chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 11 years old male patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Details of laboratory data not reported.  It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines.   It was not reported if the patient received a corrective treatment.  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.  There will be no information available on the batch number for this case.
Pt recv vax on 10/27/98; on 10/28/98 pt exp sore/hard lump of vax site x 1 day
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021 at 4:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.   This case was linked to MOD-2021-402935 (Patient Link).
Needle broke and disconnected from the syringe during administration; Needle broke and disconnected from the syringe during administration; A spontaneous report was received from a pharmacist, concerning a 39 year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced needle broke and disconnected from the syringe during administration (device connection issue and underdose).   The patient's medical history was not reported. No Relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 15 Feb 2021, the needle broke during the vaccine administration to the patient. Also, the needle disconnected from the syringe. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events was considered resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273.  There were no reported adverse events associated with this case.
Information has been received from a nurse concerning a 13 year old female patient female patient who on approximately 23-Oct-2008 was vaccinated with the first dose of GARDASIL. The nurse reported that on approximately 23-Oct-2008 the patient began swelling up and ended up going to the emergency room. It is unknown whether the patient was admitted to the hospital. Follow-up information has been received from a licensed practical nurse concerning a 13 year old female patient with no known allergies and no relevant medical history who on 22-OCT-2008 at 4:02 pm was vaccianted intramuscularly in her left deltoid with GARDASIL (659055/0560X) at her doctor's office. It was reported that the patient experienced dizziness less than 5 minutes after receiving the injection which progressed to complaints of shortness of breath. The patient stated "not feeling like I can catch a full breath:". An emergency room visit wa required but the patient was not hospitalized. On 22-OCT-2008 the patient recovered. No further information is available.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (patient received expired first dose after 30-day use-by-date) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 068H21A) for COVID-19 immunization. No medical history reported. On Feb 24, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 24, 2022, patient administered expired product (patient received expired first dose after 30-day use-by-date). At the time of the report, administered expired product (patient received expired first dose after 30-day use-by-date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vial was initially stored in the refrigerator on January 24, 2022. It did not undergo any temperature excursions. This case linked to MOD-2022-494857 (patient link).
Patient started to present with involuntary movements of the head and upper and lower extremities 5 days after receiving the vaccine.  Jerky movements happens even while patient is asleep. School has also noticed.  +Dyskinesia
Patient stated symptoms - redness, swelling, and pain to back of left arm started the day after vaccination 8/2/11. Instructed to take pain med and applied ice pack. 8/4/11, patient followed instructions, but no relief. Instructed to see an MD to evaluate left arm. MD recommend patient to take BENADRYL.
This case was reported by a healthcare professional and described the occurrence of fever in a child of unspecified gender who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  On an unspecified date on or before 18 December 2006, the subject received unspecified dose of Pediarix.  At an unspecified time after vaccination with Pediarix, on an unspecified date on or before 18 December 2006, the subject experienced fever, pain and crying. The subject was seen at a physician's office.  The subject was hospitalized.  The healthcare professional considered the events were clinically significant (or requiring intervention).  The outcome of the events was not reported.  The healthcare professional considered the events were probably related to vaccination with Pediarix.  Follow-up information was received on 13 April 2007 via a registered nurse, who reported that the subject was 2 months old (gender unspecified).  On 28 November 2006, the subject received a .5 ml dose of Pediarix.  The subject also received Prevnar and PedvaxHIB intramuscularly on 28 November 2006.  On 28 November 2006, the subject experienced fever, pain and crying.  On an unspecified date, the subject had a blood culture result of gram positive cocci.  The reporting nurse questioned the positive test result as possibly being due to poor venous collection technique.  As of 03 December 2006, the events were resolved.  At the time of reporting, Pediarix had been reintroduced to the subject and the symptoms did not recur.  The reporting nurse considered the events were possibly related to vaccination with Pediarix.  The reporting nurse also indicated that the events could have been associated with a blood culture result of gram positive cocci.
sick; Initial information received on 18-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.   This case involves an unknown age and unknown gender patient who experienced sick while receiving vaccine influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.     On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dose, route, batch number and expiry date) in unknown administered site for prophylactic vaccination. Information on batch number is requested  On an unknown date the patient developed "sick" (illness)  (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the events (sick).
the 4 month old female was given Imovax in a divided  dose of 0.5 ml in the same leg so she received the 1 ml dose but in 2 injections on the same day. No AE; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who was given RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number, expiry date not reported), in a divided dose of 0.5 ml in the same leg so she received the 1 ml dose but in 2 injections on 19-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to wrong technique in product usage process.  At the time of the report, adverse event was not 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.  List of documents held by sender: none.
Hives and redness at the sight for the second dose. Hives for the first dose on 4/3/2023
Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache.  Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine.  Was in communication with my PCP. My daughter, 3 years old  tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.
104 fever for 3 days and rash on chest/belly/neck on 02/25/2010.
My heart felt very inflamed like it was going to burst in my chest.  I needed to stay almost fully immobilized for 2 days until the sensation subsided.  Following the event I could feel my heart racing at times which progressively got worse and was since diagnosed with atrial fibrillation.
multiple erythemic papules approx 1 cm in size on legs and arms x 5 days started day after immunization. lesions have increased in size and #'s
Reporting side effects from Zoster Vaccine (Shingles). Soreness, headache, chills and slight fever.
Extreme pain in lower back; inflammation in lower back; elevated white blood count; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm left on 05Jun2021 02:45 PM (Age at Vaccination: 46 years) as dose 2, single for COVID-19 immunisation. Facility type vaccine was reported as Pharmacy or Drug Store. The patient medical history included Chronic hives and had none known allergies. Covid prior vaccination was reported as none. Other vaccine same date product was reported as None. Other vaccine in four weeks was reported as no. The patient Concomitant medications in two weeks included Fexofinidine . The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm left on 18May2021 03:00 PM (at the age of 46 years) as dose 1, single for COVID-19 immunization. On 11Jun2021 03:00 PM, the patient experienced Extreme pain in lower back, inflammation in lower back, elevated white blood count. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid tested post vaccination was reported as no. The lab tests included test: White blood cell count, result: Increased on 11Jun2021. Therapeutic measures were taken as a result of events and treatment included Steroids and antibiotics. The outcome of the events was not recovered.  Information about lot/batch has been requested.
During verification process, pharmacist verified pt's name/dob/vaccine and provided vaccination card before administration- pt confirmed information was correcy. After vaccination when next pt was called, discovered patient mistakenly misidentifed himself was supposed to received 2nd dose of PFIZER COVID-19. Advised patient that he received Moderna, pt was ok.
(R) thigh with 2 1cm knots, (L) thigh with 1 cm knot all tender to touch, no redness.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. Date of last menstrual period: Mar2023. The patient is expected to deliver a baby(s) on 10Dec2023. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Oct2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334811 Same patient, different event;
patient said the worst symptom was she felt her head was in a fog, had some confusion, she felt like her head was swollen but wasn't sure, and had nausea that last approximately 30 days and then went away
Pt reports to pharmacy with continued pain in left arm after receiving Moderna dose number 2. Painful to raise arm above head. Believes it is getting better but arm still hurts when moving. Does not hurt to touch.
I have been breaking out in hives and rashes since January 12 2022.  The hives are very red and very itchy and it happens 3-4 times a day. The hives look like welts and scratches all over my body. The hives have been on my face. neck, chest, B/L breast, B/L arm, B/L legs, and stomach. I also get a one-sided sore throat that comes and goes. I have went to my PCP multipe times in the past month and two allergists. My blood work panel came back with the results of being allergic to nuts, soy, wheat, egg and milk. I changed my diet, and I am still breaking out in hives. I saw a new allergist and got the skin prick test performed and I tested negative for all food allergies. I am still suffering with hives 3-4 times aday
Incredibly painful exacerbation and onset of new  psoriasis legions. My usual topical ointments also seem to worsen the pain. This happened with all three prior Pfizer COVID vaccines as well EXCEPT with the first booster. The intense pain lasted a good many weeks with vaccines #1 and #2. Hoping this #4 response is shorter-lived. The pain (and redness) is intense. ALSO, with the #1 vaccine, I suffered for about 3 weeks with an inflammatory reaction in my left jaw--the pain was so severe, I was on liquids and soft foods and could barely open my mouth wide enough for a toothbrush. I could not use my electric toothbrush during that time. And much worse with #1 and #2 and intermittently at a lower pain level ever since, I now live with painful squeezing in the tips of my toes and painfully squishy fingertips (I'm a guitarist and this has now limited my playing considerably). BUT, I did have one month of non-squishy/non-painful fingertips about 5 mos after vaccine #3 (first booster), when it ALL resolved. But having just gone for the second booster (vax #4), I'm right back to where I was before.
Heart palpitations lasting about 2 days (normal sinus rhythm on EKG, irregularities auscultated by MD)
A non-serious, spontaneous report of rash, fever, and very irritable has been received from a physician concerning his 24-mouth-old son subsequent to FluMist. This case is submitted in accordance with the manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history and concomitant medications were not reported. The patient received FluMist on 04-Sep-2009. Not long after receiving FluMist, the patient contracted rash, fever and was irritable. As of 18-Sep-2009, only the symptoms of irritability exist at time in the child. The rash and fever resolved. All follow-ups have been completed per company SOP.  No further information available.
Patient has received both doses of Moderna COVID19 vaccine, on 2/3/21 and 3/3/21. A couple of days after the second dose, he began to feel unwell. During the month, he has been developing worse cough and shortness of breath. He hears wheezing at times. Feels dizziness at times lately with SOB. Denies hemoptysis. No history of DVT/PE. He has chronic left knee pain for which he has used meloxicam (which caused swelling), diclofenac and more recently naproxen. He is not using anything for his knee pain now. No one else is sick at home. He is an aircraft mechanic. He's been working during the month of not feeling well. No known exposure to or recent test for COVID19.
Patient received Johnson & Johnson (#207A21A, exp 09/21) to the left deltoid. While reviewing instructions for post-vax the patient asked if he should be feeling nauseous and then immediately felt lightheaded. Told him it was possible, sit where he was (did not drive to post-vax), turn up AC & honk if felt any worse. Returned to check on the patient & found him unresponsive. Unable to arouse him to verbal command, touch, or sternal rub for 2-3 minutes. 911 was immediately called when the patient was found unable to arouse. Vitals of BP 105-82, pulse 60. Once he awoke he was unable to answer questions or remain awake. After nearly 5 minutes of re-awakening & questioning the patient, he gave his name.. Fire & EMT showed up with pressure 60, pulse 40, 02 90. Patient was moved to an ambulance, where he was evaluated and determined to be stable. Family was called and came to pick up the patient.
The first day there was just the usual small red welt at the injection site. Nothing unusual on day two, same as the first two shots, red welt at injection site with tenderness.  On the third day, which was Wednesday,  the red welt now extended out 5 inch circle but nothing else from injection site.    Thursday started the rash on my tummy and from then on continued to crop up on different parts of my body with intense itching, small blisters and some areas of angry red welts.  By Sunday morning  it reached a crescendo with me, intense rashes now all over my torso, behind my knee, upon my shoulder and backside.  Contacted Pfizer and they took a report and gave us a incident report # U8NA0WZM.  I researched online and found out that one of the side affects of the vaccine is a rash usually on first or second dose.  Since this is new...booster shot....no information was available. The itching and pain was very intense so I took Benadryl tablets and Benadryl gel to relieve some of the intense itching.    We could literally follow the path of the vaccine as blisters and rash started on the left side of the body and each day proceeded down and then around to the right side of the body, the right side not being as severe as the left side.  Woke up this morning, Monday September 27th  and found two new small areas that cropped up on my leg and arm on the right side .  Contacted our primary care doctor this morning and emailed her pictures of the rash to get her opinion and to keep them recorded in my files.  Waiting for a call back from primary doctor.
Itching on left arm and back of neck. I offered the patient Benadryl, but she was going to church tonight, and didn't want to be drowsy. Happened during 15 minute monitoring period.
chills, fever, swollen arm, extreme weakness, headache, dizziness, nausea, vomiting