chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discomfort; bumps forming from these hives; Hives from her arms,going to the waist till her ankles / bumps forming from these hives; Vaginal spotting; Itchy all over; Throwing up; Nausea; Headache; Dizzy spells; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizzy spells), VAGINAL HAEMORRHAGE (Vaginal spotting), PRURITUS (Itchy all over), DISCOMFORT (Discomfort) and URTICARIA (Hives from her arms,going to the waist till her ankles / bumps forming from these hives) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (codeine, Vicodin), Food allergy (coconut, seafood, shellfish: anaphylactic shock) and Asthma. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA HANDIHALER), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYDROCHLOROTHIAZIDE + LOSARTAN) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-May-2021, the patient experienced DIZZINESS (Dizzy spells), PRURITUS (Itchy all over), VOMITING (Throwing up), NAUSEA (Nausea) and HEADACHE (Headache). On 18-May-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal spotting). On 19-May-2021, the patient experienced URTICARIA (Hives from her arms,going to the waist till her ankles / bumps forming from these hives). On an unknown date, the patient experienced DISCOMFORT (Discomfort) and SKIN MASS (bumps forming from these hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy spells), VAGINAL HAEMORRHAGE (Vaginal spotting), PRURITUS (Itchy all over), DISCOMFORT (Discomfort), URTICARIA (Hives from her arms,going to the waist till her ankles / bumps forming from these hives), SKIN MASS (bumps forming from these hives), VOMITING (Throwing up), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Left upper dorsal arm is erythematous and warm. Vaccine entry site is visible, but no signs of infection. To apply cold compresses and take BENADRYL.
rash; Sore Left arm at the injection site; I still have the rash, I noticed a few more spots on my shoulders, breast area and waist; loss of sense of smell; This is a spontaneous report from a non-contactable consumer (Patient).   A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included brain surgery on 05Dec2020 because patient had a brain tumor and had meningioma. She had lost sense of smell due to the tumor pressing on the nerves but got it back (sense of smell) after the surgery. She had headaches all of the time, so this is hard to say why and had sinus disease and her doctor feels that these symptoms were more from the brain surgery than anything else. She had history of asthma and had post nasal drip and received a couple of asthma medications. No concomitant medications were reported. Past drug included flu shot. On 13Feb2021, Saturday, she broke out in a rash. Her skin was kind of sensitive and stated that she will notice things, like bites, and had an exaggerated reaction. Her rash was not itchy or bothersome. On an unspecified date in Feb2021, she experienced sore Left arm at the injection site, more spots on shoulders, breast area and waist and lost her sense of smell this weekend and noticed when she put her nose to the bag of coffee and realized that she was back with no sense of smell. She mentioned that if she get a bee sting, or touch a Virginia creeper, she get a severe reaction. Patient stated that she doesn't think she was experiencing anything severe but will call doctor to discuss. At the time of this report, the outcome of rash was not recovered, Sore Left arm at the injection site was recovered on unknown date in Feb2021 and other events was unknown.  No follow-up attempts are possible. No further information is expected.
six year old patient patient received Flublok vaccine/NO AE; patient received Flublok vaccine instead of Fluzone Quadrivalent vaccine/No AE; Initial information received on 16-Jan-2020 regarding an unsolicited valid non-serious case received from a Consumer.  This case involves a six years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age and wrong product administered)  Medical history, medical treatment, vaccination and family history were not provided.  On 16-Jan-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot QFAA1913, expiry date: 29-JUN-2020] in her left thigh instead of INFLUENZA QUADRIVAL A-B VACCINE via an unknown route.  This was a case of actual medication error due to inappropriate age at vaccine administration and wrong product administered.  At the time of report no adverse event was 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.
Patient developed a rash 10/28 on the left arm, over the vaccination site. This is reported as pruritic. Diagnosed with Shingles. Treated with Valacyclovir
2nd done: well delineated slightly raised, erythematous welt 5x6cm.  Resolved promptly!
mom noticed 27OCT93 lt thigh raised & reddened area; induration is about 20-25 mm in diameter; mom denies any fever, any display of discomfort or pain, no pruritis; no problems w/sleep or appetite;
In the evening on day she received vaccines, noted tenderness in right arm pit area; progressed to nodule (3mm - solitary node in right axilla) Antibiotics prescribed on 6-26-13.
Initial report received from a consumer on 12/Jun/2006.  A mother reported that her 12 year old daughter who had no illnesses developed a headache, sore arm, dizziness, difficulty hearing and had sweats 24 hours after receiving the injection of Adacel, lot number not reported in the left deltoid on 09/Jun/2006.  No diagnostic tests or lab work was performed.  Per mom, her daughter was treated with MOTRIN and symptoms resolved.  Follow up report received on 10/Jul/2006 from a health care professional.  The lot number for Adacel vaccine was reported as C2457AA.  It was administered on 09/Jun/2006 at 16:30 pm in the left deltoid.  As per the reporter, the events were not reported to the physician's office by the patient of her mother.  No medical treatment was sought.  Further information is not anticipated.
This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. ON an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, (lot number, expiry date and route was not reported). On an unknown date, the patient complained of arm pain at the injection site that lasted more than 6 months. The patient was receiving physical therapy for her arm, but it was unknown whether she started receiving therapy before or after administration of PNEUMOVAX 23. The outcome of the event was unknown. Additional information has been requested.
Moderate tinnitus symptoms and Eustachian tube has unequalized pressure. Severe symptoms aggravated by excess noise, and travel by plane. Impacts daily life constantly and increases frequency and severity of migraines, leading to an ER visit for severe migraine in March25. unequal pressure has also effected sinus cavity and resulted in constant dry mouth. Symptoms seem to be chronic and ultimately leading to expensive alternative medical solutions.
he experienced a slight bronchial congestion; cough; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program Covax US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that week and half on an unknown date, he got the 1st dose and then he experienced a slight bronchial congestion and cough. The patient just wanted to know what would happen if tested positive for Covid-19 in between the 1st dose and 2nd dose. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Flu like symptoms; aches; Drowsiness; fever; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Dec2021 11:45 (Lot number: FH8027) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, brand=Pfizer), administration date: 16Feb2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, brand=Pfizer), administration date: 26Jan2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 11:45, outcome "unknown", described as "dose received: 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "Flu like symptoms"; PAIN (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "aches"; SOMNOLENCE (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "Drowsiness"; PYREXIA (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza like illness, pain, somnolence, pyrexia.  Additional information: The patient had no known allergies.The patient did not receive any other vaccine in four weeks.The patient did not receive any other medications in two weeks.The patient was not diagnosed with COVID-19 prior and post vaccination.  No follow-up attempts are possible. No further information is expected.
Mild-Chill, cutaneous hypersensitivity - maybe had a RXN to PREVNAR. Red heat chill and skin hypersensitivity shot at same area he had a staph abscess in past he is better today. Warmth pink no induration or abscess. Continue APAP MOTRIN and ice pack. Add ADR and DOXY. The patient received PNEUMOVAX 0.5ml IM today in Left Deltoid. Merck Lot # and Expiration Date: L029306 EXO 3/26/2017.
Patient had pain throughout whole body, bad headache, dizzy, lightheaded, felt very strange "like flying," very weak and very thirsty. The patient stayed home. Symptoms lasted about one month and then sought help. The doctor said patient had inflammation throughout whole body and sent her home with walker. Muscles very tense. She is doing better but still fatigued very easily. She has pain in her legs and feels "heavy." Patient continued to have pain throughout body, but not quite as bad as within month after shot. Sent to physical therapy.
Patient reported initially some dizziness. she reports she is a diabetic but has eaten today. she  reports a slight mid sternal pressure and shortness of breath. no nausea, cutaneous or other respiratory symptoms. she took an anti histamine this morning. heart rate 98  and oxygen 98%. patient instructed to lie down and remain on site until symptoms subside. patient instructed to notify staff of any worsening symptoms.
Right eye brow twitching, intensity of twitching has progressed each day. On day 5 right eye brow twitching is almost constant and a mild pain in my whole right eye socket area is persistent.
A non-serious spontaneous report of chills, fever, and leg cramps has been received from a physician concerning a 30 month old female subsquent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received one dose of FLUMIST intranasal on 08-Oct-2009 for influenza vaccination. The events chillds, fever, and leg cramps resolved by the date of this report per the physician
This spontaneous report as received from a nurse refers to a patient of unknown age. On 15-OCT-2013 the patient was vaccinated with PNEUMOVAX23 intramuscularly (lot # J000388 exp. date: 06-AUG-2014, dose, strength, site of administration not reported). The reporter stated that PNEUMOVAX23 was exposed to -2.8C for 68 hours with the vaccine possibly going above and below 0'C more than two times during this excursion. No adverse effect reported. This is one of two reports from the same reporter (MARRS case # 1311USA001488). Additional information has been requested.
Itching in legs, arms, tingling in lips, mouth, tongue.  Heart rate increased.
Patient immediately complained of a frontal headache but was not dizzy. Headache progressed at home. No nausea or emesis. Patient had a non-febrile epileptic convulsion (pre-existing seizure disorder) at 3 AM. Negative CT exam, EEG positive.
Patient noticed rash, swelling and itching the morning after her vaccination. The rash and swelling area became larger each day accompanied by warmness to the touch.
using vaxelis instead of giving act-hib as a stand-alone vaccine with no adverse event; Initial information received on 10-May-2023 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 2 months old female patient who had been administered VAXELIS instead of giving HIB (PRP/T) VACCINE [ACT-HIB] as a stand-alone vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 10-May-2023, the patient received a dose 1 at a dose of 0.5 ml suspect HIB (PRP/T) VACCINE for Powder and solvent for solution for injection (with an unknown frequency, strength, expiry date, lot UJ792AA) via intramuscular route in unknown administration site for immunization (immunisation).  On an unknown date, the patient received suspect VAXELIS not produced by Sanofi Pasteur (with an unknown dosage, formulation, frequency, strength, expiry date, lot number) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event (wrong product administered) (latency: same day) .  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
I had the shot many years ago. I have had the shingles twice/ suspected Vaccination failure; have had the shingles twice; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient got the shots many years ago from the date of reporting and had the shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Site: Swelling at Injection Site-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: 14 year old child fainted following Pfizer vaccination. Hit head on carpet, leaving carpet burn on side of face. Was alert and up talking to me when I approached him. Patient was taken to local emergency room for evaluation.
left shoulder joint pain; left arm pain; unable to raise his arm over his head; Initial information received on 23-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 41 years old male patient who experienced left shoulder joint pain (arthralgia), left arm pain (pain in extremity) and unable to raise his arm over his head (injected limb mobility decreased), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Dec-2019, the patient received a 0.5 ml fourth dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Prefilled syringe) lot UT6713NA and expiry date 30-Jun-2020 via intramuscular route in the left deltoid.  On 18-Dec-2019, the patient experienced a non-serious joint pain (arthralgia), left arm pain (pain in extremity) and unable to raise his arm over his head (injected limb mobility decreased) 14 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included No lab data..) Final diagnosis was injected limb mobility decreased, pain in extremity and arthralgia.  It was not reported if the patient received a corrective treatment.  On an unknown date, the outcome was reported as Unknown for all the events.
p/vax pt exp febrile sz & was hosp x 2 days;head CT scan was nl;pt recovered;
Administered Pfizer Bivalent 12 and up for a 10 year old patient. Pharmacist consulted father that patient does not need extra booster dose.
This spontaneous report as received from a physician via a company representative refers to a female teenager patient of unknown age. On an unknown date in July 2014, "this week", the patient was vaccinated with a first dose of GARDASIL (lot # and expiration date were unknown) (0.5 ml, intramuscular. On an unknown date in July 2014, the patient experienced severe headache within 24 hours of receiving the administration of GARDASIL. Her mother called the office to seek medical attention. The outcome of the event was unknown. Additional information is not expected.
Unexplained dizziness, feeling very disoriented, almost vertigo like symptoms but it has affected my entire body not just my head. I?ll be functioning normally and then a wave of dizziness runs through me. This has persisted for nearly 4 weeks with only minor improvement. It feels like I?m ?off?, not debilitating enough to cancel work/plans, but persistent enough to know something isn?t normal. Had no symptoms prior to receiving the shot.
Patient came in for vaccine only. A PCV-13 should have been ordered and administered at the nurse visit. In error influenza vaccine FLULAVAL 0.5ml was ordered and administered to the 2month old.
With the first vaccine I had a few aches in my arm. With the second vaccine I felt very fatigue and ran a fever. I had to take Motrin and Tylenol to feel better. And I also experience sweating. When I got the second dose on January 27, 2021 I went to the hospital on March 26 , 2021 I was diagnosed with Tachycardia.
Severe bone and muscle pain. Numbness and tingling in right arm and right leg. Extreme fatigue/all started within 24 hrs of vaccine administration with pain and fatigue worsening 4 months post vaccine. Numbness and tingling in right arm and right leg started April 8, 2021. Saw Dr Saturday 4/10/21 with complaints of these symptoms. Instructed to take motrin. The following week news reporting issues with Jannsen vaccine including blood clots. My doctor felt it was best to order brain scan, and arterial and venal dopplers to check for blood clots. Test results negative. Pain intensifying as of today. Difficulty walking
Had to take them to the hospital; Feeling really bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Had to take them to the hospital) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Had to take them to the hospital) (seriousness criterion hospitalization) and FEELING ABNORMAL (Feeling really bad). At the time of the report, HOSPITALISATION (Had to take them to the hospital) and FEELING ABNORMAL (Feeling really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller contacted to cancel an appointment for the second dose for a friend (patient), because the patient was feeling really bad and they had to take them to the hospital. Caller did not want to stay on the line because they had to go.  Company Comment - Very limited information regarding this event/s has been provided at this time. Critical details is lacking in this case report to include, the specific event or signs and symptoms, mRNA-1273 vaccination, onset dates of the event, patient's underlying medical history and concomitant medication. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Critical details is lacking in this case report to include, the specific event or signs and symptoms, mRNA-1273 vaccination, onset dates of the event, patient's underlying medical history and concomitant medication. Further information has been requested.