chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Just a sore arm, due date is May 8th, 2021, just reporting because I was asked to report my pregnancy and vaccine.  Got my second dose today, again sore arm, I feel a little out of it 14 hrs later but no serious symptoms at this time. Thank you for making this happen! Hopefully my daughter is born with the antibodies too!
Injection site soreness, lethargy for 2 days after injection then no issues until a month later when illness with headache, fever to 101 F, nausea for 2 days and diarrhea for 4 days.  Lightheaded with vaso-vagal reaction and fainted on Day 2.  No long-term sequelae.
This spontaneous report was received from a patient's mother and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in approximately 2017 (reported as recently), the patient was vaccinated with M-M-R II injection (route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date in approximately 2017 (reported as after receiving the injection), the patient had a fever. The outcome of the event and the causality between the event and M-M-R II were not reported.
First influenza vaccine given approx. 3pm 1/21/09. Caregiver noted "hives" around injection site and torso approx. 6pm. No other sx other than hives noted by caregiver. Treated with APAP only. Hives described to be faded morning of 1/22/09.
Itching all over body with rash; Itching all over body with rash; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2022 11:30 (Lot number: 331308A) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: VISTARIL [HYDROXYZINE EMBONATE]; EFFEXOR. Past drug history included: Known allergies: zithromax, reaction(s): "known allergies: Zithromax"; Known allergies: benadryl creams, reaction(s): "known allergies: Benadryl creams", notes: known allergies: Benadryl creams. The following information was reported: PRURITUS (non-serious), RASH (non-serious) all with onset 26Jan2022 21:30, outcome "not recovered" and all described as "Itching all over body with rash". Therapeutic measures were not taken as a result of pruritus, rash.  Additional information: The patient had not received any other vaccine within four week prior to vaccination. Prior to vaccination the patient was not diagnosed with Covid-19. Since vaccination the patient was not tested for Covid-19. These adverse events did not result in emergency room/physician visit.  No follow-up attempts are possible. No further information is expected.
On 11/23/21 at 415 I had given a 12 year old a pediatric dose Covid instead of an adult dose. She Turned 12 on 9/26/21.   I spoke to doctor since he is the PCP as well. I documented this correctly as a Peds dose,  but have not notified the pt yet as I am unsure what needs to be told.
Migrane; GI/Digestion Issues - but had a recent flair-up; This is a spontaneous report from a contactable consumer. This 30 year old female consumer (patient) reported for herself that:   A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248; Expiration Date: Apr2021), dose 2 intramuscular, administered in arm left on 04Feb2021 (at the age of 30 years old) as dose 2, single for covid-19 immunisation. Medical history included gastrointestinal disorder from 24Aug2021 and ongoing Blood work ultrasound and HIDA scar performed to assess issues. The patient concomitant medications were not reported. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248 Expiration date: Apr2021), dose 1 Intramuscular, administered in arm left on 14Jan2021 as dose 1, single for covid-19 immunisation. On 2021, the patient experienced gi/digestion issues - but had a recent flair-up. On 05Feb2021, the patient had migrane. The patient assessed the events as non-serious. The patient underwent lab tests and procedures which included blood test: unknown results, hepatobiliary scan: unknown results, ultrasound scan: unknown results on an unspecified date. The outcome of the event GI/Digestion Issues - but had a recent flair-up was unknown and migrane was recovered on an unspecified date Feb2021.  Follow-up attempts are completed. No further information is expected.
Local skin reaction 2 1/2 in x 2 1/2 in. Redness/slight Left arm.
Intense soreness, tiredness immediately after for 3 days Starting on 4/11 loss of taste and smell Starting on 4/12 loss of taste and smell plus sore throat, runny nose and difficulty breathing
Rapid heart rate, light headed, nausea, fatigue 2 days post vaccination.
It began with head jerks sort of like moving my head back and forth or even in a diagonal way including a thrashing back and forth of my torso with stress to loud noises or it becomes worse. A warning sign is if I am tired or feel moody. I received a diagnosis of Functional Disorder on 12/07/2022 other symptoms include muscle contractions in the calves or legs it does not effect cognition and I am fully conscious when occurring my foot will turn sideways or not straight as well. Treatment is OT and PT as well as counseling. I have yet to receive any counseling. I have no structural issues in my neurological system. It is called "Functional Movement Disorder".
Patient was known to have fainting spells due to vaccinations in the past. Shortly after immunization took place he became hot and fainted while sitting in his chair. After a few moments he came to and we provided him a cooling pack for the back of his neck. He confirmed he was able to leave after another 15 minutes of monitoring.
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and feels awful. The patient was treated with ADVIL. On an unknown date the outcome of the influenza-like symptoms and feels awful were unknown. It was unknown if the reporter considered the influenza-like symptoms and feels awful to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional heard report from another provider who was asking about trends in adverse events reported with SHINGRIX doses. The health care professional stated that the patient she heard about experienced flu like symptoms and felt terrible after receiving SHINGRIX. The patient took ADVIL, took a nap, and felt fine after. The health care professional stated this was not her patient and didn't want to report adverse events. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked with US2018GSK095204, reported by the same reporter for the same patient and US2018GSK092161, reported by the same reporter.
Flushed cheeks, nausea, vomiting, low-grade fever, diarrhea, irritability for two days following event onset.  Given oral fluids for hydration and Tylenol to reduce fever.
This spontaneous report was received from a healthcare worker, referring to a 2 patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-AUG-2016, the patients were vaccinated with improperly stored M-M-R II (lot # M004899 exp. date 27-JAN-2018 rHa; lot # M008589 exp. date 16-FEB-2018 rHA; lot # L032044 exp. date 24-AUG-2017 and lot # L037356 exp. date 28-SEP-2017) (strength, dose and administration route were not provided). No adverse effects was reported and no product quality complaint was involved. It was reported that the vaccines were exposed to a temperature of "19C for 5 hours", it was data logger involved, but no previous excursions. Additional information has been requested.
Patient was administered with flublok instead of fluzone high dose, no reported adverse event; Initial information received on 01-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professionals via Medical Information (under reference number 00837197).  This case involves a 69 years old female patient who was administered with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, sometime in the last month as per report, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered (same day latency).  It was reported "Caller was administered FLUBLOK "sometime last month" although she asked for FLUZONE HIGH DOSE; caller has been advised by her allergist to reach out to medical information on counseling regarding having another FLUBLOK shot administered in order to be protected for her age range; caller states she needs to start diabetic medicine and is refusing to do so until has information regarding another dose of a flu vaccine. Upon transfer, caller asked how Flublok Quadrivalent, Fluzone High-Dose Quadrivalent, and Fluzone Quadrivalent compare in terms of the dose of the 4 strains in the vaccine. Caller asked if she could get another dose of a flu vaccine to "make up" for not having gotten the Fluzone Quadrivalent High-Dose. Caller asked what is a situation where someone would get the Flublok rather than the Fluzone High-Dose. Caller asked if the 4 strains are the same in the Flublok and the Fluzone."  At time of reporting, no adverse event was reported.   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.  There will be no information available on the batch number for this case.
Medical assistant administered Flublok instead of standard dose to child patient; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves female patient of an unknown age (child) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route in unknown administration site on an unknown date instead of standard dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  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.  Information on the batch number was requested.  Documents held by sender: none.
Initial and follow up information has been received from a physician and by telephone from a registered nurse (R.N.) concerning a 17 year old female patient who on 28-APR-2008 was vaccinated with a first dose of GARDASIL lot # 659180/1758U. Concomitant therapy included DTAP-IPV, MENACTRA and ACCUTANE. On 01-MAY-2008 the patient experienced severe headache and nausea and after getting the first injection and went to the emergency room (ER). The next day, on 02-MAY-2008 she went to her physician's office and her physician sent her to the hospital. While at the hospital she was given Intravenous (IV) Fluids and narcotics for the pain. Unspecified laboratory blood work was done. In follow up telephone call to the office the nurse reported that there was no documentation regarding patient's hospitalization. No additional information was provided. The patient was reported as recovered at the time of this report. Additional information has been requested.  8/15/08 Reviewed hospital medical records of 5/2/2008. FINAL DX: acute HA; fever; vomiting; & dehydration Records reveal patient experienced severe vomiting, HA, low grade fever & dehydration.  Patient admitted to HA prior to vaccination & was on Accutane.  Also had leg pain.  Seen in PCP office where she could not stand w/o vomiting.  Had been seen in ER on 5/1 as well w/decreased urine output & dry lips.  Tx w/IVF & improved.  D/C to home on same day.
None - just to report accidental (unintentional) administration of 23-polyvalent (PNEUMOVAX ) vaccine to a 2 1/2 hour old newborn. Infant doing clinically well - post event.
Information has been received from a physician concerning a male pt with history of hypercholesterolemia, coronary artery disease and squamous cell carcinoma of the right eye, who on 10/27/02 was vaccinated with a dose of Fluzone SV '2002-'2003 (lot number unspecified). The pt developed hematochezia, thrombocytopenia, and platelet refractory one week after vaccination. On 11/4/02 at 8pm. Bone marrow aspiration and biopsy were performed. The pt was reportedly hospitalized. It was not reported whether the pt recovered.  Reported on 03/04/2003: "From follow-up #1 correspondence received on 02/26/2003 it was reported that the patient was hospitalized for 14 days.  Bone marrow results provided - normal marrow elements; abundant megakaryocytes.  The patient reportedly recovered from this experience.  This case is closed.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic pain. On 27th June 2018 17:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 12 hrs after receiving SHINGRIX, the patient experienced general body pain and unable to walk. On an unknown date, the outcome of the general body pain and unable to walk were recovering/resolving. It was unknown if the reporter considered the general body pain and unable to walk to be related to SHINGRIX. Additional details were provided as follows: On the day before reporting, around 5:00pm, the patient received SHINGRIX in the right arm. The patient went to bed around 11:00pm and then experienced pain that woke her up around 5 to 6 am. The patient's entire body was in pain and she was not able to move or walk. The patient managed to go back to sleep then woke up again around 7:00 or 8:00am and still had pain. The patient went back to sleep until 10:00am and the pain had lessened and she could function. The patient did not know the lot number and expiration date of the vaccine. The patient has denied permission to contact their physician. The patient did not have a primary care doctor.
Information has been received from a nurse concerning a 6 month old female who was vaccinated with the first dose of oral ROTATEQ on 11-Mar-2008 (Lot # 659855/1692U), the second dose on 14-May-2008 (Lot # 657987/1394U) and the third dose on 09-Jul-2008 (Lot # 659855/1692U).  On 05-Aug-2008, the patient experienced vomiting; abdominal pain and diarrhea after administration of the three doses of ROTATEQ and was hospitalized from 05-Aug-2008 to 06-Aug-2008.  Stool sample on 05-Aug-2008 was positive for rotavirus.  It is reported that the patient is recovering.  No product quality complaint.  Vomiting, abdominal pain and diarrhea were considered to be immediately life-threatening and disabling.  A lot check has been requested.  Additional information has been requested.
Passed out cold/lost consciousness; violently ill; really sweating; Vomited; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 021C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood test: antibodies (Inconclusive) Had antibodies and donated plasma.         Company comment: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the non-serious expected events loss of consciousness, illness and hyperhidrosis and expected vomiting and chills. The events occurred the next day after the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medications were reported. Patient did not take any medications for the symptom relief. Patient stayed in bed for 2 days to recover.   This case was linked to MOD-2022-460285 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the non-serious expected events loss of consciousness, illness and hyperhidrosis and expected vomiting and chills. The events occurred the next day after the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
I had my vaccination on 09/30/2022. On 02/15/2023 I started to experience fatigue very sore throat runny eyes and nose low grade fever body aches and loss of appetite. I tested COVID-19 positive at home on 02/15/2023. I contacted my physician office and they prescribed my PAXLOVID. I presently feel I have recovered on 04/03/2023.
This spontaneous report as received from a nurse refers to a child patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 18-JUN-2018, the patient was vaccinated with the first dose of ROTATEQ oral liquid, orally, lot# R003534, expiration date 31-AUG-2019 for prophylaxis. The patient received about quarter to half a dose but spit it up and then received a little more and retained it. No adverse effect were reported.
Headache, Myalgia, Arthralgia, Diarrhea, WEAK LEFT ARM, ARMPIT SWOLLEN/PAIN Narrative:
Awakened early AM, 12/08/03 with a irritating itchy rash covering 70% of body.  No difficulty breathing.  Rash persisted.  Reported by phone at 08:10.  Advised follow up at ER incase of anaphylaxis.  NP @ER could not determine conclusively that the reaction was caused by the vaccine.  Administered steroids IM and prescribed Hydroxyzine HCL 50mg and Prednisone 4mg, to be taken if reaction persists.
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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 48 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Mar2021 as dose 1, single (Lot number: 038A21A), on 11Apr2021 as dose 2, single (Lot number: 036B21A) and on 22Sep2021 as dose 3 (booster), single (Lot number: 939902) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: 01Jun2016; SULFASALAZINE, start date: 01Nov2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In October 2014, at age 65, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at an urgent care center for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, and economic losses. Additional information has been requested.
Patient got Pfizer COVID-19 vaccine and had vomiting x 4 and pruritus 15 minutes after administration. She was given Benadryl, Pepcid, Solumedrol with symptom relief. She did not require epinephrine.