chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain-Barré syndrome; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media serious case received from non-healthcare professional.  This case involves an unknown age male patient who experienced guillain-barré syndrome after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date, the patient developed guillain-barré syndrome (guillain-barre syndrome) (unknown latency) following the administration of Influenza vaccine. This event was assessed as medically significant.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Guillain-Barré syndrome).  At time of reporting, the outcome was Unknown for the event guillain-barré syndrome.; Sender's Comments: Sanofi company comment dated 25-Oct-2023: This case involves an unknown age male patient who experienced guillain-barré syndrome after receiving vaccine Influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
12 hours after receiving the second dose of Pfizer I felt fatigued and my injection site was red and swollen. 24 hours after the vaccine I was experiencing abdominal cramping, headache, and fatigue. 48 hours after I developed a severe full-body rash/hives/welts. It started as a small patch on my left arm and progressed to my hips, legs, arms, chest, back, and face - my whole body. The rash is extremely itchy and has caused me to bust blood vessels from scratching so hard and frequently. I began rotating Benadryl and Zyrtec, but it seemed to make it worse. I visited the ER in the middle of the night on 4/18 where I was given steroids and Benadryl IM along with Pepcid. The rash went away a few hours after, but has since then reappeared and I am currently running a low grade fever of 100.2. I am taking Prednisone 20mg 3x a day as prescribed by my doctor along with Benadryl 50mg every four hours and Pepcid twice a day. Despite these medications the rash continues to persist.
This report was received from NOVARTIS and was assigned manufacturer report number S2010USA01949, from a 20 year old female patient reporting on herself, who on 20-JAN-2010 was vaccinated with a dose of GARDASIL. It was reported that on 21-JAN-2010 the patient experienced rash on her neck. The patient could not think of anything else she may have done before rash appeared. The outcome of the patient was not reported. This was originally reported by a consumer. No further information is available.
About an hour after the vaccine I went out for lunch and was eating some radishes and felt sensitivity on my tongue. It passed in about 5-minutes. I noticed the sensation because I was hypervigilant about any sensations I might be feeling after the vaccine.
Patient made statements that he was having a harder time swallowing. Blood pressure was taken.  We assessed and then he began to report difficultly breathing and a very difficult time swallowing. Blood pressure was taken and lung sounds assessed. EMS was called.   Epi pen was given. Within 5 minutes he reported feeling much better and no issues with swallowing or breathing. EMS arrived on site and he was transferred to the local hospital.
10 year old patient received FLUBLOK QIV, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 year old patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 26-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).  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.  There will be no information available on the batch number for this case.
In July 2022, at a regular doctor's appointment I was told that my blood pressure was high. I don't remember the reading, but I was shocked to know how high. For many months now, we have tried several different medications to help with the blood pressure. I have had the following side effects that they attributed to each new medication, including edema and diarrhea and heart palpitations, massive fatigue, nausea but no vomiting. We are still monitoring multiple medications to help balance my blood pressure. I have been referred to a heart doctor.
Information has been received from a physician concerning a 12 month old white female with no known allergies or medical history who on 16SEP2003, at 9:30, was vaccinated in the left thigh with the first dose of varicella virus vaccine live. Illness at the time of vaccination included symptoms of an upper respiratory infection. The physician reported on 29SEP2003, at 9:15, the pt developed multiple vesicular lesions on her head and trunk, a low grade fever of 100 degrees, a decreased appetite and occipital adenopathy. On 30SEP2003. the pt was seen by a physician and received symptomatic treatment for her events. On 07OCT2003, the pt's multiple vesicular lesions and occipital adenopathy resolved. At the time of this report, the outcome of the pt's decreased appetite and low grade fever was unknown. Additional information is not expected.
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild
Client presented into clinic on 5/9/2022 after receiving vaccination on 5/6/2022 by transcriber. Client stated 24 hours after vaccination administration noticed swelling of neck and red area. On observation, lymphedema with red circular present on left neck above clavicle area. This is same side transcriber administered vaccination. Explained to client, lymphedema has been reported with Covid-19 vaccination and is an adverse reactions. Should gradually go away in 4 weeks and to seek or go to emergency room if condition worsens or persists. Denies pain, discomfort, or difficulty breathing at this time.
Dose received=3; Feel horrible and can't get out of bed today; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Dec2021 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. It was unknown whether the patient received any other medication within two weeks of vaccination. Vaccination history included: Covid-19 vaccine manufacturer unknown (DOSE 1, SINGLE; Lot number: UNKNOWN; Route of Administration: Unspecified; Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation and Covid-19 vaccine manufacturer unknown (DOSE 2, SINGLE; Lot number: UNKNOWN; Route of Administration: Unspecified; Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "Dose received=3"; MALAISE (non-serious) with onset an unknown date in Dec2021, outcome "unknown", described as "Feel horrible and can't get out of bed today".  Additional information: It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a Registered Nurse refers to 2 patients of unknown demographics. The patient's medical history and current conditions are not reported. On 24-SEP-2014 the 2 patients were inadvertently administered improperly stored RECOMBIVAX HB injextion 10 Y (strength, dose and frequency not reported) (Lot # and expiry date not reported). No adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. This is one of the several reports received from the same reporter and Linked to cases MARRS # (1410USA007243, 1410USA000627, 1410USA007240 and 1410USA007241). Additional information has been requested.
This spontaneous report as received from a physician via company representative refers to a 15 year old female patient. On 16-SEP-2016 the patient was vaccinated with GARDASIL 9 dose 1 for prophylaxis. The patient received 2nd dose on 25-APR-2017. No other details were provided. Additional information has been requested.
Patient received vaccines (MMR, VZV, Prevnar 13) on Monday 11/07/2016. Pt began having fever on Tuesday 11/8/16 and then rash on Wednesday 11/9/16. Pt seen at PCP 11/11/16- erythematous papules, blisters, scabs noted on arms, legs, trunk primarily. Diagnosed with vaccine induced varicella.
SWELLING, PAPULES Narrative:  acute visit related to left arm swelling and diffuse maculopapular rash to recent COVID-19 vaccine, Moderna vaccine. One week after injection into left deltoid of COVID-19 vaccine, patient developed onset of diffuse swelling, erythematous skin, indurated lateral arm, and papules which have subsequently spread to the right upper arm, abdomen, groin. There is pain with deep palpation, but mainly itchy. No new medications otherwise, no new detergents or fragrance. Cortisone cream makes it feel better but rash has not improved.
syncopal episode while standing at school.  hit back of head in fall.  was seen at urgent care.  then developed fever on 11/7 which has lasted 48 hours and necessitated covid testing.  head injury has resolved, fever persists as of yesterday, which is why I am checking no in #20
Fatigue, upset stomach, diarrhea, sore arm, skin red around injection site
transient right sided facial droop lasting 2-3 seconds 4 days after COVID-19 shot #1 of 2
Patient received the vaccine at 8:01 and at 8:10 patient felt lightheaded (like she was going to pass out.)  Patient was given ice packs and continued to feel same.  Patient was lowered to the floor (BP 79/55, HR 83, O2 sat 98%).  Patient felt much better supine.  with legs elevated BP 110/69.  Patient feeling much better and was put sitting in chair.  BP 122/81.  Felt much better, did not want to go to ED.  Patient given juice and snack.  Pt stated she felt fine.  Time increased for observation.  at 8:40 patient began to feel lightheaded again.  Lowered to floor, BP 78/58 HR 65 o2sat 98%.  Patient stated felt fine.  Rapid response called and patient transferred to Emergency Department.  BP 98/72, HR 71, O2sat 100%.
Within 5 minutes I had tingling in the bottom of my feet spreading upto my knees. Also had tingling in my hands. Almost fainted with heavy curtain coming down over my eyes. During that night my fever shot to 104, respiration was 111, and I had bad chills with nausea. 2 days later (today) I still have a fever of 101.1
She is not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "She is not feeling well".
Muscle twitching in calf muscles begain immediately after injection. Muscle twitching in right calf muscle continued for 11 hours before subsiding.  Increase in tinnitus level 7 hours later; tinnitus likely at higher baseline level weeks later. Two small spots of petechiae developed on left arm five days later: one spot on shoulder, other spot underneath bicep.
loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information were not provided by the reporter. Concomitant medications were not reported by reporter.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 49.52.  No concomitant medications were reported.  On 03-Apr-2021, 20 vials were moved to clinic.   The vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021.   On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 03-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to  clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during  COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.
Palm Planter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE unknown manufacturer, Batch/lot number: Unknown, her received dose was last Mar2022 and with a monovalent dose.), administration date: Mar2022, for Covid-19 Immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Batch/lot number: Unknown), for Covid-19 Immunization. The following information was reported: PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (medically significant), outcome "unknown", described as "Palm Planter".  Clinical course: Caller also briefly mentioned that she experienced "Palm Planter" on her left hand after getting the second booster dose of the Pfizer BionTech Covid-19 Vaccines. Caller also stated that she is about to undergo surgery. Unable to obtain age information. Gender: Female. Caller wanted to know how long she will be protected after her Pfizer BionTech Covid-19 Monovalent booster vaccine shot. Caller wanted to know if she could get the PfizerBioNTech Covid-19 Bivalent Booster dose if her received dose was last Mar2022 and with a monovalent dose.  Follow-up attempts are completed. No further information is expected.
A little feverish; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (A little feverish) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (A little feverish). At the time of the report, PYREXIA (A little feverish) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-402659 (Patient Link).
Information has been received from a pharmacist concerning a female patient in her sixties who on approximately 10-APR-2007 was vaccinated SC in the back of the arm with a dose of Zostavax. A few hours later, the patient developed an injection site reaction. She had pain, swelling, and redness at the injection site which was one half inch and two inches long in a rectangular shape. Unspecified medical attention was sought. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Redness and swelling at injection site. (R) thigh measures 10cm at injection site. (L) upper thigh measures 20 cm at injection site. (L) lower thigh measures 15 cm at injection site.
pt was immunized with 0.2 ml of undiluted vaccine with Pfizer (5-11)
Hives began about 10 minutes after the injection was administered. Hives started at the injection site and rapidly spread to chest and other extremities. Benadryl was administered and the hives then went away.
Patient received second dose of Moderna on 07/26/2021.  Before getting vaccinated patient had stated, she normally feels dizzy after getting vaccinated. When I asked about her first Moderna vaccine, she stated she felt okay and did not experience any symptoms. Shortly, after getting her second dose (about 5 mins in) patient mentioned she was feeling a bit dizzy. I went up to her and asked about severity, but patient continued to say she felt dizzy. I advised patient to lie on her back and elevate her feet while and had one of the technicians call for help; management was also notified. While we were calling ED, patient said she felt better and did not need further assistance. Symptoms lasted about 5-7 minutes. patient waited in store for at least 30 minutes after onset and left.
Guest in Post vaccine monitoring area.   Reported to staff  she had skipped breakfast and was feeling nauseated. Was provided  juice and fig bar.  Monitored for  15 minutes, no further complaints.  Was able to leave facility with friend who brought her under own power alert oriented to home.