chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NON-SPECIFIC ISSUES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 patient experienced non-specific issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of non-specific issues was not reported. This report was non-serious.
Case number PHHY2011US33313 is an initial spontaneous report received from a nurse on 15 Apr 2011. This report refers to a patient of unknown age group and gender. This patient was given a portion of MENVEO vaccine (batch number: unknown) diluted with saline, intramuscularly on an unspecified date. No other adverse reaction was reported.
I received the flu shot at around 3:30 and by 10:30, I had a problem breathing. It became so severe that 911 was called and I was taken to the hospital. A breathing tube was inserted to correct the problem.
Migraine; Fever; Dizziness; Drowsiness; Arm pain; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 15May2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included just mental illnesses, ADHD and mood disorder. The patient had no known allergies to medications, food or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lamotrigine (LAMICTAL) and atomoxetine hydrochloride (STRATTERA). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021, the patient experienced migraine, fever, dizziness, drowsiness and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events migraine, fever, dizziness, drowsiness and arm pain were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approx 2 PM on 10/21/10, c/o itching of arms and stomach. Approx 5 pm observed "welts" on arms, neck and stomach. 2 BENADRYL taken at 9PM-topical BENADRYL applied also. Contacted P.A on 10/24 with cont c/o urticaria - Started on Prednisone 10/26 AM. Describes as welts, not hives.
Starting 2 days after the first Moderna vaccine, I have experienced heavy periods 3 days a week that have not stopped.
Presented with confusion and weakness, cough, SOB, diarrhea x 2 days; Covid + ED; Admit 9/22 medical with Covid infection; tx : 9/22 Rocephin, vancomycin, 9/22 No supplemental O2 needed;
Initial medication error report received from a healthcare professional on 03 October 2013. The 10 year patient had received DAPTACEL vaccine. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Pt recvd 2 doses of Hep B vax & 4 hrs p/1st dose devel a h/a which lasted 24 hrs; 24 hrs following the 2nd dose devel back, shoulder & neck pain & stiffness which persist
This case was reported by a consumer via out of hour services and described the occurrence of runny nose in a 33-year-old female patient who received HAVRIX. On 4th May 2018, the patient received HAVRIX (intramuscular). On 7th May 2018, 3 days after receiving HAVRIX, the patient experienced influenza-like symptoms and tiredness. On 10th May 2018, the patient experienced runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, general body pain, sore throat and dizziness. On an unknown date, the patient experienced breast feeding. On an unknown date, the outcome of the runny nose was recovering/resolving and the outcome of the headache, memory impairment and sore throat were not recovered/not resolved and the outcome of the muscle soreness, decreased appetite, confusion, influenza-like symptoms, dizziness and tiredness were recovered/resolved and the outcome of the general body pain was not reported and the outcome of the breast feeding was unknown. The reporter considered the runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, influenza-like symptoms, general body pain, sore throat, dizziness and tiredness to be probably related to HAVRIX. See case US2018085809 for details regarding the baby case. Additional details were provided as follows: The patient's concomitant medications included birth control pills. The patient received the vaccine due to her job requiring the vaccination. The patient received HAVRIX in the left arm. The patient started to feel tired and have flu like symptoms.  The reporter stated the rest of the symptoms started on 10th May 2018. Six days after vaccination, the patient experienced runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, general body pain, sore throat and dizziness. The reporter stated all symptoms were gone except headache. The reporter stated she did call her healthcare professional and they instructed her to call GlaxoSmithKline. No healthcare professional information was provided.
swollen arm  on the arm where she has received flu shots, flu shot every Oct; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Flu vaccine.     Linked case(s) involving the same patient: US2016018882, US2022AMR097788, US2022AMR097791, US2022AMR097795   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The case was self-reported by the patient. The patient received Flu vaccine in the past into unknown arm and had swollen arm. The patient had a Flu shot every October of each year. The patient did not know the manufacturing company of these Flu shots, but she experienced a swollen arm after each dose. The reporter did not consent to follow up. For tolerance to the other suspects refer case US2016018882, US2022AMR097788, US2022AMR097791 and US2022AMR097795. This case is linked to the case US2022096943 and US2022AMR097632, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022096943:Same reporter US-GLAXOSMITHKLINE-US2022AMR097632:Same reporter US-GLAXOSMITHKLINE-US2016018882:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097788:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097791:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097795:Same patient, same reporter
blotches and lumps all around the face; blotches and lumps all around the face; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included antihistamines. The patient experienced blotches and lumps all around the face on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Adverse Event was getting Covid 3 months after receiving 5th vaccine. Diagnosed December 24 at urgent care and given prescription for Paxlovid same day. Extremely tired and had dry cough for about a week.
seizures, tremors, Left side jerky movements, uncontrolled right side movements, head and shoulders, all over jerky movements. complaints of dizzy feelings, eyes feel like they are moving in ocean. able to talk during episodes. past seizures could not talk.  This activity is new, and not like past seizure activity.
chest hurt; dizzy; body aches; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. This report was received via a sales representative. A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had experienced chest hurt, dizzy and body aches on an unspecified date. The outcome of all the events was unknown.   Information on Lot/Batch number has been requested.
Information has been received from a physician's assistant concerning a female patient who received two doses two of VARIVAX (Merck) at unstated schedule.  After an unknown period of time she developed Herpes Zoster on one side of her trunk on 03-SEP-2008.  No additional information at the time of report.  VZVID offered and Representative will call the office that day, 12-SEP-2008. The patient sought medical attention in the office.  Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: fainted after admin of fist dose of modern vaccine.  recovered quickly.  ems arrived and checked her out.  she was fine
Patient presented to clinic 9 days after vaccination in acute distress, shivering, tachypneic and having difficulty with speech. Heart rate at 130 beats per minute, Spo2 91% on room air, temp 99.9f oral. Initial difficulty obtaining blood pressure due to shaking. Patient was treated with 500mL NS and 2L O2 via nasal cannula, which immediately improved symptoms. Due to elevated glucose and minimal austere conditions, patient was evacuated from camp to hospital. There, patient diagnosed with COVID-19 infection, bilateral basilar and right apical pneumonia, diabetes and sepsis.
10JUL96 4PM t101-102 APAP given;high pitched cry 4PM-8PM very fussy p/that;MD instructed Motrin saw MD 11JUL96;temp 102, leg very red & swollen;very fussy 11JUL96;does not want bottle;no ear infect
Sudden onset tinnitus in left ear, ~30 hours after covid booster administered.  Patient had previously experienced sore jaw (difficulty chewing), tightness and sharp pain in neck.  Patient has previously experienced tinnitus from 2007-2011, in both ears due to head trauma, with no recurrence after 2011 (until today).
Here 1-4-08 for 2 yr. P.E.-Normal growth, no problems. DTaP Sanofi # C2780AA given IM (R) thigh; Hepatitis A Merck Recheck PMA 1-7-08-Swelling noted around (R) knee. No fever, no pain-CBC and blood cultures done- all WNL- x-ray no fx; soft tissue swelling no osteomyelitis
On 12-8/21 after the booster i experienced bad headache, and head pressure including ear pain and ear ringing; within few weeks i experience tingling and pain in my head and my eye started drooping experiencing symptoms of stroke. My husband took me to hospital that evening; determined no stroke; however visited neurologist because continued to experience head tingling finger numbness and stroke symptoms along with ear pain and ringing. It is March 15, 2022 and still experiencing the symptoms, am now in physical therapy and visiting chiropractic to help me witb my nerve and cervical spine issues that I suddenly developed after the booster
This spontaneous report as received from a nurse (other health professional) refers to a patients of unknown age and gender. On unspecified date in August 2014 the patient was vaccinated with one unsupported, improperly stored dose of GARDASIL lot # K001631, exp. date:06-NOV-2016; 0.5 ml, intramuscularly. No adverse effect was reported. Additional information has been requested. This is one of several reports received from the same reporter.
The Moderna Booster Vaccine was drawn up by an RN on staff and then given to me to administer to the patient. 15 minutes later after the patient left the clinic the RN told me the dose she gave me was only .2 instead of .25. The CDC was contacted and they recommended immediate re-vaccination at the correct dose.
The third dose she had a metallic taste from the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "The third dose she had a metallic taste from the first dose".  Additional Information: The Product is PAXLOVID.Caller started her Paxlovid medication on 11Jan2022 and is having side effects. Caller states that she is in a lot of stress and is having black stool and feeling very weak. In the first couple of days she feels better, very good and just a little tired. On the third dose she had a metallic taste from the first dose. Caller is stopping her medication today. Caller states that she is taking a lot of food supplements and has a weak liver. She mentioned that her HCP never told her that she can't take supplements. Caller wants to go cold turkey on her medication. Caller is most concerned if "black stool" is a reported side effect of her medication.  Follow up attempts were closed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 09-OCT-2018, there was an storage temperature excursion and on 09-NOV-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N035958 with expiration date on 18-DEC-2019 (strength, dose, anatomical location or route of administration were not provided), for prophylaxis; which was administered concomitantly with a sterile diluent (MERCK) that was not reported as improperly stored. The storage temperature of the vaccine was reported as 47 to 77 degrees Fahrenheit (°F) (58.5 °F) for a time frame of 13 hours and 20 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were being reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA012810.
The first shot gave me itches on my chest and body aches. The second one gave me intensified body aches and sniffles.
rash; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced rash. The reporter was looking to see how he/she could report a rash reaction to Shingrix vaccine. The follow-up would not possible as no contact details were available.
Patient up to date on COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) history of paroxysmal aflutter, asthma, DM2, hypertension, hyperlipidemia, MDD, GERD presented to cough, abdominal pain, emesis, and shortness of breath initially. Transferred to ICU for septic shock symptoms and known to have klebsiella bacteremia c/b renal abscess, initially managed with levophed, vasopressin and BiPAP. She was treated with ceftriaxone and gentamycin initially, weaned down to ceftriaxone with ID following after she was stabilized and transferred to the floor. Plan will be to send with midline placed for prolonged IV ceftriaxone course. She also had a left ureteral stent placed during this admission. She also has right brachiocephalic and left subclavian stenosis, surgery was consulted with no plans for interventions during this admission. Cardiology also consulted about the same, but no plans for stent at this time, will defer to oupatient follow up with cardiology. Restarted on high intensity statin. She also had episode of atrial fibrillation/flutter, cardiology consulted and resumed her home lopressor. She later self converted to Normal Sinus Rhythm. Also was COVID+ with pneumonia, s/p isolation period and treated with symbicort and spiriva and NC O2, weaned down to home 2L NC. She additionally had acute ITP which was treated with steroids and IVIG. Currently, medically stable for discharge. "
This spontaneous report was received from a 78 year old female patient concerning herself. Concurrent medical conditions included high blood pressure and allergy to zinc. Concomitant medications included an unspecified medication. In February 2013, the patient received one dose of ZOSTAVAX for prevention of shingles (route and lot number not provided). On approximately 01-DEC-2016 (reported as three weeks ago), the patient developed shingles. She went to the Emergency Room (ER) and was treated with triamcinolone. The patient's present status was not recovered. Additional information has been requested.
Was seen in our office on 4/9/2013 with lesions on trunk that had started on Sunday. Lesions had started increasing in number by this time.
rash dark red, flat large over chest & behind knee looks like a spider bite;no itching/fever;chickenpox 7 days ago;
Numbness 20min after vaccine & persisted rest of day then 12hrs later pain @ site. Then redness @ injection site 16hrs. 3cm erythema & swelling deltoid to deltoid.
Infant found in respiratory arrest at home in crib (at night). EMS responded; unable to resuscitate at home or in ER. Probable SIDS. Per F/U done by FDA researcher who contacted the ME, the COD was SIDS.
Approx 3 min after receiving the vaccine, (Patient) suffered a seizure. He experienced cold sweats, rapid heart rate, and blacked out. His eyes moved rapidly side to side. The seizure lasted approx 10 seconds. Pt. was lucid and able to answer basic questions when he came through. We took him to the hospital for additional evaluation. He received a CAT scan and blood work. Those results are pending
This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats) and HEADACHE (Headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy and Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, DICYCLOMINE [DICYCLOVERINE] for an unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats), HEADACHE (Headache), PHARYNGITIS STREPTOCOCCAL (Strep Pharyngitis) and NAUSEA (Nausea). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats), HEADACHE (Headache), PHARYNGITIS STREPTOCOCCAL (Strep Pharyngitis), COVID-19 (Tested positive for COVID-19) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, SARS-CoV-2 antibody test: positive (Positive) Tested positive for COVID-19. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PHARYNGITIS STREPTOCOCCAL (Strep Pharyngitis) to be not related. No further causality assessments were provided for ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats), HEADACHE (Headache), COVID-19 (Tested positive for COVID-19) and NAUSEA (Nausea). Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up appended: Reporter details (address, phone number and fax number), patient's demographics (pregnancy details was changed from 'no to unknown', height, weight, race, and ethnicity), medical history details (allergy, current condition and COVID-19 was deleted from medical history section), concomitant medication details (Levothyroxine's indication for use, route and dose), vaccine facility information, additional event (Tested positive for COVID-19), event verbatim (updated from Strep to Strep Pharyngitis) and causality for the event Strep Pharyngitis (updated from not provided to not related) were provided.
This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 13-FEB-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
PATIENT EXPERIENCED AN OUTBREAK OF SHINGLES.  INITIALLY STARTED WITH ARM PAIN, CHILLS, NAUSEA THE SAME EVENING AS SHE RECEIVED THE VACCINATION.  AS WELL AS A RASH/BRUISING AT THE INJECTION SITE.  DEVELOPED MYALGIAS FOLLOWED BY RASH ON NECK AND LEFT BREAST WITH ASSOCIATED NUMBNESS.
Patient received both doses of COVID19 Pfizer vaccine. Second dose was given on 1/8/21. Patient reportedly tested positive for COVID19.