chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.41.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.    Temperature recordings were taken using a temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
At 9:30 am felt warm, lower lip started to itch/burn, and scratchy throat. Flushed in face, ears, neck, upper chest, and shoulders. Was given .3mg Epinephrine IM with immediate results. Flushing and itchiness went away.
Burning sensation from left temple down to neck, stiff neck, dizziness, fatigue, nausea. Felt the symptoms right away and it lasted for a couple of hours. The fatigue did not go away and I still feel fatigued now.
Local reaction to both vaccinations. Treated with ibuprofen, ice, Benadryl.
possible effects of vaccines could be autoimmune problems.; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (possible effects of vaccines could be autoimmune problems.) in a female patient of an unknown age 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 AUTOIMMUNE DISORDER (possible effects of vaccines could be autoimmune problems.) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (possible effects of vaccines could be autoimmune problems.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment medication was not reported.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Fever (101.3F), body aches, nausea, arm pain. Managed with Acetaminophen and resolved within 24 hrs of onset
This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received INFANRIX for an unknown indication. On an unknown date, the patient received INFANRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate age at vaccine administration to be related to INFANRIX. Additional information received: INFANRIX was inadvertently administered to a 12 years old patient instead of BOOSTRIX.
The patient was prepped for COVID vaccine, Moderna booster dose. Vaccine was taken from the cooler and needle was injected into the left deltoid. When going to press on the flange of the syringe there was resistance and vaccine would not inject through the needle. Needle was taken out of the patients arm and needle safety was performed. After safety was placed syringe was inspected and on inspection visible signs that vaccine had become frozen. Vaccine placed in sharps container. I took another vaccine from the cooler, inspected it to affirm it was liquid, and administered into the left deltoid of the patient with no issues.
Tested positive for Covid 19 on 14Apr2022 after being fully vaccinated.; Tested positive for Covid 19 on 14Apr2022 after being fully vaccinated.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: 3247), on 23Mar2021 as dose 2, single (Lot number: 3247) and on 01Dec2021 as dose 3 (booster), single (Lot number: ED0809) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Apr2022, outcome "unknown" and all described as "Tested positive for Covid 19 on 14Apr2022 after being fully vaccinated.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Apr2022) Positive. Clinical course: Patient's symptoms were generally mild and include cough, nasal congestion and fatigue.
Patient was given an adult vaccine that is only for 18years+. Patient returned to clinic a month later for 2nd dose of Hep B and had no adverse events from the first injection. His second dose was the correct pediactric Hep B dose.
Information has been received concerning a 10 year old female who on 14-MAY-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot#656572/0115U). There was no concomitant medication. On 15-MAY-2007, the patient developed a red swollen area, which was very itchy and tender. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no other information provided. Additional information has been requested. This is one of several reports from the same source.
nurse used MMR Chicken Pox Diluent and did not use the HIB Diluent to reconstitute the ActHIB; Initial information received on 08-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who was vaccinated with the HIB (PRP/T) VACCINE [ACT-HIB] (formulation: unknown, lot: UI988AA and expiry date 03-Oct-2020 via intramuscular route in the left thigh) that was mixed with the vial of the diluent for MMR chicken pox vaccines on 07-Jul-2019.  The patient's medical history were not reported.  Concomitant medications included Prevnar 13 and  Dtap  It was an actual medication error due to wrong solution used in drug reconstitution as nurse used MMR Chicken Pox Diluent and did not use the HIB Diluent to reconstitute the ActHIB. Sterile water was used to reconstitute ActHib  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 and Module VI of the 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.
Body aches, fatigue, brain fog, severe rash on face especially around eyes and cheeks. Lasted more than a week and only got better with topical steroids
SEcond   dose   of   Pfizer vaccine              Fever over 100 degrees       F         for         48 hours so far..          WEakness,   feel awful.         Taking  aspirin,  Nsaids  to  lower fever..
This case involves a female pregnant patient of an unknown age who was exposed to vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and was supposed to get DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (wrong product administered) and (exposure during pregnancy). Data regarding this pregnancy were received prospectively. Patient was exposed to the vaccine at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered and vaccine exposure during pregnancy (same day). At the time of reporting, no adverse event 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 the 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.
Rapid heart rate, extreme fatigue, muscle weakness, problems with coordination, disorientation, gastrointestinal upset lasting one week. I am still experiencing some fatigue and gastro issues.
Information has been received from a licensed practical nurse concerning a 50 year old female patient with asthma, hyperlipidemia, hypertension, and mitral regurgitation who on 26-OCT-2006 at 2:45 PM was vaccinated with a second dose of Pneumovax 23 (lot # 651331/0003F).  There was no illness at the time of vaccination.  Subsequently, the reporter "heard" that the patient experienced a large, six inch swelling at the injection site. It was also reported that the patient had "large swollen arm next day."  It was noted that the patient's first and second dose of the vaccine were given to this patient within one month's time because the first dose of the vaccine was improperly stored below the recommended temperature.  Unspecified medical attention was sought.  The patient recovered.  No product quality complaint was involved.  There were no relevant diagnostic tests or laboratory data.  Additional information is not expected.
High fever 102 F & crying. No local rxn. Vomited X 1 on 21May90. No prior problems.
Rash it was blotchy at the side of the shot.  No treatment  Shot February 13 today is February 16 and the rash is still there
On December 4 2022 I began to feel a little sinus congestion and a raw throat feeling, TYLENOL or ZYRTEC was not helping on Tuesday December 5 2022 my doctor had me come in for both a COVID-19 and Strep throat test. I used my own home remedies of elderberries and honey which I finished, I also took generic brand THERAFLU day/night combinations they did not help and symptoms got worse, my nose was very congested and I had postnasal drip with almost incontrollable coughing my left side more congested and puffy, I also took ADVIL cold and sinus this helped ever so slightly, I began MUCINEX nighttime, as of the reported date this being the first night I could sleep in my own bed. I still have sore throat.
14 days post vax the pt experienced low grade fever. 22 days post vax the pt developed one chickenpox.
pt in SNF; tested positive for COVID; c/o runny nose; pt began to decline rapidly; O2 supplementation; unable to eat or drink; unable to swallow medications safely; hospice called in; pt's condition worsened and he died in the facility
pt recvd vax 21FEV94 next day fever 101 x 3 days; 24FEB small bump; not acting or feeling well; 3MAr woke up w/bruises all over body; mom took pt to MD bleeding internally; ITP
pt recv vax; devel staring spells & glassy appearance; staring episodes were brief w/out change in tone or LOC; resolved spontaneously by 12 days p/ vax;
very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (very sick). At the time of the report, ILLNESS (very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Flu 36 m/o increase 0.5 ml administered to a 2 y/o D.O.B. 10/27/07 11 m/o patient. Pt. was not yet 3 y/o was 12 days from being 3 y/o.
Arm is sore; Stiffness in joint; Itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), JOINT STIFFNESS (Stiffness in joint) and VACCINATION SITE PRURITUS (Itchiness at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AEF21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is sore), JOINT STIFFNESS (Stiffness in joint) and VACCINATION SITE PRURITUS (Itchiness at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm is sore), JOINT STIFFNESS (Stiffness in joint) and VACCINATION SITE PRURITUS (Itchiness at injection site) outcome was unknown.            Concomitant medication use was unknown.
One week after first dose of vaccine, patient experienced a red rash around site of injection.   She reported it was approximately 2 inches in diameter and was very itchy.  She took Benadryl for a few days and the rash cleared in approximately 7 days.
5 yo boy presented with left arm edema/erthema 10 hours after influenza vaccine; admitted to hospital for vaccine reaction vs cellulitis and discharged on 10/8 with imporved sympotms and no evidence of cellulitis10/22/07-records received for DOS 10/6-10/8/07-DC DX: Vaccine Reaction with Possible Asthma Exacerbation. developed left arm pain, edema, erythema 10 hours after receiving influenza vaccine. crackles and wheezes heard on pulmonary exam. Treated for vaccine allergy reaction vs cellulitis. Pruritis.
I received a Johnson and Johnson covid vaccine from the fire Department and got covid requiring 2 months hospitalization and also had several blood clots in my right leg.i was put on zarelto and sent home from the hospital. 1 week ago I had to go back to the hospital for more blood clots in my right leg. After doing an ultrasound again the Dr reported to me that most of the same blood clots were still there and some had connected forming a rather large one there. I was diagnosed with chronic DVR right lower extremity and am being referred to a hemotologist and a vascular surgeon. I think it's related to the vaccine
About 4 days after receiving my 4th dose of the Moderna vaccine, my heart rate started to increase. I started to feel very weak and sweaty. I knew I was experiencing an SVT (Supraventricular tachycardia). I sat around trying to see if it would decrease, but it didn't. The last SVT I experienced was 2 years ago. When I experienced this 2 years ago I took two pills of diltiazem. This time, I took 4 pills of diltiazem, and it did not help. I went to Hospital ER. They were not able to slow the rate, so I was given intravenous adenosine. My heart rate started to decrease almost immediately. I was in the ER overnight for observation. I went to see my Cardiologist Doctor, a couple weeks later for a follow up and he told me that since I have had SVT's in the past, he couldn't say for certain if the vaccine contributed to the SVT's. Everything looked great at my visit.
At approximately 130pm on 8/27/12 the pt received a flu shot. At about 215pm it was brought to my attention that the pt was passed out in her car. EMS was called and I stayed with the patient until they arrived. Pt eventually walked home.
Diffuse abdominal pain after first dose.  Chest pain, difficulty breathing, shortness of breath, palpitations and cramping after second dose.  No wheezing on exam.
Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a second dose of Varivax. Subsequently, the patient "had a reaction to the second dose of Varivax", unspecified medical attention was sought. The patient experienced pain and redness at the injection site. The patient also "developed a knot at the injection site." No fever was reported and the reaction lasted as "few days." There was no product quality complaint involved. No further information was provided. Additional information has been requested.
On 12/29/2001, patient experienced a febrile seizure at 0100.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE 3/7/2023  &  2/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
vomiting; fatigue; generally feeling unwell; muscle pain; headache; joint pain; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), as dose number unknown, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; PHENTERMINE; VIT D [COLECALCIFEROL]. The following information was reported: FATIGUE (non-serious) with onset 27Oct2023, outcome "recovering"; MALAISE (non-serious) with onset 27Oct2023, outcome "recovering", described as "generally feeling unwell"; HEADACHE (non-serious) with onset 27Oct2023, outcome "recovering"; ARTHRALGIA (non-serious) with onset 27Oct2023, outcome "recovering", described as "joint pain"; MYALGIA (non-serious) with onset 27Oct2023, outcome "recovering", described as "muscle pain"; NAUSEA (non-serious) with onset 27Oct2023, outcome "recovering"; VOMITING (non-serious) with onset 27Oct2023, outcome "recovering". Therapeutic measures were not taken as a result of vomiting, fatigue, malaise, myalgia, headache, arthralgia, nausea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 31-AUG-2016, the patient was treated by a physician's assistant for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a physician concerning an approximately 6 year old male with epilepsy and seizure disorder, and no drug reactions or allergies who on 26-MAR-2001 was vaccinated with VARIVAX (Merck). Concomitant therapy included unspecified seizure medication. In April 2006 the patient developed shingles. Unspecified medical attention was sought, which included an office visit. The patient subsequently recovered on an unspecified date. No lab diagnostic studies were performed. It was noted that the physician was not interested in VZV analysis at this time. There was no product quality complaint. Additional information has been requested.
Exposed to sibbling with varicella at end of March and 1st week of April. Vaccine given on 4/15/00. Developed clinical varicella on 4/17/2000.
Headache; Swollen neck lymph node; Night sweats; My rm was extremely painful; This case was reported by a consumer via call center representative and described the occurrence of night sweat in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On 16th February 2021, the patient received the 2nd dose of Shingles vaccine. In February 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm. On 25th February 2021, the patient experienced night sweat. On 26th February 2021, the patient experienced headache and lymphadenopathy cervical. On an unknown date, the outcome of the night sweat, headache and lymphadenopathy cervical were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the night sweat, headache, lymphadenopathy cervical and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporting case for him/herself. After receiving Shingles vaccine, the patient had night sweats, headache and swollen neck lymph node. The patient's rm was extremely painful for four days, then sorta of for two more. The reporter did not consent to follow up. The patient was scheduled for first covid vaccine on 02nd March 2021.
patient fainted for a few seconds post administration (approximately 10 minutes post administration). Patient immediately regained consciousness and was sweaty.