chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of Kinrix was given to male patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 21-JUL-2022 Reporter's Comments: The expired dose of Kinrix was given to patient. No symptoms reported. The reporter consented to follow-up via email. Additional Supportive Information: The patient received Kinrix, which was already expired, which led to expired vaccine used.
Sore arm from vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm from vaccination) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm from vaccination). In 2021, VACCINATION SITE PAIN (Sore arm from vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       IT was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-631387 (Patient Link).
Bell's palsy; shingles; Information has been received from a lawyer and the consumer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In or around 19-MAY-2011, pt was inoculated with zoster vaccine live (ZOSTAVAX) by unknown route, for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, pt suffered shingles and Bell's palsy. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using the vaccine. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition, severe and permanent personal injuries, also suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, loss of enjoyment of life, physical impairment and injury. At reporting time, pt was not recovered from shingles and Bell's palsy and the events were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event Facial paralysis was determined to be medically significant.
Would only take water not formula x 2 days; cried 5-6hrs temp not checked just told slight fever. Seen at ER. Blood drawn & was told low on iron child released on pedialite - seen UMC 11JAN91 per father.
He slipped and fell on the ice; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 27Jan2021 at a single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Since receiving the vaccine, the patient slipped and fell on the ice on an unspecified date and was wondering if he can take Tylenol for the pain during the vaccination series. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Diarrhea; Heart palpitation; occasional low pulse rate; sore joints; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection), first dose on 14Jan2021 at 12:45 (lot number: EL0140 and expiration date was unknown) and second dose on 04Feb2021 at 12:45 (Lot Number: EL3302 and expiration date was unknown) both administered in Left Arm via an unspecified route of administration at a single dose for COVID-19 immunization. Medical history included diabetes, CAD (coronary artery disease), aortic stenosis, COPD (chronic obstructive pulmonary disease), arthritis. Concomitant medication was not reported. The patient was not received other vaccines within four weeks of vaccination. The patient received unspecified medications within two weeks of vaccination. On 05Feb2021, the patient experienced diarrhea, heart palpitation, occasional low pulse rate, sore joints, and low-grade fever. The patient not received treatment for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.
Pt. Described a bounding irregular heartbeat, weakness, general malaise, no nausea, no dizziness, no respitory distress approx 1 hour post flu shot. Reported to medical department at work. Rested for approx. one half hour with no improvement. EMS called and transported Pt. to hospital. ER Dr. diagnosed as a "physiological reaction" to the flu shot. Did not DX. an allergic reaction. Sent home from ER With Rx for tylenol prn. Described feeling  fully recovered in 48 hours. Has had flu shots in the past without incident. Spoke with Pt. on 11/5 sx's fully resolved no residual effects.
16OCT97 became very drowsy, lethargic in early afternoon;did c/o sore throat, T103 @ 8PM;about 7PM laid in grass outside very diff to arouse twice;mom states this not a usual drowsiness from illness of being tired;
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 08-JUN-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009706, expiration date: 15-AUG-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient states that site became, swollen, red, and hot. She had her doctor examine it today (09/4/13). He stated that there may have been an infection at the site but it did not require antibiotics and was healing.
Approximately one week after second dose I became extremely itchy. That was beginning of October and the itching continues to this day. I have sores similar to chicken pox.  I cannot stop the itching I used cortisone cream it helps. The itching and sores are primarily on my arms hands legs and belly.
Within 24 hours, post vax, child developed seizure-like activity later identified by Peds neurologist as infantile spasms; EEG confirmed. per doc 212684, annual follow up, patient has infantile spasms.
Fever (100.1), nausea, vomiting, fainting (21 hours after vaccine), chills, headache, body ache, sore arm, light headed/dizzy. All symptoms discovered upon waking in morning 21 hours after vaccine. Fainted 15 minutes after waking, Treated with DayQuil and sleep, Symptom length of time unknown since ongoing and treated  quickly.
Peripheral numbness feet, legs; tingling in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FF2588), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pancreatic carcinoma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VIT D3; ASPIRIN [ACETYLSALICYLIC ACID]; PANTOPRAZOLE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL9261, Vaccine location= Right arm), for Covid-19 immunization, reaction(s): "Peripheral numbness feet, legs", "Peripheral numbness feet, legs", "tingling in hands"; Bnt162b2 (DOSE 2, SINGLE; Lot number: EN6200; Vaccine location= Right arm), for Covid-19 immunization, reaction(s): "Peripheral numbness feet, legs", "Peripheral numbness feet, legs", "tingling in hands". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Peripheral numbness feet, legs"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in hands". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, peripheral numbness feet, legs and tingling in hands. Started after first dose but didn't equate it with vaccine until after the most recent booster. Initially in left foot/leg only about two three weeks after shot. A week after the 4th booster my right foot/leg and fingers were affected and right leg worse. Then connected the dots from beginning.
Her throat get closed, it was very painful; Her throat get closed, it was very painful; She was really worried; Arm didn't get sore until the next Thursday afternoon; Legs was shaken a little; She felt a terrible taste (may be from a gum) metallic and chemical taste; Extreme taste in her lips and out side on her mouth; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Her throat get closed, it was very painful), OROPHARYNGEAL PAIN (Her throat get closed, it was very painful), TREMOR (Legs was shaken a little), DYSGEUSIA (She felt a terrible taste (may be from a gum) metallic and chemical taste) and TASTE DISORDER (Extreme taste in her lips and out side on her mouth) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and METOPROLOL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced TREMOR (Legs was shaken a little). 02-Mar-2021, the patient experienced DYSGEUSIA (She felt a terrible taste (may be from a gum) metallic and chemical taste) and TASTE DISORDER (Extreme taste in her lips and out side on her mouth). On 04-Mar-2021, the patient experienced THROAT TIGHTNESS (Her throat get closed, it was very painful), OROPHARYNGEAL PAIN (Her throat get closed, it was very painful), ANXIETY (She was really worried) and PAIN IN EXTREMITY (Arm didn't get sore until the next Thursday afternoon). At the time of the report, THROAT TIGHTNESS (Her throat get closed, it was very painful), OROPHARYNGEAL PAIN (Her throat get closed, it was very painful), TREMOR (Legs was shaken a little), DYSGEUSIA (She felt a terrible taste (may be from a gum) metallic and chemical taste), ANXIETY (She was really worried) and PAIN IN EXTREMITY (Arm didn't get sore until the next Thursday afternoon) outcome was unknown and TASTE DISORDER (Extreme taste in her lips and out side on her mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment information was not provided.
Joint and muscle soreness; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint and muscle soreness) and MYALGIA (muscle soreness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint and muscle soreness) and MYALGIA (muscle soreness). At the time of the report, ARTHRALGIA (Joint and muscle soreness) and MYALGIA (muscle soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 101.5 (High) temperature of 101.5 degrees..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter Treatment information was not provided
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: rash all over body, low grade fever and chills
On the morning of 11/30/21, patient noticed a mass on his left axillae. On 12/1/21, the mass was large enough to cause discomfort and presented to medical clinic. Patient denies fever + chills, rashes, pain or drain on the deltoid area where the flut shot was given.   On evaluation, no signs of cellulitis or concern for MRSA infection   Treatment included warm compresses and NSAID treatment (ibuprofen 600 mg PO Q6H PRN). Chest CT is ordered to rule out other lymphadenopathies. Patient is to return in 1 week on 12/8/21 for follow-up.
Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Same date vaccine BNT162B2 and FLU on 12Oct2022; Same date vaccine BNT162B2 and FLU on 12Oct2022; BNT162B2 bivalent vaccine administered as primary series; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 12:00 as dose 1, single (Lot number: GJ6665) at the age of 79 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 12Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 12Oct2022, outcome "unknown", described as "BNT162B2 bivalent vaccine administered as primary series"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Oct2022, outcome "unknown" and all described as "Same date vaccine BNT162B2 and FLU on 12Oct2022"; AXILLARY PAIN (non-serious), MYALGIA (non-serious), BURNING SENSATION (non-serious) all with onset 15Oct2022 at 07:00, outcome "not recovered" and all described as "Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm". The events "excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of axillary pain, myalgia, burning sensation.  Additional information: Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm and adverse event traveled to the upper muscles in the right arm and across the back. I'm taking Tylenol which the doctor recommended. It's doing me no good. Patient was applying heat and other soothing ointments. No Known allergies. No covid prior vaccination. Adverse events resulted in: Emergency room/department or urgent care.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300005938 Same product, patient and different AEs;
Heart burn; Rash all over body; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the arm left on 30Mar2021 at 12:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetic. The patient did not have any allergies to medications, food or other products. Concomitant medications included unspecified diabetic medicine from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 17:00, the patient experienced rash all over body and heart burn. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events rash all over body and heart burn were resolved with sequelae at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A report has been received from a Health Professional concerning a 57 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). Concomitant medications included vitamins and amlodipine, benazepril. FLUMIST quadrivalent (intranasal) started on 06-Nov-2014. The patient experienced FLUMIST given to a 57 year old which started on 06-Nov-2014, sneezing, redness in the eye, headache and congestion. The outcome of the event of sneezing, redness in the eye, headache, congestion and FLUMIST given to a 57 year old is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 14-Nov-2014 from health professional via spontaneous source: New events of headache, congestion, sneezing and redness in the eye were added. PQC was ticked. Strength of the suspect drug was added. Reporter's information was updated. Case was unsuppressed.
Colitis flare up  Called office on 2/22/2021 to report  Had not had a flare up since medication change 8 mos prior
evening of vax pt devel T104.3 & inj site rxn of pain & swelling; taken to ER & hosp; tx w/IV fluids; IV cefuroxime & oral analgesics; disch 3days later w/prescriptions of ceftin & tylenol w/codeine; recovered
This spontaneous report was received from a pharmacist refers to a 61 year old female patient. The patient's concurrent conditions and medical history were not provided. On 29-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, vial, intramuscular injection, 0.65 ml, once, in the arm ("assuming into deltoid"). Concomitant therapies included an unspecified "birth control" medication. On an unspecified date, in 2015, the patient arm (at the injection site) was red, swollen and warm to touch. On 04-NOV-2015, the patient contacted the pharmacy for medical attention. There were no laboratory studies performed. The pharmacist was asking for treatment recommendations for the patient as no treatment had been employed yet. There was no product quality issue involved. At the time of the report, the outcome of injection site warmth, injection site swelling and injection site erythema was reported as not recovered. The reporter did not assess the relatedness of injection site warmth, injection site swelling and injection site erythema with ZOSTAVAX. Additional information has been requested.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who had inadvertently received an expired dose of DAPTACEL lot C5065AA, expiry date- 08-Oct-2018 via intramuscular route in the left thigh on 23-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunisation; and PREVENAR 13 for Immunisation. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. 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 and Module VI of the 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.
Excessive Dose: Patient had received both Pfizer Vaccines and then came to pop up clinic to receive a J&J dose.  Patient reported no adverse reactions. Sore arm but not significant adverse effects
Child rec'd ACTHib vaccine in R thigh 5/30/08. Seen 6/16/08 with 24 hour history of fever to 104. Exam was normal, diagnosed with viral syndrome. On revisit 6/19/08 presented with ~24 hour history of rash at R thigh injection site, afebrile, normal exam other than irregular ~7x8 cm rim of palpable, non-tender erythema with clinical appearance similar to E. Marginatum. Still a bit fussy but easily consolable and drinking well.
flare of left eye idiopathic uveitis, previously in remission on adalimumab monotherapy
Right thigh, around injection site it is red and swollen and it is hot to the touch.
Pt received vaccine 5/2/11 on (R) thigh. On 5/3 site had small area of erythema & scab where needle injected. On 5/3, pt scratched scab & evening of 5/4 parents saw large area of erythema. They saw me, the PMD 5/5 with 13 cm erythema around injection site, warm, swelling. C/O pruritus, but none witnessed. I started KEFLEX today as it looks infected to me. Pt feels well & is AF.
Exactly one week after the vaccination I woke up with redness, swelling and itching  all around the injection  site (approx. about 4"-5" in diameter)
I was cold and then I started getting chills and all I wanted to do was sleep. I didn't want to eat just go to sleep. So today my legs are sore.