chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the shipment had been in transit to long with no AE; FLUZONE HIGH DOSE QUADRIVLAENT administered after the vaccine was in transit to long with no AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 83 years old female patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ546AA, expiry date: 30-Jun-2021) via intramuscular route in the left arm on an 19-Oct-2020 for prophylactic vaccination. It was also reported that shipment had been in transit to long (product storage error and product distribution issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant medication was given to the patient.  It was an actual medication error due incorrect product storage.  It was a case of product shipment delay.  At the time of report, no adverse event was reported.  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 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.
Information has been received from a registered nurse and an office administrator concerning the nurse's 16 year old daughter with no pertinent history who on 01-JUL-2009 was vaccinated with the first dose of GARDASIL (Lot # 658271/0558X). Concomitant therapy include HAVRIX (unspecified) (lot# AHAVB238AA) with the first dose of GARDASIL. On 05-JUL-2009 the patient went to the emergency room with nausea, vomiting, fever, severe stomach pains and headaches. On 08-JUL-2009 the consumer called the office complaining of joint pain and ibuprofen was recommended. On 09-JUL-2009 the the consumer called the office again with complaint of increased joint pain It was reported that the patient could still eat food, but on 18-JUL-2009 the patient went to the emergency room since what she was experiencing was not getting better. The registered nurse also reported that the patient was admitted to hospital. At the hospital the patient was given fluids in case it was her kidney and also drew blood. The patient was also given SEPTRA which caused her to have tiny bruises on top of her two thighs. The registered reported that the patient was in the hospital for four days and was doing better after that. Then on 05-SEP-2009, the patient received her second dose of GARDASIL (Lot# 662404/0312Y) and then on 15-SEP-2009 (also reported as 11-SEP-2009) the patient started to experience severe stomach pains, nausea, vomiting, fever and headaches. No complaints of joint pain at that time. Therapy with GARDASIL was discontinued. The results of blood work were unknown. The registered nurse reported that they had called her physician, but the patient had not yet recovered. This is one of several reports from the same source. Additional information has been requested.   9/30/09 Hospital records, DC summary, received DOS 7/5/09 to 7/8/09. Assessment: Febrile illness, purpuric rash, maculopapular rash. Patient presents with a 3 day history of crampy abdominal pain aggravated by urination. Dysuria, vomiting, and hematuria. Red rash abdomen and left thigh. Pulse 108 bpm (H).  ICD-9 Codes: 287.0 Allergic Purpura, 780.60 Fever NOS.  9/30/09 PCP medical records received DOS 7/1/09 to 7/8/09. Assessment: Drug reaction to Septra. Patient presented with petechia on thighs and feet. Fever, emesis. Joint pain in ankles, knees, wrists feet.
Developed a rash on her upper body on 01-14-21.  Patient states the rash burns, making wearing clothing uncomfortable.  She took antihistamines over the weekend per her medical providers' recommendation.  Her rash has not improved.
sore arm; extra dose administered; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm and extra dose administered. On an unknown date, the outcome of the pain in arm and extra dose administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter shared that his son was given a 3rd dose of Bexsero and experienced a sore arm. The reporter stated that mistake probably occurred due to transition from a pediatric to adult practice and the original 2 dose series may not have been documented in the immunization registry.
The pain that is felt is like many needle punctures on primarily the right lung, but has been felt on the left lung at times. The pain is not constant but rather at random times throughout the day.  This sudden, sharp, needle-like pain was felt mostly on the following dates: Tuesday, 04/13/2021 (both lungs felt pain twice early in the morning around 1:00 AM and a few more times in the afternoon), Sunday, 04/18/2021 (pain felt twice only on right lung around 2:00 PM), Monday, 04/19/2021 (pain felt on right lung around 10:00 AM and again around 4:00 PM), and on Tuesday, 04/20/2021 (pain felt on right lung around 1:30 PM). Since Monday, 04/19/2021, a constant feeling of discomfort, tenderness, and slight burning has been felt on the right lung.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. Information regarding pertinent medical history and drug reactions or allergies was not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L042265 with expiration date 26-OCT-2017 (dose, route, anatomical location, lot# and expiry date not reported) for prophylaxis. The sterile diluent (MRK) used for reconstitution did not undergo a temperature excursion. No adverse effects were reported. The administered doses experienced a temperature excursion between 15 degree Fahrenheit to 46 degree Fahrenheit for 15 hours 16 minutes. The previous temperature excursion was between 15 degree Fahrenheit to 46 degree Fahrenheit for 14 hours. The call was because of a data logger. There was no Product Quality Complaint (PQC) involved.
7 or 8 days after vaccine administration patient said a small rash developed around the injection site.  It spread to bigger area.  No blisters.  It itched.  It went away about a week later.
Papule started 1 day after flu injection, 2 1/2 from injection site, size 1 1/2x 1 1/4, erythematous, itchy. Size increased over 2 days. Injection date 11/12/2008, papule appeared 11/13/2008. Treatment, topical hydrocortisone cream.
Received HAB vaccine on 9/1/2015 - approximately 2 weeks later - urine color changed darker, generalized itching, bumps developed on arms and back, advised to follow-up with PCP and advise as to findings.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On or about 01-DEC-2002, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the long term prevention of shingles (dose, frequency, route of administration, lot number and expiration date were not reported). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2003, according to the report, the patient was treated in the hospital, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. On or about 18-FEB-2015, the patient sought subsequent treatment in a private specialty clinic for a persistent vesicular rash, which was diagnosed as Postherpetic Neuralgia. The patient was prescribed with LYRICA for management of the painful symptoms and chronic pain. According to the report, as a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient did suffer and was going to continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure, herpes zoster, neuralgia, emotional distress, injury and pain was unknown. The reporter considered vaccination failure, herpes zoster, neuralgia, emotional distress, injury and pain to be related to ZOSTAVAX. Additional information has been requested.
Cluster of 2 patients (no individual identification provided) developed a "cellulitis type reaction" on the left deltoid after Adacel (lot number C2610AA) on 11 April 2007, received from a health care professional in the USA on 12 April 2007. No description available except sites red, swollen and the patients were treated with antibiotics. The patients had not recovered.
The day after the vaccination, I am experiencing difficulty breathing and fast heartbeat.  I'm still experiencing these effects after the 5th day.
My left upper arm has been in pain for 12 days. A muscle pain. Feels exactly like the 36 hour pain after the shots but it will not go away. I have taken Tylenol & other days Aleve. It is very uncomfortable & noticeable.  Can My primary care doctor do a test to see if this is vaccine related? I don't know what else it can be but I want it to stop.
Information was received from a physician who reported that an unspecified patient received a three dose series of an unknown Hepatitis B vaccine (manufacturer unknown) that was completed at age 4 (dates of vaccination, dosage and route of administration unknown). While a Merck vaccine could not be identified, a Merck vaccine could also not be ruled out. The patient, now age 13, has an anti-HB titer of 9 mIU/mL (test was performed on an unspecified date). The physician stated that the patient was diagnosed with renal disease, on an unspecified date after the initial vaccination series was completed.  The outcome of the anti-HB titer of 9 mIU/mL and the renal disease was not reported. No additional information is available. Additional information has been requested.
The patient had numbness in her left arm and her arm was tender and sore. She doesn't normally get shots and also experienced body pain all day and pain from elbow to pinky finger.
Side effects pretty strong; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side effects pretty strong) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Side effects pretty strong). At the time of the report, ADVERSE REACTION (Side effects pretty strong) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment were provided
Hives - face, arms, trunk developed a few hours after vaccination. Also developed a low-grade fever - 99.4 overnight. Seen next morning (this morning) and still a few residual hives - face, back of head and neck.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received SHINGRIX for prophylaxis.  On 11th December 2018, the patient received the 1st dose of SHINGRIX. On 12th December 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, feeling cold and pain. On 12th December 2018, the outcome of the influenza-like symptoms, feeling cold and pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, feeling cold and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The day after receiving the vaccine, the patient experienced flu-like symptoms, felt cold and achy. The patient stated that, these symptoms lasted for approximately 24 hours. The reporter did not consent to follow-up.
Swelling under right eye resulting in dark circles under eye, eyelids remaining slightly squinted, and right eye being sore to the touch. Began morning after booster dose, continues to be sore and swollen 4 days after injection.
This spontaneous report was received from a medical assistant refers to a 14 year old patient (gender unknown). No medical history was reported. On 22-FEB-2013, the 14 year old patient was vaccinated with a 0.5 ml dose of PROQUAD (lot#, expiry not reported) subcutaneously. No concomitant medications were reported. The child is not experiencing any adverse reactions. Follow-up information was received from the reporting medical assistant. On 22-FEB-2013 at 14:30 the male patient received the first dose of PROQUAD (Merck) vaccination in the left arm with valid lot # H015643. Additionally on the same date, he received the second dose of hepatitis A vaccination (other company) intramuscularly in the left arm, the first dose of GARDASIL intramuscularly in the left arm with lot # H009746 and the first dose of a flu vaccine (other company) intramuscularly in the right arm. Additional information is not expected.
immed pt exp a metalic taste in mouth; c/o feeling faint, exp shaking diaphoresis (profuse sweating); pt was taken to hosp ER; BP dropped; pt was dx as experiencing a vaso vagal reaction; observed for 2 1/2 hrs; & released;
I experienced severe shoulder pain in both arms (the pain lasted for 20 seconds per episode). By late March, my right arm improved considerably with minimal episodes of pain. My left arm continued to be a problem with decrease range of motion and the sharp pain lasted for 20 seconds per episode in the shoulder joints. I saw my doctor and she advised me to put lidocaine patches on the back of my neck, which did not help. She recommended for me to see neurologist. He told me that I should do a nerve conduction study, but that did not pan out. In June 2021, I ended up with frozen shoulders or adhesive capsulitis; due to the immobilization & posturing of my arm that I was doing to prevent the horrible pain I was dealing with. By July 2021, the shoulder pain subsided. I've been seeing a chiropractor, which has provided some relief.
sinus started acting up; elevated A1C; first 24 hours after the vaccine she was feeling sick; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Nov2021 14:00 (Lot number: FF2593) at the age of 54 years as dose 2, singe for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing); "obesity" (unspecified if ongoing); "prediabetic" (unspecified if ongoing), notes: her numbers were at a 6 for several years. There were no concomitant medications. Past drug history included: Benadryl. Vaccination history included: Comirnaty (first dose, Batch/lot number: FH8027), administration date: 08Nov2021, when the patient was 54 years old, for COVID-19 Immunization, reaction(s): "Elevated A1C", "COVID arm", "Sick for like 3 weeks", "Knot in her arm for 3 weeks", "Swelling", "Fever". The following information was reported: GLYCOSYLATED HAEMOGLOBIN INCREASED (medically significant) with onset 2021, outcome "unknown", described as "elevated A1C"; ILLNESS (medically significant) with onset 2021, outcome "recovering", described as "first 24 hours after the vaccine she was feeling sick"; SINUS DISORDER (non-serious), outcome "unknown", described as "sinus started acting up". The events "elevated a1c" and "first 24 hours after the vaccine she was feeling sick" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; glycosylated haemoglobin increased: (2021) elevated.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient returned to clinic on 5-13-09. Lft arm injection site with 4-5 cm area of swelling. Area red and non tender to touch. Patient reports itching to area. Denies any other discomfort. Patient to take Benadryl for itching and see personal MD if condition worsens.
No adverse event but vaccine was found to be expired.  Vial removed from freezer on 7.20.2021 and expired on 8.20.2021.  Dose given on 8.24.2021.
Pt was given the Boostrix and advised to stay at the pharmacy for 5-10 minutes just in case if there's any allergic reaction. 10 minutes later, Pt felt that he has difficulty of breathing, but there's no swelling of the face/tongue, etc. Pt was given an Epi-pen junior while the staff call 911.
kPatient received first dose of Pfizer vaccine 0.3ml L deltoid in seated postion. Within first 3 minutes following vaccine, patient reported dizziness, and presented with diaphoresis, pallor, and glassy, unfocused eyes. Patient was transported to sick bay stetcher area with wheelchair and assisted into supine position, hob elevated 45 degrees. Patient remained conscious and verbal throughout. B/P was recorded via electronic monitor with large adult cuff. Readings as follows:  18:57- 67/40  18:58- 69/40  19:00- 78/44  17:01- 98/66   17:03- 109/74    Patient was provided water, juice, and crackers (all consumed without issue). after 30 minute observation, patient was free to leave, demonstrated Alert+Oriented x4 LOC, skin and lip color WNL, and stated, "That just happens with medical stuff. I get like that. I feel fine now though."  Patient accompanied by spouse. Patient advised to request follow-up doses in supine position in future.
Severe muscle pain radiating down my arm to my hand. Swelling of entire arm. After 24hrs: Muscle aches all over body, general weakness and malaise.
Approx 7 hrs after administration experienced rapid heartbeat, shortness of breath.  Resulted in discharge of ICD device. Started O2 @ 1ltr. Called my cardiologist office responding doctor advised rest as heart rate settled 90-100 BPM. Debriefed by device lab next AM, by then heat rate had returned to normal for me.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 68-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805413 was crossed linked to original case 201804863 due to same reporter.
POST VACCINATION PATIENT REPORTED NOT FEELING WELL, TURNED PALE AND CLAMMY BUT DID NOT LOSE CONSCIOUSNESS. PATIENT DID NOT FALL D/T NEAR SYNCOPE EPISODE. BP 114/66 RIGHT ARM LYING DURING EPISODE. HR 66. PATIENT WAS SITTING IN A CHAIR W/HIS HEAD DOWN, BETWEEN HIS KNEES WHEN I ENTERED THE ROOM. DAD REPORTED HE DID NOT FEEL GOOD. PATIENT INSTRUCTED TO LAY DOWN ON EXAM TABLE, FEET ELEVATED X 5 MINUTES W/COOL CLOTH PLACED ON FOREHEAD. ABOUT 3 MINUTES AFTER LYING DOWN, PATIENT BEGAN FEELING BETTER. AFTER 5 MINUTES OF LYING DOWN W/FEET ELEVATED HE SAT UP FOR A 5-7 MINUTES AND HE WAS GIVEN A BOTTLE OF WATER, A PACKAGE OF FRUIT SNACKS, AND SOME CANDY TO DRINK/EAT. HE THEN STOOD UP FOR A FEW MINUTES AND THEN WAS D/C FEELING NORMAL AFTER 15 MINUTES OF OBSERVATION. DISCUSSED W/PATIENT AND DAD PATIENT HAD A VASOVAGAL RESPONSE TO THE VACCINATION WHICH IS NOT AN ADVERSE REACTION TO VACCINATION. UNDERSTANDING VOICED
Exposed to the COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Stents" (unspecified if ongoing), notes: he has a couple of stents . The patient's concomitant medications were not reported. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "Exposed to the COVID".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a physician assistant via company representative refers to a male patient of unknown age. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with GARDASIL 9 intramuscular (dose, lot number and expiration date were not reported). On an unknown date, the patient experienced bilateral rashes on both hands 48 hours after receiving GARDASIL 9. It was unknown if this was the first, second or third injection in the series. The patient seek medical attention via called physician and did not receive any treatment. The outcome of rash was unknown. The relatedness between the event and suspect therapy was not reported. Additional information has been requested.
Heart palpitations and chest pressure, still in diagnostic stages, prescribed Holter Monitor for 48h and consultation with cardiologist
STOMACH HURTS OFF AND ON; NASAL DISCHARGE AND SNIFFLING; BODY FEELS TOO HEAVY; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 12:00 to right arm for prophylactic vaccination. Concomitant medications included methadone, mirtazapine, propranolol, and risperidone. On 20-MAR-2021, the subject experienced stomach hurts off and on. On 20-MAR-2021, the subject experienced nasal discharge and sniffling. On 20-MAR-2021, the subject experienced body feels too heavy. On 20-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, stomach hurts off and on, nasal discharge and sniffling, and body feels too heavy. This report was non-serious.
About 2 hrs after vaccine, was nauseous and pain in left arm. By 8PM I could not move my left arm from my side, 3 days and nights of nausea. Still have pain in upper left arm.
Numb feet/legs/L. side of face/tingling in hands/nausea/fluid and swelling in knee. Guillain Barre syndrome.