chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received dose one of Shingrix in 2019; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received dose one of Shingrix in 2019). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 04-OCT-2023 The pharmacist reported the patient received dose one of Shingrix. The reporter did not provide patient demographics, lot number, and expiration date.  No exact date of administration of dose one provided. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. Consent to follow-up granted.
Vaccine administered on 1/13/21. Swollen supraclaviclar, posterior cervical and submandibular lymph nodes, foggy head, (started 1/19/21), sudden redness/fever/swollen at injection site some nausea (started 1/21/21)
At 1845 EMT noticed client leaning to the side of her chair and family member alerted staff she needed help. EMT  and RN responded at 1845. Site Manager informed lead PHN . PHN  arrived at 1849. Upon arrival client sitting on chair, pale, awake and questioning why so many people were surrounding her. First vitals at 1849 by EMT Anthony: blood pressure 120/70, pulse 61, oxygen sat 99%. Client reported "I felt dizzy and tingling of my legs" and "then I remember being surrounded by staff". Family member reported he "saw her faint for a few seconds". Client alert and oriented x4. Reports history of syncope with blood draws, no other medical history, no medications and no known allergies. Client able to transfer to anti-gravity chair without assistance. Vitals at 1855: blood pressure 110/70, pulse 65, oxygen sat 98%. Client denied headache, blurred vision, nausea, chest pain, or shortness of breath. Client also reports tingling sensation below knees in addition to dizziness. RN  assessed legs and client with full sensory and motor intact. Vitals at 1902: blood pressure 120/68, pulse 72, oxygen sat 95%. Per client tingling sensation and dizziness improving. Vitals at 1913: blood pressure 108/68, pulse 76, oxygen sat 99%. Per client dizziness and leg tingling resolved. Client sat in upright position in anti-gravity chair for remainder of observation time. Client stated family would drive her home. PHN  advised client to follow up with provider and gave ER precautions. RN had client stand at 1918 from chair to assess for dizziness. Client stated feeling fine. Client left facility with steady gait at 1920.
Mother reports child developed eczema after 2 mo immunizations and slight temp. After next set of shots, eczema increased in severity and increased in temp <101F. Mother reported change in general nature from very content to agitated/fussy. Received topical steroid treatment from dermatologist. Information from missing date report states 7/18/05 child reportedly improved, but still has some eczema.
Narrative:  Patient stating that he has been experiencing side effects from COVID vaccine. Fever, headache, body aches, and fatigue. Patient wanted to report it.
very bad case of corona virus in Jun, It took 3 months to get her voice back, she had breathing problems and low energy; very bad case of corona virus in Jun, It took 3 months to get her voice back, she had breathing problems and low energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "very bad case of corona virus in Jun, It took 3 months to get her voice back, she had breathing problems and low energy".  Clinical course: She is 77 years old and had a very bad case of corona virus in Jun, It took 3 months to get her voice back, she had breathing problems and low energy. Caller also states she has had all her prior covid vaccinations from Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296155 same pt, diff event;
mild numbness/tingling sensation tongue and lips for 30 minutes post vaccine lasting for 4 hours ,mild headache and fatigue 1-2 days, sore arm for 3 days
Developed  hives one hour after first vaccine over lower face, neck, chest, and torso.  Tingling in mouth with burning lips.  Started having reactions to foods I eat daily (milk chocolate, peanuts, toothpaste).  Finally eased on 2/18/21.   Before taking second shot on 2/20/21, I took Singular in morning and Benadryl 40 minutes prior to shot.  Within 10 minutes of second vaccine (EN6201), hives broke out and have not eased yet (5/2/21).  Allergist has put me on Xyzal (2xday), and Zafirlukast, and they haven't changed anything.
Severe pounding  head ache, right nape stiffness, nausea. Tylenol 500 2tablet every 4 hours and  mucinex 2 caplet every 4 hours for pain and pressure. Ice pack on the head.
Caller is reporting tiredness; I've not been able to do anything.; Caller reports that her brain was in a fog and she was not able to process anything.; she is a little anxious about it; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Caller reported that she was perfectly fine after receiving the first dose of the vaccine. Caller was reporting tiredness that started on Thursday around noon (11Feb2021). On an unspecified date in Feb2021, caller stated that she was not been able to do anything. She had been in bed since then and very distressed about it. Caller reported that her brain was in a fog and she was not able to process anything. As of 14Feb2021 night and this morning 15Feb2021, caller reported that her brain to be much less foggy, but her fatigue was overwhelming both mentally and physically. Caller stated that she became physically tired out within 5 minutes and she was a little anxious about it. The clinical outcome of the event tiredness was not recovered and brain was in a fog was recovering whereas outcome of the other events were unknown.  Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received SHINGRIX for prophylaxis. On 17th February 2019, the patient received SHINGRIX. On 17th February 2019, less than a day after receiving SHINGRIX, the patient experienced headache, muscle pain and shivers. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache and muscle pain were not recovered/not resolved and the outcome of the shivers was unknown. It was unknown if the reporter considered the headache, muscle pain and shivers to be related to SHINGRIX. Additional details were provided as follows: At morning of the day before the reporting date, the patient got vaccine and had headache, muscle pain (back and neck area) and shivers all night. Till the reporting time, the patient had headache and muscle pain.
Initially loss of hair. Then dizziness and nausea with vomiting and severe abdominal pain.  After 20 months of multiple doctor visits, patient was diagnoses with POTS, Postural Orthostatic Tachycardia Syndrome.  She is required to take meds every 3 hours including a beta blocker.  She has been on homebound study for her last 2 years of school.   9/29/09 PCP medical records and multiple consultations received DOS 7/18/05 to 10/2/08. Assessment: Vestibular hypofunction. Patient presents with otalgia, ears fell clogged. Injured ankle. Pharyngitis, URI. Hair falling out, dizziness. Feels cold. Orthostatic tachycardia. Snores. Progressive fatigue. Dehydration. Sudden increased heart rate at rest with nausea. Cardiologist - Normal cardiac exam. ENT Consult performed T&A. Peripheral vestibular lesion. Vomiting, stomach pain. Neuro consult - migraine varient. Feels off balance. Otology Consult - Transient decreased hearing (R). Visual vestibular hypersensitivity. Vestibular hydrops.
10 minutes post shot intense itching without any rash. 12 minutes post shot MIGRANE. SEVERE. (not a bad headache or normal headache), spinning room, significant brain fog... Confusion. 30 minutes post shot stomach cramps. 2 hours post shot diarrhea, body ache. MIGRANE continues.
Bell's Palsy; A spontaneous report received from a Healthcare Professional concerning, 81-year-old female patient who received the first dose of Moderna COVID-19 vaccine and was hospitalized for Bell's Palsy.   The patient's medical history was not included/ unknown. There were no concomitant medications provided.    On 15-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient was hospitalized on 19Jan2021 because developed Bell's palsy. Patient was observed because it was thought that she had a stroke. It was not a stroke. On 22Jan2021 the patient left the hospital. Second dose of Moderna COVID-19 vaccine is scheduled on 12Feb2021. Reporter wanted to know if patient should get second dose of Moderna COVID-19 vaccine.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.    The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age with thyroid condition and no drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (Lot # 0566AE, expiration date 01-APR-2013) SC on 18-SEP-2012. No other co-suspects were reported. Concomitant medications included LEVOXYL. The pharmacist reported that on an unknown date, the patient experienced a small red rash at the injection site. The pharmacist recommended her BENADRYL and ADVIL. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
MD reported pt w/Guillain Barre-like synd p/vax w/asymmetrical smile & crooked mouth;
Information has been received from a physician's assistant concerning a 37 year old female patient who on 16-JUL-2010 was vaccinated with a 0.5mL dose of VARIVAX (Merck) (Lot number 665582/1232Y) (Expiration date: 27-AUG-2011). The physician's assistant reported that on 18-JUL-2010 the patient experienced rash all over his body. On 31-JUL-2010, the patient was seen in the office by physician's assistant and he noted a red rash with one mm papules covering the entire body. Patient had pruritus. Physician's assistant provided betamethasone cream and had not heard back from patient since. At the time of the report, the patient's outcome was unknown. The patient sought medical attention. Additional information has been requested.
Chest pressure, nausea, vomiting, soreness at injection site X 2 weeks
5/5/10 post vaccine arm red and sore. 5/6/10 arm red and swollen. 5/7/10 red and swollen measured by school nurse 2" x 4" area.
sore arm,legs, lower back; slight headache; some fever; I'm sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm, headache, fever and general body pain. On an unknown date, the outcome of the pain in arm, headache, fever and general body pain were unknown.   It was unknown if the reporter considered the pain in arm, headache, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and during the night woke up with sore arms ,legs, lower back and a slight headache with some fever this morning sore was this normal.
Right thigh injection site has red, hot and indurated area encompassing about 1/3 of anterior surface of thigh. Actual injection site with 1cm clearing wound injection area; small vesicular lesion by site. Pt febrile which started immediately.
Pt recvd DTP on 24JUL91 & upper rt arm became reddened from shot site extending down to elbow region; extremely tender to touch & pt guarded movement of arm due to pain x 2 days; Not seen by MD;
was experiencing headaches; fatigue; This case was reported by a consumer and described the occurrence of headache in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On 25th August 2020, the patient received the 1st dose of Bexsero. On 25th August 2020, less than a day after receiving Bexsero, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache and fatigue were unknown.   It was unknown if the reporter considered the headache and fatigue to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Bexsero and experienced headaches and fatigue. The reporter asked how long should side affects from Bexsero last.
She developed vertigo and nausea and vomiting 3 days ago. Skin warm raised and red arond injection site and down arm.
This non-valid spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant therapies or drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX injection, lot # N026070 with expiration date on 20-SEP-2019, for prophylaxis (exact dose and route of administration were unknown) reconstituted with properly stored sterile diluent (MRK). The vaccines experienced a temperature excursion at 46 degrees Fahrenheit for 10 minutes. There were no previous temperature excursion. The digital data logger was not involved in recording the temperature excursion details. No adverse events were reported. This case is non-valid due to lack of patients' identifiers. As of 05-OCT-2018, all attempts to obtain follow-up information were unsuccessful.
experienced malaise and headache for 3 days as well as loose stool x1.; experienced malaise and headache for 3 days as well as loose stool x1.; experienced malaise and headache for 3 days as well as loose stool x1.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date 11Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "type II well controlled diabetic" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 immunization; Bnt162b2 (Dose 2, Single), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), HEADACHE (non-serious), DIARRHOEA (non-serious) all with onset Oct2021, outcome "recovered" (Oct2021) and all described as "experienced malaise and headache for 3 days as well as loose stool x1.".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
itching at the injection; Hives at injection; redness at the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (Hives at injection), INJECTION SITE ERYTHEMA (redness at the injection) and INJECTION SITE PRURITUS (itching at the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE URTICARIA (Hives at injection), INJECTION SITE ERYTHEMA (redness at the injection) and INJECTION SITE PRURITUS (itching at the injection). At the time of the report, INJECTION SITE URTICARIA (Hives at injection), INJECTION SITE ERYTHEMA (redness at the injection) and INJECTION SITE PRURITUS (itching at the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatments were reported.
C/o severe dizziness and n/v started 7/23/11. Went to ER 7/25/11 and refused to stay overnight for observation. Headache, dizziness and sharp pain to Lt eye. Dr at ER referred pt back to pt family internal medicine Dr. at 1:30 on 7/26/11, and to return to ER if symptoms persist or worsen. Says Dr. told her "she had fluid in Lt ear" takes meclizine. (Referred pt back to ER).
Information has been received from a consumer's daughter refers to an 81 years old male patient with blood sugar issues and no drug reactions or allergies. On 12-SEP-2012, the patient was vaccinated with ZOSTAVAX (lot number not provided) one time, subcutaneously. No other co-suspects were reported. Concomitant medications included several medications not provided. In October 2012, the patient contracted shingles after receiving ZOSTAVAX vaccine. The patient sought unspecified medical attention and received unspecified treatment. At the time of the report, the outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information is not expected.
Immediate pain shot down arm to thumb and index finger lasting 2 weeks for each shot. Residual nerve pain in thumb and index finger 2 months post shot.
scratchy throat; runny nose; loss of taste; loss of taste and smell; elevated temp; This spontaneous case was reported by a patient and describes the occurrence of THROAT IRRITATION (scratchy throat), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of taste and smell) and PYREXIA (elevated temp) 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)) for COVID-19 prophylaxis.     Patient did not report any relevant medical history, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (scratchy throat), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of taste and smell) and PYREXIA (elevated temp). At the time of the report, THROAT IRRITATION (scratchy throat), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of taste and smell) and PYREXIA (elevated temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received all 3 shots. And within 8 hours, the patient had covid symptoms.  No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a patient (unknown age and gender) with no reported medical history, who experienced the non-serious unexpected, AESIs of ageusia and anosmia, which occurred within 8 hours after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as a dose of COVID-19 vaccination schedule, dose number not provided. The outcome of both events was reported as unknown. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
3 DAYS AFTER INJECTION, LOCAL REACTION 1cm- TENDER NODULE WITH MINOR ERYTHEMA AND WARMTH ABOUT 1.5 IN DIAMETER
Seizures; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history included epilepsy. The patient's concomitant medications were not reported. The patient hadn't had seizures in 3 years but 36 hours later from receiving her first dose, she had her first seizure after 3 years. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Myalgia bilateral arms (Left greater than right); Administered expired vaccine; Sore arms/aches; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arms/aches), MYALGIA (Myalgia bilateral arms (Left greater than right)) and EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced PAIN IN EXTREMITY (Sore arms/aches) and EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On an unknown date, the patient experienced MYALGIA (Myalgia bilateral arms (Left greater than right)). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arms/aches) outcome was unknown and MYALGIA (Myalgia bilateral arms (Left greater than right)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not reported.  The patient experienced mild to moderate (3 or 4 out of 10) on scale myalgia bilateral arm (left greater than right), lasting less than 24 hours, resolved at the time of reporting.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up contains significant information. Case became valid, patient details, suspect drug information, vaccine facility information, new event were added.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, ANTERIOR WALL HYPOTENSION 11/12/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS