chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from pharmacist on 06-Oct-2017. This case involves 69 year old female patient who was vaccinated with a 0.5 ml one dosage of FLUZONE HIGH-DOSE (Batch number- UI812AB, expiry date, dose in series, site not reported) intramuscularly on an unknown date. Patient had a medical history COPD and had no known drug allergy. Concomitant medications were not reported. On an unknown date, four hours following vaccination patient had pain in the right and left hand and having difficulty grasping. No report of numbness or tingling. Pain started in the right hand and then began in the left hand a short time later. Laboratory investigations and corrective treatment were not reported. Outcome of the event was recovering as seen some improvement in the symptoms. follow-up information was received from pharmacist on 13-Nov-2017. The event outcome was recovered for both of the events on an unspecified date without any additional treatment.
Arterial regurgitation; Cardiac changes/EKG changes were observed in heart; Sweating profusely; Hands went cold; Felt dizzy; Chest pain; blood pressure elevated 180s over 110s/hypertensive; doesn't feel well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AORTIC VALVE INCOMPETENCE (Arterial regurgitation) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced AORTIC VALVE INCOMPETENCE (Arterial regurgitation) (seriousness criterion medically significant), CARDIAC DISORDER (Cardiac changes/EKG changes were observed in heart) and VACCINATION COMPLICATION (doesn't feel well). 16-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating profusely), PERIPHERAL COLDNESS (Hands went cold), DIZZINESS (Felt dizzy), CHEST PAIN (Chest pain) and HYPERTENSION (blood pressure elevated 180s over 110s/hypertensive). At the time of the report, AORTIC VALVE INCOMPETENCE (Arterial regurgitation) and CARDIAC DISORDER (Cardiac changes/EKG changes were observed in heart) had not resolved and HYPERHIDROSIS (Sweating profusely), PERIPHERAL COLDNESS (Hands went cold), DIZZINESS (Felt dizzy), CHEST PAIN (Chest pain), HYPERTENSION (blood pressure elevated 180s over 110s/hypertensive) and VACCINATION COMPLICATION (doesn't feel well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Blood pressure measurement: 180/110 (High) 180/110. On 16-Jan-2021, Electrocardiogram: abnormal (abnormal) EKG changes were observed in the heart.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. The patient went to the emergency room due to sweating profusely, blood pressure elevated 180s over 110s/hypertensive, hands went cold, felt dizzy, and chest pain.  She reported she will have to follow-up with a cardiologist because electrocardiogram (EKG) changed were observed in her heart.  The patient was not receiving treatment at the time of the initial report.  The patient called back on 13 Apr 2021 and noted continual, ongoing cardiac changes and "arterial regurgitation."   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient reported continual, ongoing cardiac changes and arterial regurgitation.  Outcomes of initially reported events changed from not resolved to unknown.  Narrative updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provided at this time. Further information has been requested.
~ 6 months after my second dose I have developed very mild peripheral neuropathy symptoms.  Primarily right foot numbness, occ L foot tingling, rare fingertips numbness/tingling bilaterally.    Has now lasted ~ 6 weeks, seems stable.  I have not sought medical care.  My husband, also Moderna, vaccines from a different facility, has also developed much more significant peripheral neuropathy in his feet that has been worked up as idiopathic.
Noticed painful small lumps in scalp and on back of neck, right side.  Also noticed a red lump on the front of neck, also right side.  Discomfort was not sufficient to warrant my concern until morning of 2/05/15 when I noticed lumps were very swollen, red, and painful.  Also referred pain in right ear.
Boostrix that was exposed to 70 Fahrenheit for up to 32 days.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 20-OCT-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix that was exposed to 70 Fahrenheit for up to 32 days.). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2023 The pharmacy operations manager called to report three patients were inadvertently administered Boostrix that was exposed to 70 Fahrenheit for up to 32 days.  Manager mentioned the Boostrix was left in the stock room and three patients received it during that time. The HCP unable to provide vaccine details of lot and expiration. The patient received temperature excursed product, which led incorrect storage of drug. The reporter did not consent to follow-up from safety. The case is link with US2023151105, US2023151104, by same reporter.; Sender's Comments:  US-GSK-US2023151105:Same reporter US-GSK-US2023151104:same reporter
positive antigen test/Treatment of COVID-19; positive antigen test/Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "positive antigen test/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Reported Negative antigen for day then on day 10 running nose and positive antigen test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Patient given Pfizer .3mL instead of Pfizer pediatric .2mL  given at 10:00am. During the documentation of what to enter, it was caught by the RN that the wrong Pfizer was given. Mother was called and explained what happened. Gave directions on what symptoms to watch for and told to call the office with further questions as a RN will answer after hours.
bad reaction; This spontaneous report as received from a other health professional via Pfizer regarding to a 55 year old female patient. The patient's medical history included extensive nerve damage, concurrent condition and concomitant medications were not reported. On an unknown date, (also reported as patient inn her 30's) the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route, lot#  and expiry were not reported) for prophylaxis. The reporter described that, the patient had a really bad reaction (adverse reaction) to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). The outcome of adverse reaction was unknown. The reporter considered adverse reaction to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).; Sender's Comments:  US-PFIZER INC-2018352490:
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Injection site on her left arm was sore; Itchy injection site; Swollen injection site; Red (4"X6") Injection Site; Hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site on her left arm was sore), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE ERYTHEMA (Red (4"X6") Injection Site) and VACCINATION SITE WARMTH (Hot to touch) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site on her left arm was sore), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE ERYTHEMA (Red (4"X6") Injection Site) and VACCINATION SITE WARMTH (Hot to touch). At the time of the report, VACCINATION SITE PAIN (Injection site on her left arm was sore), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE ERYTHEMA (Red (4"X6") Injection Site) and VACCINATION SITE WARMTH (Hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
I got uncontrollable chills for 2 hours, a fever of 100.6 that has lasted at least 23 hours as of the time of submission, extreme body aches, breast tenderness, and a headache that felt like my skull was being crushed in--the worst of my life.
slight symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (slight symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (slight symptoms). At the time of the report, VACCINATION COMPLICATION (slight symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
no additional information provided; an expired dose of PROQUAD was given to the patient; This spontaneous report has been received from a registered nurse referring to a 5 years old patient of an unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.  On 21-DEC-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, frequency and route of administration were not reported; lot # was unknown, but the expiration date was reported as 19-DEC-2021) for prophylaxis (expired product administered). The reporter stated no previous temperature excursion. No additional information was provided. No product quality complaint was reported.
Patient has had a rash show up on both arms.  The rash is primarily on the inside of the arm.  It has been red, very itchy, and painful.  The rash has improved as of today 6/8/21 but is still present.
This spontaneous case, initially received on 09-Oct-2018 reported by other non-health professional and concerns a female patient of unspecified age. The patient's medical history included stomach upset upon taking scrambled eggs. The patient stated that, she could eat boiled eggs and eggs in baked products. On an unspecified date in 2002, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacture: not reported). On an unspecified date in 2002 after vaccination, the patient's arm was swollen up to the size of a football. At the time of this report, the outcome of the event was not reported.
Vaccine 3:13pm, pain redness and some swelling started about 4:30pm (same day). On 2/14/2020 Redness and swelling worsened and she went to primary doctor. An EKG was done & was told she was in A-Fib (no history & not on any anticoagulations). Worsened even more on 2/15/20 & came to ER. (Swelling in entire left arm). Also has this nodularity in the right base. Found-slightly hypoxic & right lower lobe infiltrate & treated with right sided pneumonia. Treatment - methylprednisolone, Azithromycin and Ceftriaxone. Outcome: patient treated for Pneumonia and swelling. Patient improving
Pt. received the two injections. Next day had fever and vomiting. Pt. did have 2 other HPV injections and 1 TRUMENBA without reaction.
Patient had muscle aches, and low grade fever night of shot.  She developed her sore throat and a hard palate ulcer on July 24, 2012.  She went to the ER on July 25th when she was having difficulty talking.  She was treated with prednisone, Augmentin, and Valtrex.
On 07/13/2022, 15 minutes post immunization, donor approached center staff complaining of nausea, dizziness, tetany and feeling lightheaded. The immunization site was examined and determined to be normal and free of irritation. Donor appeared pale and diaphoretic. Donor stated she had not eaten since the prior day and was given comfort care along with an electrolyte drink. After electrolyte drink was consumed, donor stated that her symptoms were better. Less than 30 minutes after the onset of symptoms, donor stated she was completely recovered.
With in 5 minutes of receiving the vaccine, my feet began to burn.  It continued to get worse throughout the day and turned into numbness and tingling in both feet and both hands. Still continuing to have these symptoms 17 hours post vaccine and unable to sleep.
the reporter stated that several pt devel inj site rxn characterized by redness, itching, & swelling w/in 3hr of vax;
Moderna COVID-19 Vaccine EUA- Red raised itchy bump at the injection site.
Localized pain @ inject site on lt arm; pain immediate @ time vax; has remained painful @ same site since; PE neg for deformities;
Initial misuse report received from a healthcare professional on 15 January 2013. A 06-week-old patient (no other information was provided regarding the patient) had received ACT-HIB vaccine diluted with MENACTRA vaccine on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Post 24 hrs of vaccination, chills & fever with aches in joints & esp. in (L) arm where vacc. administered. Chills, fever & nausea (started post 36 hr) continued for 4 days. 3 ADVIL tablets TID helped. Swelling & redness in arm continued for 5 days.
high Fever; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: L3247) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: unknown) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced high fever on an unspecified date. The outcome of the event pyrexia was unknown.  No follow-up attempts are possible. No further information is expected.
Itching around eye; This case was reported by a consumer via call center representative and described the occurrence of eye pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced eye pruritus. On an unknown date, the outcome of the eye pruritus was unknown.   It was unknown if the reporter considered the eye pruritus to be related to Shingrix.     Additional Information: GSK Receipt date: 09-FEB-2023 Reporter comment: The consumer reporting that, the itching around the eye which developed few months ago and wanted to know if its shingles. The patient said she got Shingrix few years ago and not sure if she got both the doses but sure she got at least one of the dose. The reporter did not consent to follow up. No other information available.
Pt stated she bled for a bit afterwards, 2 months Hep C reactivated,  In August 2021 started having palpitations, and was then diagnosed with Breast cancer.  Pt feels this needs to reported.  She has been seen multiple times since the incident and has never reported this.  There is no documentation about the bleeding at the time of the injection either.
itching in vaccine spot; swelling at lips; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th September 2021, the patient received Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced injection site itching and lip swelling. On an unknown date, the outcome of the injection site itching and lip swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching and lip swelling to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine six days ago and still experiencing itching in that spot, swelling at the lips for which he/she cannot find a logical excuse. The patient not eaten or drank anything different. The patient wanted to know could this be a side effect. The follow up would not be possible as no contact details were available.
patient got red bull eye type of rash around the injection site, she says it sore and painful, recommended to put some ice on it , no fever per patient. told her to monitor and let me know if it worsens.
It was reported patient after receiving vax cried with a high pitch for 2 hours, no fever. the next day the patient slept more than normal. Followup: During internal review of all files, it was deemed necesary to amend the report by updating the Adverse Event coding (added somnolence).
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 24-AUG-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot number unknown) dose 1. No other suspect therapy or concomitant medication was reported. On an unspecified date in August 2013 (reported as a couple days after the patient received ZOSTAVAX) the patient experienced stinging and tingling on her back. One week later the patient experienced the same tingling and stinging on her back. patient was concerned as she had shingles, previously (date unknown). No treatment information was reported. The outcome of shingles was reported as recovered/resolved. The outcome of stinging and tingling on her back is unknown. The reporters relatedness of stinging and tingling on her back and shingles to ZOSTAVAX is unknown. Additional information has been requested.
Patient noticed patch of red skin in area where vaccine was administered 7 days after vaccine was given.  No itchiness, pain, or heat noted at site.  No other symptoms noted.
cried & screamed x 5 hrs; lt leg edematous & painful on 13OCT93; 18OCT93 improved;
DULL ACHES AND PAINS IN LEGS; TIREDNESS; This spontaneous report received from a consumer concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced dull aches and pains in legs. On 19-JUN-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and dull aches and pains in legs was not reported. This report was non-serious. This case, from the same reporter is linked to 20210642462.
Extreme weakness, can't stand up, low-grade fever, restlessness, dementia symptoms increased, confusion, anxiety, inability to find words or speak what's on his mind.
h/a, rash lower legs & waist a day p/flu P\& pneumonia shot x 1 wk; no treatment needed;
p/recv vax pt exp a bruise at inject site w/red streaks halfway down arm.
Vomiting; Body Chills; abdominal pains; body aches,; sharp pains in knees,; back spasms; and violent headaches,; warmth throughout the body,; severe exhaustion.; 100F; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 14:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included asthmatic and mushroom allergy (Food allergy). The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 06:00 the patient experienced vomiting, body chills, 100 degrees Fahrenheit, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion. The clinical outcome of the events vomiting, body chills, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion and 100 degrees Fahrenheit were recovering at the time of the report.   No follow-up attempts are needed; information about the lot number cannot be obtained.
Patient states day after she received PNEUMOVAX her right arm developed a rash from shoulder to elbow.