chrisvoncsefalvay/vaers-outcomes huggingface dataset:
complain of chest pressure and numbness of left arm blood pressure 183/116, 90,18, 100 % RA, ECG-NSR,  12 lead shows no ST elevation noted Patient did not want to go to hospital. Husband stated he would take her in personal care. Alert and oriented x4 - signed refusal
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:50 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient 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 44.67  No concomitant medications were reported.  The vial was initially stored in the fridge on 30-Mar-2021, moved to the clinic on 03-Apr-2021 and proposed beyond use date was 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 31-Mar-2021, at 08:00 A.M., the temperature recorded was 32 degree Fahrenheit and at 09:00 A.M., the temperature recorded was 32 degree Fahrenheit that has been reached by the vial.  On 03-Apr-2021, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Patient developed itching and hives initially only at injection site which resolved but several days later, itching and hives appeared over various parts of body.
arthritis flared up; rash; headache; muscle pain; tired; cold; warm; ringing in her left ear; dizzy; Lethargic; A spontaneous report (United States) was received from a Consumer who is a 69-years-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cold symptoms, feeling warm, ringing in her left ear, rash, headache, arthritis flare-up, muscle pain, dizziness, lethargy, and tiredness.  The patient's medical history was not provided. Concomitant medications reported were Synthroid, singular, losartan, escitalopram, Vitamin D, Xopenex, Alvesco for unknown indication.  On 27-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 029L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 27-JAN-2021, the patient experienced cold symptoms, feeling warm, and ringing in her left ear. On 28-JAN-2021, the patient experienced rash, headache, arthritis flare-up, muscle pain, dizziness, lethargy, and tiredness.  Treatment was reported to include Advil.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, cold symptoms, feeling warm , ringing in her left ear, headache and arthritis flared, was resolved on 28-JAN-2021. The outcome of event muscle pain was resolved on 30-JAN-2021. The outcome of event rash was resolved on 01-FEB-2021. The outcome of events dizziness, lethargy, tiredness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a nurse prescriber referring to a 20-month-old patient of unknown gender. The patient's pertinent medical history or concurrent conditions were not reported. On 12-DEC-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R007693 (expiration date: 14-MAR-2020), subcutaneously for prophylaxis, which was reconstituted with a properly stored STERILE DILUENT. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 21 Fahrenheit degrees (15 to 45 Fahrenheit degrees) for a timeframe of 8 hours. It was found because of a digital data logger and there were no previous excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1812USA012876.
Administered Bexsero after exposed to 29.8 F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 459MC, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The Medical Assistant reported that the patient received Bexsero vaccine which was exposed to 29.8 F. The reporter consented to follow-up via mail. Additional supportive information: The Bexsero vaccine was exposed to temperature 29.8 F, which led to incorrect storage of drug. This was one of the 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022132076:Same reporter. US-GSK-US2022132079:Same reporter. US-GSK-US2022132075:Same reporter. US-GSK-US2022132078:Same reporter.
Approximately 12 hours after injection, my psoriasis was "on fire" so bad that it woke me up. The pain was pretty severe for about two hours. I never have this type of pain unless I am having a psoriasis outbreak, which I was not experiencing at the time of injection. It seems as if the injection  "woke up" my psoriasis.
Employee stated her arm started to itch later the same day she got the immunization and then by the two days the itching had spread all over her upper and lower torso.  She took Benadryl at home but it was not helping with the itching.
This case was reported by a healthcare professional and described the occurrence of viral infection in a subject of unspecified age and gender who was vaccinated with hepatitis A vaccine (manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of Hepatitis A vaccine (unknown). At an unspecified time after vaccination with Hepatitis A vaccine, the subject experienced viral infection. The healthcare professional considered that this was not an adverse reaction as other family members experienced similar symptoms. At the time of reporting the outcome of the event was unspecified.
On 09/24/22 I woke up with a scratchy throat and sneezing, I tested with a home COVID-19 test, it came back positive. On 09/26/22 I started using an inhaler, I had fevers, chills, diarrhea. I also used FLONASE nasal spray as needed. I went to the doctor's office in the beginning of November and started a 10-day course of prednisone and another month of using the oral inhaler for the lingering cough. I just went to see my doctor on 12/05/22 and I am taking another 10-day course of prednisone and I have been switched to a different oral inhaler. I also had psoriasis on my torso, my doctor says my body is reacting to the virus.
COVID 19 Treatment; COVID 19 Treatment; J&J vaccine dose: 1; J&J vaccine dose: 1; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2021 as dose 2 (booster), single (Lot number: FH8020) and on 16Sep2022 as dose 3 (booster), single (Lot number: GJ2524) at the age of 27 years for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 23Mar2021 as dose 1, single (Lot number: 1808609) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "bipolar disorder (1)" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergies to cats" (unspecified if ongoing); "allergies to dogs" (unspecified if ongoing); "allergies to horses" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE HCL; ADDERALL; LAMOTRIGINE; BUDESONIDE nasal; TRELEGY ELLIPTA; AZELASTINE HYDROCHLORIDE; NORETHINDRONE ACETATE; EMGALITY [GALCANEZUMAB]. Past drug history included: Verapamil, reaction(s): "Known allergies: Allergic to verapamil". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 16Sep2022, outcome "unknown" and all described as "J&J vaccine dose: 1"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: 12 days after my initial positive test I am still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Antiviral details, Treatment start date: 26Sep2022, Treatment stop date: 30Sep2022.  No follow-up attempts are possible. No further information is expected.
MOM STATED DAUGHTER WAS DIZZY AND FELL IN THE STORE. A CHAIR WAS PULLED UP FRONT FOR THE PATIENT TO SIT DOWN FOR 10-15 MINUTES.  MOM GAVE PATIENT GATORADE, WE ASKED IF SHE WOULD LIKE US TO CALL EMS AND SHE DECLINED. WHEN WE WENT BACK TO CHECK, MOM AND PATIENT HAD ALREADY LEFT.
Child received MCV4, Tdap without noticeable change in mental status. Upon administration of Human Papilloma Vaccine, patient's eyes rolled up and she began to slump from chair. She was caught and placed supine by paramedics. Per (paramedic administrators), "As soon as she was supine, she opened her eyes and began conversing with us". There was no alteration of her mental status from that point on. Patient was monitiored for another 15 minutes and was then allowed to leave. She was alert and oriented appropriately; color was good; gait was steady; speech was clear. Subsequent attempts to follow-up with patient's family revealed a non-working phone number.
Pregnancy test negative at time of administration, recently found out pregnant. EDD 12NOV2018. No specific adverse event. Needs to be added to registry for Anthrax and Smallpox vaccination in a pregnant patient.
the evening after 8 days of receiving my vaccine, my left arm around the shot site began to get sore and became swollen to about the circumference of a soft ball. A rash appear in the area. I did feel fatigue all day.  This is the next day.  The rash is gone but the area is still sore, red, hard, and swollen.  I have no fever.  I feel no fatigue. I had no side effects at the time of the shot except for a sore arm for a couple of days and I also felt cold the first day. I just want to report this side effect that hit me last night. I plan on icing and taking Advil.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 months old patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck) (lot J009002, expiration date 19-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Rash lasted four days. Less than 50 pox on whole body. Unknown fever for 2 days. Took Advil for 2 days.
Pt received FLUMIST 11/13/14 at approx 9 AM on car ride home pt noted chest pain, coughing went to school and noted wheezing by school nurse; pt came back to office, started PROAIR inh for wheezing.
This spontaneous report was received from a health care professional refers to unspecified patient of unknown age and gender. On 18-MAR-2016 the patient was vaccinated with second dose of improperly stored PROQUAD (Merck) immunization series (dosing regimen unspecified) (lot # L040411, expiry 13-APR-2017). Excursion details are as follows, which were exposed to the following conditions, were administered to the patient: temperature: 14.7 F, Time frame: 6 hours 42 minutes, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
mom reported pt was white & would not respond for about 15min;mom called EMS but pt responsive @ that time & p/speaking to MD decided ER visit not necessary;t104.11PM;mom cancelled appt scheduled for 5FEB97;pt seem much better;
not being able to smell anything/Cannot smell anything; Sinus issues; Cough; Congestion; Feels hot; backache; fatgue; headache; This is a spontaneous report received from a contactable other health professional (who is also the patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm, on 15Dec2020, at single dose, for COVID-19 immunization. There was no medical history. The patient's concomitant medications were not reported. The patient reported that she got the COVID vaccine last Tuesday, on 15Dec2020. She is a psychologist and works close with patients all the time. She has had symptoms since last Wednesday (16Dec2020). She clarified that her symptoms were back ache shortly after the vaccine, fatigue, headache, sinus issues and cough. Then her backache went away. She also had congestion and felt hot on 16Dec2020. She had an appointment last Friday (18Dec2020) and they took her temperature, but she did not have a fever. And then since yesterday (20Dec2020), she cannot smell anything. She has a baby and cannot smell the dirty diapers. She cannot smell her perfume. She asked other people who received the vaccine if they experienced this, and they did not. She was wondering if this is the vaccine or does she possibly have some other infection or should she get tested for COVID or is it possible this is from the vaccine? The patient clarified that at first her back ache went away but it is still ongoing now. It has persisted at the same level as well as all of the other symptoms. The outcome of the events was not recovered.
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not provided. It was reported that since 17-JAN-2017, the patient have been administered doses of improperly stored RECOMBIVAX HB injection (lot # reported as  M036156, expiration date 23-FE-2019) for prophylaxis (strength, dose and route were unknown). On an unknown date, the vaccine was stored to a temperature excursion between 0 Celsius degrees and 2 celsius degrees for 48 hours. There was no previous temperature excursion. The call as made because of a digital data logger. No adverse effects reported. This is one of several reports from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA013818: US-009507513-1701USA013819: US-009507513-1701USA013820: US-009507513-1701USA013821:
Test: Nasal Swab, Result: positive; Test: Nasal Swab, Result: positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3248), on 24Mar2021 as dose 2, single (Lot number: EL3248) and on 28Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa Drugs" (unspecified if ongoing), notes: known allergies: Sulfa Drugs. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 14Oct2021 as dose number unknown, single. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin, Sulfa Drugs", notes: known allergies: Augmentin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "Test: Nasal Swab, Result: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive. Clinical course: Other vaccine 4weeks details: other vaccine 4weeks product: Flu Vaccine. Other vaccine 4 weeks vaccine date: 14Oct2021. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Device Date : 02Jun2022.
Within 5-10 minutes after administration of the vaccine the patient started experiencing diaphoresis, nausea, headache and slight chest pressure.  Pt denied dizziness, SOB, cough, swelling in face/tongue/throat or rapid heart beat.  Pt given juice and monitored.  Pulse was normal.   After waiting an additional 20 minutes patient continued to have same symptoms with extra attention to headache and nausea.  Pt did mention she had not eaten normal qty's and was poorly hydrated on day of vaccine.  Pt was able to leave clinic/pharmacy on own with no further intervention.
Inappropriate schedule of vaccine administered; sore were with all covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore were with all covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 62-year-old 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 Psoriatic arthritis.    No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (sore were with all covid-19 vaccine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In 2021, VACCINATION SITE PAIN (sore were with all covid-19 vaccine) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported. 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.   This case was linked to MOD-2021-625693 (Patient Link).
Patient came in to receive her booster dose of Pfizer. Vaccinator went to get Pfizer vaccine, but misheard instructions of where vaccine was located. Took a Moderna vaccine and vaccinated patient. Lead/Mixer realized when counting that count was off and called Supervisor. Informed patient and discussed what happened, how it would be prevented in the future, and the CDC information about mixing and matching vaccines for booster. Took patient's email address and emailed her information directly from the CDC about mixing and matching vaccines.
tired and fatigue, soreness in arm on first day, diarrhea,sore knee, magnified any type of pain he initially had:shoulder pain as well
7 days following 2nd  vaccine I developed a rash (measles type). It spread around my torso. This began on Sunday evening, no itching or other symptoms. By the evening of the 24th I started a fever and the rash continued to spread on my torso. The 27th the rash started to fade but is very itchy and the low grade fever has continued until present. Also very tiered.
01/10/22 presents to EC ED for "worsening dyspnea". PMHx of "COPD on 3L home O2, HFrEF (last EF 60% in September), HTN, and pulmonary HTN"
Patient saw dr. and he did not advise treatment told patient was normal reaction and would go away, but that the pharmacy needed to report it.
Redness, heat, swelling and itching at injection site (left arm). Did not treat. Cleared on it's own 4 days later.
At the time of administration, there was a sharp pain at the shot location which felt internal. I could not lift my arm without extreme pain for one week. For 12 hours after administration, I experienced fever, chills, body aches, and sharp pains shooting down my extremities. Arm pain in the shoulder/deltoid area (area of injection) continues to current day, approximately 3 weeks after injection. I?ve been to an urgent care facility who believes my nerve was affected by the injection needle. Additional testing and treatment may be needed if not healed within one week.
Shortly after receiving flu shot, I developed flushing, dizziness, throat tightening, and nostrils closing, as a result had difficulty breathing and unable to continue working.
Pfizer 2/3/21, 3/24/21. Positive on 2/3/22
Rec'd one dose Varicella, 48hrs later injection site red & swollen, then painful red welts on entire body. Patient also experienced nausea and dizziness, fatigue.