chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid; Lack of drug effect; Didn't feel good; Really sore arm; Fever after second dose; Red arm around injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid), DRUG INEFFECTIVE (Lack of drug effect), VACCINATION COMPLICATION (Didn't feel good), PAIN IN EXTREMITY (Really sore arm) and PYREXIA (Fever after second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema (Patient has gotten eczema patches in the past but nothing terrible).    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Didn't feel good), PAIN IN EXTREMITY (Really sore arm), PYREXIA (Fever after second dose) and INJECTION SITE ERYTHEMA (Red arm around injection site). In August 2021, the patient experienced COVID-19 (Tested positive for Covid) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid), VACCINATION COMPLICATION (Didn't feel good), PAIN IN EXTREMITY (Really sore arm), PYREXIA (Fever after second dose) and INJECTION SITE ERYTHEMA (Red arm around injection site) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications include birth control pills.  Company comment: This is a spontaneous case regarding a 49-year-old female patient with no relevant medical history who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 33 days and who experienced non serious, AESI, unexpected event of COVID-19 which occurred approximately 6 months after the second dose. Patient developed pain and fever that lasted about 5 days and was treated with Tylenol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-515549, MOD-2022-515567 (Patient Link).; Sender's Comments: This is a spontaneous case regarding a 49-year-old female patient with no relevant medical history who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 33 days and who experienced non serious, AESI, unexpected event of COVID-19 which occurred approximately 6 months after the second dose. Patient developed pain and fever that lasted about 5 days and was treated with  Tylenol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Tongue pain, runny nose. Cough - staccato, difficulty breathing, wheezing. BENADRYL, steroid, Albuterol, EPIPEN. Observation hospital.
This is a spontaneous report received from a contactable reporter(s) (Physician). A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUDESONIDE, start date: 22Mar2022, stop date: 06May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Clinical course includes Patient received vaccine and other medications in 2 weeks. No Known allergies. Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=07May2022, treatment stop date=11May2022, indication=Treatment of COVID-19, administrator route=Other, Adverse event: Paxlovid induced rebound. Worsening, SX 2 days after completion of therapy. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
My son suffers from horrible eczema on his legs, he has a speech delay, and is also working with an occupational therapist due to low sensory awareness. He is currently working with a speech specialist as well.
CRANKY; REDNESS OF EYE; HEADACHE; DIZZINESS; BOTH EYES ARE SWOLLEN AND RED; RIGHT EYE BURNS; VISIBILITY NOT GREAT DUE TO SWELLING OF EYE; CHEEK BONE SWELLING; DIARRHEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included poison oak, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included no illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced visibility not great due to swelling of eye. On APR-2021, the subject experienced cheek bone swelling. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced both eyes are swollen and red. On 08-APR-2021, the subject experienced right eye burns. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced redness of eye. On an unspecified date, the subject experienced cranky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from both eyes are swollen and red, right eye burns, and dizziness, and the outcome of cranky, diarrhea, cheek bone swelling, visibility not great due to swelling of eye and redness of eye was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
This literature marketed report refers to an unspecified number of patients of unknown age and gender. In order to better understand individual variations in persistence of neutralizing antibodies following M-M-R II, the authors conducted an expanded analysis of the data set. They identified patterns of seropositivity and antibody persistence following receipt of M-M-R II, compared antibody kinetic patterns across all three M-M-R II antigens, and estimated the rate of decline in antibody titers over time using regression models, accounting for differences between and within subjects. The authors included 313 participants who received on an unknown dates, the first dose of M-M-R II between 12 to 24 months of age for prophylaxis (dose, route, anatomical location, lot number and expiration date were not reported) and the second dose of M-M-R II on an unknown dates between 4 to 6 year of age for prophylaxis (dose, route, anatomical location, lot number and expiration date were not reported). The mean time between the first and second dose was 3.7 years. Serum samples were collected for antibody testing prior to M-M-R II (baseline) and throughout a 12 year follow-up period (post-vaccination at 1 month, 6 months, 2 years, 5 years, 7 years, 10 years, and 12 years). Antibody testing for rubella and mumps was performed at the end of the 12 year study, and specimens from the same individuals were tested in the same run. For measles, specimens collected through the 10 year post - M-M-R II, visit were tested after completion of that visit. The 12 year post - M-M-R II, measles visit samples were tested after completion of that visit using the same reagents and operators as the other tests. Of 313 patients who received the second dose of M-M-R II, 302 had measles antibody data and 296 had mumps and rubella data for the baseline visit, 1 month post-vaccination, and at least 1 additional follow-up visit. On an unknown dates, 5 patients (2%) became and remained seronegative for measles sometime after 6 months post vaccination; 20 patients  (7%) were seronegative converters for mumps, and 11 patients (4%) were seronegative converters for rubella (drug effect incomplete). The outcome of the drug effect incomplete was unknown at the time of reporting. The authors considered drug effect incomplete to be related to M-M-R II as they stated that the rate of antibody decline was associated with M-M-R II response and baseline titer for measles and age at first dose of M-M-R II for rubella.
Information has been received from a company representative concerning her 11 year old son with no pertinent medical history, drug reactions or allergies who on 16-JUN-2008 was vaccinated in the arm with a second dose of VARIVAX (Oka/Merck). On the same day the patient also received a dose of secondary suspect VAQTA. Other concomitant therapy included Meningococcal vaccine (unspecified) and Tetanus toxoid booster. On an unspecified date the patient developed large red patch on his arm at the injection site. It was reported that no reaction was reported with the first dose of VARIVAX (Oka/Merck). The patient was treated with KEFLEX. At the time of the report, it was unknown if the patient had recovered from the event. The patient went to physician. Additional information has been requested.
From telephone contact with reporting physician, it was stated that an 18 month old female patient received an IPOL, a Tripedia, a Hibtiter and a Prevnar vaccination on 7/24/01. On 7/25/01, the patient developed a local reaction of redness, swelling and irritability. Patient was treated with ibuprofen.
2 month old infant received a dose of Fluzone Quadrivalent in error, no AE.; Initial information received on 21-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a two months old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in error (lot UT6713LA and expiration date not reported) via intramuscular route in the right thigh on 21-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was an actual medication error case due to Inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  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.
The nurse stated child's mother called and said the child was seen in the ER the night the flu vaccine was administered. She had a temp of 104.8 and chills. She was treated and sent home. ADH nurse tried to contact parent but the phone number could not leave a message.
Primary vaccination series.  Dose 2 given at Day 23  - too short of interval by 5 days.    Vaccination will be considered Invalid.  Plan to repeat the dose in 28+ days.  Parents informed.
Patient's arm is red, swollen and warm to the touch. She complained about severe pain on her right arm the night after the injection. Patient presented to the pharmacy 48 hours after vaccination. Informed patient to continue ice/ibuprofen/rest. If not resolved in 24 hours to contact primary care physician.
right eye double vision, hospitalized: received three MRI,s, Ecocardigram, blood draw to rule our autoimmune deficiency (still no results provided).  Scheduled for: m Neuro-pthalmologist, EMG, and Neurology follow up.  Thus far no diagnosis!
Little capsule thing was open; A spontaneous report was received from the patient on 23AUG2022. Additional information was received on 28AUG2022. It described a 67-year-old female patient (height: 154 cm/61 inches, weight: 58.05 kgs/128 lbs) who observed that the "little capsule thing was open" (PT: Product dosage form issue). The patient took the Vivotif capsule (typhoid vaccine live oral Ty21A) [lot number: 3003783, expiry date: AUG2023, item number: 00369401000027, serial number (SN): 9150345807005] for travelling. On 21AUG2022, the patient took the first dose of Vivotif and later went to take her second dose on 23AUG2022 (this morning) and noticed that the little "capsule thing" was open. She stated that she consulted her pharmacist however the pharmacist did not know whether this was significant or not and asked her to consult with the manufacturing company. Furthermore, she confirmed that when she opened the Vivotif box the first time it didn't look like any of the sections were open and did not observe any sign of tampering so she did not know how her second pill opened however she believed it might have stretched while opening the first Vivotif pill. She also confirmed that she did consume the second Vivotif dose that was open. She further confirmed that she did not experience any adverse event after taking the opened second Vivotif dose and also confirmed the capsule itself was intact and was kept refrigerated.  Additionally, it was reported that the patient had taken all four Vivotif capsules by now (as per reporting).  The outcome of the reported event was not applicable.  The patient underwent eye surgery for cataract.   The patient was taking Fluoxetine for anxiety since 2011 and started an unspecified medication one week after eye surgery.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company Comment: It was reported that when a patient took the second Vivotif dose she observed that the little capsule thing was open (product dosage form issue). She confirmed that she did not experience any adverse event after taking the second Vivotif dose. The causality of product dosage form issue is assessed as not applicable to Vivotif .The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that when a patient took the second Vivotif dose she observed that the little capsule thing was open (product dosage form issue). She confirmed that she did not experience any adverse event after taking the second Vivotif dose. The causality of product dosage form issue is assessed as not applicable to Vivotif .The case is considered non serious as per medical assessment.
53 year old male with hx HTN, HLP, anxiety, presents for evaluation of high fever of 105 today, fatigue, weakness, aches, dry cough, sore throat, mild shortness of breath. He started with symptoms 9 days ago and got worse and went to clinic last thursday 9/9/21 and was told he was positive COVID 19 by PCR.  He was concerned due to his high fever so he presented here. He also had intermittant nausea and vomiting, no diarrhea or loss of taste or smell.  He has been vaccinated with Moderna back in february 2021.
This spontaneous report as received from a nurse practitioner via a field representative refers to a 79 year old male patient. Relevant medical history and concomitant medication were not provided. On 06-AUG-2013 the patient was vaccinated with ZOSTAVAX at a pharmacy. Lot number, dose, route and frequency were not provided. On 25-AUG-2013, the patient experienced at t2 distribution rash and was diagnosed with "shingles". The outcome of a t2 distribution rash and was diagnosed with "shingles" was unknown. The reporter causality was unknown. Additional information has been requested.
sore throat;  sneezing;  lot of mucus; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN ( sore throat), SNEEZING (sneezing) and RHINORRHOEA ( lot of mucus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN ( sore throat), SNEEZING (sneezing) and RHINORRHOEA ( lot of mucus). At the time of the report, OROPHARYNGEAL PAIN ( sore throat), SNEEZING (sneezing) and RHINORRHOEA ( lot of mucus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.    Co-suspect product included non-company product LOSARTAN for an unknown indication.    Concurrent medical conditions included Allergy to gold (Allergy to gold salts), Latex allergy, Drug allergy (allergy to lisinopril), Drug allergy (Allergy to Balsam Peru-zinc Oxide), ADD, Hypertension and Perioral dermatitis. Concomitant products included TACROLIMUS MONOHYDRATE (PROTOPIC) for Perioral dermatitis, VITAMIN D3 and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 10-Sep-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and LOSARTAN (Oral) 50 mg once a day. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug was provided by reporter.  concomitant medication include Multivitamin.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Patient initial, demographic details, Allergy (Gold Salts, Latex, Lisinopril & Balsam Peru-zinc Oxide) and current conditions (HTN, facial dermatitis) added. Concomitant medications (Vitamin D3, Lexapro, Losartan, Protopic and Multivitamin) added.
Patient was supposed to receive the pfizer monovalent vaccine as ordered but received the pfizer bivalent vaccine as the first dose.
m arm at about 2-3 inches below the injection site is swelling; arm at about 2-3 inches below the injection site is warm to touch; arm at about 2-3 inches below the injection site is painful; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE SWELLING (m arm at about 2-3 inches below the injection site is swelling), INJECTION SITE WARMTH (arm at about 2-3 inches below the injection site is warm to touch) and INJECTION SITE PAIN (arm at about 2-3 inches below the injection site is painful) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE SWELLING (m arm at about 2-3 inches below the injection site is swelling), INJECTION SITE WARMTH (arm at about 2-3 inches below the injection site is warm to touch) and INJECTION SITE PAIN (arm at about 2-3 inches below the injection site is painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (m arm at about 2-3 inches below the injection site is swelling), INJECTION SITE WARMTH (arm at about 2-3 inches below the injection site is warm to touch) and INJECTION SITE PAIN (arm at about 2-3 inches below the injection site is painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications were not provided.
Patient came in to get intradermal Jynneos vaccine. Vaccinator staff was unsuccessful in attempting to get the bleb or wheal. Notified pharmacy and OK to give next ID dose by another vaccinator. Patient was also ok with this second attempt. Second attempt successful.
Body ache, muscle pain, headache, chills, nausea, vomiting and fever
12/17/2020 patient vaccinated with Pfizer COVID 19 vaccine. A few minutes after  receiving vaccination patient reported feeling very dizzy,weak,lip swelling,  "pressure" and "tingling and swelling" in her throat.  A rapid response was  called.  EpiPen 0.3 mg/0.3mL administered IM into the right thigh.  In ED patient  was treated with Decadron 10 mg IV x1, Benadryl 50mg IV x1, and sodium chloride  0.9% 1 liter x1.  Patient was discharged home after 4 hours of observation and no  further complaints. Patient was instructed to follow up in the family medicine  clinic and take all medications as prescribed.  No follow-up in clinic related to  allergic reaction noted in records.
Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Knee surgery NOS in November 2022.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient had Knee surgery in NOV 2022. She stated, tested positive for COVID in APR or MAY 2022, about 6 months after receiving the vaccine. She does not have vaccine information. All of hers previous doses were Moderna brand COVID-19 vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-746856 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746856:Husband case
Information has been received from a physician concerning a 4-year-old female with acute lymphoblastic leukemia (in remission) who on 16-AUG-2002 was vaccinated with a dose of Varivax. The physician reported that a varicella titer was checked after a course of chemotherapy and was negative for seroconversion. Medical attention was not sought. At the time of this report the outcome was unknown. Additional information has been requested.