chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 02:00, the subject experienced body aches. On 08-APR-2021 02:00, the subject experienced fever. On 08-APR-2021 02:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on APR-2021, and the outcome of fever and headache was not reported. This report was non-serious.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa and Crohn's disease.    Concurrent medical conditions included Crohn's disease and Hidradenitis suppurativa.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt received her vaccine in her L deltoid at 3:26PM 04/10/2021. At 3:38PM, the Pt alerted Observers that she felt dizzy and warm. Pt was assisted to one of the cots for assessment. Vitals at 3:40 (138/88BP, 126P, 32RR, 97%). PT's skin was warm, dry, and of normal color. Pt's skin turgor was normal. When assessed, the Pt's tongue was moist and did not appear cracked, therefore, poor hydration was not a differential diagnosis. Pt stated she had only had a candy snack approximately 2 hours prior to the incident. Secondary to this information and the Pt's complaints, the Observer deduced a low BGL was the cause of the Pt's symptoms. Pt was given 15g of oral glucose, and self administered 350ml water orally. (Cont. Pg 2)    A Glucometer was not available, so Pt's BGL was not able to be assessed. VS at 3:50(136/78, 80P, 18R, 100%) Pt stated feeling improved.  Pt stated she did not want any further EMS assistance or to be transported to the ED.  Pt was assisted outside of the facility by Observer. **All care occurred without complications.** **All times are approximate secondary to Pt care being paramount**
My toes have been numb or tingling for the last three days. I either don?t feel them or they?re extremely tingly so I can?t sleep well. My legs are tingly - like when you?re trying to wake your legs up after they fall asleep. On 4/20/21 the day I got the vaccine my legs were convulsing and my body was forcing itself to stretch out & when it did my whole body shook. My legs have been constantly tingling since and it hasn?t stopped in over 3 days.
5 days after receiving the vaccine I developed cutaneous hyperesthesia where my skin hurts to touch. This so far has lasted 11 days.
Tested positive for COVID-19 a year after vaccine. Called doctor, but wasn't prescribed anything for COVID-19.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). It was reported, that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from the physician on 16-OCT-2017. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided). It was reported, that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. This is one case from several cases from the same reporter. Follow up information was received from the physician on 16-OCT-2017. The patient was 16 months old. On 16-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # M046140). The patient's identifiers and the patient's guardian's identifiers were provided. Sender's Comments: US-009507513-1709USA007325.
patient received the second dose shot in the left arm, it was sore next few days; This is a spontaneous report from a contactable consumer (patient). A 53-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in the left arm on 18Mar2021 15:00 (batch/lot number: EP6955) at 53 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included diabetes and high blood pressure, both from 2017 and ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in the right arm on 25Feb2021 15:00 (batch/lot number: EN6202) at 53 years old, as DOSE 1, SINGLE for COVID-19 immunization and experienced shoulder pain, right arm still hurts (pain in arm), can't throw a ball or move arm quickly (mobility decreased), with limited range of motion at times (joint range of motion decreased). The patient received the second dose shot in the left arm, it was sore next few days (in Mar2021) and then went to back normal. The patient recovered from the event on an unspecified date in Mar2021.  Follow-up attempts are completed. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: stabbing pain in back running down spine, from shoulders to lower back-Severe, Systemic: Shakiness-Medium, Additional Details: Patient presented with lightheadedness about 3 minutes post dual vaccination.  Patient was sitting in walker while complaining of lightheadedness when back muscle pain occured.  Ambulance called at daughter's request.  Patient was checked out by the local fire department within 5 minutes of 911 call.  Patient stabilized and left store with daughter.  Pain subsided after 10 minutes with paramedic checking vitals.
After the vaccination I experienced a rash in different spots of my body like my legs and stomach. I also had a very severe itch.
Information has been received from a 63 year old male consumer with herpes simplex who about two months ago, was vaccinated with a 0.5 mL first dose of VARIVAX (Merck). The patient received a 0.5 mL second dose of VARIVAX (Merck) on an unspecified date. Concomitant therapy included acyclovir. A month later the patient had a titer test done and it came back negative. At the time of this report the patient had not recovered. The patient sought unspecified medical attention. Additional information is not expected.
Redness / around the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2020, the patient received Shingrix. On 7th November 2020, 4 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient had reported the event for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received vaccine on Tuesday and on the day of reporting in morning he/she developed redness about the size of a softball around the injection site. The consent to follow-up was not required.
Swollen and painful lymph nodes in left armpit; Swollen and painful lymph nodes in left armpit; This is a spontaneous report from a contactable other hcp (patient).A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 (at the age of 46-years-old), as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history of the patient was not reported. Concomitant medications included colecalciferol (VITAMIN D 3,50000 IU) taken for an unspecified indication, start and stop date were not reported; omeprazole (PRILOSEC) taken for an unspecified indication, start and stop date were not reported. The patient did not have any allergies to medications, foods or other products. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had tested for COVID-19 as well. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 13Mar2021 at 17:00, the patient experienced swollen and painful lymph nodes in left armpit.The patient did not received any treatment for the events reported.The patient underwent lab tests and procedures which included nasal swab test on 30Jan2021 and the test result was found to be negative. Outcome of the events were reported as recovering at this time of the report.  No follow-up attempts are needed. No further information is expected.  Follow Up (25May2021): The following information was updated reporter, VAERS Primary Reporter Addl Qualification updated to patient,Age/Units captured as 46 years per event's onset:13Mar2021. relevant medical history none, for both events: Treatment Received  captured No Vit D, recoded as VITAMIN D 3, PRILOSEC recoded as PRILOSEC [OMEPRAZOLE] concomitant medication reported.
5 year old moved suddenly before shot was given and scratched his left arm.Vaccine was administered in right arm. Patient said it did not hurt at all.  Patient is ok. Followed up with mom. patient is ok.
The morning after getting vaccinated my armpit got swollen almost the size of a tennis ball. It has been like that after 2 days of vaccination. It feels bothersome and a little painful scale 3. I experience this SE after the 2nd dose with the same vaccine.
This spontaneous report as received from a registered nurse refers to a 14 year old female patient. On 10-AUG-2013, the patient was vaccinated with the first dose of GARDASIL injection, 0.5 ml, intramuscular. The second dose of GARDASIL on 20-OCT-2011 and the third dose of GARDASIL on 25-OCT-2013. No adverse effect reported. Additional information has been requested.
First fever and body aches day 2.  On day 5 developed a stroke and later developed Bell's Palsy.  Hospitalized because of this.  Currently moved to a rehab hospital.
Very sore arm by pm. Today 4/28/21 I am running temp 99 and now 100 via ear. Achy, chills, tired. I had a colonoscopy done Monday 4/26/21 and did fine.  Just want to stay in bed. Not yet feel need to call doc or be seen at ER.
had the shot to prevent the Shingles / had the Shingles.it was Hell.n it was almost two solid months; my back was just burning / some time it will burn; some time it will / itch; couldn t wake up till noon ..drinking several cups of cafene coffee; had the Shingles.it was Hell.n it was almost two solid months; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation, pruritus and hard to awaken. The patient was treated with coconut oil, naproxen (Aleve) and ibuprofen. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, pruritus and hard to awaken were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and hard to awaken to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received Shingles vaccine and 30th November patient back was just burning and patient Shingles.it was Hell and it was almost two solid months. after some time it will burn and itch. The patient found coconut oil relieves it the best. It's been quite a year the medical field just want to prescribed capenpendan patient took it bonce and  couldn't t wake up till noon. The patient drinking several cups of caffeine coffee and refused and over dosed on Aleve n ibuprofen. The patient kept track and wrote if down when and  how much he/her took. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided
felt high and giddy; felt high and giddy; tested Positive for PCP in her blood test; had a rushing sensation comparable to an IV rushing into her veins/ felt weird; 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 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Event:She mentioned that it felt weird and that she also felt high and giddy after the 1st and 2nd dose), for Covid-19 immunization. The following information was reported: EUPHORIC MOOD (non-serious), DIZZINESS (non-serious), outcome "unknown" and all described as "felt high and giddy"; BLOOD TEST ABNORMAL (non-serious), outcome "unknown", described as "tested Positive for PCP in her blood test"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "had a rushing sensation comparable to an IV rushing into her veins/ felt weird". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient mentioned that it felt weird and that she also felt high and giddy after the 1st and 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
c/o SOB that began worsening 3x days ago. She also c/o dry cough, body aches, and wheezing, cxr clear. on home level of O2.
Developed tinnitus four days after first shot and this has persisted four weeks out.  Of note tested positive for COVID 3/29/21 (about three days before his first shot)
Information has been received from a registered nurse concerning a 1 year old patient who was vaccinated with a dose of varicella virus vaccine live.  Subsequently, 48 hours after vaccination the child developed a flat and red rash beyond the injection site on her arm and also on her trunk.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information is no expected.
This is a breakthrough case. I got COVID-19 from friends that I visit. I had running nose; mild cough; headache; low energy. Talk to my doctor she prescribed me Paxovid but I did not take it.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 57-year-old male patient who received SHINGRIX. Concomitant products included Blood Pressure Medicine (Unknown) and doxycycline. On 16th March 2018, the patient received SHINGRIX (intramuscular). On 18th March 2018, 2 days after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovering/resolving. The reporter considered the injection site swelling to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient had a course of doxycycline 15 days prior to the vaccination. The patient received SHINGRIX in left deltoid. The patient developed a 3 inch swollen red spot on his arm at the injection site.
Caller reporting an AE for PROQUAD being administered after an excursion that occurred on 4/25/2022.; This spontaneous report aws received from a medical assistant and  refers to a patient of unknown age. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.   On 25-APR-2022, measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (rHA) (PROQUAD), was exposed to -2 Celsius (C) during 1 hour and 12 minutes. Also, the vaccine had previous temperatures excursions: -10°C up to 8°C (7.3C) for 2 hours 37 minutes 0 seconds and -10°C up to 8°C (0.7C) for 2 hours 56 minutes 0 seconds.  On 03-MAY-2022, the patient was vaccinated with an incorrect storage dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (rHA) (PROQUAD), lot # U029319, expiration date 13-MAR-2023, 0.5 milliliter (route was not reported) (storage error) for prophylaxis. There was no product quality complain reported.  Thias is one of several reports form the same reporter.; Sender's Comments:  US-009507513-2205USA002635: US-009507513-2205USA002473: US-009507513-2205USA002581: US-009507513-2205USA002746: US-009507513-2205USA002531:
3:26 - OXYGEN SATURATION 99, PULSE 80. PATIENT STATED THROAT FELT ITCHY AND NOSE WAS RUNNING LIKE WHEN SHE GETS AROND CATS. 3,:30 - GAVE PATIENT WATER, TOLERATING WELL. NO COMPLAINTS OF CHEST PAIN, SHORTNESS OF BREATH, OR DIZZINESS. 3:40 -  PATIENT TOOK ZYRTEC, EXPLAINED TO ME THAT SHE HAS CALMED DOWN AND IS FEELING A LITTLE BETTER. I WILL CONTINUE TO MONITOR 3:50 - NO COMPLAINT OF BREATHING, JUST SINUS DRAINAGE IN THROAT. PULSE 88, OXYGEN SATRUATION 98. WILL CONTINUE TO MONITOR 3:55 - NO ANAPHYLACTIC REACTION NOTED AT THIS TIME, NO SWELLI G, NO REDNESS 3:57 - PATIENT GIVEN TEACHING ABOUT MEDICAL FOLLOW AT THIS TIME. IF SYMPTOMS GET WORSE TO GO TO THE EMERGENCY ROOM. IF NOT, TO FOLLOWUP WITH PRIMARY DOCTOR. 4:05 - PATIENT STATED STILL A LOT OF DRAINAGE (SINUS).  PATIENT HAS CALMED DOWN. OXYGEN SATURATION 99, PULSE 54. PATIENT DRANK MOR WATER, AND IS TOLERATING WELL. 4:15 - SPOUSE CONFIRMS THAT THIS IS NORMAL SEASONAL ALLERGIES AND PATIENT DEPARTED WITH NO ACUTE DISTRESS.
Severe joint and muscle pain overall and particularly severe in left hip and back. Could walk for at least two days. Better today but still limiting; some viral symptoms--chills, sniffles, dizziness. Better today, but still not gone.
big red warm spot/ red patch; redness at injection site; injection site warmth; This case was reported by a consumer via call center representative and described the occurrence of spot-like rash in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th May 2019, the patient received Shingrix. On 13th May 2019, 5 days after receiving Shingrix, the patient experienced spot-like rash, injection site erythema and injection site warmth. On an unknown date, the outcome of the spot-like rash, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the spot-like rash, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were reported as follows: At the time of this report, the patient was having a big red warm spot on her arm. The patient experienced red patch that was warm to the touch. The patient wanted to know how long it would last. The pharmacist reported that Individual responses could vary, but the majority of general adverse events seen with Shingrix had a median duration of 2 to 3 days. Solicited adverse reactions were collected for 7 days after each dose. Some patients may continue to experience reactions beyond 3 days. Unsolicited adverse events were collected for 30 days after each dose.
Nausea began at 20:00 PM on 8/24/00, followed by extreme achiness, restlessness and insomnia. At 02:00-05:00 AM on 8/25/00, pt had fever and chills (low-grade fever of 102F). Upon waking, on 8/25/00, was lethargic with nausea, fever, body aches and was bed-ridden all day. On 8/26/00, there was slight improvement and pt stayed in bed.
FELT TIRED; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 80.286 kilograms, and height was 160.02 centimeters. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included no drug abuse, no known allergy. 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 20-MAR-2021 for prophylactic vaccination. Batch /Lot number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired on 20-MAR-2021. This report was non-serious.  Additional information was received from patient(16-apr-2021).The following information was updated and incorporated into the case narrative.  Height( 160 centimeter), weight (80.286 centimeter) Age group(over 65 year)
pt recvd vax; approx 6" diam erythematous area at inject site; area itchy; resolved w/in 2 days;