chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain when urinating; May have an infection - UTI; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Pain when urinating) and URINARY TRACT INFECTION (May have an infection - UTI) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L208) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DYSURIA (Pain when urinating) and URINARY TRACT INFECTION (May have an infection - UTI). At the time of the report, DYSURIA (Pain when urinating) and URINARY TRACT INFECTION (May have an infection - UTI) had resolved.            Concomitant product use was not provided by the reporter.  The patient reported that she had received both the shots and was fine. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Additional information received captured reporter contact details, event outcome and dosage information.
patient has had headaches for 10 days consistently; night sweats; fever; chills; This is a spontaneous report from a contactable physician. A 29-year-old female non pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736, Expiry date was not reported) via an unspecified route of administration on 12May2021 (age at vaccination: 29 years) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date 2021, it was reported that patient has had headaches for 10 days consistently, night sweats, fever, and chills. The case was assessed as non serious. The outcome of the event headache was recovered on an unspecified date 2021 and other events were unknown.  Follow-up attempts are completed. No further information is expected.
Resting heart rate increased from 62 to 67 to 80's - lasted 2 weeks.  Heart rate increased and would not go down - periodically for 2 weeks..  Fatigue - had to take 1 to 2 hour per day naps for 2 weeks.  Chills - one night all night.  Projectile vomit.  Diarrhea.  Nausea.  Blood pressure up 10 on top and bottom - lasted 12 days.
Abdominal pain, headache, nausea, vomiting, diarrhea, rash on left chest, red, round warm area above injection site
Vaccine administration error.  It is suspected that a 1/2" needle syringe was used for administration instead of a 1" IM needle syringe.
This spontaneous report as received from a pharmacist via a company representative refers to a 49 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and frequency unknown) (dosing regimen and frequency unknown) for shingles vaccine. No concomitant medications were reported. On an unknown date the patient experienced red rash around the injection site. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of red rash around the injection site was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. It was reported that the event lasted a couple of weeks. Additional information has been requested.
allergic reaction; throat swelling; raspy voice; flushed face; itching; fever; redness and splotchy areas on her chest; redness and swelling at injection site; swelling at injection site; redness at injection site; Based on information received on 11-Sep-2020, the report previously considered as non-valid becames valid: [events added for validity].  Initial information received on 17-Sep-2019 regarding an unsolicited non-valid non-serious case received from a consumer/non-hcp and additional information received on same date.  This case involves a 60-year-old female patient who experienced allergic reaction (hypersensitivity) with symptoms throat swelling (pharyngeal swelling), raspy voice (dysphonia), flushed face (flushing), itching (pruritus), redness and splotchy areas on her chest (rash macular) and also fever (pyrexia), redness and swelling at injection site (vaccination site inflammation with vaccination site swelling and vaccination site erythema), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing asthma that was sulfide sensitive.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]); and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]).  On an unknown date (last year), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (single dose) (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity), throat swelling (pharyngeal swelling), raspy voice (dysphonia), flushed face (flushing), itching (pruritus), fever (pyrexia), splotchy areas on her chest (rash macular), redness and swelling at injection site (vaccination site inflammation with vaccination site swelling and vaccination site erythema), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other case details: reporter requested to know if the Flublok contains sulfates, latex, nickle, or gelatin as she had a reaction for Fluzone Quad (single dose) in the past.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of all events was unknown.  There will be no information available on the batch number for this case.  Follow up information was received on 11-Sep-2020, from a consumer.  Case was updated from non-valid to valid. New events added. Concomitant medications were added.
This initial spontaneous report was received from a lawyer regarding a case and litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was inoculated with ZOSTAVAX for the long-term prevention of shingles. The patient brings to action for personal injuries and damages suffered as a result of being inoculated with the ZOSTAVAX vaccine. No further information was provided. Additional information has been requested.
Patient had bloody stool, jelly like consistency.  Patient was seen in primary care clinic and then sent to hospital.  Pt was diagnosed with intussusception.  Pt had two air enemas were performed for reduction.  Patient was monitored in ED for four hours post reduction and discharged home.
The patient came to our pharmacy to receive the Shingrix vaccine, which she was given. We also asked her if she would like get her flu shot. she said yes and filled out all corresponding forms. Then on 1023 the patient called us stating she never asked to get her flu shot she already got it from he dr's office. She is having side effects with the shot such as soreness, feeling weak, and asked us to write a report
HEADACHE; FELT TIRED; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced felt tired. On APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, felt tired and nausea was not reported. This report was non-serious.
burning tonge, oral mucosa burning few hours after vaccine dose #1,  much milder after vaccine dose #2
Vaccine at about 4pm Heart attack 7pm  Stent placed Full body hives, still persistent 2 months later
pt recv vax & exp muscle weakness;2mo p/vax pt exp slurred speech;the reporter will provide no further details on follow up;
Systemic: TONGUE TINGLING AND FEELING WEEK LIP TINGLING, TOOK BENADRYL WITHOUT CONCERNING PHARMACIST BUT FELT BETTER WITH IT. OBSERVED FEW MINUTES
Woke up in the middle of the night couldn't raise her left arm, very weak, whole left arm was red very sore. Didn't go for treatment. Stayed in bed for two days, couldn't eat.
1st dose Oct 2022, 3rd Mar2023; 1st dose Oct 2022, 2nd Dec 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   In March 2023, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In December 2022, the patient received the 2nd dose of Twinrix. In December 2023, the patient started Twinrix Pre-Filled Syringe Device. In December 2022, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device and unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. In March 2023, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's Comments: The reporter was patient's wife called on behalf of her husband. The reporter did not provide demographic information.  Adverse event filled. The reporter did not consent to follow up. Additional Supportive Information:  The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Twinrix earlier than recommended interval, which led to shortening of vaccination schedule.
Pt. had immunization 6-3-15. Return 6-5-15 with redness to RUQ thigh. Script for BENADRYL PO and hydrocortisone topical. Call if worsens. Will check on pt Monday. (see note for additional questions). Area is 7 cm x 5.4 cm red raised. Will check Monday. 6-8-15 - mother state area has improved.
I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose; I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose; I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Dec2021 16:00 (Batch/Lot number: unknown) at the age of 21 years as dose 1, single for covid-19 immunisation.  Relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes.  The patient did not have any known allergies. Concomitant medication included: paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: CHEST PAIN (prolonged hospitalization), CHEST DISCOMFORT (prolonged hospitalization), DYSPNOEA (prolonged hospitalization) all with onset 12Dec2021, outcome "not recovered" and all described as "I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose".  The event "I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose", "I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose" and "I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose" was evaluated at the physician office visit and emergency room visit.  Therapeutic measures were not taken as a result of I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose . It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient received BNT162B2 dose 2 administration date 07Jan2022, administration time 03:00 PM, vaccine location was Right arm.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Severe pain in right shoulder. Deltoid muscle is compromised. Diagnosed with shoulder injury due to vaccine administration (SIRVA) on 05/18/21. Commenced physical therapy 06/07/21 and continued until 0/08/21. Further testing and MRI examination on 08/09/21 indicated the Brachial Plexopathy nerves were damaged. Final diagnosis was Parsonage-Turner-Syndrome on 11/01/21.
Client received 3 vaccines in her left arm without incident and tolerated them well. She proceeded to the book area to pick out a book with her siblings and suddenly fell to the carpeted floor. Client never lost consciousness and no injuries were identified. Cold cloth and juice provided and after care instructions provided for parents. Client remained in the clinic until both parents felt as if she was back to her normal self. At the end of the day her mother was contacted to check on her well-being and her mom verbalized that she was doing well and denied any concerns at this time.
patient expired 2/10/2021.  Unknown whether the death was even related to the vaccine. Pt did not have any problems during 15 min observation period and no issues reported to HD after vaccination.  reported because the person expired within 7 days of vaccination.
When patient left pharmacy after waiting about 15 minutes after being inoculated, she told me that as she was sitting in the waiting area she developed a clear metallic taste in her mouth.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 22-year-old male patient who received BEXSERO (batch number 156801A, expiry date August 2017). On 6th March 2017, the patient received the 1st dose of BEXSERO. In March 2017, 1 day after receiving BEXSERO, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown. The reporter considered the injection site swelling and injection site pain to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient received on left deltoid and 1 to 2 days after experienced swelling and pain in left deltoid. The patient required emergency room visit. The symptoms eventually subsided but health care professional was not sure of the exact date.
Information has been received from a pharmacy technician referring to a patient of unknown age and gender. There was no information about medical history, concomitant medication or concurrent condition. On 17-JUL-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose and route unknown, lot# N009167, expiration date 02-FEB-2018) for prophylaxis. Properly stored sterile diluent (dose and route unknown, lot# N008378, expiration date 08-JUN-2018) was used to reconstitute ZOSTAVAX. The vaccine was exposure to 6 Fahrenheit degree (F) to 14F for 7 days, 15F to 46F for 3 days. No previous temperature excursion was involved. No data logger was involved. This is one of the reports received from the same reporter (MARRS# 1707USA010616). Sender's Comments: US-009507513-1707USA010616.
CHILLS; EXTREME TIREDNESS; MUSCLE ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808509, expiry: UNKNOWN) dose was not reported, 1 total, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced extreme tiredness. On 18-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from extreme tiredness, and muscle aches. This report was non-serious.
Received Moderna vaccine at 11:55 am on May 4th.  Beginning May 6th at 1:30 am I began experiencing pain in my appendix and the muscles in the abdomen.  Although the pain became more manageable, it continued until May 10th. On may 10th, I went to the hospital and was diagnosed with appendicitis. They performed a laparoscopic appendix removal around 22:00 on May 10th and I remained in the hospital until 12:00 on May 11th.
Vaccines including ROTATEQ administered 12/15/16 became "constipated, vomited several x (bilious) x 1-2 days, lethargic, presented to our office this AM with "currant jelly" stool - to ED.
I WOKE UP WITH DIARRHEA AND A CONSTANT HEADACHE THAT HASNT LEFT
LEFT ARM RED AND WARM TO TOUCH -L DELTOID AREA  7 X 8 CM - WARM SWOLLEN RED, TENDER
arm began to swell within 1/2 hour of receiving vaccine.  started to become painful during the evening of march 1 and woke me during the night.  pain continued for several days.  I applied an ice pack to the injection site for the first 24-36 hours.   approx.  4 to 5 days after vaccine, the palms and fingers of both hands turned very red and kind of mottled and there was some puffiness.   Feeling of being tired continues.  I am very hesitant to get the second dose of this Moderna vaccine.
Patient presented to the ED and was subsequently hospitalized for acute CVA within 6 weeks of receiving COVID vaccination. Patient received second dose on 5/26/2021
itchiness, severe abdominal cramping, diarrhea, chills (about 2 hours after vaccine)
death Atrial fibrillation; Acute kidney failure, unspecified; Dehydration; Low back pain; CVA (cerebral vascular accident); History of bladder cancer; Elevated serum creatinine; History of urethral stricture; History of cancer metastatic to bone; Urothelial carcinoma of bladder
on blood thinners; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "on blood thinners". Therapeutic measures were taken as a result of thrombosis.  Clinical Course: Stop promoting this damn shot Two of patient friends have ended up with heart problems and four are now on blood thinners for the rest of their lives.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300014834 same reporter/drug, different patient/event;US-PFIZER INC-202300035009 same reporter/drug/event, different patient;US-PFIZER INC-202300035000 same reporter/drug, different patient/event;US-PFIZER INC-202300035001 same reporter/drug/event, different patient;US-PFIZER INC-202300035011 same reporter/drug/event, different patient;
sore arm 1st day felt like a bruise 3rd day - welt size of band aid 4th day - ballsized hard/red/hot lump ?afraid about infection 8th as it resolved she became fatigued/"body drawing! body aches no fever
eyelid twitching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (eyelid twitching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter. .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced BLEPHAROSPASM (eyelid twitching). At the time of the report, BLEPHAROSPASM (eyelid twitching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medical  provided by the reporter.
Extreme fatigue for 6 days; woke up with swollen face on left side; This is a spontaneous report from a contactable Consumer. This 56-Years-Old female Consumer (patient) reported. A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 14:30 (at the age of 56-years-old) as a single dose for covid-19 immunization. Medical history included arteriospasm coronary, asthma, congenital cystic kidney disease. Concomitant medication(s) in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR); fexofenadine hydrochloride (ALLEGRA); isosorbide; nifedipine. The patient had allergies with sulfa, penicillin. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Mar2021, the patient experienced extreme fatigue for 6 days, day number six woke up with swollen face on left side. Outcome of the event was not recovered, at the time of this report. No follow-up attempts are possible. No further information expected.
Shortly after vaccination (within 15 min), patient experienced warmth and itching at injection site, some radiating pain.  Patient asked to stay longer to be observed, but eventually returned back to work without progress in symptoms.  Approximately an hour later, she was prompted by her supervisor to return to vaccine area when she developed a headache and tingly lips.  She was given 50mg of diphenhydramine PO.  In no apparent distress after dosing
Administered patient her Pfizer booster Vaccine and noticed a large amount of blood into her inject safe bandage. I placed another regular bandage over it to help with additional blood but then patient alerted me while she was waiting her 15 minutes that the blood started flowing out down her arm. I proceeded to help her clean the area and blood that had dripped down her arm. When I felt the area it was tender, inflamed, and had a small bump. I placed another bandage on her arm and proceeded to have her lift her arm above chest level and place an icepack to help with inflammation. After a few more minutes the blood was no longer flowing and her arm was less inflamed.