chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: A pharmacist called to ask for information about the administration of Flulaval to 7 staff members.  The Flulaval vaccines that were administered were exposed to room temperature for a few weeks.  The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the 7 people that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consented to follow-up. This case was for 1 of 7 linked patients reported by same reporter. Additional supportive information: The patient was administered Flulaval after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR157001:Same reporter US-GSK-US2022AMR157003:Same reporter US-GSK-US2022AMR157002:Same reporter US-GSK-US2022156225:Same reporter US-GSK-US2022AMR157006:Same reporter US-GSK-US2022AMR157008:Same reporter
12/01/09 @ 7:05pm: I administered Tdap (ADACEL) to pt instead of GARDASIL #2.
Patient received the vaccination at around 10:15am. As she was being transported from the facility, she complained of chest pain.  Her transporter called 9-1-1 and the patient was taken to the ER at around 11:22am.
Patient was given the vaccine on 10/4/18. On 10/05/18 the patient states when she woke up that her arm was red and swollen around the injection site and she had some pain. The next day the redness and swelling had started to spread further on her arm and was still hot to touch. She states it was very painful to move her arm. Patient came in today 10/7/18 and I could visibly see the patient's arm was red and swollen at the injection site and spreading further around her arm from the elbow up on the backside of her arm. It was hot to touch. She said she was finally able to move her arm some today. I told the patient to apply a cool compress and she could take some TYLENOL for the pain. We will contact patient's PCP and be in contact with the patient for further instructions. She said that she took 2 BENADRYL on 10/05/18 and it did nothing for her. Patient states she has not had trouble breathing or any type of anaphylactic reaction.
Severe headache from the evening of Feb 25, 2021 to Feb 28, 2021, followed by a stroke incident on Feb 28, 2021 with slurred speech and left-sided weakness.  Spent 18 days at hospital. (Field 21 was found to be not editable so we placed that information here).
pt recvd vax 29JUN95 & noc of vax pt could not sleep,felt anxious,agitated&nervous;pt's exp lasted just that noc following pt's first inj;nurse reported into recvd from pt's wife on 3AUG95;pt recovered 30AUG95;No further details reported
Patient is 16 years old and received Moderna COVID vaccine, which is only approved for ages 18 and above. I have contacted the manufacturer who states: If the patient received the 1st dose between 16-17 years of age, it will be considered off-label use and the patient can still receive the 2nd dose 28 days later. If the patient is below 16 years of age, the patient cannot receive the second dose. Case # is MOD21-091150.  No reaction noted as of today. Doctor on site notified.
Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/4/2021 for unknown duration.
A rash on my arms, legs, chest, back and torso; This is a spontaneous report received from contactable consumer (Patient himself).. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198 and expiration date: Not reported), via an unspecified route of administration in the left arm 27Feb2021 at 10:30 am ad 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included allergy to Antibiotics (Allergies to medications, food, or other products: neosporan), high blood pressure. The patient's concomitant medications were not reported. The patient concomitant medication hydrochlorothiazide at 25mg and losartan 100mg. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient 2 weeks prior vaccination included hydrochorothidzide 25mg, Lorsartan 100mg. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 01Mar2021, the patient developed a rash on arms, legs, torso, chest and back. The patient wanted to know how long he should go on with this event and asked whether there was any treatment or creams he can use to calm down the itching. The patient did not receive any treatment for the events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Patient states she felt very dizzy and could not lay down at night after receiving SHINGRIX vaccination in the morning. Patient also experienced fever.
vaso event after shot. Pt with no history of issues with injections. After waiting 15 mins, stood up to leave and felt wea; had near syncope event and was evaluated for vaso event. There was no food intake; given water and advised to hydrate prior to 2nd dose.  09:51-Bp-115/82 p 74 Resp 12; 10:00a-118/73 P 66 resp 12; 10:10 BP 112/76 P 62 Resp 12. Pt released to father. Pt was  evaluated by on-site NRP.
The Medical Assistant thought she saw an order for MenQuadfi for the patient. She pulled the vaccine and administered the vaccine to the patient. The patient has not experienced any adverse reaction.
Within 30 min, dizzyness, sore arm, numb hands, severe abdominal pain that lasted over 3 days, extreme lethargy, after 5 days complete numbness to entire body with no explained cause still currently numb.
2nd Injection on Saturday. Slightly dizzy that evening. Still dizzy the next morning on Sunday. Very sort left shoulder. All joints sore. General malaise. Late Sunday (around 11 pm) I fainted while standing. Hit head on tile bath. Woke up a few seconds later. Otherwise, feel OK. Now on Monday, feel pretty good. No reaction of any kind after the first shot in October.
I had a headache, fatigue, body ache, mild fever, chills, vomiting and diarrhea. I treated it ibuprofen and TYLENOL. It lasted for 48 hours and then all symptoms subsided. I also felt like I was punched in the arm. Arm pain at the site of the injection. I had had 3 subsequent vaccines that were Pfizer with no issues.
Mild to moderate fatigue from 3/23/21 8pm - 3/24/21 11pm Chills 3/24/21 3am - 3/24/21 7am Moderate headache and nausea 3/25/21 9pm - 3/26/21 1am.  Took 1 pill or regular strength Tylenol.
soreness in eyes and throat.  Pt had similar reaction with first vaccine and was given a benedryl.  SHe talked to an allergist in the interim and was advised it was ok to get second dose but maybe bring a zyrtec.  Pt brought the zyrtec and decided to take it with the onset of these symptoms. Symptoms resolved within 20 minutes, observed for a few extra minutes then went home.
Prolonged arm soreness and redness which started 1/10; by 1/18, sought medical attention for cellulitis from 1-2 inches below armpit to elbow (prescribed antibiotic), redness and hardness resolved in 1 to 1.5 weeks; 2/1- still has some are soreness, headache, body ache
This spontaneous report was received from a Certified Medical Assistant referring to unspecified number of unspecified patients. Patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L019298 and expiry date 22-JUN-2017 (strength, dose, frequency and route were not reported). Concomitant medications were not provided. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
patient rec'd grey cap pfizer vaccine after it was stored in freezer for 22days- we have attempted to call patient several times and have not reached them
Vaccine given at 1226, approximately 15 min later felt a bit lightheaded. By 330pm, difficulty breathing/swallowing - 5pm took 25mg BENADRYL - (430pm eyes began to drain) approx 6pm nauseated. Achy took 800mg ibuprofen at 7pm to urgent care 8pm. Given eye drops and TAMIFLU. Pt was febrile. Pt with no symptoms prior to vaccine.
Per patient report:  Patient works in hospital setting and states that she began feeling numbness of left face at about 1130 on 01/06/2021.  Patient walked to ED and while walking, began to have numbness of left arm and leg as well.  Patient  reports being given Valtrex. Patient was discharged from hospital on 01/07/2021.  Patient is being followed by her private provider as well as neuro.
The patient felt dizzy and weak then fainted while her mom was holding her . Her mom gradually led her to the floor from a sitting position. She felt nauseous and dizzy. I laid her on floor with her feet elevated on a chair with her head to the side so she would not aspirate if she vomitted.. She felt better after a while and wanted to sit. When she was sitting in the armchair she vomitted and said she felt worse, so I then called 911.   They evaluated her and her blood pressure was very low and they gave her iv fluids and took her to the emergency room
Sore immediately after vaccine, swelling by night time.  The next morning, fever, aches, chills, nausea, lower back pain, arm soreness,  She had to stay in bed all day.  She could not go to running practice for school team.  Red hot swelling across her whole upper arm.  Still sore and had back pain and slight nausea even the second day.  Swelling and redness lasted for five days.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a positive diffuse, red, papular eruptions throughout consistent with chickenpox. The pt had more than 30 pox noted.
Pt is experiencing hives and itching to bilateral lower extremities and taking Benadryl
PLATELET COUNT INCREASED; MIGRAINE; RED BLOOD CELL COUNT ABNORMAL; HAEMOGLOBIN ABNORMAL; HAEMATOCRIT ABNORMAL; MALAISE; FATIGUE; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included polycythaemia vera. The patient was previously treated with hydroxycarbamide for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: ruxolitinib phosphate (tablet, oral, batch number was not reported) 10 mg, 2 times every 1 day, therapy dates were not reported, for polycythaemia vera. Concomitant medications included acetylsalicylic acid, ascorbic acid, oenothera biennis oil, sulfamethoxazole/trimethoprim, topiramate, and vitamin e nos.  On an unspecified date, the platelets went to a critical level/had 800 000/uL platelets/platelets levels so high/ platelets went up/ platelets have been all over the map/ went up in to the 800s/plateIets going up (Platelet count increased). The patient was not feeling well (Malaise), Migraine headaches/ having migraines more often (Migraine), some issues with her red blood counts levels/ RBC 12/8 4.04, 1/5/21 4.15, 2117/21 4.34/4/20/21 4.40 (Red blood cell count abnormal), H/H 12/8 12.3/36.7, 115/21 12.1/36.9, 2/17/21 12.8/39.6 (Haemoglobin abnormal), I-UH 12/8 12.3/36.7, 1/5/21 12.1/36.9, 2/17/21 12.8/39.6 (Haematocrit abnormal). The patient had been feeling a little bit more tired (Fatigue) coincident with Jakafi (ruxolitinib). The reporting physician considered the events platelet count increased, malaise, migraine, and red blood cell count abnormal as not related to Jakafi. The events were considered related to stopping Hydroxyurea suddenly instead of weaning off while starting Jakafi. The units were not provided for all laboratory values.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ruxolitinib phosphate was not changed. The patient had not recovered from platelet count increased, migraine, and fatigue, and the outcome of malaise, red blood cell count abnormal, haemoglobin abnormal and haematocrit abnormal was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210617549-COVID-19 VACCINE AD26.COV2.S- Platelet count increased. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE.
Pt said the site of the injection is big, navy blue and purple in color, and pt was bleeding out of her nose and mouth and unable to stop. Called ambulance and went to hospital. They told her no vaccines while on COUMADIN and checks pt Q Monday.
This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient. A 46-year-old patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 2, single (Lot number: ER8730) intramuscular, in left deltoid for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism", start date: 1995 (ongoing); "Vitamin D deficiency", start date: 2018 (ongoing); "Thyroid" (ongoing); "Allergies" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for thyroid disorder, start date: 1995 (ongoing); VITAMIN D NOS oral taken for vitamin d deficiency, start date: 2018 (ongoing); CLARITIN ALLERGIC oral taken for hypersensitivity, start date: 2017 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Date: 03Mar2021, Time: 07:30 AM, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "I tested positive for covid this week"; BNT162b2 (Dose: 1, Date: 03Mar2021, Time: 07:30 AM, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 03Mar2021, for Covid-19 immunization, reaction(s): "I tested positive for covid this week", "bilateral tinnitus/ amplified", "taste salty", "arm soreness", "fatigue". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "bilateral tinnitus/ amplified"; THIRST (non-serious), outcome "unknown", described as "extreme thirst"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Side effects from 2 nd dose covid vaccine included arm soreness, fatigue, extreme thirst. Tinnitus never went away, on 16Jun2022, I noticed the tinnitus was marked by louder.
I had no immediate symptoms other than slight redness and muscular pain at injection site for a couple days, which was tolerable. 8 days after my vaccine (1/14/21) I noticed tightness in my right cheek and my tongue feeling a little numb or burnt in the evening while relaxing watching tv.  The next morning (1/15/21) when I woke up, the right side of my face was drooping.  It was mild at the time, but I was worried I was having a stroke, called my doctor and she felt comfortable having me come for an office appointment.  At my appointment, she diagnosed me with Bell's palsy and did 3 blood tests and had me get a head CT.  Results for all were unremarkable. I am 14 days out from when symptoms started and still dealing with Bell's palsy.  I did start a round of oral steroids on 1/19/21 and will finish those in the next 3 days.  I did not start any antivirals or any other treatments.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 28-JAN-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot # reported as R0123571 was invalid, expiration date was reported as 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
I woke up around 3:30 AM 01/26/2021 and I was running fever, my temperature was as high as 102.4. I ended up sleeping in  the recliner because I was sweating. I had a massive headache, achiness, and I really couldn't eat anything. I slept for about 36 hours in a recliner. This lasted for two days. Fatigue and fever. After 36 hours I felt normal. My NP kept calling and checking on me to see if fever went down. No medical care.
PT ARRIVED AT STORE 7/13/2021 AND MODERNA VACCINE WAS ADMINISTERED. PT CLAIMED TO HAVE NEVER RECEIVED COVID VACCINE.  VACCINE REGISTRY WAS REVIEWED LATER AND FOUND THAT PT HAD RECEIVED:  3/26/2021 - MODERNA (DOSE 1) 4/29/2021 - MODERNA (DOSE 2)  5/28/2021 - JANSSEN (DOSE 1)  *7/13/2021 - MODERNA (DOSE 3)*
Patient received Janssen COVID19 vaccine on 4/3/21 (lot 042A21A) and also received a full series of the Pfizer COVID-19 vaccine on 11/1/21 & 11/22/21 (both lot #s EW0191), instead of a one-time booster. Pt concerned for the effects of the extra vaccine, but currently asymptomatic. Several breakdowns in communication leading up to the mistake; was debriefed and reviewed with the office staff.
Bigeminy PACs; This spontaneous case was reported by a patient and describes the occurrence of SUPRAVENTRICULAR EXTRASYSTOLES (Bigeminy PACs) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058081) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 12-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced SUPRAVENTRICULAR EXTRASYSTOLES (Bigeminy PACs). At the time of the report, SUPRAVENTRICULAR EXTRASYSTOLES (Bigeminy PACs) had not resolved.            No concomitant drug was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment drug was reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 73-year-old female patient, with no medical history reported, who experienced the unexpected and non-serious AESI of Supraventricular extrasystoles, which occurred 2 days after an unspecified dose of SPIKEVAX 2023-2024. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
diagnosed with the mumps on an unspecified date; This spontaneous report has been received from a physician, referring to an unspecified 8 or 9 years old child patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis (reported as prevention of measles, mumps and rubella).         On an unknown date, after having been immunized with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), the patient was diagnosed with mumps. Whether treatment was given to the patient or not was unknown. The outcome of mumps was unknown. The causallity assessement was not provided.
covid; he has had "a lot" of infections; This spontaneous report has been received from a male patient of unknown age concerning himself. His concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date in 2022, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered as prophylaxis (dosage frequency, route of administration, lot number and expiration date were not reported).   The patient wanted to know if HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was made of live or dead virus before getting the second dose because, since an unknown date in 2022, he has had "a lot" of infections (Infection) and coronavirus disease (COVID) recently (COVID-19). On an unknown date in December 2022 (also reported as now), the patient reported he was COVID negative.   Outcome of the event COVID-19 was reported as resolving, outcome of the event infection was not provided.   Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events COVID-19 and infection was not reported. The reporter refused to provide additional information or clarifying statements.