chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, between May 2016 and December 2016, the patient was vaccinated with improperly stored VARIVAX lot # L021214, expiration date of 10-JUN-2017, for prophylaxis (dose and route of administration were not reported); which was diluted with properly stored sterile diluent (MRK), for prophylaxis ( lot number and expiration date were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 15-46 degrees Fahrenheit (46F) for 12 hours. There were previous excursions of 15-46 degrees Fahrenheit for 29 hours. There was not Data logger involved. No further information provided. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001693: US-009507513-1705USA001692:
Pt received the Shingrix  vaccine first dose 2 years ago; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date, 2 years prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reported stated that do they need to start over with the two vaccines. The reporter stated that the first dose was not administered at their facility, no vaccine details available (lot,exp, exact date). No date of birth available. The reporter consented to follow up
Patient experienced tachycardia 7 days post vaccination.  MD attributed this to vaccination.  Patient required treatment with a beta blocker (Bystolic 5mg).  Pt took only 1 dose.  Had EKG done at MD office.  Pt stated HR approximately 60 normally and 93 when experiencing symptoms.
Patient stated they were vaccinated fully but presented to ED and tested positive for COVID-19 on 8/22/2021.
Vomiting, diarrhea, loss of appetite, sleeping issues, fussiness, low grade fever, hives, skin rash(eczema).
Patient experienced a cryptogenic cerebrovascular accident while on a road trip on 9/23/21, seen in an hospital, with a right MCA vessel occlusion. Received tPA with improvement in symptoms. Placed on Plavix, aspirin, lipitor. Feels 85% back to normal with some right-sided residual symptoms.
Three days post vax, pt developed diarrhea & gen maculopapular rash.
pt states after he got 2nd dose he became hot, itchy and developed small hives that merged together that became a rash that went from his legs to his arms and eventually his mouth around the lips.  Pt is taking Prednisone 20 mg and fluocinonide 10% and triamcinolone cream which is helping about 50-80%.  Pt will continue to take this meds until he sees his PCP on 3/12/2021.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Starting 15 min post vaccine administration, my face, tongue and throat felt numb. This resolved after 5 hours. On the 7th day post vaccination, I developed a bright red rash around the vaccination site. It did not hurt or itch but was hard to the touch. My face and ears were also bright red. I felt hot and was sweating more than usual. This lasted 48hrs and then cleared up. No medical interventions were implemented.
Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; Patient had full forth dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and ACCIDENTAL OVERDOSE (Patient had full forth dose) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Jun-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and ACCIDENTAL OVERDOSE (Patient had full forth dose). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and ACCIDENTAL OVERDOSE (Patient had full forth dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. On 08Jun2022 vial moved from freezer to refrigerator. Excursion duration 15 min. The vials stored in Fridge quarantined and was thawed. The vial first punctured on 15Jun2022 at 9.15 AM. The vial stored in portable fridge. The vial undergone 1.9C to 6.4 C temperature excursions. Treatment information was not provided.
Swelling, redness, tenderness around injection site, patient states swelling has diminished over past 48 hours, no treatment provided, will continue to monitor.
headache and body aches night of shot. Took one acetaminophen before bed at 10:00pm.  Bad night of sleep.  Woke up next day with headache, body ache and blurry peripheral vision issue with right eye. Took another acetaminophen and slept more.  By the 8pm on Thursday the headache and body aches were gone.  Eye issue continued. Applied saline drops to the eyes over the weekend.  No change. Monday morning placed a call to Ophthalmology.  Dr. saw me that day.  He said the eyes looked healthy.  Thought it could be inflammation in the eye muscles.  Suggest taking Aleve for 2 days and come back on Wednesday (4/7/21). No change in blurred vision. Suggested I get in touch with my primary doctors office.  Saw the NP today.  He is prescribing a steroid.
fever; Chills; Body aches; extreme lethargy; exhaustion; Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, chills, general body pain, lethargy, exhaustion and incomplete course of vaccination. On an unknown date, the outcome of the fever, chills, general body pain, lethargy and exhaustion were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, chills, general body pain, lethargy and exhaustion to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had the 1st dose in mid of April 2019. The patient experienced fever, chills, body aches and extreme lethargy and exhaustion after 1st vaccination. The patient was curious because the side effects were pretty bad and meant 36 hours of down time. Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient asked If missed the 2 to 6 months window for my 2nd dose of Shingrix, do I have to get the 1st dose again and then get the 2nd dose within 2-6 months after that.
I contracted COVID-19 on 06/28/2022 with symptoms of rattling in chest, congestion, fever of 100.9, body aches, and fatigue. I was prescribed PAXLOVID on 06/30/2022 and had a bad reaction so I did not take more than one dose. I was ill for 7 days before my symptoms began to resolve. I have fully recovered with no lingering symptoms.
Within 10 minutes: lightheaded, dizzy. Within 20 minutes: redness at injection site, global congestion, angioedema.
Patient received influenza vaccine 9/30/16 and developed decreased grip strength in left arm starting the following morning. Later in the day on 10/1/16, patient developed decreased right arm grip strength. Patient was hospitalized and on 10/2/16, patient noticed weakness in left quadricep. Patient was ultimately diagnosed and treated for Guillain-Barre Syndrome that was thought likely secondary to the influenza vaccine.
Local reaction at the injection site / swelling/horrible reaction after vaccination; Local reaction at the injection site / severe pain/horrible reaction after vaccination; Terrible reaction in her arm / it was very very painful; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mastectomy bilateral and lymph node excision.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site pain and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by a nurse. Patient identifiers other than gender were not provided. Date of first dose, batch number nor expiration date was provided. The patient developed a local reaction at the injection site which included swelling and severe pain. Patient had a terrible reaction in her arm. She had severe swelling. Her entire arm swelled up from her upper arm and it was very very painful and took a long time to go down. Vaccination was done in a different facility.  The second dose had not been administered yet and nurse wanted to verify if there was any other injection site apart from the arm.  Patient had a double mastectomy and lymph nodes removed and patient thought that might have contributed to her reaction in her arm.
Had a golf size ball redness around vaccine - woke up in the middle of the night around 4am with a massive headache. Headache stayed for 6 hours - had headache next day in the middle of the night again - took ALEVE - for 7 days - never had a reaction before - also redness around vaccine & hot to touch. Used ice packs for 2 days & ALEVE relieved headache & swelling.
Tightness in chest, chest congestion, can't take a deep breath, extreme nasal congestion, little or no swelling at injection site.
Patient developed substernal chest pressure 5/10 Patient was given Benadryl 50 mg IM  Immediately  Continued observation Patient then developed nausea and continued chest pressure 5/10  Given  Dexamethasone 4 mg IM at 10:30  Continued observation Patient then developed some eyelid edema and upper lip fullness Patient given Epinephrine 0.3 mg IM at 10:43 am NO trouble breathing  NO tongue swelling No throat tightness
Llittle bit sore left arm; Urinary infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary infection) and VACCINATION SITE PAIN (Llittle bit sore left arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030120A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced URINARY TRACT INFECTION (Urinary infection). On an unknown date, the patient experienced VACCINATION SITE PAIN (Llittle bit sore left arm). At the time of the report, URINARY TRACT INFECTION (Urinary infection) and VACCINATION SITE PAIN (Llittle bit sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient needed to take ciprofloxacin since today for urinary infection.  No treatment information was provided.   Reporter did not allow further contact
3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal swab was positive for SARS-CoV-2 and she was diagnosed with COVID-19.  3/17 She presented to ED w/ cough, HA, weakness and decreased appetite. Room air pulse ox was 88%. She was found to have bilateral infiltrates on CRS and was hyponatremic. She was admitted to the hospital on oxygen and decadron.. On 3/18 she was weaned off oxygen. She was discharged to home on 3/19 to complete a 10 day course of decadron.
vomiting; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 08May2021 (at the age of 64-years-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced vomiting on 08May2021. But because he takes other essential medication, he needed to be admitted to the hospital. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 09May2021. Therapeutic measures were taken as a result of vomiting. The event was assessed as serious, hospitalization. The outcome of the event was unknown.    No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Feeling like I had covid for 12 hours and then having fever 3 or 4 days later for a couple of hours twice. That's all I remember, the vsafe app is better  to look at because I reported it there.
Covid-19 5yr-11 dose diluted with sterile water for injection not normal saline for injection.
This initial spontaneous report was received from a Certified Medical Assistant (CMA) referring to multiple patients (ages and genders not provided). Medical history and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA, ROTATEQ and RECOMBIVAX HB (lot numbers not provided). Temperature: 47 to 77 degrees Fahrenheit. Time frame: 3 hours. Previous temperature excursion: No. The CMA called because of a data logger. No adverse effects were reported. Additional information has been requested.
This is a spontaneous report from a non-clinical study program for a contactable consumer reporting for his wife. A female patient of unspecified age and ethnicity received PREVNAR 13, subcutaneously in the middle of the arm, on unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. According to all the information available the patient should have been given the vaccine in the deltoid but in fact was given subcutaneously in the middle of the arm. On unspecified date the patient experienced rash with outcome of unknown. Follow-up (19Mar2015): Follow-up attempts completed. No further information expected.
This spontaneous report was received from a pharmacist, who was also the patient's father, referring to his daughter, a female patient of unknown age. The patient's pertinent medical history and concomitant medications were unknown by reporter. Concurrently, she was sensitive to mosquito bites and had food allergies. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). On unspecified dates, the patient experienced adverse events after vaccination with GARDASIL 9; she was more sensitive to mosquito bites and food allergies. It was unknown if the patient received treatment for the adverse experiences, if she sought medical attention or if any laboratory study was performed. At the reporting time, the outcome of allergy to arthropod bite and food allergy was unknown. The causality assessment between the aforementioned adverse events and GARDASIL 9 was not provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Hep B carrier" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies opoids, reaction(s): "Known allergies Opoids", notes: known allergies: Opoids.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient previously receive a COVID-19 Vaccine. Paxlovid treatment started from 19Nov2022 to 23Nov2022. Device Date: 02Dec2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
A 72 year old male pt was treated with Oncotice since 5/27/05 for bladder cancer. After his first instillation, he experienced a 4 deg C fever, chills and hematuria on 5/30/05. The fever, chills and hematuria lasted for only 24 hours and resolved after taking acetaminophen. After his second instillation on 6/3/05, he experienced a high blood pressure and nausea on 6/4/05. The high blood pressure was regulated by changing the consumers blood pressure medication from Quinapril to Enalapril. The nausea continued to recur after every instillation of Oncotice and lasted for two to three hours. A gastroenterological examination revealed a tiny hiatal hernia and a tiny colonic polyp, all other investigations were normal. Zofran was described for the nausea, but reportedly the pt was non complaint. Acetaminophen.
Patient received a dose of TDap, before her dose was due, patient's last dose was in 2016 and she received a  dose on 01-Apr-2020/ No AE; Initial information was received on 02-Apr-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 45 years old female patient who in 2016 received dose one of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) via unknown route in unknown administration site and on 01-Apr-2020 received dose two of the same vaccine (lot U6512AA and expiry date 31-Oct-2021), via intramuscular route in the left deltoid for prophylactic vaccination (inappropriate schedule of product administration)  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and INFLUENZA VACCINE (FLU) for immunisation.  It was an actual medication error case due to inappropriate schedule of product administration.   At a time of reporting no adverse event reported.  There will be no information available on the batch number of first dose of the product for this case.  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 and Module VI of the. 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.
a1c went up i had no idea until i saw something on social media and i was like that's what happened to me and now that i got my 3rd i see it for myself my eye site is a mess and i was doing fine until the vaccine numbness and tingling in fingers and toes my bottom of right foot went numb ringing in my ears brain fogs and this is every time i get my shot i have had all three
onset of erythema, swelling around inject site within 2-3 min, high pitched screaming
This is a spontaneous report received from a contactable reporter(s)  A 33-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: She has had COVID before. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "She has all the shots/they did a covid test and she is positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive.  Clinical course: Caller states that he had a friend, she texted him last night, so upset. 7 texts regarding the fact she felt lousy, horrible. She has had COVID before. She has all the shots and is up to date he states. She is 33 years old and feels lousy. She went to the doctor, they did a covid test and she was positive. She was going to the doctor today and she was very upset about that. he states. He said that he told her the shot does not say you won't get it, it prevents you from dying and that's what it boils down to not dying.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.