chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nauseous) 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 13-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 HEADACHE (headache) and NAUSEA (nauseous). At the time of the report, HEADACHE (headache) and NAUSEA (nauseous) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant product use was not provided by the reporter. No treatment information was provided.
received an expired Fluzone Quadrivalent 0.25 ml, no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient who was inadvertently vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (frequency once) lot UT6315RA, expiry date: 30-Jun-2019 via intramuscular route in an unknown administration site on 07-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to expired vaccine used.  At the 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 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.
made me sick hospital for 2 days; Secondary infection; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced sickness (serious criteria hospitalization) and secondary infection. On an unknown date, the outcome of the sickness and secondary infection were unknown.   It was unknown if the reporter considered the sickness and secondary infection to be related to Flu vaccine.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not reported. The patient was sick and in hospital for 2 days. The patient also experienced secondary infection due to shot. The follow up was not required.
difficulty breathing; difficulty sleeping; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) and INSOMNIA (difficulty sleeping) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2022, the patient experienced DYSPNOEA (difficulty breathing) and INSOMNIA (difficulty sleeping). At the time of the report, DYSPNOEA (difficulty breathing) and INSOMNIA (difficulty sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2022, Heart rate: elevated (abnormal) elevated.         Concomitant medications was not provided by the reporter.  Treatment information was not provided.
Redness and swelling at injection site and surrounding area noticed ~day 1. Today is day 10 and the redness and swelling (same shape/area)  and now warmth to touch (noticed warmth on day 9) have not gone away. No other symptoms of note.
11/12/2023- pain, itching , swelling, redness. soreness and warmth at injection site.  Continues today.
Fever; chills; aches for 24 hrs; swollen lymph nodes under left arm; sore, swollen lymph node under myleft arm for several day; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 the patient experienced fever, chills, aches for 24 hours and a sore, swollen lymph node under left arm for several days. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, aches for 24 hours and a sore, swollen lymph node under left arm was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever and headache.  Pain at vaccination site. Allergy on the body -> Allegra 18D , beclomethasone dipropionate.
1st dose 2 years ago and did not follow up due to the pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 05-MAY-2022 Reporters comment: The patient received their 1st dose of Shingrix, 2 years ago from the date of reporting and did not follow up due to the pandemic. The reporter asked, if they need to restart the series or they could get the 2nd dose now. The reporter consented to follow up.
Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. No treatment was reported.
Shot given 9/3/19, hives started 9/6/19 no fever and mild itching with hives over entire body but more pronounced on hands, mom went to clinic 9/14 and was told hives were from vaccines. Put on benadryl for 3 days, resolved. Saw patient today no hives or rash seen. No other complaints or adverse effects
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Mar-2021 at 4:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 4:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 87.38.  No concomitant medications were reported.  Batch number 014M20A administered on 03-Mar-2021 underwent temperature excursion with temperature range was 51, 34 and 35 degrees Fahrenheit from 09:00 AM, 10 AM and 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Number of vials sent to clinic were 20. Total doses given for the day 200.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
dose 1 on 17Mar2021 and dose 2 on 08May2021; Crohn's disease aggravated; Bowel incontinence; Oral intake reduced; Sleep unwell; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 08May2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. Relevant medical history included: "Diarrhea" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Route of Admin: Intra-muscular, Therapy Dates/Duration: 17Mar2021), administration date: 17Mar2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: CROHN'S DISEASE (medically significant) with onset 2021, outcome "not recovered", described as "Crohn's disease aggravated"; ANAL INCONTINENCE (non-serious) with onset 2021, outcome "unknown", described as "Bowel incontinence"; HYPOPHAGIA (non-serious) with onset 2021, outcome "unknown", described as "Oral intake reduced"; POOR QUALITY SLEEP (non-serious) with onset 2021, outcome "unknown", described as "Sleep unwell"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08May2021, outcome "unknown", described as "dose 1 on 17Mar2021 and dose 2 on 08May2021". The patient underwent the following laboratory tests and procedures: weight decreased: (Dec2021) 15 lbs. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of crohn's disease, anal incontinence, hypophagia, poor quality sleep. Clinical course: The patient was treated with PREDNISONE. It was reported that, on an unknown date patient experienced Leakage In The Morning. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of Bowel Accident, Could Not Eat Much and Could Not Sleep Well was not provided. The reporter's causality for the event(s) of Crohn's Disease Flare Up and Leakage In The Morning with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a possible causal relationship between the reported events crohn's disease, anal incontinence, hypophagia, poor quality sleep and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
got COVID; felt "funnier than I usually do"; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt "funnier than I usually do") and COVID-19 (got COVID) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced FEELING ABNORMAL (felt "funnier than I usually do"). On 20-Oct-2022, the patient experienced COVID-19 (got COVID). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt "funnier than I usually do") and COVID-19 (got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2022, SARS-CoV-2 test: Positive.         Concomitant product use was not provided by the reporter. Patient interpreted that COVID-19 infection may happened while Patient sat for half an hour for  the 5th dose . Patient past vaccination included Moderna Vaccination.
2.25 X 2.25 in erythematous rash with halo reaction around. Slight itchy. Started w/ a small red mark went to sleep + woke up today enlarged. Not overly painful unless deep pressure. No induration. Had done ice prior to exam. Area marked. Gave 10ML benadryl. Recommended Q6-8hr, ice, ibuprofen if area of redness increasing or not improving then to call.
This spontaneous report was received from a consumer referring to herself as a child White female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, lot/batch # and expiration date were not reported) as prophylaxis. The patient reported that the vaccine she was gave was not good, but she never caught measles or mumps and only had 2 pock marks from chickenpox. The outcome of varicella was unknown. The reporter did not provide a causal assessment between varicella and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).
About 1 week after injection, Large swollen red  spot about 3 inches below injection site
Within 2hrs of receiving vaccine patient experienced soreness and swelling of left scapular area adjacent to site of injection; persistent for 6 wks with swelling, tenderness of muscle.
Numb, blue and swollen finger tips and numbness in toes. Toes ache as well.
this morning mom noticed red lt arm APAP given by mom a/immun yesterday & last noc AAO-no fever reported;
On office visit 6/4/04 mother states she usually gets big bumps like bug bites after her immunizations, was with her grandmother yesterday around 9:30PM who said she shook all over, eyes rolled back in head and was unconscious 3-5 min went to ER and was told it could be from immunizations. Mom states she had a subj. fever on the way to ER.
FATIGUE Narrative: FEVER,MYALGIA,ARTHRALGIA LASTED ONE HOUR. FATIGUE STARTED THE NEXT DAY AND LASTED ALL DAY
lost blood through his stool; weight loss; feeling bad; tongue turning white; being unable to eat food because it tasted bad; being unable to eat food because it tasted bad; his arm is still hurting; he does not think he was given the correct vaccine; Consumer also states they did a biopsy of his back to see if he had cancer; This spontaneous report was received from Consumer and refers to himself, a 67-year-old (also reported as 68-year-old) male patient.  The patient's medical history was not reported. The patient's concurrent conditions included hepatitis C. Concomitant medications included metformin, vitamins, acetylsalicylic acid (ASPIRINE) and composition unspecified (PENTAZOLE).   On 29-SEP-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #T040202, expiration date: 11-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided).  On 01-OCT-2021, 2 days after this vaccine, he started feeling bad, he lost blood through his stool, experienced weight loss and he had to be given 2 units of iron. He also had a biopsy of his back to see if he had cancer. He went to the emergency room for these symptoms, and they referred him back to his primary care physician. He was given pain medication in the emergency room as treatment. He was also in and out of the emergency room and asked to see a specialist which was refused. He reported his tongue turning white and being unable to eat food because it tasted bad, and he had to spit it back out. His arm was still hurting and he got the vaccine over a year ago. He stated over and over that he did not think he was given the correct vaccine. He went to the doctor's office for a flu shot and signed for the flu shot. A young woman came in with 2 syringes and because he had Hepatitis C when he was 21 or 22 years old, he assumed the second shot was a Hepatitis C shot. The doctor's office forged his signature for the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shot as the young woman took his paperwork from him and when it was brought back to him it was different. He did not consent to receive a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shot. This shot almost killed him. He states he is trying to find a lawyer with the intent to sue the doctor's office for giving him the wrong vaccine that he did not consent to. At the time of reporting, the patient had not recovered from the event of feeling bad, lost blood through his stool, weight loss, biopsy of his back to see if he had cancer, his arm is still hurting. The outcome of tongue turning white, being unable to eat food because it tasted bad.   The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.   Upon internal review, the event lost blood through his stool was determined to be medically significant.
Vaccine exposure before pregnancy; Patient received vaccine after expiry date; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) and MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On an unknown date, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved. At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) and MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) to be possibly related.    The pharmacist stated in the questionnaire that the patient stated yes for could be pregnant or become pregnant in the next month. The pharmacist was unaware if the patient was taking medication and if the patient had the side effects. No concomitant and treatment medication were provided Company Comment: This is a case of expired product administered for this 28-year-old, female patient with no relevant medical history, who experienced maternal exposure before pregnancy following administration of the third dose of the Moderna COVID-19 Vaccine. No associated adverse event was reported. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This is a case of expired product administered for this 28-year-old, female patient with no relevant medical history, who experienced maternal exposure before pregnancy following administration of the third dose of the Moderna COVID-19 Vaccine. No associated adverse event was reported. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
A spontaneous report has been received from a Health Professional concerning a female patient, who had been receiving FLUMIST Quadrivalent, 0.1 ml in each nostril. FLUMIST Quadrivalent started during 2011. It was reported that the patient experienced wrongful administration . The outcome of the event of wrongful administration is unknown. The report was considered to be to non-serious. The reporter and company physician considered that there was no casual relationship between wrongful administration and QLAIV.