chrisvoncsefalvay/vaers-outcomes huggingface dataset:
leg weakness; Fever; Stiffness; Soreness; arm was hot to the touch; arm swelled up; hypertonia; This case was reported by a other health professional via call center representative and described the occurrence of lower extremities weakness of in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA70BA, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th September 2020, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than a year after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced lower extremities weakness of, fever, stiffness, pain, skin warm, large arm swelling and hypertonia. The patient was treated with non-drug therapy (Physical Therapy). On an unknown date, the outcome of the lower extremities weakness of, fever, stiffness, pain, skin warm, large arm swelling and hypertonia were recovered/resolved.   It was unknown if the reporter considered the lower extremities weakness of, fever, stiffness, pain, skin warm, large arm swelling and hypertonia to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by an office manager reported for her daughter. The patient received bexsero vaccine and had bad reaction. The patient's  arm swelled up and was hot to the touch, she had soreness, stiffness, fever, and leg weakness. The reporter stated that, the patient was diagnosed with hypertonia and received physical therapy. The events resolved after about 2.5 months. The reporter consented to follow up. The reporter works at the doctor's office and her daughter was the patient experiencing the adverse events. The reporter did not have the expiration date of the Bexsero. The reporter has consented to follow-up via email.
Readness-Left arm; itchy - left arm; swollen - left arm; hard - left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Readness-Left arm), VACCINATION SITE PRURITUS (itchy - left arm), VACCINATION SITE SWELLING (swollen - left arm) and VACCINATION SITE DISCOMFORT (hard - left arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Readness-Left arm), VACCINATION SITE PRURITUS (itchy - left arm), VACCINATION SITE SWELLING (swollen - left arm) and VACCINATION SITE DISCOMFORT (hard - left arm). On 02-Apr-2021, VACCINATION SITE PRURITUS (itchy - left arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Readness-Left arm) had not resolved and VACCINATION SITE SWELLING (swollen - left arm) and VACCINATION SITE DISCOMFORT (hard - left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included two tylenol.
approx 1 1/2min p/v pt appear to loose consciousness about 10 seconds;VS remained stable;los of consciousness;BP 120/70, 96% 02 sat;c/o paresthesia lt arm immed regained feeling in arm;c/o numbness;weakness;
red bumpy dots, ovals w/yellow centers that itchy back, chest, arms, legs & buttocks since 9/23/99;pt still has rash;
Swollen glands in her throat; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands in her throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen glands in her throat). At the time of the report, LYMPHADENOPATHY (Swollen glands in her throat) outcome was unknown.            No Concomitant drugs were provided Upon Internal review on 04-Aug-2021, discrepant information was noticed in age and DOB of the patient hence, not updated in patient section.
Patient received Pfizer vaccine outside of the time frame.  Vaccine was diluted at 8:45AM, and after the six hours after dilution vial should have been thrown out, but it was not and patient received vaccine after the 6 hours.
PT did not want to sit in the observation section after getting the covid vaccine, pt wanted to walk around the pharmacy store instead of sitting down, after 15 minutes from the shot, pt fainted in one of the aisle and hit his head on the ground. we did call the ambulance to tend to the patient.
Heart palpitations; This is a spontaneous report from a contactable consumer. A 64-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Formulation: solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration in arm right on 8Feb2021 at 19:00 as single dose for covid-19 immunisation. Medical history included diabetes mellitus, palpitations, hyperlipidaemia and diverticulum. Concomitant medications included metformin, aspirin [acetylsalicylic acid] (Aspirin [Acetylsalicylic Acid]), atorvastatin, diltiazem and cinnamomum verum (Cinnamon). Patient did not receive other vaccine in four weeks.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 08Feb2021 at 20:00, heart palpitations but I get those frequently. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
This spontaneous report as received from a pharmacist refers to an approximately 54 year old male patient. On 14-NOV-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J006921, expiry date 09-AUG-2014 (also reported as August 2014)) 1.5 ml intramuscular. The patient was taking unspecified concomitant medications. On 14-NOV-2013, the patient experienced injection hurt. It was reported that the patient was not treated for the events. There was no lab diagnostics performed. The outcome of injection hurt was reported as not recovered. The relatedness of the events to the therapy with PNEUMOVAX23 was unknown. Additional information has been requested.
Have had constant nausea, diarrhea, cramping, sometimes burning sensation in stomach since getting the shot.
Legs and arms itch as well as small red bumps, small red bumps covered facial rash. 4-5 days post vax, last 2 weeks.
pt recv vax 30SEP97 & pt exp shingles & swollen glands;it was noted that the shingles were actually dx on 2OCT97;
Suspected vaccination failure; I got the shingles; Not fun very painful .; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had a shot for shingles, however the patient got the shingles. It was not fun very painful. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset for event and laboratory confirmation of shingles were not provided.
vaccine given 10/20/22 @ 0853 symptoms of projectile vomiting at 1130, fatigue began after vomiting, laid down to rest vomited again, was cold feeling off and on, only ate one cracker and held down, awoke 10/21/22 @ 0430 feeling better.  Went to work and feeling better today per patient.
MUSCLE SPASMS; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's past medical history included severe acid reflux, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 18:30 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced muscle spasms. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and had not recovered from fever, muscle spasms, and headache. This report was non-serious.
Dizziness; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER6213) via an unspecified route of administration in left arm on 17Mar2021 at 20.45 (at the age of 36-years-old) as a single dose , for COVID-19 immunisation. Medical history included celiac, asthma and penicillin allergy. Concomitant medication included XOPENEX for unknown indication and SYMBICORT for unknown indication. The patient did not receive other vaccines in four weeks.  It was unknown if the patient was diagnosed with COVID prior to vaccination and the patient was not tested for COVID  post vaccination. On 18Mar2021 the patient experienced dizziness, fatigue and headache.  The patient did not receive any treatment for the events. The clinical outcome of dizziness, fatigue and headache was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a CMA (certified medical assistant) regards an unknown number of patients (no demographic details were provided). The medical history of the patients was unknown. The reporter stated that an unknown number of patients may have received VAQTA, RECOMBIVAX HB, VARICELLA (Merck), LIQUID PEDVAXHIB and GARDASIL that was improperly stored. This report concerns GARDASIL. No details were provided regarding the administration dates, dosing regimen or lot number. No adverse event was reported. This report is linked to the cases with MARRS ID 1305USA003372, 1305USA007106, 1306USA007107 and 1306USA007108 which concern VAQTA, RECOMBIVAX HB, VARIVAX (Merck) and LIQUID PEDVAXHIB respectively. Additional information has been requested.
Ball under armpit; Ball under armpit; This is a spontaneous report from a contactable consumer or other non-HCP (patient's girlfriend). A 20-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration in Arm Left on 15Mar2021 09:30 (age at the time of vaccination 19-years-old), as a single dose for COVID-9 immunization. The patient's medical history and concomitant medication were not reported. No prior vaccinations within 4 weeks. On 16Mar2021, the patient experienced Ball under armpit. Patient did not received treatment for adverse event. Caller wanted to see if it was swollen lymph nodes. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse practitioner via sales representative refers to a 30 year (reported as patient in her 30's) old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (therapy start dates, strength, route was not reported). The reporter stated that on an unknown date the patient broke out with shingles after receipt of the vaccine. The outcome of broke out with shingles is unknown. No product quality complaint was involved. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, 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 SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the vaccine did not stop the shingles and made it much worse and more frequent. It was reported that, it was a disaster. The reporter disconnected the call while on hold and about to transferred the call to Regulatory Authority. The reporter provided the external phone number to the inquired for future reference. This case was considered as suspected vaccination failure as details regarding vaccination schedule and time to onset were unknown. This case has been linked with case US2018GSK227345, reported by the same reporter.
Alopecia areata. On 12/13/2021, I noticed a single dime-sized bald patch on the top of my scalp, which rapidly progressed to many bald patches. I started seeing a dermatologist one month later and was diagnosed with autoimmune alopecia areata in February 2022. At that point, I started receiving monthly steroid injections into my scalp, along with a daily topical steroid and a topical Tofacitinib. Treatments have been minimally effective. I currently have lost about 80% of my scalp hair and have bald patches on my eyebrows and nose hair. My eyelashes are also thinning.
Flu like symptoms, chills and body aches with A 100.2 temp.. last 12/31-1/1
now arm has redness; its hot; redness at injection site; pain at injection site; weakness; light headedness; severe headache; rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PAIN (pain at injection site), ASTHENIA (weakness), DIZZINESS (light headedness) and HEADACHE (severe headache) in a 76-year-old female patient 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PAIN (pain at injection site), ASTHENIA (weakness), DIZZINESS (light headedness), HEADACHE (severe headache) and RASH (rash). On 06-Feb-2021, the patient experienced ERYTHEMA (now arm has redness) and INJECTION SITE WARMTH (its hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PAIN (pain at injection site), ASTHENIA (weakness), DIZZINESS (light headedness), HEADACHE (severe headache), RASH (rash), ERYTHEMA (now arm has redness) and INJECTION SITE WARMTH (its hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.
Within minutes of pt receiving covid vaccine, verbalized to 'not feel well' and fainted. A friend and staff members gently assisted pt to the floor. Immediate assessment of vital signs and pt taken to private area for monitoring. Pt may have had vasovagal response due to anxiety.
Parent of client called reporting that arm site where VARICELLA vaccine was given become swollen & had hive like reaction.  Client was seen by PMD & antibiotics prescribed.  Client called 8/20/09 & seen by PMD 8/19/2009.
About four hours after I received my shot, I started to feel severe arm pain in the arm/shoulder that received the vaccine. The arm/shoulder continued to be extremely sore and immobile the following two days, with a combination of constant aching, throbbing, and stabbing pain. On Friday, I began to regain some movement in my arm and it began to hurt only when moving it rather than a constant pain during the day. I am now 10 days out from my vaccine, and it continues to give me significant pain at night that impedes my ability to sleep. I also have not regained the ability to complete weight-bearing activities such as push-ups.   While being vaccinated, I thought my injection seemed too high on my arm. The injection site was just one finger width below my shoulder bone. I sought medical care through my local urgent care 48 hours after my vaccine, and the doctor who saw me agreed that the injection placement seemed odd.   I have not yet sought additional medical care, but I fear I will need to soon if the pain continues at the current level at night and continues to hinder my ability to exercise. After doing some reading, I'm afraid the vaccine may have been placed in the bursa rather than the deltoid muscle, causing a vaccine injury that is causing my current pain despite being 10 days beyond my vaccination.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown demographic patient who vaccinated with FLUZONE HIGH DOSE (lot UJ038AB and Exp. date 03 May 2019) via unknown route in the left deltoid on 05-Oct-2018. The patient's medical history and concomitant medications were not reported. It is an actual medication error case due to vaccine underdose. It is also a case of syringe issue and exposure via skin contact. It was reported that, pharmacist screwed on the needle and it was tight and sealed but there must be a crack or something because it was leaking out when she was giving it. She had an irate patient because it leaked all over him. No information reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Pt recvd 3 doses of Engerix-B, 3rd dose given 26FEB91 & it was determined that pt exp non-response;
Difficulty breathing, shortness of breath. Felt like I was drowning at night when I was sleep.
Two weeks after receiving the vaccine I started feeling like I was coming down with COVID-19 or cold. My husband and I went on vacation as I started to feel a bit better. When we got back from vacation I went to the doctor because I was not feeling well and had developed diarrhea. She ran bloodwork and found that my liver enzymes were up. In November I had an abdominal ultrasound that found liver fine but found that there was a shadow on the gallbladder. This could be an enlarged gallstone, multiple gallstones or a blocked duct. I will be going back in on March 20, 2023 to discuss the results of the ultrasound and the HIDA scan.
Fever, chills within 24 hours of receiving vaccine. Hormonal changes impacting period- acne and severe cramps within 48 hours of receiving vaccine.
Headache; sinuses and ears hurting down to cheeks, teeth and gums; sinuses and ears hurting down to cheeks, teeth and gums; sinuses and ears hurting down to cheeks, teeth and gums; sinuses and ears hurting down to cheeks, teeth and gums; sinuses and ears hurting down to cheeks, teeth and gums; glands swollen beneath mouth; Nausea; Upset Stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 11:15 (Lot number: EN6207) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: couldn't lift her head off the pillow. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EN6201), administration date: 01Mar2021, when the patient was 68 years old, for Covid-19 immunisation; Whooping cough vaccine (a booster shot about 5 years ago), administration date: 2016, for immunisation, reaction(s): "headache". The following information was reported: HEADACHE (non-serious) with onset 23Mar2021 06:00, outcome "recovered" (24Mar2021), described as "Headache"; SINUS PAIN (non-serious), EAR PAIN (non-serious), FACIAL PAIN (non-serious), TOOTHACHE (non-serious), GINGIVAL PAIN (non-serious) all with onset 23Mar2021 06:00, outcome "recovered" (24Mar2021) and all described as "sinuses and ears hurting down to cheeks, teeth and gums"; LYMPHADENOPATHY (non-serious) with onset 23Mar2021 06:00, outcome "recovered" (24Mar2021), described as "glands swollen beneath mouth"; NAUSEA (non-serious) with onset 23Mar2021 06:00, outcome "recovered" (24Mar2021), described as "Nausea"; ABDOMINAL DISCOMFORT (non-serious) with onset 23Mar2021 06:00, outcome "recovered" (24Mar2021), described as "Upset Stomach". Therapeutic measures were taken as a result of headache, sinus pain, ear pain, facial pain, toothache, gingival pain, lymphadenopathy, nausea, abdominal discomfort.  Additional Information:  The facility where the most recent COVID-19 vaccine was administered was reported to be "other". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that after the second dose, she felt fine the rest of the day. She stated that her headache completely got worse and it said on the sheet not to take paracetamol (TYLENOL) because they weren't sure how it would react and so it got worse. She stated that it got so bad that she went to an urgent care, not to emergency room nor to physician office. She stated they gave her a shot of "Motrin type thing" for the pain and told her to take ibuprofen (MOTRIN) every 4 hours after that. She stated that her headache got better within a half hour of the "Motrin shot" and she took Motrin for the rest of the evening. She stated that her headache lasted for the rest of the night but was gone on the day of report.  No follow-up attempts are possible. No further information is expected.
pain, redness, swelling of right arm from shoulder to elbow to axilla; fever greater than 101  x 4 days, severe nausea, chills/rigors, body aches, headache x 4 days.  All unrelieved with tylenol and ibuprofen and nausea unrelieved with zofran.