chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all; This is a spontaneous report from a -sponsored program Support. A contactable consumer reported similar events for himself and wife. This report is for reporter self. A contactable consumer reported a 60-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 10Apr2021 (at the age of 60-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 19Mar2021 (at the age of 60-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that patient and his wife received both doses of the Pfizer COVID 19 vaccine-1st dose 19Mar2021 and 2nd dose was 10Apr2021, not exactly sure of the schedule as he does not have his card with him. He is experiencing general body pain specifically on shoulder, feeling like he has a fever-headache, he has no energy at all, asking for recommendations on what to do with the symptoms and if they need to consult their doctor, his wife also experienced similar symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101047312 same reporter, events, diff pt
Pain at injection site 8-7-13. Woke up during night with increased pain. In am 8/8 - large area of swelling over (R) deltoid-"hand sized"; warm took ALEVE, applied ice. Swelling was worse in evening, about c/o HA took ibuprofen, continued icing. Woke up 8/9/13 -swelling decreased - oral area 4 inches long. 3 inches wide. Reddish area around injection site 2 inches in diameter. Instructed to continue with cold pack x 20 min of off x 1 hour. Pain med. 1% hydrocortisone BID.
TIA on 8/14/21 approximately 6:00PM, Loss of motor function, difficulty word finding, left side facial deficits, inability to write or type.
DEHYDRATED; DIZZINESS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; STRIDOR; FELT LIKE SUFFOCATING; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: unknown) dose was not reported, 1 total administered on 03-SEP-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 03-SEP-2021, the patient experienced injection site pain. On 08-JAN-2022, patient started with food and was not able to taste (100%) and loss of smell (85%) on and off for 2 days. Patient had these spine chills down to patient's back and went to sleep early. On 09-Jan-2022 patient experienced low-grade fever, headache, very sore throat, dizziness, malaise. The patient experienced suspected covid-19 infection which led to suspected clinical vaccination failure. On an unknown date in JAN-2022, the patient had a stridor (loud breathing) and felt like broken glass. Patient completely lost voice as well, and if patient coughed, it caused severe pain, but nothing would come up. That lasted for 3 days. Patient felt very dehydrated. Patient ended up with steroids, Mucinex. On 11-JAN-2022 patient had telephonic appointment in which patient was prescribed prednisone, guaifenesin. On JAN-2022, lab test was performed and result was received on 12-JAN-2022 (unknown) and on 13-JAN-2022 amoxicillin sodium; clavulanic acid (Augmentin) was prescribed. The patient had worst days on 15-JAN-2022, 16-JAN-2022 and 17-JAN-2022. Patient got scared because patient was coughing up bright green mucus. Patient had appointment on 17-JAN-2022. On an unknown date in JAN-2022, the patient felt like suffocating and put on oral and inhaled steroids. Patient was on ivermectin, montelukast sodium (Singulair), budesonide for 10 days. Patient was on rescue breathing treatments. Patient never had any breathing issues prior. Patient was on doxycycline for 2 weeks, famotidine, acetylsalicylic acid twice a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected clinical vaccination failure, suspected covid-19 infection, and dizziness, and the outcome of injection site pain, dehydrated, stridor and felt like suffocating was not reported.  This report was serious (Other Medically Important Condition). This report associated with product quality complaint: 90000219228.; Sender's Comments: V0: 20220256505-  covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report as received from a registered nurse via a company representative refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot numbers were not provided). Concomitant medication was not reported. On unknown dates at unspecified time in the past, the patients experienced mild swelling at the injection site for PNEUMOVAX 23 vaccination. The outcome of mild swelling at the injection site was unknown. Causality was not reported. This is one of two reports from the same reporter (MARRS# 1408USA011463). Additional information is not expected because the reporter refused further follow up.
3rd dose of Anthrax series.  Patient noted immediate discomfort at injection site. Has had mild left arm pain to date that occasionally radiates to fingers.  Point tenderness at injection site.  No history of adverse reaction to anthrax immunization.
has been doing poorly at home with fatigue and subjective unwellness. He has had waxing and waning fatigue
Information has been received from a 27 year old female with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 27-SEP-2006, the patient was vaccinated with 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included unspecified hormonal contraceptives (reported as "birth control"). On 28-SEP-2006, the patient developed red, itchy and swollen hands and feet. The patient sought unspecified medical attention. At the time of this report the patient was recovering from the events. Additional information has been requested.
AFib occurred again; Dyspnea on exertion in my work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (115193). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (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), administration date: Mar2021, for Covid-19 immunization, reaction(s): "AFib", "Palpitations". The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2021, outcome "unknown", described as "AFib occurred again"; DYSPNOEA EXERTIONAL (non-serious) with onset 2021, outcome "unknown", described as "Dyspnea on exertion in my work". The patient underwent the following laboratory tests and procedures: electroencephalogram: (2021) atrial fibrillation; heart rate: (2021) elevated. Therapeutic measures were taken as a result of atrial fibrillation with metoprolol to manage elevated resting heart rate.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed an irregular shaped blister (1cm) at injection site 3 days post injection. No other symptoms.
Moderna vaccine administered to patient outside of EUA approved age range.  No adverse event has been reported by the patient/caregiver.  Patient received 1st dose on 3/12/21.  It was not identified that the patient was under 18 years of age until after the second dose was administered on 4/9/21.
when the needle was pulled out, blood and serum leaked out; thinks did not get the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (when the needle was pulled out, blood and serum leaked out) and UNDERDOSE (thinks did not get the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE DISCHARGE (when the needle was pulled out, blood and serum leaked out) and UNDERDOSE (thinks did not get the vaccine). On 25-Feb-2021, VACCINATION SITE DISCHARGE (when the needle was pulled out, blood and serum leaked out) and UNDERDOSE (thinks did not get the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever of 103 with seizure that lasted for about 30 seconds at 3 AM 1/19/23. Symptoms resolved completely after 5 minutes.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 64-year-old female patient who received Shingrix for prophylaxis. On 18th April 2018, the patient received the 1st dose of Shingrix. On 18th April 2018, less than a day after receiving Shingrix, the patient experienced skin warm. On 19th April 2018, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm and skin warm were recovered/resolved. The reporter considered the swelling arm and skin warm to be probably related to Shingrix. Additional details were provided as follows: The patient's arm felt warm after receiving the Shingrix vaccination on right arm. The next day of vaccination, the patient developed swelling in her arm that lasted about a week.
face & chest swollen p/bathed;no temp, no cough, no fever;pt only swollen on face & swollen along sternal;
Hep A and MENACTRA were given in left deltoid IM without any apparent initial reaction. About one minute later GARDASIL 9 was given in right deltoid IM and within 5 seconds of giving vaccine patient had a quick jerking reaction and then passed out which lasted about 20 seconds or less. When patient came to he asked if he was still alive because he had a vivid dream (couldn't remember what) and knew something had happened. Patient also states he was suddenly very hungry and did not eat breakfast. He also C/O being a little dizzy. Patient was given water and CHEEZ-ITS to eat and then a fruit cup of peaches and cup of orange juice. After about 20 minutes of the episode patient stated he felt like himself again and was ready to return to class. Made sure BP was normal and that patient was able to ambulate without any dizziness prior to returning to class. Provider notified parent also.
Numbness (down arm to thumb), heaviness, itching and persistent radiating pain in posterior deltoid and scapula.  Discomfort is still present at time of completing this report (2 months post injection), currently in physical therapy (6 sessions completed.)
RHABDOMYOLYSIS; This spontaneous report received from a patient of unspecified age and sex with unknown race and ethnicity. 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, batch number and expiry date were not reported) dose was not reported, 1 total, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  About 2 weeks later after vaccination patient had really bad cramps and spasms all over body 4 to 5 times a day. On 12-JUL-2021 patient went to hospital for having cramps like an heart attack. But did not had heart attack. Patient was said it was rhabdomyolysis. Patient had given intravenous fluids. But was still having them in legs, arms butt chest growing area calfs side and back. Pain lasted about 30 mins each time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rhabdomyolysis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210826860-covid-19 vaccine ad26.cov2.s-Rhabdomyolysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
03/28/14 Client in for 5 year vaccines. Became upset and combative after MMRV vaccine given. Attempted to give KINRIX in same arm but child pulled away so full dose wasn't given. Drew up another full dose to give in same arm, different site. Mother unable to restrain child so another nurse in to help with process. KINRIX given in LD and then Hep A given in RD all the while child screaming and resisting restraint. Right after Hep A given child eyes closed and body became flaccid. Child had good color and strong pulse but not responsive to verbal stimuli. Mother with child on her lap layed in supine/reverse Trendelenburg position. Cool cloth placed on child's head and neck. Child did not respond for at least one minute. Maintained appropriate color and adequate pulse. Once child responded, he was somewhat sleepy but answering questions appropriately. Gave juice box and snack and had mother and child lay for 15 min. Child able to walk out. Encouraged mother to keep watchful eye on child after leaving office. Take to ED if needed. 04/01/14 Call to mother to f/u. Mother reports child had fever the next day and sore arms. Was also fatigued. 2 days post-vaccination to current: no issues.
This spontaneous report as received from a pharmacist refers to a 55 years old female patient with allergy to sulfa and azithromycin and no past drug history. The patient was vaccinated with expired lot # (669776/0614AA, exp. 27-SEP-2012), 0.5 ml PNEUMOVAX23, IM on 19-OCT-2012. There was no concomitant medications. Additional information has been requested.
magnetic objects sticking at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (magnetic objects sticking at the injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (magnetic objects sticking at the injection site). At the time of the report, VACCINATION SITE REACTION (magnetic objects sticking at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Ears and buttocks started itching; small hives and redness developed from neck to armpits to below navel and stopped at upper thighs; chin became itchy and bottom lip swollen; he started coughing and clearing throat and had some redness a swelling in throat.
COVID-19 mRNA Pfizer gray top monovalent dose ordered, dispensed, and administered. Upon later review, noticed patient had already received 3 mRNA vaccine doses previously and should have received a bivalent booster.
This spontaneous report has been received from a physician via a company representative and refers to a 16 or 17 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in June 2016 (reported as within the "last 4 weeks"), the patient was vaccinated with GARDASIL 9, 1 injection (frequency, route of administration, lot # and expiration date were not reported) and after being administered the patient fainted. No treatment was provided for the event. The subject did not seek medical attention. No product quality complaint was reported. The outcome of the event was not reported. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
now I have serious side effects / pain where the shot was injected; now I have serious side effects / Loss of arm muscle about 15 - 20 percent; now I have serious side effects / eyes are blurry / Blurry Eyes. Eyes changing daily; now I have serious side effects / shivers / Uncontrolled Shivering; now I have serious side effects / headache; vomiting; loss of taste for 1 week; This case was reported by a consumer and described the occurrence of shivers in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19 (in August 2020), loss of smell, taste loss, influenza-like symptoms, labored breathing (took approximately 10 to 12 weeks to be able to work again), difficulty breathing, transient ischemic attack (same exact time in the morning), transient ischemic attack (same exact time in the morning), covid-19 (in February 2020'), loss of smell, taste loss and influenza-like symptoms. Concurrent medical conditions included allergy to chemicals (severe allergy to THC, can not breath).   In April 2021, the patient received the 1st dose of Shingrix. In April 2021, immediately after receiving Shingrix, the patient experienced shivers (serious criteria other: Serious as per reporter), headache (serious criteria other: Serious as per reporter), vomiting (serious criteria other: serious as per reporter), taste loss (serious criteria other: serious as per reporter) and blurred vision (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced injection site pain (serious criteria other: Serious as per reporter) and muscle wasting (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the shivers, headache, vomiting, blurred vision, injection site pain and muscle wasting were not recovered/not resolved and the outcome of the taste loss was recovered/resolved.   The reporter considered the shivers, headache, vomiting, taste loss, blurred vision, injection site pain and muscle wasting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Covid-19 symptoms in February 2020.The symptoms were loss of smell, loss of taste and flu like symptoms before Covid-19 was confirmed. The patient had Covid-19 in August 2020 and had same symptoms but much worse. Breathing was heavier and took Approx 10 to 12 weeks to be able to work again. The patient had serious side effects of Shingrix. Immediate, side effects were shivers, headache, vomiting, loss of taste for 1 week, eyes are blurry, etc.    As of today, August 8 2021. The patient still had pain where the shot was injected, loss of arm muscle about 15 to 20 percent, blurry eyes and uncontrolled Shivering. The patient wrap in blankets when the patient was at home. The patient had blurry eyes. Eyes changing daily. The patient was due for the second shot in October but the patient was very scared the side effects might be much worse. The patient asked for advice.
Has not received the second dose (>35 days); Numbness and tingling were so bad in fingernails hurt; Light headedness and dizziness; Numbness and tingling in hands; Light headed and dizzy; Tingling in lower jaw; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed and dizzy), PARAESTHESIA ORAL (Tingling in lower jaw), HYPOAESTHESIA (Numbness and tingling in hands), ONYCHALGIA (Numbness and tingling were so bad in fingernails hurt) and DIZZINESS (Light headedness and dizziness) in a 53-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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (Light headed and dizzy) and PARAESTHESIA ORAL (Tingling in lower jaw). In March 2021, the patient experienced HYPOAESTHESIA (Numbness and tingling in hands). In April 2021, the patient experienced ONYCHALGIA (Numbness and tingling were so bad in fingernails hurt) and DIZZINESS (Light headedness and dizziness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose (>35 days)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 24-Feb-2021, DIZZINESS (Light headed and dizzy) and PARAESTHESIA ORAL (Tingling in lower jaw) had resolved. At the time of the report, HYPOAESTHESIA (Numbness and tingling in hands), ONYCHALGIA (Numbness and tingling were so bad in fingernails hurt), DIZZINESS (Light headedness and dizziness) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose (>35 days)) had resolved.        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.  The patient were treated with  water, IV steroids and Benadryl.
got sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patient's who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 01-JUL-2023 This case was reported by consumer via interactive digital media. The reporter stated that do not be suckered in on taking the Shingles shot as they will give shingles. The reporter had talked to a lot of people that they got sick after taking it. The reporter stated that just deal with it if you get them naturally and detox yourself. The people would be ok. The follow-up could not be possible as no contact details were available.
Pt fainted hitting R/frontal side of head.  Loss of consciousness for 1-3 seconds. Ice applied to head, but no swelling or discoloration noted.  BP 116/86 P80 R16  3:08 Moved to observation area to cot with legs elevated.  Color improving 3:15 Pt alert & talking w/mother 3:30 Eating crackers & drinking juice. left w/o assistance with mother.