chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of Ipol was inadvertently administered to patient/No AE; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 6 years old male patient who received vaccine IPV (VERO) [IPOL] and reported that expired dose of Ipol was inadvertently administered to patient/no AE (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DTAP, MMR and VARICELLA.  On 02-Dec-2019, the patient received a dose four of 0.5 mL suspect IPV (VERO) [lot N1K931M, expiry date: 18-NOV-2019] via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  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 referring to unspecified number of patients of unknown age and gender. There was no information about the patient's medical history and concurrent condition. On an unknown date these patients were vaccinated with improperly stored GARDASIL (lot # K011325, expiration date 08-APR-2017 or lot # K010574, expiration date: 08-APR-2017; strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
About 12 hours after getting the vaccine, I had mild flu-like symptoms that lasted about 24 hours (fever chills, headache, body ache, fatigue) and a seriously sore arm that lasted for about 3 days. After those symptoms subsided, I started having a sensation that felt like an insect was crawling around inside my ear, and the sensation began spreading to around my ear too. I went in to see my doctor & they flushed my ear to insure there was no parasite or anything in my ear. There was nothing. My doctor asked about medication changes in the past month. The only change had been getting the second dose of the COVID19 vaccine about a week or two prior.  My doctor concluded it was a side effect from the vaccination.  Since this appointment sometime a week or two after 3/25/21, the sensation has changed a bit. It comes and goes, but it?s a numbness / pins & needles kind of sensation above ear on the left side of my head (lower left temporal lobe area). I?ve also been extremely fatigued and been experiencing frequent headaches.
9:20 child went limp to floor, did not lose consciousness.  Put in supine position, feet raised.  BP 90/60 P 100 looked pale.  Checked BP again @ 9:26 90/70, she drank a few ounces of orange juice brought to nurses office at school.  10:00 AM sitting on side of bed, taking with her mother.  BP 86/60 P 96.  Went home with her mother.
I did not have any arm soreness on the day of the vaccine was given. The next day I felt exhausted like I hadn't slept and texted my son "boy, do I feel wiped out." I slept on and off all day and most of the night Tuesday til Wednesday evening around 11pm. This was approximately from 2pm Tuesday through 11pm Wednesday- 33 hours. I am writing this report at 2:24 AM on Thursday morning reasonably awake.
Within four days of administration I developed  the following a) hot swollen painful knuckle joint, left hand b) vaginal yeast infection c) hives on left arm c) headache, mild, began evening on day I received the injection and continued through the following day d) aura similar to that of classical migraine: some numbing and tingling in left foot and around the lips
Extreme fatigue.  Feel asleep within 5 minutes.  It came on so fast...,like I hit a wall.  Chills.  99.9 temperature.  Couldn?t open eyes or move fingers.  Light headed...blacking out when I got up to go the bathroom.  Couldn?t have any sounds (like tv) on.  Just needed to lay still and sleep.    The above lasted 19 hours.    Then my temperature ended.  I had trouble walking and standing for another 20 hours. No stamina.   I went to work near the end of this and noticed I had trouble looking at my paperwork and figuring what to do for my job.  Not sure if this was still the fatigue just in a different way.  Then it disappeared.
The pt experienced fatigue, muscle ache, fever of 104 degrees. No complaints of headache or respiratory problems. The reaction lasted for 1 day.
Started with nausea. I came home felt lethargic, headache, fever, and body ache. I did not feel well at all. I was bed bound for 5 days. I had not energy. They fever went away after 3 days. The nausea continued for about 5 weeks. I had joint pain with inflammation in my joints. I have swelling in both of my feet's. After the swelling in my feet my ankles had torn ligament. My endocrinologist thinks it was vaccine related. My blood sugar level have been elevated ever since the vaccination.
Headache, food aversion, nausea, fever, chills, chest and neck is itchy, sores in mouth, shortness of breath, heavy chest.
Immediate sharp, burning, aching pain during administration of vaccine in left upper arm via needle. Within hours, severe arm pain requiring use of sling. Could not lift or use arm without severe pain for approximately 6 weeks. The same evening of the vaccine, additional pain and stiffness started in left shoulder, across upper back and into neck, resulting in daily headaches that are still occurring, waking me up frequently during sleep and most severe in the mornings upon waking. The site of the vaccination is still sore and very sensitive to pressure.
administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature; Dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature) in a 77-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The vial was first punctured on 25-Jul-2022 around 10 AM and then it was left unattended and kept at room temperature range (8 to 25 degree Celsius/46 to 77 degree Fahrenheit) for 23 hours. The vial did not undergo any temperature excursion.  It was reported that the vial was never in the fridge and it was moved from the freezer to room temperature directly on 25-Jul-2022.  No treatment medication details was reported.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, SARS-CoV-2 test: positive (Inconclusive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided Treatment information provided as Monoclonal antibody treatments
My sister received the PFE vaccine today while approximately 36 weeks pregnant; This is a spontaneous report from a contactable consumer (patient's sister). A 32-year-old (pregnant) female received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (age at the time of vaccination was 32 years) solution for injection, lot number and expiration date were unknown), via an unspecified route of administration, on 08Mar2021at 14:00, as single dose for COVID-19 immunization. Medical history included factor V leiden. Concomitant mediations were not reported. The patient was allergic to stone fruits. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The delivery date provided as 22Mar2021 and the gestational period was 36 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Other medications in two weeks were unknown. On 08Mar2021, today at 14:00, the patient received the PFE vaccine, while approximately 36 weeks pregnant.She was likely to be induced on 22Mar. The (store) location also told her it was their policy at all locations to have the second shot after 4 weeks rather than 3 weeks. No treatment medications included. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Received small pox vaccine on left shoulder. Developed papular rash on chest, abdomen, arm and upper thigh and eyelid; right arm 5 vesicles; afebrile and otherwise well.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 18-OCT-2017, the patient was vaccinated with improperly stored doses of VAQTA lot # N019924, expiration date 02-SEP-2018, orally, for prophylaxis (strength, dose and frequency were not reported). The temperature/Time frame was 34.8°F for 8 hours 23 minutes and 34.8°F for 8 hours 15 minutes. The previous temperature excursion was 47.6°F for 5 minutes. There was a data logger involved. No adverse effects reported. This is one of several cases from the same source. Sender's Comments: US-009507513-1710USA010653: US-009507513-1710USA010654: US-009507513-1710USA010656: US-009507513-1710USA010312.
Nickel size 1/2 inch swelling at injection site.  EMS evaluated.  Bandaid removed and client did arm exercise and felt better and swelling went down.
light sensitivity; fatigue; increase in hay fever symptoms; post nasal drip, sore throat; injection site soreness; post nasal drip; sore throat + lymph nodes around jaw; This is a spontaneous report received from a non-contactable other health care professional. An 18-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: Unknown) via an unspecified route of administration on an unknown date (at the age of 18-year-old) as a single dose for COVID-19 immunization. Medical history included eczema. The patient was allergic to pistachio and had hay fever allergy. The patient previously had taken fluoxetine, retinoids and had experienced allergy. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 09:30, the patient experienced light sensitivity, fatigue, increase in hay fever symptoms, post nasal drip, sore throat and lymph nodes around jaw, injection site soreness (24+ hours). Therapeutic measures included extra dose zyrtec allergy pill, ibuprofen and rest. The clinical outcome of light sensitivity, fatigue, increase in hay fever symptoms, postnasal drip, sore throat and lymph nodes around jaw, injection site soreness was unknown at the time of report.   Amendment: This follow-up report is being submitted to amend previously reported information: 1. patient's initial added in first name field in patient tab.  2. final sentence updated to No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 24MAY95 & 9DEC96 pt devel clinical varicella w/fever & lesions all over including mouth & vagina;
A report has been received from a Health Professional concerning a 17 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 09-Jan-2013. The patient experienced tested positive today for influenza A which started on 15-Jan-2013. The outcome of the event of tested positive today for influenza A is unknown. The report was considered to be non-serious.
Pt given vaccine. Within 5 minutes pt developed red none raised rash with 3 x 2 inch. No other signs. Ice pack applied to area. Rash diminishing after 15 minutes. Mother instructed on aftercare and follow-up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EP7534), on 13Apr2021 as dose 2, single (Lot number: EW0162) and on 12Jan2022 as dose 3 (booster), single (Lot number: 33030BD) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Clozapine, reaction(s): "Known allergies: clozapine"; Ibuprofen, reaction(s): "Known allergies: ibuprofen"; Cipro, reaction(s): "Known allergies: cipro"; Loxapine, reaction(s): "Known allergies: loxapine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Oral Paxlovid from 05Apr2023 to 08Apr2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events vaccination failure, Covid-19 and the suspect  product BNT162b2.
SWELL ON BOTH EYES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced swell on both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swell on both eyes. This report was non-serious.
Pt examined 11/19/09 and diagnosed with Cellulitis 8 inches x 9 inches. Pt treated with po Ibuprofen and Keflex.
Severe dizziness. Looked online and did positional treatment for vertigo. Never had vertigo before! Husband affected even worse!
1st vaccine dose given 4/20. Expected symptoms occurred. Several provider visits past 72 hours from injection for abdominal pain, vomiting, diarrhea, muscle pain. Hospitalized first time on May 13th. Colonoscopy with focal active colitis and lab tests performed. No clear cause identified. Advised to get dose#2 on May 24th. Normal vaccine side effects occurred for 72 hours along with continued abdominal pain. Hospitalized #2 06/02/2021  with left gonadal vein thrombosis. Started on blood thinners and labs drawn. No genetic markers or predisposition for clotting. Referred to Hematology. Continued abdominal pain. Upper Endoscopy performed without ulcer or significant findings. Continued abdominal pain. Admitted to outpatient psychiatry for increased anxiety. Continued abdominal pain, poor appetite, vomiting, significant weight loss, body aches. No cause identified. Referred to rheumatology with high rheumatoid factor without other significant findings.
Injection site swollen, red, itchy and painful for over 1 week.  No treatment.
10 hours after my vaccine I got a rush of heat to my feet...felt like they were swelling. Tingling & numbness followed & also went to my hands. 9 days later I still have some residual tingling, mostly in my feet.
Arm is red below the shot; Stomach issues; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th December 2022, the patient received Shingles vaccine. On 13th December 2022, 1 days after receiving Shingles vaccine, the patient experienced erythema of extremities. In December 2022, the patient experienced stomach discomfort. On an unknown date, the outcome of the erythema of extremities was not recovered/not resolved and the outcome of the stomach discomfort was unknown.   It was unknown if the reporter considered the erythema of extremities and stomach discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-DEC-2022 Reporter's comments: The case was reported via interactive digital media. The reporter was patient's wife. The reporter reported that the patient got the shot yesterday and the day of reporting his arm was red below the shot he had some stomach issues that night. The reporter said should be concerned. Additional supportive information:  Follow up would not possible, as no contact details were available.
Dizziness, 89/56 (pulse 64), 111/71 (pulse 79).
He received first dose of Pfizer COVID vaccine 1/15. Next day, he felt right axilla and trunk numbness after that which lasted 2-3 weeks and was resolving.  After the second dose early Feb 5th, he started having difficulty swallowing and SOB and felt a little better after a course of steroids and antibiotics but got a lot worse after finishing the course and presented to ED 2/16 and was found to have supraglottic edema requiring intubation and treatment with IV steroids. Was extubated on 2/19, in ICU until 2/21. He did well with treatment and was discharged 2/22. Patient received a dose of influenza vaccine (FLULAVAL - GSK lot: 7N43B) on 2/22/21 3/2 he started having burning pain in the right midthoracic area, the next day he noticed right hand weakness/numbness (4th and 5th digits), gradually progressed.  3/4 noticed right facial weakness, initially was lower face, Unable to drink without drooling. MRI brain was done 3/5 and was normal. 3/5 facial weakness progressed to upper face. Unable to close right eye for the last 24 hrs. He also reports numbness left 5th digit. Presented to the ED on 3/6. Found to have elevated transaminase in ED. Hospitalization continues at this time. Etiology of symptoms is unknow, but includes vaccine reaction, shingles or early stages of autoimmune disease.
pt recvd vax & devel parotitis following vax w/MMR; pt presented to MD; a work-up revealed that pt had chronic osteomyelitis of the mandible caused by staphylococcus aureus; MD did not believe that it was related to vax;
Breathing difficulties started about 3 hrs. post flu vaccine, severe coughing, headache, sinus pressure, eye drainage, weakness in right hand, throat felt "funny".  Patient called in today with the above information and stated she did not go to ER last night because of transportation issues.  Was instructed to go to ER today as we have no appointments.
Arm was not so sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was not so sore) in a 121-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was not so sore). At the time of the report, PAIN IN EXTREMITY (Arm was not so sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon internal review on 21-May-2021, the age was corrected to unknown. No concomitant medication details were provided. No treatment medication details were provided.   Reporter did not allow further contact
Approximately 3 weeks after second shot vision problem started to surface, 5-6 months after second shot heart pounding and rapid heart beats. Things I did not have before vaccinations.
Fever, body-wide severe pain, skin sensitivity (itching/pain), nerve pings, headache, weakness and dizziness. Symptoms ramped up in the evening (last night) and became most severe by 10 pm, preventing sleep for most of the night.  Felt like I would pass out when walking to the bathroom. Too sick to look up symptoms or make a phone call. I thought about calling 911. Feeling better this morning: no fever or headache, no skin sensitivity,  less pain, but very weak and no appetite.  I will spend the day lying on the couch.  I did not have an unusual reaction to the first dose of shingrix - just a sore arm. This is the first time I've had a reaction to any vaccine.
Palpitations; Full body rash; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) and RASH (Full body rash) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 immunization.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PALPITATIONS (Palpitations) and RASH (Full body rash). On 18-Apr-2021, PALPITATIONS (Palpitations) and RASH (Full body rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment reported as Benadryl.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.