chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Injection site pain; It was a pediatric dose. It required the dilution and it was given without dilution/one dose was inadvertently administered without dilution to a 6 years old; It was a pediatric dose. It required the dilution and it was given without dilution/one dose was inadvertently administered without dilution to a 6 years old; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 6 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 05Mar2022 (Lot number: FL0007) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, date: 12Feb2022, Route of administration: Intramuscular, Anatomical location: Right deltoid Arm, Lot number: FL0007/Diluent Lot#2315BDK, Expired date: 01Nov2022), administration date: 12Feb2022, for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 05Mar2022, outcome "unknown" and all described as "It was a pediatric dose. It required the dilution and it was given without dilution/one dose was inadvertently administered without dilution to a 6 years old"; PYREXIA (non-serious) with onset 06Mar2022, outcome "recovered" (09Mar2022), described as "Fever"; CHILLS (non-serious) with onset 06Mar2022, outcome "recovered" (09Mar2022), described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 06Mar2022, outcome "recovered" (09Mar2022), described as "Injection site pain". Therapeutic measures were not taken as a result of pyrexia, chills, vaccination site pain.  Additional Information: Patient did not receive any other vaccines were within 4 weeks prior to the COVID vaccine. No specific relevant test were done. Reporter clarified regarding the type of medication error that no diluent was used, resulting in higher than authorized dose for pediatric Pfizer vaccine. The stage of medication error (e.g., prescribing, dispensing, preparation, and administration) was during vaccine preparation step, it was drawn from the pediatric Pfizer vial without dilution. Contributing factors to the medication error was inadequate training/forgetfulness. They had Informed the recipient's guardian of the vaccine administration error. Patient experienced fever, chills, injection site pain (Nothing outside of the expected side effect profile). Patients mother was informed to monitor 5x and if anything.
Information has been received from a medical assistant concerning a 62 day old male with no pertinent medical history or drug allergies who on 02-MAR-2009 was vaccinated with the first dose of ROTATEQ vaccine (lot #: 663260/1794X). There was no concomitant medication. On 02-MAR-2009, after receiving the vaccine, the patient vomited. The patient recovered on 02-MAR-2009. The patient sought unspecified medical attention. Additional information has been requested.
Initial information was received on 29 October 2008 from a manufacturer whose initial reporter was a health care professional. A patient experienced Guillain Barre Syndrome after receiving a flu vaccine in 1980. No further information was available. Follow-up information received 02 February 2009 from a health care professional. According to the reporter, "the only situation that would fall under adverse event was when [she] called S-P regarding a patient who was late for #2 GARDASIL and what or #3 schedule should be used". No further information was provided. List of Documents held by Sender: None.
trouble with muscle soreness especially in her thighs.; worst pains in her thighs like cramping; Lethargic; She says her arm still hurts from the shots; headaches; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 84-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration on 22Feb2021 (at the age of 84-year-old) as single dose for COVID-19 immunization. The patient medical history reported as none and concomitant medications were not reported. The next day on 23Feb2021 the patient felt lethargic all the day, on an unspecified date in 2021 she had headaches, She thinks she had a headache when she woke up in morning. She probably had one yesterday. She says it was hard to say when the headaches began but she would go along with yesterday. On 24Feb2021 she had trouble with muscle soreness especially in her thighs, felt the worst pains in her thighs like cramping. The patient stated her arm still hurts from the shots on 22Feb2021. She knows these are probably all effects from the shot. She thought she would be getting better. She says she will do whatever was necessary to help. Outcome of the events trouble with muscle soreness especially in her thighs, felt the worst pains in her thighs like cramping, arm still hurts from the shots were not resolved. Outcome of rest all events were unknown.  Follow-up attempts completed. No further information expected.
Pains in both  legs; Both legs are cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pains in both  legs) and PERIPHERAL COLDNESS (Both legs are cold) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L2DA) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 01-Jan-2001, High cholesterol since 01-Jan-2009, Dry eyes since 01-Jan-2013 and Drug allergy (patient is allergic to codeine). Concomitant products included SIMVASTATIN from 01-Jan-2009 to an unknown date for Blood cholesterol, AMLODIPINE BESYLATE from 01-Jan-2001 to an unknown date, ATENOLOL from 01-Jan-2001 to an unknown date, HYDROCHLOROTHIAZIDE from 01-Jan-2002 to an unknown date and LOSARTAN from 01-Jan-2002 to an unknown date for Blood pressure high, CICLOSPORIN (RESTASIS) for Dry eyes, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE 600+D3), VITAMIN D3 and CENTRUM SILVER +50 for an unknown indication.    On 27-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021 at 10:00 AM, the patient experienced PAIN IN EXTREMITY (Pains in both  legs) and PERIPHERAL COLDNESS (Both legs are cold). The patient was treated with IBUPROFEN at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pains in both  legs) and PERIPHERAL COLDNESS (Both legs are cold) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-255678 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: follow up received and it contains information about patient demographics, and allergies, medical history and dose 2 information added and concomitant and treatment mediations were updated and events outcome were added.
hot - dry heaves - lightheadedness - feeling of passing out.  when laying down felt better
I felt fine for most of the first 24 hours.  I had a slight ache in  my ovaries and in my kidney area during the night... The next day I was okay... was drinking ALOT of water.... I had some hematuria...light then it happened again, a bit darker this time... I continued to drink my water.... no pain!  It did not clear up until another 24 hours.... I am a bit concerned!!!
I've always had a very regular, 28 day cycle my whole life.  I've never had an irregular period or any irregular bleeding. I've also never been on birth control.  I got the 1st shot on 10/2.  I started my period on time on 10/8; however, my breast pain didn't go away when I started (which is not normal).  My period only lasted from 10/8 - 10/10 (which also isn't normal for me).  Then it stopped.  But I got a second period on 10/18 and have been bleeding continuously for the last 11 days...bleeding  VERY heavily, with hemorrhaging and clots.  I also could tell that I didn't ovulate this month.  I've always been able to tell when I'm ovulating and I definitely didn't.  The bleeding won't stop and I will not be getting the second shot because now I'm terrified that it has messed up my reproductive system, which was a very healthy one before I got the shot.
This case was considered medically important (OMIC). Info regarding Prevnar was received from a healthcare professional regarding a 2 year old female pt who developed right lower lobe pneumonia. At 11 months of age, the pt received the fourth dose on 10/28/03. Indication for Prevnar was immunization. Product was administered on 10/28/2003. Dose regimen was 1 dose IM. Event Details: The pt developed right lower lobe pneumonia (drug ineffective) on 1/31/05. The pt was treated with Zithromax. A culture was not performed. On an office visit of 2/2/05, the pt's lungs were clear. It was additionally noted that the pt had received the 4th dose of Prevnar, 8 days before her first birthday (medication error). No additional info was available at the time of this report.
Swollen lymph nodes behind collar bone; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration on 23Jan2021 13:00 at a single dose on right arm for COVID-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies. Concomitant medications included fish oil, ibuprofen, and niacin. The patient previously received first dose of BNT162B2 on 02Jan2021 at 1:00 PM on right arm (lot number: EK9231) for COVID-19 immunization. No other vaccines received four weeks prior to vaccination. The patient experienced swollen lymph nodes behind collar bone on 24Jan2021 18:00. It was unknown if treatment was received for the event. The patient  has not been tested for COVID-19 post vaccination. The patient was recovering from the event.
Headache & Myalgia Narrative: Employee reports symptoms of chills, headache, and body ache began approximately 24 hours after receiving second dose of COVID-19 vaccine. Per report, employee has had reaction to a previous vaccine in the past, but individual taking report did not ask which vaccine employee had reaction to or what their reaction was. No medications were reported.
first Shingrix vaccine on September 30, 2020 / second Shingrix vaccine accidently on November 3, 2020.; This case was reported by a consumer and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd November 2020, the patient received the 2nd dose of Shingrix. On 3rd November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The sister called for her brother. The age at vaccination was not reported. The patient had first dose of Shingrix on 30th September 2020 and accidently second dose was administered shorter than the recommended interval, which led to shortening of vaccination schedule. All information was not available. The sister was reluctant to report the adverse event. This case is linked to the case US2021090116, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090116:Possible same reporter and patient
beyond the recommended dosing interval; This spontaneous case was reported by a non-health professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the recommended dosing interval) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the recommended dosing interval). On 28-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the recommended dosing interval) had resolved.            Concurrent medication not available. Treatment medication not available.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, third dose, lot # N004815 with expiration date on 07-OCT-2018. The vaccine underwent a temperature excursion of 51.8 degrees Fahrenheit for 55 minutes. Digital Data Logger was used in the recording of the excursion. No previous temperature excursions were reported. No adverse events were reported.
Engerix-B exposed to 27°F, administered; This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. A pharmacist staff called to report that an Engerix-B vaccine was exposed to a lowest temperature of 27 degree fahrenheit for 1 hour and 30 minutes and then administered to a patient, which led to incorrect storage of drug. Healthcare professional did not have any patient's details or date of the injection. The reporter consented to follow up and requested to follow up by email.
4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade fever continued (99.5 F), sweats/chills, sharp headache, fatigue, muscle aches 4/26 - low grade fever continued (99.5 F, dropped to 99.3 F in evening), sweats/chills continued, sharp headache continued, fatigue + aches continued 4/27 - low grade fever (99 F), sharp headache, chest pain when coughing, developed sinus congestion, wet cough which produced mucous (clear), slight fatigue and aches (lessened), new symptom of low humming tinnitus in left ear only (when surroundings quiet) 4/28 - fever gone for 18 hours w/o fever-reducing medication, fatigue still present, cough with phlegm still present, slight headache, slight sinus congestion, low humming tinnitus in left ear continues (when surroundings are quiet)
Stroke on left side of brain, plus brain bleed.  Paralyzed on right side, cannot walk, plus aphasia.
2nd shot of FLUZONE HIGH DOSE QIV was given today, the last one being in September with no reported AE; Initial information received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who had 2nd shot of fluzone high dose qiv was given today, the last one being in september with no reported ae while receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Dec-2022, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (Lot number: UJ917AD and Expiration Date :  Expiration Date)(strength, dose, formulation, frequency: not reported) via unknown route in unknown administration site for Immunization (Immunisation).  On 01-Dec-2022 the patient developed a non-serious event of 2nd shot of fluzone high dose qiv was given today, the last one being in september with no reported ae (inappropriate schedule of product administration) 1 day following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
02/13/2021 (beginning at 3:30 PM): Slight fever (99.8), chills, soreness at the injection site, headache, slightly stuffy nose; 2/14/2021 (all day): Slight fever (peaked at 100.3), chills, soreness at the injection site, swelling of the arm above the injection site, hot to the touch above the injection site, headache, tightness of chest, slightly stuffy nose; 2/15/2021 (all day): Soreness at the injection site, swelling of the arm above the injection site, hot to the touch above the injection site, headache, nausea, diarrhea; 2/16/2021: Soreness at the injection site, swelling of the arm above the injection site, hot to the touch above the injection site, swollen lymph nodes in the armpit of the same arm as the injection, headache, nausea
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The healthcare worker reported that the patient received the first dose of GARDASIL about 2 years ago (in January 2011) and on 16-JAN-2013 the patient received the second dose of GARDASIL. No adverse event reported. Additional information has been requested.
Patient complained of dizziness which persisted for a while.  She was given some water and some juice which she drank.  She was awake and coherent while under monitor. Blood Pressure readings were 177/87 ( Pulse 59) at 1:30pm Right Arm. 203/93 , Pulse 57 at 2:15pm Right Arm, 147/95 Pulse 60 at 2:17pm Left Arm, 160/83 Pulse 58 at 2: 30pm Left Arm, , 170/93 Pulse 58 at 2/53pm Right Arm.  Her Healthcare Provider was notified.  She was assessed by her Health Care Provider who recommended she seek further evaluation at the ER
sneezing, runny nose, cough, congestion, fatigue- symptoms started 6/28/2021.  I started antibiotics on 7/21/2021 x 7days.
Migraine diagnosis after the shots. Possible skin condition not diagnosis yet but making the studies at the clinic.  Initial OV on 6/13/2006 for c/o migraines.  PE: WNL. DX. Migraine. Episode of chest pain 2/2007. Cardiac eval WNL. Difficulty managing stress. Assessment:  Anxiety, Atypical chest pain, hyperlipidemia, migraine. C/o shoulder pain 4/4/07. DX: muscle spasm.
I felt pain in right shoulder and collar bone  I felt dizzy. The onsite nurses monitored my blood pressure, pulse and breathing. I went home and took an unexpected nap out on the couch. I experienced extreme fatigue that took at least a week to resolve. I also had dizziness and headaches that accompanied the exhaustion.
This spontaneous report as received from a physician refers to a 37-year-old female patient with allergy to sulfonamides (referred to as "sulfa" allergy). On 09-FEB-2017, the patient was vaccinated with M-M-R II for prophylaxis, because she had negative titers and had never received this vaccine previously. Dose, route, lot number and albumin status were not reported. The patient did not receive any concomitant therapy. On 12-FEB-2017, the patient developed an unspecified rash on both her arms, back and hips. She was seen by the physician on 13-FEB-2017, but did not have any laboratory tests done after the event onset and did not receive any treatment. The patient did not recover from the rash at the time of the reporting. The relatedness between the rash and the suspect vaccine was not provided. Additional information has been requested.
Slightly raised, erythema, hot patch on arm just below injection site about 5.5 inches long and 2 inches wide
Patient received his 1st dose COVID vaccine at 6:56 PM and immediately said he felt lightheaded and nauseated. Patient had an emesis x1 which was clear. Vitals taken: BP 92/60, HR 55, SpO2 100%, Temp: 99.0, RR, 20. Patient is present with his father who both decline that the patient have any past medical hx, patient denies taking any medications, denies any known allergies to food or medicine. Per the patient's father, "my son always gets like this after shots". Patient's father verbalized that his son always gets extremely anxious prior to getting any vaccine. Patient rested in a clinic room for 15 min with his father, was provided water, and said he felt much better post 15 min. Patient requested anti-nausea prescription. Zofran e-prescribed to patient's pharmacy. Patient stable prior to leaving clinic. Strong ER precautions provided. Both patient and his father verbalized understanding.
some of vaccine dripped down arm; hot to touch; hardness,knot near injection site; redness; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (some of vaccine dripped down arm), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (hardness,knot near injection site) and VACCINATION SITE ERYTHEMA (redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (some of vaccine dripped down arm), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (hardness,knot near injection site) and VACCINATION SITE ERYTHEMA (redness). The patient was treated with IBUPROFEN, PARACETAMOL (ADVIL DUAL ACTION) at an unspecified dose and frequency. At the time of the report, ACCIDENTAL UNDERDOSE (some of vaccine dripped down arm), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (hardness,knot near injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.      No concomitant medication was taken. The patient has been using ice packs to treat her symptoms.