chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 65 year old male patient. The patient's concurrent conditions were not provided and his medical history included thrush. The patient did not have any drug reactions or allergies. In November 2015, the patient was vaccinated with ZOSTAVAX injection, (lot number, dose, route and anatomical site of injection were not reported). Concomitant therapies were not provided. On an unspecified date in 2015, after vaccination, the patient experienced a rash across his back, that was treated with valacyclovir hydrochloride (reported as "valcyclovir") for 7 days, starting on 08-DEC-2015. Later, he was treated with acyclovir for 10 days, starting on 27-DEC-2015. On an unknown date, the patient experienced pneumocystis jirovecii pneumonia that required him to be admitted in the hospital on 30-MAY-2016, where it was stated that he received treatment with LEVAQUIN and BACTRIM for this condition. On the same date, the patient was diagnosed to be human immunodeficiency virus (HIV) positive. No product quality complain (PQC) was involved. It was stated that no intervention to prevent serious criteria was necessary and that the adverse events were not significant disability or incapacity or life threatening. At the time of reporting, the outcome of rash was not recovered as the patient still had lesions on his back. It was also reported that the patient was still receiving BACTRIM for pneumocystis jirovecii pneumonia, however, it was unknown the outcome for this condition. The outcome of HIV test positive was unknown. The reporter did not provide a causality assessment between the events and the ZOSTAVAX. Upon internal review, it was determined that Pneumocystis jirovecii pneumonia was considered as other medically significant adverse event. Additional information has been requested.
10FEB APAP given @ 9PM t102, 11FEB APAP given 5AM & 1PM t102, non stop crying & screaming for 3hr on 11FEB;mom unable to comfort child;advised to discuss future DTP's w/PMD, inc fluids;
Mentally unstable patient who came into the clinic on 02/09/22 requesting for a booster dose. On the clinic record he only had Johnson and Johnson which was administered in  september, Unknown to the nurse he had taken pfizer in a different clinic which he talked about after the booster was administered.
Information has been received from a physician concerning a 6 year old female who on 13-AUG-2002 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck). Medical attention was sought. On 17-AUG-2007, the patient presented to the physician's office and was subsequently diagnosed with shingles. The physician reported that the patient "cleared up and was fine". The date of recovery was not reported. There was no product quality complaint. Additional information has been requested.
MULTIPLE BLOOD CLOTS IN LUNGS; MULTIPLE BLOOD CLOTS IN LEGS; This spontaneous report received from a patient concerned a 57year old female. 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: 82286 and expiry: 23-JUL-2021) dose was not reported, 1 total administered to left arm on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-JUN-2021, the patient experienced cough and fatigue. Two weeks later on 30-JUN-2021, the patient's feet and ankle started swelling. Two weeks later, the patient went to doctor. Her doctor took an X-Ray and everything was fine. Then the patient started having shortness of breath. On 14-JUL-2021, shortness of breath was pretty good and it got worse and the patient was taken to emergency room. On 01-AUG-2021, the patient was found to have multiple blood clots in lungs and legs and was hospitalized. The doctors couldn't determine why the blood clots developed. The patient was hospitalized for 3 days and was discharged on 03-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from multiple blood clots in lungs, and multiple blood clots in legs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210808076-COVID-19 VACCINE AD26.COV2.S- multiple blood clots in lungs, multiple blood clots in legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23. Additional information has been requested. Sender's Comments: US-009507513-1707USA009810: US-009507513-1707USA009900.
Patient experienced rigid fingers, nausea, fever, and stuffy ears about 8 minutes after the vaccine was administered. Patient was given a cold water bottle, an ice pack to place on her forehead, and bucket in case she needed to vomit. EMS was called right away. They arrived and checked her out. She was not transported to the hospital. She waited approximately for 30 more minutes and then felt well and left.
This spontaneous report as received from healthcare worker refers to a patient of unknown age (gender not reported). On 08-MAR-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB, intramuscularly (dose and lot number not reported). On 20-JUN-2013, the patient was vaccinated intramuscularly with the second dose of RECOMBIVAX HB lot # 668558/0894AA that was expired (exp. date 17-MAY-2013). No adverse events were reported with either dose of RECOMBIVAX HB. The patient's outcome was unknown. Additional information has been requested.
The vial was initially stored in refrigerator on 27-Feb-2023 and was administered on 03-Apr-2023; No adverse event; Adult patient received expired Bivalent Moderna COVID-19 vaccine, after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine, after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 27-Feb-2023 and was administered on 03-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Apr-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-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine, after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 27-Feb-2023 and was administered on 03-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine, after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 27-Feb-2023 and was administered on 03-Apr-2023) 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 EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine, after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 27-Feb-2023 and was administered on 03-Apr-2023).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. The 2.5ml vial did not underwent any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-718357 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718357:same reporter
She got her vaccine, when she first got it she was fine until 7:30 in the evening.  Her arm did hurt after the shot.  The pain then started gone into the palm of her hand first.  Around 9:00 PM the headache started coming.   The following day she called the doctor, the PA told her to take an allergy pill, so she did that, Loratadine.  It was still about the same, but Saturday she noticed that her skin was starting to peel.  Her calves were starting to peel, as well as her ankles and feet.  Then she started having whelps on her arms, lower arms.  They went on her forehead as well.  The whelps were red to touch and the one on her arm spread, got bigger but did not turn red.  The whelps have diminished in size, but are still present.  It is black, but not raised any more.  Her skin is peeling in that area as well.  Her legs are still peeling, calves are really bad.  She is putting lotion on them, medicated cream that she is using, also another cream that she uses.  The peeling is improving a little with the creams, but if she rubs her skin too much is starts peeling again.  She is calling to call her doctor next to discuss with him the peeling of her skin.    After she got the shot on Thursday night she has felt very irritable, loss of appetite as well.
Severe worsening pain. Severe edema spreading Arm twice the size. Severe red rash spreading over the past 24 hours since receiving vaccine.
Mild nausea; light headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, expiry date unknown), intramuscular at the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced mild nausea and light headache on 30Jan2021 08:00. Events were non-serious. No treatment was received for the adverse events. Facility where the most recent COVID-19 vaccine administered was workplace clinic. The outcome of the events was recovering. Events were non-serious.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a health professional and refers to unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patients were probably vaccinated with improperly stored doses of GARDASIL (dose, route of administration, anatomical location, lot# and exp. date were not reported). Concomitant therapies were not reported. No adverse effects were reported. This is one of the two reports received from the same source. Additional information has been requested.
Ran fever of 102 degrees and had body aches and pains the next day after being vaccinated.
Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L007560 with expired date 15-JUN-2017; dose and route were unknown). No concomitant medication was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a patient who in August 2007, was vaccinated with Gardasil. After being vaccinated with Gardasil, the patient experienced sweating and abdominal cramps. The patient's outcome was not reported. Additional information has been requested.
Patient received COVID vaccine dose #1 on 05/20/2021 @ 1310.  At 1315, while sitting in a chair, pt had a syncopal episode, fell onto the floor without warning.  No head injury.  Syncopal episode lasted ~20 seconds.  Pt was alert and oriented x 4 immediately following episode.  Vital signs taken: patient remained hypotensive, mildly diaphoretic and pale in color despite laying down.  Oxygen saturation dropped to 92%.   O2 @ 4L via mask started, and O2 level improved to 97%.    EMS was called, patient was then taken to  Medical Center Emergency Department for further workup @ 1343.    Patient was called on 05/20/2021 @ 1645 and reports he was now home from the hospital.  Pt reports EKG was within normal limits, but no laboratory data was done.  Pt reports feeling fatigued at the time of call, but denies dizziness or other symptoms.
Since receiving the first dose on 4/21/21, my shoulder I received it on started bothering me. It was tolerable, so I ignored it. Received second dose 5/19/21 and same thing - it was bothering me but tolerable. I received the third booster 12/1/21. My shoulder hurt from that time on and has been absolutely unbearable since then. I went to see an orthopedic doctor late December 2021; after an MRI of my shoulder, diagnosed with some bursitis and frozen shoulder. The chronic pain throbs all night long numbing my arm/fingers, so my quality of life has diminished by 90%. I can barely move my arm without having a sharp pain jolting in my shoulder. My Orthopedic doctor is sending me for an MRI of my neck, as well as an EMG (nerve test).
Pt received 1st  dose pediatric Pfizer COVID vaccine left deltoid. Mother and sibiling present.   @ 1515 mother noted hives on left shoulder, arm, and face post vaccination. No wheezing or shortness of breath noted. No facial or tongue swelling noted. Denies chest pain. SPO2 99% and HR 84 noted.  notified. Assessed by MD and RN @ 1521. VS 89/52, HR 93.    Benadryl 12.5 MG PO administered @  1525. Continue to monitor for worsening hives or anaphylaxis. Okay to discharge home after observation per MD.   Hx Peanut allergy.    @ 1533 V/S HR 84, 100% RA. Decrease in hives and redness noted. No worsening rash noted. Denies shortness of breath.    @ 1553 BP 85/65, HR 82, 100% RA. Pt ambulated out of clinic with stable gait/balance @ 1554 with parent and sibling.    Due to allergic reaction or adverse side effect, advised parent to consult PCP regarding 2nd dose vaccination. Parent verbally agreed with intent to comply.
pt recvd vax 16AUG95 & 17AUG95 devel fever, which resolved w/APAP;19AUG95 fever recurred & erythematous papules appeared on the neck;devel crankiness, dec feeding;dx Kawasaki disease;adm to hosp r/o Stevens-Johnson synd;abdo pain
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness) and FATIGUE (feeling tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. No Medical History information was reported.On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness) and FATIGUE (feeling tired). At the time of the report, MYALGIA (soreness) and FATIGUE (feeling tired) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.Company Comment-This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected event of Pain and expected event of Fatigue. The events occurred on an unknown date after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was unknown since the mentioned events also happened on the second dose but the outcome was unknown. The event Fatigue is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.The patient was not using any concomitant medication.The patient did not use any treatment medications of the events.This case was linked to MOD-2021-389098, MOD-2021-389050 (Patient Link). Sender's Comments: This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected event of Pain and expected event of Fatigue. The events occurred on an unknown date after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was unknown since the mentioned events also happened on the second dose but the outcome was unknown. The event Fatigue is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
rash/hive developing on extremities and face, painful and extremely pruritic, worsening after receiving second dose of vaccine
Tightness in chest, chest pain, shortness of breath for about 12 hours.
Symptoms were from delivery of the vaccine and not the vaccine; is solid red, it's a dark red; severe arm pain/It hurst so much/it does not look good; swollen; arm started hurting/hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of INTERCEPTED PRODUCT ADMINISTRATION ERROR (Symptoms were from delivery of the vaccine and not the vaccine), PAIN IN EXTREMITY (severe arm pain/It hurst so much/it does not look good), PERIPHERAL SWELLING (swollen), VACCINATION SITE PAIN (arm started hurting/hurt a little bit) and VACCINATION SITE ERYTHEMA (is solid red, it's a dark red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm started hurting/hurt a little bit). On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain/It hurst so much/it does not look good) and PERIPHERAL SWELLING (swollen). On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (is solid red, it's a dark red). On an unknown date, the patient experienced INTERCEPTED PRODUCT ADMINISTRATION ERROR (Symptoms were from delivery of the vaccine and not the vaccine). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, INTERCEPTED PRODUCT ADMINISTRATION ERROR (Symptoms were from delivery of the vaccine and not the vaccine), PAIN IN EXTREMITY (severe arm pain/It hurst so much/it does not look good), PERIPHERAL SWELLING (swollen), VACCINATION SITE PAIN (arm started hurting/hurt a little bit) and VACCINATION SITE ERYTHEMA (is solid red, it's a dark red) outcome was unknown.            Concomitant drugs including betablockers used for unknown indication    other treatment include hot and cold compresses on it (it bring the swelling down, it has gone but it's still red)     Consent for safety follow up with HCP denied.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information received on 25-may-2021,New AE Added On 25-May-2021: Non-significant follow up appended
Pt fainted after receiving COVID vaccine injection.  Resident physician tended to pt. she was awake when laying down and reported feeling much better when sitting up.
experienced COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (experienced COVID) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In June 2022, the patient experienced COVID-19 (experienced COVID). At the time of the report, COVID-19 (experienced COVID) had not resolved. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The patient number was reported as 1382149. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was provided. No treatment medication was provided.  Company comment: This spontaneous case concerns a 63-year-old, female patient with no relevant medical history reported, who experienced the unexpected non serious event of Covid-19, which occurred unspecified dose of mRNA-1273 vaccine. Current ongoing pandemia is confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 63-year-old, female patient with no relevant medical history reported, who experienced the unexpected non serious event of Covid-19, which occurred unspecified dose of mRNA-1273 vaccine. Current ongoing pandemia is confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Awoke with eye infection both eyes eyes felt like sand paper!  Blurred vision,  watery and miserable
Kinrix was given off label as not given as the 5th dose of Dtap due to patient being behind on immunizations. Contacted the health department and they will recognize this dose as a 4th dtap in the series . Patient is 5 years 4 months, appropriate age for Kinrix, appropriate spacing with the last Dtap 10/14/2016 and last polio 10/14/2016.
Recently hospitalized for leg fracture.  Current hospital policy is to administer Janssen COVID vaccine at time of discharge to those giving consent.  Report received from interested party that individual had received and completed the Moderna COVID vaccine series an indeterminate time earlier.  No record of adverse event noted, though communication with interested family member is still pending.
got so sick; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who got so sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.    In 1969, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got so sick  (illness) and had never taken another one,  (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient only had to get medication in last year for fluid in ears. It is unknown if patients physician provided consent to be contacted It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine unknown.  It is unknown if there were lab data/results available.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.