chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to multiple unknown patients of unknown age and gender. Information about pertinent medical history and drug allergies was not provided. On multiple unspecified dates, multiple unknown patients were administered improperly stored M-M-R II (lot#/ expire date: M008589/16-FEB-2018, lot#/ expire date: M016234/31-MAR-2018, dose and frequency were unknown) for prophylaxis. The temperature of storage for M-M-R II was 22 Celsius for 5 minutes. This alarm happened while plugging in the Data logger. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004318: US-009507513-1612USA003676: US-009507513-1612USA004315: US-009507513-1612USA004316.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent condition or medical history was unknown. On unknown dates, the patients each were vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # M040422 with expiration date 07-JUL-2019, route and dose unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored under temperature 9-25 degrees Celsius with time frame 1 hour and 13 minutes. There was no previous temperature excursion. No data logger involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA008913: US-009507513-1707USA009010:  US-009507513-1707USA009012: US-009507513-1707USA009013: US-009507513-1707USA009014:
This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsiness), VERTIGO (vertigo), TENDERNESS (Tenderness), ERYTHEMA (Red arm) and PERIPHERAL SWELLING (Swollen arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDROCHLOROTHIAZIDE (HTZ), CITALOPRAM and VALACYCLOVIR [VALACICLOVIR] for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Drowsiness), VERTIGO (vertigo), TENDERNESS (Tenderness), ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm) and PAIN (Achiness all over). The patient was treated with IBUPROFEN at an unspecified dose and frequency; Manual therapy (Icepack) for Tenderness; Manual therapy (Icepack) for Peripheral swelling and Manual therapy (Icepack) for Pain. At the time of the report, SOMNOLENCE (Drowsiness), VERTIGO (vertigo), TENDERNESS (Tenderness), ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm) and PAIN (Achiness all over) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient experienced symptoms few days after vaccination.
On Saturday, April 17, 2021 after I received the 1st Moderna vaccination shot, later in the day I had a pins an needle feeling on my back but it went away after a few hours. On Sunday, April 25, 2021, exactly 8 days since receiving 1st  Moderna vaccine shot, I broke out in a severe rash on my front torso. I was raised whelps that covered my sides to my stomach, my armpits and part of my back. They itch and burn at the sale time. I started taking over the counter Benadryl.
6 hours after flu shot she developed nervousness, anxiety, head felt like it "cotton cloud".
pain at injection site immediately, worsening for 4 hours overall body ache, 5 hours post ijection fever 100.5F 15 hours post injection
Doses administered past the published expiry; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Patient stated that he woke up a couple of days later and he could not walk. His vision has doubled. He feels that he is virtually blind. Hearing is also defected. Right hand and leg have no feel like he has had a stoke, Or is making motion on its own.
Circumferential erythema approx. 3 in above site of injection and approx. 6 in below site of injection.  Limited range of motion of injected arm and warm to touch.
MODERNA COVID-19 VACCINE EUA GENERAL SIDE EFFECTS: FATIGUE, HEADACHE, MUSCLE PAIN, JOINT PAIN, CHILLS.
Pain, swelling and bruising of left breast; swelling and bruising of left breast; swelling and bruising of left breast; body aches; fatigue; I was nursing/I continued to nurse throughout the adverse event; I was nursing/I continued to nurse throughout the adverse event; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF8841) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 37 years old, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264), administration date: 11Feb2021, when the patient was 37 years old, for Covid-19 Immunisation. The following information was reported: BREAST PAIN (non-serious) with onset 09Oct2021, outcome "unknown", described as "Pain, swelling and bruising of left breast"; BREAST SWELLING (non-serious), CONTUSION (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "swelling and bruising of left breast"; PAIN (non-serious) with onset 09Oct2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 09Oct2021, outcome "unknown", described as "fatigue"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 08Oct2021, outcome "unknown" and all described as "I was nursing/I continued to nurse throughout the adverse event". Therapeutic measures were not taken as a result of breast pain, breast swelling, contusion, pain, fatigue, off label use, product use issue  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications were received the patient within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101484960 mother case
Rash/ hives and itching all over body the day after vaccine. Citrizine and ice packs used, lessened symptoms. Went to employee health the next day, still presenting with hives. Employee health prescribed Pepsid, hives lessened. Today 10/7 took a hot shower and rash and hives returned all over body. Took Benadryl and Pepsid. Symptoms unresolved. Took Allegra still waiting for symptom resolution.
about 10 at night I started feeling cold, followed by chills that were uncontrollable for like four hours, body aches, sweating cold sweat all through the night.  about 6 weeks later started having symptoms like a sinus infection went to an Urgent care, they did a covid test it was positive.
immediate rash, redness over entire body, shortness of breath, swelling and tightening of chest, dizziness, extreme nausea and faintness,? spacey ? feeling all within 30 seconds of vaccine. administered benadryl 50 IM by pharmacists immediately.  dizziness continued 3 hours. 911 called paramedics arrived and assessed. allowed to go home with parents.
Incomplete Kawasaki disease with conjunctival injection, erythematous rash, fever. He received IVIG 2 grams/kg once and infliximab mg/kg once. Fever resolved.. On discharge his echocardiogram showed no coronary artery dilation or heart function deficits.
Fever (up to 102 degF) for 2 - 3 days. Chickenpox-like lesions on face and trunk.
Rash started from injection site within 24 hours. Fever to 102-103 and developed vesicular all over body.
The pt experienced a fever of 103 at 2:00am on 1/3/01. The pt also experienced "jerky movements" seen at the ER. The pt was diagnosed with febrile seizure. The pt was treated with Tylenol, and Motrin.
Fever, chills, muscle aches/pain with lifting arm especially at vaccine sites (patient was given 3 vaccines at one time: flu vaccine, DTaP, and pneumonia; DTaP in left arm, flu and pneumonia in right arm). Signs/symptoms persistent throughout day and throughout the following day (10/16/12)with fever subsiding/recurring periodically.
arm is sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is sore at the injection site) in a male 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.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is sore at the injection site). At the time of the report, VACCINATION SITE PAIN (arm is sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Hives and swelling of upper lip occurring 5-10 mins after varicella vaccine. Responded well to one Benadryl.
Lump felt in throat, flushed face and ears (hot to touch), slightly swollen and numb lips (especially upper lip). Symptoms started about 20-25 min after injection. Took Benadryl  orally and symptoms resolved within about an hour or slightly longer.
Started feeling tired, nausea, headache that would not subside after taking tylenol.  Woke up the morning of 3/28/2019 with body aches.
Heart palpatations; Coughing; Swollen tongue; Achiness; Headache; Shakiness; Chills; Inability to breathe; This case was reported by a consumer via call center representative and described the occurrence of palpitation in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2020, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 11th November 2020, less than a day after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing. On 16th November 2020, the outcome of the palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing were recovered/resolved.   The reporter considered the palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing to be related to FluLaval Tetra 2020-2021 season. It was unknown if the reporter considered the palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing to be related to Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported The patient received vaccine of Flulaval and within a few hours she began to experience heart palpatations, coughing, a swollen tongue, achiness, headache, shakiness, chills, and an inability to breathe. The patient reported that these symptoms have subsided. The reporter did not consent to follow up.
Pt developed pain, swelling and redness the size of an orange, early PM on 11/13/01. By late PM on 11/13/01, it was the size of his thigh. By early AM on 11/14/01 to late PM, it was down below his elbow but less swelling. Treated with a cortisone shot.
Information has been received on 16-AUG-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician at a medical center for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-FEB-2013, the patient was treated by a physician at a medical center for herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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.
24hr p/vax pt noticed a few hives on lt leg & lt side of back;waited to see if had any more, pt is a hiver;was not uncomfortable; 2 days later called MD to ask if OK to take DPH;confirmed & told pt to never take flu shot again;
Cold sweats: 6 hrs Arm soreness: 24 hrs Body aches: 24 hrs Severe headache: 48 hrs
Client stated approximately 2 hours after receiving the shingles vaccine her arm began to swell the size of "a lemon" after a couple of days the swelling and wheals had increased down to her elbow.
Information has been received from a physician concerning an approximately 12 year old female patient with sulfonamide allergy who was vaccinated with her first dose of Gardasil and had a "slight" reaction with a red swelling rash at injection site. In March 2007, she was vaccinated IM with her second dose Gardasil and had "a more extreme" rash. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007.  Initial and follow up information has been received from a physician concerning 13 year old female patient wit ha sulfonamide allergy who on 12-JAN-2007 was vaccinated IM into the left arm with her first dose of GARDASIL (lot # 653937/0637F).  She had a "slight" reaction with a red swelling rash at the injection site, a red bumpy rash on arms around breast and "mouth burned."  On 14-MAR-2007, she was vaccinated IM into the left arm with her second dose of GARDASIL (lot #655617/1447F).  Two days later on 16-MAR-2007 the patient developed the same reaction, described as a red, bumpy "more extreme" rash on arms, around breast and "mouth burned."  Additional information has been requested.  This is a consolidation of two reports concerning the same patient.  It has been determined that WAES # 0705USA00322 is a duplicate of WAES # 0704USA05691.  Therefore WAES # 0705USA00322 is being deleted from our files and the information consolidated into WAES # 0704USA05691.
Child had redness at site of immunization on left arm.  Mother noticed this and felt some hardness at site - noted 04/13/2006 at 07:00AM, by 3:45PM mother states hardness disappeared.
21-year-old female patient received COVID-19 vaccine (Moderna) last week and has been feeling as though she cannot take a deep breath. It is painful on pain scale of 7 or 8. Fever, chills and cough started after receiving shot. She presents to clinic today for an acute visit for 4 days of shortness of breath, pleuritic pain, fever and cough. She states she got the Moderna  COVID-19 vaccine on 07/08/2022, and her symptoms started shortly after. She reports chills without fever, a generalized headache 4 days after receiving the vaccine, which went away after taking an aspirin. She reports her coughs are nonproductive. Denies nausea, vomiting, diarrhea, or congestion. She describes the pleuritic chest pain as a 7 or 8/10, sometimes central, sometimes ventral at bottom of her bilateral rib cages. She denies any recent injuries to the area. She has not taken anything for her cough, pain, or fever. She denies pregnancy, as she is not sexually active. Last menstrual cycle: June 24, 2022. Reviewed vaccine information with patient, including generalized pharmacokinetics. Explained her fever was likely her body's immune response to the vaccine, and that the vaccine cannot make her sick with COVID-19. Reviewed likely ideology of pain, including psychosomatic, pleural membrane inflammation, costochondritis and pneumonia. Explained a chest x-ray is unlikely to be helpful, but can rule-out pneumonia and fracture; patient would like to get one. Chest x-ray as below. Tylenol and or ibuprofen for the pain and fever. Return if symptoms worsen or fail to improve, or as indicated by imaging. The patient indicates understanding of these issues and agrees with the plan.
Patient presented to BWH ED on 5/22/21 with 10 days of malaise in the setting of known covid 19 infection.  Patient was fully vaccinated. Patient was treated for covid 19 and got discharged on 5/27/21.
Received YF vaccine on 12/9/06. On 12/13/06 felt tired and said she didn't feel well. On 12/14/06, had respiratory arrest and was intubated in Hospital. Is being admitted to ICU. Currently has fever of 102. No labs results available yet. DOS 12/14-12/23/06- Admitted with severe shortness of breath. PMH: Hypertension Prior history of hospitalization for respiratory failure intubated and later extubated after left hip open reduction and internal fixation followed by cardiac arrest.  Complete heart block followed by permanent pacemaker 7/06. Hospital course:intubated on mechanical ventilator Possibility of drug reaction from yellow fever vaccination but it seems unlikely. Elevated liver function tests, likely due to shock liver secondary to heart failure. Vaccine probably triggered heart failure. Temp on admission 101.4. Extubated on 12/7/06. 01/04/07-DC Summary received and reviewed for DOS 12/14-12/23/06 DC DX: Congestive Heart Failure Respiratory failure requiring mechanical ventilation Cardiomyopathy with ejection fraction of 25% Severe aortic stenosis Moderate mitral regurgitation Elevated liver enzymes, likely secondary to shock liver, now resolved. Negative hepatitis profile as well as ultrasound of liver History of biventricular pacemaker placed Hypothyroidism on Synthroid supplement Candida urinary tract infection.
Immediately after receiving vaccination, patient felt dizzy and fainted. She regained consciousness quickly and vomited twice. EMS was called. They checked vitals and offered transport to local hospital, which was refused by patient and her mother.
INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. Batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination. On 09-AUG-2021, the patient experienced inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious.
fevers, nausea, achy, right side of face swollen, bilateral eyes swollen, rash on left arm, swollen left arm, headache flushed
I should have administered DTaP and instead administered Pediarix so the patient got an extra dose of IPV and Hep B.
Patient states that the next day after her vaccine, she started to notice her skin on her hands was different. She thought it was simply dry skin and began to use lotion, but it did not help.  Later, she realized it was not dry skin when it began to peel off between her fingers and along her torso.
Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA791A, expiry date 31st January 2024) for prophylaxis.   On 11th October 2022, the patient received Menveo. On 11th October 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The reporter called to inquire that if we need to repeat the vaccine. The reporter reported, they reconstituted the Menveo lyophilized powder with sterile water instead of the GSK approved Menveo diluent and inadvertently administered to a patient at the time of reporting. No other details were provided, the reporter was unable to provide any patient details.  The reporter stated that, vaccine was administered at an alternate facility site. The reporter did not consent to follow-up. Additional Supportive Information: The reporter reported, they reconstituted the Menveo lyophilized powder with sterile water instead of the GSK approved Menveo diluent and inadvertently administered to a patient at the time of reporting, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Mother reports fever, rash, cough, runny node. Similar symptoms after last vaccines 3/19/14 but mom attributed to "cold". Recurred this time - so reported.