chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Told had some allergic type reaction; dry voice; productive cough; swollen Lymph nodes; ear pain; This is a spontaneous report from a non-contactable consumer reported for a female patient. A non-pregnant elderly female patient of unspecified age received unknown dose of bnt162b2 (Pfizer covid-19 vaccine, solution for injection, Lot number: not reported), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient allergies were not known. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received unknown medications in two weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient has been tested for COVID-19. On an unknown date, patient had some allergic type of reaction within 48hrs of shot. She went to emergency room, given antihistamines. Medical professionals felt related to blood pressure medication. However, now 2 weeks removed she informed my mom, who tells me she still has dry voice, productive cough, swollen Lymph nodes and ear pain. Scheduled to test for an allergen. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The clinical outcome of the events was patient with lasting effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
got covid 19; got covid 19; This is a spontaneous report from a contactable consumer.  A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) at SINGLE DOSE for covid-19 immunisation.   The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient was scheduled to receive the second dose of the vaccine on 18Mar2021, he had Covid-19 in the time between doses.   Information on the lot/batch number has been requested
This case was reported by a physician and described the occurrence of dilated common bile duct in a currently 53-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 4 January 2014 the subject received 1st dose of HAVRIX (unknown details). On 17 January 2014, 13 days after vaccination with HAVRIX, the subject experienced hepatitis a infection (described as "mild case of clinical hepatitis A") and hepatitis a virus igm antibody positive. On an unknown date in January 2014, the subject experienced dilated common bile duct. Per the physician, the immunization series was not delayed. Medical attention was received at the doctor's office. The physician was "unsure" if the events were "an adverse reaction, coincidental, or if there was another cause." The physician was not sure "if this dilated common bile duct was present before the HAVRIX vaccine because it was never investigated." This case was assessed as medically serious by GSK. Relevant test results included: On January 17 2014, the subject had a positive hepatitis A IgM result. The subject received an ultrasound examination in January 2014 with results showing a "dilated common bile duct that is 10 millimeters and, per the physician, "that is a bit long." At the time of reporting the outcome of the event of dilated common bile duct was unknown. The event of hepatitis A infection and hepatitis A virus IgM antibody positive was noted by the physician as improved.
arm hurt; shakes all day long, I was freezing like I couldn't get warm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), TREMOR (shakes all day long, I was freezing like I couldn't get warm) and HEADACHE (headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for an unknown indication.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), TREMOR (shakes all day long, I was freezing like I couldn't get warm) and HEADACHE (headache). On 14-Mar-2021, TREMOR (shakes all day long, I was freezing like I couldn't get warm) and HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt) outcome was unknown.            Treatment details included Ibuprofen.  Action taken with the mRNA-1273 in response to the event is not applicable.
Swollen arm at site of injection, under arm pain, cannot raise arm, body aches, fatigue.
Felt sick went to bed when I got home from work, some tummy upset, stomach upset on Saturday, Arm was sore for about 48 hours,  felt a little tired, some bathroom issues
HE RECEIVED PFIZER FROM MEIJER PHARMACY ON THE FOLLOWING DATES 4/21/21 LOT EW0167 5/19/21 LOT EW0176 THEN HE CAME TO AN OFF SITE AND RECIEVED MODERNA ON 5/27/21 THEN ON 6/21 RECIEVED JANSSEN. THIS ALL CAME TO LIGHT WHEN HE WENT BACK TO THE OFFSITE TO RECEIVE HE 2ND MODERNA, WHICH HE WAS DENIED  AND LEFT THE CLINIC.
After receiving a 10mcg dose of the Orange Cap formulation on 01Dec, this child experienced tingling in his toes within 15 minutes of administration which resolved a few minutes later; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 8 years as dose number unknown, 10 ug single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 01Dec2021, outcome "recovered" (01Dec2021), described as "After receiving a 10mcg dose of the Orange Cap formulation on 01Dec, this child experienced tingling in his toes within 15 minutes of administration which resolved a few minutes later".  Additional information: Event took place after use of product.  Follow-up attempts completed. No further information is expected.
This spontaneous report was received from a licensed practical nurse regarding unspecified patients age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since unspecified dates starting on or after 05-MAY-2016, the patients were vaccinated with an improperly store doses of ROTATEQ (orally, dose was not reported, lot #L035508 with expiration date 12-MAY-2017 or lot# L029618 with expiration date 20-MAY-2017 or lot #L033693 with expiration date 31-MAY-2017). The temperature was 11 Fahrenheit degrees during 11 days (digital data logger). There was no previous temperature excursion. There was no adverse events reported. Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of fever in a patient who received PEDIARIX (batch number 33E9E, expiry date 16th November 2018). This case was associated with a product complaint. On 23rd AUGUST 2016, the patient received PEDIARIX .5ml in AUGUST 2016, less than a week after receiving PEDIARIX, the patient experienced fever and irritability. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fever, irritability and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the fever and irritability to be related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The office manager reported that they were concerned about this particular lot of PEDIARIX because they had three patients who experienced adverse events within a 2 day period of vaccination. This patient experienced fever and was fussy. They had used PEDIARIX for many years and never experienced this type of problem so they are concerned  that the lot was defective and do not want to use any further doses from it. They had 6 full boxes and then some partial boxes but the field representative did not have an exact total. There was no other obvious  defect with these vaccines but reporter advised him that he would register a complaint. The reporter advised the representative that GlaxoSmithKline did not credit or replace for this situation but if the quality department did decide to retrieve some from this lot and found a defect upon investigation then credit could be arranged. The field representative asked that someone contacted him to provide follow-up regarding how GlaxoSmithKline was proceeding with his complaint. The representative did not have further information. The healthcare professional was supposed to call medical information with additional information. This is one of the 3 cases reported by same reporter.
Narrative: An 86yo Male with PMH of Hyperlipidemia, Recurrent GI bleeding, HTN, BPH, Shoulder Pain and Anemia Per Nurse's documentation; he received Pfizer Covid-19 vaccine per policy and protocol without complication on January 12, 2021. No ADEs were reported On January 28, 2021 the patient presented to the ED with complains of General weakness Arrived in mask and remained in mask. Upon examination abnormal breath sound and oxygen sat of 90% were reported. ED Physician's documentation included the patient had syncopal episode prior to the generalized weakness, blacked out and fell down while stepping out of his bathroom. The report included patient's acknowledgement of hitting his head. the patient was started on ceftriaxone and azithromycin for PNA, hydrated with 1 L of NS for AKI, CT of head ordered given syncopal event with fall and was admitted to Head CT was reported as -ve for acute changes, O2 saturation improved w/ 2L NC but continued to have weakness, chills and fever. His condition worsened with increased oxygen requirement CXR showing significant LLL consolidation with most likely DX documented as Bacterial Pneumonia since he tested Covid -ve x 2 and got transferred to MICU. His treatment was switched to vancomycin and Zosyn. He improved and was transferred to medicine but still requiring oxygen and discharged to subacute Rehab center to gain his strength, Placed on contact Isolation for sputum MRSA and MDR Pseudomonas per Feb 8/2021 culture result The system showed this patient passed away on February 27 2021
Patient received vaccine on Jan. 5, 2021 at one o'clock and symptoms began when she got home at 5:30 pm. She experienced headache, nausea, vomiting, chills, night sweats, sore arm, dry mouth, mild fever 99.7 was the highest recorded temperature. Patient called our employee hotline and was told to have a Covid test seeing as the symptoms were the same. She tested negative and began to feel better by the third day with residual symptoms of nausea and fatigue.
Case number PHEH2015US018519 is an initial spontaneous report received from a health care professional on 17 Sep 2015. This case refers to a 63 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN, (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 Sep 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error (incorrect storage of drug). The reporter declined further follow up contact. Follow up information received from the health care professional on 27 Oct 2015: Clinical notes updated.
The pt experienced extreme, inconsolable, irritability for 3-4 hours. Very irritable for 3 days. Febrile for 24 hours.
Inflammation, redness, soreness from bicep to wrist (R) arm, possible cellulitis, mild fever (100 degrees). Advised to ice, BENADRYL, ibuprofen, pt did ice, but did not use ibuprofen or BENADRYL.
Coughing, phlegm, chills but no fever. Internist diagnosed as bronchitis, prescribed Azithromycin antibiotic, Z-pack 5 days, starting 12/29/22
Pt called pharmacy to report hotness & bump on 8/12 - revisited pharmacy on 8/16/11 to report she went to ER - doctor told her shot should have been "IM" incorrect it is "sub-Q"! Pt OK now.
Woke up morning of 12/30  2 days after receiving the vaccine , approx 6am rolled over felt dizzy while in bed.  Got out of bed at approximately 6:30am and felt dizzy almost not balanced and felt like stumbling to the left when I stood upright.  I quickly squatted to floor felt my heart beat fast but for only seconds.  Didn?t feel like passing out but I was able to walk to the bathroom but Still felt like I was leaning to the left side.  My heart beat felt within normal range. The rest of the day I had brief episodes with dizziness but not as severe as when I got out of bed.  I I also developed a mild headache to my forehead the rest of the day and felt chilled but no fever.  By the end of the day I felt better the symptoms resolved. Today 12/31 I am feeling myself.  I am fearful of getting the next vaccine. I need someone to call me and give me answers if possible.
REDNESS, SWELLING AND HIVES AT SITE--GIVEN BENADRYL 16.25 MG OF 12.5/5MG OR 6.5ML- REPEATED BENADRYL DOES AT BEDTIME
the first shot of the Covid-19 vaccine, he had a headache for one day/He has had lots of headaches starting on 07May2021; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 55-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0164) via an unspecified route of administration in left arm on 15Apr2021 as 1st dose, single dose and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0165) via an unspecified route of administration in left arm on 06May2021 13:30-14:00 (as reported) as 2nd dose, single dose for COVID-19 immunization. Patient was 55-years-old at the time of vaccination. Vaccination Facility Type was reported as Megasite. Vaccine was not administered at Military Facility. No prior vaccinations within 4 weeks. On 16Apr2021, patient experienced headache after first dose. Patient received the second dose of the Pfizer Covid 19 vaccine on 06May2021. He has had lots of headaches starting on 07May2021. He has had headaches off and on every day since then. Patient reported that he received the second dose of the Covid-19 vaccine on 06May2021 and has had a lot of headaches. Patient reported that with the first shot of the Covid-19 vaccine, he had a headache for one day. Patient reported that he got the second dose of the Covid-19 vaccine on Thursday (06May2021) and Friday (07May2021) he had a headache all day nonstop. Patient reported that for the past week and a half to 2 weeks, he has been having a headache every day, in and out all day. Patient inquired if it was normal to have a headache for 2 weeks following the Covid-19 vaccine and if he should go to the doctor. Patient reported that the headache has stayed the same since it began on 07May2021.  Patient reported that the headache comes and goes and that he is taking Tylenol to ease the pain. The events did not result in emergency room or physician office visit. The outcome of the event was not recovered.   Follow up attempts are needed. Further information has been requested.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. On 08-NOV-2013 the patient who was 34 weeks in her pregnancy was vaccinated with the first dose of GARDASIL (dosage detail, lot number unspecified). The patient last menstrual period (LMP) was on approximately 15-MAR-2013 and Estimated Date of Delivery (EDD) was on approximately 20-DEC-2013. The patient exposure to GARDASIL during third trimester. No adverse effects reported. Additional information has been requested.
Dizziness; BP 134/78 (pulse 60), 100% O2 sat; 125/75 (pulse 61), 99% O2 sat.
4-22-13 PNEUMOVAX given (R) deltoid. Developed arm pain 4-23-13 - no redness, edema, fever or heat. 4-24-13 Pain resolved with ice, TYLENOL, rest.
Complaints of nausea and abdominal pain; treated for dehydration. CT revealed enlarged spleen and lymph glands.
Numbness and tingling in arm. Still persisting 3 days later.  Seeing MD 10/4/2011.
26DEC96 devel abd pain;spoke w/MD who dx flu;pt to ER 31DEC96;dehydrated, had inc pain, lethargy, BM black & rash on feet;dx inflamed derm & +H.S.P. & vasculitis;legs & ankle swollen;BP inc & bloody diarrhea;
Attendee  with history of fainting with needles. was given his single shot while sitting. Had declined offer to go to cot, Staff observed Attendee's color changed after Initially attempted to stand up, observed and told to remain sitting. Given ICEPacks, Monitored, reports tingly cold hands Transitioned to lying down. declines EMS and medications,  Symptoms resolve after WIfe arrives, transitioned to standing, D/c to wife /daughter/ car to home.
fever 101.8 degrees Fahrenheit; Headache; generalized pain; little tenderness where the injection; This is a spontaneous report from a contactable nurse, the patient.  A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization.   Medical history included diabetes mellitus and COVID-19 (prior to vaccination). Concomitant medications included metformin (MANUFACTURER UNKNOWN) and glipizide (MANUFACTURER UNKNOWN).  On an unknown date after the vaccination, the patient had a fever 101.8 degrees Fahrenheit, headache, generalized pain, and a little tenderness where the injection was given. The patient took acetaminophen (TYLENOL) for the events. The clinical outcomes of fever 101.8 degrees Fahrenheit, headache, generalized pain, and a little tenderness where the injection was given were unknown. The events of fever 101.8 degrees Fahrenheit, headache, generalized pain, and a little tenderness where the injection was given were assessed as related to the vaccine.
Patient symptomatic since 12/23/2021 with multiple symptoms. Tested COVID-19 positive on 12/26/2021. Isolated until 1/2/2022, then she needed follow-up. She did not participate in a clinical study and does not want antibody testing done.
PAIN TO RIGHT SIDE OF THE NECK; NUMBNESS OF RIGHT ARM/RIGHT SIDE OF NECK/RIGHT EAR; RIGHT ARM TINGLING; PAIN TO RIGHT EAR; PAIN TO RIGHT SIDE OF GROIN; RIGHT LEG PAIN/RIGHT ARM PAIN/EXCRUCIATING PAIN THAT FELT LIKE AN INTENSE CHARLIE HORSE; HEADACHE; QUEASY FEELING THAT FELT LIKE DID 100 SIT-UPS; STOMACH PAIN; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 135 pounds, and height was 65 inches. The patient's past medical history included thyroidectomy, and concurrent conditions included thyroid replacement medication, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had uses. the patient did not have any history of drug abuse or illicit drug use. the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced stomach pain. On 11-APR-2021, the subject experienced lower back pain. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced queasy feeling that felt like did 100 sit-ups. Laboratory data included: Pain scale (NR: not provided) 5/10, 3/10, 1/10. On 15-APR-2021, the subject experienced right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse. On 24-APR-2021, the subject experienced pain to right side of the neck. On 24-APR-2021, the subject experienced numbness of right arm/right side of neck/right ear. On 24-APR-2021, the subject experienced right arm tingling. On 24-APR-2021, the subject experienced pain to right ear. On 24-APR-2021, the subject experienced pain to right side of groin. On 25-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Normal, CBC (NR: not provided) Normal, Creatinine (NR: not provided) Normal, Laboratory test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 26-APR-2021, Laboratory data included: ECG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, lower back pain, headache, and queasy feeling that felt like did 100 sit-ups on 20-APR-2021, and pain to right side of the neck, numbness of right arm/right side of neck/right ear, right arm tingling, pain to right ear, pain to right side of groin, and right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse on 05-MAY-2021. This report was non-serious.
Bell's palsy (left-side facial paralysis). 72-hour onset. Symptoms started 3/26/21. Diagnosed 3/28/21. Prednisone and Zorivax prescribed.
Patient developed rash away from injection site for which she sought treatment from her doctor; her doctor diagnosed her with shingles at this time.  This was three days after administration of ZOSTAVAX.
the patient received PENTACEL subcutaneously and not intramuscularly at the 4 month visit, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00824918) and transmitted to Sanofi on 22-Oct-2021.   This case involves a four-month-old (unknown gender) patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot and expiry date not reported) via subcutaneous route at an unknown administration site on an unknown date for prophylactic vaccination (incorrect route of product administration).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination (latency was on same day).  It was reported "Caller states they have a new 9-month patient that has already had their routine 2, 4, and 6-month shots. However, the patients mother stated that at the 4-month visit the patient received PENTACEL subcutaneously and not intramuscularly. Patient also received a dose of PENTACEL at their 6-month visit. The new MD would like to know if the patient should be revaccinated for the incorrect administration of PENTACEL?"  At the time of report, no adverse event reported.  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 the 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.  There will be no information available on batch number for this case.