chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: now testing positive; (05Sep2022) Negative, notes: tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient reported that she tested negative for Covid on 05Sep2022 and was feeling better. She experienced new symptoms on 07Sep2022 and am now testing positive. The patient did not receive other medication in two weeks.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
sore throat, cough, fever. went to urgent care, received antibiotics, got better within 1 week
rash where Td given red swollen;entire upper arm red & swollen unable to move arm above 45 degree angle;
Red, raised lump at the injection site (right arm) still present 9 days after the injection.  The red area is a little over 1 inch in diameter.  The area on the right arm is still very warm to the touch.  The injection site was painful for the first 2-3 days.  Although no longer painful, it is sometimes very itchy.   Also have felt quite tired and just generally run down for the past 2 to 3 days.
PER PATIENT: AT 1800 PATIENT BEGAN FEELING VERY "ILL". PATIENT STATES SHE CALLED HER DAUGHTER BUT BEGAN REALIZING SHE COULD NOT GET HER WORDS OUT OR MAKE SENSE WHEN TALKING. PATIENT REPORTED CHILLS. PATIENT ADVICED BY DAUGHTER TO CALL AN AMBULANCE. SHE DID SO AND WAS TRANSPORTED TO HOSPITAL.
At the site of administration the next day there was an erythematous coloration, swelling and localized heat.
This study case was received from the investigator on 28 January 2013. A male subject (date of birth not reported) had received the ACAM2000 (lot number, site, and date of vaccination not reported). An unreported amount of time later, the subject experienced transient elevated troponin. On 21 August 2010, the subject had blood drawn for Rapid Troponin I Levels and the result was within normal limits (negative). On the same day, 21 August 2010, the subject had blood drawn for central laboratory Troponin I levels and the result was 0.36 ng/mL (abnormal). Elevated troponin was also reported on 26 August 2010 with no values provided. The subject had normal follow-up troponin on 31 August 2010. The subject had an electrocardiogram reading on 31 August 2010, and the reason provided was "unable to interpret, rhythm strip only". On 21 August 2010, the subject reported a stuffy nose (treated with SUDAFED), sore throat, chest congestion, cough, headache, lightheadedness, and feverish. The subject had a past medical history of swollen or painful joints, frequent or severe headaches, cold or influenza. The subject took concomitant medication of SUDAFED for stuffy nose. The subject did not drink alcohol, smoked cigarettes and cigars within the past year, and had smokeless tobacco within the past year. In the subject's lifetime, he smoked at least 100 cigarettes and started smoking at age 18. He had an average of at least 3 cigarettes per day for 1 year and smoked half to one pack per day. The subject admitted to have quit smoking. The subject's outcome was not reported. According to the investigator, the event of Transient Elevated Troponin was considered a medically important event and possibly related to vaccination. According to the ACAM2000 Myopericarditis Adjudication Committee, the subject met the case definition for subclinical myopericarditis. Documents held by sender: None.
Nausea Chronic headache Dizziness/blurred vision Increased Blood Pressure (erratic - avg 160/92 again) Nervousness/Anxiety Decreased sexual desire
On 02/13/2023, in the morning, my nose started running.  I thought I was allergic to a coffee I drank. I sneezed a few times.  The next day, I had an unrelated doctor's appointment and I mentioned my runny nose.  I did not test there. Then I did a home test, which was negative. During the night 02/16/2023, I had chills, fever, body aches, headache, cough.  I felt very unwell. It felt like the flu.  I took Tylenol.  On 02/16/2023, I took a home test and it was positive. I went up the back staircase of the doctor's office and had a negative flu test. The doctor prescribed Paxlovid.  I began to feel better, but I am still testing positive 22 days later.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported), for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
no additional AEs; CMA called to report multiple TEs for PNEUMOVAX 23 dating back to 12/1/22 and confirms that vaccines were administered to 2 patients from affected lot. No further information provided, no additional AEs, no PQCs. PNEUMOVAX 23 (PFS) LOT W004863 EXP 8/; This spontaneous report was received from a medical assistant and refers to a 52-year-old female patient. Her concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 22-DEC-2022, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, dose: 0.5ml/once, lot #W004863, expiration date: 21-AUG-2023 (strength, vaccination schedule, site and route of administration were not provided) for prophylaxis (Product storage error). The medical assistant reported the vaccine underwent multiple temperature excursions dating back to 01-DEC-2022. No additional adverse events were reported.
SWELLING, REDDNESS, SEVERE ITCHING IN THE VACCINATED ARM.  RED BUMP AROUND 3"
Patient received 3rd dose of ROTATEQ vaccine on 3/16/2012. On 3/25/12, he developed intermittent episodes of severe irritability followed by vomiting and decreased urine output. He was found to have blood stools on 3/26/12 and was evaluated and found to have an intussusception. It was successfully reduced by air contrast enema. He recovered uneventfully.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Throat almost completely closed. Had to take three 50 mg visteral  that's 150 mg of visteral . Throat continued to close off then disappeared. Almost had to be rushed to the emergency room.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 27th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th March 2019, 12 hrs after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, headache, fatigue, shivering, weakness, upset stomach and flu-like symptoms. On an unknown date, the outcome of the injection site pain, muscle pain, headache, shivering, weakness and flu-like symptoms were recovered/resolved and the outcome of the fatigue and upset stomach were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, muscle pain, headache, fatigue, shivering, weakness, upset stomach and flu-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The case was reported by the patient for himself. The patient stated that by 12 hours after the dose his arm was really sore where he got the injection, he had bad muscle pain, headache, fatigue, shivering, weakness and upset stomach, he felt like he had the flu. On the day of reporting, he was mostly feeling better but his stomach was a little upset and he had a little fatigue, but the rest of the symptoms had resolved. The upset stomach was the worst part for him. The reporter consented to follow up. This case has been linked with case US2019057159, reported for patient's twin sister.
Patient complained of pain at the injection site mild swelling and redness noted. Stated she had fever the night of immunization date.
Area of redness x 5 1/2 ". Sore to touch. Heat from spot.
68 YO male with PMH significant for coronary artery disease, DM, COPD, and atrial fibrillation who presented with atypical chest pain. Given cardiac history cardiology was consulted. No further ischemic work-up was recommended as patient had LHC 9/2020. His Imdur dose was increased with improvement of his symptoms. Patient was positive admission screening for COVID-19 despite no respiratory symptoms. He had previously contracted the infection 11/2020 and completed his Pfizer COVID vaccine series: first dose on 3/1 and second dose on 3/22. Unclear if the test was a false positive; he was informed to remain isolated for a 10 day period from the test.
Primary Care Physician at Discharge: Hematologist/Oncologist: Dr. Admission Date: 8/12/2022; Discharge Date: 08/18/2022; Patient's Discharge Disposition:  Home in stable condition. PRESENTING PROBLEM: Pneumonia [J18.9] Hospital course: This is a 73 year old man with a past medical history as listed above who presented toHospital with SOB, 4 days of fevers and chills, and general malaise having failed outpatient antibiotics from his PCP. In the ED, the patient was febrile with increased WOB in the ED. CXR demonstrated RML PNA. He was started on Zosyn/Vanco and admitted to Hospital. MRSA was neg so Vanco was stopped. CT chest 8/12 demonstrated extensive right sided PNA. ID was consulted and Merrem was started. ID felt that the patient warranted transfer to hospital for pulmonary evaluation. The patient was transferred to hospital for further evaluation and management. Pulmonology and ID assisted in management. A bronch was completed on 8/13 with the above results. A covid test was done for a cycle threshold, which was 21.4. This is indicative of an active covid infection and the patient was started on steroids, remdesivir, and received high titer plasma. The remaining infectious work up remained negative throughout the admission. The patient's symptoms greatly improved and he was able to be weaned off oxygen. The patient was eating and ambulating at the time of discharge. He was instructed to hold his Eliquis and Venetoclax until his follow up appointment with Dr. Discharge medications and follow up as listed below. Answered all questions and the patient and family were comfortable with the discharge plan.
High pitched unusual crying; mom mentioned for first time about sx 29MAY91; when in w/same child for weepy eye;
Unable to keep food down for the next day; Injection site pain.; Severe headache; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Oct2021 17:00 (Lot number: EW0183) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), when the patient was 32 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), when the patient was 32 years old, for COVID-19 immunization; Flu shot (Flu shot). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Oct2021, outcome "recovering", described as "Injection site pain."; HEADACHE (non-serious) with onset 26Oct2021, outcome "recovering", described as "Severe headache"; NAUSEA (non-serious) with onset 26Oct2021, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 26Oct2021, outcome "recovering", described as "vomiting"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Unable to keep food down for the next day". It was unknown if therapeutic measures were taken as a result of vaccination site pain, headache, nausea, vomiting.  Additional information: Prior to vaccination, was the patient diagnosed with COVID-19?:Unknown. Since the vaccination, has the patient been tested for COVID-19?:Unknown  No follow-up attempts are possible. No further information is expected.
I never in my life have I has any skin issues.   These issues started after receiving the first dose.  I am still trying to get these rashes under control.  My head itches, neck issues, waist, ears etc.   These little bumps pop up at any given time.  I've been dealing with this for since I received the 1st vacine dosage.  I've had 3 so far and am not getting the 4th.
No additional AEs were reported; The nurse reported that a patient received improperly stored vaccine; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 03-OCT-2022, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1879866, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and upon internal validation established as 30-OCT-2023) (dose, anatomical location, route of administration, lot# and expiration date were not reported) for prophylaxis. The vaccine was stored at a temperature of 55.8 Fahrenheit degrees (F) for 44 hours (Product storage error). The vaccine did not have previous temperature excursions.  No additional adverse events were reported.; Sender's Comments:  US-009507513-2210USA000978:
Shortly after vaccination, patient began to experience a sensation of itching to her throat.  Denied dyspnea and lightheaded ness.  Vital signs within normal limits with slight BP elevation.  Monitored for 20 min and improved.
Started heavy vaginal bleeding and severe abdominal pain within 6 hours of receiving vaccine.  Bleeding continued for 6 days. Abdominal pain at time of report has not fully resolved.
This case was reported by a physician to a sales representative and described the occurrence of Bells palsy in a 14 year old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed (Boostrix) for prophylaxis. Concurrent medical condition included mild asthma. On 5/15/06 the subject received 0.5 ml of Boostrix in her right arm. On 5/17/06, 2 days after vaccination with Boostrix, the subject experienced Bell's palsy. At the time of initial reporting. 5/17/06, the event was ongoing. The physician considered the event was possibly related to vaccination with Boostrix. Follow up received on 5/19/06 from another sales representative indicated that the vaccination was three weeks prior to this follow up. The event was unresolved at the time of reporting. Comment Bell's palsy was assessed as medically serious by manufacturer (OMIC).
He experienced a cough beginning at 7pm of 07/10/2022 along with fatigue. The cough has became more frequent each day since vaccination. He has been given Zyrtec 2.5ml to try to manage the cough, and it has helped to manage the cough. The cough has remained steady, and has not resolved as of yet.
This case was reported by a other health professional via call center representative and described the occurrence of lip blister in a 53-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 13th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th July 2018, less than a day after receiving SHINGRIX, the patient experienced lip blister, swelling arm, rash, fever and chills. On an unknown date, the outcome of the lip blister, swelling arm, rash, fever and chills were recovered/resolved.  It was unknown if the reporter considered the lip blister, swelling arm, rash, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient experienced swelling in the right upper arm. Fever and chills were resolved in 24 hours. The patient called the office, however, was did not come in to be seen by the doctor. The contact details of the physician was provided.
Right shoulder redness and swelling, approx 3" x 5". Tender to touch.
Swelling and redness from right upper mid arm to right forearm. Patient stated feeling hot and pain/soreness at the injection site (Rt. triceps area).
UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 were not reported) dose, start therapy date were not reported 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 an unspecified date, the subject experienced unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
8 days after injection,  swelling, redness, itching and soreness of injection site. Nothing before then. Using ice, hydrocortisone cream and Ibuprofen.
injection site pain; she was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain; she was a little sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for an unknown indication.    No Medical History information was reported.   On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (DUPIXENT) (unknown route) 150 mg/mL (first dose). On 08-Nov-2021, the patient experienced VACCINATION SITE PAIN (injection site pain; she was a little sore). On 09-Nov-2021, VACCINATION SITE PAIN (injection site pain; she was a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   It was not reported if the patient received a corrective treatment for the event (injection site pain; she was a little sore).  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I had arm soreness from the time of injection to the next few days, Saturday morning I had moderate tiredness and body aches and headaches that were really bad until the 23rd that was sporadic. I felt feverish malaise  really bad headache and body aches. I took Tylenol and Advil around the clock. on the 20th I also had very mild runny nose for 2 days. I went to get a covid test on the 23rd and it was negative. Symptoms resolved by the 25th I had no symptoms
Patient experienced increased confusion several hours after receiving both COVID19 vaccine and high-dose influenza vaccine. Confusion resolved within 24 hours.
Sx - mild wheezing, mild headache, mild nausea, muscular pain injection site. Tx- self administered inhaler
Patient developed fever 103 during night, early morning after getting vaccine. C/O leg pain, weakness. Injection site red & swollen 4 to 5 in. Warm to touch per patient.
Vertigo/extreme dizziness and vomiting beginning at about 8:45 am. Called my doctor office and they directed me to go to the Emergency Room. ER ran EKG and blood pressure test, and also took bloodwork. All came out within normal ranges. After an IV, I was released around 12:00 pm.
Pt recvd measles vax on 21AUG91 & 4 days later pt devel nausea which persisted x 3 days; No further details were provided;
Boyfriend grabbed her arm it hurt. Looked and saw a few blotches around site and redness at injection site. Resolved next day or two.
patient states that her arm starting swelling well below injection site and that her arm has gotten very swollen. went to the dr who said she was reacting to the IMZ  and should elevate her arm or wrap in an ACE bandage.  no medications needed to resolve pt issue
Dose 2: pale red urine color; This is a spontaneous report from a contactable consumer. A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 18Jun2021 (age at vaccination 35 years) as dose 2, single for covid-19 immunisation. Medical history included headache from an unknown date and unknown if ongoing (Occurred in the evening on Monday or Tuesday before the vaccine, he was not really sure. He states maybe 6:14-6:15pm for onset. Complete recovery the same day). Concomitant medication included paracetamol (TYLENOL) taken for headache, start and stop date were not reported. The patient previously took dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0186) on 28May2021 (age at vaccination 35 years) left arm dose 1 single for covid-19 immunization. The patient experienced dose 2: pale red urine colour on 18Jun2021. Reporter stated, He was seeing his urine colour as red after the vaccine. He was having the problem still today. Every time when he passes urine, he sees the colour red. Red colour urine has been ongoing since Friday night. He was not sure if what he was experiencing is a normal side effect of the vaccine. he has seen this before when he has had a beet root, but for the past two days he has never had a beet root. The outcome of event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Expected pain for days after shot. Then on day 7, as the day progressed, pain increased and became unbearable that evening. Attempted OTC aleve, ibuprofen, and Tylenol for relief. After 2 days, went to the emergency room as condition continued to worsen. They provided shot of toradol and Tylenol 3 prescription. Returned to ER approximately 12 hours later as pain worsened. Received morphine twice, toradol, phenergan, and hydrocodone prescription.  . Extreme pain in left arm and very limited motion.
arm and back itchiness and redness 15 minutes after dose treated with benadryl and famotidine  resolved