chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site warmth/heat at injection site; Feeling unwell/did not feel good; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth/heat at injection site), MALAISE (Feeling unwell/did not feel good) and FATIGUE (Tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) tablet for Chronic lymphocytic leukaemia.    No Medical History information was reported.   In September 2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 400 milligram once a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth/heat at injection site), MALAISE (Feeling unwell/did not feel good) and FATIGUE (Tiredness). In 2021, INJECTION SITE WARMTH (Injection site warmth/heat at injection site) had resolved. At the time of the report, MALAISE (Feeling unwell/did not feel good) and FATIGUE (Tiredness) was resolving.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of injection site warmth, fatigue and malaise was not provided with VENCLEXTA(VENETOCLAX).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
With my second vaccine, I also broke out in hives. My hands got vey red and itchy.  I took Benadryl for relief of itchiness.
I have blood blisters on right palm and right leg. I have had no known injury that would have caused theses
Vaccine administration error related to temperature excursion from recommended storage temperature, not known to this writer to be associated with an adverse event. The clinic has relayed to this writer that prior to the vaccine's thawing and administration to the vaccine recipient, the administered vaccine was stored in frozen temperatures for longer than recommended by the manufacturer. (This writer assigned to form completion was not the administrator of this vaccine.)
Temperature, red face, intense nausea, shivering, intense headache, body and muscle aches, dizziness, fatigue, pain at injection site and shoulder.
Pt recv vax on 1/6/99; 6 - 10 hr post vax pt exp malaise, myalgias, fever(to 102), swelling & pain at vax site; tx=Benadryl & acetaminophen
Myalgia Sore arm, mild sore throat Narrative:  Other Relevant History:
Nausea, vomiting, fever of 102 for 5 days, chills, body aches, joint pain. Local reaction on day 7, itchy, swelling, hard lump, bright red, roughly 8 ×10 cm. Kidney pain
RASH STARTED EVE OF SHOT ABOUT 1 AND 1/2 TO 2 INCH FROM INJECTION SITE. ITCHY, SWOLLEN, LUMP IN THAT AREA FOR DAYS AND HAS DIMINISHED AND RETURNED HERE AND THERE.  AS OF TODAY, IT'S A DIME SIZED RASH AND INCREASING IN ITCHINESS. STILL SORE TODAY AS WELL.  NOT CERTAIN WHICH DAY THE NEXT REACTION STARTED, BUT REPORTS NUMBNESS/TINGLING/FALLING ASLEEP FEELING FROM SHOULDERS TO PALMS OF HANDS OF BOTH ARMS, THIS IS BECOMING MORE FREQUENT AND CONSTANT.  ADVISED PATIENT TO TRY BENADRYL AND HYDROCORTISONE FOR RASH/ITCHING, AND TO CONTACT PCP REGARDING THE NUMBNESS.
The following morning after rec. the vaccine ct. noted site of injection was a "red spot the size of an orange--with unconrollable iching--there was also swelling and tenderness in my arm pit". Pt. stated she, "applied Benadrl lotion--later taking oral Benadryl."
Got Covid Toe.  Pinky toe on left foot became purple then black and blue 2 days later. No pain unless squezzed. Almost completely gone by today.
Severe headach escalated to migraine lasting about 5-6 days and still ongoing...taking Excedrin Migraine and 5 day supply of Prednisone 20mg 1xday
Patient reported chills and fever the evening after receiving vaccines. Her right inner arm developed severe bruising and rash/discoloration (red). The bruise/discoloration is still present at 3 days post vaccination. The arm was hot to the touch as well. No mobility issues. The patient took ALLEGRA and TYLENOL for the pain and allergy and will continue these OTCs until it resolves. Pharmacist will call patient's PCP tomorrow to inform of the adverse effect and to follow up with patient.
Single Dose Janssen - one minute after injection - lightheadedness - inability to focus/concentrate  - ringing in both ears -,tingling in hands/feet.   Time now is approx 25 minutes post vaccine and he is feeling mostly better
elevated heart rate; fever; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced heart rate increased and fever. On an unknown date, the outcome of the heart rate increased and fever were recovered/resolved.   It was unknown if the reporter considered the heart rate increased and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was 68 years old at the time of reporting. In 2019, couple of months before the date of reporting, the patient received Shingrix. In 2019, the patient experienced elevated heart rate and fever and went to the emergency room due to the severity of the reaction. It was reported that the that patient was not admitted, stabilized at the emergency room (ER) and was sent home. C The patient's prescriber advised the patient not to receive the 2nd dose of Shingrix due to the severity of the reaction. The reporter consented to follow up. The outcome reported for all the adverse events AES in the structured field of database is "recovered with sequele" instead of  "resolved" (outcome uploaded in database).      Lab Comments: on an unknown date, the heart rate was elevated
Was really tired, ran a 100.6 fever, chills, couldn?t get warm. Had neck pain. Had a headache, felt tingling in my fingers, was super sore all over. Soreness at injection sight. Symptoms only lasted 36 hours.
Has not received second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received second dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: This report refers to a case of product dose omission issue for mRNA-1273 (lot/batch: 030M20A) with no associated AEs reported.
tetanus hypersensitivity/reaction to the vaccine; lumps in my body; difficulty with mobility; Initial information received on 04-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced tetanus hypersensitivity/reaction to the vaccine while receiving vaccine tetanus toxoid.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date in 2011, the patient received suspect tetanus toxoid produced by unknown manufacturer at an unknown dose (lot number, expiry date, form, strength: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious tetanus hypersensitivity/reaction to the vaccine (allergy to vaccine) with lumps in my body (mass) and difficulty with mobility (mobility decreased) (unknown latency) following the administration of TETANUS TOXOID.  Health care professionals initially thought she has rheumatoid arthritis, but the allergist believed it was a reaction to the vaccine. Her health issues have since resolved, but she was trying to determine the causative factor, so she would know what to avoid in future vaccines.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Recovered / Resolved on an unknown date for the event tetanus hypersensitivity/reaction to the vaccine.
feeling achy all over; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (feeling achy all over) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (feeling achy all over). At the time of the report, MYALGIA (feeling achy all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       patient was exposed to two of positive covid people, after 12 days he had taken vaccination. no treatment given and no concomitant medication provided   This case was linked to US-MODERNATX, INC.-MOD-2021-133136 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-133136:wife
shakes, insomnia first night, chills the following morning, fever from 24-96 hours post-shot that ranged from 101-105, nausea and vomiting the day after, confusion for several days, pain of arm, swelling of lymph nodes and lump/hardness in left breast that lasted 96 hours past injection
This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# M006112 with expiration date :16-NOV-2017, lot# M041815 with expiration date: 20-JUN-2018, lot# M045546 with expiration date: 12-JUN-2018, lot# M035828 with expiration date: 28-MAY-2018 (dose was not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly (lot# and expiration date were not reported). The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 18 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009050: US-009507513-1707USA009051: US-009507513-1707USA009052: US-009507513-1707USA009053: US-009507513-1707USA009055: US-009507513-1707USA009056: US-009507513-1707USA009057:
This spontaneous report was received from a pharmacist regarding a 21 year old female patient. Information on her concurrent conditions, medical history and drug allergies were not reported. Illness of the patient/sibling at the time of/prior to vaccination was not reported. It was also reported that the patient was not pregnant. On an unknown date in 2009 (about 7 years ago), the patient was vaccinated with GARDASIL (lot, expiry date, dose#, route and anatomical location were not specified). Concomitant medication were not reported. On an unknown date in the year 2009 (about 7 years ago) the patient experienced itching of both arms after administration of a dose of GARDASIL (reporter had confirmed it as not GARDASIL 9). The patient  had sought medical attention by an unknown type. It was unspecified whether lab diagnostic studied were performed for the adverse event. On an unknown date, outcome of the event pruritus was reported as recovered/resolved. There was no Product Quality Complaint (PQC) filed. No further information was provided. Reporter did not provide the causal relationship of the event pruritus with GARDASIL. Additional information is not expected as reporter refused additional contact.
The PM of 1st set of shot cried from 7PM to 2AM high pitched @ times; fever 101;
Last night 12/30 started feeling chills and cough.  Post nasal drip started 2 days ago.  No fever.  Today feeling worse 12/31/2020.
Patient tested positive for Covid infection; Patient tested positive for Covid infection; Booster Dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2021 16:45 (Lot number: FF2589) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number=EU0180, previous dose administrator route=Intramuscular, previous dose administration date=06Jun2021 , previous dose dose number=2, previous dose vaccine location=Left arm), administration date: 06Jun2021, when the patient was 16 years old, for COVID-19 immunization; Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number=EW0177, previous dose administrator route=Intramuscular, previous dose administration date=16May2021 , previous dose dose number=1, previous dose vaccine location=Left arm), administration date: 16May2021, when the patient was 15 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021 16:45, outcome "unknown", described as "Booster Dose"; VACCINATION FAILURE (medically significant) with onset 11Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 11Jan2022, outcome "recovering" and all described as "Patient tested positive for Covid infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) negative; (11Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient took other medication Multivitamins and birth control pill with in two weeks. Patient did not have any Known allergies.The patient did not receive any other vaccines within four weeks prior to the vaccination.COVID prior vaccination was none reported.
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, drug reactions or concomitant medications reported. On 01-OCT-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot number K004483; expired date 16-AUG-2015, 0.5 ml, subcutaneous). No adverse effect reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Patient felt like he had the COVID-19 virus all over again after the first dose like he did in; Patient had super severe headache immediately after the first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Patient felt like he had the COVID-19 virus all over again after the first dose like he did in) and HEADACHE (Patient had super severe headache immediately after the first dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Migraine.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced COVID-19 (Patient felt like he had the COVID-19 virus all over again after the first dose like he did in) and HEADACHE (Patient had super severe headache immediately after the first dose). At the time of the report, COVID-19 (Patient felt like he had the COVID-19 virus all over again after the first dose like he did in) and HEADACHE (Patient had super severe headache immediately after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
12/2 pt seen with shingles L arm (cx + varicella zoster) that started at approx vaccine site, then scattered down L arm.
After receiving her shot within 5 minutes she was feeling dizzy and her tongue got swollen. We lay her down and gave some water and call 911. They checked her vitals and she had high BP. They took her to urgent treatment center just to make sure she is ok
Fever 101.8, generalized body aches, chills, sweating, fatigue, starting 24 hours post vaccination
I had the vaccine around 1:30PM around 2:30PM I started to have my heart pounding and I have a smart watch and I did an EKG with that. I called my doctor, and he said yes, I am in a-fib, and I went to the emergency room locally. When I got there it had resolved itself. They put me on a monitor. Yesterday I had chills, fever like I did with the other vaccines. Today I am fine. I am going to wear the heart monitor for 14 days and see a cardiologist.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 12Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation; treprostinil sodium (REMODULIN), first regimen since 26Sep2022 (ongoing) (Batch/Lot number: unknown), second regimen since 2022 (ongoing) (Lot number: 2102128, Expiration Date: 31May2023) at 0.014 ug/kg, subcutaneous and third regimen since 2022 (ongoing) (Lot number: 2102233, Expiration Date: 31Oct2023) at 0.026 ug/kg, subcutaneous for pulmonary arterial hypertension; gabapentin (GABAPENTIN), (Batch/Lot number: unknown) for bone pain. The patient's relevant medical history included: "primary pulmonary arterial hypertension." (ongoing); "Bone pain" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "recovering", described as "Tired"; NAUSEA (non-serious), DIARRHOEA (non-serious), BONE PAIN (non-serious) all with onset 2022, outcome "recovering" and all described as "With each Remodulin dose titration has nausea, diarrhea and severe bone pain"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Nov2022, outcome "unknown" and all described as "On 12Nov2022 (Saturday), the patient got his COVID and Flu vaccine". The action taken for treprostinil sodium was dosage increased; for gabapentin was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild: Fever 101.2, red painful area on arm.  Severe:  full body aches, chills, nausea for two full days.
Upon waking up the morning following the injection, a ~2 inch diameter erythema was present on the patient's upper arm at the injection site.  In the center was a ~1 inch raised bump, painful and hot to the touch.  Later in the day, corresponding to ~24 hours post injection, the patient developed 101 degree fever, an unusually strong headache, chills and myalgias.  The symptoms peaked ~28 hours post injection.  The patient took 1,000 mg of acetominophen which didn't appear to have an impact.  Before going to bed that day, the patient took a full dose of Nyquil liquid.  The fever, headache, myalgias and chills resolved overnight.  The arm was painful and the myalgia/bump persisted for 4 additional days.
Initial information received on 05-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (Unknown demographics) who experienced extra dose administered, while he received vaccine MENACTRA. The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL VACCINE lot C5385AA via unknown route at an unknown site. On an unknown date, (Unknown latency period), following the administration of MENINGOCOCCAL VACCINE the patient experienced mistakenly given a patient, 3 injections of MENACTRA, instead of the recommended 2. Final diagnosis was extra dose administered. It was not reported if the patient received a corrective treatment. The patient outcome reported as Not Applicable. Documents held by sender: none.
Approximately 4 hours after immunization rash on face. Vaccine around noon - that afternoon face rash - the next AM woke up shaking and feverish (felt warm). Over nite 2 hrs rash on (L) leg and (L) arm. Normal exam - to take BENADRYL and Tylenol.
INJECTION GIVEN TOO HIGH AND UNKNOWN AMOUNT ADMINISTERED VIA INJECTION. 3rd DOSE TO BE GIVEN
A few hours after receiving vaccine fatigue, headache, chills, arm pain, and menstrual period. Fatigue, arm pain, and chills lasted for a day. Period lasted 11 days. Another period 9/23 - 9/28. Three hours after second dose period started again on 10/2/21 - 10/8/21. Headache persisted until approximately early October after the second dose.