chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a dose on 23rd April 2021 that has been expired in 2020; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HAV (Havrix) (batch number 3KT7B, expiry date 10th December 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd April 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd April 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a licensed practice nurse. The patient had received a dose of Havrix in 2021 that had been expired since 12th October 2020, which led to expired vaccine administration. The reporter consented to follow-up.  Note: Expiry date mentioned in narrative as 12th October 2020 seems discrepant as batch number corresponds to expiry date of 10th December 2020 as per structured field which is retained in the case until further clarification obtained in follow-up.
Information has been received from a physician referring to a female patient of unknown age. On unknown dates the patient was vaccinated with the first and second doses of GARDASIL (lot#, expiration date, dose and route were unknown). The physician was intended to administer the patient a dose of GARDASIL 9 to complete the series on 19-MAY-2015. No adverse effect was reported. Additional information has been requested.
17 year old patient rec'd Fluzone High Dose, no treatment necessary, no adverse reaction
After dose one( given 7/22/21) had onset of shortness of breath treated in urgent care 6 days after (two visits w/in ten days of vaccination). It was treated with inhaler and  ruled out as cold/smoke inhalation.  I found the best treatment was several allergy medications daily for several days.   I was in normal health 5 days prior to 2nd vaccine. One hour after 2nd vaccine I had the onset of asthmatic cough and started to feel similar to  symptoms I had felt after dose one. It escalated to asthmatic cough relieved with allergy medication.  I had 36 hrs of significant asthmatic cough.  Some chest pain and severe back pain.  I went to ER was rx another inhaler. I took allergy medication with relief for 3-4 days. I used the inhaler 1-2 times  after visit. All symptoms resolved and I have been in normal health since.
Arm red & swollen size of orange given 8/31 - noticed 9/1/10. No MD visit. TYLENOL; cool cloth. 9/3/10 better.
Information has been received from a father concerning his daughter who in 1997 was vaccinated with MMRII (site not reported). About six weeks after the patient received MMRII, in 1997, she developed a severe arthritic knee condition. The a patient went through several tests including a bone  scan and a biopsy (results not provided) to try to determine the cause. The father reported that the specialist felt that the arthritis knee condition may have been a result of the rubella component of MMRII. The knee condition lasted about 2 months. No further information is available
"Since January", the patient "has not had her period"; This spontaneous report has been received from the patient's mother concerning to her 16-year-old daughter. There were none pertinent medical history, concurrent conditions or concomitant medications were reported.  On an unknown date in July 2018, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) one dose intramuscularly (frequency, lot number and expiration date were not provided); furthermore, on an unknown date in January 2019, the patient received one booster of hepatitis a vaccine, inactivated (VAQTA) (frequency, lot number and expiration date were not provided) for hepatitis prevention.  Approximately on an unknown date in January 2019 (reported as since January), the patient had not her period (amenorrhea). The patient sought medical attention and called the physician, the patient did not receive any treatment and none laboratories or studies were performed.  Therapy with hepatitis a vaccine, inactivated (VAQTA) was reproted as continued. The outcome of amenorrhea was reported as not resolved. The causal relationship between the adverse event and the therapy was not assessed.
Right axillary adenopathy - approximately 1.5 cm lymph node and possibly 2nd 0.5 cm lymph node noted by patient on self-exam 5 weeks after booster COVID-19 vaccine. History of ipsilateral primary breast cancer (stage 2 invasive ductal carcinoma) dx 3 yrs prior. Patient contacted primary oncologist who recommended waiting 3-4 weeks before getting ultrasound and clinical breast exam (if node remains palpable at that time).
dizziness, tingling in face to neck and nausea; rested and refused emergency department
Patient was given  COVID 19 booster at 11 am in left deltoid. At 11:03AM patient felt anxious and lightheaded. Patient was instructed to sit in a chair. Skilled nurse notice patient walking sideways, skilled nurse stopped patient in hallway to sit and rest in chair; patient stated she felt ok about 2 minutes after siting in chair. Patient stated that she was fine and wanted to continue to observation room, upon getting out the chair patient stated she felt  Dizzy. Patient was eased to floor to keep her from falling, A RRT was called; no head injury; patient was stable. Patient was transferred to ER via stretcher
Sob wirh act. Worsened. Came to hosp and was dx with many PEs and right Leg dvt. No other obvious caus3
My child is currently 7yrs old. when she was 3yrs old she was diagnosed with shingles. This is very bizzare considering she has never had chicken pox. I believe the vaccine caused this virus. We have documentation and pictures with a local dermatologist when she was first dx. Since then, every summer she has outbreaks. We keep an active prescription of accylovir on hand just for that reason. I believe this is a dangerous vaccine and others should know the possible side effects and dangers related to this.
Pt came in and stated he had not received a covid vaccine- that this would be his first.  We only had moderna at the time so we gave him the Moderna vaccine and scheduled him for his 2nd appt.  When our report came up of patients that missed their 2nd dose, we looked on the website to make sure he had not received the 2nd dose at another pharmacy.  It then showed us he supposedly received a Pfizer vaccine on July 1.  We called the wife and she said she knows nothing about another covid vaccine and she should have been notified because he is disabled.  She is checking with the hospital tomorrow to see if they gave him one because she had not taken him anywhere else for the vaccine
Information has been received from a certified medical assistant concerning a 1-year-old male with no pertinent medical history or allergies who in February 2007, was vaccinated subcutaneous with 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 653434/0563F). There was no concomitant medication. On 03-SEP-2007, the patient developed varicella and had about 10-15 lesions. The patient sought medical attention via an office visit. No diagnostic labs were performed. At the time of the report it was unknown if the patient had recovered. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of facial palsy in a 15-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  Concurrent vaccination included MENACTRA (Sanofi) given on 7 July 2008.  There were no concurrent medications.  On 7 July 2008 the subject received 1st dose of BOOSTRIX at 1.0 ml in the left arm.  On the evening of 8 July 2008, 1 day after vaccination with BOOSTRIX, the subject experienced facial palsy, a systemic reaction.  The healthcare professional considered the events were clinically significant (or requiring intervention).  At the time of reporting the outcome of the event was unspecified.  The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.
Injection site had developed redness, elevation and warm to touch 8 days after vaccination was given. Topical benadryl applied to site to lessen redness..
No immediate AE/ reaction. Member was given FLUAD (for 65years and up);  member was 57 years old at time of vaccination.
Soreness and Swelling at the injection site; Rash at the injection site; Swelling at the injection site; low grade Fever; Chills; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st December 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site rash, injection site swelling, fever, chills and fatigue. On 3rd December 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site rash, injection site swelling, chills and fatigue were recovered/resolved.   The reporter considered the injection site pain, injection site rash, injection site swelling, fever, chills and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had fatigue, Chills, low grade Fever, soreness and swelling at the injection site, and rash at the injection site.  The reactions lasted between three to five days. The reporter consented to follow up. All information was not available.
4x5 cm. area of dark red discoloration and induration with some mild tenderness at the site. No vesicles, pustules or skin breakdown. Does not appear to be hematoma at site of injection because there is no involvement of deeper tissues.
Pt received the vaccine around 11:40 am in the morning and by the evening she said her arm started to hurt/swell/warm to touch. She came back to the pharmacy today with a large area of redness, swelling and warm to touch. The size is bigger than the size of my palm. Pt did not peel the bandaid off since the day of the shot, I removed it to check the injection site underneath. There was no oozing but there was a stinky smell to the area. We have contacted the pt's doctor and they will have a nurse follow up with the patient.
pt recv vax 19AUG94 & 3 days later devel numbness on one side of mouth & drooping of the rt side of mouth;
Right arm swollen and red, pt given 40mg single vial of DEPO MEDROL in clinic, Cephalexin 500mg oral capsule.
exp burning sensation when fluid put in rt arm much bleeding;arm remained sore 2 firm knot @ site for several days;nauseaous, severe h/a, diarrhea (p/eating) several timeas a day;loss of appetite, fever 98.9-100.7;muscle & bone soreness;
NOT FEELING WELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the patient experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling well was not reported. This report was non-serious.
LARGE REDNESS ON UPPER LEFT ARM( SITE OF SHINGRIX VACCINATION) AND WARM TO TOUCH WITH SOME ITCHINESS
Reporter stated that Cosentyx was discontinued due to ineffectiveness that was noticed after taking vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of DRUG INTERACTION (Reporter stated that Cosentyx was discontinued due to ineffectiveness that was noticed after taking vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product SECUKINUMAB (COSENTYX) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and SECUKINUMAB (COSENTYX) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DRUG INTERACTION (Reporter stated that Cosentyx was discontinued due to ineffectiveness that was noticed after taking vaccine). At the time of the report, DRUG INTERACTION (Reporter stated that Cosentyx was discontinued due to ineffectiveness that was noticed after taking vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.
Entire left arm swollen and painful. for about 1 week.  Next day started getting itchy hives on extremities. One or two per day in different locations. Last about one day and go away. Then a new one develops in a new place. Still getting new ones after 2 weeks.
Sore arm, red and swollen at injection site Symptoms beginning same night and lasting 36 hours: Headache Sore throat Nausea Chills and Fever  General malaise   36 hours on: continued lack of energy and inflammation at injection site
20 yr old Female patient received first dose Pfizer covid19 vaccine in left arm administered by pharmacy intern at 3:27pm .  supervising pharmacist was (Name) pharmD.   Prior to patient receiving the covid19 vaccine  pharmD reviewed and went over all the DUR and digital patient questionnaire questions.  Mother of patient was present and mentioned that in the patient's past , the patient had fainted after receiving a vaccine.  PharmD told patient that because this occurred in the past, the patient will have to wait 30 minutes after vaccine administration for observation.    Patient was sitting in post-vaccination area, and about 3 minutes later patient's father notified staff , that patient felt dizzy and  looked pale and had blurry vision and patient was sweating.  PharmD  asked the patient if she had any difficulty breathing and if she felt itchy or had any rash as a result of the vaccine reaction.    We immediately called the pharmacy and notified (Name) of the situation.  The patient refused us to contact 911 and refused 911 care.  The pharmacy manager immediately arrived to the Clinic fitting room area.  Upon arrival,  the pharmacy manager provided alcohol swabs to patient to inhale because at that moment we did not have ammonia inhalants. PharmD  quickly made his way to the pharmacy to obtain the ammonia inhalants , which is a respiratory stimulant.  The pharmD returned to the Covid19 clinic with ammonia inhalants, which were never used, because we did not see the need.  Patient remained conscious the entire incident.    We decided not to  use epinephrine.   The pharmD measured the patient's blood pressure at 3:38pm .  bp reading was 109/65.  Pharmacy manager took pt temperature at 3:45pm, reading was 97F.  Pharmacy manager retook blood pressure at 4pm.  bp reading was 93/63, pulse of  72.   The pharmacy manager advised the patient to seek medical attention if patient continues to get worse.  bp was lower the second reading.  The pharmacy manager asked  patient a second time at 4pm if patient wanted us to call 911 again, and again patient refused us to contact 911.
Rash erythema, spots on tongue, cheilosis lips, fever x 1 day, SX onset 11 days post vaccination.
LIKE I SAID EARLIER, AFTER MY FIRST SHOT, I HAD NERVE TWINGES IN MY LEFT ARM (INJECTION ARM FOR FIRST SHOT). THE SECOND SHOT, I HAD IN MY RIGHT ARM TO NOT AGGRAVATE LEFT ARM MORE.  ON THE NIGHT OF MY SECOND VACCINE, I STARTED HAVING NERVE PRICKS AND TWINGES THROUGHOUT MY ENTIRE BODY. THEY FEEL LIKE ELECTRIC SHOCKS HAPPENING INTERMITTENTLY - EVERYWHERE IN MY BODY. AS OF TODAY, APRIL 30, ALMOST TWO WEEK LATER, THEY HAVE NOT STOPPED.
Patient received the vaccine on 3/23/21 and developed symptoms of COVID on 4/5/21 (abdominal discomfort, heartburn, shortness of breath, and cough). On 4/8/21 she was admitted to hospital with COVID and is currently on supplemental oxygen.
Breakthrough case admission after 3 vaccines Pfizer 2/25/21 Lot# EN6200;  Pfizer 3/17/21 Lot# EN6199;  Pfizer 10/10/21 Lot# FH8020
death; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient was the reporter's little brother. The age at vaccination was not reported. The patient died from complications after receiving a Flu shot.; Reported Cause(s) of Death: Unknown cause of death
allergic reactions to the additives. It has happened to me twice when I took the old people vaccine version; Initial information received on 12-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved unknown age patient who reported allergic reactions to the additives. it has happened to the patient twice when patient took the old people vaccine version (Allergic reaction to excipient), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant medication medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who reported allergic reactions to the additives. it has happened to me twice when patient took the old people vaccine version (Allergic reaction to excipient), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was allergic reactions to the additives. it had happened to the patient twice when patient took the old people vaccine version.    It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for allergic reactions to the additives. it had happened to the patient twice when patient took the old people vaccine version.  There would be no information available on batch number for this case.
This spontaneous report as received from a currently 29 years old female patient who was a certified medical assistant (C.M.A.) refers to herself via a field employee. The patient's concurrent conditions included Sjogren's syndrome and rheumatoid arthritis. On unknown dates, the patient was vaccinated with a first and a second dose of GARDASIL and on an unknown date in 2007, she was vaccinated with a third dose of GARDASIL (doses, routes of administration, lot # and expiration dates were not provided). The patient did not take any concomitant medications. On an unknown date (reported as "several months" after the patient received the third dose in the GARDASIL series), she felt paralyzed due to severe joint pain all over her body. The patient also felt  immobilized for an unspecified amount of time prior to receiving treatment with unspecified doses of methotrexate (manufacturer unknown), Sulfa and prednisone (manufacturer unknown) for an unspecified amount of time. On an unknown date, the patient had a follow up appointment with her physician where the physician ran some unspecified tests and gave a diagnosis of rheumatoid arthritis. The physician also told the patient that her rheumatoid arthritis was "dormant in her body" prior to receiving the GARDASIL series and the vaccine could have possibly triggered the rheumatoid arthritis. At the time of the report, the patient still had the rheumatoid arthritis, was on an unspecified dose of XELJANZ and was no longer on the treatment with methotrexate (manufacturer unknown), Sulfa and prednisone. The event of rheumatoid arthritis was considered to be disabling by the reporter. Additional information has been requested.
SEVERE HEADACHE/MIGRAINE FOR APPROX. 48 HOURS WITH TIREDNESS. MOTRIN/ADVIL WOULD NOT HELP. NO OTHER SYMPTOMS. HAVE HAD NO OTHER REACTIONS WITH SEASONAL FLU SHOT. CALLED PHARMACY WHERE WAS GIVEN AND DOCTOR THEY SAID HEADACHE IS COMMON, BUT THIS WAS A MIGRAINE FOR 48 HOURS, DOES NOT GET HEADACHES OFTEN. MILD OTHER SYMPTOM AT SHOT SITE WAS REDNESS, AND ITCHING AT SHOT SITE.
Patient stated a day after receiving the shot her arm began to swell and turn red. She stated that it was extremely swollen. She stated that a couple of more days passed and then a rash developed on her an extremely, large rash developed on her back. Per the doctor from urgent care it was an allergic reaction to the immunization. It did not appear to be shingles. After further questioning of the patient, she stated that she had arm swelling and redness on her first shot. She received a medrol dosepak and triamcinolone cream today (1/2/21). She had previously tried cortisone cream which gave some relief but not enough.
From 2/20/2022 I started getting rashes and itches in both my arms, legs, and back of the neck.  I visited my primary physician Dr and he did all the allergy tests and everything came negative.  He suggested taking Benadryl for a week. I took 2 tablets every day for a week and the itches and rashes got reduced. So i stopped taking it.  Then after 2 days, it is starting to come back. I'm still having this issue.  I never had any allergies in the past and only the variable I see now is the Covid 19  booster which could have caused this issue,
2 days after vaccine given - whole (L) arm was painful from shoulder to fingers 8 (1-10). TYLENOL X-strength muscle cream. Heating - helped some. Did not sleep well x 4 nights. Pain continued for 4 days.