chrisvoncsefalvay/vaers-outcomes huggingface dataset:
accidentally an adult dose of Havrix was administered to a pediatric patient; accidentally an adult dose of Havrix was administered to a pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 22-month-old female patient who received HAV (Havrix adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 27-JUL-2023, the patient received Havrix adult. On 27-JUL-2023, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: accidentally an adult dose of Havrix was administered to a pediatric patient) and adult product administered to child (Verbatim: accidentally an adult dose of Havrix was administered to a pediatric patient). The outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 27-JUL-2023 The reporter did not consent to follow-up. The pediatric patient accidentally received an adult dose of Havrix, which led to accidental overdose and adult product administered to child.
Patient had swelling and tingling in lips and teeth.  Unable to have normal bowel movement since vaccine.  Cycle problems since administration.  Patient reports being extremely tired for 5+ days.  Unable to perform mcommon physical activities.  Patient reports increased inhaler usage needed since vaccine.  Patient used Benadryl for approximately 24 hours to resolve the swelling and tingling issues
I took 2 doses and got covid again/ I took both doses of Pfizer and still got COVID-19 second time.; I took 2 doses and got covid again/I took both doses of Pfizer and still got COVID-19 second time.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jun2021 12:30 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included COVID-19, start date: Oct2020 (unspecified if ongoing), he got COVID last year. There were no concomitant medications. The following information was reported DRUG INEFFECTIVE (medically significant) with onset 2021, outcome unknown; SUSPECTED COVID-19 (medically significant) with onset 2021, outcome unknown. The events I took 2 doses and got covid again/ I took both doses of pfizer and still got covid-19 second time, were evaluated at the physician office visit. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19. Patient took both doses of Pfizer and still got COVID-19 second time. So, even his doctors were puzzled and they were not sure why this happened to him again. Patient was really fit and healthy. There was no lab test. Patient had not taken any treatment other than test (unspecified). Patient had severe symptoms this time. So, he was in touch with the doctor and they are monitoring the situation.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Itchy red rash on L & R legs and feet. About a dozen large pustules, five of which turned into blisters the morning following the day of vaccination.
Cold sweats, headache, fatigue and body aches started about 12 hours after vaccine and lasted to about 36 hours post vaccine. Petechiae and bruising started about 36-72 hours after vaccine. Platelet count on day of vaccine was 175K, and was 56K four days later. I have immune thrombocytopenia that was stable with counts around 175K regularly prior to  COVID-19 vaccination. My counts have been unstable and trending lower since vaccination.
Palpitations and pounding heart that woke me up and continued all day, starting about 36 hours after vaccine. Also had headache, chills, body aches, fatigue and pain at injection site. This was my first dose. Palpitations and pounding heart continued intermittently for three weeks then became infrequent.
Sneezing a lot, runny nose, nasal congestion, headache, no cough, fatigued, body aches.  I felt like someone hit me with a shovel on my back.
This spontaneous report as received from a other health professional refers to a 72 years old female patient. The patient was vaccinated with ZOSTAVAX on 14-NOV-2012. No other co-suspects were reported. Concomitant medications included vitamin D (unspecified), omega-3 marine triglycerides, flaxseed, calcium (unspecified), BENADRYL and red yeast. On 16-NOV-2012 the patient experienced redness, 3 days after onset of therapy and injection site swelling. Patient was treated with Prednisone for events redness and injection site swelling. The outcome of redness and injection site swelling is recovered. The relatedness for redness and injection site swelling is unknown for ZOSTAVAX. No further information was provided.
After receiving the 2nd vaccine later that night around 7:30ish, my leg was warm to the touch, pinkish in color, I had chills and a low grade fever. I contacted my regular doctor, who advised me to wait a day or two due to the fever. Once the fever went down I was able to visit with the doctor on April 30th Friday. Upon examination the doctor stated an infection had developed in my leg, the doctor then gave me a prescription. The infection cleared up in 2 weeks and came back in early May. I proceeded to contact Dr for another visit and received another prescription. The infection cleared up however 2 weeks later the infection returned. I returned to Dr. again and received  a 3rd prescripAt the end of June I returned to Dr's office for the 4th time and received a  4th perscription. Dr. then recommended therapy at local HCF. Towards the end of June I was receiving massage & wrap therapy at HCF. The threapy worked for a while however on July 8th the infection came back and also aggravated the papillomas, which began ozzing. Prior to these events the papillomas were not ozziing or causing a problem. I returned to Dr's office who was unavailable so I saw another dr. That dr perscribed an ointment for the papillomas and Clindamycin for 10 days by mouth. On July 31, I became sick with 101 fever, my leg discolored to a pinkish color and was extremely warm to the touch which made me very weak and tired. My neighbor called the ambulance for me, they took me to a local Hospital and not the hospital where I received the vaccine  since it's not on their route. I was admitted.  I received blood work, urinalysis, Covid-19 test (negative) a chest x-ray. I received Keflex intravenously during my stay.  After receiving Keflex I began to feel better, I was discharged the following day later in the day. I received a perscription for10 days for Keflex in pill form. A week later, after completing a refferral, I returned to the massage threapy however the papillomas were still ozzing. To this day the leakage improved some but not completely I am still under doctors care. Dr. then recommended I go to Wound Care which I am still attending to this date.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 71-year-old male patient who received Shingrix for prophylaxis. In August 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced tiredness and weird feeling. On an unknown date, the outcome of the tiredness and weird feeling were recovered/resolved. It was unknown if the reporter considered the tiredness and weird feeling to be related to Shingrix. Additional details were provided as follows: The patient received the vaccine on his left shoulder mid day a couple of months ago. The patient reported that he felt a bit tired and weird after receiving Shingrix vaccine. The reaction happened one day after the vaccination and he felt that way for a day or so and then it resolved.
30F w/ PMHx of seizure disorder and asthma who reported after receiving 2nd COVID vaccine to be nauseous. Upon assessment, pt vital signs 125/83, P84, SaO2 100%. Pt stated that throat began to itch. after further assessment, pt reporting worsening of throat itching and "chest tightening". vitals reassessed SaO2 80%. decision to call ER proceed out made. ER team arrived, and transfered patient to ER for treatment and observation .   ER Course:   Exam remarkable for bilateral expiratory wheezes and uvular edema.  Treated with epi, benadryl, famotidine, albuterol and steroids.   EKG nonischemic.   Bedside scope shows mild swelling to the larynx without evidence of airway compromise.   Patient was observed for 4-6 hours and discharged once all symptoms resolved.
It was reported that a 49 year old female pt received fluzone unspecified vaccination on 11/03/2000. Reportedly in November 2000 the pt experienced a "muscle injury, rotator cuff syndrome, injection site reaction and injection site pain." The pt was hospitalized for surgery. The pt has recovered.
had a worst Flu; Initial information was received on 18-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had a worst flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had a worst flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
On April 4 (throughout the day) -- began to show symptoms of feeling abnormal / off-center (beginning around 10am).  by 5pm -- became uncoordinated / unbalanced (couldn't access phone, put on clothes, etc.).  Advised by Neurologist to seek ER treatment and directed to local hospital.  Initially, diagnosed as showing symptoms of a Stroke.  Upon further analysis, hospital determined it was a MS Flare Up.    Since April 4 -- patient lost use of left side (hands, legs).  Right Side brain also affected.  Currently in acute rehab (Since April 17) to regain functionality.   As of May 3 -- still unable to walk on her own or use left hand.  Still experiencing visual issues.  Acute Rehab facility believes recovery may take up to a year.    Patient's normal  Neurologist was puzzled by diagnosis because the symptoms as well as the duration and acuteness of the episode is inconsistent with her MS condition.  Patient was originally diagnosed  with MS in 2009 and there have no MS flare-ups since the initial diagnosis.  The normal Neurologist noted that the symptoms are inconsistent with her history.    Believe it was proper to notify, given the recent vaccination.  Can provide full medical records, if helpful
pt recvd vax & exp numbness sensation on rt side of face; pt also ran a low fever;
Pt recvd vax & several other unspecified vax in a study of immunocompetence; subsequently devel induration & warmth @ the inject site; pain, induration & hyprthermia were felt to have occurred @ SC injection site of neo-antigen KLH;
developed what she thinks its an UTI; lower back pain; chills; very sore arm (couldn't even lift her arm); low grade fever; body aches; feel very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain), PYREXIA (low grade fever) and MYALGIA (body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (feel very tired). On 20-Feb-2021, the patient experienced URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain) and CHILLS (chills). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) (oral) on 20-Feb-2021 for UTI, at a dose of UNK dosage form. On 12-Feb-2021, PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), MYALGIA (body aches) and FATIGUE (feel very tired) had resolved. At the time of the report, URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain) and CHILLS (chills) outcome was unknown and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 5 years old male patient who received fifth dose of vaccine IPOL (Batch number, expiry date, dose, route and site of administration were not reported). The patient's past vaccination(s) included IPOL with series of 3 plus a booster dose in his school. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the product was administered to a patient after the temperature excursion (the refrigerator reached a low of 32 degrees Fahrenheit for 20 minutes). That 5th dose was from the opened IPOL MDV that had reached a temperature < 35F. No other effects were 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 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. Documents held by sender: none.
Pt felt faint, was pale and sweaty, laid down, refused PO 2 hours nausea, EMT placed on oxygen, rested x 20 minutes no better checked over sx get by ambulance to ER, at ER throat swelling and tx allergic reaction. Rx with Epipen, steroids IV fluids, ER x 6 hours. 12/27/09 - much better after problems with steroid psychosis, sx anxiety x several days.
Narrative:  Pt covid-19 positive after 2 doses of moderna covid-19 vaccinations were given on 1/7/21 & 2/4/21. Pt with low grade fever. Pt is immunosupressed on chemotherapy for CMML diagnosis. Pt was treated with monoclonal antibody therapy in ED on 8/19/21 (with Casirivimab & Imdevimab combo) . Pt discharged home from ER after post infusion monitoring period completed. pt's chart flagged with ADR to covid vaccines as failure of vaccination to prevent infection.
Pt reports to pain in L shoulder that is localized to injection site. This vaccination was administered at a healthfair and it is unclear of the exact name of the flu shot. He followed up with us in primary care 6 weeks after the injection to report the pain. He has no exam findings to suggest infection, nerve damage, obvious muscle damage.
Patient received third booster shot of Pfizer which has not been yet approved by CDC for age group,
Redness, swelling with patch vesicles (quarter size), left arm, upper left arm 4cm larger than right arm, warm to touch, afebrile.
NONE, PT MAY OR MAY NOT HAVE RECEIVED VACCINE WHO'S STORAGE MAY NOT HAVE BEEN CONSISTENT.
soreness in his left chest and left arm; heart rate was a little high; soreness in his left chest and left arm; pain felt like achy muscles/body aches; a fever of 100 degrees F; achiness in his back and a little bit in his chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his left chest and left arm), PALPITATIONS (heart rate was a little high), CHEST PAIN (soreness in his left chest and left arm), MYALGIA (pain felt like achy muscles/body aches) and PYREXIA (a fever of 100 degrees F) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006_321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced MYALGIA (achiness in his back and a little bit in his chest). On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in his left chest and left arm), PALPITATIONS (heart rate was a little high), CHEST PAIN (soreness in his left chest and left arm), MYALGIA (pain felt like achy muscles/body aches) and PYREXIA (a fever of 100 degrees F). On 05-Apr-2021, MYALGIA (achiness in his back and a little bit in his chest) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in his left chest and left arm), PALPITATIONS (heart rate was a little high), CHEST PAIN (soreness in his left chest and left arm), MYALGIA (pain felt like achy muscles/body aches) and PYREXIA (a fever of 100 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 100 (High) 100 F. On 12-Apr-2021, Chest X-ray: normal (normal) Normal. On 12-Apr-2021, Full blood count: normal (normal) Normal. On 12-Apr-2021, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported. The patient used to be heavily involved in weight lifting and states that the pain felt like achy muscles to him. Patient states his 2nd shot is due on 30Apr2021
Shooting pain up and down arm. Patient states pain was a 10+ on scale from 1-10.
Pain on left front side of chest. Doctor diagnosed it as Herpes Zoster. Rash on left front of chest. Has Herpes Zoster leisons. Prescribed an antiviral.
fever of 100.9/eventually peaking at 102.8; Chills; Body aches; bad body aches it hurt to walk across her apartment to the bathroom even; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 25Mar2021 at 14:45 (at the age of 23-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient was allergic to Zythromax. The patient received Loloestrin birth control within two weeks of vaccination. The patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FN6205) via an unspecified route of administration in the right arm on 04Mar2021 at 15:45 (at the age of 23-year-old) as a single dose for COVID-19 immunization and on 05Mar2021 at 14:00, the patient was tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 26Mar2021 at 02:00, the patient woke up with a fever of 100.9. The patient called out of work and spent entire next day in bed with horrific chills and an off and on fever eventually peaking at 102.8 around 17:00. Sometime after that, the patient felt asleep and slept until around 7:00 the next morning and by then her fever had broken. The whole day that she was feverish, she had such bad body aches it hurt to walk across her apartment to the bathroom even and she spent the day off and on sleeping. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the resulted adverse events. The outcome of the events fever, chills and body aches were recovered on an unknown date in Mar2021 and of other event was unknown.  No follow-up attempts are needed. No further information is expected.
Noticed rash completely covering inner thighs and small area of upper abdomen With very little progression since noticing. The rash is accompanied by mild itching.
Patient is a 80 y.o. male with significant PMHx of CAD, HTN, HLD, CKD who is admitted to ICU as a transfer from hospital for acute liver failure and cardiac arrest. Pt presented to hospital on 04/28 w/ complaints of nausea and vomiting. He stated that he had recently gotten his COVID vaccine. Pt was found to be in acute liver failure in the ED w/ AST and ALT > 1000. Lactate > 15.0. BMP showed AKI on CKD and BG >500. Pt did have cardiac arrest while undergoing CT Scan and ROSC was achieved after CPR x 20 mins.  Pt was hence transferred to the ICU for higher level management and admitted for cardiac arrest and acute liver failure.   Upon arrival, Pt was intubated and sedated. He was non-responsive to verbal and physical stimuli. Pt was acidotic. ABG: 6.99 / 28 / 165 / 7. 1 amp of HCO3 was given upon arrival. Pt was started on insulin gtt for DKA and was started on Levophed for low BP.  Pt underwent cardiac arrest shortly after arrival to the ICU. CPR was performed for > 20 mins without ROSC. Family arrived at bedside and decision was made to stop CPR at 0205 on 04/29/2021.
Burning sensation around the waist area on the lower left side; Weird sensation like its sun burn to touch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation around the waist area on the lower left side) and RASH ERYTHEMATOUS (Weird sensation like its sun burn to touch) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced BURNING SENSATION (Burning sensation around the waist area on the lower left side) and RASH ERYTHEMATOUS (Weird sensation like its sun burn to touch). At the time of the report, BURNING SENSATION (Burning sensation around the waist area on the lower left side) and RASH ERYTHEMATOUS (Weird sensation like its sun burn to touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.50% of body covered in a rash - His arms, thighs, back and going up his neck