chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body ache; Chills; Headache; This is a spontaneous report from a contactable consumer via Pfizer sales Representative. The consumer reported on three patients. This is the second of three reports. A patient of an unspecified age and gender received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, on the second dose of vaccination the patient experienced body ache, chills and headache. The patient was treated for body ache, chills and headache with ibuprofen and the symptoms went away in one day. The clinical outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117236 same reporter/product/event, different patient;US-PFIZER INC-2021117324 same reporter/product/event, different patient
My kid age almost 15 got moderna vaccine; A Spontaneous report was received from a consumer concerning,  a 14-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273)/product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 on unknown date.  On 20 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19.  On 20 Mar 2021, the patient was doing well without any events. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of event, Inappropriate age at vaccine,  was considered resolved on 20 Mar 2021.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (14 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Left thigh swelling, rash and pain. Parent gave Ibuprofen and put warm cloth on the thigh. Pt. was seen and sent to ER.
gen scattered macular/papular eruption on trunk & extremities;fever of 102 for 1 day;eruption started 12JAN96-eruption cleared w/o sequelae on 19JAN96
Since having my Covid vaccine, I?ve had elevated liver enzyme levels (AST & ALT). I don?t know if this is a result of the vaccine, but I?ve had my blood taken several times and had an ultrasound done on my liver. The ultrasound was fine, but each time I get my blood taken the levels are still elevated. I had this same test done in December of last year and the levels were within normal range.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No medical history and current conditions were provided. On 26-JUN-2015 the patient was vaccinated with an unspecified dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided). There was not concomitant medication reported. On an unspecified date, in June 2015, the patient broke his ankle. The patient may started 10 days of therapy with 40mg of unspecified steroids. No laboratory tests were provided. At the time of the report the outcome of broken ankle was unknown. The reporter did not suspect a causal relationship between the vaccine administration with ZOSTAVAX and the broken ankle. The reporter consider the broken ankle to be a serious adverse event (medically significant). Additional information has been requested.
Pt began generalized itching of entire body the evening of vax. Pt developed rash, red, raised welts over most of body on day post vax; worse around neck and upper back. Three days post vax skin is flaking off and itching continues.
Dose 1,2,3: Moderna and Dose 4: Pfizer; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Chronic fatigue syndrome" (unspecified if ongoing); "Chronic migraines" (unspecified if ongoing); "herpes simplex type ii" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Corn (mild)" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE, start date: 01Jan2013; CYMBALTA, start date: 01Jan2014; VERAPAMIL, start date: 01Jan2015; CLONIDINE, start date: 01Dec2022, stop date: 18Mar2023; MIRTAZAPINE, start date: 01Oct2017, stop date: 18Mar2023; NEUPRO, start date: 01Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1,2,3: Moderna and Dose 4: Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 19Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pr brought to ED with increasing weakness and unable to walk; dementia; decrease in appetite; swallowing impaired; wife tested positive for COVID and is unable to care for him; pt tested positive for COVID; wife states he's been steadily declining over the past month; there has not been any SOB, and pt is breathing on RA and well hydrated; pt's condition worsened and he was made comfort care; pt passed away in the hospital
About a week after she received Pfizer vaccine she noted she began having some hair loss and then proceeded to lose the great majority of her hair.
This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # K008879, expiration date 30-MAR-2017, lot # K016964, expiration date 16-JUL-2017; lot # K026533, 07-AUG-2017; lot # L004740, expiration date 16-NOV-2017; lot # L014426, expiration date 08-MAR-2018; lot # L014428, expiration date 12-MAR-2018; dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
THREW UP FIRST DOSE OF VIVOTIF; This spontaneous case report (PVX2019-1894) was received from a consumer on 22-Jul-2019. It described a 22-year-old female consumer who "threw up first dose of Vivotif" (PT: Vomiting), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 19-Jul-2019 and after three to four hours, she threw up the Vivotif dose. She took second dose on 21-Jul-2019. She stated that she threw up due to her birth control pill, Sprintec (norgestimate and ethinyl estradiol), that she just started recently that makes her queasy. She also stated that she did not expose to any foreign or unhygienic food or drink.  Action taken with Vivotif was dosage maintained.  The clinical outcome of the reported event was unknown.  The reporter considered the event of "threw up first dose of Vivotif" was unrelated to vaccine.  Company's Comment: In this case, it was reported that the consumer "threw up first dose of Vivotif". There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, vomiting is labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer  "threw up first dose of Vivotif". There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.  Also, vomiting is labelled as per CCDS
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: 014M20A), on 26Apr2021 as dose 2, single (Lot number: 047AZ1A), on 01Nov2021 as dose 3 (booster), single (Lot number: FH8U20) and on 22Apr2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient's relevant medical history included: "BPH with urine retention" (unspecified if ongoing), notes: BPH with urine retention; "Osteoarthritis in both knees" (unspecified if ongoing), notes: Osteoarthritis in both knees. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment for the event included Paxlovid on 03Mar2023 to 08Mar2023.
Began with a sore arm in the evening of the day of the flu shot. The next day by 10:00 AM I was light headed with a mild headache. If I put my head down for any reason I felt dizzy and like I would throw up. I have not thrown up but I have been light headed up to today. Unable to put my head below my heart without feeling dizzy.  Also dizzy when getting up from lying down. Situation improving but not over. On the day after the flu shot (10/31/2013) I had fatigue, runny nose, fever/chills and headache, along with the dizzy sensation.
Pt presented to our office on 6/18/09 with left sided rash. Rash began one day after varivax was administered in the left arm.  Rash is present on the left side of the neck, torso, and left arm. Rash is vasicular and papular.
it was rpt fr HCP concerning  pt who was vax & subsequently pt exp excessive inject site swelling. no further info avail
No specific adverse event, however second bivalent Moderna COVID-19 vaccine was erroneously administered at 64 years old (patient is not yet 65 years old and is not immunocompromised) which is outside of current authorization.
I tested positive for Covid; I tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "known allergies Cipro", notes: known allergies Cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Apr2022, outcome "recovered" (30Apr2022) and all described as "I tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (13Apr2022) Positive; (21Apr2022) Negative; (22Apr2022) Positive; (30Apr2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course; COVID 19 Treatment Brand Paxlovid treatment start date was 14Apr2022 and treatment stop date was 18Apr2022, Indication of treatment of COVID-19. He had a relapse of COVID after taking Paxlovid. He was tested positive for Covid on 13Apr (on an Antigen test). He began Paxlovid on 14Apr and ended on 18Apr. Symptoms quickly subsided and by 21Apr He had a nearly negative antigen test. Then 0n 22Apr2022 He began testing more and more positive on Antigen tests and remained positive until a negative antigen test on 30Apr. He was experienced mild symptoms during both phases of the infection. Device timestamp was reported as, 30Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning an 18 week old male, with no medical history and no allergies, who on 30-Oct-2006, at 6:15 pm, was vaccinated with a second oral dose of Rotateq vaccine (human-bovine) (lot#654664/0726F). Concomitant vaccines administered at the same time included a first intramuscular dose of IPOL (Lot# 20306-2) and second intramuscular dose of Prevnar (lot#B08646C). There was no illness at the time of vaccination. On 31-Oct-2006, at about noon, the patient did not want to drink and had a fever of 102 F. The patient was seen in the office, and it was reported that the exam was normal. The patient's fever lasted 24 hours. It was reported that the patient recovered on 01-Nov-2006. Additional information has been requested.
Narrative:  COVID infection following COVID vaccine series 04/06, Pfizer, dose #1 04/27, Pfizer, dose #2 09/14 COVID swab, result: detected 09/11 pt cc: fatigue exposure: unknown 09/14 CXR impression Pulmonary vascular crowding due to the expiratory technique. Superimposed bibasilar interstitial pulmonary opacities as seen in viral pneumonia are not excluded. 09/14 pt admit to ED cc: cough dx: Hyperglycemic state likely secondary to acute covid-19 infection and 2. COVID-19 complicated with pneumonia and mild hypoxemia LOS: 4 09/18 FIBRINOGEN: 267 09/18 DDIMER: <0.22 09/18 CXR impression: Interval development of patchy right greater than left airspace opacity. 09/22 clinically resolved
patient was prescribe pfizer per age but was given moderna as a booster instead of pfizer no untoward effects currently.
Hidradenitis Supportive, associated with hormones; flare up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hidradenitis suppertiva" (unspecified if ongoing), notes: I have Hidradenitis Suppertiva, associated with hormones. I have not have flare ups for 3 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization.  The following information was reported: HIDRADENITIS (non-serious), outcome "unknown", described as "Hidradenitis Supportive, associated with hormones"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "flare up".  Additional information: I have read about several women having hormonal changes after getting vaccinated. I hope this is research you are pursuing. I have Hidradenitis Supportive, associated with hormones. I have not have flare ups for 3 years. After my second dose of Pfizer, I experienced a flare up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On the evening of 02/12/2023, I began to feel some scratchiness in my throat and mouth. I woke up the next morning, feeling more congested than usual, in the head mostly. I had a slight cough and a low-grade fever. My wife had already tested positive for COVID-19. We were isolating from each other, but I still caught it. I did an at home COVID-19 test and it was positive. I had a low-grade fever for a few days, which I treated with TYLENOL. I was very fatigued and did not have a lot of energy. 02/14/2023, was my highest temperature. It was 102.2. I spoke with my doctor, who prescribed molnupiravir. By the evening of 02/25/2023, I was back to normal and have had normal temperatures since then. On the evening of 02/20/2023, I developed quite a bit of chest pain and had trouble breathing in. I went to an urgent care clinic and was given an x-ray. I had developed Pleurisy. They prescribed an XOPENEX inhaler and gave me a breathing device. By 02/27/2023, that was all cleared up. At this point, I feel like I have almost gotten back to normal.
Off-label use; Drug use in unapproved population; undetectable levels in breast milk; milk changed to blue/green color; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Off-label use"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Drug use in unapproved population"; EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "undetectable levels in breast milk"; LACTATION DISORDER (non-serious), outcome "unknown", described as "milk changed to blue/green color". Additional information: The reporter reported as non-serious. Caller would like to obtain some general breastfeeding information and read that some mom breast milk changed to blue/green colour, but nothing was mentioned in how long that lasted or the composition of it. Also, the majority of case studies have found undetectable levels in breast milk.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 10/21/00, pt presented to ER with rash and swelling of left arm from mid-upper arm to fingers. Cellulitis was dx'd. Unknown what treatment was done, if any.
My husband died after a seizure on October 11, 2018. His heart stopped. He was pronounced dead at Hospital. He had Marfan syndrome and a 4.9 abdominal aneurysm. He had never taken the flu shot since a time several years ago when he ended up getting the flu after taking it. He was due for surgery soon, so he agreed to take it.
Dizziness, Palpitations, HYPERtension &  Tachycardia
~a week and a half after Vaccine, I experienced 'room spinning' vertigo and dizziness at around 1am. I was sick for the next few hours, vomited for around the first hour after. Symptoms of dizziness for the next two days, then Vertigo/dizziness/vomiting again the following night. After around 3 more days, the symptoms subsided. I had my 2nd Moderna shot on 5/18/2021 (Lot 036C21A) and on 6/10/2021 the symptoms began again. After the first case, I saw online Urgent care and was referenced to an in-person visit to a primary care doctor. I was 'diagnosed' with BPPV, which I've never experienced symptoms of before. They ran me through several tests at the office, but by the time I got to the primary care doctor the symptoms had subsided again. I'm currently still experiencing a light dizziness 24/7 since 6/10/2021.
Patient tested positive for COVID-19 1/16/2022. This past Friday she felt increasingly more fatigued and noticed shortness of breath mostly with exertion and relieved with resting. She called her PCP on Tuesday and was prescribed Prednisone, Z-pak and Mucinex DM, however, despite taking all medications as prescribed she did not notice any improvement of her symptoms. Patient further endorses LLE edema starting on Tuesday. She denies any pain, redness and/or coolness to touch of her LLE. She is on hormone replacement therapy that she states was started after her uterine cancer diagnosis. Patient called her PCP office again today due to no improvement of her symptoms and after being advised to continue with her current medications she decided to come to the ED for further evaluation. No chest pain, palpitations, cough, fever and/or chills.   US LLE with finding of occlusive thrombus throughout the entirety of the leg leg deep and superficial venous system. CTA chest with filling defects consistent with pulmonary emboli are present within the pulmonary arterial system bilaterally, greater on the right. No evidence for right heart strain. Finding of lung nodules were noted.  Discharged 1/28/2022  Pt Vaccinated with Jenssen 3/21/21
Diarrhea, fever (101.5) for 2 1/2 days, headache, muscle pain, brain fog, chills, extremely sore arm.
BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE WITH DEATH.  71-year-old female with failure to thrive froma residential facility. Admitted requiring 3 L oxygen with suspected aspiration PNA , acute hypoxic resp failure on 4L NC, COVID + (6/27) DX COVID PNA complicated by potential Aspiration PNA in the setting of new PEG tube placement. Rx treatment with Rocephin. Found with tachycardia and elevated white count s/p PEG placement (6/26) with suspected aspiration PNA , acute hypoxic resp failure on 4L NC (6/27), pleural effusion.6/28/2022 positive sepsis alert & consult infectious disease, pt placed on Vancocin. Pt declined, 25L Oxygen by nonrebreather after several rapid response incidents. Death 06/29/2022 14:51
No adverse event; administration of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions, allergies, and concomitant medications.   On 16-DEC-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliters (ml), route defaulted to oral, lot # 1741817, expiration date: 30-JUL-2022, (route of administration and anatomical location were not provided), for prophylaxis. (Product storage error). The administered dose of vaccine experienced temperature excursion of 50.5 degrees Fahrenheit for 57 minutes. There was no previous temperature excursion reported.     No product quality complaint (PQC) and no additional adverse event (AEs) were reported.
Patient sat about 2 minutes after getting vaccine and started to walk away  to  sit in our designated area.   She immediately turned  around to sit down again.  She then  proceeded to start falling to her right and passed out.  I was able to catch her and then she started  shaking as if having a seizure.  This lasted about 5 seconds .  She stopped  and then it happened again  for about 5 seconds.  When she came to, she tried to walk away again and had to return to sitting.  Then she vomited twice.  Upon checking her blood pressure after about 30 minutes, it was 97/66.  She sat for a total of about an hour before feeling  good enough to leave.  She was nauseous for the remainder of the day and the next day as well.
10:25 AM. Patient was in Observation Area post vaccination 2nd dose of Pfizer.  Suddenly, she complained to RN who was the Observation Nurse that she has the pressure in her Left arm radiating to her neck and chest. She looked pale and clammy too. Oxygen saturation was on 83%, HR 93, Temp 97.5. No blood pressure taken due to unavailability of the apparatus at the site. 911 was called and took the patient into their VAn.
throat is sore on the L side. It feels swollen. He has some clear/white sputum. Dull HA and body aches. starting 1/22/2022
Begun feeling fatigued and weak when waking up in the morning, progressed into chills and feeling of faintness. Difficulty swallowing and some pain and shortness of breath when swallowing.