chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very mild malaise type of feeling; Soreness at the injection site; feeling of tiredness; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (very mild malaise type of feeling), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (feeling of tiredness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A OR 02C120A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Hypertension (High Blood Pressuer), BPH, Sleep apnea and Atrial fibrillation. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), FLECAINIDE, AMLODIPINE BESILATE (NORVASC), TADALAFIL (CIALIS), HYDROCHLOROTHIAZIDE and NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, 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 experienced MALAISE (very mild malaise type of feeling) and FATIGUE (feeling of tiredness). an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, MALAISE (very mild malaise type of feeling) and FATIGUE (feeling of tiredness) outcome was unknown and VACCINATION SITE PAIN (Soreness at the injection site) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Dose-3 on 25-AUG-2021 and he had experience Hot, typical covid arm,giving him a little bit of problem. On 26-AUG-2021 he felt much better than 25-AUG-2021 and later itchiness and soreness is much better but the swelling and redness is a little bit better or the same. Other Treatment medicine: CBD Cream.   This case was linked to MOD-2021-297029, MOD-2021-297099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received contains no new information.
Hives and itching rash on both arms and chest, swollen face with hives, sore eyes
Headache; Feeling Sick; Body Aches; Chills; This case was reported by a other health professional via call center representative and described the occurrence of headache in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA93AA, expiry date 28th February 2022) for prophylaxis.   On 10th August 2020, the patient received Bexsero. In August 2020, less than a day after receiving Bexsero, the patient experienced headache, malaise, general body pain and chills. On an unknown date, the outcome of the headache, malaise, general body pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the headache, malaise, general body pain and chills to be related to Bexsero.  Additional information was received as follows: The case was reported by the Clinical Supervisor. The patient experienced feeling sick, headache, body aches, and chills. Healthcare Professional noted the event began the night the vaccine was received. The events were ongoing, with no outcome at the time of this report. The reporter consented to follow up. This case was linked to case US2020158056, US2020158058 and US2020AMR159262 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158056:same reporter US-GLAXOSMITHKLINE-US2020158058:same reporter US-GLAXOSMITHKLINE-US2020AMR159262:same reporter
headache; legs and muscles felt like under a heavy blanket and stiff; heart rate shooting up by 30 points of 100 - 115/my heart rate was closer to the 80's and 90's; this was a terrible feeling - tachycardia and there was pain in left arm with shot; this was a terrible feeling - tachycardia and there was pain in left arm with shot; this was a terrible feeling - tachycardia and there was pain in left arm with shot; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Left arm on 16Apr2021 14:00 at the age of 56-years-old as dose 2, single for covid-19 immunisation. Medical history included thyroid issues from an unspecified date and COVID-19 on an unspecified date prior vaccination. The patient had no allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: not reported) on an unspecified date as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. Facility type vaccine was other. The patient was diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that after shot 2, on 17Apr2021, the patient experienced headache, legs and muscles felt like under a heavy blanket and stiff, and heart rate shooting up by 30 points of 100 - 115# Typically his heart rate is in the 70's so this was a terrible feeling - tachycardia and there was pain in left arm with shot, literally the next day it stopped and my heart rate was closer to the 80's and 90's, so a bit better. The patient received did not receive treatment for adverse events. Adverse events resulted in None of the above. The patient underwent lab tests and procedures which included heart rate: shooting up on 17Apr2021 (30 points of 100 - 115/my heart rate was closer to the 80's and 90's). The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Rash, itchy and diffuse. Present on chest, arms, legs, palms of hands and neck. Clinically appears consistent with Varicella. Treated initially with steroids IM, however did not respond. Initiated treatment with antivirals. Response unclear at this time.
As of today I couldn't stop smelling smoke, except nobody in this house smokes. It's an unbearable live smoke smell that comes and goes. I've looked up "smoke smell, Pfizer." What came up was phantosmia.
On Friday morning, starting about 9am I felt extreme cold that could only be remedied by laying under three blankets in a 72 degree room, on Friday afternoon I spiked a fever of 101.5 that was successfully treated with Tylenol through the evening.  Appetite suppressed through end of day Saturday.
Information has been received from a medical assistant referring to multiple patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of Gardasil 9 (lot # M003659, expiration date 20-SEP-2017) intramuscularly. Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt requested  Pfizer Booster/Bivalent to be given, with other vaccines of TDaP and Flu. Pt was given Pedi Pfizer (5-11yo) dose, that was undiluted. AE was noted when counting waste of vaccine for day. Pfizer was called for advise of treatment or steps to be completed for Pt health concerns. Pfizer reported, "Pedi Pfizer Bivalent (5-11yo) dose undiluted , is same as Pfizer Bivalent  12 and up." No further treatment or steps should be taken.
patient presented to the Emergecy department complaints of 1 day of dyspnea and discomfort while breathing. Patient was found to have a D-Dimer of 10.6, a CT was performed finding filling defects seen within the distal R and L main pulmonary arteries. Additional pulmonary emboli extend into the segmental branches of the lingula and L lower lobe as well as into the right middle lobe and R lower lobe. additional pulmonary emboli are seen within the segmental branches. Mild pulmonary emboli are seen within the segmental branches within the left upper lung. elevated R heart pressures shown by compression of the left ventricle with enlargement of the right ventricle and bowing of the intervertebral septum into the left heart. Patient bolused with heparin and places on heparin drip. Elevated troponins
Covid Arm - Raised rash that is sore and itchy on and around injection site.  About the size of a playing card
Information has been received from a county health registered nurse concerning a 36 month old male who on 08-OCT-2001 was vaccinated with VARIVAX (Merck). On 27-APR-2001, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Merck). This is one of 28 reports received from the same source. No further information is available.
Information has been received from a physician concerning a 5 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient developed breakthrough chickenpox in December 2006. No further information was provided. This is one of several reports received from the same source. Additional information is not expected.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age (gender unspecified). On 23-AUG-2013 the patient was vaccinated with an expired dose of M-M-R II lot # 670080/0402AA, exp. 16-MAR-2013. No adverse effects reported. Additional information has been requested.
pt recv vax; following day exp difficulty voiding & burning upon urination;f/u MD stated pt was dx w/ hematuria not related to vax;
This spontaneous report as received from a nurse refers to a currently 3 months old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date in 2017, the patient was vaccinated with an improperly stored ROTATEQ lot # N013885 (dose was not provided). Data logger was not involved. No adverse effects were reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA012873: US-009507513-1712USA012874: US-009507513-1712USA012875: US-009507513-1712USA012876: US-009507513-1712USA012877: US-009507513-1712USA012878:
1 week after my first dose, I was bed ridden from fatigue, body ache, head and neck pain, nausea, weakness and pain that I felt in my veins and bones, and slight dizziness and occasional warmth/fever.  All symptoms relieved naturally 1 week later.
It attacked thoracic nerve and pain; couldn't use right arm for 2 years; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced attacked thoracic nerve and pain (neuralgia) and couldn't use right arm for 2 years (mobility decreased), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (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 it attacked thoracic nerve and pain (neuralgia) and couldn't use right arm for 2 years (mobility decreased) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information available on the batch number for this case.
Day 8 after vaccine I developed a red rash directly under the injection site. The rash spread and now covers much of my upper left arm. It?s red, itchy, raised, and hot.
Patient received Varicella Vaccine on 8/6/08.  He started to develop a rash on 8/7/08 and still has rash at present. He developed a generalized body rash; on his face, neck, chest, right leg, and left arm. Patient received the Varicella Vaccine in his left arm and mother noticed most of rash is on his Left arm.  The mother estimates there are 50 lesions on his body.  Patient saw a doctor on 8/8/08 and the doctor felt that Patient has chickenpox due to him receiving the Varicella Vaccine.
Fever, Chills, Muscle Aches, Pounding headache, Fatigue, Malaise, Joint pain, stuffy nose, shortness of breathe, chest feel heavy, injections site pain (not red or swollen), sinus congestion, inner ear ache.
tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 (Lot number: EL0142) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glucose intolerance" (ongoing); "Hyperlipidemia" (ongoing); "Hypothyroid" (ongoing); "Acid Reflux" (ongoing). Concomitant medication(s) included: BIOTIN; CHOLECALCIFEROL; GINGER [ZINGIBER OFFICINALE]; LEVOTHYROXIN; METFORMIN; CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; PREBIOTICS NOS;PROBIOTICS NOS. The following information was reported: TENDERNESS (non-serious), outcome "unknown", described as "tenderness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Nothing in her life has changed, medication, foods, nothing. She did have tenderness after the first injection, more than after the second or the booster. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None  Follow-up attempts are completed. No further information is expected.
Vaccine error: Vaccine administered past its beyond use date. The vaccine stored in the freezer beyond the timeframe recommended by the manufacturer.
Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
tested and the result showed positive; tested and the result showed positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 at 12:00 as dose 1, single (Lot number: EL3247) intramuscular, in left arm, on 12Apr2021 at 13:00 as dose 2, single (Lot number: EL3247) intramuscular, in right arm, as dose 3 (booster), single (Batch/Lot number: unknown) and on 05Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FH8027) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "recovered" and all described as "tested and the result showed positive". The events "tested and the result showed positive" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received 2 Pfizer Covid vaccines plus 2 Pfizer Covid boosters. The last booster was on 05Apr2022. About a month after that, she was with a friend who later tested positive for Covid, so when she started to feel symptoms, she tested herself, and the result showed that she too, was positive and categorize symptoms as being mild. The patient went to emergency room/department or urgent care. Treatment reported as IV fluids and Advil. Covid test type post vaccination was a Nasal Swab on 21May2022 (positive).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were administered a dose of GARDASIL (dose, route, lot number and expiration date not reported) that was exposed to a temperature outside the prescribing information. The temperature excursions were not reported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Arm hurts; Still has some tightness when he bends it in; Not being able to move his leg/could not straighten it/could not bend it; kept on waking up/ not sleeping last night; Throbbing; Left knee started hurting so bad/agonizing pain, agonizing joint pain in his left knee he describes it as a banging pain in the knee for multiple hours; He could not walk; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), GAIT INABILITY (He could not walk), MUSCLE TIGHTNESS (Still has some tightness when he bends it in), MOBILITY DECREASED (Not being able to move his leg/could not straighten it/could not bend it) and INSOMNIA (kept on waking up/ not sleeping last night) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced GAIT INABILITY (He could not walk), MOBILITY DECREASED (Not being able to move his leg/could not straighten it/could not bend it), INSOMNIA (kept on waking up/ not sleeping last night), PAIN (Throbbing) and ARTHRALGIA (Left knee started hurting so bad/agonizing pain, agonizing joint pain in his left knee he describes it as a banging pain in the knee for multiple hours). On 09-Aug-2021, the patient experienced MUSCLE TIGHTNESS (Still has some tightness when he bends it in). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts). On 09-Aug-2021, GAIT INABILITY (He could not walk), MOBILITY DECREASED (Not being able to move his leg/could not straighten it/could not bend it), INSOMNIA (kept on waking up/ not sleeping last night), PAIN (Throbbing) and ARTHRALGIA (Left knee started hurting so bad/agonizing pain, agonizing joint pain in his left knee he describes it as a banging pain in the knee for multiple hours) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurts) and MUSCLE TIGHTNESS (Still has some tightness when he bends it in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Reporter Information and event added. On 09-Aug-2021: Event details added
wheezing same day as vaccine- albuterol hfa and prednisone dyspnea exacerbated over next several days leg deep venous thrombosis developed/diagnosed 11 days later
patient received expired dose of V AQTA; No adverse effects reported.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions and allergies were not provided.  On 04-DEC-2019, the patient received an expired dose (expired product administered) of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis; lot number R030120 and expiration date 15-NOV-2019. Information about strength, dose, frequency and route of administration was not provided. No additional adverse effects were reported.
Itching, swelling, red, hot, burning, placed ice bag on swelling and took Benadryl.
Low grade fever for 6 days, dry cough, general fatigue.  Anemia, enlarged lymph nodes.
Sleeplessness; Swelling of lymph glands; Feeling tired; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 09Mar2021 at 17:15, as a single dose for COVID-19 immunisation. The patient's medical history included degenerative joint disease, mild hearing loss, asthma, depression, anxiety, seasonal allergies, migraines and vertigo. The patient had no history of allergies to food, medications or any other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included ZOLOFT, joint support (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), VIT D (MANUFACTURER UNKNOWN), ZYRTEC and probi (MANUFACTURER UNKNOWN), all for unknown indications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021 at 16:00, the patient experienced sleeplessness (9 days so far), swelling of lymph glands which lasted for 3 days and feeling tired for 4 days. The patient did not receive any treatment for the reported events. The clinical outcome of the events sleeplessness was resolving; swollen lymph glands was resolved on 13Mar2021 and feeling tired was resolved on 14Mar2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter state that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration date not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 18 months old infant patient of unknown gender. On 19-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.