chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Next day I had fever and headache, vomited the day after, On 4/23 in the morning, all the sudden I started hearing high pitched ringing in both of my ears (tinnitus).  Tinnitus was continuous since it started which was disturbing my sleep as it was more noticeable when the surrounding was quiet, I had to go to ER after starting my 4th day of continued tinnitus.  Later I saw the ENT.  The headache and tinnitus is still continuing as the time of report.
administered an pediatric dose to an adult patient; administered an pediatric dose to an adult patient; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 41-year-old male patient who received HBV (Engerix B pediatric) (batch number 9KJ7R, expiry date 9th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th March 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Engerix B pediatric in right deltoid. The patient inadvertently received a pediatric dose of Engerix B at the age of 41 years, which led to adult use of a child product and underdose. The reporter inquired as what dose to proceed with. The reporter did not consent to follow-up.
17 year old received 1st dose Moderna. 2nd dose Moderna administered according the CDC guidelines for off label use  -unauthorized age.  Medical Director signed off on Moderna administration
On Day 8 after my first Moderna dose COVID vaccine I developed a great deal of swelling, pain, rash, itching of my Right shoulder where I was vaccinated.  It started on 2-20-21 and conitues today 2-21-21.
Local reaction noted 10/04/2017 (11x9 CM erythema & mild warmth). NO MEDICATION TREATMENT REQUIRED. PATIENT USED OTC TYLENOL FOR PAIN and PLACED ICE ON THE AREA FOR WARMTH/SWELLING.
It was reported that a female pt received a Fluzone SV '00-'01 vaccination on 12/28/00. Reportedly, on 1/20/01, the pt was admitted to the hospital with the dx of respiratory distress. The pt spent 3 days in MICU. The pt's mother states that the pt is in "fragile" health so does not go out. Pt's mother and her husband have not had the flu and neither have the nurses who visit the pt. The pt's physician feels it was the vaccine which caused this. The pt is still having some respiratory problems but is getting back to baseline.
Red swollen bump in the upper left arm. A little itchy and sore. It showed a week after getting the first shot of the vaccine . Started with the itch and the redness on Wednesday 03/31 in the afternoon.
CVA (stroke) around 2:00 p.m., was immediately transported to hospital.  Meds were given (I believe Alteplase, but would need to confirm.) 3 brain bleeds after medications.  Patient passed away at 5:40 p.m.
modernashotgivemeheartattack; Modernashotgivemeashortofbreath; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (modernashotgivemeheartattack) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (modernashotgivemeheartattack) (seriousness criterion medically significant) and DYSPNOEA (Modernashotgivemeashortofbreath). At the time of the report, MYOCARDIAL INFARCTION (modernashotgivemeheartattack) and DYSPNOEA (Modernashotgivemeashortofbreath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  Very limited information regarding the events has been provided at this time.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Regulatory Authority follow up received. On 28-Jul-2021:Regulatory Authority follow up received.; Sender's Comments: Very limited information regarding the events has been provided at this time.
Weakness, Low O2, death. Positive for COVID on 1/12/21, dies on 1/16/21
Suspected vaccination failure/Vaccinated. Still got shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and still got shingles. The patient stated that got vaccine 16 percent chances you could still get the shingles and he/she got shingles just his/her kick. Follow-up would not be performed as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
I saw my daughter walking like confused, not feeling well she sat down then stand up and told me she had nausea and was cold to the touch , pale very pale as her lips, tongue, nails and lower eyelids pale, she was also shakinyg. I rapidly though it was a hypoglycemic event and let her sit on the floor and rushed to the fridge and gave her apple juice and a she started to feel well.  She told me she felt her stomach crumbling and then she started to gain her normal lips pinkish color back also her tongue had color again... and she told me the the site of vaccination including the whole left arm was hurting and she asked for her breakfast and ate and felt better.
24 hours after administration, red and raised 2-3", 48 hours - red, arm, and raised 4-5", 4 days later, redness, warm but no longer raised. No pain. Pt started KEFLEX and VISTORIL at 48 hours.
Felt as though I had the flu- extreme fatigue, achiness, low grade fever, neck pain- also pain at injection site and jnability to raise arm
I lost mobility, not total mobility, in my left shoulder for explain if someone wants to scratch their back mine does not go past my waist. I can't even put deodorant on. And I can't even move it that well. And if I try to move it past that point there is pain. And even if I lay on it there is a pain.
Very sore left arm and left side of body, much more severe than usual. Appeared shortly after vaccination lasting several days
Patient repots should hurting where injection was given starting the day after injection. The pain continues to this day. Injection give on 6/24/20. No limit in range of motion of arm. Hurts when she moves it. Patient does not want to go to her doctor due to Covid-19. Refuses to call office.
pain in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in his arm). At the time of the report, PAIN IN EXTREMITY (pain in his arm)  had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information was reported.    This case was linked to MOD-2021-030731 (Patient Link).
On 09/16/2000 the patient experienced a fever greater than 102F. On 09/18/2000 the patient developed chickenpox (macropapular rash) on his face, trunk, limbs, and groin. Unspecified medical attention was sought. The nurse reported that the patient "has no postulates on his face or trunk; it is not seeping". The patient had not yet recovered at the time of the report. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Seizure disorder" (unspecified if ongoing). Concomitant medication(s) included: PHENYTOIN; SULFASALAZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported other medication in 2weeks: Yes. Treatment for COVID-19, start date: 21Jul2022, stop date: 25Jul2022. Other AE's reported Nasal congestion. Tired. Sneezing. Known allergies: NKDA.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Breakthrough case admission after three vaccines Pfizer 1/5/21 Lot# El3249;  Pfizer 2/5/21 Lot# Em9810;  Pfizer 11/11/21 Lot# FF2590
6 days after-swollen cheek and gland behind right ear;  7 days after-low grade fever for 24 hours and lethargic/tired 8 days after-sore/bright red throat and tired
Dizziness (continuing still). Bodyaches. Sore throat. Ear ache, slight Nausea.
Site: Swelling at Injection Site-Medium, Additional Details: Patient's wife stated he had a tennis ball sized lump at his injection site.  we recommended patient see his md or go to an urgent care.  we followed up with patient today but have not been successful at reaching him.  we will continue to follow up.
pt devel 3 radiculopathies: lt C8,rt L5,lt S1 3 days to 2 wk p/vax;s/s persisted 5months until was given a course of IV immunoglobulin which resulted in resolution of the polyradiculopathy
Patient given a Prevnar 13 and not a Prevnar 20 as they thought they were getting
PATIENT IS 16 AND RECEIVED THE J&J COVID VACCINE, NO AE'S AT THIS TIME
after an unspecified amount of time the patient fainted; This spontaneous report was received from a physician via company representative, referring to a 12 year old male patient. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot/batch # and expiration date were not provided) for the prevention of Human Papillomavirus (HPV) related disease. During, the same office visit the patient also received a meningococcal conj vaccine (unspecified) (dose, frequency, route, indication, lot/batch # and expiration date were not provided). After an unspecified amount of time, the patient fainted (syncope). The outcome of syncope was unknown.     The causal relationship between syncope and the suspect therapies was not provided.   Upon internal review, the event of syncope was considered to be medically significant.
fever keeps going up; 1st it was 99, then 100 and then 101; headache; body aches; Not feeling well; weak; This is a spontaneous report from a contactable consumer (patient) via Medical information team.  A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 13May2021 at 15:00, (at the age of 47-years-old) at 1ST DOSE single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever and it  kept going up, 99 at first, then 100 and then 101, had headache, body aches, not feeling well and weak in May2021 after the first dose. He stated he just took two pills of Tylenol Extra Strength. Treatment was given for the events. Patient wanted to know if it was normal to have a fever and other symptoms and how long it would lasts. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pain and swelling, plus blistery rash around injection site, nausea, fatigue and muscle aches. Began morning after injection. Lasted about 3 days with all symptoms waning each day. Rash lasted 1 more day but very fine in appearance at that time.  I had no fever or stomach  pain.
Patient has been fully vaccinated as of 5/25/21, she is now symptomatic and has tested positive as of 8/16.
Vaccine was expired on 01 Apr 2022 and was administered on 02 Apr 2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 02 Apr 2022.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.  No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 02 Apr 2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 02 Apr 2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It was reported that the pharmacist thought the vaccine expiry would be in Jun-2022, however it expired on 01-Apr-2022. The  date the vial was initially stored in refrigerator was 04 Apr 2022. The vial did not undergo any temperature excursion. Treatment information was not provided.
4 yo came in for 4 yr check up and received Dtap, IPV, and MMR vaccinations. No prior hx of problems within 24 hrs, pt returned with 12 hr, increasing right leg pain and swelling but no fever. Treated with Benadryl, Tylenol and Motrin and resolution within 72 hrs.
COVID+ 10/29/21 at another hospital. Patient transferred to this hospital on 11/6/21 and was on 15L of Oxygen.
That evening, I had fever and chills and body aches starting about 10 pm. I had a headache too. Next morning, I stayed in bed and took ibuprofen and went back to sleep and 30 minutes later the fever broke. I still had body aches and headaches for two to three days. I went to get test for a concern that ended up not being a health concern at all.
Myalgia, Fever,  BODY ACHE  Narrative:  :Employee got the second dose 01/28/2012 Stated that the  following day at 01:am she had worsening fever, bodyache, temp 104.5 She felt  some relief with tylenol She could not make it to work the 01/29/2021
Chills early morning of 2/17/21.  Severe headache  joint and muscle pain throughout the day of 2/17/21
Both hands went cold, numb and gray in color; patient stated put wool gloves to warm hands and s/s cleared after 2 hours.
Fever for about 36 hours, leading to water in the ear that lasted 3 weeks. I rarely run a fever and have never had middle or inner  ear issues. Only swimmer's ear (outer ear).
extreme vaginal bleeding; stomach pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: was not reported), via an unspecified route of administration, administrated in left arm on 09Jul2021 14:00 (age at the time of vaccination 43-years-old) as a single dose for COVID-19 immunization. Patient previously received first dose of BNT162b2 vaccine, on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had known allergy to Penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jul2021, the patient experienced extreme vaginal bleeding, and stomach pain. Patient visited to the emergency room for pain, was prescribed antibiotics for a possible infection. The outcome for all the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient passed out and fell and hit his head on the floor, and became unconscious for about 2 minutes.  Paramedics were called to the scene.  Patient regained consciousness but continued to be confused.  He did not display any signs of localized allergic or anaphylactic reactions.  He was taken to local hospital for evaluation.  It was believed that the vaccine did not cause the loss of consciousness, but possibly low blood pressure as reported by the patient the next day.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL. The physician reported that she received a phone call from the patient's mother saying that the patient was experiencing back pain after GARDASIL. The patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from a Licensed Practical Nurse who stated that she did not know who this patient is. Additional information is not expected.
received a dose past 30-day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) 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 EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.
The area around her left eye is very swollen; warm at injection site; sore at injection site; Arm is swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (The area around her left eye is very swollen), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PAIN (sore at injection site) and VACCINATION SITE SWELLING (Arm is swollen at injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIORBITAL SWELLING (The area around her left eye is very swollen), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PAIN (sore at injection site) and VACCINATION SITE SWELLING (Arm is swollen at injection site). At the time of the report, PERIORBITAL SWELLING (The area around her left eye is very swollen), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PAIN (sore at injection site) and VACCINATION SITE SWELLING (Arm is swollen at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
severe flu like symptoms for four days after second dose, followed by fatigue, lightheadedness, vertigo and muscle weakness from then on, still having vertigo and fatigue.
The customer reported PROQUAD was administered after a temperature excursion; This spontaneous report was received from a patient of unknown gender and age referred to himself/herself.  The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 30-APR-2021, the patient was administered measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection (lot #U028184 has been verified to be a valid lot number with expiration date 08-MAR-2023 (dose, and route of administration were not provided) for prophylaxis after four hours of temperature excursion under the temperature of -12.3 degree Celsius. (Product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA006621: US-009507513-2204USA006030: US-009507513-2204USA006215: US-009507513-2204USA006070:
Mom noticed red raised rash to arms and legs about 5 hours after vaccine. Spread to face today. Rash - 3/17/10 spread to face 3/18/10
Extreme joint pain in my feet in my back, shoulders, and feet for 3 days after shot.
Approximately 2.5 hours post vaccination, patient felt extremely dizzy and nauseous. Patient was transported to hospital by ambulance for further evaluation.
Patient received FLUZONE IM in deltoid muscle and PNEUMOVAX 23 SQ on 9-28-11. On 9-30-11 the patient returned to pharmacy complaining of swollen lymph node in axilla area, pain throughout arm and erythema at site of PNEUMOVAX injection. No temperature. Patient advised to visit doctor. Patient received cephalexin from MD and skin is improving by 10/3/11.
Received first Pfizer vaccine (LOT#: EW0179) at 1457 ON 4/27/21. Patient alerted EMT. Patient stated that she felt like she was having an anxiety attack. EMT took patient vital signs at 1520. BP: 130/70, pulse: 90, O2: 99%. Patient stated that she has constant anxiety attacks. EMT asked patient to stay an extra 15 minutes for observation. Patient agreed to stay longer. EMT took second set of vital signs at 1531. BP: 130/80, pulse: 83, O2: 100%. Patient completed observation time. EMT reassessed patient. Patient stated that she was feeling a lot better. Patient left vaccination site with husband at 1535 unassisted with a steady gait.