chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 23rd July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, contusion, chills, fever, nausea, loss of energy, appetite absent and stomach discomfort. On an unknown date, the outcome of the pain in arm, contusion, chills, fever and stomach discomfort were unknown and the outcome of the nausea, loss of energy and appetite absent were recovering/resolving. It was unknown if the reporter considered the pain in arm, contusion, chills, fever, nausea, loss of energy, appetite absent and stomach discomfort to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the 2nd dose of SHINGRIX, the patient experienced soreness in his arm, which was not as bad as experienced with the 1st dose, however it bruised quite a bit. Later on the day of vaccination, in the afternoon, the patient felt horrible and went to bed. He experienced chills, shivering, fever and nausea all the night. On the next day of vaccination, the patient's arm was a little sore than the first day after the vaccination. 1 day after the vaccination, the patient experienced no energy, no appetite and stomach felt awful. The patient had no energy or appetite. The patient's stomach felt awful and he stayed in the bed most of the day. One day before the date of reporting, the patient started to improve but still at the time of reporting felt a bit nauseated with a very little appetite. This case was linked with case US2018134297(1st dose), reported by the same reporter for the same patient.
Partially collapsed lung; pain in my abdomine; shortness of breath; Atelectasis; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at Pharmacy or Drug Store, administered via an unspecified route, in left arm on 03Oct2021 13:30, at 26 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included autoimmune haemolytic anaemia (AIHA) from an unknown date; splenectomy, appendicectomy, tumor removal of the colon, tubal removal, gallbladder removal and intracranial brain anyerisum surgery on unknown dates and allergy to morphine and penicillin from an unknown date. The patient's concomitant medications were not reported. The patient didn't receive any other vaccine in the 4 weeks prior BNT162B2 vaccination. The patient was not diagnosed with COVID-19 prior vaccination. On 04Oct2021 the patient started to have pain in her abdomen and shortness of breath, therefore she went to the ER and got a chest X-ray and was told it was atelectasis or a partially collapsed lung. She received treatment with pain managment and oxygen. The event "partially collapsed lung" was assessed as medically significant. On 06Oct2021 the patient underwent SARS-CoV2 test via nasal swab, which resulted negative. At the time of the report the events were resolving.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Pain, muscle pain radiating from site of injection, radiated down into arm (R).  Approximately within an hour pain also radiating into R neck area.  By 11 (1.5hr post injection) took 2 Advil which helped pain some.
Initial report received on 20 September 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 4-year-old female subject (initials not collected) was identified by the investigator based on review of data from the system's electronic database. The subject's vaccine history included 4 doses of DAPTACEL; lot number C2552AA on 24 July 2007 and 24 September 2007, lot number C2607AA on 26 November 2007 and lot number C2934BA received on 28 August 2008 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 01 September 2011, approximately three years after the last dose. On 06 September 2011, the subject developed a paroxysmal cough and sleep disturbance. It was not reported if a whoop accompanied cough. Laboratory testing included positive PCR on 06 September 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 06 September 2011 for five days. The subject was not hospitalized. At the time of final contact on 16 September 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Mom reported on 12-04-12 that on 11-26-12 at 330 pm "(R) leg had redness and swelling from hip to knee." Mom applied cold compresses & adm TYLENOL. By next am swelling had subsided.
LIGHT HEADED; LITTLE WEAK; FEVER; CHILLS; TIRED FATIGUED FEELING; BODY ACHES; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced tired fatigued feeling. On 09-APR-2021 03:00, the subject experienced chills. On 09-APR-2021 03:00, the subject experienced fever. On 12-APR-2021, the subject experienced light headed. On 12-APR-2021, the subject experienced little weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 11-APR-2021, was recovering from tired fatigued feeling, and the outcome of little weak and light headed was not reported. This report was non-serious.
Headache, head felt heavy 11/26 headache worsened on 11/28 has improved since, but feeling of heaviness has continued. Feeling mentally fuzzy slow mental processing 11/27 began to notice on 11/27 has worsened over time. Feeling dizzy, off balance, depth perception is off 11/27 continued to present. Eye problems, at the start seemed like depth perception was off. Intermittent twitch in left eye 11/29 continues to present. Pain in jaw, hurts to smile, hard to keep lower jaw closed 11/30 pain has lessened in jaw, still hurts to smile. Reported symptoms to clinic 12/02 they advised symptoms should go away with time. Unable to taste food difficulty performing work on computer noticing difficulty remembering names 12/4 continues to present. Reported to Urgent Care who recommended a blood test and to make an appointment with Dr. 12/5. Body feels numb, can't feel hot water in shower or hands don't feel heat on the stove 12/6 continues to present. Trouble sleeping, sleep four hours and wake up don't get deep sleep 12/7 noticed this around 11/26, but thought it would go away. Slower reaction time when driving 12/7 continues to present.
After getting shots had 3 days of non-responsive, no smiling, no moving, just staring.
Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 mL dose of Gardasil (yeast). Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Patient with 2 Moderna vaccinations, last dose 04/13/21, who admitted with COVID detected PCR and COVID symptoms.  Provider D/C note below:  "75  female with past medical history significant for recent hospitalization for diarrhea found to have C. Difficile colitis and Enteropathogenic E. Coli status post 14 day course of fidaxomicin completed on 11/25 after failing to improve on oral Vancomycin.  Patient presents with several day history generalized weakness, fatigue, LLQ pain and recurrent diarrhea. She also complained of headaches.  She is vaccinated for COVID 19 but is found to be positive.     Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  *Fever with LLQ abdominal pain in setting of recent treatment for C. Difficile colitis and Enteropathogenic E. Coli with known diverticulosis and history of diverticulitis - no evidence of diverticulitis on CT of Abdomen - GI stool PCR not sent because no loose stools throughout admission, fever likely due to COVID 19, chronic abdominal pain consistent with history of IBS, Dicyclomine for abdominal cramping, using Norco as at home, could consider adding Nortriptyline 25 mg BID as an outpatient if patient continues to have symptoms, recommend referral to GI for possible colonoscopy   *Acute respiratory failure in setting of COVID 19 pneumonia with chest imaging showing multifocal bibasilar opacities, CRP 23.7, D-dimer 1,390, ABG with central hypoxia with paO2 of 55 on room air, received Decadron 6 mg daily, Heparin subq for DVT prophylaxis, did not give Remdesivir with advanced kidney disease, patient weaned to 2 liters by NC by time of discharge (she typically wears 2 liters a night when sleeping at home).   *Acute on chronic kidney injury stage IV - slowly resolved after 1 liter NS fluid bolus and some limited maintenance IV Fluids, holding home blood pressure medications including ARB, continued home sodium bicarbonate tablets   *Peripheral vascular disease status post bilateral SFA stents in 2015, L anterior tibial angioplasty 7/2019, on DAPT and Statin for that   *History of lacunar strokes - Aspirin, Statin   *COPD - continue home Symbicort, Albuterol prn   *Restless leg syndrome - Ropinirole   *GERD - PPI"
Booster dose given too early. Received 0.5 ml of Moderna on 3/30/21 and 4/27/21. Received booster dose (0.25 ml) on 11/15/21.  Received another booster on 12/22/2021.
Pt. C/O feeling dizzy and nauseated. Had an episode  of seizure that lasted for 5 sec, vomited small undigested food  particles and became diaphoretic afterwards. A pkt of 125 mls of apple juice and water offered. (11 call made. Pt. finished the apple juice but had few sips of water. Pt reported having had similar episodes whenever he got blood draws and confirmed the reaction was related to sensitivity to needles ( vaccination needle) than  the vaccine. Paramedic team arrived at 3:25 p m. Pt. and mom refused the Ambulance services to the ER, but agreed to remain in the observation room for further observation.at about 4:05 p m. Pt and mom left the recovery hall .
Pt felt nausea after 3 vaccines administered. No loss of consciousness. No emesis. Kool-Aid given. Seek medical attention PNU. BP 100/62.
Looks like flu; I felt like crap; Headache; Fever; Muscle / aches; Joint aches; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 10th February 2021, the patient received the 2nd dose of Shingrix. On 10th February 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, feels awful, headache, fever, muscle pain and joint pain. On an unknown date, the outcome of the influenza-like symptoms, feels awful, headache, fever, muscle pain and joint pain were unknown.   The reporter considered the influenza-like symptoms, feels awful, headache, fever, muscle pain and joint pain to be possibly related to Shingrix. Additional details were provided as follows: The patient was reporting for himself. The age at vaccination was not reported. On 10th February 2020, the patient received Shingrix in afternoon and in night he experienced flu like reaction. Overnight, the patient felt like crap with headache, fever, muscle and joint pain.
17SEP hives over entire body; swelling of hands & neck; mom said "breathing was nasal sounding" no blue color; tx Decadron;
Localized reaction to first Menveo vaccine on 8/5/19. Swelling, pain, redness to arm at site of injection. Size of baseball. Viewed picture of patient arm with reaction on MOC phone today. Reaction started same day, but by the next day was worse. Associated blotchy rash to face, neck, and arm. No anaphylaxis. Patient/family did seek care at urgent care and was treated with prednisone. Improvement within 24 hours and resolved within a few days of treatment.
6 days post MMR/VARIVAX administration child developed a fever. Went to ER same day and received AMOX for OM. 2d after ER visit  developed rash and had a seizure.
A non-serious spontaneous report of a we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a 40-month-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date 12-Feb-2010, had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Joint Pain (feels like a rheumatoid arthritis flare-up) Cold sore on the bottom lip Itching (feels like I've had a mild allergic reaction)
Fever: 102F, annular hives-like rash from knee to upper thigh with central clearing.  On right leg initially then on left leg with clearing on right.  Also 14 days later 5 pox-like lesions on head and trunk.
Vaccinations administered at approximately 2:20 pm. Pt. was instructed to remain seated. I was speaking to pt.'s mother for approximately 10 min. when episode occurred. Pt. did not state feeling ill or faint. Suddenly, she rolled forward out of chair onto floor. Head struck floor (slightly puffy over L eyes et slight bruise L cheek) 1-2mm blood blister on R index finger after fall.
Progressive visual loss 'like a grey curtain', retinal detachment on eye exam, panuveitis. Started on IV Steroids with minimal improvement thus far.
Veteran reports 5/9 received pneum vaccine in PCP office- felt woozy then, the next day, shoulder/upper arm where received vaccine was red, slightly swollen, and hot to touch- not present currently, but is still tender near injection site. intermittent feelings of lightheadness with position changes, not falling.
Pericarditis: Chest pain, inflammatory markers were elevated. Improved with Colchicine
Small rash that presented 8 days after vaccine and expanded to the top half of my arm, raised, red and warm. It also itches.
Don't know how much for sure but the nurse thinks almost half went to the floor; Hard time inserting the needle into the arm; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Don't know how much for sure but the nurse thinks almost half went to the floor) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Hard time inserting the needle into the arm) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced UNDERDOSE (Don't know how much for sure but the nurse thinks almost half went to the floor) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Hard time inserting the needle into the arm). On 15-Mar-2021, UNDERDOSE (Don't know how much for sure but the nurse thinks almost half went to the floor) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Hard time inserting the needle into the arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided by reporter. Treatment medications were not provided by reporter.; Sender's Comments: This report refers to a case of wrong techniques in device usage process and accidental underdose for mRNA-1273, with unknown lot number.  with no associated AEs.
A 15-year-old male patient, with no pre-existing medical conditions, received an injection of Menactra (lot number, route, and site not reported on 30 June 2005. On 27 January 2008, two years and seven months after vaccination, he was diagnosed with Neisseria Meningitidis, Strain Y. Per the patient's parent, this was confirmed via laboratory testing by the State Health Department. He was hospitalized for four days, and treated with Vancomycin and Rocephin. The patient was subsequently discharged to home, and had recovered with no sequelae.  03/05/2008 MR received for DOS 1/27-30/2008 with D/C DX:  Meningococcal Meningitis.  Pt had meningitis vax at age 12.  Pt presented to local hospital with fevers, headache, vomiting, achiness, and petechial rash which was worsening. LP revealed increased WBCs and protein and pt was transfered for higher level of care. Pt had poor po intake, rhinorrhea, myalgias and arthragias in addition to above on admission.  PICC line was inserted for IV abx.  Petechial rah was fading and po intake improved upon d/c.  To continue IV abx as an outpt.
Information has been received from a physician concerning an 13 year old male who on 29-JUL-1997 was vaccinated with the first dose of MMR II, on 07-JUL-1999 was vaccinated with the second dose of MMR II. On 13-JAN-2010 the patient experienced mumps. Diagnose on 14-JAN-2010 revealed the patient had parotitis L. Additional information has been requested.
Around 20 minutes after vaccination, patient notified staff of pareshesias to her face.  Noted with pallor.  Vital signs showed hypertension.  Dizziness remained intermittent with improvement in blood pressure.  Symptoms resolved on own.
The day after the vax, I had fever, chills, and I started with debilitating headaches.  I have been taking my migraine prescription to no avail.  I also experienced nausea.  Two days after the vax I started my period (12 days early).  I had severe cramping, extremely heavy flow with clotting.  This went on for 3 days and just stopped.  I went from major clotting, cramping and bleeding to nothing at all.  No step down.  I am still experiencing nausea and horrible headaches.  It feels like my hormones have been disrupted.
A non-serious spontaneous report of "administration of expired product" was received from a non healthcare professional concerning a 47-year-old female out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
This spontaneous report was received from a physician and refers to a patient of unknown demographics. No medical history or concurrent conditions were reported. On an unknown date in May 2013, the patient was vaccinated with first dose of GARDASIL, the patient was vaccinated with the second dose on an unknown date in August 2013 and the third dose on an unknown date in May 2014 (inappropriate schedule of drug administration). On 01-APR-2015, the patient was vaccinated with a fourth dose of GARDASIL. No adverse events were reported. The outcome of the event was unknown. No PQC was involved. Additional information has been requested.
Wonders if the vaccine has damaged his heart; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (Wonders if the vaccine has damaged his heart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Wonders if the vaccine has damaged his heart). At the time of the report, CARDIAC DISORDER (Wonders if the vaccine has damaged his heart) outcome was unknown.            No concomitant medications were reported.   It was unknown if the patient had any adverse events following dose 1 vaccination.  Reporter assessed event wonders if the vaccine has damaged his heart as possibly related to Janssen COVID-19 vaccine.  No treatment details were reported.
This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): UNT-2022-004274 (Regulatory Authority). A 75 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2022 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for Covid-19 immunisation; influenza vaccine (FLU), administration date Feb2022 (Batch/Lot number: unknown) as unknown, single for antiviral prophylaxis; Treprostinil sodium (TYVASO), first regimen since 29Jan2022 (Batch/Lot number: unknown) at 36 ug 4x/day, second regimen since Feb2022 (Batch/Lot number: unknown) at 18 ug 4x/day and third regimen (ongoing) (Batch/Lot number: unknown) at 36 ug 4x/day for pulmonary arterial hypertension. Relevant medical history included: "Pulmonary arterial hypertension", start date: Feb2022 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; manufacturer unknown), for Covid-19 Immunization. The following information was reported: COUGH (non-serious) with onset Feb2022, outcome "not recovered", described as "Continued baseline cough associated with IH TYVASO treatments"; THROAT IRRITATION (non-serious) with onset Feb2022, outcome "unknown", described as "Throat irritation"; OEDEMA (non-serious) with onset Feb2022, outcome "unknown", described as "Edema"; DIZZINESS (non-serious) with onset Feb2022, outcome "unknown", described as "Was not moving around well and was getting dizzy". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for Treprostinil sodium was dosage not changed. Additional information: The male patient began therapy with IH TYVASO (Treprostinil sodium, concentration of 0.6 mg/ml) delivered by TYVASO Inhalation Device (TD-300/A), on an unspecified date in Feb2022 for pulmonary arterial hypertension. The current dose was reported as 18 µg (3 breaths) four times a day (QID), via inhalation (IH) route. On an unspecified date in Feb 2022 (late last week), the patient got her third Covid vaccination and flu shot. Her blood pressure and weight remained stable. She was overall feeling better after that day with the vaccination. It was unknown if the physician was aware. The reporter's causality for the event cough with IH TYVASO was considered to be possibly related. The reporter did not provide causality for the events of throat irritation and oedema. The reporter did not provide causality for the event of dizziness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.