chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received a 0.5mL dose (approved for immunocompromised people) instead of a 0.25mL dose (for all other indicated people).  This event occurred today, 11/27/21 and the patient had not yet reported any adverse effects.
9 days ago, got Pfizer vaccine #1. Immediately after vaccine, felt nausea, lightheaded. She was sitting in a chair and felt unable to sit in chair, needed support. "It was too much work to talk, knew answers, hard to speak." No LOC. BIBA to ED. Athol ED notes reviewed, found to be anemic (drew off IV), subsequently not confirmed. She has ongoing nausea (without vomiting), poor appetite (eating toast with avocado, pizza pockets), fatigue (slept 11 hours and felt tired on awakening, napping), shaky (whole body), weak (unable to break apart frozen bread loaf, but no focal weakness), high HR on ambulation (on apple watch, 170-180, even 200), vertigo (when turns head, feels tilting or rarely spinning, lasting a few seconds or minutes), gets cold very easily, throat felt and appeared to be jumping, maybe a little hard to swallow. Per mother (by text) she is "shell of her former self." Works front desk  has missed work except yesterday when she was able to get through a 3 hour shift. Cognition is mostly intact. She and mom do not know what to attribute this to. She if feeling better than after she left the hospital, better for a while, some worse now but not as bad as immediately after. No CP, no cough, fever. She has felt a little SOB last week, maybe after standing or taking a few steps.
the patient received her first dose of PNEUMOVAX 23 on an unknown date in 2020; No other AE; the patient may not hace received full dose of PNEUNOMAX 23; The caller said the product leaked from the syringe; This spontaneous report has been received from a nurse and refers to a 67-year-old female patient. The patient's concurrent conditions included smoker. The patient's medical history, previous drug allergies or reactions, and concomitant therapies were not reported.  On an unknown date in 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot number, expiry date, route of administration, and anatomical site of administration were not provided). On 15-SEP-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot number u026796, expiration date reported as 28-JAN-2023, administered for prophylaxis (strength, route of administration, and anatomical site of administration were not provided); at the moment of the administration the product leaked from the syringe, and the patient may not have received the full dose of the vaccine (syringe issue, incorrect dose administered, inappropriate schedule of product administration). No other adverse event occurred.
It started with an elevated body temperature and fatigue. I just generally felt awful. I had difficulty breathing with a subpar oxygen level. I also had body aches and an elevated pulse rate. I experienced these symptoms for 2 days and then went to an urgent care center at the hospital. They gave me a COVID-19 PCR test, took my vitals and sent me to the ER. My oxygen level was 89% and I was admitted.  I was placed on continuous oxygen and a 5 day protocol of Remdesivir, a blood thinner and steroids. I begin to see improvement in my symptoms within 6 days and I was discharged after 8 days. I was given oxygen. I am still attempting to recover from the episode. I am still struggling to maintain focus. My mental processing has slowed down excessively. I am still so fatigued that I have to nap. I have trouble sleeping and I am dealing with depression and anxiety. I also still have issues holding my breath. I self treat with oxygen that I have at home.
64 year old patient was inadvertently given the Fluzone High Dose vaccine instead of an influenza vaccine/ no AE; 64 year old patient was inadvertently given the Fluzone High Dose vaccine instead of an influenza vaccine/ no AE; 64 year old patient was inadvertently given the Fluzone High Dose vaccine instead of an influenza vaccine/ no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 64 years old male patient who vaccines INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ251AB, expiry- 01-05-2020 via unknown route in the left arm instead of INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose.  At the time of 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.  Information on the batch number was requested.  Documents held by sender: none.
Information has been received from a physician concerning a female patient with diabetes who in February 2007, was vaccinated with a 0.65 ml dose of ZOSTAVAX. The patient developed herpes zoster after getting ZOSTAVAX. At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. The patient was enrolled on the program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the vaccine VZV strain. Follow-up information has been received from a physician concerning a 68 year old female with diabetes and multiple sclerosis and a history of chicken pox and no known allergies, who on 5-FEB-2007 was vaccinated in her right upper arm with 0.65 ml dose of ZOSTAVAX (lot # 656606/0033U). Concomitant therapy included SANTURA, TOPROL XL tablets, ACTONEL, losartan potassium, interferon (unspecified) and insulin (unspecified). In January 2009 the patient developed herpes zoster on the injection site. She had no recent exposure to chicken pox or shingles. It was reported that  the patient was seen by her dermatologist. At the time of reporting the patient was recovering. A direct fluorescent antibody was not performed. No photo was taken by the physician. No further information is available.
headache; swelling under eyes after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and EYE SWELLING (swelling under eyes after the vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (headache) and EYE SWELLING (swelling under eyes after the vaccination). At the time of the report, HEADACHE (headache) and EYE SWELLING (swelling under eyes after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment details were provided.
Severe Chills, Dizziness, Headache, Unrelenting painful body convulsions continuous for one and one-half hours.
Patient started to be unconscious and not alert  5-10 minutes after vaccination. Patient was twitching, clenched hands, stiffness of muscles for <1 minutes.    911 was called but patient denied ems assistance.
Pt Left arm red swollen, painful within hours of injection High dose FLUZONE. Pt felt nauseous.
Started with pain at injection site 2 days later felt itching all over then found redness and swelling and redness the size of a  surgical gauze radiating from her shoulder to the crook of her arm. It was warm to touch.
Interchange of vaccine products; COVID treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 14:30 as dose 5 (booster), single (Lot number: 7H9694) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Feb2021 as dose 1, single (Lot number: 031M20A), on 17Mar2021 as dose 2, single (Lot number: 001B21A) and on 05Nov2021 as dose 3 (booster), single (Lot number: 032F21A) for covid-19 immunisation. The patient's relevant medical history included: "Slightly high cholesterol" (unspecified if ongoing); "Slightly high BP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Nov2022, outcome "unknown", described as "COVID 19 treatment"; DRUG INEFFECTIVE (medically significant) with onset Nov2022, outcome "unknown", described as "COVID treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures, Paxlovid from 21Nov2022 to 26Nov2022, were taken as a result of drug ineffective, covid-19. Patient felt much better after the Paxlovid treatment. The patient has no known allergies.
Red at the injection site; very swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red at the injection site) and INJECTION SITE SWELLING (very swollen at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Epidural injection (received epidural steroid injection) since an unknown date.    On 08-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Red at the injection site) and INJECTION SITE SWELLING (very swollen at injection site). At the time of the report, INJECTION SITE ERYTHEMA (Red at the injection site) and INJECTION SITE SWELLING (very swollen at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
pt recvd vax 6FEB96 & 7FEB96 PC-arm swollen;tx DO to MBER;7FEB96 MBER-rocephin given-blood culture;9FEB96 dec appetite,dec sleep,c/o arm hurting,diarrhea;10FEB96 fever 103.2;10FEB96 lt arm cellulitis adm to hosp-cellulitis & sz
Rashes and hives all over the body ten days after the booster shot (moderna). On going to this day, five weeks later. Taking once daily antihistamine over the counter helps a little bit.
Finger tip swollen, red; Raspy throat; The initial case was missing the following minimum criteria: as there is no indication that the consumer experienced an event under BNT162B2. Upon receipt of follow-up information on (11Jun2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) reported similar events for three patients. This is the first of three reports. A 80-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via intramuscular route of administration, administered in arm on 12Feb2021 12:30 (at the age of 80-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history included she has allergies, allergies to latex, sulfa; patient is a breast cancer survive, diagnosed on an unspecified date in 2008 (survivor 13 years), mastectomy from on an unspecified date in 2008. The patient concomitant medication included diphenhydramine hydrochloride (BENADRYL) via oral route from 22Jan2021 to 23Jan2021 and 02Feb2021 to 03Feb2021. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EL1283, Expiration date: 30Apr2021), via intramuscular of administration, administered in arm left on 22Jan2021 10:00 AM (at the age of 80-year-old) at a 1st dose, single dose for COVID-19 immunization and experienced headache, her finger tips got red and she had swollen red hands, red puffed up, chills/terrible chills, throat raspy was with a dry mouth, muscles hurting. Duration of reaction was 21 days. Events were recovered on an unspecified date in 2021. Patient previously took flu shot prior vaccinations (within 4 weeks), Cipro and experienced allergies to cipro. The patient experienced finger tip swollen, red; 5 minutes after it raspy throat on 12Feb2021 10:00. Patient said she, her husband and her sister received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last 22Jan2021 and was scheduled to receive the 2nd dose 2 weeks after the 1st dose. Patient got the first shot on 22Jan2021 and was sent an email that her second dose is scheduled for 05Feb2021. Patient had an allergic reaction to the vaccine she is nervous about getting the second shot. Outcome of the events was unknown.   Follow-up attempts completed. No further information needed.; Sender's Comments: Linked Report(s) :PFIZER INC-2021128085 same reporter/vaccine and different patients.;PFIZER INC-2021128086 same reporter/vaccine and different patients.;PFIZER INC-2021128086 same reporter/drug/AE and different patient
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug information was provided by reporter.  No treatment medication was provided by reporter.   Reporter did not allow further contact
Erythematous maculopapular exanthem (morbilliaform). Some with coalescent plaque on face, trunk, extremities. (+) lesions on soles. ? measles vaccine related rash vs amox allergy.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No medical history provided. On an unknown date the patient was vaccinated with GARDASIL (dose 1). Concomitant medication included unspecified migraine medication. On an unknown date the patient experienced her period one week prior receiving her second dose of GARDASIL. Then, she had her period again approximately one week (unknown date) following the administration of her second dose. The reporter stated she does not believe the patient had a pregnancy test prior receiving her second dose of GARDASIL. The patient sought medical attention by contacting the pharmacist. The outcome is unknown. Additional information has been requested.
Headache, Myalgia, Fever, chills, fever to 100.1 F with 1000mg tylenol Narrative:  TOOK DAY OFF
I was laying in my bed in my dorm and I was suddenly overcome with intense chest pain and difficulty breathing. I immediately used my nebulizer thinking that I was just having an asthma attack. After waiting for about 45 minutes and receiving no relief from the medication I asked my roommate to drive me to the hospital. When I get to the hospital I could barely breath and was unable to find a position to sit/stand/lay in that wasn't excruciatingly painful. The doctors eventually diagnosed me with costal chondritis. I spent the next 5-6 months in and out of the doctors office and the hospital as various different infections attacked different parts of my body (stomach, kidneys, lungs, skin, and eventually my mouth and throat resulting in ulcers so bad I was hospitalized because I could not eat or drink due to the pain. I also have non-epileptic seizures.
ACTHIB was given past the expiration date with no reported adverse event; Initial information received on 24-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1-year-old female patient for whom HIB (PRP/T) vaccine [ACT-HIB] was given past the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel), Varicella Zoster Vaccine (Varicella Vaccine) And Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR), all for Immunisation.  On 24-Aug-2023, the patient received an expired dose of 0.5 ml (Frequency = once) of standard strength suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot: UJ796AA, Expiry date: 12-Aug-2023) via intramuscular route in the left thigh for Immunization no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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 the guidelines. 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.
Pt recvd 3rd dose of Engerix-B & inject was beginning to hurt; reporting nurse described the pt as color pasty, lips blanched; exp dizziness; pupils were dilated & became unresponsive; apnea noted; unable to palpate a pulse brachially; sz;
developed hives on arm along with fever, chills and muscle aches.  Self treated and symptoms resolved
unbearable pain at the back of the right side of his neck around the area of the ear lobe; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (unbearable pain at the back of the right side of his neck around the area of the ear lobe) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced NECK PAIN (unbearable pain at the back of the right side of his neck around the area of the ear lobe). At the time of the report, NECK PAIN (unbearable pain at the back of the right side of his neck around the area of the ear lobe) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Information has been received from a nurse concerning a male patient in his 60's who about 6-7 years ago, approximately in 2005 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). Concomitant medication included unspecified statins and a few other unspecified products. The nurse reported that a patient was in the intensive care unit (ICU) for something unrelated and was administered PNEUMOVAX 23. Within 60 days, the patient developed rhabdomyolysis. The therapy with PNEUMOVAX 23 was not reintroduced. The patient sought unspecified medical attention. On an unknown date, the patient fully recovered from rhabdomyolysis. Upon internal review, rhabdomyolysis was determined to be an other important medical event. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 13-NOV-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (dose, frequency and route of administration were not reported) lot # N001348 and expiration date: 31-OCT-2019. No adverse effects were reported. On 08-NOV-2017, the PEDVAXHIB was stored in between 47 Fahrenheit degrees to 77 Fahrenheit degrees for 45 minutes. There was no previous temperature excursions. The digital data logger was involved in recording the temperature excursion. This is one of five reports received from the same reporter. Sender's Comments: US-009507513-1711USA006682: US-009507513-1711USA006683: US-009507513-1711USA006683: US-009507513-1711USA006084.
After admin of vaccines pt became tense, eyes rolled towards back of head, began to shake. Pt was laid down on table shaking stopped. Vitals taken. MD assessed pt. Pt kept in office for 30 mins. Orthostatic b/s done. OJ given. Ice pack placed behind pt's neck. Pt d/c to home after stabilized.
Fever/chills, redness and swelling at injection site.  Arm was very sore, hard to move it.  Took aleve for pain/swelling.
Individual felt pre-syncopal. Left obs area after 8 minutes to get fresh air. Sat down on grassy area and was found down, pale and diaphoretic. Suspect LOC. Recovered spontaneously. Normal mental status after event. Treated with oral rehydration. Declined further evaluation. Sent home by POV.
Chest tightness-Went to emergency room department and was given an albuterol nmt and 60 mg of prednisone,
Staff having running nose, cough, fatigue, arm/body ache. States its post nasal drip. Same symptoms she had after her last flu shot. Took sudafed and is feeling better.
Two days and four days later I had a total loss of strength in both legs that lasted a minute. It was a rapid unset that left me sitting down quickly. No pain before during or after. I recovered completely in about a minute.
Information has been received from a Registered Nurse concerning a male patient who about 2 years ago was vaccinated subcutaneous with a dose of PNEUMOVAX and developed redness at the injection site which traveled down the arm.  Patient used ADVIL and TYLENOL as treatment.  She recovered.  Additional information has been requested.
Narrative:  Patient received two doses of Pfizer COVID 19 vaccine in Feb/Mar 2021. The patient tested positive for COVID 19 on 27 August 2021 and was admitted to the hospital with COVID Pneumonia. The patient was treated with remdesivir and dexamethasone and was discharged on 23 September 2021 in stable condition.
On 4/29 pt worked out at 7am and then during the evening saw a rash on the arms, neck and torso. Rash improved some but then flared significantly from neck to knees. Gets severe "needles" or itchy feeling when he heats up.