chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID Infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID Infection) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 09-May-2022, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID Infection). In May 2022, COVID-19 (COVID Infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: positive positive (Nasal swab).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment drug was reported. Company comment-This spontaneous case concerns an elderly male patient with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 1st dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient has received second and 3rd dose of co suspect TOZINAMERAN (interchange of vaccine products).The event occurred 7 days after the 3rd dose of co suspect TOZINAMERAN in covid 19 vaccination series.  Home rapid test was positive as on 16th May2022. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event was resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly male patient with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 1st dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient has received second and 3rd dose of co suspect TOZINAMERAN (interchange of vaccine products).The event occurred 7 days after the 3rd dose of co suspect TOZINAMERAN in covid 19 vaccination series.  Home rapid test was positive as on 16th May2022. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event was resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine was given after published expiration date. No adverse reaction. Vaccine was given on 05/02/2022. expiration 04/29/2022. No signs or symptoms noted at the time of vaccination, Patient was monitor for 15mins after administration and tolerated well.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine was given after published expiration date. No adverse reaction. Vaccine was given on 05/02/2022. expiration 04/29/2022. No signs or symptoms noted at the time of vaccination, Patient was monitor for 15mins after administration and tolerated well.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired moderna vaccine was given. No adverse reaction. Vaccine was given on 05/02/2022. expiration 04/29/2022. No signs or symptoms noted at the time of vaccination, Patient was monitor for 15mins after administration and tolerated well.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired moderna vaccine was given. No adverse reaction. Vaccine was given on 05/02/2022. expiration 04/29/2022. No signs or symptoms noted at the time of vaccination, Patient was monitor for 15mins after administration and tolerated well.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired moderna vaccine was given. No adverse reaction. Vaccine was given on 05/02/2022. expiration 04/29/2022. No signs or symptoms noted at the time of vaccination, Patient was monitor for 15mins after administration and tolerated well.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired moderna vaccine was given. No adverse reaction. Vaccine was given on 05/02/2022. expiration 04/29/2022. No signs or symptoms noted at the time of vaccination, Patient was monitor for 15mins after administration and tolerated well.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine expired 04/29/2022 and was given to patient on 05/02/2022. No adverse reaction at the time of vaccination or 15 min after administration. Vaccine was tolerated well.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna vaccine expired 04/29/2022 and was given to patient on 05/02/2022. No adverse reaction at the time of vaccination or 15 min after administration. Vaccine was tolerated well.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Feeling abnormal, Headache, Sleep disorder
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Epistaxis, Fatigue, Headache, Ocular hyperaemia
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Epistaxis, Fatigue, Gait disturbance, Headache
Clinical narrative: Error: Incorrect Reconstitution-
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Rhinorrhoea
Clinical narrative: Error: Incorrect Reconstitution-
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine was given after published expiration date. No adverse reaction. Vaccine was given on 05/02/2022. expiration 04/29/2022. No signs or symptoms noted at the time of vaccination, Patient was monitor for 15mins after administration and tolerated well.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna vaccine was given after published expiration date. No adverse reaction. Vaccine was given on 05/02/2022. expiration 04/29/2022. No signs or symptoms noted at the time of vaccination, Patient was monitor for 15mins after administration and tolerated well.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: extreme fatigue after the second dose of the vaccine which lasted for 1 day; sore left arm/Hurt to lie on the arm when she was sleeping.; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (extreme fatigue after the second dose of the vaccine which lasted for 1 day) and PAIN IN EXTREMITY (sore left arm/Hurt to lie on the arm when she was sleeping.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (extreme fatigue after the second dose of the vaccine which lasted for 1 day) and PAIN IN EXTREMITY (sore left arm/Hurt to lie on the arm when she was sleeping.). On 11-Feb-2021, FATIGUE (extreme fatigue after the second dose of the vaccine which lasted for 1 day) had resolved. At the time of the report, PAIN IN EXTREMITY (sore left arm/Hurt to lie on the arm when she was sleeping.) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.       This case was linked to MOD-2022-583832, MOD-2022-583836 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: extreme fatigue after the second dose of the vaccine which lasted for 1 day; sore left arm/Hurt to lie on the arm when she was sleeping.; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (extreme fatigue after the second dose of the vaccine which lasted for 1 day) and PAIN IN EXTREMITY (sore left arm/Hurt to lie on the arm when she was sleeping.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (extreme fatigue after the second dose of the vaccine which lasted for 1 day) and PAIN IN EXTREMITY (sore left arm/Hurt to lie on the arm when she was sleeping.). On 11-Feb-2021, FATIGUE (extreme fatigue after the second dose of the vaccine which lasted for 1 day) had resolved. At the time of the report, PAIN IN EXTREMITY (sore left arm/Hurt to lie on the arm when she was sleeping.) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.       This case was linked to MOD-2022-583832, MOD-2022-583836 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore left arm and could not sleep on the arm.; tired for 24 hours.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm and could not sleep on the arm.) and FATIGUE (tired for 24 hours.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 09H121A, 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore left arm and could not sleep on the arm.) and FATIGUE (tired for 24 hours.). At the time of the report, VACCINATION SITE PAIN (sore left arm and could not sleep on the arm.) outcome was unknown and FATIGUE (tired for 24 hours.) had resolved.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-583835, MOD-2022-583832 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore left arm and could not sleep on the arm.; tired for 24 hours.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm and could not sleep on the arm.) and FATIGUE (tired for 24 hours.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 09H121A, 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore left arm and could not sleep on the arm.) and FATIGUE (tired for 24 hours.). At the time of the report, VACCINATION SITE PAIN (sore left arm and could not sleep on the arm.) outcome was unknown and FATIGUE (tired for 24 hours.) had resolved.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-583835, MOD-2022-583832 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Computerised tomogram, Drug ineffective, Suspected COVID-19
Clinical narrative: an inner ear infection in both ears; This is a spontaneous report received from contactable reporter (consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 14Apr2021 as dose 2, single (batch/lot number: ER8733) at the age of 58 years, in arm for covid-19 immunization at a clinic facility and not in a facility. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "gastric issues" (unspecified if ongoing); "chronic kidney disease stage 2 mild" (unspecified if ongoing); "lupus" (unspecified if ongoing). The patient took concomitant medications (unspecified). Past drug history included: Benlysta for lupus, reaction: "infusion was not working", notes: had her last one in March. Vaccination history included: BNT162b2 (dose 1; batch/lot number: EN6207), administration date: 23Mar2021, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: LABYRINTHITIS (non-serious) with onset 17Apr2021, outcome "unknown", described as "an inner ear infection in both ears". The event "an inner ear infection in both ears" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: CT scan: unknown results; COVID: unknown results.  Additional information: The patient informed that the anatomical location of administration of Pfizer vaccine was upper arm and vaccination facility type was clinic and not administered at facility. The patient informed that she was fine after her first dose of the COVID-19 Vaccine but she had a reaction after her 2nd dose. She was out of commission for 10 days with an inner ear infection in both ears. Her rheumatologist said given her reaction and being a lupus player and trying the Benlysta infusion, she should not receive any boosters for the COVID-19 Vaccine. The patient informed that she made a trip to the Emergency Room, her primary doctor, a CT scan, and finally an Ear Nose and Throat Doctor who diagnosed her.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Labyrinthitis, SARS-CoV-2 test
Clinical narrative: an inner ear infection in both ears; This is a spontaneous report received from contactable reporter (consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 14Apr2021 as dose 2, single (batch/lot number: ER8733) at the age of 58 years, in arm for covid-19 immunization at a clinic facility and not in a facility. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "gastric issues" (unspecified if ongoing); "chronic kidney disease stage 2 mild" (unspecified if ongoing); "lupus" (unspecified if ongoing). The patient took concomitant medications (unspecified). Past drug history included: Benlysta for lupus, reaction: "infusion was not working", notes: had her last one in March. Vaccination history included: BNT162b2 (dose 1; batch/lot number: EN6207), administration date: 23Mar2021, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: LABYRINTHITIS (non-serious) with onset 17Apr2021, outcome "unknown", described as "an inner ear infection in both ears". The event "an inner ear infection in both ears" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: CT scan: unknown results; COVID: unknown results.  Additional information: The patient informed that the anatomical location of administration of Pfizer vaccine was upper arm and vaccination facility type was clinic and not administered at facility. The patient informed that she was fine after her first dose of the COVID-19 Vaccine but she had a reaction after her 2nd dose. She was out of commission for 10 days with an inner ear infection in both ears. Her rheumatologist said given her reaction and being a lupus player and trying the Benlysta infusion, she should not receive any boosters for the COVID-19 Vaccine. The patient informed that she made a trip to the Emergency Room, her primary doctor, a CT scan, and finally an Ear Nose and Throat Doctor who diagnosed her.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the expiration or beyond-use date
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Abdominal pain lower, Decreased appetite, Diarrhoea, Epistaxis
Clinical narrative: Very stiff neck (never B4 with any vax) Bad headache on & off 4 1 week ( I do not get headaches, & never B4 with any vax) Bloody nasal mucus (never before with any vax) Baseball size swelling, deep red skin with itch like bee sting 4 3 days Nausea for three days no appetite for one week Extreme lower abdominal pain Friday morning contemplating visit to urgent care Bloody mucus and diarrhea Sunday through Wednesday with abdominal pain
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Headache, Musculoskeletal stiffness, Nausea, Pruritus
Clinical narrative: Very stiff neck (never B4 with any vax) Bad headache on & off 4 1 week ( I do not get headaches, & never B4 with any vax) Bloody nasal mucus (never before with any vax) Baseball size swelling, deep red skin with itch like bee sting 4 3 days Nausea for three days no appetite for one week Extreme lower abdominal pain Friday morning contemplating visit to urgent care Bloody mucus and diarrhea Sunday through Wednesday with abdominal pain
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Very stiff neck (never B4 with any vax) Bad headache on & off 4 1 week ( I do not get headaches, & never B4 with any vax) Bloody nasal mucus (never before with any vax) Baseball size swelling, deep red skin with itch like bee sting 4 3 days Nausea for three days no appetite for one week Extreme lower abdominal pain Friday morning contemplating visit to urgent care Bloody mucus and diarrhea Sunday through Wednesday with abdominal pain
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Exercise tolerance decreased, Heart rate increased, Sinus tachycardia
Clinical narrative: Tackycardia was developed after taking the first dose of the Pfizer COVID-19 vaccine (Feb 24). About two weeks after taking the second injection, paid a visit to a cardiologist on Apr 8. Echocardiogram was performed afterwards to check for heart abnormality. Sinus tachycardia slowly resolved with time after the follow-up doctor visit on May 10. However, I wasn't able to exercise for several months because of the abnormally high heart rate (>130 beats/min) in response to medium-strength physical activities such as walking. Even six months after taking the second shot, it would take several hours for my heart rate to go back to normal level after routine exercises I used to do regularly before taking the vaccination.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Palpitations
Clinical narrative: I have received three Pfizer shots, my first one was in March 2021, my second was in April, then I got a booster in November. Starting in April 2022 (possibly a few times before but I can?t easily recall) I have noticed on a several occasions that my heart feels like it?s racing really fast or fluttering if I?m laying down getting ready to go to bed or just sitting on the couch. Sometimes if I hold my breath, the feeling stops. It?s not painful, but it is alarming when it happens. Sometimes it lasts just a few minutes, and other times it last almost 20-30 minutes on and off.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECIEVED MENACTRA VACCINE AND TDAP BOOSTRIX ON OCTOBER 12TH 2021, PATIENT RECIEVED MENACTRA VACCINE AND TDAP BOOSTRIX AGAIN TODAY ( JUNE 9TH 2022 ). PATIENT IS STABLE AT THIS TIME. INSTRUCTED PATIENT TO REPORT TO ER OR PCM IF ANY CONCERNS.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Diarrhoea, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: husband says nausea and diarrhea first. Worsened to severe back pain, numb hands, feet, elbows, and knees. Then severe abdominal cramps with severe pain in calves and thighs. Felt like shingle pain. This happened over 5 month period. She went to hospital and was just diagnosed with Guillan-Barre from neurologist. They were unsure until now what was happening. diag around 5-24-22  per husband by Dr.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: husband says nausea and diarrhea first. Worsened to severe back pain, numb hands, feet, elbows, and knees. Then severe abdominal cramps with severe pain in calves and thighs. Felt like shingle pain. This happened over 5 month period. She went to hospital and was just diagnosed with Guillan-Barre from neurologist. They were unsure until now what was happening. diag around 5-24-22  per husband by Dr.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Balance disorder, Dizziness, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: patient started expiring "imbalance issues", especially when she was running or playing sports; the patient was experiencing fatigue and tiredness; has headaches; troat pain; Dizziness; neurological imbalance; This spontaneous report was received from a consumer and refers to her 12-year-old daughter. The patient's medical history was not reported. She was perfectly healthy.  On 02-SEP-2021, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1687293, expiration date: 30-APR-2023, administered for prophylaxis (strength, and route of administration were not provided). Concomitant medications included tozinameran (PFIZER BIONTECH COVID-19 VACCINE).  On an unknown date in November 2021, the patient experienced imbalance issues, especially when she was running or playing sports. It was also reported that the patient was experiencing fatigue and tiredness. Among other things, like headache, throat pain and dizziness, it was reported that all of these mentioned symptoms became "worse" during the month of December 2021. Since then, the symptoms were on and off every 3-4 weeks and they only really occurred when the patient was playing sports. The patient had such an imbalance that she could not run. The doctor thought that she had a neurological imbalance going on. It was also reported that the patient would not receive the second dose of the  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine.  Causality assessment was not provided. The outcome of events was reported as not recovered.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reporting an AE for PROQUAD being administered after an excursion that occurred; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 02-MAY-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number U024509, expiration date 02-FEB-2023 (dose and route of administration not reported) for prophylaxis (product storage error).   The temperature excursion was of -2 degrees Celsius (°C) for 1 hour and 12 minutes. The vaccine had another previous excursions as follows:   -10°C up to 8°C (8.1C) for 2 hours 58 minutes; -10°C up to 8°C (7.3C) for 2 hours 37 minutes; -10°C up to 8°C (0.7C) for 2 hours 56 minutes
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE; The vaccine was administered to a 1 year old infant; This spontaneous report has been received from a physician concerning a 1-year-old infant of unknown gender.  The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies, were not reported.  On 10-MAY-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 mL (lot # T039467 with expiration date on 20-MAY-2023), administered intramuscularly for prophylaxis (Product administered to patient of inappropriate age). No additional adverse events (AE) were reported.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administration of a 3rd dose of PEDVAX HIB/ /the dose were administered at 2, 4 and 6 months.; No additional AE reported; This spontaneous report has been received from a registered nurse regarding a 6-month-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On unspecified dates, at 2 and 4 months old, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAHIB) for prophylaxis (strengths, doses, routes of administration, and anatomical locations were not reported). On an unknown date, at 6 months old, the patient was vaccinated with the third (3rd) dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAHIB) (strength, dose, route of administration, and anatomical location not reported) (product administered to patient of inappropriate age) (conflicting information as it was also reported that the reporter can not confirmed if the dose was administered).  No additional adverse events reported (no adverse event).
Sex: F
Vaccine: HEP
Symptoms: Accidental exposure to product, Exposure via eye contact, Eye pain, Eye swelling, Pain
Clinical narrative: the eye is more swollen; the vaccine- once the needle was retracted- a "Mist" of the residual RECOMBIVAX from the syringe went into the patient's mother's eye; the vaccine- once the needle was retracted- a "Mist" of the residual RECOMBIVAX from the syringe went into the patient's mother's eye; complained of stinging and pain in eye (unknown which eye is effected); blurred vision; This spontaneous report has been received from a registered nurse concerning a female patient of unknown age. The patient's drug reactions or allergies, concomitant therapies, medical history, and concurrent conditions were not provided.   On 19-MAY-2022, the patient's daughter was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) thimerosal-free (RECOMBIVAX HB) pre-filled syringe (dosage regimen, route of administration, and anatomical site were not reported) lot #T018888, expiration date 03-NOV-2022, administered as prophylaxis.  On that day, after the administration of the vaccine -once the needle was retracted- a "Mist" of the residual from the syringe went into the patient's eye (Accidental exposure to product) (Exposure via eye contact). The patient immediately complained of stinging and pain in eye (unknown which eye was affected) (eye pain); also, the caller reported that she was taken to eye wash station and did rinse her eyes for approximately one minute. The patient also complained of blurred vision. On the same date, she sought medical attention and was seen by ophthalmologist and prescribed a lubricating eye drop. On 20-MAY-2022 (also reported as, "the day after incident happened"), she stated that the eye was more swollen (Eye swelling). At the reporting time, the patient had not recovered from the events.     The causal relationship between Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) and the events of eye pain, blurred vision, and eye swelling was not provided.
Sex: F
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: the eye is more swollen; the vaccine- once the needle was retracted- a "Mist" of the residual RECOMBIVAX from the syringe went into the patient's mother's eye; the vaccine- once the needle was retracted- a "Mist" of the residual RECOMBIVAX from the syringe went into the patient's mother's eye; complained of stinging and pain in eye (unknown which eye is effected); blurred vision; This spontaneous report has been received from a registered nurse concerning a female patient of unknown age. The patient's drug reactions or allergies, concomitant therapies, medical history, and concurrent conditions were not provided.   On 19-MAY-2022, the patient's daughter was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) thimerosal-free (RECOMBIVAX HB) pre-filled syringe (dosage regimen, route of administration, and anatomical site were not reported) lot #T018888, expiration date 03-NOV-2022, administered as prophylaxis.  On that day, after the administration of the vaccine -once the needle was retracted- a "Mist" of the residual from the syringe went into the patient's eye (Accidental exposure to product) (Exposure via eye contact). The patient immediately complained of stinging and pain in eye (unknown which eye was affected) (eye pain); also, the caller reported that she was taken to eye wash station and did rinse her eyes for approximately one minute. The patient also complained of blurred vision. On the same date, she sought medical attention and was seen by ophthalmologist and prescribed a lubricating eye drop. On 20-MAY-2022 (also reported as, "the day after incident happened"), she stated that the eye was more swollen (Eye swelling). At the reporting time, the patient had not recovered from the events.     The causal relationship between Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) and the events of eye pain, blurred vision, and eye swelling was not provided.
Sex: U
Vaccine: PPV
Symptoms: Off label use
Clinical narrative: A 43 year old patient with a history of pneumonia may receive PNEUMOVAX 23 which would be off label use but was prescribed by an unknown physician; This spontaneous report was received from Pharmacist and refers to a 43-year-old patien of unknown gender. The patient's medical history included  pneumonia. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was prescribed pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), which would be off label use but was prescribed by an unknown physician.  It was confirmed that the patient did not received the vaccine.
Age: 0.58
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE or PQC reported; PROQUAD was administered to 7 month old infant.; This spontaneous report has been received from a medical assistant concerning to a 7-month-old patient of unknown gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not provided.  On 23-MAY-2022, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 mL, lot # U030590, expiration date 29-MAR-2023 (route of administration and anatomical location were not provided) as prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) was reported.
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event, Wrong product administered
Clinical narrative: no additional AE was reported; was given PROQUAD instead of MMRII; PROQUAD was inadvertently administered concomitantly with VARIVAX; This spontaneous report was received from a medical assistant referring to a 12-month-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 24-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter (route of administration, lot number and expiration date not reported) and inadvertently received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number U039255, expiration date 09-JUN-2023 (route of administration not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot number and expiration date not reported) (wrong product administered and accidental overdose). No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: No additional AEs were reported; A nurse reported that an adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a licenced practical nurse concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-MAY-2022, the adult patient was vaccinated with a paediatric dose (incorrect dose administered) of hepatitis a vaccine, inactivated (VAQTA), lot number U024504 with expiration date 15-OCT-2022, serial number reported as 101139666936, 0.5 millilitre (mL) dose, once for prophylaxis (route of administration and anatomical location were not provided).  No adverse events (AEs) were reported.  At the reporting time, the patient's outcome was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Improperly stored VARIVAX administered to patient; This spontaneous report was received from a healthcare business professional and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 04-MAR-2022, there was a temperature excursion of -14 up to -10 degrees Celsius (-10.77°C) for 30 minutes, registered for varicella virus vaccine live (oka/merck) (VARIVAX).  On 18-APR-2022, there was another temperature excursion of -11.45 degrees Celsius for 1 hour. On the same date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot #U022320 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date: 15-JUL-2023 (strength, dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error). There was no additional adverse event reported (no adverse event).; Sender's Comments:  US-009507513-2206USA000626: US-009507513-2205USA007031:
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE deatils; improperly stored vaccine administered to a patient; This spontaneous report was received from a certified medical assistant and refers to a 8-year-old male patient. The patient's medical history, concomitant therapies and concurrent conditions were not provided.   On 25-APR-2022, the patient was vaccinated with first dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered subcutaneously, lot # U025790, expiration date 19-AUG-2023 (dose and anatomical location) for prophylaxis (product storage error). No treatment for the event was required. On 23-MAR-2022, the administered vaccine underwent temperature excursion of -14 Celsius degrees up to - 10 Celsius degrees for 3 hours and -10 Celsius degrees up to 8 Celsius degrees for 1 hour and 30 minutes. There were no previous temperature excursions. No additional adverse event was reported (no adverse event). It was an initial use of vaccine/vaccine-device. The operator of the vaccine/vaccine-device was healthcare professional. The vaccine/vaccine-device was not available for return/evaluation as it was given to the patient.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA003614: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007739: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007852: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA008830: US-009507513-2205USA007957: US-009507513-2205USA008069: US-009507513-2205USA008800: US-009507513-2205USA008100: US-009507513-2205USA008105: US-009507513-2205USA008189: US-009507513-2205USA007978: US-009507513-2205USA008795: US-009507513-2205USA008066: US-009507513-2205USA007982: US-009507513-2205USA008064: US-009507513-2205USA008028: US-009507513-2205USA008000: US-009507513-2205USA008008: US-009507513-2205USA008004: US-009507513-2205USA007852: US-009507513-2205USA008002:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients/temp ezcursion occured March 23; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-APR-2022, the patient was vaccinated with an improperly stored dose of with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U025790, expiration date: 19-AUG-2023, administered subcutaneously for prophylaxis (strength, exact dose, and anatomical location of administration were not provided) (product storage error). There was no adverse effect reported (no adverse event). Administered dose of vaccine experienced the temperature excursion of -14 degrees Celsius for 3 hours. There were no previous temperature excursions. The viability of the vaccine was verified at Merck hotline. The reporter also stated that there was a device or device component malfunction (discrepant information, as varicella virus vaccine live [oka/merck] [VARIVAX] is not a medical device or medical device component product).; Sender's Comments:  US-009507513-2205USA008051: US-009507513-2205USA008004:
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Improperly stored vaccines were administered; This spontaneous report was received from a registered nurse concerning a 25-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 21-MAY-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) lot # U007684, expiration date 09-MAR-2023, for prophylaxis (Dose, route of administration, and anatomical location were not provided); which was improperly stored at 13.8 Celcius degrees for 7 hours and 30 minutes (Product storage error). No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA007635: US-009507513-2205USA007519: US-009507513-2205USA007519:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Product storage error; This spontaneous report has been received from a medical assistant, regarding a 5-year-old female patient. The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On 23-MAR-2022, a varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U025790, which was determined to be valid, with an expiration date of 19-AUG-2023) underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours and -10 degrees C up to 8 degrees C for 1 hour 30 minutes. It was stated that a data logger was involved. There was no previous temperature excursion reported. Then, on 12-APR-2022, the patient was vaccinated with the second dose of the aforementioned improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneously (sq) as prophylaxis (dose and anatomical location were not reported) (product storage error). It was stated that the event was attributable to the device component malfunction, however there is no device involved. No additional adverse event was reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA007982: US-009507513-2205USA008105: US-009507513-2205USA008189: US-009507513-2205USA008004:
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Chest pain, Discomfort, Dizziness, Dysgeusia
Clinical narrative: Caller is a consumer. Caller stated that she experience a severe reaction from the PNEUMOVAX 23 vaccine. Caller stated that she received this vaccine for the first time in April of 2020 and didn't experience any symptoms. However, she received the v; stated that she experienced a metallic taste in her mouth; severe chest pain; thinking in short sentences,; general discomfort; nausea; light headedness/dizziness; high heart rate; Caller stated that she received this vaccine for the first time in April of 2020 and didn't experience any symptoms. However, she received the vaccine for the second time on 5/25/2022; Caller stated that she received this vaccine for the first time in April of 2020 and didn't experience any symptoms. However, she received the vaccine for the second time on 5/25/2022; This spontaneous report was received from the consumer and refers to a 68-year-old female patient.  The patient's concurrent conditions included drug hypersensitivity to penicillin. The patient's medical history was not reported. Concomitant medications included diphenhydramine hydrochloride (BENADRYL).   On an unknown date in April 2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).  On 25-MAY-2022 the patient received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly into the left upper arm as pneumococcal disease prevention, NDC number: 00006-4837-03 (dose, lot number and expiry date were not provided) (extra dose administered) (inappropriate schedule of administration).  On 25-MAY-2022, the patient experienced severe reaction, metallic taste in her mouth, severe chest pain, thinking in short sentences, general discomfort, nausea, light headedness, dizziness and high heart rate.  The outcome of the events of severe reaction, metallic taste in her mouth, severe chest pain, thinking in short sentences, general discomfort, nausea and high heart rate was resolved on an unknown date in 2022. At the time of reporting, the patient had not recovered from the event of light headedness/dizziness.   The action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not applicable.   The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events of severe reaction, metallic taste in her mouth, severe chest pain, thinking in short sentences, general discomfort, nausea, light headedness, dizziness and high heart rate was considered to be related.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Heart rate increased, Inappropriate schedule of product administration, Nausea, Thinking abnormal
Clinical narrative: Caller is a consumer. Caller stated that she experience a severe reaction from the PNEUMOVAX 23 vaccine. Caller stated that she received this vaccine for the first time in April of 2020 and didn't experience any symptoms. However, she received the v; stated that she experienced a metallic taste in her mouth; severe chest pain; thinking in short sentences,; general discomfort; nausea; light headedness/dizziness; high heart rate; Caller stated that she received this vaccine for the first time in April of 2020 and didn't experience any symptoms. However, she received the vaccine for the second time on 5/25/2022; Caller stated that she received this vaccine for the first time in April of 2020 and didn't experience any symptoms. However, she received the vaccine for the second time on 5/25/2022; This spontaneous report was received from the consumer and refers to a 68-year-old female patient.  The patient's concurrent conditions included drug hypersensitivity to penicillin. The patient's medical history was not reported. Concomitant medications included diphenhydramine hydrochloride (BENADRYL).   On an unknown date in April 2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).  On 25-MAY-2022 the patient received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly into the left upper arm as pneumococcal disease prevention, NDC number: 00006-4837-03 (dose, lot number and expiry date were not provided) (extra dose administered) (inappropriate schedule of administration).  On 25-MAY-2022, the patient experienced severe reaction, metallic taste in her mouth, severe chest pain, thinking in short sentences, general discomfort, nausea, light headedness, dizziness and high heart rate.  The outcome of the events of severe reaction, metallic taste in her mouth, severe chest pain, thinking in short sentences, general discomfort, nausea and high heart rate was resolved on an unknown date in 2022. At the time of reporting, the patient had not recovered from the event of light headedness/dizziness.   The action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not applicable.   The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events of severe reaction, metallic taste in her mouth, severe chest pain, thinking in short sentences, general discomfort, nausea, light headedness, dizziness and high heart rate was considered to be related.