chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 07-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
There was no adverse event that occured.  Patient was given the HPV vaccine instead of the Flu. The correct flu vaccine was administered and the patient was notified. He had no follow-up questions but was told to reachout to the clinic if he had any questions in the future. The event was resolved that day.
Chest pain (likely cause from a gastro intestinal upset) - lasted approximately 2 months. Symptoms resided with use of famitodine.
After second vaccine developed low grade fever body aches that went away then two weeks after was out of work with a concussion for 3 months went back to work 1 month later so 4 months after my second dose I developed covid like symptoms negative flu strep covid told adenoids inlarged was seen by ent who put me on Gerd meds and Zofran then hospitalized month of June diagnosed lupus ms hashimotos and optic neuritis with general weakness pain rashes no family hx I'm aware of parents are deceased. Struggle to walk malnourished
Shot given 10/5 - large localized reaction 10/7 - red, swollen 6 inch area.
Pt c/o Left hand/finger tingling 15min after receiving his first dose.  BP 130/76, HR 63, RR 16, 98% on RA.  Pt mentating well and speaks in full sentences.  No CP, SOB, DIB, N/V.  NP monitored pt and pt stated that his condition is improving.  Pt stated that he was on his computer all day.  Possible carpal tunnel.  Wrist brace encouraged.  Stop repetitive movements until tingling subsides.  Pt stable and released from vaccination site.  Recommended that the pt follow up with their healthcare provider, follow up instructions provided.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 9:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 9:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 19.06.  Concomitant products were not provided.  On 28-Apr-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 28-Apr-2021. 4 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 28-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 AM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41, 4 PM: 40 and 5 PM: not provided.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt vaccinated w/Meruvax II developed arthralgia, maculopapular rash, desquamation of the hand, fever, sedimentation rate of 97.
2nd GARDASIL adm 7-11-14 - pt had physical with another office a routine CBC showed a platelet CT 50 - pt referred to Hematologist Dx with ITP rec. prednisone with improvement in CBC.
Pt with H1N1 shot given 11/19 - started with h/a / sore throat / fever 11/20 and tested positive for influenza A 11/23.
73 y/o female c/o severe pains, redness and swelling on the right arm after she had an Immunization of PCV 13 last week. She also had fever of 102, chills, feeling cold, +nausea but no vomiting, no shortness of breath, no throat tightening, no chest pains, no headaches, feels sleepy most of the time.  She has been taking Tylenol every 2 hours. Denies to have adverse reactions to immunizations in the past. Severe cellulitis of right arm. Post vaccination. Will send patient to ER for further evaluation.
Extreme Lethargy, stomach upset, headache, chills and low grade fever.  Symptoms lasted three full days with both vaccine dosages.
AFTER INJECTION, PATIENT DESCRIBED FEELING NOT QUITE RIGHT, EXPLAINED AS A "FOGGY" FEELING. PATIENT STAYED SEATED AND BLOOD PRESSURE WAS TAKEN. SYSTOLIC BP IN 160'S, PATIENT IS TYPICALLY NORMOTENSIVE. PATIENT DESCRIBED A TIGHTNESS/HEAVYNESS IN THE CHEST AND THAT LEFT ARM WAS SORE. PATIENT WAS MONITORED FOR APPROXIMATELY 40 MINUTES TOTAL. TOWARDS END OF OBSERVATION, PATIENT STATED SHE WAS FEELING BETTER. NOT DIZZY AND NO C/O CHEST DISCOMFORT. I PERSONALLY CHECKED ON PATIENT APPROX. 4.5 HOURS AFTER VACCINATION, PATIENT STATED SHE FELT FINE WITH NO COMPLAINTS OTHER THAN A SORE ARM. INSTRUCTED PATIENT TO FOLLOW UP WITH HEALTHCARE PROVIDER IF ANY ADDITIONAL SYMPTOMS PRESENT.
Narrative: Per chart review, pt contacted cal center approx 45 minutes after his 2nd dose of the Moderna vaccine. He reported throat swelling and chest pain that developed approx 30 minutes after vaccine dose at the hospital. RN at call center instructed him to go to nearest emergency department. Pt stated he was driving and near a hospital after he received instructions to go the nearest ED. No further information available at time of reporting.
headaches; This is a spontaneous report received from a non-contactable reporter. A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained..
This case was reported by a healthcare professional via sales representative and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced swelling injection site, fever, chills, pain and nausea. The pharmacist via sales representative reported that the hospital had several subjects have injection site pain, dermatologic reactions and respiratory type problems. The sales representative clarified with a nurse, that three subjects experienced adverse events, two of the subjects were previously reported (cases A0999291A and A0999318A). The nurse stated for the third subject (current case A0999643), a female was administered FLUARIX and had swelling at the injection site the size of a tennis ball, fever, chills, aching and nausea. No further information was provided. At the time of reporting the outcome of the events were unspecified. For the other two cases that were previously reported please see A0999291A and A0999318A.
The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I felt tired and chilled, without fever. After the third day, symptoms subsided and I was back to normal activity. On the 7th day following the vaccine, I began having pain in the armpit of the left side. It was painful to have pressure on the area and to raise the arm overhead. It progressed on the the 8th day with increased pain and tenderness to touch. On the 9th day, I had severe pain with palpation and could feel a lump in the armpit. I have no redness, heat, or rash in the area. I went to my physician with concern because I have had a double mastectomy two years ago.
chills; FEVER; Tired; Flu; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) once a total dose was not reported, administered on 26-MAR-2021 10:14 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced flu. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced tired. On 26-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 99.7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu, chills, fever, and tired on MAR-2021. This report was non-serious.
Chills, body aches, diarrhea, vomiting  and tiredness for 24 hours.
After around 12 hours from getting my vaccine, I experienced strong aches, mild fever, and headaches. Treated with ibuprofen. 21 hours post vaccination was the peak of the symptoms, temperature of 101.6 with ibuprofen, strong body aches, weakness, and anorexia. Symptoms became more mild at hour 31 post vaccine. I had a swollen lymph node after the first vaccine above my left collarbone (injected on left side) and still have this, and now I have a swollen armpit that is very painful on my right side (injected on the right side).
This spontaneous report as received from a medical assistant/practice manager refers to multiple patients of unknown demographics. Reporter stated that improperly stored doses of ROTATEQ (Lot # L038534, expiry date: 19-AUG-2017/Lot # reported as L042219, expiry date: 02-JUN-2017/Lot # M019706, expiry date: 24-OCT-2017/Lot # L033694, expiry date: 16-JUN-2017) were administered to the patients on unspecified dates (incorrect product storage). No adverse effects were reported. The outcome was unknown. Temperature and time frame was 65F for 65 hours. Data logger was involved. There were no previous excursions. Back in range: Yes. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine administered 3 days after expiration date of 10/10/21. Patient has no adverse side effects and was advised to repeat vaccine in 4 weeks.
Woman, 58 years old, in excellent health, 5'5" 130 lbs. Had second Shingrix vaccine on 1/18/20. Had mild side effects upon awakening the next morning which were helped with Advil. Was very tired during the day and continued to need Advil to mitigate the symptoms. The following nights about 30 hrs after the vaccine was administered, I experienced gastric discomfort, body aches, nausea, chills and had difficulty sleeping due to the discomfort I was experiencing. On the third day after the injection I got a rash on my Left wrist, right side of my neck and on my face. On day four I am not noticing any new rash developing but at the existing rash sites my skin is red, swollen, blistered and feels like it was burned.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, stuffy nose, no appetite, chills and fatigue. pain and swelling at the injection site.
Breakthrough case admission after 3 vaccines Pfizer 4/1/21 Lot# Ew0153;  Pfizer 5/21/21 Lot# Ew0183;  Pfizer 1/7/22 Lot# FL3209
sz activity x 15 secs on 8FEB95; seen in hosp ER by MD-CBC, UA & CXR done; had more szs 10-15 secs each on 9FEB95; rx'd w/IM phenobarbital; to get EEG in 1 month;
muscle pain in her lower right side of back; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of age 70 (unspecified unit)received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration on 20Feb2021 as 1st dose, single for COVID-19 immunization on 20Feb2021. The patient medical history and concomitant medications were not reported. On 23Feb2021, (3 days later), the patient experienced muscle pain in her lower right side of back. Caller asking if symptom has been reported? Also, if it's okay to take Acetaminophen.   E-TRANSMITING, AE Noted while documenting after caller was disconnected. The seriousness of the event was reported as non-serious. The clinical outcome of the event was unknown.  Follow-up information was received on 06Apr2021: Case closure was added in the narrative  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
pt seen by 9SEP92 by DR w/ c/o pain in the lt deltoid; has erythematous area w/sharp border 1/2 x 8cm; no fever, crying or other sx; treated w/DPH prn by mouth;
6/27/22, Fever 6/30/22 Fever, Developed widespread erythematous rash that was described as urticarial and involved palms and left upper extremity pain. Normal elbow xray 7/2/22: Fever, developed hand and feet swelling 7/3/22: Fever, Hand/Feet swelling improving, rash persistent 7/4/22:Fever,  developed left knee pain/ swelling and refused to bear weight. Rash resolved. Normal xray of the knee. 7/5/22: Afebrile, knee pain resolved and able to bear weight.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details, Paxlovid, treatment start date: 01Jun2022 and treatment stop date: 05Jun2022. Indication: Treatment of COVID-19. Rebound covid after taking paxlovid dose. The patient reported inhaler as treatment for the event. The patient has no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable physician via sales representative. This physician reported similar events for four patients. This is 4th of 4 reports. An adolescent (Age: 16-17) patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date, at single dose for immunization. The patient medical history and the patient's concomitant medications were not reported. The patient experienced arm pain, swelling and fever, all on an unspecified date with outcome unknown.
5 hours after received vaccines pt started with urticaria under her chin. Continued in different areas. No sign of illness. Temp 99.9. No difficulty breathing or vomiting. Resolved with benadryl.
Patient presented to the ER presented to the emergency department with a chief complaint of shortness of breath. He tested positive for COVID-19 previously and was scheduled to have a monoclonal antibody infusion. When he went to the clinic and he was noted to be hypoxemic so he was sent here for further evaluation.  Patient was complaining of generalized fatigue over the last 2-3 days.  The degree of hypoxia was not reported or charted at the outlying facility.  Patient denied any syncopal episode, chest pain, fever, chills, nausea, vomiting, diarrhea. Was diagnosed with COVID-19 recently, tested positive for COVID-19 and noted to be hypoxemic saturating 88% on room air in the emergency department.  Chest x-ray showed pulmonary hyperexpansion with bilateral code infiltrates.  He was transferred to the ICU as he developed pneumothorax, patient passed away on 01/06/2022.
Pt. described soreness at injection site, armpit, shoulder & back of upper neck, (T99.0) per pt. (all on (R)), s/s began on afternoon following injection. No treatment. Instructed to go to ER if s/s severe. Did not go to ER.
6 days p/vax pt was exposed to sun;5-6 small (3-5) white raised bumps noted @ immun site only;
Eye infection; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (Eye infection) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Plaque psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 31-Jul-2022, the patient experienced EYE INFECTION (Eye infection). At the time of the report, EYE INFECTION (Eye infection) was resolving.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality was possible for PFIZER BIONTECH COVID-19 VACCINE with respect to eye infection. Not applicable if the event was abate after stopping drug. No treatment medication was provided.
I had a typical reaction of fever and chills for 24 hours post vaccine. I had seemed to be fine, but in June 2021 I started having bad anxiety that was getting worse and worse. I had a physical in November 2021 and they did blood work and seen that my thyroid level had dropped, so they think that was causing it. I was getting hives all of the time for no reason since May 2021 and they still don't know what it was. Ibuprofen was making it worse so I stopped taking that. I get them randomly all over my body and they don't think it's any other allergies. They changed my medications for thyroid and the hives are still ongoing and chronic.
Information has been received from a Registered Nurse concerning a 0 day male baby patient. On 13-OCT-2010 the patient's mother was vaccinated IM with the third dose of GARDASIL (Lot# 666596/0766Z) (Expiration date: 15-OCT-2012). The patient's mother also received on the same day a third dose of RECOMBIVAX HB (Lot# unknown) (manufacturer unknown) and a first dose of AFLURIA (Lot# unknown) (manufacturer unknown). The nurse reported that the patient was born at gestation age of 36 weeks and 5 days. The baby boy was admitted to neonatal intensive care unit (NICU) for oxygen desaturation and was diagnosed with severe laryngomalacia. Epiglottis prolapsed was present as well. At the time of the report, the patient's outcome was unknown. The mother's experience has been captured in WAES# 1012USA02470. Additional information has been requested.
No adverse effects; improperly stored dose of PEDVAX and ROTATEQ; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications, drug reactions and allergies were unknown. On 18-NOV-2019, the patient was vaccinated with improperly stored (product storage error) haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) with lot # S006470, expiration date reported as 15-JAN-2021 but upon internal validation established as 15-JAN-2022 and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) with lot # R029818, expiration date 09-JUL-2020 (both suspect therapies dosing details, route, anatomical location were unknown). Both vaccines were at a temperature of 10.1 degree Celsius for a time frame of 1 hour. The previous temperature excursion was 10.6 degree Celsius for 15 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; This is a spontaneous report from a Pfizer sponsored program. This consumer reported adverse events with similar suspect for 4 patients. This report is One of four patients. This consumer (patient) reported that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated. Exposure could not have occurred before Monday 21Jun2021 and symptom onset (all positive tested individuals were symptomatic) was by 25Jun2021. We are all researchers and recognize the impossibility of this not being a variant. I am totally willing to participate in any studies that might help understand variants and the efficacy of the vaccine on them. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Jun2021. The outcome of the event Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated was unknown.  Information on the lot/batch number has been requested.