chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information received from a published article, concerning a group of 149 patients from an analysis study that were vaccinated with a dose of zoster vaccine live (manufacturer unknown) Context: Based on limited data, the live attenuated herpes zoster (HZ) vaccine is contraindicated in patients taking anti-tumor necrosis factor (anti-TNF) therapies or other biologics commonly used to treat immune-mediated diseases. The safety and effectiveness of the vaccine are unclear for these patients. Objective: To examine the association between HZ vaccination and HZ incidence within and beyond 42 days after vaccination in patients with selected immune-mediated diseased and in relation to biologics and other therapies used to treat these conditions. Herpes Zoster (HZ) Incidence Rate Within 42 days: A total of 7780 vaccinated patients contributed person-time within 42 days after vaccination; fewer than 11 HZ cases were observed, resulting in an overall incidence rate of 7.8 cases per 1000 person-years (95% C1, 3.716.5). HZ Incidence Rate after 42 days: During the period of more than 42 days after vaccination, the authors observed 138 HZ cases during 20639 person-years (6.7 cases per 1000 person-years; 95% C1, 5.7.9), resulting in a ration of 0.58 when compared with the incidence rate during unvaccinated person time (11.6 cases per 1000 person-years; 95% C1, 11.4-11.9; P< .001). A limitation relevant to the safety results was not that for HZ cases shortly after vaccination, the authors were unable to determine whether the HZ cases were caused by the vaccine virus strain or the wild-type virus strain, which is possible if biological samples from skin lesions were available for analysis. Another limitation was that the actual vaccine administration dates were unknown for 59% of the author's patients which resulted in the exclusion of these patients from safety (but the effectiveness) analyses. In conclusion, the author's data suggested that the live zoster vaccine may not be associated with increased risk of HZ shortly after vaccination in patients currently treated with biologics and that it was possibly associated with a significantly reduced longer-term HZ risk in patients with immune-mediated disease. The authors' data called into question the current recommendations that HZ vaccine was contraindicated in patients receiving biologics. No further information is available.
Given H1N1 & Influenza vaccine @ 10:30. Never received either vaccine prior to this. @ 14:30 developed a tickle in my throat, began coughing unable to stop coughing. Was given Benadryl 50mg  PO. Decadron 4mg PO. Albuterol aerosol. Symptoms resolved completely.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm, nausea, vomiting and discomfort. On an unknown date, the outcome of the erythema of extremities, swelling arm, nausea and vomiting were unknown and the outcome of the discomfort was recovered/resolved. It was unknown if the reporter considered the erythema of extremities, swelling arm, nausea, vomiting and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after the SHINGRIX shot her arm swelled up and turned red. The patient stated that she was throwing up and nausea for the first day. The patient stated she was uncomfortable for about a week. The patient had denied permission to contact their physician.
diagnosed with strep pneumonia and is currently in picu; diagnosed with strep pneumonia and is currently in picu; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. A 16-month-old male patient received four doses of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), all via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with strep pneumonia and was in  Intensive Care Unit. The outcome of the event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13- valent conjugate vaccine in this patient cannot be completely excluded.
Vaccine given to person 16 years of age. No adverse health effects related to this event.
Vulvar Aphthous Ulcer. First symptoms occurred 3 days later, chills, nausea, generally not feeling well enough to go to school. Extreme pain and ulcers in the vaginal area over the next two days. On the 3rd day we saw a nurse and 1 week from the booster (3rd dose) we were able to see an OBGYN Dr.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) lot # L035105 expiration date 14-MAY-2017, dose and route were unspecified. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree (also reported as Celsius degree). The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree (also reported as Celsius degree). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Redness and warmth 10 cm x 10 cm in the Lt shoulder, Redness and warmth 10 cm x 4 cm in the Rt shoulder.
1st smallpox-2/17/62 couldn't control my legs have had similar problems since I had the vaccine; including not being able to use my legs. Lasted for three weeks.
2.25 hours after receiving the vaccine, patient began to feel numbness around her mouth, as well as a constricted feeling in her throat with some difficulty swallowing. Patient was given 25 mg of Benedryl, and later, 40 my of Pepcid, and throat constriction went away but feeling of numbness remained for a while. Her BP generally runs high, but was elevated at 160/100 (1:20 pm), then lowered to 138/89 (1:52 pm). Patient returned to work at 2:06 pm after symptoms had resolved.
Severe body aches in back & legs; Severe body aches in back; Headache; Loss of appetite; Fever; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease and allergy to gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included medication for birth control (unspecified) and montelukast sodium (SINGULAIR); both from unknown dates, for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 11:00, the patient experienced severe body aches in back and legs, headache, loss of appetite, fever and fatigue. 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 severe body aches in back, severe body aches in legs, headache, loss of appetite, fever and fatigue was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash looks like shingles; This case was reported by a nurse via sales rep and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not reported. The patient had rash that developed after she got the second Shingrix dose. She did not remember when it started exactly but it was after the second dose and it looks like shingles although it did not presents pain it itches. The rash was present in the upper abdomen and upper back, right side. The reporter consented to follow up.
Artery inside of elbow is leaky per patient report. looks like a bruise on the left elbow. No pain, increasing in area. Advised patient if it worsens to reach out to her primary care provider.  As of report time it was 4.5 cm in length and 2 cm in with.
I am filling this this out to report similar symptoms and reactions for three of us in the same household (ages 47, 45, and 18). Flu-like symptoms: fever reaching as high as 101.2, night sweats, joint pain, chills, unable to get warm, exceedingly tired, loss of appetite, upset stomach. Missed work (two of us) and school (one of us) within a couple days of the shot.
This spontaneous report as received from a pharmacist refers to a 43 year old patient. On 20-DEC-2013 the patient was vaccinated with PROQUAD (Merck). No concomitant medications were reported. The pharmacist reported that the patient was vaccinated with PROQUAD (Merck) instead of M-M-R on 20-DEC-2013. No adverse effects were reported. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing), notes: Other medical history: Hyperthyroid.; "AORTIC ROOT ENLARGEMENT" (unspecified if ongoing), notes: Other medical history: Enlarged aortic root valve in heart. Concomitant medication(s) included: SYNTHYROID. Past drug history included: Neosporen, reaction(s): "Known allergies: Neosporen", notes: Known allergies: Neosporen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: tested negative for two days; Negative, notes: tested negative for two days; Positive, notes: woke up the third day felt more congested and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product=COVID 19 Treatment, Treatment start date=02Aug2022, Treatment stop date=08Sep2022, Indication=Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately one hour after administering a flu vaccine. Child began to feel nauseated and became very pale. Two nurses on the scene noted that child's heart rate was irregular. Child had been to PE after receiving flu vaccine.
death I46.9 Cardiac Arrest J18.9 - Multifocal pneumonia
typical-chills,headache, muscle ache AND a bad, bad case of cold scores-worse I have ever had!
This is a spontaneous report from a contactable nurse reporting for her daughter via a Pfizer sales representative. This 23 year-old female patient of an unspecified race and ethnicity received the second single dose of TRUMENBA via an unspecified route of administration on 01Feb2017 for immunization.  No other vaccine was administered the same day. The patient had previously received for immunization the first single dose of meningococcal group b rlp2086 on an unspecified date. The patient medical history and concomitant medications were not reported. On 01Feb2017 two hours after the vaccination the patient experienced vomiting and severe chills. Outcome of events was unknown.
I have two eye disease which doctor has seen in her clinic.  I had problems two weeks after.  I had floaters with flashing light.  I was tested and it was found that I had one very rare disease.  I have Pan Uveitis and Retinal Vasculitis with HLA B27 Positive.  I never had a problem before getting the vaccine.
Tachycardia (Increased heart rate); Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia (Increased heart rate)), NAUSEA (Nausea) and VOMITING (Vomiting) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). On 25-Sep-2021, the patient experienced TACHYCARDIA (Tachycardia (Increased heart rate)) (seriousness criterion hospitalization). The patient was hospitalized from 25-Sep-2021 to 26-Sep-2021 due to NAUSEA, TACHYCARDIA and VOMITING. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 26-Sep-2021, TACHYCARDIA (Tachycardia (Increased heart rate)), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, White blood cell count: 21000 (High) 21000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient does not have a heart issue and she has never had high blood pressure.She states that her blood pressure was not affected during this reaction Treatment details includes: IV antibiotics. Concomitant medication was not reported by the reporter.  Company comment: This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the unexpected events of Nausea, Vomiting, and Tachycardia. The events of Nausea and Vomiting occurred approximately 22 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine)  and the event of Tachycardia occurred 24 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the unexpected events of Nausea, Vomiting, and Tachycardia. The events of Nausea and Vomiting occurred approximately 22 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine)  and the event of Tachycardia occurred 24 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Case number PHEH2014US003607 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 16-year-old female patient. Her medical history and concomitant medication was not reported. On an unknown date in JAN 2014, she was vaccinated with FLUCELVAX (batch number: 006031A) intramuscularly. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Polymyalgia, jaw pain, headache, sinusitis, laryngitis, sore throat, inability to ambulate. Treated with Omnicef, Levaquin & prednisone. Evaluated by PCP, ENT, rheumatology. Sx and treatment ongoing as of 11/30/2016.
Weakness, muscle aches, splotchy and Welty rash over entire body lashing 24 hours, beginning 8 days after vaccine dose
In November, I had negative tests for COVID and I returned to work the 2nd of December. My cycle came late in December before the vaccine - it's normally the first or second week of month and it came the last week of December. . In January, I started bleeding heavily - this was after the vaccine. I had headaches that wouldn't let up, fatigue, dizziness, pallor and general malaise.  I went to my doctor. 17 - My hematocrit number was 17 when they checked it at the doctor on Tuesday, the 12th. I went to ER on January 13th on  to get a blood transfusion. I needed two units of blood. I felt a whole lot better. I was at ER overnight but not admitted. My doctor kept me out of work for a little longer and then I returned to work.
Started wit a headache  numbness in my face  difficulties of breathing heart rate was high dizzyniess blood pressure was high numbness on the whole right side of body
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question; No adverse event; Doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question).    No concomitant medication was reported.  Reportedly, temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction.  No treatment information was reported.
Patient stopped in to mention that after his Shingles vaccine he had noticed, both on the first vaccination and the 2nd vaccination, that he gets a darkening of his skin (almost like dark spots) on the lower extremity of the arm that was vaccinated He stated that it was more pronounced on the 1st vaccine than the 2nd. He has not brought it to the attention of a physician...he states that it is not bothersome it is just something that he has noticed. He states that his skin is returning to normal slow but sure.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Swollen lymph node under left jaw, no pain or fever, fatigue (Lymphadenitis)
When I put the daily pataday and/or travoprost drops in my eyes, starting the night of my first injection, I often have vertigo - not just diziness, but dramatic everything turning uncontrolably.  The vertigo goes away in a few minutes, but is uncontrolled while it lasts, and happens within a second or so after putting in the drops.