chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Area is swollen, raised red, itchy, warm: sore when touch cover with 1 inch x 3 inch bandage. Pharmacist at 1339 instructed patient to take Claritin and Hydrocortisone to area. If worsens, instructed to contact MD. She reports no problem in movement.
Information has been received from a medical assistant referring to a 3 month old female patient. No relevant medical history or concurrent conditions were reported. On 08-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTAEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
A nurse from a doctors office reported that a 9 year old female, with no previous medical history, experienced fever, cough and cough out blood, 4 days after she received FluMist vaccine on Oct 28 2005. On Nov 1 2005, the patient began to have fever. On Nov 2 2005, the patient felt worse and was coughing so much that she cough out a glob of blood. She was seen a physician who ordered that the patient use a mist tent. Per the reporter, as of Nov 10 2005, the patients mother has not called the doctors office nor has she brought patient back for follow up. The patients clinical outcome is unknown at the time of report. The reporter causality is not provided.
Right arm with swelling and erythema measuring 17.5 cm. No pain or fluctuance.
pt recv vax 29APR96 & 15MAY96 pt devel fewer than 10 lesions;tx w/med & the lesions dried up w/in 2 days;pt recovered;
Swollen tongue; Swollen cheeks; Swollen lips; This is a spontaneous report from a contactable other healthcare professional, the patient. A 56-year-old non-pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0177), via an unspecified route of administration in the left arm on 21May2021 at 17:15 (at the age of 56-year-old), as a single dose for COVID-19 immunization. Medical history included hypertension, hypothyroid, hyperlipidemia and migraine  from unspecified dates. The patient had a history of allergies to penicillin, atorvastatin calcium (LIPITOR),  rosuvastatin calcium (CRESTOR), and  terbinafine hcl (LAMISIL). The patient received unspecified medications within two weeks prior to the vaccination for years. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21May2021 at 17:15, the patient experienced swollen tongue, swollen cheeks and swollen lips.  Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included rapid (nasal swab) test on 19May2021 and the result was negative. 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. Therapeutic measures were taken as the result of adverse events which included diphenhydramine 25 milligrams x 2. The clinical outcome of the events, swollen tongue, swollen cheeks and swollen lips was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Immediately I had a slight tingling in my tongue and lips, back of my throat and within the hour, my arm was itching at the injection site. After the 45 minute ride home,  I had a rash at the injection site.  That night, I had  chill, fever, migraine with all things resolved by Saturday.
two allergic reactions; This is a spontaneous report from a contactable pharmacist via Pfizer-sponsored program. This is 2nd of two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534) via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the pharmacist reporting that two allergic reactions with two separate patients within 30 minutes of each other, same lot of vaccine, lot #EP7534. The outcome of the event was unknown. No follow up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021323765 same reporter and product / different patients
Rash. Small red/pink bumps all over body. Feels like small pimples. No fever.
Cl states he got a sudden fever felt very ill & heart rate went up 100-130 & was pounding. About 12 hrs after taking med. Took at 4:30 PM woke at 4 AM with sx.
This spontaneous report was received from a physician refers to a patient of unknown age. On an unknown date in November 2012, the patient was vaccinated with first dose of GARDASIL, (lot  number, expiry date and route was not reported). On an unknown date in April 2013, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). No adverse effect was reported. Additional information has been requested.
About 5 hours after the shot I was extremely lethargic, literally fell asleep in the middle of a conversation. I had muscle and joint pain, to the point of not being able to get out of bed. I had severe migraines. I had nausea and diarrhea as well.  These symptoms lasted from 5pm on August 30th through August 31st. When I woke up on September first I finally felt somewhat normal again.
First 5 days-fever, pain joints muscles lightheaded  Since to date- racing heart and pulse. Severe dizzy spells. Intense pain and tingling I n legs.
Soreness; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness) and HEADACHE (Headache). At the time of the report, PAIN (Soreness) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   Reporter did not allow further contact
No additional AE reported.; HCP reported VARIVAX was administered after a temperature excursion to patient. Date of administration: Jul 10, 2023. No further information provided. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): VARIVA; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not provided.  On 10-JUL-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, once (lot# W034708 has been verified to be a valid lot number, expiration date reported as 02-NOV-2024, but upon internal validation established as 01-NOV-2024) administered for prophylaxis (strength, exact dose, anatomical location, and route of administration were not provided). The varicella virus vaccine live (oka/merck) (VARIVAX) experienced temperature excursion under -13.4 degree Celsius for 15 minutes (Product storage error) with no previous temperature excursion. No further information provided. No additional adverse events (AEs) were reported, and no product quality complaints (PQCs) were reported.
The patient had a history of fainting that she state beforehand. About 2 to 5 minutes after receiving the vaccination she fainted. Her spouse was with her during the vaccination upon her request.  We watched her for 20 minutes to make sure she was ok and until she felt comfortable to leave. Tried to call patient on 12/22/20 (24 hours later). Was unable to reach her but left a message for her to call me back.
Difficulty breathing, temperature, congestion. Went to Hospital on 4/11/2018 at 3:00PM, while in the Emergency room the wall suctioned patient, tried a breathing treatment through an inhaler which did not help. Patient was admitted to the hospital that evening and was on oxygen support for 2 days along with wall suction every two hours. Was discharged on 4/15/2018.
I received the PFIZER Updated Booster Bivalent GLO446 on 2/18/2023 which is what I put in Item 4.  Your system would not allow me to select this option saying it was not available before 8/31/22.  I think you have a glitch.  Within 10 days of receiving the Pfizer Bivalent booster I had a sudden onset on ringing in my ears, intense pain in my right ear and constant pressure in my left ear, and dizziness.  I have been to my PCP, audiologist, chiropractor and am waiting to see an ENT.  I have been diagnosed with tinnitus. I have had an MRI of my head and am waiting for an mri of my upper cervical spine.
Patient always get really sick; Initial information received on 15-Nov-2020 regarding this unsolicited valid non-serious social media case from a consumer (patient) via Social Media.  This case involved a patient with unknown demographics who always got really sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient always got really sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  So, the patient had to stop it and rarely ever got sick and if the patient did catch something never very sick.   Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Red, swollen area at injection site and the surrounding area. The patient took Benadryl by mouth, naproxen, and is using warm compresses , which has helped with the symptoms.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 05-DEC-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had two temperature excursions: 24 and 48 hours respectively. The lowest recorded temperature was 34 (1.111111111 Celsius degrees). The highest recorded temperature was 47 (8.333333333 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt is 41 yo female, s/p full Moderna COVID vaccination: dose on on 1/11 and dose two on 2/8. Pt is an employee of this institution. Reports new onset of cough and congestion/runny nose on 8/3. Denies known exposure to COVID. COVID rapid test results positive on 8/4. Pt received casirivimab/imdevimab infusion on 8/5.
Itchiness on both arms, tongue strange feeling , pain on site of vaccine 30 minutes after vaccination. 7 days after vaccination, hardness on site of vaccine, redness,  very itchy.
herpes zoster; postherpetic neuralgia; flank pain; a cardiovascular event; hearing problems; Information has been received from a lawyer regarding a case in litigation and referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 09-DEC-2011, the patient was administered the zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot#, expiration date were not reported) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by health providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX): herpes zoster, postherpetic neuralgia, flank pain, a cardiovascular event and hearing problems. The outcome of these events was unknown.
Patient's wife called in mid March 2021 letting us know that the patient, needed to re-schedule his 2nd dose of Moderna Covid-19 vaccine - he had missed his scheduled 2nd dose date due to being hospitalized - doctors had thought he might need a defibrillator but then discharged him without one. Patient's wife called back on 4/16 to let us know that he passed away on 4/14.
Very high fever 105.9 called telemedicine dr. Who had him alternate Tylenol and ibuprofen and recommended a shower (2100). By 0330 temp was down to 103.8 . Temp kept coming down but ran a fever most of the day but not as high with alternating medication.
No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 12-JUN-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) prefilled syringe injection, lot # S026003, expiration date 17-OCT-2020 (exact dose and injection site were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026003; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA001137: US-009507513-2007USA001777: US-009507513-2007USA001778: US-009507513-2007USA001780: US-009507513-2007USA001781: US-009507513-2007USA001782: US-009507513-2007USA001783:
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient developed a case of shingles within 24 to 48 hours. The reporter was enquiring about what he should suggest to his patient about receiving 2nd dose and also if the dose administered to the patient given a case of the shingles to the patient, if so, what was the percentage chance of that happening. The reporter consented to follow up. This case had been linked to the case US2019186035, reported by the same reporter.
Arm swelling and itch from shoulder to elbow - not localized at site of injection - the entire upper arm was hot, red, swollen, and itchy. Resolved in 4-5 days.
Approximately 2 hours after receiving the vaccine, patient experienced nausea and temperature.  Lymph nodes in neck on left side enlarged constricting airway. "My mouth felt funny like when you get the shot at the dentist office". The temperature rose as high as 101 degrees and finally broke on Monday, June 23 around 3:00 AM.  She never sought medical attention although in retrospect believes she should have gone to the emergency room.  Today she is reporting continued tenderness and swelling of the lymph nodes as well as soreness at the injection site.  She has been tested for allergies and is sensitive to a number of allergens.  She has been advised to call her personal physician for evaluation today.
Information has been received from a pharmacist concerning a 66 year old female who on 24-JUL-2008 was vaccinated with a dose of PNEUMOVAX 23 (unspecified which dose, lot # not reported). On 24-JUL-2008 the patient experienced cellulitis. The patient had redness and swelling at the injection area. The patient sought an unspecified medical attention. She was treated with LEVAQUIN. It did not resolve and was further treated with AUGMENTIN. She was already in the hospital for another cause and this may have prolonged the stay. The patient recovered on an unspecified date. Follow-up information was received on 09-APR-2009 from pharmacist who reported that the patient was admitted to the hospital on 23-JUL-2008 for alcohol withdrawal. It was reported that the patient was discharged from the hospital on 26-JUL-2008. This is one of several reports from the same source. No further information is available.
Pt died one day after receiving Prevnar 20; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), administration date 14Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "had emergency appendectomy" (unspecified if ongoing), notes: 2 weeks prior to receiving a Prevnar 20; "diabetes" (unspecified if ongoing), notes: during the same 2 weeks. The patient's concomitant medications were not reported. The following information was reported: DEATH (death) with onset 15Jan2022, outcome "fatal", described as "Pt died one day after receiving Prevnar 20". Event took place after use of product. The patient underwent the following laboratory tests and procedures: investigation: normal. The patient date of death was 15Jan2022. The reported cause of death was "Pt died one day after receiving Prevnar 20". It was not reported if an autopsy was performed.  The lot number for pneumococcal 20-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: Apart from the plausible temporal relationship, the patient's death is considered unlikely causally associated to PREVNAR 20.  Recent surgical experience of an emergency appendectomy in the patient with underling diabetes may have played a more likely contributory role towards the fata event.  Further information such as complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: Pt died one day after receiving Prevnar 20
This spontaneous report as received from other health professional via company representative refers to a patient of unknown age and gender. Patient medical history and other previous drug allergic reactions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX vial (strength, dose number, route, lot number and expiry date unknown) subcutaneously. On an unknown date later, patient developed full blown shingles. The outcome of full blown shingles was unknown. The reporter did not provide the causality of full blown shingles to ZOSTAVAX. No further information provided. Additional information has been requested.
Patient received Pfizer COVID vaccine on 1/27/21 and 2/18/21. On 12/11/22, patient admitted from SNF to our inpatient facility intubated with a positive COVID test. Patient was admitted to our ICU intubated with acute respiratory failure with hypoxia and sepsis due to COVID, acute metabolic encephalopathy, and severe dysphagia. On 12/22/22, patient was extubated and transferred out from ICU to med/surg unit. As of today (12/15/22), patient is still admitted in the med/surg unit.
Headache; ache joints and muscles; ache joints and muscles; chills; sleep from 10-11 then tossed and turned and by 3am the adverse effects kicked in and have lasted all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 10:15 (Lot number: FF8841) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure. Concomitant medication(s) included: FLU, administration date 23Sep2021; LOSARTAN + HIDROCLOROTIAZIDA. Past drug history included: Demerol, reaction(s): "Allergy: demerol", notes: Known allergies: demerol. Vaccination history included: Bnt162b2 (dose number=1, dose lot number=EL3247,), administration date: 28Jan2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (dose number=2, dose lot number=EL3247,), administration date: 18Feb2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 28Oct2021 03:00, outcome "not recovered", described as "Headache"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 28Oct2021 03:00, outcome "not recovered" and all described as "ache joints and muscles"; CHILLS (non-serious) with onset 28Oct2021 03:00, outcome "not recovered", described as "chills"; INSOMNIA (non-serious) with onset 28Oct2021 03:00, outcome "not recovered", described as "sleep from 10-11 then tossed and turned and by 3am the adverse effects kicked in and have lasted all day". Therapeutic measures were not taken as a result of headache, chills, insomnia. Therapeutic measures were taken as a result of arthralgia, myalgia.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Yes. Other vaccine 4weeks product=Flu. Other vaccine 4weeks vaccine date=23Sep2021. Other medications in two weeks: Losartan/HCTZ 100/25. Adverse event: Headache, ache joints and muscles, chills. sleep from 10-11 then tossed and turned and by 3am the adverse effects kicked in and have lasted all day. I did take Advil for the aches. If treatment ae: no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Vaccine Facility information available.  No follow-up attempts are possible. No further information is expected.