chrisvoncsefalvay/vaers-outcomes huggingface dataset:
previously reported temperature excursion for menquadfi with no reported adverse event; after temperature excursion clinic did administer a dose of the menquadfi to a patient with no reported adverse event; Initial information was received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 11 years old male patient who reported that previously reported temperature excursion for menquadfi with no reported adverse event and after temperature excursion clinic did administer a dose of the menquadfi to a patient with no reported adverse event after receiving meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Sep-2023, the patient received a dose 1 of 0.5 ml of suspect meningococcal a-c-y-w135 (t conj) vaccine (Solution for injection) (lot U7633AB, Expiry date :25-Apr-2025, strength was unknown) via intramuscular route in the right deltoid for Immunization.  On 15-Sep-2023 the patient previously reported temperature excursion for menquadfi with no reported adverse event (product storage error) and after temperature excursion clinic did administer a dose of the menquadfi to a patient with no reported adverse event (poor quality product administered) (latency : same day) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event previously reported temperature excursion for menquadfi with no reported adverse event and was Unknown for the event after temperature excursion clinic did administer a dose of the menquadfi to a patient with no reported adverse 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.  Additional information was received on 21-Sep-2023 from Other health care professional : Correspondent reporter, Patient initials, therapy start date, dosage, dose number, route, events were added. Case was upgraded from Non case to valid. Text amended accordingly.
Slightly raised, red, roughly circular rash at the site of the injection. 24 hours after first appearance approx. 4? x 3? in diameter. Ibuprofen and hydrocortisone creme applied helped get rid of itching and slight soreness.
Information has been received from a healthcare worker in immunization official referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. Between 08-SEP-2015 and 11-SEP-2015, the patient was vaccinated with an unspecified dose in VARIVAX (Merck) ((lot # K021936, expiry date 10-NOV-2016 or lot # L018001, expiry date 19-MAY-2017) (dosage, strength and route were not reported)) that was improperly stored. Concomitant medication information was not provided. At the time of the report, no adverse effects was reported. Additional information has been requested.
Running with fever 102.1; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Jul2021 (Lot Number: Unknown) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on unspecified date as a single dose for covid-19 immunisation. The patient received vaccine shot yesterday (on Jul2021, second one) and she left with she is running with fever 102.1. Patient took one tylenol for the event and patient's husband told she shouldn't take that, so she didn't take the second (Tylenol). The reported want to know can patient take the tylenol with the vaccine if she has the fever. The outcome of event was unknown.  No follow-up attempts are possible; No further information is expected.
Site: Pain at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chills-Severe, Systemic: Dizziness/Lightheadedness-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Headache-Medium, Systemic: Weakness-Medium
Booster was given 3 hours after puncture of a 12 hour vial.
no adverse event; Patient was administered with a dose more than 12 hours after the initial vial puncture; Moderna Covid 19 Bivalent vaccine administred to a patient 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with a dose more than 12 hours after the initial vial puncture), POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 12 hours post puncture) and NO ADVERSE EVENT (no adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with a dose more than 12 hours after the initial vial puncture) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with a dose more than 12 hours after the initial vial puncture), POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 12 hours post puncture) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with a dose more than 12 hours after the initial vial puncture) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 12 hours post puncture).    No concomitant medication was reported.  No treatment information was reported.
Pediatric dose of Engerix-B was administered instead of an adult dosage. No harm to the patient. Patient was notified, no side effect reported.
Left arm swelling, pain, redness, tenderness since immunization 2/12. On 2/13, developed fever (103.3 F), chills, headache, nausea, vomiting, epigastric burning, progression of arm swelling, redness, and tenderness.   Of note, patient has received the influenza vaccine in the past and had no reaction.   Follow up on 2/14: Treatment: Cetirizine 10mg QAM, Prednisone 40mg QD x 5 days. Benadryl QHS prn.   Follow up on 2/17: Much improved following Prednisone course.  Treatment: ibuprofen prn inflammation after prednisone course.
Received the vaccine approximately 1pm on Saturday 12/19/20 while working at the hospital. Slight pain at injections site but no other problems that day.  Did not sleep well that night due to achy muscles especially in my neck.  Next morning went to work and felt chills and I could not seem to warm myself up.  Also felt very sore with all my muscles aching as though I has been exercising every muscle in my body.  This continued during the day but was helped by Ibuprofen 800mg.  Also very tired and exhausted during the work day. (10hrs)  Went home and went to bed and slept well.  Monday am I felt fine again.
Hot/cold (chills); fever; achy feeling; redness down arm and red band below where shot was given and above elbow. Advised to see MD.
12 hour later my mouth on the inside was swollen & there were ulcers under tongue & on roof of mouth. Resolved without treatment by 11/25/11.
PATIENT SAYS THEY HAVE DIFFICULTY LIFTING RIGHT ARM. VAR FORM SAYS VACCINE GIVEN IN LEFT ARM
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's pertinent medical  history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 27-JUL-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L012476, expiration date 10-JUL-2016, subcutaneously)(strength, dosing details, anatomical location were unknown)(expired product administered). No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Dose was given on 9/28/22 beyond expiration date of 8/31/22
A report has been received from a Health Professional concerning a 6 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 14-Jan-2015. The patient administered by expired FLUMIST quadrivalent which started on 14-Jan-2015. The outcome of the event of expired FLUMIST quadrivalent administered is unknown. The report was considered to be non-serious.
9/19 received shots, that day fussy. Overnight vomiting x 2.  Fever.   9/20 started having increasing pain doubled over with extreme crying for 30+ minutes.  Seen in ER.  Developed petechiae in ER.  Abd u/s negative.  Sepsis work up done including LP, urine, blood , negative.  Resp pathogen panel negative.  Hospitalized 9/20-9/22.  Over course of hospital, vomiting x 5, loose stools, fever.  Another abdominal u/s negative.
Abdominal pain, back pain, pelvic pain, and side pain began around 2 pm on 10/31. Went to the Emergency Room around 7 pm. Ultrasound was performed. Diagnosed with ovarian cyst.
mild generalized vaccinia, complaints of one day of multiple red spots (0.5cm)on chest.
Documentation of appropriately spaced primary childhood series followed by negative titer upon hire.  Challenge dose of Heplisav-B.  No immediate reaction.  Reported that approximately 30-45 minutes later she felt flushed, developed headache, nausea and vomiting.  No rash or any respiratory symptoms.
Headache, Myalgia, Nausea Vomiting, feeling off-balance Narrative:
pt states she got weak and nauseated.  She developed headache and chills so went to bed.  The next day she was very sick and dizzy causing her to fall.  She has been having to use a walker to get around since she has hurt her hip when she fell.   She has only had water and energy drink since being sick and continues to have a headache. She is not feeling any better so will call the admin office to let them know and contact her PCP so she can get an x-ray of her hip.
After receiving the vaccine on 4/8/21 patient experienced nausea, staff took her blood pressure and she was hypertensive. Paramedics was called and reports her blood pressure as 300/160. She denied blurred vision, headache and chest pain at this time . She was then admitted to the hospital. Two days later while hospitalized (4/10/21) around 12:30pm a stroke alert was called ion the patient. Patient reported to having blurry vision and slurred speech. Her systolic blood pressure at the time of the event was around 170. CT scan was unremarkable, MRI of the brain showed an acute infarct in the right occipital lobe.
pt recvd 1 dose of Engerix-B & 4 hrs p/dose exp asthma & bronchospasms which lasted over noc;
Case previously recorded as MA2009-6267. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Patient with short (approximately 1 minute) febrile seizure (temperature 101F as measured by mother) approximately 1 hour after vaccine administration while on the way home from clinic. Patient with known history of complex febrile seizures.
Participant states first flu vaccine. Staff, requested her to remain in area for observation following administer of vaccine. Beginning 09:50, participant stated at 09:57 slight dizziness and nausea; no SOB; no itching; no other symptoms. Participant was monitored. B/P readings as follows: 09:57 B/P 124/70, Pulse 78. At 10:05 am BP 126/70; Pulse 80. 10:12 a.m. Blood pressure 118/80, Pulse 70. RN reassessed. Nursing Director, contacted; participant will be escorted by event lead, to Employee Health for further evaluation. Note: Employee went directly to E.R. from Employee Health Department. I do not have access to that record.
Initially had pain and redness at site (left deltoid).  Then developed diffuse erythemic rash across chest and both upper outer arms. Patient took Benadryl without relief. Seen 11/7/14 and started on Prednisone.
Afib; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer, the patient. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm on 30Jan2021 at 11:30 (Batch/Lot number: EL9265 and Expiration date: Jan2021) (at the age of 87-years-old) and dose 2 intramuscular, administered in Arm on 27Feb2021 at 13:30 (Batch/Lot number: EN6205 and Expiration date: 27Feb2021); both as single dose for covid-19 immunization. Medical history included none. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced Afib (Atrial fibrillation). Lab tests was none. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
pt recv vax 17FEB98 & 6PM in evening c/o nausea/dizziness, chest pain, temp & sore throat went to ER;CBC, CXR nl results syncope today 19FEB98;
body rash/The rash was across her groin, up the side of her body, and along her bust line and on her neck; kind of felt miserable; she got bad virus; feeling unwell; nausea; low fever; chills/chilled feeling; no appetite; fatigue/ tiredness (pretty much didn't get out of bed); sleeping through out the day/ Stayed in bed and was napping; injection site pain and swelling (little achy); injection site pain and swelling (little achy); This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: FF8841) via an unspecified route of administration, administered in Arm Right on 05Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization(at the age of 69-year-old). The patient's medical history included drug hypersensitivity from an unknown date and unknown if ongoing, she is allergic to a few antibiotics, gastroesophageal reflux disease from 2020 to an unknown date Had some problems over the last year or so and had some acid reflux attacks and received Fluzone shot on 2017 and experienced Fluzone shot kicked her in the rear and was not used to it. The patient received Flu vaccine 4 weeks prior vaccination on 04Sep2021. Concomitant medications included influenza vaccine (FLU VACCINE) taken for immunisation from 04Sep2021 to 04Sep2021, esomeprazole magnesium (NEXIUM) taken for gastroesophageal reflux disease from an unspecified start date and ongoing. Historical vaccination included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN6206) via an unspecified route of administration, administered in Arm Right on 15Mar2021 as DOSE 1, SINGLE for covid-19 immunization and she felt fatigue and common symptoms and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on 05Apr2021 as DOSE 2, SINGLE for covid-19 immunization and she felt fatigue and common symptoms. On 06Oct2021, patient experienced she got bad virus, feeling unwell, nausea, low fever, chills/chilled feeling, no appetite, fatigue/ tiredness (pretty much didn't get out of bed), sleeping through out the day/ stayed in bed and was napping, injection site pain and swelling (little achy), kind of felt miserable. On 07Oct2021, patient experienced body rash/the rash was across her groin, up the side of her body, and along her bust line and on her neck. On 08Oct2021 the rash started to fade and the body rash was gone by 09Oct2021. She also added that she had some improvements from the other side effects from the first few days and the body rash developed. The events did not result in emergency room or physician office visit. The outcome of the event for rash was recovered on 09Oct2021. The outcome for other events was recovering.  No follow-up attempts are possible. No further information is expected.
Red swollen dots around injection site. Hives on upper deltoid to elbow. Pt to take BENADRYL q 6 hours prn call if worse. 15cm hive around injection site.
my ear buzzed; my vision was burning; injection site hurts; My head started to hurt; all my muscles are hurting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Sep2023, outcome "unknown", described as "My head started to hurt"; MYALGIA (non-serious) with onset Sep2023, outcome "not recovered", described as "all my muscles are hurting"; VACCINATION SITE PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "injection site hurts"; TINNITUS (non-serious) with onset Sep2023, outcome "not recovered", described as "my ear buzzed"; EYE IRRITATION (non-serious) with onset Sep2023, outcome "not recovered", described as "my vision was burning".  Additional information: The patient was vaccinated with Prevnar 20 on 01Sep2023. His head started to hurt, ear buzzed, vision was burning. The doctor told the patient to go to the medical emergency section. To date, 14 days later, the patient still had the buzzing sound in his ear, burning of the eyes, all his muscles are hurting and the injection site hurts. The patient had no medical information questions beyond how to treat the symptoms he was experiencing. Patient believed that Pfizer had ruined his life with this vaccine. He was only going to treat one ailment and went out with more of them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderate-severe pain @ injection site persisting x 1 month extending to shoulder joint, and occasionally down to wrist.  Still unable to lift arm above shoulder level, to twist it, or cross it over chest without significant increased pain.  On Ibuprofen/Tylenol combo x 1 month. (pain has not resolved). (Note: manufacturer was Sanofi Pasteur (Adacel), but that option wasn't available in the list).
This spontaneous report was received from a 62 year old female consumer who refers to herself. There were no concurrent conditions and medical history reported. The patient had no allergies or drug reactions. On 02-AUG-2016, the patient was vaccinated with the first dose of ZOSTAVAX (lot number and expiration date were not reported), 19400 plaque-forming unit (PFU), vial, 1 vial (19400 PFU) administered subcutaneously. Concomitant therapies included balsalazide disodium, SYNTHROID and inhaler (composition, brand and manufacturer unspecified). The patient reported that while sleeping on night of 05-AUG-2016, and into 06-AUG-2016, she experienced extreme joint pains, swollen joints, aching joints, cramping, back pain, swollen and inflamed stomach, diarrhea, headache and extreme swelling underneath her eyes. The patient also reported feelings of anxiousness and trouble breathing. She also had flu-like symptoms. After a week, the patient was still having the same symptoms. The patient did not go to the doctor nor the hospital. No treatment was given for the patient's symptoms and no diagnostic labs were drawn. It was also reported that the patient had ulcerative colitis (reported as "ulceric cholitis") and mild asthma. The outcome of colitis ulcerative and asthma was unknown at the time of the report. The patient did not recover from joint swelling, arthralgia, headache, diarrhoea, influenza like illness, anxiety, dyspnoea, eye swelling, gastritis, abdominal distension, back pain and muscle spasms at the time of the report. No further information was provided. No product quality complaint was involved in this case. The causality between all reported events and ZOSTAVAX was not reported. Upon internal review, ulcerative colitis was determined to be medically significant. Additional information has been requested.
Injection site slightly swollen. Child began crying/screaming uncontrollably for 2-3 hours. Completely inconsolable, wouldn't eat. Went to a pediatric chiropractor for an adjustment, gave TYLENOL, and had a bath with Epsom salts, ginger, and lemon.
This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On 23-OCT-2012, the patient was vaccinated with a dose of GARDASIL (lot # 0420AE and expiry date was 02-NOV-2014, route and dose were not reported) that was exposed to 25 degree Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. This is one of the several reports received from the same reporter (MARRS # 1212USA000913, 1212USA000914, 1212USA003709, 1212USA003711, 1212USA003712, 1212USA003713, 1212USA003714 and 1212USA004285). Additional information has been requested.
Started feeling ill about 10-12 hours after received vaccine. Started with malaise and headache. Motrin helped with both symptoms. The morning of 1/9/20 I experienced all other listed symptoms. Highest fever was 100.6. Motrin and Tylenol would help a little bit, but I felt too ill to get out of bed.  Chills, fatigue, fever, headache, injection site pain, malaise, new or worsened joint paint and new or worsened muscle pain
Sick for two weeks. Severe, constant whole body pain with hot stabbing pain in right LE. Constant headache. Fever, sweating, nausea, loss of appetite, weight loss, vertigo, dizziness, weakness, loss in of hearing in right ear (need hearing aids now - both ears), painful sores & scabs inside nose and all over tongue (ongoing), painful fissures on tongue (ongoing).