chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; believe Shingrix has reactivated the virus in the geniculate ganglion; deafness/profound hearing loss in her right ear; affected facial nerve; affected vestibular nerve; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), geniculate herpes zoster (serious criteria GSK medically significant), deafness (serious criteria GSK medically significant), facial nerve disorder and vestibular disorder. On an unknown date, the outcome of the vaccination failure, geniculate herpes zoster, deafness, facial nerve disorder and vestibular disorder were unknown.   It was unknown if the reporter considered the vaccination failure, geniculate herpes zoster, deafness, facial nerve disorder and vestibular disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, Shingrix had affected her facial nerve and vestibular nerve in addition to profound hearing loss in her right ear. She believed that, Shingrix had reactivated the virus in the geniculate ganglion, which affected her nerves. The reporter contacted an attorney again. She was provided the address to the legal department. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event and laboratory test confirmation were unknown. This case had been linked with case US2019153169 reported by the same reporter.
Blood clot; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 02201176 (Agency).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot".  Clinical course: A Nurse Practitioner was asking for any information we have on a patient receiving the GARDASIL 9 vaccine after experiencing a blood clot after the COVID vaccine manufactured by Pfizer. The patient seems to be worried that the GARDASIL 9 vaccine may cause her to have a blood clot as well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event THROMBOSIS and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
The patient was given Moderna, but she was not yet 18 years of age. The patient did not have any signs or symptoms at the time of reporting.
a woman who received 2 doses of the vaccine and got covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (a woman who received 2 doses of the vaccine and got covid) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Spikevax. Past adverse reactions to the above products included No adverse event with Spikevax.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (a woman who received 2 doses of the vaccine and got covid). At the time of the report, COVID-19 (a woman who received 2 doses of the vaccine and got covid) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  It was reported that, woman who received 2 doses of the vaccine and got covid and felt like shit after getting covid.  No treatment medications was reported.   Reporter did not allow further contact
Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-354306, MOD-2021-355109.
2nd dose beyond approved interval; Pt may be got 0.1ml; gave a 2nd dose with faulty syringe and needle came off; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond approved interval), ACCIDENTAL UNDERDOSE (Pt may be got 0.1ml) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (gave a 2nd dose with faulty syringe and needle came off) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012S21A and 022C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy NOS. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETIRIZINE [CETIRIZINE HYDROCHLORIDE]) for Allergy NOS, OMEPRAZOLE for an unknown indication.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond approved interval), ACCIDENTAL UNDERDOSE (Pt may be got 0.1ml) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (gave a 2nd dose with faulty syringe and needle came off). On 27-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond approved interval), ACCIDENTAL UNDERDOSE (Pt may be got 0.1ml) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (gave a 2nd dose with faulty syringe and needle came off) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
got vaccine 12/23/20 then on 01/04/21 arm was swollen sore and hot to touch
Right eye neurologically closed, eventually opening and stayed 1/4 closed all the time; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 08Feb2021 at 12:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 18Jan2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. On 08Mar2021, about 30 days after the second shot of Pfizer for COVID, the patient's right eye was neurologically closed, eventually opening and stayed 1/4 closed all the time. The eye doctor referred the patient to a neurologist and the patient underwent a brain scan, magnetic resonance imaging (MRI) of the chest and a pulmonary exam and all came back clean. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 16Mar2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were taken as a result of the event which included treatment with pyridostigmine bromide (MANUFACTURER UNKNOWN) 60 milligram tablet twice a day to keep the eye open.  The clinical outcome of the event right eye neurologically closed, eventually opening and stayed 1/4 closed all the time was resolving at the time of the report.
This spontaneous report was received from a licensed practical nurse regarding a 14 year old patient of unknown gender. Information on pertinent medical history, concomitant medication and drug reactions/allergies were not reported. On 14-AUG-2017, the patient inadvertently received PROQUAD, lot# M037010 with expiry date of 22-FEB-2018,  0.5 ml, Subcutaneously for prophylaxis (frequency not provided). No adverse effects were reported. No product quality complaint (PQC) was involved.
I have allergies/ My Mom has same thing happen; allergy induced asthma/  My Mom has same thing happen; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age (mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The physician has allergies and allergy induced asthma. It started slowly and became worse. The physician had to take allergy pills and double the steroid inhalent. It's the middle of winter this never happens. The physician's mom has same thing happen and she had vaccine near the same time. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122699 Same reporter/product/event, different patient
nO ADDITIONAL ADVERSE EVENT REPORTED; consumer received the GARDASIL-9 vaccine while pregnant.; This spontaneous pregnancy report has been received from a nurse via a company representative, referring to a 21 years-old female patient. The last menstrual period was not reported. At the reporting time the patient had 16 gestation weeks. The pregnancy outcome was unknown. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-NOV-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U008897, expiration date on 16-MAY-2023 (anatomical location and administration route were not reported) for prophylaxis.  The reporter stated that the patient received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) while pregnant. No additional adverse events were reported.
took the shots, shingles kept coming back/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the 2 Shingles shots and the shingles kept coming back and coming back. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Child developed erythema and induration (area measuring greater than 50 mm) at injection site for DTaP. Did not show this to mother until 6 days after injection. Non-tender, warm to touch. No fever, seizures noted.
Full-body skin pain/burning without rash; Full-body skin pain/burning without rash; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 23Apr2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included environmental allergies from an unknown date. The patient had known allergies to erythromycin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D3) and krill oil (MANUFACTURER UNKNOWN); both taken for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 16:00, the patient experienced full-body skin pain/burning without rash. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events full-body skin pain/burning without rash was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Developed redness of left arm just below the deltoid. Dark red flat oblong non indurated area.
Pt recvd vax & 3 days later was found to be pos for hepatitis B surface Antigen;
DVT DEEP VEIN THROMBOSIS; BLOOD THINNERS AND FOLLOW UP CARE WITH PHYSICIAN. OUTCOME, PISAED OFF AND READY TO SUE.
hurting was felt during injection while using pre-filled pen; Initial information was received on 20-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care via voicemail.  This case involves a 49 year-old female patient who felt hurting during injection while using pre-filled pen (vaccination site pain), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) 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) not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient felt hurting during injection while using pre-filled pen (vaccination site pain) (Unknown latency) following the administration of INFLUENZA VACCINE.  At the time of the report, it was unknown whether the unknown medication was continued or discontinued. Additional information: the dosage, route, frequency, start date, indication, lot number and expiration date were not provided in the voicemail. Limited information obtained from the voicemail. No additional information at the time of the report.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from the event (immediately resolved afterwards).  There will be no information available on batch number for this case.
Redness, swelling & pain to upper left arm ongoing - applied ice pack with no relief.
I was watching TV and dozing on and off, when I was jolted upright by an instantaneous and sharp pain across my upper back. I has some tightness in my chest and my breathing became a little labored. The pain was extreme and I thought maybe it was a heart attack.  I called the local hospital and the person who answered the phone called the on -call doctor at my PCP's office, which is affiliated with the hospital. I was instructed to call the hospital back if I hadn't heard from the doctor within 20 minutes. The doctor called and I explained what at happened. By then the pain was slightly diminished. The doctor said she didn't know if it was related to the booster shot, and added that if it was a heart attack the pain would be constant. She said that if it got unbearable that I should come to the hospital.   The pain continued to diminish, but moved from my back to the area of my right lung (front and back). It took two hours for most of the pain to subside. I did not need to go to the hospital.
After receiving the vaccine I was okay, it wasn't until the next day that I got a sharp pain in my joints and lower back and I had a high fever of 103.6, this all lasted about 30 hours. I took Tylenol. I saw the doctor a few weeks later as the joint pain had not gone away all the way. The doctor gave me a steroid and that made it better.
No adverse event; PROQUAD was improperly stored on 15-DEC-2021 and administered to a patient; This non-valid spontaneous report was received from a nurse and referred to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date the patient was vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), (unspecified dose, frequency, route of administration, lot # T032149 has been verified to be a valid lot number, expiration date was reported and established as 20-MAR-2022, lot # U024508 has been verified to be a valid lot number, expiration date was reported and established as 02-FEB-2023, lot # U009261 has been verified to be a valid lot number, expiration date was reported and established as 19-SEP-2022, lot # U026794, expiration date: 26-FEB-2023, vaccination site was not provided) for prophylaxis.   It was reported that one dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), was improperly stored on 15-DEC-2021 and was administered to a patient. on an unknown date (product storage error). The vaccine was stored at a temperature of -8.1 Celsius (C) for a time frame of 8 hours and 35 minutes with no previous temperature excursion.   No product quality complaint (PQC) and no additional adverse event (AEs) was reported.   This case was considered non-valid due the lack of patient identifiers.   Follow-up information was received  from the nurse on 01-FEB-2022.  Demographics of the patient were provided. The case concerned a female patient of 2 years and 4 months old.   Concomitant vaccines administered were diphtheria vaccine toxoid, hib vaccine conj (TET TOX), pertussis vaccine acellular 5-component, polio vaccine inact 3v (MRC 5), tetanus vaccine toxoid (PENTACEL) and influenza vaccine (FLUZONE.)  On 23-DEC-2021, the patient was vaccinated with first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous route lot number U024508 (rHA) expiration date 02-FEB-2023 as prophylaxis.   The nurse reported that the freezer was found out to be out of range due to a digital data logger. The problem was corrected, however, the vaccine was administered before the problem was reported.
** Prolonged symptoms:             She reports that she recieved her 1st Pfizer COVID-19 vaccine on 8/30/21 from Pharmacy            Symptoms started that night with fever, body aches, chills, sweating, chest pressure, and loss of appetite            Fever has been running from 99.4-102.7 and has persisted. rest of symptoms have gradually resolved ;  Her fever finally resolved 9/8/2021            Denies CP, SOB, cough, sore throat, congestion, changes to taste/smell, N/V/D             She has been taking Tylenol and Motrin scheduled to help with symptoms, which did help             She denies any known recent COVID exposures
Severe Sleepiness... on going on 3rd day.. Blurred vision... on going 3rd day.... Diarrhea.... on going 3rd day
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 24th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and rash. On an unknown date, the outcome of the pain in arm and rash were recovered/resolved. It was unknown if the reporter considered the pain in arm and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a rash on her left arm for a week as well as painful to touch. The reactions disappeared after a week. The patient had a concern regarding 2nd dose of SHINGRIX. The patient stated that, she understand that there was a national shortage on SHINGRIX. She had been told that the pharmacy might not get their shipment until next January.
Breakthrough case admission after 3 vaccines Moderna 1/21/21 lot# 012L20A;  Moderna 2/18/21 lot# 004M20A;  Moderna 11/23/21 lot# 004M20A
pt recvd vax 13NOV95 soreness that evening;On Tuesday red; By 15NOV95 arm red, hot & tight;16NOV95 redness approx 6"x3" upper to inner lt arm;reports some itching today, w/low fever;area tight warm to touch
pt c/o dizziness, lightheadedness, and numbness in upper extremities. Pt transferred to stretcher.   Vitals signs: 740 BP 107/63, HR 52, O2 100%   Pt states fear of needles. Given water and ginger ale. 800 Vitals BP 108/67, HR 60, O2 100%   Pt states symptoms have subsided. RN provided education on calling 911 if symptoms resurface.   Patient discharged home.
4 to 5 hr p/vax pt noticed arm began hurting, swelling;erythema & induration from mild upper arm down to mid lower arm;localized erythema;
22AUG98 devel runny nose, T100, a little irritable;rash began on stomach, back, neck & face;maculopapular initially then becoming weeping vesicles;less than 25 total rx w/APAP & aveeno bath for itching;
Patient's wife came in and reported that the patient has suffered from chest congestion following his last immunization. She also claims that the same episode occurred last year after the same immunization. He had not suffered these symptoms when receiving the regular dose. Patient was seen by MD which informed him that his condition as a direct result from the immunization and prescribe cough medication.