chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fourth dose not received; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 22nd February 2013), Twinrix (2nd dose received on 1st March 2013) and Twinrix (3rd dose received on 27th March 2013).   On an unknown date, the patient did not receive the 4th dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The nurse reported that a patient started Twinrix accelerated dosing in 2013 and did not receive the fourth dose.   The doses were given at a different facility and the reporter did not had the lot numbers or expiration dates. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 4th dose of Twinrix, which led to incomplete course of vaccination.
Mild fever only the night of vaccination date Extreme muscular soreness, shoulder to elbow for 3 days, beginning the night of injection Moderately severe headache beginning the day after vaccination; lasting for 3 days By day 4, all side effects had disappeared  By choice, Aleve was taken only once, the night of vaccination date.
pt recvd vax;following day devel severe upper arm redness & swelling & myalgia of bicep;md reported that pt devel redness, swelling & pain at inject site which resolved by 1jul94;
My right upper arm and shoulder were extremely painful. My range of motion seemed limited, due to "shocks-of-pain" with certain movements.
Pt vaccinated with DTP/OPV became irritable & cried all week following DTP vaccine. No fever, Difficult to console, didn't sleep well.
pt recv vax; cheeks were red and had large circular reddened area w/ in it;rxn resolved;
1. Got sick on 07.25.2021  with running nose, coughing, sneezing, headache (lasted for 3 weeks). Tested for COVID on August 2- negative  2. Infection in the throat on August 19 while  on vacation, had to admit myself to the emergency room 3. Swallowing parts of the  face from  around September 7.  It swallows by sections: lower lip, upper lip, under and above left eye, then the same around right eye, forehead and nose.
Patient received 1st seasonal flu vaccine within 1 hr later observed jerks and patient fell. Dr picked him up and no iced eyes rolled back and stiff. This lasted about 1 min. Father states sleepy in ER. ER DID state fire on arm
Site reaction...red hot sore to the touch...swelling size of large egg that began on day two after injection and remains inflamed on day four.(today)
Pain at time of injection - probably insignificant with soreness till presently Within 24 hrs., All over body weakness, inflammation of the mouth & right nasal passage, diarrhea, difficulty walking - low energy, body chills all day Today I am better
SOB: ~25 min post injection, lasted ~1 min then resolved. Nausea 1 hour post dose, intermittent, sever x12  hours, then intermittent and mild x1 additional day. Fatigue & pain at injection site
Vaccinated 5/13/03 Patient did not have C/O except for itching post vaccination. On November 26, 2003. Patient reported that 2-3 weeks after vaccination he started getting tired and weak. He states this weakness progressed to where he would have to take frequent rests, could not run up the stairs. Legs felt like jelly, eye-sight progressively decreasing in acuity, neuralgias of the trunk.  He has since had to quit work d/t the failing health and eyesight. And is now unable to ski, continue as a flight instructor or drive. 5/20/03: Appointment with doctor for decrease in energy and intermittent blurry vision. DX: with Type II DM, Uncontrolled mild early peripheral neuropathy, Hyperglobulinemia. TRT: Started on Glucovance. 7/28/03: Doctor office visit: C/O "pain around the right side of abdomen in the dermatomal area, which started about two months ago but wasn't really severe until about a week or so ago." DX: Peripheral neuropathy, related to diabetes mellitus versus herpes zoster neuralgia. TRT: Neurontin, Vicodin. 8/5/03: Office visit: TRT: trial of Amitriptyline. 9/9/03: Office visit: C/O continues and increasing dysequilibrium and trouble walking in a straight line. 10/20/03: Office visit: C/O progressing leg weakness. Continues with neuropathy. DX: Pregressive leg weakness, possible related to smallpox injection. 12/2/03: Office visit: C/O neuropathy continues. TRT: acupuncture, Trialled Ultram, herbs, vitamins. December 2003: Doctor visit, Retinologist. Laser eye treatments. 1/5/04: Doctor visit, Neurologist. DX: Diffuse weakness, progressive, diabetes mellitus, peripheral neuropathy, autonomic neuropathy, diabetc myopathy. 1/9/04: Doctor office visit: DX: Type II diabetes mellitus with complicatons of retinopathy and neuropathy with leg weakness and possibly complicated by the Smallpox injection last year. 1/2004 saw doctor who reffered patient to Smallpox Research.  Patient has since found that the medical center is not doing current research. 2/5/04: Doctor office visit: BS WNL DX: Atypical rapidly progressing bilateral ulnar neuropathy and truncal neuropathy, rule out spinal cord injury. 2/10/04 Doctor office visit, allergist: DX: feels the rapid progression of symptoms is an allergic reaction to the smallpox vaccine.  Per annual follow up report patient continues with following S/S tires easily with physical activity, strenght is not back to 100%, right eye is swollen, vision is 20/60 R and legally blind in the left, continues with neuropathies and is on RX, can only read or use the ocmputer for about 10-15 minutes when  he gets a severe headache lasting up to 8 hours, no longer is emploted, is on disability.
pt recv vax & devel an inj site rxn, characterized by swelling of the entire thigh;presented to ER & was treated w/DPH & Ibuprofen;swelling resolved overnoc;
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history was reported. On 28-MAY-2013 the patient was vaccinated with an expired dose of ZOSTAVAX lot # 671020/0746AA, expiry 15-JUL-2011 (reported as 18-AUG-2012). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Fever to 101 deg F; rapid heart rate to 120 BPM; dehydration.  Took Tylenol (2 x 500 mg) every 6 hours plus copious amount of water plus applied ice pack.  Fever broke approx 1 AM.  Also, unusually painful injection site.
severe case of shingles on her head and face; nerve damage; facial scaring; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 23Mar2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "contracted COVID" (unspecified if ongoing), notes: contracted COVID on unk date in late 2020 or early 2021. The patient's concomitant medications were not reported. Vaccination history included: Shingrix vaccine (1st dose), administration date: 24Jun2020, when the patient was 53 years old, for Immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: HERPES ZOSTER (disability) with onset Apr2021, outcome "recovered with sequelae", described as "severe case of shingles on her head and face"; NERVE INJURY (disability) with onset Apr2021, outcome "recovered with sequelae", described as "nerve damage"; SCAR (disability) with onset Apr2021, outcome "recovered with sequelae", described as "facial scaring". In Apr2021, she developed severe case of shingles on her head and face. She had nerve damage and facial scaring from the shingles outbreak that may be permanent. She was unsure if she developed shingles due to the COVID vaccine. She was afraid to get the (3rd) booster for fear that she may have another shingles flare. The events "severe case of shingles on her head and face", "nerve damage" and "facial scaring" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of herpes zoster, nerve injury, scar. Patient was treated at hospital on or around 07Apr2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
chills; injection site soreness; fever; headache; fatigue; This is a spontaneous report from a non-contactable consumer. A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176, expiration date not reported) via an unspecified route of administration on the left arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included hepatitis B and patient had tested positive for Covid in May2020 and had recovered. Concomitant medications included hepatitis B experimental medicine. On 13Jan2021, the patient experienced injection site soreness, chills, fever, headache, fatigue. No treatment was received for the events. Post vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Donor noticed swelling, redness about the size of a baseball.  There was hardness, hot.  Donor had headache and was tired. Donor stated did not have temperature but took Ibuprofen for discomfort and headache.  Feeling better today 12/24/13 and most of redness gone but still has hard lump in arm.
Got sick after second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Got sick after second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick after second shot). At the time of the report, ILLNESS (Got sick after second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Intestine discomfort, multiple bowel movements (no diarrhea), chills, feverish (but no fever), muscle aches. I'm reporting this 24 hours after getting the 2nd Pfizer shot.  Reaction started overnight.  Don't know at this time how long this will last.  Have not called doctor. Taking Tylenol.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Jan2021 at 15:45 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "asthma" (unspecified if ongoing); "lung disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Levaquin, reaction(s): "Known allergies: Levaquin"; Morphine, reaction(s): "Known allergies: morphine". The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 12Jul2022, outcome "recovered" (28Jul2022) and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) positive, notes: I was covid positive on 12Jul2022; (Jul2022) positive, notes: test was positive; (28Jul2022) negative, notes: 28Jul2022 retested and was negative; (23Jul2022) positive, notes: Did home test on 23Jul2022 showed positive again. Therapeutic measures were taken as a result of covid-19.  The course of the events were reported as the patient was covid positive on 12Jul2022 and was prescribed paxlovid on the same day. The patient took her medication for the week, went back to work on 18Jul2022 saw doctor in the morning advising him that the patient was still having fevers but the patient was told to go back. Wednesday of that week, the patient was getting pain behind her ears and throat had a white coating. The throat started hurting Friday night. Got worse Saturday along with chest pressure, fatigue, fever. The patient did home test on 23Jul2022 showed positive again went to urgent care on the Sunday and was given steroid shot and was told to take mucinex and netty pot and test was positive and the patient was out another week of work until 28Jul2022, retested and was negative. The patient saw her doctor who gave her antibiotics.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
15 YO patient got TWINRIX in error; This case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 15-year-old patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter reported that, a 15 year old patient got Twinrix in error when the recommended age was 18 years and older.  No additional adverse event reported.  No PQC (Product quality complaint) was reported.  No further information was provided. Additional Supportive Information: The reporter reported that, a 15 year old patient got Twinrix in error when the recommended age is 18 years and older, which led to inappropriate age at vaccine administration.
Vomiting 3 days prior with cough, runny nose, low grade temperature about 100.  Vesicles on face, trunk and spreading (+) exposure to varicella 2 weeks ago at school  Began Acyclovir for 5 days. (10.3 y)
Red rash, circular in shape, very painful, hot to the touch, itchy, fever, flu like symptoms. Red and swollen at injection site, covering about 3-4 inches around.
low grade fever with temperatures going up to 99.F (his usual temperature is 98.F); Chest pain; This is a spontaneous report from a contactable nurse reporting for her husband. A male patient of an unspecified age (age: 77, unit: unspecified) received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 26Feb2021 at single dose for COVID-19 immunization. Medical history included heart disorder (reported as long heart history). The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced low-grade fever with temperatures going up to 99 degrees Fahrenheit that lasted for about 24 hours, his usual temperature was 98 degrees Fahrenheit. The next day, he went to the ER because of chest pain, but they attribute it to his long heart history. The outcome of the event low-grade fever was recovered on an unspecified date in 2021 and unknown for chest pain.   Information on the lot/batch number has been requested.
This previously healthy 22-month-old male had the following vaccinations on 1/20: 4th HIB, 1st hepatitis A, and 1st varicella. The following day, he developed an unsteady gait with walking. The symptoms progressively worsened and he also developed some upper extremity and truncal "shakiness". He presented to the ED on 2/18, where it was noted that he was able to ambulate but had a wobbly, unsteady gait and had intermittent falls. There was no seizure activity and no history of head trauma or other prior medical conditions. He began walking at age 1 year and, prior to the vaccinations, was ambulating without any difficulty, running, and had a normal and steady gait. A CT scan of the head without contrast was negative. The case was discussed with the on-call ID physician, who reported that ataxia is a rare complication of varicella vaccination. The patient was admitted to the hospital, had an MRI of the head and spine was read as normal, and discharged after 1 day. The discharge diagnosis was acute onset of truncal ataxia that was most likely post-infectious/vaccine cerebritis.  Summary: probable cerebritis secondary to varicella vaccination.  3/27/09 Received vaccine & PCP medical records of 1/19-3/17/2009. FINAL DX: ataxia Records reveal patient experienced cold w/cough, nasal discharge, no fever, dx w/URI on 1/19/09.  RTC 2/10 f/r anemia f/u.  RTC 2/24 s/p hospitalization for weakness of legs & ataxia.  Neuro f/u.  RTC 3/3 & 3/17 continued to improve.  4/6/09 Received hospital medical records of 2/18-2/19/2009. FINAL DX: ataxia Records reveal patient experienced progressively worsening ataxia x 1 day.  Had unsteady gait day after vaccines & seen by PCP then some improvement & then worsening s/s x 1 day.  Wobbly unsteady gait w/frequent falls, upper extremity & truncal shakiness.  Cast discussed w/ID & Neuro.  Admitted overnight for observation.  D/C to home next day when labs & scans all WNL.
Fever up to 104, nausea, vomiting, arthalgia, particularly in his elbows. Headache and chills.   He was diagnosed with a Pilonidal cyst vs abscess on 4/19/19.
severe hearing loss in his right ear; tinnitus/ringing in his ear; Initial information received on 21-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 74 years old male patient who experienced severe hearing loss in his right ear (deafness unilateral) and tinnitus/ringing in his ear (tinnitus), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2019, the patient received a single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ253AA via intramuscular route in the arm nos.  On an unknown date, the patient developed a serious severe hearing loss in his right ear (deafness unilateral) after having symptoms of tinnitus/ringing in his ear (tinnitus) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  Patient required visit to ENT specialist on the date of vaccination.  No lab test was reported.  Final diagnosis was deafness unilateral and tinnitus.   The patient was treated with 10 mg of PREDNISONE (PREDNISONE) and was put on steroids as suggested by ENT specialist.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for the events (symptoms were still ongoing at the time of reporting).; Sender's Comments: This case involves a 74 years old male patient who experienced severe hearing loss in his right ear and tinnitus/ringing in his ear post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Degeneration of inner ear structure, trauma or exposure to loud noise, infection is most common factor of hearing loss in elderly age, which need to be excluded before any conclusion can be drawn. Additional information including patient's medical history, condition at the time of vaccination, any history of trauma, lab test ruling out other etiologies is needed for further assessment of the case. Based on available information the role of vaccine cannot be assessed.
Chills and Fever starting at 3:00 AM continued until approx. 7:00 AM following Tylenol. Headache throughout the day on 4/9/21. Took Tylenol throughout the day. Chills and Fever returned and continued for 2 additional days. Periodic headaches continued for approximately 7 days. Exhaustion persisted for approximately 14 days.
5 days after  one year old vaccines, patient was found unresponsive and blue in crib at daycare when provider checked her during nap.  CPR initiated, patient transported to Hospital.  CPR efforts were unsucessful and patient was pronounced dead at 451 pm on 6/15/2021. In ER , patient had no pulse or heart rate and was noted to have temperature of 102.6 rectal.  Patient was well appearing the per parents the morning she was dropped at daycare, no unusual symptoms. Had been recovering from a cold.  Autopsy results are pending.
the afternoon after the shot, tingling itching in areas I have had previous cold sores, plus the outside left side of nostril. By the next day cold sore appearing vesicals occured, by evening the nose was swollen and red, as well as a sort of channel area from the eye to nose, and a swelling under the left jaw area.  The area on my shoulder where I had shingles over 10 years ago was experiencing some shooting pains.  Treated with Zovirax per advice of my dentist as Dr. was out of town.  Did go to clinic Monday was given diagnosis of Rosecia and prescribed a tube of ointment.   Did get a 2nd opionion due to severe itching and pain, who thought it was herpes and said to continue Zovirax.
At 18:20 on 02/03/2021 Patient received Moderna Vaccine 0.5ml in Right Deltoid. At approximately 18:23 patient began complaining of shortness of breath and chest tightness. Assessment of patient showed a heart rate of 116 and SPO2 reading of 89. Patient was place on 2L/hr of oxygen via nasal cannula and encouraged to take deep breaths. Patient stated that " she felt like her throat was closing and she was going to pass out". After noting hoarseness in her voice LPN administered 0.3 Epinephrine via auto-injector and 911 was dialed. Patient was transported by ambulance at 18:35 hrs to Hospital.
Pt. had a seizure on May 9th at 720am.  He has never had any seizure activity prior to this.