chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching an unspecified length of time after receiving Fluvirin on an unknown date. On an unknown date an unspecified number of vaccinees experienced localized hives, swelling, redness and itching on an unspecified length of time after receiving Fluvirin. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 2/16/04: A follow up report was received from a health care professional indicating that an 11 year old female vaccinee developed an event described as red, swelling and itchy on 10/14/03, 1 day after receiving Fluvirin on 10/13/03. The outcome of the adverse event was not reported at the time of reporting. Update 4/16/04: Further follow up information received from a health care professional indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of 4/04. No follow up pending. All information received.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a five-years old female patient who received a second dose of 0.25 ml instead of 0.5ml of vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included a dose of FLUZONE QUADRIVALENT in Nov-2017 but did not receive 2nd dose in 2017. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medication was none. On 02-Nov-2018, the patient received 0.5 ml of first dose of suspect Influenza Quadrival A-B Vaccine lot number not reported via unknown route. On an unknown date (reported as today) she also received 0.25 ml of Second dose of the same vaccine lot UT6259MA via unknown route in the left deltoid. It was a case of actual medication error due to Vaccine under dose. It was not reported if any adverse reaction was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Patient's husband reported the patient had a  104.8  degree fever. This occurred around 24 hours after receiving the first dose of the Moderna vaccine. It was recommended the patient take tylenol or ibuprofen. The patient's PCP was notified.
Numbness under right eye, eye won't close. Mouth is drawn, right side pulls to left. Physician feels this is a reaction to vax. Bell's Palsy. At the time of this report, his condition was unchanged.
Chest pain approx. 20 minutes after recieving the flumist, ear lobes tingley and very jittery  I gave her benadryl, she called her doctor and went home to rest.  The synmptoms disapeared within 30 min of taking the benadryl.
received / first dose of Shingrix on Nov 18 2020 / not received the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th November 2020, batch number XG52X, 28th November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this case. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Entire arm is swollen and black and blue. Really tired as well as a lot of pressure in my arm and chest
Area of erythema and swelling about 3 inches below the injection site of the R deltoid (PNEUMOVAX PPV23).
29May91 PC from mom in am,T under 101F-giving APAP q 4hrs-leg puffy below inject site-walks only when forced to.Irritable since DTP recvd 28May91;30May01 PC mom @ bedtime stopped voluntary walking-swelling inc-redness hip to knee-To ER
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose number unknown, single (Lot number: ER8732), in left arm and on 20Apr2021 as dose number unknown, single (Lot number: EW0164) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Dec2021 as dose number unknown, single (Lot number: 028K21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing); "back surgery" (unspecified if ongoing), notes: I had recent back surgery and knee surgery; "knee surgery" (unspecified if ongoing), notes: I had recent back surgery and knee surgery; "Asthma" (unspecified if ongoing), notes: I am a healthy, elite athlete. Compromised meaning asthma. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive, notes: Tested positive on 24Jul; immune compromised- 25Jul called my PCP, Rx Paxlovid; (31Jul2022) Positive, notes: 31Jul rebound - fully symptomatic and texted positive both rapid and a PCR; (31Jul2022) Positive, notes: 31Jul rebound - fully symptomatic and texted positive both rapid and a PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
a little dizziness, at 5:30pm, strong dizziness, hands were shaking, increased heart rate, palpitation eyes (both), temperature- 99.2F; constant headache, right eye started to close, feels heavy like I was punched.
fogginess; tiredness; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "fogginess"; FATIGUE (non-serious), outcome "not recovered", described as "tiredness"; NAUSEA (non-serious), outcome "not recovered", described as "nausea"; VOMITING (non-serious), outcome "not recovered", described as "vomiting".  No follow-up attempts are possible. No further information is expected.
RECEIVED THE CITRATE FREE VERSION/EXPECTING THE ORIGINAL/QUESTIONED IF PHYSICIAN CHANGED THE PRESCRIPTION/PHARMACIST UNSURE OF HOW IT WAS WRITTEN; Sore arm after covid booster; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up), VACCINATION SITE PAIN (Sore arm after covid booster) and PRODUCT DISPENSING ERROR (RECEIVED THE CITRATE FREE VERSION/EXPECTING THE ORIGINAL/QUESTIONED IF PHYSICIAN CHANGED THE PRESCRIPTION/PHARMACIST UNSURE OF HOW IT WAS WRITTEN) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In 2020, the patient experienced PSORIASIS (Psoriasis flare-up). In 2021, the patient experienced VACCINATION SITE PAIN (Sore arm after covid booster). On an unknown date, the patient experienced PRODUCT DISPENSING ERROR (RECEIVED THE CITRATE FREE VERSION/EXPECTING THE ORIGINAL/QUESTIONED IF PHYSICIAN CHANGED THE PRESCRIPTION/PHARMACIST UNSURE OF HOW IT WAS WRITTEN). At the time of the report, PSORIASIS (Psoriasis flare-up), VACCINATION SITE PAIN (Sore arm after covid booster) and PRODUCT DISPENSING ERROR (RECEIVED THE CITRATE FREE VERSION/EXPECTING THE ORIGINAL/QUESTIONED IF PHYSICIAN CHANGED THE PRESCRIPTION/PHARMACIST UNSURE OF HOW IT WAS WRITTEN) outcome was unknown.            No concomitant and treatment medication were provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Significant follow-up appended(narrative updated) On 20-Apr-2022: Non Significant follow-up event verbatim updated
10 week male 2 days of fussiness above baseline with marked fussiness 3 day post immunization. had 60 second episode of limpness during a screaming episode - red in face/no pallor or cyanosis and was sobbing. No residual sequelae.
Patient is a 52-year-old man with past medical history significant for Cystic fibrosis F508/ 2789+5G to A mutation with associated, bronchiectasis, chronic pancreatitis, GERD, pancreatic insufficiency and chronic abdominal pain.  Additional history includes MAC, for which he was previously on treatment through Infectious Disease including azithromycin, ethambutol, and rifampin, 3 times weekly (10/23/18).   He was evaluated for COVID-19 infection and hypoxia on 10/18/2021.  His symptoms had started 10/12, noted to be positive on 10/15.  He received a good day course of dexamethasone and also remdesivir. He received compassionate use Regeneron on 10/20/2021.His hypoxia was thought to be multifactorial-COVID and bronchiectasis related to cystic fibrosis. He was started on Zosyn on 10/22/2021 in addition to aggressive airway clearance with Pulmozyme, bronchodilator, and hypersaline. Patient was gradually weaned off oxygen supplementation but still required 2L with activity (He has oxygen at home.)   His MAC regimen was continued inpatient including inhaled amikacin,azithro and ethambutol and Trikafta. Patients renal function was noted to have been up trending, patient received IV fluid hydration with noted improvement in his renal function. On the day of discharge, white count increased from 10.64 to 12.51.   He would receive repeat labs (CBC and BMP) on Monday 10/31/2021 (ordered) He will finish a 14 day course of Zosyn total ( October 22-November 4) Has follow up 12/15/2021
The day of the vaccine, anaphylaxis (difficulty breathing, accelerated heartbeat, fever, chills, confusion). From then and ongoing for the last six months, severe daily heart pains and very weak immune system.
Headache, muscle weakness (in entire body), muscle pain in shoulders and neck, chills, hot flashes.  Treated with 400mg of Ibuprofen.
Hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurts). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that there was to many vaccines for everything and it hurts but it goes away. The patient stated that we must live like this. Follow-up would not possible as no contact details were available.
This spontaneous report as received from a certified medical assistant and refers to a 5 month old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 10-OCT-2018 the patient was vaccinated with improperly stored doses of ROTATEQ lot # N030150, expiration date: 29-AUG-2019, oral for prophylaxis, (strength, dosage and frequency were not provided) and PEDVAXHIB lot number: N031492 expiration date: 02-MAY-2020, for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. No adverse effects were reported. The storage characteristics were the following: Temperature: 0°C to 1°C (0.9°C) for 30 minutes. Previous temperature excursion: 0°C to 1°C (1.4°C) for 7 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA005632: US-009507513-1903USA003267: US-009507513-1903USA003268: Original Case: 1903USA003268.
Patient received the first Pfizer vaccine dose on 12/18/20. Patient mistakenly received the Moderna vaccine instead of Pfizer for his second dose. This was not discovered at the time of administration, but rather discovered through a retrospective data review. No adverse events were reported. Of note, the patient's vaccine card  only indicated the lot number for the first dose, and not the manufacturer. The lot was written, and not Pfizer anywhere on the card for the first dose.
11-26-09 Fever-102 and cough. 11-27-09 11-28-09 and 11-30-09 conjunctivitis left eye (Levaquin and eye drops). 12-3-09 Numbness left side of face (nose area). 12-5-09 pimples on lips, nose face with pain severe. 12-6-09 saw MD diagnosis -> shingles. Rx with antiviral  VALACYCLOVIR 500mg Tid.
Information has been received from a consumer concerning her daughter who on unknown dates was vaccinated with the first and second dose of GARDASIL (lot no, and route not reported). It was reported that the patient experienced rash after first and second dose of GARDASIL. The patient sought medical attention at the doctor's office. No further information is available.
On same day of vaccination 5hours after vaccination. I could not stop puking. Could not get water or ice cubes in my system, due to me vomiting. I could not sleep and was dizzy. This went on for 5 days, and then on 6th day, I started hallucinating. It progressed to get worst with hallucinating. They found me in the street, and took me to the emergency room. They placed an IV in me to give me potassium. During the time I was puking, I could not go to the bathroom. I now have vertigo and memory loss. I cant remember what I am saying or doing. Now, I take potassium and all kind of stuff everyday to make sure I have everything in my system. The vertigo really bothers me as well. My veins are actually protruding above my skin.  I now take medicine for acid reflux. So now I can eat better with medicine. Now I cant drink any alcohol due to this. I just want to be normal again. They basically have no idea what is wrong with me. I was 100% healthy prior to me getting this shot.
Started with numbness and tingling in the left side of my face, lips and tongue. Went to ER (5:00 PM 2/25/21).  They did bloodwork and 2 CT scans. CT scans were inconclusive so I was transferred (9:45 PM 2/25/21), admitted and an MRI scheduled for 24 hours later. MRI (12:00 AM 2/27/21) was negative for stroke. Beginning stages of Bells Palsy was diagnosed. Prescribed Prednisone, Lipitor, Valtrex,  and baby aspirin upon discharge 1:45 PM 2/27/21).  By 2/28/21  symptoms had increased to the point where I can not suck through a straw, speaking is difficult and overall, extreme loss of muscle control in my face and feel like I have a bad head cold.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles 5 times. The patient reported that, if it could be prevented, he/she would like to know how and also stated that, Shingles shot did not work. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Local edema/erythema at injection site - woke next morning with some. OV 8/18/11. Arm 12 cm area without cardinal signs of infection. No airway compromise. Reassured. Supportive care only/recheck in 5 days.
Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 17 years old male patient who was vaccinated with a 0.2-0.3ml dose of a single dose vial of MENACTRA (lot U6151AB; expiry date: 16-Mar-2020 via intramuscular route in the left deltoid on 25-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient didn't administer any concomitant vaccines. It was a case of actual medication error due to off label use and vaccine underdose. It was reported that physician noticed one MENACTRA single-dose vial contained between 0.2-0.3ml of product, but administered that dose. She reported the injection was delivered intramuscularly to his left deltoid. Reporter had not noticed any crack in the vial or problem with the stopper for the vial, a problem with the syringe or needle. It was reported the needle in that tray is 27g by 0.5 inch length regular needle. No signs of adverse reaction at the time of injection. This is also a case of Product packaging quantity issue. 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. List of documents held by sender: none
This is a serious observational study case initially received  on 30-Jan-2019, concerning a 28-year-old, adult female, pregnant, subject of body weight: 146.4 lbs, height: 65.5 inches and body mass index (BMI). The subject had no maternal or paternal history with major congenital malformations. The subject's obstetrical history included 2 previous pregnancy with 1 live birth and 1 spontaneous abortion. No birth defects were reported in previous pregnancies. The father did not receive any medications prior to conception. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's concomitant medications included: prenatal vitamin for pregnancy. The subject's last menstrual period (LMP) date was 27-Aug-2018. On 05-Nov-2018, prenatal blood-work performed, and no major congenital malformation was noted. On 06-Nov-2018, at gestation age of 10 weeks, the subject was administered Flu Vaccine Egg Split QIV CSL (influenza vaccine, dose, batch number, route of administration, expiry date and anatomical location: not reported) (explicitly considered as vaccine exposure during pregnancy) for an unknown indication. On 18-Dec-2018, at gestation age of 16.1 weeks, the subject had spontaneous abortion. It was reported that for a foetal loss, factors that might have had an impact were previable rupture of membranes, anhydramnios and chorioamnionitis. The subject's estimated delivery date (EDD) was reported as 03-Jun-2019. Reporter's Comments: A 28-year-old pregnant subject experienced chorioamnionitis, anhydramnios, previable rupture of membranes and spontaneous abortion, 1 month 12 days after receipt of Flu vaccine egg split QIV (considered as vaccine exposure during pregnancy). Considering implausible temporal relationship and the infective origin of the event chorioamnionitis, the causal role of study vaccine is ruled out. Hence, the causality of the event assessed as not related. The event previable rupture of membrane can be explained by the underlying chorioamnionitis and the event anhydramnios and spontaneous abortion are the consequences of the underlying events. Hence, causality assessed as not related to these events. The decision to administer a vaccine during pregnancy is related to medical decision made by the mother and her physician and is not related to any property of the medication. Hence, the event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Initially felt cold-like symptoms. Mild reaction. Then, peripheral numbness and tingling began on or around 8/22/2016. Developed into transverse myelitis affecting lower extremities, upper extremities and thorax. Was seen at hospital.
arm hurting immed p/inj,later could hardly move arm;then just stopped & next morning woke up w/ h/a & vomiting;6FEB95 f/u had vomiting for 8hrs;treated w/phenergan supp & resolved;