chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wrong vaccine/monovalent received instead of bivalent; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B.) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Dose 1), COVID-19 VACCINE (Booster dose) and Pfizer COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications was reported. The reporter was trying to find out if her children were given the monovalent or bivalent. She thinks they were given the wrong vaccine at the pharmacy. The pharmacy says they gave the children the monovalent, but they were scheduled for the bivalent vaccine. Her 3 children received two Pfizer doses and a booster.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660584, US-MODERNATX, INC.-MOD-2022-660593 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660584:Patient 1 US-MODERNATX, INC.-MOD-2022-660593:Patient 2
No adverse effects reported; received improperly stored ROTATEQ between 03-OCT-2019 and 28-OCT-2019; This spontaneous report as received from a Vaccine Coordinator refers to a 9 week old female patient.  The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.   On 11-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided) (lot #S000961 had been verified to be valid lot number; expiration date 19-OCT-2020) (product storage error). The  temperature  excursion was above 9 degrees Celsius (C) (0.6 C, multiple) for a time frame of 5 hours. There were no previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA016835:
urinary frequency; urinary urgency; chills; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (urinary frequency), MICTURITION URGENCY (urinary urgency) and CHILLS (chills) 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 24-Feb-2021, the patient received second 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POLLAKIURIA (urinary frequency), MICTURITION URGENCY (urinary urgency) and CHILLS (chills). At the time of the report, POLLAKIURIA (urinary frequency), MICTURITION URGENCY (urinary urgency) and CHILLS (chills) outcome was unknown.            No concomitant medications reported.  Treatment medications was not provided by the reporter   Reporter did not allow further contact
Patient was seen in Urgent Care 1/30/07 for croupy cough, strep throat and unexplained rash on his legs and face. He had a few pox on 1/29/07. He was put on amoxicillin on 1/30/07 for strep throat. On 1/6/07 mother was concerned by the petechiae on his body and called Dr. He was admitted to Hospital on 1/6/07 and placed in ICU with diagnosis of Idiopathic Thrombocytopenia. He has 3 days with Gamma Globulin.  3/22/07 Received medical records from hospital which reveal patient experienced petechia, oral bleeding & chicken pox.  Chicken pox & nonproductive cough startedapprox 1 wk prior to admit.  Tx w/acyclovir at clinic.  Developed petechiae over legs 1 day prior to admit & also dx w/strep throat.  Tx w/antibiotics. Developed petechiae on ears & had gum & nose bleeding. Admitted to hospital 2/6/07-2/11/07.  Admit exam noted nose bleed, bleeding gums & left ear pinna w/bruising, cough & congestion.  Vesicles noted on trunk, chest, neck, back & mouth in various stages of healing.  Petechaie noted on legs, genitals, stomach, chest.  Throat had erythema & petechia.  In PICU for first 3 days then transferred to peds floor.  Tx w/IVIG x 3, antibiotics & IVF hydration.  Consults obtained from ID, Heme/Onc.  Developed vomiting on 2/10 which resolved by 2/11 d/c date.  D/C exam revealed left eye scleral hemorrhage & bruising on gums w/erythema of tonsils.  D/C to home on continued antibiotics for full 10 day course & f/u w/n 2-3 days for labs. Final DX: ITP secondary to Varicella (classroom outbreak) & strep pharyntitis. 3/31/2010 Follow up: Mom clarified that he still is cernemic and has to take vitamin with iron. His platelets returned to normal range.
Information has been received from a physician via company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 28-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 24-FEB-2017) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine has six temperature excursions: 1172, 80, 336, 168, 24 and 416 hours respectively. The lowest recorded temperatures were 30 and -3. The highest recorded temperature were 49, 47 59 and 48. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several received from the same reporter. Additional information has been requested.
No adverse event; received a Moderna vaccine on 12Jun2023 vaccine Lot 017H22A/it had the same LOT number as the dose he received on Oct2022/after researching they told him that lot expired on 29May2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine on 12Jun2023 vaccine Lot 017H22A/it had the same LOT number as the dose he received on Oct2022/after researching they told him that lot expired on 29May2023) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (had a mild case of Covid in the middle of 2022.) in 2022.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine on 12Jun2023 vaccine Lot 017H22A/it had the same LOT number as the dose he received on Oct2022/after researching they told him that lot expired on 29May2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine on 12Jun2023 vaccine Lot 017H22A/it had the same LOT number as the dose he received on Oct2022/after researching they told him that lot expired on 29May2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine on 12Jun2023 vaccine Lot 017H22A/it had the same LOT number as the dose he received on Oct2022/after researching they told him that lot expired on 29May2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient saw the card and it had the same lot number as the dose patient received on Oct-2022. No treatment information was provided.
upper arm hurt; feel a lot lousier than with the first dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and feeling bad. On an unknown date, the outcome of the pain in arm and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm and feeling bad to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient experienced upper arm hurt and felt a lousier with the first dose of Shingrix. The case has been linked with the case US2019AMR084199, reported by same reporter for same patient.
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 2-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 04-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
joint pain; Severe body ache/pain; itchiness; chills; migraine; fever; headache; This is a spontaneous report from a contactable consumer(patient). A 22-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration, administered in Arm Left on 17Apr2021 14:00 (Age at Vaccination 22-years-old) as DOSE 2, SINGLE for COVID-19 immunization at Pharmacy or Drug Store. Medical history included epilepsy from an unknown date and unknown if ongoing, allergies Cats. Concomitant medication was not provided. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ep6955) via an unspecified route of administration, administered in Arm Left on 27Mar2021 14:00 (Age at Vaccination 22-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, has the patient did not test for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination. On 18Apr2021 17:00 the patient experienced joint pain, severe body ache/pain, itchiness, chills, migraine and fever. Patient experienced headache on 18Apr2021. Patient did not received treatment for the adverse event. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Elevated resting heart rate - 20-40bpm higher than normal. Was 90-105bpm at rest for 24 hrs starting around 10pm evening of vaccine. (Normal is high 60s for me.) Fever - 101.1 - noticed morning after vaccine, lasted 18 hrs Arm soreness - 2 days Splitting headache with drooping eyelids - started morning after vaccine and continued 24 hrs Fatigue/exhaustion - started 8 hrs after vaccine and lasted 1.5 days
Mother was carrying patient after vaccinations. Within 5 minutes, he became stiff - whole body and arched back. Eyes glazed and he looked pale and sweaty. Lasted < 30 seconds. He was back to normal after 15 minutes.
Slight chills night 10pm. and still continuing 10 days later; heat waves 2 to 4 am. at night which disturbs sleep pattern-- put cool cloth on forehead helps and taking off layers of clothes which continued for 8 days.  I did test temperature, but read 98 which is normal for me up to 98.3.; I did not have a headache but could definitely feel extra pressure; my body aches were about even all over body, not stronger at shot site probably because I relaxed before shot and stayed resting  in my car for 30 minutes before driving away; I did not have swelling or any redness at the vaccination site; I have had a dry mouth which wakes me up a night even thought I have taken Biotine .  It usually lasts the whole night.  I did drink extra water during day as well as at night.  I have had nausea but did not vomit for about 8 days.    I lack energy and am still experiencing fatigue.  I continue to swim laps and areobics at least one hour every day.
Episodes of dizziness x 2 and syncope greater than 24 hours after receiving vaccine. Redness, bruising and swelling of the left injection site.
After 8+ hours post vaccine, I was running a low grade fever and had all over body aches.  The body aches continued through the second day off/on all day.
Went into atrial fibrulation about 25 minutes after received njection.  Lasted for about 6 hours.  Pulse rate was also elevated and fluctuating between 68 and 125.  My normal pulse rate is between mid 60s and high 70s.  When afib subsided, the pulse rate was steady, but still elevated about 10 higher than usual (around 90).  Pulse returned to normal rate around 8 AM the next day, June 15, 2021.
Patient complained of pain when washing her hair on 6/22/02. Woke up 6/23/02 with blisters covering body and throughout hair. Had fever as well. Seen at ER and diagnosed with varicella. Was told to do symptomatic treatment including Tylenol Q4-6 hours. Blisters lasted until 7/5/02.
Tested positive for Covid; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L204) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided   This case was linked to MOD-2021-018295 (Patient Link).; Reporter's Comments: COVID-19 in this patient is unlikely to be due to Moderna's mRNa-1273 vaccine.
Myalgia, NauseaVomiting,  Started with vomiting around 10:30pm; then arm pain and small swelling around injection site, muscle soreness. Narrative:
I have pain at injection site; I have pain at injection site but there is pain under my armpit; my arms started hurting bad and under my arms; Pain at the injection site not that bad but it's under my armpit; Fever; At night I had chills; My arms started hurting bad and under my arms; It did in night in my sleep last night yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 (Lot number: EW0180, Expiration Date: Nov2021) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood triglycerides" (ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, administration date 30Sep2021; EUTHYROX taken for thyroid disorder; TRIGLYCERIDES. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Dose 2), administration date: 2021, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "I have pain at injection site"; AXILLARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "I have pain at injection site but there is pain under my armpit; my arms started hurting bad and under my arms; Pain at the injection site not that bad but it's under my armpit"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "At night I had chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "My arms started hurting bad and under my arms"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "It did in night in my sleep last night yes". Therapeutic measures were taken as a result of vaccination site pain, axillary pain, pyrexia, chills, pain in extremity, insomnia.  Additional information: Any prior vaccination within 4 weeks included flu shot. Concomitant Products Euthyrox: Consumer stated, "0.75, Once in a morning, Tablet for Thyroid. Patient have pain at injection site but there is pain under armpit. Patient have a fever and at night had chills. When paraphrased the above concern, patient stated, "It did in night in my sleep last night yes, I got the chills and my arms started hurting bad and under my arms. Treatment: Consumer stated, "Ibuprofen, just 2 tablets of 500 mg, I just took the first one this morning so, next day patient woke up with they didn't bother me at night I didn't get up to take anything last night."  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stores doses of ZOSTAVAX (lot # L006382 with expiration date 25-MAY-2016, lot # L024999 with expiration date 06-OCT-2016, lot # L040445 with expiration date 15-JAN-2017, dose and route unknown). The vaccines were stored under 6.6 F for 20 minutes without previous excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Fatigue, nausea, fever 102.  This was my first shot. I was given two shots because the first one didn't have the needle on all of the way and a lot ran down my arm. They decided to give a second one.
Mother of child called back to clinic At 11am and stated child was crying non-stop and not moving legs. Came in to Dr. and was checked. No rashes or reaction noted at sites. Possible joint tenderness. Mom called back at 3pm and said child was now crawling and no longer crying.
Initial information received on 11-Jun-2018 regarding an unsolicited valid non-serious case received from another health professional. This case involves an 18 years old patient who was vaccinated with an expired vaccine vaccine MENACTRA. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient received a dose of suspect MENACTRA (lot number: U5416AA, expiry date: 20-OCT-2017) via intramuscular route on an unknown administration site. It was an actual medication error due to expired product administered. It was not reported if the patient received a corrective treatment. 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 and Module VI of the 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.
Redness, warmth in 4" area around vaccine site, R arm 2cm bruise at injection site, with tenderness Fever first night after vaccination.
Joint stiffness,  blurry vision,  fatigue,  abnormal periods, bleeding Psoriasis
This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored dose of PNEUMOVAX 23 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007303: US-009507513-1709USA007306: US-009507513-1709USA007304: US-009507513-1709USA007305.
Racing heart, high blood pressure(179/94), rash on chest,neck,ears., slight trouble breathing Injection of Moderna given at 8:00am, allergic reaction approximately 1:30 pm.
No adverse Effects; Improperly stored dose of GARDASIL9 was administered; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported.  The reporter stated that, on either 16-JUL-2019, 22-JUL-2019 or 29-JUL-2019, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R020947, expiration date 04-MAY-2021, for prophylaxis (strength, dose, route, anatomical site and frequency were unknown), which has a temperature excursion of 47F for 3 hours and 15 minutes on 10-MAY-2019, and a temperature excursion of 36F for 2 minutes on 20-JUN-2019. The reporter stated that the vaccine had no previous temperature excursion and no adverse effects were reported.
Vesicular rash on Rt chest and back for 72 hours - pt unsure exactly when rash occurred.