chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse concerning to unspecified number of patients of unknown age or gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unknown date, the patients' were vaccinated with improperly stored doses of VARIVAX (lot # L011084, expiration date: 01-APR-2017, lot # L003775, expiration date: 04-FEB-2017, lot # K009759, expiration date: 09-JUL-2016, and lot # L019124, expiration date: 27-MAY-2017), (dose, route and anatomical location were unspecified). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
This spontaneous report was received from a currently 48-year-old female patient who was a pharmacist and who referred to herself. The patient's medical history included receiving natalizumab (TYSABRI) and hypersensitivity to this drug. The concomitant therapies included multiple unspecified medications. On unknown dates, when the patient was a child, she was vaccinated with unspecified number of doses of M-M-R II (reported as an unknown MMR series, manufacturer unknown, but M-M-R II could not be ruled out) (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis (reported as routine vaccination). On an unknown date in 2008, the patient developed multiple sclerosis. On an unknown date in 2008, the patient was given a treatment for multiple sclerosis, which included stem cell transplant. It was reported that this treatment wiped out the patient's immunity to everything. On an unknown date, the patient developed urinary incontinence and urinary urgency. The patient sought medical attention. Health Care Professional stated that revaccination was not necessary at that time. It was reported that no treatment was given for the events. No laboratory diagnostics and studies were performed. The outcome of the events multiple sclerosis, wiped out the patient's immunity to everything was reported as not recovered. The outcome of the events urinary incontinence and urinary urgency was not provided. The relatedness between the events and M-M-R II was not provided. Upon internal review, the event of multiple sclerosis was determined to be medically significant.
TOOK VIVOTIF WITH COFFEE; A spontaneous case report was received from a caregiver on 17-Jan-2019 for three consumers.  Based on the information obtained from the caregiver, three individual case safety reports PVX201901-000046 (PVX2019-172; mother), PVX201901-000047 (PVX2019-173; son) and PVX201901-000048 (PVX2019-174; husband) were created and cross-linked in the database.  This case report describes a male consumer who "took Vivotif with coffee". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took a dose of Vivotif with coffee.  The action taken with Vivotif with respect to event "took Vivotif with coffee" was not applicable.  The clinical outcome of the event "took Vivotif with coffee" was unknown.  Company's Comment: The causality of the event "took Vivotif with coffee" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with coffee" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000047: US-PaxVax Berna GmbH-PVX201901-000046:
PT WAS GIVEN FIRST DOSE OF PFIZER IM LEFT ARM.  APPROXIMATELY 3-5 MIN AFTER ADMINISTRATION PATIENT PASSED OUT.  911 WAS CALLED, PT BECAME ALERT, NO EPI-PEN NEEDED, COMPLAINE DOF HEADACHE AND NAUSEA.  SHE USED HER ALBUTEROL INHALER.  BP TAKEN 101/67 PULSE 85.  EMS ARRIVED AND TOOK MORE VITALS.  PT IMPROVED ENOUGH TO WALK TO CAR TO GO HOME FOR OBSERVATION.  MOM WAS PRESENT AND OPTED NOT TO GO TO ER
I had a mammogram the day after my second shot and the results showed inconclusive swelling on the left side. I was vaccinated in my left arm.
The worst night sweats; Shortness of breath; Lost to eat/and not eating like usual; Lost of taste with the lost to eat; Aching; Diarrhea; Nausea; Really bad chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (The worst night sweats), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Lost to eat/and not eating like usual), AGEUSIA (Lost of taste with the lost to eat) and PAIN (Aching) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: VARICELLA ZOSTER VACCINE (Shingles first dose on 9 Mar 2021 and received second dose of Shingles vaccine on 27Mar2021) from 09-Mar-2021 to 27-Mar-2021, PNEUMOCOCCAL VACCINE (Pneumonia vaccines) on 09-Mar-2021 and FLU on 09-Mar-2021. Concomitant products included TAMSULOSIN, INSULIN DEGLUDEC (TRESIBA), EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY), SIMVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL BISULFATE (PLAVIX), FUROSEMIDE (LASIX [FUROSEMIDE]), GLYBURIDE, ISOSORBIDE MONONITRATE, LISINOPRIL, METOPROLOL TARTRATE and FISH OIL for an unknown indication.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced NIGHT SWEATS (The worst night sweats), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Lost to eat/and not eating like usual), AGEUSIA (Lost of taste with the lost to eat), PAIN (Aching), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Really bad chills) and FATIGUE (Fatigue). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, NIGHT SWEATS (The worst night sweats), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Lost to eat/and not eating like usual), AGEUSIA (Lost of taste with the lost to eat), PAIN (Aching), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Really bad chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient had chills at night, but then after a day or so had severe knee pain, so severe that patient had to use a cane for a couple of days.  Patient is otherwise in good health and has no prior knee pain history, etc.
Moderate side effects of headache, stomach ache, nausea, heat and redness at injection site, chills, diaphoresis, muscle aches and joint pain, significant fatigue
developed SOB with Negative work up of COVID 19, symptoms progressed, resulted in hospitalization. There diagnosis of Myasthenia gravis crisis.
Shortness of breath; Loss of voice; Feels like on fire; Neck pain; Left shoulder pain; Pain at injection site (left arm); Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (Shortness of breath), APHONIA (Loss of voice), BURNING SENSATION (Feels like on fire), NECK PAIN (Neck pain) and ARTHRALGIA (Left shoulder pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced DYSPNOEA (Shortness of breath), APHONIA (Loss of voice), BURNING SENSATION (Feels like on fire), NECK PAIN (Neck pain), ARTHRALGIA (Left shoulder pain), VACCINATION SITE PAIN (Pain at injection site (left arm)) and FATIGUE (Fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 2 tablets. At the time of the report, DYSPNOEA (Shortness of breath), APHONIA (Loss of voice), BURNING SENSATION (Feels like on fire), NECK PAIN (Neck pain), ARTHRALGIA (Left shoulder pain), VACCINATION SITE PAIN (Pain at injection site (left arm)) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes Multivitamins with collagen.
inadvertently administered with 1.0 ml of the vaccine; inadvertently administered with 1.0 ml of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) and INCORRECT DOSE ADMINISTERED (inadvertently administered with 1.0 ml of the vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A,) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) and INCORRECT DOSE ADMINISTERED (inadvertently administered with 1.0 ml of the vaccine). At the time of the report, ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) and INCORRECT DOSE ADMINISTERED (inadvertently administered with 1.0 ml of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Pt had a syncopal episode w/ associated dizziness.  Vitals: 13:53 139/83, 77, 17, 98.7F, 100% -- > 14:07 126/79, 68, 16, 98.2F, 97% Ammonia inhalant used @1351 Pt provided water and crackers.  Pt denies hx of fainting.  Pt AxO x4, breathing fulland easy.  VSS.  Pt responding to stimuli appropriately.  Pt stable and released from the vaccination site.
pt recvd vax; pt devel fever, chills, jt aches x 6 hrs; no tx;
SORE ARM; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, fever and chills was not reported. This report was non-serious.
No additional adverse event; patient was administered MMR II which was reconstituted with STERILE DILUENT which had expired.; patient was administered MMR II which was reconstituted with STERILE DILUENT which had expired; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 24-FEB-2020, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (recombinant human albumin) (M-M-R II) for prophylaxis (lot number R030809, has been verified to be a valid lot number, expiration date reported and validated as 24-OCT-2020) (concentration, dose, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).  The nurse informed that an expired sterile diluent ( lot number N026287 has been verified to be a valid lot number, expiration date reported and validated as 07-FEB-2020) was used for the reconstitution of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (recombinant human albumin) (M-M-R II) (expired product administered, product preparation error).   No additional adverse event was reported.  No further information provided.
Pt came to ER with cough and exposure to Covid, onset 1 day prior.
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a Consumer (non-health care professional) via phone. This case is linked to case 2018SA250332 (same reporter). This case involves a 50 years old patient (gender not reported) who received 0.5 ml expired dose of FLUZONE QUADRIVALENT (frequency once, lot number UI852AD, expiry date and route of administration were not reported) in right deltoid on 04 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. Reporter thought that they sent back all of the out dated vaccines. But, there must have a bottle left. Patient had not reported any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Pain at injection site, swelling and redness (1/23/2021 12:00 am); Chills and fever 1/23/2021 1:30 pm; Lightheadedness 1/23/2021 5:30 pm
itching at sight of Abrysvo vaccine ( right arm) and itching of face that has lasted since 24 hours after vaccine administration ( today is 9-17-2023) Patient states itching is not as bad today as it was. Recomended some cetirzine or loratadine to help with itching.
Hypersensitive reaction; Rash in her face and body; This spontaneous case was reported by a physician and describes the occurrence of HYPERSENSITIVITY (Hypersensitive reaction) and RASH (Rash in her face and body) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitive reaction) and RASH (Rash in her face and body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Hypersensitive reaction) and RASH (Rash in her face and body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided
Weakness, headache, lethargic, dark circles around eyes Diarrhea, vomiting and muscles weakness.  Flu like symptoms.
Numbness in mouth area. Tingling in face and hands. Pt was given CLARITIN.
17 year old patient was given FluBlok which is indicated for patient's 18 years or older
parent reports excessive crying in spells of 3hr or longer since evening of 16APR98;also cried the entire noc per parents first 2 nights & fever as high as 102 since 18APR98, cough, runny nose & mild diarrhea;
pt had a positive COVID test on 9/23/21 and again showing positive on 10/10/21; pt passed away at home; attempted to get medical records from physician who signed death certificate, but received a phone call from the office stating the pt had never been seen by the dr prior to her passing; death certificate sent per VAERS request
Swelling in left arm and armpit; Swelling in left arm and armpit; Pain at the injection site; This spontaneous case was received on 24-Aug-2021 from a pharmacist via regulatory authority (reference number: SEQW21-01687) and concerned a 51-year-old, female patient.  The patient had no relevant concurrent conditions. The patient's historical vaccine included Shingrix (varicella zoster vaccine rgE (CHO)) in 2020 after which the patient experienced swelling in left arm and armpit along with pain at the injection site. When the patient got anything in her right arm, she had no symptoms. The patient was not taking any concomitant medications.  On 22-Aug-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location: left deltoid and route of administration: not reported) as influenza prophylaxis. The batch number reported was P10035097 (Seqirus batch number closest match: P100350397) and expiry date was 21-Jun-2022.  On 23-Aug-2021, one day after receiving Afluria Quadrivalent, the patient experienced swelling in left arm and armpit. The patient also experienced pain at the injection site. The patient was treated with Advil (Ibuprofen) and ice.  The outcome of all events was unknown.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: A 51-year-old patient was vaccinated with Afluria Quadrivalent. One day after receiving Afluria Quadrivalent, the patient experienced vaccination site pain, lymphadenopathy and peripheral swelling (reported as swelling in left arm and armpit). Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: A 51-year-old patient was vaccinated with Afluria Quadrivalent. One day after receiving Afluria Quadrivalent, the patient experienced vaccination site pain, lymphadenopathy and peripheral swelling (reported as swelling in left arm and armpit). Causal role of the suspect vaccine is assessed as possibly related for all events.
On 12/21/2021 I had cold symptoms, runny nose, no fever, coughing, congestion. On 12/27/2021 I got tested for Covid and it came back positive. I only took Mucinex. I still have some cold symptoms, because I have allergies year round, it is hard to differentiate each from one another. I still have a runny nose.
This spontaneous report was received from a physician reporting to himself a 86 year old male with allergy on amoxicillin and a history of shingles (three times). In May 2010 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX, (Lot number, expiration date and dose was not reported). In April 2013 the patient experienced shingles located in his right eye. The patient sought medical attention and received antivirals treatment. The patient queried should he continue using antivirals, after getting the shingles for the fourth time. The outcome of shingles in right eye is unknown. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Patient developed tingling and red rash on chin within 10-15 minutes after administration. Administered 50mg liquid BENADRYL & observed - no further reaction as of 3 PM.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date of 2014, reported as since 14-OCT-2014, the unknown number of patients were vaccinated with RECOMBIVAX HB (dose, routte, lot# and expiration dates were not provided) for prophylaxis that had been improperly stored. No concomitant medications were reported. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was retrieved via a search of scientific literature on 14 November 2011. The reporter for this case is the same as for case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods: Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results: CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A six month-old patient (gender not reported) with a history of eczema had received on an unspecified date the following vaccines: IPV (manufacturer, lot number, route and site of administration not reported), HEP B (manufacturer, lot number, route and site of administration not reported) and PCV7 (manufacturer, lot number, route and site of administration not reported) and seven days later, developed a pyogenic abscess. The causality was assessed as probably related. No further information was available at the time of the report. Outcome was not reported. Documents held by sender: None.
10Dec96 pt recv 1 dose vax. 21Jan98 pt exp lesions on thorax,back & abdomen. Pruritus & low grade fever. Seen by MD 30Jan98 & pt had numerous healed & crusted lesions. Another pt reported w/similar exp WAES98020563
Patient at first seemed sleepy and quiet.  He developed a fever of 101-103 which lasted for four days.  On day two of the fever he also developed a measles rash on the roof of his mouth.  This rash lasted for 2-3 days.  The fever and rash have resolved but he is still very irritable and has poor appetite.