chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe back pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp.  A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 at 09:30 (Batch/Lot Number: EP6955, age at the time of vaccination: 60-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included severe case fibromyalgia from 2006 and ongoing (started more or less 15 years ago, in those days they didn't know much about it, but she was diagnosed in 2006). No concomitant medications. The patient experienced severe back pain on an unknown date in Mar2021. A few days (3 to 4 days) after the vaccine she started to experience severe back pain. It was the in middle of her low back. She just had it and couldn't figure out why. She ignored it, thinking maybe she may have twisted her back or maybe she moved or made the wrong turn, she didn't think it was related to anything. But it never stopped. It was bad but it wasn't like it was that bad. She took Tylenol Extra Strength as a corrective measure. Caller declined to provide physician information. Caller has not disclosed to them her experience. Caller knows we are all so new at this, and how it is. She had spoken with her doctor friends and they have advised her they are all new at this and don't know what the side effects can be. She was waiting and hoping it will go away and it definitely has not. When she would lay down, she has pain. Gets up, pain. When she moves, pain. Caller added, her pain tolerance is very high. Vaccine not Administered at private Facility. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not visit Emergency Room or physician office due to events. No prior Vaccinations (within 4 weeks) of vaccination. No relevant Tests. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
red rash; c/o itching, hair & groin area; onset of rash 3NOV92 upon arising however itching began 31OCT92; hands were swollen & red; inject site sore for 1 day; swelling of eyes, hands, sensation of throat closing up;
crying to the extent that extremities were twitching; would not nurse, nerve racking high pitched cry 2-3 hrs also had trouble sleeping in PM; no fever; given APAP;
Administration date unknown, dose number=3; Headache; Chills; Sweat; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On an unknown date, the patient had "administration date unknown, dose number=3". On 07Oct2021, the patient experienced headache, chills and sweat. Therapeutic measures were not taken as a result of the events headache, chills and sweat. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of headache, chills and sweat was recovered on an unknown date in Oct2021. The clinical outcome of the event "administration date unknown, dose number=3" was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SLIGHT HEADACHE; TUMMY FEELS FUNNY WITH MOVEMENT; FEELING VERY TIRED; UNABLE TO SLEEP; This spontaneous report received from a patient. The patient's past medical history included ovarian cancer, blood infection, and headache, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced slight headache, tummy feels funny with movement, feeling very tired and unable to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight headache, tummy feels funny with movement, feeling very tired, and unable to sleep. This report was non-serious.
Hospitalized 11/12/2021; illness onset on 11/12/2021 and includes myalgia, cough, SOB, and difficulty breathing
Patient is positive for COVID-19 and being admitted to the hospital.  Patient received dose 1 of the vaccine on 2/11/21 and began feeling ill several days before presentation to the ED. He is unable to pinpoint an exact date but states it has been a few days that he has felt unwell. Presentation to the ED was on 2/23/21 and his oxygen saturation on presentation was in the 80s with mild confusion. Patient is requiring supplementary oxygen. The patient is receiving dexamethasone.
Immediately after receiving Pfizer booster to right arm patient started to have itching in her throat, some hives noted to left of neck. Patient was able to swallow water. She was given Benadryl 25 mg 1 tab orally. States is feeling fine approximately 5 minutes. She did wait her total of 15 minutes and went back to work.
Patient experienced pain went to MD where they said (virtual visit) pt is experiencing nerve pain at the site of injection. Pt reports pain going down the arm with discomfort like neurologic. They suspect shot was given to high. Pt was prescribed Medrodosepack.
Diagnosed with herniated disk; Heart racing 1 week after first dose, Heart racing  before & after first shot; Chest pain 1 week after first dose; She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (Diagnosed with herniated disk), PALPITATIONS (Heart racing 1 week after first dose, Heart racing  before & after first shot), CHEST PAIN (Chest pain 1 week after first dose) and INCOMPLETE COURSE OF VACCINATION (She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (Heart racing and fluttering during anxiety.), Heart racing (Patient  had heart racing  after vaccination also but  thought it was related to her anxiety.) and Heart fluttering (Heart racing and fluttering during anxiety.).    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot). On 31-May-2021, the patient experienced PALPITATIONS (Heart racing 1 week after first dose, Heart racing  before & after first shot) and CHEST PAIN (Chest pain 1 week after first dose). On 14-Jun-2021, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Diagnosed with herniated disk). At the time of the report, INTERVERTEBRAL DISC PROTRUSION (Diagnosed with herniated disk) outcome was unknown and PALPITATIONS (Heart racing 1 week after first dose, Heart racing  before & after first shot), CHEST PAIN (Chest pain 1 week after first dose) and INCOMPLETE COURSE OF VACCINATION (She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) swelling in the neck that caused the disk move and press on the nerve..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter Event Pharmacist refused to give 2nd shot on 24-MAY-2021 was provided. Treatment product was not provided by the reporter. Patient went to the emergency room. MRI showed swelling in the neck that caused the disk move and press on the nerve. Diagnosed with herniated disk.
Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 46-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215097:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215096:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215095:different patient, same reporter US-GLAXOSMITHKLINE-US2021214412:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215093:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215098:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215092:different patient, same reporter
Narrative: Hospitalization: COVID-19 fully vaccinated, COVID-19 positive upon admission for fluid overload due to acute HF exacerbation
After 6 hours of vax I expericeed severe sweats and pounding headache.   I took a 800MG moltrin with little relief.  Around 10PM head still pounding and had extreme chills.  Woke up today with same pounding headache. I already had covid back in Nov 2020 with no issues, but I had to get shot today to keep my job.
Strong  pain in arm around injection site, hardness of arm area, and heat in injection site area
Within 30 minutes (after leaving the pharmacy), I felt faint, dizzy and light-headed.  Within 3 hours, I developed a headache, tingling and numbness in my left arm, extreme fatigue and nausea.  I also felt sharp sensations traveling up my spinal column.  Two days later, my neck and back muscles are swollen and sore.  I am experiencing pain in places where I have previous injuries - broken ribs, cervical spine injury, etc.  I am still experiencing intermittent nausea and dizziness.  I have received chiropractic care today in an attempt to mitigate symptoms.  I will be receiving additional chiropractic care next week.  I am now taking acetaminophen along with a multivitamin, Vitamin D 1,000 IU, Vitamin C 1500mg.
Menveo powder was mixed with sterile water diluent instead of provided diluent by healthcare worker in the facility.  No adverse reaction or response occurred while patient in the office.  We called GlaxoSmithKline and notified of error.  Representative that took information states that no adverse reaction should occur and replacement Menveo needs to be given.  This can be given at anytime and is not time sensitive based on dose given today.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. 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.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients received unspecified doses VAQTA (lot # K005958, expiry date: 09-FEB-2017) that were improperly stored. Nurse stated that the dates of administration was presently unknown. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This case is also related to 1509USA008456, 1509USA009767, 1509USA009768 and 1509USA009769 (same reporter link). Additional information has been requested.
11/21/09 - numbness in feet. 11/25 - spread to legs. 11/26 - numb feeling from arms progressing to finger tips, muscle twitches, irritable, fatigued, headache. At flu exam 12/14 - stocking glove numbness and mild weakness of interossci, dorsiflexors, plantar flexors. FAAG NCS - normal. 1/18/10 exam - improved strength, sensory symptoms resolved on exam.
p/vax pt had strange taste in mouth;noted a lot of mucus in throat;uncontrollable cough;couldn't swallow fast enough;taken to ER;shoulders hurt;heart palpitations;felt anxious;IV DPH given-released on DPH q 8hr x 2 days;
Pt brought to ER by EMT  w/hx of convuls episode, cyanosis, & hyporesponsiveness;
My arm has a bump where the shot was about 2 inches across and a ring around it, in total 3; swelling in my throat; red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (My arm has a bump where the shot was about 2 inches across and a ring around it, in total 3), VACCINATION COMPLICATION (swelling in my throat) and VACCINATION COMPLICATION (red arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 10-Jan-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 VACCINATION SITE REACTION (My arm has a bump where the shot was about 2 inches across and a ring around it, in total 3), VACCINATION COMPLICATION (swelling in my throat) and VACCINATION COMPLICATION (red arm). At the time of the report, VACCINATION SITE REACTION (My arm has a bump where the shot was about 2 inches across and a ring around it, in total 3), VACCINATION COMPLICATION (swelling in my throat) and VACCINATION COMPLICATION (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A, 001B21A, 022C21A and 084J21A) for COVID-19 vaccination.     The patient's past medical history included Sleep apnea. Concurrent medical conditions included Drug allergy, Sulfonamide allergy and Allergy to chemicals. Concomitant products included MIRTAZAPINE from 05-Oct-2020 to 06-Jun-2022 for an unknown indication.   On 10-Mar-2021 at 7:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021 at 5:45 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            The patient took other medications or products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  Patient was given PAXLOVID. After 7 days of my diagnosis and the end of the pills, my symptoms were gone although I tested positive. Two days later patient started having new symptoms, headache, nasal congestion, nausea with strong positive testing results using two different brands of home testing kits. Device Date: 06Jun2022   This case was linked to MOD-2022-585139 (Patient Link).
Pt recvd vax & exp achy, tired, nausea & diarrhea; sx lasted 24 hrs;
Immunizations given 3/28. Some redness 3/28 pm. By 3/29 - 1/2 dollar size. By 3/30 - redness size of baseball in am. 3/30 afternoon 10cmx12cm red, warm, tender area (R) thigh.
Patient developed lip swelling, facial numbness and area of hives on the thigh. Symptoms started day after the vaccine and resolved after 24 hours.
expired dose of ActHIB was given with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00549606) and transmitted to Sanofi on 06-Apr-2021.  This case involves a patient with unknown demographics who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] lot UJ112AAC, expiry date- 21-JUN-2020 via unknown route in unknown administration site for prophylactic vaccination on 06-Apr-2021.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was the actual medication error due to expired vaccine used (latency same day).  At the time of report there was 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.  There will be no information available on the batch number for this case.
Five swollen "bites" across left shoulder and one on chest, left side.  These became more swollen and then blistered and weeped within the next 24 hours. Very itchydeveloped two red spots on each. By third day sharp pains deep in arm pit and on surface.  These were relieved by pressure for short time.  today is 06/03/2014 and pain continues but not so frequent. Bites are hard lumps, still red and swollen, but milder. I believe that I was bitten by stink bugs as they were present in the room in the morning and that these bites provoked a case of shingles..which I have never had previously.
Shingles. Deep, sharp visceral pain in lower right quadrant starting on 4/24 and escalating in intensity.  No rash present at that time. Went to ER on 4/25. After medical tests (see below), musculoskeletal pain was diagnosed and I was sent home with pain meds. Rash on right abdomen/flank began to appear on 4/27. Continuing pain made me go to doctor on 5/3 and was officially diagnosed with shingles.
Dose administered 19 hours after vial was open/Exceeded 12 hours time frame; 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 EXPIRED PRODUCT ADMINISTERED (Dose administered 19 hours after vial was open/Exceeded 12 hours time frame) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 19 hours after vial was open/Exceeded 12 hours time frame). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered 19 hours after vial was open/Exceeded 12 hours time frame) had resolved.        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.   The pharmacist stated the vaccine did not have any excursions except that it was administered after it was expired. Visual inspection of the vial showed no change of vaccine state. Concomitant product information was not provided. Treatment information was not provided.
Her husband got his dose and all he was tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Her husband got his dose and all he was tired".  Additional information: The reporter reported that her husband got his dose and all he was tired, he took a nap and he was fine.  The lot number for bnt162b2 was not provided and will be requested during follow up.