chrisvoncsefalvay/vaers-outcomes huggingface dataset:
40 patients administered with vaccines that have undergone temperature excursion; 40 patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications was reported It was reported that only lot number: 059H21A was affected and it was first thawed on 28-Jan-2022 It was reported maximum or minimum  temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. No treatment information was reported.
This case was reported by a healthcare professional and described the occurrence of crying in a 2-month old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-gsk). Concurrent vaccination included PREVNAR (non-gsk); Pfizer; unknown given on 2 May 2012. There were no concurrent medications. On 2 May 2012 at 11:30 the subject received 1st dose of PEDIARIX (unknown, left thigh). On 2 May 2012 the subject received the 1st dose of ACTHIB (Non-GSK) (unknown). On 2 May 2012, 1 hour after vaccination with ACTHIB (Non-GSK) and PEDIARIX, the subject experienced crying, irritability and pharmaceutical product complaint. At the time of reporting, the crying was resolved. The outcome of the irritability was unspecified. The healthcare professional considered the events were probably related to vaccination with PEDIARIX and ACTHIB (Non-GSK). The healthcare professional reported another case see A0976319A. Follow-up information was received on 23 May 2012 via healthcare professional who reported the events of crying and irritability resolved on 02 May 2012. Action taken with PEDIARIX was withdrawn, the symptoms resolved. The immunization series was not discontinued but it was noted that the subject will receive "Ped dt in the future". The healthcare professional indicated the haemophilus influenzae type b vaccine (non-gsk) vaccine was "not given". Quality Assurance (QA) results received on 05 June 2012. The nurse reported an undetermined quality concern with this box of PEDIARIX vaccine (lot AC21B323AA, expiration 31 October 2013) that resulted in two separate adverse events for two subjects, reported separately (see case A0976319A for details regarding other subject). The responsible physician would not allow the use of the remaining syringes and wished to have this investigated. Based on the fact that no precise technical problem was reported and the conforming test results, no technical investigation was performed. GlaxoSmithKline Biologicals considered the complaint as unsubstantiated.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 15-AUG-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II, lot # K011188, expiration date 12-AUG-2016, (dose, route and anatomical location were unspecified). No adverse effect reported. Additional information has been requested.
This report described the occurrence of joint pain in a male pt who received Lyme disease vaccine recombinant (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix "on 6/14/99, 5/13/99, and a later dose, the date of administration is not know to the client." On 9/3/03, the pt's attorney alleged that the pt "suffered shoulder pain, restriction of movement, low back pain and knee pain. The onset of her symptoms is not clear at this time."  Treatment and outcome of the alleged events were not reported.
This spontaneous report as received from a Certified Medical Assistant refers to a 59 years old female patient. The patient was vaccinated with ZOSTAVAX (lot# unspecified) on 10-OCT-2012. No other co-suspects were reported. Concomitant medications included acetaminophen, VICODIN, "fish oil" and probenecid. On 25-OCT-2012, the patient was in the doctor's office with a rash that started on her left breast and wrapped around to her back. It was reported that the patient had a burning sensation. The patient was given gabapentin. The outcome of burning sensation and rash was unknown. The events were considered to be other medically significant events by the reporter. Additional information has been requested.
pt recvd vax;t of 103.5 R; unconsolable crying x 6 hrs; high pitched cry; to er at 1am; no tx, changed formula;
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot #, expiry date, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
PT REPORTS HEADACHE CHILLS STOMACH UPSET-RED, HOT ARM AT INJECTION SITE, PAIN AND ACHE IN ARM-- GOOD SIZED RED CIRCULAR AREA BELOW INJECTION SITE ( FURTHER DOWN ARM)-DREW A PEN CIRCLE AROUND THE RED ARM CIRCLE WHICH FORTUNATELY DIDN'T GROW LARGER
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 16-OCT-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a medical facility for a vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt recv vax; states redness, warmth, swelling & itching on rt upper arm fr shoulder to elbow;seen in ofc;tx w/ ice packs, hydrocortisone cream to affected area & dph;sx occurred w/in 24 hr p/ vax;
This spontaneous report was received from a registered nurse (R.N.) refers to multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL injection (lot # K011562, 08-APR-2017) (dose, site and route of administration was not reported). No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. This is one of several reports from the same reporter. Additional information has been requested.
felt tingling in her lips for about 20 minutes.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (felt tingling in her lips for about 20 minutes.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia since 1991, Arthritic pains since 1991, Temporomandibular joint disorder since 1991, Neck pain since 1991 and Muscle pain since 1991.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PARAESTHESIA ORAL (felt tingling in her lips for about 20 minutes.). On 22-Mar-2021, PARAESTHESIA ORAL (felt tingling in her lips for about 20 minutes.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was reported.  The patient also reported that about 2-3 hours after receiving the vaccine, she felt relieved from her chronic pain. Her pain-free period lasted for about 36 hours after receiving the vaccine. Usually she is always in pain all day long and her muscles are usually tense and knotted. She has TNJ but after the vaccine, her muscles in her jaw which were always tight became more relaxed and did not hurt on the side when she talked. She usually barely sleeps though the night due to her muscle spasms and pain being unbearable but after the first dose, she slept through the entire first night pain free.
PATIENT COMPLAINED OF PAIN, WARM AND RASH AT THE INECTION SITE. PATIENT IS TAKING DOXYCYLINE HYCLATE 100 MG TWICE DAILY
Initial report was received on 12 March 2012 from a health care professional. A 58 year-old female (date of birth not reported) with a history of "Thyroid", arthritis, increased cholesterol and Sjogren's syndrome had received on 03 March 2012 an intramuscular left arm injection of ADACEL (lot number not reported). On 06 March 2012, the patient reported a lump under her left armpit, achy joints, flu like symptoms and a headache. The patient had an ultrasound and a mammography with showed "lymph nodes noted". The patient was evaluated by a physician. Treatments were not reported. Concomitant medications included: CRESTOR, Glucosamine, OSCAL, Folic acid, NORVASC and SYNTHROID. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Symptom; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Symptom) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION COMPLICATION (Symptom). At the time of the report, VACCINATION COMPLICATION (Symptom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient wanted to know if should get the second dose.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
her right eye was crusted shut; headache on the same side; shingles; rash on her forehead and scalp; This spontaneous case was reported by an other caregiver and describes the occurrence of EYELID MARGIN CRUSTING (her right eye was crusted shut), HEADACHE (headache on the same side), HERPES ZOSTER (shingles) and URTICARIA (rash on her forehead and scalp) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Aneurysm (aneurism in 2015). Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced EYELID MARGIN CRUSTING (her right eye was crusted shut), HEADACHE (headache on the same side), HERPES ZOSTER (shingles) and URTICARIA (rash on her forehead and scalp). At the time of the report, EYELID MARGIN CRUSTING (her right eye was crusted shut), HEADACHE (headache on the same side), HERPES ZOSTER (shingles) and URTICARIA (rash on her forehead and scalp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were provided No treatment were provided
This spontaneous report was received from a licensed practical nurse and refers to a 4-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 27-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916.
No appetite, left side of face burning up, bruised right arm, no fever. Pt got vaccine on 6/22/16. Pt felt symptoms on 6/25/16. Pt feels sick.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. In September 2018, 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. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient's arm was sore and achy for a day or two. For tolerance of 2nd dose of SHINGRIX, refer case US2019GSK012893.
Two days post vax, right thigh with 2 3/4 inch diameter wide with erythema and swelling.  Non-tender.
Urticaria over upper ext, back, neck, face 2 days after receiving GARDASIL #3.
Pt. arm is red and warm to touch. Site has some swelling and ecchymoses. The site on upper arm is 65 mm vertical and 60 mm horizontal.
heart inflammation; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 15-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "recovering", described as "heart inflammation". Clinical course: the patient's parent reported the side effect of their son after he took the Pfizer COVID-19 vaccine. The reporter's son was 15 years old and he developed heart inflammation after took the fourth vaccine. The patient received treatment since earlier the year and made improvement; however, the patient still had "less symptoms exists."   Therapeutic measures were taken as a result of myocarditis.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL SEVERE ALLERGY) from 17-May-2022 to 24-May-2022 for an unknown indication.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). In May 2022, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine. Patient received treatment for COVID-19 with unspecified Pfizer drug from 19-May-2022 to 24-May-2022. It was reported that patient had COVID Rebound on 06-Jun-2022 (12 days after testing negative of COVID). Device Date :06-Jun-2022.  Company Comment: This spontaneous case reported by a patient concerns a 34-year-old male patient, with no reported medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after vaccination with a third dose of mRNA-1273.  Approximately 6 months post-vaccination, he received treatment for Covid19 with an unspecified Pfizer drug.  Around 12 days later, he had rebound Covid infection.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient concerns a 34-year-old male patient, with no reported medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after vaccination with a third dose of mRNA-1273.  Approximately 6 months post-vaccination, he received treatment for Covid19 with an unspecified Pfizer drug.  Around 12 days later, he had rebound Covid infection.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
COVID-19; Feels out of sorts and feels ill; Very fatigue; Nausea; does not feel like herself; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), FEELING ABNORMAL (does not feel like herself), MALAISE (Feels out of sorts and feels ill), FATIGUE (Very fatigue) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM HYDROCHLORIDE (TIADYLT ER), ESOMEPRAZOLE, CELECOXIB (CELEBREX), ACETYLSALICYLIC ACID (ASPIRIN), CALCIUM and VITAMIN D3 for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced FEELING ABNORMAL (does not feel like herself). On 15-Mar-2021, the patient experienced COVID-19 (COVID-19), MALAISE (Feels out of sorts and feels ill), FATIGUE (Very fatigue) and NAUSEA (Nausea). At the time of the report, COVID-19 (COVID-19), FEELING ABNORMAL (does not feel like herself), MALAISE (Feels out of sorts and feels ill), FATIGUE (Very fatigue) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.
Recently received the first dose of the Moderna COVID vaccine.  Approximately 48 hours later, experienced an episode of severe vertigo/dizziness and bradycardia (down to 30 bpm).   After the vertigo escalated, went to ER where the following was observed:  SINUS BRADYCARDIA MODERATE VOLTAGE CRITERIA FOR LVH, MAY BE NORMAL VARIANT ST & T WAVE ABNORMALITY, CONSIDER ANTERIOR ISCHEMIA ABNORMAL ECG NO PREVIOUS ECGS AVAILABLE Confirmed by MD, on 5/22/2021 9:55:55 AM  No prior cardiac issues.  Elite level competitive athlete (cyclist).  MRI is scheduled for 7/27/2021.
On 02/02/22 had a ZOS (Herpes zoster recombinant) Shingrix shot along with an influenza shot. On Saturday 02/05/22, woke up with itchy feeling on shoulder. Discovered raised red bumps. Present on Sunday as well. Monday 02/07/22 at 10:00 am after a 25 min brisk walk, large welts on both inner arms, back, torso, stomach, breasts.
Parent reports inj. site very tender, unable to fully raise his arm for two days after imm, BEXSERO, given. Pt did not show for site check but parent wanted VAERS.
Right upper arm with violaceous erythema, induration, non-tender to palpation, spares the skin under the deltoid muscle and the medial upper arm, extends down to the antecube.  No ulceration or pustule.  No fluctuence.  Right elbow has about 95% flexion as compared to left.
Increased local response with localizied cellulitis around vaccination site. no limb neurovascular compromise