chrisvoncsefalvay/vaers-outcomes huggingface dataset:
this spontaneous report as received from a consumer (patient's daughter) refers to an 85 year old female patient who was enrolled in a  patient support program. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX injection (strength, dose, route of administration, indication, lot # and expiry date unspecified). No concomitant medications were reported. The patient developed shingles on an unspecified date after vaccination. The outcome of the event was unknown. The reporter also stated, the patient was revaccinated with ZOSTAVAX a year after the first dose (date unknown). No adverse effects were reported after the 2nd dose.The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there is no patient and physician's contact information and we could not do follow up with them.
After receiving 1st dose of the pediatric pfizer vaccine, pt stated she felt light headed. We had her sit down and drink water and had her feet elevated. BP was measured at 86/59. Pt stated that her headache was worsening, and paramedics were called. Paramedics stated she was fine and to have some ice cream and was sent home.
Patient states the evening of her shot she developed a fever and chills. The next morning a rash had developed about 2 inches in diameter and lasted for approximately 1 week.
Shoulder and forearm ache and pain; Shoulder and forearm ache and pain; This is a spontaneous report received from a contactable consumer or other non hcp.A 86-years-old male patient received bnt162b2 (COMIRNATY,Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 23Feb2021 14:00,at the age of 86 years old,as Dose number unknown,single for covid-19 immunization.Medical history included none from an unknown date and unknown if ongoing.There were no concomitant medications.  The patient experienced shoulder and forearm ache and pain, shoulder and forearm ache and pain on 24Feb2021 03:00.The patient had not received any other vaccine in 4 weeks.The patient had not received any other medications within 2 weeks.The patient was not diagnosed with covid prior vaccination and not tested post vaccination.The patient didn't receive any treatment for the event.The patient reported no allergy.The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
flu; Initial information received on 20-Dec-2021 regarding an unsolicited valid  serious case received from a consumer non health care professional under reference number: US-SA-SAC20211222000641.  This case involves an unknown age and unknown gender patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There was be no information on the batch number for this case; Sender's Comments: This case concerns an unknown age and unknown gender patient who experienced influenza (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
my tinnitus has at least doubled in intensity / constant and does not come and go; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 11:15 (Lot number: EN6202) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "minor tinnitus" (unspecified if ongoing), notes: since teenage years; usually at times when extremely tired or stressed; "extremely tired" (unspecified if ongoing); "stressed" (unspecified if ongoing); "pain" (unspecified if ongoing); "bothersome" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Niacin, reaction(s): "known allergies", notes: oral tablet. The following information was reported: TINNITUS (non-serious) with onset 18Mar2021 15:00, outcome "not recovered", described as "my tinnitus has at least doubled in intensity / constant and does not come and go". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Prior the vaccination, the patient's tinnitus (mild) and it symptoms would come and go. A pain, yes, bothersome, not usually. Its symptoms where annoying, but it was not very troublesome and was very manageable. It was usually at times when the patient was extremely tired or stressed. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was reported that since the patient got the first Pfizer injection, her tinnitus has at least doubled in intensity; and was constant and does not come and go. The patient's second Pfizer injection was scheduled on Friday (as reported) and he would like to know if he should go through with it or put it on the back-burner for a couple of more weeks.  No follow-up attempts are possible. No further information is expected.
Been in and out of Hospital since 09/05/21-09/27/21 and again on 10/03/21-10/07/21 and again on 10/12/21 for a Rash from head to toe - Front and Back of Body since receiving the 3rd Booster Pfizer shot.   Was absolutely fine before the 3 rd booster shot . Have run into problems with being septic and my Type 2 Diabetes sugars elevating into 500-900  and my Potassium and Magnesium being severely low that my AICD may go off
Chief Complaint: SOB.  pt was COVID tested 10 days ago and tested positive for it. He ten tested negative again as of 2 days ago but has had persistent N/V, SOB, and fever.  Pneumonia due to COVID19- airborne isolation. Zinc, Singulair, Lovenox. Currently requiring 3L NC. Start dexamethasone, remdesivir. discharged today to home.
Received Varicella vaccine-R.t. upper arm on 10/24/17 after 24hrs-mild redness at site, mild sore 10/26/17 large inflamed area 12cm x 7.5cm; with 6.5cm x 2cm firm area with rows of blisters. No fever.
high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the fourth of eight reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter, drug, events, and different patients
pt recv vax 20FEB97 & on 27FEB97 pt devel a very mild rash on stomach, cheek & back w/ 5 to 10 lesions;
Hospitalization: 4/1/2023 - 4/4/2023 (3 days) Presentation to the ED: SOB.  COVID + date: 4/1/2023 Treatment: remdesivir, steroids,    Discharge to: home.   013L20A 1/19/2021 031L20A 2/16/2021 041J21A 12/17/2021
After receiving vaccination my eyes caused me issues.  The gel from inside my eye torn loose and has caused an enormous amount of floaters, I had intense pain in my eyes and head aches.  I did  follow up with an ophthalmologist immediately. .
Child presented to Urgent Care on 4/20/22 for ear pain.  Pulse was 130 -140 (persistent)  Mom stated child had one dose of vaccine at their primary care provider in January and developed chest pain a few days later.  Never evaluated previously.  Referred child to primary care provider for more complete evaluation.
05/25/06 at 1310 pt went to the Emergency Room for eval of Right Arm (deloid) where tetanus and pneumovax given on 05/23/06.  Patient complained of onset fever on 05/24/06 evening.  Site appeared to be erythema, warm to the touch, but muscle tissue soft otherwise with limited ROM secondary to pain per ER report.  Sensation intact, motor intact, no vascular compromise and tendon function normal per ER report.  Patient clinical impression was 1)Soft tissue localized reaction 2nd to immunization. 2)fever 2nd to immunization.   05/26/2006 Contacted mother of patient, are not as red - possible bigger in size, but patient is moving more.  Overall better.  Fever in evening os 5/25 was 101.7 AX but goes down with medicine.
initial fatigue, headache, brain fog for approximately 4-5 days . Severe muscle cramping and pain, immobility of injection arm 4 days after shot.
6 hours after immunization, patient projectile vomited and stopped breathing. Went to Hosp. 2/4/09-records received for DOS 11/17/08-presented with C/O vomiting episode, limp, pale.
Pt reported minor itching/hives in her arms and back after 15 minutes of receiving the vaccine. Pt was given diphenhydramine IM 25mg Denies SOB, chills, or trouble breathing. Will continue to monitor.
PT was given smallpox vaccine and had a robust reaction. Original vaccination site measures at 2x2 and satellite lesions at 3mm x 3mm. PT vitals were taken and normal . Pt also placed cayanne pepper on smallpox site as a home remody. PT is being monitored.
Atrial fibrillation started,  one hour after vaccine. Rushed to ER, Electrical Cardioversion given Experienced Vertigo, 18 hours after vaccine.
It looks like varicella virus on my arms and legs; German measles on my back and stomach; This is a spontaneous report from a contactable other health care professional (nurse) reported for herself. A 59-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), intramuscular, administered in right arm on 07Jan2021 at 14:30 (at the age of 59-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included food allergy (known allergies: Shellfish) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) and vitamin taken for an unspecified indication, start and stop date were not reported medications received in two weeks. The patient previously took iodine (Known allergies: Iodine) and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Facility type Vaccine at workplace clinic. On 13Jan2021, the patient experienced it looks like varicella virus on arms and legs and german measles on back and stomach. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: negative (Nasal Swab). Adverse event resulted in Doctor or other health care professional office/clinic visit. Treatment include Hydrocortisone cream. The outcome of the events were not recovered.  Information on lot number/batch number has been requested. Follow-up attempts completed. No further information expected.
Child received DTaP, IPV, MMRV on 8/17/07 - on 8/23/07 began breaking out with what looked like varicella. Broke out on 8/23/07; 8/24/07 was very irritable, temp 101 - starting to scab. On 8/24/07, is recovering. Pt had generalized varicella like event; chicken pox too numerous to count.
POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023.; This spontaneous safety report, with reference number: 2023SA240546  (Inquiry number:01716271 ) was received by the partner on 03-AUG-2023 and forwarded on 07-AUG-2023, from a health professional.    Due to the nature of the event, the causality between the event "POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023." and Vaxelis was not applicable.   This case is linked to other temperature excursion cases: MCM-005121, MCM-005127, MCM-005135, MCM-005136, MCM-005138, MCM-005140.   Further information is expected.
c/o headache, slight neck stiffness, moderate diaphoresis, difficult breathing (reported, not observed). .3ml 1:1000 Epinephrine given. Refused transport to hosp @ 2:00pm, walked out, no distress noted.
Injection site pain, swelling and rash.  Chills with sub normal temperature of 93.2, sick head ache , metallic taste in mouth, odd smell to urine.
This spontaneous report was received from a registered nurse and refers to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-JUN-2016, the patient was vaccinated with improperly stored VAQTA (lot # L048456, expiration date: 25-MAY-2017; dose and route of administration were not provided). On the same day, the patient was also vaccinated with DAPTACEL and ACTHIB. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt given influenza vaccination intranasally and immediately developed a bloody nose.  Bleeding controlled with direct pressure after 10 minutes.  Per patient this is his intranasal immunization.
102 degree fever (for 10+ hours), migraine, body aches, chills, nausea  Treated with rotating Tylenol and ibuprofen for 24 hours
Flu vaccine administered 10/19 in (L) deltoid. On Sunday 10/23 patient notice a red, raised pimple-like bump near site of vaccination. Put NEOSPORIN on it and got better. Patient came to pharmacy where administered on 11/3/12 to show RPh a dime size, red, scaly patch of skin near administration site.
Patient first had lip tingling  5 minutes after vaccination, but no changes in respiration. Patient began to develop hives 2 hours after vaccination.  She came down to pharmacy.  She was given 1ml of diphenhydramine 50mg/ml.  Measurements of her blood pressure yielded very high readings.  Called EMT due to high BP readings.
Patient was given HPV vaccine at 10:00 a.m.   Patinet stated she was nausated.  She did vomit.  She did not pass out,  Then she stated she felt better after she vomited.  About five minutes she stated she felt faint again.  She wa pale.  Pt dropped B/P to 84/62.   Layed patient on exam table.  Started IV.  Called ambulance.  Pt stated she began to feel better soon after IV fluids were started.  Paramedics assesed patient.   Stated there was not need to tke patient to ER unless patient wanted to go. Patient refused to be taken to the ER.  Stated she was feeling better.  Ate some crackers.  Patient remained in the clinc for 30 minutes.  Patient was discharged/  BP 118/83.
Dysmenorrhea - Lasted for 16 hours of contractions to pass large clotts. Went to ER as pain was getting worse
Fever of 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99 degrees) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (Fever of 99 degrees). At the time of the report, PYREXIA (Fever of 99 degrees) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090264, US-MODERNATX, INC.-MOD-2021-090279 (E2B Linked Report). This case was linked to MOD-2021-090387 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090264:Husband dose 1 case US-MODERNATX, INC.-MOD-2021-090279:Husband dose 2 case
Woke up in the middle of the night with strong chest pain. Considered going to the ER, but the pain subsided within about 10 minutes. No issues since then.
Slightly elevated temperature; Onset within 8 hours: Fever up to 101 Fahrenheit; Extreme chills; Strong joint and muscle pain; Strong joint and muscle pain; Persistent headache; Nauseating; Dizziness; Sweats; Debilitating fatigue; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 13Apr2021 at 17:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included recently diagnosed with high blood pressure but low end of spectrum and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included metoprolol succinate (METOPROLOL SUCCER), esomeprazole sodium (NEXIUM) and calcium (CALCIUM SUPP), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in left arm on 23Mar2021 at 17:30, as a single dose for COVID-19 immunisation. The patient previously received erythromycin (MANUFACTURER UNKNOWN, for unknown indication on an unknown date and experienced drug allergy. On 14Apr2021 at 01:15, onset within 8 hours, the patient experienced fever up to 101 Fahrenheit, extreme chills, strong joint and muscle pain, persistent headache, nauseating, dizziness, sweats and debilitating fatigue. It was reported that the duration was two days. On 16Apr2021, third day, the patient had slightly elevated temperature, headache, sweats and light fatigue. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the reported events. The clinical outcome of the events fever up to 101 Fahrenheit, extreme chills, strong joint and muscle pain, nauseating and dizziness was recovered on 16Apr2021, after the duration of 2 days, while that of headache, fatigue, sweats and slightly elevated temperature was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Info has been received from an LPN concerning a 37 month old white female with no medical history who on 12/2/05, at 15:50, was vaccinated, SC in the left thigh, with the 1st 0.5 ml dose of varicella virus vaccine live (lot 651174/0422R). There was no illness at the time of vaccination. The LPN reported that on 12/6/05, the pt developed 12-20 vesicular lesions on her chest and back (mother though daughter had broken out in chickenpox). Unspecified medical attention was sought, but no lab/diagnostic tests were performed. No other symptoms were noted. In 12/05, the pt's vesicular lesions resolved. Additional info is not expected.
I received the live shingles vaccine administered by the store pharmacist, and the next day experienced shingles on left side of face, neck, hand, chest wall and arm. I received antiviral med from APRN and the condition cleared in 10 days. A chronic itch continues on left trunk/chest wall.
Sharp pain left arm starting the morning of Dec 19th that worsened throughout the day, limiting active range of motion. Fever started in the late morning, and by that evening my temperature was 102.7. By the morning of the 20th my fever has resolved. L arm soreness improving but not gone, and still feeling fatigued throughout the day.
10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours later (03:30 the next day) fever up to 102, skin felt on fire all over my body, gi cramps, mild intermittent cough, myalgias, fatigue, extreme headache behind my eyes, occiput, and jaw pain, rigors.
Not acting like usual self, lethargic, irritable, inconsolable crying, swelling at injection site, high fever.
My left knee became non weight bearing and swollen. I got up in the morning and couldn't put weight on it.
Kinrix administered to a 10 months-old; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th December 2022, unknown after receiving Kinrix and Kinrix 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: 16-Dec-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter told that it would be better to follow-up by phone than by e-mail. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Vomited twice in 2 hours could not eat headache fatigue 3 days ate very little because did not feel like eating Rash on right behind check and down a little bit on thigh very red painful and swelling I am on SMZ-TMP DS Tab 800-160 twice a day rash still there but not as painful. Fever as high as 102.7 for several hours on 01/03/2021 then ran in the 101.5 range for 01/04/2021, then on 01/5/2021 it ran in the low 100's. It is getting better every day.
Pt w/hx of 3 previous febrile seizures w/o sequelae had febrile seizure;
Extreme pain in both of my arms that went up into my neck and head extremely rigid neck pain unable to even move without crying out.
The pt developed dermatitis medicamentosa post immunization. Treated with Benadryl.