chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of bloody diarrhea in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, extremities hot feeling of and swelling arm. On 9th November 2018, the patient experienced bloody diarrhea (serious criteria GSK medically significant), cramp, gut pain, diarrhea, body temperature decreased, cold and weakness. In November 2018, the patient experienced muscle soreness. On 9th November 2018, the outcome of the gut pain and diarrhea were recovered/resolved. On an unknown date, the outcome of the bloody diarrhea, erythema of extremities, extremities hot feeling of, swelling arm, muscle soreness, cramp, body temperature decreased, cold and weakness were recovered/resolved. It was unknown if the reporter considered the bloody diarrhea, erythema of extremities, extremities hot feeling of, swelling arm, muscle soreness, cramp, gut pain, diarrhea, body temperature decreased, cold and weakness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. After receiving SHINGRIX in the evening, the patient's arm was very red and warm and swollen. Redness went from her elbow to her shoulder. The redness and swelling gradually went away as the week went on. Less than a week after receiving SHINGRIX, the patient had normal soreness in the muscle. Three days after receiving SHINGRIX in the early evening on Friday, the patient started getting cramps and an hour later severe pain in her gut and diarrhea for an hour. She was in a lot of pain and could not stand up. She was too weak to get up and she stayed there for 45 minutes to an hour. She was able to walk a little bit and then half an hour later another incident of diarrhea which was a shorter duration but it had blood. She was still weak and her temperature was a degree under normal. She was cold. She was also somewhat sore from the incident in her intestines after the incident. The severe reaction she experienced resolved that night. The pain was so bad that she almost called 911. The patient already reported this information to the Food and Drug Administration. The reporter consented to follow up.
When the immunization was being administered, the patient was having difficulty raising sleeve.  The vaccinator administered the vaccine to the best of her ability as high as the sleeve would allow.  When the syringe was withdraw, some (but not estimated more than half of the dose) leaked from the arm.  The patient reported a swelling feeling before leaving the pharmacy, but he said he was fine.  He was given an ice pack to put on the area.
Inappropriate age at vaccine administration; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.
Started with a sharp headache in the back left of my head about two hours after shot. Headache got worse over two days. On afternoon of second day, Monday Nov 29 Nov 2021 my left side of my face went numb and my left eye became blurry. The following morning the entire left half of my body went numb.  I went to the ER on 30 Nov 2021.
5-10 seconds of eye fluttering and eyes rolled back. No apnea or distress. Afebrile
PATIENT STATES WOKE UP N 11/17/20 AND FACE WAS DROOPED TO ONE SIDE, WENT TO ER AND THEY DIAGNOSED HER AS HAVING BELL'S PALSY. SHE STILL HAS NOT RECOVERED
Had a sore arm after injection, within two weeks became very ill, shortness of breath, arms and legs feeling heavy, feeling dehydrated went to hospital and received IV fluids, received J&J has diarrhea,  and extreme fatigue
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M040412, expiration date 30-JUN-2019, lot # M036059, expiration date 03-JUN-2019 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. The administered doses of GARDASIL 9 were stored in the temperature between 9 degrees Celsius and 25 degrees Celsius for 1 hour and 45 minutes. There were no previous temperature excursions reported. Data logger was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA006295: US-009507513-1707USA006294: US-009507513-1707USA002309: US-009507513-1707USA006293:
covid vaccine breakthrough case    All Pfizer dose 1  2/24/21  EN6198 dose 2  3/17/21  EN6205 dose 3  10/22/21  FF2593
Red, itchy bump at injection site. Hot to touch. She noticed at noon 8/15/17.
states arm started to swell & became red & hot; no fever because took APAP; arm was also pain; date reported to clinic 18FEB94;
had some redness to the leg where it was administered; This is a spontaneous report from a contactable physician. A 2-month-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 11Aug2021 (received at the age of 2-month-old) as DOSE 1, SINGLE for immunization. The patient medical history and concomitant medications were not reported. The patient experienced some redness to the leg where the vaccine was administered on 11Aug2021. The reporter is a pediatrician calling regarding a reaction someone experienced after receiving Prevnar 13. She stated that a 2-month-old baby was receiving the Prevnar 13 for the first time and had some redness to the leg where it was administered, and it went from the leg to the foot. The reporter stated this happened immediately after the vaccine was administered and then resolved in 4 to 5 minutes. There was no swelling, and she doesn't think it was really a reaction. She thinks it was due to the nurse positioning while holding down the baby. The reporter stated that the parent is hesitant to give the vaccine again. The reporter would like to know based on the reaction if the baby should receive the vaccine again or if there are any precautions that need to be taken next time. Outcome of the event was recovered on 11Aug2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient experienced flu like symptoms within 24 hours of vaccine. Chills, fever of up to 101 , severe injection site pain, headache, body aches, fatigue.  Also had swelling below injection site that wrapped around arm.  Symptoms subsided by 48 hours.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. It was reported that an unspecified number of patients have received improperly stored doses of PEDVAXHIB (lot #, expiration date, strength, dose and route of administration were not reported) on 15-OCT-2014. No symptoms reported. This is one of several reports received from the same reporter. Follow up information has been received from a medical assistant on 24-OCT-2014 concerning 2 months old patient of an unknown gender. On 26-SEP-2014, the patient received improperly stored dose of PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Case Narrative: Information received from a 49 year old male consumer on 27AUG2015 who inquired whether BioThrax was known to cause low hemoglobin. On approximately 02AUG2015, in preparation for deployment, the male received vaccination with BioThrax, dose two (lot unknown); at the same time he received both MMR and typhoid vaccines. Medical history: Non-Hodgkin's lymphoma stage I (JUL2012) - treated with chemotherapy x 3, and radiation. In JUL2013 he was deemed to be in remission. Approximately one week later, he began to experience joint pain and weakness. He was tested for Lyme disease - result negative. The symptoms continued with the addition of headaches and fatigue. On or around 18AUG2015 laboratory testing revealed hemoglobin of 5.5 and white blood cell count of 1.5. He was hospitalized at that time. During the hospitalization he received 5 units of blood. He noted that in July, at a check-up, all of his "numbers were good", hemoglobin was 14, and a CT scan was negative. He denied any blood in his stool. On 22AUG2015, his hemoglobin reached 9.5, and he was discharged. The reporter indicated the hospital staff felt that the incident may have been a "virus". At the time of report, his symptoms (fatigue, headache, joint pain and weakness) had resolved, and he was scheduled for additional testing and follow up. On 01SEP2015 a follow up attempt revealed the consumer's hemoglobin and white blood cell count were improving, but his liver enzymes were "up". Further information was requested. Concomitant medications: occasional NSAIDs. Sender's Comments: This report was received from a consumer without medical records. The complicated past medical history and the limited anemia evaluation provided do not rule out other causes. The WBC count is also noted to be low and we are not provided a differential. Lastly, he received live virus vaccines concomitantly (MMR) that confound the case further. Therefore, in this instance there is insufficient information available to provide a causality assessment.
Fluid filled bubble right at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male 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 06Apr2021 at 13:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus. The patient did not have any allergies to food, medications, or other products. Concomitant medications included insulin lispro (HUMALOG) and atorvastatin (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Erz613) via an unspecified route of administration in the right arm on 16Mar2021 at 15:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. 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 07Apr2021 at 16:00, the patient developed a fluid filled bubble right at the injection site of the second dose. Two days later, it was still there. No therapeutic measures were taken as a result of the event. The clinical outcome of the event fluid filled bubble right at the injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
administration of vaccine past 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of vaccine past 30 days in the fridge) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of vaccine past 30 days in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of vaccine past 30 days in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   HCP vaccinated patients with vials that were past 30 days in the fridge. No concomitant drug details were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Updated dose 1 and dose 2 details.
This spontaneous report was received from a registered nurse and refers to a 1-year-old patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date, also reported as "on unspecified same day", the patient was inadvertently vaccinated with both properly stored VARIVAX (dose, route of administration, lot# and expiration date were not reported) and PROQUAD (dose, route of administration, dose, lot# and expiration date were not reported), both reconstituted with properly stored sterile diluent (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported.
I experienced a sharp shooting pain down my entire arm to my finger tips immediately following injection. Since then my range of motion is cut down to a third and my right arm has had severe pain. I get a tingling sensation in my fingertips and elbow, and this worsens when it is aggravated. My grip strength is also weakened.
Symptoms include a large lump at injection site, redness, soreness for ~10 days following the vaccine.
Responded to Nurse Alert in Covid vaccine clinic  Department.    Interventions:  IV NS 0.9% started @ rate: Bolus ,  time: NA, per instruction (Verbal Order) by Dr.   Blood Sugar Reading (per accucheck):  106 mg/dl;  Nourishment offered: no   Baseline and succeeding Vital Signs:    Time Taken 1945     Temperature na     Pulse Rate 42     Respiration Rate 16     Blood Pressure 96/62     O2 Saturation 72       Quick Nursing Assessment at the Scene:  Pt was dysphoretic, A&Ox3 gray in color. Cold and clammy. Pt reports feeling dizzy and almost falling in the bathroom. During assessment Pt want unresponsive. Pt never lost his pulse. Nurses alert was called than 911. Pt was A&Ox3 when EMS arrived. 2L of O2 NC was placed on Pt and SPO2 increased to 100%. 20G IV was started in the left AC and NS bolus was rendered. EMS ALS took Pt to the nearest hospital. Pt did receive 0.3 second dose of Pfizer vaccine.    Patient Disposition: 911 called.
I have had a very bad headache, fatigue, and some body aches which I read could happen but in addition I've had a very intense brain fog. It almost felt like I was intoxicated when I wasnt. I had a hard time focusing, concentrating and finding words when trying to have a conversation.  Today is the second day post vaccine and the brain fog is slightly decreased but still present and bothersome. I would not have felt comfortable caring for patients yesterday or today with this feeling.  It does seem to be dissipating but I am hesitant to get any more doses of the vaccine if this could be worse next time.
Within 24 hours, normal side effects including, muscle pain and  aches; Resolved after 1 day  On 4/23/2021, 14 days after vaccine, patient began experiencing loss of appetite  On 4/26/2021, 16 days after vaccine midday on 2, patient began experiencing  sudden onset of upper stomach pain, heart palpitations   4/29/2021, patient went to ER due to extreme upper abdominal pain and intermittent back pain and intermittent heart racing. Prior to going to hospital, patient was healthy with no prior health issues or diagnoses. She also took baby aspirin, 81 mg several days prior to being admitted, took 2 chewable gas- except tablets and had her glucose checked  which was a 96.  Patient was not admitted and discharged the same day with a diagnosis of acute pancreatitis. She has had 2 children in the last 3 1/2 years and still nursing a 14 month old and hasn't count alcohol in years.  Pain meds prescribed but using them every 8 hours to manage pain and barely eating or drinking, yet pain still persists.
pedriatic dose to a 20-year-old patient; pedriatic dose to a 20-year-old patient; no additional AE reported; Spontaneous information has been received from a nurse via company representative, referring a 20-year-old female patient. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided.   On an unknown date, the patient received a pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) as prophylaxis (dose, route, lot # and expiration date were not provided) (Incorrect dose administered, Product administered to patient of inappropriate age). No additional adverse event reported.
kidney function down to 30%; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4620420.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 23Sep2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient's concurrent condition was not reported. Vaccination history included: Covid-19 vaccine (Primary Series of immunization completed; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: RENAL IMPAIRMENT (medically significant), outcome "recovered", described as "kidney function down to 30%".  Clinical course: On 23Sep2021, patient started therapy with Covid booster for unknown indication. On unknown date it was reported that patient experienced: kidney function down to 30%. No further information available regarding the reported event(s) described above. Any additional material information received will be forwarded in accordance with agency's policies and procedures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Experienced fatigue; Dizziness; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the right arm on 09Apr2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included nitrofurantoin (NITROFURANTOIN MONO/MAC) for unknown indication, from an unknown date and unknown if ongoing. On 09Apr2021 at 16:00, about 5 hours after shot the patient experienced fatigue, dizziness and nausea. Fatigue continued for 24 hours. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event fatigue was recovered on 10Apr2021 at 16:00 (24 hours). The clinical outcome of the events dizziness and nausea were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Developed fever and muscle aches over night. Ecchymosis, erythema, swelling, tenderness and warmth 5x8cm.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 4 years old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M003435 and expiration date on 19-JUL-2017, lot # M038229 and expiration date on 06-MAR-2018 or lot M044020 with expiration date on 01-MAY-2018 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses PROQUAD were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments:  US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA001141: US-009507513-1710USA008687:
This spontaneous report was received from a medical assistant and refers to a 13 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 14-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M005921, expiration date 02-FEB-2018; site, dose and route of administration were not reported). No adverse effects were reported. This  is one of several reports received from the same source. Additional information is not expected as no further information is available.
I experienced day after dizziness, body aches, headaches, fever and stomach pain, upset stomach, these lasted symptoms lasted 4-5 days. The pain to my stomach was very intense.  I saw my PCP through telehealth  but she did not give my any medicine or treatment.  I no longer have these symptoms.
Mild erythema, 5 x 5 cm area of induration at vaccine admin. site (L) deltoid.