chrisvoncsefalvay/vaers-outcomes huggingface dataset:
oral blisters/sores mainly on tongue; oral blisters/sores mainly on tongue; 12Sep2021: Fluzone Quad/ 12Sep2021: Pfizer; This is a spontaneous report from a contactable consumer (patient herself). A 29-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FE3590; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 03Oct2021 11:30 (at the age of 29-years-old) as DOSE 2, SINGLE and patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: 301308A; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 12Sep2021 11:30 (at the age of 29-years-old) as DOSE 1, SINGLE both for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient had also received the influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), via an unspecified route of administration on 12Sep2021 (Batch/Lot number was not reported) as a SINGLE DOSE for immunization. Medical history included COVID-19 from Jan2021 to an unspecified date. Other medical history: COVID-19 at beginning of third trimester of pregnancy in January 2021. Severe preeclampsia resulting in hospitalization, emergency c-section 3 months early. There were no concomitant medications. Patient had not any known allergies. Patient did not any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient experienced oral blisters/sores mainly on tongue (oral mucosal blistering and glossodynia) on 12Sep2021 14:30. On same day patient had 12sep2021: fluzone quad/ 12sep2021: pfizer (product use issue). Patient did not receive any treatment for adverse event. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on Jan2021. Since the vaccination, patient has not been tested for COVID-19. The outcome of events oral blisters/sores mainly on tongue was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. In approximately 2015, reported as on multiple unspecified dates ranging from 15-OCT-2015 to 06-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot# L011846, expiry date 16-JUN-2017; dose and route of administration were not reported). There were no concomitant therapies reported. 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.
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No concomitant medication information was provided  No treatment product information was provided   Reporter did not allow further contact
breaking out in a lone shingle on my trunk/suspected vaccination failure; breaking out in a lone shingle on my trunk; mild itching; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   Additional patient notes included had received the Merck single dose vaccine in 2020.   On an unknown date, the patient received Shingrix and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: breaking out in a lone shingle on my trunk/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: breaking out in a lone shingle on my trunk) and pruritus (Verbatim: mild itching).  The patient was treated with hydrocortisone (Hydrocortisone Cream). The outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pruritus to be related to Shingrix.   Additional Information: GSK receipt date:12-Oct-2023 The patient received Shingrix in 2021 and recently went to a new practice and was given both the high-dose flu vaccine and Pneumovax-20 in a single day. The patient's body responded to the double dutch vaccines by breaking out in a lone shingle on the trunk no nerve pain, mild itching, controlled with hydrocortisone topical cream. All this to say that Shingrix works. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to influenza vaccine.
She has been extremely, extremely ill; red blood cells they are very low; white blood cells have taken over; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age: 86; Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the second vaccination and since then she has been extremely, extremely ill and was told that the patient is not going to make it have been told her that is due to the vaccine because there are issues with her red blood cells they are very low and her white blood cells have taken over. The reporter added that it was life threatening as the patient is dying. It was further reported that the patient is in the hospital getting blood transfusion. The outcome of events was unknown.  Information on about lot/batch number has been requested.
Forty eight hours after receiving vaccine in the left arm, arm found to be red with slight swelling, slightly indurated but not painful. Treated for cellulitis by covering doctor with full resolution.
Patient was given dose from cracked vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient was given dose from cracked vial) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jun-2021 at 10:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient was given dose from cracked vial). On 13-Jun-2021, PRODUCT ADMINISTRATION ERROR (Patient was given dose from cracked vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter.  No treatment details were added.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Tiredness, hearing disturbance/loss, alteration of taste, hair loss/thinning, nasal/head congestion, runny nose, cough, eyes swelling with discharge and darkening around eyes-resembling bruising, vision disturbance-blurring- mainly right eye, general miserableness. sore itchy scratchy throat, odd smell in nasal cavity/sinuses.  Exaggeration of my seasonal allergy symptoms.
mediastinal, bilateral hilar, axillary lymphadenopathy; mediastinal, bilateral hilar, axillary lymphadenopathy; mediastinal, bilateral hilar, axillary lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Consumer-patient's husband) from legal division.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY MEDIASTINAL (medically significant), HILAR LYMPHADENOPATHY (medically significant), LYMPHADENOPATHY (medically significant), outcome "recovered" and all described as "mediastinal, bilateral hilar, axillary lymphadenopathy". The event "mediastinal, bilateral hilar, axillary lymphadenopathy", "mediastinal, bilateral hilar, axillary lymphadenopathy" and "mediastinal, bilateral hilar, axillary lymphadenopathy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy mediastinal, hilar lymphadenopathy, lymphadenopathy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax & exp pain lt eye, dizziness & h/a; pt took Ibuprofen;
Tuesday - small dot where needle went in, no swelling no redness to left thigh. Wednesday - 0900 - no redness, swelling. Went swimming and after mom noticed a nickel size spot at 0930. 1830 - 6 cm by 6 cm of red spot then mom called nurse advice line and informed to go to ER. 1900 - mom took pt. to ER. In ER - vitals done and MD stated no concern, and reaction localized.
Fever (104 degrees), chills (for more than 16 hours), loss of appetite, nausea, headache and body pain.
redness in her arm that went down to her elbows and her arm felt "fevered."; fever, chills, and her arm was sore; fever, chills, and her arm was sore; fever, chills, and her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (fever, chills, and her arm was sore), ERYTHEMA (redness in her arm that went down to her elbows and her arm felt "fevered."), PYREXIA (fever, chills, and her arm was sore) and CHILLS (fever, chills, and her arm was sore) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN (fever, chills, and her arm was sore), PYREXIA (fever, chills, and her arm was sore) and CHILLS (fever, chills, and her arm was sore). On 24-Feb-2021, the patient experienced ERYTHEMA (redness in her arm that went down to her elbows and her arm felt "fevered."). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (fever, chills, and her arm was sore), ERYTHEMA (redness in her arm that went down to her elbows and her arm felt "fevered."), PYREXIA (fever, chills, and her arm was sore) and CHILLS (fever, chills, and her arm was sore) outcome was unknown.            Action taken with mRNA-1273 was not applicable. Concomitant medication were not reported by the reported.
severe pain and spasm on both legs and feet.  both legs and feet were massaged.  the  pain became unbearable.  911 was called.   before their arrival the pain and spasm reduced a bit.   I was informed that there was no room at the ER.  I was advised to keep up the massaging and take tyledol.  I experienced the same pain and spasm on both legs and feet 24hrs later the following day, but not as intense as the first day.   I also had headaches for the first two days.  I also had muscular pain around the neck and both arms .  all pain have reduced, but are still lingering.
Patient received vaccination without noted reaction. On 04/10/2021 patient was transported to hospital via ambulance c/o shortness of breath. Patient was diagnosed with pneumonia. Patient refused admission and returned home with prescriptions for inhalers, steroids, and antibiotics. Patient claims on 02 at home prior to event. Patient also c/o left leg pain (unspecified) but has not sought medical care. Patient treated at Hospital. Patient was advised to follow with her PCP for leg pain.
sore arm; so much energy, she feels good; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (so much energy, she feels good) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (so much energy, she feels good). At the time of the report, PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (so much energy, she feels good) had resolved. Not Provided          No concomitant medications were provided by the reporter.   Treatment was not reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-046468 (E2B Linked Report). This case was linked to MOD-2021-046468 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046468:1st dose
Booster; COVID-19 confirmed by positive COVID-19 test/currently diagnosed positive with Covid-19, currently asymptomatic; COVID-19 confirmed by positive COVID-19 test/currently diagnosed positive with Covid-19, currently asymptomatic; This is a spontaneous report received from a contactable reporter (Physician) from medical information team for a Pfizer sponsored program.  An 80 year-old male patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 28Sep2021, outcome "unknown", described as "Booster"; ASYMPTOMATIC COVID-19 (medically significant) with onset 2021, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown" and all described as "COVID-19 confirmed by positive COVID-19 test/currently diagnosed positive with Covid-19, currently asymptomatic". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. The reporter wanted to know if the use of nirmatrelvir tablets; ritonavir tablets will require a prescription from a licensed healthcare provider and if Paxlovid has been studied in asymptomatic people.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
KINRIX was given into left arm and injecting the medicine seeped out around needle. Noticed defect in syringe after taken needle off.
Increased menstrual bleeding. Normal menstrual period lasts 5 days; currently on day 10.of menstruation with no end in sight.
Severe incapacitating vertigo, vomiting intermittent sever headache, significant injection site pain
Approximately 5 minutes after vaccine given pt. became dizzy-c/o feeling faint-did lose consciousness briefly. Placed by staff in supine position w/ feet elevated-frequent VS.
start radiation for cancer; This case was reported by a consumer via call center representative and described the occurrence of cancer in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient was overdue for 2nd dose. The patient had trips and surgeries in last 6 months and due to that the patient did not received 2nd dose. It was reported that the patient was going to start radiation for cancer. The patient wanted to know if it was too late and if it was possible to take 2nd dose before radiation. The patient was advised to consult physician regarding 2nd dose.
Pt received Pediarix, Hib, PCV, and rotavirus vaccines on 11/6/08.  On 11/17 he was admitted for intussusception.  He was discharged 11/19 after successful reduction by barium enema.  11/26/2008 MR received for DOS 11/17-19/2008 with D/C DX: Intussusception.  Diarrhea. Pt presented to ER with 5 day hx of diarrhea, irritabily, ear grabbing, fever and decreased appetite and 1 day hx of vomiting everything eaten. En route to ER vomited, turned blue and appeared to have stopped breathing, but quickly recovered. Upon admission appeared dehydrated. initially thought to be AGE. Pt remained lethargic and unable to take po. IS dx by X-ray and US.  Reduced by barium enema with immediate improvement in pt condition.
Initial unsolicited report received from consumer (patient's mother) via social media on 22 August 2016. This case is linked with case 2016SA157332, 2016SA158486, 2016SA158504 and 2016SA157319 (same social media report). This case involves a male patient (age not reported) who was vaccinated with a dose of DPT (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination the patient developed high fever, vomiting, diarrhea and high pitch screaming. Lab data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Physician diagnosed tendinitis in upper right arm near injection site. severe pain when lifting right arm. flexor patch did not alleviate pain. day two of oral nabumetone. 11/25/09 Medical reocrds received for date 11/11/09 and 11/16/09. DX:tendonitis Pt. c/o arm pain from vax x1 month ago. Assessment: Shoulder pain rt. ant. deltoid, myalgia rt arm(+), ROM decreased, arm acutely tender w/ palpation. Phone call from pt. 11/12 stating no relief in arm pain.
It's starting to get annoying now; terrible ring in my ear for 3 days; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events terrible ring in my ear for 3 days, it's starting to get annoying now, a sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011L20A) via unknown route for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced the event(s) terrible ring in my ear for 3 days,On an unknown date, the patient experienced the event(s) It's starting to get annoying now, a sore arm.  Treatment details included Patient reports using ear drops for tinnitus called Simalasan starting today 09Feb2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, terrible ring in my ear for 3 days, it's starting to get annoying now, a sore arm was unknown.
No adverse reaction. Patient notified, Vaccine given was Moderna bivalent, patient was given 0.25mL of Moderna Bivalent booster dose.
fatigue for 1-2 days. Then had R posterior thigh pain for 2-3 days during the week of March 22, denies SOB, chest pain, leg swelling. Symptoms resolved  Narrative:
Information has been received from a registered nurse concerning herself, a 70-year-old female, with a history of muscle weakness caused by PRAVASTATIN who on 17-OCT-2008 was vaccinated with ZOSTAVAX (Oka/Merck), subcutaneously.  Concomitant therapy included AGGRENOX and VYTORIN.  The nurse reported that she received improperly stored ZOSTAVAX (Oka/Merck) and developed an injection site adverse reaction.  ZOSTAVAX (Oka/Merck) was stored in the refrigerator for 18 hours prior to the receiving the vaccination.  Within 6 hours of receiving ZOSTAVAX (Oka/Merck) the nurse developed a tender, raised, warm, red area at the injection site.  The area was described as 2 inches in diameter and raised C2BD inch in height.  As of 22-OCT-2008, the swelling had gone down and the area was still tender and red.  The red area had decreased to the size of a quarter.  At the time of reporting, the patient was recovering.  No additional information is available.
Patient experience a pain in face similar to trigeminal neuralgia. His son is an EENT specialist and he said that could have experienced a slight case of the shingles. Patient said he wanted this reported.
Information has been received from a physician's assistant concerning a 13-15 year old female who on 08-JAN-2009 was vaccinated with the third dose of GARDASIL, and lost consciousness. It was also reported that the patient had a sinus infection. The patient sought unspecified medical attention. On the same day, the patient recovered. No further  information is available.
This spontaneous report was received from a pharmacist and refers to a currently 39-year-old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot number and expiry date were not reported). No concomitant therapy was reported. On an unknown date, titers drawn with blood work showed no immunity measles, mumps, and rubella. On an unknown date, the patient received another dose of M-M-R II. The patient's outcome was not reported. Relatedness between the adverse events and the vaccination with M-M-R II was not reported. Additional information has been requested.
Severe headache, fever, body aches, arm pain, numbness in hand extremity, dizziness, nausea and sometimes blurry vision.