chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feel like very fluish), ABDOMINAL DISCOMFORT (Stomach's a bit upset), ILLNESS (Feeling so sick) and MYALGIA (All over body aches/pain in arm, neck, shoulder) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014H21A, 016C21A and 026B21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE (DELSYM) from 22-Nov-2021 to an unknown date for Cough, FLUOXETINE HYDROCHLORIDE (PROZAC), ETONOGESTREL (NEXPLANON), TILACTASE (LACTAID), COLESTIPOL and VITAMINS NOS for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (All over body aches/pain in arm, neck, shoulder). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Feel like very fluish), ABDOMINAL DISCOMFORT (Stomach's a bit upset) and ILLNESS (Feeling so sick). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Feel like very fluish), ABDOMINAL DISCOMFORT (Stomach's a bit upset), ILLNESS (Feeling so sick) and MYALGIA (All over body aches/pain in arm, neck, shoulder) outcome was unknown. The concomitant medications included generic birth control pill and vitamins 1 per day. Patient just got the booster shot and  feel like very fluish. she thought it was half the normal dose and she didn't remember feeling so sick. Got booster at 11 am yesterday about 10pm last night started getting more pain in arm, neck, shoulder and woke up this morning and feel like have all over body aches. Stomach's a bit upset. Patient  took a COVID-19 test (no results) but did not think it's COVID-19.The patient, took a COVID-19 test with inconclusive result. This case was linked to MOD-2021-069680 (Patient Link).
At 10:13 am, patient experienced syncope and hypotension. No loss of consciousness. Patient laid down with feet elevated and blood pressure taken. Cool compress applied  to forehead. Offered juice. Monitored blood pressure which returned to normal range at 10:20 am.  Patient consumed 8 oz juice and reported she felt better. Symptoms improved and patient monitored for an additional 15 minutes. Advised to seek emergency care if symptoms return again. Patient left clinic at 10:40 am with adult guardian.
Covid + on 6/20; admitted in through the ED on 6/23 with cough, decreased appetite. Pt did not require oxygen, but started on remdesivir x3 days for concern for worsening of COVID.  Pt was not admitted for COVID concerns - had an abdominal wall seroma which needed surgical intervention
Severe chills/shaking that resulted in fall. Unable to walk for 15 minutes.  Severe fever, diaphoresis.
June 24, 2021 approx 4pm, called 911 for stroke symptoms. Admitted to hospital l for 1 wk then discharged to Rehab.  An unknown rash also developed on June 27/28 all over his back & cleared up approx 5 days later without treatment.
Urticarial rash on abdomen 1 week after vaccination.  treating with OTC Benadryl.
Headache, Fever 101.3, Left arm Temp 103.3, Nausea, Chills, Body Aches, Very sore arm, metallic taste in the mouth, tired and sleepy,
Client is a 12 year old female, scheduled for a Pfizer 12+ second dose. Client received a pediatric dose.  Parent of the client has been notified of error and recommendation to revaccinate the client.                             Client vaccinated with Pfizer 12 + vaccine 11/23/21 @ 1618.  11/24/21 Communicate with the client's mother via text message. Mother stated that the client has had a sore arm. Client?s mother denied the client having any other symptoms. Client?s mother denied having any questions or other concerns. Client?s mother advised to encourage client to move her arm and offer over the counter medications to alleviate the pain as needed according to package directions.
patient that had received two Fluzone Quad vaccinations during this flu season. The first one was administered on 10/2/2020 and the second one on 01/17/2021/no AE; Initial information received on 08-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involved a 57 year old female patient who received 0.5 ml of two INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number: UJ506AB and expiry date: 30-Jun-2021) via unknown route in right deltoid for prophylactic vaccination during this flu season. The first one was administered on 02-Oct-2020 and the second one on 07- Jan-2021 (Extra dose administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to extra dose administered (latency 3 months 5 days post the first dose).   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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Had fever on 11/24, but on 11/25 it went to 104. Mom called 11/29 & left this info w/Sec. Finally, talked to mom and she said Dr had diagnosed child with respiratory infection.
(Moderna COVID-19 Vaccine)  I received my Inoculation in my upper left arm & by approximately 10 hours later,  I have what looks like a knot the size of a golf ball (or maybe a tad bit larger)  at the injection site.  My arm is warm & sore to the touch at injection site. My entire left arm hurts, but much more pain from my elbow to my shoulder.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 16-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (Lot # L013192, dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information has been requested.
Case number PHEH2014US025335, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 29 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 23 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
Fever, chills, diarrhea, fatigue started Saturday early morning 1:15 am until late Saturday. Sunday morning no more fever but fatigue started to have an appetite. Monday, today, still having body fatigue slight headache in the morning no more fever since Saturday night.
had a mammography and they found something on it; enlarged lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MAMMOGRAM ABNORMAL (non-serious), outcome "unknown", described as "had a mammography and they found something on it"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was vaccinated on the left arm, but the nodes appeared in the right breast.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a consumer via a company representative refers to a female patient of unknown age (the consumer's daughter). In approximately 1999 the patient was vaccinated with VARIVAX (Merck) (dose, route, lot# and expiration date were not reported), the indication was reported as against "Barcelona". The patient contracted a mild varicella infection in 2004. The outcome of the event was not reported. The relatedness between the event and VARIVAX (Merck) was not reported. Additional information has been requested.
Vaccine exposure before pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) in a 35-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M2019 and 028L20AL1) for COVID-19 vaccination.     The patient's past medical history included Miscarriage on 09-Nov-2020. Concurrent medical conditions included Nicotine abuse on 29-Jul-2002.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Jul-2021 and the estimated date of delivery was 13-Mar-2022. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) outcome was unknown. Not Provided          No adverse events reported.  Concomitant medications were not provided.  Treatment medication was not provided.  Date of positive pregnancy test was 08 Aug 2021  Estimated date of conception was 18 Jul 2021  No Maternal history of subfertility and complications or acute illnesses during pregnancy to date.  Number of fetuses were unknown  Number of previous pregnancies were two. On 05 Sep 2012 patient gave live full term birth and on 09 Nov 2020 patient had a miscarriage at 13 weeks genetic issues as per labs.  No Family history of congenital anomalies/genetic diseases   Patient have the current history of substance use on Nicotine 1 pack per day, since 29-Jul- 2002.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Additional information received on 25 Aug 2021 contains significant information. Reporter  details updated. Patient details updated. Product details updated. Event onset date updated.
Information has been received from a physician concerning an 15 year old female who on 29-AUG-1994 was vaccinated with the first dose of MMR II, on 14-Oct-1994 was vaccinated with the second dose of MMR II.  On 11-NOV-2009 the patient experienced mumps.  Diagnosis on 10-DEC-2009 revealed the patient had parotitis R and the patient was afebrile.  Follow-up information was received which reported that on 03-JAN-2010 the patient experienced mumps.  Diagnosis on 03-JAN-2010 revealed the patient had parotitis R.  Follow-up information was received which indicated the patient was 18 year old (also reported as 10 year old) at the time of the event.  Additional information has been requested.
sl listless, malaise, dizziness localized redness & swelling w/axillary redness in same arm;
Received Twinrix instead of Engerix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 54-year-old male patient who received HAB (Twinrix adult) (batch number X239D, expiry date 07-AUG-2022) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX-B).   On 13-JUL-2022, the patient received Twinrix adult. On 13-JUL-2022, an unknown time after receiving Twinrix adult, the patient experienced wrong vaccine administered (Verbatim: Received Twinrix instead of Engerix). The outcome of the wrong vaccine administered 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: 20-MAR-2023 The reporter reported that a patient received Engerix-B (1st dose) on 14-Jun-2022 at another pharmacy and on 13-Jul-2022 received Twinrix inadvertently at her pharmacy. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. HCP was unsure if the lot no. for Twinrix provided was correct - she had a hard time reading it. At the time of reporting, the patient received Twinrix inadvertently instead of Engerix-B, which led to wrong vaccine administered.
Case number PHEH2014US008493 is an initial spontaneous report from the consumer (patient) received on 25 Apr 2014 and a follow up report received from the consumer on 30 May 2014. This report refers to an adult male patient. The patient was vaccinated with RABAVERT (batch number: C93011/538011A, expiry date: Sep 2016) intramuscularly in Nov 2013. It was reported that the vaccine received by the patient looked like it was bubbling and foaming. The patient felt RABAVERT vaccine was like water with something else in it that he could die of it. On an unknown date, after vaccination he experienced pain. The outcome of the event was unknown. The patient thought that the event pain was due to the RABAVERT vaccine which he received in Nov 2013. Follow up report received from the consumer on 30 May 2014: Changed seriousness from non-serious to life threatening. Added event (feeling abnormal). Updated patient details and expiry date of RABAVERT vaccine.
For the first few days: sore arm but was otherwise fine. About a week later, noted itching, redness, and swelling around the injection site. A couple days after that, developed general itchiness and some eye irritation; no rash or fever. Symptoms improving with antihistamine.
zoster related injuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a n elderly patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about September 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequently, the patient was treated for the following injuries resulted from zoster vaccine live (ZOSTAVAX) use: shingles and zoster related injuries. The outcome of shingles and ill-defined disorder were not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Left upper arm, eryth, firm & warm to the touch, painful to raise her arm. Patient seen by immediate care center on 9/24/11 and give Cefdinir for infection to injection site.
Breakthrough case admission after 4 vaccines  Moderna 1/4/21 Lot# 026L20A; Moderna 2/1/21 Lot# 007M20a;  Moderna 11/12/21 Lot# 034F21A;  Moderna 3/31/22 Lot# 027L21A
Headache, Arthralgia, Fever,  FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, TENDER/SWELLING LOCAL LYMPH NODES  Narrative:   Other Relevant History:
Large rash at injection site.  Tingling at both wrists and hands for about five days.
Patient experienced intense pain in the arm the immunization was given. The pain was so intense she wasn't even able to lift her arm past her head. Patient claims she went for physical therapy for the pain in her arm.
Swollen, itchy, rashy, painful and still discolored and looks like bloody pinpricks around my shoulder. The lump from the shot has gone down.
This patient received 12 month vaccines early at their 7 month well child check. This error took place due to mis-reading of the MCIR and staff not verifying orders with the vaccine schedule.  Patint was not harmed and did not have any adverse reactions.
Father noticed red raised hive patches on face (cheeks), trunk, legs a few day p/vax; rash would start & leave; pt taken to clinic 25JAN95 w/hive like rash; rash was red raised & dermographic; was itchy;
No adverse event; received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In September 2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced WRONG PRODUCT ADMINISTERED (received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine).    No concomitant medications were reported. Patient received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine. The patient received his Moderna Covid-19 vaccine primary series and also the first two booster doses.   No treatment medications were reported.   Reporter did not allow further contact
Rash 1 1/2 weeks post vaccination developed few small bumps of lower extremities spreading to hands and arms as well Narrative:
He got cold and clamy and passed out in the chair with head slumped.  His wife rubbed his chest and spoke to him and I, waved ammonia inhalants under his nose.  He immediately came to.  We got him a bottle of water and a snack (he had not eaten yet today).  I also checked his blood pressure and it was normal.  We had him sit a little longer until he felt better.  We initially called an ambulance, but called it off at his request.
Pain in chest; Jaw pain; Nausea; Hand pain; Feeling very aches/Body aches; This non-serious case was reported by a consumer and described the occurrence of chest pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-SEP-2023, the patient received Shingrix. On 06-SEP-2023, 1 days after receiving Shingrix, the patient experienced chest pain (Verbatim: Pain in chest), jaw pain (Verbatim: Jaw pain), nausea (Verbatim: Nausea), pain in hand (Verbatim: Hand pain) and general body pain (Verbatim: Feeling very aches/Body aches).  The outcome of the chest pain, jaw pain, nausea, pain in hand and general body pain were not resolved.   It was unknown if the reporter considered the chest pain, jaw pain, nausea, pain in hand and general body pain to be related to Shingrix.     It was unknown if the company considered the chest pain, jaw pain, nausea, pain in hand and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2023 This report was submitted via the online direct entry reporting system. The patient self-reported this case. The patient was not pregnant. After administration of Shingrix vaccine, the patient was feeling very aches, pain in chest was like the ribs area. The patient just felt extremely terrible. The symptoms were not treated. No other products were administered by the patient. The reporter gave permission to contact.
Information has been received from a registered nurse concerning a 17 weeks male patient, with no pertinent medical history and no known drug allergies who on 29-DEC-2010, was vaccinated with the first dose of ROTATEQ, oral administration (Lot number 668361/1062Z and expiration date: 07-May-2012). There was no concomitant medication. The registered nurse reported that on approximately 25-FEB-2010 ("1 week ago") the patient developed severe diarrhea and fever after administration of the first dose of ROTATEQ. The patient was diagnosed with rotavirus. On 01-MAR-2011 there was a stool sample performed with -positive for rotavirus as result. The patient sought unspecified medical attention. The patient received hydration as treatment. At the time of reporting the patient was recovering. Additional information has been requested.