chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VS were normal, physical examination was remarkable for jaundice and mild RUQ tenderness; This is a literature report.  A 55-year-old male patient received BNT162b2 (BNT162B2), 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: "ulcerative colitis" (ongoing), notes: on home sulfasalazine. Concomitant medication(s) included: SULFASALAZINE taken for colitis ulcerative (ongoing). The following information was reported: AUTOIMMUNE HEPATITIS (hospitalization, medically significant), outcome "unknown", described as "VS were normal, physical examination was remarkable for jaundice and mild RUQ tenderness". The events "vs were normal, physical examination was remarkable for jaundice and mild ruq tenderness" required emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1476 IU/l; Aspartate aminotransferase: 1621 IU/l; Bilirubin conjugated: 4.5 mg/dl; Blood alkaline phosphatase: 167 IU/l; Blood bilirubin: 6.0 mg/dl; C-reactive protein: 3.40 mg/dl; Endoscopic ultrasound: diffuse abnormal echotexture, notes: in the visualized portion of the liver; Gamma-glutamyltransferase: 339; reactive oxygen species: Negative; Magnetic resonance imaging: unremarkable; Pathology test: No significant ductal pathology; physical examination: was remarkable for jaundice and mild RUQ tendernes; Red blood cell sedimentation rate: 99, notes: mm; Ultrasound abdomen: unremarkable; Vital signs measurement: Normal. Therapeutic measures were taken as a result of autoimmune hepatitis. Clinical course: The patient with ulcerative colitis on home sulfasalazine who presented to the emergency department (ED) with complaints of a vague, non-cramping, and dull RUQ abdominal pain for 3 weeks duration. The patient's social history is unremarkable. No recent travel, occupational exposures, herbal supplements use, or acetaminophen use. He received 2 doses of Pfizer COVID -19 vaccines, last dose was around 21 days before admission. The patient was treated with azathioprine and prednisone 60 mg daily with slow tapering and with continuation of his home dose sulfasalazine.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Autoimmune hepatitis and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Nausea, chills, fever, headache and body aches for a period of about 24 hours.   I took Advil for the headache and body aches.  I was only able to drink water most of the day.
She experienced migraine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection), via an unspecified route of administration on 04Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she received the 1st dose of Pfizer COVID- 19 vaccine yesterday and she experienced migraine that was yesterday on 04Jun2021 and this morning and she drank acetaminophen (NDC number, UPC number and Expiry Date of acetaminophen were unknown) as treatment and now she was asking if she can drink Butalbital 335 mg? It was reported that she was still experiencing Migraine. The outcome of the event was not recovered.   Information on Lot/Batch number has been requested.
TRAVELLED TO CHEST/CHEST SYMPTOMS/DIFFICULTY BREATHING (COULDN'T GET A DEEP BREATH); SEVERE HEADACHE (RESIDUAL HEADACHE STILL ONGOING); FEVER; OVERWHELMING BODY ACHES; COULD NOT WALK DUE TO EXCRUCIATING PAIN; WOKE UP EVERY 2 HOURS; CRAMPING IN LEFT FOOT(FELT LIKE A CHARLIE HORSE IN THE ARCH OF THE FOOT); PAIN IN LEFT FOOT(FELT LIKE A CHARLIE HORSE IN THE ARCH OF THE FOOT); This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 129 pounds, and height was 62 inches. The patient's concurrent conditions included: alcohol user, non-smoker, and antibiotic induced colitis, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient was previously treated with ergocalciferol for drug used for unknown indication; and experienced bad reaction to vaccine (gets the flu) when treated with influenza vaccine for prophylactic vaccination, and joints hurt/upper shoulder hurt when treated with tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, Z06AZ1A, expiry: UNKNOWN) dose was not reported, administered on 31-AUG-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 31-AUG-2021, the patient experienced overwhelming body aches. On 31-AUG-2021, the patient experienced could not walk due to excruciating pain. On 31-AUG-2021, the patient experienced woke up every 2 hours. On 31-AUG-2021, the patient experienced cramping in left foot (felt like a charlie horse in the arch of the foot). On 31-AUG-2021, the patient experienced pain in left foot (felt like a charlie horse in the arch of the foot). On SEP-2021, treatment medications included: paracetamol. On 01-SEP-2021, the patient experienced severe headache (residual headache still ongoing). On 01-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 02-SEP-2021, the patient experienced travelled to chest/chest symptoms/difficulty breathing (couldn't get a deep breath). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from overwhelming body aches, and could not walk due to excruciating pain, travelled to chest/chest symptoms/difficulty breathing (couldn't get a deep breath) on 07-SEP-2021, and fever on 03-SEP-2021, was recovering from pain in left foot(felt like a charlie horse in the arch of the foot), severe headache (residual headache still ongoing), and cramping in left foot(felt like a charlie horse in the arch of the foot), and the outcome of woke up every 2 hours was not reported. This report was non-serious.
Large, hot, red circle that appeared within 24 hours of shot, at site.. It was painful, hard and grew in size for 2-3 days before slowly subsiding. As of 2/9/2021, there is still occasional itching at the site, no redness but still a little muscle "stiffness".
One day post vax the pt developed an injection site reaction characterized by swelling, redness and tenderness. Additional information indicated that the pt developed some skin discoloration at the injection site and was treated with unspecified oral steroids for 4 days. The discoloration resolved within 2 months.
Approximately one day after vaccinations starting having subtle tinnitus in both ears. It is not overwhelming but has been consistent over last few days.
The day after receiving the immunization she began experiencing pain in her shoulder, that quickly spread throughout her arm. She also experienced numbness in that arm to the fingertips. Both persist to some degree to this day, one month later. She has tried to put some heat on it, with minimal to no relief. She has not sought medical attention, but plans to soon.
developed papules then pustules (pox) lesions 6/22 with low grade fever. Fever resolved in 1 day. Maximum 27 lesions all resolving. Lesions concealed on head and neck
2/1/2023 onset of sudden hearing loss right ear, aural pressure and Tinnitus. Urgent Care facility 2/4/2023 prescribed antibiotic Augmentin. Primary doctor 2/17/2023 prescribed antibiotic  Cefdinir and Prednisone, ENT 3/9, 3/31, 4/14,4/26 given audiology tests including Audiogram, Tympanogram, Otoacoustic emissions, Reflexes  and Tinnitus matching . Prescribed oral steroid, Prednisone on each visit.
On 04.23.2021, developed leg swelling and was diagnosed with Right lower DVT.   Was not admitted to the hospital.  Was give RX for Eliquis
I experienced a rash in my left arm after getting the first dose of Moderna and stand for 3 days. But after 7 days of the vaccine I get another rash in the same arm , it?s  big red splotch itchy and painful. I experienced an itchy in my neck too.
CC: Rash second MMR and Varicella received 9/26/14. Patient OV 10/10/14 with acute (L) ear pain. Dx'd bulbous myringitis and rx'd amoxicillin for infection triamcinolone for eczema. Returned 10/15/14 with itchy vesicular/ulcerative rash x 2 days.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a 51-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, weakness and nausea. On an unknown date, the outcome of the influenza-like symptoms, fever, weakness and nausea were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, weakness and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; it could be 50 or 51 years. Field representative was informed by back office manager that a medical assistant at the practice experienced side effects from her 2nd dose of SHINGRIX that she did not had with the 1st dose and the events lasted about 4 days. Specifics date of vaccination and the onset of events were not known at the time of this report. Medical Assistant was also the patient she would receive follow up at the office if required. The field representative was educated about 24 hour reporting time frame.
Pt. stated that he had to go the bathroom, as he walked down the hallway he fainted. He also appeared jittery and diaphoretic. The patient had their feet elevated shortly after and was then given water and some cookies, since it was learned that the patient had not eaten this morning. Blood pressure and pulse were checked and bothe were WNL. Patient was instructed (with mother) to wait for 15 minutes before leaving and was then escorted back to their vehicle.
3 to 4 inch of swelling on his arm; This is a spontaneous case, reported by pharmacist to Agency (case ID: SEQ19-03354) and initially received on 26-Sep-2019,  concernig a 65-year-old male patient.   The patient's relevant medical history and concomitant medications were not provided.  On an unknown date, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, anatomical location, route of administration, batch number and expiration date were not reported] for an unknown indication.  On an unknown date, after vaccination, the patient experienced 3 to 4 inch of swelling on his arm.  The outcome of the event was not reported.  The reporter did not provided causality and seriousness criteria.  Event was assessed as related per company.  Non-significant follow-up reported by Agency (reference number: SEQ19-04923) on 17-Oct-2019: Additional Agency reference number added. No changes in narrative.; Sender's Comments: Event was assessed as related per company.
Pinched nerve in neck leading to severe nerve pain in left arm (felt like a spoon digging out the bond in forearm); Pinched nerve in neck leading to severe nerve pain in left arm (felt like a spoon digging out the bond in forearm); This is a spontaneous report from a contactable consumer (patient herself).  This 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9261), via an unknown route, on 05Feb2021 14:15 (at the age of 56-year-old) at single dose for COVID-19 immunisation, administered at hospital.  Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL1283), via an unknown route, on 15Jan2021 (at the age of 56-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included high blood pressure. Past drug history included allergies to benzylpenicillin (PENICILLIN) and codeine. Relevant concomitant medications included antibiotic therapy for face, sultopride hydrochloride (TOPRAL), irbesartan (AVAPRO), rosuvastatin calcium (CRESTOLIP), and cetirizine hydrochloride (ZYRTEC). On 12Feb2021, the patient had pinched nerve in neck leading to severe nerve pain in left arm (felt like a spoon digging out the bond in forearm). The event was reported serious as medically significant. The patient performed a physician office visit due to the event.Therapeutic measures taken as result of the event included steroids (X 3), muscle relaxers, physical therapy. Pre and Post vaccination COVID-19 tests were not done. The patient had recovered with sequelae from the event on unknown date.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 01-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received. ; Sender's Comments: US-009507513-1704USA001661:
Pain scale used for this report: Mild (easy to ignore) Moderate (impossible to ignore, interferes with normal activities)  Severe (disabled)  First adverse effect: Sore left deltoid (moderate, throbbing and could not sleep on left side) from ~ 1400 Sept 8 to ~1400 Sept 9 when pain transitioned to mild. Pain essentially gone by ~ 1000 Sept 11.  Second adverse effect: Neck pain (moderate, constant and distracting) from base of head down left side to shoulder ~ 2000 Sept 8 to ~ 1200 Sept 9 when pain transitioned to mild. Pain essentially gone by ~ 1200 Sept 10.
This vaccine was given after BUD.  Parent did not report any adverse reaction after receiving this vaccine.
Caller reported her daughter did not complete any of her "vaccine series" when she was younger due to a anaphylactic response to milk products.; her daughter did not complete any of her "vaccine series" when she was younger; This spontaneous report was received from a patient's mother regarding a female patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date (reported as "when she was younger"), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered as prophylaxis. It was stated that she did not complete any of her "vaccine series" (specific vaccines were not provided) (Incomplete course of vaccination) due to a anaphylactic response to milk products (Anaphylactic reaction). At the time of reporting, the outcome of anaphylactic reaction was not provided.  The causal relationship between anaphylactic reaction and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  Upon internal review the event of anaphylactic reaction was determined to be medically significant.
Patient reported prolong presence of fever, chills, malaise for 3 weeks after first vaccine dose.
Lyme Disease; rec'd one shingrix approx 3 yrs ago / Now/ wants to finish the series.; This case was reported by a nurse via call center representative and described the occurrence of lyme disease in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced lyme disease (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the lyme disease and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the lyme disease to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age at vaccination was not applicable for 2nd dose of Shingrix. Approximately 3 years before the date of reporting, the patient received 1st dose of Shingrix and then when it was time for her 2nd immunization, she had been diagnosed with active lyme disease and was told to not get her 2nd dose of Shingrix. At the time of reporting the patient was feeling better and wants to finish the series. Till the date of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
There was immediate ache in arm. By p.m. lateral arm movement was limited due to pain. Next day, ache in shoulder joint, extreme pain in muscles, icy/hot skin sensation on forearm and upper arm. Six months later, same symptoms except different arm movements cause extreme pain. Order of treatment: rest, massage, rest, x-ray, MRI, cortisone shot, exercises, cortisone shot, rest. (Cortisone shots had no effect).
pt recv vax 5AUG98 & became ill w/vomiting, fever & fussy late PM 5AUG98 & early AM 6AUG98;pt was having vomiting & was in need of IV hydration;
Patient received vaccination with no immediate reaction. Approximately 3-5 minutes later after the patient was helped to the observation area, the patient told her son that she was very hot. Her head then slumped forward and she became unresponsive to verbal and physical stimulation. Patient also threw up while unresponsive. She almost fell out of her chair onto the floor, but was caught before hand. When patient became unresponsive, emergency medical services was contacted and a dose of epinephrine was going to be administered. The training EpiPen was used so a dose was not administered. Patient recovered within a couple of minutes and paramedics arrived to evaluate patient.
Within 5 min of receiving vaccine, my blood pressure dropped and I started to black out. I experienced hot sweating and nausea. I threw up. After a few minutes, I began to feel better and regained color in my face. Overall, experience lasted about 5 -10 min. I was able to drive myself home after the fact.
Arthritis aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis aggravated) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRITIS (Arthritis aggravated) (seriousness criterion medically significant). At the time of the report, ARTHRITIS (Arthritis aggravated) had not resolved.            No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.  Company Comment:  This spontaneous case concerns an adult male patient with relevant medical history of Psoriatic arthritis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Arthritis (Arthritis aggravated) on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be established as date of event onset was not provided. Patient received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart. The relevant medical history of Psoriatic arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with relevant medical history of Psoriatic arthritis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Arthritis (Arthritis aggravated) on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be established as date of event onset was not provided. Patient received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart. The relevant medical history of Psoriatic arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Mild facial numbness and tingling over L edge side of face, from L sided hairlines, L lateral cheek, to L mandible angle. Nontender to palpation. Full ROM of facial muscles. CN V & VII intact. Sensation intact to light touch bilateral face. Improvement with use of ice.  No other sx per pt.
Received call at office from Emergency Room physician on 9/14/07.  Stated he was treating pt for a febrile seizure.  States mom told him that fever began shortly after vaccines were administered on 9/13/07.  Mom and child had gone shopping, child collapsed in store and had seizure. Taken to ER. Physician felt the seizure was directly related to the fever that was caused by the vaccines administered.  MD given name of shots administered and other medical information requested about patient. The on call physician at the office, was notified.  Pt was released from ER on 9/14/07.
My blood pressure was very much under control. However, 10 days after receiving my second dose, my BP rose dramatically and remained high. I waited a few days, then I had to go to my cardiologist. He had to double my amlodipine dose and ordered several tests. I am still on 10 mg of amlodipine.  Also, shortly after my second dose, I my breasts became sore, tender, and swollen. That eventually resolved, but it was very uncomfortable. The only thing that had been different was getting the vaccine.
Date-of-birth written on consent. No profile found in the system at time patient presented at clinic. Profile created and updated with date of birth, making patient 4 years of age (too young to receive COVID-19 vaccine at the time).
June 5th or 6th -Post menopausal bleeding  - that was for a week.  July 19th, Doctor's appt; and then same day, I  had biopsies: endometrial biopsy and an endocervical biopsy - benign polyp  No treatment - it's just  a wait and see to get a check up every year.