chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a little injection site pain; Fluzone HD was administered to a 54 year-old woman; Fluzone HD was administered to a 54 year-old woman; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 54 years old female patient who experienced a little injection site pain (Vaccination site pain) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  This case involves a 54 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ29688, expiry date: 06-Jun-2020), via intramuscular route in the right deltoid on 18-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unspecified date, unknown latency post vaccination, the patient experienced a little injection site pain (Vaccination site pain).  It was an actual medication error due to Inappropriate age at vaccine administration. It was also a case of overdose.  It was not reported if the patient received a corrective treatment.  The outcome of the event injection site pain was not 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.
Headache; Feeling Chilly; I feel tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I feel tired), HEADACHE (Headache) and FEELING COLD (Feeling Chilly) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L201A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 06-Jan-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 (I feel tired), HEADACHE (Headache) and FEELING COLD (Feeling Chilly). At the time of the report, FATIGUE (I feel tired), HEADACHE (Headache) and FEELING COLD (Feeling Chilly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
This spontaneous report was received from a medical assistant and refers to a 2 months old patient of unknown gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The medical assistant reported that on 09-JAN-2018, the patient was vaccinated with a pediatric dose of VAQTA Injection, 0.5 ml, lot # N020689, expiration date 22-OCT-2018, for prophylaxis (strength, route, dose number and anatomical location were not reported). The reporter denied any adverse effect on the patient.
allergic reaction; hives all over body; lips swollen; hands swollen, arm swollen; Arm swollen; eye swollen; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), URTICARIA (hives all over body), LIP SWELLING (lips swollen), PERIPHERAL SWELLING (hands swollen, arm swollen) and PERIPHERAL SWELLING (Arm swollen) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included ROSUVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN LOW) and LOSARTAN for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), URTICARIA (hives all over body), LIP SWELLING (lips swollen), PERIPHERAL SWELLING (hands swollen, arm swollen), PERIPHERAL SWELLING (Arm swollen), EYE SWELLING (eye swollen) and RASH (Rash). At the time of the report, HYPERSENSITIVITY (allergic reaction), URTICARIA (hives all over body), LIP SWELLING (lips swollen), PERIPHERAL SWELLING (hands swollen, arm swollen), PERIPHERAL SWELLING (Arm swollen), EYE SWELLING (eye swollen) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported.
Case's spouse reported that case has a sore throat, cough, fatigue, congestion. Hospitalized 04/08/2022 with COVID induced pneumonia.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 15-JUN-2015, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot number, dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
2PM vax given-en route home 15mins later, gen body motion, slumped forward, no response to verbal stimuli x 10sec; somnolence p/w/dizziness, nausea & h/a; vasovagal response
Shot given 1PM Wednesday, arm and neck sore Wed. Thursday Left arm shoulder neck stiff and sore. Fri whole neck and shoulder stiff
The morning after the shot I got body aches chills and fatigue. I woke up from a nap with my heart pounding. My heart rate was elevated and it did not calm down. I started to have trouble breathing. I was advised by my OBGYN to go to the ER. My heart rate was 100-115 and my D-Dimer level was abnormal. I was given a saline drip and my heart rate was still elevated. My breathing was still a little labored. when I tried to breathe deeply. I was prescribed with a blood thinner for the weekend. I returned for a repeat CT scan. My heart rate returned to normal after about 48 hours. I had not had any symptoms with the first dose. Due Date: 07/17/2021 Pregnancy: First
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 19-SEP-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This case is one of the several received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report.  There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that a 20 month old female vaccinee inadvertently received Fluvirin on 10/24/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received.  Cross reference with: PJP200300957, PJP200400013, PJP200400014, PJP200400015, PJP200400016, PJP200400017, PJP200400018, PJP200400019, PJP200400020, PJP200400021, PJP200400023, PJP200400024.
Patient received Moderna Covid-19 vaccination IM. She developed pruritic lips and a headache within 5 minutes.  Zyrtec, and Benadryl administered PO with good effect.  Patient did endorse anxiety.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: fn6204), in left arm, on 31Mar2021 as dose 2, single (Lot number: ep7533), in left arm, on 18Oct2021 as dose 3 (booster), single (Lot number: fe359), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: ps4989) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE; LOSARTAN HCTZ; VALACYCLOVIR HCL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive; (28Jul2022) Negative; (01Aug2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical information: Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment, also patient had previously received a COVID-19 Vaccine. Patient tested positive for covid on 23Jul2022 and Patient took paxlovid for covid-19 treatment started on 23Jul2022 to 27Jul2022 and Tested negative on 28Jul2022. Started sneezing a lot the evening of 31Jul2022, tested positive again 01Aug2022.
Pt awoke shaking and cranky (possible tonic posturing then jerk-like movements lasting about 5 minutes as per history given to neurologist).  Visual tracking not as optimal since that morning. Pt seen by private MD 08/28 and neurologist on 08/30/04.  Exam normal except for decreased visual tracking. Probable reaction to DTAP per neuro).
The patient received her covid booster in addition to a high dose flu vaccine instead of the standard dose flu vaccine that she should have received. No adverse event has been reported so far.
received Pfizer vaccines on 1/8/21 and 1/29/21. Tested positive for COVID-19 by PCR on 4/21/21.
High fever (103.1 was the highest) beginning Saturday, 10/30, continuing between 101-102.7 throught the night. Hard, hot shoulder at injection site, with red rash spreading over Saturday-Monday morning when I was seen. Swelling in lymph node in armpit of arm where shot was administered. Rotated Tylenol and Ibuprofen, but it was not helping. Tried icing the arm.
The vaccine that expired on 24-April-2022 was administered on 5-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.; no adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 5-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (no adverse event) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 5-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 5-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 5-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.).    No concomitant medications were reported.  On 5-May-2022, the patient received a fourth dose (booster dose)(Lot: 022J21A) of Moderna vaccine. The vial were initially stored in the refrigerator on 5May2022, 6May2022,19May2022, 02Jun2022, 09Jun2022 and 23June2022. vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator. The vial did not undergone any temperature excursions.   No treatment medications were reported.
Pt presented to clinic on 10/29/2018, after receiving flu shot on 10/24/2018, with temp of 100.6, decreased appetite and fluid intake and fussiness x 4 days. Tests done in clinic. Rocephin injection given IM in clinic. Pt F/U in clinic on 10/30/2018, doing better.
This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and gender who on 09-FEB-2015 was vaccinated with an improperly stored dose of M-M-R II (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   On 07-MAR-2023, the patient received Bexsero. On 07-MAR-2023, an unknown time after receiving Bexsero, [the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 07-MAR-2023  The patient received a 7 days expired dose of Bexsero, which led to expired vaccine used. The reporter consented to follow up.
Raised temperature (fever) lethargy, red swollen injection site, cranky (crying). 4 days later onset of high fever (over 103) and lethargy, crying, still red injection site. Fever continues (as does lethargy)
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. Concurrent medical conditions included gestational diabetes and gestational hypertension. Concurrent medications included Prenatal vitamins. On 27 September 2010 the subject received a dose of BOOSTRIX (.5 ml, unknown, left arm). Her last menstrual period was on an unspecified date and estimated date of delivery was on 30 January 2011. The subject was exposed to BOOSTRIX during an unknown trimester. On 27 September 2010, at the time of vaccination with BOOSTRIX, the subject experienced vaccine exposure during pregnancy and prescription dispensing error. The healthcare professional reported that a pregnant subject received a BOOSTRIX inadvertently. The subject received this vaccination in error due to it not being prescribed for her (prescription dispensing error). At the time of the report, no other adverse events occurred. The outcome of the pregnancy was unknown. Follow-up information was received via the patient's physician on 26 October 2010. It was reported that the patient's date of last menstrual period was 25 April 2010 and that conception was normal. She receives prenatal vitamins with DHA. The subject's gestational age at the time of vaccination was 22 weeks. The pregnancy was an intrauterine pregnancy with an intrauterine device (IUD) in place. The IUD was removed on 23 June 2010. Follow-up information was received via a nurse on 13 April 2011. It was reported that conception was normal. The subject experienced a premature delivery on 28 November 2010, at 31 weeks gestation. The male neonate was delivered via cesarean section and weighed 4 pounds and 2 ounces. APGAR scores at 1 and 5 minutes were 08 and 09. No defect were noted, however, the neonate was sent to the neonatal intensive care unit due to the pre-term delivery. The event was not considered to be serious although premature delivery is considered medically serious by GSK.
This is a spontaneous report from a contactable physician. A 66-year-old female patient received PREVNAR 13 lot number and expiration date unknown intramuscular on 01Apr2019 at a single dose for routine pneumonia vaccine. Medical history included low vitamin D level vitamin D 12 level (as reported). It was reported that the patient discovered to have low vitamin D level, vitamin D 12 level for which she was supposed to go on supplements but have not started it. The patient has no concomitant medications. On 02Apr2019, the physician reported a moderately serious reaction to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The physician reported that it caused a very large rash it's almost like 3 inch/ 5 inch long rash and reported that it started 2 days later (as reported) and has become larger after a week. The physician described the rash as itchy and hard. The physician has applied betamethasone cream (treatment) because of the rash and the itching. The patient has not recovered from the events. The physician really believed that rash experienced by consumer is because of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and stated that "Absolutely because, it start in that location and started like within a day, there is no question." The following information on the batch number has been requested.; Sender's Comments:  Considering a plausible drug-event temporal association and the consistency of the event with the known safety profile of the suspect product, a reasonable possibility that itchy rash is related to PREVNAR 13 administration cannot be excluded.
5:40 am 6/2/2021 awakened to cold sweat. 8:00 am unable to keep morning coffee down. 11:00 eat 1/2 bagel with peanut butter, unable to keep it down.  2:00 and after further attempts at water, saltine cracker, unable to keep anything down 11:00 pm, attempt to drink sparkling water,  unable to keep down.    No appetite, inability to keep food down and cold sweats after vomiting each occurrence.    June 3, once again able to tolerate food, energy low I assume from available energy from lack of food, progressive improvement through the day. Self managed care.
Injection site pain; joint pain; muscle pain; severe headache - 10 on the pain scale; fever102 degrees F; CHILLS; fatigue; nausea; vomiting; Fever 99 to 100°F at ER; weakness; dizziness upon standing; feeling horrible; rapid heart beat; difficulty breathing; shallow breaths; deep breathing causes coughing; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS POSTURAL (dizziness upon standing), FEELING ABNORMAL (feeling horrible), PALPITATIONS (rapid heart beat) and DYSPNOEA (difficulty breathing) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID in November that lasted for a couple of months.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Mar-2021, the patient experienced ASTHENIA (weakness), DIZZINESS POSTURAL (dizziness upon standing), FEELING ABNORMAL (feeling horrible), PALPITATIONS (rapid heart beat), DYSPNOEA (difficulty breathing), HYPOPNOEA (shallow breaths), COUGH (deep breathing causes coughing), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (severe headache - 10 on the pain scale), PYREXIA (fever102 degrees F), CHILLS (CHILLS), FATIGUE (fatigue), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (Fever 99 to 100°F at ER). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site pain). At the time of the report, ASTHENIA (weakness), DIZZINESS POSTURAL (dizziness upon standing), FEELING ABNORMAL (feeling horrible), PALPITATIONS (rapid heart beat), DYSPNOEA (difficulty breathing), HYPOPNOEA (shallow breaths), COUGH (deep breathing causes coughing), VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (severe headache - 10 on the pain scale), PYREXIA (fever102 degrees F), CHILLS (CHILLS), FATIGUE (fatigue), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (Fever 99 to 100°F at ER) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Body temperature: 102f (High) 99 to 100°F at ER. On 27-Mar-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On 27-Mar-2021, Heart rate: high (High) Rapid heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.