chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIABETIC; URINARY ISSUES; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (DIABETIC) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe).   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced DIABETES MELLITUS (DIABETIC) (seriousness criterion medically significant) and URINARY TRACT DISORDER (URINARY ISSUES). At the time of the report, DIABETES MELLITUS (DIABETIC) and URINARY TRACT DISORDER (URINARY ISSUES) was resolving.            Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the event(s) of urinary issues and diabetic with Humira (adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of Crohn's disease, who experienced the unexpected serious (medically significant) event of Diabetes mellitus after receiving a dose of mRNA-1273 vaccine. The onset date of the event was not reported. Patient received primary series of mRNA-1273 vaccine within the same month. Clinical course and treatment details were not reported. On unknown date, patient received Adalimumab for Crohn's disease which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of Crohn's disease, who experienced the unexpected serious (medically significant) event of Diabetes mellitus after receiving a dose of mRNA-1273 vaccine. The onset date of the event was not reported. Patient received primary series of mRNA-1273 vaccine within the same month. Clinical course and treatment details were not reported. On unknown date, patient received Adalimumab for Crohn's disease which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
He became sick 2 days later and it progressed into his Immune system attacked his kidneys. He has been treated with oral prednisone with no response and had to do several  iv therapies to suppress his immune system. He?s also had to go on tacrolimus to further suppress his immune system. Qbrelis is also taken to help prevent his kidneys from spilling protein.
The first day I had mild fatigued. The 2nd day I was drenching in sweat, I had diarrhea, fatigued, and I had a headache. I had a temperature of 101.1. The 3rd day I was fatigued and had a headache. The 4th day I had a headache and then the symptoms finally resolved.
Patient states about 1 hour after receiving pfizer  Covid-19 vaccine she had left-sided facial swelling  and a numbing sensation of the face along with lip  swelling . she complains of Left upper extremity and  injection site pain .
Neuropathy, tingling in the hands and feet and burning sensations, constant heat and pins and needles.
Pt has had no adverse reaction as of 8-11-08, called CDC upon their advice.  Pt is not to be given the ADACEL she was supposed to receive.
Ear pain/pressure, headache, and body aches started on 3/11 around 7pm. Around 11am on 3/11 through the end of the day I was having waves of feeling very hot. No fever. Body aches, ear pressure, and fatigue on 3/12 with radiating left arm pain which stopped. Radiating arm/shoulder pain came back on 3/13 around 12:45PM.
This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On unknown dates since 01-NOV-2016 (reported as "excursion started on 01-NOV-2016 and vaccination may have occurred since then"), the patients were vaccinated with unspecified doses in series of improperly stored doses of M-M-R II (which had the lot # L032182, expiration date 25-AUG-2017) (dose, route and vaccination site were not informed). Information regarding concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 12.6 C. The time frame was 168 hours. There was not previous temperature excursion. The call was not because of the a "data logger". And there was not product quality complaint involved. A list of patients and actual dates of administration was not available. Additional information has been requested.
Case number PHEH2014US025362, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 61 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 23 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
Patient developed swollen eyes and lips and went to the ER.  She was admitted to the ICU with angioedema.
This spontaneous report was received from a physician referring to a 6-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 31-JUL-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017 and 26-JUL-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1711USA003164: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1711USA003160: US-009507513-1709USA012767: US-009507513-1711USA003157: US-009507513-1711USA003165: US-009507513-1711USA003158:
Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 22Feb2021 at 15:15 (age at the time of vaccination was 49-year-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain at injection site on 22Feb2021 at 15:30. Patient did not receive any treatment to the event. Patient was not diagnosed with Covid-19 prior to vaccination and not tested for covid since vaccination. The outcome was recovered with sequelae for the event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Presented to the ED c/o chest pain onset x 3 days; c/o cough, shortness of breath, subjective fever, chills, nausea, vomiting, diarrhea, and body aches x 1 wk. +COVID at clinic for which pt then presented to ED; admitted for PNA d/t COVID; 10/10 - tx w/Remdesivir, Decadron, zinc; 10/11 - added Vit C; pt required 2L NC during stay and was weaned to RA on DC.
Patient is fully vaccinated for COVID-19 with Janssen on 8/31/21. Transferred to reporting hospital by dialysis. Patient complained of loss of taste and smell, GI upset, diarrhea, mild cough, weakness and SOB. Patient admitted to reporting hospital on 8/31/21 and discharged 9/1/21. She was given cefriaxone/azithro with 6mg Dex.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 39.64 for dose administered on 20-Mar-2021. No concomitant medications were reported.  On 20-Mar-2021, the vaccine with batch number 031A21A was moved to fridge on 09-Mar-2021, 19 vials were moved to the clinic on 20-Mar-2021 at 09:00 AM to 10:00 AM, vials underwent temperature excursion with temperature of 34 to 37 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 08-Apr-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a  traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
So when I got the first vaccine, I had heart palpitations and felt my throat closing. The nurse practitioner who administered it hit a blood vessel and caused dramatic bleeding after. I felt pretty light-headed after leaving the pharmacy. The intense pressure intensified over the next couple of days. I was busy around the clock and just sort of ignored the side effects. I consulted doctors who informed me to continue my dosage and receive the second dose. I then had piercing headaches, confused dizziness, head and throat pain, itchy ears, tinnitus, body tingling, pain and numbness throughout the body. If you name it, I had it. The majority of it I had dizziness, headaches, head pressure, blurry vision, ear discomfort, and ear sound sensitivity. Now, I'm very temperature sensitive. I've gotten bloodwork, MRI, CT scans, and everything done to try to receive a diagnosis. But I was told my reactions are all microscopic so nothing can be done to help. I've visited Hospital in April 2021 for the MRI and EKG performed. In April 2021, I also visited Neurology and had VNG, EEG and bloodwork done there during May and June 2021. I had a CT scan done in June 2021. I did bloodwork with a rheumatologist in October 2021. All of the tests came back normal and I'm still currently suffering from the results of the vaccine.
Patient returned to the health center at 3:00 PM complaining of weakness, numbness of right arm with paraesthesia of right digits.
hurt his leg; didn't feel well; had COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had COVID-19), PAIN IN EXTREMITY (hurt his leg) and MALAISE (didn't feel well) 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 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 COVID-19 (had COVID-19) (seriousness criterion death), PAIN IN EXTREMITY (hurt his leg) (seriousness criteria death and hospitalization) and MALAISE (didn't feel well) (seriousness criterion death). The patient died on 23-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed.     No relevant concomitant and treatment medications were reported.  Company Comment - This case concerns an unknown age male with no medical history provided. Limited information regarding this case is provided. The patient experienced Covid-19, Pain in Extremity, and Malaise. He died on on 23-Sep-2021. No date for which the vaccination is provided, nor is the date of any of the events provided.The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.; Sender's Comments: This case concerns an unknown age male with no medical history provided. Limited information regarding this case is provided. The patient experienced Covid-19, Pain in Extremity, and Malaise. He died on on 23-Sep-2021. No date for which the vaccination is provided, nor is the date of any of the events provided.The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.; Reported Cause(s) of Death: unknown cause of death
shoulder pain that day and for the next 6 days; axilla pain starting the next day and lasting about 4-5 days; fatigue and achy back all the next day and evening; fatigue and achy back all the next day and evening; This is a spontaneous report from a non-contactable physician (patient). A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unknown date. After received the second COVID-19 vaccine dose the patient felt shoulder pain that day and for the next 6 days. She had axilla pain starting the next day and lasting about 4-5 days. She had fatigue and achy back all the next day and evening. The outcome of all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
After the 1st dose, about a week or so afterwards I developed an awful painful red rash around my mouth. It burned and was very uncomfortable. My lips started to peel off severely. I went to the dermatologist who tested samples for fungal, viral, and bacterial infections and they all came back negative. While we waited for the tests to come back she gave me an anti-fungal nystatin cream to treat the lips which within days cleared up the red/peeling. Then I got my 2nd dose on 04/05/21 and within a few days after that I started to develop pain and soreness inside of my mouth and white patches around my tongue, cheeks, etc. which made eating very uncomfortable. I went back to my dermatologist and she said it looked like oral thrush and has given me a nystatin mouth wash to use for the next 7-14 days.
A consumer reported that her 3 month old grandson inadvertently received two doses of Prevnar eight days apart, on 4/16/03 and on 4/24/03. The infant's medical history includes premature birth (26.6 weeks gestation), a "host of issues," respiratory distress syndrome, unspecified infections, and a patent ducturs arteriosus which was closed with unspecified medications. The infant had been hospitalized for an unknown condition and received a dose of Prevnar on 4/16/03 while hospitalized. He was discharged on 4/21/03. Reportedly, the initial Prevnar dose was not reported on the infant's discharge summary and the infant's pediatrician administered another dose on  4/24/03. At eight o'clock that same evening, the infant developed cardiac arrest and was hospitalized. As of 4/25/03, the infant was in a pediatric ICU. No further info was available at the date of this report.
Received Flu vaccine on Monday 9/24/18 (11:45am) at Employee Health. When I woke up the next morning I had a localized reaction at the injection site. It was about 2 inches in diameter, very red, painful, and hot. The pain was not the normal immunization muscle soreness but rather more injury like pain. The reaction remains today (9/26/18) unchanged. I have tried taking Tylenol and applying ice packs to the area and there has been no change.
I am suffering from severe tinnitus after the 2nd moderna shot.  It came on about 6 hours after the shot.  I really wish that these ear side effects would be shared by the FDA and the CDC.  I have suffered from short bouts of tinnitus before, 2-5 minutes, but nothing like this.  I have had constant and severe tinnitus since 6 hours after my 2nd moderna shot, and am very frightened that it will not go away.  I would have been fine with just having the first shot, and do not understand why the FDA and the CDC are not advising women -- the ones who are affected by the vaccines -- to just go for one shot.  I should not be receiving the same dosage as a 300 lb man.
My Estimated due date was 09/04/2021. My sons birth weight was 5lbs 14oz. I was classified as low risk. I had marginal cord insertion, but it was not severe enough to impact my sons development.  My blood pressure was increasing throughout pregnancy. On 08/06/2021, it was over the threshold, so I had blood work completed. At my next appointment on 08/13, my blood pressure was very high again. My creatine levels were above the normal amount as well. I had pre-eclampsia. I was admitted to the hospital and I was told that I would not be released until my son was born. My liver protein levels were high. I was not dilating very fast and I suggested a C-Section, to which the doctors agreed. My son is doing well, but we are keeping an eye on certain things. He has chordee and penile torsion. They are both mild, but they will require corrective surgery when he is 9 months old. He also has an umbilical hernia. I'm hoping that he will not need surgery for his umbilical hernia because it usually corrects itself.
On 1JUN90 employee experiened discomfort in the lt arm at the site of injection & a sore throat after TTA. Following day developed pain on the lt side of the jaw & had difficulty opening his mouth.  4JUN90 symptoms began to subside.
Extreme fatigue, dizziness, headache, felt cold, nauseous. Lasted 3 full days. Better on 4th day, but not well. Went to ER 09.14.2014. Checked urine, EKG, Troponin I, Telemetry monitoring, Saline Lock IV - 1 time, CBC D, Metabolic Panel all normal.
I have had pain in my Deltoid area the entire muscle since 11/05/09. I have had itching in that area as well as in the back of the shoulder.I have pain all the way down the arm precisley over knuckle of the index finger of the left hand. The hand is sometimes numb and tingling in the palm. Movement is slightly limited in the hand and arm. I am just now reporting because I had believed the soreness was just the regular reaction but I still have the imprint of the Bandaid on my arm from placement on 11/05/08 and the injection site just healed as well. I tried to explain that to the RNP that examined me but she was adamant that the flu shot could not cause the kind of reaction so she refused to listen. I think the virus was very strong and may be still culminating. My arm is aching right now as I type and the left index finger is where the sharpest pain is felt.
Info has been received from a health professional concerning a 4 month old male with no pre-existing condition who on 10/16/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (lot #641804/0035M) instead of the intended vaccine Streptococcus pneumoniae vaccine (Prevnar). Also, on approximately 10/16/2002 (also noted as 10/14/2002) the pt developed a local injection site reaction and fever for 24 hours. It was noted there was no illness at the time of vaccination, the pt did not have prior events following previous vaccinations and no diagnostic or laboratory tests were done. No medical attention was sought (also reported as serious criteria: none (required ER visit)). Subsequently, the pt recovered. Follow-up info for this report was received from Manufacturer for Streptococcus pneumoniae vaccine (Prevnar) and was assigned manufacturer report number HQ4727321OCT2002. This was originally reported by a health care professional.
I started to feel numbness in my right leg from my knee to above my ankle. It lasted for several days. They did an ultrasound to be sure I didn't have any blood clots.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided. On 05-NOV-2021, Hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion with temperature excursion of 47.1 Fahrenheit degrees for 36 minutes. No previous temperature excursion. On the same day, the patient was vaccinated with the improperly stored hepatitis a vaccine, inactivated (VAQTA) (1 time dose, lot # T031201, expiration date 14-JUN-2022; strength and route not reported) for prophylaxis (product storage error). No other adverse event (AE) or product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-2111USA005243: US-009507513-2112USA000877: US-009507513-2112USA000882: US-009507513-2112USA000883.
Blood in stool 10-6-09. G.I. Dr. 10-8-09/bloodwork. Blood in stool 10/30-31/09. G.I. Dr. 11-6-09 bloodwork/stool sample.
INJECT BECAME WARM THEM LATER HAD CHILLS, SLIGHT SWELLING AT INJECTION SITE, NECK PAIN.