chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Overall achiness.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraines. The patient had no known allergies. Concomitant medications included ibuprofen (ADVIL), camphor, diphenhydramine hydrochloride, zinc oxide (BENADRYL) and  sumatriptan succinate (SUMATRIPTAN) for unknown indication and on unknown date within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 07:00, the patient experienced overall achiness. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event overall achiness was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
pt recvd vax & Lt Leg was very hard & inflammed at inject site; unable to walk for 1 day; pt taken to MD; no abscess or infect;
Very severe (8/10) left arm pain with any movement of the arm which lasted approximately 8 hours .   There was very little pain with the arm at rest.   This severe pain was much different in intensity than "normal injection site pain" which I have had many times with many types of flu and covid vaccines in the past.
Flu and Pneumonia vaccine give in same syringe currently in process of re-vaccinating per CDC. No adverse effects.
Approximately 1.5 hours after vaccine administration, pt felt nauseated, clammy, racing heart, and dizzy/faint.  She was treated by parent-laying her down to rest, cool clothes on face.
Rt knee pain on 10/16; lt knee pain 11/10/06. Bilateral knees swollen and stiff. Pain in AM; decreases during day with activity.
Nerve with joint & muscle pain of left arm - currently using ibuprofen, ice, gentle positioning, & rest (all self-treatment currently). Reports pain began about 30 minutes post-injection. States will be seeking medical treatment.
Dizziness; fever 103.7; severe body aches; neck & back pain; severe diarrhea; eye pain; lack of appetite.
Developed dermatographia on 1/20/22. Symptoms including intense itching/burning of skin, hives/welts all over body from scalp to face, neck, chest, arms, legs, buttocks, genitals, palms, and feet. Worsened by touch, rubbing, emotional stress, and heat. I have never experienced hives in my entire life.
her husband completed the primary series as well, on 18Jan2021 and 8Feb2021. Caller reported her husband is now sick with COVID 19; her husband completed the primary series as well, on 18Jan2021 and 8Feb2021. Caller reported his husband is now sick with COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 08Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 18Jan2021 (Batch/Lot number: unknown) 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: VACCINATION FAILURE (medically significant), outcome "unknown", described as "her husband completed the primary series as well, on 18Jan2021 and 8Feb2021. Caller reported her husband is now sick with COVID 19"; COVID-19 (medically significant), outcome "unknown", described as "her husband completed the primary series as well, on 18Jan2021 and 8Feb2021. Caller reported his husband is now sick with COVID 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: The reporter mentioned that she and her husband were both vaccinated on different dates. It was reported that her husband had got Covid-19 positive now and the she was suspected to have Covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever of 100 degrees; Muscle aches; Fatigue; Headache; General malaise; Pain at injection site (radiated down to elbow, pain on movement); Pain at injection site (radiated down to elbow, pain on movement); This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 03May2021 at 15:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 12Apr2021 at 15:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation and ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 04May2021 at 02:45, the day after second dose of vaccination, the patient experienced a fever of 100 degrees, muscle aches, fatigue, headache, general malaise, and pain at injection site that radiated down to her elbow, pain on movement. On 04May2021 at 02:45, the patient's body temperature was found to be 100 degrees. Day two after second dose of vaccination, the patient felt much better but still did not feel good. The clinical outcome of the events fever of 100 degrees, muscle aches, fatigue, headache, general malaise, and pain at injection site that radiated down to her elbow was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated Lab data, Best Doctor/Health Care Professional Information, Treatment Received as No was updated.
Information has been received from a registered nurse concerning her daughter who was vaccinated with a dose of varicella virus vaccine live in the past and 3 years ago, in 2001, the patient developed a full blown varicella rash with high fever.  Unspecified medical attention was sought.  At the time of this report the patient's present status was unknown.  No product quality complaint was involved.  Additional information is not expected.
About 2 hours after injection - 8PM - I went into shock and seizures. I had severe chills. Head hurt, jaw hurt, lips were tremering, and right arm had tremers - would not stop. Whole body felt funny like every organ was affected - breathing was tight - lungs affected - heart affected - Left arm developed severe pain from injection site on down, slowly eased off and stopped by 12PM
Patient called to report significant swelling to the injection site, noticeable to another healthcare provider seen on day of report. Also reporting pain extending from the injection site up the side of the neck. Patient has used ibuprofen during the course of symptoms without noticeable effect on the pain or swelling. Recommended to also ice the area tonight and report to primary care if there is no resolution by tomorrow morning or if the symptoms worsen. Denies any other symptoms at this time. Symptom onset started the day after receiving the immunization in the afternoon.
Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; This is a spontaneous report from a contactable Other Health Professional (patient). This 59-year-old female Other Health Professional (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685) on 21Dec2020 11:00 AM at single dose in Left arm for covid-19 immunization. Medical history was hypertension, hypothyroidism. Concomitant drug included levothyroxine/liothyronine (NP THYROID), HCTZ, Amlodipine. No other vaccine in four weeks. Started with aches in the back NA increased temp swollen lump nodes under the arms and neck bottoms of the feet swollen from 27Dec2020 with outcome was recovered. No treatment. No covid prior vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19: negative on 28Dec2020.  No follow up attempts are needed. No further information is expected.
I had a sore arm the first two days which is normal.  But on day 4, I started with a very bad sore throat and then had difficulty breathing. and couldn't stop coughing. When I was a child I used to get asthma, it has been 30 years since I have had asthma.  I went to urgent care and they tested for strep throat and Covid 19.  I tested negative for both.  A week later I called urgent care because I could not stop coughing and was having difficulty breathing.  They prescribed a very low dose of Prednisone for 6 days.  That did not help so I finally went to my asthma and allergy doctor.  He prescribed the correct dose of  Prednisone which I am now on day 3 taking.  As well as an Inhaler which helps as well and a gel tablet to help with cough.  I feel like I am finally on the rode to recovery but I am nervous about taking a 2nd Pfizer Vaccine.  My doctor also told me I should not take the 2nd Vaccine until 10 days after I am finished with Prednisone.  That will be passed the 42 day recommended time frame to get the 2nd Vaccine.  I don't know if the vaccine caused these breathing problems but I do know that I was 100% healthy and hadn't had breathing difficulty for 30 years.  That is why I think it may be possible that the vaccine triggered this.  I felt it important to report.
This spontaneous report was received from a patient's mother who was also a company representative and refers to a 9-year-old female patient. The patient had an allergy to amoxicillin. The patient's concurrent condition included 18 to 20 small warts on her hands for over a year. There was no concomitant therapies reported. In April 2018, the patient was vaccinated with the first dose of GARDASIL 9 (route of administration, lot # and expiration date were not provided) for prevention of HPV. In approximately August 2018 (reported as sometime within the past month which was about 4 to 5 months after receiving the vaccine), the patient's warts started to disappear and currently had almost completely disappeared. The reporter considered this adverse event as an unexpected therapeutic benefit. The patient had an appointment to receive second dose of GARDASIL 9 in October 2018.
Dizzy, vision and hearing loss, sweating profusely, blank look, and not responsive to nurse and/or mother.  Ammonia used and EMT called.
Within one week of vaccine dad lost interest in everything, developed incontinence, became extraordinarily sleepy, stopped gregarious talking and only responded to questions asked, became extremely confused, eventually losing his ability to walk, talk, and swallow.  All occurring in short order.  ER twice, hospitalized twice, rehabilitation twice.  As yet, no formal diagnosis despite three hospitals seeing my father and testing him extensively.
Information has been received from a male patient who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot # not reported). On an unspecified date "he experienced weird side effects after receiving a dose of RECOMBIVAX HB. No further information is available.
Began having leg weakness 4 days after the vaccine on the evening on 1/29/21. The next day the leg weakness was more significant and went to the emergency room where they found greater weakness in the left leg than the right leg. An MRI showed "Punctate focus of diffusion restriction within the left cerebellar vermis consistent with acute infarct." He was also found to have a critically low platelet level of 30 and then 27 while in the emergency room. He was then admitted to the hospital, placed on steroids to increase his platelet level and given physical therapy following the stroke. He was admitted to the hospital for a total of 3 nights. He was discharged home on Aspirin, Carvedilol, and Atorvastatin, has follow up with hematology to check platelets and physical therapy.
9/8/2021 admitted to Medical Center for Myocarditis 6/7/2022 after contracting the COVID virus, Traponion I elevated to 16.2, admitted back to Medical Center for round 2 of Mayocarditis.   Hospital records attached.  Shot record attached COVID vaccination card attached. These events have made a significant inpact on patient.  She is constantly checking her blood pressure, pulse and O2 when she feels funny.  She does seem to know when her traponions are elevated, as both times she was not feeling well she asked to go to the hospital.  She has not been able to go back to her regular child life and activities as she has been told by the cardiologist not to stress out her heart.   I have all supporting documentations.
This spontaneous report was received from a registered nurse referring to 88 year old male patient with gastric reflux. The patient's medical history included transient ischaemic attack. Concomitant therapies included PLAVIX, simvastatin, clonazepam and vitamin D (unspecified). On 02-JUN-2017, the patient was vaccinated with PNEUMOVAX 23 with lot # N005096 and expiration date 22-OCT-2018 for vaccination (prophylaxis) (route, dose, dose number, frequency and anatomical location were unknown).  No product quality complaint (PQC) was involved. On 05-JUN-2017, the patient reported to his primary physician that on an unspecified date in June 2017, he experienced redness and swelling around the injection site, and the skin was tender to touch. No laboratory diagnostic studies were performed. His physician wrapped his arm, and applied a cold compress and instructed him to take TYLENOL as treatment. At the time of reporting, the outcome of injection site erythema, Injection site swelling and pain of skin was unknown. The causality between the events and the therapy with PNEUMOVAX 23 was unknown.
A report has been received from a Pharmacist concerning, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 28-Sep-2013. It was reported that consumer was administered FLUMIST to a pregnant female two to three weeks ago who was 28 to 30 weeks pregnant. Patient was 7 and half month pregnant. The outcome of the event of Administered FLUMIST to a pregnant female is unknown. The consumer was in third trimester and pregnancy result was unknown. The report was considered to be non-serious by the reporter. Follow-up of insignificant to be non-serious by the reporter. Follow-up of insignificant information received by MedImmune 02-Nov-2013 from pharmacist: drug start date added.
Chills Terrible headache Heart palpitation Muscle pain Terrible pain in arm where shot was given
Started with a dry throat after 15 minutes -3:45. Thought I just needed water. Drank water in car and as we continued to drive my face started tingling and feeling numb. I called the pharmacy at 3:50 and said I should take Benadryl or go to ER if symptoms worsen.  I took liquid Benadryl 10ml at 3:55.  The feeling continued for the next three hours. The feeling in my throat went away but the tingling feeling continued.  On 3/20/2021 I went to urgent care at 9:40am due to continued tingling and numbness in the right side of my face and heaviness in my right arm . I was prescribed prednisone.
I am a very fit retired hospital CEO who has always supported flu vaccinations.  Within 15 minutes of getting the high-dose flu vaccine, for no reason severe pain began in the right hip/glute area while shopping. Within 30 minutes I was down in excruciating pain. Old pain meds got me through the night. Dr the next morning ordered an MRI and Percocet that eased the pain somewhat. It took a week to get the MRI and the referral appointment with Dr at the Clinic.  After 15 days bedridden Dr did a L4 L5 epidural that significantly helped the pain. I go for #2 injection the piriformis Monday. I can walk slow with crutches.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 21 year old of unspecified 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 administration was not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on 15-SEP-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-JAN-2022, the patient experienced headache, fever, runny nose and tested positive for COVID-19 (confirmed clinical vaccination failure and confirmed covid-19 infection) and was symptomatic for about 3 or 4 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on JAN-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0-20220303244-covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
complaint of itchy throat, tightening. patient had similar reaction with first dose. Patient self-medicated with ventolin and diphenyhydramine 50 mg with relief of symptom.
Papular, pruritic, scabbed lesions, on left neck, trunk, chest, and arm. Presumed break through Varicella.
One hour after I had been administered the flu shot I experience severe pain on my left side from head to the lower leg, thigh, and hips, I could hardly move out of my car. I felt miserable and achy. Afterwards the pain was also on my right hip. I have fibromyalgia which was activated. I hardly ever feel its effects anymore and I did not understand what was happening. I felt dizzy, weak at 2:30 I took 2 Advils 400 ml.I could hardly walk, it affected my sciatica nerve.  I could not stand the pain anymore and went to get a massage, but did not help much. the pain continued for several days, until today I started feeling better.
This case was reported by a healthcare professional (nurse, subject) via sales representative and described the occurrence of pain in left arm around injection site in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 25 October 2013 the subject received a dose of FLUARIX (unknown details, left arm). On 25 October 2013, immediately after vaccination with FLUARIX, the subject experienced pain in left arm around injection site. Per the nurse, "it was immediately painful with a sharp pain that extended all the way down my arm." The nurse also reported that "it was extremely painful that night." Over the next week, the nurse reported that the pain "eased up." The nurse described the pain in left arm around injection site as "left shoulder muscle is 'stiff' and painful" and "worse in the mornings." In 2013, within a month after vaccination with FLUARIX, the subject experienced arm heaviness (post injection site reaction) and injection site reaction (difficulty in moving arm). The nurse described her arm as feeling "heavy and" the nurse has "limited range of motion." The nurse decided to seek medical attention from a doctor. At the time of reporting, the nurse had not yet seen a doctor. The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. At the time of reporting, "it has been 3 weeks" and the nurse considered the events as "becoming more of a chronic problem." The healthcare professional considered the events were probably related to vaccination with FLUARIX. The nurse stated that her symptoms were "absolutely 100 percent caused by the flu shot."
Became lightheaded, nausea, dizzy, 1 episode vomiting after bloodwork and vaccines completed.
Itchy patch on arm; Big patch on arm; Slight fever; Headache; Chills; Red patch on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy patch on arm), VACCINATION SITE RASH (Big patch on arm), PYREXIA (Slight fever), HEADACHE (Headache) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy patch on arm), VACCINATION SITE RASH (Big patch on arm), PYREXIA (Slight fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red patch on arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchy patch on arm), VACCINATION SITE RASH (Big patch on arm), PYREXIA (Slight fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red patch on arm) outcome was unknown.            Treatment using  Tylenol was reported   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Contact information provided.
ABOUT 1 HOUR AFTER ADMINISTRATION, PT COMPLAINED OF "STUFF POURING DOWN MY THROAT".  ADMINISTERED 25MG OF ORAL DIPHENHYDRAMINE.   20 MINUTES LATER, PT COMPLAINED OF "SORE THROAT THAT FELT LIKE IT MIGHT CLOSE".  ADMINISTERED EPI PEN AND SENT TO ER.
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.