chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain (serious criteria other: serious as per reporter), walking difficulty (serious criteria other: serious as per reporter), injection site erythema (serious criteria other: serious as per reporter) and leg pain (serious criteria other: serious as per reporter). The patient was treated with pregabalin (Lyrica). On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the walking difficulty and leg pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, walking difficulty, injection site erythema and leg pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the gluteal. After receiving SHINGRIX, the patient experienced pain at the injection site that resolved and pain down her leg which had not resolved causing her to have difficulty walking. The sales representative reported that the nurse was also the office manager. The contact detail of the physician was provided.
Patient lied about his age.  He signed up using a scheduling tool and provided a DOB and also filled out the consent form and put down that DOB in 3 separate fields.  Patient was 17 at the time of vaccination.
Pain at injection site; little "not feeling well" sensation like fatigued; Missed the recommended interval inter doses; little "not feeling well" sensation like fatigued; General Discomfort; Shoulder Pain; Covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval inter doses), MALAISE (little "not feeling well" sensation like fatigued), DISCOMFORT (General Discomfort), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (little "not feeling well" sensation like fatigued) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac ischemia in 2015. Concurrent medical conditions included Iodine allergy and Penicillin allergy. Concomitant products included TAMSULOSIN from 2016 to an unknown date for Hyperplasia of prostate, METOPROLOL from 2015 to an unknown date, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 2015 to an unknown date, ATORVASTATIN from 2015 to an unknown date, CENTRUM SILVER +50 and COLLAGEN from 2016 to an unknown date for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced COVID-19 (Covid-19 positive). On 14-Mar-2021, the patient experienced ARTHRALGIA (Shoulder Pain). On 15-Mar-2021, the patient experienced DISCOMFORT (General Discomfort). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval inter doses), MALAISE (little "not feeling well" sensation like fatigued), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (little "not feeling well" sensation like fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Mar-2021, DISCOMFORT (General Discomfort) and ARTHRALGIA (Shoulder Pain) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval inter doses), MALAISE (little "not feeling well" sensation like fatigued), VACCINATION SITE PAIN (Pain at injection site), FATIGUE (little "not feeling well" sensation like fatigued) and COVID-19 (Covid-19 positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications include Antibodies.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: On 23-Jun-2021, Follow Up document was uploaded which contains added event : Shoulder pain, General discomfort, Outcome of the events Shoulder pain, General discomfort  as recovered, second dose details, Concomitant medications and historical condition.
PROQUAD administered in office. Within 10 min of administration, patient began wheezing, had swollen/puffy eyelids and broke out in hives. BENADRYL and albuterol nebulizer given with improved symptoms.
Chills, malaise, muscle pain at injection state started about 24 hours after injection. Fever spiked at 100 degrees at 3p. Fever gone by 9a the following day.  Chills, aches, muscle pain continues almost 48 hours post injection
This case was reported by a consumer and described the occurrence of muscle soreness at injection site in a 39 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included gastric reflux. Concurrent medications included Esomeprazole (Nexium) which was indicated for the gastric reflux. The subject had received an unspecified number of influenza virus vaccine immunizations in previous years with no adverse events. On 14 November 2005 at 15:00 pm, the subject received a dose of Fluarix in his left arm (dose number and lot number not provided). On 14 November 2005, less than one day after vaccination with Fluarix, the subject experienced "deep muscle" soreness at injection site. The subject "went back to the health clinic" as a result of the event, "and the nurse was not able to help him." The event was ongoing at the time of initial reporting, 15 December 2005.
Blotchy and itchy skin around neck, on back, around midriff, and under arms. Tried children's benedryl (2 tsps) twice, didn't reduce symptoms. Went to see PA at doctor's office and she suggested taking Pepcid and Zyrtec together Have taken them the last 2 days and it   Reduced the itchiness during the day, but it has returned. Also bathed twice with an oatmeal solution, which eased the itchiness for  a while, but again, itchiness has returned. At this point will continue the Zyrtec/Pepcid combo for another day, along with the oatmeal bath, but may need to return to the doctor.
her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; getting a rash on her skin; This is a spontaneous report from a contactable consumer (patient reported for herself) communicated to Pfizer sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 30Jun2021, as dose 2, single for COVID-19 immunization. Medical history included autoimmune disorder from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. It was about 10 days after the 1st dose of vaccine and it was the weirdest thing, the top of her, she believed, right ear at first it was itching and burning and then started to crack and that lasted 5 days. She Stated she applied Neosporin and Vaseline on it and did not think much of it. On an unspecified date, about a week after receiving the second dose, she reported that her other ear was burning, bright red and felt hot and started cracking again. She also had a rash on her skin after receiving the second dose. She stated she thought it was sunburn, but she wears hat and her ears were covered. Investigation Assessment was not Provided. The outcome of the events was unknown at the time of this report. She reported that 4 different people from 4 different locations have all experienced the exact same side effect after receiving the Pfizer COVID-19 vaccine.   Information on the Lot/Batch number has been requested.
INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; DIFFICULTY IN WALKING; GRIP STRENGTH DECREASED; ACTIVITIES OF DAILY LIVING IMPAIRED; COVID-19; FATIGUE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on APR-2021, and received an additional second dose of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (Dose number in series 1).  Age at time of vaccination 55 years old.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number: 1159243) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  On an unspecified date in APR-2021, the patient experienced fatigue (Dose number in series 1). On an unspecified date in 2021, the fatigue was resolved.  On an unspecified date in NOV-2021, the patient experienced covid-19 (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient received booster dose with non-company suspect vaccine elasomeran (Dose number in series 2) (form of admin not reported, intramuscular, batch number not reported) dose was not reported, administered on JAN-2022 for prophylactic vaccination.  On an unspecified date in JAN-2022, the patient had fatigue (Dose number in series 2).  On 26-APR-2022, the patient was struggling to walk (difficulty in walking), struggling to open things (grip strength decreased) and difficult time with typing (activities of daily living impaired) (Dose number in series 2). It was unknown if patient was involved in COVID-19 vaccine trial. The action taken with elasomeran was not reported. The patient recovered from fatigue in 2022, was recovering from difficulty in walking, grip strength decreased, and covid-19, and the outcome of activities of daily living impaired, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
My hands are pealing and my skin is in rashes and I keep having my skin break out all the time. I have already visited my doctor and specialist and dermatologist and there is not much they can do for me.
Patient developed hives and hallucinations 6 days after administration of MMR, DTaP, IPV, Hepatitis A.
Varivax give SQ in L thigh at 1510. At 1515 child was note to have a dime sized raised welt with white spot in center about .5cm in middle. 1516 MD was called gave order for 10mg Benadryl to be given po.
On Aug 6 2009, I received the TDAP vaccine, on Aug 6 2009 fever 101 degrees, chills and body aches along with arm soreness could not move arm for approximately 1 week.  Had fever, chills and body aches until Sunday Aug 9 2009.  On Aug 8 2008 at 2:40 A. M. could not open left eye on Aug 12 2009 I could not open my RT eye after I had woken up from falling asleep.  Not opening of either eye this has been occurring for approximately 3 weeks, every 3rd or 5th day this occurs after I woken up after falling asleep.  Since September 2, 2009 cannot open both eyes after I woken up from falling asleep.  On September 24, 2009, could not open both of my eyes, had to use my fingers to open both of my eyes aster I woken up from falling asleep. If there are more questions or information at VAERS may need call patient.  As of this time I can not receive my MMR shot due to the fact that I am having a problem with he TDAP vaccine.  the reason that I need the MMR shot is for my clinician with out the MMR shot I will not be able to do my clinicals and will automatically fail my EMT-Basic course. Update: I am still having problems opening my eyes after I woken up from sleeping.
Fever of 100.6, chills, nausea, fatigue, pain at injection site. Started 24 hours after injection, lasted about 12 hours.
ADMITTED TO HOSPITAL 3/30/21  HISTORY OF COMPLETING COVID VACCINATION BUT DATE UNKNOWN LUNG TRANSPLANT PATIENT ADMITTED WITH IMMUNOSUPPRESSION AND COVID
No adverse reaction to vaccine, but unknowingly received a J&J vaccine 25 days after receiving a 1st dose of Moderna
This spontaneous report has been received from a 23 year old male patient referring to himself. The patient's pertinent medical history included papilloma viral infection (HPV). The patient's drug reaction/allergy included amoxicillin. Concomitant therapy included active hexose correlated compound (AHCC, mushroom). From March 2018 the patient was vaccinated with three doses of GARDASIL 9 (three dose injection schedule; strength, batch/lot # and expiration date were not reported) intramuscularly in the left deltoid muscle as a form of treatment to prevent re-infection and spreading of the HPV. The last dose was on 04-SEP-2018. The patient stated that the "vaccination didn't give him full immunity, and that at the beginning of August 2018 his warts spread a couple of times when touching other parts of his body while using GARDASIL 9". The patient "had taken topical treatment such as apple cider, and thuja oil as a form of treatment, which temporarily removed the warts, but then reappeared after one week". The patient visited physician to seek medical attention. The patient was hospitalized for a duration of one day to undergo a surgery for removal of warts. Unspecified tests were performed. The outcome of the events was reported as not recovered/not resolved. The causality between the events and suspect therapy was not reported. No product quality complaint (PQC) was involved.
Symptom onset started 5-6 hours after injection. Sxs included large red welt (~2inches in diameter) that was warm to touch and swollen, a low grade fever, chills, lack of appetite, general malaise.
I immediately began itching at the site of vaccination.  Mild swelling began immediately, but serious swelling occurred 3 days later by noon on August 8 to the point that I could feel the swelling moving toward my elbow.
I started having horrible upper back left shoulder blade pain that was tight on 4/26/21 mid afternoon. I thought I may have slept weird. Two days later and it?s worse and it spread to my neck and other right shoulder blade. It?s so sharp and awful. It?s gotten worse. Today it?s awful and it spread to the ride side of my chest. Same type of pain. I feel like I can?t breathe in that well and my lungs burn.
Superficial blood clots in both upper legs; each leg had one in the front and one in the back. They were very painful and tender with bruising around the area. The clots could be seen and felt.
Arm got really swollen red and hot all the way down to her fingertips; Arm got really swollen red and hot all the way down to her fingertips; Arm got really swollen red and hot all the way down to her fingertips; Injection site soreness; Metal taste in her mouth; had a weird feeling to her fingertips; arm was really sore; Injection site swelling; wave of heat go through her and it was like a hot flash; Headache/mild headache; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 20Jul2021 at 12:00 (at the age of 56-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Jul2021, the patient experienced arm got really swollen, red, and hot all the way down to her fingertips, and injection site soreness. Later than night the patient had a heat wave go through her, metal taste, and then a headache. The clinical course was the patient had the first dose at like 12:00 and the red arm started happening at 16:30 or 17:00. Her arm was really sore, hot, red and swollen, and had a weird feeling to her fingertips. This eventually went away but the injection site swelling was still there for a week. The injection site was still sore when she put the injection in for the second dose (on 11Aug2021). After the first dose, the patient had a wave of heat go through her and it was like a hot flash and then she got the metal taste in her mouth. The metal taste lasted about 30 minutes. Her mild headache lasted for a day and a half or two days. The sore arm at the injection site was sore for about a week, like it hurt. The heat wave went away and then the patient was more focused on her arm. The outcomes of arm sore, hot, red, and swollen, weird feeling to her fingertips, heat wave, metal taste, headache, and injection site swelling were recovered. The outcome of injection site pain was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101128576 same patient, different vaccine dose/AE
Sore arm starting 30 min post dose and continuing till hour 50 post dose. extremely vivid dream at ~hour 40 post dose.
given vaccine which underwent temperture excursion; No adverse event; given vaccine which underwent temperture excursion; given vaccine which was beyond the 30 day use by date; vaccine which underwent temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion). On 19-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion) and EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion).    No concomitant medicine were reported.  I t was reported that the vaccine lot had undergone temperature excursion between 15 -17 AUG 2022.   No treatment medicine were reported.
Information has been received from a registered nurse concerning a patient who was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Within 24 hours of the vaccination the patient experienced an injection site reaction. The patient had a hard raised swelling area the size of a "half dollar" following the varicella virus vaccine live (Oka/Merck) vaccination. The overall size of the swelling was about 6 to 8 inches in diameter on the arm. It was reported the patient contacted their physician. At the time of the report the patient was recovering. A product quality complaint was not involved. Follow-up information was received on 13-SEP-2007. Follow-up information has been received from a registered nurse concerning a 12-year-old female with no pertinent medical history or allergies who on 24-AUG-2007 was vaccinated subcutaneous with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 657192/0362U). Concomitant vaccines administered on 24-AUG-2007 included a first dose of Gardasil (MSD) (Lot # 6469U), sixth dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (GlaxoSmithKline) (Lot # AC52B02AA), first dose of Menactra (Sanofi Pasteur) (Lot # U2391BA), and first dose of hepatitis A virus vaccine (unspecified) GlaxoSmithKline) (lot # AHAVB186AA). On 24-AUG-2007, the patient developed severe increased left thigh left groin pain; 2 inch edematous; reddened area noted on left thigh; lymph node in groin area enlarged and fatigue. The patient returned to the clinic for medical attention on 27-AUG-2007 and had a mean platelet volume of 10.0 fluid (normal range 0.0-9.9 fl). Subsequently, the patient recovered from all adverse experiences on 29-AUG-2007. This one of several reports received from the same source. Additional information is not expected.
Chills; other discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, unknown manufacturer), for Covid-19 immunisation. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; DISCOMFORT (non-serious), outcome "unknown", described as "other discomfort". Additional information: Patient had chills and other discomfort after 2nd COVID-19 Vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.