chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not yet received her second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date: 29-NOV-2022 Reporters comment: The reporter was the patient.  She mentioned she had not yet received her second dose because she didn't know it was a two-dose series. Nothing else was reported. The reporter did not consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Red raised whelps on same arm as injection (left) Pain, extreme fatigue, weakness of arm. Pain radiating to fingertips. Slight fever of 100, chills.  Symptoms lasted for more than 7 days.
BODY ACHES; FATIGUE; FEVER; RECEIVED 2ND DOSE AFTER 57 DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on FEB-2021, and dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On FEB-2021, the patient experienced received 2nd dose after 57 days. On FEB-2021, the patient experienced fatigue. On FEB-2021, the patient experienced fever. On APR-2021, the patient experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fatigue, and fever, and the outcome of received 2nd dose after 57 days was not reported. This report was non-serious.
After vaccination, patient was ok, talking and eating.  Suddenly, patient complains of dizziness, and "didn't feel right".  Patient was laid flat on a couch, but then passed out and was not responsive to sternal rub.  After a code was called, the patient woke up.  At no time was there a loss of pulse or SOB.  Patient was transported to the ER and was subsequently discharged same day.  Patient did report that prior to the vaccination, she ran 13 miles in the morning, which may have had something to do with the reaction.
Was having burning pain in left shoulder the morning after shot. Pain continued to worsen as the week progressed. By the next weekend, experienced limited mobility of movement in left shoulder and acute severe pain. Also began to have facial swelling on the right side of face and severe headache the following weekend after getting booster shot. Sought doctor treatment on 1/24/22 for symptoms.
R eye pain developing around 1-2 weeks after influenza vaccine. The eye pain evolved over the course of a few weeks to a small monocular visual field defect and then to severe monocular visual loss with color vision loss in addition to T2/FLAIR and GAD+ signal in  the right optic nerve on MRI consistent with optic neuritis.  Treated with high dose IV corticosteroid and has experienced nearly complete recovery.  CSF was normal but the MOG ab was found in serum.  she was diagnosed with MOG ab related optic neuritis.  This is considered to be possibly related to vaccinatoin.
I had an abnormally long menses; I was confirmed to be post menopausal; I have autoimmune ovarian failure; This is a spontaneous report from a contactable nurse (patient). A 38-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EJ-1686, Expiry date: not reported), via an unspecified route of administration, administrated in left arm on 29Dec2020 16:00 (at age of 38-years-old) as dose 1, single for COVID-19 immunization in workplace clinic. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 22Jan2021, the patient experienced I had an abnormally long menses, I was confirmed to be post-menopausal, and I have autoimmune ovarian failure. On 06Sep2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test: Negative, Nasal Swab. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The reporter stated that after first dose, she had an abnormally long menses, then never had one again. In July, the patient was confirmed to be post menopausal at age 38. The patient was referred to a specialist who said that she had autoimmune ovarian failure. No therapeutic measures were taken in response to the events. The outcome of the events was unknown.  Follow-Up (06Oct2021): Follow-up attempts are completed. No further information is expected.
rapid heart beat of 110 BPM for about 30 minutes on 8/5/2021 rapid heart beat of 110 BPM for about 30 minutes on 8/6/2021 continued rapid heart beat and high blood pressure
slept for three days; sweat; dizziness; severe body ache; headache; chills; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for three days), HYPERHIDROSIS (sweat), DIZZINESS (dizziness), MYALGIA (severe body ache) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013HNA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPERSOMNIA (slept for three days), HYPERHIDROSIS (sweat), DIZZINESS (dizziness), MYALGIA (severe body ache), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (slept for three days), HYPERHIDROSIS (sweat), DIZZINESS (dizziness), MYALGIA (severe body ache), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Severe headaches; Diarrhea; Nausea; Tiredness; Feeling unwell; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 28Jul2021 at 08:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included bacterial meningitis (when the patient was a teen). The patient previously took amitriptyline hydrochloride (TRIPTIN) (reported as medications containing triptin) and experienced drug allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the 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. On 28Jul2021 at 15:00, the patient experienced severe headaches, diarrhea, nausea, tiredness, feeling unwell and chills. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events severe headaches, diarrhea, nausea, tiredness, feeling unwell and chills were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Transient petechiae began 1 week after initial shot, then worsened 1 week after second dose.
Red, swollen, hot, sore to touch left deltoid. Also complained of stiff neck and chest pain.
I broke out in Hives only around site of injection. I took Benadryl and put Hydrocortisone Benadryl cream on it.
PROQUAD Route Of Administration IV; The patient experienced diarrhea; The patient experienced rash on injection site; This spontaneous report was received from an other health care professional (HCP), concerning a male patient of unknown age. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  On 27-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) administered intravenously (incorrect route of product administration), therapy type: rHA, lot number: X018581 and expiration date: 05-JAN-2025 (dosage regimen, strength, dose, anatomical location) for prophylaxis; and with diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX).   On that day, the patient experienced diarrhea and a rash on injection site later that day. It was stated patient experienced symptoms for 3 days. Reporter stated patient went to HCP on 30-OCT-2023, for follow up. At the time of the report, the outcome of the events was unknown.  The causal relationship between events and the suspect vaccines was unknown; however, HCP stated diarrhea may be caused by separate virus that was not known at the time and may not had been from the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) vaccine.
Fever, leg cramps, calf pain and tenderness.  Lasted a few days and resolved.  Noted difficulty walking (toe-walking) due to calf pain.
Deep, severe aching of most body joints, esp. legs - started day after shot in pm and increased to severe by following morning, peaking on days 3-5, then begining to decrease every day thereafter up to this date; still some mild discomfort in knees; Weakness/fatigue:  peaking as aching on days 3-5, then continues till this date to experience unusual weakness and fatigue.
fatigue, fever of 102.5F, chills, tremors, body aches, headache, sore throat. Alternated tylenol and advil every 4 hours.
Soreness in arm, back pain and fever of 100.4 as of 5:25 pm in 4-17/21. Extreme fatigue, body aches and my eyes are feeling dry as well.
Pt reported that after receiving SHINGRIX vaccine his arm became sore, he developed slight chills, and redness at the site of injection. Pt reports he took acetaminophen and went to sleep. Woke up and chills were gone. Arm was still sore at site of injection. Pt. reported event 4/23/18 -via online portal.
patient called on 05/03/2021 to pharmacy to let pharmacist know that her right eye is swollen and red and on 05/04/21 she woke up with left eye swollen and red too. On 05/03/2021, Pharmacist advised Patient to contact her Physician and her doctor sent her to ER for check up and prescribed some eye drops and allergy medication. she also got steroid shot from dr's office.
Upper body flushing and dizziness (arms/face).  Dizziness resolved in approximately 20 minutes.  Pt left observation area still slightly flushed.
BODY ACHES; FEVER; HEADACHE; RIGHT ARM SORENESS (INJECTION SITE); This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 20-MAR-2021 (vaccinated in right arm) for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced right arm soreness (injection site). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and right arm soreness (injection site), and the outcome of body aches was not reported. This report was non-serious.
NauseaVomiting Per patient: "I had severe nausea for 2 days. For 1 1/2 days, I stayed in bed". Soreness at injection site since day of vaccination.  Narrative:  Further information per patient: "I felt the nausea as soon as I woke up Friday morning. I took meclizine and stayed in bed. The nausea continued to Saturday but I was able to drink something and get out of the bed. I never was able to eat anything Friday or Saturday but got out of bed and sat on the sofa, Saturday. Sunday morning I felt much better and was back to my baseline. My arm is still painful since 12/31 but it's not infected".
Patient called the morning following vaccine and complained of fever/chills/nausea and tenderness and swelling at injection site.
Patient recived a dose of improperly stored PROQUAD; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 23-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
4:30 PM - difficult to walk on leg and had hives. 5:15 PM - administered Benadryl and called local hospital. 6:00 PM - Went to ER. 7:30 PM - had seizure for 15-30 seconds. Given injection of Benadryl and oral Amoxicillin susp. 12:30 AM - discharged from ER to home. 3/28/03 - leg sore, difficult to walk.
Pt c/o flushing/sweating but denies other symptoms 5mins after vaccination.  BP 113/79, HR 86, RR 18.  Pt remained on the stretcher 10mins.  Pt provided water and juice and pt symptoms resolved.  Pt stable and released from the vaccination site.
Initially bruising for almost 2 weeks at site of injection. Subsequently, I had unusual bruising at IV site for CT scan with contrast greater than one week,  site of blood draw for testing and Power Port IV site for immunotherapy both greater than one week. I have been cancer patient with these treatments regularly for many years and this bruising and length is not normal. Additional information, Heparin is administered to flush port after treatment.
Pt. is unable to move her left arm because its been sore since the day after vaccination. Pt could not sleep well because of the throbbing pain. Pain level is 7-8 (10 being the highest from scale 1-10). ALEVE, hot/cold compress temporarily relieve soreness.
I got very ill from the second dose; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer (patient himself) reported that a male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. On an unspecified date the patient asked about ingredients in the vaccine, got very ill from the second dose and would like to know what was injected. The event was reported as non-serious. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: gj6739) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: Positive test result following Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid treatment start date: 04Feb2023 to 08Feb2023.
Got the shingles and she talked to her doctor and got told it was probably from the vaccine.
TOOK FOUR UNREFRIGERATED DOSES; A spontaneous case report was received from a consumer on 25-Feb-2019 for two consumers.  Based on the information obtained from the consumer, two individual case safety reports PVX201902-000150 (PVX2019-502; wife) and PVX201902-000151 (PVX2019-503, husband) were created and cross-linked in the database.  This case report describes a 59-year-old female consumer who "took four unrefrigerated doses". The consumer was receiving oral Vivotif (one dose every other day; lot no: 3003241) for typhoid fever prophylaxis.  It was reported that the consumer did not refrigerate Vivotif for 24 hours and took all the doses. The first dose was taken on 17-Feb-2019 and the last was on 23-Feb-2019.  The action taken with Vivotif with respect to event "took four unrefrigerated doses" was not applicable.  The clinical outcome of the event "took four unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000151:
After initial dose patient reported tenderness and soreness at the injection site for the first 2 days which then went away and subsided. Patient did not take anything for the discomfit. Her arm felt "heavy" this went away. Then about a week later she developed a "pinching" sensation when she raises her arm
Pain, swelling (hive), itching, photophobia in Left eye, and pain in injection site Right arm.
I received the JJ vaccine on 3/23/2021 and then the Moderna booster on 11/18/2021. Since receiving the latter, I have had reoccurring upper respiratory issues.  I still have an incessant cough that keeps me awake during the night and very tired during the day due to the lack of sleep. I have been prescribed different meds through my personal physician, gastro, and a pulmonologist (first time in my life that I had to see a pulmonologist).  I also contracted Covid.  Medical records will be released upon request.
Order for recombivax Adult Hep B, Obtained Hep B vaccine and checked it with second Nurse. Gave Hep B vaccine, but it was the 2 dose Heplisav recombivent Hep B, instead of the 3 dose recombivax Adult Hep B. The patient had already had 1 dose of the 3 dose recombivax Adult Hep B.
On 2/12/21 noticed that she had some itching in the area of the vaccine, a week after the vaccine.  Now she has a red, roundish rash, looks like covid arm from the internet.  No other problems.  She put some cortisone cream on it as it itches at times.
45 minutes after getting the seasonal flu shot, pt. c/o dizziness and inability to "catch her breath". Very anxious within 2 minutes, pt. stated "her lips feel weird" and there were notable spasms in both hands. Pt. has a history of asthma, we tried to give her, her inhaler but she was unable to inhale the medication. EMS was called and she was given 0.5mg IM of epinephrine. Breathing soon became better but she remained anxious. Bilateral hand spasms subsided. Taken by ambulance to hospital.
Swelling after shot same day went to ER. Given 3 day course of steroids. 12/28/11 - started with hives, very itchy. Hives got worse. Started on BENADRYL & ZANTAC was better, but worsened when trying to wean off. Was seen at PCH u/c & ER as well.
Zoster - (L) leg dermatoma vesicles with reactive arthritis of knee.
Discharge Provider:  MD; Primary Care Provider: DO; Admission Date: 8/22/2022; Discharge Date: Aug 25, 2022 PRESENTING PROBLEM: COVID-19 [U07.1] HOSPITAL COURSE: Sixty-nine year old male with past medical history significant for obesity, nonambulatory at baseline, hypertension, hyperlipidemia, recent admissions for E coli bacteremia related to diskitis/osteomyelitis from L3-S1 as well as suspected vertebral abscess at the level of S1 that was drained.  He was readmitted in May for altered mental status found to have large gluteal abscess was also drained.  He presents to emergency department on 08/22 with worsening fatigue and lethargy.  He is mildly hypotensive on admission and otherwise stable.  Labs were notable for elevated inflammatory markers.  He did test positive for COVID-19.  His checks x-ray was normal.  Admitted to Medicine Service further assessment and management. As far as COVID-19 goes, patient was treated supportively.  He did not develop respiratory failure and did not require steroids or other treatments.  Improved over the course of the days he was hospitalized. In regards to his hypotension, this resolved with IV fluids.  We did switch his home Lasix to p.r.n. basis.  Blood pressure normalized by the day of discharge. Patient was on Coumadin for history of DVT.  This was continued in the hospital setting and started on a bridge with Lovenox which he will continue at his facility for  infra-therapeutic INR. Interventional Radiology and surgical specialist evaluated patient is drains from prior diskitis/osteomyelitis and gluteal abscess.  Blood cultures were obtained and remained negative.  It did not feel there was any issue with the drains and recommended outpatient follow-up. Patient is discharged back to his facility in stable and improved condition.