chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Monday, I started feeling like I had a cold, runny nose, sore throat, a little bit of a cough. By Wednesday, I started having trouble breathing. My PCP could not see me, so they told me to go to urgent care. I went on 07/08/2021. They did nothing. They did a chest x-ray and it was clear. They did a lot of blood work and everything was normal. They told me to take my inhaler and sent me home. That following Wednesday things were getting really bad. I went back to urgent care. I went on 07/14/2021. At that point they had just given me prednisone. I went back that Friday on 07/16/2021. They gave me antibiotics. Then I saw a doctor on 07/20/2021 and she sent me for another x-ray or CT scan, I cannot remember, and they diagnosed me with pneumonia. They gave me another antibiotic. On 07/25/2021 I went to the emergency room. They gave me another 2 antibiotics. By Tuesday 07/27/2021 I was feeling ok. It was not great but I did not feel like I was dying. I still have a lot of trouble breathing.
atrial fibrillation; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 21Apr2021 (Batch/Lot Number: ER8731) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced persistent atrial fibrillation on Apr2021 (reported as within 3 days of receiving the second dose). The event resulted in Doctor office/clinic visit. Outcome of the event was not recovered. The patient received first dose of Comirnaty (lot number EP87533, administered to Left arm) on 31Mar2021.
This spontaneous report as received from a registered nurse refers to a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of VAQTA (doses and routes were not reported) lot # K004856, expiration date 07-DEC-2016, that were exposed to temperatures outside of the recommended range. The registered nurse was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Patients came to pharmacy because right upper hand is red, hot swollen. Patient also complains of rash in the area. This appear today in the morning.
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose & titer result was 2.4, indicating a low pos response;
No Adverse reaction, Learned Moderna had been approved. Believed this was from the CDC. It was from another committee however.  No Adverse Reaction occurred.
Had severe rash just below injection site and states was very painful. Rash was about 6 inches wide and firm covered must of her arm. She came to me to look at it on 9-22-17 she said she went to emergency room and they told her it was a reaction to vaccine and possible infection. She said they gave her antibiotics.
exposed @ daycare on 1SEP97 chickenpox appeared;#10 small amount itching dec appetite;3SEP97 grumpy & dec energy;By 5SEP97 almost all crusted over-feeling fine per father;
Severe swelling at shot site (arm), redness, itching, headache, soreness, coughing, dizziness, pain, confusion, inability to lift arm.
Caller got both Covid doses and after her 2nd dose she experienced a very dry mouth; her lips were numb and so were her cheeks; her lips were numb and so were her cheeks; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced caller got both covid doses and after her 2nd dose she experienced a very dry mouth, her lips were numb and so were her cheeks, her lips were numb and so were her cheeks. The outcome of the events dry mouth, hypoaesthesia, hypoaesthesia oral was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Pt recvd Engerix-B on 27APR90, 31MAY90, & 24OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
At 10 PM the night of the vaccine I had involuntary, uncontrollable severe movements of my legs. I imagine it would be what severe restless legs would feel like. The movements in my legs were uncontrollable and almost convulsive-like. It lasted a couple of hours that night-took PRN clonazepam and it finally went away and I was able to sleep. The next morning, the movements in my legs were gone and felt fine other than soreness from the injection site. However, I wanted to report because the reaction was severe, but thankfully short-lasting for me. It was the stranded sensation not to feel in control of my legs and definitely would?ve went to the emergency room if it would?ve continued much longer than it did.
This spontaneous report as received from a nurse refers to 20 unspecified patients of unknown age and demography. No concurrent conditions and medical history were reported. On an unknown date approximately in 2015 (also reported as between 29-APR-2015 and 29-JUN-2015) the patient was vaccinated with PROQUAD (Merck) (lot: K011967; expiration: 21-FEB-2016) subcutaneously which was improperly exposed to minus 12.3 degrees Centigrade for a cumulative of 17 hours. On unspecified dates from 05-MAY-2015 to 29-JUN-2015, 20 patients each received the improperly exposed vaccine. It was also unspecified exactly how long the lot was actually improperly stored before being administered to each patient. No concurrent medications were reported. No adverse effects were reported. There was no product quality complaint reported. The action taken and outcome of the events was unknown. This is one of the two reports from the same source. Additional information has been requested.
Since the vaccine, I have been extremely tired and was diagnosed with pnuemonia and dehydration. I was treated for that and then 2 weeks later diagnosed with bronchitis. I had blood work done and was VERY low on vitamin D. I don?t know if the symptoms are related to the vaccine, but it was a day or two after the vaccine that I started experiencing the extreme fatigue. After a few weeks of the extreme fatigue, I went to urgent care and was diagnosed with pneumonia.
Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA344122 (same reporter). This case involves a 46 years old female patient who was vaccinated with a 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (Suspension for injection) lot UJ040AA and Exp. Date not reported via unknown route in the right deltoid on 03-Dec-2018. The patient's past medical history included Endometrial disorder with Hysterectomy. No concomitant vaccines given. It was reported that, vaccine storage was potentially out of range for 7 days and exposed to freezing temperature, range was between 32 F and 47 F for 1 week. It was an actual medication error case due to incorrect product storage and vaccine was administered to a patient. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient experienced numbness of the tongue and a feeling of her tongue feeling "thick". Patient said that the feeling only lasted approximately 60 seconds and resolved on its own without any treatment. There was no swelling noted.
CLIENT PRESENTED TO CLINIC ON 12/02/19 REQUESTING FOLLOW-UP FOR LT ARM PAIN REDUCED RANGE OF MOTION SUBSEQUENT TO FLU VACCINE RECEIVED AT CLINIC ON 11/04/19.  CLIENT REQUESTED EVALUATION BY A PHYSICIAN.  WRITER WAS ABLE TO REFER CLIENT TO COMMUNITY BASED CLINIC FOR EVALUATION ON 12/04/19.  TC TO CLIENT BY WRITER ON 12/10/19: CLIENT REPORTS SHE WAS SEEN BY A PHYSICIAN, RECEIVED PAIN MEDICATION AND REPORTS MILD IMPROVEMENT IN PAIN.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: PT SAID HER EXTREMITIES FELT UNUSUAL-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: PT SAID SHE HAS LOW BLOOD PRESSURE TO BEGIN WITH, SHE SAID HER EXTREMITIES FELT FUNNT LIKE BLOOD RUSHING BACK TO THE. BLOOD PRESSURE AT 540PM WAS 106/73, PULSE WAS 53. BLOOD PRESSURE AT 550PM WAS 107/76. PULSE 55.
improperly stored vaccine was administered on 25JAN2021; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) vial, lot # T004378 was confirmed to be valid, expiration date was reported as 31-OCT-2022, but upon internal validation process, it was established as 01-NOV-2022 (dose, route of administration and anatomical location were not reported). Administered dose of vaccine was stored in the temperature of above 9 degrees Celsius (C) (13.4 degrees C) for 2 hours 9 minutes.  There were no previous temperature excursions reported. The improper storage was recorded by digital data logger.
Sometime in late-Jan 2010, SM noted increased thirst, increased urination, and increased hunger with notable weight loss. (SM estimates 30-pound weight loss between Jan and March 2010.) When he sought evaluation on 11 Mar 2010, his serum glucose level was 455, his HgbA1c was 10.6, and his urine was positive for ketones. At that time, insulin was initiated and has since been treated as an outpatient. SM has also received outpatient diabetes self management training. SM's diabetes has been managed by local health care providers, but primarily by a Endocrinologist. SM denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and PT and had a normal BMI (26.78) prior to diagnosis. Family history of Type 2 diabetes in both grandfathers.
This spontaneous report was received from a care coordinator nurse practitioner (who works in the physician's office) via a company representative and refers to an 81 year old female patient. The patient's concurrent conditions, medical history were not provided. On 05-SEP-2015, the patient was vaccinated with PNEUMOVAX23 (lot, batch no # K008410, expiry date 26-FEB-2016, 1 vial) at an unspecified long term care facility. The patient was on unspecified concomitant medication. On an unknown date, the patient developed pea size red spots on her skin (unspecified location) (rash macular), runny nose (rhinorrhea) fever (pyrexia), did not feel well in general (malaise). The patient left the care facility on an unspecified date. The patient visited the physician's office and sought medical attention. The outcome of the events rhinorrhea, malaise, pyrexia and rash macular was unknown. Product quality complaint (PQC) was not reported. Causality assessment was not provided. No further information was provided. Additional information has been requested.
Mild runny nose and cough start on 10/25/2009, AM. Temperature 100.4 to 100.6. Remove his long sleeve clothes. Temperature went down. At 2:00 AM, 10/27/2009 temperature went back to 100.5. Motrin was given at around 4:00 AM. Temperature went down around 4:30 AM. He woke up, runny nose and cough worsen until now 10:00 AM. Dr. has been contacted and have been in conversation with the nurse. Decision is if he have another temperature, difficult to breath or cough worsen, he need to see Dr.
A few minutes after receiving HPV #1, child described black dots in front of her eyes, felt extremely nauseous, was pale and clammy. She did not vomit, laid down for 10 min, then sat up and felt much better. Left office after 25 minutes.
SEVERE BODY PAIN; NERVE ISSUES; This spontaneous report received from a patient 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  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced severe body pain, and nerve issues. The action taken with covid-19 vaccine was not applicable. The outcome of the severe body pain and nerve issues was not reported. This report was non-serious.
This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown demographics. No patient's concurrent conditions or medical history were provided. On an unknown date, those patient's were vaccinated with improperly stored doses of VARIVAX injection (lot # L046885 with expiry date: 23-NOV-2017; strength, dose, route and site of administration were unspecified). The administered vaccines underwent the temperature excursion of 26.7 degrees Fahrenheit for 2 hours 24 minutes. There was previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Patients received the Moderna COVID-19 vaccine after temperature excursion; Patients received the Moderna COVID-19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID-19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 vaccine after temperature excursion) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID-19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID-19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 vaccine after 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.  The reporter stated that the facility where she worked, there had been temperature excursions with freezer. It had been happening for weeks since April 2022.  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus 18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.  The vails were stored in frozen state at the time of reporting.  The visual inspection noting any vaccine state change was reported as No  Proposed use by date was reported as No.  No treatment information was reported.
Pt reports the tips of her middle, ring, and thumb on her left (same arm as vaccine was given) hand are tingle like they are asleep and also itchy. No pain, not hot to the touch.
5x8cm2 area of redness, noted at injection site. Tx with Augmentin 875mg bid x 7d.
Adverse reaction approximately 7days after vaccine.  Itchy, reddened Left upper arm.  I woke up Sunday  AM with blotchy, itchy rash on  areas of upper body.  The swelling and rash on the left arm had increased. I went to Urgent care/Med access in Person County about 10AM.  Prescription written by the P.A. for  Prednisone. Benedryl PRN over the counter as needed
Information has been received from a consumer for the pregnancy registry of GARDASIL vaccine concerning his fiancee who has has two doses of GARDASIL vaccine beginning in June 2008. It was reported that the patient had the symptoms of pregnancy such as morning sickness and bloating. At the time of the report the patient had no pregnancy test done. The patient did not seek medical attention. No further information is available.
6/6/21 tingling in legs.  6/10/21 treated in the ER for Bells palsy
left arm really hurts today at the injection site; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine.   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced shivering. On 29th October 2020, the patient experienced injection site pain. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the injection site pain and shivering were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her left arm really hurts at the injection site.  The patient also reported some shivering which she said could be related to the cold weather. The patient had been taking acetaminophen for her symptoms. The reporter consented to follow up and could follow up with the patient directly.
Information has been received from physician concerning an 87 year old female with Polymyalgia rheumatics, hypertension, hypothyroidism, osteoporosis and a history of chickenpox and no drug reactions/allergies history reported who on 11-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot #659407/0295X) 0.65ml SQ in the right deltoid. Concomitant therapy included PREDNISONE (manufacturer unknown), FOSAMAX, LIPITOR, DIOVAN and SYNTHROID. On 14-JUN-2008 the patient experienced shingles. The patient sought medical attention in the office. On the morning of 14-JUN-2008, the patient noted the rash below the left breast which spread to her left trunk at night time. Lesions distribution was noted to be on the T1-T2 dermatome. The patient rated her pain an eight on a scale of zero (least) to ten (most). The patient had itching and a temperature of 99 degrees F. The patient had no recent exposure to shingles of chicken pox. A specimen was collected on 16-JUN-2008 from a crusted vesicle/papule. The patient was recovering. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present to identifyif it is associated with the wild type strain or with Oka/Merck vaccine strain. Follow-up information was received on 02-JUL-2008. The final PCR result was wild type strain. On 02-JUL-2008 the physician reported that the patient's rash was better, but she was still having pain which he was treating with medication. Additional information has been requested. This is one of several reports from the same source.
KINRIX vaccine given in (R) thigh at age 8 wk 4 day old.
Red; Irritated; Sore Aching Arm; Initial Report Received 30-Jan-2020 and 31-Jan-2020  A physician reported that on 21-Jan-2020, a 30-year-old female employee received the first injection of HEPLISAV-B.  No concomitant vaccinations were administered.    The employee reported red, irritated, and sore aching arm.  No treatment was administered, and all events resolved within a day.     None of the events were reported as serious.    Company comment: The company assessed the events as non-serious.    ; Sender's Comments: The company assessed the events as non-serious.
319 patients who received the expired dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (319 patients who received the expired dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (319 patients who received the expired dose). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (319 patients who received the expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported. Date of refrigeration mentioned as 7-May-2021.   This case was linked to MOD-2021-363245 (Patient Link).
shortness of breath 40 minutes after vaccination. Continued for several days with tachycardia up to 130 bpm. Patient went to ER 5 days after vaccination, CTA ruled out pulmonary embolus, labs showed slightly elevated WBC/eosinophils. Symptoms resolved approximately 10 days after vaccination.