chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Recurring shingles every 6 weeks for 3 episodes so far; Circumstance or information capable of leading to medication error; considering giving a third dose; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On 29-JUN-2022, the patient received the 2nd dose of Shingrix. On 29-APR-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix and not applicable after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Recurring shingles every 6 weeks for 3 episodes so far), circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error) and extra dose administered (Verbatim: considering giving a third dose). The outcome of the vaccination failure, circumstance or information capable of leading to medication error and extra dose administered were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 and 30-MAY-2023 The pharmacist was considering giving a third dose to the patient and called to ask for the information and explained wanted to review as the patient who was fully vaccinated with recurring shingles every 6 weeks for 3 episodes so far. The patient received 1st and 2nd dose of Shingrix on April 29, 2022 and June 29, 2022 respectively. The pharmacist was considering giving a third dose to the patient, which led to extra dose administered and circumstance or information capable of leading to medication error. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting The consent for follow up was not asked.
Bell's Palsy/facial paralysis on left side had occurred approximately 1.5 months after second Pfizer-BioNTech COVID19 vaccine.  Facial movement was recovering from full paralysis to nearly full movement in left half of face prior to date of adverse event (~1.5 months after "booster"/third Pfizer-BioNTech COVID19 vaccine).  Patient experienced degradation of facial movement, notably the eye/eyebrow area became much less mobile, and left eye droop.  The Bell's Palsy seemed to "relapse" in some areas that were previously recovered.
Pt received Jansseen vaccine on 03/30/2021. Pt presented to the ED on 1/5/22 with complaints of not feeling well overall. Pt noted that he tested positive for COVID on 12/26/21.
Outside dosing Interval (>42 days); A spontaneous report was received from a Consumer concerning a male patient of unknown age, who experienced outside dosing Interval (>42 days)/product dose omission issue.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 21 Jan 2021 intramuscularly  for prophylaxis of COVID-19 infection.    The patient is having difficulty getting the 2nd dose as the earliest appointment he can get is in April which put him beyond the recommended 28 days of getting the second dose and even beyond the 42 days after getting the 1st dose.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration, no vaccine administered, for mRNA-1273,  with no associated AEs
I haven't have a menstrual cycle since receiving the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 18:45 (at the age of 29-years-old), as a single dose for COVID-19 immunisation.The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021 at 00:00, the patient did not have a menstrual cycle since receiving the vaccine and pregnancy had been ruled out. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event did not have a menstrual cycle since receiving the vaccine was unknown at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 20:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation..   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, Chills, night sweats, severe pain in armpit area radiating into lymph nodes and breast adjacent to vaccination site.
VACCINATED (BOOSTER) ON 11/24/21. (PT HAS H/O COVID) 11/25/21 REPORTED INCREASED WEAKNESS AND MEMORY RECALL, PROGRESSIVE WEAKNESS AND DECREASED FUNCTIONALITY, TREMORS. 911 CALLED ON 12/1/21 AND PT TAKEN TO LOCAL ED
Initial and follow up information has been received from a physician and from a health professional and concerning a 35 year old male with no known drug allergies and no previous medical history who on 20-JUN-2008 at 12:00PM was vaccinated with a dose of PNEUMOVAX (lot# 659487/1960U) (route not reported) into the left deltoid at 12:00PM. The patient  had also been vaccinated with Tetanus vaccine in the other arm. There was no concomitant medication. The physician had indicated that the patient had experienced pain at the injection site from the PNEUMOVAX vaccine. The dose came from a single 5-dose vial. The pain had occurred a few hours after administration and resolved within 24-48 hours later. No further information is available. Additional information is not expected.
an expired Adacel vaccine was administered on 22-Jul-2019, no AE; Based on information received on 16-OCT-2019, the report previously considered as non-valid became valid: patient information reported  Initial information received on 24-Jul-2019 regarding an unsolicited non-valid non-serious case received from a pharmacist.  This case involves a 11 years old patient (143.2 cm and 45.351 kg) who received 0.5 mL expired dose (booster dose) of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine on 22-Jul-2019 lot number U5729AA, expiry date 21-Jul-2019 via intramuscular route in left deltoid.  It was an actual medication error due to expired vaccine used. The vaccine dose was repeated on 31-Jul-2019.  No adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow-up information received on 26-Aug-2019 regarding an unsolicited non-valid non-serious case received from a licensed practical nurse.  Vaccine details and event description updated.  Follow-up information received on 16-OCT-2019 regarding an unsolicited valid non-serious case received from a licensed practical nurse.  The report previously considered as non-valid became valid.   Patient details, date of vaccination, lot number and expiry date updated in field and narrative.
Extreme fatigue, sore throat, petechial rash to face and chest, loss of appetite.
pt devel fever approx 2 hrs p/immun; also anorexia & irritability; mom became concerned about 3PM when pt became increasingly lethargic; EMS called @ 5PM to transport pt to ER; t103 & very lethargic; pt shakey but no sz; difficulty w/balanc
did not receive the second dose of Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence did not receive the second dose of Moderna Vaccine in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Suspected COVID-19, Patient was assuming that she had Covid in December and was asymptomatic in December 2020.    On 10-Apr-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 did not receive the second dose of Moderna Vaccine. At the time of the report, did not receive the second dose of Moderna Vaccine had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test normal test showed immunity.         No concomitant medications were reported.  Patient was assuming that she had Covid in December and was asymptomatic. Her son and her husband had it at that time with symptoms.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above included Follow up received on 7-SEP-2021. Reporter details, Patient gender, Date of birth, pregnancy status, and date of administration of 1st dose was updated. Medical history was updated which was missed from initial document.
pt. recvd 2nd dose of M-M-R II AUG89.dx w/ mumps 16NOV90.
Patient fainted shortly after receiving. Sat in the chair, stood up, then sat down and fainted.  Patient had not eaten that morning.  Patient came to right away and was provided a drink and a snack and then felt much better.
DEATH; JOINT ISSUES; APPETITE ISSUES; OTHER HEALTH PROBLEMS; This spontaneous report received from a consumer via social media through a company representative concerned an elderly female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and at the age of 88, the patient had been in a hospital once before the vaccination. On an unspecified date, the patient was previously vaccinated with covid-19 vaccine ad26. cov2. s (manufacturer unspecified) (Dose number in series 1) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 01 total (dose 1) administered for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (manufacturer unspecified) (Dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (manufacturer unspecified) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total (dose 2) administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced joint issues, appetite issues, and other health problems (Dose number in series 2). On an unspecified date, the patient died from unknown cause of death due to the second Covid vaccine (Dose number in series 2). It was unspecified whether an autopsy was performed or not. It was reported as "After a few long weeks of joint issues, appetite issues, and other health problems I lost my healthy mom to the second Covid vaccine. At 88, she had only been in a hospital once before the vaccination." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of joint issues, appetite issues and other health problems was not reported. This report was serious (Death).; Sender's Comments: V0: 20220940060-covid-19 vaccine ad26.cov2.s-death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.; red big  knot on their left side hip; pain on the right side of their leg; swelled up to their buttocks; not been able to go to work; feel so bad; cannot stand on their leg for too long.; not been able to eat; not been able to go to work, eat or sleep for 6 days.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.), MASS (red big  knot on their left side hip), PAIN IN EXTREMITY (pain on the right side of their leg), SWELLING (swelled up to their buttocks) and IMPAIRED WORK ABILITY (not been able to go to work) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE, CELECOXIB (CELEBREX) and PREGABALIN (LYRICA) for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.), MASS (red big  knot on their left side hip), PAIN IN EXTREMITY (pain on the right side of their leg), SWELLING (swelled up to their buttocks), IMPAIRED WORK ABILITY (not been able to go to work), FEELING ABNORMAL (feel so bad), DYSSTASIA (cannot stand on their leg for too long.), FEEDING DISORDER (not been able to eat) and INSOMNIA (not been able to go to work, eat or sleep for 6 days.). At the time of the report, SWELLING FACE (started waking up with their whole left side of their face swelled up, mainly their mouth and jaw.), MASS (red big  knot on their left side hip), PAIN IN EXTREMITY (pain on the right side of their leg), SWELLING (swelled up to their buttocks), IMPAIRED WORK ABILITY (not been able to go to work), FEELING ABNORMAL (feel so bad), DYSSTASIA (cannot stand on their leg for too long.), FEEDING DISORDER (not been able to eat) and INSOMNIA (not been able to go to work, eat or sleep for 6 days.) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No concomitant medications reported. No treatment reported
Pt recv vax on 1/25/99; on 1/26/99 pt exp diarrhea, dehydration, red skin rash
Yellow  snot, cough,  fever, and loose stool 3-5 days Motrin/Tylenol
Injection site on left arm started itching about 2 or 3 hours after injection. Injection site became swollen and hot to the touch. A round red rash appeared. Site is very sensitive and painful to touch.
I contracted COVID-19. I had a moderately sore throat on the right side between my ear and my throat. I had some congestion in my nasal area. I cough occasionally. It was like a post nasal drip cough. I felt tired and didn't want to do too much. I had a telemedicine visit with my doctor, and I was put on an oral steroid for 6 days. I also took DayQuil and NyQuil. I was symptom free once I started taking the steroid. My symptoms lasted for about 5 days, and they were only moderate.
Dizziness/lightheaded after getting vaccine. BP 181/111; repeat 174/82 (pulse 73). Given water and crackers. Patient has a history of anxiety and panic attacks.
Received Influenza vaccination on 10/26/07.  Describes a 3-day delay, then increased pain, localized swelling, non-erythematous.
tested positive; tested positive; Symptoms experiencing include having no taste, smell and slight bodyache; Symptoms experiencing include having no taste, smell and slight bodyache; Symptoms experiencing include having no taste, smell and slight bodyache; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable other-healthcare professional (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive on 24Dec2020, and symptoms experiencing include having no taste, smell and slight body ache in Dec2020. The patient asked if she could get the second dose. The outcome of the events was unknown.   Information about the Lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the COVID-19, with symptoms of having no taste, smell and slight body ache, and vaccination with BNT162B2 cannot be excluded.
N93.9 - Abnormal uterine and vaginal bleeding, unspecified ANEMIA DIZZINESS SHORTNESS OF BREATH
The first thing I noticed was occasional tingling in my left hand on April 9.  On April 10 a little more frequent and almost like it was "going to sleep" slightly.  Today, April 11, more of the same but also in my arm.  I am also having some stiffness on the back side of my neck, occassionaly that I have had in the past at times.  Today, I have also noticed the left side of my tongue feeling a slight tingling.
Started with tightness in chest, some difficulty breathing, headaches started earlier that day.  Headaches lasted five days and still feel like they come and go.  I have pain on upper left back and feel as though something not do to coughing.  I went to my physician for the headaches and other reason related to how I felt after vacine.  I did not mention to him that I had the vacine.  He said I had an upper respiratory infection put me on antibiotics.  Still have pain in back and a cough that is not persistent but makes my chest feel tight when coughing.  I never experienced this before having the vaccine.  I plan on seeing my physician this week again, because back pain and tightness of chest has not gone away,  I will inform him that the onset of this was after vaccine.
she is breaking out hives; This is a spontaneous report from a contactable Consumer or other non-HCP (mother of patient) reported for a female patient (daughter). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: UNKNOWN) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced breaking out hives. Reported stated that her daughter who is fifteen and half just got her first Pfizer Covid shot(Further not clarified hence captured as Unspecified vaccine) and she was breaking out hives. It did not seem to wear and was asking if she could put her daughter on Benadryl. The patient outcome of the event was unknown at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-NOV-2011, the patient was treated at an urgent care for a persistent and severe vesicular rash, which was then diagnosed as herpes zoster. The patient has been prescribed acyclovir and prednisone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.
Redness, swelling, rash to right arm.  Pt reported dizziness, chest pains, difficulty breathing & muscle aches.  Tactile warmth at injection site.  Patient noted rash the morning of 9/25/20 and later that day felt like passing out.  Pt took Benadryl.
1st dose, felt really really bad; 1st dose, could not move their arm; Went to work, could not move arm, left work; 1st dose, arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (1st dose, felt really really bad), LIMB DISCOMFORT (1st dose, could not move their arm), PAIN IN EXTREMITY (1st dose, arm was sore) and IMPAIRED WORK ABILITY (Went to work, could not move arm, left work) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced FEELING ABNORMAL (1st dose, felt really really bad), LIMB DISCOMFORT (1st dose, could not move their arm), PAIN IN EXTREMITY (1st dose, arm was sore) and IMPAIRED WORK ABILITY (Went to work, could not move arm, left work). At the time of the report, FEELING ABNORMAL (1st dose, felt really really bad), LIMB DISCOMFORT (1st dose, could not move their arm), PAIN IN EXTREMITY (1st dose, arm was sore) and IMPAIRED WORK ABILITY (Went to work, could not move arm, left work) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided.   Treatment information was not  provided.   This case was linked to MOD-2021-302230 (Patient Link).
Vaccine Recipient vaccinated with Pfizer pediatric dose 0.2mL instead of Pfizer 12+ 0.3mL dose for second dose.