chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cataract on left eye; Poor circulation in legs; Fell; Headache; This is a solicited report from a contactable consumer (patient) via a non-Pfizer-sponsored program (Other Manufacturer Control Number: 21K-163-4088265-00).   Solicited report by a consumer of an adult (64-year-old) female with events of cataract on left eye and non-serious poor circulation in legs and fell four times and headache when getting bangs cut/attributed to a mineral allergy with Rinvoq (Upadacitinib). There was no reported medical history. On unknown dates, the patient experienced Cataract on left eye, poor circulation in legs and fell four times and headache when getting bangs cut/attributed to a mineral allergy. PFIZER BIONTECH COVID-19 Vaccine (Tozinameran) was also considered suspect. The patient had cataract surgery on her left eye. She had poor circulation in her legs, and she fell four times. She got a headache when getting her bangs cut, attributed to a mineral allergy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 15Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 19Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for upadacitinib was unknown. The patient had not recovered from the events.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of cataract on left eye, poor circulation in legs and fell four times unknown onset, poor circulation in legs and fell four times unknown onset, headache when getting bangs cut/attributed to a mineral allergy unknown onset and headache when getting bangs cut/attributed to a mineral allergy unknown onset was not provided. Opinion is that there is no reasonable possibility that the events of cataract on left eye, poor circulation in legs and fell four times unknown onset, headache when getting bangs cut/attributed to a mineral allergy unknown onset and headache when getting bangs cut/attributed to a mineral allergy unknown onset are related to Rinvoq (Upadacitinib). Opinion is that the event of poor circulation in legs and fell four times unknown onset is not assessable.  The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current information available, the event cataract mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. non-serious event headache was considered related.
shortness of breath, chest tightness, elevated blood pressure. Was sent to urgent care for further evaluation and treatment
Vial was open for more than 12 hours post puncture; Patient was administered booster dose from a vial that had been open for 24 h; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 8:02 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Apr-2022 at 8:02 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the booster dose of Moderna COVID-19 Vaccine.  No concomitant medications information was reported.  On 12-Apr-2022, the vial was initially stored in the refrigerator.  On 13-Apr-2022 at 8:00 am, the vial was first punctured and was administered on 14-Apr-2022 8:02 am. Post puncture the vial was stored in refrigerator at 4-5 °C. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8  to 25 degree Celsius = 46 to 77 F) was 30 min or less.  No symptoms were experienced by the patient.  No treatment medications were provided.
Temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Poor quality product administered; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 47-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine).    Concomitant medication was not provided.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
EVERYONE IS GETTING VERY SICK; This spontaneous report received from a consumer concerned multiple patients. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the subject experienced everyone is getting very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of everyone is getting very sick was not reported. This report was non-serious.
On the day of the injection 2/3/2021, the site was sore, red and swollen.  I also had a headache for 3-4 days afterwards.  The redness and swollen area went away.   Yesterday morning on 2/11/2021 (8 days after the injection) the injection site began to itch terribly.  Then the site turned red and irritated.  Last night, the site swelled and the red area and swollen area is the size of a baseball. It itches and is sore.
Patient was administered Pfizer as a 2nd dose. It was later discovered that the patient received Moderna as his first dose.
lasting nervous system issues; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (lasting nervous system issues) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (lasting nervous system issues). At the time of the report, NERVOUS SYSTEM DISORDER (lasting nervous system issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Quickly after got shot, called into room because mom said she wasn't feeling good. Nose was purple, hands got red and swollen, face pale and lips pale and just kept saying when asked "don't feel right". Pulse ox okay, no stridor, wheezing on exam. Talking without difficulty. Given BENADRYL po. Did give DECADRON once IM in office.
Few hours after injection my arm was sore. 24 hrs later there was no more pain. Mon feb 1st, 5 days after the vaccine my arm pit was swollen and sensitive. Feb 3 my arm pit is still swollen and tender and now my injection site is swelling, red, hot, and itchy.
left arm pain all the way  down to hand. and feeling  tired all this time but can't sleep. This has been going on since  date of vaccine. couldn't use left arm at all. until this morning (Wed) where  injection site is very tender.
Patient reports mild soreness to right upper arm at the injection site on 10/20/2021 at 7:15 pm.  On 10/21/2021 at 2:45 pm, there was no obvious warmth or swelling  noted on exam. There was positive point tenderness of right upper arm soreness on exam.
At exactly 24 hrs after the vaccine, I was at work, was seriously sick with elevated temp. my breathing was abnormal, cannot walk a block without resting, that was going on like 2 months. I took tylenol and a lot of resting period.
I had severe chills all night 8 Jan, was unable to get warm.  Then I had  fatigue, headache and body ache on 9 Jan.  Felt better on 10 Jan and each day I feel a little better.  I did not got to doctor.
Information has been received from a licensed practical nurse concerning a 4 year old female with no known allergies and a history of febrile seizures in December 1997 who on 07/01/1998 was vaccinated with a first dose of varicella vaccine SC in the left arm and a fourth dose of Hib-TITER IM inthe left thigh, Ael-Imune IN in the right thigh concomitantly. On 10/05/2001, the pt was seen in the office with a few "bumps" and itching after being exposed to three children in school with chicken pox. On 10/06/2001, the pt was seen for follow-up and a few more "bumps" were present wit one on the anus with a clear head. The pt remained afebrile. The pt was diagnosed with a "modified" case of varicella. The pt received medical attention for her experiences. The pt was treated with Benadryl or cyproheptadine HCL and Veeno. On 10/10/2001, the pt recovered. No additional info is expected.
Started getting fever about mid-day Monday after vaccine on Sunday. Fever got higher throughout day til 11pm when it was 101.4. Went to sleep, woke Tuesday morning with no fever, but fatigued. Also arm was very sore, including armpit. Injection site was a little itchy. Took Tylenol and Benadryl, feeling pretty normal by Wednesday 3/31/21 night.
dizziness; vertigo; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and VERTIGO (vertigo) 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.  Concomitant products included PALBOCICLIB (IBRANCE) from 21-Oct-2019 to an unknown date for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced DIZZINESS (dizziness) and VERTIGO (vertigo). At the time of the report, DIZZINESS (dizziness) and VERTIGO (vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided   Reporter did not allow further contact
Patient received second Hep A vaccine, remained in office for routine lead testing. After immunization was given it was noted that patient had a large red area of hives around the area of immunization, as well as hives on face and back. Provider examined patient and he was free of edema and and difficulty breathing. Hives resolved with Benadryl treatment
Per nurse practitioner ar dr office called re informed about this incident: Patient developed rash all over the body-sides right after the vaccination. No blisters. Itching is there. She is going to give him BENADRYL and SOLUMEDROL xfer him to primary care.
pt reported feeling nauseated and itchy in her throat. pt received vaccine in the clinic no reaction after 15 min. mother had an appt with NP, during moms visit she began with symptoms vitals takes and IM Benadryl administer pt observed for about 35 min post Benadryl pt felt better,
15 min after administration pt had visual disturbance seeing white vertical lines and white spiders dropping from the ceiling.
I have been diagnosed with dysfunctional uterine bleeding post-vaccine due to experiencing menstrual periods every 2 weeks since my first vaccination. This has continued since the initial dose, through the current date of 9/9. On 8/24 I was prescribed progesterone hormones to help regulate this issue. I have also been experiencing significant hair loss and brittle nails since about 2 weeks post second vaccination.
This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. Information regarding the multiple patient's concurrent conditions and medical history were not provided. The physician reported that multiple patients received RECOMBIVAX HB (Lot # J013394 with an expiration date on 25-AUG-2016) (dose and route were not reported). This vaccine was improperly stored. No adverse effects were reported. The storage temperature was 34F, the time frame: 120 hours and there was no previous excursion temperature. This is one of several reports received from the same reporter (MARRS # 1604USA008481). Additional information is not expects as the physician can not be contacted.
PT REPORTS HER ARM BECAME SORE AND PAINFUL THE EVENING OF 7/8/16. SHE CALLED A NURSE WHO TOLD HER THIS WAS NORMAL AND COULD TAKE 7 DAYS TO RESOLVE. THE ARM REMAINED VERY PAINFUL, ITCHY, DIFFICULT TO USE ARM AND DEVELOPED A LARGE RASH 5" X 4" THAT WAS VERY SWOLLEN. PT USED IBUPROFEN AND ICE TO SITE AND WAS RX'D ABX BY PCP AFTER 7/15 APPOINTMENT. PT REPORTS IMPROVEMENT TO SITE 7 - 10 DAYS AFTER THE INJECTION.
This spontaneous report was received from a nurse regarding a 17 year old patient of unknown gender. No historical or concurrent medications were reported. On 30-NOV-2015, the patient was vaccinated with a dose of improperly-stored GARDASIL (lot # K011562 and expiry: 08-APR-2017). This dose of GARDASIL was the patient's third dose in her HPV series. No adverse experience was reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Day after injection developed small, itchy water blisters behind knees. About 10 blisters behind each knee. They dried up and scabbed -over within about 3-4 days.
This spontaneous report as received from a licensed nurse practitioner (LPN) refers to an unspecified number of patients (demographic details are unknown). On an unknown date, the patients were vaccinated with GARDASIL. The dose and route were not reported. No other co-suspects and no concomitant medications were reported. On an unknown date, the patients received either their second or third dose of GARDASIL late. No treatment information was reported, The outcome of the patients received either their second or third doses of GARDASIL late is unknown. It was reported if the patients experienced any adverse events. Additional information has been requested.
As of 1/9/2021 upon waking, experienced low grade fever 100.1, and diarrhea, which has continued to this day upon waking at 7am on 1/11/2021
Hematoma in neck above collar bone and swelling in lymph node under right arm and around hematoma.
atrial Fibrillation with rapid ventricular response Narrative: Patient presented in Atrial fibrillation with rapid ventricular response within 24 hours of receiving second dose of MODERNA COVID-19 vaccine. Required inpatient hospitalization and IV anti-arrhythmic medications.
Vaccination failure; acute HAV infection; Incomplete course of vaccination;   This literature marketed report was received from authors of a published article, titled as above.  It refers to a 30 year old male patient with human immunodeficiency virus (HIV) infection. Information about concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route, lot # and expiration date were not reported) for prophylaxis (incomplete course of vaccination). After 13 days, the patient experienced acute hepatitis A virus (HAV) infection. Previous vaccination for hepatitis did not reliably provide protection among some persons with HIV infection (Vaccination failure). CD4 count before first HAV vaccine dose was 887 cells per cubic millimeter. HIV viral load before first HAV vaccine dose was 154 copies per milliliter. CD4 count before HAV infection was 779 cells per cubic millimeter. HIV viral load before HAV infection was 20 copies per milliliter. The patient received postexposure prophylaxis (PEP) consisting of 1 dose of monovalent vaccine at 7 days and immune globulin (IG) at 14 days after the latest possible exposure but developed illness 6 days after PEP was completed. The outcome of vaccination failure and hepatitis A was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of the several reports received from the same literature (link reports # 1905USA003825, 1905USA005761).; Sender's Comments:  US-009507513-1905USA003825:
Staff came back 1 hour post vaccine administration s/o tingling lips, tongue swelling, raspy throat. Started coughing continuously after 5 minutes. SpO2 95% Pulse 95 1448 - epi pen left thigh, benadryl 50 mg IM R deltoid Taken to ED
Information has been received from a physician concerning a 20 year old female patient with no allergies or medical history who on 09-NOV-2006, was vaccinated with the first 0.5 L, dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot unspecified). Concomitant therapy included penicillin.  On 09-NOV-2006, at 1:30 P.M., the patient developed chills and fever of 102.7 degrees on 10-NOV-2006 at 7:00 P.M.  The patient did not seek medical attention.  The patient treated herself with acetaminophen (TYLENOL). The patient's symptoms lasted until noon on 11-NOV-2006.  Additional information has been requested.
Basic headache and lethargy was expected and did occur. However I've had Lichen Planus for maybe 10 years. At date of vaccination I hadn't had a flare up or irritation in at least 2 years. Day after vaccination, and now day 3 after I've had a large flare up of my lichen planus. My Leg (calf) and penis (glans) very itchy and obviously broken out. I can't be only assume it's vaccine related.
An itchy, raised, warm-to-the-touch rash, a few inches in diameter, appeared at the injection site the week after vaccination.
minor muscle aches at the sight of the injection; minor aches/super minor aches; minor muscle pain; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot# EL3248), via an unspecified route of administration in left arm on 17Jan2021 10:30 at single dose for COVID-19 immunization.  Medical history included the patient had a spit of asthma since a child and she didn't have any trouble after the vaccine.  Concomitant medication included ongoing montelukast sodium (SINGULAIR) for asthma taking for 3 or 4 years.  Vaccination Facility Type: hospital. Vaccine Administered at Military Facility?  No. History of all previous immunization with the Pfizer vaccine considered as suspect: none. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. Prior Vaccinations (within 4 weeks): none. Family Medical History: none. The patient experienced minor muscle aches at the sight of the injection, minor aches/super minor aches, minor muscle pain, all on 17Jan2021 with outcome of recovering. Relevant test none. Investigation Assessment: No. She had some minor muscle pain and maybe some minor aches. Today was the day that you felt like you always do when you go back to work after being sick. She had minor muscle pain that was low grade right away, minor, started right away and consistent through today but not like it kept you up. She also had super minor aches, not feeling herself, but not bad in any way. The minor muscle aches started later on the 17Jan2021 at the sight of the injection, like a bruise. She is planning to receive the second dose on 07Feb2021. No event required a visit to physician or emergency room.
weak, fatigue, nauseaus, stomach pain, diarrhea, headache.  Diarrhea and vomitted last 24 hours.  All other symptoms continue to persist daily from that day up thru today.
The next day after vaccination patient called to report extremely red and sore arm around injection site and extending around into armpit. Patient had taken some tylenol, It was recommended to apply ice and take some benadryl as well.
Two days after vaccine, cheeks very red ,hot to the touch  resolved by evening. Nine days post injection  woken up by very painful, swollen, fiery red area around injection site on left arm. Tried taking allergy med, ibuprofen neither helped. It is now 2 weeks exactly since injection less erythema ,still slightly swollen and tender.