chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain behind my left knee in the bend; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset 26Jun2021, outcome "not recovered", described as "pain behind my left knee in the bend". Therapeutic measures were not taken as a result of arthralgia.  Additional information:The patient had no known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100913031 same patient, different dose vaccine and similar event.
Developed fever, 1/6/00 x 1 day; then a generalized rash that was worse on 1/9/00. Started on Benadryl drops, seen on 1/10/00 w/generalized erytr rash, similar to erthema multiforme. Tx'd with Benadryl.
Information has been received from a physician concerning a 3-year-old female who was vaccinated "a year and a half ago" with a dose of Vaqta. Concomitant therapy included Motrin or Tylenol. Subsequently, on an unspecified date the patient experienced Stevens-Johnson syndrome. Unspecified medical attention was sought. The reporter did not identify any serious criteria and no outcome was reported. No product quality complaint was involved. Upon internal review, Stevens-Johnson was determined to be an other important medical event. Additional information has been requested.
Patient received Twinrix and Typhoid injection for travel. Within 3-4 minutes the patient fainted and had a mild seizure with body stiffness, shaking and rapid eye movement.
Flaccid, shrunken penis. The adverse event occurred the day after the initial GARDASIL vaccine and noticed after working out moderately (gym) and using the restroom. The event continued during, after shower & through evening. This has never happened before under any other conditions. My son was verbally & noticeably shaken & scared. Normal the following morning.
(R) injection site on arm swollen. Hard to move arm and warm to the touch. Suggested to pt. to take Ibuprofen or acetaminophen and use a cold compress to injection site.
Large swollen supraclavicular lymph node.  Red, swollen, hot knot at injection site.
Approx. 10 min. after recieving flu vaccine began feeling 'funny"-nausea, darkened vision, hot, hearing muffled--no c/o difficulty breathing or swallowing.  Face reddened across cheeks similar to rash.  Skin warm and dry, color pale with red cheeks, resp. unlabored but fast. 911 called and .8 mg Epinephrine 1:1000  administered. Began feeling better--color improved within 5 minutes-rash disappeared, vision improved. Transported to Emergency Room per EMS.
No V/S provided. Topical skin rash, chest up. Neck and arms tingled.
Patient came to the office for a physical 10/24/2015 to see provider during the visit vaccines were ordered and the MA gave only the diluent of the 2 part vaccine.
Redness with swelling > 50 cent piece approximately 2-3 inches in width and 5 inches long that appeared in upper left arm. Temp increased to 102.4. Treated with Pediapred and antibiotics in ER. Kept in ER for a few hours for observation.
This spontaneous report was received from a registered nurse regarding her daughter a 20 year old female patient. No medical history was reported. The patient was vaccinated with VARIVAX dose 1 on 17-OCT-1995 and dose 2 on 23-OCT-2008 subcutaneously (lot# and expiry not reported). The patient also received RECOMBIVAX HB dose 1 and dose 2 respectively on 17-NOV-1994 and 21-JUL-1995 (lot# and expiry not reported). The reporter stated that it was unknown which hepatitis-B vaccine the patient received but RECOMBIVAX HB cannot be ruled out. No concomitant therapy was reported. On 01-JUL-2015, the patient had routine titers drawn as required by the patient's nursing school which she attends. The patient's results returned showing negative immunity to both varicella zoster virus and hepatitis B. The hepatitis B surface antibody results as <5mIU/ml and the varicella zoster (IgG) antibody resulted as 1.05 liters in the equivocal range. The nurse reported that the patient's report stated that, the patient might not have immunity or adequate response to chicken pox and revaccination was recommended. The outcome of the events were unknown. The causality of the events were unknown. Additional information has been requested.
Red, pain, swelling, erythema,  size of half dollar started 1 day after vaccination. Headache 7 pm on 1/13/21 then intermittent to 1/16. Fatigue 1/13-1/18, Sore throat 1/17-1/18
Date of Admission: 9/24/2023   Date of Discharge: 9/25/2023   Issues to be Addressed at Follow-up: 1. Determine when to resume entresto. 2. Ensure compliance with gallbladder diet. 3. EtOH and tobacco cessation. 4. Follow up with general surgery for elective cholecystectomy after COVID isolation period ends.
This case was reported by a health professional and described the occurrence of an injection site reaction in a 5 year old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 02May03 the pt received the 5th dose of Infanrix. On 03May03, 24 hours post-immunization, the pt experienced an injection site reaction characterized by swelling and redness. The pt was seen by the physician, who prescribed an unspecified antibiotic. The events resolved within 48 hours of initiating antibiotic therapy. The reporter considered the injection site reaction to be related to vaccination with Infanrix.
had an overall itching; their entire body itched; 99 temp; were itching from head to toe; face was red; felt their scalp itching; soreness in their arm; redness in their arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (had an overall itching), PRURITUS (their entire body itched), PRURITUS (felt their scalp itching), PAIN IN EXTREMITY (soreness in their arm) and ERYTHEMA (redness in their arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse drug reaction.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PRURITUS (felt their scalp itching), PAIN IN EXTREMITY (soreness in their arm) and ERYTHEMA (redness in their arm). On 15-Mar-2021, the patient experienced PRURITUS (had an overall itching), PRURITUS (their entire body itched), PYREXIA (99 temp), PRURITUS (were itching from head to toe) and ERYTHEMA (face was red). On 16-Mar-2021, PYREXIA (99 temp) had resolved. At the time of the report, PRURITUS (had an overall itching), PRURITUS (their entire body itched), PRURITUS (felt their scalp itching), PAIN IN EXTREMITY (soreness in their arm), ERYTHEMA (redness in their arm), PRURITUS (were itching from head to toe) and ERYTHEMA (face was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (had an overall itching), PRURITUS (their entire body itched), PRURITUS (felt their scalp itching), PAIN IN EXTREMITY (soreness in their arm) and ERYTHEMA (redness in their arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse drug reaction.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PRURITUS (felt their scalp itching), PAIN IN EXTREMITY (soreness in their arm) and ERYTHEMA (redness in their arm). On 15-Mar-2021, the patient experienced PRURITUS (had an overall itching), PRURITUS (their entire body itched), PYREXIA (99 temp), PRURITUS (were itching from head to toe) and ERYTHEMA (face was red). On 16-Mar-2021, PYREXIA (99 temp) had resolved. At the time of the report, PRURITUS (had an overall itching), PRURITUS (their entire body itched), PRURITUS (felt their scalp itching), PAIN IN EXTREMITY (soreness in their arm), ERYTHEMA (redness in their arm), PRURITUS (were itching from head to toe) and ERYTHEMA (face was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Reporter did not allow further contact
Glaucoma; This spontaneous case was reported by a consumer and describes the occurrence of GLAUCOMA (Glaucoma) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced GLAUCOMA (Glaucoma) (seriousness criterion medically significant). At the time of the report, GLAUCOMA (Glaucoma) outcome was unknown.            No concomitant medications were reported.  Patient had wore mask and had hard time seeing, She was older and could not see as well, clouds were floating in front of her eyeballs and was diagnosed with Glaucoma. She had two Covid Moderna shots and two Moderna Covid Boosters.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of GLAUCOMA with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  No treatment medications were reported.  Company Comment:  This is a spontaneous case concerning a elderly female patient of unknown age under treatment with RISANKIZUMAB for unknown reason, with no other medical history reported, who experienced the unexpected serious (medically significant) event of glaucoma. Patient received 4 doses of mRNA-1273 vaccine. It is unknown after which dose the event was diagnosed.  RISANKIZUMAB was also reported as a suspect drug. Patient range of age is a risk factor for the event. No further information was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a elderly female patient of unknown age under treatment with RISANKIZUMAB for unknown reason, with no other medical history reported, who experienced the unexpected serious (medically significant) event of glaucoma. Patient received 4 doses of mRNA-1273 vaccine. It is unknown after which dose the event was diagnosed.  RISANKIZUMAB was also reported as a suspect drug. Patient range of age is a risk factor for the event. No further information was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported), as prescribed and/or administered by a healthcare provider in nursing home for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was reported as not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.
Pt. c/o lateral pain and numbness to L lateral deltoid started at 1200. Pt. continued with pain and was evaluated by Dr. Cold pack was applied and vitals were taken and were noted as normal.
Swollen lymph node underneath left armpit. Shot was received on left arm. The area was swollen slightly larger than a golf ball for a little over a week and caused discomfort. The area was tender but there was no physical mass in the swollen area. Was uncomfortable to work with and was treated with ibuprofen and a warm compress.
Patient called 9/2/20 to report that he had shortness of breath on 9/1/20, but that it was resolved today.  He also reported that a rash started on his arms on 9/1/20 and continues today.
Narrative:  84yo male residing at nursing facility died on 8/14/2021. Pt had history of: 1. Culture Negative Meningitis POA treated, Vanc + Ampicillin + Cefepime.+ Acyclovir with IV Dex 10 mgq6 x 4 days. Stop date for ABX 6/27/21 HAS FINISHED COURSE NOW. 2. Hx of R Thalamic Stroke POA 3. COPD POA 4. HTN POA 5. GERD POA with history of Barrett esophagus 6. GI bleed notPOA PPI accepted but declining GI interventions 7. Mood Disorder POA Psychiatry evaluated for SI 6/17/21 recommended NO 1:1 sitter. Patient is decisional. 8. Chronic pain POA lidocaine patch and Hydrocodone provided 9. Debility POA he desires comfort care with long term care placement, still not eating, palliative aware. 10. Chronic HA, will increase dose of venlafaxine per recs, they discussed with him yesterday and he was agreeable. Pt had received covid 19 vaccines on 2/5/21 & 3/5/21 at grocery store pharmacy. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
He died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "He died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: the patient have taken the Pfizer vaccine since the outbreak of covid but died.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: He died
DRY PATCH ON THE VACCINE SIGHT ON THE ARM; OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media and concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received two doses (first and second dose) of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with two doses of covid-19 vaccine (dose number in series 1). The patient previously received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for Covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with third dose of covid-19 vaccine ad26. cov2.s (dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was off label use (off label dosing frequency) and revaccination with different covid-19 vaccine (dose number in series 3). 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 dry patch to the vaccine sight on the arm (Dose number in series 3). It was reported that patient visited physician office. The reporter stated "I have had all the vaccine including the booster the only reaction I have had is a dry patch on the vaccine sight on my arm from the forth vaccine doctor said it should go away but it hasn't". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry patch on the vaccine sight on the arm, and the outcome of off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20221244567.
Urinary Tract Infection/ she currently has a UTI; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th September 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 19th January 2023, the patient experienced urinary tract infection. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the urinary tract infection was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and urinary tract infection to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's comments: The caller was the patient and had reported that, she had received her Shingrix vaccine in the left arm. The caller reported that, she only had felt soreness at the injection site that had resolved.  The caller had also mentioned in the call that, she currently had a urinary tract infection (UTI) which she would be starting with antibiotics at the time of reporting. The reporter did not consent to follow-up.  The reporter does not give permission to contact HCP. Additional supportive information:  115 days after receiving Shingrix, the patient experienced urinary tract infection.
w/in 2hr p/vax pt devel hives;pt was seen @ hosp ER w/generalized urticaria;no resp distress;recv DPH w/significant improvement;
I just got sick with the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I just got sick with the first shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (hospitalized for 21days on ICU but not intubated.) in June 2020. Concurrent medical conditions included Asthma, Prediabetes, Obesity, Blood pressure high and Anxiety. Concomitant products included SERTRALINE for Anxiety, MONTELUKAST, METFORMIN, LOSARTAN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION COMPLICATION (I just got sick with the first shot). At the time of the report, VACCINATION COMPLICATION (I just got sick with the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-368965, MOD-2021-369052 (Patient Link).
I mean it just, you know the extreme fatigue, long lasting fatigue. It was an exasperation of what I was already going through. I can not walk or stand for very long any more. I had some long standing conditions prior to the vaccine. I feel the vaccine exasperated my sx. I would have been better off getting COVD. It just really amplified everything (all the health conditions I already had). I have a genetic d/o inflammation each dose was increasing the amount of inflammation in my body, my doctor stated no further doses, body can not handle any more. Starting in January 2022, I started having vertigo and dizziness, they still did not figure that out, so I am wondering if that is something from the vaccine that exasperated from my conditions. I have been to 42 or 43 doctors appointments in 2022 due to all of the increased issues I have been having.
Saturday 4/19/08 low grade temperature 99.  Tylenol given 1/day Saturday.  Saturday night temperature 100.  Sunday am 99 at 3:30 pm red spot noted on left side, small of back and arch of foot.  Rash had spread to crest and feet.
Patient was not in approved age range at time of vaccine (under 18 years old). Patient reported no adverse effects from the vaccination.
Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with no drug reactions or allergies who on 15-SEP-2008 was vaccinated IM with the first dose of GARDASIL (Lot # 659184/0843X). There was no concomitant medication. On 20-JUN-2010 the patient experienced vaginal bleeding and went to the E.R. At the E.R., the patient was told the baby stopped growing (EDD: 20-DEC-2010), and an unnamed medication was given to her and that night she "miscarried". The nurse reported that the medication probably forced the expulsion of the fetus. The patient was recovered on unspecified date. On 26-AUG-2010, the patient was being seen for a OB/GYN well check. Upon internal review, abortion was considered to be an other important medical event. No further information is available.
Major swelling in the armpit lymph nodes and armpit itself.  It is also extremely sore and has been like that since day 6 own.  I'm concerned about the getting the second injection and possible damage to the armpit lymph node.