chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding a "flu shot" was received from a consumer regarding his 86 year old mother who experienced stroke, slight fever and malaise. The pt received a dose on an unspecified date four years ago. The pt's medical history included a "weak heart," arthritis, and high blood pressure; however, onset dates were not specified. The reporter stated that the pt "previously got flu shot without any problems." The pt developed a slight fever and malaise after receiving an unknown brand of "flu shot" four years ago. The next afternoon, she experienced a stroke. She was hospitalized for about one month. She was then admitted to a nursing home for three months due to paralysis on her left side. She experienced trouble with her left leg while walking, which required "a lot of therapy." She also experienced some memory problems and incontinence. The reporter indicated that the pt continues to have problems walking, and "can't even get around with a walker." She now also has "circulation problems." The reporter stated that the pt's current medications include: buffered aspirin, vitamin E, Lasix, Plavix, and an unknown blood pressure medication. No additional info was available at the date of this report.
Arm that patient received vaccine in (left arm) had tiny, red, somewhat itchy raised bumps from the shoulder down about 6 inches towards the elbow.  Patient reports no pain in bumpy area. Patient tried oral diphenhydramine last night (5/23/21) and went to the local urgent care today to have area checked.  She called back and said they told her it was likely just a localized reaction and gave her an antihistamine to take if needed. She was advised to go back to the Dr if rash progressed or spread.
Information has been received from a physician concerning a 59 year old male who on 18-AUG-2009 was vaccinated with ZOSTAVAX (Merck). No concomitant medication, drug reactions/allergies or medical history were reported. On an unspecified date the patient experienced an outbreak of shingles after administration of ZOSTAVAX (Merck). He was examined in the emergency department on 17-SEP-2009 completing a course of acyclovir. He was not admitted and released with an additional prescription of acyclovir. He was administered a second dose of VARIVAX (Merck) on 08-DEC-2009. No lab diagnostic studies were performed. On an unspecified date the patient recovered from outbreak of shingles. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Difficulty moving  due to body pain.; difficulty moving due to body pain; Severe chills 12 hours after shot; High fever, normally run fever at 99, fever spiked at 102.5, fever was very high; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 16Apr2021 at 12:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The medical history included blood pressure high (HBP, under control with medication), post-traumatic stress disorder (PTSD, under control with medication) and high cholesterol (under control with medication). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included citalopram hydrobromide (CELEXA), lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), fenofibrate (MANUFACTURER UNKNOWN) and antacid (unspecified), all from unknown dates and for unknown indications. On 17Apr2021 at 00:15, the patient experienced high fever ( the patient normally ran fevers at 99). After 12 hours of shot, the fever hit with severe chills and fever spiked at 102.5. The patient had difficulty moving due to body pain. The patient understood that these symptoms ran normally with influenza, however, the fever was very high for the patient and the patient did not had influenza. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On an unknown date, the patient underwent body temperature and tested with a temperature of 102.5 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event difficulty moving, body pain, severe chills, high fever and fever spiked at 102.5  was not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
throat starts to close; Itching/pruritus; Cough; hives appeared on sides, arms but not at injection site,; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives appeared on sides, arms but not at injection site,), OROPHARYNGEAL DISCOMFORT (throat starts to close), PRURITUS (Itching/pruritus), COUGH (Cough) and RASH (Rash) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included Hives (throat starts to close.) on 01-Jan-1980 and Stent insertion NOS. Concurrent medical conditions included Shellfish allergy (shrimp). Concomitant products included NIFEDIPINE and ACETYLSALICYLIC ACID (ASPIRIN LOW) for Anticoagulant therapy, ATORVASTATIN for Cholesterol, VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced RASH (Rash). On 12-Feb-2021, the patient experienced URTICARIA (hives appeared on sides, arms but not at injection site,). On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (throat starts to close), PRURITUS (Itching/pruritus) and COUGH (Cough). The patient was treated with PREDNISONE for Symptomatic treatment, at a dose of 1 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash, at a dose of 180 mg; EPINEPHRINE for Symptomatic treatment, at a dose of 1 dosage form; TRIAMCINOLONE for Itching, at a dose of 1 dosage form four times; DOXEPIN for Symptomatic treatment, at a dose of 10 mg   2x daily for 5 months and FAMOTIDINE for Symptomatic treatment, at a dose of 40 mg daily for 9 months. At the time of the report, URTICARIA (hives appeared on sides, arms but not at injection site,), PRURITUS (Itching/pruritus), COUGH (Cough) and RASH (Rash) had not resolved and OROPHARYNGEAL DISCOMFORT (throat starts to close) had resolved.            Treatment medications of the patient also included Antihistamines, Oxygen Concomitant medication start date : Nifedipine (??-02-2014), low dose aspirin (??-02-2014), Atorvastatin (??-02-2014), Vitamin C (??-04-2014). treatment medications : Prednisone  10mg 3 tablets daily for 3 days, 2 tablets for 2 days and 1 tablet for 2 days (first time).  20mg, 2 daily for 5 days, 1 tablet daily for 5 days (second time). Stent was put in ??-02-2014   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up was received on (27-MAY-2021) Patient demographics, events, concomitant medications, medical history, treatment medications, vaccination facility details added. Dose details updated.
At first the Injection site was swollen, red and painful to the touch; after that the pain radiated up to the Left Shoulder across the neck and over to Right Shoulder.
Went to bed and when I laid down I heard a ringing in both ears.  Asked my husband if he had the ringing also as we both got the Adacel TDAP at the same time.  He did not hear anything.  Then in about 5 minutes I started with pressure in my ears.  The kind of pressure you get when going up in the air in an airplane.  It hurt and every time I swallowed, my ears cracked.  Then my glands in my neck started to hurt.  Got up and drank a glass of water. Next my nose started to just drip out of me.  Blew my nose which helped relieve some pressure in both ears. There was more pressure in my right ear. The pressure lessened and I was able to go to sleep.  Woke up with ears ringing and pressure in both ears.  It's been 6 days now and sometimes the pressure in my ears is worse than at other times.
nausea; vomiting; dizziness; rapid heart rate (139 beats/min)/heart rate was elevated; This is a spontaneous report from a contactable pharmacist. A 46-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5813), intramuscularly in the left arm on 02Feb2021 at 11:00 as a single dose for COVID-19 immunization. The patient's medical history included history of reacting to flu vaccines and flu-like symptoms. The patient's concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of the vaccination. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. It was unknown if the patient tested positive for COVID-19. It was reported that, on 02Feb2021 at 11:00 PM, approximately 12 hrs after inoculation, the patient experienced nausea, vomiting, dizziness and rapid heart rate (139 beats/min). The patients heart rate was elevated for 2 hrs. The treatment received for the events was unknown. On 02Feb2021, the patient underwent lab tests and procedures which included heart rate and resulted as 139 beats/min, rapid. The outcome of the events was recovered.  The reporter classified the events as non-serious and seriousness criteria that resulted in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect was reported as no.  Follow-up attempts are completed. No further information is expected.
1105 AM: Moderna Covid 19 vaccine administered.  1107: Patient reported difficulty swallowing and a rapid response was called. Upon team arrival, patient's oxygen saturation on room air was 81% and angioedema to the lips was present.  1112- Epinephrine 0.3 mg IM; 1115- Solu-Medrol 125 mg IV; 1116- Pepcid 20 mg IV; 1117- Epinephrine 0.3 mg IM; 1122- 0.9% sodium chloride bolus;  1130-EMTs arrived and transported patient to ER. Symptoms had improved upon EMTs arrival.  Disposition from ER:  Discharged home on Medrol-Dose Pak
Sick feeling; fever of 101.4 ºF; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Sick feeling), PYREXIA (fever of 101.4 ºF) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced MALAISE (Sick feeling), PYREXIA (fever of 101.4 ºF) and NAUSEA (Nausea). At the time of the report, MALAISE (Sick feeling), PYREXIA (fever of 101.4 ºF) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol. No concomitant medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information.
ALLERGIC REACTION, INIT 3/7/2023 -- RECURRENCE OF SAME SYMPTOMS
Employee reports having pain in (R) arm. Called MD 2 wks. - used ice. Advised to call staff if still having pain - pain continued saw MD on 11/10/17 - xray ordered.
A report was received from a healthcare professional concerning a 56 year old male vaccinee. No details concerning the vaccinee's past medical history were provided. On 11/7/06 the vaccinee was administered influenza vaccine (brand unspecified) and Pneumovax 23 0.5ml SC in separate sites (not specified). It was reported that the vaccinee developed a cellulitis shortly after his recent Pneumovax 23 vaccination, which was treated with oral antibiotics. The event outcome was not provided. The reporter considered the events to be serious, medically significant (OMIC).
This spontaneous report was received from Registered Nurse regarding unspecified number of patients of unknown age and gender. The pertinent medical history of patients and their concurrent conditions were not reported. On an unspecified dates the patients were vaccinated with improperly stored VARIVAX (therapy type digital data logger) (lot # L039093, expiry date 06-OCT-2017) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to temperature excursion of -6.1 degrees C for a time frame of 30 minutes. The vaccines were not subjected to previous temperature excursions. The outcome of temperature excursion was reported to be supported until expiry date. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two reports from the same reporter. Additional information is not expected as reporter did not wished to be contacted further.
Patient complained of a headache, feeling a little lightheaded immediately after shot. Approximately an hour to an hour and a half after the injection, patient became very dizzy lightheaded chilled cold and shivering and felt as though she were having an out of body  experience. She at this time also began to have diarrhea and vomiting, vomited three times.  Patient felt tired the rest the evening but slowly improved. And at this time has no problems.
Pregnant patient received the first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025a21a and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live full term birth.) on 17-Feb-2019. Concurrent medical conditions included Palpitations (Taking beta blockers as needed. Decreased with pregnancy.) since 15-Sep-2019 and Alcohol use (Occasionally 1-2 drink/week) since 2006. Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) from 20-Jul-2021 to an unknown date for Palpitations, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 17-Mar-2021 at 10:41 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-Aug-2020 and the estimated date of delivery was 16-May-2021. On 17-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The patient had a vaginal delivery which occurred on an unknown date, which was reported as Full-term. For neonate 1, the birth weight was 4000 grams (8lbs 13oz) with an APGAR score of 8 at 1 minute. The outcome was reported as Delivered NOS. Length of the(male) baby-53.35 cm Head circumference(cm) was 33 cm. On 17-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2020, Blood test: normal (normal) normal. On 15-Sep-2020, Pregnancy test: positive (Positive) positive. On 31-Dec-2020, Scan: normal (normal) Normal. On 22-Feb-2021, Blood glucose normal: normal (normal) Normal. On 22-Feb-2021, Blood iron decreased: decreased (Low) Moderately low, Taking iron supplements.         Treatment medication information was not provided by the reporter. date of conception-24 Aug 2020 Previous pregnancy end date was 17 Feb 2019, with live birth.   This case was linked to MOD-2021-265631 (Parent-Child Link).   See case MOD-2021-265631 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Pregnancy report form ,- updated patient demographics, updated historical conditions, updated lab data, updated second dose details and updated event stop date. On 23-Jul-2021: Pregnancy Outcome form- Patient weight, Lab data updated, Pregnancy outcome updated.Event stop date and coding was updated
No adverse reaction; Patient was given an extra covid vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient was given an extra covid vaccine) and NO ADVERSE EVENT (No adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1 at 04:58 PM, intramuscular, on left thigh, batch/lot number: FT9142) on 19-Aug-2022, Pfizer (Dose 2 at 11:36 AM, intramuscular, on Right thigh, batch/lot number: FT9142) on 23-Sep-2022, Pfizer (Dose 3 at 07:56 AM, intramuscular,  on right thigh and batch/lot number: FT9142) on 02-Dec-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 09-Mar-2023 at 9:36 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 09-Mar-2023 at 9:36 AM, the patient experienced EXTRA DOSE ADMINISTERED (Patient was given an extra covid vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXTRA DOSE ADMINISTERED (Patient was given an extra covid vaccine) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient was given an extra covid vaccine).    No concomitant medications were reported. It was reported that patient received product of moderna bivalent (6m-5y). It was reported that the error was not noticed and intercepted before the product was supplied to the patient. It was reported that inadvertent human error was the factor responsible for the medication error. It was reported that the dose should have not been given to the patient. It was reported that for Pfizer product the dose has their expiry date of 09-Jan-2023 which was 10 weeks after it was placed in the refrigerator. The patient didn't provide information regarding the reported adverse event with the use of product.    No treatment medications were reported.
fever; Headache; Nausea; chills; shaking; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 23-Feb-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 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 24-Feb-2021, the patient experienced TREMOR (shaking), PYREXIA (fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.
Immediately after injection, noted tingling along the left face and chin. Also experienced racing heart rate and sensation of throat tightness. Treated with Benadryl 25mg. Throat tightness and tachycardia resolved. Tingling of the face/jaw persisted for ~12 hours
Administered 09-26-16. Patient reported red streaks and swelling in administration arm 9-27-16. Patient was referred to Physician. Patient saw physician 09-28-16. Per patient physician diagnosed as allergic reaction and prescribed cetirizine. Per patient 9-29-16 the site is improving.
This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received MENVEO (batch number M16172, expiry date 30th October 2018). Concomitant products included BOOSTRIX. On 2nd October 2017, the patient received MENVEO (intramuscular) .5 ml. In October 2017, less than a week after receiving MENVEO, the patient experienced extensive swelling of vaccinated limb, rash and skin warm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, rash and skin warm were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, rash and skin warm to be related to MENVEO. Additional details were provided as follows: The case was reported by an office manager. At 14:30 hours, the patient received MENVEO in right arm. The patient experienced a severe rash with swelling down the entire arm where the injection was administered that was hot to the touch. The office manager did not have access to the full records at the time of reporting. She did not indicate filing a quality assurance, so no quality assurance was completed at the time of reporting. The reporter indicated this had already been called in by a Medical Science Liaison (MSL), so this event had been marked as a follow up. This case has been linked with case US2017GSK154147, reported by the same reporter.
In the evening of 9/26/2022 I started having a headache and congestion and scratchy throat. The next day I felt worse with headaches again and body and I developed and cough. At that point I took a at home COVID-19 test and I was positive. I called my primary doctor which ordered PAXLOVID. I started taking the medication along with MUCINEX and ADVIL. For the next few days, I slept because I felt very fatigued and tired.
Pt. was given the vaccine at 4:00 PM on 7/30/2009.  He returned to the clinic on 8/1/2009 with a localized area of errythema and edema at the injection site.  He was referred to his PCP.  The PCP diagnosed pt. with a staph infection at the injection site and he was placed on antibiotics for 10 days.  He fully recovered.