chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 4 month old that received Acthib and Pentacel on the same day; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 4 month old patient who received 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] lot number was not reported via unknown route in the unknown, on the same day.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due extra dose administered.  It was unknown whether the patient had any adverse event.  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.
Severe tingling ,mostly upper and lower extremities which has not improved after 6 weeks now. Upper extremities weakness, weak grip (right hand) which is better now.
Employee believes that she received the HD dose of the flu vaccine because she said she saw a green label.  She was given a copy of the consent she signed with the vaccine sticker affixed documenting the dose she received before she left the clinic but was not convinced.    We did not have any HD doses in clinic for use that day.  The HD inventory that was received recently from Sanofi was intact in a separate refrigerator.
Patient complained at home of not feeling well and complained of stomach pain and leg pain.  Shortly afterwards patient vomited and experienced an elevated temperature.  Patient was kept quiet with ice applied to her leg and fluids encouraged.  Tylenol was given the next day.  Patient improved by the afternoon of the following day.  MD spoke with parents the evening of the event and the following morning.
chest tightness and weakness in her chest which is making her cough more.; chest tightness and weakness in her chest which is making her cough more.; felt lightheaded again and had to stand against the bathroom wall to let it pass; fell and hurt her knee; very fatigue/ sleepy/ no energy.; felt lightheaded and as if she was going to pass out.; no appetite; red, long area on her arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red, long area on her arm), DIZZINESS (felt lightheaded again and had to stand against the bathroom wall to let it pass), DIZZINESS (felt lightheaded and as if she was going to pass out.), DECREASED APPETITE (no appetite) and CHEST DISCOMFORT (chest tightness and weakness in her chest which is making her cough more.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ERYTHEMA (red, long area on her arm). On 27-Feb-2021, the patient experienced DIZZINESS (felt lightheaded and as if she was going to pass out.), DECREASED APPETITE (no appetite) and FATIGUE (very fatigue/ sleepy/ no energy.). On 28-Feb-2021, the patient experienced ARTHRALGIA (fell and hurt her knee). On 01-Mar-2021, the patient experienced DIZZINESS (felt lightheaded again and had to stand against the bathroom wall to let it pass), CHEST DISCOMFORT (chest tightness and weakness in her chest which is making her cough more.) and COUGH (chest tightness and weakness in her chest which is making her cough more.). At the time of the report, ERYTHEMA (red, long area on her arm), DIZZINESS (felt lightheaded again and had to stand against the bathroom wall to let it pass), DIZZINESS (felt lightheaded and as if she was going to pass out.), DECREASED APPETITE (no appetite), CHEST DISCOMFORT (chest tightness and weakness in her chest which is making her cough more.), COUGH (chest tightness and weakness in her chest which is making her cough more.), ARTHRALGIA (fell and hurt her knee) and FATIGUE (very fatigue/ sleepy/ no energy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Got the vaccination / got shingles/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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient had shingles after getting vaccinated. The follow-up would not possible as no contact details were available. This case considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
The patient was 42 years old when he received his first dose of GARDASIL 9. The patient is now 44 years old and never received the third dose of GARDASIL 9; No additional adverse event (AE) reported; This spontaneous report has been received from a nurse, concerning a currently 44-year-old male patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 28-DEC-2021, when the patient was 42-year-old, he was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9); followed by a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered on 20-JUL-2022 (exact doses, lot numbers, expiration dates, routes of administration, and anatomical locations were not provided) as prophylaxis.  At the reporting time (reported as "now"), the patient was 44-year-old and never received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration). No additional adverse event (AE) was reported.
Moderna COVID-19 Vaccine EUA Low grade fever, body aches, fatigue for 4 days Previously contracted COVID-19, tested positive 11/4/2020; symptoms began 11/2/2020 and ended 11/18/2020 Reaction to 1st dose of Moderna same as symptoms seen during COVID-19 infection
Pt received yearly influenza vaccine, receives yearly. Approx 10 minutes after vaccine pt had seizure lasting <30 seconds. VSS. EMT called/further evaluated pt, pt sent home with mother. Pt has mental disability,  hx of seizures as child- mother states no seizures since childhood (pt now 46 yo), denies seizure activity after receiving influenza vaccine in past.
Pt recvd vax & exp severe gastrointestinal upset & severe flu-like sx; No further details were provided;
Patient broke out in hives all over the back side of his body. Resembled poison ivy but knew it was not that because the patient has not been outside/exposed to that.
Swelling of the Feet: Took Tylenol and Water Pill Menstrual Cycle Lasted 3 Weeks: Took Tylenol Swollen Arm  Cold and Flu Symptom: Took Alkaselza Cold and Flu
Soreness, redness, slight swelling at injection site, a little itchiness at injection site. Slightly warm at injection site.
within 10 minutes of vaccine administration, patient could not communicate verbally.  She could understand questions being asked and shake her head, but she could not speak.  She was given benadryl which she swallowed with no issues.  911 was called to the scene. Blood pressure was taken and SBP >200 using a wrist monitor.  Blood pressure was taken again with traditional monitor and SBP >190.  Baby Aspirin 81mg was given orally, and the patient swallowed with no issues.  While waiting for EMS to arrive, patient continued to understand questions being asked and was able to shake head yes/no.  She would try to speak, but words were incoherent.  She was asked to squeeze both hands, she recognized the request and acknowledged that she was squeezing, but minimal force was being applied.  EMS arrived by 11:30am and patient was taken to the hospital.
Approximately 1 week later I developed Shingles which I have never had before; dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A 61 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Nov2021 14:00 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included High Blood pressure (unspecified if ongoing); Sleep Apnea (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Obscured by other product labelling, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 31Mar2021, when the patient was 60 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 01Mar2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 23Nov2021 14:00, outcome unknown; HERPES ZOSTER (non-serious) with onset 02Dec2021 16:00, outcome recovering. The event approximately 1 week later developed shingles which never had before, was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of herpes zoster. The lot number for bnt162b2 was not provided and will be requested during follow up.  COVID-19 vaccine was administered in the facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.  Since the vaccination, patient has not been tested for COVID-19. No known allergies were reported.
Aches, tired, weak, muscle cramp, chills, fever, wheezing, nausea, dizzy.
This patient is a 72 y.o. female presenting to the emergency department with a chief complaint of acute palpitations onset this afternoon. Patient works as a pediatrician and states that after work today she went to receive her COVID-19 vaccine. She reports that about 10 minutes after getting the vaccine, she began to develop a heavy sensation in her chest as well as palpitations. EMS at the vaccine site performed a field EKG which the patient observed to have isolated PVCs. They then obtained a full EKG that again showed isolated PVCs. At this time the patient's blood pressure was taken and recorded to be elevated at 160/110. This caused the patient concern as she has no prior cardiac history or history of hypertension. Patient notes her systolic pressure at baseline is usually 110-120. Following onset patient reached out to her husband's cardiologist, Dr. who recommended she present to the ED as he was unable to see her in his office. Upon arrival to the ED patient reports that the heavy sensation in her chest has resolved, but she still feels "off".
(L) th leg (Hep A, varicella) nickel sz red area warm compress to sites.
pt devel sore throat w/lt ear & eye pain 5days post vax;MD dx hunt synd/herpes zoster;has residual lt facial paralysis
I started getting symptoms of headache, nasal congestion, sinus pressure, chills, cough, tiredness, fatigue, and severe body pains. I had positive COVID-19 test. I contacted my doctor and was prescribed Paxlovid. The Paxlovid is helping. My right foot also hurts. I still have lingering effects of cough, chest heaviness, nasal congestion, headache, ad fatigue. I took another COVID-19 test and I am still positive.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (concentration, dose, route of administration, lot number and expiration date were not reported). Concomitant medications were not provided. On an unknown date, the patient received a second dose of ZOSTAVAX. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Approximately 2 hrs after vaccination, I felt extremely tired. Tired feeling continued for 3 days. Arm developed sore lump at vaccination site, again about 2 hrs after vaccination, which dissipated over the course of a week.  Day after vaccination, I felt aching all over my body. This feeling only lasted the day.   I do not consider myself to have had an adverse reaction. I am only reporting for research purposes.
Fever, chills, headache, body aches, lack of energy. From 4/7/21 6 am until 4/8 4 pm. Headache did not subside until 4/9 10 pm
History of adverse event after first administration at 2 months. No further doses of DtaP have been given. 1 year shots were given, except for DtaP. Mom reported that the next day, the child had temperature of 103+ axillary which has been continuing every day. She took child to doctor 7/19/2005. No signs of other illness. Temp today 104.3 rectal. Continues to treat with acetameniphen. Temp spikes when sleeping, down during awake time.
PT RECEIVED 2ND DOSE OF BIVALENT BOOSTER. CURRENTLY, GUIDELINES INDICATE PT SHOULD ONLY RECEIVE ONE DOSE OF THE BIVALENT BOOSTER. PT WAS NOTIFIED OF ERROR VIA PHONE ON 02/03/2023, PT REPORTS NO ADVERSE EVENTS AND WAS INSTRUCTED TO CONTACT PHARMACY, DOCTOR, AND/OR VAERS IF ANY ADVERSE EVENTS DEVELOP.
pt recv flu shot & T102, chills, shaking, n/v, diarrhea noc p/vax;localized rxn lt deltoid;
Right after the injection, there was a rush through my body ( like an epideral) and then my heart started pounding fast, I sat down for the 15 minutes and thought it would go away but it wouldn't and seemed to be getting faster, after 20 minutes ( 4:10ish)  I waved a person over who worked in the clinic and they took my BP and pulse.  The person took me to the ER in a wheelchair, since it was across the hall.  They did an EKG on me, and evaluated me for an hour, and I was released once my pulse slowed down to 99 and I felt better.  It has been 7 days and I have continued to have tachycardia while sitting, with my pulse going from the 70s to to 130s for no reason.  It will come in episodes. I went and saw my primary care doctor today and my pulse was 105-115 sitting.  I have cut out coffee since the incident on 12/29/2020.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient noted the day after receiving the vaccine that she started to form 2 "knots" near the injection site, which eventually merged into one. The site is now just red with a dark red circle on her warm. Site is warm to the touch. Patient notes of taking benadryl at night, which helps it and clears it up a bit by the time she wakes up, but forms again during the day.
Grandmother reported fever, body rash approx 17 days after MMRV vaccination TYLENOL to control fever. Refuses to be seen at office at this time - symptoms persists x 4 days.
Injection site redness, warmth, and itching. Symptomatic treatment with antihistamine and cool compass.
12 hours after the shot, the symptoms appeared. Fever; chills; headache; muscle cramps. Fever broke after about 12 hours. Healing began. Never had medical care.
She received her first dose on 2/6/21 around 11:30 a.m.   On 2/7/21 she was a bit tired and her arm was a little sore.  Sometime after the afternoon of 2/7/21 and the morning of 2/8/21 she was found unconscious and unresponsive on the floor.  As her dinner from the evening of 2/7/21 was still on the table unfinished and she was fully dressed we assume that whatever caused her to end up on the floor unconscious happened on 2/7/21  She was taken to the emergency room and it was determined that she was not going to survive.  She never regained consciousness and was having seizures all the way to the hospital in the back of the ambulance.  She was made comfortable and passed on 2/11/21.
This spontaneous report was received from a pharmacist via company representative and refers to a female patient of an unknown age (reported as "approximately 20 years"). The patient's medical history, drug reactions/allergies and concomitant therapies were not reported. On an unknown date in 2011, the patient was vaccinated with GARDASIL, one dose (dosage form) for prophylaxis (lot#, expiry date, and route of administration were not reported). On an unknown date, unspecified time after receiving vaccination with GARDASIL the patient fainted (syncope). The outcome of syncope was unknown. The causality assessment was not provided. Product quality complaint was not involved. Upon internal review, syncope was determined to be medically significant.
Pt recvd vax 10JUL92 & a few hrs following vax pt exp sz; pt recvd 2nd dose of vax w/Phenobarb & there were no adverse exp;
NO ADVERSE EVENT AT THIS TIME. PATIENT IS BEING MONITORED FOR POSSIBLE ADVERSE EVENT.
Extremely red itchy eyes, eyes lips face and tongue swollen throat sore hacking cough.
Customer called for a temperature excursion and reported GARDASIL 9 that had undergone temperature excursion was administered to a patient before calling. No additional AE reported. No PQC reported. No further information was provided.  ?    N; no adverse event; This spontaneous report was received from an office manger and an administrative assistant, regarding a 21-year-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-FEB-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose not provided) lot #W011264, expiration date: 05-SEP-2024, administered intramuscularly in her left deltoid for prophylaxis. Previous administration the vaccine had undergone a temperature excursion with a temperature of 35.6 Fahrenheit (F) during a time frame of 5 hours and 15 minutes. No previous excursions reported. No Adverse event reported. No other vaccines were given on the same day. Additional information was not expected.
She began a slight fever 5 days after vaccination that lasted about 6 days and ranged from 99.9 F to 101.9 F I treated her with motrin twice during that period. 11 days after the vac. and the day when her fever went away, she was covered in a light rash starting in her diaper waist band area and within 3 hours spread up her back, front to her arms and neck. Also the next day she had a low Iron Screen 10.3
In the area of the 2nd, injection, a wide irregular red rash that is hot to the touch.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Headache-Medium
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 30-DEC-2014 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 17-DEC-2015; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had a syncope event minutes after receiving first moderna covid vaccine. She was in and out of consciousness more that once for a period of 10 -15 minutes. She fully regained consciousness at the end of that period and stayed that way until she was comfortable enough to leave the premise.
Hard to move arm; Arm is sore; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Hard to move arm), ARTHRALGIA (Arm is sore), PYREXIA (Fever) and MYALGIA (Body ache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No specified medical history has been reported.  Concomitant products included LEVOTHYROXINE, ATORVASTATIN, CANDESARTAN, AMLODIPINE BESYLATE, OMEPRAZOLE, PROBIOTICS NOS and CALCIUM for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced LIMB DISCOMFORT (Hard to move arm), ARTHRALGIA (Arm is sore), PYREXIA (Fever) and MYALGIA (Body ache). At the time of the report, LIMB DISCOMFORT (Hard to move arm), ARTHRALGIA (Arm is sore) and MYALGIA (Body ache) outcome was unknown and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-258990 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant Followup added on 16 Jul 2021  to include ,age,new reporter