chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STROKE; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (STROKE) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced CEREBROVASCULAR ACCIDENT (STROKE) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (STROKE) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   COVID-19 vaccine taken one in once. Humira was citrate free.  In 2022, the patient had a stroke. She was concerned if Humira was the cause and whether Humira was working, but, she felt Humira was not working.  No treatment drug information was provided.  The reporter's causality for the event of Stroke with Humira (Adalimumab) was a reasonable possibility. The reporter's causality with Humira (Adalimumab) for the event of humira was not working was not provided.  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.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a 63-year-old female patient with current medication of Adalimumab, who experienced the unexpected serious (medically significant) adverse event of special interest Cerebrovascular accident, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor the exact event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The co-suspect drug Adalimumab remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 63-year-old female patient with current medication of Adalimumab, who experienced the unexpected serious (medically significant) adverse event of special interest Cerebrovascular accident, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor the exact event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The co-suspect drug Adalimumab remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
A report has been received from a Pharmacist concerning a 22 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient experienced administration of only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious by the reporter.
This spontaneous report as received from a health professional refers to a 4 year old patient. On 02-MAY-2014 the patient was vaccinated with M-M-R II (lot# J010993, expiration date 06-SEP-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
On 11/5/99, the pt developed a generalized vesicular rash that consisted of less than 50 lesions. The pt was seen by a physician. Additional information has been requested.
Headache, dizzy, couldn't move left arm, drowsy, fever. Dx: Acute viral syndrome. Volume depletion. Intermittent Bradycardia (with ? PR interval).
Mother of patient came home on 4/12/21 to find patient wandering outside of their house with his shirt off and confused. She suspected possible drug use and brought him to his doctor the following day.  He says he does not remember anything from that day, doesn't remember taking any drugs but has taken xanax  in the past. Later that night on 4/13 patient had a seizure at home and was taken to ER. There urine drug screen was done alond with CBC, CMP, CT of head all of which was normal.  Patient has no history of seizure in the past.
vaccines being given post temperature excursion, with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid non-serious case received from a healthcare professional via Physician.  This case involves a 11 years old male patient for whom vaccines being given post temperature excursion, with no reported adverse event while receiving Influenza Quadrival A-B Vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV Vaccine (HPV Vaccine) for Immunisation.  On 02-May-2022, the patient received a dose of 0.5 ml TOTAL of suspect Influenza Quadrival A-B Vaccine (lot UT7376NA; expiry date 30-Jun-2022) via intramuscular route in the right deltoid for Immunization.  On 02-MAY-2022 the patient reported vaccines being given post temperature excursion, with no reported adverse event (product storage error) following the administration of Influenza Quadrival A-B Vaccine.  Action taken with Quadrivalent Influenza Vaccine (Fluzone QIV) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01090544: 01092803: 01092787: 01092741: 2022SA167374:
Next day developed rash - area became swollen and tender. Since immunization developed headache, body aches, malaise and subjective fever this am 6-18-10 per mom. See copy of visit notes.
Patient was given the Moderna COVID vaccine at age 17, and the vaccine is only approved for18 years and older.  No side effects or other contraindicated symptoms present after vaccination.  Patient tolerated procedure well, and was observed for 15 minutes post vaccination and then released.  Patient's parent was present and signed consent for vaccine.  Patient's age was missed upon registration at large scale community vaccination clinic and was subsequently vaccinated.  Error was not noted until end of clinic.  Followed CDC guidance on COVID-19 Vaccine Administration Errors and Deviations (updated 03/17/2021) and provided 2nd dose of Moderna vaccine on 04/28/2021.  Parent was present and signed consent for vaccine.  Patient tolerated procedure and was observed for 15 minutes post vaccination and then released.
I had a raised spot come up on my arm at the injection site. I started having symptoms of congestion and fever on 12/30 and 31. I tested positive for COVID-19 on 01/02/2023 with a home test. The nurse on staff at the urgent care center recommended that I wait a couple of days to see how my symptoms do. I ended up taking Theraflu, Mucinex DM, cough drops and Tylenol to help with my symptoms.
About 5 hours after receiving the vaccine, the patient reported shortness of breath and extreme chest pain.  He saw his cardiologist the next day who said everything was normal.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6198), on 06Mar2021 as dose 2, single (Lot number: EP6955) and on 26Sep2021 as dose 3 (booster), single (Lot number: FF8125) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: BUSPIRONE; SERTRALINE. Past drug history included: Thimerosal, reaction(s): "Allergy: thimerosal", notes: Known allergies: thimerosal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.
The pt stated that after receiving 2nd Anthrax shot on 5/25/00 she immediately felt burning in her right arm, which she states that it was a normal reaction. Pt states that the burning continued up until bedtime and when she woke up on the following day, he whole arm was very sore to the point where she didn't want to move it. Pt also states that at the injection site, it was also swollen. Pt states that by the next day, the pain was unbearable and she took Motrin and she called and made an appointment. The pt states that after taking the Motrin, she felt somewhat better but an area on her wrist and forearm continued to hurt. Pt also states that her fingers were tingling.
suspected vaccination failure; very mild case of it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The case was reported for the reporter's husband. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got very mild of shingles. The reporter stated that, it was worth the vaccine and suggested to get the Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Mouth filled with foam; Hiccuped; Whole mouth was filled with a very thick, veryfoamy saliva; This is a spontaneous report from a contactable other healthcare professional, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 02Apr2021 at 14:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 15:30, one hour after receiving the vaccine, the patient experienced mouth filled with foam, hiccuped, felt the mouth was filled with saliva and when she looked in the mirror the whole mouth was filled with a very thick, very foamy saliva. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events mouth filled with foam, hiccuped and whole mouth was filled with a very thick, very foamy saliva was resolved with lasting effects on 02Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
DtaP-Hib combo given before 15 months of age. No side effects reported.
Fever Cellulitis Elevated troponin Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present"
scheduled his 2nd dose on 17March2021 and he knows that's way passed 42 days; A spontaneous report was received from a consumer of unknown age on 11 FEB 2021 stating that he received his 1st Moderna vaccine on 21Jan2021 through the department of health at Goldsboro, North Carolina. They didn't schedule his 2nd dose until 10 FEB 2021. They called him on 10 FEB 2021 and scheduled his 2nd dose on 17 March2021. He knows that's way past 42 days, so he wants to know if that'd still be effective and if he needs to start over the vaccine series.   Patient's medical history was not provided. Action taken with mRNA-1273 was not reported. The outcome of the event was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 with no associated AEs.
Patient reported feeling sensation of "warmth" around 5 minutes post immunization.   Patient was escorted to waiting area and sat in seat within range of nurse site line.   RN later sat with patient 5 minutes later as she continued to have feeling of "warmth" / flushing. Patient given water and moved closer to nurse area.   Patient then shortly after c/o light headedness and now feeling cool. Remains alert / oriented.   BP: 142/80 HR: 127 RR: 20 SPO2: 100%   ICC called. Medic and Dr arrived for patient handoff. RN escorted patient to ICC with Medic and MD following.   Patient to finish visit in ICC for final dispo.
Patient reports development of overall body aches and pains followed by a mild fever the day after receiving vaccination. She also reports a patchy rash that was itchy but not painful. This rash developed at the ends of both arms, on the backs of the knees, and down the calf muscles. The rash appeared 2 days after receiving the vaccine and lasted for 2 days. Patient took Ibuprofen to treat the fever but did not take anything to treat the rash.
pt recv vax 11OCT96 & 12OCT96 pt devel a total body itch w/a  red, raised measles-like rash transient but especially on back;tx in ER w/pred burst;DPH & a cortisone inj & obtained no relief;
This spontaneous report as received from a registered nurse refers to a 9 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054:
patient received his 2nd dose and as he was waiting the 15 minutes he passed out . patients significate other/ girlfriend  . stayed with him . 911 called patient  was okay , all vitals fine . patient had similar passing out first dose but dr said he was okay to get  2nd . patient denied any further treatment from paramedics
Injection site erythema, induration, itching. Generalized body aches, fever of 102.6, chills. Symptoms started one day after receiving vaccine.
14 y/ male, admitted from the ED for further evaluation and management of chest pain, acute onset.  Patient was well until 6/21/21 at ~ 6 AM when patient was woken up by  sharp pain in his chest, he describes as intense for about 30 minutes. He was brought to the ED where chest pain was more bearable "heaviness". By 10 AM patient states that the pain is gone. EKG showed ST segment changes.  Troponin 3.87 ng/mL. Due to concerns for myocarditis, patient was admitted to the ICU. Cardiology consulted. Echocardiogram obtained 6/21/21 was normal. LR started for maintenance fluids to ensure adequate hydration.  Patient had no further episodes of chest pain. No pain medications administered in ED or PICU.  Repeat EKG on 6/22 with  Normal Sinus Rhythm with sinus arrhythmia. Pt discharged on 6/22/21 AM.
8/1 mother reported left deltoid area hot, red, swollen twice the size of the other arm.
4 to 5 hours after first injection of a rabies vaccine 09/1998 had a fever of 102.7 for three days. Severe pain in all muscles and joints along with stiffness. Severe Flu like symptoms, stomach problems and overall feeling of ill health. Routine severe diarrehia. Severe Headache for approximately two years everyday at base of skull/top of neck which would not go away with any over the counter pain medication.     Four months after vaccine for the first time in my life suffered a severe cold sore on my upper lip. Have had routine canker sores inside my mouth ever since which correspond to severe pain in joints and muscles and stiffness.      For two years following vaccine (until 2000) was extremely fatigued many times sleeping for as much as 16 hours per day along with constant joint and muscle pain and stiffness.      From 2000 (until 2003 when treatment was sought) suffered periodically from severe fatigue. Suffered daily from severe muscle and joint pain and stiffness. Also routine severe headaches at base of skull/top of neck. An overall feeling of sickness including stomach problems and diarrehia.       Was put on numerous anti inflamatory drugs which didn't help i.e. Bextra, Mobic.      Was put on 20 miligrams of Prednisone for one week and stiffness and joint muscle pain decreased by 80 percent upon return visit. Stayed on Prednisone for one year while doctor tried numerous drugs to relieve symptoms so I could get off Prednisone.       Currently off Prednisone for three months and now taking Salsalate, Lexapro, Plaquenil, Folic Acid, Ultracet as needed for pain which are all working very well. Still suffer from slight pain, stiffness and swelling and sometimes redness everyday. Once or twice a month pain and stiffness will spike and become severe and need to take ultracet for pain for 2 or three days. Again canker sores, stomach problems, headache at base of skull and all over feeling of poor health correspond with increased joint and muscle pain and stiffness.     Stiffness continues to spread to more and more new joints over time.
rash at the injection site occurred on the same day (10/10/2021) but not severe, however, patient came to us on 10/13/21  indicating the rash is spreading and felt hot. No other symptoms noted. I recommended patient to put ice at the injection site and  may use benadryl if  needed, however, patient should also seek medical attention at same time.
Extreme fatigue for 48 hours post injection Low grade headache for 96 hours post injection
Severe headache, stiff neck, sore throat, skin sore to the touch, swollen glands, low grade fever, rash (bad) and painful injection site, rash on body. Went to my doctor who said I had brain swelling. Received RXs for inflammation and to kill the virus.
Redness, discomfort, itching approximately 35 mm bright red indurated area right posterior arm, further light redness extending to 1" above elbow.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt was given vaccine on 1/22/02. On 2/4/02, after vigorous exercise, he developed severe proximal arm aching with gradual onset of severe headache over a 5-7 day period. He was evaluated on 2/7/02 in the office with severe elevation of CPK to 87,000. On 2/8/02 was admitted to the hospital with rhabdomyolysis, aseptic meningitis and hepatitis. He is better but is still in ICU.
Stood up to go to the observation chair after getting vaccine. After sitting down at observation area, heart rate seemed to drop/become abnormal, and I began to lose hearing, and vision began to get fuzzy. The pharmacist accompanied me as I was experiencing symptoms, talking me through things. I then began to get profuse cold sweats, after which I asked for water. After drinking a bottle of water and not moving for about 15 minutes, everything turned to relative normalcy. I was able to walk home afterwards.
?Covid arm? hard pink/red rash developed 7 days after vaccine around injection area of left arm. A little itchy/sore. Puffy and irritated looking.
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 06-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
They day after the first vaccine I began to feel body aches, nausea, diarrhea, and lethargy. Three days later my syncope from my heart condition has increased. Now I have been fainting several times a day (usually it?s just once a day or once every other day). A week after the vaccine a red spot about the size of a quarter appeared on my right wrist and then went away 12 hours later. The other symptoms didn?t improve. Then when I got the second vaccine my symptoms worsened. My nausea, lethargy, body aches and diarrhea have gotten worse and now I?m fainting even more often then I was after the first vaccine. I also feel lightheaded all day everyday. 4 days after the second vaccine a second red spot appeared on my left hand (this time about the size of a pea). It also went away 12 hours later like the first spot did. Now I am on my 5th day after the second vaccine and my symptoms still haven?t improved.
rash all over his trunk area; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over his trunk area) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced RASH (rash all over his trunk area). At the time of the report, RASH (rash all over his trunk area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.