chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, regarding to a currently 11-year-old male patient. As part of his past medical history, the reporter mentioned that the patient was healthy, immunocompetent and fully vaccinated. There was no drug reactions or allergies and no concomitant medications. It was specified that the patient had never chickenpox and had no a prior history of herpes zoster or herpes zoster ophthalmicus. On 27-JUN-2008, 23-AUG-2011, and 09-DEC-2012, the patient was vaccinated with either PROQUAD or VARIVAX lot number reported as "16902Z", for prophylaxis (also reported as vaccine) (strength, dosage schedule, route of administration and anatomical location were not provided). The physician reported that he was uncertain which vaccine was administered. The reporter mentioned that this uncertainty was due to a clerical error from switching from paper documentation to electronic documentation. On an unknown date, the patient experienced meningitis (neck stiffness, photophobia, headache, tremor) and was admitted to hospital on 09-FEB-2019. There were various unspecified studies performed, included a Cerebrospinal fluid (CSF) analysis, which sample was collected on 12-FEB-2019, and the results were: Protein 115 (units not provided), Red Blood Cell (RBC) count 7 (units not provided), Glucose 58 (units not provided) and White Blood Cell count (WBC) 635 (units not provided) and the varicella zoster virus Polymerase Chain Reaction (PCR) test was positive. It was reported that the patient did not experienced a rash at the injection site, following the vaccination; that there was no rash, no encephalitis, no pneumonia; that the patient did not have recent varicella zoster virus (VZV) exposure to chickenpox or shingles. It was stated that the physician would like to do a genotyping in order to see if the patient's meningitis was caused by the community or the vaccine strain that he received. At the time of the report, the patient was recovered and receiving valacyclovir hydrochloride (VALTREX) as part of the treatment given. The outcome of varicella virus test positive was not provided. The causality between meningitis and varicella virus test positive, and PROQUAD was not provided. The causality between meningitis and varicella virus test positive, and VARIVAX was not reported. Upon internal review, meningitis was determined to be medically significant.
Fever; General flu like symptoms; This is a spontaneous report received from a contactable consumer, for patient. A 52-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and the patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 11:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient medical history included multiple sclerosis (MS). The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had taken concomitant medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 07:00, the patient experienced fever and general flu like symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events fever and general flu like symptoms were resolved on an unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderna vaccine was stored in lower temperatures than what was recommended. Moderna confirmed, vaccines are viable.
Symptoms of Lower Back, Pelvis, and Bilateral Thigh pain and Head Ache began after the Influenza vaccine. Patient went to ER @ 7:00 PM. Patient has a history of mild Guillain Barre after an Influenza Vaccine in 2017 but has received annual Influenza vaccines each year since 2017 without complications. Patient was examined by MD who ordered Laboratory studies with unremarkable results. Patient was discharged home and instructed to return to the ER if she developed weakness. Patient
On 02/02/2002, given tetanus in ER. About two hours later, developed slightly pruritic examtham (2-5mm) on lower extremities. On 02/03/2002, nausea. On 02/04/2002, in ER for abdominal pain. Noted to have blood in urine. Per follow up: Pt did not recover. Still has proteinuria. Pt still has hematuria. 60-day follow up on 11/21/2003: "Vaccine recipient did recover from the adverse events that were reported for this vaccination.  Child has recovered." Annual follow up on 11/21/2003: "Vaccine recipient recovered from the adverse events that were reported for this vaccination.  Child has recovered."
PATIENT RECIEVED A VACCINATION THAT WAS KEPT IN REFRIGERATED TEMPERATURES FOR LONGER THAN 30 DAYS. NO ADVERSE REACTION REPORTED PER PATIENT INTERVIEW.
10JAN91 at 1PM child began running a T 101.6-102.6(AX) given Tylenol at 2PM. 5PM made a groaning sound & began seizuring. Seizure lasted about 3mins & child then vomited once. Pt taken to ER & T was 103.6(R). DX ear infect. 11Jan91 loose stools.
Tiredness, Headache, Muscle Pain, Chills, Joint Pain, Low Fever, Nausea, feeling unwell (over two days following the 2nd dose)
On 10/12/14 had a terrible headache around 5:30 to 7:30pm., loss of appetite, sweating and vomited about 5 times and had the chills.
PT RECEIVED VERY SEVERE CASE OF VARICELLA AFTER 2 DOSES OF VARIVAX VACCINE. THIS WAS BREAKTHROUGH ILLNESS. PT HAD OVER 500 BLISTERS VERY HIGH FEVER. VARICELLA REPORT IN CDRSS CASE ID 463809
This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 76-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "I developed acid reflux"; Amoxicillin, reaction(s): "affected ability to sleep". Vaccination history included: Bnt162b2 (Dose 1, Single, Right Arm, Lot# Not Provided), administration date: 08Feb2021, for COVID-19 immunization, reaction(s): "no adverse reaction". The following information was reported: INSOMNIA (non-serious) with onset 06Mar2021, outcome "recovered" (2021), described as "affected ability to sleep"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 06Mar2021, outcome "recovered" (2021), described as "I developed acid reflux". Therapeutic measures were taken as a result of insomnia, gastrooesophageal reflux disease. Additional Information: The patient did not receive any other vaccine in four weeks. The patient has taken diabetic medications in two weeks. The patient has no allergies. The patient did not have COVID-19 Infection prior vaccination and has not tested for COVID-19 since post vaccination. On 06Mar2021, approximately three days after the second Covid vaccination (also reported as 08Mar2021), the patient developed acid reflux, which affected his ability to sleep. The patient didn't know if the condition was caused by the vaccination (there was no such reaction after his first shot). Those problems went away after a course of Omeprazole. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
cut the HCP's middle finger; the rim (plastic collar) broke off / BROKEN FINGER FLANGE; This spontaneous report was received from a female nurse of unknown age referring to herself. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reaction or allergy were not reported.  On 29-JAN-2021, the patient was administering a dose of hepatitis a vaccine, inactivated (VAQTA) (25U/0.5ML, lot # T020442, Expiration Date: 26-JAN-2022, 0.5 milliliter, route and indication was not reported) in a prefilled syringe this am to her patient. While the patient was just finishing administration, as the plunger was pushed fully into the syringe hub, the finger flange fell off, cutting her middle finger (unknown depth of injury, just stated cut) before it fell to the ground. The patient was able to maintain the hub of the syringe and plunger and withdraw it out of the patient without injury to her patient or affecting the administration. The full dose of hepatitis a vaccine, inactivated (VAQTA) was injected without a problem. The broken syringe would be obtained and the finger flange that broke off would not be returned as it was thrown in the sharp's container. The patient had a small cut to her middle finger that did not need any attention other than to be cleansed and bandaged. The outcome of finger injury was not recovered. The causality assessment was not provided.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020442; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA002696:
Client was seen at Urgent Care Center with itching to throat and S.O.B.  They gave BENADRYL 50 mg & KENALOG 40 mg - then sent client to ER.  I called 6/10/08-at home-client states doing fine.
Narrative: 71yo patient receiving only mental health from facility died on 9/18/2021. Pt was receiving cancer therapy from outside cancer center. No mention of type of cancer however pt was concerned would be dying soon based on mental notes in chart. Pt also had received covid vaccines on 1/27/21 & 2/24/21 from outside hospital. Likely this death is not related given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
A report has been received from a Health Professional concerning a 9 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The reporter mentioned that patient experienced administration of expired FLUMIST on 09-Dec-2013. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious.
Within 20-25 minutes of receiving her first dose of the vaccine all of the tissues surrounding the right eye of my 7 year old daughter swelled dramatically and turned somewhat red. The white of the eyeball did NOT turn red. She did not touch her eye the entire time. It was very uncomfortable and shocking. The pharmacist advised me to take her to a pediatric eye specialist to make sure there was no damage/pressure residual behind her eye (later when the swelling eventually subsided). I did that. The pediatric eye specialist found it disturbing that the reaction was so strong in one eye. 4 days later there were still faint indications of slight edema. I am her mother and received my vaccines and booster with no obvious adverse effects so I had not anticipated this. I know sometimes genetics matters in these things. I would also like to note that all my children have always received ALL their childhood vaccines on schedule and never had a reaction like this before. We are not anti-vaccine. However, this reaction was immediate and dramatic and I am scared a little now honestly. I will try having her get the Johnson shot next because it is a different type. Thank you for your time and reading this. I am happy to give more details if needed.
Fever of 102 F for 2 days, followed by rash all over body on day 3.  Fever elevated to high of 104 F on day 3.
C/O DIZZINESS AND VOMITING WITHIN FIRST 15 MINUTES WHILE ON SITE. RESOLVED IMMEDIATELY AFTER VOMITING. NO OTHER SYMPTOMS AFTERWARDS EXCEPT FOR LEFT ARM SORENESS. DENIES ANY SOB, CHEST PAIN, DIB OR SWELLING OF MOUTH/TONGUE.
Right upper arm became extremely swollen and painful times 3 days which did not respond to heat or cold.
4 inch area around shot, site, red and painful.  Vomited night of shot.  Mother applied warm compress.  Redness and pain subsided after 1.5 days of Tylenol/Motrin/Benadryl schedule.
PATIENT'S DAUGHTER REPORTED PATIENT WAS HOSPITALIZED WITH SEVERE ALLERGIC REACTION, DAY AFTER VACCINE ADMINISTRATION
Information has been received from a physician concerning an approximately 12 year old patient who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL (therapy route and lot # not provided). It was reported that the patient passed out after being given GARDASIL, the patient sought unspecified medical attention. At the time of reporting, the patient's status was not provided. Additional information has been requested.
no adverse effect reported; inadvertently administered an expired dose of M-M-R II; This spontaneous report was received from a health care professional regarding a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT). On 18-JUL-2019, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency and route not reported) lot # N024697 and expiry date: 31-DEC-2018 (Lot No. N024697 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live], expiration date reported as 31-DEC-2018, but upon internal validation established as 13-DEC-2018) for prophylaxis (expired product administered). No adverse effects were reported.
Subclinical hypothyroiditis. No symptoms. I have never had elevated TSH. All other blood work fairly normal.  I do have heart flutters that are being evaluated as well. My TSH was 5.36 . I will go for more blood work in 6 weeks.
EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180501A expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced expired product administered. The outcome of expired product administered was not reported. This report was non-serious.
Pt brought to ER w/fever of 106, 3 hrs post/vax. Pt became delirious. By the next AM, pt had a seizure & was transferred to other hosp & admitted. Put on respirator & managed for encephalopathy & cerebral edema. MRI abnormal & pt w/RSV.60 day follow-up dated 11/01/00 states the pt is fully recovered, but MRI of brain shows some resigual abnormality.
Redness and swelling on arm at site of injection pain and ache in arm and legs,
Could not move his neck side to side; Was not feeling well/not his normal self; Rash on his foot/Rash on his head; Neck swelling; Getting dizzy/got so dizzy at work that he had to sit down; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Neck swelling), DIZZINESS (Getting dizzy/got so dizzy at work that he had to sit down), MUSCULOSKELETAL DISCOMFORT (Could not move his neck side to side), MALAISE (Was not feeling well/not his normal self) and RASH (Rash on his foot/Rash on his head) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Diabetes.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced SWELLING (Neck swelling) and DIZZINESS (Getting dizzy/got so dizzy at work that he had to sit down). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Could not move his neck side to side), MALAISE (Was not feeling well/not his normal self) and RASH (Rash on his foot/Rash on his head). At the time of the report, SWELLING (Neck swelling), DIZZINESS (Getting dizzy/got so dizzy at work that he had to sit down), MUSCULOSKELETAL DISCOMFORT (Could not move his neck side to side), MALAISE (Was not feeling well/not his normal self) and RASH (Rash on his foot/Rash on his head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: went way up than normal (High) went way up than normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. Treatment included some antibiotic cream   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received had no new information recorded
Dizziness, short breath 15 min after the shot. Arm discomfort the next day.
31 Oct: Normal soreness at injection point 1 Nov: Fever (100-101), extreme pain in arm, limited mobility.  Fever and pain treated with ibuprofin 2 Nov: Fever (100-101), extreme pain and redness in arm, limited mobility.  Fever and pain treated with ibuprofin and acetaminophen. 3 Nov: Fever (100-101), moderate pain in arm. Red streaks projecting down arm from injection point. Fever and pain treated with ibuprofin and acetaminophen. 4 Nov: Mild pain in arm.  Red streaks receding.  No medication taken. 5 Nov: Mild pain in arm.  Red streaks receding.  No medication taken. 6 Nov: No symptoms
Widely scattered what-looks-like faded welts on his torso and upper arms.  Not itchy or painful at all. No treatment recommended.
Right Arm indurated about 10 inches warm with excoriation's. Given Prelone syrup in urgent care center. Advised to use cool compress and F/up with MD on Monday.
After 8 days I started feeling a headache I took ibuprofen then I felt numbness of my mouth and my right eye would not fully close only half way, my mouth started drooping sideways when I ate and swallowed food, my throat felt strange the liquid like water would come out a little. My eyes burned, predominately my right eye.
Within minutes of receiving Pentacel and Varicella in left arm, child developed localized urticaria---pink papules and confluence and edema near sites of injections to left arm. (+) pruritus. No trouble breathing. No trouble swallowing. No lip or tongue swelling. Diphenhydramine (12.5mg/5mL) 10 mL provided. Called family that evening at ~7:30 pm and child was doing well with resolution of rash.  Vaccines were given the afternoon of 7/27 at ~3:30 pm.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with ZOSTAVAX at a hospital as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2010, the patient was treated a medical services facility for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
The injection site is hot to the touch. It?s red, swollen,  and rash like all around.  It itches a lot! It started about 4 days after the initial injection.  I?ve put Neosporin and took Benadryl. I?ve spoke to the pharmacist and they referred me to this site to report it. The pharmacist also suggested topical Benadryl. It was also suggested to get a doctors opinion on getting the second dose.
Pt was dxed with allergic reaction just minutes post vax. Pt started to suffer numbness peripheral, blurred vision, tachycardia, fainting sensation, metallic taste. He was not hospitalized. He had no previous reaction from IZs. He was treated with Prednisone and was noted as having partial recovery.
Blood pressure and pulse rate went up and I felt woozy for a couple of hours, never dangerously high, but high for me. Then got flu like symptoms of headache, congestion of head, fatigue, chills, fever, muscle and joint pain, weakness walking. 2nd day arm fever, rash, hard knot, itching.
On 4/27/2011 complained he had arm pain since injection. Called again on 5/1/2011 and was seen by the APN. No signs of erythema, swelling, has not missed work.
Approximately 3 inch round, red circle around injection site. Area is  red, hard, and slightly sore.
At 2 hours after vaccine was administered patient had dizziness, nausea and weakness that lasted for about 2 hours,vital signs temperature 98.0, respriations 20, pulse 93, blood pressure 149/70. Blood pressure recheck 199/81, pulse 90. She was perscribed Benadryl as needed and sent home and returned to work the next day.
Sore, painful: from left breast toward the middle of chest, heart area, was sore and painful.; Sore, painful: from left breast toward the middle of chest, heart area, was sore and painful.; booster; 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 received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 (Lot number: FH8020) at the age of 49 years as dose 3, (booster) single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (Dose 1, Lot: EV or EN 6208, handwritten, Expiration: Jun2021, Site: right arm, First and Second: hospital vaccine site), administration date: 22Mar2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "mild temperature"; Bnt162b2 (Dose:2, Lot: looks like EW0150, handwritten, Expiration: Jul2021, Site: right arm, First and Second: hospital vaccine site), administration date: 12Apr2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Tired", "achy". The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "booster"; BREAST PAIN (non-serious), CHEST PAIN (non-serious) all with onset 16Nov2021, outcome "recovered" (17Nov2021) and all described as "Sore, painful: from left breast toward the middle of chest, heart area, was sore and painful.".  Additional Information: AE(s) require a visit to Emergency Room and Physician Office  Follow-Up (04Jan2022): Follow-up attempts are completed. No further information is expected.