chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Dizziness, Fear of injection, Hypoacusis, Loss of personal independence in daily activities
Clinical narrative: From ED note: Patient is a 19 yrear old female with h/o POTS, migraines w/aura, asthma, and endometriosis who presented for evaluation of syncopy. She reports she feels lightheaded and nauseaous in the settong her POTS disease, but was feeling worse yesterday 9/19/2023 and this moring.  Patient then recieved her influenza vaccine at 1600 and felt worsening lightheadedness and nausea. Has significant phobia of needles.  Patient reported a spinning senation and distoreted hearing, sat down and then had a syncopal episode, not breathing and had a weak pulse.   syncopal event requiring CPR. Campus response was called, caregiver was transported to PCH ED. Required oxygen via NC.  Witnesses did not report patient hitting her head.  Has had syncopal episodes before, but has never stopped breathing or required chest compressions 9/19 had migraine and nausea, 9/20 was feeling a little nauseous before shot. 9/21 stayed home from school today.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Postural orthostatic tachycardia syndrome, Pulse abnormal, Respiratory failure, Resuscitation
Clinical narrative: From ED note: Patient is a 19 yrear old female with h/o POTS, migraines w/aura, asthma, and endometriosis who presented for evaluation of syncopy. She reports she feels lightheaded and nauseaous in the settong her POTS disease, but was feeling worse yesterday 9/19/2023 and this moring.  Patient then recieved her influenza vaccine at 1600 and felt worsening lightheadedness and nausea. Has significant phobia of needles.  Patient reported a spinning senation and distoreted hearing, sat down and then had a syncopal episode, not breathing and had a weak pulse.   syncopal event requiring CPR. Campus response was called, caregiver was transported to PCH ED. Required oxygen via NC.  Witnesses did not report patient hitting her head.  Has had syncopal episodes before, but has never stopped breathing or required chest compressions 9/19 had migraine and nausea, 9/20 was feeling a little nauseous before shot. 9/21 stayed home from school today.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Vertigo
Clinical narrative: From ED note: Patient is a 19 yrear old female with h/o POTS, migraines w/aura, asthma, and endometriosis who presented for evaluation of syncopy. She reports she feels lightheaded and nauseaous in the settong her POTS disease, but was feeling worse yesterday 9/19/2023 and this moring.  Patient then recieved her influenza vaccine at 1600 and felt worsening lightheadedness and nausea. Has significant phobia of needles.  Patient reported a spinning senation and distoreted hearing, sat down and then had a syncopal episode, not breathing and had a weak pulse.   syncopal event requiring CPR. Campus response was called, caregiver was transported to PCH ED. Required oxygen via NC.  Witnesses did not report patient hitting her head.  Has had syncopal episodes before, but has never stopped breathing or required chest compressions 9/19 had migraine and nausea, 9/20 was feeling a little nauseous before shot. 9/21 stayed home from school today.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: I received the vaccine at 4:10 and at 4:55 my lips and my left arm went numb. 2 hours later at 6:55 I had full on numbness and I noticed that the side effects started to subside. I called the pharmacy to let them know. An hour later or so, around 8pm, everything was gone and I was fine. The whole incident lasted about 3 hours.
Age: 79.0
Sex: F
Vaccine: FLUA4
Symptoms: Cough, Food allergy, Throat irritation, Throat tightness
Clinical narrative: Patient has a known egg allergy, developed sensation of itchy, tight throat and persistent cough no wheeze oral or edema
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt had flu vaccine on 9/29/23 at Left Deltoid. Pt developed reactions a few hours after vaccination. Initially swelling, redness, itching, and warm to touch on the left deltoid. Denies discharges. No fever. Pt still continues to experience itchiness and swelling at the injection site. Pt aware and watch for any signs of infection and worsening of symptoms. Pt is aware to follow up with her physician of choice for any worsening of symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Lethargy, Myalgia
Clinical narrative: Symptoms started at 2 AM on September 29. Fever of 100.3  , headache chills.   Fever continued for 48 hours. Very lethargic and fatigued. Multiple muscle aches. Intense headache. Symptoms did not update until the morning of October 1.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased, Condition aggravated, Disorientation, Feeling abnormal, Heart rate increased
Clinical narrative: Arm has been very sore now for 2 days, day after vaccine I was very ?out of it?, almost disoriented. My blood pressure spiked as did my heart rate the morning following, although those have now returned to normal.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Arm has been very sore now for 2 days, day after vaccine I was very ?out of it?, almost disoriented. My blood pressure spiked as did my heart rate the morning following, although those have now returned to normal.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: heart inflammation; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 15-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "recovering", described as "heart inflammation". Clinical course: the patient's parent reported the side effect of their son after he took the Pfizer COVID-19 vaccine. The reporter's son was 15 years old and he developed heart inflammation after took the fourth vaccine. The patient received treatment since earlier the year and made improvement; however, the patient still had "less symptoms exists."   Therapeutic measures were taken as a result of myocarditis.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Flushing, Heart rate increased, Paraesthesia, Rash
Clinical narrative: Rash- face and arms Flushing of face -cheeks increased pulse 97-100bpm tingling in hand
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anxiety, Conjunctival hyperaemia, Erythema, Flushing, Heart rate increased
Clinical narrative: Rash- face and arms Flushing of face -cheeks increased pulse 97-100bpm tingling in hand
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: Rash- face and arms Flushing of face -cheeks increased pulse 97-100bpm tingling in hand
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site swelling, Paraesthesia
Clinical narrative: Rash- face and arms Flushing of face -cheeks increased pulse 97-100bpm tingling in hand
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus
Clinical narrative: Patient complained of bilateral arm itchiness. She refused benadryl at the pharmacy for fear of drowsiness while traveling home but purchased some to take home with her
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Abdominal pain, Aphasia, Asthenia, Immunisation reaction, Laboratory test
Clinical narrative: Patient said that the next day she felt nauseous, lost her energy, her muscles would not move, she could not lift her arm, or talk. They called an ambulance and she was taken to the hospital. They ruled out other causes and the ER doctor told her it was from the flu shot.  She had nausea for several days and abdominal pain. Prior to the shot she went to have blood work done to check her liver enzymes. She is following up with her pcp.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Mobility decreased, Muscle disorder, Nausea
Clinical narrative: Patient said that the next day she felt nauseous, lost her energy, her muscles would not move, she could not lift her arm, or talk. They called an ambulance and she was taken to the hospital. They ruled out other causes and the ER doctor told her it was from the flu shot.  She had nausea for several days and abdominal pain. Prior to the shot she went to have blood work done to check her liver enzymes. She is following up with her pcp.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Diarrhoea, Palpitations, Pyrexia, Rash
Clinical narrative: Tongue lesions with high fever, speeding heartbeat,  stomach pain, diarrhea and skin rash. High fever and high heart rate started approx 12 hours after injection. Fever abated approx 72 hours after. Ongoing high heart rate, stomach pain, rash and tongue lesions, but not life threatening. Lesions and rash appeared approx 48 hours after injection. Similar rxn of fever, rash and lesions with prior Moderna injections. New with Pfizer is heart rate and stomach pain/diarrhea.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tongue disorder
Clinical narrative: Tongue lesions with high fever, speeding heartbeat,  stomach pain, diarrhea and skin rash. High fever and high heart rate started approx 12 hours after injection. Fever abated approx 72 hours after. Ongoing high heart rate, stomach pain, rash and tongue lesions, but not life threatening. Lesions and rash appeared approx 48 hours after injection. Similar rxn of fever, rash and lesions with prior Moderna injections. New with Pfizer is heart rate and stomach pain/diarrhea.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered their last pentacel yesterday but it already expired on Monday with no reported adverse event.; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 6 months old female patient who was administered their last diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] yesterday but it already expired on monday with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Sep-2023, the patient received a standard total dose 3 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml (lot UJ737AAA, expiry date- 18-SEP-2023) via intramuscular route in the right thigh for Immunization.  On 19-SEP-2023 the patient was administered their last pentacel yesterday but it already expired on monday with no reported adverse event (expired product administered) (latency- same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  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: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red and itching circle area approximately 1 and 1/2 in in diameter at injection site. Dose not  feel warm to touch, She states hydrocortisone cream helps the itching. I suggested to continue and an ice pack occasionally and check back in 3 days still having issues.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema
Clinical narrative: Left arm redness and right arm blister
Age: 13.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Dizziness, Hyperhidrosis, Pallor, Skin warm
Clinical narrative: Patient reports of dizziness and light headedness. Patient was pale, diaphoretic, and hot to the touch.  Patients denies rash, trouble breathing, swelling to lips, tongue or throat or itchiness.  Unable to take a blood pressure reading due to store's emergency bag not having an appropriate size cuff or stethoscope.  Patient's father reports patient had not eaten  since noon. Patient reports he had very little  water that day. Outer jacket removed, legs elevated, cool wet cloth applied, water provided and chocolate peanut candies. ten minutes post interventions, patient reports" I am feeling a lot better" and " I am not dizzy anymore". Color returned to patients face, diaphoresis resolved, skin temperature decreased.  Father denied offer to call EMS. Encouraged Father to seek additional medical assistance.  Father and patient walked out of store thankful for nursing interventions.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an uapproved storage unit
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Date of Admission: 9/24/2023   Date of Discharge: 9/25/2023   Issues to be Addressed at Follow-up: 1. Determine when to resume entresto. 2. Ensure compliance with gallbladder diet. 3. EtOH and tobacco cessation. 4. Follow up with general surgery for elective cholecystectomy after COVID isolation period ends.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 80.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site reaction
Clinical narrative: Patient returned to pharmacy with more serious local injection site reaction, needing medical attention/antibiotics. I referred to PCP. Patient prescribed antibiotics.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Arthralgia, Breast mass, Breast pain, Neck pain
Clinical narrative: Left shoulder soreness started 10/2 at 1600; left breast pain & large lump noted 10/2 at 2100 and left upper quadrant and neck achiness noted 10/3 0600AM
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling cold, Heart rate irregular, Hypoaesthesia, Pyrexia
Clinical narrative: I woke freezing, chattering teeth. Later my heart rate was staying between 112 and 122 but dropping sometimes to 69, most of the time 122. I started running a fever that hit 101.5. I took tylenol to reduce pain and fever. Now, next day, no fever but my right set of toes are odly numb.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acquired diaphragmatic eventration, Acute kidney injury, Acute respiratory failure, Asthenia, Blood creatinine increased
Clinical narrative: Patient is an 86 year old  male with a history of HFpEF, Hypertension, COPD, CAD s/p CABG, Lung Cancer s/p RUL lobectomy, Arthritis on chronic steroids, who presented to Hospital Observation 8/30/2023 with 3 weeks of cough, diarrhea, generalized weakness and found to have COVID-19 infection.      1. COVID-19: s/p vaccination. Symptoms onset ~3 weeks prior to presentation with cough, diarrhea, nausea. Positive test date 8/30/23.  Evaluated by pulmonology, no indication  for Remdesivir or decadron.  Discharged on 2L O2 NC. 2. Acute Respiratory Failure with Hypoxia: In setting of above, no baseline oxygen requirements. Evaluated by Pulmonology. Discharged on as needed home oxygen, was requiring 1-2L O2.  3. AKI on CKD stage 3b: baseline Cr ~1.8 Admit Cr 2.2. Suspected pre-renal in setting of COVID19, poor PO intake, complicated by ACE Inhibitor/Loop diuretic. Reduced home lasix dose at discharge.  Creatinine 1.79 at discharge. 4. Elevated Right Hemidiaphragm: in setting of prior RUL lobectomy. Admit Chest X-ray with elevated right hemidiaphragm unchanged from 2017. 5. HFpEF: per history. TTE (7/2019) with G1DD, LVEF 65%. Hypovolemic on admission. Continued home meds, reduced dose of lasix at 20mg BID at discharge.   6. Hypertension: Continued home meds. 7. CAD: per history. s/p CABG (2015). Continued home medications.  8. COPD: per history. Follows with Dr. (Pulmonology). No evidence of exacerbation on admission. 9. History of  Lung Malignancy: s/p RUL lobectomy (2012).  10. T2DM: Continued home meds. 11. Polymyalgia Rheumatica/Arthritis: follows with Dr. (Rheum). Continued home chronic low-dose Prednisone
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray abnormal, Chronic kidney disease, Condition aggravated, Cough
Clinical narrative: Patient is an 86 year old  male with a history of HFpEF, Hypertension, COPD, CAD s/p CABG, Lung Cancer s/p RUL lobectomy, Arthritis on chronic steroids, who presented to Hospital Observation 8/30/2023 with 3 weeks of cough, diarrhea, generalized weakness and found to have COVID-19 infection.      1. COVID-19: s/p vaccination. Symptoms onset ~3 weeks prior to presentation with cough, diarrhea, nausea. Positive test date 8/30/23.  Evaluated by pulmonology, no indication  for Remdesivir or decadron.  Discharged on 2L O2 NC. 2. Acute Respiratory Failure with Hypoxia: In setting of above, no baseline oxygen requirements. Evaluated by Pulmonology. Discharged on as needed home oxygen, was requiring 1-2L O2.  3. AKI on CKD stage 3b: baseline Cr ~1.8 Admit Cr 2.2. Suspected pre-renal in setting of COVID19, poor PO intake, complicated by ACE Inhibitor/Loop diuretic. Reduced home lasix dose at discharge.  Creatinine 1.79 at discharge. 4. Elevated Right Hemidiaphragm: in setting of prior RUL lobectomy. Admit Chest X-ray with elevated right hemidiaphragm unchanged from 2017. 5. HFpEF: per history. TTE (7/2019) with G1DD, LVEF 65%. Hypovolemic on admission. Continued home meds, reduced dose of lasix at 20mg BID at discharge.   6. Hypertension: Continued home meds. 7. CAD: per history. s/p CABG (2015). Continued home medications.  8. COPD: per history. Follows with Dr. (Pulmonology). No evidence of exacerbation on admission. 9. History of  Lung Malignancy: s/p RUL lobectomy (2012).  10. T2DM: Continued home meds. 11. Polymyalgia Rheumatica/Arthritis: follows with Dr. (Rheum). Continued home chronic low-dose Prednisone
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diarrhoea, Diuretic therapy, Hypophagia, Hypovolaemia, Malaise
Clinical narrative: Patient is an 86 year old  male with a history of HFpEF, Hypertension, COPD, CAD s/p CABG, Lung Cancer s/p RUL lobectomy, Arthritis on chronic steroids, who presented to Hospital Observation 8/30/2023 with 3 weeks of cough, diarrhea, generalized weakness and found to have COVID-19 infection.      1. COVID-19: s/p vaccination. Symptoms onset ~3 weeks prior to presentation with cough, diarrhea, nausea. Positive test date 8/30/23.  Evaluated by pulmonology, no indication  for Remdesivir or decadron.  Discharged on 2L O2 NC. 2. Acute Respiratory Failure with Hypoxia: In setting of above, no baseline oxygen requirements. Evaluated by Pulmonology. Discharged on as needed home oxygen, was requiring 1-2L O2.  3. AKI on CKD stage 3b: baseline Cr ~1.8 Admit Cr 2.2. Suspected pre-renal in setting of COVID19, poor PO intake, complicated by ACE Inhibitor/Loop diuretic. Reduced home lasix dose at discharge.  Creatinine 1.79 at discharge. 4. Elevated Right Hemidiaphragm: in setting of prior RUL lobectomy. Admit Chest X-ray with elevated right hemidiaphragm unchanged from 2017. 5. HFpEF: per history. TTE (7/2019) with G1DD, LVEF 65%. Hypovolemic on admission. Continued home meds, reduced dose of lasix at 20mg BID at discharge.   6. Hypertension: Continued home meds. 7. CAD: per history. s/p CABG (2015). Continued home medications.  8. COPD: per history. Follows with Dr. (Pulmonology). No evidence of exacerbation on admission. 9. History of  Lung Malignancy: s/p RUL lobectomy (2012).  10. T2DM: Continued home meds. 11. Polymyalgia Rheumatica/Arthritis: follows with Dr. (Rheum). Continued home chronic low-dose Prednisone
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, SARS-CoV-2 test positive
Clinical narrative: Patient is an 86 year old  male with a history of HFpEF, Hypertension, COPD, CAD s/p CABG, Lung Cancer s/p RUL lobectomy, Arthritis on chronic steroids, who presented to Hospital Observation 8/30/2023 with 3 weeks of cough, diarrhea, generalized weakness and found to have COVID-19 infection.      1. COVID-19: s/p vaccination. Symptoms onset ~3 weeks prior to presentation with cough, diarrhea, nausea. Positive test date 8/30/23.  Evaluated by pulmonology, no indication  for Remdesivir or decadron.  Discharged on 2L O2 NC. 2. Acute Respiratory Failure with Hypoxia: In setting of above, no baseline oxygen requirements. Evaluated by Pulmonology. Discharged on as needed home oxygen, was requiring 1-2L O2.  3. AKI on CKD stage 3b: baseline Cr ~1.8 Admit Cr 2.2. Suspected pre-renal in setting of COVID19, poor PO intake, complicated by ACE Inhibitor/Loop diuretic. Reduced home lasix dose at discharge.  Creatinine 1.79 at discharge. 4. Elevated Right Hemidiaphragm: in setting of prior RUL lobectomy. Admit Chest X-ray with elevated right hemidiaphragm unchanged from 2017. 5. HFpEF: per history. TTE (7/2019) with G1DD, LVEF 65%. Hypovolemic on admission. Continued home meds, reduced dose of lasix at 20mg BID at discharge.   6. Hypertension: Continued home meds. 7. CAD: per history. s/p CABG (2015). Continued home medications.  8. COPD: per history. Follows with Dr. (Pulmonology). No evidence of exacerbation on admission. 9. History of  Lung Malignancy: s/p RUL lobectomy (2012).  10. T2DM: Continued home meds. 11. Polymyalgia Rheumatica/Arthritis: follows with Dr. (Rheum). Continued home chronic low-dose Prednisone
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: fluzone high dose quadrivalent is tainted, as the vaccines have exceeded the two-day window due to a possible excursion, that one of vaccine was given to a consumer with no reported adverse event; Initial information received on 25-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 65 years old female patient and is reported influenza quadrival A-B high dose HV vaccinE [Fluzone High-Dose Quadrivalent] is tainted, as the vaccines have exceeded the two-day window due to a possible excursion, that one of vaccine was given to a consumer with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2023, the patient received a dose 0.7 ml of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength, expiry date: not reported lot U8132DA via intramuscular route in unknown administration site for immunization.  On 25-SEP-2023 fluzone high dose quadrivalent is tainted, as the vaccines have exceeded the two-day window due to a possible excursion, that one of vaccine was given to a consumer with no reported adverse event (poor quality product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone high dose quadrivalent is tainted, as the vaccines have exceeded the two-day window due to a possible excursion, that one of vaccine was given to a consumer with no reported adverse 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: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysphagia, Headache, Nausea, Swollen tongue
Clinical narrative: Dizziness, lightheaded, nausea, headache, swelling of tongue, difficulty swallowing.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Exercise tolerance decreased, Injection site pain, Loss of personal independence in daily activities, Muscular weakness, Pain
Clinical narrative: Received seasonal flu vaccine in left arm during annual provider exam.  Next day experienced pain at the injection site, worse with movement of affected arm.  Pain has continued at various levels dependent on activity for 9+ months since the date of the vaccine.  Pt experiences pain when raising left arm to shoulder level and above and when lying on or putting pressure on left arm.  Patient is left-handed and cannot lift as much weight with the left hand as she can with the right when exercising, which was not the case prior to this vaccine injury.  Patient went to Dr on 10/03/2023, and he recommended trying Voltaren cream.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Bone pain, Decreased appetite, Fatigue, Headache
Clinical narrative: Extreme headache over 3 days, bone and joint pain, nausea, loss of appetite, neck and chest rash, and tiredness.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Nausea, Rash
Clinical narrative: Extreme headache over 3 days, bone and joint pain, nausea, loss of appetite, neck and chest rash, and tiredness.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Body temperature increased, Nausea, Pain
Clinical narrative: Body and joint aches, nausea,  temperature elevated by 1.5 degree F
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Rash, Rash pruritic, Skin warm
Clinical narrative: My right arm got a rash and it was warm  and itchy for a week and I had a slight headache. The rash is leaving slowly.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin lesion
Clinical narrative: got flu shot 9/29/23 in office- leg swelling/redness started after that  never had fevers  +pain to leg with severe itching  R leg swelling progressed with leg being 2-3x L leg with marked erythema/some open lesions from itching  took to urgent care 10/1- given script for possible cellulitis but told to continue benadryl q 6 hours and wait for 24 hours if comfortable before starting abx  Mom waited and yesterday leg started to look much more normal  no motrin/benadryl since last night, taking daily zyrtec  swelling significantly improved, redness improved, itching improved
Sex: U
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: product was not suitable for use since it had been in transit for too long (with no reported adverse event); already been administered to one patient before they were informed that it was no longer suitable (with no reported adverse event); Initial information received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age/gender patient, product was not suitable for use since it had been in transit for too long (with no reported adverse event) and already been administered to one patient before they were informed that it was no longer suitable (with no reported adverse event) for diphtheria-2/tetanus/5 AC Pertussis Vaccine [Adacel].  On an unknown date, the suspect diphtheria-2/tetanus/5 AC Pertussis Vaccine via unknown route in unknown administration site for prophylactic vaccination (dose, batch number, expiry date: unknown), already been administered to one patient before they were informed that it was no longer suitable (with no reported adverse event) (poor quality product administered) (latency same day).  On an unknown date product was not suitable for use since it had been in transit for too long (with no reported adverse event) (product storage error).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for 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 and Regulatory Authority 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: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Medication error, No adverse event
Clinical narrative: fluzone high-dose quadrivalent was leaking from a patient's arm when the vaccine was given with no reported adverse event; Initial information was received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 68 years old female patient who reported that influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] was leaking from a patient's arm when the vaccine was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Sep-2023, the patient received a dose of 0.5 ml of suspect influenza quadrival a-b high dose hv vaccine (lot U8084BA, Expiry date : 30-Jun-2024, Frequency : Once, strength, formulation was unknown) via intramuscular route in the right deltoid for Immunization.  On 22-Sep-2023 the patient developed a non-serious event of fluzone high-dose quadrivalent was leaking from a patient's arm when the vaccine was given with no reported adverse event (accidental exposure to product) (latency : same day).  Action taken with QUADRIVALENT influenza vaccine (Fluzone HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone high-dose quadrivalent was leaking from a patient's arm when the vaccine was given with no reported adverse 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: 30.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received FLUZONE-HD QIV however they were under the age of 65 with no reported adverse event; Initial information was received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 30 years old female patient who received influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] however they were under the age of 65 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot U8135AA, Frequency : Total, Expiry date, strength, formulation was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient received fluzone-hd qiv however they were under the age of 65 with no reported adverse event (product administered to patient of inappropriate age) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient received fluzone-hd qiv however they were under the age of 65 with no reported adverse 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.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: pharmacist inadvertently mixed the YF-VAX with sterile water instead of the proper diluent along with the vaccine and administered it to 2 patients with no reported adverse event; Initial information received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 2 patients with unknown age and unknown gender for whom pharmacist inadvertently mixed the yellow fever vaccine [YF-VAX] with sterile water instead of the proper diluent along with the vaccine and administered it to 2 patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect yellow fever vaccine Solution for injection (lot number, expiry date, dosage, strength- not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On an unknown date the pharmacist inadvertently mixed the yellow fever vaccine with sterile water instead of the proper diluent along with the vaccine and administered it to 2 patients with no reported adverse event (product preparation error) (latency- same day). Caller asks for manufacturer's guidelines on this situation.  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: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered pentacel to an 18 month old patient, but it was seven days expired with no reported adverse event; Initial information received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 18-months-old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine [Pentacel (Vero)], but it was seven days expired 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 pneumococcal vaccine (Pneumococcal); and influenza vaccine (Flu Vaccine VII) for Immunisation.  On 25-Sep-2023 at around 16:30 hours, the patient received 0.5 mL Dose 4 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/  IPV  (vero)/ HIB (PRP/T) vaccine, suspension for injection (Strength: standard; Frequency: once ) (batch number: U774BA; expiry date: 18-Sep-2023) via intramuscular route in the left thigh for Immunization but it was seven days expired with no reported adverse event (expired product 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.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: tested positive for influenza A; Initial information was received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and gender patient who was tested positive for influenza after receiving influenza quadrival A-b high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-b high dose HV vaccine (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number will not be available.  On an unknown date, the patient had tested positive for influenza a (influenza) (Reportedly, 3 to 4 days later) unknown latency) following the administration of influenza quadrival A-b high dose HV vaccine.  Relevant laboratory test results included: Influenza A virus test - On an unknown date: Positive  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  No follow-up possible as caller declined to respond to questions and refuses future follow-up.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Mild local redness, tenderness, warmth at injection site; Mild local redness, tenderness, warmth at injection site; Mild local redness, tenderness, warmth at injection site; This spontaneous report was received from a nurse practitioner via other company; referring to a female patient of unknown age. The patient's current conditions, historical conditions, allergies and drug reactions could not be determined.  On an unspecified date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (strength, dose number, dose, frequency, route and anatomical location of administration, lot numbers and expiration date were not provided) administered as prophylaxis.  On an unspecified date, the patient experienced an allergy to the vaccine, consisting of mild local redness, tenderness, warmth at the injection site (vaccination site erythema, vaccination site pain and vaccination site warmth). The outcome of the events was not provided.  The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) regarding vaccination site erythema, vaccination site pain and vaccination site warmth was not applicable.  The causal relationship of the vaccine was assessed as related to the events.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Injection site pain; Drug dose administration interval too long; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a adult female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix with an associated reaction of injection site pain (on 10th March 2023, received  1st dose and had Injection site pain, reference case US2023038115).   On 08-SEP-2023, the patient received the 2nd dose of Twinrix (left arm). On 08-SEP-2023, less than a day after receiving Twinrix, the patient experienced injection site pain (Verbatim: Injection site pain) and drug dose administration interval too long (Verbatim: Drug dose administration interval too long).  Rechallenge with Twinrix was positive. On 08-SEP-2023, the outcome of the injection site pain was resolved. The outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023038115   Additional Information: GSK receipt date: 08-SEP-2023 The patient received a subsequent dose and had injection site pain. The case was related to the existing case. The patient received 2nd dose after the recommended schedule, which led to lengthening of the dose schedule. The reporter was requested for follow up. The case is linked with US2023038115, by same reporter.; Sender's Comments:  US-GSK-US2023038115:Same patient
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Balance disorder, Feeling abnormal, Injection site pain, Malaise
Clinical narrative: her arm was hurting really bad; She just felt lousy; feeling bad/I feel terrible; She had unsteadiness with walking; upset stomach without vomiting/she woke up with an upset stomach; very sore arm at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 83-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 12:00 as dose number unknown ,single (Batch/Lot number: unknown) at the age of 83 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BALANCE DISORDER (non-serious) with onset 26Sep2023, outcome "not recovered", described as "She had unsteadiness with walking"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Sep2023, outcome "not recovered", described as "upset stomach without vomiting/she woke up with an upset stomach"; INJECTION SITE PAIN (non-serious) with onset 26Sep2023, outcome "not recovered", described as "very sore arm at injection site"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was hurting really bad"; MALAISE (non-serious), outcome "unknown", described as "She just felt lousy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling bad/I feel terrible". Therapeutic measures were not taken as a result of balance disorder, abdominal discomfort, injection site pain. Additional information:Patient had unsteadiness with walking, upset stomach without vomiting, very sore arm at injection site and asking if these are common side effects and when they would go away. Upon further discussion, consumer confirmed his wife got the most recent 2023-2024 formula for adults yesterday (26Sep2023) at around 12 noon.  She is age=83 years old.  That evening, she woke up with an upset stomach and her arm was hurting really bad.  She was very unstable on her feet, I had to walk her to the bathroom 3 times last night.  She did not vomit and does not have a temperature. There is no swelling or redness at the site of injection. She just felt lousy.  She said she started feeling bad around 10pm when we went to bed.  She did go to sleep for a while and woke up and said 'I feel terrible' and that was around midnight.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was hurting really bad; She just felt lousy; feeling bad/I feel terrible; She had unsteadiness with walking; upset stomach without vomiting/she woke up with an upset stomach; very sore arm at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 83-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 12:00 as dose number unknown ,single (Batch/Lot number: unknown) at the age of 83 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BALANCE DISORDER (non-serious) with onset 26Sep2023, outcome "not recovered", described as "She had unsteadiness with walking"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Sep2023, outcome "not recovered", described as "upset stomach without vomiting/she woke up with an upset stomach"; INJECTION SITE PAIN (non-serious) with onset 26Sep2023, outcome "not recovered", described as "very sore arm at injection site"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was hurting really bad"; MALAISE (non-serious), outcome "unknown", described as "She just felt lousy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling bad/I feel terrible". Therapeutic measures were not taken as a result of balance disorder, abdominal discomfort, injection site pain. Additional information:Patient had unsteadiness with walking, upset stomach without vomiting, very sore arm at injection site and asking if these are common side effects and when they would go away. Upon further discussion, consumer confirmed his wife got the most recent 2023-2024 formula for adults yesterday (26Sep2023) at around 12 noon.  She is age=83 years old.  That evening, she woke up with an upset stomach and her arm was hurting really bad.  She was very unstable on her feet, I had to walk her to the bathroom 3 times last night.  She did not vomit and does not have a temperature. There is no swelling or redness at the site of injection. She just felt lousy.  She said she started feeling bad around 10pm when we went to bed.  She did go to sleep for a while and woke up and said 'I feel terrible' and that was around midnight.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "unknown", described as "Arm pain". It was unknown if therapeutic measures were taken as a result of pain in extremity. Additional information: Vaccine location: Deltoid  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.