chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer (wife of subject) and described the occurrence of influenza in a male subject of unspecified age who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma, chronic pneumonia and unknown cause of death. The consumer reported that her husband was "no longer living" at the time of reporting. At the time of the adverse event reported, the subject was living and had the concurrent conditions of asthma and chronic pneumonia. The subject had received "live flu vaccine once and got sick as a dog." On an unspecified date the subject received unspecified dose of Influenza vaccine (unspecified) (unknown details). At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced influenza, got sick and vaccination failure. The subject's wife reported that he "would get sick and get the flu every time he would get a flu shot and then eventually pass the flu on to his wife" (the reporter, see case A1046926A). The manufacturers of the flu shots he received were unknown. No additional details were provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. After the next vaccination with Influenza vaccine (unspecified) the events recurred. Specific details were not reported. The consumer documented another case with influenza vaccine unspecified. See A1046926A for details on the other case.
Received  2nd dose of Moderna booster 4/13/22. And came in ER  c/o headache, dizziness, chills,and left arm numbness.  Stated whenever she breathes deeply she feels like her left lung would hurt. Medicated for pain with Toradol IM and Norco 1 tab po. Discharge to home with  Rx Norco for pain.
Lethargic Extremely achy Both for about 24 hours. Rested and took tylenol.
Initial unsolicited report received from a healthcare professional (vaccine provider) on 12 July 2016. This case involves a 15-year-old male patient who was vaccinated with a first dose of MENACTRA (batch number: U5282CB, expiration date not provided) intramuscularly in right deltoid and second dose of VARIVAX (batch number: L049536, expiration date, site and route of administration were not reported) on 11 July 2016. Patient's Illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects and medical conditions was reported as no known allergy (NKA). Concomitant medications were not reported. On 11 July 2016, one hour following the vaccination, the patient experienced fever, chills and aches. It was reported that the patient required ER or doctor visit. Lab data and corrective treatment were not reported. Outcome of the event was reported as not recovered. List of documents held by sender: none.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Systemic lupus erythematosis, Immunosuppression NOS (Chronically immunosuppressed) and Heart disease, unspecified. Concomitant products included PREDNISONE, MIRTAZAPINE, ROSUVASTATIN, WARFARIN and LISINOPRIL for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.            No treatment medications were reported.  Concurrent medical conditions also included lupus related kidney disease.   This case was linked to MOD-2021-304558, MOD-2021-304574 (Patient Link).
fever for 6 hours shaking chills for 6 hours (extreme to the point of feeling like I was possibly going to pull muscles) extreme discomfort/malaise for 36 hours fatigue for 36 hours brain fog for 36 hours painful and swollen lymph node in arm pit on injection side appearing 24 hours after injection and lasting 48 hours minor soreness at injection site for 36 hours
Headache; Backache; fever; nausea; exhaustion; sore throat; dry cough; bronchitis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9263, Expiration date not reported), via an unspecified route of administration in left arm on 31Jan2021 09:30 (at the age 77-year-old), as a single dose for COVID-19 immunization. Medical history included Type 2 Diabetes. The patient previously took ondansetron (ZOFRAN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included insulin degludec (TRESIBA), insulin aspart (NOVOLOG), Bupropion, Alprazolam and Estradiol. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 14:00, the patient experienced headache, backache, fever, nausea, exhaustion, sore throat, dry cough and bronchitis. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was tested for COVID twice by covid test type: one Nasal Swab test, on 08Feb2021, the result was negative. The treatment received for the events were antibiotics and steroid. Outcome of the events were reported as recovering.
Pericarditis - 4 days inpatient; 8 weeks later still working with severe symptoms, including heart in afib and lungs filled with fluid.  Previously very healthy and exercised 1-2 hours per day; no history of heart disease in family.
Upper right arm began itching which spread to other arm and upper torso. Diagnosed as urticaria on 10.27.08. Treated with 9 day course of Prednisone 20mg tabs and Prilosec.
Fever high of 102.5F Strong chills Fatigue Soreness at injection site Body aches Headache Treated with 500mg of Tylenol
21 weeks pregnant at time of Moderna booster with date of delivery estimated to be 7/9/2022. Began diffuse rash on Thursday morning 3/10/2022. Rash includes redness patches and hives that come and go across whole body. Extreme itchiness. Contact with anything on skin causes flare up (example: brushing hair causes whole scalp to flare up).
About 8-10 small red maculopapular rash with one vesicle.  Vesicle painful and very tender if touched.
Nausea; TIRED; Headache; Fever; Vomiting; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight was 140 pounds, and height was 68 inches. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A2A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 11:30 in left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced vomiting. On 07-APR-2021 15:30, the subject experienced nausea. On 07-APR-2021 15:30, the subject experienced tired. On 07-APR-2021 15:30, the subject experienced headache. On 07-APR-2021 15:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 08-APR-2021 03:00, and nausea, headache, and fever on 08-APR-2021, and was recovering from tired. This report was non-serious.
a 6 month old female received the QUADRACEL vaccine with no reported adverse event; Initial information received on 27-Jan-2022 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 6 months old female patient who received the quadracel vaccine with no reported adverse event, after receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 24-Jan-2022, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength, formulation, dose: unknown, frequency: once, (product use issue, onset, latency; same day) with lot C5763AA, expiry date:26-Aug-2022 via intramuscular route in the right thigh as immunization.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event    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 the 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.
I'm feeling like lazy; Body ache; Headache; but I do not feel confident going to work like that; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiry dates were not reported), via an unspecified route of administration, on 28May2021 as a SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. Patient stated that I already got my second one and that was on last Friday (28May2021), so five days ago so I am doing okay just yesterday (31May2021) I am feeling like lazy and like body ache, headache and all the body ache is gone but I still had the headache a little bit and it comes back like once or twice a day. The patient had been taking Tylenol (treatment) for the events Laziness, Body ache and headache and that helped and, but I do not feel confident going to work like that. Outcome of the events headache was not recovered; body pain was recovered on an unknown date in 2021; and for other events it was unknown.  Information on the lot/batch number has been requested.
This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 4-month-old patient who received PEDIARIX. Co-suspect products included ROTARIX. Previously administered products included ROTARIX, PEDIARIX and PREVNAR (all the vaccines received at 2 months of age without experiencing any adverse reaction). Concomitant products included PREVNAR. On an unknown date, the patient received PEDIARIX and ROTARIX. On an unknown date, 2 days after receiving PEDIARIX and ROTARIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to PEDIARIX and ROTARIX. Additional details were provided as follows: A GlaxoSmithKline's sales representative reported on behalf of other healthcare professional that the patient received several vaccines, which included PEDIARIX, ROTARIX and PREVNAR and after 48 hours experienced general rash. No further information reported regarding the event.
Diagnosed with brain tumor/Glioblastoma; This spontaneous case was reported by a nurse and describes the occurrence of GLIOBLASTOMA (Diagnosed with brain tumor/Glioblastoma) in a 67-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLIOBLASTOMA (Diagnosed with brain tumor/Glioblastoma) (seriousness criterion medically significant). At the time of the report, GLIOBLASTOMA (Diagnosed with brain tumor/Glioblastoma) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  No treatment medications were provided.  Reporter was enquiring whether they saw an increase of Brain tumors after receiving two shots plus booster vaccine. Reporter was wondering if doctors were reporting this and how would they determine if vaccine was cause or not. Reporter mentioned it was either a rare coincidence or suspicious.  Company Comment: This spontaneous case concerns a 67-year-old male patient with no medical history reported who experienced the unexpected serious event of Glioblastoma (Diagnosed with brain tumor/Glioblastoma) unspecified days after receiving a dose of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old male patient with no medical history reported who experienced the unexpected serious event of Glioblastoma (Diagnosed with brain tumor/Glioblastoma) unspecified days after receiving a dose of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
My husband had some loose stools after one or two doses, however, a few hours after the fourth dose, at 11PM June 1st, he had a health crisis. His reaction started at night and we did not react initially, assuming he was in bed with the same problems I suffered. However, in the morning, when he had debilitating balance issues, and could not even crawl to the bathroom, it became clear that this problem required medical attention. We went to the doctor and they discovered an arrhythmia and sent us to the emergency room where he was diagnosed with atrial fibrillation and atrial flutter and admitted to the hospital. After 2 days in the hospital and a battery of tests he was diagnosed with a cerebellar stroke. My husband is now home, with a walker and Meclizine and a medication to thin his blood, and has started on his journey toward recovery that will include trips to his doctor, a cardiologist, a neurologist and physical therapy. I am sure that you can see why I thought this was worth reporting. We are praying for his health and strength to return to normal.
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 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: take medication for it.; "high Cholesterol" (ongoing), notes: take medication for it. Concomitant medication(s) included: LISINOPRIL, start date: Jan2019; ROSUVASTATIN, start date: Jan2020, stop date: 27Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Feb2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Feb2023) Positive; (05Mar2023) Negative; (15Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. The patient caught Covid and tested positive on Monday 27Feb2023. By Sunday 05Mar2023 had largely recovered and tested negative. But then on Tuesday 07Mar2023 symptoms returned worse than they were the first time. It had taken until 15Mar2023 to test negative again and still felt quite tired. Paxlovid started from 27Feb2023 to 04Mar2023.  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.
Mild cold like symtoms, no fever, slight headache, mild stuffy nose, dry throat
Flu like symptoms (4 days), Tongue swelling with knots, Canker sore on tongue ( lasted 3 months), Headache, severe fatigue, heart palpatation, chest pain, runny nose. T cells dropped  400 point from 500 to 100. 5 visits to the emergency room. Symptoms stopped, but now reoccurring.
While waiting for release my BP dropped, I was lighted headed and nauseated.  They staff took my BP several times (it went up 130/90 then dropped back down to 90/60, then back up and back down.   I was laid down on a cot and monitored for a while (about an hour).  At home, the nausea got worse but never resulted in vomit.  Sever headache, and extreme arm pain.  (I couldn't move my right arm from the elbow up)  By the 14th, my joints hurts.  It felt like the each joint was swelling and stiff.  like the pain was slowly moving   through my whole body.  My right shoulder and neck was hot to the touch and movement was extremely painful.    the pain started to lessen on the 16th but I was exhausted and felt like I was recovering from the flu..    Today is the 27th and my finger joints are still stiff and hurt, especially my thumbs.
Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Trembles, Diaforesis, Hepatomegalia,  Insomnia and Death by Heart Failure
Myalgia INCREASING RIGHT SHOULDER PAIN Narrative:  ECIEVED VACCINE 12/26/20 HAD INCREASING RIGHT SHOULDER PAIN F/U WITH HERE PCP TX 2-4 WEEKS OF PT AND DEEP TISSUES WORK
Lethargy, t102, high pitched cry, dec appetite, vomiting, diarrhea;
Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided. No Treatment Information were provided. Patient received the expired vaccine with lot number 031B21A(22 Sep 2021).
Acid reflux, anemia, anxiety, dizzy spell, blood pressure high, blood count low, joint ache, nasal drainage, stomach & thyroid problems, tiredness
06/01/2021 and on going, new condition that popped Mass Cell activation syndrome waiting on official diagnosis. New cartilage damage issue that requires surgical repair that was not pre-existing. Ongoing issues.
On 2/28/02, the subject received her 1st injection of Engerix-B. On 3/2/02, 2 days post vax, she noticed "a lot" of her hair came out from her temples and the back of her head while in the shower. On 4/29/02, a 2nd injection of Engerix-B was administered and the subject again experienced the recurrence of hair loss, which she described as "hair falling out with flaky, itchy scalp". Additionally, the subject developed "headaches at times". A Hep-B surface antibody (HBsAb) was performed following receipt of the 2nd injection and was reported to have responded (greater that 150). On 5/30/02, the subject reported "less hair loss", however, the symptom persisted. The immunization series was discontinued after the 2nd injection of Engerix-B. The event of alopecia was reported to have improved as of 6/20/02, however, the outcome of other events was not specified. The reporter considered alopecia to be related to Engerix-B.
Increasing redness and swelling around the site of injection. In first 24 to 48 hours patient started on oral Benadryl and local cold packs. On day 3 brought in to follow up. Mother says it is larger, measured: 10cm x 15cm, tender, erythematous, swollen ill-defined area on right upper thigh where she received DTaP. Otherwise eating and behaving as usual, no fever. Due to continued enlargement, started on oral antibiotics.
Couple of hives developed in upper inner thighs.  Woke up the following morning, 10/8, at 5:00am to swollen lower lip.  Took Allegra at 7:00am.  By noon, 10/8, all symptoms were gone.
STERILE WATER 0.7MLS USED INSTEAD OF 1.3MLS OF SALINE..DISCOMFORT AT INJECTION SITE.
Immediately, it was about 14 hours later: Body aches, chills and not feeling good. That was kind of in a cycle. I took Tylenol and it went away, and I felt well enough to go to dinner (out) and about 10 pm it started again, and I took some more Tylenol, and it went away and the next day, I felt a little icky. Last Thursday, I had a sore throat, earache, body aches, fever and chills. Took a COVID-19 and flu test and they were both negative. I went to a child and an adult care on Thursday. Saw real doctor on Monday - she did a strep test (do not have results yet). Ceftin -an antibiotic she prescribed me that I'm on now; the fever went away yesterday but I'm getting it back again today. She wants me to come back in for another COVID test and get a chest x-ray and do some bloodwork. I am going to do the chest x-ray and COVID test today. I got my flu shot on the 19th of September 2021.
Patient devloped a fever the day following administration of a influenza vaccine. Yesterday she had severe body aches and was confused.  She was seen at the emergency room.  She had a full workup for an infectious illness none was found.  He fever resolved and she felt much better after started takeing tylenol.
12/29/21: BODY ACHES, CHEST CONGESTION, NASAL DRAINAGE, COUGH, EAR PAIN
Temp of 1.5 degrees for 2 days. Home test positive congestion 3-4 days Not low on energy after that Phone visit with physician-prescribed Paxlovid Took Paxlovid 5 days Home test Negative on day 8 4/20/2023