chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Patient reported swelling at injection site and states that her arm itched following the vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Dry mouth, Erythema, Skin warm
Clinical narrative: PT COMPLAINS OF SKIN ERYTHEMA, SCALP IS HOT, NO ITCHING; EYES AND MOUTH ARE EXTREMELY DRY
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient received the 5-11 year old dose instead of the 12+ dose
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Myalgia
Clinical narrative: Donor described reaction onset approximately 30min post immunization erythema up the arm and across the face.  Muscle soreness onset "a couple days" after immunization
Age: 81.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient received the 5-11 dose of pfizer covid 19 instead of the 12+ dose
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Chills, Insomnia, Myalgia, Pyrexia
Clinical narrative: onset on symptoms near midnight on 10/4/23 that lasted until 6:30 am on 10/5/23. Experienced unbearable fever/chills, joint/muscle pain and burning and insomnia. Feels better today.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient received Fluad in left arm on 9/22/23. Pt reported to pharmacy on 10/5/23 complaining that her arm still hurt and she had some radiating pain going up her neck. She showed me her arm and she still has a bruise on her deltoid where she got the shot. Patient claims she still has to take Tylenol and is worried about potential nerve damage. She said the pain has not gotten worse, but she can feel it still there and it has not gone away yet.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Neuralgia, Pyrexia, Renal pain
Clinical narrative: Migraine headache for 10 hours, nerve pain 10 hours, fever 8 hours, nausea 4 hours, kidney pain the follow day.
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Loss of consciousness
Clinical narrative: PATIENT RECEIVED COMIRNATY AND FLUZONE VACCINE. PATIENT PROCEEDED TO CHAIR IN WAITING ROOM AS HER FATHER WAS THE NEXT PATIENT FOR VACCINATION. PATIENT PASSED OUT IN CHAIR. I WENT BACK INTO THE PHARMACY FOR ADDITIONAL GAUZE. I WAS NOTIFIED OF A PATIENT SLUMPED OVER IN THE  CHAIR. I ABRUPTLY TAPPED HER SHOULDER AND ASKED WAS SHE OKAY. SHE AWAKENED, BUT DID NOT REALIZE WHAT HAPPENED. PATIENT'S FATHER SAID SHE 1) HAD AN EMPTY STOMACH, 2) HAS HAS SIMILIAR REACTION WHEN GIVING BLOOD.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unkown
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Induration, Injection site pruritus, Rash
Clinical narrative: Induration, lacy rash over chest and upper left arm, itchy.  Ongoing 9 days later
Age: 33.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction: erythema, edema, warmth, soreness xalmost 24 hours and ongoing.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discharge, No adverse event
Clinical narrative: After screening patient for vaccine eligiblity, RN Vaccinator attempted to give 0.5ML of Fluzone vaccine in patient right arm.  When giving this initial injection, an undetermined amount of FLUZONE vaccine was leaking from the injection site. RN vaccinator alerted Clinical Manager who consulted with Pharmacist , regarding the situation.  Per protocol, it was advised that client should be revaccinated.  Client informed of situation and reccomendation for re-vaccination and agreed to get re-vaccinated with 0.5ML of FLUZONE . 2nd Dose was administered in Right arm without any problems.  Pt. reported no side effects.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: After screening patient for vaccine eligiblity, RN Vaccinator attempted to give 0.3 ML of COVID-19 Pfizer vaccine in patient L arm.  When giving this initial injection the Vantage point needle/syringe failed as when needle was pulled from the patient, more than half of the vaccine was leaking from syringe.   RN vaccinator alerted RN/Clinical Manager who consulted with Pharm D , regarding the situation.  Per protocol, it was advised that client should be revaccinated.  Client informed of situation and reccomendation for re-vaccination and agreed to get re-vaccinated with 03.ml of Pfizer Covid-19 . 2nd Dose was administered without any problems.  Ct. reported no side effects.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Erythema, Immunisation reaction, Induration, Pruritus
Clinical narrative: ?COVID arm? or delayed cutaneous hypersensitivity Raised red bump, about 2? across, firm to the touch. Itches!
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: ?COVID arm? or delayed cutaneous hypersensitivity Raised red bump, about 2? across, firm to the touch. Itches!
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection related reaction, Injection site erythema
Clinical narrative: redness at injection site. about size of golf ball.  getting better by the day
Age: 68.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Vaccination site urticaria
Clinical narrative: Patient called stating she had a welt in the area the vaccinations were given.  She noticed it on 10/5/23.  Welt is approximately 2 to 3 inches in diameter.  Does not itch and is not irritated or burning.  Patient states it is not really bothering her and will contact her primary care doctor tomorrow (too late to reach md tonight).  Not sure of outcome with provider since patient has not contacted them yet.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Neck pain, Pain
Clinical narrative: Within 3 minutes of the vaccine, patient reported soreness and pain moving from the injection site up the neck.  Patient then called about a half an hour later to report the pain has turned into a numbness that moved across the chest and up the right side of the face. Patient has not yet been evaluated by a physician, but has been advised to seek additional medical advice. No other symptoms reported.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Back pain, Chills, Nausea, Pain
Clinical narrative: Severe body aches, chills, low back ache, nausea
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Parkinson's disease, Tremor
Clinical narrative: Parkinsons Disease - uncontrollable tremors, poor balance
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: severe muscle ache, fever (100-102f) for approximately 48 hrs.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 dose of the RSV (arexvy) on 9/25/2023 and on 10/05/2023 at the pharmacy.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature increased, Dizziness, Electrocardiogram abnormal, Headache, Heart rate increased
Clinical narrative: Elevated heart rate up to the 160bpm at approximately 22 hours post vaccine with lightheadedness, headache and nausea. Contacted PCP who directed to urgent care. Upon arrival to urgent care, temp 100.5, hr 150. Covid and flu tests completed and negative. EKG showing only sinus tachycardia. Sent home. Over the course of the next 12 hours, continued to have tachycardia, lightheadedness, and nausea. Around 1pm developed severe body aches and temp increased to 101. By 2pm temp was 102. Other symptoms remained, severe headache, had to stop working for the day. 4pm temp 102.2, took Tylenol, 6pm 100.8 took ibuprofen and fell asleep. Woke next morning with all but tachycardia resolved. Tachycardia still present (120-130) at time of writing. Slight local reaction to injection site and extremely sore arm present throughout . Previously had 2 Pfizer and Moderna booster. COVID twice, most recent January 30, 2023.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Impaired work ability, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Injection site reaction
Clinical narrative: Elevated heart rate up to the 160bpm at approximately 22 hours post vaccine with lightheadedness, headache and nausea. Contacted PCP who directed to urgent care. Upon arrival to urgent care, temp 100.5, hr 150. Covid and flu tests completed and negative. EKG showing only sinus tachycardia. Sent home. Over the course of the next 12 hours, continued to have tachycardia, lightheadedness, and nausea. Around 1pm developed severe body aches and temp increased to 101. By 2pm temp was 102. Other symptoms remained, severe headache, had to stop working for the day. 4pm temp 102.2, took Tylenol, 6pm 100.8 took ibuprofen and fell asleep. Woke next morning with all but tachycardia resolved. Tachycardia still present (120-130) at time of writing. Slight local reaction to injection site and extremely sore arm present throughout . Previously had 2 Pfizer and Moderna booster. COVID twice, most recent January 30, 2023.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Local reaction, Nausea, Pain, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Elevated heart rate up to the 160bpm at approximately 22 hours post vaccine with lightheadedness, headache and nausea. Contacted PCP who directed to urgent care. Upon arrival to urgent care, temp 100.5, hr 150. Covid and flu tests completed and negative. EKG showing only sinus tachycardia. Sent home. Over the course of the next 12 hours, continued to have tachycardia, lightheadedness, and nausea. Around 1pm developed severe body aches and temp increased to 101. By 2pm temp was 102. Other symptoms remained, severe headache, had to stop working for the day. 4pm temp 102.2, took Tylenol, 6pm 100.8 took ibuprofen and fell asleep. Woke next morning with all but tachycardia resolved. Tachycardia still present (120-130) at time of writing. Slight local reaction to injection site and extremely sore arm present throughout . Previously had 2 Pfizer and Moderna booster. COVID twice, most recent January 30, 2023.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus tachycardia, Tachycardia
Clinical narrative: Elevated heart rate up to the 160bpm at approximately 22 hours post vaccine with lightheadedness, headache and nausea. Contacted PCP who directed to urgent care. Upon arrival to urgent care, temp 100.5, hr 150. Covid and flu tests completed and negative. EKG showing only sinus tachycardia. Sent home. Over the course of the next 12 hours, continued to have tachycardia, lightheadedness, and nausea. Around 1pm developed severe body aches and temp increased to 101. By 2pm temp was 102. Other symptoms remained, severe headache, had to stop working for the day. 4pm temp 102.2, took Tylenol, 6pm 100.8 took ibuprofen and fell asleep. Woke next morning with all but tachycardia resolved. Tachycardia still present (120-130) at time of writing. Slight local reaction to injection site and extremely sore arm present throughout . Previously had 2 Pfizer and Moderna booster. COVID twice, most recent January 30, 2023.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy, Facial pain, Trigeminal neuralgia
Clinical narrative: Severe facial pain developed over the week post-vaccination. Dentist cleared patient. UC diagnosed Bell?s palsy or trigeminal neuralgia six days post vaccination. Prescribed prednisone and gave a toradol shot. Primary care doc saw patient the following day, confirmed trigeminal neuralgia diagnosis, referred to neurologist and prescribed gabapentin.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever, malaise, chills, myalgia, fatigue
Age: 68.0
Sex: M
Vaccine: COVID19, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was incorrectly given the pediatric Moderna vaccination. As of now there are no symptoms. The patient was informed and will let us know if anything occurs.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased
Clinical narrative: Pain at injection site within 20 hours of receiving vaccination. Numbness in right wrist all the way down to the base of the thumb. Inability to extend wrist upward for about 30 minutes. Slowly regaining range-of-motion.
Age: 36.0
Sex: F
Vaccine: FLUC4, PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Large bump under injection site. Red, sore. Warm to the touch. Arm has been weak for days, painful to move. Red splotches around injection site about 4 inches wide. Site bruising. Nearly 90 hours post injection my arm aches to use. No treatment other than warm compress and light massage to area to help dissipate the lump.
Age: 36.0
Sex: F
Vaccine: FLUC4, PNC20
Symptoms: Injection site warmth, Muscular weakness, Pain
Clinical narrative: Large bump under injection site. Red, sore. Warm to the touch. Arm has been weak for days, painful to move. Red splotches around injection site about 4 inches wide. Site bruising. Nearly 90 hours post injection my arm aches to use. No treatment other than warm compress and light massage to area to help dissipate the lump.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Blood magnesium, Blood potassium, Chills, Condition aggravated, Diarrhoea
Clinical narrative: 5 hours after vaccination - fell sleep, very tired 6 hours after vaccination - severe diarhea for an hour 7 hours after vax - chills Day 2 - severe headache, chills alternating with fever, continued fatigue, severe fibromyalgia pain all over body and took tizanidine in am & late pm Day 3 - headache, fever, fatigue, almost blacked out (took tizanidine in early am), very weak arms and legs, muscle pain like strained muscles - recognized tizanidine is counter-indicated for my arrhythmia genetic condition and discontinued Day 4 to present (7 days after vax) - each day slight improvement in muscle weakness, still fatigued but improved
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Fibromyalgia, Headache, Muscular weakness, Myalgia
Clinical narrative: 5 hours after vaccination - fell sleep, very tired 6 hours after vaccination - severe diarhea for an hour 7 hours after vax - chills Day 2 - severe headache, chills alternating with fever, continued fatigue, severe fibromyalgia pain all over body and took tizanidine in am & late pm Day 3 - headache, fever, fatigue, almost blacked out (took tizanidine in early am), very weak arms and legs, muscle pain like strained muscles - recognized tizanidine is counter-indicated for my arrhythmia genetic condition and discontinued Day 4 to present (7 days after vax) - each day slight improvement in muscle weakness, still fatigued but improved
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Presyncope, Pyrexia
Clinical narrative: 5 hours after vaccination - fell sleep, very tired 6 hours after vaccination - severe diarhea for an hour 7 hours after vax - chills Day 2 - severe headache, chills alternating with fever, continued fatigue, severe fibromyalgia pain all over body and took tizanidine in am & late pm Day 3 - headache, fever, fatigue, almost blacked out (took tizanidine in early am), very weak arms and legs, muscle pain like strained muscles - recognized tizanidine is counter-indicated for my arrhythmia genetic condition and discontinued Day 4 to present (7 days after vax) - each day slight improvement in muscle weakness, still fatigued but improved
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: PT REPORTED TO PHARMACY THAT SHE HAD REDNESS OF SKIN ON THE  LEFT ARM WHERE INJECTION WAS GIVEN
Age: 52.0
Sex: M
Vaccine: COVID19, FLUR4
Symptoms: Neck pain, Pain
Clinical narrative: Neck pain, specifically on the right side (Covid injection side), when neck extended up and tilting head down. Feels like a lymph node getting pinched. About 8 on pain scale (to 10) Had to stabilize my neck to prevent that motion.
Age: 26.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Chills, Fatigue, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Covid shot burned/felt like stinging as it was administered, and feeling lasted for a few hours after injection before starting to subside. Starting the morning of 10/4 woke up tired/fatigued with a headache and body aches. Arm very sore at injection site and hurts to lift arm. Had taken 400mg Advil the evening of 10/3 around 10pm, and again 10/4 around 3am and 8am. Around 3:30pm of 10/4 existing symptoms got worse and additionally got chills and a fever of 101.1F. Took 500mg Tylenol around 5pm and chills subsided around 5:30 and temperature went down to 99F. Morning of 10/5 woke up with no fever and had taken no additional medication, still tired/fatigued with a headache and muscle aches but all less severe than 10/4.  Arm still very sore and painful to raise arm. Around 9:30pm noticed the injection site now had a large red blotch over it
Age: 26.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: Covid shot burned/felt like stinging as it was administered, and feeling lasted for a few hours after injection before starting to subside. Starting the morning of 10/4 woke up tired/fatigued with a headache and body aches. Arm very sore at injection site and hurts to lift arm. Had taken 400mg Advil the evening of 10/3 around 10pm, and again 10/4 around 3am and 8am. Around 3:30pm of 10/4 existing symptoms got worse and additionally got chills and a fever of 101.1F. Took 500mg Tylenol around 5pm and chills subsided around 5:30 and temperature went down to 99F. Morning of 10/5 woke up with no fever and had taken no additional medication, still tired/fatigued with a headache and muscle aches but all less severe than 10/4.  Arm still very sore and painful to raise arm. Around 9:30pm noticed the injection site now had a large red blotch over it
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: He was to receive Fluzone (6 months and up) and not to have received FluBlok for 18 yrs and up
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was 3 days expired. No adverse symptoms, or reactions.
Age: 55.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presented to the office as a walk-in complaining of arm swelling and mild pain. Arm from left side below injection site was red and warm to touch. Home care instructions provided. Denied fever or any signs of infection.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a red raised wheel reaction at injection site on Saturday 09/30/23, that spread and was itchy and read, and warm to touch on sunday but styed localosed to the arm. Patient cjecked with pharmacist and MD and advised to use hydrocortisone 1% OTC and reaction is subsiding gradually, no oral meds required
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: Patient had a red raised wheel reaction at injection site on Saturday 09/30/23, that spread and was itchy and read, and warm to touch on sunday but styed localosed to the arm. Patient cjecked with pharmacist and MD and advised to use hydrocortisone 1% OTC and reaction is subsiding gradually, no oral meds required
Age: 68.0
Sex: F
Vaccine: FLUA4, PNC20
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was given TUBERSOL as injection of 1 ML vial given intramuscular in the left arm LOT # 2CA92C2 EXP 08202023.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: no erection; overtime started feeling a little odd, slowly more odd than usual; started to forget things; hot flash; harder to breathe; body aches; always tired; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), on 25Aug2022 as dose 4 (booster), single (Lot number: FP7140) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose: 3, Batch/Lot No: FE3590), administration date: 08Oct2021, when the patient was 63-year-old, for COVID-19 Immunization; bnt162b2 (Dose: 2, Batch/Lot No: ER2613), administration date: 17Mar2021, when the patient was 62-year-old, for COVID-19 Immunization; bnt162b2 (Dose: 1, Batch/Lot No: EN6201), administration date: 24Feb2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: ERECTILE DYSFUNCTION (medically significant), outcome "unknown", described as "no erection"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "overtime started feeling a little odd, slowly more odd than usual"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "started to forget things"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flash"; DYSPNOEA (non-serious), outcome "unknown", described as "harder to breathe"; PAIN (non-serious), outcome "unknown", described as "body aches"; FATIGUE (non-serious), outcome "unknown", described as "always tired"; DIZZINESS (non-serious), outcome "unknown".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300262981 Same reporter, patient and product, different dose and events;
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Erectile dysfunction, Fatigue, Feeling abnormal
Clinical narrative: no erection; overtime started feeling a little odd, slowly more odd than usual; started to forget things; hot flash; harder to breathe; body aches; always tired; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), on 25Aug2022 as dose 4 (booster), single (Lot number: FP7140) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose: 3, Batch/Lot No: FE3590), administration date: 08Oct2021, when the patient was 63-year-old, for COVID-19 Immunization; bnt162b2 (Dose: 2, Batch/Lot No: ER2613), administration date: 17Mar2021, when the patient was 62-year-old, for COVID-19 Immunization; bnt162b2 (Dose: 1, Batch/Lot No: EN6201), administration date: 24Feb2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: ERECTILE DYSFUNCTION (medically significant), outcome "unknown", described as "no erection"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "overtime started feeling a little odd, slowly more odd than usual"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "started to forget things"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flash"; DYSPNOEA (non-serious), outcome "unknown", described as "harder to breathe"; PAIN (non-serious), outcome "unknown", described as "body aches"; FATIGUE (non-serious), outcome "unknown", described as "always tired"; DIZZINESS (non-serious), outcome "unknown".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300262981 Same reporter, patient and product, different dose and events;
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Memory impairment, Pain
Clinical narrative: no erection; overtime started feeling a little odd, slowly more odd than usual; started to forget things; hot flash; harder to breathe; body aches; always tired; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), on 25Aug2022 as dose 4 (booster), single (Lot number: FP7140) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose: 3, Batch/Lot No: FE3590), administration date: 08Oct2021, when the patient was 63-year-old, for COVID-19 Immunization; bnt162b2 (Dose: 2, Batch/Lot No: ER2613), administration date: 17Mar2021, when the patient was 62-year-old, for COVID-19 Immunization; bnt162b2 (Dose: 1, Batch/Lot No: EN6201), administration date: 24Feb2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: ERECTILE DYSFUNCTION (medically significant), outcome "unknown", described as "no erection"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "overtime started feeling a little odd, slowly more odd than usual"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "started to forget things"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flash"; DYSPNOEA (non-serious), outcome "unknown", described as "harder to breathe"; PAIN (non-serious), outcome "unknown", described as "body aches"; FATIGUE (non-serious), outcome "unknown", described as "always tired"; DIZZINESS (non-serious), outcome "unknown".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300262981 Same reporter, patient and product, different dose and events;
Age: 1.5
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Culture, Culture urine positive, Dialysis, Discomfort, Fatigue
Clinical narrative: Parents reported a fever started on Sunday 9/24
Age: 1.5
Sex: M
Vaccine: MMRV, MMRV
Symptoms: General physical condition abnormal, Infection, Irregular breathing, Laboratory test, Lethargy
Clinical narrative: Parents reported a fever started on Sunday 9/24
Age: 1.5
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Oxygen saturation decreased, Pyrexia, Red blood cell count decreased, Respiratory rate increased, Skin warm
Clinical narrative: Parents reported a fever started on Sunday 9/24
Age: 1.5
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Transfusion, Urine analysis, Vomiting, White blood cell count increased, X-ray
Clinical narrative: Parents reported a fever started on Sunday 9/24
Age: 1.5
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Pyrexia
Clinical narrative: Parents reported a fever started on Sunday 9/24
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Oropharyngeal discomfort
Clinical narrative: pt. felt as though the left side of her throat was closing.  Last flu shot 10 yrs ago. No history of a reaction. Pt. has her own EpiPen which was used.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Throat tightness
Clinical narrative: pt. felt as though the left side of her throat was closing.  Last flu shot 10 yrs ago. No history of a reaction. Pt. has her own EpiPen which was used.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product leakage, Underdose
Clinical narrative: No other AE; full dose was not administered; This spontaneous report was received from a nurse referring to a 1-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 02-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA) lot # W029538 with expiration date 15-SEP-2024, for prophylaxis (strength, dose, route of administration and anatomical locations were not reported). It was reported that the patient moved while attempting to administer a dose of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine. Reporter stated the full dose was not administered (incorrect dose administered) and some of the dose leaked out and was unsure of how much of the dose was received. No other adverse event (AE) was reported.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031283) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Moderna (Dose 1, lot number 011J20A) on 24-Dec-2020, Moderna (Dose 2, lot number 032L20A) on 21-Jan-2021, Moderna (Dose 3, lot number 939903) on 26-Nov-2021, Moderna (Dose 4 and lot number 016H22A. Patient got COVID-19 on 21-Dec-2022.) on 21-Nov-2022; for Product used for unknown indication: flu vaccine on 22-Sep-2023. Past adverse reactions to the above products included COVID-19 with Moderna; and No adverse event with Moderna, Moderna, Moderna and flu vaccine.    On 28-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy).    Concomitant and treatment medications were not reported.  Company comment: This spontaneous case concerns a 36-year-old, female patient with no gynecological medical history information reported, who experienced the unexpected non serious event of maternal exposure during pregnancy. The event occurred on the same day after receiving the fifth dose of SPIKEVAX 2023-2024 PFS. Date of patient's last menstrual period, expected delivery date, and gestational age at time of exposure were not provided. No further information about the event was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.
Age: 74.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Injection site swelling
Clinical narrative: COVID infection; Shoulder swelling after injection (15 minutes post injection).; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE SWELLING (Shoulder swelling after injection (15 minutes post injection).) and COVID-19 (COVID infection) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Trigeminal neuralgia, Hypertension and Congestive heart failure.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (Shoulder swelling after injection (15 minutes post injection).). an unknown date, the patient experienced COVID-19 (COVID infection). At the time of the report, INJECTION SITE SWELLING (Shoulder swelling after injection (15 minutes post injection).) had resolved and COVID-19 (COVID infection) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: they made a mistake of double dosing ipv to a patient, 1 dose from sanofi and 1 is from pediarix with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1 years old male patient to whom administered by mistake of double dosing Ipv (Vero) [Ipol] to a patient, 1 dose from sanofi and 1 is Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix).  On 28-Sep-2023, the patient received a dose 2 at a dose of 0.5 ml of suspect IPV (VERO) suspension for injection (strength: unknown, expiry date: 10-Feb-2025 and lot W1A101M) via intramuscular route in the left thigh, also received Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix) (strength, expiry date, route, anatomical location and batch number: not reported) as immunization and they made a mistake of double dosing ipv to a patient, 1 dose from sanofi and 1 is from pediarix with no reported adverse event (extra dose administered) (same day latency)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.08
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired PENTACEL to a patient (with no reported adverse event); Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 6 weeks old female patient who was administered an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine for prophylactic vaccination; pneumococcal vaccine for prophylactic vaccination; and hepatitis B vaccine for Prophylactic vaccination.  On 28-Sep-2023, the patient received a Standard expired dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 mL total (lot UJ754AB, expiry date- 26-SEP-2023) via intramuscular route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: they are not sure how much went in the patient/1 dose leaked with no reported adverse event; they are not sure how much went in the patient/1 dose leaked with no reported adverse event; Initial information received  on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72 years old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and the pharmacist was not sure how much went in the patient/1 dose leaked with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On 28-Sep-2023, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and the pharmacist was not sure how much went in the patient/1 dose leaked with no reported adverse event (incorrect dose administered) and (underdose) (latency: same day) (formulation unknown) (lot U8130AA and expiry date: 06-Jan-2024) (Frequency = once) (Strength = standard) via intramuscular route in the left deltoid for immunization.  It was reported that "They want to know if there any precedent for giving another dose since they are not sure how much went in the patient."  It was unknown if there were lab data/results available.   It was unknown if the patient experienced any additional symptoms/events.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Amnesia, Crying, Dyskinesia, Impaired work ability, Laboratory test
Clinical narrative: After I gave the flu shot, I told the patient you are all set, but not responding to me so when I checked her she was not responding.Patient became unconscious for 5 seconds or less, had jerking movement like having a seizure. Eyes still open though. Then suddenly woke up did not recalled what happened so we told her she was unconscious for awhile then afterwards she cried realizing what happened to her. Called the Mom and I asked if she ate anything then told us nothing to eat did not even drink water that morning. We told the Mom will call 911 just to be sure although they said she was fine. After maybe 10 minutes or less the EMT arrived and checked her said she was fine but continue to observe her at home and will not go to work that day.
Age: 18.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Loss of consciousness, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: After I gave the flu shot, I told the patient you are all set, but not responding to me so when I checked her she was not responding.Patient became unconscious for 5 seconds or less, had jerking movement like having a seizure. Eyes still open though. Then suddenly woke up did not recalled what happened so we told her she was unconscious for awhile then afterwards she cried realizing what happened to her. Called the Mom and I asked if she ate anything then told us nothing to eat did not even drink water that morning. We told the Mom will call 911 just to be sure although they said she was fine. After maybe 10 minutes or less the EMT arrived and checked her said she was fine but continue to observe her at home and will not go to work that day.
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt received FluBlok (ages 18 and up) instead of FluZone (ages 6 months and up)
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Temporal fever for one day, blotchy erythematous rash (<24 hours, resolved by follow up next day)
Age: 0.5
Sex: F
Vaccine: COVID19-2, DTAP, FLUC4, HIBV, PNC13
Symptoms: Petechiae, Skin lesion
Clinical narrative: Developed petechial lesions on bilateral lower legs Tuesday 10/3.  Seen in clinic Thursday 10/5.  Most lesions beginning to fade.  No new lesions developing.  No known trauma.  Patient otherwise eating and playful.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: baby given the wrong vaccine, Afluria 3yr + instead of the Fluzone for 6m and above.  No reactions were observed after baby received the vaccine.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Epistaxis, Pyrexia
Clinical narrative: 10/5/23-bloody nose, fever 101.2
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Pt was accidentally given 2 Pfizer Comiranty doses
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pruritus
Clinical narrative: EXPERIENCED INTENSE ITCHING, STARTING ON THE PALMS OF HANDS AND SOLES OF FEET AND PROGRESSING THROUGHOUT ENTIRE BODY.  TOOK 2 BENADRYL TABLETS TO RELIEVE THOROUGHLY FRIGHTENING SYMPTOMS.  CONGESTION IN UPPER NASAL PASSAGES.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child is under 12 and was given adult Pfizer Bivalent vaccine
Age: 6.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Sex: F
Vaccine: RSV
Symptoms: Anal pruritus, Fatigue, Rash, Tenderness, Vulvovaginal pruritus
Clinical narrative: rash on arm/arm rash; vaginal itching; intense anal itching; fatigue; tenderness; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included hemorrhoids.   On 22-SEP-2023, the patient received Arexvy (unknown arm). On 23-SEP-2023, 1 days after receiving Arexvy, the patient experienced rash (Verbatim: rash on arm/arm rash), vaginal itching (Verbatim: vaginal itching), anal pruritus (Verbatim: intense anal itching), fatigue (Verbatim: fatigue) and tenderness (Verbatim: tenderness).  On 23-SEP-2023, the outcome of the fatigue was resolved. The outcome of the rash, vaginal itching, anal pruritus and tenderness were not resolved.   It was unknown if the reporter considered the rash, vaginal itching, anal pruritus, fatigue and tenderness to be related to Arexvy.     It was unknown if the company considered the rash, vaginal itching, anal pruritus, fatigue and tenderness to be related to Arexvy.   Additional Information: GSK receipt date: 28-SEP-2023 The following day of vaccination, patient experienced rash on arm, tenderness, and fatigue.   The fatigue resolved the same day, arm rash and tenderness were still ongoing.   The patient also started experiencing intense anal and vaginal itching, which remained ongoing.   She declined to provide any further details. The reporter asked for permission to follow-up but she declined to answer. The reporter did not consent to follow-up.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: A patient received first and only dose of GARDASIL 9 while pregnant.; No additional adverse events were reported; This spontaneous prospective pregnancy report was received from a medical assistant and refers to a 17-year-old female patient. The patient did not have drug reactions or allergies and no pertinent medical history. There were no concomitant medications.     On 14-SEP-2023, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly, 1 dose, lot # 1957404, expiration date 05-OCT-2025 ,for immunisation. The patient was vaccinated while she was pregnant (exposure during pregnancy). The last menstrual period and estimated date of delivery were not reported. The pregnancy outcome was pending. No additional adverse events were reported.