chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dont feel like themselves; lymph node in the right arm, looks prominent like an egg; temperature came back; lymph node in the left arm; pale looking in the face; temperature of 101.3 for three days; arm was sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PALLOR (pale looking in the face), FEELING ABNORMAL (dont feel like themselves), PYREXIA (temperature of 101.3 for three days) and LYMPHADENOPATHY (lymph node in the right arm, looks prominent like an egg) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, LISINOPRIL, CARVEDILOL, ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 27-Feb-2021, the patient experienced PYREXIA (temperature of 101.3 for three days). On 02-Mar-2021, the patient experienced PALLOR (pale looking in the face). On an unknown date, the patient experienced FEELING ABNORMAL (dont feel like themselves), LYMPHADENOPATHY (lymph node in the right arm, looks prominent like an egg), PYREXIA (temperature came back) and LYMPHADENOPATHY (lymph node in the left arm). On 02-Mar-2021, PYREXIA (temperature of 101.3 for three days) had resolved. On 03-Mar-2021, PALLOR (pale looking in the face) had resolved, LYMPHADENOPATHY (lymph node in the right arm, looks prominent like an egg) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (dont feel like themselves), PYREXIA (temperature came back) and LYMPHADENOPATHY (lymph node in the left arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 101.3 (High) fever- 101.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30 April 2021 NNI
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Chronic migraines" (unspecified if ongoing); "COVID", start date: Nov2020 (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE, start date: 01May2021; CANDESARTAN CILEXETIL, start date: 01Mar2022; EMGALITY [GALCANEZUMAB], start date: 11Apr2022, stop date: 11Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19 with Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2020) diagnosed with long Covid. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Additional information: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 04May2022, treatment stop date: 08May2022, indication: Treatment of COVID-19 with Paxlovid. There was no known allergies. Chronic migraines induced by Covid/ diagnosed with long Covid from first infection Nov2020.
2 hours after vaccine administered pt experience bilateral arm and leg weakness with difficulty walking, tingling joint pain and shaking lasting about 18 hours, he has experienced weakness and paresthesia symptoms reoccurring 3 additional times over the past 5 months. Pt was seen on 10/13/17 for minor R clavicle injury, immunizations were given during this visit. Mother with hx of Guillain-Barre and is concerned with the recurrent symptoms.
Foreign body reaction to something in the vaccine; Foreign body reaction to something in the vaccine; Developed a draining area; This case was reported by a physician via sales rep and described the occurrence of injection site discharge in a 4-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   In November 2018, the patient received Fluarix Quadrivalent 2018-2019 season. In January 2019, between 2 and 3 months after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced injection site discharge. On an unknown date, the patient experienced foreign body reaction and reaction to excipient. On an unknown date, the outcome of the injection site discharge, foreign body reaction and reaction to excipient were unknown.   It was unknown if the reporter considered the injection site discharge, foreign body reaction and reaction to excipient to be related to Fluarix Quadrivalent 2018-2019 season.  Additional case details were provided as follows: The age at vaccination was not reported but it could be 3 years or 4 years. In November 2018, the patient received Fluarix quadrivalent. Subsequently developed a draining area in general area of where vaccine was administered in January 2019.  Biopsy was done by a pediatric dermatologist which showed negative culture and the dermatologist thought the patient likely had a foreign body reaction to something in the vaccine.
Pt c/o feeling hot and lightheaded. Lowered to ground and monitored. Pt. pale. Pt. c/o of pain in Left arm and numbness in Left figners/hand. Pt. Transferred to Urgent Care.
Difficulty breathing; Chest pains; Blood clots in both of her lungs; Blood clots in both legs; Tired/ wiped out; A spontaneous report was received from a consumer (patient's daughter), concerning a 75-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing (dyspnoea), chest pains, blood clots in both of her lungs (pulmonary embolism), blood clots in both legs (deep vein thrombosis), tired/ wiped out (fatigue).   No medical history was reported. No concomitant medications were reported.  On 03 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided).  On 03 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient was completely wiped out for a couple of days following the vaccine. She was very tired and out of it. On an unknown date, over the weekend, the patient had difficulty breathing. On 08 Mar 2021, in the morning, the patient was hospitalized for chest pains and difficulty breathing. On the same day lab data revealed that she had blood clots in both of her lungs. On an unknown date, the patient had clots in both legs as well. She was hospitalized for a week and was in rehabilitation being monitored. The reporter also informed that the patient will be hospitalized until 18 Mar 2021 for the clots in both legs. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the events of difficulty breathing (dyspnoea), chest pains, blood clots in both of her lungs (pulmonary embolism), blood clots in both legs (deep vein thrombosis), tired/ wiped out (fatigue) was unknown.  The reporter did not provide assessment for the events of difficulty breathing (dyspnoea), chest pains, blood clots in both of her lungs (pulmonary embolism), blood clots in both legs (deep vein thrombosis), tired/ wiped out (fatigue). Follow-up received on 16 Mar 2021 included hospitalization end date, date of first dose of vaccine.; Reporter'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.
A consumer report has been received. The report concerns a female consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, unknown for influenza. FLUMIST QUADRIVALENT Intranasal) started on an unknown date for influenza. The patient experienced rash. FLUMIST QUADRIVALENT (intranasal) was continued. The outcome of the event of rash is unknown. The report was considered to be non-serious.
I had an immediate reaction to dose 1 on 04/02/2021.  I felt tingling going up to arm, face and head on my right side. My vision was distorted. I felt off like my equilibrium was off.  I had episodes that made me decide to go to the doctor on 05/12/2021. I had issues with my eye when the eyebrow would raise up and stay there for a few minutes or just a few seconds. Sometimes my eye would be half way closed  and just stay like that for a few minutes.  I would get really bad headaches during those episodes too.  I have seen my primary care doctor, a neurologist and a chiropractor for my symptoms. My symptoms have improved but I continue to have problems.
I had no symptoms at all from the vaccination but I caught covid two weeks later.  Starting on the 13th of June I had sinus congestion, sore throat and cough with a little bit of a fever. They were moderate mild. They lasted about a week. My wife had covid before I did and i had a bunch of negative covid tests the previous week.
Severe arm  pain, headache, feeling extremely hot and having chills, nausea, and drowsiness.
PATIENT RECEIVED A BIVALENT BOOSTER DOSE WITHOUT EITHER PRIMARY VACCINE DOSE.
Information has been received from a third party claims administrator regarding a female. On an unspecified date, the female was vaccinated with a dose of ZOSTAVAX (route, site, lot number, expiration date not reported). On 19-DEC-2012, the female sustained an adverse reaction to Zoster Vaccine Live, more specifically, allergic reaction to vaccine. no further information has been reported. Additional information has been requested.
No sense of taste since injection.; No sense of taste or appetite since injection.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female 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 06May2021 at 14:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fluoxetine hydrochloride (PROZAC), vitamin (MANUFACTURER UNKNOWN) and acetylcysteine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 06May2021, the patient experienced no sense of taste or appetite since injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events no sense of taste or appetite since injection were not resolved at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After vaccination, patient developed symptoms, not immediately, but within a few hours, nausea, chest tightening, altered taste, went to Emergency Dept. Determined to have anaphylactic reaction.
PATIENT COMPLAINED OF ARM SORENESS AND HEAT FOR ABOUT 1 WEEK POST VACCINATION THAT RESOLVED. PATIENT THEN PRESENTED TO PHYSICIAN'S OFFICE ON 10/19/2017 WITH SMALL KNOT ON LEFT ARM (BACK OF ARM A FEW INCHES ABOVE THE ELBOW PER NURSE) AND ARM SORENESS.
Booster; Cold symptoms; Sore throat; nasal congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FH2082) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (dose 1, Manufacturer Unknown.), for Covid-19 Immunization; Bnt162b2 (dose 2,), for Covid-19 immunization, reaction(s): "nausea", "fever 99.9", "vomiting". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "nasal congestion". Additional information Description of Event: Cold symptoms- Sore throat and nasal congestion.  No follow-up attempts are possible. No further information is expected.
5hr p/vax pt had T101.5 & c/o perioral numbness;also c/o numbness of hands (up to mid forearm);pt adm overnight & was given ibuprofen & DPH;sx resolved in 12hr;still c/o myalgias but no paresthesia;had local swelling & warmth;
her COVID 19 Diagnosis on 01Jan2022; her COVID 19 Diagnosis on 01Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 01Jun2021 (Lot number: EW0187) at the age of 17 years as dose 2, single and administered in arm right, administration date 11May2021 (Lot number: EW0168) as dose 1, single for covid-19 immunisation. Relevant medical history included: "she has a history of pseudo seizures" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "her COVID 19 Diagnosis on 01Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive; (09Jan2022) negative; (01Jan2022) positive; (09Jan2022) negative.  No follow-up attempts are possible. No further information is expected.
Patient was exceptionally tired 10/24/2022 to 10/27/2022. The evening of 10/27/2022 she had diarrhea and emesis. She had nausea but not dysuria. It was suspected there was a UTI leading up to sepsis, so she was brought to the ER at 5 am 10/28/2022. Subject presented to the ER at Medical Center 10/28/2022 with fever, chills, myalgias. In the ER she has documented pyuria. Upon arrival her vital signs were temp 99.6. heart rate 122 and regular, SBP 145/90, 97% on 2 L nasal cannula. UA was drawn and reveals positive nitrates with 25 white blood cells and few bacteria. She was initiated on vancomycin and Zosyn for treatment of sepsis either from a urinary source or perhaps recurrent C. difficile colitis. Initial cultures results display likely UTI with possible worsening C. diff infection. Patient was diagnosed with Sepsis, due to unspecified organism. She is being treated with ceftriaxone and cipro. Subject was administered the Janssen Ad26.CoV2.S vaccine on 10/17/2022. This adverse event is unrelated to the Janssen Ad26.CoV2.S vaccine that was administered on 10/17/2022.
Covid Arm 3 times; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid Arm 3 times) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm 3 times). At the time of the report, VACCINATION SITE REACTION (Covid Arm 3 times) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was reported. No concomitant medication was reported.   This case was linked to MOD-2021-182721 (Patient Link).
The pt experienced weakness, falling, ataxia with incontinence, chills, body aches, neck and shoulder pain.
Patient received a dose Pfizer Covid 19 vaccine for 6 months -4 years old, the vaccine was not diluted prior administration. Client was observed for 15 minutes after vaccination as recommended, no signs or symptoms of an allergic reaction noted. The med error was discovered after the patient had left clinic. The family was notified and reported the child had no signs of an allergic reaction. A follow up call was made later in the evening, there had been no changes.  Family encouraged to monitor child closely.
I had COVID-19 vaccination on 10/08/2022. I woke up on 11/14/2022 with sinus pressure, fever and runny nose. I contacted my doctor on 11/14/2022 and I was given monoclonal antibodies on 11/15/2022.
she had a mini - stroke or TIA on March 27 - 18 days after the second dose of the vaccination.  This happened after the first dose also -  with the same timeframe.
About 2 hr. after receiving vaccine, pt began to get dizzy, couldn't focus to read, gradually worsened, and pt became nauseated due to dizziness about 7 pm- cont. for approx. 36 hours.  Also had pain in neck
PNEUMONIA FROM A VIRUS; FEVER; COUGH; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine (live, attenuated)), via nasal route for the last 5 years for a severe fainting reaction to needles, can not take the flu shot. The mother reported that her son received the Flumist Quadrivalent in Oct or Nov-2017.    On the first day of school, Aug-2018, reporter stated that her son came home with a fever (preferred term: Pyrexia) and he had a cough (preferred term: Cough).    Reporter stated that patient was diagnosed with pneumonia from a virus (preferred term: Pneumonia viral).     The patient recovered from the events of fever, cough and pneumonia from a virus on an unspecified date.     The events were considered non-serious.     The reporter considered the following event unrelated to treatment with Flumist Quadrivalent (influenza vaccine (live, attenuated)): pneumonia from a virus, fever and cough.
This spontaneous report as received from a physician refers to a patient of unknown age. On 22-AUG-2012, the patient was vaccinated with the first dose of GARDASIL, dose and route not reported. On 07-OCT-2013 the patient was scheduled to receive the second GARDASIL, dose and route not reported. No symptoms reported. The patient's outcome was unknown. Additional information has been requested.
Dizzy, difficulty breathing, racing heartbeat, throat and face felt tight (swollen hard to swallow) and flushed, muscle weakness. At hospital ER, restricted blood flow to heart.
developed fever, morbiliform rash, face then neck, chest, back. Approx 10 days /p receiving MMR/DPT
Patient complaining of general malaise. Afebrile, local tenderness left deltoid at injection site. Pale"Halo" around site( no heat or swelling).
Fever over 100 degrees, full body aches, nausea, chills, no appetite.
The Smallpox Vaccine Adverse Event Active Surveillance Worksheet was filled out and filed by the patient herself.  She reports that she has a history of chronic urticaria for which she takes hydroxyzine.  This apparently was not identified at the time of screening, but the patient admits that she did not provide this information at the time of screening.  She states that she noticed additional lesions on her abdomen four days after being vaccinated.  These resolved without treatment over the following week, and she still has not had any evaluation of this apparent problem.  There were only two lesions and she reports that she has made a full and complete recovery.  The patient herself stated on her Active Surveillance Worksheet that she thought she had generalized vaccinia, but it sounds more like inadvertent autoinoculation, if it was related to the vaccination at all.  Because nobody but the patient saw these lesions this report should be regarded as unconfirmed.  Further relevant information will be submitted via an addendum as it becomes available.
running a fever of 101; felt really bad this morning; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. Investigation assessment was not provided. It was reported that she got her second covid shot yesterday, 09Feb2021. She was running a fever "today" (10Feb2021) of 101. She was feeling really bad "this" morning, but now she was feeling much better. She still has a fever. She was supposed to get her grandson "today". She was wondering if it is safe to get him. She does not want to complete a report. She would like to get over to Medical Information. She said her doctor said to treat it like COVID. The patient underwent lab tests and procedures which included fever: 101 (unknown units) on 10Feb2021. The outcome of the events was reported on resolving.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
She couldn't walk; She's been shaking and still shaking; Been sick for almost a week; Whole body was hurting; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (She couldn't walk), TREMOR (She's been shaking and still shaking), ILLNESS (Been sick for almost a week) and MYALGIA (Whole body was hurting) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 121031) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Dec-2021, the patient experienced GAIT INABILITY (She couldn't walk), TREMOR (She's been shaking and still shaking), ILLNESS (Been sick for almost a week) and MYALGIA (Whole body was hurting). At the time of the report, GAIT INABILITY (She couldn't walk), ILLNESS (Been sick for almost a week) and MYALGIA (Whole body was hurting) outcome was unknown and TREMOR (She's been shaking and still shaking) had not resolved.            No concomitant drug details were reported. No treatment details were reported.
Patient complained about nubness in her face. No complaints with the 1st dose.  Onsite EMS was called vitals BP 153/118 HR 103 BG 198. She was given 25 mg Benedryl orally given. She was released to go home.