chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she gave Covid to her 58 year old husband, who got the Pfizer vaccine; she gave Covid to her 58 year old husband, who got the Pfizer vaccine; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter asked if we can e-mail her a list of the ingredients for the Pfizer BioNTech COVID-19 vaccine Comirnaty and asked if the vaccine works to prevent getting Covid. She stated that she was not vaccinated, but she gave COVID to her 58 year old husband, who got the Pfizer vaccine. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 with batch number L016248 and expiry date-30-JUL-2017 (dosing regimens unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to GARDASIL 9. Additional information has been requested.
Information has been received from a nurse concerning an 80 year old female with hypertension, coronary artery disease, chronic anxiety and codeine, statins allergies who on 20-MAR-2007 was vaccinated SC with a dose of ZOSTAVAX (Merck). Concomitant therapy included COUMADIN and "quite a few medications". The patient presented to the physician's office on 02-MAR-2011 and was "diagnosed with shingles." No lab diagnostics study was performed. The patient was being treated with VALTREX, PERCOCET and NEURONTIN. There were no lab diagnostic studies performed. At the time of the report, the patient had not recovered. Follow-up information was received from a physician indicating that the patient got shingles in March 2011, although she received the vaccination in 2007 or 2008. The physician felt that shingles was not related to therapy with ZOSTAVAX (Merck). No further information is available.
pt rcvd vax; t 102 & lethargy; pt vomited*3 this am; also had b/l OM this am; RX lorabid 200;
Achy; TIREDNESS; have a red spot on my thigh; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), FATIGUE (TIREDNESS) and VACCINATION SITE ERYTHEMA (have a red spot on my thigh) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity NOS, Hives, Penicillin allergy, Diabetes (Diabetes controlled by diet) since 2019 and Breast cancer. Concomitant products included ANASTROZOLE and CALCIUM, IRON (CALCIUM & IRON) for Breast cancer, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Vitamin D supplementation, FISH OIL, OENOTHERA BIENNIS OIL, TOCOPHERYL ACETATE (OMEGA 3 & 6) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (Achy), FATIGUE (TIREDNESS) and VACCINATION SITE ERYTHEMA (have a red spot on my thigh). On 02-Aug-2021, PAIN (Achy), FATIGUE (TIREDNESS) and VACCINATION SITE ERYTHEMA (have a red spot on my thigh) had resolved.            Concomitant medications also included Turkey Tail & Maitake mushroom capsules- Breast cancer prevention 500mg/day & 300mg/day from 2019 onwards.  Treatment information reported as tested for allergy main ingredients of vaccine - not allergic from 02-Mar-2021 to 19-mar-2021.   This case was linked to MOD-2021-028004 (Patient Link).
This spontaneous case reported by a healthcare professional, describes the occurrence of peripheral swelling (swollen left hand) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the 2nd dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced peripheral swelling (swollen left hand). At the time of the report, peripheral swelling (swollen left hand) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: not applicable. The reporter did not provide any causality assessments, concomitant medication or treatment information.
pt recv vax 13OCT97 & 5 days later was hosp dx of atrial fibrillation/flutter;
I had a cough, headache, fever of 100.5, joint pain, muscle pain in particularly my neck, chills, nausea, and fatigue. The fever lasted 1 day. I had a sore arm too. The chills, muscles aches, and joint pains lasted about 2 weeks. The fatigue and nausea are still ongoing. I have lost 5-10 pounds in the last few weeks because I have been having difficulty eating anything. In the last couple of days, I have had a metallic taste when drinking or eating. Now nothing tastes right anymore. I can taste the metallic taste more so when drinking water. I have been to the doctor, but I haven't been diagnosed with anything yet.
Pt returned after 90 minutes receiving her 2nd Covid vaccination.  C/o Itchiness in throat, rash/heat on back starting 45 minutes ago.  C\o a cough with scratchy/dry throat.   Waited in Observation area BP 157/82 P 67 R 16. 7:45PM Pt stated symptoms were improving & feeling better.  Pt instructed to take some benadryl at home & call 911 if symptoms became worse.   Left walking w/o assistance.
Fever of 104 after every single vaccine up to 15 months shots,  Autism symptoms and jerky movements, delayed speech, staring spells, social withdrawal, regression.
Leg was extremely sore, to the point that he refused to walk on it.  The following day he had a red spot on his leg and then by 48 hours the spot had grown significantly and was very hard and sore.
Starting on 01/04/21 Employee noticed red swollen area below injection site. States itching warm to the touch. Area is 7 X 4.5cm on posterior of left arm not deltoid. States took 2 doses of Benadryl with minimal improvement. Explained conservative interventions including, cool compresses, IBU and OTC allergy medication if allowed by PCP. Employee verbalized understanding and will continue to monitor site. Employee advised to contact patient safety as the injection was misplaced by the vaccinator.
Pt reported dizziness and disorientation the evening after vaccine.  States he "got lost in my bathroom" and "felt like I was going to die".  He did have body aches and headache
Blood clots causing pulmonary embolism on 3/29 .   Hospitalized on 4/6-4/8.  Clots also caused a mild stroke on 5/5.  Hospitalized 5/5-5/6
This spontaneous prospective pregnancy report was received from a female patient of unknown age who was reporting on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-MAY-2017, the patient was vaccinated with a dose of GARDASIL 9 (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). There was no information about diluent provided. After receiving the dose on 10-MAY-2017, the patient learned at a later unspecified date, that she was pregnant. The last menstrual period (LMP) was estimated to be on an unknown date in 2017, estimated date of conception was in 2017. The estimated date of delivery (EDD) was not known and could not be calculated. At the time of this report, the pregnancy outcome was pending. The foetal outcome was unknown. At this point in time, the patient stated that she was uncertain if she was going to continue with the pregnancy or terminate the pregnancy. Additional information is not expected as the reporter's contact details were not provided and there was no consent to contact the patient's physician.
Hives and dermatographism developed 3 weeks after booster dose. Initially started on upper back, then spread to trunk, arms and legs. Treated with diphenhydramine, then started on cetirizine 20 mg twice daily. On December 7, symptoms persisted so famotidine 20 twice daily and prednisone were added.  Symptoms still present on 12/23, hydroxyzine was added.
Blockage in colon; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jul2021 13:15 (Lot Number: EW0196) as single dose (at the age of 63-years-old) for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. Concomitant medication included metformin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jun2021 13:15 (Lot Number: EW0196) as single dose (at the age of 63-years-old) for COVID-19 immunization. The patient experienced blockage in colon on 16Aug2021, acute inflammation of colon, rectum, vagina, stomach and throat on 16Aug2021. Events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included computerised tomogram: results unknown on 2021. Therapeutic measures were taken as a result of the events which included Antibiotics. The outcome of the events was recovering. Not tested for COVID post vaccination. The reporter assessed the events as not serious. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store.  Follow-up attempts are completed. No further information is expected.
Metallic taste in mouth; Body ache; Fever; chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth), MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills), NAUSEA (Nausea) and VOMITING (Vomiting). On 05-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth). At the time of the report, DYSGEUSIA (Metallic taste in mouth), MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-APR-2021 and added additional contact information. The outcome of the event (s) changed from unknown to not applicable.
Facial, scalp, gingiva,throat, ear neuralgia - C2 dermatone Patient developed pain on left ear, left side of face, scalp, left lower gums, left eye, and left side of throat. he thinks he had blisters in his throat and gums, but none appeared on his skin. He was out of town when symptoms developed and unable to be seen for 5 days. He received a Shingrex vaccine on 07/24/2020. Lot # GB429 Exp 12/05/21. We believe this was a reaction to the vaccine. When seen in the office he had one remaining mostly healed erosion on left lower gingiva where pain had been prevalent.
Several hours after getting the vaccine I experienced aches & itching all over. Next morning I was better, but still had some itching.
Pt reports symptoms began 10 min after vaccines given of headache, dizziness, nausea.  Pt was seen at clinic at 1400 pm on 5/12/08 and given Motrin.  Pt states no relief from Motrin.  Pt returned to clinic Immunizations today c/o of worsening of headache, dizziness, nausea.
The patient was supposed to be given 0.25mL of the Moderna vaccine as the 3rd dose in the series. She was actually given 0.15mL. The CDC recommends that this is considered a full dose and the series is complete. The patient has been notified. No other follow up required.
I had taken a short walk on a flat surface and was so out of breathe that ended in me going to the ER. The blood work showed my Iron levels were very low.
medication started to leak and then went down the patients' arm, no AE; there was leakage at the hub of the syringe, where the needle attached, no AE; medication started to leak and then went down the patients' arm, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.    This case involves a patient of unknown demographics who received a dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe (lot: UT6647LA, expiry date: 30-Jun-2020) via unknown route in arm NOS, on an unknown date.  It was an actual medication error case due to vaccine underdose and Exposure via skin contact. It was reported that the junction between the needle and the medication started to leak and then went down the patients' arm..  It was also a case of syringe issue.   At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "thyroid condition" (ongoing); "high blood pressure" (ongoing); "Overweight" (unspecified if ongoing). The patient's family history included: "mini stroke" (unspecified if ongoing), notes: grandmother had stroke, that was years ago. The patient took concomitant medications. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: tested positive for Covid, had Covid vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Expiry Date of Covid vaccine: Unknown. 76 year old diabetes patient, took Paxlovid 31Oct. That time, tested negative for Covid, husband had Covid. Healthcare provider stated to caller, she should get the medication, as she was in contact with husband. Caller was also taking Apixaban. Last Saturday, caller went to urgent care. Caller tested positive with Covid this morning, was prescribed Paxlovid again. She started previous round of Paxlovid, 30Oct2023 or 31Oct2023. Concomitant Products/Medical Conditions: Got thyroid condition, had diabetes, high blood pressure, was on all kinds of medicine. Had probably been a couple of years at least, had mini stroke, then they put her on it.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300188223 same patient/product, different event;
PINPRICK RASH TO ELBOWS; SWEATING; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa drugs allergy, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced sweating. On 17-APR-2021, the subject experienced pinprick rash to elbows. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 09-APR-2021, and had not recovered from pinprick rash to elbows. This report was non-serious.
Near syncopal episode, numbness and tingle in extremities, abdominal pain started within 1 min after vaccine was given to the patient.
Feeling of heart fluttering and tension. Resting heart rate increased from average of 61-71 to 104-131 as reported by watch around 8:30.  Took  asprin tablet. Resting heart rate reduced to 80-97 by 9:30pm.  Remained sitting during entire event.  Used blood pressure cuff at 9:45-10:00pm. Reported 137/88 with BPM of 74. As of 9:45pm Aug 14, resting heart rate being reported by watch as 74-92. Feeling of tension and fluttering has subsided but heart rate remains noticeably higher than before.
Dad reports swollen (L) deltoid, raised and red. They applied ice and ibu. Today area viewed, area red/pink. Measured 130mm x 100mm. Pt stated it felt like it was getting better. Area raised and slightly warm to the touch.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 14-MAY-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot #, route of administration and dose  were not reported). No adverse effects were reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
Chills, fatigue, muscle pain, body aches, mild headache  Didn?t take any meds Slept 15 hours straight  Drank water Lasted 36 hours
Symptoms began at 14:50. Tingling and shortness of breath progressed to dizziness and hand cramping, bilaterally. BP 132/94; O2 saturation: 98%, blue lips, anxiety. Had patient lay down, monitored VS x 5, called EMS at 15:12pm. Transferred to EMS at 15: 26pm. No rashes, swelling on nausea. Patient assessed by EMS and declined transfer to hospital.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient devolved a rash within 5 minutes of receiving the first dose. Concomitant medications were not reported. The patient was treated with Benadryl (diphenhydramine).  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Increased swelling, pain, and redness at vaccine site. Raised and hot, irritated by clothing.
anyone who has received the first Moderna shot and second shot mistakenly was given Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (anyone who has received the first Moderna shot and second shot mistakenly was given Pfizer) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (anyone who has received the first Moderna shot and second shot mistakenly was given Pfizer). On 15-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (anyone who has received the first Moderna shot and second shot mistakenly was given Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  This patient received the second shot with Pfizer vaccine by accident on 15-OCT-2021 Lot FF8839.   The patient was fine and she does not have any side effects.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Additional information received and patient demographics were updated
Almost immediately b felt some numbness and pins and needles type feeling in opposite hand and forearm.  This persisted for approximately three days.  Also, the day after vaccination, noticed a sore enlarged lymph node just below collarbone on injection site.  This has not gone away.
Experienced a DVT in lower right leg which then lead to a PE in lower right lung. Absolutely no known risk factors or family history. I am an otherwise healthy, in-shape 47 year-old male.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-SEP-2014 the patient was vaccinated with (Oka/Merck) VARIVAX 0.5 ml dose, subcutaneously (lot number and expiration date were not provided) that underwent a supported temperature excursion. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
3/30/16 at 11:23AM pt was given PREVNAR 13 0.5 ml intramuscular (L) arm. Called office 3/31/16 10:12AM states she is so itchy all over no rash, just itching Lot #M51194 Exp: 5-30-17.
Patient received her first dose of vaccine on Monday, January 18th.  Two days later on Wednesday, January 18th, she retired to bed early.  Later that night when her husband went to bed, he found her in the bed deceased.  No other details of the event are know.
PT GOT THE FLU IMMUNIZATION AND LEFT THE ROOM AND FELL BACKWARD AND GOT HER HEAD HURT AND BLED. WE CLEANED HER, APPLIED ANTIBIOTIC OINTMENT AND PT LEFT. SHE SAID SHE HAD HEADACHE.