chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adacel use generally gives arm pain; Initial information was received on 12-Mar-2021 regarding an unsolicited valid non-serious case from a other health professiona ( Inquiry Number: 00516621)  This case involves an adult patient who experienced adacel use generally gives arm pain (injection site pain), while the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious adacel use generally gives arm pain (injection site pain) unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number for this case.
Patient reported arm and joint  soreness (w/out redness) especially in knees, chills , aches, and headache that started approximately 24 hours after vaccination.
3OCT PM onset of screaming intermittent; rt leg rigid; felt hot, restless; swelling @ site of inject; 4OCT AM walked on outer edges of feet & screamed when walking;
soreness of left arm after each injection; they got the first 2 doses 2 weeks apart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6199; Anatomical location: left arm), administration date: 06Mar2021, for COVID-19 immunization, reaction(s): "Soreness of arm after each injection". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "they got the first 2 doses 2 weeks apart"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of left arm after each injection".  Additional information: Reporter stated that they had both had the series of Pfizer injections where they got the first 2 doses 2 weeks apart.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201369161 same patient and drug, different dose and event;US-PFIZER INC-202201369165 same reporter and drug, different patient and event;US-PFIZER INC-202201369162 same reporter and drug, different patient and event;US-PFIZER INC-202201369163 same reporter and drug, different patient and event;US-PFIZER INC-202201369164 same reporter and drug, different patient and event;US-PFIZER INC-202201375453 same reporter/patient/AE, different vaccine dose;US-PFIZER INC-202201375452 same reporter/patient/AE, different vaccine dose;US-PFIZER INC-202201375418 same reporter/patient/AE, different vaccine dose;
Long list of symptoms that have happened 10 days after vaccine inlcluding abdominal pain, pins and needles of skin, leg numbness and hard time navigating stairs, and tremors in hands.
Pain in upper arm the day after and has not subsided after two weeks. Shoulder not frozen but very sore and arm movement much more limited than it was. Pain progressively getting worse instead of better. Have used stretching, painkillers and liniment to treat condition. Relief only temporary.
Swelling, redness at site and upper arm  day after injection;No fever but felt warm day after,No fever no chills 2 days after injection
Patient received Moderna Covid-19 vaccine that under went a temperature excursion.; Patient received Moderna Covid-19 vaccine that under went a temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that under went a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that under went a temperature excursion.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 007D21A, 012L20A and 025J20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that under went a temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that under went a temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that under went a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that under went a temperature excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, the temperature in the refrigerator that the Moderna Covid-19 vaccine reached 13.1 degrees Celsius on 28-Jun-2022. None of the vaccine in the refrigerator underwent two different temperature excursions. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The Nurse used the online temperature excursion tool and was comfortable that her patient's doses were valid and that the affected vaccine was viable for future doses.  It was unknown if the patient had any side effects after any dose.  No treatment details were reported.
Information has been received from a registered nurse (R.N.) concerning her father, an 83 year old male with a history of macular degeneration and "neuropathies" who was vaccinated with a dose of ZOSTAVAX (lot# not reported) in Feb 2008. Concomitant therapy included COUMADIN and "NORAGEN". In Nov 2008, the patient experienced shingles. The shingles rash extended from ear to head. The patient sought medical attention at the physician's office. PCR analysis not requested at this time. The patient had not recovered at the time of reporting. Additional information has been requested.
A gentleman came into our office last night stating he received a flu shot at Clinic. He stated that he is having "static noise in his left inner ear". When he lies down it moves to his right ear. He also stated that 1 other neighbor was having the same symptoms. He went to Hospital but would not give us copies or even let him look at the papers. He stated MC referred him to a MD who prescribed him medication that didn't help him. The name of the medication is "Methyprednisolone" which he showed to someone but would not let her touch it.
RASH ON BOTH LEGS; ITCHINESS AT RASH SITE; BURNING SENSATION AT RASH SITE; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. 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, administered on 08-APR-2021 16:31:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced rash on both legs. On 09-APR-2021, the subject experienced itchiness at rash site. On 09-APR-2021, the subject experienced burning sensation at rash site. Treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on both legs, itchiness at rash site, and burning sensation at rash site. This report was non-serious.
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-287599 (Patient Link).   Reporter did not allow further contact
Customer experienced  nausea and vomiting .  Emergency personal came , customer was checked and few hours later she left to go home
Erythema, edema, 8.5cm X 7cm on left deltoid area. DTAP was given on that area, 24 hours ago (5th dose).
Information has been received from a physician concerning a female patient who was vaccinated with all 3 doses of GARDASIL (lot#, route and site of administration not reported). The patient was tested positive for HPV. It was unspecified if the patient sought medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Severe joint pain and weakness.  Prior to the Pfizer vaccination I was a runner and now I can barely walk due to severe joint pain and stiffness.  I also experience a low grade fever daily.
have problems with knees; This is a spontaneous report from a contactable consumer or other non hcp. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection in pre-filled syringe, Batch/lot number: Unknown), via an unspecified route of administration on 12Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 22Mar2021 patient experienced had problems with knees. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
p/vax pt exp approx 20 lesions;the reporting MD noted that pt was treated w/famciclovir & calamine lotion;
Information has been received from a physician's assistant and a medical assistant concerning an 18 month old male patient whose sister developed wild type chicken pox about two weeks ago (on approximately 22-JUL-2010). Eight days ago, on 29-JUL-2010, the patient was vaccinated with a dose of VARIVAX (Merck). One day post vaccination, on 30-JUL-2010, the patient broke out in a chicken pox rash. On 05-AUG-2010, eight days after received the VARIVAX (Merck), the patient was vaccinated with a dose of MMR vaccine. There was no adverse effect noted from the MMR. At the time of the report, the patient was recovering from chicken pox, there was no fever and crusting scabs. The physician's assistant did not feel that chicken pox was related to VARIVAX (Merck) but the related to the wild type exposure. Additional information has been requested. The patient's twin brother experience has been captured in WAES 1008USA00592.
headache, muscle aches Narrative: Took OTC Tylenol  Other Relevant History:
difficulty breathing; Body aches; Dizziness; Cough; Tight chest; Thirsty; Loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: EN6198 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 27Feb2021 11:00 (at the age of 53-years-old) at dose 2, single for COVID-19 immunization. Medical history included kidney disease, diabetes, hypertension, CVA(cerebrovascular accident ), GERD (gastrooesophageal reflux disease), IBS (irritable bowel syndrome), bipolar disorder and others, known allergies to Penicillin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: EL8982 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021 13:45 (at the age of 53-years-old) at dose 1, single for COVID-19 immunization. The most recent covid-19 vaccine was administered at Doctor's office/urgent care. The patient experienced body aches, dizziness, cough, tight chest, difficulty breathing, some congestion, thirsty and loss of appetite on 27Feb2021 17:00. No treatment was given for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sterile abscess dx by MD to R/thigh. Redness, swelling, warmth, fever.  Resolved 10/18/99.  Given antibiotics.
this spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Unknown number of improperly stored ROTATEQ (dose, route, lot # not reported) were administered to patients. No adverse effects were reported.  This is one of several reports from the same source.  Follow up information was received from the nurse on 26-SEP-2014. A six month old patient had experienced a low grade fever and crankiness after receipt of the vaccine. The outcome of the events was unknown. There was one cycle that reached -40 centigrade, with the balance of the excursions of 0 centigrade. The total excursion timeframe was less than 300 hours. ROTATEQ excursion support. Additional information has been requested.
Injection site tenderness; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 07:45 at single dose in left arm for COVID-19 immunisation at the age of 25-year-old. Lot number was EL9264. Pregnant was not pregnant at the time of vaccination. Medical history included asthma, allergies, anxiety, frequent bronchitis. Concomitant medications included mefenamic acid (ADVIL), sertraline hydrochloride (ZOLOFT), fluticasone propionate (ARMONAIR), fexofenadine hydrochloride (ALLEGRA), ipratropium bromide (IPRATROPIUM BROM). The patient experienced Injection site tenderness on 04Feb2021 at 13:00; the patient was not treated for the event. The patient recovered from the event. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Diagnosed with Afib; Couldn't breath/Gasping for air; Eyes yellow; Asthma flairup; Couldn't sleep; Shaking; A spontaneous report was received from a consumer concerning a 73-year old female patient, who experienced asthma flair up, couldn't sleep, couldn't breathe, gasping for air, shaking, eyes yellow, admitted to hospital, diagnosed with Afib .  The patient's medical history mentions asthmatic since the age of 3 years old and Atrial fibrillation. Concomitant medications provided were steroids NOS and a zpack.  On 16 Jan 2021, one month and 6 days prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (Batch number: 0281120A) for prophylaxis of COVID-19 infection.   On 08 Feb 2021, patient reported having an asthmatic flair up that was bad. She took medication provided by her hcp and could not sleep, could not breathe, gasping for air, eyes yellow and shaking. She was admitted to the hospital on 11 Feb 2021 and was diagnosed with Atrial fibrillation. She missed her planned dose as she was hospitalized.  The event atrial fibrillation was deemed medically significant and the patient was also hospitalized.  Treatment information mentions Xanax. Lab tests were not provided. Action taken with respect to mRNA-1273 was not reported.  The outcome of the events, atrial fibrillation was unknown. The outcome of the events asthma flair up, couldn't sleep, couldn't breathe, gasping for air, shaking, eyes yellow, admitted to hospital was resolved on 21 Feb 2021.; 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.
This spontaneous report was received from a pharmacist regarding a 14 year old female patient. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with GARDASIL 9 too soon at the age of 14 years (dose strength, route and lot number was unknown). No concomitant medication was reported. No product quality complaint (PQC) was involved. Patient enquired that what should be done now. The outcome of the event was unknown. Additional information has been requested.
This spontaneous report was received from a registered pharmacist concerning an approximately 67 year old female patient with no drug reactions or allergies. Current conditions of the patient included high blood pressure and arrhythmia. On 07-AUG-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J003723 and 28-JUN-2014 (also reported as 25-JUN-2014) respectively), subcutaneously in the left arm. Concomitant therapies included sotalol hydrochloride and enalapril maleate. Approximately since an unknown date in 2013, the patient was experiencing pain in the left arm where she received the vaccination whenever she sleeps or puts pressure on that arm. The patient sought medical attention (spoke to pharmacist). No treatment was given and no lab tests were performed. The patient was not recovered from the event at the time of reporting. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Around 6 weeks after getting the shot I started getting weird sensations in my feet. At first I didn't give it too much importance. My feet where numb. The numbness started slowly going op my legs. To the point that I could not move them or feel anything. Took a plane to another city to get treated there. I wento to the ER on Tuesday the 22 nd of June, exactly two months after getting the shot. The sympthmos started about two weeks earlier. I spent a week at the hospital. I was diagnised with a an autonnmune desease triggered by the vaccine. An inflammatory polyneuropathy. Today (27th July 2021) I can walk and move, but still have strange feelings in my legs.
soreness at injection site, migraine, second day on menstrual cycle - heavy bleeding, extra hungry, feeling tired, itchiness, hives around neck area
Had no issues with shots 1 and 2 I received 3/2021. Received shot 3 (booster) 9/8/21. Felt normal all day 9/8. Woke up 9/9 with severe body ache, headache, fever (close to 102 F), chills. Missed work 9/9. Did not improve despite rest, fluids and tylenol. Woke up on 9/10 even worse. Fever was over 102. Same symptoms from day before but they were worse. 9/11, fever was well into 102 F range. Had same symptoms, but also had nausea, vomiting, diarrhea, fatigue and loss of appetite. Fever was between 102 and 103. On 9/12, went to hospital. Had fever close to 104. Admitted to hospital and spent three nights. Was diagnosed with bacterial pneumonia, cause unknown. Not sure if related to covid shot. Dr's were unsure if shot caused infection, or if infection was already present and the shot temporarily lowered my immune system.
pt exp rash (hives) to body on 2FEB98;med given;c/o h/a, yellow runny nose, lt sinus pain & heaviness, lt eye pain;pressure around eyes, stuffy nose;h/a (temples);sinusitis;nose boggy++, throat inc sinus tender;
Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown; This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Photopheresis (monthly) since an unknown date. Concurrent medical conditions included Graft versus host disease since 04-Oct-2019 and Weakness (frequently since 2018) since 2010. Concomitant products included RUXOLITINIB from 13-Jan-2021 to an unknown date for Graft versus host disease, PREDNISONE, BUDESONIDE and TACROLIMUS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) (seriousness criterion hospitalization). The patient was hospitalized from 05-Mar-2021 to 23-Mar-2021 due to RHABDOMYOLYSIS. On 23-Mar-2021, RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Aldolase: elevated (High) elevated levels consistent with myositis. In March 2021, Biopsy muscle: abnormal (abnormal) demonstrated mild myopathy, mitochondrial dysfunction, mild reinnervation and severe type 2 fiber atrophy. Microscopic analysis also demonstrated lymphocytic infiltration, along with apoptotic bodies, providing overall gestalt most consistent with a mixed nonspecific liver injury, along with some findings to support graft-versus-host-disease of the liver. In March 2021, Blood creatinine: elevated (High) elevated levels consistent with myositis. In March 2021, Electromyogram: abnormal (abnormal) consistent with myositis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) to be possibly related.    Extensive serologic workup was done in March 2021 which were grossly negative for new autoimmune processes. No specific treatments were reported.  Company Comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Fever, coughing, sneezing, congestion, headache, joint pain, malaise, fatigue, congested inner ears
Child broke out with the Herpes virus 4 days post vax. She now has Herpes and has mouth pain off and on. We are very very angry that we had to give this shot to our child!