chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was fine on the day the vaccine was given, i.e. 08/01/2016. But on the next day towards afternoon, she started feeling sick. The patient stated that she had fever (she did not know how much). She was feeling very weak and not able to keep food down. At the same time her arm started developing a rash. The rash was not itchy but more painful. Patient has barely been able to eat since. She is feeling a little better today.
HEFTY REACTION; FELT SICK; This spontaneous report received from a patient via social media from a company representative concerned a patient of unspecified age, sex and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 in total administered 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. It was reported that the patient had no reaction, following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, patient received booster dose of non-company suspect vaccine included: mrna 1273 (Moderna), (Dose number in series 2) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown), dose, start therapy date were not reported for prophylactic vaccination. On an unspecified date, following vaccination with mrna 1273 (Moderna), the patient experienced hefty reaction (adverse event nos) and felt sick (Dose number in series 2). It was reported that " I had the Janssen shot and then my doctor told me to get the Moderna booster so I did". The patient "had quite a hefty reaction to the booster. Not real bad, Sickish for 2 day". The patient recovered from felt sick, and the outcome of hefty reaction was unknown. This report was non-serious.
pt recv vax 17MAY95 & approx 30hr later chills, body ache, h/a, shooting pains in ears-skin hurt; fatigue, t101 lasted until 20MAY05; currently @ site of inj-warm to touch, reddened 4"x4" itches @ site; temp OK now; still weak; APAP given;
I felt a little achy and a fever for about two days. I traveled to a wedding in 02/2023. The weather was miserable and cold the whole time. I began not feeling well in 03/2023 with a runny nose, cough and I thought it was a cold. I did not test positive for COVID-19, but I did lose your sense of smell and taste. I have had multiple respiratory illnesses recently and never tested for COVID-19.
Major pain in all joints, cervical-lumbar, neck, wrists shoulders, mental disorders, insomnia erectile disorders, abdomen pain, allergies, anxiety arthritis, conjunctivitis, depression, dermatitis, headaches memory difficulty, sinusitis, lipoma.
nurse administered a dose of Bexsero subcutaneously instead of intramuscular; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   On 28-JUL-2023, the patient received the 1st dose of Bexsero (subcutaneous, right arm). On 28-JUL-2023, an unknown time after receiving Bexsero, the patient experienced intramuscular formulation administered by other route (Verbatim: nurse administered a dose of Bexsero subcutaneously instead of intramuscular). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-JUL-2023 The dose was administered in the right upper arm of a patient. At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The reporter reported that a float nurse administered a dose of Bexsero subcutaneously instead of intramuscular, which led to intramuscular formulation administered by other route.
I've never had blood pressure issues in my life, but suffered from significantly elevated blood pressure for several months after taking my second Moderna shot.  I did not need medical attention for the issue, but it was very concerning.
Almost died with septic shock; NSCLC stage 4 with Alk mutation; Sick; Dehydrated; This case was reported by a consumer via media and described the occurrence of septic shock in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included metformin for diabetes.   Concurrent medical conditions included diabetes.   On an unknown date, the patient received Shingles vaccine and metformin at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced septic shock (serious criteria GSK medically significant and life threatening), non-small cell lung cancer (serious criteria GSK medically significant), sickness and dehydration. The action taken with metformin was unknown. On an unknown date, the outcome of the septic shock, non-small cell lung cancer, sickness and dehydration were unknown.   It was unknown if the reporter considered the septic shock, non-small cell lung cancer and dehydration to be related to Shingles vaccine. The reporter considered the sickness to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient reported case for himself or herself. After vaccination patient was sick. The patient was dehydrated and was on Metformin for diabetes. The patient was almost died with septic shock due to metformin toxicity. Less than 3 months later patient was diagnosed with NSCLC (Non-small cell lung cancer) stage 4 with Alk mutation. The physician never warned the patient of the dangers and informed be careful, it could cost your life As the hospital physician said, it was the perfect storm. The patient still struggle with health yet. It was unknown if the reporter considered the septic shock, non-small cell lung cancer and dehydration to be related to Metformin. The follow up was not required.
On day 8 after receiving my second vaccine, the vaccine site started itching. A few hours later, I noticed quarter sized raised red welts on the vaccine site. Area is very hot to the touch.
Janssen COVID-19 Vaccine EUA  headache, fever, fatigue, soreness of arm - as of this date, April 9, 2021; 9:30 am.  I expect to recover, but reporting these side effects for your information
Pt states had numbness on left side, (left arm, left side of face), dizziness. Left jaw also affected. Pt feels discomfort from left arm to fingers. Pt said symptoms started 15 minutes after flu shot. Pt states was having heart palpitations. Pt called around 6 pm and stated going to ER. Pharmacist called answering service for primary care Dr. Dr was not on call. Answering service stated they would leave message for office and nurse practitioner on call.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 30-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number  was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
TINGLING IN HEART/TINGLING IN LEFT ARM AND NECK OF LEFT SIDE; LOOPY; WORDS NOT COMING OUT RIGHT; SORE ARM; TIREDNESS; NAUSEA; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A and expiry: not reported) dose was not reported, administered on 02-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced tingling in heart/tingling in left arm and neck of left side. On 02-APR-2021, the subject experienced loopy. On 02-APR-2021, the subject experienced words not coming out right. On 02-APR-2021, the subject experienced sore arm. On 02-APR-2021, the subject experienced tiredness. On 02-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and words not coming out right, and had not recovered from tiredness, loopy, sore arm, and tingling in heart/tingling in left arm and neck of left side. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Headache, Myalgia, Diarrhea, Chills, fatigue, loss of appetite  Narrative:
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 6 (booster), single (Lot number: GJ2524) at the age of 60 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Moderate asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19.
Within 25 minutes of administration of vaccine, patient's mother brought the patient back to the pharmacy to alert the pharmacist that he was experiencing an allergic reaction. Patient experienced swelling of his lower lip, denies itching, hives,  and shortness of breath.  Patient was administered diphenhydramine 50 mg under supervision of the pharmacist and counseled the mother to continue to watch for symptoms of anaphylaxis and follow up PCP if any changes occurred.
VACCINE GIVEN SUBCUTANEOUSLY INSTEAD OF INTRAMUSCULARLY BY STAFF (STAFF IS CURRENTLY IN ORIENTATION/TRAINING)
Pt developed red, hot, swelling shoulder to elbow. No other sx. No fever. Dx cellulitis rx'd BACTRIM DS X 10 d.
had both shots and still got them; got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both shots and still got them) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 21-Mar-2023 The patient's boyfriend reported this reported the case via interactive digital media. The reporter's girlfriend had both shots and still got them.  The reporter asked what was with the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR058178:Same reporter
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with a dose of M-M-R II, injection, (lot # J002502, expiration date 28-FEB-2015). There was no concomitant medication reported. The nurse practitioner reported that the vaccine was exposed to a highest temperature of 11.5 degree centigrade for 9 hours. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, once/single administration. FLUMIST quadrivalent started on an unknown date. It was reported that patient number six given FLUMIST that underwent a temperature excursion and it was unknown if the dose of 0.1ml was given in each nostril. FLUMIST quadrivalent was continued. The outcome of the events of patient number six given FLUMIST that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril is unknown. The report was considered to be non-serious. Corrected report on 02-Nov-2015: Event coding updated. Narrative edited. Case was suppressed.
Information has been received from a nurse practitioner, via a company representative, concerning a 16 year old female patient, who in April 2007, was vaccinated with a dose of Gardasil. Concomitant therapy included Menactra and Vaqta. The nurse practitioner stated that the patient "fainted after she received the Gardasil vaccination. " The "patient was given liquids to drink and something to eat, and she was fine." Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Initial follow up information has been received. There was no illness at the time of vaccination. The nurse practioner stated that as the patient walked from the exam room at 8:35, she felt lightheaded, passed out and fell and hit her right occipital area. The NP stated that the patient had not eaten that morning, and was given juice and a banana. The patient left the office after about 10 minutes, and recovered on the same day, 10-Mar-2007. No further information is expected.
The evening after receiving the vaccination, mom noticed a baseball sized red area in right deltoid that was warm to touch and firm. No complaints of pain or itching at site. Patient had a fever of 100.2 that evening and given Ibuprofen. Treatment is to use ice and BENADRYL, watch for signs and symptoms of infection.
psoriasis; This initial spontaneous report was received from a lawyer on 07-JAN-2021, regarding a case in litigation and refers to a currently 57-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 20-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and dosage regimen information was not provided) for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced psoriasis.  At the time of the report, the outcome of psoriasis was unknown. The reporter considered psoriasis was related to Zoster Vaccine Live (ZOSTAVAX).
Pt recv vax on 3/1/99; on 3/2/99 pt exp swollen/red/ hot/ painful knot
2:44pm pt said upper arm was tingling and numb surrounding injection site, resolved after a few minutes after applying an ice pack at 2:48pm to area, checked bp and pulse 2:49pm hr 114 bp 120/89, pt said she was nervous and later said dehydrated from playing softball yesterday, 2:52pm  bp121/85 pulse 113, 2:56pm hr 113bp 137/82, 2:57pm 112/77 pulse 114, 3:08 pm 123/86 bp and 104 pulse- said was feeling fine and left
This is serious spontaneous case, initially received on 12-Feb-2018, reported by other non-health professional, concerns a 13-year-old, adolescent, male patient. On 30-Sep-2017, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195210, dose, expiry date: not reported). On 12-Feb-2018, 4 months 14 days after vaccination, the patient was diagnosed with type A Influenza [considered as vaccination failure (lack of efficacy)]. At the time of this report, the outcome of the event type A Influenza was not reported.
It started with discomfort in my mouth in the middle portion of lower gum. It radiated and moved to the back of my lower right gum area as well. I had an occasional sore throat, pain radiating into my head, and occasional headaches on one side of my head. Eventually I ended up with a large white canker sore on my lower right jaw. I went to see the dentist at his local office 11/3/2021. I ended up with a tooth sensitivity, and they ended up doing a root canal on my tooth.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2008, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-AUG-2012, the patient was treated by a certified physician assistant (PA-C) for a blistering vesicular outbreak, which was then diagnosed as shingles. The patient was prescribed lidocaine, ketoprofen, dexamethasone and gabapentin for management of his painful symptoms and excruciating pain. On or about 05-SEP-2012, the patient sought subsequent treatment from the same certified physician assistant (PA-C) for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed tramadol to manage his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
On April 23, flu-like symptoms began with nausea and diarrhea. As those subsided, allergy-like symptoms began with a cough and wheezing (no history of asthma or previous wheezing). Primary care doctor prescribed VENTOLIN HFA for relief. Symptoms continued. Saw the clinic Nurse practitioner on May 16. She felt it was still allergy based. May 20, breathing was so difficult, he was taken to the Emergency Room and was admitted, diagnosed with viral cardiomyopathy.
Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration on 04Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 04Mar2021, the patient received the 1st dose of COVID-19 vaccine. On 08Mar2021, she started developing symptoms of Bell's palsy. On 15Mar2021, she saw an internal medicine physician and confirmed that the patient has Bell's palsy. The patient was advised not to take the second dose but also suggested contact Pfizer for further advice on the second dose. The patient will see the physician for follow-up 22Mar2021. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Pain in entire arm; numbness/tingling in lower left arm into hand. Unable to grip anything without pain going through arm.
Patient had a missed menses the month after the vaccination, and it has yet to resume. Date of vaccination was 9/10/21, and she should've had her menses by 9/20/21. She had all of the symptoms that would accompany her menses but no actual menses.
Patient called to mention hives began on Thursday evening around bedtime ~10 PM. Friday has gotten more red and began to spread more. Pt was given recommendation to seek care at urgent care.
Shoulder got tight; Shoulder got swollen; Where he got the injection is warm; Where he got the injection is itchy; Red dot where he got the injection; Where he got the injection that is swollen; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Shoulder got tight), JOINT SWELLING (Shoulder got swollen), VACCINATION SITE WARMTH (Where he got the injection is warm), VACCINATION SITE PRURITUS (Where he got the injection is itchy) and VACCINATION SITE ERYTHEMA (Red dot where he got the injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Shoulder got tight), JOINT SWELLING (Shoulder got swollen), VACCINATION SITE WARMTH (Where he got the injection is warm), VACCINATION SITE PRURITUS (Where he got the injection is itchy), VACCINATION SITE ERYTHEMA (Red dot where he got the injection) and VACCINATION SITE SWELLING (Where he got the injection that is swollen). At the time of the report, MUSCULOSKELETAL STIFFNESS (Shoulder got tight), JOINT SWELLING (Shoulder got swollen), VACCINATION SITE WARMTH (Where he got the injection is warm), VACCINATION SITE PRURITUS (Where he got the injection is itchy), VACCINATION SITE ERYTHEMA (Red dot where he got the injection) and VACCINATION SITE SWELLING (Where he got the injection that is swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment included ice.   Reporter did not allow further contact