chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Sunday, July 17th, pt. developed diarrhea. Due to the frequent stools, he also developed diaper rash, including open sores. As of today, July 21st, he still has diarrhea and diaper rash. 3 calls have been made to his doctor office for advice on treatment. On Monday, he started use of Lotramin cream for presumed yeast infection for topical use in area of buttocks and perineum.  In addition to this Paste was applied on top of the Lotramin. On Wed, it was advised to put him on a clear liquid diet and switch to soy formula and apply milk of magnesia to diaper rash area in lieu of lotramin. After this application to apply a mixture of diaper rash cream with Zinc and cornstarch. On Thursday, due to his refusal to take soy formula, it was recommended by a doctor in his office to slowly wean him off his lactose formula and switch to Whole milk. To gradually transition off lactose while he has diarrhea. At no time did he have any other symptoms such as: fever, etc.
the day after vaccine patient w left leg swelling- 4 days later diagnosed with pulmonary embolus.
Pt presented with nausea, headache, dizziness 15 minutes post vaccine. Pt vomited subsequently times 1 also. and also felt distal parasthesias.
hot; hard; injection site is swollen; painful; The rest of the body is bit achy; feels like having a fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (injection site is swollen), INJECTION SITE PAIN (painful) and MYALGIA (The rest of the body is bit achy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (injection site is swollen), INJECTION SITE PAIN (painful), MYALGIA (The rest of the body is bit achy) and PYREXIA (feels like having a fever). At the time of the report, INJECTION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (injection site is swollen), INJECTION SITE PAIN (painful), MYALGIA (The rest of the body is bit achy) and PYREXIA (feels like having a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Non-ischemic cardiomyopathy with systolic heart failure.  Diuresis with IV lasix, metoprolol, Lisinopril.
Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date and time vial was first punctured was on 15-Jun-2022 at 9.15 AM, the vial undergo temperature excursions of plus 1.9C to plus 6.4 C for 15 mins.  Storage condition at the time of the excursion was Refrigerator.  Vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022  Visual inspection noting any vaccine state change was thawed.  Proposed desired use by date was 15-Jun-2022 afternoon.  No treatment medications were reported.
Narrative:  N-Herpes Zoster Vaccine administered in clinic. Rash observed by nurse and PCP
Pain in armpit near injection site. Worse with movement. Has lasted 3 full days.  Full center of armpit.
I started to feeling a little run down and a little flu like, my stomach was uneasy. On Monday I was coughing severely, fever of 101F, GI pain, severe flu symptoms, I took a home COVID 19 test that came up negative. On Tuesday it came up positive, I could not swallow so I could not eat or drink anything. I called my doctor on Wednesday, she prescribed me PAXLOVID, after my first dose I started feeling better.  By the following Wednesday I was able to go back to work but it took a month before I felt 100 percent myself. I felt fatigue that whole month. While I had COVID 19 all my underlying conditions got worse.
On February 16th I had a dry cough. I did an at home COVID-19 test and it was positive. I called my doctor because I have asthma and hypertension and I was concerned. She put me on a five day treatment of PAXLOVID. I never experienced any severe symptoms, it was all pretty mild. I did experience some fatigue, body aches and chills but no fever.
Kawasaki disease was admitted to the hospital and given IVIG and REMICADE.
Hive reaction; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558).  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 04Oct2021, outcome "recovering", described as "Hive reaction". The event "hive reaction" was evaluated at the physician office visit.  Additional information: The reporter stated the patient experienced hive reaction after receiving the first dose of the Pfizer Covid-19 vaccine. The reporter stated that this report was reported to VAERS. The reporter asked if the patient should get the second dose of the Pfizer Covid-19 vaccine and does Pfizer considered hives an allergic reaction. This report was not related to study or program. NDC number of Pfizer COVID-19 vaccine was unknown. The reason for no information about the batch/lot number of Pfizer COVID-19 vaccine was that reporter does not have the information available. Expiry date of Pfizer COVID-19 vaccine reported as unknown. The patient was not received other products. The reporter assessed the causality between the suspected drug and event was related. The reporter stated it is highly likely that the patient reaction was caused by the Pfizer COVID-19 vaccine. The patient has no medical history. There was no investigation assessment. The seriousness of the event was reported as unknown. The reporter denied any other medications, medical conditions, labs, testing, or treatments relevant to these events for the patient. Time of the vaccination was reported as unknown. Vaccination facility type reported as available. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) reported as none (this was the patient first dose). Additional Vaccines Administered on same date of the Pfizer suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect reported as none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines reported as none. Adverse event following prior vaccinations reported as none. Family medical history relevant to adverse event reported as none.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 days after pt developed swelling and redness over the whole bicep area of upper arm, warm to touch and pain. Redness is spreading to elbow on inner aspect of arm. She will contact MD. Already improving, getting better.
Felt dizzy and lightheaded  after 5 minutes post injection. Also had tingling  sensation on the tongue through the evening. Palpitations after 40 mInutes after vaccine  one time for a few seconds. Slight nausea after 1 hour  and 1/2.  Heavy head feeling  and dizziness like a cold without the congestion for 8 hours. Arm soreness was the least of my concern.
it caused him to go deaf in one ear.; This case was reported by a consumer via interactive digital media and described the occurrence of deafness unilateral in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included theraflu unknown unknown (batch number UNK, expiry date unknown) for flu.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and theraflu unknown at an unknown dose and frequency. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season and theraflu unknown, the patient experienced deafness unilateral (serious criteria GSK medically significant). The action taken with theraflu unknown was unknown. On an unknown date, the outcome of the deafness unilateral was unknown.   It was unknown if the reporter considered the deafness unilateral to be related to Influenza vaccine Quadrivalent unspecified season and theraflu unknown.  Additional information was provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient received his shot a year before reporting because he works in the medical field, it caused him to go deaf in one ear. The case had been linked with US2020AMR215313, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215313:same reporter
Muscle soreness/aches; headache; injection site pain; fatigue; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot number: En9581), via an un-specified route of administration, administered in Arm Left on 15Feb2021 17:00 (at the age of 36-years-old) at a single dose for COVID-19 immunization. Medical history included colitis ulcerative, blood pressure increased. Concomitant medication included sertraline hydrochloride (ZOLOFT) 50 mg; losartan potassium (LOSARTAN POTASSIUM) 25 mg, lansoprazole (LANSOPRAZOLE) taken for an unspecified indication, start and stop date were not reported. Patient took other_medications_in_two weeks: Zoloft -50mg, losartan pot -25mg, lansoprazole. On 16Feb2021 10:00 Muscle soreness/aches, headache, injection site pain, fatigue; The patient not received treatment, Patient not had Covid prior vaccination; covid not tested post vaccination; The outcome of the events was recovering.
Third dose due not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 28-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date) and Twinrix with an associated reaction of no adverse event (received 2nd dose on 10th November 2020, batch number dk23d expiry date 8th February 2022).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable. The patient received 1st and 2nd dose of Twinrix at primary reporter's facility. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. No date of birth was provided. The reporter consented to follow up.
Patient was in the carseat while I drove, so I could not observe the onset of the reaction. She was very quiet and around 12:30 PM she started coughing and then vomiting. She coughed and vomited profusely - at least 5 large projectile vomits and then began to retch and became pale and lethargic. The corners of her eyes were red.  I gave her an epipen (per food allergy action plan) and she began to improve very quickly - she began to cry & scream. She threw up twice more about 30-60 seconds after the epi and continued to cry. The ambulance arrived and took her to Hospital. She had tachycardia and a fever in the ambulance of 101.8 F, (no fever prior to the vaccine) but her fever was gone by the time we arrived at the hospital. She was given steroids, Zantac and Benadryl at the hospital and observed for 5 hours. Her heart rate went down but was still slightly elevated upon release. That evening she pulled at her mouth and tongue and was given more Benadryl. On 11/2/10 she had dark purple circles under her eyes and had two very mucousy stools, one loose, one normal. She was seen by her pediatrician and determined to be healthy and I had a follow up phone call with her allergist.  She had normal stools for two days, but has had soft, greasy, foul smelling, floating stools from 11/4 to 11/7 (day of the report) and developed a diaper rash on 11/7.  It is unknown if these delayed conditions are related to the vaccine. They have been seen following prior allergic reactions.
Information has been received from a registered nurse concerning a male who was vaccinated with a dose of MMR. Subsequently, the patient developed autism. No medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Autism was considered to be an other important medical event. Additional information has been requested.
Narrative: Patient completed Moderna COVID series in February 2021 and residing in Nursing Home. Had congestion and low O2 sat. Taken to hospital and tested positive for COVID-19 on 8/22/21 but not admitted. Sent back to nursing facility with oral dexamethasone and require more oxygen. Admitted to  hospital 8/23 and treated with remdesivir, dexamethasone, and enoxaparin. Discharged back to nursing home 8/26/21.
p/recvd vax, mom gave APAP thru 21DEC91 for t100-100 R; 22DEC91 pt woke/t103 parents called MD & gave more APAP; pt pupils became fixed & dilated w/no blinking; breathing was sl eratic; has nervous tick on rt side; sz; virus; pt vomited x 2
Tested positive for coronavirus on a home test; only very mild symptom (light cough); no fever; no sore throat; no other symptoms; prescribed Paxlovid after a call with my primary care physician; symptoms ended in a very short time, and I tested negative twice across 48 hours in home tests, 3 days and 5 days after initial positive test, and 2 days and 4 days after beginning Paxlovid.
I had feelings of indigestion. It felt like a fullness in my chest. I have a family history of heart disease, so I feared it was a heart attack. I was having a tingling effect in my trunk area. I went to an emergency room where they hooked me up to an EKG and did blood tests. I was kept overnight for observation at the hospital. They did 3 tests looking for troponin. All 3 came back normal. They did determine that my potassium was very low. They said the chest pain was due to that. After they brought my potassium levels back to normal, the chest pain went away entirely. They also said the blood pressure medication, being a diuretic, was starving my body of potassium. I was taken off and given a different blood pressure medication to take. Since then, I have felt fine.
Patient started feeling dizzy, her face became red, she was having trouble swallowing 10 to 15 minutes after vaccination. She did not have trouble breathing or did not break out into hives. She became even more delirious and could not walk after 10 more minutes. An epinephrine shot was administered, and she was watched for another 15 minutes. The symptoms subsided. Breathing and face color returned to normal, dizziness went away. I asked her if I could call 911, she said no. I advised her to visit ER.
pt recv vax & described sx of eye itch, eye worsening & aching all over, joints are aching, can't put weight on feet the lt side of body but ankles are very sore 2 days p/vax;
After a day or two, the vaccination site bubbled up.  There was fluid and blood in the bubble.
per pt:  hospitalized a few days after flu vaccine with severe chondritis in the neck, left arm, all lymph nodes on left side,  hositilization lasted 3 days.
SHINGRIX vaccine Severe pain for 4 days, soreness at site for 2 weeks, rash and hotness at injection site, extreme fatigue.
On 12/1/99, the pt developed generalized rash. The number of lesions was unknown. It was noted that the rash resolved but reappeared. The pt was scheduled to see a physician.
the patient had no symptoms or adverse events following administration; nurse who reports administration of vaccines following temperature excursion.; This spontaneous report has been received from a nurse referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions were not provided.  On 29-JUN-2022, the patient was vaccinated with  a improperly stored hepatitis a vaccine, inactivated (VAQTA) at a dose of  0.5ml/once, lot number U031911, expiration date: 11-NOV-2022, as prophylaxis (strength, vaccination scheme, and route of administration were not provided) following a temperature excursion of minus 0.8 degrees Celsius (C) for 1 hour 10 minutes, there was stated that no previous temperature excursion occurred. The patient had no symptoms or adverse events following administration of the vaccine.  This is one of several cases from the same reporter.
I felt very dizzy on the 8th day after getting the vaccination and have been feeling dizzy for 10 days now.  It's not as bad as it was when it first started but I still don't feel like myself and feel like I have to move slower than I used to.  A couple of days ago I felt almost normal again but  dizziness returned the next day.  I have a doctor's appointment scheduled on 9/30/2021
Information has been received from a registered nurse concerning a 33 year old female, who is trying to get pregnant and never had measles or mumps but does not have a good vaccination record history, who was vaccinated with her first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot #656670/0866U); expiration 30-MAY-2009). The patient was negative for rubella titers. The nurse did not know if the vaccination was ineffective since it was unknown if the patient ever received the vaccine. Since there was no documented history of the vaccination, it was assumed the patient had not been vaccinated. The patient sought medical attention and titers were drawn in the office. The patient was scheduled to return for the second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) in about a month. There was no product quality complaint. Additional information has been requested.
SHORTNESS OF BREATH   BLOOD CLOTS IN LEFT LEG  2 PE IN LUNGS  LOW HEMOGLOBEN COUNT ANEMIA
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 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid, Treatment start date: 27Jan2023, Treatment stop date: 31Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Site of injection became  very itchy today and noticed large sore knot about the size of a small apple.
Pt was given Engerix-B p/1st dose of vax given pt exp tingling in fingers (exact time of event is unk); no tx given;
Felt unwell, developed fever, felt nausea and fatigue. On 4/14/16 Developed severe tic, tilting head side to side, back and forth and to the far right and left as many as 95 times, every 4-5 seconds this tic has continued to the current date of 4/28/16, has shown no signs of reducing but rather has increased in intensity.
Had flu shot at 130pm then at 630pm SOB muscle tightness went to ER.  Flu like symptoms cont. for 2 days.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient got shingles after receiving the vaccine. The reporter did not consent to follow up.