chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 10/8/99 and 11/8/99, the pt received his 1st and 2nd injections of Engerix-B, with no untoward effects. On 4/3/00, he received the 3rd dose of Engerix-B and 1-2 weeks later, reportedly experienced tingling, numbness and weakness in his extremities. This started in his feet and legs and then spread to his arms. He lost muscle strength (NOS). The pt went to the ER and was dx'd with Guillain-Barre Syndrome, but was not hospitalized. It was reported that the pt's symptoms were not life threatening but were disabling. At times, the pt has needed crutches to walk, and he has been receiving physical therapy. He has been evaluated by a neurologist, but this evaluation will no be available. The pt reported to the nurse on 5/10/00, the symptoms of numbness and tingling to hands were still present. The weakness to hands and feet is ongoing but improving. The pt stated he does not have to use crutches as often and was continuing physical therapy and was unable to work. The physician told the pt his symptoms were associated with Engerix-B vaccine. No further information will be available.
PATIENT RECEIVED INCORRECT VACCINE FOR AGE GROUP. AT TIME OF VACCINATION, PATIENT WAS 12 YEARS OLD AND PFIZER 0.2ML DOSE IS INDICATED FOR 5-11 YEARS. NO SYMPTOMS OF REACTION OBSERVED OR DOCUMENTED. ERROR DETECTED IN AGENCY.
This case was reported by a consumer and described the occurrence of polymyalgia rheumatica in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included type 1 diabetes. Concurrent medications included HUMALOG, LANTUS, LASIX and COUMADIN. In June 2014, the subject received an unspecified dose of BOOSTRIX (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with BOOSTRIX, the subject experienced polymyalgia rheumatica arthritis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified.
SUSPECTED COVID-19 INFECTION; MYOCARDITIS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a 65 year old female of an unspecified ethnicity. The patient's weight was 58.06 kilograms, and height was 163 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at the time of vaccination 64 year old. No concomitant medications were reported.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). Patient reported that she had a good night's sleep and was fine after Janssen vaccine.  The patient additionally received non-company suspect vaccine Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: EW0186 expiry: unknown) dose was not reported, administered on 20-NOV-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2).  On 25-NOV-2021, 5 days after Pfizer booster vaccine the patient experienced myocarditis (dose number in series 2). She went to the doctor, had a number of tests then went to the cardiologist and had a number of tests. Patient had some chest pain. She mentioned that after 5 weeks she was fine. Cardiologist read all the results and told her even though she did not fit in the demographic that he believed she had myocarditis and it passed. Patient did not receive any treatment for myocarditis. On an unspecified date, patient had a chest X-ray, echocardiogram and a lunar nuclear stress test for which results were not reported. On 31-DEC-2022, the patient experienced covid-19 (suspected covid-19 infection, dose number in series 2). Patient still had some effect and had not received any treatment for covid-19. On the day of reporting, the patient said that she will be tested tomorrow for covid. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient recovered from myocarditis on JAN-2022, had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20230203582- Myocarditis. The event has an compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered related.
Patient called in 10/17/2016 reporting concerns with pain at injection site. Offered Office Visit.
Patient received (DTAP, MMR, Varicella & Hep A vaccines) earlier this morning. Mother called clinic at around 3:30 pm to state that patient briefly fainted for a few seconds and prior to that her eyes rolled to the back of her head. Patient was alert/responsive when mom called. Referred mom to take patient to childrens ER ASAP.
PT. COMPLAINED OF TONGUE SWELLING AND DRY THROAT. THAT STARTED TO SUBSIDE IN 5 MINUTES. PT. WAS NOT HAVING ANY BREATHING DIFFCULTIES PT WAS FLUSHED. I TOOK PT. BLOOD PRESSURE AND CHECKED OXYGEN LEVELS. SWELLING STARTED IN PT. LIPS AT THIS TIME AND  I ADMINISTERED EPINEPHRINE AT THIS TIME. PT STARTED TO GET COLOR BACK IN HER FACE AND SWELLING OF THE LIPS SUBSIDED. I HAD PT. TO CALL HER SISTER TO DRIVE HER HOME
Body aches (entire body), lethargy/tiredness, alternating between sweating and chills, 102.1 degree fever, headache, sinus/eye pain, injection site pain, nausea, lack of appetite, brain fog.
I had a severe case of shingles. It stared with severe back pain which was incorrectly diagnosed as a back spasm. The next day pain became so serious I was admitted into the emergency room. I was then diagnosed and treated for shingles. On the same day I was diagnosed and treated for a UTI. I received medication for both for which I received various medications which included the narcotic NORCO. After days of shingles pain, nausea, constipation and a loss of about 10 pounds I was admitted into the emergency room again and then hospitalized for 6 days starting on April 8, 2017. I was diagnosed with ischemic colitis and was in very serious condition. I recovered from the ischemic colitis but my digestive system is not back to normal. I still suffer from shingles pain but feel better as the weeks go by. I do not know what role the shingles vaccine played in my subsequent medical problems, but I would like to know. I Do know the vaccine failed to protect me from the devastating effects of the shingles. Thank you for caring.
Spiked fever of 103 and became very lethargic.  Would not stand up on his own, crying, and very fussy.  Very sleepy too.
Really rapid heartbeat; A spontaneous report was received from a consumer concerning of an unknown age, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, really rapid heartbeat, progressed and became more frequent.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Mar 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 025A21A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, really rapid heartbeat, progressed and became more frequent.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, really rapid heartbeat, progressed and became more frequent was unknown.
Pt had an immunization on 05 Aug and has had a slowly expanding red area around the site of injection. States it appears to improving. Rash. Diphenhydramine 25 mg QID.
8p-Just didn't feel "well", took TYLENOL 1GM approx 830p. 9p In bed started mild shaking & chills. Face warm, flushed. Torso & extrems norm temp. 930 - moderate, uncontrolled shakes & chills. Beneath covers. 12AM - awoke, felt very hot. Temp 101.4 (O) TYLENOL at 1230. 230a Emesis, achy generalized weakness, (L) arm (inj. site very sore since early eve). 10/26-27 tired & weak but no N/V.
sick for over a week; Initial information received on 02-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient who was sick for over a week after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient was sick for over a week (illness) (unknown latency) following the administration of influenza vaccine.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick for over a week).  At time of reporting, the outcome was Unknown for the event sick for over a week.
Came to office 08/25/2003- had received DTaP and IPV right arm on 08/22/2003.  Right arm red, swollen with small blistered area noted.  Mom then stated "this has happened before."
very Weak; Infection on the arm; Welt arm; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very Weak), LOCALISED INFECTION (Infection on the arm), URTICARIA (Welt arm) and TREMOR (Shaking) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Infection (Infection after Chemotherapy which was resolved) in November 2020 and Chemotherapy (Not Specified) in November 2020. Concurrent medical conditions included Cancer (Not Specified) and Red rash (Red rash all over the arms prior to vaccination and still going on). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Red rash.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (very Weak), LOCALISED INFECTION (Infection on the arm), URTICARIA (Welt arm) and TREMOR (Shaking). At the time of the report, ASTHENIA (very Weak), LOCALISED INFECTION (Infection on the arm), URTICARIA (Welt arm) and TREMOR (Shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose05/07/21 2nd dose Diagnosed covid positive: Symptom onset:09/02/21 Exposure:COMMUNITY Symptoms:cough, sore throat,diarrhea, chills, runny nose.
pt recvd vax & felt dizzy & nauseated; pt was cool , clammy & unresponsive for a very short while; B/P 60/30;
Patient states that within a few days his arm was in pain but it was tolerable. On May 22nd and 23rd patient states he felt extraordinarly weak and was unable to walk steadily and felt he was about to pass out. This had not occured in the past nor since so he feels it is related to the vaccination.
pt had a reaction with flu vaccine red and hurt a lot and itch for a week and some swelling today no more itchiness but it is tender. Rec. pt to go see a doctor but she does not want to rec. ibuprofen and ice for a few days and call her doctor and let her doctor know. Patient is fine she will get the regular flu vaccines next time not HD.
Partial loss of taste and smell; Partial loss of taste and smell; Shortness of breath now and then; Cough now and then; Maybe post nasal drip; Sore arm; Nasty fever at night/Fever; Very tired; Mild headache; Nausea; Left arm near shoulder ached; Chills; Back pain at the waist line; Unable to sleep; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain at the waist line), INSOMNIA (Unable to sleep), AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell) and DYSPNOEA (Shortness of breath now and then) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mitral valve prolapse, Sleep apnea and Kidney stones.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (Back pain at the waist line), INSOMNIA (Unable to sleep), PAIN IN EXTREMITY (Sore arm), PYREXIA (Nasty fever at night/Fever), FATIGUE (Very tired), HEADACHE (Mild headache), NAUSEA (Nausea), ARTHRALGIA (Left arm near shoulder ached) and CHILLS (Chills). On an unknown date, the patient experienced AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell), DYSPNOEA (Shortness of breath now and then), COUGH (Cough now and then) and UPPER-AIRWAY COUGH SYNDROME (Maybe post nasal drip). On 17-Feb-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Mild headache) had resolved. On 18-Feb-2021, BACK PAIN (Back pain at the waist line) had resolved. At the time of the report, INSOMNIA (Unable to sleep), AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell), DYSPNOEA (Shortness of breath now and then), COUGH (Cough now and then), UPPER-AIRWAY COUGH SYNDROME (Maybe post nasal drip), PYREXIA (Nasty fever at night/Fever), FATIGUE (Very tired), NAUSEA (Nausea), ARTHRALGIA (Left arm near shoulder ached) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
rhinorrhea, headache, tested for COVID-19 on 1/04/2021 and was Positive
Pt recvd 2 doses of Engerix-B on the same day;
3-9-21 4:50PM SYNCOPAL EPISODE APROX 2 MIN. PT LOWERED TO FLOOR, LEGS ELEVATED- PT BECAME ALERT. PALE W/D, NO SOB,  NO NAUSEA, NO PAIN. STATES SHE 'ALWAYS PASSES OUT WITH SHOTS'.  4:55PMP SAT PT UPRIGHT FOR 2-3MIN THEN PLACED ON WHEELCHAIR - TOLERATED WELL. GIVEN JUICE AND CRACKERS. CALLED FRIEND TO COME DRIVE HER HOME.  4:17 'FEELS BETTER'.  TO EXIT PER W/C TO BE TAKEN HOME PER FRIEND. A/O, PINK, W/D, RESP REG EASE.
Patient received first dose 12/28/20 and second dose 1/8/21, 11 days later instead of 21 days. He did not experience any adverse effects from either vaccine when I contacted him on 1/11/21.
I was injured at work on 11/8 (gouge wound to my arm) & was sent to medical center for a tetanus shot. At medical center I received a Tdap injection (no simple tetanus vaccine was available). Within 1 hour of vaccine administration, I felt feverish, achy, & fatigued. I took some aspirin & fell asleep by 6 PM. When I woke up at 2:15 AM, the injection site was red, swollen, & painful. Today (11/12) the injection site is still swollen & red. While running errands today, I developed a fever of over 101 degrees & had to go to bed. I reported this to my employer's nurse referral service; she said that I should take Advil or aspirin, apply a cold pack, take antihistamine, & rest. She also asked me to call medical center to report the reaction. I spoke to a supervisor there who consulted with an MD who wanted me to come back to medical center & see an MD. I did not feel well enough to do that. I have taken aspirin, used an ice pack on the injection site, & will be taking Benadryl. My temperature has currently dropped to 99.9.
3 days later (R) thigh (injection site) w/ hives, whelps, itching. (+) scratching/itching.
Diarrhea; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Mar2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Mar2021, the patient experienced diarrhea and sore arm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea and sore arm was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine EUA Swelling, rash, welts, pink, every couple of days, then gone within 24 hours, with no treatment, starting with upper lip 3/22, right eye 3/28, upper right chest 3/31,  stomach 4/4, right and left hip 4/5
Bruised injection site; Headache; Vomiting; Hives all over face; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. 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 concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Mar2021 at 11:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Mar2021 at 13:00, the patient experienced headache, vomiting, bruised injection site and hives all over face. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events headache, vomiting, bruised injection site and hives all over face. The clinical outcomes of the events headache, vomiting, bruised injection site and hives all over face were recovering at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I feel horrible and it''s already been 3 days and I don''t know if I am having like an adverse reaction to it; I don''t feel any better; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "not recovered", described as "I feel horrible and it''s already been 3 days and I don''t know if I am having like an adverse reaction to it"; MALAISE (non-serious) with onset Nov2021, outcome "not recovered", described as "I don''t feel any better".  Additional information: It was reported that caller took the Pfizer shot on Wednesday night at a local pharmacy and I feel horrible and it's already been 3 days and I don't know if I am having like an adverse reaction to it or what I should do. But I don't feel any better." Patient provided the mailing address. The lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts completed. No further information is expected.
This spontaneous report as received from a registered pharmacist refers to a 59 years old female patient. The patient was vaccinated with a dose lot # (669863/0365AA), exp. date (09-JUN-2012) ZOSTAVAX (dose and route not reported) on 18-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 18-MAY-2012, the patient experienced a reaction after ZOSTAVAX was administered. The patient broke out in hives all over her body that were very painful. The patient was treated at the hospital for 2 days. At the time of the report, the patient's outcome was unknown. The relatedness to the events was unknown for ZOSTAVAX. No further information is available.
SYSTEMIC PAIN; DIFFICULTY EATING DUE TO NAUSEA; FEVER; MIGRAINE WITH AURA/ NEUROLOGICAL EYE TWITCHING/ HEADACHE/ RUNNY NOSE/ FLASHING LIGHT/ BLUE SPOTS/RINGING IN EAR (TINNITUS)/PAIN IN EYE/ NAUSEA/PAIN IN CHEEK; MIGRAINE WITH AURA/ NEUROLOGICAL EYE TWITCHING/ HEADACHE/ RUNNY NOSE/ FLASHING LIGHT/ BLUE SPOTS/RINGING IN EAR (TINNITUS)/PAIN IN EYE/ NAUSEA/PAIN IN CHEEK; CHILLS; HEADACHE/STABBING HEADACHE BEHIND THE EYE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine with onset at age 16, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient was having allergies but wishes not to disclose allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced migraine with aura/ neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus) /pain in eye/ nausea/pain in cheek. On 20-MAR-2021, the subject experienced migraine with aura/ neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus) /pain in eye/ nausea/pain in cheek. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headache/stabbing headache behind the eye. On 20-MAR-2021, the subject experienced difficulty eating due to nausea. On 20-MAR-2021, the subject experienced fever. On 23-JUN-2021, the subject experienced systemic pain. Treatment medications included: ketorolac tromethamine. On 29-JUN-2021, treatment medications included: topiramate. Laboratory data (dates unspecified) included: Complete blood count (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 22-MAR-2021, headache/stabbing headache behind the eye on 03-APR-2021, and systemic pain on 23-JUN-2021, and had not recovered from difficulty eating due to nausea, migraine with aura/ aura neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus)/pain in eye/ nausea/pain in cheek, and migraine with aura/ neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus)/pain in eye/ nausea/pain in cheek. This report was non-serious.
Localized Pain, redness, swelling, fever at sight. Asthma attack. Fever of 102.1. Fatigue.
Given expire vaccine PENTACEL lot # C3853AA LT exp: 10/28/12 Sanofi Pasteur.