chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DUPIXENT (ongoing). Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation; Bnt162b2 (Dose 2, single), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown".  Additional information: Reporter was asking if the current COVID drug being made now was active or inactive. Reporter clarified inquiry and asked if vaccine was a live vaccine. Reporter was taking Dupixent every other week and could not take any live vaccines. Stated she took 2 of the Pfizer COVID vaccines and a Pfizer booster and developed a rash. Stated they never discovered what the rash was from. Stated just in case it was due to Pfizer COVID vaccine, she would avoid the vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
2/22/21 She was seen at ED due to worsening upper extremity swelling and redness, secondary to COVID-19 vaccine reaction. She was previously taking cefalexin 1000 mg BID without relief. Additional details are limited at this time.
Patient stated that she started breaking out in hives the day after the injection. She described the area as down her arms, across her chest, and across her neck. She reported the reaction on 7/23/2021 and said that she was still experiencing hives.
Started out with high fevers, sore throat, and extreme tiredness and body aches Vaginal ulcers triggered by autoimmune response in June 2013. She kept having issues and ended up having inflammatory response in her back which started January 2014. Complained of increasing back pain. Xrays and MRI completed in 9/2014. Her condition has become worse and currently she's in and out of wheelchair due to inflammation of her back. 2nd MRI 2017 continues to show inflammation. She is experiencing severe back pain.
Still got sick.; Initial information received on 23-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who experienced still got sick while receiving vaccine Influenza Vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, dose, strength, form not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious still got sick (illness) (unknown latency) following the administration of Influenza Vaccine.  Action taken: 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.
Chills, fever shivering, also has headache , body aches which is continuing.  Sweating during night, continuing today..
Bilateral blurring vision (30 minutes) followed by transient aphasia, difficult word finding(another 30 minutes). Entire episode lasted  1 hour, resolved with vision and speech returning to normal.
Initial misuse report received from a healthcare professional on 06 February 2013. A 09-year-old patient was administered MENACTRA, IPOL and DAPTACEL. No adverse event was reported. List of documents held by sender: none.
Pt returned to clinic.  Told practitioner that he visited the ER on 9/14/11 as the site of pneumonia vaccination was red and swollen, staes that ER treated him with antibiotic for infection at site, at this time 9/15/11 10 am site L arm is erythematous from site of injection L deltoid extending down to L wrist, slight edema in this extremity, no warmth or induration at site, pt denies having a fever, states that he is on blood thinner medication.
bacterial throat infection; SWOLLEN THROAT; A spontaneous case was received from a non health care professional concerning a 65-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bacterial throat infection and throat swelling..   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.  On 24 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (Lot 012M20A) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient developed bacterial throat infection and throat swelling.  Treatment for the event included oral antibiotics for 7 days, but patient had not started yet.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for both events were not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
severe fatigue, muscle aches, unable to move due to Weakness, was at work so sent to ER given fluids and sent home. Pcp originally believed was Lymes disease ( tick bite in 2011, labs negative) which prescribed doxycycline and steroids. for 21 days. went back to work when meds finished lasted 2 weeks then woke up and couldn't move arms.  Been to neurologists, rheumatologists, have had several mri's, labs, EMG's all coming back normal.
I have had 4 Pfizer vaccines and today I just got my 5th via Moderna.; I have had 4 Pfizer vaccines and today I just got my 5th via Moderna.; I have had 4 Pfizer vaccines and today I just got my 5th via Moderna.; I have had 4 Pfizer vaccines and today I just got my 5th via Moderna.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 5 (initial moderna dose), single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious), OFF LABEL USE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown" and all described as "I have had 4 Pfizer vaccines and today I just got my 5th via Moderna."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient had red rash form in a band around her at the injection site. Patient received antibiotics from a medical doctor on 10/17/18.
My son died 5 days after being vaccinated from an intussusception.  5/13/08 Autopsy report states COD as complications of intussusception.  Report states patient had clinical history of abdominal distension & vomiting; IS w/5 in telescoping of ascending into transverse colon beginning at the ileocecal valve;partially reducible telescoping w/colonic infarction & prominent lymph nodes at leading colonic edge; dilated abdomen w/increased abdominal distention; BRB per rectum on autopsy & history of currant jelly stool at home; sepsis w/E.coli cultures from heart blood, spleen & lung' interstitial pneumonitis w/positive RSV antigen from nasopharynx swab.
Probably started 12-15 hours after the shot, I got COVID arm, from the injection site to the elbow. I was put on antibiotics. I had a fever of 99 to 103.2 which lasted about 3 days. I had extreme flu-like symptoms and lost the feelings in my legs. I could not walk for about a half a day. I went to urgent care and that is where I got the antibiotic by the way.
Information has been received from a pharmacist concerning a pt who was vaccinated in the arm with a dose of PPV (lot #650082/0691P). The pharmacist reported that the pt subsequently developed a swollen arm. Unspecified medical attention was sought; however it was noted that the pt "never called the clinic to report it." At the time of this report, the outcome was unknown. The pharmacist requested that a lot check be performed. The pharmacist considered the swollen arm to be an other important medical event (OMIC). Additional information has been requested.
Expired PROQUAD administered; This spontaneous report was received from a nurse concerning a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, historical drug, drug reactions/allergies and concomitant were not provided.  On 20-NOV-2020, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, lot number S012534 expiration date 20-OCT-2020 as prophylaxis. (Route of administration was not provided)  Lot No. S012534 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD).
Information has been received from a county health professional concerning a 6 month old male who on 15-JAN-1998 was vaccinated with VARIVAX (Oka/Merck).  On 24-MAR-2007 the patient developed varicella < 50 lesions.  The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation.  An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Oka/Merck).  This is one of 28 reports received from the same source.  No further information is available.
reaction after second dose: mild soreness in arm after the shot....12 hours later high fever and chills, Muscle and joint pain, and headache. These lasted 12 hours.  Three days later a semi-circular rash on arm below injection site and a blister at injection location. Mildly itchy and red...this is still present but diminishing.
PATIENT DID NOT EXPERIENCE ADVERSE EVENTS.  THE PATIENT IS 16 YEARS OLD AND WAS INADVERTENTLY GIVEN A MODERNA VACCINE, WHICH IS NOT YET APPROVED FOR ANYONE UNDER THE AGE OF 18.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 01-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 40 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Elevated blood sugars minimally affected by insulin intake.; This is a spontaneous report received from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown), as a single dose via an unspecified route of administration in the left arm on 17Mar2021 at 09:15 AM (at the age of 29 years old) for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's medical history included type 1 diabetes. The patient concomitant medications Levothyroxine, Errin, Novolog, Wellbutrin within two weeks of vaccination. The patient visited to pharmacy or drug Store for COVID-19 vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021, the patient had elevated blood sugars minimally affected by insulin intake. Corrective treatment included highly increased insulin therapy. The clinical outcome of the event was reported as not resolved at the time of report. Information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 18-year-old male patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine and Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder and drug dose administration interval too long. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional information was reported as follows: The age at vaccination was not reported. The band Hepatitis B vaccines was unknown. In 2000, the patient was vaccinated with the 1st and 2nd dose of Hepatitis B vaccine. In 2002, the patient was vaccinated with the 3rd dose of Hepatitis B vaccine, which led to drug dose administration interval too long. The patient was required to get an antibody titer drawn prior to entering the college. The titre after analysis showed as non-responsive, which led the patient to be therapy non-responder. Their was no laboratory proof, showing appropriate titer. The healthcare provider had planned for re-vaccinating the patient with another course (3 doses) by using ENGERIX-B.
soreness in her arm; fever; Nausea; Body aches; Cold sweats; raging headache; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9266; Expiration date: unknown) intramuscular, administered in Arm Left on 20Feb2021 12:20 (at age of 51-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included lung neoplasm; lung cancer, lung cancer metastatic, adrenal gland cancer metastatic, throat cancer, metastasized to spine; had Chemo 1 year ago and SBRT radiation in Aug2020. In remission as of Sep2020 and bone cancer from an unknown date and unknown if ongoing. Rheumatoid arthritis from 2005 and ongoing. Concomitant medication included oxycodone (OXYCODONE) taken for rheumatoid arthritis and bone cancer from an unspecified start date and ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to AE(s) was none. It was reported that, patient just got her 1st dose on Saturday, 20Feb2021, and she was a cancer patient so her doctor recommended that she call and report her side effects. Her side effects were not bad enough to go to the hospital, but they were kind of bad. It was reported that, on 22Feb2021 04:00 she had a fever, thought it never went above 100.2; she had nausea, and body aches which felt like she had been hit by a bus, cold sweats, and a raging headache. Also stated that she had soreness in her arm that kind of felt like someone punched her in the arm on an unspecified date. Stated that all the events began around 4 am on Monday; she woke up feeling not so good. She had about 48 hours of misery and she was feeling much better today. States that it was much better than getting COVID. Adverse event did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included body temperature: 100.2 fever never went above 100.2 on 22Feb2021.The outcome of event soreness in her arm was unknown while all other events was resolved on 24Feb2021.  Follow-up attempts are completed. No further information is expected.
29APR97 2AM pt woke up w/dyspnea-pressure in chest, itchy, anxious, cough;no fever;went to MD dx w/swollen nasal chords-poss rxn? achy @ site;no pox;5MAY97 to ER rxn to rx-cough med;poss not a rxn to vax but viral illness;
After receiving the vaccination, she suffered a painful rash/was diagnosed with herpes zoster and postherpetic neuralgia; After receiving the vaccination, she suffered a painful rash/was diagnosed with herpes zoster and postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was administered with zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles (lot#, expiration date, dosage and route of administration not specified). After receiving the vaccination, the patient suffered a painful rash. As a result of these symptoms, she presented to a medical provider and was diagnosed with herpes zoster and postherpetic neuralgia. Thereafter, she had continued to suffer the effects of herpes zoster and postherpetic neuralgia. The reporter considered that shingles was related to Zoster Vaccine Live (ZOSTAVAX).   Additional information has been requested.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11Jan2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter. This case contains information of 44th patient out of 100 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
pt recvd vax & devel shrill cry & screaming for 48 hrs; cyanosis; secondary to screaming;
48 hours after DTaP injection, mother noted dark, pink, warm, raised area at injection site on left arm.
HOARSENESS, THROAT SWELLING, SWELLING & REDDENING OF EYES, DISCHARGE FROM EYES, CHILLS
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), on 28Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Negative, notes: Tested negative for 2 days before the rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness at injection site, low grade fever, body aches, limp at injection site.
red rash around injection site soreness at injection site had bump on injection site body aches headache
after the first dose she "was sick for about a week, like with the flu"; after the first dose she "was sick for about a week, like with the flu"; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date (at age of 68-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included COVID-19 and drug hypersensitivity; she was sensitive to medications from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced after the first dose she "was sick for about a week, like with the flu on an unspecified date. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.