chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19, FLU4, FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: medical assistant should give FLUZONE HIGH-DOSE QIV and a COVID-19 vaccine. but their MA accidentally ended up giving FLUZONE HIGH-DOSE QIV and FLUZONE QIV NP to the patient with no reported adverse event; medical assistant should give FLUZONE HIGH-DOSE QIV and a COVID-19 vaccine. but their MA accidentally ended up giving FLUZONE HIGH-DOSE QIV and FLUZONE QIV NP to the patient with no reported adverse event; Initial information was received on 29-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 81 years old female patient who experienced medical assistant should give influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] and a covid-19 vaccine. but their ma accidentally ended up giving influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] and influenza quadrival a-b vaccine [Fluzone QUADRIVALENT] to the patient 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 CONJ 20V (CRM197) (Prevnar 20) for Immunisation.  On 29-Nov-2023, the patient received a dose of 0.7 ml of  suspect influenza quadrival a-b high dose hv vaccine lot UT8131BA, strength, formulation, expiry date was unknown via intramuscular route in the  right and left deltoid, received a dose of 0.5 ml of suspect influenza quadrival a-b vaccine Suspension for injection ot UT8109KA, strength, expiry date was unknown via intramuscular route in unknown administration site, received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for all prophylactic vaccination and medical assistant should give fluzone high-dose qiv and a covid-19 vaccine. but their ma accidentally ended up giving fluzone high-dose qiv and fluzone qiv np to the patient with no reported adverse event (wrong product administered) and (extra dose administered) (latency : same day).  Action taken was 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 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: M
Vaccine: RAB
Symptoms: Exposure via skin contact, Occupational exposure to product, Syringe issue
Clinical narrative: plunger rod disconnected or separated and the product spilled all over his hands with no reported adverse event; plunger rod disconnected or separated and the product spilled all over his hands with no reported adverse event; Initial information was received on 29-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age male patient who while administering RABIES (HDC) VACCINE [IMOVAX RABIES] plunger rod disconnected or separated and the product spilled all over his hands with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Nov-2023, the patient received a  dose of suspect RABIES (HDC) VACCINE,Powder and solvent for suspension for injection (lot V1E122M) (dose, strength, and expiry date: unknown) via unknown route in unknown administration site for vaccination..  On 27-NOV-2023, patient while administering plunger rod disconnected or separated and the product spilled all over his hands with no reported adverse event (occupational exposure to product and exposure via skin contact) (latency same day).  Reportedly:- The pharmacist who was handling the product in question reported by email that this event occurred: pharmacist stated that they followed all the reconstitution steps. During reconstitution, the plunger automatically depresses to dispense the diluent into the vial. He swirled the contents, then unscrewed the syringe from the reconstitution needle to release the pressure. He reattached the needle and drew the reconstituted vaccine into the syringe. He was removing the reconstitution needle in order to attach an administration needle. While he was doing that, the plunger rod disconnected or separated and the product spilled all over his hands and the towel he had on the counter. He washed his hands and discarded the product appropriately
Age: 0.42
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of FLUZONE QIV NP to a 5-month-old patient with no reported adverse event; Initial information received on 30-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 months old male patient who was administered Influenza Quadrival A-B Vaccine [Fluzone Qiv] 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), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (vaxelis) for prophylactic vaccination; pneumococcal vaccine conj 7v (crm197) (prevnar) for prophylactic vaccination; and rotavirus vaccine (rotavirus vaccine) for prophylactic vaccination.  On 29-Nov-2023, the patient received an unknown dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: U8200BA) (Expiry date: 30-Jun-2024) (Frequency: Once) (Strength: Standard) via intramuscular route in the right thigh for immunization.  On 29-Nov-2023, the patient was administered of was administered Influenza Quadrival A-B Vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, Practice manager asks for recommendations following the administration of FLUZONE QIV NP to a 5-month-old patient. This situation is pre-assessed as a medication error/an inappropriate use due to administration of FLUZONE QIV NP to a 5-month-old patient.   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: Incorrect route of product administration, No adverse event
Clinical narrative: patient received FLUZONE HD QIV intravenously with no reported adverse event; Initial information received on 30-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] intravenously 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 suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml total  (lot number, strength, formulation, expiry date- not reported) via intravenous NOS (not otherwise specified) route in unknown administration site for Immunization with no reported adverse event (incorrect route of product administration) (latency- same day). Information on the batch number was requested.  Reportedly, Caller asks what they would need to monitor the patient for? The pharmacist states that she does not have any specifics regarding the event at this time; states that she was informed of the event by a nurse.  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: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Bad flu symptoms; This spontaneous case from was received on 27-Nov-2023 from other non-healthcare professional (consumer) via agency (reference number: SEQW23-04510) and concerned a female patient.   The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving the influenza vaccine, the patient had really bad flu symptoms.   The outcome of the event 'Flu symptoms' was not reported.  The reporter did not provide a causality assessment.   The event of 'Flu symptoms' was considered to be medically significant by a Physician within CSL Seqirus Pharmacovigilance Department.  Company comment: An elderly patient experienced flu symptoms an unknown amount of time after receiving the suspect product influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.; Sender's Comments: An elderly patient experienced flu symptoms an unknown amount of time after receiving the suspect product influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Vaccine brand other=Moderna; Vaccine administration date=25Oct2022; covid; covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 17Sep2021 at 14:30 as dose 3 (booster), single (Lot number: FC3181), in right arm and on 12May2022 at 04:30 as dose 4 (booster), single (Lot number: FM7553) at the age of 67 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Oct2022 at 16:45 as dose 5 (booster), single (Lot number: A57162B), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies:latex" (unspecified if ongoing); "allergies: histamines" (unspecified if ongoing); "allergies:gluten" (unspecified if ongoing); "Breast cancer", start date: 2014 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codein, reaction(s): "allergies: Codein". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other=Moderna; Vaccine administration date=25Oct2022". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 22Nov2023 to 26Nov2023.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Eye contusion, Feeling abnormal, Head injury, Headache
Clinical narrative: Patient came back to the store to report that she had a problem after her vaccination. She said she had gone to her daughter's and was sitting on the couch reading when she began to feel bad. She said it was about 2.5 to 3 hours after she had gotten the shot. She said that she got up to go lay down and passed out. She hit her head and got a black eye (actually the bruise was around the whole side of her head on the left side when she came to the pharmacy to report what happened). She said she went to her MD and he checked her. Her blood pressure was normal, and she had eaten breakfast around 9am and then she had lunch. After hitting her head, she had a headache for a couple of days and her head was tender. Her md said everything was normal but for her to come by the pharmacy and report it so we could report it to the database.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Tenderness
Clinical narrative: Patient came back to the store to report that she had a problem after her vaccination. She said she had gone to her daughter's and was sitting on the couch reading when she began to feel bad. She said it was about 2.5 to 3 hours after she had gotten the shot. She said that she got up to go lay down and passed out. She hit her head and got a black eye (actually the bruise was around the whole side of her head on the left side when she came to the pharmacy to report what happened). She said she went to her MD and he checked her. Her blood pressure was normal, and she had eaten breakfast around 9am and then she had lunch. After hitting her head, she had a headache for a couple of days and her head was tender. Her md said everything was normal but for her to come by the pharmacy and report it so we could report it to the database.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Breast induration, Breast swelling, Mastitis, Pain
Clinical narrative: She noticed warm, hard and swollen area on her left breast, this morning in the shower. Denies history of injuries to breast. Had a COVID vaccine yesterday. --Her symptoms are consistent with mastitis. She has not nursing, she is no longer having periods and has no history of injuries so it is unclear what may have caused the mastitis. --She did have a COVID vaccine yesterday and did read outline that this is a possible side effect of the COVID vaccine. --Since her symptoms are consistent with mastitis, if she continues to have pain tomorrow morning with redness and swelling, then I would recommend treatment for mastitis with Augmentin twice a day for 7 days. --She may take ibuprofen if needed for the pain.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: She noticed warm, hard and swollen area on her left breast, this morning in the shower. Denies history of injuries to breast. Had a COVID vaccine yesterday. --Her symptoms are consistent with mastitis. She has not nursing, she is no longer having periods and has no history of injuries so it is unclear what may have caused the mastitis. --She did have a COVID vaccine yesterday and did read outline that this is a possible side effect of the COVID vaccine. --Since her symptoms are consistent with mastitis, if she continues to have pain tomorrow morning with redness and swelling, then I would recommend treatment for mastitis with Augmentin twice a day for 7 days. --She may take ibuprofen if needed for the pain.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Amnesia, Aphasia, Blindness, Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately after receiving vaccine, I became dizzy, had loss of vision, increased brain pressure followed by neurological symptoms such as short term memory loss, aphasia and tachycardia. This went on for 3+ months following event.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Intracranial pressure increased, Neurological symptom, Tachycardia
Clinical narrative: Immediately after receiving vaccine, I became dizzy, had loss of vision, increased brain pressure followed by neurological symptoms such as short term memory loss, aphasia and tachycardia. This went on for 3+ months following event.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthma, Chills, Fatigue, Headache
Clinical narrative: Severe body muscle pain all over, moderate headache, moderate nausea, chills, moderate fatigue,   asthma. Anxiety. I continue to experience all  symptoms severe and moderately. Resting in bed unable to do much.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Nausea
Clinical narrative: Severe body muscle pain all over, moderate headache, moderate nausea, chills, moderate fatigue,   asthma. Anxiety. I continue to experience all  symptoms severe and moderately. Resting in bed unable to do much.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Skin mass
Clinical narrative: Patient experienced several red nodules along both sides of waist. no reported pruritus or pain. Nodule size varied from 1-3cm in diameter.
Age: 65.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Balance disorder, Sleep disorder, Urinary incontinence, Vertigo
Clinical narrative: Patient describes waking up in the night after receiving the vaccines with Vertigo, Imbalance, Loss of bladder control. This lasted for 2 days after receiving the vaccines
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: ITCHING AROUND INJECTION SITE, SWELLING A LITTLE AND FEELING WARM REPORTED ON 12/6 BY PT
Age: 64.0
Sex: F
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Erythema, Pruritus, Rash, Scar, Skin irritation
Clinical narrative: Severe back rash and itching that is believed to be the result of one or all of the vaccinations that was received to travel on October 31st - November 16th.  The itching was consistent and I went to see the dermatologist on numerous occasions. The severe redness has subsided but the scars and itching are still there. It was recommended by the travel nurse who administered the vaccines and my acting primary care physician to contact the CDC because this was an unusual case.  No irritation occurred at the injection site only my back.  No medications have worked and only receiving temporary relief from rubbing vitamin E oil on my back and taking allergy medications
Age: 64.0
Sex: F
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Therapy non-responder
Clinical narrative: Severe back rash and itching that is believed to be the result of one or all of the vaccinations that was received to travel on October 31st - November 16th.  The itching was consistent and I went to see the dermatologist on numerous occasions. The severe redness has subsided but the scars and itching are still there. It was recommended by the travel nurse who administered the vaccines and my acting primary care physician to contact the CDC because this was an unusual case.  No irritation occurred at the injection site only my back.  No medications have worked and only receiving temporary relief from rubbing vitamin E oil on my back and taking allergy medications
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: 101+ degree fever for two days; extreme fatigue for 2-3 days; diarrhea; pain and redness at injection site.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: At site of injection is a red spot, warm, swollen, hard, round, and described as the size of a lemon.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: patient starts to feel tingling , numb at the hand and feel dizzy, just like panic attack. we let patient sitting on the chair, giving her ice pack and watch her. Patient gradually returned to normal and left.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Developed hives less than 12 hours after receiving shots; initially on right thigh but then occurring on bilateral upper and lower extremities, trunk and face. No vomiting, shortness of breath, swelling of mouth. Seen in ER approximately 36 hours later, discharged without treatment. Hives self-resolved over days.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertensive crisis, Renal cancer, Syncope
Clinical narrative: Pt had a syncope episode and htn crisis.  Recovered.  Now has new diagnosis of kidney cancer
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: patient stated that her arm started hurting about 3 hours after the vaccine was given, then had severe pain and decreased range of motion for 3-4 days. patient followed up with doctor and per patient doctor stated this could have been a sirva reaction.
Age: 71.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Injection site pain, Limb discomfort, Pain, Pain in extremity
Clinical narrative: PATIENT HAS EXPERIENCED ABNORMAL PAIN AT INJECTION SITE AND RADIATING DOWN HIS ARM.  HE IS STILL EXPERIENCING DISCOMFORT IN THE ARM THAT HE RECEIVED THE FLU VACCINE IN 2 MONTHS LATER.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reactions noted - patient was administered Fluarix when he should have received Fluad, as he is >65 years old
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Pain
Clinical narrative: Severe chills Body Aches Headache
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Cardiac disorder, Chest pain, Dyspnoea, Lung opacity
Clinical narrative: PRESENTED TO ER 12/6 WITH 5 DAYS OF SHORTNESS OF BREATH AND CHEST PAIN. FOUND TO HAVE SADDLE PULMONARY EMBOLI REQUIRING IR THROMBECTOMY.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary mass, Right ventricular dilatation, Thrombectomy
Clinical narrative: PRESENTED TO ER 12/6 WITH 5 DAYS OF SHORTNESS OF BREATH AND CHEST PAIN. FOUND TO HAVE SADDLE PULMONARY EMBOLI REQUIRING IR THROMBECTOMY.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Headache
Clinical narrative: Saturday approx 8:40 pm headache and chills started. Sunday: headache went away Monday: sore throat stuffy nose Tuesday: Sneezing, Congestion,  Cough Wednesday: Loss of taste and smell, still sneezing, Congestion and cough.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Respiratory tract congestion, Sneezing
Clinical narrative: Saturday approx 8:40 pm headache and chills started. Sunday: headache went away Monday: sore throat stuffy nose Tuesday: Sneezing, Congestion,  Cough Wednesday: Loss of taste and smell, still sneezing, Congestion and cough.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acoustic stimulation tests, Deafness unilateral, Tinnitus
Clinical narrative: Sudden Complete loss of hearing in my left ear with tinittis
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Immediate post-injection reaction, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: Headache immediately following, severe 8/10 for 5 hours. Neck stiffness and pain following until 8am next morning. Next morning sore throat and nausea x1 commit. Nausea and sure throat all day
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: Headache immediately following, severe 8/10 for 5 hours. Neck stiffness and pain following until 8am next morning. Next morning sore throat and nausea x1 commit. Nausea and sure throat all day
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: PT REPORTS ITCHING STARTED ON 11-17-23. ON 18TH MORNING SHE HAD HIVES.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute cardiac event, Angiogram, Blood test, Cardiac assistance device user, Chest X-ray
Clinical narrative: I have had all of the available COVID vaccines and booster when the became available. 4 weeks after the first vaccine I had a cardiac event which included ventricular fibrillation. I needed to be resuscitated with and AED and CPR was administered. The second two vaccines there were no issues with my heart. The last vaccine I had the same event reoccur  again 4 weeks after that vaccine. There may not be any correlation, however I feel compelled to report because the timing of these incidents is about the same for the first and last vaccine I received. Also the first vaccine was from Moderna. The remaining vaccines were from Pfizer.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Echocardiogram, Electrocardiogram, Resuscitation, Ventricular fibrillation
Clinical narrative: I have had all of the available COVID vaccines and booster when the became available. 4 weeks after the first vaccine I had a cardiac event which included ventricular fibrillation. I needed to be resuscitated with and AED and CPR was administered. The second two vaccines there were no issues with my heart. The last vaccine I had the same event reoccur  again 4 weeks after that vaccine. There may not be any correlation, however I feel compelled to report because the timing of these incidents is about the same for the first and last vaccine I received. Also the first vaccine was from Moderna. The remaining vaccines were from Pfizer.
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Blood immunoglobulin G increased, Blood immunoglobulin M increased, Contusion, Epistaxis, Haematocrit decreased
Clinical narrative: Seen at primary care 11/29/23 for being 3rd day with noted rash and biruising that was   worsening, he also swoke up with a bloody nose and a blood blisteron lip.Lab work was obtained via venus draw. Platelets were n oted to be at and a manual diff  was obtained 18.0.Patient ab direct Igm and Igg were both strongly positive.  Child was referred to Pediatric  Hematology, whereatt his time the plan is to watch him and wait for any further signs of bleeding. Per Hematology the BAT score was 3 lab work done.
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Haemoglobin decreased, Laboratory test, Lymphocyte count increased, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal
Clinical narrative: Seen at primary care 11/29/23 for being 3rd day with noted rash and biruising that was   worsening, he also swoke up with a bloody nose and a blood blisteron lip.Lab work was obtained via venus draw. Platelets were n oted to be at and a manual diff  was obtained 18.0.Patient ab direct Igm and Igg were both strongly positive.  Child was referred to Pediatric  Hematology, whereatt his time the plan is to watch him and wait for any further signs of bleeding. Per Hematology the BAT score was 3 lab work done.
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Neutrophil count normal, Neutrophil percentage decreased, Oral blood blister
Clinical narrative: Seen at primary care 11/29/23 for being 3rd day with noted rash and biruising that was   worsening, he also swoke up with a bloody nose and a blood blisteron lip.Lab work was obtained via venus draw. Platelets were n oted to be at and a manual diff  was obtained 18.0.Patient ab direct Igm and Igg were both strongly positive.  Child was referred to Pediatric  Hematology, whereatt his time the plan is to watch him and wait for any further signs of bleeding. Per Hematology the BAT score was 3 lab work done.
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Platelet count decreased, Rash, Red cell distribution width increased, White blood cell count increased
Clinical narrative: Seen at primary care 11/29/23 for being 3rd day with noted rash and biruising that was   worsening, he also swoke up with a bloody nose and a blood blisteron lip.Lab work was obtained via venus draw. Platelets were n oted to be at and a manual diff  was obtained 18.0.Patient ab direct Igm and Igg were both strongly positive.  Child was referred to Pediatric  Hematology, whereatt his time the plan is to watch him and wait for any further signs of bleeding. Per Hematology the BAT score was 3 lab work done.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Pt stated she has tolerated vaccination past yrs.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Employee states noticed rash at 5 pm on 11/30/23 at 5:15 pm took benadryl for the itching. States rash was slightly raised on bilateral arms and chest.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Nausea, Tinnitus
Clinical narrative: PT. went to vehicle with mom after vaccine, and mom came back into store and stated that her daughter was having ringing in the ears, she was nauseous, and her face is becoming flush. This occured within 20 minutes of receiving vaccine. I instructed mom to take pt. straight to emergency room incase she is experiencing and anaphylatic reaction. Mom said they would go straight there.
Age: 7.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: No adverse event
Clinical narrative: Patient received Dtap at the age of 7 when qualified/ should have received Tdap instead. No adverse symptoms reported, parent has been contacted to inform that child is still covered and protected and will be due to receive Tdap at age 11.
Age: 7.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Dtap at the age of 7 when qualified/ should have received Tdap instead. No adverse symptoms reported, parent has been contacted to inform that child is still covered and protected and will be due to receive Tdap at age 11.
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: a pregnant women less than 60 years of age, received Arexvy vaccine; a pregnant women less than 60 years of age, received Arexvy vaccine; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5P4A5, expiry date 27-MAR-2025) for prophylaxis.   On 18-NOV-2023, the patient received Arexvy. On 18-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: a pregnant women less than 60 years of age, received Arexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: a pregnant women less than 60 years of age, received Arexvy vaccine). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 20-Nov-2023 Pharmacist reported that a pregnant women less than 60 years of age, received Arexvy vaccine, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration. The reporter consented to follow-up.
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: a pregnant women less than 60 years of age, received Arexvy vaccine; a pregnant women less than 60 years of age, received Arexvy vaccine; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5P4A5, expiry date 27-MAR-2025) for prophylaxis.   On 18-NOV-2023, the patient received Arexvy. On 18-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: a pregnant women less than 60 years of age, received Arexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: a pregnant women less than 60 years of age, received Arexvy vaccine). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 20-Nov-2023 Pharmacist reported that a pregnant women less than 60 years of age, received Arexvy vaccine, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration. The reporter consented to follow-up.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cardiovascular symptom, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: heart attack symptoms; increased and persistant chest pain and weakness; increased and persistant chest pain and weakness; Feeling of muscle in chest severely strained; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 14:00 as dose 1, single (Lot number: HG4628) at the age of 58 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; LOTREL [LOTEPREDNOL ETABONATE]; PLAVIX; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; METFORMIN; ZOLOF. 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; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCLE STRAIN (non-serious) with onset 27Oct2023 at 09:00, outcome "recovered with sequelae", described as "Feeling of muscle in chest severely strained"; MYOCARDIAL INFARCTION (medically significant) with onset 27Oct2023 at 09:00, outcome "recovered with sequelae", described as "heart attack symptoms"; CHEST PAIN (non-serious), ASTHENIA (non-serious) all with onset 27Oct2023 at 09:00, outcome "recovered with sequelae" and all described as "increased and persistant chest pain and weakness". The events "heart attack symptoms", "increased and persistant chest pain and weakness" and "feeling of muscle in chest severely strained" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Negative. Therapeutic measures were taken as a result of myocardial infarction, chest pain, asthenia, muscle strain.  Clinical course: After 48 hours increased and persistant chest pain and weakness, feeling of muscle in chest severely strained. ER visit after heart attack symptoms, 96 hours after vaccine. The events treatment required ER Visit/Cardiology Follow-up. There was no covid prior vaccination.  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: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Fatigue, Hyperhidrosis, Hypertension
Clinical narrative: heart attack symptoms; increased and persistant chest pain and weakness; increased and persistant chest pain and weakness; Feeling of muscle in chest severely strained; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 14:00 as dose 1, single (Lot number: HG4628) at the age of 58 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; LOTREL [LOTEPREDNOL ETABONATE]; PLAVIX; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; METFORMIN; ZOLOF. 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; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCLE STRAIN (non-serious) with onset 27Oct2023 at 09:00, outcome "recovered with sequelae", described as "Feeling of muscle in chest severely strained"; MYOCARDIAL INFARCTION (medically significant) with onset 27Oct2023 at 09:00, outcome "recovered with sequelae", described as "heart attack symptoms"; CHEST PAIN (non-serious), ASTHENIA (non-serious) all with onset 27Oct2023 at 09:00, outcome "recovered with sequelae" and all described as "increased and persistant chest pain and weakness". The events "heart attack symptoms", "increased and persistant chest pain and weakness" and "feeling of muscle in chest severely strained" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Negative. Therapeutic measures were taken as a result of myocardial infarction, chest pain, asthenia, muscle strain.  Clinical course: After 48 hours increased and persistant chest pain and weakness, feeling of muscle in chest severely strained. ER visit after heart attack symptoms, 96 hours after vaccine. The events treatment required ER Visit/Cardiology Follow-up. There was no covid prior vaccination.  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: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza virus test, Laboratory test, Loss of consciousness, Muscle discomfort, Nausea
Clinical narrative: heart attack symptoms; increased and persistant chest pain and weakness; increased and persistant chest pain and weakness; Feeling of muscle in chest severely strained; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 14:00 as dose 1, single (Lot number: HG4628) at the age of 58 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; LOTREL [LOTEPREDNOL ETABONATE]; PLAVIX; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; METFORMIN; ZOLOF. 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; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCLE STRAIN (non-serious) with onset 27Oct2023 at 09:00, outcome "recovered with sequelae", described as "Feeling of muscle in chest severely strained"; MYOCARDIAL INFARCTION (medically significant) with onset 27Oct2023 at 09:00, outcome "recovered with sequelae", described as "heart attack symptoms"; CHEST PAIN (non-serious), ASTHENIA (non-serious) all with onset 27Oct2023 at 09:00, outcome "recovered with sequelae" and all described as "increased and persistant chest pain and weakness". The events "heart attack symptoms", "increased and persistant chest pain and weakness" and "feeling of muscle in chest severely strained" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Negative. Therapeutic measures were taken as a result of myocardial infarction, chest pain, asthenia, muscle strain.  Clinical course: After 48 hours increased and persistant chest pain and weakness, feeling of muscle in chest severely strained. ER visit after heart attack symptoms, 96 hours after vaccine. The events treatment required ER Visit/Cardiology Follow-up. There was no covid prior vaccination.  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: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: heart attack symptoms; increased and persistant chest pain and weakness; increased and persistant chest pain and weakness; Feeling of muscle in chest severely strained; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 14:00 as dose 1, single (Lot number: HG4628) at the age of 58 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; LOTREL [LOTEPREDNOL ETABONATE]; PLAVIX; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; METFORMIN; ZOLOF. 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; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCLE STRAIN (non-serious) with onset 27Oct2023 at 09:00, outcome "recovered with sequelae", described as "Feeling of muscle in chest severely strained"; MYOCARDIAL INFARCTION (medically significant) with onset 27Oct2023 at 09:00, outcome "recovered with sequelae", described as "heart attack symptoms"; CHEST PAIN (non-serious), ASTHENIA (non-serious) all with onset 27Oct2023 at 09:00, outcome "recovered with sequelae" and all described as "increased and persistant chest pain and weakness". The events "heart attack symptoms", "increased and persistant chest pain and weakness" and "feeling of muscle in chest severely strained" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Negative. Therapeutic measures were taken as a result of myocardial infarction, chest pain, asthenia, muscle strain.  Clinical course: After 48 hours increased and persistant chest pain and weakness, feeling of muscle in chest severely strained. ER visit after heart attack symptoms, 96 hours after vaccine. The events treatment required ER Visit/Cardiology Follow-up. There was no covid prior vaccination.  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: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest pain, Muscle strain, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: heart attack symptoms; increased and persistant chest pain and weakness; increased and persistant chest pain and weakness; Feeling of muscle in chest severely strained; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 14:00 as dose 1, single (Lot number: HG4628) at the age of 58 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; LOTREL [LOTEPREDNOL ETABONATE]; PLAVIX; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; METFORMIN; ZOLOF. 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; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCLE STRAIN (non-serious) with onset 27Oct2023 at 09:00, outcome "recovered with sequelae", described as "Feeling of muscle in chest severely strained"; MYOCARDIAL INFARCTION (medically significant) with onset 27Oct2023 at 09:00, outcome "recovered with sequelae", described as "heart attack symptoms"; CHEST PAIN (non-serious), ASTHENIA (non-serious) all with onset 27Oct2023 at 09:00, outcome "recovered with sequelae" and all described as "increased and persistant chest pain and weakness". The events "heart attack symptoms", "increased and persistant chest pain and weakness" and "feeling of muscle in chest severely strained" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Negative. Therapeutic measures were taken as a result of myocardial infarction, chest pain, asthenia, muscle strain.  Clinical course: After 48 hours increased and persistant chest pain and weakness, feeling of muscle in chest severely strained. ER visit after heart attack symptoms, 96 hours after vaccine. The events treatment required ER Visit/Cardiology Follow-up. There was no covid prior vaccination.  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: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: SIRVA (Shoulder Injury Related to Vaccine Administration). Injection site was inflamed and infected. Severe left arm and shoulder pain, limited range of motion, and extreme weakness using left arm.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site infection, Injection site inflammation, Mobility decreased, Muscular weakness
Clinical narrative: SIRVA (Shoulder Injury Related to Vaccine Administration). Injection site was inflamed and infected. Severe left arm and shoulder pain, limited range of motion, and extreme weakness using left arm.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA (Shoulder Injury Related to Vaccine Administration). Injection site was inflamed and infected. Severe left arm and shoulder pain, limited range of motion, and extreme weakness using left arm.