chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have ultra high pitch loud 24 hours a day; Did not received 2 dose; Worsened (severe) Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Worsened (severe) Tinnitus), DYSPHONIA (Have ultra high pitch loud 24 hours a day) and PRODUCT DOSE OMISSION ISSUE (Did not received 2 dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus. Concomitant products included ATORVASTATIN from 01-Jan-2010 to an unknown date for Acid reflux (esophageal), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 30-Mar-2020 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] from 01-Jan-2010 to an unknown date for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced TINNITUS (Worsened (severe) Tinnitus). On an unknown date, the patient experienced DYSPHONIA (Have ultra high pitch loud 24 hours a day) and PRODUCT DOSE OMISSION ISSUE (Did not received 2 dose). The patient was treated with VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and VITAMIN B COMPLEX at an unspecified dose and frequency. At the time of the report, TINNITUS (Worsened (severe) Tinnitus) had not resolved, DYSPHONIA (Have ultra high pitch loud 24 hours a day) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not received 2 dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information received reporter contact details, patient demographics, suspect drug details, concomitant medications and additional event were added, and outcome of the event was updated. On 21-Jul-2021: NNI FU- No new information
Pt developed rash on her stomach and arms about 2 days after receiving the IM H1N1 vaccine. States rates progress to legs and all rash went away 7 - 10 days after onset. Rash was pruritis and self treated with ZYRTEC. Rash was red/pink - slightly bumpy.
Patient said started getting larger at injection site and swelling the evening of the 27th and bothered her all night.  I suggested she take Benadryl for swelling and itching and to use a cold compress.  I also had her mark the edges with a pen so she can see if it is getting larger or smaller over the next 24 hours.
Pneumonia and influenza vaccines given 10/24/13. Later that day pt c/o fever and pain in (L) deltoid. TYLENOL and BENADRYL given. Temp 100.2. On 10/26 in medical rounds pt c/o redness and induration (L) deltoid. Diagnosed as cellulitis. Cold compresses and KEFLEX ordered. On 10/27 pt discharged to home.
60 y.o.       Admit Date:  8/30/2022     Discharge Date:   9/6/2022     Discharge Diagnosis:  Principal Problem:    Perinephric abscess, left  Active Problems:    COVID-19 virus infection    COPD with acute exacerbation    Failure of outpatient treatment    Essential hypertension    Uncontrolled type 2 diabetes mellitus with hyperglycemia    Hypomagnesemia        Hospital Course:  60 year old female was admitted with left perinephric abscess. She also required treatment for Covid-19 infection. She was septic from the abscess. She had placement of drain by IR on 8/31. Fluid culture and urin culture grew E coli. ID was involved and she has been on Merrem therapy. The drain was removed on 9/5 by urology. She has improved significantly. ID recommendation is for the patient to be continued on Ertapenem for 2 weeks from drain removal. She had mid line placed. She will be discharged home today with HH for continued therapy. Patient educated on appropriate level of care post-discharge. Follow up with urology and ID. Total discharge time >30 minutes.     Physical Exam on the day of discharge:  Last Recorded Vital Signs: Temp: 97.9 °F (36.6 °C)  Heart Rate (Monitor): 82  Pulse: 76  BP: 103/79  Respirations: 16  SpO2: 100 %  O2 Flow Rate (l/min): 0 l/min  General Appearance: no distress   Eyes: PERRLA  ENT: moist mucus membranes, no adenopathy  Lungs: clear to auscultation bilaterally   Heart: regular rate and rhythm  Abdomen: soft, non-tender   Skin: No rashes or lesions   Extremities: full ROM  Neuro: alert, normal strength and tone      Consults:  IP CONSULT TO UROLOGY  IP CONSULT TO INFECTIOUS DISEASES  IP CONSULT TO INTERVENTIONAL RADIOLOGY  IP CONSULT TO SOCIAL WORK  IP CONSULT TO SOCIAL WORK  IP CONSULT TO IV THERAPY     Significant Diagnostic Studies:   CT abdomen and pelvis, CTA chest     Operations: Placement of 12 Fr percutaneous drain at left pararenal abscess under CT guidance        Disposition:  Home with HH
9-29:  Reported to ER with red welt on arm that increased since administration, red area w/lump under it, red raised area upper left arm where shots given.  Per pt report, has felt flulike symptoms since 1st Hep B vaccine about 1 month prior.  She is getting series in order to qualify for job.  Some pain and redness at injection site and spread over past 2 days.  Only tried Benadryl cream on area.  ER gave pt hydrocortisone cream and advised ice to area and f/u with employee health.   Employee health referred pt to Allergy clinic.  10-3:  Allergy clinic noted at 1 week that pt still had local redness and tenderness at injection site, fever, chills, fatigue, diarrhea.  Assessed as type 3 hypersensitivity reaction.  Lab work ordered.  Possible serum sickness / local arthus reaction.  Steriods declined by pt.  Hep B likely culprit, but cannot rule out tetanus.  10-22:  Noted hematuria on UA and pt referred to urology for assessment.
pt recv vax 3JUN97 AM-evening of 5JUN97 noticed a large swelling 3-4" in diameter under rt arm, area sore to touch;during noc 5JUN97 devel chills & sweats;temp no taken;denies swelling under other arm or in neck area;lt side of jaw tender
Starting 2 days after the injection he had severe fatigue that lasted for a number of days.
Within approximately 3 minutes of receiving Menactra and Trumenba vaccines patient started complaining of difficulty breathing. Pulse ox was 97%. Wheezing was noted and patient started breathing treatment of Albuteral 2.5mg immediately . Patient then developed a rash with itiching . Benadryl 25mg and Dexamethasone 8mg was given IM at 9:43 AM. Wheezing, rash and itiching then resolved but patient was complaining of chest pain. Patient was transported by EMS to ER
A report has been received from a Health Professional concerning a female subject of 58 years, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 mL. FLUMIST Quadrivalent started on 28-Sep-2015. FLUMIST was administered to 3 women on Sept. 28, 2015 who are over the age of 49 years. Ages are 57, 58 and 61. FLUMIST Quadrivalent was discontinued on 28-Sep-2015. The outcome of the event of over 49 years of age is unknown. The report was considered to be non-serious.
no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 12-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004090: US-009507513-2306USA004089: US-009507513-2306USA004087: US-009507513-2306USA004082: US-009507513-2306USA004088: US-009507513-2305USA007959: US-009507513-2306USA004085: US-009507513-2306USA004083: US-009507513-2306USA004084:
This spontaneous case was reported by a non-health professional and describes the occurrence of ANTIBODY TEST NEGATIVE (Got the antibody test and it came back negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced ANTIBODY TEST NEGATIVE (Got the antibody test and it came back negative). At the time of the report, ANTIBODY TEST NEGATIVE (Got the antibody test and it came back negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: Negative.
swollen, red, hot, itchy, circle about 9 cm  circumference with right arm pain directly around injection site. in addition, a cold sore on the same day.
Headache, fever, shortness of breath, high blood pressure, low oxygen levels, post nasal drip, night time cough
Really bad headache; Fever; Chills; Nausea; Fatigue; nausea (including vomiting); This is a spontaneous report from a contactable consumer, the patient or other non hcp.  An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Left on 19May2021 16:30 as DOSE 2, SINGLE (at the age of 18-year-old) for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 28Apr2021 at 16:30, the patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0171) via an unspecified route of administration in the left arm on (at the age of 18-year-old) as a single dose for COVID-19 immunisation. On 20May2021 01:00, the patient experienced really bad headache, fever, chills, nausea, fatigue and nausea continuing for three days after vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of all events was recovering.   Follow-up attempts completed. No further information expected.
pt recv vax 27AUG96 930AM & approx 1145 h/a started;pt c/o rt leg shaking around 1230PM;took ASA 230PM-no relief;c/o chills & elevated temp in early evening & vomited p/supper & states felt better;feels achy all over & queasy;advised ER;
Moderna Bvalent Booster dose given 7 days earlier than was eligible to receive dose.
Vomiting, fever, headache, confusion, on the morning of 11/4/2017 continuous low blood sugar even after glucose and juice was given to the patient.
This spontaneous report as received from a nurse refers to a patient of unknown age (gender not reported). The patient's current conditions, medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored (incorrect product storage) VARIVAX lot # M039317, expiration date: 20-SEP-2018, (strength, dose and route of administration were not reported) for prophylaxis after first temperature excursion but previous to second temperature excursion. Concomitant therapies included sterile diluent(STERILE DILUENT) (lot/batch#M024783, expiration date: 15-JAN-2019). No adverse effects were reported. On an unspecified date, the temperature excursion was 1.7 °C for 7 hours 36 minutes. Previous temperature excursion was reported as -8 °C for 1 hour 39 minutes. No PQC was involved. The outcome of incorrect product storage and no adverse effects was unknown.
Patient has localized reaction to Anthrax vaccine. Patient signs and symptoms are the following: Reaction on left arm (redness), nausea, and dizziness reported by paitent. No adverse reaction of swelling to throat or closed airway.
The pt experienced a fever of 105.7, unresponsiveness, periods of blank staring, would not eat, fall over in sitting position and fall down when standing, could not walk for days.
Both parents of the child that received the varicella vaccine were diagnosed with shingles a little over a week after the child was given the vaccine. Onset began as mild pain and itching, which yielded patches of tiny blisters that were confirmed to be shingles. Both parents were treated with Valtrex. Both parents did have chicken pox as children.
Pt. had large, red, hot lump on left shoulder where the KINRIX vaccine was given IM.
Pt reported redness and tenderness at injection site/deltoid and under arm. At time of report this was resolved.
Swollen painful lymph node appeared on left collarbone 3 days after the injection. It resolved 2 days later and had now reappeared the morning of the 14th day after injection.
Hot like high fever,huge big knot at injection  site, very sore ,after injection blood ran down my arm then it was taped with cotton ball and bandaid  when I got back home cotton ball was full of blood I changed it only to continue to bleed
Inconsolable crying x 3 hrs - l thigh red & swollen shot area extending to knee.
Very tender and sore (not swollen or red). Unable to rotate neck for 2 days (chiropractor was not able to do adjustment and was only able to ice it down to reduce tension).
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
pt vax hepta B. 5 days after rec. the second dose developed n/v/fever of 101F. symptoms persisted for 12 hrs and remitted spontaneously.  No further details
The person is 16 years old and a Johnson and Johnson vaccine was given.  Johnson and Johnson vaccine is not recommended for persons under 18 years.
Symptons of VIRUS (long periods sleeping, chills, fever, no appetite) RASH and discoloration at site of vaccination; arm is peeling.
Approx 4 hours post vaccine administration, pt. developed scratchy throat, cough, hoarseness, watery eyes.
I went on a cruise ship when I got COVID-19. On 11/28/2022 that when I started to feel ill. I thought I had a cold, I had a runny nose and feeling very tired. I also developed a cough about 2-3 days later. I also felt very exhausted and then the cough came. I had the cough until the second week of January 2023. I did lose my sense of taste and smell for about one week. I took a COVID-19 test at pharmacy but do not remember the date. About two weeks later I did an at home COVID test and it was negative.
After being bitten by a dog, the 71 year old pt received 3 doses of RabAvert IM. After each dose, the pt experienced systemic itching, welts, and hives. A few days after the third dose of RabAvert, the pt developed difficulty breathing and went to the ER where she was given a dose of corticosteroids. Treatment included Benadryl every 4 hours. the pt has a hx of asthma. Further information is pending. Additional info received on 11/20/2000, the pt received five doses of RabAvert on 10/06, 10/10, 10/13, 10/19, and 11/02/2000. She also received two doses of rabies immune glovulin on 10/06/2000 in the right and left gluteus, two more doses on 10/10 in the right and left gluteus, and one dose on 11/02/2000 in the right gluteus. On 10/17/2000, the pt experienced itching and urticaria. The adverse events resolved. The pt has a history of leukemia.
Patient received  0.3ml dose of Pfizer.  No adverse outcome. No signs or symptoms. no treatment needed.
Flu shot given in R arm no problem. PREVNAR 13 in left arm, patient fell ground and had partial seizure for 30 seconds then woke up. Gave orange juice made patient sit for half hour, and patient wife drive home.
11:38am c/o headache.  11:55am patient c/o feeling a little better. BP 110/60, HR 81, 99%.
p/vax reported not feeling well that day; c/o chest hurting w/elevated temp of 101;had nausea & vomiting;c/o body aches & weakness;T102;throat has been sore;
Narrative: Pt has lupus and reported prior to vaccine administration he ha a bilateral lower extremity rash with swelling and itching from ankles to just below his knees. He reports this seemed to have worsened following vaccination.
The day after my 1st vaccine dose, I had chills, light fever, diarrhea, upset stomach, nausea, fatigue,  and cough. Chills and the low grade fever lasted for 7 days, but the cough lasted for 4 weeks after my 1st dose. So I went to my PCP to get a check up, they ran all my blood tests, and I was recommended to NOT receive my 2nd dose yet.
About a week after getting the first vaccine does, I started having massive headaches. I've never had a headache before in my life. The searing pain was accompanied by very high blood pressure and near fainting. I thought I was dying and I have no health insurance so I could never get it checked out. It has continued for months now, randomly hitting me from time to time a few times a week. I can feel my blood pressure rise and my had hurt. I have to lay down for about half an hour and let it pass. I was healthy before the vaccine, I've never experienced anything like this before, so I am confident it was caused by the vaccine. Like I said, I don't have insurance so I have just been dealing with it myself...
I have developed a blood clot in my left leg- am the picture of perfect health, ( still no cavities even!)zero % risk factors and thought the medical field should be studying possible long term effects.
Patient states that later in the evening (approximately 6 hours)  after getting immunization on March 24th she started feeling muscle aches and itching. Thursday March 25th, in the morning, she was having trouble standing and could not walk, plus confusion understanding  husband when he talked to her about  her problems. They went to hospital and she was admitted.  Do not know what tests or treatment patient got at hospital, but she was released to go home on Saturday March 27, 2021.
This spontaneous report was received from a Licensed Practical Nurse refers to a 3 year old patient (unknown gender). No medical history was reported. The patient was vaccinated with first dose of VAQTA (lot#, expiry not reported) on 17-JUN-2008 and dose 2 of VAQTA (lot #, expiry not reported) on 07-JUL-2009. No concomitant medications were reported. The nurse reported that the patient received a pediatric dose of VAQTA (Lot # 666030/1397Y, expiry- 27-AUG-2012) instead of RECOMBIVAX HB on 05-MAR-2010. No adverse event reported. Additional information is not expected.
Within 12 hours of her second dose of the Moderna COVID-19 vaccine, she developed a disseminated rash over her chest and face as well as paresthesias of her feet and hands that progressed up to her face over hours to days. The paresthesias became more painful (dysesthesias), associated with disabling burning, worse with bearing weight, leaving her unable to ambulate long distances. She has lost endurance but her power is good. Symptoms worsened slowly over 5 weeks, and stabilized with hospitalization and treatment using gabapentin as well as a Medrol course. Initially thought to be Guillain-Barre Syndrome, however she had preserved (even heightened) reflexes and normal CSF testing.
Increaeed dermatitis developed in February and March 2021 and progressed to plaques all over the scalp by April. Diagnosed with psoriasis, the skin on the scalp became inflamed and pus started to form around the hairline. The condition spread from the scalp to the body in pustulars and rashes on the leg by June. Diagnosed with pustular psoriasis. Lupus flare caused joint pain and swollen lymph nodes and legs. Developed cellulitis and was given antibiotics Cephalaxin and doxycicline. Topical creams and ointments given but not effective, made conditions worse. Otezla prescribed and caused severe allergic reaction in June 2021
About 45 minutes-an hour later, my tongue swelled a little, cheeks swelled, left side of face and chin swelled. I also had a rash on face. Swelling and Rash lasted about an hour or so.
Patient had slight swelling in her hand and tingling at the injection arm. Patient took two Benadryl 25 mg capsules and the swelling subsided. 15 minutes later, patient had swelling in both legs. An ambulance was called and patient was taken to urgent care to get treated. Patient was released from urgent care the same day and has recovered.
Headache, Fever backache, chills, swollen at injection site, sore arm Narrative:
Day 1...Fever, up to 100.7, nausea, body aches, sore arm with slight rash at injection site. Day 2...felt great, energy, mild fever (99), sore arm.  Day 3 slight fever (99), slightly sore arm with slight rash.
PER MOM CHILD HAD 30 SECOND SEIZURE AFTER RECEIVING VACCINES AT AROUND 6 PM. NO FEVER PRIOR TO VACCINES AND LOW GRADE 99 FEVER AFTER SEIZURE PER MOM.
This spontaneous report as received from a healthcare worker via a field representative refers to a 24 year old female patient. On an unknown date the patient was inadvertently administered a dose of PROQUAD (dose, lot# and route not reported). No adverse effects reported. Additional information is not expected because the physician is not allowed to contact.
no other AEs reported; concomitant administration of PROQUAD and VARlVAX; Information has been received from a nurse referring to a patient of unknown age or gender. Information about pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.   On 08-JUN-2021, the patient had concomitant administration of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 injection, lot #: T036735, expiration date: 28-APR-2022, therapy type: recombinant Human albumin (RHA)) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (1 injection, lot #: S032357, expiration date: 14-OCT-2021) (both vaccines' strength and route were not reported) for prophylaxis (inappropriate schedule of product administration). The patient was not exhibiting any side effects. No other adverse events (AEs) reported.
Patient reported leakage of the vaccine on the arm. However over 1/2 of the dose was administered so a third dose was not required.