chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a pharmacist reported that a 3 years old patient received a bexsero dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: a pharmacist reported that a 3 years old patient received a bexsero dose). The outcome of the inappropriate age at vaccine administration 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: 18-Jul-2023 The reporter consented to follow-up. The patient received a dose of Bexsero at an inappropriate age, which led to inappropriate age at vaccine administration.
Receive vaccines on 8-12-08, Tdap, Hepatitis A, Varicella.  Received call from babysitter, pt. c/o headache, leg cramps, fever 102.0.  Tepid bath & TYLENOL 325 given to client per nurse line per babysitter.  Also consult pediatrician.  Have been calling to f/u no response to calls. Babysitter returned called-client doing fine.  Fever broke that evening.  States it took 2 day for fever to return to to normal.
Received vaccine ahead of dosing schedule; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received vaccine ahead of dosing schedule) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received vaccine ahead of dosing schedule). On 05-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received vaccine ahead of dosing schedule) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
5.5 hours post injection patient experienced significant labial swelling and tachycardia (100 BPM) that subsided after 5 hours and self-administration of 50 mg. Benadryl.
Neuropathy, My Hands and Feet were Red and severely Burning. The onset of Depression.
Fever, Nausea, Strong Headache, Exhaustion - 2 Days after injection. Spontaneous broken blood vessel in LEFT(opposite injection arm) hand - Night after injection.
I started feeling body aches and runny nose that was causing me a sore throat. Due to the throat cancer radiation it was causing irritation. I started getting chills here and there. When it started on the 11th by the 12th I was feeling worse. I was away when I contracted COVID-19, and when I traveled I tested positive. I started taking something to dry up my nose and developed a pretty dry cough. My doctor gave me prednisone which I'm taking. My worst day was the 12th and the 13th, since then I'm feeling better and functioning fine. When I exert myself I sweat a lot. I'm still testing positive as of yesterday.
Arm pain (injection site); fatigue; muscle aches; headaches; brief back of neck (upper spinal) pain; chest pain (left side); pressure on chest when lying flat on back; irregular heart beat, eventually leading to a significant heart episode, including chest aching, difficulty breathing, cold extremities, lightheadedness; brief sore throat; digestive discomfort; labored breathing, primarily focused in the larynx area. Nearly all symptoms diminished by the fifth day.
Phone call received from patient's mother, stating daycare noted redness, swelling, warm to touch of (L) arm 4-5-13 upon arrival at daycare. Patient taken to doctor for evaluation. Advised to give BENADRYL for allergic reaction and report reaction to health dept. Encouraged cool compress and ibu. Stated patient doing well.
The patient is a pleasant 66-year-old female, has been sick for the last week or 10 days. She was recently tested positive for COVID. She was given antiparasitic medication. Patient's symptomatology has not improved. She continued to have shortness of breath. Three days ago, she also developed chest pain. Patient's family was quite concerned about her. Oxygenation has been also dropping. Her shortness of breath got worse. Now she is running fever and chills as well as body aches. Her daughter got concerned, brought her to the emergency department. Patient was again tested positive for COVID. She underwent a CT scan of the abdomen, which was found to be negative except for diverticulosis. CT angiography of the chest shows pulmonary embolism as well as patchy infiltrates consistent with multifocal pneumonia
Breakthrough COVID-19 case and hospitalized. Patient experiencing fever, cough, chills, fatigue, rigors and shortness of breath since 7/12/21. Patient has congestive heart failure and has a pacemaker/defibrillator. Reports having shortness of breath at baseline at times.
Information has been received from a nurse practitioner referring to 1 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 6lb 3oz . Concomitant therapies included (Oka/Merck) VARIVAX and hepatitis A (unspecified). On 22-APR-2016 at 11:56, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # reported as L042818  dose 1, subcutaneously in the left thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received rom the same reporter. Additional information has been requested.
This spontaneous report was received from a physician concerning a female patient of unknown age. Medical history and concurrent conditions were not reported. In 2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date and strength were not reported) (dose reported as single standard dose), intramuscular. Co-suspect and concomitant therapies were not reported. On 30-MAY-2014 (reported as about a week ago), the patient developed a fever and chills after vaccination with PNEUMOVAX 23. At the time of the report the outcome was unknown. Patient seek medical attention. Additional information has been requested.
Vaccine placed 6-28-11. 6-29-11 noted redness, edema and warmth on (L) arm at vaccine site.
6 minutes after receiving vaccination, patient felt dizzy/lightheaded and had heart palpitations. Clinic facility monitored patient for over an hour following vaccine. Dizziness lasted an hour, then subsided. However, dizziness returned later in the afternoon of the day of vaccination (around 6 hours after) and lasted a few hours,
Information has been received from a 24 year old female who in February 2008 received her first dose of GARDASIL (lot # not provided) and on 02-Apr-2008 received the second dose of GARDASIL (lot # not provided) without knowing she was pregnant.  The patient had no medical history or concurrent condition.  Concomitant therapy included vitamins (unspecified).  The patient's LMP was reported as 07-MAR-2008.  The patient was scheduled to be due in December however when she went in for a Ultra Sound on 17-Sep-2008 the baby had no heart beat and was dead.  The patient delivered the baby on 18-Sep-2008 and was hospitalized for 12 hours after giving birth.  Additional information has been requested.
Sweating, clammy. SOB. Laid pt on floor. Administered 1 EPIPEN injection. Called 911; 2nd EPIPEN approximately 10 minutes later. EMT arrived. Pt recovered full consciousness.
HEALTH DECAYING; DIAGNOSED AS DIABETIC; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 08-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUL-2021 (since vaccination), the patient's health was decaying and he had good health before vaccination. On an unspecified date in JUL-2021, the patient was diagnosed as diabetic and his sugar level was unstable. Laboratory data included: Blood glucose (NR: not provided) Unstable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from health decaying, and diagnosed as diabetic. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210744411-covid-19 vaccine ad26.cov2.s  Diagnosed as Diabetic  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).
I have Epstein Barr Virus and my symptoms flared after both shots. It was just 2 days of symptoms after the first shot, but 3 weeks of symptoms after the second shot.; I have Epstein Barr Virus and my symptoms flared after both shots. It was just 2 days of symptoms after the first shot, but 3 weeks of symptoms after the second shot.; This is a spontaneous report from a contactable consumer (patient).   A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 12:00 PM, at age of 49 years old (Batch/Lot Number: Unknown) as 1st dose, single; dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 03:00 PM (at age of 50 years old), (Batch/Lot Number: Unknown) as 2nd dose single, for covid-19 immunisation.  The patient was not pregnant at time of vaccination. Medical history included Epstein Barr, allergies: Penicillin.  The patient's concomitant medications received within 2 weeks of vaccination: fluoxetine hydrochloride (PROZAC). Adverse event reported that: "I have Epstein Barr Virus and my symptoms flared after both shots. It was just 2 days of symptoms after the first shot, but 3 weeks of symptoms after the second shot." Adverse event start date was 20Mar2021 08:00 AM. No treatment received for adverse events. Outcome for events was unknown.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The lot/batch number has been requested.
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 11-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Arm soreness Migraine headache Nausea Hot and cold Fatigue Unsure of fever Numbness and tingling in both hands
The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022; The patient received vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022 at 4:10 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 03-Feb-2022 at 4:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed.  No treatment information was provided.
No adverse event; Maternal exposure during breast feeding; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 05-Feb-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Feb-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 05-Feb-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, 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 MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    No concomitant and treatment medications were reported.  Company comment: This spontaneous prospective pregnancy case concerns a 36-year-old, female patient with no medical history information reported, who experienced the unexpected non serious events of maternal exposure during pregnancy and maternal exposure during breastfeeding with no adverse events reported. The patient received the 4th dose of mRNA-1273 bivalent BA.4/BA.5. No information about last menstrual period and estimated date of delivery as well as gestational age at  time of exposure was provided. It was reported that patient was pregnant and was nursing. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.   Reporter did not allow further contact
Patient tested positive for COVID 19 on 8/3/21 despite completing two part vaccine series. Patient is admitted to the ICU with increased oxygen requirments and COVID pneumonia.
Swallowing difficult; Heartburn; Headache; Rheumatoid arthritis flare up; This is a solicited report based on the information received by Pfizer, (Mfr. Control No.: 21K-163-3863221-00). Solicited report by a consumer of a 70 year old female with events  of non-serious heartburn, headaches since had covid-19 vaccine, rheumatoid arthritis flare ups on on HANDS/FEET and difficult swallowing with Rinvoq (upadacitinib). In 2021, the patient experienced rheumatoid arthritis flare ups on on hands/feet. In Feb2021, the patient experienced heartburn, headaches since had COVID-19 vaccine and difficult swallowing. COVID-19 vaccine was also considered suspect. Patient had a flare up on her hands and feet from time to time. In 2021, she had last one after moving furniture. She stated that Rinvoq helped her a lot with her rheumatoid arthritis. In Feb2021, she had been having headaches since she had her vaccine. They really put her down when she gets them. She had been having  heartburn also experienced difficulty of swallowing and she was not sure if it was Rinvoq or Chili that was the cause. Her headache and heartburn was on and off. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 28Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number EL9261. On 16Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number EM9810. The patient was treated with TYLENOL.  Causality for RINVOQ (UPADACITINIB) The reporter's causality for the event(s) of heartburn, headaches since had covid-19 vaccine, Rheumatoid arthritis flare ups on on hands/feet and difficult swallowing with RINVOQ(UPADACITINIB) was a reasonable possibility.  Change History On 26Apr2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, treatment drug information and narrative description. The event of "Difficult Swallowing" was added. The event of "Headaches" was amended to "Headaches Since Had Covid-19 Vaccine".  No follow-up attempts are possible. No further information is expected.
pain, tenderness and swelling, fatigue, right shoulder joint pain, fever. Took Aleve for fever. Used Lidocaine patches for right arm/shoulder pain. Symptoms lasted approximately 29 hours
lower blood pressure after dose 1/even lower blood pressure after dose 2; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (lower blood pressure after dose 1/even lower blood pressure after dose 2) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-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 experienced HYPOTENSION (lower blood pressure after dose 1/even lower blood pressure after dose 2). At the time of the report, HYPOTENSION (lower blood pressure after dose 1/even lower blood pressure after dose 2) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 101/66 and 101/65 less than or around.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.   Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.    There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and dilluted per Instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Pt. reports that she became violently ill with nausea/vomiting approx. 6 hours after influenza injection.  She went to the ER 1 hour after becoming ill and was given IV hydration and nausea medications.  She reports that she "shook all over", as with a fever, but had no thermometer.
CHIEF COMPLAINT:   pt brought to ER by EMS for sob that started 3 weeks ago. started getting worse today neg wheezing noted pt on cpap by EMS pt switched to hospital cpap. medicated with solumedrol.   HISTORY OF PRESENT ILLNESS:     Patient brought into the ER by EMS for shortness of breath that started 3 weeks ago.  It seems to be getting worse.  Patient was put on CPAP by EMS.  Patient was not given Solu-Medrol in the ambulance.  Patient states that he just feels like he cannot catch his own breath.  He has been on CPAP before.  He denies any expressed history of heart failure.  Does have a history of pulmonary hypertension and bad COPD.  He denies any fever chills.  No cough cold or congestion is vaccinated against Covid.  No leg pain or swelling history of blood clots.  No other complaints.
I started having pain in my leg 3 days later and was hospitalized over night. I had a deep blood clot in my left leg. I found out that I have a blood disorder (lydon 5 factor) at the time. Still currently has blood clot and is on blood thinners. It's been more than 6 months. Last ultrasound back in September and its still not showing any improvement.
had 2 fluid filled blisters, 1 inch away from the injection site; one of the blisters had already popped; Information has been received from a pharmacist referring to a male patient of unknown age. The patient did not have any drug reactions/allergies. Medical history included pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) in 2018 (reported as a year ago). Information about concomitant medication was unknown.    On 12-APR-2019 the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (intramuscular; strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis (reported as "received pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) a year ago"). On 13-APR-2019, the patient returned to the pharmacy and had 2 fluid filled blisters, 1 inch away from the injection site. The pharmacist reported that "one of the blisters had already popped" and the patient did not receive any treatment. The outcome of the events was reported as recovering. The causality was not provided.