chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs; GARDASIL 9 was administered to 15 month old female patient on 12/22/22, along with MMR II, VARIVAX and HEPATITIS A vaccines.; This spontaneous report was received from a nurse prescriber via company representative and refers to a 15-month-old female patient (discrepancy, also reported as 3-month old).  The patient's medical history and concurrent conditions were not reported. The patient's concomitant medications included: Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), varicella virus vaccine live (Oka/Merck) (VARIVAX), Hepatitis A Vaccine, Inactivated (manufacturer unknown) (reported as hepatitis A vaccine), all administered on 22-DEC-2022 for prophylaxis.  On 22-DEC-2022, the patient was vaccinated also with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter, administered once (strength, route of administration, vaccination site, dose number, lot number and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events were reported.
Exquisitely painful right upper quadrant oral rash/blisters, (not able to eat or chew) Right facial pain  with muffled diminished hearing , ear pain,  headache, right face sore to touch  Treated with one week course of Valacyclovir and Prednisone for presumed Ramsay Hunt Syndrome Improvement noticed by day 3 of treatment course.       Patient now developing cold sore of Left Upper Lip (bring treated with Valacyclovir.
The patient received her 2nd dose 1 week earlier, which is 14 days after the 1st dose.  Patient's father registered for the 2nd dose 1 week earlier, and our staff also miscalculated the 2nd dose date.   We also informed the father that vaccine administered up to 4 days before the minimum interval may be counted, and do not repeat the 2nd dose.  However, the patient received the 2nd dose 3 days earlier than the grace period, so  she is recommended to receive additional dose 21 days later according to the CDC 's 'Administration errors revaccination guidance' .  We also recommended him to inform the patient future pediatrician of this early shot: the patient just moved, so she did not have her pediatrician yet.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications were not reported.  It was reported that 51 doses from Lot AS7140C and 60 doses from Lot AS7148B were administered. No treatment information was provided.
Information has been received from a medical assistant concerning a 25 year old female who on 27-MAR-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # not provided).  On 31-MAR-2008 the patient called the office and stated she had back spasms.  The patient was treated with a warm compress.  The patient's back spasms have persisted.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Followup information has been received from a nurse practitioner. It was reported that the 25 year old female, with a secretarial occupation, weighing 119 pounds, height of 5 feet 2 inches, with no illness at the time of vaccination, on 27-MAR-2008 was vaccinated IM in the left deltoid with a first 0.5mL dose of GARDASIL (lot # 659182/1757U (reported as 17570)). On the following day, 28-Mar-2008, the patient experienced back spasms lasting all day. The patient had recovered.
Soreness on arm; muscle ache; fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2, administered in arm left, administration date 31Mar2021 14:30 (Lot number: EL3247) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose; Lot number: EL3247, Administration time: 01:30 PM, Vaccine location: Left arm), administration date: 10Mar2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Apr2021 09:00, outcome "recovered", described as "Soreness on arm"; MYALGIA (non-serious) with onset 01Apr2021 09:00, outcome "recovered", described as "muscle ache"; FATIGUE (non-serious) with onset 01Apr2021 09:00, outcome "recovered", described as "fatigue". Therapeutic measures were not taken as a result of pain in extremity, myalgia, fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severely chapped lips, particularly at edges.  Center of upper lip feels a bit swollen and numb.  Staying hydrated, but skin on lips sheeting off at times.  Also, using Chapstick.  This is not normal for me and I can only connect it with having received the vaccine.  I think the symptom is improving, but it very slow and minimal.  This started shortly after receiving the vaccine a month ago and continues to this day.  Other side effects were very temporary:  Headache, fatigue.  No arm soreness at all.  Mild body aches within 24 hours, but diminished rapidly.
swollen right parotid gland without fever. chills, malaise, myalgias or fatigue.
Pt called in 1 hr post vax c/o hives on face, weakness, not feeling right; referred to ER-seen in ER given IV & meds; called pt 3PM-"feeling groggy" had been sleeping;
2nd dose of Pfizer COVID vaccine in the am on 6/9/21. Facial edema to the lips and periorbital region  starting at 1400. No evidence of anaphylaxis on arrival to the ER at 2000. Pt given Benadryl 50mg and Dexamethasone 10mg with mild improvement of edema. Pt discharged home with Benadryl and epipen.
Pfizer-BioNTech COVID-19 Vaccine EUA I woke up at about 4:30 AM and couldn?t fall back asleep, I kept feeling sleepy until I would get jolted back awake over and over. My joints were hurting, I had somewhat severe nausea, my head started throbbing. At about 6:40 AM my migraine started, my arm felt hot to the touch, and I got dizzy so I took some acetaminophen. At 10:00 PM I noticed the area under my left armpit was a little swollen and really sore, my throat and right tonsil was also sore and it hurt to swallow. The next day (today) I have another migraine, my throat and left armpit are still sore,  and my muscles hurt. I?m getting better though.
Information has been received from a healthcare worker referring to a 31 year old female patient. No drug reaction or allergy was reported. The healthcare worker reported that the patient was seen by an unspecified physician on 16-JAN-2015 for a physical and during the physical, the patient reported to the physician that she was pregnant. The healthcare worker reported that the patient came back to the office on 30-JAN-2015, and on the same day patient received a dose of VARIVAX (Merck) (Lot# was reported as K00T186, expired on 28-MAY-2016), injection, 0.5 ml, subcutaneous (strength was unspecified). It was reported that at the reporting time patient had 2 months pregnancy (according to this, last menstrual period (LMP) was in DEC-2014). No adverse effect was reported. Additional information has been requested.
pain in the whole body; fever; fatigue; got the 3rd dose thinking it was the booster for her age, because she is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the whole body), PYREXIA (fever), FATIGUE (fatigue) and OFF LABEL USE (got the 3rd dose thinking it was the booster for her age, because she is not immunocompromised) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 023M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced MYALGIA (pain in the whole body), PYREXIA (fever), FATIGUE (fatigue) and OFF LABEL USE (got the 3rd dose thinking it was the booster for her age, because she is not immunocompromised). On 23-Sep-2021, OFF LABEL USE (got the 3rd dose thinking it was the booster for her age, because she is not immunocompromised) had resolved. At the time of the report, MYALGIA (pain in the whole body), PYREXIA (fever) and FATIGUE (fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.  No Treatment Information was provided by the reporter.   This case was linked to MOD-2021-350396 (Patient Link).
A pediatrician reported that, over a year ago, a 9 month old female received a dose of Prevnar on 18 JUL 2000. That same day the child experienced vomiting, diarrhea, irritability and a low grade temperature which lasted three days. The child recovered.
Systemic: Dizziness / Lightheadness-Mild, Systemic: anxiety-Mild
High fever , sore arm , aching body , foggy mind, not thinking  as normally , she began to have a cough that lasted for months  at the point where her rib was fractured from coughing severely and it was then when she saw a doctor and they found out she had stage 4 cancer my wife passed away in December 27 2019
High temperature, irritability, stiff neck, sneezing, coughing, congestion. Duration approximately 1 week; required hospitalization. Sore inside of mouth. Discharge summary states viral infection, meningitis. msv
I had a cough, sinus congestion with blood, I did not have a fever that turned out to be a sinus infection. I called and had a telehealth visit with doctor who advised me to use a saline rinse and also prescribed Augmentin. I am now feeling much better.
This is a spontaneous report from a Pfizer sponsored program PFE PAP SP Lyrica. A contactable adult female consumer (patient) reported for herself that she received bnt162b2 (Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated it works very well for her. And she has a sore arm from vaccination shot. The outcome of event was unknown. Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 13 year old female who was vaccinated with a dose of Gardasil. Subsequently "few weeks ago" the patient experienced dizziness, headaches and blurred vision. Subsequently, the patient recovered from dizziness, headaches and blurred vision. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Follow up information has been received from a medical assistant concerning a 13 year old female who on 07-AUG-2007 was vaccinated IM in the left arm with a first dose of GARDASIL (lot# 653736/0014U). On 02-OCT-2007 the patient was vaccinated IM in the left arm with the second dose of GARDASIL vaccine. Subsequently the patient claimed "redness, swelling and soreness at injection site, fever, headache. Second dose reaction worse than first. Also dizziness and blurred vision. " Subsequently, the patient recovered from dizziness, headaches, blurred vision, redness at injection site, swelling at injection site, soreness at injection site and fever. No further information is available.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 16 April 2008 from an other manufacturer, who received the original report through their National Service Center.  The original reporter to the other manufacturer was a pharmacist.  An unidentified patient (demographics not provided) received a dose of tetanus vaccine (Trade name, manufacturer name, lot number, route and site of administration not provided), and a dose of erythromycin approximately 10 years ago (in 1998), and experienced an "anaphylaxis reaction to the erythromycin and tetanus."  No further information was available at the time of this report.  Treatments received, and diagnostic tests performed were not provided.  The recovery status of the patient was not reported.  Additional information has been requested.
pt given 2nd dose moderna L arm 9/18/21; developed red painful rash. Pt instructed to use tylenol and ice pack
light headedness, nausea, headache, fever 100, chills, extreme fatigue lasted 12 hours at least recovered after 24 hours
first shingle shot turned him diabetic; This serious case was reported by a consumer via interactive digital media and described the occurrence of diabetes in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included hypoglycemia (was hypoglycemic all his life).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced diabetes (Verbatim: first shingle shot turned him diabetic) (serious criteria GSK medically significant). The outcome of the diabetes was not reported.   It was unknown if the reporter considered the diabetes to be related to Shingles vaccine.     It was unknown if the company considered the diabetes to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-Mar-2023 The case was received from the patient's friend via interactive digital media. The reporter reported that the shingles were terrible, but a few people did the shot was worse one example of a friend of him/her (the patient) had the first shingles shot and turned him diabetic, be careful. The follow-up could not be possible as no contact details were available.
This spontaneous case, initially received on 09-Jan-2017, was reported by a health professional and concerns patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date about 2 years ago, the patient received AFLURIA for indication not reported. Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient experienced chills (hospitalized, outcome: not reported), dizziness (hospitalized, outcome: not reported), fainting spells (hospitalized, outcome: not reported). Sender's Comments: Listedness: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, syncope and dizziness are unlisted. Chills is listed. Causality: Unassessable. Time to onset following vaccination not specified. Temporal relationship cannot be established; causality is unassessable.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47 Fahrenheit degrees (°F) to 77 Fahrenheit degrees (°F) for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
So I'm kind of floating out there; My skin is a total mess, I am having an awful problem with my skin. This spontaneous case was reported by a patient and describes the occurrence of SKIN DISORDER (My skin is a total mess, I am having an awful problem with my skin.) and FEELING ABNORMAL (So I'm kind of floating out there) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SKIN DISORDER (My skin is a total mess, I am having an awful problem with my skin.). On an unknown date, the patient experienced FEELING ABNORMAL (So I'm kind of floating out there). At the time of the report, SKIN DISORDER (My skin is a total mess, I am having an awful problem with my skin.) had not resolved and FEELING ABNORMAL (So I'm kind of floating out there) outcome was unknown.            No concomitant drug information was provided. It was reported that the patient had an issue with her skin after receiving the booster. The patient had received the booster shot six months after the primary series. Patient had seen a dermatologist. It was reported that the patient would never go back to the dermatologist and had lost the primary care.    Treatment drug information was not provided.
a patient received improperly stored V ARlV AX.; No additional AEs were reported; This spontaneous report was received from a Licensed Practical Nurse and refers to a currently 15-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On and unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml, (route of administration, anatomical location were not reported), lot # U016065 was confirmed to be valid, expiration date 20-MAY-2023 for prophylaxis. The temperature excursion was 0.3 degree Celsius (C) for 2 hours and 34 minutes; no previous temperature excursions were reported. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA006386: US-009507513-2110USA006418:
Shortness of breath, Cough,, back pain, 10% pneumothorax right side
3/26-vaccine 3/29- pain, swelling, redness, hot to touch, hard lump at injection site. Was mostly gone by 4/9. As of 4/15 hard lump remains at injection site. 4/6- 12:15pm hives, redness, itching, burning on sides of upper thighs, buttocks, within 2 hours hives spread to backs of arms, all the way down legs. Went to quick care facility at 2:30pm. Waited in waiting room until 3:50pm checked legs with doctor at 4:00pm and little red dots appeared in random clusters down both legs. Doctor assumed folliculitis, prescribed Cephalexin. 5:00pm took 50mg Benadryl while waiting for prescription. Picked up antibiotic around 6:30pm. When I got home around 7:00pm both legs were burning. Discovered huge painful red patches all over both legs. 10:00pm took 50mg Benadryl again. Went to bed 4/7- 9:00am red patches still painful, burning. Took 50mg more Benadryl. Spent most of the day sleeping 4/8- hives gone due to benadryl. Red patches slightly less painful. New red patches/dots appeared on ankles and tops of feet 4/9- red dots spread over tops of feet/toes, new itchy bumps with red dots appeared trailing down the backs of calf area on both legs. 8:30am went back to quick care facility. Saw new doctor who instructed to stop taking antibiotic and switch to cream form of "triamcinolone 0.1%" twice daily. Also referred to dermatology specialist. 3:30pm first application of steroid cream made legs burn and feet/ankles swell. Determined too much was used 4/10-4/13 smaller amount of cream applied twice daily as directed. Burning stopped but feet/ankles still swollen each day 4/13-original large red patches mostly cleared. New red dots on backs of calves and tops of feet still prevalent. 4:00pm saw dermatology specialist who determined red dots were a form of vasculitis. Ordered blood and urine analysis to determine if other organs have been affected. Scheduled appointment with laboratory for 4/17 at 11:00am Other symptoms: dizziness, abdominal pain/pressure, diarrhea at various points throughout the day from 4/9-current
patient first dose of Covid 19 vaccine was Modena, but for second dose Pfizer vaccine was given to patient mistakenly.
12/22 site of injection red, swollen, painful, harden, warm to touch,
Fine when left here, after home about 5:30 pm went upstairs and suddenly started screaming with sever h/a. Given ADVIL, laid down in dark room, quiet and h/a went away about 1/2 hr. Fine thereafter until about noon Tues 2/23. Suddenly had severe h/a again at school. Given ADVIL laid down and it went away again. 2/24 Weds fine - no problems again. Mom called pediatrician and talk to her Tues 2/23 also.
This spontaneous report as received from a medical assistant refers to an unspecified number patients of unknown age and gender. Medical assistant reported that an unspecified number patients received an unspecified pneumococcal vaccine (dose, route and lot number were not reported) about one to two weeks ago, in approximately September 2013. Medical assistant reported that about fifty percent of those who received the pneumococcal vaccine had been "coming down sick". Medical assistant reported that these patients had also experienced "slowing of the arm" with a "red streak" down the arm (in 2013). She also stated that these patients were in enough pain that they missed one day of work (in 2013). The outcome of coming down sick, patients were in enough pain that they missed one day of work, red streak down the arm and slowing of the arm was not reported. The relationship between the unspecified pneumococcal vaccine and the events was not reported. Upon internal review patients missed one day of work was considered to be a disabling event. This case is linked to case 1310USA008712 via same reporter link. Additional information has been requested.