chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness in arm; extreme fatigue; Headache; chills; cold symptoms; sore throat; felt like I got hit by a truck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 10Nov2021 09:15 (Lot number: FF8841) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN; ADVIL [IBUPROFEN]; TYLENOL. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EE3247, prev dose lot unknown: False, prev dose administrator route: Intramuscular, prev dose administration date: 18Feb2021, prev dose administration time: 10:00 AM, prev dose number: 2, prev dose vaccine location: Right arm), administration date: 18Feb2021, when the patient was 63 years old, for Covid-19 Immunization; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EL3247, prev dose lot unknown: False, prev dose administrator route: Intramuscular, prev dose administration date: 28Jan2021, prev dose administration time: 10:30 AM, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 28Jan2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "soreness in arm"; FATIGUE (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "extreme fatigue"; HEADACHE (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "Headache"; CHILLS (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "chills"; NASOPHARYNGITIS (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "cold symptoms"; OROPHARYNGEAL PAIN (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "sore throat"; MALAISE (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "felt like I got hit by a truck". Therapeutic measures were not taken as a result of pain in extremity, fatigue, headache, chills, nasopharyngitis, oropharyngeal pain, malaise.  Additional information: No other vaccine in four weeks. No covid-19 prior vaccination. Not tested positive covid-19 post vaccination. No known allergies.   No follow-up attempts are possible. No further information is expected.
Pt recvd vax & devel nausea, diarrhea & fever approx 5 hrs following vax w/Hep B vax; sx persisted for approx 4 days; pt missed several days of work; No further details;
Bradycardia: heart rate in 30s and 40s for 48 hrs
cloudiness in eyes (started day of booster) red ring around eyes, heart palpitations and general malaise (started day after booster) all symptoms resolved in a day and a half
Fever, eyes rolled back, limp body, child unfocused.  911 was called. Child began to cry but still wasn't focused.  Fever or 101.
Collapsed on the living room floor @ 4 am and wasn't able to move. Had a throbbing headache, weakness in legs, dizzy spells and chest pains. Waited to speak w/doctor and got an emergency apt and followed up w/a neurologist the same day in Feb 2012. On 4/2/2012, fainted due to migraine and was unconscious for close to 15 minutes and was rushed to the hospital, which later became the 1st of 24 hospital visits for 32 different symptoms.
SWELLING, ECCHYMOSIS, TENDER TO TOUCH, HOT OVER INJECTED AREA OF 8 X 10 CM.
itching; a little bit of swelling; redness; a little bit of tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (a little bit of swelling), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (a little bit of tenderness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Premarin                                                       had a hysterectomy, LEVOTHYROXINE, Sumatriptan                                                    for migraines, Rizatriptan                                                    alternative for migraines, butalbital/ acetaminophen/ caffeine                            alternative for migraines, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CALCIUM for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (a little bit of swelling), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (a little bit of tenderness). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (a little bit of swelling), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (a little bit of tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Had some benadryl cream (but it was expired).
fever; chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient) reported in response to Non-HCP follow-up letter sent in cross reference case.  A 60-years-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch No: not reported/Lot Number: ER8730) via intramuscularly administered in arm right (reported as right shoulder) on 22Mar2021 at 09:30 (at the age of 60 years old) as dose 2, single for covid-19 immunization at Public Health Clinic/ facility. Medical history included covid-19 experienced from 22Oct2020 to 02Dec2020. Concomitant medication was none. Historical vaccine included patent received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE solution for injection Batch No: not reported/Lot Number: EN6201) via intramuscularly in arm right (reported as right shoulder) on 20Feb2021 at 15:48 (at the age of 60 years old) as dose 1, single for covid-19 immunization and experienced with fever and chills. Prior vaccinations administered within 4 weeks were No. On 23Mar2021, the patient experienced with fever, chills. Seriousness criteria reported as not serious. The relevant lab test underwent was none. No therapeutic measure was taken. The outcome of the event fever and chills was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194475 same patient and drug, different dose and events
headache, cough, nasal congestion, fatigue, myalgias, and arthralgias.
12 y/o client received pediatrics COVID-19 vaccine for first and second doses. Parent requested but did not have a physician note.
Narrative:  69 yo M with h/o recently diagnosed AML, hypertension, hyperlipidemia and anxiety died on 06/25/2021 at Hospital. Pt had received covid vaccinations on 02/19/2021 and 03/23/2021. Death unrelated to vaccinations.
Initial case received from a nurse practitioner, who is also the patient, on 13 March 2014. A 56-year-old female patient, with no reported medical history and no reported concomitant drug, had received an intramuscular dose of FLUZONE on the left deltoid on 01 October 2013 (batch number UH909AA). She had received the vaccine from employee health nurse as part of employee health program for the hospital where she works. She had received several previous doses of FLUZONE (exact number not reported). On 01 October 2013, the same day of the vaccination, she had some initial soreness at the injection site. On the next day, she experienced left upper arm muscle spasms. She continued to have intermittent muscle spasms in her left arm which extended upward to her shoulder and extended down to her elbow. She did not consult any health care professional for evaluation or treatment of upper arm muscle spasms. At the time of the report, the patient had not recovered. Documents held by sender: none.
TIREDNESS; This spontaneous report received from a consumer concerned a 67 year old male. The patient's weight, height, and medical history were not 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 07-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness. This report was non-serious.
4 year old female patient recieved a 0.25 mL FLUZONE Quad dose, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a four year old female patient who received 0.25 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (PT: underdose).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 30-Sep-2020, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ452AC and expiry date: 20-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to vaccine underdose (latency on same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
In the evening of the same day (Monday around 7 pm), I began to feel severe fatigue and soreness at the injection site along with moderate muscle aches. At about 9 pm I felt chills and decided to take a warm bath. After the bath, I was not able to warm up and began shivering, the muscle aches increased as well. I took my temperature with a digital thermometer which read 102 degrees.  At around 11 pm I then experienced nausea and vomiting which continued until 3 am that same night. By Tuesday morning, all symptoms had decreased from severe to moderate, and no longer febrile. At night my fever rose again to 99.8 degrees with some mild nausea. The soreness at the injection site remained between moderate to severe with new pain at my underarm (same arm of injection). Today, Wednesday morning I continue to have pain and sensitivity on my underarm and at the injection site.
Nausea; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.
The third dose was inadvertently administered sooner than recommended dosing schedule; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 43-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 7th December 2022). Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 06-APR-2023, the patient received the 3rd dose of Twinrix. On 06-APR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: The third dose was inadvertently administered sooner than recommended dosing schedule). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Jul-2023 The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. The patient received the 3rd dose of Twinrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Vaccine administered 08/20/2009. Client had nausea and vomiting on 08/21/2009.  Client had rash to L arm accompanied by fever of 101.5 and fatigue on 08/22/2009.  Client had rash on the rest of the body with fever on 08/23/2009.  Client recovered 08/24/2009 when event called into health department.
Initial report received on 06 March 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 8-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 01 August 2011, 03 October 2011 and 05 December 2011 (lot numbers, routes and sites of administration not reported). The subject developed a paroxysmal cough without whoop on 10 February 2012, approximately 2 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 11 February 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 11 February 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 29 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Patient reported feeling dizzy, light headed and a feeling of pins and needles after his first covid pfizer vaccine.  His blood pressure was monitored and readings were as follows: approx 30 min after vaccine 149/92 hr 69, 2:00pm 148/85 HR 67, 205pm 162/105 HR 74 208pm 166/94 HR 71. 1 dose of Epinephrine autoinjector 0.3mg was given at 210pm.  212pm: 154/85 HR 71, 216pm 145/86 HR 86 EMS was called at 2:10pm after epeneprine. EMS arrived and transported patient to hospital
Pt admitted for TAVR. Was post op day 5 and awaiting placement and needed a COVID swab. Turned up COVID positive without symptoms.
Vertigo and dizziness. 2d day vertigo was intense when I woke up. I had to sit on edge of the bed for several minutes before I could stand. The room was spinning. Has dissipated over time, but I have experienced vertigo when I lie down to sleep just about every night since 26 Mar. I also have dizziness sometimes when I look down. Mostly resolving in that the room doesn't spin as intensely as at first, but I can tell something is not right.  Feels like I have a low grade headache most of the time. I am hesitant to get the second shot.
Hives, vomit, 104.5 fever, chills, body aches, joint pain, swelling, diarrhea, fatigue, nausea, no eating , pain, welts, 4 werks
Gestational age at outcome 35.9 weeks/Preterm birth; Foetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 23-Jul-2019, concerning a female neonate patient.   The patient's mother was a 26-year-old, female who had no previous pregnancies. The patient's mother had no history of offspring with major congenital malformation. The patient's mother used tobacco during pregnancy and consumed 10 cigarettes per day. The patient's mother did not have a prior history of use of alcohol or illicit drugs during pregnancy. The patient's mother had no maternal or paternal history with major congenital malformations.  The current conditions of the patient's mother included polycystic ovaries and RhD negative. The patient mother's concomitant medication included prenatal vitamins (minerals NOS, vitamins NOS) as supplement.  The patient's mother's last menstrual period (LMP) date was 22-Oct-2018 and type of pregnancy was singleton.   On 21-Dec-2018, at gestational age of 8 weeks, the patient was exposed to Afluria Quadrivalent [influenza vaccine, batch number: YF42609, route of administration: transplacental, dose, anatomical location and expiry date: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On the same day, the patient's mother underwent ultrasound test and no major congenital malformation was noted.  On 25-Jan-2019, the patient's mother underwent nuchal translucency and inheri test, no major congenital malformation was noted. On 15-Mar-2019 and 12-Apr-2019, the patient's mother underwent ultrasound test and no major congenital malformation was noted.  On 03-Jul-2019, at gestational age of 35.9 weeks, the patient's mother gave a live birth to a female neonate (reported as preterm birth) (coded as premature birth) by vaginal method. The characteristics of neonate included birth weight: 3090 grams, head circumference: no data, body length: no data, appearance, pulse, grimace, activity and respiration (APGAR) scores 8 at one minute, 9 at five minutes and for ten minutes: no data. There were no major congenital malformations identified at birth.  The patient's mother estimated date of delivery (EDD) was reported as 29-Jul-2019 and corrected estimated date of delivery (CEDD) was reported as 01-Aug-2019.  This case is linked to the case 201904218 (the correspond ding maternal pregnancy report).; Reporter's Comments: A female neonate experienced premature birth at 35.9 weeks of gestation, 6 months 12 days after maternal receipt of Afluria Quadrivalent vaccine (considered as foetal exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event premature birth assessed as not related. Maternal use of tobacco (10 cigarettes per day) is considered as known risk factor. The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Arm: redness, swelling, very painful for 5 days; muscle pain, headache,  shivering for 2 days (was in bed all day on day after vaccine); tired, weak, dizzy off and on for 6 days.  Took ibuprofen first day.
Patients got their vaccines from vials that went through a temperature excursion,covid-19 vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Patients got their vaccines from vials that went through a temperature excursion,covid-19 vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patients got their vaccines from vials that went through a temperature excursion,covid-19 vaccination). At the time of the report, PRODUCT STORAGE ERROR (Patients got their vaccines from vials that went through a temperature excursion,covid-19 vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that temperature excursion occurred on 12-OCT-2021 and the vial got warmest of -9.2 C.
Initial misuse report received from a doctor on 01 October 2013. The 4 years old female patient had received FLUZONE HD and patient pulled away and much of the does dripped down their arm. The patient received incorrect dose. No adverse event was reported. List of documents held by sender: none
Patient complaining of body aches, redness and sore arm 4 days post injection. Client states she took ADVIL for pain and states it has not gotten any worse but she is still very sore and red. Client will follow up with primary care if symptoms continue.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
pt recvd vax; day p/ vax devel pink rash & the area around inject site was red & sore;sxs persisted for 3-4 days;
Infant was found in bed, seizing. Seizure lasted for 1 hour. Resulting in PICU admission. Workup there there was entirely normal.