chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 15 seconds after patient received covid-19 vaccine pt had syncopal episode which lasted a few seconds, she was able to regain some consciousness for a few seconds but had syncopal episode again. Pt was unconscious for less than a minute. When pt awoke, she was pale, confused, and clammy. An ice pack was placed in the back on her back, ice water was given for patient to drink, legs were elevated, vital signs taken at 1203. Initially vital signs were 66/38, HR62, 99% O2 on room air. At 1210 second set of vitals were taken and recorded as the following, 87/40, HR88, 100% O2 on room air. Pt was placed on the gurney when patient was feeling better, pt was able to walk to gurney with no issues. Pt taken to treatment room for further observation at 1215. Report was given to RN who took patient down on gurney with Covid-19 RN, alongside pt's father. Both pt and father state pt has never had a syncopal episode in the past with vaccines or blood drawn.
Varicella - Information has been received from a registered nurse concerning a 5 year old female who on 30 dec 1998 was vaccinated with the first dose of varicella virus vaccine live in the left arm (lot 628182/1327H) on 29 Mar 2000, the patient developed chickenpox with about 100 pox and a low grade fever.  The patient sought unspecified medical attention, follow up information received 17 apr 2000 from a registered nurse reported that the patient has recovered.
Woke up in night with chills and nausea and all-over achiness.  The chills lasted for hours.  Finally went back to sleep.  Woke up in the morning with same symptoms plus splitting headache and nasal congestion.  I looked at my phone and tried to read a couple of texts.  I was able to read one word at a time, but couldn't put together the meaning of the sentence.  I could not understand a simple text.  It was quite disturbing.  I went back to sleep for most of the morning.  The headache persisted, but the other symptoms slowly disappeared.  By early evening I was able to work on my laptop and understand sentences again!  The next day, I was back to normal.
Arms pain/soreness to his arms; Sinus pressure; Headache; Sore throat/Throat hurt really bad; A super runny nose; Sneezing; A little tired; Really sick; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp. A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after receiving the first dose of vaccine on an unspecified date the patient experienced the sore arms for the following day or so and was a little tired. For the next 5-6 days the caller had sinus pressure and headaches. Today (on unspecified date) was the two-week mark, and the first week it was the arms pain, sinus pressure and headaches. That past week the patient was really sick and was feeling unwell with sneezing, a super runny nose and had sore throat and his throat hurt really bad. The Patient had been taking Dayquil, Nyquil, and cough drops. The Reporter could not find anything online about people having these side effects for this long. Patient asked how long this will last and will the symptoms go away. The patient was looking online and couldn't find anything about people having a runny nose. Caller asked if he should take the second shot. Mentally the patient felt better so he was hoping he is getting better. The patient's throat was really hurting ask is this something that has been reported. Weather the patient should see a doctor. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Patient started feeling dizzy and like his lips were tingling after dose.  Given oral Benadryl and symptoms resolved.  Presented to the ED the next day with a rash and intermittent chest pain and dizziness.
delayed hypersensitivity reaction with urticarial rash primarily on patient's lower right cheek and suprapubic area.  Did not observe the rash directly.  Patient self reported. resolved within 12 hours
pt recv vax; sz, general myoclonic; started 3 days p/ vax;
p/vax pt T100; whining & rash started 9/11; progressed to head et upper torso-splotchy rash on skin; not bumpy
This case was reported by a other health professional via sales rep and described the occurrence of injection site allergic reaction in a adult patient who received SHINGRIX. On 4th May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site allergic reaction, injection site rash and injection site hives. On an unknown date, the outcome of the injection site allergic reaction, injection site rash and injection site hives were unknown. It was unknown if the reporter considered the injection site allergic reaction, injection site rash and injection site hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Medical Assistant. The age at vaccination was not reported. The patient developed a rash near injection site, explained as a hive like rash. The patient would like to know if this would be a problem when she would get her second injection as far allergic reaction being worse. The patient was asking if anyone else has experienced this type of reaction. The patient was asking for help to find the answers to these questions.
Chills, low grade fever, headache, back ache between shoulder blades, body aches, exhausted
No additional AEs; Nurse reported that GARDASIL 9 was administered to 1 patient following temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection that suffered a temperature excursion; lot # U031056, expiration date on 16-JUN-2024, for prophylaxis (route of administration and anatomical location were not provided).  The temperature excursion ranged from a temperature of 33.5°C for 7 hours and 31 minutes to a temperature of 16.3°C for 7 hours and 53 minutes. No previous temperature excursion occurred and no additional adverse events were reported.
pain or soreness on the neck; little itchy; swollen; little soreness; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain or soreness on the neck), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (little soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Bell's palsy (Bell's Palsy on the right side of the face). Concomitant products included FINASTERIDE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pain or soreness on the neck), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (little soreness). At the time of the report, NECK PAIN (pain or soreness on the neck), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (little soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included, Fenestra and Sterol lactone were reported.   Treatment information was not provided.
expired Fluzone High Dose given with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA392579(CLUSTER).  This case involves Elderly (of over 65 years) and unknown gender patient and expired fluzone high dose (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE) given with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UJ772AA, expiration date: 30-Jun-2022 in unknown administration site a s Immunization .  On an unknown date the expired fluzone high dose given with no reported adverse event (expired product administered) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was unknown if there were lab data/results available. It was unknown if  the company suspect product inappropriately used as per local Marketing authorization  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired Fluzone High Dose given with no reported adverse event).  At time of reporting, the outcome was Unknown for the 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 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.
DIZZINESS; OUT OF REALITY; EARLY MENSTRUAL CYCLE WITH HEAVY FLOW; ARM PAIN; FATIGUE; NAUSEA; OVERALL WEAKNESS; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202a21a, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced out of reality. On APR-2021, the subject experienced early menstrual cycle with heavy flow. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced overall weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and overall weakness, and the outcome of dizziness, arm pain, nausea, out of reality and early menstrual cycle with heavy flow was not reported. This report was non-serious.
nausea; vomiting; fatigue; headache; body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 10Mar2021 at 15:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 10Mar2021 at 23:00, the patient experienced nausea, vomiting, fatigue, headache and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, vomiting, fatigue, headache and body aches was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
6/22/09 - ER Hospital for elevated temp/ generalized rash, cathed urine negative/chest x-ray negative/ Influenza A negative. 6/23/09- MD's office. vomiting/ diarrhea x 1/ sclera pink/ temp 101 1/2 / macular rash- generalized > admitted to Hospital. (CBC-32.3 with 65 polys) 6-24-09 - seen by ID - Dx - Kawasaki. Echo done / IVIG given. 9/24/09 Medical records received for date of service 6/22/09. Presented to ER with fever 100.2F, generalized rash, discharge from eyes, cough, diarrhea.  DX: Urinary tract infection
Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021.  Provider informed me I was there on the wrong day but told me she would fit me in so I would not have to come back.  After receiving the 2nd dose and waiting the 15 minutes, I realized that the time between shots were 14 days instead of 21.  The HCP was contacted and was to reach out to vaccine provider. 1/23/2021 = date of receiving shot = no symptoms 1/24/2021 = 3:10 am woke with 102.1 fever, sore arm, body aches, and my skin hurt.  Woke again at 8:00am with fever of 101.3 and the same symptoms.  Alternated Tylenol and Ibuprofen every 2 yours.  Fever went away around 10:00am but  went still had body  and skin aches and tired. 1/25/2021 = woke with no fever, but arm still hurt and so does the gland in my armpit.  Still have body & skin aches.  I am tired and I feel slightly off.  My eyes are very tired.
A nurse reported that the patient developed an injection site reaction characterized by redness and swelling. The patient recovered. This is 1 of 3 patients from this facility who experienced an adverse event following receipt of Acel-Imune lot 464-307.
Pt had approximately 20 lesions. At first developed bumps at vaccination site then developed rash on trunk, back and face. Some spots are starting to scab over. No fever, no s/s of cellulitis or pneumonia.
28 Minutes after vaccination client began with a dry cough, stated felt like a tickle in her throat. BP 130/90 (client stated this is high for her), HR 104 (client states this is high for her), O2 Sat 100%, Lung sounds clear. Monitored client in the office for 45 minutes, dry cough persisted. Denied any other symptoms. (Denied difficulty breathing, denied SOB, denied swelling, denied itching). Client appeared stable, no swelling or flushing noted. After 45 minutes EMS called and client was transferred to ER
Hives on Lower Back (No temperature) BENARYL cream & BENADRYL tabs Hives would only resolve w/BENADRYL tabs, cream alone did not help completely.
Rt upper arm with moderate warmth, redness over the proximal 1/3rd of Deltoid Region, and edema that is most noticeable over the distal 1/3rd of dorsal upper arm. Diameter of Rt upper arm distal portion is 28cm compared to Lt distal upper arm 26.5cm. No dyspnea
tested positive for covid today; tested positive for covid today; This is a spontaneous report received from a male non contactable HCP (patient) reported for him self. A male patient of an unknown age received BNT162B2(BNT162B2 formulation: solution for injection, Batch/lot no: not reported), via an unknown route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In January after the complete vaccine series, the patient tested positive for covid-19. The outcome of the events covid-19 and vaccination failure was unknown. The reporter does not wish to be contacted for follow-up.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The contributory role of the suspect BNT162B2(BNT162B2 formulation: solution for injection, Batch/lot no: not reported),  to reported vaccination failure and COVID-19 (tested positive for covid) is possible.
Patient came in for IPOL vaccine at 8:30 this morning, parents called our office at 5:18pm this evening. After immunization was given the family went to restaurant but declined to eat; family travelled 1 hour back home. Child was dropped off at grandparents house for the day. They reported to parents that child had decreased appetite/ fluid intake, took 1.5 hour nap and complaint of not feeling well. Had 4 episodes of vomiting that afternoon and by 5pm child was only doing liquids. Temp at 5pm was 98.8-100.4; child ate gold fish and sips of water at 6:30pm with no vomiting
Patient received immunization on 10/25/04 and saw RNP 10/29/04 for red, raised rash on his trunk area with white patch in his mouth and a fever. Starting with right leg.
Sometimes he says he can't move his left arm; Pain goes up to his shoulder joint and down to his elbow,Pain in right shoulder sometimes; excruciating pain in left arm that won't go away ,sometimes into his lower arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (excruciating pain in left arm that won't go away ,sometimes into his lower arm), MOBILITY DECREASED (Sometimes he says he can't move his left arm) and ARTHRALGIA (Pain goes up to his shoulder joint and down to his elbow,Pain in right shoulder sometimes) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 19-Jan-2021. Concomitant products included ATORVASTATIN, METFORMIN and AMLODIPINE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (excruciating pain in left arm that won't go away ,sometimes into his lower arm). On an unknown date, the patient experienced MOBILITY DECREASED (Sometimes he says he can't move his left arm) and ARTHRALGIA (Pain goes up to his shoulder joint and down to his elbow,Pain in right shoulder sometimes). At the time of the report, PAIN IN EXTREMITY (excruciating pain in left arm that won't go away ,sometimes into his lower arm), MOBILITY DECREASED (Sometimes he says he can't move his left arm) and ARTHRALGIA (Pain goes up to his shoulder joint and down to his elbow,Pain in right shoulder sometimes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not reported. patient stated that pain is still ongoing on 28-aug-2021.   This case was linked to MOD-2021-259987 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received on 27-aug-2021. contains patient history, concomitant medication, date of onset and outcome of the event were added.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Seems to have a tic (or frequent blinking)of the right eye.  He said it started "after I got the flu shot in in my nose"
Vertigo episode; Stomach pain; Indigestion; Head was on fire/Burning in head; Dizziness; Chills; Injection site pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo episode), ABDOMINAL PAIN UPPER (Stomach pain), DYSPEPSIA (Indigestion), BURNING SENSATION (Head was on fire/Burning in head) and DIZZINESS (Dizziness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 15-Apr-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On an unknown date, the patient experienced VERTIGO (Vertigo episode), ABDOMINAL PAIN UPPER (Stomach pain), DYSPEPSIA (Indigestion), BURNING SENSATION (Head was on fire/Burning in head), DIZZINESS (Dizziness), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, VERTIGO (Vertigo episode), ABDOMINAL PAIN UPPER (Stomach pain), BURNING SENSATION (Head was on fire/Burning in head), DIZZINESS (Dizziness), CHILLS (Chills), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) outcome was unknown.            Patient stated after the second Moderna vaccine she had injection site pain, stomach pain, indigestion which she had to take acid reflux medicine. Patient stated it felt like her head was on fire, burning in head, fatigue, chills, dizziness and a vertigo episode.   This case was linked to MOD-2021-168476 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up
Pt describes intolerable pain in (R) arm and getting worse at night. Pain stays constant per patient. Doctor recommending physical therapy for relief.
sick; headache/brain felt like it was squeezing; stiff; chills; didn't feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2022, outcome "unknown"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "didn't feel good"; HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "headache/brain felt like it was squeezing"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "sick"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2022, outcome "unknown", described as "stiff". Additional information: The last time she took a vaccine last year, she got a Pfizer bivalent and got so sick. She had a headache for over a month, my brain felt like it was squeezing, I was stiff for 2 days, had chills and just didn't feel good. She believes the bivalent was not safe for patients, so Pfizer has changed it back to a monovalent product. She understands she can't say that but that is what she believes. She states she will never get another Bivalent vaccine because it made her so sick.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.