chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at the injection site; Pain on right side of face; Ear ache; blistery rash along my jaw line; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, between 1 and 3 weeks after receiving Shingles vaccine, the patient experienced facial pain, ear pain and blistery rash. On 23rd May 2022, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the facial pain, ear pain and blistery rash were unknown.   It was unknown if the reporter considered the injection site pain, facial pain, ear pain and blistery rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-MAR-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient received his/her Shingles vaccine and had soreness at injection site. This week the patient started with pain on the right side of the face, ear ache and a blistery rash along jaw line. Eleven days after receiving shingles vaccine the patient experienced injection site pain. Additional supportive information: The follow up would not possible as no contact details were available.
Feb 26, 2021 (night after shot) woke up with ITCHING on left arm and stomach -- also, SORE THROAT.  Sensitive arm for 36 hours.  8 days post vaccine, March 5,2021, woke up with sore arm.  By noon, ITCHING AND RASH on left arm began.  Itching continued off and on through day.  Morning of March 6, rash is still visible, although mild.  Some itching on back in the morning.
About 2 hours after the Influenza Vaccine was administered, the first symptoms started including wheezing, hoarseness and tightness in the throat and burning eyes. Then it developed into full-blown flu symptoms, including extreme malaise, chills, fever (101+), sweats, headache and nausea.  I couldn't eat for two days due to the nausea and I couldn't sleep due to the extreme feeling of malaise and headache. This was beyond 'mild' flu-like symptoms. It was full blown - just as bad as any flu I've had, but it lasted for a shorter period of time. I will never ever have another flu shot again. It was the most miserable  days I've had since my cancer.
Pt recvd 2nd dose of vax on 29JUL92 & approx 1 hr following vax pt turned very white & felt faint; pt slept for 2 hrs then awoke feeling fine;
Soreness, erythema, swelling of arm, worsened over 2 days to 12 x 25 cm.  No fever.
Patient had 4 vaccines and TB skin test placed on 01/31/14. Site of (L) deltoid (Hep B) has some redness and swelling. Site of (R) arm (Varicella vaccine) has some redness and swelling and hot to touch. Does not feel sick, started a day after the vaccines were placed.
Pain & swelling at site, raised red rash covering legs, arms, trunk, back, buttocks, and around mouth. Sleeplessness, fussiness, & hyperactivity.
Patient has fatigue and shortness of breath starting a few days after J&J vaccines. Also chest tightness and occasional dry cough. Low grade fever of 99.6 today.  Symptoms have not improved despite 10 days have passed since administration of vaccine.
she is experiencing hair loss or hair shedding after receiving this vaccine; thinning of my hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose number 2, single (Lot number: EL9261) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, Lot number: EL8982), administration date: 05Jan2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "Hair shedding"; Bnt162b2 (DOSE 2, Lot number: EL9261), administration date: Feb2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "Hair shedding". The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "she is experiencing hair loss or hair shedding after receiving this vaccine; thinning of my hair". Relevant laboratory tests and procedures are available in the appropriate section.
Patient received Janssen vaccine after denying having a previous COVID-19 vaccine. She then showed her other card which indicated she had Moderna 031L2DA on 1/31/21 but she had allergic reaction of hives. She came on 3/7/21 to Facility and was turned away for already having reaction to previous vaccine. She states she was cleared by allergist and returned on3/9/21 for the Janssen vaccine and showed up with her 3/7/21 ticket. Unfortunately it was not caught in time and she was vaccinated with COVID. She is being observed for over an hour.
I contracted a virus in January 2023 and was feeling unwell for about 5 weeks. It started with cold symptoms and progressed to having a severe sore throat. I ended up having a sore throat for about 3 weeks and developed crusty sores in my nose. I ended up going to urgent care 2x and, finally, my primary care physician, which helped with my sore throat as she was able to provide me with antibiotics. I was able to see an ENT PA to help with the sores in my nose and she provided me with a cream antibiotic to use in my nose and nasal spray and which helped heal my sores.
Vaccinator may have given too low, below muscle tissue. Closer to insertion of deltoid rather than bulk of muscle. Redness showing, more anterior side.
Pt. went to school after receiving vaccine at office, two hours later began to have hives on various parts of body.
25 minutes after injection started feeling ?Weird? She was Flushed, Hot, No Respiratory effects, BP 173/96, P 105, 98.2 ? She was sent out to hospital.
Adverse reaction; arm is swollen/from the top of my shoulder down to my elbow; My arm is swollen from the top of my shoulder down to my elbow. It's painful; itches; got worse by Friday; tight; really red; hot; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction), PERIPHERAL SWELLING (arm is swollen/from the top of my shoulder down to my elbow), PAIN IN EXTREMITY (My arm is swollen from the top of my shoulder down to my elbow. It's painful), PRURITUS (itches) and FEELING HOT (hot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by reporter.  Concomitant products included ANASTROZOLE (ANASTRAZOLE DENK), SULFASALAZINE, CELECOXIB (CELEBREX), OMEPRAZOLE, METFORMIN, ZIPRASIDONE HYDROCHLORIDE (GEODON [ZIPRASIDONE HYDROCHLORIDE]), BACLOFEN, BENZTROPINE [BENZATROPINE], PREGABALIN (LYRICA), ROSUVASTATIN CALCIUM (CRESTOR), LOSARTAN POTASSIUM (COZAAR), CLONAZEPAM, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), ETANERCEPT (ENBREL), LORATADINE (CLARITIN [LORATADINE]) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced FEELING HOT (hot), VACCINATION SITE INDURATION (tight) and VACCINATION SITE ERYTHEMA (really red). On 12-Nov-2021, the patient experienced CONDITION AGGRAVATED (got worse by Friday). On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction), PERIPHERAL SWELLING (arm is swollen/from the top of my shoulder down to my elbow), PAIN IN EXTREMITY (My arm is swollen from the top of my shoulder down to my elbow. It's painful) and PRURITUS (itches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (Adverse reaction), PERIPHERAL SWELLING (arm is swollen/from the top of my shoulder down to my elbow), PAIN IN EXTREMITY (My arm is swollen from the top of my shoulder down to my elbow. It's painful), PRURITUS (itches), FEELING HOT (hot), CONDITION AGGRAVATED (got worse by Friday), VACCINATION SITE INDURATION (tight) and VACCINATION SITE ERYTHEMA (really red) outcome was unknown.            Narrative states that patient received 2 doses of Pfizer vaccine & also patient  was told to do cold compresses for the itching.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Significant follow-up : Events Added & Email added
Site: Redness at Injection Site-Mild, Systemic: sctrached, bleeding-Mild, Additional Details: A 3-year old came in along with his parents to get flu shot. He was sitting at his dad's lap. He started crying before the fact, and his dad had his both arms an the child was sitting still. As soon as the shot was given, needle still in the arm, pt. moved away to the side caused the needle to  scratch his arm and started bleeding. Both mom and dad Acknowledge the fact the son movement. His arm stopped bleeding before they leave the pharmacy. No upset by the parents.
The customer reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a medical assistant concerning to an unknown age and gender patient. The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 10-MAY-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) administered for prophylaxis, (strength, dose, frequency, route of administration and anatomical injection site were not provided; lot number U028184 with an expiration date on 08-MAR-2023, was verified to be valid lot numbers) (product storage error).  Administered dose of the suspect vaccine experienced a temperature excursion of -12.7 degrees Celsius (C) for 3 hours. The previous temperature excursion was -12.3 degrees C for 4 hours.  This is one of several reports received from the same reporter.
Received Pfizer vaccines on 1/29/21, 2/19/21; tested positive for COVID-19 by PCR on 7/13/21. Symptoms of cough, loss of taste, unknown onset date.  Will receive monoclonal antibodies.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Severe, Error: Incorrect Reconstitution
pt recvd 3rd dose of vax on 5NOV91 & following vax devel pain @ the inject site; about an 1 later pt recovered; no further details were provided;
SOB that is still lingering, Sharp pain in lungs and heart, dull chest pain that is still persistent. Lung infection.
Arm sore; Arm sore and "heavy" after bivalent booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm sore"; LIMB DISCOMFORT (non-serious), outcome "recovered", described as "Arm sore and "heavy" after bivalent booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 17-year-old female subject who was vaccinated with HAVRIX 720 (GlaxoSmithKline), meningococcal acwy vaccine (non-gsk) and HPV vaccine (non-gsk). On 3 August 2009 at 09:00 the subject received 1st dose of HAVRIX 720 (unknown, left arm), 1st dose of Meningococcal ACQY vaccine  (Non-GSK) (unknown) and 1sr dose of HPV vaccine (Non-GSK) (unknown) and experienced vaccine exposure during pregnancy. The subject found out she was pregnant on 08 September 2009, she is in her second trimester. [Pregnancy Notes] On 04 January 2017, this case was considered as lost to follow-up.
Six months after injection #2, I had middle of the day severe heart palpitations with chest pain that continued for 30 minutes.  There was no stressful incident that had occurred prior to the onset of chest pain/palpitations.  Had to be taken to an empty office at work and laid down to try to calm/get them to stop.   Previous to that moment patient had never experienced chest pain.  Patient had also stopped receiving a menstrual bleed from the time of injection #1 to that point.   Booked an urgent care appointment but then cancelled due to anxiety/exhaustion following cessation of heart palpitations, tho chest pain lingered into next day.  Doctors office called and said I needed to be seen by PCP next day.  Next day appointment (1/25/10), heart-related tests and pelvic ultrasound ordered.  Based on ultrasound results PCP did not think patient had PCOS, based on healthy weight within BMI, but referred to a GYN who did diagnose patient with PCOS and after physical examination reported patient would have issues conceiving naturally.  Patient was healthy up until this point and there is no family history on either side of family for PCOS nor infertility.
Antibody test positive; numbness on her face; Shortness of breath, ¨it was pretty bad, and lasted 2 weeks and a half¨; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath, ¨it was pretty bad, and lasted 2 weeks and a half¨), HYPOAESTHESIA (numbness on her face) and ANTIBODY TEST POSITIVE (Antibody test positive) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath, ¨it was pretty bad, and lasted 2 weeks and a half¨). On 20-Feb-2021, the patient experienced HYPOAESTHESIA (numbness on her face). On 24-Mar-2021, the patient experienced ANTIBODY TEST POSITIVE (Antibody test positive). On 21-Feb-2021, HYPOAESTHESIA (numbness on her face) had resolved. At the time of the report, DYSPNOEA (Shortness of breath, ¨it was pretty bad, and lasted 2 weeks and a half¨) and ANTIBODY TEST POSITIVE (Antibody test positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Shingrix (1st dose received on 2019). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient received first dose on 2019). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 07-JUL-2023. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did consent to follow up.
"felt a little spritz" on the bottom of his arm near his wrist at some point during administration/the back of his arm above his elbow felt wet afterward; his arm does feel sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as ""felt a little spritz" on the bottom of his arm near his wrist at some point during administration/the back of his arm above his elbow felt wet afterward"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "his arm does feel sore".  Additional information: The patient was getting 2nd of dose of covid vaccine yesterday and felt a little spritz on his wrist and neck. He said something to person giving vaccine and they said they didn't notice anything. Also he wiped back of his arm and it was also kind of wet. The patient asked if it was possible to push the plunger and cause spray before the needle was inserted.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Noticeable heart beat in stomach; Deep pain in hamstring area; Sciatic pain; Chest rash; Pain/tender back of head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Aug2021 at 12:00 as dose 1, single (Lot number: EW0173) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 01Sep2021 at 11:00, outcome "not recovered", described as "Chest rash"; MYALGIA (non-serious) with onset 01Sep2021 at 11:00, outcome "not recovered", described as "Deep pain in hamstring area"; HEART RATE INCREASED (non-serious) with onset 01Sep2021 at 11:00, outcome "not recovered", described as "Noticeable heart beat in stomach"; HEADACHE (non-serious) with onset 01Sep2021 at 11:00, outcome "not recovered", described as "Pain/tender back of head"; SCIATICA (non-serious) with onset 01Sep2021 at 11:00, outcome "not recovered", described as "Sciatic pain". The events "noticeable heart beat in stomach", "deep pain in hamstring area", "sciatic pain", "chest rash" and "pain/tender back of head" required physician office visit. Therapeutic measures were not taken as a result of heart rate increased, myalgia, sciatica, rash, headache.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200857479 same patient/ drug, different dose/event;
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a physician's assistant. This case involves a 74 years old male patient who received a 0.5 ml of ADACEL, lot C5577AA via intramuscular route in unknown administration site, on 10-Mar-2019 as prescribed by the physician's assistant. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate age at vaccine administration and product prescribing error. It was reported that the caller had written orders for a patient who was 74 years old to receive a ADACEL vaccination. Received an IM, of 0.5ml ADACEL, in the right arm on 3/10/2019 by, from a multi-dose vial. It was unknown whether the patient had any adverse reactions. 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. List of documents held by sender: none.
This spontaneous report was received from Vaccines for Children Program (VFC) program coordinator refers to 9 patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (dose, route, anatomical location and lot # were not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Vaccines were given on December 10, 2015. Left thigh got swollen and red. Hep A given in right leg was 4 x 2 cm. DTaP in left leg was 16 x 12 cm. Treatment 9 mg = 2.25 ml.
Patient had a primary series with Moderna, yet was given a booster of Pfizer.  No adverse event, just a vaccine choice error.
Patient got his shot at 4:30pm. While in the observation period, he raised his hand and said he felt faint.  He reported not eating much for lunch. He has a history of anxiety with vaccines. He was not diabetic and does not have HTN. BP was 134/94 pulse was 73.  I got him orange juice and a donut. He came around quickly.
The patient was seen and examined as above.  Differential diagnosis includes Covid pneumonia, dehydration, electrolyte abnormality, renal failure, arrhythmia.  I suspect the patient had syncope due to orthostasis.  I considered doing a head CT but he fell last yesterday, and has no worsening headache, a nonfocal neuro exam, and is not on blood thinners.  He was hypoxic when he got to the room and was placed on oxygen.  His sats were 88 to 89% on room air.  His chest x-ray shows bibasilar atelectasis.  He was given some fluids.  He has an acute kidney injury which is likely due to GI losses.  His troponin is negative.  His EKG shows no concerning signs for arrhythmia.  At this time given that he needs oxygen he needs admission.  I spoke with with the hospitalist who accepted the admission.
Nausea: I was seen at for Nausea. and abdominal pain.
Pt stated that she had a rash that lasted several days. She also had numbing, tingling and shooting pains. Pt states she now has nerve damage. She has seen her family physician who has prescribed her an anti-inflammatory. She is now seeing a Neurologist because she cannot move her arm at times and the sensation is traveling toward her chest.