chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The expired Jynneos vaccine was administered to the patient, intradermally; The expired Jynneos vaccine was administered to the patient, intradermally; Case reference number US-BN-2023-000055 is a spontaneous case report initially received from other health care professional via Communications (reference number: USBAV23-0056) on 11-Jan-2023 and concerns an adult patient of unknown gender.  The patient's medical history and concomitant medication details were not provided.  On 27-Dec-2022, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; expiration date: 19-Dec-2022), at an unknown dose or site of administration, intradermally, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').    At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Jan-2023 included the local BN case ID.  This case is linked to cases US-BN-2023-000050, US-BN-2023-000051, US-BN-2023-000052, US-BN-2023-000053 and US-BN-2023-000054 (same reporter).; Reporter's Comments: An adult patient was vaccinated with the first dose of expired Jynneos vaccine intradermally. Intradermal injection and expired product administered are listed by convention. No associated adverse events have been reported. Intradermal injection and expired product administered have been considered not related to the suspect product. The case is non-serious.; Sender's Comments: An adult patient was vaccinated with the first dose of expired Jynneos vaccine intradermally. Intradermal injection and expired product administered are listed by convention. No associated adverse events have been reported. Intradermal injection and expired product administered have been considered not related to the suspect product. The case is non-serious.
This literature report has been received from the authors of a published article, titled as stated above and refers to a 27 patients between the ages of 1 and 15 years old (the age group with less than 19 years was considered as children by the authors). The patients' gender was not provided. On unknown dates, the patients were vaccinated with a Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dose, route of administration, anatomical location, lot# and expiration date were not provided). As part of the initial patient assessment programme and in accordance with the Centers for Disease Control and Prevention (CDC) guidelines, all incoming patients received their first vaccination against hepatitis A and B at their first healthcare encounter. The patients received three or four previous documented doses of Hepatitis B Vaccine (Recombinant) (manufacturer unknown). Tests for immunity to both viruses were performed also at the first healthcare encounter. Decisions about the continuation or discontinuation of the vaccine series were made on the basis of test results. Demographic data, vaccination history, and results of blood tests for hepatitis A antibody (HAV Ab), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and hepatitis B core antibody (HBcAb) were collected. HBsAb was deemed reactive if detected at =10 mIU/mL. On unknown date, it occurred that HBsAb was absent in the patients. The patients were considered nonresponders. The interval between the last received dose of vaccine and testing for HBsAb in this group averaged 47 months (median 35 months) and ranged from 5 months to 178 months. Refugees showed no immunity in spite of having received three or four documented doses of Hepatitis B Vaccine (Recombinant) (manufacturer unknown). This apparent nonresponse was considered to be due to many things including genetic factors, malnutrition or other illness, documentation errors, expired vaccine, or poor vaccination technique. Some individuals might have had no initial serologic response to vaccination, others might have had initially adequate antibody levels that waned over time. On the other hand, since no interval between series completion and testing was shorter than 5 months, the nonresponse is unlikely to be attributable to a postvaccination gap during which provoked immune systems were not yet producing antibodies. A copy of the published article is attached as further documentation of the patient's experience.
pt rcvd vax; approx 2 dys later pt devel a high fever t104 & flu-like symptoms;
Blurred vision, sensitivity to light, migraine headache 10 minutes after injection, heart palpitations within 4 hours of injection. Headache and heart palpitations still present now.
1 hour after imz given patient had a golf ball size welp over injection site, ice pack was applied as advised. 3 hours later welp was size of baseball.. ice pack was applied and ibuprofen started.. area of welp was warm to touch prior to ibuprofen being taken.
After giving patient vaccination within 4-5 min patient informed pharmacist she is having shallowing and she was trying to talk but had difficulty getting her word out. Patient throat was visible swelling . RPH instructed technician to call 911 and take permission from patient to administer Epipen . After she administered epipen patient was getting better within him few minutes and waited close to patient until EMS people arrived. Patient was taken to hospital.
Mild Chest pain lasting since 2 days post vaccination. Reported 7/15/21
This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ (dose, route, site of administration and lot# not reported). Concomitant medication was not mentioned. The reporter further informed that the vaccine was exposed to a temperature of 47F for 20 hours. No adverse effects were reported. No further information was available. Product quality complaint was not filed. Additional information has been requested. This is one of the two reports received from the same reporter.
This is a spontaneous case (prospective) pregnancy case, initially received from other non-health professional on 18-Nov-2018 and follow-up received on 19-Oct-2018 (combinedly processed), concerning a 26-year-old, adult, female pregnant patient. The patient had 1 previous pregnancy. The patient had no history of still birth, miscarriage, congenital anomaly and birth defect in previous pregnancy. The patient had no maternal medical history relevant to pregnancy and had no paternal medical history (hereditary disease). The patient did not take any contraceptives. The patient's current condition included asthma. The patient's concomitant medication included BREO ELLIPTA inhaler (reported as BREO inhaler). The patient's last menstrual period (LMP) date was 06-May-2018. It was reported that, it was patient's second pregnancy. There was no evidence of a defect or adverse finding from a prenatal test. On 13-Oct-2018, at 23 weeks gestational, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252664, expiry date: 30-Jun-2019). At the time of this report, the patient and foetus had not experienced any adverse events. The patient's estimated delivery date (EDD) was reported as 08-Feb-2019. The reporter assessed the case as non-serious.
arm is very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is very sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History was reported).   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is very sore). At the time of the report, VACCINATION SITE PAIN (arm is very sore) outcome was unknown.
Aches, headache, chills, night sweat, tired.  All were over in 36 hrs.
This spontaneous report as received from a pharmacist refers to a patient of unknown age, unknown gender. The patient was vaccinated subcutaneously with a single dose of ZOSTAVAX (lot # 671144/1269AA, expiration date 05-NOV-2012) on 06-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was inadvertently administered ZOSTAVAX on 11/06/2012 that had expired on 11/05/2012. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
This spontaneous report as received from a nurse practitioner refers to a 10 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
facial swelling, red eyes and redness on face to neck that feels like a sunburn.  This has been ongoing from several hours after the vaccine until currently still experiencing. Has to take Benadryl to keep symptoms under control.  Also now experiencing rapid heart rate and PVC's.
Low platelet levels after booster (as low as 14x10third) Have pulsed steroids several times, infused IVIG two days, now considering Retuxant protocols.  Currently platelets have hovered in the 30-60 range.
Early in the morning 3 days after receiving the vaccine, patient awoke with chest pain that carried down his left arm.  He drove himself to the emergency room at 7am because he just wasn't feeling right.  After two EKG's, the Dr. at Hospital located in the area decided to air lift patient to another Hospital for an assumed fatal heart attack.  Upon arrival, he was given a heart catheter and no blockages were found.  They determined the had myocarditis, inflammation of his heart.  However, he had not been sick or battling any illness.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 9:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:18 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.98 for dose administered on 02-Mar-2021 and 74.06 for dose administered on 30-Mar-2021.  No concomitant medications were reported.  014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 degrees Fahrenheit at 9 AM, 29 degrees Fahrenheit at 10 AM, 32 degrees Fahrenheit at 11 AM, 33 degrees Fahrenheit at 12 PM, 35 degrees Fahrenheit at 2 PM and 36 degrees Fahrenheit at 3PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
24 hours later, I was giving patient a bath and noticed her whole arm from the shoulder down to the elbow was bright red, swollen, hard and warm to the touch. I have photos if you?d like to see them, also the carbon copy from the consent form
an expired Menactra to a patient; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 18 years old female patient who was vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Batch number: U5848AAand expiry date: 11-Mar-2019, dose, dose in series, route and site of administration were not reported) on 10-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  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.   Documents held by the sender: none.
Diagnosed with Stage 1A breast cancer July 2022.   Underwent lumpectomy Sept 2022, completed radiation Nov 2022  - all successful and tolerated well.   Began endocrine therapy Nov 28, 2022.
Received an Adacel, IM, 0.5 ml in left deltoid on Thursday, March 27, 2008. Developed cellulitis, fever, painful joints. Placed on antibiotics on Monday, March 31, 2008.
patient developed left facial paralysis consistent with Bell's Palsy 7 days after receiving the COVID19 Pfizer vaccine #1
feeling like he was going to pass out; throat was really dry within 15 minutes; Was very shaky. He was not falling over but had to be very careful with his steps.; burning sensation like a really bad acid reflux in chest that went to his back; he felt off. It is hard to explain.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 31Dec2020 07:20 at single dose for covid-19 immunization. Medical history included ongoing acid reflux, gout, anxiety depression. Ongoing Concomitant medication included allopurinol from Dec2020 for Gout, fluoxetine hydrochloride (PROZAC) at 20mg daily from Dec2020 2 weeks ago for Anxiety depression, omeprazole from Dec2020 3 weeks ago for Acid reflux (esophageal), calcium carbonate (TUMS ANTACID) from 2019 as needed for acid reflux. He experienced some unusual side effects that were not listed on the web. His boss advised him to call. Within a few minutes on 31Dec2020 after getting the vaccine he was feeling like he was going to pass out but didn't. His throat was really dry within 10-15 minutes on 31Dec2020.  He was very shaky. He was not falling over but had to be careful with his steps. After getting the vaccine you have to sit and be monitored for 15 minutes. After that he was ok enough. He thought this was an expected reaction. He usually reacted to things though he didn't know why. He did fine with the flu shot. He had burning sensation like a really bad acid reflux in chest that went to his back on 31Dec2020. His throat was no different compared to like when you were going to get sick. He had drank a ton of water and his throat was still dry. He was not shaky but he felt off. It was hard to explain. Investigation assessment was no. The outcome of shaky and feeling like he was going to pass out was recovered on 31Dec2020, of dry throat was not recovered, of burning sensation was recovering, of others was unknown.   Information on Lot/batch number has been requested.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included adalimumab for rheumatoid arthritis. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, and headache. This report was non-serious.
Per mom, pt was shaking, eyes rolled backward face became pale and fell over while still sitting in her chair. We called paramedics & pt was taken to the hospital. Seizure like symptoms happened within a few minutes after vaccine was given & lasted a few seconds.
Within 10 days of administering VARIVAX vaccine, patient developed focal areas of itchy vesicular crusty lesions
Hives all over body, Swelling at injection site, itching, soreness, low fever (100.8). fever started 8/27/20. rash started 8/26/20. has been given Benadryl and Ibuprofen as directed.
lightedheaded & dizzy 2 hrs p/inject, nausea 3 hrs p/vax, mild h/a, t99.5, diarrhea since 18AUG92;
Patient stated she didn't feel well and then starting shaking < 1 minute.  She had a total of 3 shaking/seizures instances< 1 minute each.  After the 2nd instance, she was placed on the ground on her side as she started to make gagging/vomit sounds.  After the 3rd instance, she fell asleep/passed out and the Ambulance was called.
It was reported, "The pt, a 4 month old white female, was vaccinated on 7/23/99 with 3 vaccines of which only 2 were provided as DPT and TD. On 7/26/99 the pt's leg that had received 2 of the 3 vaccinations, developed a red bump at the injection site." "It was high and hard and warm to the touch." The reporter indicated that his physician had told him to take his sister to the ER room. No further information was provided." From correspondence received on 10/12/99, additional pt and responsible information was provided.
For two days after the injection the arm had an area that was red, raised, and sore to the touch around the injection site, diameter of about 2 inches.  After that, things calmed down, settling into a bruise that was healing well.  Nine days later, the area around the injection site became very itchy, red, and raised.  The itchiness persisted for 4 days.  At this same time, I also had a stiff neck, especially at the base of the skull.
2 minutes after I received my vaccine I got really dizzy and then couldn?t breathe. My head got super heavy and I couldn?t hear well. I was about to pass out. They laid me on the ground for awhile and when I felt better I noticed my arms hurt. I had broken out in hives all over them. Pharmacist gave me Benadryl and in about 10 minutes I felt better. While I was receiving the shot it hurt really bad and usually shots don?t bother me.
No additional adverse effect reported. Patient is not experiencing any symptoms.; an unspecified 19 year old patient received a second dose ofGARDASIL9 outside the recommended dosing schedule per the PI. Patient received her first dose of GARDASIL9 on 6/25/2019 and second dose on 7/22/2019.; Information has been received from a nurse via the company representative referring to a 19 years old female patient. The patient's medical history, concurrent condition and concomitant medications were not provided.      On 25-JUN-2019, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis. On 22-JUL-2019, the patient received a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis outside the recommended dosing schedule per the prescribing information (PI) (inappropriate schedule of product administration). No additional adverse effects was reported. Patient was not experiencing any symptoms.
Local reaction at vaccine site 3cmx4cm, right anterior thigh warm, erythema, edema
12/30/22 I had severe head congestion, severe headache and muscle aches, dizziness, coughing, nauseous and loss of taste and smell. I went to the doctor on 12/31/22. I tested positive for COVID. I was given LAGEVRIO and started taking it that day. I stayed home for a week. It took until 1/6/23 for the symptoms to go away and to feel better. I have now recovered.
ACUTE RESPIRATORY FAILURE 10/30/2021 NONTRAUMATIC ACUTE KIDNEY INJURY  HYPOXIA 10/30/2021 NONTRAUMATIC ACUTE KIDNEY INJURY  ACUTE RESPIRATORY FAILURE 10/30/2021 ACUTE RENAL FAILURE, UNSPECIFIED  HYPOXIA 10/30/2021 ACUTE RENAL FAILURE, UNSPECIFIED
Twitching eye; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Twitching eye) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MUSCLE TWITCHING (Twitching eye). On 31-Mar-2021, MUSCLE TWITCHING (Twitching eye) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-066986, MOD21-066987 (Patient Link).
The day after the shot I had pain in my arm and then it went away. Then, two weeks later I had could not lift anything with my arm and it was painful. I woke up at 3am and went to the hospital. They gave me a shot for the pain and ran a lot of tests.  They sent me home with OTC pain medicine but I ended up going back to the ER two days later. They said they could not find anything. To this day I still have pain and weakness in my left arm/hand. I can barely use that arm. My regular doctor could not give me any answers either. I don't know if I want to get the booster at this point.