chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain-Barre diagnosed 1/18/16 at hospital by Dr. Treated with intravenous immunoglobulin.
This case was reported by a pharmacist and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (1 ml, unknown) and experienced decreased therapeutic response. The pharmacist reported that four subjects in a row were non-reactive with a count less than 2.89. At the time of the report no additional information was provided. This is the fourth of four cases reported by the pharmacist, please see cases A0975396A, A0975397A and A0975398A. Follow-up information was received on 23 May 2012 via healthcare professional who reported on 16 February 2012, 16 September 2011 and 19 August 2011 the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (1 ml, unknown right deltoid) respectively. On 19 April 2012, 63 days after vaccination with 3rd dose ENGERIX B, 7 months after vaccination with 2nd dose ENGERIX B, 8 months after vaccination with 1st dose ENGERIX B, the subject experienced decreased therapeutic response. On 19 April 2012 Hepatitis B titer result was less than 2.80(9.99 or less is negative, greater than 10 positive). The subject received a booster dose of ENGERIX B on 26 April 2012.
Within 2-4 hours pt noticed localized red/hot/painful area at injection site. Overnight (10-12 hours after injection) fever up to 102 degrees F, body aches, chills, and continued local reaction.
Large Red are with large blister that broke open.  Went to doctor on Feb 16th 2021  Was put on Cephalexin 500MG 3 x daily for 10 days and Mupirocin 2%  3 x daily for 10 days
Rash on left arm started as a small area approximately one inch across.  Now covers most of the inner arm.  Has spread to the right arm and covers over 3/4 of the inner arm.  Also rash on right leg near the knee.  About three inches across.  Extremely itchy.  Topical and oral medications don't offer much relief.  Rash seems to spread more every day.
pt recv vax 3JUN96 & 11JUL96 & 6OCT96 lab eval revealed a failure to seroconvert (VZV antibody test was negative);
It started with itching with the left side of my scalp, through out the day while I was at work, at night the itching and burning spread down the scalp and into my eye all of the left side. I went to urgent care, the doctor did not know what was happening, they used a topical scalp treatment and cortisone cream for my face. I work at an exotic animal care, we saw a rare case of unknown hair loss on a rabbit so I do not know if that was related. The symptoms went away after 3 days of using the medications.
Apparent dermatographia: severe widespread pruritis that worsens in response to scratching. Even very light scratching causes localized urticaria that appears within 5-15 minutes and fades after 1-2 hours. Pruritis was most severe on the first day of the event, with severity peaking around 11 PM; on subsequent days, the pruritis has been mild and less widespread during the day but moderate to severe in the evening. I haven't yet had a chance to visit a doctor to confirm the diagnosis, hence "apparent" dermatographia.
Redness, heat, edema and pain at injection site that has continues to today (04-20-2018)-used cool packs to area. General malaise, decease appetite, diarrhea, nausea started 04/16/2018-diarrhea continues for one day only - pt continues to c/o general malaise, decease appetite with occasional nausea. Pruritus stated 04/18/2018 continues today- applied topical anti-itch oint. today.
Received flu and pneumonia vaccine 12/20/16 in right deltoid. Next day noticed redness, tenderness, warmth. Redness spread to shoulder, and down to elbow. Pt came to UC 12/22/16.
pt reports a stinging pain in arm that is sharp but resolves quickly at site of moderna booster injection.  1st occurance was 1 month after moderna booster.  It has happened 5 or 6 times since booster received, several weeks apart from each other.
12/27/20 10:30AM swelling at the injection site, muscle aches, fatigue; 4:30PM sharp, pounding headache; 06:00PM chills, body soreness, night sweats. 12/28/2020 nausea, loss of appetite, fatigue Tylenol, some relief.
Periodic  pain underarms and in groin area.  Slight enlargement of lymph nodes.
Rash to forearms, legs, chest and abdomen developed one day after vaccine administered. Denies use of new skin laundry products or new foods.
This 16 year od received a dose of Janssen vaccine which is not authorized for 16 year olds.
4/2/21 Phone call received at Health Department to Public Health RN from patient in order to notify us of swelling and redness in her arm after vaccination with the second Pfizer COVID vaccine.  Patient states she went to Hospital on 3/27/21 for a Walk-In Clinic offering the second Pfizer vaccine. She states she had no problem with the first Pfizer vaccine she received. However, this time she developed a rash, swelling, and a ?hot lump? on her right arm several inches under where she had been vaccinated. She states that as of today (4/2/21), the area is much improved. She treated the swelling by taking Benadryl at night for several nights. She states she has not let her PCP know of the symptoms she experienced. She did not go to ER or Urgent Care.  Patient was interviewed regarding her experience. She has no significant medical history, she only takes MVI and has no other medications, and her only allergies are to PCN and adhesive. She denies any previous reaction to vaccines. RN encouraged patient to let her PCP know about her symptoms and to use a cool compress to relieve swelling if desired. Patient denies any questions at this time.
The patient was accidently given a vaccine that was 2 days past the beyond use date (BUD). The Pfizer vaccine lot had been placed in the refrigerator and therefore was only good for 10 weeks from the date removed from the ultra-cold freezer. The BUD was 08/21/2023 and this vaccine was administered on 08/23/2023.
Case numberPHEH2044US019855 is an initial spontaneous report from the nurse received on 01 OCT 2014. This report refers to a patient of an unknown age and gender. The patient was inadvertently vaccinated with a single dose or FLUCELVAX 2014/2015 (batch number: not reported) via subcutaneous route instead of intramuscular route on an unknown date. No adverse event reported following this medication error (inappropriate route of vaccination).
1 day after vaccination, patient reported swelling around her collar bone (raised skin about 1/2 inch) with pain, and reported coughing.  Patient was instructed to take Benadryl and ibuprofen and to ice the affected area and call back if symptoms got worse. Patient did not call back to report any other worsening symptoms.
Arm very painful, felt nauseous, faint, diaphoretic. Upper arm became hard and swollen.
Patient received vaccinations on the morning of 27OCT.  Reported generalized body aches and local vaccination site (L arm) soreness with difficulty fully raising arm later in the evening and continued through the following day.  Patient presented to clinic the following day where he was determined to be clinically stable and no other apparent cause of symptoms based on history and examination other than likely vaccine-related adverse event.  He declined as needed symptom meds and discharged with instructions to follow-up for any emergent symptoms or any other concerns.
t103.6 R & malaise 8 days p/immun; fully recovered w/in 24 hrs;
Had flu vaccine on 10/13/19, on 10/14/19 patient started experiencing numbness and tingling bilateral feet.
Patient c/o soreness and pain in left hip area after receiving the HRIG (Human Rabies Immune Globulin Lot # X0084-4) and Rabies vaccine (RabAvert) for postexposure treatment.  The initial dose was administered on 7-21-04 and the pt. stated she was still having some discomfort on 8-18-04.
Red lump like rash on arms, abdomen and face. Still apparent today, almost 24 hrs after appt. no pain or itching so no treatment needed, just monitoring.
Patient had 3 other doses of flu vaccines given in the past year / NO AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Regulatory authority (Reference number- 00799351) and transmitted to Sanofi on 05-Oct-2021.  This case involves a 73 years old male patient who administered 3 other doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in the past year (inappropriate schedule of product administration).  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing Memory impairment.  On 19-Oct-2020, 06-Feb-2021, 06-Mar-2021, 05-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ764AC and expiry date: 30-JUN-2022) via an intramuscular at an unknown administration site for prophylactic vaccination.   It was an actual medication error due to inappropriate schedule of vaccine administered (latency: same day).  It was reported "Patient was given FLUZONE HD QIV on 05Oct2021, and practice found out afterwards he has had 3 other doses of flu vaccines administered in the past year. The original dose was given by the practice on 19Oct2020, with the two following on 06Feb2021 and 06Mar2021, which were not administered by the practice."  HCP states that patient also received 2 flu vaccines in 2018.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
walks with a cane; she has shrunk; tiredness/ extremely tired; vomited twice; lightheadedness/ Very lightheaded; sore throat/ throat is sore; loss of taste/ She has no taste; swollen and puffy mouth/ mouth swollen/puffy; experiencing dry mouth to the point that she cannot talk/ Dry mouth; can hardly talk; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), on the left arm, intramuscularly, on 23Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history included mild case of asthma from an unknown date. There were no concomitant medications. No prior vaccinations within 4 weeks. The patient reported that she received her first vaccine a week ago this past Saturday. She didn't feel anything different until 2 days later on 25Jan2021. She became extremely tired and vomited twice, became very lightheaded, has no taste, throat is sore, mouth seems like it is swelling when she wakes up in the morning, her mouth is puffy. Her mouth is getting so dry she can hardly talk. On a unspecified date, the patient reported that she walks with a cane in her own house, she normally doesn't. But since she has had the shot, she has had to use the cane in her own house, she has shrunk. The reporter did not require a visit to a physician's office or emergency room. She mentions she is scheduled for her second vaccine. The patient was vaccinated on an active aging building. The outcome of the events extremely tired and vomited was recovered, for the events very lightheaded, throat is sore, mouth seems like it is swelling/mouth is puffy, mouth is getting so dry she can hardly talk was not recovered, while for the events has no taste, walks with a cane, and has shrunk was unknown.
The patient age has a 5 (15) but was misread as an 8 (18) and the 15 year old got a flublok shot
fever, pain, irritability, would not walk that evening ER visit 29SEP-both legs (thighs) red, painful no s/s infect;t101.8R;pt doing some walking;30SEP MD visit;pt walking, t100.6 R;no swelling, no pain;cont APAP, Ibuprofen;remains irritabl
Pt c/o palpitations, pain at injection site. Starting same evening vaccine given. Arm then became clot and swollen and red. Dx=Cellulitis. Seen 2 days post injection. Rx KEFLEX, warm compresses, EKG normal. Holter monitor ordered.
A swollen, 3" diameter area around the injection site that is reddened, swollen, appears like a rash and is hardened; A swollen, 3" diameter area around the injection site that is reddened, swollen, appears like a rash and is hardened; A swollen, 3" diameter area around the injection site that is reddened, swollen, appears like a rash and is hardened/pinkish reddish around the site; A swollen, 3" diameter area around the injection site that is reddened, swollen, appears like a rash and is hardened; This is a spontaneous report from a non-contactable Pharmacist. A male patient of an unspecified age receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccination 1 week before 14Jan2021 (Jan2021). He didn't feel anything wrong until yesterday (13Jan2021), and presented with a swollen, 3" diameter area around the injection site that was reddened, swollen, appears like a rash and was hardened. It looked obvious, was pinkish reddish around the site. Patient was wondering if heard of similar experiences, if it was a real side effect or allergy. Pharmacist told patient to watch it to see if it gets smaller. The outcome of events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Pt  began to get red in face about 10 minutes after receiving the vaccine. felt a little warmbut was fine. about 30 minutes after the vaccine pt had itching around jaw line , gave pt 20ml of liquid benadryl at 3:19 she was feeling les itchy and not as red in face. pt left with family memeber at 3:36
Information has been received from a health professional concerning a 16 year old female who on 23-Aug-2007 was vaccinated intramuscularly using the pre-filled syringe with her first dose of Gardasil (Lot #655154/1210U).  There was no concomitant medication.  On 14-Nov-2007 the patient was vaccinated with the second dose of Gardasil and subsequently experienced pain at administration.  The patient was given ice packs to apply to the area while in the office.  It is unknown if the patient experienced the same pain with the first dose.  Subsequently, the patient recovered from pain at administration on the same day.  This is one of several reports received from the same source.  Additional information has been requested.
Extremely dizzy when got up during night (2 am). Fell twice. Extremely dizzy when got up during night 2nd time (5 am). Fell once.  In the morning (about 7:30) I noticed a rash all over his trunk (small pink spots) As the result of the falls, he hit chin and cut it. Hit left temple and bruised it. Back is very sore and painful. May have cracked rib(s). Currently 2:20 pm on March 14. He is no longer experiencing the dizziness. The rash seems to be clearing up (brownish spots instead of pink spots on trunk). He's resting.
sz, generalized for 10 mins assoc w/fever of 102 occurred 48 hrs p/vax given;
chills, aches, at 5pm through the night, then vomit at 8 am, chills and aches rest of the day, resolved by 4pm
Client had a breakthrough infection, client was symptomatic on 5/11/21. Client has received both doses of Pfizer.  3/4/21 Lot number EW6199 3/26/21 Lot number ER8732 both were Intramuscular in the right deltoid
Chills; fever; swollen glands; nausea; lack of sleep; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number : EN6207), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 17:30 (at the age of 41-year-old) as DOSE 1, SINGLE for covid-19 immunization (Facility type vaccine : Hospital). The patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 (at the age of 42-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient did not have Covid prior to vaccination. The patient was not tested for COVID post vaccination. Medical history included food allergy (Pineapple, kiwi, pecans) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 18Mar2021 01:00 AM Chills, fever, swollen glands, nausea and lack of sleep for 3 days after 1st vaccine and 2 days after 2nd vaccine. The patient did not receive any treatment for the events. The outcome of all the events was recovered 2021.  No follow-up attempts are possible. No further information is expected.
pt presented to ED with weakness and non-productive cough; dx with hyponatremia and positive for COVID; admitted to hosp; hx of adenocarcinoma of left lung with metastasis to bone and brain; DNR/DNI; placed on BiPAP; given ATB, remdisivir, dexamethasone, and therapeutic anti-coagulation med; pt's condition worsened; became extremely hypotensive and hypoxic; she passed away in the hosp
Patient came back to pharmacy within 5 minutes of receiving her vaccine and stated she did not feel well.  She was lightheaded, dizzy, profusely sweating, and lethargic.  She never completely lost consciousness but had difficulty concentrating and keeping her eyes open.
Skin became severely dry and itchy. Rash and nonspecific skin eruption. Blanching erythematous papules and excoriation on arms and upper back.  No rash in groin. Well developed, well nourished, male in no acute distress, oriented and without outward signs of anxiety or depression. Complete examination of the scalp and hair, head, face, ears, nose, lips, eyelids and conjunctiva, neck, chest, breasts and axillae, back, abdomen, right and left arms, digits/nails,  right and left legs was normal except for the following significant findings: - Erythematous papules coalescing in areas into nummular plaques with scattered excoriations on the back, flanks, lower legs.  Eczematous dermatitis  - Start Triamcinolone acetonide 0.1% ointment BID over affected area, no more than 2 weeks per month.  - Reviewed side effects of prolonged steroid use including skin atrophy, telangiectasia, hypopigmentation, and striae. - Recommended bathing with lukewarm water, using minimal fragrance-free soap only in intertriginous areas. Options include Cetaphil and Dove.   - We discussed the importance of regular moisturizing (2-3x per day) with an emollient (Hydrolatum or Aquaphor) or thick cream (Cetaphil, CeraVe, Vanicream, Eucerin etc) even when eczema seems to be doing well.  - For itch and poor sleep, start hydroxyzine 25 mg PRN at bedtime. Reviewed potential SE including sedation.
Persistent, worsening, and significant tinnitis developed after Covid booster. Condition effected ability to hear patients and made difficult routine workplace tasks such as conducting patient screenings and assessments. ENT exam and hearing evaluation was conducted after approximately 3 months when symptoms did not improve.
it was rpt by nurse concerning pt who p/recv vax subsequently devel fever & rash; the rash resolved within 10 days
New Hire-Hep B SAB titer showed non-immune to Hepatitis B (despite having history of 4 total doses of Hep B), presented to Occ Health for booster, administered Heplisav B (20mcg) by RN-Clinic nurse. Heplisav B approved for 18yrs and older. No adverse  reaction to vaccine, but should have been administered Engerix 10mcg based on age.
Staggering all over the place; Weak; Cold; Sweating; Severe headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Staggering all over the place), ASTHENIA (Weak), NASOPHARYNGITIS (Cold), HYPERHIDROSIS (Sweating) and HEADACHE (Severe headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced GAIT DISTURBANCE (Staggering all over the place), ASTHENIA (Weak), NASOPHARYNGITIS (Cold), HYPERHIDROSIS (Sweating), HEADACHE (Severe headache), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, GAIT DISTURBANCE (Staggering all over the place), ASTHENIA (Weak), NASOPHARYNGITIS (Cold), HYPERHIDROSIS (Sweating), HEADACHE (Severe headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient was given a flu shot in left arm on 10/08/07.  Public health contacted the clinic to take a look at arm.  Softball sized welt on childs arm was present rd and raised.  Patient stated does not itch.  He presented on 10/10/07 2 days after shot given.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 33 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014,  AFLURIA again had temperature  excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. No adverse reactions have been reported since administration. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Low lumbar radicular pain and numbness and parathesias bilateral hands and feet. Progressive began within 1 month of H1N1 vaccine.
This spontaneous report was received from the patient's mother, concerning her female daughter of unknown age via Center (Other Company No. US15-027834). No concurrent conditions or medical history were reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL injection once (dose, route, Lot No. were not reported) (also reported as unknown indication). No concomitant therapy was provided. The mother reported, that on an unknown date, the second and third dose of GARDASIL were administered late to her daughter (she could not remember). As on 14-JUN-2015, the patient had completed her series of GARDASIL. This is one of several reports received from the same source. Additional information is not expected due to no consent to contact was given and the reporter refused to provide any safety report information.
Shortness of breath, chest tightness, jittery, slight lower lip swelling and tingling
Right deltoid area he has area of erythema 5x5 cm and adjacent there is a bruise 2x2 cm.
pt recv vax & exp transverse myelitis p/vax;pt has not yet recovered;sx still persists;
PAIN EXTENDING TO THE NECK; FEELING PAIN FROM SHOULDER TO ARM; This spontaneous report received from a patient concerned a 50 year old male. 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: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-APR-2021, the subject experienced pain extending to the neck. On 17-APR-2021, the subject experienced feeling pain from shoulder to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling pain from shoulder to arm, and pain extending to the neck. This report was non-serious.