chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse forgot to reconstitute ipv/dtap with him in pentacel and used diligent instead with no reported adverse event; Initial information received on 30-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Child and unknown gender patient who experienced nurse forgot to reconstitute ipv/dtap with him in pentacel and used diligent instead with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Nov-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in unknown administration site for Immunisation.  On 30-NOV-2022 the patient developed a non-serious nurse forgot to reconstitute ipv/dtap with him in pentacel and used diligent instead with no reported adverse event (vaccination error) (latency : same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Nurse forgot to reconstitute ipv/dtap with him in pentacel and used diligent instead with no reported adverse event).  At time of reporting, the outcome was Unknown for the event nurse forgot to reconstitute ipv/dtap with him in pentacel and used diligent instead 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.
Received injections @ 0900 on 12/15/05. Fussy around 1500. Bilateral thighs red and warm to touch, R>L. Vomiting x1 @ 1730. Lethargic and irritable. Would not move legs.
It was reported that a male patient received a Tripedia vaccination on 11/16/1998. According to the reporter, the child experienced an immediate injection site reaction characterized by redness and swelling, fever and vomiting. He recovered after an unspecified period of time.
Tender, welted area surrounding 1x3 inch red rash. First noted evening of day following injection, persisting into evening two days following injection, no treatment required.
Patient was hospitalized due to pneumonia 6 days after receiving 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Patient was hospitalized due to pneumonia 6 days after receiving 1st dose) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included Lung infection NOS. Concomitant products included IMIPRAMINE for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Apr-2021, the patient experienced PNEUMONIA (Patient was hospitalized due to pneumonia 6 days after receiving 1st dose) (seriousness criteria hospitalization and medically significant). On 01-May-2021, PNEUMONIA (Patient was hospitalized due to pneumonia 6 days after receiving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included Antibiotics and Steroids.  Very limited information regarding this event has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding this event has been provided at this time. No follow up is possible.
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. The pharmacist reported that those unspecified patients may had received improperly stored GARDASIL (lot #, dose, route not specified) on an unknown date. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician and a 22 year old female patient with genital warts. The patient's medical history included Lyme disease. On 19-JAN-2013, the patient was vaccinated with the first dose of GARDASIL (Lot # not reported). Concomitant therapies included ethinyl estradiol, ALTAVERA. The physician and the consumer reported that on 29-JAN-2013, the patient experienced aggravation of genital warts. The patient reported that she increased a rapid increase in genital wart growth within 10 days of vaccination. The patient did not receive treatment for the adverse event. The outcome of aggravation of genital warts was reported as not recovered/not resolved. Additional information has been requested.
Patient began to feel light headed about 5 minutes afterward.  She came up to the counter to tell us and by the time we got to her with a chair she fainted into the technicians arms.  We sat her down and she was only unconscious for about 3 seconds.  We called 911.  She asked for some water and we also gave her some OJ.  By the time the paramedics got here she was pretty much back to normal and said she knew it was because she was anxious.  She signed a refusal for the paramedics and sat for a few more minutes before she said she felt fine to leave.
They have used a 5/8 inch needle so she believes it was administered subcutaneously; A spontaneous report was received from a healthcare facility staff member concerning a 51-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced incorrect route of product administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) in the right arm for prophylaxis of COVID-19 infection.  On 30-DEC-2020,  it was reported that a 5/8 inch needle was used and the reporter believed that the vaccine was administered subcutaneously.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event,  incorrect route of product administration was considered recovered/resolved.; Reporter's Comments: This report refers to a case of inappropriate route of vaccine administration for mRNA-1273 (lot/batch: 026L20A)  with no associated AEs.
Information has been received from the mother  concerning her daughter (age not provided) who an unspecified date was vaccinated with a first dose of GARDASIL. Subsequently, the patient passed out a couple of times after receiving the first dose of GARDASIL. Subsequently, the patient recovered. Her sister also experienced adverse events after being vaccinated with a first dose of GARDASIL, reported in WAES # 0803USA05046. Additional information has been requested.
Flare of psoriatic arthritis (swelling, hot joint, pain, reduced range of motion) in right elbow
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756555A, A0756557A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Patient had a previous dose of Janssen SARS-COV 2 vaccine on 03/12/2021. Patient tolerated Moderna vaccination well. No adverse reaction or health concern.
9 hours late, woke up with intense chills, temp that got up to 103, eventually turned in feeling of body on fire
patient received Pfizer vaccine and within 5 minutes of administration had a syncopal episode while seated. Patient was diaphoretic and clammy during monitoring period. Vitals 147/87, HR 50, Spo2 100%. Patient reports prior syncopal episodes during blood draws and acupuncture as stated by girlfriend. Was sent to to Urgent care onsite for further monitoring.
Breakthrough case admission after 3 vaccines MOderna 1/25/21 Lot# 027L20A;  Moderna 2/22/21 Lot# 043L20A;  Moderna 12/13/21 Lot# 058H21A
redness in arm; hot itching area; hot itching area; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema of extremities, feeling hot and pruritus. On an unknown date, the outcome of the erythema of extremities, feeling hot and pruritus were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, feeling hot and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had redness, hot, itching area covering an 3 X 6 long, it lasted 5 days. The reporter asked was this normal.  The patient felt fine the first day of the shot but then her whole arm was red, hot and itching. The reporter did not consent to follow up.
feels very tired after vaccination.; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feels very tired after vaccination.) and PAIN IN EXTREMITY (Sore arm) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feels very tired after vaccination.) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (feels very tired after vaccination.) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This is a spontaneous report from a contactable Nurse. A 71-year-old female patient received PREVNAR 13 (lot Number: R49357, Expire Date: 31May2018) as routine prevention on 31May2017 10:00 via intramuscular route in the left deltoid, at 0,5ml single dose for immunization. On the same date the patient also received the first dose of TDAP IMMUN (lot U5626AA, exp. date 05Apr2019, Manufacturer: Sanofi) via intramuscular route in the right thigh. Concomitant medication included Fish oil at 1000 mg, 3x/day for High cholesterol, ongoing, glucosamine for joint issues at 50 mg, 1x/day, loratadine for Allergy at 10 mg, daily, ongoing and calcium as supplement, ongoing. Relevant medical history included Diabetes, Hypertension, High cholesterol diagnosed for at least 5 years, kidney cancer. On an unspecified date in Jun2017 the patient experienced acute left arm redness, swelling and pain and she did not feel well. The outcome of the events was not recovered.
Here with mom who reports that about a day after the shots, he broke out in spots (first on L arm, and then spread arms, legs, face) and low-grade temp about the day after his shots (which included MMRV). Overnight, the fever got up to 103.8 and again up to 103 last night. During the day, low-grade tactile temp. Mom appied calamine lotion, thinks maybe it has been making him less miserable. No scratching, but she worries that "he has an itch he doesn't know to itch" Has been giving him Tylenol, which helps a bit, but both haven't slept the last couple days.
Patient called around 230pm  to report to following adverse event.  After leaving pharmacy she experience numbing in the face.  There was no inflammation on the face and no hives.  Told her to follow up with PCP right away and if she cant  get a hold of doctor to see ER.   Patient will follow  up with PCP.
administered Tdap, Menactra, Hep A IM and drew up and administered sterile diluent solution SC instead of diluting varicella vaccination solid and then administering.  immediately upon administration of sterile diluent, pt. complained of lightheadedness, was too dizzy to walk.  Sat in chair and vomited x2.  Several minutes later, pt. stated sxs were gone.  1/2 hr later, patient left clinic with family.
RECEIVED PFIZER VACCINE AFTER  BEING FULLY VACCINATED WITH  JANSSEN COVID 19 VACCINE; This spontaneous report received from a consumer concerned multiple patients of unspecified age and sex.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:unknown ) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination.  On an unspecified date, the patient experienced received pfizer vaccine after being fully vaccinated with janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received pfizer vaccine after being fully vaccinated with janssen covid 19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905638 and 20210909555.
baby given the wrong vaccine, Afluria 3yr + instead of the Fluzone for 6m and above.  No reactions were observed after baby received the vaccine.
This spontaneous report was received from a registered nurse and refers to a 20 month old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 04-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 25 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Had adverse reaction; More than 36 days from fist vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Had adverse reaction) and PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Had adverse reaction) and PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination). At the time of the report, ADVERSE REACTION (Had adverse reaction) and PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
starting the day after vaccination, red swollen area about 3 inches tall and 2 inches wide. hurt to touch and swollen. advised pt to take pain medicine (aleve) and let us know if things get worse & contact dr office
Redness, hot to touch L deltoid. Rx: Cephalexin; 3 days from immunizations.
rt arm red, warm, swelling around elbow was painful on Saturday;feels better now but moving up arm;3NOV96 inc pain-swelling;4NOV96 no pain today, swelling dec to being sl swollen;
Child arrived at office right arm red, edematous with 3 small blisters noted upper arm. Pt admitted hospital for cellulitis vs vaccine reaction.
This is a spontaneous report from a contactable medical assistant reporting on behalf of a medical practice. This medical assistant reported similar events for 3 patients. This is the third of 3 reports. A 83-year-old female patient received PREVNAR 13) Lot # R45377, Expiry Date Dec2017) via an unspecified route of administration at 0.5 ml, single in the right arm on 22Dec2016 for immunization, at physician office. Relevant medical history was none. Concomitant medications were not reported. No additional vaccines were administered on same date or within 4 weeks. In Dec2016, about 2 days after receiving the vaccine, the patient experienced redness, swelling, heat and pain at the injection site.  He went back into the office, one week after vaccination and was treated for cellulitis. The patient recovered on an unspecified date.; Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the temporal relationship. 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.,Linked Report(s) : US-PFIZER INC-2017005456 Same reporter/product/events, different patients;US-PFIZER INC-2017005458 Same repoter/product/events, different patients.
start to have some discharge and have been a month and still; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of DISCHARGE (start to have some discharge and have been a month and still) 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.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCHARGE (start to have some discharge and have been a month and still). At the time of the report, DISCHARGE (start to have some discharge and have been a month and still) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided/unknown by the reporter Treatment information was not provided.
Patient called stating that about an hour after she recevied the vaccination her arm started to be weak and felt numb, her hand is shaking. Asked patient to take MOTRIN and put ice pack on the arm.
Initial report received from the lawyer on 18 Dec 2009: The patient was vaccinated with FLUVIRIN suspension for intramuscular injection 2009-2010 formula on 02 Sep 2009. The patient presented with GUILLAIN BARRE syndrome after receiving the vaccine and was hospitalized on an unspecified date. The outcome of event was not reported. Following internal review on 12 Apr 2010 of the data received on 18 Dec 2009, it was noted that suspect vaccine was incorrectly reported as FLUVIRIN. The patient received seasonal FLUVIRIN vaccine and not the pandemic one. Therefore, drug coding was changed to FLUVIRIN seasonal 2009/2010. Follow-up report received on 03 Apr 2010: Onset of the incident was about 2-3 weeks after the flu injection.
Multiple scattered vesicles varying sizes, some crusted with yellow along trunk, hands, face and scalp.
Varivax vaccine breakthrough. Diagnosed with Varivax 6-14-07. Had about 40 lesions. No fever.
Pt was admitted for fall, elevated troponin, ck total possible due to demand ischemia, rhabdomyolysis, acute on chronic respiratory failure possible due to covid 19 infection treated with respiratory protocol, decadron abx, anti tussive. Pulmonology recommend continue current medications. Currently on 2 lpm oxygen, uses oxygen at home as needed. Rhabdomyolysis improving, ck total trending down; Cardiology recommend elevated troponin possible demand ischemia, continue cardiac medications. Therapy recommend post acute rehab which pt declined.  Acute on chronic hypoxic respiratory failure resolved, covid 19 infection, pneumonia improved, finished abx course. Rhabdomyolysis improved. Pt was discharged home stable condition, script for decadron given upon discharge.
after 30 minutes approximately of receiving the shot Covid Madura vaccination I began having a loud humming in both ears and this has continued and has not stop and I just received my second shot of the Madera vaccination and ringing still continues never stops.I have never had this condition before whatsoever, and I?m very concerned.
Pruritus whole body on day 8 followed by erythematous rash and patches, Pruritus lasted 4 weeks with hypersensitivity of skin
Flushing /sweating, dizziness.  Pt has a fear of needles (info not disclosed at the time of vaccination).  VSS.  Patient stable and released from vaccination site.
-No adverse event. -Gave monovalent for 3rd dose vs. Bivalent