chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel generally crappy; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th May 2022, the patient received the 1st dose of Shingles vaccine. On 25th May 2022, 1 days after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient got Shingles shot on the day before the reporting. The patient felt generally crappy on the date of reporting. The patient said that if it kept he or she away from getting shingles, he or she would deal with feeling crappy for a day or two.
since I recieved second dose my arms hurt in the morning can not strech arms with out being in pain, joint pain all the time specially in morning, knee pain right side. mother in father went at same time same clinic feeling same pain. they are elderly late 80's
The injection site is sore and swollen 1 week after the injection. It was sore 1 day after, subsided, and returned suddenly 1 week later
1650 patient reports symptoms: lightheadedness, blurry vision, dry and thick throat, thickened tongue, left arm weakness and numbness in left hand. 1705 Center chest pain, chin and throat numbness. Twitching in corner of right mouth. Unable to puff out right cheek
Information has been received from a certified medical assistant concerning a 68 year old female with non-remarkable past medical history and no drug allergies, who on an unspecified date was vaccinated intramuscularly in the right arm with a dose of PNEUMOVAX 23.  Concomitant therapy included LIPITOR and amlodipine LOTREL.  Subsequently the patient developed severe swelling at the injection site and redness.  The patient was instructed to visit the emergency room, but was not admitted to the hospital.  No laboratory or diagnostic studies were performed.  After several days swelling was gone and the redness dissapated.  The reported was concerned about the lot being tainted in some way.  It was also reported that a male patient and two unidentifiable patients developed severe swelling at the site and redness after being vaccinated with doses of PNEUMOVAX 23 from the same lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with industry standards and was released.  Additional information has been requested.
A non-serious spontaneous report of FLUMIST administered to a patient over 49 years old was received from a registered nurse concerning a 66 year-old female. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Information has been received from a physician concerning a 26-year-old female who "four years ago" in 2002 was vaccinated with a dose of Varivax. Subsequently, the patient had a titer test and it showed negative results. At an unknown time, another dose of Varivax was given. A booster dose was also given at an unknown time. The patient had a repeat titer taken and it still showed a negative titer. No specific dates were given regarding the vaccine doses. Unspecified medical attention was sought. No further information was available at the time of this report. Additional information has been requested.
After receiving the vaccine, I had a mild sore arm and a slight stomach discomfort. I had discomfort in the center of the chest primarily and the secondary discomfort in the belly button area. The belly becomes really bloaty, swollen, tight, sore, and uncomfortable. My ultrasound showed a lot of lumps and enlarged lymph nodes. My MRI showed primary lump in the stomach, and it showed a few lymph nodes and small tumor in the abdomen. My endoscopy showed I had a lump pushed into the stomach by 6cm. The biopsy I had also confirmed the same thing as the endoscopy. I had enlarged gastric lymph nodes. The doctors thought it was a cyst but with diagnosis the biopsy showed I had malignant endoplasmic monocytic microphage orgy. I developed a cough after I did endoscopy. The medicines I took to stop the cough did not work. My X-ray showed I have stuff in the center of my chest. My health was at it's peak before vaccine. I also noticed around my pelvic and vaginal area that my muscles are bigger and softer.
Information has been received from a physician concerning an approximately 10 year old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck). The physician reported that the patient received the chickenpox on 15-MAY-2008. At the time of the report the patient was recovering. No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "von Willebrand type 1" (unspecified if ongoing); "known allergies: yes many antibiotics" (unspecified if ongoing). Concomitant medication(s) included: BUDESONIDE, start date: 01Jul2021; ARFORMOTEROL, start date: 01Jul2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Dec2022) diagnosed with COVID; (12Dec2022) Positive, notes: retested positive; (Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient diagnosed with COVID 01Dec2022 took Paxlovid, Zpac antibiotic, and Prednisone. Tested negative then retested positive on 12Dec2022. By 15Dec2022 serious symptoms. On 15Nov2022 patient was taking Resprimat as concomitant medication in 2 weeks.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  The box of vials was received on 14 Oct 2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm.
5 crusting, dark grey scabs on erythematous bases, 3 in a tight cluster, on L superomedial thigh. Filled w clear fluid before bursting. Burning pain radiates down medial leg to ankle, dermatomal-like pain distribution, improving (8->6/10). Denies new soap, irritating contact. Given gabapentin for pain.
I had a very dry mouth with a chalky feeling to it. My taste was altered, but not gone. It started out as a metallic taste but now nothing taste good. I get a dry cough at times. My sinus's feel really dry too. I have difficulty swallowing foods like bread and crackers. i had a upper GI test did that showed a schatzki ring in my esophagus. I had a CAT scan of my neck and throat area, but I haven't gotten results to that yet. My doctor feels as though my symptoms could be related to rheumatoid arthritis.
Nausea; dry heaving; Temp climbed to102/ Fever broke at 630 am; chills came on; body aches; This is a spontaneous report from a non-contactable consumer. This 59-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) , via an unspecified route of administration on unspecified date at 4:00PM at single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient reported that temperature started at 11:30, "temp climbed to102 and fever broke at 06:30AM with Tylenol" (onset date not reported) with outcome of recovered, then chills came on on an unspecified date with outcome of unknown. The patient also continued having body aches on an unspecified date with outcome of not recovered, dry heaving on an unspecified date with outcome of not recovered and nausea on an unspecified date with outcome of unknown. Her doctor prescribed Zofran because the nausea and dry heaving was awful. The patient stated she was "down in bed for 2 days and missed 2 days of work". Lab tests and procedures included body temperature of 102 (no units provided) on unknown date.  Therapeutic measures were taken as a result of "temp climbed to102/ fever broke at 6:30 AM, dry heaving and nausea.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse referring to a 59 year old patient of unknown gender. Patient's medical history, current condition and concomitant therapy were not provided. On 26-JAN-2015, the patient was vaccinated with a dose of expired PNEUMOVAX 23, lot # J005068, expiration date 18-JAN-2015, 0.5 ml, intramuscular in the right deltoid. No adverse effects were reported. Additional information has been requested.
pcr tested positive; pcr tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 05Apr2021 as dose 2, single (Lot number: EW0150), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type IV Vascular EDS" (unspecified if ongoing); "Vissers-Bodmer syndrome." (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; ROBITUSSIN 12 HOUR COUGH RELIEF; CALCIUM; OMEGA 3 SELECT; MELATONIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "pcr tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) positive; (09Jun2022) Negative; (15Jun2022) positive; (11Jun2022) positive; (unspecified date) Unknown results; (unspecified date) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was tested positive for pcr on 06Jun and started Paxlovid that evening. She started pcr testing negative again on 09Jun and confirmed pcr test negative on 10Jun. She finished the Paxlovid course on the morning of 11Jun and pcr tested positive again on 15Jun. Had no symptoms but was scheduled to travel so she decided to test herself again just in case. She confirmed the positive test with two PCR tests and two antigen tests. She had not tested the two days prior so don't know if would have tested positive the two days prior or not. The patient did receive other medication in 2 weeks. The patient was treated with paxlovid from 06Jun2022 to 11Jun2022 for covid-19. The patient's other medications in 2 weeks included daily vitamin. The patient had no known allergies.
Left thigh - No initial local reaction until 4 day post injection, 0 fever 0 change in appetite, sleep or play.  9 days post injection site increased size, warm and increased reddened area.
Similar to how things were with the first shot, the morning after the day of the vaccine, I woke and had to run to the bathroom for a sudden bowel movement.   I developed a mild stomach ache and loose/sudden bowel movements for about two more weeks.  On occasion I had in the evening a shot of brandy to try to help my stomach, which worked quite well again.  After about 2 weeks, like with the first shot, the condition appeared to go away.  With the first shot, I thought maybe it was a coincidence.  Now that it happened twice so similarly, it seems to me that it is related to the vaccine.  I wanted to get this report in so that if it happens to me on the third shot whenever I get a booster, I'll have a better idea if it was the vaccine.  I don't feel like I have any long term problems, though I am a little concerned about the idea that my digestion is getting affected, when I had not heard reports of this in the news.  I intend to get the booster.
body aches, next day sl temp, immed p/vax diff breathing (also sl);
72 hours post vaccination I had head pain, vision change, and unregulated blood pressure that sent me to the E.R. I have since been on two blood pressure medications and my blood pressure is still not regulated.
I developed a rash that was painful, itchy, I could not sleep. It did not have the blisters that comes with shingles, so I was not sure if it was that, but I endured the uncomfortableness through the weekend. I called and made an appointment for Monday. I was given a prescription for acyclovir to help clear up the rash just in case it was shingles. There has been improvement in the area, I do not have pain, or itching but I am still seeing bumps.
10/5, rash on arm, 10/6, pain in left kidney area, rash extended from injection site to elbow, very hot. Trouble urinating. Seen by doctor the the afternoon and started on treatment with Keflex (4 X/day). Tylenol for pain and warm/moist compresses. Rash almost gone today. Pain in kidney area continues. Relief of medication only lasts 4-6 hours.
Case reports almost exactly 24 hour post 2nd vaccine, watery diarrhea started, felt it smelled "medicinal".  Is still having loose/soft stools.  PCP told her she needed to call Public Health and make a report
Started having symptoms in the first week of March with hives, from my elbow to wrist and to ankles to knees on both limbs and they itch like the dickens, real red and pimply. They lasted about 8 months before I got treated at the clinic with the dermatologist, I got it cleared up but only up to a degree and come back often and irritates the day lights out of me. I am currently under treatment with the dermatologist, last visit was May of 2022. I see any of the Dermatologist there at the clinic.
COVID -19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID -19) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN CALCIUM (LIPITOR), ESCITALOPRAM OXALATE (LEXAPRO), MELATONIN and TELMISARTAN for an unknown indication.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID -19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID -19) had not resolved.            Patient didn't had any allergies. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine.  On 22-May-2022 relapse of COVID symptoms occurred 5-6 days after taking Paxlovid.  Relapse of COVID symptoms 5-6 days after taking Paxlovid. Device Date : 23May2022.  Company Comment: This spontaneous case concerns a 52-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 12-May-2022 to 16-May-2022 and had a relapse of COVID symptoms 5-6 days after taking Paxlovid. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 52-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 12-May-2022 to 16-May-2022 and had a relapse of COVID symptoms 5-6 days after taking Paxlovid. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Initial unsolicited report received from a health care professional (nurse practitioner) via other company (Pfizer) (Manufacturer Report Number: 2016540822) on 07 Dec 2016. This case involves an adult female patient (age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number, expiry date, dose, route and site of administration was not reported) on an unknown date and time frame. The patient medical history and concomitant medications were not reported. It was reported as on an unknown date the patient had allergy to FLUZONE. The patient lab tests and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
RASPY VOICE; This spontaneous report received from a patient concerned an adult 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: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 10-MAR-2021, the subject experienced raspy voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of raspy voice was not reported. This report was non-serious.
Extreme pain in left arm. Symptoms start as numbness and tingling in left arm down to my hand. That is followed by extreme pain radiating down my left arm. Pain is so severe I cannot go to sleep or it wakes me up.
Rash/hives with swelling and redness on right side of face, and right orbit. Redness and warmth at injection site for first 48 hours after injection. Generalized itching to her back and face.
This spontaneous report was received from a registered nurse refers to a patients of unknown age and gender. Since 26-JUN-2015 the patients were vaccinated with ROTATEQ (dose and route of administration were not reported; lot # K010221 with exp. date: 12-MAY-2016, lot # K023535 with exp. date: 22-MAY-2016, lot # K013868 with exp. date: 27-MAY-2016, lot # K004795 11-FEB-2016, lot #K006805 with exp. date: 24-MAR-2016, lot # K006458 with exp. date: 24-FEB-2016) which were exposed to temperatures outside of the recommended ranged. No adverse experiences have been reported. This if one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax & 10AM following inject exp very severe muscle & joint pain that persisted for several days; also exp h/a & flu-like sx; seen by MD for muscle & joint pain;
8MAR94 6PM SOB, irreg heartrate, severe; 830AM  h/a & vomiting; 21MAR93 fine red rash on abdo & arms;
No additional AE; Nurse called and reported VARIVAX which had a temperature excursion on 06/01/2023 and was short-dated with the outcome "Supported-Within 3 months" was administered on 09/18/2023 after the three-month time period. See information below per attached ar; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-JUN-2023, the varicella virus vaccine live (oka/merck) (VARIVAX) had a temperature excursion of 47 to 77 Fahrenheit degrees for 2 minutes. And the vaccine was short-dated with the outcome "Supported-Within 3 months". On 18-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #W031812, expiration date: 05-OCT-2024; strength, dose and route of administration were not provided) for prophylaxis (Product storage error). No additional adverse event or product quality complaints (PQC).
chestpain, flushing of face, ringing ears, back pain, trouble breathing. lasted 8 minutes
Case number PHEH2015US021015, is a combined initial and follow-up spontaneous report from a nurse received on 16 Oct 2015. This report refers to a female patient of an unknown age. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173537, expiry date: Apr 2016 subcutaneously on 16 Oct 2015. No adverse event was reported following this medication error.
High fever (39C); Headache; Body pain; Chills; This is a spontaneous report from a contactable consumer. A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via an unspecified route of administration in left arm on 03Mar2021 at 12:00 AM as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient had no known allergies. Patient did not receive other vaccine in four weeks. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination the patient was diagnosed with COVID -19. Since the vaccination, the patient was not tested for COVID-19. On 04Mar2021, the patient experienced headache, body pain, chills and high fever at 39C. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 31-JUL-2013 the patient ws vaccinated with a dose of VARIVAX (Merck) and a dose of PROQUAD, both vaccine's lot #, dose, route were not reported. No adverse effect was reported. Additional information has been requested.
On 3/23 was admitted to hosp. with extremely low platelets. Was given platelets at hosp. & had lots of testing. Pt reports dark stools, bloody nose & bleeding gums on approx. 3/12/21. Now sees hematologist. Diagnosed with immune thrombocytopenia.