chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave expired Flublok vaccine with no reported adverse event.; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received via a consumer (under Medical Information Inquiry Number-00814642).  This case involves a 22 year old female patient who experienced gave expired flublok vaccine with no reported adverse event (expired product administered) while receiving vaccine influenza quadrivalent recombinant vaccine [flublok qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 03-Sep-2021, the patient received a dose of suspect influenza quadrivalent recombinant vaccine (lot- QFAA2017, expiration-30-jun-2021) via intramuscular route in unknown administration site.  On 03-Sep-2021 the patient reported gave expired flublok vaccine with no reported adverse event (expired product administered) following the administration of influenza quadrivalent recombinant vaccine.  It was reported "There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."  Relevant lab data was not reported.  Action taken with quadrivalent recombinant influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received 1st dose of vaccine on 2/6/21. That afternoon, developed malaise and fever/chills over the next few days. On the evening on 2/9/21, began to have left-sided chest pain (severe, pleuritic, radiating to left arm) leading her to seek medical care. Was determined to have viral pericarditis and admitted to the hospital for several days
Patient ,, was vaccinated at approximately 2:15pm today at  Vaccine Clinic. While in the observation area post-vaccine, patient lost consciousness at approximately 2:20pm for 60-90 seconds. Patient was not nervous, did not feel dizzy, nauseous, or feel she had an allergic reaction to the vaccine. Patient is an employee of  Environmental and was accompanied by a co-worker.  PA  evaluated the patient, initial pulse rate was 104, a few minutes later was 87, then rose again to 97.BP was 125/78. Patient reported feeling weak and cold, has not eaten or had anything to drink today except a cup of coffee and cookies in the morning. PA assessed the patient vasovagaled due to dehydration, not due to a reaction from the vaccine. Patient drank 3 small bottles of water, ate saltine crackers and a granola bar.   EMS was called and we attempted to cancel as the nurse was going to take the patient to  ED, but EMS arrived on site already, assessed the patient and the patient refused to go to the ED by nurse or EMS.  Patient was observed until 3:12pm and went home in an Uber.   Patient info:   Appointment #D11KA5Q
FRIDAY, APRIL 5, 2019, 7am, Received second SHINGRIX vaccination in right deltoid. Took BENADRYL, ibuprofen, and TYLENOL. 11am - Hot flashes, Sweats. 12pm - Muscle aches everywhere, but increased on right upper arm, right side of neck. Continue BENADRYL, ibuprofen, and TYLENOL. 7p - Skin on chest and arms feels like sunburn. Chills/uncontrollable shivering. Increased temp. Muscle aches everywhere, but increased on right upper arm, right side of neck, bilat shins. Mild headache. Unquenchable thirst. Injection site swelling and tenderness. Continue BENADRYL, ibuprofen, and TYLENOL. Had to leave restaurant due to above symptoms. 3am - Swelling, warm to touch, and tenderness from injection site on right deltoid, right shoulder, to up the right side of my neck to my ear Injection site tenderness. Chills/uncontrollable shivering and temp continues. Continue BENADRYL, ibuprofen, and TYLENOL. SATURDAY, APRIL 6, 2019, 730am - Swelling, warm to touch, and tenderness from injection site on right deltoid, right shoulder, to up the right side of my neck to my ear Injection site tenderness. Chills/shivering have subsided. Continue BENADRYL, ibuprofen, and TYLENOL. 12p - Sweats. Neck swelling has gone down Swelling, warm to touch, and tenderness continues on right deltoid and right shoulder. Continue Ibuprofen and TYLENOL. 6p - Sweats have discontinued. Swelling, warm to touch, and tenders continues on right deltoid. SUNDAY, APRIL 7, 2019, 6am - No swelling in right upper arm, Tenderness at injection site only. 6pm - All symptoms have subsided.
Varivax given durin teperature excursion; This spontaneous report as received from a certified medical assistant refers to a 16 year old patient of unknown  gender. Medical history, concurrent conditions and concomitant medications were not provided.  13-JAN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (route, anatomical location were not provided )(lot # S021925, expiration date 15-JUL-2021) for prophylaxis, that was given during a temperature excursion that was later found supported. Temperature excursion was  -9.1 C, during a time frame 1 hour and 11 minutes, no previous temperature excursion. No data logger was involved.
Symptoms developed over about 36 hours. Started with injection site pain, followed by that arm feeling very heavy. Overnight, the bottom half of my body also felt very heavy -- I had difficulty moving my legs. The following morning, I had a slight fever (99.5 vs my normal 97.5), was nauseated and extremely tired. I slept most of that day. The following day, I was still fatigued (but functional) and the other symptoms had dissipated.
6/30-7/4: bad headache. 7/7: sudden onset of arthritic symptoms in fingers, knees, ankles, and toes. Tried NSAIDs for one week (ibuprofen then indomethacin), with no improvement. Now on a 6 week course of prednisone as prescribed by Drs. at Rheumatology Clinic.
Mom states yesterday 6/25/08 after shower noticed Lt upper red swollen and itchy arm
Large pinkish-red rash--itches.  Started 24 hrs. afater injection.  Instructed to take oral benadryl and use benadryl cream.
Pt has been scratching injection site on both legs since injection date. pt now has raised, red dry patch on both legs by injection site. pt has been rx's meds also referred to specialist.
Nongranulomatous anterior uveitis in the eye; Painful to move her eye or head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood thinner" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing), notes: Since she was a child and has been on since 18 years old. The patient's weight reported as 107 - 108 lbs. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single; ELIQUIS taken for anticoagulant therapy; LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: moderna (DOSE 1, Lot number: 038K20A or 038K26A), administration date: 21Jan2021, for Covid-19 immunization, reaction(s): "Hives"; moderna (DOSE 2, Lot number: 006M20A), administration date: 18Feb2021, for Covid-19 immunization, reaction(s): "Hives"; BNT162b2 (DOSE 3 (BOOSTER), Route of Administration: Intramuscular, Lot number: FJ1611), administration date: 16Dec2021, for Covid-19 immunization, reaction(s): "Hives", "Interchange of vaccine products". Within 3-4 days after COVID-19 Vaccine Bivalent, patient's eye got very red, white part got swollen, and was painful to move her eye or head. She could not see well. Because this happened during a holiday, she could not see her doctor till Monday. Her doctor said she developed non-granulomatous anterior uveitis in the eye. Her doctor prescribed her eye drops and steroids which helped with pain. She knows some people have gotten this shot and have gotten this reaction and her fear is that she will lose vision in her eye. She would like to know what the outcome of people has been who have had this side effect from this shot. She wishes she had not gotten the shot. The events were assessed as serious (medically significant). The outcome of the events was unknown.
I began symptoms November 21st 2019 which slowly progressed to being paralyzed by Jan 27th 2020 I was diagnosed with GBS and treated with IVIG, sent to rehab got worse. Readmitted to another hospital and diagnosis changed to CIDP. Still in treatment to this day.
Suspected vaccination failure; Didn't work - Shingles; Pain free in a week to 10 days; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and lysine. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient took the first vaccine and it did not work.  The patient got the second vaccine, the 2 jab and did not work.  After receiving Shingles vaccine, the patient got shingles. The patient stated that, Lysine helped and doctor prescribed Valacyclovir to take at onset.  The shingles usually was pain free in a week to 10 days.  This was the best he/she could do since the vaccines did not work. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
3 hours, post vax, pt experienced difficulty focusing eye, body tingling, fatigue and inability to stay awake. Blood sugar checked and was 130. Pt slept for 1 1/2 hours and upon awakening, felt better but not normal. Had another similar episode approx. 22 hours, post vax. Referred to PMD.
15 minutes following injection of varicella and mmr to left thigh mom returned with child and wanted us to see left thigh reddness and swelling.  2 3/4 inch in diameter reddness noted on left lateral thigh extending out around injection site of varicella.  MMR vaccine was also given in left thigh but 2 inches proximal to site of varicella injection.  No wheezing, SOB, no other skin reactions noted.  calm and drinking milk bottle.  Benadryl 6.25 mg given po.  instructed to apply cold compresses x10 minutes every 2-4 hrs for 24 hours and then warm compresses 4-5 times daily until swelling gone.  instructed mom to call clinic if he has further swelling, fever > 101 or change mental status.  instructed mom to call 911 with any sob, wheezing or decreased level consciousness.
Vomiting (vomited about eight times); massive headache; chills; sweats; and fatigue. Lasted another 30 hours.
blood presure went 154/104 rapid heart palpitations, diziness and weakness. Nausea. After 15 minutes I was rush to the Emergency room
One hundred fifty days after receiving the fifth vaccine I started having signs that my autoimmune disease is back. My skin on parts of my body has turned yellow. I went to my doctor, who took blood test confirm that the autoimmune disease was back. Once the blood test confirmed what both the doctor and I suspected, I started receiving the infusion treatment.
Injection given 8/25/2020 in left thigh IM. Next day presented with red, swollen skin around the injection site that measures 7"x6.5" in diameter. 8/27/2020 was given cephalexin & Ibuprofen
This spontaneous report was received from a state immunization official who is a health worker refers to seven patients of unknown age and gender. No medical history and concomitant medication was reported. On an unspecified dates seven patients were inadvertently vaccinated with (Oka/Merck) VARIVAX lot # J000152 (Strength, Dose, Route were not reported) that had been improperly stored. No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Morning after Shingrix  was received (03/19), terrible burning pain in teeth on right side of upper jaw.  Next morning (03/20) visited dentist & was diagnosed with cracked molar.  The molar was extracted by dental surgeon 0n 03/21.  On 03/22  pain in jaw and lower part of my face so severe that I had my wife take me to the Urgent Care emergency room where the attending physician diagnosed that I had shingles in my upper right jaw, right nostril & right side of face.  The morning of 03/23 the shingles blisters were in full bloom.
Myalgia, Arthralgia, Fever, discomfort at injection site Narrative:
Feeling tired and week; Swollen arm and itch; Swollen arm and itch; Bright red cherry rash on right arm; Feeling tired and week; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling tired and week), PERIPHERAL SWELLING (Swollen arm and itch), PRURITUS (Swollen arm and itch), RASH (Bright red cherry rash on right arm) and FATIGUE (Feeling tired and week) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032A21A and 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Fibrodysplasia ossificans progressiva, AMLODIPINE for Hypertension, LEVOTHYROXINE for Hypothyroidism.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced ASTHENIA (Feeling tired and week), PERIPHERAL SWELLING (Swollen arm and itch), PRURITUS (Swollen arm and itch), RASH (Bright red cherry rash on right arm) and FATIGUE (Feeling tired and week). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Feeling tired and week), PERIPHERAL SWELLING (Swollen arm and itch), PRURITUS (Swollen arm and itch), RASH (Bright red cherry rash on right arm) and FATIGUE (Feeling tired and week) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
pt recv vax 3SEP97 & 4SEP97 pt exp fever of 99.1;5SEP97 fever inc to 100 & on 8SEP97 it inc to 101.5;8SEP97 pt exp cold sx & tinea w/no rash;no cold sx were noted prior to vax;25SEP97 lesions;T104;
48 hrs of fever following vax then onset of maculo papular rahs x 48 hrs; sib had similar rxn p/3rd DTP;
Roughly 7-10 mins after the patient received the vaccine he complains of black out and cant see anything for a couple minutes and feeling weak and nausea.  I measured the patient blood pressure and it seems lower than normal. After the patient rest for a while I reassess the patient blood pressure and he seemed to feel a lot better. I asked the family to stay for additional 15 mins or 20 mins to observe him but they insist on leaving . I instructed the parents to observe him and if he gets worst get medical help. I have a staff member at the facility to call the family after 30 mins later and the parents stated he is moving around and feel a lot better.  The parents also called back a few hours later and stated he is doing good.
Three days post vax, the pt experienced local tenderness at injection site. The pt reported her deltoid muscle was warm to the touch and felt like itching coming from inside of her skin. The pt sought unspecified medical treatment.
Patient stated she had a 2 to 3 inch round mass on arm opposite the injection site. It is red and inflamed.
pt recved vax & was a non-responder to the vax; No further details were provided;
Cold chills,bad headache and lower back and neck ache/pain  from 12:30 on the 18th till 19th then cold chill stopped back and head ache pain continues till Saturday 20th am Tylenol was taken didn't help much   I continue to get slight headache as of today 22nd Monday fine now except slight head and back pain
constant itching; redness; burning sensati on of my skin; severe,acute hives urti caria which covered 80% of my body and persisted for more than two weeks.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (severe,acute hives urti caria which covered 80% of my body and persisted for more than two weeks.), PRURITUS (constant itching), ERYTHEMA (redness) and SKIN BURNING SENSATION (burning sensati on of my skin) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 038B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (severe,acute hives urti caria which covered 80% of my body and persisted for more than two weeks.). On an unknown date, the patient experienced PRURITUS (constant itching), ERYTHEMA (redness) and SKIN BURNING SENSATION (burning sensati on of my skin). At the time of the report, URTICARIA (severe,acute hives urti caria which covered 80% of my body and persisted for more than two weeks.), PRURITUS (constant itching), ERYTHEMA (redness) and SKIN BURNING SENSATION (burning sensati on of my skin) outcome was unknown. Not Provided          Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Administered far up his upper arm almost on his shoulder; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder). On 20-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder) to be not applicable.    Concomitant medications were not provided. Treatment details were not provided.
Patient received first dose of Pfizer vaccine. Patient was told to wait in the observation area for 15 minutes post dose to monitor for allergic reactions. Patient after 10 minutes advised the pharmacist that she was having a bit of difficulty breathing, short of breath, and her throat was feeling funny. Patient remained conscious, breathing, and alert during this period, while sitting down. Pharmacist called 911. Pharmacist proceeded to draw up Benadryl for injection. However, as dose was being drawn up, EMS arrived.  Within 5 minutes, EMS arrived to assist patient. EMS took patient to provide additional care. Patient was conscious, breathing, and alert as EMS took her for further care.
her arm (where the injection was given) was sore / soreness/achiness /  little soreness left; This case was reported by a consumer and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included cholesterol. Concurrent medical conditions included irritable bowel syndrome. Concomitant products included INFLUENZA VACCINE (INFLUENZA SHOT).   On 26th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in unknown arm. After receiving 1st dose of Shingrix, the patient experienced arm (where the injection was given) was sore. The pharmacist suggested she get tested for Covid and result came back negative. The reporter was the patient. The reporter consent to follow up. This is 1 of the 6 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020245582:same reporter US-GLAXOSMITHKLINE-US2020245580:same reporter US-GLAXOSMITHKLINE-US2020AMR246337:same reporter US-GLAXOSMITHKLINE-US2020AMR246336:same reporter
part of vaccine running down arm; part of vaccine running down arm; part of vaccine running down arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 4J9T5, expiry date 17th April 2023) for prophylaxis.   On 30th January 2022, the patient received the 1st dose of Shingrix (intramuscular). On 30th January 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were reported as follows: The vaccine was administered on patient's left deltoid. The patient received a dose of Shingrix and noticed small part of vaccine running down the arm which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. Consent to follow up was granted.
Headache, fever, chills, neck pain, body and joint aches, left breast pain and fever, injection site pain and fever.  All side effects lasted three days.