chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL, (GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. Dehydration was also reported. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was hospitalized. At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758812A, A0758822A, A0758823A and A0758824A.
Developed Gianotti-Crosti and has had eczema off and on since.
pain in her back; Rash; shoulder pain, left knee pian; Red; swelling rash; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in her back), VACCINATION SITE RASH (Rash), ARTHRALGIA (shoulder pain, left knee pian), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (swelling rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain in her back), VACCINATION SITE RASH (Rash), ARTHRALGIA (shoulder pain, left knee pian), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (swelling rash) and MYALGIA (Body ache). At the time of the report, BACK PAIN (pain in her back), VACCINATION SITE RASH (Rash), ARTHRALGIA (shoulder pain, left knee pian), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (swelling rash) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Unable to get a hold of patient until 11/05/07.  Patient received flu vaccine 11/01/07, reports during that night she felt like she might of ran a fever (some sweating, never took temp)  When she awoke the next morning, she noticed a large walnut size lump under left jaw and small one under right jaw, not sore to the touch, or sore throat or any other adverse effects.  11/05/07 reports lumps almost gone.  Instructed to see HCP.
Intense itching - subsequent scratching of patient on site of shot - cellulitis in area where IPV given Right deltoid area.
Patient received Moderna COVID Vaccine Lot 028A21A Exp 04/28/2021, no adverse event reported, this was given past expiration listed on manufacture website.
wrist got really itchy; I had rash on bicep over a week/I also broke out in a rash on my biceps of the same arm; slight rash and some kind of sprinkling; it is a slightly itchy; She also had a headache the night off and felt flushed; She also had a headache the night off and felt flushed; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took tamiflu for flu and had allergy. The patient said that the after getting the vaccine her wrist was inoculated and itchy. Her wrist got really itchy that was the only side effect from the vaccine for the first hour. The patient had rash on bicep over a week. She broke out in a rash on her biceps of the same arm. It was slight rash and some kind of sprinkling but it lasted for over a week and it was slightly itchy. She also had a headache the night off and felt flushed. She wanted to know if she can receive the second dose. The outcome of the event itchy rash was recovered on unspecified date and unknown for the other events.  Information on lot/batch number has been requested.
Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 56-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The Dose administered after 30-day Use By Date or after manufacturer date of expiry  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  Dates of administration of vaccine were reported as 8Apr2022, 12Apr2022 and 13Apr2022.  The vial did not undergo any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received, contains reporter details was updated.
Tinnitus in both ears since 3 days past 1st dose. Has gotten worse with 2nd dose.
Information has been received from a nurse practitioner concerning a 15 year female who in May 2008, was vaccinated with the first 0.5ml dose of GARDASIL lot#655327/1287U. Concomitant medication included YASMIN. Up to 4 months after receiving GARDASIL (Sep-2008), the patient experienced vomiting and a headache. It is unknown  whether patient will continue with the series however she has yet to receive the second dose. At the time of reporting (08-Jan-2009) the patient was recovered. The patient sought medical attention. Additional information has been requested. with the series however she has yet to receive the second dose. At the time of reporting (08-Jan-2009) the patient was recovered. The patient was recovered. The patient sought medical attention. Additional information has been requested. Follow up information was received from a Nurse Practitioner reporting that the 14 year old female patient was vaccinated in the right deltoid with the first dose of GARDASIL (lot# 655027/1287U) on 28-MAY-2008. The physician saw patient for the first time on 23-DEC-2008. It was reported that the patient had intermittent vomiting, dizziness, headache for 4 monoths after the first dose of vaccine. The patient also had intermittent hives in the left arm. Shot was given by previous office. The patient also had a birth control pill change the same time. The physician felt that this could have accounted for the patient's nausea and headaches. No relevant diagnostic tests or laboratory data was collected. The patient was recovered on an unspecified date. The patient sough medical attention. Additional information has been requested.
Immediate sore and swollen arm.  Approximately 28 hours after vaccine, slight fever, chills, achy - this lasted only a few hours and I would say this was mild.  Swollen, tender area of arm where the injection was given persists almost a week later - although not as bad as first couple of days.
patient reports arm pain x 1 month , alleviated with massage/pressure, persistent x 1 month.
Fever of 99.6 for several hours during night. Temperature 97.1 upon awakening in a.m.
patient received two doses of MenQuadfi about 5 weeks apart with no reported adverse event; Initial information was received  on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 18 years old male patient who received two doses of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] about 5 weeks apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Jun-2023, the patient received a dose 1 of suspect meningococcal a-c-y-w135 (t conj) vaccine (Solution for injection) (expiry date, lot number not reported) via unknown route in unknown administration site and On 28-Jul-2023 he also received a dose 2 of 0.5 ml of the same vaccine lot U7594AD (strength, expiry date unknown) via unknown route in the left arm for Immunization.  On 28-Jul-2023 the patient developed a non-serious event of patient received two doses of menquadfi about 5 weeks apart with no reported adverse event (inappropriate schedule of product administration) ( latency : same day) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  It was reported that "A medical assistant (MA) made error and administered MenQuadfi instead of the intended Gardasil. The result is that a patient received two doses of MenQuadfi about 5 weeks apart. The first and intended MenQuadfi dose was administered on 14Jun2023. The second and erroneous MenQuadfi dose was administered on 28Jul2023 in the left arm. The MA documented that the 28Jul2023 dose was administered subcutaneously (SC). The caller stated that she is not sure if the dose was actually given SC because the MA often makes a documentation error of SC when she means to document IM. The MA is not available today for the caller to check with her about the possible SC administration. No other vaccines were administered to the patient on 28Jul2023. The ordering provider is at the same address and phone as the caller. The lot and expiry in the template below are for the erroneous dose on 28Jul2023. "  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event patient received two doses of menquadfi about 5 weeks apart with no reported adverse 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 guidelines. 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.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Migraine" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Allergy: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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. Patient had received vaccine. Patient had not received any other medication in 2weeks. Patient received Paxlovid as COVID 19 Treatment from 14Sep2022 to 19Sep2022. It was reported that two weeks after onset of symptoms and one week after completion of Paxlovid treatment I have redevelopment a cough, nasal congestion, and ear fullness (I originally developed an ear infection with the onset of COVID).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hospital Course and Significant Findings: 81 year old woman with multiple medical problems including DM2, HTN, hypothyroidism, vaccinated against COVID 5/2021, admitted 11/14/21 with acute hypoxemic respiratory failure due to COVID. She was started on dexamethasone and remdesivir. Oxygen requirement 1-2L. Noted to be hyperglycemic and started on NPH, however patient adamantly declines to use insulin at home.  At the time of hospital discharge, patient is feeling well and she is very eager to go home. Continued admission was offered to complete 5th dose of remdesivir, however patient prefers to forego this in favor of going home, which I think is reasonable given her clinical stability. She will continue dexamethasone for total of 10 days. Insulin teaching for home use was highly recommended but patient adamantly refuses to use insulin at home, she will continue metformin and check blood glucose regularly.  Discussed return precautions with patient and daughter including fever, chest pain, shortness of breath, increasing oxygen requirement, hyperglycemia. They are in agreement with the discharge plan.
Moderna COVID Vaccine: COVID-19 case resulting in Hospitalization / Death. Received Moderna Vaccine on 1/15/21 and 2/12/21. Dx'd with COVID 1/26/22. Presented to ED via EMS 2/2 worsening sxs, O2 down to 80% on room air, resolved w/2L NC. Lab significant elevation of BNP of 1928. Procalcitonin 0.43.  Troponin 0.12.  INR 3.3 (patient is on Coumadin). CBC showed leukopenia 3.3 with lymphopenia, hemoglobin 12.3, and plts of 58K - lower than his baseline of 146. CXR - ground-glass and patchy infiltrate in the left mid lung field and base and right base PNA. Course c/b bacterial sepsis 2/2 PNA. Transitioned to comfort care Tx'd with Decadron,ceftriaxone, and doxycycline. Expired on 2/08/22.
11/07/06 1st 12/06/06 2nd vac. No adverse effects, Accidentally  given pregnant (26 5/7 weeks) a second flu vaccine, reported per phone 12/06/06 conversation will not cause harm but is off label use so must report.
I contracted COVID-19. I experienced chills, nausea, diarrhea, coughing, headache, and my throat tickled. I felt like I had a fever. I went to an urgent care. They prescribed me with some medication. I also spoke to my oncologist. My symptoms lasted for 3 to 4 days. The coughing and the throat tickle lasted for possibly 30 days, but that eventually faded away.
Got the vaccine, and on 2/22/21 she woke up at 2-3:00 AM with violent vomiting, two episodes.  Her arm was sore, still having nausea.  She feels like she is going to throw up still, 2/24/21.  She has not taken anything for the symptoms.
temp to 103; extremely irritable mom called ofc 2d p/shots w/ c/o above tx w/APAP
Headache, NauseaVomiting, Fatigue, pain  Narrative:
nausea; and cold sweats - they assume he had temperature but couldn't chec; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), NAUSEA (nausea) and COLD SWEAT (and cold sweats - they assume he had temperature but couldn't chec) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN).    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (chills). On 12-Mar-2021, the patient experienced NAUSEA (nausea) and COLD SWEAT (and cold sweats - they assume he had temperature but couldn't chec). At the time of the report, CHILLS (chills), NAUSEA (nausea) and COLD SWEAT (and cold sweats - they assume he had temperature but couldn't chec) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Redness to site (Right tricep area), itchyness, hot to touch. Next day, worse with a raised area where subcutaneous injection given and a large area of flat redness surrounding it. RN measured it on 01/25/2013 as 25 mm x 20 mm raised area and the surrounding redness as 70 mm wide by 48 mm long.  Client took Benadryl x1 for itching on this a.m.  Instructed client to continue Benadryl PRN, try ice to area, seek medical attention if condition worsens, and return on Monday 01/28/2013 for nurse to evaluate. Client agreeable to instructions.
Headache, Myalgia, chills, injection site pain, swollen/tender. Left axillary lymph node with palpable firmness Narrative:
Traveling down to the elbow; Itchy; Felt hard; Injection site  red; Injection site was sore; felt like it was burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Traveling down to the elbow), PRURITUS (Itchy), INDURATION (Felt hard), VACCINATION SITE ERYTHEMA (Injection site  red) and VACCINATION SITE PAIN (Injection site was sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, High cholesterol, Allergy (Adhesive tapes and band aids) and Penicillin allergy. Concomitant products included LISINOPRIL, ATORVASTATIN, EZETIMIBE (ZETIA), TOLTERODINE L-TARTRATE (DETROL LA), VITAMIN A [RETINOL] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (Traveling down to the elbow), PRURITUS (Itchy), INDURATION (Felt hard), VACCINATION SITE ERYTHEMA (Injection site  red), VACCINATION SITE PAIN (Injection site was sore) and VACCINATION SITE PAIN (felt like it was burning). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (Traveling down to the elbow), PRURITUS (Itchy), INDURATION (Felt hard), VACCINATION SITE ERYTHEMA (Injection site  red), VACCINATION SITE PAIN (Injection site was sore) and VACCINATION SITE PAIN (felt like it was burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
devel severe cellulitis rt arm @ site of inj;pt hosp for 2 days for IV ATB;
the patient did not receive the ActHib portion of the Pentacel vaccine, she asks if she can go ahead and administer it now and if so what diluent to use; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient of unknown age who did not receive the Act-HIB portion of the Pentacel vaccine, she asks if she can go ahead and administer it now and if so what diluent to use, while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 09-Apr-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6138AB via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  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.  List of documents held by sender: none.
no other AE's reported; temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5ml, lot # T021821 has been verified to be a valid lot number, expiration date was reported as 25-JUN-2022 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of (-7.4) Celsius for 3 hours and 54 minutes. Data logger was involved. There were no previous excursions reported. The outcome of product storage error and no adverse event was unknown.
side effects- side effects after 5 days; bleed out your nose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects- side effects after 5 days) and EPISTAXIS (bleed out your nose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (side effects- side effects after 5 days) and EPISTAXIS (bleed out your nose). At the time of the report, VACCINATION COMPLICATION (side effects- side effects after 5 days) and EPISTAXIS (bleed out your nose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  Patient stated that its been five days since the booster.