chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 mm x 7 mm elevated nodule on right arm deltoid region at site of previous SPV.  Borders even.  Some inconsistency in coloration with faint hyperpigmented areas on nodule.  S/P Smallpox vaccination 02/02/03.  Diagnosis:  Keloid vs. dermatofibroma  HPI: Patient is a 20 yo male who received his primary smallpox vaccination on 02 Feb 2003.  He states that he attended the smallpox briefing and received the educational brochures.  Around the time of the vaccination, he does not recall any local or systemic problems other than perhaps mild flu-like symptoms for about a week.    He states that his primary SPV site healed normally except he had three scab formations at the site.  Approximately two weeks after the vaccination, he developed a scab, but it was inadvertently torn off when a medic took off his band-aid.  Approximately two weeks after this, he developed another scab, which was also inadvertently torn off.  One week later, he developed a third scab that fell off on its own.  He estimates that the remaining Jennerian scar was approximately 6 mm at that time.  He describes it as just a flat scar.  Approximately two months later, he noted that he was developing a bump at the site of the SPV.  He describes it as a puffy, non-pruritic, non-draining bump that he estimates was approximately 8 mm.  This area has gradually grown in size to a 15 mm elevated firm mass.  Although he states it is mostly non-tender, he does recall two occasions when he felt a stinging sensation at the site ("like he had been stung").  The stinging sensations lasted a couple of seconds, occurred when he was at rest, and he does not recall any injury or insect bite to the site.  He has a history of hypertrophic scar formation at the site of childhood scars on his right elbow, right wrist, and right lower abdominal area.  In addition, he has some elevated areas on at the site of tattoos on bilateral upper extremities.  In addition, he reports that his mother has a large elevated surgical (Cesarean section) scar on her abdomen.  He denies any personal or family history of skin cancer.  Patient has been referred to Dermatology.  Appointment pending at this time.
Dizziness/very dizzy; This is a spontaneous report received from contactable reporter (consumer) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 09Apr2021 13:15 (lot number: EWO150) at the age of 70-years as dose 1, single for COVID-19 immunisation and methimazole (TAPAZOLE) (Batch/Lot number: unknown). Relevant medical history included: "Heart Problems" (ongoing), notes: born with the heart problem; "Prolapse Valve" (ongoing); "Heart attack", start date: 2011 (unspecified if ongoing), notes: 2 heart attacks, 10 years apart; "Heart attack", start date: 09Jan2021 (ongoing), notes: 2 heart attacks, 10 years apart; "Diabetes", start date: 2011 (ongoing); "Asthma" (ongoing), notes: Born with asthma; "High blood pressure", start date: 1991 (ongoing); "Circulation problem with legs", start date: 2017 (ongoing); and "Thyroid Problem", start date: 2011 (ongoing). There were no concomitant medications. Vaccination history included: Flu Vaccine (had to go back to the doctor 3 times), administration date: 2017, for Immunisation, reactions: "Pneumonia", "Coughing", "Sneezing", "Short of breath", and "Very sick." The following information was reported: DIZZINESS (non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "Dizziness/very dizzy". The action taken for methimazole was unknown. Therapeutic measures were taken as a result of dizziness. Additional information: 5 days after her first shot (as reported), the patient experienced dizziness. She was very dizzy. She was fine now as far as the vaccine thing goes. Treatment included TYLENOL. Her daughter received the Moderna and she just had flu like symptoms for 2 days and a mild case of vertigo for 2 days. The event did not require emergency room as the patient was trying to be brave. She stated that if a person has a heart condition and goes to the ER, they want to keep her overnight to observe her and she didn't want to do that. She also did not visit a physician office. No additional vaccines were administered on the same date of the Pfizer suspects. Prior vaccinations within 4 weeks were reported as none.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070997 same reporter, patient, and drug; different dose and events
Patient returned to the clinic area about thirty minutes after taking the injection stating that she fell asleep in class, felt dizzy, and stating her face felt "hot". Had facial flushing and hives on her upper chest, neck and upper arms. Called parents, by the time they arrived less than one hour later her hives had gone away, but she still felt the same. Parents gave her oral Benadryl 25mg, and took her home. Instructed parents on what to watch for and when to seek help of the physician/ER. Denied ever having respiratory symptoms and vital signs remained stable throughout the time I spent with her.
Rash and swelling headache and sore arm and stiff neck. Pt given Tylenol and Motrin and given heating pad.
This case concerns an 87 year old female pt.  The pt received a 0.5ml dose of influenza vaccine, manufacturer unknown, batch # not reported, given IM on 09/30/04.  On 10/1/04 the pt died at home during sleep. A post mortem was carried out, the cause of death was established as acute myocardial infarction. The pt was taking the following concomitant medications: Omeprazole, 20mg per mouth for gastritis since 01/17/00; Bendroflumethiazide, 2.5mg per mouth for essential hypertension since 03/18/03; Enalapril, 2.5mg per mouth for essential hypertension since 03/11/03; Salbutamol, 100mcg inhaler for acute bronchitis NOS between 04/22/03 and 08/11/04 and paracetamol 500mcg per mouth for localized osteoarthritis since 03/17/97.  No further information is expected, case is closed.
Red lump at injection site; Warm to touch; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 04Nov2021 at 07:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient also had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient received first dose of influenza vaccine (FLU VACCINE) via an unspecified route of administration in the right arm on 05Oct2021, within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration on 13Jan2021 (at the age of 45-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration on 03Feb2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 04Nov2021 at 08:00, the patient experienced red lump at injection site, which was approximately 2 inches in diameter. It was warm to touch, and lasted about 2 days. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events red lump at injection site and warm to touch was resolved on 06Nov2021, after a duration of 2 days.
Mom walked in to office complaining of reaction to immunization. DTaP RD: measuring 123mm. Immunization given at clinic. Tried to phone mom re: address info. No phone no.
Information has been received from a physician concerning a 17-week female who on 20-APR-2007 and 21-JUN-2007 was vaccinated PO with the first and second 2.0 mL doses, respectively, of Rotateq (Lot #656384/0237U). The physician reported that on 24-JUN-2007, the patient developed severe diarrhea. Unspecified medical attention was sought. On 28-JUN-2007, the patient was hospitalized. On 10-JUL-2007, the patient was discharged from the hospital. The patient subsequently recovered. This is one of several reports from the same source. Additional information has been requested.
Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 86-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX 6 months and 3 weeks ago before the date of reporting. After the first dose of SHINGRIX he had a little soreness that went away after about 1 day. The reporter did not consent to follow-up. This case has been linked to the case US2019050309, reported for the same patient.
Hoarse throat/ couldn't talk very well; overall feeling of extreme illness; lasted for 3 full days before I was well again.
Diagnosed with Bell's Palsy in 29th week of pregnancy. Was seen and diagnosed in the Emergency Room.
I have a sore throat, cough, and fatigue. I have developed a sinus infection and a double ear infection This has lasted for about two and a half months so far. I was prescribed doxycycline and ZITHROMAX. I am feeling better, but I still have a cough that won't go away. I tested negative for COVID-19, flu, and Pneumonia.
About 10 minutes after receiving the shot I got a slight taste and a sensation in the back of my nose. Within an hour it moved a little lower to listen station in the back of my throat. Almost a sensation like before you would throw up but not the same. Soon after developed nausea which lasted and intensified until bed around 10pm. A sore arm that eve, but not major. Woke up feeling pretty well with just a sore arm. Developed chills and mild fever which persisted rest of that day and following day. Fever mostly around 100-100.4. Got up t0 100.6. Ear  thermometer registered 101 at one point but shortly after jumped down so it seemed unreliable. On day 4 fever subsided and felt normal.  On day 5, sensation in back of throat and nausea returned. No fever.
3 days later I began to have a very bad fever and chills and at the injection site I had pain, I developed a sever cough that would not go away. I went to the emergency room. I had issues breathing and was diagnosed with inflammation of the heart. I was unable to care for my son nor was I able to walk any distance without gasping for air. I was misdiagnosed with heart failure and was given the wrong medication. I went to other cardiologist  and they diagnosed me with inflammation and went me to a cardiologist who stated that I had issues with my lungs, As a result of this, I currently suffer from asthma. I was admitted to Hospital for 2 days to have test run on my heart and lungs. I am still struggling to breath especially when conditions are to hot or to cold, it affects my ability to breath. This happens more when I am to hot.
Some mild redness around the vaccination site immediately after vaccination. Slowly the (R) arm was swollen by about a inch all the way from the shoulder down to hand.
10/2 L arm redness and swelling some local pain x 2 days. 10/3 no pain but more swollen around the elbow with some blisters. Rx Keflex 250mg TID on 10/2. 10/3/02 Omcif/gm in.
IMMEDIATELY AFTER DOSE WAS ADMINISTERED PATIENT COMPLAINED OF DIZZINESS WHILE SEATED. IMMUNIZING TECHNICIAN IMMEDIATELY CAME AND NOTIFIED ME, AT WHICH POINT I ENTERRED OUR VACCINATION ROOM AND KNELT DOWN NEXT TO SEATED PATIENT.  HE CONFIRMED THAT HE FELT REALLY DIZZY AT WHICH POINT I ENCOURAGED HIM TO SIT BACK IN THE SEAT AND RELAX AND I WOULD STAND BY HIM. WITHIN APROX 5 MINUTES OF VACCINATION PATIENT FAINTED IN THE CHAIR AT WHICH POINT EMS WAS CONTACTED. WITHIN APROX 30 SECONDS PATIENT STARTED TO REGAIN CONCIOUSNESS (NOTED BY EYE, MUSCLE MOVEMENT) OVER THE COURSE OF THE NEXT FEW MINUTES PATIENT SLOWLY BECAME ALERT AND ORIENTED AT WHICH POINT EMS ARRIVED AND TOOK OVER HIS CARE. AFTER APROX 15 MINUTES OF CARE FROM EMS PATIENT OPTED TO GO HOME WITH HIS DRIVER. I CONTACTED THE PATIENT AT APROX 130 TO CHECK IN ON HIM AND HE ADVISED ME HE WAS FEELING NORMAL AND THANKED US FOR HELPING HIM THROUGH HIS FAINTING EPISODE.
affecting her at work; arm of injection site swelled up to the size of a tennis ball; could still feel a hardness underneath; pain when she stretches her arm just a little bit/ pain is excruciating for 1-3 minutes; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting her at work), VACCINATION SITE SWELLING (arm of injection site swelled up to the size of a tennis ball), VACCINATION SITE INDURATION (could still feel a hardness underneath) and VACCINATION SITE PAIN (pain when she stretches her arm just a little bit/ pain is excruciating for 1-3 minutes) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting her at work), VACCINATION SITE SWELLING (arm of injection site swelled up to the size of a tennis ball), VACCINATION SITE INDURATION (could still feel a hardness underneath) and VACCINATION SITE PAIN (pain when she stretches her arm just a little bit/ pain is excruciating for 1-3 minutes). The patient was treated with Manual therapy (acupuncture, chiropractor, massage therapy, and stretch therapy) for Vaccination site pain. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting her at work), VACCINATION SITE SWELLING (arm of injection site swelled up to the size of a tennis ball), VACCINATION SITE INDURATION (could still feel a hardness underneath) and VACCINATION SITE PAIN (pain when she stretches her arm just a little bit/ pain is excruciating for 1-3 minutes) had not resolved.            No concomitant medications were reported.  On 29-Nov-2021, the patient received the booster dose of Moderna COVID-19 vaccine. Patient still had a side effect that could be debilitating at tim es. Patient went to her doctors but there was no relief. Patient reported that a week and a half later, swelling at injection site went down, but she could still feel a hardness underneath. It has been like this for almost a year. Patient had ultrasounds, nerve testing, X-rays, acupuncture, chiropractor, massage therapy, stretch therapy. Patient would have physical therapy next week.
Information has been received from a pharmacist concerning a male physician who was vaccinated with a dose of PNEUMOVAX (lot # 662041/0612X). It was unknown if this was the first dose for the physician or not. Subsequently the patient experienced soreness and redness at the injection site. At the time of reporting, the patient recovered. The patient sought medical attention via contacting the pharmacist. This is one of several reports from the same source. Additional information has been requested.
Dizzy, nausea/vomiting within 5 minutes or receiving vaccine. BP - 169/89; O2 sat 100%. Pulse 53. Received small bottle of water and felt better, with pulse of 68. Vomiting stopped.
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 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: Thyroid cancer and hypothyroidism due to thyroidectomy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given from 21Aug2023 to 25Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
they had two patients that recieved the Diluted Maroon Pfizer Covid 19 Vaccine past the 12 hour window in the fridge after first puncture; they had two patients that recieved the Diluted Maroon Pfizer Covid 19 Vaccine past the 12 hour window in the fridge after first puncture; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 2-year-old female patient received BNT162b2 (BNT162B2), on 04Aug2022 as dose 1 (maroon cap), single (Lot number: FT9142, Expiration Date: 04Oct2022) at the age of 2 years intramuscular, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (life threatening), PRODUCT ADMINISTRATION ERROR (life threatening) all with onset 04Aug2022 and all described as "they had two patients that recieved the Diluted Maroon Pfizer Covid 19 Vaccine past the 12 hour window in the fridge after first puncture". Therapeutic measures were not taken as a result of poor quality product administered, product administration error. Clinical course: It was reported as Per caller they had two patients that received the Diluted Maroon Pfizer Covid 19 Vaccine past the 12 hour window in the fridge after first puncture. The caller reports it was probably another 9 hours. Per caller the fridge was at 38.8F. Received the vaccine after 12 hours of puncture in the refrigerator and it was probably another 9 hours after those 12 hours when they were left in the refrigerator. Maroon cap Pfizer Covid vaccine for ages 6 months to 4 years old a Pfizer product. One patient was a female age 2 years old and the other was a male patient age 3 years old so he wanted to report this. Agent provided the caller with the off label information for the additional 12 hours for a total of 24 hours if they choose to use that and the refrigerator temperature was 38.8 degrees Fahrenheit. 59267007801 was NDC number of maroon cap Pfizer Covid vaccine for ages 6 months to 4 years old.  No follow-up attempts are possible. No further information is expected.
a swollen lymph node over a collarbone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 11:45 (Lot number: VY8-10188-81590) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 16Aug2021 20:45, outcome "not recovered", described as "a swollen lymph node over a collarbone". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccine in four weeks. The patient not had covid prior to the vaccination and had not been tested post vaccination. The patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.