chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced headache, stomach discomfort, chills and feeling bad. On an unknown date, the outcome of the headache, stomach discomfort, chills and feeling bad were recovered/resolved. It was unknown if the reporter considered the headache, stomach discomfort, chills and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The following day after vaccination, the patient experienced a horrible headache chills and was sick to her stomach. The patient said that the first full day of having the symptoms, she had to lay down. She did not know how she made it to work because it was bad. The patient was afraid of getting the second dose of SHINGRIX. The symptoms lasted a couple of days. The patient had denied permission to contact their physician.
Fever onset within 4 hours of getting vaccine. Lasted for about 24 hours. Body aches. Severe redness and swelling below injection site. Redness at it's largest point was 4"x5". There is also a large hard lump in my arm that is still present weeks later. Site of vaccine started to itch around day 3 and continues to intermittently itch. Was able to treat at home with benadryl and hydrocortisone cream.
Severe Joint, muscle and bone pain for 2 weeks, with generalized malaise. Some episodes chills and burning. Lymph nodes swelling on affected arm. Flu like symptoms with intermittent chest dullness when taking a deep breath.
At 9:15 vision started to blur. By 11:00 AM eyes started to burn and hurt. By 1:00 PM hard to breathe. By 3:00 PM my wife took me to emergency room. By 4:30 PM running 102 temperature. Oxygen level was low. Gave breathing Treatment to bring up oxygen level.
Thurs. 3/17/05 about 4pm, noted 1/2 inch diameter reddened area at injection site Fri 3/18/05 evening , injection site red 1 inch diam. and painful and warm to touch. mother took her to emergency dept. 8pm for evaluation was advised Motrin and ice compresses and to return if area increased. Sat 3/19/05 7:30am returned to emergency dept. 2inch diam. area, with fever about 102 degrees advised give Benadryl, Motrin and ice compresses. Sun 3/20 afebrile no worsening and less red Mon 3/21 am area much improved afebrile, light pink at site.
This spontaneous report was received from a registered nurse referring to a 14 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 12-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Information has been received from a consumer concerning her 16 year old daughter who on approximately 15-AUG-2007 "two months ago" was vaccinated with a dose of Gardasil. There was no concomitant medication. The consumer was not sure whether it was her daughter's first or second dose. It was reported that her daughter is currently four months pregnant (approximate LMP 15-JUN-2007). Her pregnancy was confirmed by a pregnancy test. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Follow up information indicated that the patient had back pain starting on 26-NOV-2007 and also urinated a little bit of blood. She went to the emergency room on 27-NOV-2007 and was checked to see if she was having any contractions and sent her home. No ultrasound was done at that time. An ultrasound was done on 05-NOV-2007 and the baby was moving and another ultrasound was scheduled for 14-DEC-2007. Additional information has been requested.
Information has been received from the mother of a 1 year old female who on 1/9/01 was vaccinated with Varicella virus vaccine live. On 1/13/01, the child developed a fever of 105.5F and had a seizure of 1-2 minutes in duration. Upon internal review, the seizure was considered an "Other Medical Event". The child was taken to the ER where the child was given Motrin. The fever went down to 94F but went back up to 103.7F within hours. At 02:30 the child had a second seizure (2 minutes in duration) and went back to the ER. The child was dx'd with an ear infection and placed on antibiotics. Additional information has been requested. Doc 205592 states that follow up information received from a registered nurse indicated that the child was seen in the physician on 01/17/2001 after a visit to the ER from a seizure on 01/13/2001. It was documented that the child had a viral illness and a febrile seizure. It was noted that the child was afebrile on 01/17/2001, and that a MRI documented in her chart (date not provided) yielded normal results. It was reported that the patient had not experienced any more seizures and has since recovered. Upon internal review, febrile seizure was determined to be an other important medical event. No further information is available. This report no longer meets the criteria for expedited submission. The adverse event of seizure has been chaged to febrile seizure, which is a labeled event.
No reaction day of shot. Next day arm and shoulder very swollen, red, hot to touch. Then became ill with abdominal pain, headache and nausea. Symptoms lasted all that day. No other symptoms. Patient took ADVIL for headache and rubbed BENADRYL on left upper arm. Duration 3 days.
started at 3:43 PM. body shake, chills, bad headache and a bit nauseous.
w/in 8 hrs employee stated came down w/a fever between 102 & 104, severe body aches, weakness x 2 days;
Patient had an acute cognitive decline less than 24 hours post 1st vaccination. This includes: weight loss, confusion, loss of ADLs (inability to dress, shower without assistance, with urinary and bowel incontinence), agitation, personality change, and impulse control issues.  Unable to determine if patient will recover from this decline and may end up in hospice.
Approximately 2.5 to 3 weeks after shot felt a noticeable and annoying tingling/numbness in fingers of both hands. This sensation has diminished over time but can still slightly feel it at times. Assumed it was a coincidence until J&J warning was issued several days ago.
Diffuse abdominal and flank rash, lesions less than 1mm in size, no lymph nodes.  Vaccinia reaction likely.
i got bells palsy on my right side of face, its very painful and showed up a litle less then 2 weeks after shot and upon talking to the doc i work for, he said i should submit this
pt recvd vax approx 2PM put to bed 830PM;mom awoke 930PM & heard pt gurgling in full sz, unresponsive;taken to ER dx w/febrile sz & UTI;treated & released;t102.5 by report;
Urticarial rash on face, chest, and arms 24 hours post influenza injection
Information has been received from a physician concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On 12-SEP-2016 (reported as "last Monday"), the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, expiration date, dose and route were unknown). On an unknown date in September 2016, the patient was inadvertently administered the second dose of RECOMBIVAX HB. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Narrative:  Fully vaccinated patient found COVID positive upon admission for acute on chronic leg pain/wounds. Had reportedly tested positive about a month prior to hospital admission. Patient did not have symptoms of COVID-19 while admitted.
p/vax c/o throat being tight & jaw being numb;given Celestone, DPH, albuterol tx;
Nausea; Injection site pain; Body ache; Muscle aches; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 in left arm (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, ADHD (attention deficit hyperactivity disorder) and auto immune disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination and included second dose of meningococcal vaccine (MANUFACTURER UNKNOWN) on 19Mar2021 in the left leg. Concomitant medication included amfetamine aspartate / amfetamine sulfate / dexamfetamine saccharate / dexamfetamine sulfate (ADDERAL), fluoxetine hydrochloride (PROZAC), colecalciferol (VIT. D), iron (FERRATE PILL) and medroxyprogesterone acetate (DEPOPROVERA); for unknown indications from an unknown date and unknown if ongoing. The patient previously received CEFZIL (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 28Apr2021, the patient had typical symptoms expected like nausea, injection site pain, body / muscle aches, vomiting which had been pretty constant last 2 hours. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of nausea, injection site pain, body ache, muscle aches and vomiting were not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt has had a 3 inchX 1 inch red, indurated area of skin on his left lateral thigh, near the site of his DTAP injection that was given yesterday.  Red swelling has been present since this morning at 9 am.  He has had no fever or pain from the area.  The region may itch.
Rash started Tuesday afternoon after vaccines; Rash and induration at area on right thigh; 5X5cm. Area of rash 19X15cm. Erythema
Covid + on 10/08/2021. Hospitalized Per ED Note: 77-year-old female with a past medical history of COPD and hypertension presents to the emergency department for shortness of breath.  Patient was brought in by EMS from home.  Per EMS, they found patient sitting in a chair and slouched over.  She was 66% on 4 L nasal cannula.  Patient does wear 2 L at home at baseline.  Patient was started on CPAP in route and was given a DuoNeb treatment.  On arrival, patient is awake and alert and states that she has felt short of breath for the past 2 or 3 days and worsened today.  She denies fever, chills, cough, nausea, vomiting, chest pain, abdominal pain and urinary symptoms.  Patient states she has never been intubated or required BiPAP for her COPD.
VACCINE WAS DILUTED INCORRECTLY.  ONLY 0.8 ML OF DILUANT WAS USED INSTEAD OF 1.8 ML.  PATIENT WAS MONITORED FOR THE REQUIRED 15 MIN, NO REACTIONS NOTED. ERROR NOT DISCOVERED UNTIL AFTER PATIENT HAD LEFT THE OFFICE.
Pt developed erythema, induration at site of immunization. She presented to the ER as erythema spread down her arm and up shoulder. High fever. Admitted to hospital. Seen by infections disease specialist who felt reaction was cellulitis in hospital x5 days on IV a lot. 2/17/06 Received hospital discharge summary which revealed patient experienced cellulits, pneumonia, pulmonary edema, hypoxia, GERD, abdominal pain, nausea/vomiting, MS, immunosuppression, anemia, parestesias, migraines, old nephrectomy, fever, SOB, malaise, productive cough, UTI, chills, night sweats & abnormal labs.
The fever started 2 days post vax and went as high as 107. The fever lasted 4 days and the pt complained of a headache, sore arm, was confused, lethargic, anorexia, and complained of left ear pain. The pt went to the ER. The pt is currently on antibiotics.
Client received Pfizer Dose 1 on 2/16/21 and Dose 2 on 3/10/21.   On 7/29/21 she had chest pain and confusion.  She was taken to the ER - diagnosed w/ "little pneumonia."  While still in the hospital, she wasn't tested for COVID until 8/2 when she tested positive.   Client passed away on 8/8 with "Acute Hypoxemic Respiratory Failure due to COVID-19."
tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: negative (Negative) done 3 times COVID-19 test, but all turned out to be negative.         No concomitant medications were reported.  Treatment information was not provided. Patient was very sick in December 2020 and had COVID-19 test 3 times which all turned out to be negative but she thinks she had the COVID-19. Patient was given experimental flu drug at that time.   This case was linked to MOD-2021-388542, MOD-2021-388559 (Patient Link).
Mom states pt was having periods of apnea requiring stimulation. Went to Urgent Care - Dr. states pt was indeed doing this pt admitted for seizures.
Nov 3, 2015 patient reported decreased ROM of (L) shoulder, dull ache when not moving arm and sharp intense pain with sudden (L) arm movement. C/O tingling in (L) hand and pain in (L) collarbone. Dr. diagnosis left shoulder inflammatory reaction.
Pt recvd vax & exp an unspecified adverse reaction; No further details were provided;
Pt came in for the Pfizer Bivalent vaccine but was given the Pfizer Monovalent Vaccine.  The patient is doing well, no issues.
Welts/hives appearing on arm. Very inflamed after exercise/taking a warm shower. Looks like shingles but i don?t think it is because I?ve had the chicken pox vax. Sometimes itchy. Still on arm almost a month later
Information has been received from a LPN concerning a female whose 12 month old son was vaccinated on 01/31/2001. On 02/09/2001 the mother had lesions and saw her physician, and was diagnosed with varicella. The nurse also reported on the patient's child who had a similar experience following vaccination with varicella virus vaccine. Additional information has been requested.
Zoster form eruption over lt deltoid, pain in lt thumb;two varicella like lesions on upper anterior thorax;
I did not have an ADVERSE event. I have had a LONG TERM POSITIVE event. There is no other way for me to report that I have had a significant lessening of my chronic Lyme symptoms. There is no other reason for this change other than having received the vaccine. I have had virtually no exercise induced fatigue and no joint or muscle pain, nor have I used Tylenol (at all) since my second vaccine. I hope that this can be reported to someone so that other patients who have auto immune or inflammatory issues might benefit.
Vaccine symptoms second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine symptoms second dose) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine symptoms second dose). At the time of the report, VACCINATION COMPLICATION (Vaccine symptoms second dose) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
This spontaneous report as received from a nurse refers to a 08-weeks-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 25-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Pt started with fever, vomiting, diarrhea on 11.9.09 and had bloody stools. Admitted to hosp. on 11-9-09. Discharge 11.11.09. CX: E Coli-(- neg).  11/18/09 Medical records received for DOS 11/9/09-11/15/09. Final DX: Colitis, fever, dehydration. Infant w/fever 102, cough, bloody, mucous diar. Vomiting, Lethargy. + salmonella stool cx. Abx therapy. D/C to home.
Patient complained of fever and chills. Her left arm is red, swollen, and hot to the touch. There are blisters at the site of injection.
The reporter advised that the patient had an allergic reaction to the Covid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NUS2022US006703 (Novartis).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "The reporter advised that the patient had an allergic reaction to the Covid.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching of face and neck at 1:20 pm itching of ear at 1:28 pm. Blood pressure 145/88 pulse 67 at 1:30 pm. Itching improved, but felt hot, flushed in face/neck. Took 25mg diphenhydramine, decreased itching. 4:00 pm felt fine and itching stopped.
High fever next morning 104 degrees, fatigue, chills, loss of taste, swollen lymph under arm lasting three days so far (fever has broken)
Fever of 100.5; body felt too hot and too cold intermittently; body aches all over; soreness and swelling at injection site; soreness and swelling at injection site; headache; dizziness; Nausea; brain fog; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 (Lot number: EW0217) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing); "Ascending aortic aneurysm" (unspecified if ongoing); "mild AI" (unspecified if ongoing); "Allergy:tree nuts" (unspecified if ongoing), notes: tree nuts; "Allergy: iodinated diagnostic agents" (unspecified if ongoing), notes: iodinated diagnostic agents; "Allergies: gluten" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ATORVASTATIN. Past drug history included: Gentamicin, reaction(s): "Allergies: Gentamicin"; Ciprofloxacin, reaction(s): "Allergies: Ciprofloxacin". Vaccination history included: Bnt162b2 (First dose:lot number=EW0217, vaccine location=Left arm"), administration date: 20Jul2021, when the patient was 44 years old, for Covid-19 Immunisation, reaction(s): "sore at injection sight for 3 days". The following information was reported: PYREXIA (non-serious) with onset 11Aug2021, outcome "recovering", described as "Fever of 100.5"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 11Aug2021, outcome "recovering", described as "body felt too hot and too cold intermittently"; PAIN (non-serious) with onset 11Aug2021, outcome "recovering", described as "body aches all over"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 11Aug2021, outcome "recovering" and all described as "soreness and swelling at injection site"; HEADACHE (non-serious) with onset 11Aug2021, outcome "recovering", described as "headache"; DIZZINESS (non-serious) with onset 11Aug2021, outcome "recovering", described as "dizziness"; NAUSEA (non-serious) with onset 11Aug2021, outcome "recovering", described as "Nausea"; FEELING ABNORMAL (non-serious) with onset 11Aug2021, outcome "recovering", described as "brain fog"; FATIGUE (non-serious) with onset 11Aug2021, outcome "recovering", described as "extreme fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, feeling of body temperature change, pain, vaccination site pain, vaccination site swelling, headache, dizziness, nausea, feeling abnormal, fatigue.  Additional information: Facility type vaccine: Doctor's office/urgent care. Second dose: within 48 hours reported Adverse events occurred. Symptoms are starting to get better on 3rd day after vaccine. COVID prior vaccination: No. COVID tested post vaccination: No. other vaccine in four weeks: No. Other medication taken within 2 weeks of vaccination coded as concomitant medications.  No follow-up attempts are possible. No further information is expected.
Fluarix + Administration of expired dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 40-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (expiry date 30-JUN-2023) for prophylaxis.   On 05-OCT-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 05-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: Fluarix + Administration of expired dose.).  The outcome of the expired vaccine used 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: 05-OCT-2023 The vaccine administration facility was the same as primary reporter The nurse reported on October 5th 2023 that today (on the day of reporting) an adult patient received a dose of Fluarix expired on June 30th 2023, which led to expired vaccine used. The reporter did not consent to follow-up.
pt c/o light headed feeling. states hx of fainting with blood donation. vitals on assesment were wnl. pt evaluated by md onsite and nursing/medical staff. give gatorade and a snack.  afterwards pt states was feeling better and was allowed to leave. hr 77 bp 113/86  o2sat 99% resp 12
Moderna COVID-19 Vaccine EUA Red ring around injection site, red bumps on inside of forearm and red rash in armpit on 8th day after injection
MMR given pt rubbed arm c/o stinging arm reddened w/aprpox 20mm raised white area; no wheezing or SOB noted; pt playful & talkative-ice pack applied intermittetnly x 1 hr;
PATIENT WAS GIVEN MODERNA VACCINE UNDER THE AGE OF 18 YO
Pt adm 2nd dose of vax in OCT90; Subsequently following vax exp a sore throat & stated that arm went numb & throat felt like it was closing; Sx were treated w/Epi;
She started feeling dizzy around 3:25pm while sitting in a chair. She did not want to go to ER. She wanted some water, so I gave her a bottle of water. she was so hungry. Hew mother who came with her had a snack bar and sandwich. she ate them and started feeling better. She left for home around 4pm.
fever, vomiting-treatment included Tylenol/Motrin prn, push fluids