ERYTHEMA (Redover elbow of arm of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This spontaneous report was received from a registered pharmacist refers to a 59 years old male patient with gastrooesophageal reflux disease (GERD), asthma, high blood pressure, high cholesterol, diabetes and allergy to CYMBALTA and DEMEROL who on 06-AUG-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot number 0422AE, Exp. Date: 27-MAR-2013) (dose not reported). No other co-suspects were reported. Concomitant medications included tramadol hydrochloride, ibuprofen, gabapentin, metoprolol, VENTOLIN, SPIRIVA, fluticasone propionate, ADVAIR, lisinopril (manufacturer unknown), gemfibrozil, oxycodone and omeprazole. The pharmacist reported that at some point after vaccination but before on 17-SEP-2012, the patient developed shingles on an unspecified area of the body. It was reported that on approximately 07-SEP-2012, the patient developed a rash on the chest that was 1/4 to half dollar size. By approximately 09-SEP-2012, there were circular rashes all over the chest and back. On an unspecified date, in September 2012, the patient was seen at general medicine at the hospital and was diagnosed with shingles with wild-type varicella-zoster virus. No treatment information was reported. At the time of the report, the patient had not recovered. The physician was confident that shingles from wild-type varicella-zoster virus was not a result from ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Blood Clots Lungs resulting in Death  Many details are not available to me and will have to be edited
In September my daughter started getting bruises on her arms and legs. Everytime we asked how she got them she would reply that she bumped into a table or something. Having 4 children bruising is not so strange. She is in Martial Arts and has contact in class. This started out less obvious and little by little got more obvious. By October I noticed one day that she had major bruises on her arms and I immediately called her Doctor but after talking to him and he telling me to bring her in to get blood work I realized that she had participated in a Martial Arts tournament and went up against a 3rd degree black belt and felt that is where she recieved the bruises so I called the Doctor back and he told me to watch them. Well after a week went by I noticed that she had more bruises and they were really getting bigger. I then called him and he told me to come in for blood work. I took her in on Nov 5th and they sent me to the hospital to get the bloodwork done but when I got to the hospital they had left for the day so I returned the next morning. I got a call later that the blood work did not turn out to bring her in again which I did before I could get home they called and had me bring her back in due to her plateletes being at a critical level 7000 and this has been going on every since and they are calling it ITP. Now although the Doctor really does not believe that the vaccination was the start of this disorder I believe whole heartly it is He kept asking me if she had gotten any kind of virus in the month of August I kept repeating no. My daughter is now in the 6th grade and has never missed a day of school in her life that is how much she gets virus's or sick. I know my children and I can count on one hand how many times this one has ever gotten anything and with my records at the pediatrician I do take my children to the doctor or call him when they are sick. My daughter has been on prednisone twice and Win Rho twice the first Iv medication only lasted about two weeks her plateletes continue to drop to a critical level. 02/07/07-records received and reviewed from PCP for DOS 11/10/06-2/5/07 DX: ITP Symptoms bruising. 02/13/07-records reviewed from hem/onc for DOS 02/01/07 DX: relapsing and remitting thrombocytopenia. Possibly since early September but documentation until early November. Looks like she is heading to have chronic IPT. Persistent low platelet counts. Bruising began in early September 2006, did not seek medical attention until first week in November. 11/8/06- platelets 7000 and on 11/10, 122000 and then on 11/10 79000. Child involved with martial arts. Began steroids.   Hospitalized on 1/13 received WinRho at that time platelets 9000.  Two nosebleed in November.   PE:WNL except for some petechiae on neck. Per 60 day follow up: Bruising, petechiae, low platelets, ITP. The brusiing started at the begining of Sept. 2006, we did not get a diagnosis immediately due to not knowing anything. It is now considered chronic with no cure. She has been hospitalized on several occassions due to platelets dropping to a critical count.
Syncopal event at home with LOC approximately 36 hours post vaccination with some fever and chills after. Unsure how long I was out, but estimated to be < 1 minute. All symptoms have resolved at this point.
pt recvd vax; 1" diam red, itchy & hot to touch at inject site
had Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced COVID-19 (had Covid-19). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, COVID-19 (had Covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported.   This case was linked to MOD-2021-106465 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; Tested positive today on Day 12 (17Aug2022); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8734), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown), on 16Oct2021 as dose 3 (booster ), single (Lot number: 3590) and on 09Apr2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 17Aug2022, outcome "not recovered", described as "Tested positive today on Day 12 (17Aug2022)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (15Aug2022) Negative, notes: on Day 10; (17Aug2022) Positive, notes: on Day 12. Therapeutic measures were taken as a result of vaccination failure, covid-19 and treatment included Paxlovid from 07Aug2022 to 12Aug2022. Therapeutic measures were not taken as a result of disease recurrence. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Migraine; top of shoulder hurting; Sore arm; Neck pain; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NECK PAIN (Neck pain), BACK PAIN (Back pain), MIGRAINE (Migraine) and ARTHRALGIA (top of shoulder hurting) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0257321A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included TOPIRAMATE (TOPAMAX), RIZATRIPTAN BENZOATE (MAXALT) and IBUPROFEN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), NECK PAIN (Neck pain), BACK PAIN (Back pain) and ARTHRALGIA (top of shoulder hurting). On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, PAIN IN EXTREMITY (Sore arm), NECK PAIN (Neck pain), BACK PAIN (Back pain), MIGRAINE (Migraine) and ARTHRALGIA (top of shoulder hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication information was provided Patient said she is definitely not receiving second dose due to horrible migraines.
became symptomatic 07/07/2021, at home test positive, rapid antigen positive, PCR positive
The date of the second dose was 05/25/2021, which is when the side effects started. I had the normal and expected effects, such as a sore arm and fatigue. I began my period that morning, before I went in for the shot. I would like to be as detailed as possible, so I will likely include some graphic details in this description. My apologies in advance.  My period normally lasts 3-4 days and is moderate (as far as I know) regarding blood loss. After the second dose, the flow was extremely heavy and my period lasted for almost an entire week (7 days). It was miserable. I was bloated and tender in that area, and extremely tired. I was also cramping, which is unusual for me nowadays.  About two weeks after that, I felt a stabbing or ripping pain in the uterus area. It stayed for about two days, throbbing every minute or so. I could not sleep those days. It was not so unbearable that I could not perform everyday actions, but it was taking up a good portion of my thoughts that weekend. After that, it went away and I thought it was over.  About three days ago from today (today is June 22nd, or 06/22/2021), the pain returned and I knew it meant the start of my period. The timing was normal. The next day I began bleeding, but the flow is again much heavier than normal. The pain is back and much worse than before. I am going through many more pads than usual and it is, for me, a worrying amount of blood. Since this is the second period in a row I am experiencing this, I felt it was necessary to report it in. I hope this is okay and not taking resources from those with worse issues.  I would also like to note that I experienced my first panic attack in 5 years the night of my second dose (for no reason- they've always had a concrete reason for occurring) and my anxiety was notably worse that week (I am on medication and was otherwise doing very well managing the anxiety). During the attack I experienced the usual symptoms: my throat closing up and making it harder to breathe, and uncontrollable shaking and crying.  I was not thinking of anything that would make me nervous at the time of the attack. I had just finished an online gaming session with a friend and was showering to prepare for bed, so I was fully relaxed.  Additionally, my mental health has notably dipped a bit over the last month, though there are a number of factors at play and I don't want to blame the vaccine for that. However, I was told to at least make note of it here just in case there does end up being a correlation.
HIVE LIKE RASH HAD IMMUNIZATIONS YESTERDAY, NO LOCAL IRRITRATION, RASH ON TORSO
Noticed rash on arms while changing clothes the evening of 20May and progressively increased/spread to torso. Associated sx include pruritus but no wheezing, swelling of lips/tongue. Seen by PCM 3 days later with no change in sx. However, 2 days later had swelling of lips so went to ER and tx with antihistamine and steroid via IV.
Very sore arm - 48 hours VERY tired, joint ache, body aches, could not get out of bed - 48 hours Same effects I had with the first shot only doubled and twice as painful and tired. By third day after I was just tired. Body aches almost gone.  I will not do a third shot if required because of these side effects and that we aren't being told this might happen
SIRVA; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 25Feb2021 at 08:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications with two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 04Feb2021 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. On 25Feb2021 at 12:00, the patient experienced SIRVA (shoulder injury related to vaccine administration). The patient did not receive any treatment for the event SIRVA. The clinical outcome of the event SIRVA was not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient called from home and stated that on the evening of the day she received the vaccine, her left deltoid developed a red, hot rash - although not itchy.  She said it was the entirety of her upper arm, from her elbow to her shoulder.  She did not see an MD.  She stated she did not experience any wheezing, SOB, fever, or itchiness.  She self-treated with a topical steroid, and it resolved on its own.
Initial reaction was pain in the arm near the area of vaccination.  By the next day the pain was worse, I also started feeling flu like symptoms, body aches & fever By the second day I developed a rash that extended down to elbow. It was hot! Started antibiotics at this time.
blocked nose; hurting nose; body aches (in the knee); pain in the arm; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (blocked nose), NASAL DISCOMFORT (hurting nose), PAIN IN EXTREMITY (body aches (in the knee)), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigued) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporte.  Concomitant products included LISINOPRIL for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced NASAL CONGESTION (blocked nose), NASAL DISCOMFORT (hurting nose), PAIN IN EXTREMITY (body aches (in the knee)), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigued). At the time of the report, NASAL CONGESTION (blocked nose), NASAL DISCOMFORT (hurting nose), PAIN IN EXTREMITY (body aches (in the knee)), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigued) had not 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.   Treatment medication was not provided