chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ONGOING BUT SLOWLY DECLINING: SEVERE CHILLS, SWEATING, ACHES, COUGH, TASTE DISTURBANCE.
Narrative:  8-year-old male with comorbidities of hepatitis C s/p treatment in 2/2019, ulcerative colitis, seropositive non-erosive rheumatoid arthritis, high risk medication use (tofacitinib and hydroxychloroquine) who presents to the ED with a chief complaint of dyspnea. Symptoms started, 8/28/2021. Dyspnea started yesterday and is progressively worsening. It is associated with a non-productive cough. He had an outpatient Covid test done that was positive. He was vaccinated with Moderna x2 in 1/2021 and 2/2021. No fevers or chills. Diarrhea started Thursday but seems to have slowed down. He is passing flatus. He has generalized abdominal discomfort with eating or drinking, as well as nausea. He is unsure how he contracted Covid. Wife also has Covid but is doing well. He has been taking tofacitibin and hydroxychloroquine throughout illness, up until ED visit. He was placed on 2 L NC due to tachypnea.
Blurry to blackout vision, loss of orientation within 10 minutes of vaccination and lasting for 20 minutes.
asymptomatic, tested as part of follow up from known exposure, tested positive on binax rapid antigen test 1/28/2022
(R) arm redness, pain and swelling x 2 days s/s starting approximately 24 hrs. s/p vaccine advised cool compress, OTC pain reliever OTC H1 and H2 blocker, Prednisone taper and BACTRIM BID.
tarry stool; Nausea; diarrhea; stomach pain; This is a spontaneous report from a contactable consumer reported for herself.  A 22-years-old female patient received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, vaccine location: right arm, on 25Mar2021 18:00 (Lot Number: ER8727) at the age of 22 years as SINGLE DOSE for covid-19 immunisation. Pregnant at the time of vaccination: No. Medical history included type 1 diabetes mellitus, coeliac disease, asthma, arthritis, post-traumatic stress disorder, food allergy (strawberries) and seasonal allergy. Concomitant medications included insulin lispro (HUMALOG); escitalopram (ESCITALOPRAM); trazodone (TRAZODONE); lorazepam (LORAZEPAM). On 26Mar2021 the patient experienced tarry stool, nausea, diarrhea and stomach pain; all with outcome of not recovered. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosed with COVID-19 and, since the vaccination, the patient did not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
10 min after receiving vaccine patient became flushed, feels like arms are swollen and itching, nausea, and sweating. Patient went to ER and they noted tachycardia and diaphoresis
Sore Right Shoulder; Bloody Nose; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Bloody Nose) and ARTHRALGIA (Sore Right Shoulder) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 045A21A) for an unknown indication.     Previously administered products included for Product used for unknown indication: flu. Past adverse reactions to the above products included Arthralgia with flu. Concurrent medical conditions included Hypertension. Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) from 01-Jan-2019 to an unknown date for Supplementation therapy, CENTRUM MEN from 01-Jan-2002 to an unknown date for Vitamin supplementation.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced EPISTAXIS (Bloody Nose). On 15-Apr-2021, the patient experienced ARTHRALGIA (Sore Right Shoulder). On 14-Apr-2021, EPISTAXIS (Bloody Nose) had resolved. On 18-Apr-2021, ARTHRALGIA (Sore Right Shoulder) had resolved.            No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow up received on 22-MAY-2021 Contains Patient demography, Medical history, Concomitant drugs and event outcome were added. On 22-Jul-2021: Follow-up received-ADR form contain no new information
allergic reaction; Pressure in the chest; pain in chest; Heart rate increased; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced allergic reaction, chest pressure, chest pain and heart rate increased. On an unknown date, the outcome of the allergic reaction, chest pressure, chest pain and heart rate increased were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, chest pressure, chest pain and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The age at vaccination was not reported. The patient received Shingrix over a year ago (was not sure of the exact date of vaccination). The patient experienced an allergic reaction that was described as pain and pressure in the chest and her heart rate increased. The patient stated she won't get the 2nd dose. The events were reported directly from patient with no information provided from healthcare professional (HCP) or any details from vaccination.
Injections listed above given. Dates and Lots checked before they were given. I did not catch that the Tdap had expired on 1/17/20. I was thinking that it was good until next January. I gave all injections without problems. When documenting is when I realized that it was in fact past it's expiration date.  Notified my NP that I work under along with the Office Manager.  I have contacted the mom of patient and she reports no side effects noted other then patients arms were sore for a couple of days due to receiving 2 shots in each.
Pt presented with worsening dementia, pt positive for uti, Pt discharged on antibiotics.
Began crying approx. on the 5th day, post vax. Cried at long intervals and had short naps between. Saw doctor the next AM of 1/4/01 and fever of up to 103F the day of shots and the next day. Ran a low-grade temperature for a couple more days. Cried for approx. 3 days, at long intervals, then for 2 days to a lesser degree. Cry was high pitched, as if in pain. Not a regular cry. No redness, swelling or hardness at injection site.
patient was given shot and approximately 5 minutes later experienced a syncope episode without losing consciousness. Patient became pale, had sweating and slight tingling in is vaccine administered arm. patient was responsive through whole episode so 911was called but cancelled as he regained composure. Cold packs were applied and patient stated no breathing distress. Pt remained in pharmacy for approximately another 25-30 minutes until family member arrived for a ride home. Pt stated would not be alonefor the rest of the evening and I verified contact info to call later to check on patient.
BOOSTRIX given today - but he also had one 5/2/07. (No symptoms/signs) (this simply acknowledges that this given too soon past DTaP)
On April 22nd, my husband and I both got our 4th shots. On the 23rd, he and I were both stopped up, congested and continued to get bad. I got us some Mucinex. On the 27th, we went to urgent care. I am home recovering from a foot surgery. We both took COVID-19 tests, flu swabs, negative. We both had pneumonia.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 28-MAR-2016, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml "SDV;Pk/10" (route of administration and anatomical location were not reported). On an unspecified dates, the  COMVAX had nine temperature excursions: 72 hours, 192 hours, 1152 hours, 488 hours, 64 hours, 88 hours, 328 hours, 64 hours and 40 hours. The lowest recorded temperature was 28 F (-2.222222222 Celsius) while the highest recorded temperature was 48 F (8.888888889 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Patient states that as soon as she got the vaccine she started to sweat and got lightheaded and put her down. Patient was given an ice pack to put on the back of her neck and that is helping. Patients vitals taken at 2:43 pm heart rate 93, o2 100 and BP 122/85. At the end of the 30 minutes we check to see how the patient was feeling and she stated that she was feeling better so we released her at 3:03 pm.
Itchy rash that started on one arm,  did not respond to topical rash cream, and continued to spread across both arms. Treatment: Methylprednisolone 4mg dose pack
Completely red blood shot eyes, uncontrollable coughing, runny eyes, fever feeling of malaise and on 12/4/12 had a stroke and platelet lever was a 9 in the hospital.
Mild frontal headache for 3 days, worse at night & when bending over. Treated with OTC ibuprofen.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: recommended to patient that she follows up with PCP to determine bone /shoulder pain that she is experiencing
I woke up that morning with blurred vision in one eye, over the day pressure built in my head which caused a headache. Went to Dr.  for blood work, on Monday still had the headache and blurred vision. I was sent to the ER for bloodwork and was called back for a MRI. I also went to the eye doctor but nothing was found.
Headache, Myalgia, arm pain that is limiting movement Narrative: employee is 25 weeks pregnant.
No other adverse event reported; a pregnant patient received GARDASIL 9; Information has been received from a registered nurse regarding a 29-year-old female pregnancy patient. The patient's drug reactions, allergies, and concomitant therapy were not provided.   On 27-MAY-2021, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot# T025367, expiration date 18-NOV-2022; strength, dose and route were not provided) for vaccine (vaccine exposure during pregnancy). The patient's gestion period was 28 weeks and 5 days. The last menstrual period was calculated as 07-NOV-2020 and estimated date of delivery was calculated as 14-AUG-2021. The pregnancy outcome was pending. The fetal outcome was unknown. No other adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025367; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
13 year old female patient inadvertently administered expired dose of IPOL, no AE; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 year old female patient who was inadvertently vaccinated with an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 01-Dec-2020, the patient received a 0.5 ml first dose of suspect IPV (VERO) (lot P1F491M and expiry date: 30-Nov-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Reporter relationship: HCP (health care professional), product used: used, first time product used: no and still using product: no  At the time of report, no adverse event was reported.  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 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.
Medical Assistant administered an expired dose of the IPOL vaccine. Vaccine expired on 7/25/22 and was administered on 7/27/22. Patient has had no reports of adverse reaction to the vaccine. This report pertains to a mistake in vaccine administration, not an adverse reaction to the vaccine.
fever of 101 - 102 started around 24 hours later lasted about 48 hours Inflamation from elbow to close to shoulder, red  and hot to the touch, improvement began on the 5th day
HAD SOME SCARS THAT LOOKS LIKE BRUISES FROM THE FIRST STAGE OF PSORIASIS; HAD DOTS ON UPPER BODY/ STILL HAS SOME SCARRING; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (HAD SOME SCARS THAT LOOKS LIKE BRUISES FROM THE FIRST STAGE OF PSORIASIS) and SCAR (HAD DOTS ON UPPER BODY/ STILL HAS SOME SCARRING) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONTUSION (HAD SOME SCARS THAT LOOKS LIKE BRUISES FROM THE FIRST STAGE OF PSORIASIS) and SCAR (HAD DOTS ON UPPER BODY/ STILL HAS SOME SCARRING). At the time of the report, CONTUSION (HAD SOME SCARS THAT LOOKS LIKE BRUISES FROM THE FIRST STAGE OF PSORIASIS) was resolving and SCAR (HAD DOTS ON UPPER BODY/ STILL HAS SOME SCARRING) had not resolved.            No concomitant drug information was provided.  It was unknown if the patient was enrolled in clinical trial.  The reporter's causality for the reported events with respect to Humira was not provided.  No treatment drug information was provided..
While in monitoring area, client reported feeling dizzy and faint. Client was ambulatory. Vitals taken and normal. After getting out of her car, client reported cold air helped and was not experiencing symptoms any longer. Client declines EMS tranpsport for further evaluation, instructed to follow up with PCP or ER if symptoms worsen/recur. Client assisted back to car with boyfriend.
received the Johnson and Johnson covid vaccine stayed at the health department for 30 min due to the anaphylactic reaction from the flu vaccine. went home. started having head to toe redness and itching. contacted the health department that gave me the vaccine to see if this was a normal reaction. started developing hives. took 25mg Benadryl. heath department advised me to contact my pcp. contacted my pcp. Nurse advised me to also take an additional 25mg Benadryl, 20mg Pepcid, and 10mg Claritin until hives and itching stopped but if symptoms worsened to go to the emergency room. stayed on the additional allergy medications for 4 days until hives where gone and itching was tolerable.
pt recvd vax 0900 hrs approx 1100 hrs pt began to feel nausea & became diaphoretic; this was followed by fever, h/a, tremors, diarrhea x 2; no evidence of resp distress/wheeze/angioneurotic edema or other evidence of anaphylasix;
Red spit below injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red spit below injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Red spit below injection site). At the time of the report, INJECTION SITE ERYTHEMA (Red spit below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.
State says that his lot number for the first vaccine in their data base is for a Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (State says that his lot number for the first vaccine in their data base is for a Pfizer) 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (State says that his lot number for the first vaccine in their data base is for a Pfizer). On 18-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (State says that his lot number for the first vaccine in their data base is for a Pfizer) had resolved.            It was reported that, the patient received his first two Moderna COVID-19 vaccines at Health Care. Health Care administered two Moderna COVID-19 vaccines for his primary series.  However, the State says that his lot number for the first vaccine in their data base was for a Pfizer vaccine. On 15-Jan-2021, he received his first Pfizer vaccine in his left arm shoulder deltoid muscle. He reports no other side effects post first vaccine. On 18-Feb-2021, he received his second Moderna COVID-19 vaccine    No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow-up information received includes no new information.
She got her vaccine, had no reaction initially.  During the morning hours of  Saturday she had severe diarrhea at least 20 some times like she had a colonoscopy prep, was living in the bed and the bathroom.  While it said it could be a side effect she had never heard of such a thing.  She did not know if her previous COVID vaccines may have caused the reactions.  She also had fatigue, slight headache and a temp of 99.  She took Tylenol for the symptoms, which did help.  By the following day the headache was gone.  She gets headaches when she gets vaccine.  The diarrhea is less, but did still have some today.  She did take 4 Pepto-Bismol tablets on Saturday.  She called her pharmacist who looked it up and told her the percentage of people that would get this and it was 2-10%, and that was it.
Had chills fever and body ache starting 01/07/21  Temperature went as high as 102.0 took ibuprofen and came down  97.9
This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN2604), at the age of 75, via an unspecified route of administration, right arm, on an unknown date Mar 2021, at 11:30, single dose, for COVID-19 immunisation. The patient had an unspecified medical history. The patient does not have any known allergies to medications, food or other products. The patient received unspecified/other medication within 2 weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021; 4 weeks after the 1st shot, patient's right arm at the injection site turned into a hard multi-cell blister. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the 4 weeks after the 1st shot; patient's right arm at the injection site turned into a hard multi-cell blister: not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
Systemic: Exhaustion-Mild, Systemic: Generalized Body Aches -Mild; symptoms lasted for 0 days
First Dose 04/13/2021 around 1:00 PM -2:00PM, I started getting hot flashes. Later on in the evening, I had body aches, chills, headaches. I went to the doctor the next morning, They told me that to take plenty of fluids and take rest. It was from the vaccine. Second dose 05/11/2021- the same day, I started feeling hot flash, body aches, chills, headaches. It lasted about one week and half. Third  dose- 10/29/2021- Same flu like symptoms as for dose 1 and 2 but middle of the night I had a high fever. I took Tylenol to reduce the fever. The next day fever was gone but other symptoms lasted for about one week and half.
Rash on the inner side of left arm below the administered site.  Pt has no fever, rash is itchy slightly warm to touch.  Rash continued but not spread as of 9/25/15 with OTC hydrocortisone topical.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 07Apr2021 as dose 2, single (Lot number: EN6204), in left arm and on 11Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing). Patient had no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication: Treatment of COVID-19; (23Sep2022) Negative; (26Sep2022) Positive, notes: Tested positive for COVID on 26Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
55 year old female with h/o hypertension controlled with medication. About 3-5 days after vaccination experience "pleuritic chest pain." Pain with breathing and movement. Rx'd with NSAID. Has h/o of pleurisy and said pain was just like previous pain from pleurisy. Saw pcp and had EKG< Xray which were normal. No blood work. Lasted 2-3 weeks.