chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 9:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 9:16 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.77 for dose administered on 02-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 to 36 degrees Fahrenheit from 09:00 AM to 03:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Severe arm pain - could not lift arm for 2 1/2 days, injection site bruise, 101 temp first 36 hours, 100.2 next 24 hours, extreme fatigue (slept 18 hours day after injection).
Patient complained about arm pain and visited MD in Oct. MD saw no reason for pain and sent pt. for MRI. Pt was given a cortisone shot and meloxicam and referred for physical therapy.
Fever, chills, body aches, headache, nausea, confusion, inappetent
Patient exhibited red and itchy face and eyes. Was given 50 mg of Benadryl P.O. symptoms decreased and B/P 180/104. H/R 120. Discharged 170/98 B/P HR 111 bpm. Discharged with her husband driving.  Advised to follow up with hospital and to follow up with her PCP before anymore immunizations.
patient reports that she started with reactivation of cancer symptoms (Chronic lymphocytic leukemia ) after Moderna Covid vaccine
Diagnosed as vasovagal syncope (fainting, vomiting) but also included flushing, temporary paralysis, shortness of breath, and disorientation. Immediately after injection, he said he couldn't move before fainting, curled up in fetal position, fainted in this position for about 30 second, then began dry heaving and turned very pale after fainting and appeared to be having trouble breathing. In weeks following he developed a rash on arms and behavioral issues associated with ADHD: inability to pay attention/finish tasks/control repetitive movements, as well as being less patient and more easily angered, increase in hitting himself and eye tics (excessive blinking and looking up to left repeatedly), intentionally running into walls/objects and increased speech dyslexia/difficulty   finding words.
Pt recvd vax & 12 hrs p/vax exp flu-like sx which lasted for 24 hrs;
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Swelling of upper left arm with hives present.
Patient candidate to receive full dose as a moderna vaccine due to chemotherapy, received booster half dose initially. Patient was notified and agreed to additional half dose to make full dose.
FELT STIFFNESS IN MORNING LATELY DUE TO LACK OF HUMIRA INACTIVITY; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (FELT STIFFNESS IN MORNING LATELY DUE TO LACK OF HUMIRA INACTIVITY) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) .4 milliliter. On 20-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (FELT STIFFNESS IN MORNING LATELY DUE TO LACK OF HUMIRA INACTIVITY). On 22-May-2022, FATIGUE (Fatigue) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (FELT STIFFNESS IN MORNING LATELY DUE TO LACK OF HUMIRA INACTIVITY) had not resolved.            No concomitant medications was provided by the reporter. Patient felt stiffness laterly due to lack of Humira activity. Patient had Lack of drug effect for Humira where the outcome was unknown. The reported causality of Humira for event such Early morning stiffness, lack of drug effect and fatigue was reported as not related. No treatment medications were reported
Pt reported after 2nd Anthrax vaccine she reported significant side effects. The day of the vaccine pt experienced fever, arthralgia, nausea, headache, generalized muscle aches and increased nasal congestion. These symptoms worsened over the next 2-3 days. pt developed abrupt onset of L side paresthesia on day 2 involving her scalp/face and shoulder. This paresthesia was present continuously X 24 hrs then occurred intermittently with lessening frequency thereafter. Pt also developed a circular blur defect in her L visual field which interfered  with her ability to focus within either near or far visual fields.This visual impairment has impacted her civilian job responsibilities and is creating eye strain and fatigue. The eye doctor diagnosed macular cyst not of genetic origin, with recommendation of no further Anthrax vaccines. finally resolving on 12/25/01
Fatigue, weakness, red eye, headache, hot flashes, nausea, stomach pain
Chills; brain fog; fatigue/exhaustion; nausea; headache; site pain; fever; This is a spontaneous report from a contactable health professional reporting for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: not known) on 27Jan2021 at 09:00 via an unspecified route of administration at single dose in the right arm for COVID-19 immunization in the workplace clinic. The patient has no medical history. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID 19 vaccine and no other medications received within 2 weeks of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination. On 29Jan2021 at 7:00 AM the patient experienced chills, brain fog, fatigue/exhaustion, nausea, headache, site pain and fever. The patient has not been tested for Covid-19 since the vaccination. The events were assessed as non-serious. The patient did not receive treatment. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Started after shot with left ear feeling full and sensitive to noise then turned to tinnitus. Spoke to my doctor who gave me ear drops which seemed to make my tinnitus worse so she said to stop taking the drops. The tinnitus progressed and i went to the ENT doctor for a hearing test. The test showed some hearing loss but at my age that is somewhat normal and that my tinnitus was from loud noise when I was younger? I don't recall having any hearing loss at a younger age went to some concerts have been around some machinery but did wear hearing protection most of the time. The tinnitus progressed and was waking me up at night I was having trouble sleeping and loud noise would set it off very severly for weeks at a time. I called my doctor and they gave me a referral to an audiologist which I am still waiting to hear from. The tinnitus has lowered down some. I have stopped most of my medication which I was taking before the tinnitus started hoping it would help. I still have buzzing in the left side of my head. I am hoping it will go away with time. I am afraid of getting another vaccine because my tinnitus was so bad it was interferring with the quality of my life.
Pain & swelling covering 3/4 of the posterior aspect of (L) arm. No reaction at the injection site. Pain started 2nd day after injection; redness on 3rd day.
Stayed in clinic for 15 minutes after injection with no problem.  15 minutes after I left the clinic (30 min post vaccine) my face became hot and flushed and my throat felt like there was something in it.    The next day I was lethargic and had a bit of swollen throat  but no problem breathing.
Booster on sat Nov 20-----Normal Weakness and nausea on Sunday---Monday continue fatigue, then coughing, Mucas,left shoulder and neck pain---Tues--same as Monday with added diarrhea--wed. and Thursday continued--- After hours clinic on Friday morning  Covid Test---negative.  Dr. suspected mild cold or mild flu--prescribed benzonatate 100mg and RLF Tab --started friday eveing.  Felt better Saturday and Sunday with still fatigue and mild mucus ---Monday 11/29 still fatigue and mild mucas
8/1-1st seizure-brief, interporlonged. Hosp 8/1-3 seizure in hosp. Last time intubated x few hrs. Neg CT scan, EEG. B/O weakness, mental states change. 8/9 home post neg LP, home 8/10.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 5-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
On 6/2/13 patient started with rash around her torso and back. After waking up the next day rash continued to spread to arms and legs and neck and face. No fever per mom.  No itching.  Patient was, aside from extensive maculopapular rash spread diffusely about body, asymptomatic.
Vaccine given 7Sep10, redness, warmth and extreme pain started on 8Sep10. Pain resolved by 10Sep10. Swelling, redness continues to spread down arm from injection site. Patient started on antibiotic treatment. Patient seen in clinic by doctor 10Sep10.
On March 19 I called my Primary because I had petechiae all over my legs, thighs and inside my mouth behind my lips.  My doctor told me to urgently go to the Hospital.  I went to Hospital and they transported me by ambulance to Hospital, where their Hematologist Department was located.  The vaccine depleted my platelets.  When I got to the hospital  I only had 1 or 1,000.
During 30 minute observation, PT reported experiencing itchiness of the throat and tingling sensation on eyelid, and feeling warm. Vitals were taken, and PT was given Benadryl 25mg PO. On-site EMT was notified and PT was assessed. PT was advised to seek further evaluation at nearest urgent care/hospital since symptoms did not resolve. PT was educated to seek medical attention if symptoms got worse or persisted.
fainting; hot flashes; Fatigue; arm pain; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 26Feb2021 10:00 at single dose for COVID-19 immunisation. Medical history included Narcolepsy, dysautonomia and POTS (Postural orthostatic tachycardia syndrome). No known allergies. Concomitant medication included modafinil. No other vaccine in four weeks. The patient experienced fainting, hot flashes, fatigue, arm pain, diarrhea, all on 26Feb2021. No treatment received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
Patient woke up and complained of a stomach ache and went to the bathroom Patient felt dizzy and complained of a headache. Had then started having a seizure. Patient does not have seizures.
rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (she will have double mastectomy.).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced RASH (rash on the arm). At the time of the report, RASH (rash on the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.
Patient given Tdap L deltoid without complaint, upon rising from chair 4-5 minutes later, pt's mother noted rash on L, R arm, chest, redness, no itching. Given BENADRYL 50 mg IM R deltoid 0956.
This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a consumer concerning her 18 year old daughter with exercise induced asthma who in March 2007, was vaccinated with the first 0.5 ml dose of the Gardasil. On approximately 31-MAY-2007, at the end of May 2007, the patient was vaccinated in the buttocks with the second 0.5 ml dose of the Gardasil. Concomitant therapy included montelukast sodium (MSD) and albuterol. On approximately 31-MAY-2007, after the vaccination, the patient reported that "it was one of the most painful shots she ever had." The pain lasted for 3 days and the patient treated herself with Motrin during that time. No laboratory or diagnostic tests were performed. Subsequently, the patient recovered from the pain. Additional information is not expected.
Menstrual irregularities - patient gets menses every 28 days and was due to get it on 4/8; as of 4/16, she has not gotten menses (36 days) which is atypical for her
3 x 5 cm central area raised and red within a 18 x 13 cm area of redness. Experiencing with no pain.
6/19 - headache (within hours of shot), by evening there was a big (3") raised red welt on his upper arm at the site of the injection 6/20 - woke up nauseated, changes in equilibrium (he described it as "sea legs"), headache, lethargic (napped for hours), spiked a fever of 104.1 by evening.
worst chills in my life; Spiked temperature; Stiffness on left side of neck and shoulder; Headache; This is a spontaneous is received from a contactable consumer (patient). A 69-years-old female patient received first dose ifbnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration in arm left on 23Feb2021 14:30 as single dose for covid-19 immunisation. Medical history included HBP, Treated for high cholesterol, Sicca syndrome. Concomitant medications included loteprednol etabonate (LOTREL [LOTEPREDNOL ETABONATE]), pravastatin (PRAVASTATIN), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), clarithromycin (MACROBID [CLARITHROMYCIN]) taken for an unspecified indication. The patient previously took tetracycline. The patient experienced worst chills in my life, spiked temperature, stiffness on left side of neck and shoulder, headache on 24Feb2021 20:15. The patient underwent lab tests and procedures which included body temperature: spiked on 24Feb2021 Spiked temperature, lasting all through the night. The outcome of the events was with recovering.
Patient arm was swollen near elbow to upper arm on inside of arm. It was not swollen near injection site. Hot to the touch and very red. Suggested patient go to urgent care and get checked out.
The vial was initially stored in refrigerator on 21-Jul-2022 and was administerd on 25-Aug-2022; No adverse event; Received expired first booster dose after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-Jul-2022 and was administerd on 25-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-Jul-2022 and was administerd on 25-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-Jul-2022 and was administerd on 25-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-Jul-2022 and was administerd on 25-Aug-2022).    No concomitant medications were reported. The vial was initially stored in refrigerator on 21-Jul-2022. The manufacturer expiration date was given as 18-Nov-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-636312 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-636312:Case for Patient 1
He got his vaccines, he had regular reactions of light fever, pain on the site of the vaccine, general discomfort and nothing else and went away within 24 hours.  Then on 9/20/22 at 1:00 AM he was vomiting, lost balance and had dizziness.  He was taken to the ER while in he ER Hospital.  He was about to be discharged due to vertigo and his husband noticed that he was having generalized body cramps and told the doctor he was manifesting stroke like symptoms . He was then taken for an MRI and the stroke was on the low left cerebellar side, which was diagnosed as nonetiological reason, ischemic stroke.  Did not have a history of stroke prior to the vaccine.  All testing to see what may have caused the stroke have all been negative.  He had a loop monitor inserted into his chest and that was also negative.  He was ten admitted and stayed for 2 days.  He was doing excellent until 9/30/22 when he had the same symptoms and was diagnosed with another stroke.  He was then admitted again this time to ICU at same hospital, and more testing was done and everything was found to be negative.  He was discharged on 10/3/22.   He was put on Plavix with the first stroke, and now is on Brilinta since the 2nd stroke, plus aspirin and his Lipitor has been increased due to the 2nd stroke.  He is seeing a cardiologist, and is going to see a neurologist and an ENT.  He is still under treatment for this condition.    He did not have any issues after the 1st stroke, but since the 2nd stroke he had some problems with his speech and it is OK now, and had 75% loss of function on the left side, but he is improving, and has to use a walker now.