chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received less than the recommended dose of the Moderna Covid 19 bivalent vaccine; due to faulty Syringe the administered a patient with less that the appropiate dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received less than the recommended dose of the Moderna Covid 19 bivalent vaccine), SYRINGE ISSUE (due to faulty Syringe the administered a patient with less that the appropiate dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received less than the recommended dose of the Moderna Covid 19 bivalent vaccine), SYRINGE ISSUE (due to faulty Syringe the administered a patient with less that the appropiate dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received less than the recommended dose of the Moderna Covid 19 bivalent vaccine), SYRINGE ISSUE (due to faulty Syringe the administered a patient with less that the appropiate dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (Received less than the recommended dose of the Moderna Covid 19 bivalent vaccine) and SYRINGE ISSUE (due to faulty Syringe the administered a patient with less that the appropiate dose).    No concomitant medication details was reported. Due to faulty Syringe the patient was administered with less that the appropiate dose. No treatment medication details was reported.
12-18 hrs after shot, pt developed large, warm red area on entire upper arm. This reaction lasted about 24 hrs. Was swollen at some parts of injection site. Arm returned to normal after 24 hrs.
Patient received influenza vaccine in the Left Deltoid muscle. Patient tolerated the vaccine well. Vaccine administrator walked out of exam room to make a copy of a form. She returned 3-4 minutes later, where mom proceeded to show the vaccinator the area. The injection site area was red. The redness was the size of a tennis ball. Vaccinator retrieved Provider from a different exam room. Provider assessed the area and advised the family to give the patient Benadryl. No other reactions noted at time of assessment. Family left a few minutes after the Provider assessed the patient and the injection site area.
Started within a day of injection. I experienced the following symptoms for the next few days: headache, diarrhea, injection site soreness, fatigue, body aches, chills, feeling unwell, stomach pain.
LETHARGY, FEVER OF 103, NAUSEA, WEAKNESS, TWITCHING OF ARM WHERE INJECTION WAS DONE, RED WELT AT INJECTION SITE.
Pt has a DX of ITP, had a platelet drop from 94 to 30 in 28 days post 1st vaccine injection; Pt has a DX of ITP, had a platelet drop from 94 to 30 in 28 days post 1st vaccine injection; This is a spontaneous report from a contactable nurse. A 37-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 09Aug2021 (37-year-old at time of vaccination) as single dose for COVID-19 immunization. Medical history included ITP and Hashimoto thyroiditis. No known allergies. Concomitant medications (Other medications in two weeks) included ergocalciferol (VITAMIN D); ascorbic acid (VITAMIN C); cyanocobalamin (VITAMIN B12). No other vaccine in four weeks. Patient has a DX (diagnosis) of ITP, had a platelet drop from 94 to 30 in 28 days (as reported) post 1st vaccine injection. Adverse event start date was reported as 10Sep2021. Adverse event resulted in Doctor or other healthcare professional office/ clinic visit. Therapeutic measures were taken as a result of the event and included Steroids. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reported information, the causal association between the events immune thrombocytopenia and condition aggravated and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Within 15 minutes of patient receiving vaccination, patient had a fainting spell and experienced brief loss of consciousness. Patient was able to communicate and say he felt tired, dizzy, nauseated and hot/clammy. Within 20 minutes of event, patients symptoms improved and she was able to sit up in a chair on her own. Pharmacist on duty assessed BP during this time (BP reading 1: 87/66, BP reading 2: 92/67, BP reading 3: 91/69) .
pt was vaxed then devel itching on both hands, bumps under skin; tx w/DPH; pt recovered; pt also recvd hypertet in lt deltoid;
intense pain; intense sensitivity; migraines; head feels like shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (intense pain), HYPERSENSITIVITY (intense sensitivity), MIGRAINE (migraines) and DIZZINESS (head feels like shaking) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (intense sensitivity), MIGRAINE (migraines) and DIZZINESS (head feels like shaking). On an unknown date, the patient experienced PAIN IN EXTREMITY (intense pain). At the time of the report, PAIN IN EXTREMITY (intense pain), HYPERSENSITIVITY (intense sensitivity), MIGRAINE (migraines) and DIZZINESS (head feels like shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal normal. On an unknown date, Magnetic resonance imaging: normal normal.
From an initial report received on 1/4/01, it was reported that a 20 year old male was given Menomune A/C/Y/W-115 vaccine on 5/4/00. Pt reportedly experienced "loss of consciousness at 19:20 X 6 seconds; mild tonic/clonic activity in arms and legs". BP 130/70; AP 44. From additional correspondence received on 3/6/01, it was reported "I have reviewed the completed VAERS form for completeness and accuracy. If you have any questions or require any additional information please call."
swelling; redness; hotness; itchiness; hardness at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 at 10:00 as dose 4 (booster), single (Lot number: GH9697) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Autoimmune gastritis" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX QUAD taken for immunisation, on 12Oct2022; LEVOTHYROXINE; ROSUVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE INDURATION (non-serious) with onset 31Oct2022 at 18:00, outcome "not recovered", described as "hardness at injection site"; FEELING HOT (non-serious) with onset 31Oct2022 at 18:00, outcome "not recovered", described as "hotness"; PRURITUS (non-serious) with onset 31Oct2022 at 18:00, outcome "not recovered", described as "itchiness"; ERYTHEMA (non-serious) with onset 31Oct2022 at 18:00, outcome "not recovered", described as "redness"; SWELLING (non-serious) with onset 31Oct2022 at 18:00, outcome "not recovered". Therapeutic measures were not taken as a result of swelling, erythema, feeling hot, pruritus, vaccination site induration.
Localized irritation. Erythema radiating out 2-3 inches from injection site. Raised white area radiating out 1/4 inch from injection site. Still evident 5 days after injection. Pain in arm greater than 4 days, most intense the first 2 days. Unable to raise arm above chest level for 2 days. Treated with ibuprofen and acetaminophen.
Parent called office reporting a fever 102.8 rectal after vaccines on 2/20/14.
AT 3:00 AM PATIENT HAD NAUSEA AND VOMITING, SHAKING, AND BURNING. AT 4:30 PATIENT BEGAN BITING HIS LIPS VERY HARD.  FAMILY MEMBER CALLED 911 AND PATIENT WAS TRANSPORTED TO THE HOSPITAL.
I did not seek medical attention for this, however my shoulder hurt for days afterwards. I took aspirin, Tylenol, etc., put ice packs on it, and put "icy hot" cream on it too. In fact it still hurt a bit about 5 days later.
the patiient was vaccinated with suspect vaccine on 10-APR-2001, 13-JUN-2001; This spontaneous report has been received from a lawyer, via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2111USA004909), concerning to a 55 years old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 10-APR-2001, 13-JUN-2001 and 17-OCT-2001, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown), respectively, all for prophylaxis (inappropriate schedule of product administration). The dose, strength, route, lot number and expiration date were unknown. The patient did not recall adverse reaction.  This is one of three cases concerning the same patient.
Pt called 2/7/11 to state she has had blurred vision in (R) eye since shot administered on 12/16/10. Advised today to see optometrist for vision check.
PREVNAR was administered first IM to the left thigh. Pt crying, being held by Mom. HAVRIX administered IM to the right thigh. Pt continues crying, holding breath. Mom attempting to comfort. Pt. then became flaccid, pale and without respirations. Dr called to room. Pt. placed to exam table, stimulated. Spontaneous respiration resumed after approx 30-40 seconds of apnea. Pt gasping and wheezing. Skin color became red and blotchy from face down. Epinephrine 0.15 mg SC administered. Redness resolved. Respirations easier. Albuterol 0.021 administered via nebulizer. O2 sats >95 %. Observed x 20 min. Stable vital signs, no further wheezing, alert. Discharged to home with Mother. After discharge from our office it was reported to us by pt's grandmother that pt was lethargic and had coarse lung sounds. Advised by dr to take pt to Emergency room. He was prescribed BENADRYL and ORAPRED and discharged to home.
This patient complains of aches, pains, headache, temperature of 101.5, nausea, vomiting, and diarrhea; onset within 24 hours. Seen by PMD, no treatment needed.
pt recvd vax 9MAR93 & devel h/a, pimples on body & flu-like sx;
This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. On an unspecified date "within the last week", in November 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). It was reported that the patient developed swelling at the injection site on an unspecified date in November 2013. The patient was treated with ice on injection site and BENADRYL. At the time of reporting, the patient was not recovered. The patient sought medical attention by calling the physician's office. Additional information has been requested.
Case number PHEH2014US004301 is an initial spontaneous report from a pharmacist received on 27 FEB 2014. This report refers to a patient of unknown demographics. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient less than 18 years old received FLUCELVAX 2013/2014 (batch number: unknown) intramuscularly on an unknown date. No adverse event was reported following the medication error (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014 of the data received on 27 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Brazo Rt area rojo culisu se a la palpacia edema. [erythema and edema right arm] 3/9/05Received medical records from Er which reveal patient experienced hot, swollen right arm & dx w/right arm cellulitis.  Did not improve after 24 hrs IV antibiotics & was transferred to another facility. 4/4/06 Received inpatient medical records which reveal Admitted 6/17/05 w/dx: right arm cellulits & r/o allergic reaction.  Received antibiotics, steroids & benadryl.  Blood c/s neg.  D/C 6/21/05to continue oral antibiotics/ss
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was immunocompetent. No medical history was reported. The nurse reported that the patient received the first, the second and the third dose of PNEMOVAX 23 (lot #, expiration dates and doses were not provided) on the following dates: on 06-NOV-1992, on 01-NOV-2001 and on 27-OCT-2008 respectively. On 08-OCT-2014 the patient also received one dose of PREVNAR 13 (lot #, expiration date and dose were not reported.) On an unknown date the patient experienced arthritis. The patient was being treated by an unspecified rheumatologist for arthritis within an unspecified dose of an unspecified steroid. The outcome of arthritis was unknown. The patient was in the office on 30-OCT-2015 ("today"), for another dose of PNEUMOVAX 23 (Lot#; dose was not reported). The nurse reported that the patient was instructed by the rheumatologist to receive a dose of PNEUMOVAX 23 every year with their flu shot. The relatedness between the arthritis and PNEUMOVAX 23 was not reported. Additional information has been requested.
Developed a rash.  Started chest and face and then spread throughout body.  Itching present.  No fever, cough, rhinorrhea, dyspnea.
Headaches, dizziness, GI upset, stiff/sore neck, fever, fatigue, body aches.
Call received from mom 8/13/09, states pt has swelling/hardness the size of a "drink coaster @ the site of the injection on right arm with rash @ site. Call received 8/14/09 states site is now red & warm, has not increased in size, remains hard.  No systemic reaction.
Fever blisters appeared outside my upper lip; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Fever blisters appeared outside my upper lip) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ORAL HERPES (Fever blisters appeared outside my upper lip). The patient was treated with CAMPHOR, EUCALYPTUS GLOBULUS OIL, MENTHOL, PHENOL, SYZYGIUM AROMATICUM OIL (NOXZEMA [CAMPHOR;EUCALYPTUS GLOBULUS OIL;MENTHOL;PHENOL;SYZYGIUM AROMATICUM OIL]) at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Fever blisters appeared outside my upper lip) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
mom states today that pt devel red splotchy rash on 4AUG96, 6 days p/vax this is especially prevalent on rt thigh where DTP vax was administered;
The pt experienced local erythema, temp of 98 degrees, inconsolable  for 2 hours. Treated with children's Motrin.
I was given flu shot on 10.04/14 and have had severe pain and a fist-sized hematoma where the injection was given. On 10/17/14 I went to Hospital seeking assistance. I have been taking Ibuprofen as prescribed but pain persists.
I feel pain in my clavicle area (right side).; I can feel a lump that feels tender and sore.; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP8955) via an unspecified route of administration on 28Mar2021 at 11:15 (at the age of 54-years-old) as a single dose in the right arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine.  Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EN6805) on 07Mar2021 at 11:00 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 29Mar2021 at 20:30 the patient experienced pain in the clavicle area on the right side. She felt a lump that felt tender and sore. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcome of pain in clavicle area on the right side and lump that felt tender and sore was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.    No follow-up attempts are needed. No further information is expected.
Big round circle around the injection site. It was puffed up; Big round circle around the injection site. It was puffed up and red; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z5N5G, expiry date 30th June 2021) for prophylaxis.   On 17th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season. In September 2020, less than a week after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site swelling and injection site erythema. In September 2020, the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. The patient received Fluarix Quadrivalent 2020-2021 season in right arm and experienced big round circle around the injection site and it was puffed up and red. The reaction lasted for 4 day. This case has been linked with US2020189733 and US2020189735 reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189733:same reporter US-GLAXOSMITHKLINE-US2020189735:same reporter
Lymphadenopathy, especially submandibular and occipital lymph nodes. Did not have fourth DTaP injection
Delayed menstruation. At time of this over 10 days yet have PMS symptoms. Cramps. Sore breasts. Reason do not believe pregnancy: spouse has vasectomy which has been cleared for five years
1 hr after immunization complained of nausea. Complained of itching on legs only, dry areas noted, hx of eczema, face flushed red. Denies SOB, chest pain, rash, hives, wheezing. BENADRYL given for itching, monitored for 30 minutes, sent home with mother with ER precautions.
Diagnosed with prostate cancer; This case was reported by a pharmacist via call center representative and described the occurrence of prostate cancer in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number TJ35Z, expiry date 1st December 2021) for prophylaxis.   On 28th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced prostate cancer (serious criteria GSK medically significant). The patient was treated with leuprorelin acetate (Eligard). On an unknown date, the outcome of the prostate cancer was unknown.   It was unknown if the reporter considered the prostate cancer to be related to Shingrix.  Additional details were provided as follows: The patient was diagnosed with prostate cancer.  Now the patient was taking Eligard, so the health care provider called asking if the patient could receive the second dose of Shingrix.  Also ask for information in the case that the patient did not want to receive a second dose or receive a late second dose. The reporter consented to follow up.