chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Affecting his life; Pretty bad,Not comfortable at all; Rash; Hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Affecting his life), FEELING ABNORMAL (Pretty bad,Not comfortable at all) and RASH (Rash) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21A, 004C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced URTICARIA (Hives all over the body) and RASH (Rash). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Affecting his life) and FEELING ABNORMAL (Pretty bad,Not comfortable at all). At the time of the report, URTICARIA (Hives all over the body) and RASH (Rash) had not resolved and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Affecting his life) and FEELING ABNORMAL (Pretty bad,Not comfortable at all) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) blood work came out good.         No concomitant medications were reported. The patient was a cyclist and works out on regular basis. The patient stated that he has rash, hives all over the body and stated that the doctors are still checking and symptoms started within 11 days after the booster dose and treatment received included antihistamines.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 04-SEP-2014 (also reported as two weeks ago) the patient was vaccinated with ZOSTAVAX (dosing regimen unknown). The reporter stated that on an unknown date he got an electric order for prednisone (manufacturer unknown) for the patient from physician's office. The reporter stated it was unknown if the patient had an adverse event. The outcome of the event was unknown. The causality of event was not reported. No product quality complaint was reported. Additional information is not expected.
Numbness, tingling sensation, weakness of left arm and leg like the Guillain - Barre syndrome (per my primary provider)
saw my son, at 17, plummet to the floor; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: FALL (hospitalization), outcome "unknown", described as "saw my son, at 17, plummet to the floor". The patient was hospitalized for fall (hospitalization duration: 7 day(s)).  Clinical course: Caller provided, "I know a lot of people are dying" [from the vaccine], "and my son ended up in the hospital for 1 week due to the Pfizer vaccine last year. Since my son took his last jab in Dec and ended up in the hospital for one week on his deathbed. because all of these people are dropping to their feet." she stated, "I saw my son, at 17, plummet to the floor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called the pharmacy the evening of the day that the vaccine was given with a warm, red arm. She reported a reddish line going around her arm about 5 finger lengths below the bandaid site. She reported some splotchy red spots as well. She ended up taking Tylenol for the pain. When I called her back 10/16 in the morning, her arm was much better. The swelling and pain had gone way down and she was no longer worried about it.
Started Approximately one week after first vaccination. Still continuing to this day (over 2 months later). Heart arrhythmia. Diagnosed frequent  PVCs (premature ventricular contractions). Daily and frequently throughout day.  Doctors could not determine cause.
fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 15:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 80 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 14Sep2022 as 0.7 ml (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Vascular issues with stents" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Thyroid issues" (unspecified if ongoing); "Known allergies: seafood" (unspecified if ongoing). Concomitant medication(s) included: TOPROL XL; SYNTHROID; LISINOPRIL; BABY ASPIRIN; Z-PAK. Past drug history included: Mycins, reaction(s): "Known allergies: Yes many meds(most mycins)". Vaccination history included: BNT162b2 (Dose number: 4,, Lot number: FJ9943, Dose administration time: 10:00 AM, Dose vaccine location: Left arm), administration date: 31Mar2022, when the patient was 79-year-old, for COVID-19 Immunization, reaction(s): "fever", "chills"; BNT162b2 (Dose number: 3, Lot number: FC3184, Dose vaccine location: Left arm), administration date: 25Aug2021, when the patient was 79-year-old, for COVID-19 Immunization, reaction(s): "fever", "chills"; BNT162b2 (Dose number: 2, Lot number: EL9267, Dose vaccine location: Left arm), administration date: 17Feb2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "sore arm"; BNT162b2 (Dose number: 1, Lot number: EL9263, Dose vaccine location: Left arm), administration date: 27Jan2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: CHILLS (non-serious) with onset 15Sep2022 at 02:00, outcome "recovered" (Sep2022); PYREXIA (non-serious) with onset 15Sep2022 at 02:00, outcome "recovered" (Sep2022), described as "fever". Therapeutic measures were taken as a result of pyrexia, chills.  Additional information: NDC for Fluzone HD was provided as 49281-0122-05. The patient did not have covid prior vaccination and did not take a covid test post vaccination. Around 10 hours after vaccination (dose 5) awoke with fever and chills which lasted around 10-12 hours and which responded to Tylenol. Exact same response for vaccination dose 4. Dose 3 was more intense and same symptoms lasted for 3 days. Oddly no after effect other than sore arm for dose 1 or dose 2.
patient was given the wrong vaccine, it was checked by one nurse, and didn't catch that it was the Proquad just saw the MMR , vaccines were switched around in the freezer and there fore was given the wrong one
8 cm x 5 cm hive at insertion site with PREVNAR. Red & painful (right leg).
Patient reported with redness at injection site with a red marl 2"x3/4" and soreness in entire arm. The donor also reported nausea/vomiting with dizziness.
I started feeling really bad about 10:15 on the 23rd. I had fever, chills, body aches. I could barely touch my own skin.  I left work around 3 :30 and I have zero memory of driving home at all. I cant remember one thing other than my friend helping me into bed.  The scary part was I cant remember driving at all.  Today is the 26th and I still have no energy, sore throat and extremely tired.
After receiving the second dose about 1PM I already had 100.2F temp and I had headache, fever, body aches like I was hit by a truck, exhausted and tired, I also had some diarrhea and my husband even had to help me a couple of times to get off of bed. I went home and took some Motrin and slept if and when I woke up I told my husband it felt like I was hit by  a truck.  I had Covid in June and since then no appetite, no sense of taste and smell and lost 130lbs. I also noticed 2 or 3 days after my shot that my diabetes would shot to 300s and then go down to like 58 without me doing anything different.
Localized redness from first dose; This case was reported by a nurse via sales rep and described the occurrence of localized erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was recovered/resolved.   It was unknown if the reporter considered the localized erythema to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR084938   Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The patient was over 50 years at the time of reporting. Patient received first dose of Shingrix back in January, 2022 and went in a month before reporting for second dose. Patient received both doses at local pharmacy. Patient had localized redness after the first dose. The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose refer linked case US2022AMR084938, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084938:Same reporter
no adverse event; On 06-MAY-2019 a patient was administered an improperly stored PROQUAD.; This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender.  Information on pertinent medical history, concomitant medications and drug reactions/allergies was not reported.   On 06-MAY-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, dose number, route, location of administration and frequency were not reported) (lot # R026350, expiration date: 15-MAR-2020) for prophylaxis.  The vaccine was exposed to temperatures from 15 degree Fahrenheit to 46 degree Fahrenheit for 77 hours. A data logger was not involved. There were no previous temperature excursions. No adverse event was reported.
1st day:  fatigue, chills, glandular soreness.  2nd day:  fever of 99, high resting pulse rate of90+, significant drop in blood pressure to 93/58, chills and weakness.  Vitals returning to near normal as of 03/29/2021
PT GIVEN DOSE 1 14 MAY.  GIVEN DOSE 2 19 MAY.
I have had high blood pressure in the past but it has been steady for years. In January I started to have a headache so I checked my blood pressure and it was 156 over 95. I went to go see my doctor 01/05/2023 and she increased my losartan dose. It did not help enough so I she added more medications to see if that works.
Patient complained of dizziness, feeling "hot" and blurred vision after injection of the third vaccine, typhim Vi. Staff RN noted the patient to be pale and diaphoretic and immediately rang for assistance and elevated patient's legs and began vital signs. Dr. and Dr. were immediately available for assistance. Patient assisted to reclining table and placed in trendelenberg position with vital sign monitoring until stable. Patient discharged from the Health Center by Dr. after 30 minutes in stable condition.
pt recv vax 17OCT95 & that evening the pt devel inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax;
Redness; Swelling; Itching; Tenderness; Fever; This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number: X39679, Expiration date was not reported) on 24Apr2019 (11:27), with route of administration unspecified, at a single dose for immunization. Medical history included diabetes mellitus 2 (DM2); irritable bowel syndrome (IBS); gastrooesophageal reflux disease; and hypertension (HTN). There were no concomitant medications. On 24Apr2019, the patient had redness. On an unspecified date in 2019, the patient had swelling, itching, tenderness and fever. The outcome of the events, redness, swelling, itching, tenderness and fever, were unknown.
Discharge Disposition:     Medications, instructions, follow up information: See patient Discharge Instructions/AVS.   Hospital Course and Significant Findings: Pt is a 90 y/o F with hx of asthma, HTN, GERD, breast CA, aortic valve regurgitation, CKD3a (baseline Cr 0.6-0.8), and L hip cephalomedullary nail insertion in 1/2021 who presented 12/17/22 to KVal ED with pain after a mechanical fall that evening. Pt reports that she was standing to use her commode when she tripped and fell on her L side. In ED, CT showed " New comminuted fracture of the right hemipelvis. Comminuted fracture of the left iliac wing distracted from the acetabulum. Comminuted intra-articular left acetabulum with 8 mm distraction along the superior acetabular surface axial image 55." Pt received tylenol 650 mg IV x 1, norco 5/325 tab 1 tab PO x 1, and zofran 4 mg SL x 1. Pt was incidentally tested (+) COVID   Palliative care was consulted and had long discussion with patient with orthopedic surgery re goals of care AM of 12/18/22. Patient ultimately elected to proceed with surgical repair of left acetabular fx. Orthopedic surgeon recommended patient be transferred to KP Vacaville on 12/18/22 for surgical repair of left acetabular fracture.   Pt also incidentally tested (+) COVID. She endorsed cough for 1 week. CXR (+) patchy airspace dz. She was mildly hypoxic and placed on 2L O2 and Decadron was started. Patient will complete 10 day course of steroid therapy. Patient was on room air satting 96% prior to discharge.
Protracted Dizziness with first and above second dose, more severe with second dose. Duration was months.
Patient received flu (lt) and pneumonia (rt) vaccinations 10/23/08 at VA, and within 24 hrs had swelling of right arm and pain at injection site.  VS wnl.  Moderate edema and redness rt f/a; no pain or tenderness c/o.  MD recommended patient use diphenhydramine as needed.
started to feel numb on the fingertips going to the arms, hands, toes, legs/ I am experiencing numbness, my whole body is going numb; Left arm feeling frozen; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age (age: 50, unit: unknown) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked if it was ok to get the second dose of COVID vaccine on 10Feb2021 after experiencing side effects. The patient got the first dose 20Jan2021 and started to feel numb on the fingertips going to the arms, hands, toes, legs, and left arm was feeling frozen; she was experiencing numbness, her whole body was going numb, all on an unspecified date in 2021. She did not report the symptoms to a healthcare professional. The first day, her fingertips were going numb and it's gradually crawling up, now it's going to her hand and up to her arm. She also mentioned that in the beginning, it was her toes and now it was crawling up and when she wakes up in the morning, she has completely numb leg and arms and added that this was progressive. The patient did not receive any treatment and has not visited the emergency room or a physician in response to the events. The outcome of the events was unknown. The events were assessed as non-serious.   Information about lot/batch number has been requested.
Vaccine was administered after being stored between 3.3°C and 6.9°C for 76 days. The ten day limit to store vaccine at these temperatures was on 5/26. Vaccine was administered on 6/1. Parent was contacted reported no adverse events. Patient has received another dose of Pfizer vaccine on 6/29/22.
Pyrexia; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Pyrexia) and DIZZINESS (dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Previously administered products included for Influenza: FLU (quadrivalent flu shot annually - historically without reaction). Past adverse reactions to the above products included Lymph node disorder with FLU. Concurrent medical conditions included Penicillin allergy (Hives) since 08-Jan-1991, Lactose intolerance (Abdominal pain) since 01-Jan-2017 and Undifferentiated connective tissue disease (as with prior two doses of vaccines, significant flare up.) since 1991.    On 12-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021 at 11:00 PM, the patient experienced PYREXIA (Pyrexia). 12-Mar-2021 at 11:00 PM, the patient experienced DIZZINESS (dizziness). In 2021, PYREXIA (Pyrexia) and DIZZINESS (dizziness) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: abnormal (abnormal) 101 to 103 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  Patient weight was 175.  Patient stated that until her initial COVID vaccination, she never had a reaction to a vaccination her life   This case was linked to MOD-2021-404048, MOD-2021-404059.
A non-serious spontaneous report of administration of FLUMIST to a pregnant female was received from a consumer concerning an adult female. No medical history was reported, the patient is 39 weeks pregnant. On 30-Sep-2009 a pregnant female received FLUMIST. The patient contacted her physician who indicated "everything should be ok." There was no adverse event experienced to date Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Feels Miserable; Chills; Fever; Headache; Aches and Pains all over; Horribly itchy; Wicked Rash (big welts); pain, Sore; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Horribly itchy), FEELING ABNORMAL (Feels Miserable), PAIN ( pain, Sore), DISCOMFORT (Discomfort) and RASH (Wicked Rash (big welts)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN ( pain, Sore) and DISCOMFORT (Discomfort). On 23-Apr-2021, the patient experienced PRURITUS (Horribly itchy) and RASH (Wicked Rash (big welts)). On 26-Apr-2021, the patient experienced FEELING ABNORMAL (Feels Miserable), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Aches and Pains all over). On 23-Apr-2021, PAIN ( pain, Sore) and DISCOMFORT (Discomfort) had resolved. At the time of the report, PRURITUS (Horribly itchy), FEELING ABNORMAL (Feels Miserable), RASH (Wicked Rash (big welts)), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Aches and Pains all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 98.4. On an unknown date, Body temperature: 100.6f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.
This spontaneous report has been received from a pharmacist concerning to a patient of unknown age and gender. Medical history, current conditions and drug reactions/allergies were not provided. On 13-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route, lot# and concentration were not reported). Concomitant medication was not reported. On 13-SEP-2013, the pharmacist stated that the patient may have received an expired dose of PNEUMOVAX23 with no adverse event reported. The pharmacist reported that a vial PNEUMOVAX23 contained about 1/3 of a dose of the vaccine, but could not state that the 5 doses were delivered from the multidose vial of PNEUMOVAX23. No adverse event reported. Additional information is not expected.  A follow up information has been received from the pharmacist, who called back and stated that he never reported that a multidose vial of PNEUMOVAX23 was under filled. Pharmacist stated that he was inquiring why he was able to draw up another 1/3 of a dose of PNEUMOVAX23 vial, if 5 doses were already delivered from this multidose vial of PNEUMOVAX23. Verified with the pharmacist that at least 5 doses were obtained from this product, and therefore no PQC identified. Reviewed information concerning overfill allowable for 5-dose vials. PQC screen inadvertently filled out. Additional information is not expected.
This spontaneous report as received from a medical assistant (M.A.) refers to patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Started to have many COVID symptoms, Fever, cough, fatigue, loss of appetite, difficulty breathing.  The difficulty breathing has worsened over the past 2 weeks. The cough has been treated, but still have dry cough.  Breathing is still labored with inhaler.
My blood pressure fell to 60/40, could not stand, light headed but did not pass out.  It took all day for my g blood pressure to return slowly to normal.  slight fever between 100 and 101, not over 100.7
VACCINE ADMINISTERED FROM PUNCTURED VIAL OPEN 17 HOURS; 6 DOSES DRAWN UP PER VIAL; This spontaneous report received from a health care professional concerned a 47 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25/MAR/2021) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced 6 doses drawn up per vial. On 27-MAR-2021, the subject experienced vaccine administered from punctured vial open 17 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered from punctured vial open 17 hours and 6 doses drawn up per vial was not reported. This report was non-serious.
Light headed, nausea, limb weakness, "Sparkly" vision to the point of loss of vision, vomiting.