chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting  2x started on 10/3/21 at 3pm, unable to hold head up and talk clearly, no appetite, very fatigued, legs hurt, joint pain, back pain Vomiting  1x and diarrhea 2x on 10/4/21, complained of joint pain (knees and toes), headache, no appetite, very fatigued, legs hurt, teeth hurt, stuffy nose, pain in the xiphoid process, back pain 10/5/21 fatigued, no appetite, knees hurt, headache, back pain 10/6/21 fatigued, knees hurt, legs hurt, headache 10/7/21  fatigued, knees hurt, legs hurt, headache Extra Strength Tylenol given every 6 hours but did not completely take away the headache
High INR; This case was reported by a consumer via call center representative and described the occurrence of international normalized ratio increased in a 90-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2020) for prophylaxis.   On 25th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 4 days after receiving Shingrix, the patient experienced international normalized ratio increased. On an unknown date, the outcome of the international normalized ratio increased was unknown.   It was unknown if the reporter considered the international normalized ratio increased to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient stated that, after vaccination with Shingrix, her international normalized ratio bloodwork for coagulation was increased. About 4 days later of vaccination international normalized ratio was 3.1, on 6th May 2019, INR was 2.9, on 13th May 2019, INR was 3.4,and on 20 May 2019, INR was 3.3. On the day of reporting the INR was 2.0. The patient had to decrease dose of Warfarin on 2 different doses. The patient consented to follow up.
Headache within one hour. Nausea and weak within one hour. (R) arm numbness that day. (R) arm very red and swollen at area of varicella shot.
Information has been received from a registered nurse referring to a 29 year old female patient. The patient did not have any pertinent disease history. The patient had a medical chart history of an allergy to CECLOR (no details or dates were available about this allergic reaction). The patient was pregnant with last menstrual period (LMP) 11-APR-2016 and estimated date of delivery (EDD) 16-JAN-2017. The patient was using PRENATE PIXIE (manufacturer unspecified) therapy which was started on 07-MAY-2016. On 19-OCT-2016, at gestation age of 27 weeks and 1 day, the patient was vaccinated with a dose of vaccinated with GARDASIL 9 (dose and route unknown; lot number was reported as M021407 with expiration date 30-APR-2018) and influenza virus vaccine (unspecified) (dose, route, lot# and expiration date unknown). No known adverse effects were reported. Pregnancy outcome was pending. The fetal outcome was unknown. Additional information has been requested.
12/14/99, 10:30am, child very cranky & fussy. Slept well. In am., 12/15/99, 10:30am, child felt hot, temp 101, fine red rash noted on abdomen. Took to Dr in am of 12/16/99; Dx:Otitis Media in both ears. Red rash measures approx 4"x1" total.
Pt complained of redness with slight swelling from shoulder to elbow, on left upper arm, site of DTaP. Noted this AM, after playing outside. Denies fever but is slightly uncomfortable: Treating with Tylenol PRN. Is getting better with movement.
Became pale, diaphoretic, wheezing after KINRIX in (L) deltoid, PROQUAD in (R) SQ arm. P 104, BP 115/78 EMS called. O2 Sat 100%. Patient stabilized. No medicine given. Mother refused trip to ER. Stated she would call family doctor.
Pt came into office on 3/16/16 to show us the effect. She had hives/welts on left deltoid. We gave pt Rx for prednisone.
Tachycardia  BP 135/93  P 117 R 18 O2: 100%      Exam:     General: Alert, anxious, labile   HEENT: Normocephalic, Atraumatic   Neck: ROM normal  Cardiovascular: tacycardic, regular rhythm   Respiratory: Normal effort, CTAB   Abdomen: Soft, Non-tender, Non-distended Feeling of impending doom
Patient noticed today that her arm was red and warm where injection was given, approx 6x6 inch area.  It is not swollen or itchy or painful.
At the injection site it became puffy and sore. She lost her voice and had nausea, vomiting, high fever of 102. Muscle aches and joint pains along with chills. With to ER and they gave her 3 high steroid pills and a pepcid. She has also developed hives.
He received Moderna Vaccine on 02/16/2021 and 03/16/2021. No reactions developed after two vaccinations.  7.7.21: Patient developed difficulties of breathing one week and presented to ER on 7/7/2021 and has been hospitalized since 07/07/2021. Presented with cough, chest pain, and shortness of breath. Diagnosed with pneumonia 7.11.21: discharged home.
RED BASE LESIONS IN VARIOUS STAGES.  VESTICLE TO  SCABBED
Rash on face around mouth up to eye. Rash worsening to rest of body.
Had a large swelling/knot and some bleeding immediately after injection. Patient took BENADRYL and the swelling resolved later on 10/4/12. Did not seek medical care.
Diarrhea; Lump on arm is a little red; discovered it was red and had swelling; arm was hurting; Chills; swelling on arm/describe it as the shape of half of a walnut shell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 08:00 (Lot number: EN2607) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease", start date: 1995 (ongoing), notes: in 1997 she ruptured, referring to her Crohn's; "Arthritis" (ongoing), notes: since the 1980's; "Nausea" (unspecified if ongoing); "Pain" (unspecified if ongoing). Concomitant medication(s) included: IMURAN [AZATHIOPRINE] taken for crohn's disease (ongoing); CELEBREX taken for arthritis (ongoing); PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL] taken for pain (ongoing); CITRACAL + D3 taken for crohn's disease (ongoing); FOLIC ACID, start date: 1997 (ongoing); ONDANSETRON taken for nausea (ongoing). Past drug history included: Humira. Vaccination history included: Covid-19 vaccine (dose 1, Lot number: EL9266, Expiry date: unknown , Location: left arm, route: injection), administration date: 01Mar2021, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 23Mar2021, outcome "recovered" (23Mar2021), described as "Chills"; DIARRHOEA (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "Diarrhea"; PERIPHERAL SWELLING (non-serious) with onset 22Mar2021, outcome "not recovered", described as "swelling on arm/describe it as the shape of half of a walnut shell"; LIMB MASS (non-serious) with onset 23Mar2021, outcome "not recovered", described as "Lump on arm is a little red"; ERYTHEMA (non-serious) with onset 23Mar2021, outcome "unknown", described as "discovered it was red and had swelling"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "unknown", described as "arm was hurting". Therapeutic measures were taken as a result of diarrhoea. Additional information: It was reported that patient has been taking Imuran probably from the beginning of her diagnosis with Crohn's, since 1996 or 1997, taking Celebrex for about 20 years, Percocet for about 2 years, multivitamin (1 tab daily) (unspecified) for about 15 years to stay healthy. It was also reported that her physician recommended she take Citracal +D3 because of her Crohns and has been taking it for 2 years because of the calcium citrate, began taking Folic Acid probably about 1997 because the Crohn's doctor said it was good for the patient. It was reported that the label stated ondansetron ODT and has been taking ondansetron as needed for nausea for 2 years.  No follow-up attempts are possible. No further information is expected.
Generalized weakness, acute on chronic encephalopathy that persisted for approx 1 week and then slowly improved.  this required a 14 day hospitalization
DTaP injection site red, swollen. 2 days. States not painful. Cold packs to site. Benadryl 3/4 to 1 tsp QID.
Fever of 104 starting the next morning.; Chills; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: #er8737) via an unspecified route of administration in the left arm on 12Apr2021 at 13:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history and no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the left arm on 22Mar2021 at 13:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever of 104 (unspecified units) starting the next morning, chills on 13Apr2021 at 06:00. Therapeutic measures were taken as a result of fever of 104 (unspecified units) starting the next morning, chills and included treatment with Advil. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fever of 104 (unspecified units) starting the next morning, chills was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
No additional adverse effects reported; an expired dose of properly stored VARN AX was inadvertently administered to a Patient; This spontaneous report was received from a nurse concerning a 19-year-old patient of unknown gender.   The patient's concurrent conditions and medical history were not reported.  The Nurse stated that on 28-JAN-2020, an expired dose of properly storedvirus vaccine live (oka/merck) (VARIVAX) (lot # R002056 and expiration date 22-JAN-2020) was inadvertently administered (dose and route were not reported) to the patient for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # and expiration date were unknown by the reporter). No additional adverse effects were reported.
Pt received SHINGRIX in left deltoid muscle on 5-17-18. On 5-19-18, came in presenting with large red area where vaccine was administered or possible cellulitis.
No additional adverse effect reported; A patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-JUN-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, for prophylaxis (lot # S005875 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 30-NOV-2020) (strength, dose and frequency were not provided).  The administered dose of the vaccine experienced a temperature below36 ° Fahrenheit (F) for 25 minutes. There was a digital data logger involved, and the previous temperature excursion was 36 °F for 1 hour and 24 minutes.  No additional adverse effects reported.; Sender's Comments:  US-009507513-2007USA000228:
Redness at the injection site that is size of baseball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site that is size of baseball) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site that is size of baseball). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site erythema, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site that is size of baseball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Tylenol.
1 week and 2 days later my arm where the injection was given is red, painful, swollen, warm to the touch, and itchy
SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORE ARM) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN and METOPROLOL for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (SORE ARM). At the time of the report, PAIN IN EXTREMITY (SORE ARM) outcome was unknown. Not Provided          No treatment information was provided.   This case was linked to MOD-2021-065167 (Patient Link).
Headache, Myalgia, Arthralgia, C/O SEVERE HEADACHE, FATIGUE, BODY  ACHES, JOINT ACHES Narrative:
The morning after Pt received his 6 month vaccines Pt woke up and began crying and shaking, staring off, not responding to mother, for about 30 seconds, then seemed to be okay briefly, then recurred, repeatedly for 25-30 minute duration. Patient spit up during this time, and seemed clammy/sweaty. No fever noted. Right afterwards he went to sleep for 2 1/2 hours. Later this day, Pt came in to our office for a follow up and had not had any further episodes.
Fever 3 days/ 10 days later fever 2 more days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 3 days/ 10 days later fever 2 more days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Hives (The patient had a allergy history of Hives/urticaria.), Coronary artery bypass (triple by-pass), Coronary arterial stent insertion (12 stents), Cardiac catheterization (18 heart catherizations) and Arterial graft (a bovine artery grafted into the right femoral artery). Concurrent medical conditions included Drug allergy (hives from vitamin C in fruits, or a new fruit , or large quantity of tablet) since 03-May-1951, Heart attack (10 heart attacks) since May 2000 and Depression since May 2000. Concomitant products included ESCITALOPRAM OXALATE for Depression, FUROSEMIDE, LISINOPRIL and ATORVASTATIN for Heart disorder, LEVOTHYROXINE for Thyroid disorder, TRAZODONE, EZETIMIBE, CARVEDILOL, ALBUTEROL [SALBUTAMOL], BUPROPION, CLOBETASOL and CLOPIDOGREL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PYREXIA (Fever 3 days/ 10 days later fever 2 more days). In March 2021, PYREXIA (Fever 3 days/ 10 days later fever 2 more days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       On 05-Mar-2021, the patient received the first shot and had fever for 3 days and 10 days later fever for 2 more days.  No treatment information was provided.   This case was linked to MOD-2022-507135 (Patient Link).
Patient reported to the TOH COVID Vaccine clinic on 2/25/21 around 4:30p to receive his second dose of Moderna vaccine.  The vaccinator verified date of birth and realized patient was 17 years of age.  The patient received the Moderna brand vaccine  on 1/28/21 which is currently only approved by EUA for patients 18 years or older.  Patient was told that he was below the age requirements and that the company would need to be contacted for further instruction before administering the second dose.      Moderna was contacted and we were informed the second dose could be given but is considered off-label.  Plan discussed with patient and legal guardian who wished to receive second dose.  Consent to treat was obtained and patient was given second shot.
Patient came in on 5/28 letting us know that he had gotten a rash which starting from the stomach and raps around the back. He also says he noticed a small rash on the left arm. Advised patient to call the Dr and make an appointment. Per package insert Shingrix can cause a rash as a side effect however, we would like him to get that check by Dr to ensure that is from the Shingrix and not from a bug bite. Spoke with patient again on 5/30 he said he is doing fine and will go to see the Dr the next day.
Headache CHILLS, CHEST PAIN THAT RADIATED TO BACK, JAW PAIN, CHILLS HOT FLASHES
I received the vaccine at work Thursday {December 31st} morning, and started feeling sick that same evening. Including malaise, low grade fever..not higher than 99.6, mild sore throat, shortness of breath, dehydration/dry mouth, light-headedness/dizziness, runny nose, and coughing. These symptoms continued on and off from {12/31-and continued all throughout the weekend and continue as of today-01/04}. Fevers don't last long, they come and go. The main symptoms that are chronic and consistent are the runny nose, sore throat, shortness of breath, and feeling tired/lethargic, just low energy.
Severe chills/shaking (teeth chattering), 103 degree temp, vomitting (for 4 hours), diarrhea, severe headache, severe muscle ache, pain when moving, exhaustion.  Major symptoms over after ~10 hours.  Headache lasted for 3+ days, exhaustion lasted for 3 days.
Intense itching at injection site. Induration of 3x3 area very red, hot and hard.
Pt came to clinic C/O raised, irritated hair follicles on both arms from shoulder to elbow, rt leg, and rt chest. Pt reports this started "1 week after the shots for travel." Pt denies itching, but reports over time, "spots got dry and felt rough like a cheese grater." Pt reports her PCP diagnosed it as an allergic reaction to the vaccines and told her to come back to office. Pt reports she has been "taking BENADRYL every night for 5 nights" and that this has provided some relief. On examination, hair follicles in affected areas appear darker than surrounding skin, raised, dry, and in some cases crusted at apex. Pt denies any difficulty breathing or fever. Advised pt to continue with BENADRYL and use a non-fragranced moisturizing lotion on affected areas. Discussed w/pt concerns about second Hep A vaccine and advised she is not required to have second Hep A if she does not wish to. Advised of pt visit and concerns. Occurrence Date: 08/30/2017; Created on 08/30/2017 at 09:16.
pt passed away in the nursing home; cause of death was COVID 19 per death certificate; pt had a positive COVID test on 9/22/21 in Hospital; pt was transferred from the hospital to the nursing home
CLOTS; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died due to clot. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died to clots on an unspecified date. This report was serious (Death). This case, from the same reporter is linked to 20210457363.; Sender's Comments: V0: 20210456400-Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: CLOTS
Pt received vaccine in right deltoid on 7/12/17 around 0830 and states that he woke up the next day with fever, chills, and cold sweats that lasted throughout the day. Over the next 3 days, his right arm began to swell up and become red and warm to the touch with a large, firm raised knot at the injection site. Pt reported mild pain and itching and states that he was unable to raise his arm without pain.
Pregnancy exposure; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy exposure) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Sep-2020 and the estimated date of delivery was 11-Jun-2021. On 02-Oct-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy exposure). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 02-Oct-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy exposure) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2020, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Patient had no known allergies.
Wheezing. Shortness of breath. Hives. Agitation. Client received 0.4 ml/IM of Diphenhydramine 10 minutes after receiving  dose decrease in wheezing, respirations within normal range. With no agitation. EMS transported client to hospital.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 16 years old adolescent patient and unknown gender. On 01-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J009788, expiration date 17-MAR-2016)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Shingles rash developing under right arm/on right rib cage late evening 3/27/2021. Originally believed to be irritation from clothing. Rash spread to middle back and became slightly painful. Doctor's appointment was made on 4/1/2021 after hydrocortisone cream did not help the rash, and shingles was confirmed and diagnosed. Valacyclovir prescribed for 7 days. As of 4/2/2021 there is mild nerve pain accompanying the rash.