chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: lapse in therapy due to missing their last of the 3-dose series for the pre-exposure schedule (with no reported adverse event); Initial information received on 19-Aug-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age female patient who had lapse in therapy due to missing their last of the 3-dose series for the pre-exposure schedule (with no reported adverse event) while receiving vaccine Rabies Vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) , Concomitant medications and family history were not provided.   On an unknown date, the patient received a dose 2 of suspect Rabies (HDC) Vaccine (Powder and solvent for suspension for injection) lot W1C431M, Expiry date:01-Oct-2025, strength was unknown via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and lapse in therapy due to missing their last of the 3-dose series for the pre-exposure schedule (with no reported adverse event) (product dose omission issue) (unknown latency).  Reportedly "Caller stated that they have a patient who got her first two IMOVAX vaccines, but then had to leave the country. Caller stated that the patient is now past the 28 day period and they want to know if she needs to restart the series or can she go ahead and still get the third dose. Caller stated that patient started the series on 31May2024. "   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: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: It has been 3 weeks since day 0 and the patient is behind schedule with no reported adverse event; Initial information received on 19-Aug-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient and reported it has been 3 weeks since day 0 of RABIES (HDC) VACCINE [IMOVAX RABIES] and the patient is behind schedule with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Aug-2024, the patient received a 1 dosage form (DF) dose of suspect Rabies (HDC) Vaccine Powder and solvent for suspension for injection (expiry date, strength, lot number not reported) via unknown route in unknown administration site for indicated for pre-exposure and post-exposure prophylaxis against rabies (Rabies immunization) and is reported it has been 3 weeks since day 0 and the patient is behind schedule with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  Reportedly, Pharmacist reports that a patient was traveling internationally, and received VERORAB vaccine after a monkey wound. The patient also received the immunoglobulin on day 0. Now, the patient is back but the IMOVAX schedule is different. It has been 3 weeks since day 0 and the patient is behind schedule. The HCP gave the patient 1 dose of the IMOVAX on 17AUG2024. She wants to treat it as day 3 and continued the schedule, is that recommended? What is the recommendation? The pharmacist states that her plan is to have the patient come back on the 21st which would be day 7 of the Imovax and then continue with the 4 doses. She states that the patient would receive a dose on 17Aug2024 and 21Aug2024 and 28Aug2024. The patient initially thought she would be following schedule, so she thought she was getting only one dose on the 31st but the pharmacist thinks she should come back earlier.  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: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired FLUZONE HD QUAD was administered to a patient, with no reported adverse event; Initial information received on 19-Aug-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old female patient to whom expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Aug-2024, the patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, 0.7 ml TOTAL expiry-30-Jun-2024 lot UT8104BA via intramuscular route in the deltoid nos for Immunization (strength unknown) with no reported adverse event (expired product administered) (latency same day).   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: 4.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was administered with Adacel instead of a DTaP vaccine with no reported adverse event; administration of Adacel to a 4 year old patient with no reported adverse event; Initial information received on 19-Aug-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves 4 years old female patient who was administered with diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of diphtheria, tetanus and acellular pertussis vaccine with no reported adverse event and administration of adacel to a 4 year old 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 polio vaccine; varicella zoster vaccine (Varicella vaccine); and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 19-Aug-2024, the patient received a standard dose of 0.5 mL of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot 3CA22C1, expiry date- 28-Feb-2026) via intramuscular route in the right deltoid for Immunization instead of diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer with no reported adverse event (wrong product administered) and administration of adacel to a 4 year old patient with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, No Treatment was received and No ER (emergency room) visit by the 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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: inadvertently administered the Pentacel liquid component without the Hib and did not reconstitute it with no reported adverse event; Initial information received on 19-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-month-old female patient who was inadvertently administered the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] liquid component without the HIB and did not reconstitute it with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Aug-2024, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection of lot UJ972AA and expiry date: 11-Oct-2024 via intramuscular route in unknown administration site for Immunization and reported inadvertently administered the pentacel liquid component without the hib and did not reconstitute it with no reported adverse event (single component of a two-component product administered) (latency: on same day).  Reportedly, Medical Assistant called to report that she had inadvertently administered the PENTACEL liquid component without the Hib and did not reconstitute it. She wanted to know how to proceed. She also inquired about the amount needed and how to obtain the specific Hib diluent. List concomitant or no other vaccines P20, Oral Rota.  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: 4.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: an inappropriate use due to the administration of the product to an underage patient with no reported adverse event; Initial information received on 19-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-year-old female patient and is reported an inappropriate use diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] due to the administration of the product to an underage 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 measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (WISTAR RA 27/3) (MMR II), Varivax and Polio Vaccine (Polio Vaccine) for Prophylactic vaccination.  On 17-Aug-2024, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection frequency: once, strength: standard of lot U79838A and expiry date: 18-Jan-2026 via intramuscular route in the left thigh for immunization and inappropriate use due to the administration of the product to an underage patient with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).  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: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: pain at injection site; muscle pain; tiredness; weakness; shivering; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   In FEB-2024, the patient received the 1st dose of Shingrix (left arm) and Influenza vaccine. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), muscle pain (Verbatim: muscle pain), tiredness (Verbatim: tiredness), weakness (Verbatim: weakness), shivering (Verbatim: shivering) and fever (Verbatim: fever). The outcome of the injection site pain, muscle pain, tiredness, weakness, shivering and fever were unknown.   It was unknown if the reporter considered the injection site pain, muscle pain, tiredness, weakness, shivering and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain, muscle pain, tiredness, weakness, shivering and fever to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR103500   Additional Information: GSK receipt date: 16-AUG-2024 The reporter was the patient who received her 1st dose of Shingrix and had experienced muscle pain, tiredness, pain at the injection site, weakness, shivering, and fever.  She also reported receiving her first Shingrix and a flu vaccine (unknown manufacturer) on the same day. It was unknown if the reporter considered the injection site pain, muscle pain, tiredness, weakness, shivering and fever to be related to Flu vaccine Consented to follow up.; Sender's Comments:  US-GSK-US2024AMR103500:2 nd dose US-GSK-US2024AMR103500:same reporter, same patient, 1st dose
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pain at injection site; muscle pain; tiredness; weakness; shivering; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   In FEB-2024, the patient received the 1st dose of Shingrix (left arm) and Influenza vaccine. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), muscle pain (Verbatim: muscle pain), tiredness (Verbatim: tiredness), weakness (Verbatim: weakness), shivering (Verbatim: shivering) and fever (Verbatim: fever). The outcome of the injection site pain, muscle pain, tiredness, weakness, shivering and fever were unknown.   It was unknown if the reporter considered the injection site pain, muscle pain, tiredness, weakness, shivering and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain, muscle pain, tiredness, weakness, shivering and fever to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR103500   Additional Information: GSK receipt date: 16-AUG-2024 The reporter was the patient who received her 1st dose of Shingrix and had experienced muscle pain, tiredness, pain at the injection site, weakness, shivering, and fever.  She also reported receiving her first Shingrix and a flu vaccine (unknown manufacturer) on the same day. It was unknown if the reporter considered the injection site pain, muscle pain, tiredness, weakness, shivering and fever to be related to Flu vaccine Consented to follow up.; Sender's Comments:  US-GSK-US2024AMR103500:2 nd dose US-GSK-US2024AMR103500:same reporter, same patient, 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: wrong vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: wrong vaccine). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2024 The reporter stated that female patient in her late 20's received Shingrix by mistake instead of a varicella vaccine which led to wrong vaccine administered. She was trying to get up to date on her vaccinations in plans of getting pregnant to be a surrogate mother. No additional details were available regarding Shingrix vaccination or patient.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue, Single component of a two-component product administered
Clinical narrative: Only diluent administered; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-AUG-2024 A pharmacist called to inform that he/she administered a Menveo vaccine to one of the customers, but the reporter only gave the gray cap, that was, only the diluent without reconstituting it with the lyophilized component which led to to inappropriate preparation of medication and inappropriate dose of vaccine administered. Customer mentioned that this had happened several days ago, but did not provide the exact date.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: her blood pressure went up to 195-90/it occurred with all 3 vaccines; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 10000051875.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic urticaria" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Food related allergies" (unspecified if ongoing); "Airborne allergies" (unspecified if ongoing); "Hives" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 23Feb2021, when the patient was 65-year-old, for Covid-19 Immunization, reaction(s): "her blood pressure went up to 195-90/it occurred with all 3 vaccines". The following information was reported: BLOOD PRESSURE INCREASED (medically significant), outcome "recovering", described as "her blood pressure went up to 195-90/it occurred with all 3 vaccines". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: went up to 195-90; finally came down to 110 or 120/80, notes: took her blood pressure 3 or 4 times; normally 110 over 60 or 70. Clinical course: On unknown date, it was reported that patient experienced: when she received the COVID vaccines first one on 23Feb2021, her blood pressure went up to 195-90 and it is normally 110 over 60 or 70, and it occurred with all 3 vaccines. The patient stated that they wanted to take her to the hospital after the vaccine but the paramedics at the vaccine site took her blood pressure 3 or 4 times and it finally came down to 110 or 120/80.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400109710 Same patient and product, Different dose and events;US-PFIZER INC-202400241875 Same patient and product, Different dose and events;
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: "After 6 days I still have allergy reaction, redness and swollen arm and area is getting bigger"
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Cough, Fatigue, Headache, Pyrexia
Clinical narrative: vomited, severe headache and achying in the verterbraes (mostly upper back), fever, chill, extreme exhausation, cough
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Spinal pain, Vomiting
Clinical narrative: vomited, severe headache and achying in the verterbraes (mostly upper back), fever, chill, extreme exhausation, cough
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Product administration error, Wrong product administered
Clinical narrative: Wrong vaccine given by clinic staff to Pediatric Patient. Vaccine that was given was in the incorrect age group. Provider has been notified and Provider has notified the Patient's mother of the error
Age: 41.0
Sex: M
Vaccine: FLUA4
Symptoms: Injury associated with device, Laboratory test
Clinical narrative: Pharmacist experienced a needle stick after giving flu vaccine
Age: 75.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Chills, Pain, Sleep disorder, Tremor
Clinical narrative: Woke in night with teeth chattering and muscles shaking but wasn't cold.  Never had a vaccine reaction like that before and wondered if I might even seize, but could bear down and stop shaking by contracting muscles.  Took aspirin and muscle relaxer and finally got back to sleep after about an hour and a half.  Very sore all over on waking, but got better as day went on.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Hypotonia, Mental status changes, Pallor, Unresponsive to stimuli
Clinical narrative: altered mental status, went limp and unresponsive, pale, lasted 20-25 minutes. happened after came home from getting 6mo vaccines today at doctors office.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Adverse reaction
Clinical narrative: VACCINE ADMINISTERED 8/23, PATIENT REPORTED REACTIONS 8/26/2024 AND STATED IS DOING BETTER. DR.  ADVISED TO CONTINUE TO MONITOR AND REPORT IF SYMPTOMS WORSEN.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: within 24 hours and lasting 72 hours patient had increasing erythema and swelling of the right arm, erythema extending  from elbow to shoulder.  swelling around the upper arm. self-resolved over 72-hours.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Delayed menstruation. Delayed menstruation sis not occur prior to vaccination.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Vaccine was not reconstituted and patient only received the diluent portion of the vaccination.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Lip swelling
Clinical narrative: Pt reported lip swelling 15 minutes after administration. Pt states he took 4 benadryl with an expiration date in 2022. His sister told him he thought his speech was slurred the next morning. Patient reported this to pharmacy 8/26/24. He states he is fine now.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cough, Fatigue, Malaise, Productive cough
Clinical narrative: She states on the day she received the immunization she was fine, however, they next day she was sick. She reports she was congested, she has a lot of phlegm, coughing, chills and fatigue for a week and a half. Patient reports symptoms improved after a few days taking Nyquil and resting. Patient reports completely felt better after a week and a half.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Respiratory tract congestion
Clinical narrative: She states on the day she received the immunization she was fine, however, they next day she was sick. She reports she was congested, she has a lot of phlegm, coughing, chills and fatigue for a week and a half. Patient reports symptoms improved after a few days taking Nyquil and resting. Patient reports completely felt better after a week and a half.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Differential white blood cell count normal, Dizziness, Electrocardiogram normal, Full blood count normal
Clinical narrative: Severe dizziness, nausea, tinnitus.  Required a visit to the Emergency room
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test normal, Nausea, Tinnitus, Troponin normal
Clinical narrative: Severe dizziness, nausea, tinnitus.  Required a visit to the Emergency room
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Migraine, Pain, Peripheral swelling, Rash
Clinical narrative: horrible migraine, slight difficulty breathing, aches, and a rash that spread over my arm that was hot and swollen. It?s been over a week and it?s still visible but finally starting to fade. DR. ADVISE TO CONTINUE MONITORING AND CONTACT OFFICE IF SYMPTOMS WORSEN
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm
Clinical narrative: horrible migraine, slight difficulty breathing, aches, and a rash that spread over my arm that was hot and swollen. It?s been over a week and it?s still visible but finally starting to fade. DR. ADVISE TO CONTINUE MONITORING AND CONTACT OFFICE IF SYMPTOMS WORSEN
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal discomfort, Dizziness, Nausea, Posture abnormal, Presyncope
Clinical narrative: After patient received vaccine patient reports light headedness and head fell back. Patient felt nausea with stomach not feeling well and did vomit.  Patient had vaso-vago reaction. He was sitting in chair when this happened.  Patient was monitored in clinic and give snack and fluids. He was stable when leaving clinic.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: After patient received vaccine patient reports light headedness and head fell back. Patient felt nausea with stomach not feeling well and did vomit.  Patient had vaso-vago reaction. He was sitting in chair when this happened.  Patient was monitored in clinic and give snack and fluids. He was stable when leaving clinic.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient states that on Saturday she noticed, on left arm below where she received her COVID shot, there was redness forming. Patient states it has been itchy. Patient states she was in store and spoke to pharmacist there who recommended follow up here. Patient had pictures on her phone and it noticeable looks better today than Saturday. Patient states it is not hot to touch but is still a little itchy.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Child should have received a Tdap, aged our of Dtap; no reaction.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Arthralgia, Blood test abnormal, Cerebrovascular accident, Computerised tomogram abnormal
Clinical narrative: October 22, 2022 at work in office became dizzy, showed signs of struggling to talk, slurred Speach, and collapsed.  Taken by Ambulance doctors determined he had suffered ITA without dementia most likely from his excessive high blood pressure. specialist would follow up to find medication to lower the blood pressure. October 22, 2022 at work in office became dizzy, showed signs of struggling to talk, slurred Speech, and collapsed.  Taken by Ambulance doctors determined he had suffered ITA without dementia most likely from his excessive high blood pressure. specialist would follow up to find medication to lower the blood pressure.  Referred to neurologist.  December 23, 2022 after hours on toilet he began to haemorrhage, rushed to hospital diagnosis was intestinal thrombosis requiring emergency surgery, Dr said patient appeared to confused, had difficulty remembering things, distracted, incoherent at times was complaining of pain in arms, elbows and fingers definite behavior change he thinks ITA could have been misdiagnosed or patient was showing signs of a more significant stroke.  Emergency Surgery was performed 1 blood clot had caused a lot of damage they would have to adapt with colostomy bag or remove damaged area.  The family elected to remove damaged area.  3 of the 7 blood clots were removed. Operating doctor advised condition would worsen and eventually become terminal expected 10-24 months, most likely 10 months at best.  consulted with pt  Neurologist confirmed prior stroke Ct Scan and Blood Work and Labs were all within range of a prior stroke. She prescribed Clopidogrel 75mg once daily (alternatively aspirin plus dipyridamole), and Atorvastatin 20-80mg. said it's hard to say when the second or third stroke occurred other than that it waas before now, said to log his signs they would fluxuate over then next several months.  He continues to decline
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Confusional state, Distractibility, Dizziness, Dysarthria
Clinical narrative: October 22, 2022 at work in office became dizzy, showed signs of struggling to talk, slurred Speach, and collapsed.  Taken by Ambulance doctors determined he had suffered ITA without dementia most likely from his excessive high blood pressure. specialist would follow up to find medication to lower the blood pressure. October 22, 2022 at work in office became dizzy, showed signs of struggling to talk, slurred Speech, and collapsed.  Taken by Ambulance doctors determined he had suffered ITA without dementia most likely from his excessive high blood pressure. specialist would follow up to find medication to lower the blood pressure.  Referred to neurologist.  December 23, 2022 after hours on toilet he began to haemorrhage, rushed to hospital diagnosis was intestinal thrombosis requiring emergency surgery, Dr said patient appeared to confused, had difficulty remembering things, distracted, incoherent at times was complaining of pain in arms, elbows and fingers definite behavior change he thinks ITA could have been misdiagnosed or patient was showing signs of a more significant stroke.  Emergency Surgery was performed 1 blood clot had caused a lot of damage they would have to adapt with colostomy bag or remove damaged area.  The family elected to remove damaged area.  3 of the 7 blood clots were removed. Operating doctor advised condition would worsen and eventually become terminal expected 10-24 months, most likely 10 months at best.  consulted with pt  Neurologist confirmed prior stroke Ct Scan and Blood Work and Labs were all within range of a prior stroke. She prescribed Clopidogrel 75mg once daily (alternatively aspirin plus dipyridamole), and Atorvastatin 20-80mg. said it's hard to say when the second or third stroke occurred other than that it waas before now, said to log his signs they would fluxuate over then next several months.  He continues to decline
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Haemorrhage, Hypertension, Incoherent, Intestinal resection
Clinical narrative: October 22, 2022 at work in office became dizzy, showed signs of struggling to talk, slurred Speach, and collapsed.  Taken by Ambulance doctors determined he had suffered ITA without dementia most likely from his excessive high blood pressure. specialist would follow up to find medication to lower the blood pressure. October 22, 2022 at work in office became dizzy, showed signs of struggling to talk, slurred Speech, and collapsed.  Taken by Ambulance doctors determined he had suffered ITA without dementia most likely from his excessive high blood pressure. specialist would follow up to find medication to lower the blood pressure.  Referred to neurologist.  December 23, 2022 after hours on toilet he began to haemorrhage, rushed to hospital diagnosis was intestinal thrombosis requiring emergency surgery, Dr said patient appeared to confused, had difficulty remembering things, distracted, incoherent at times was complaining of pain in arms, elbows and fingers definite behavior change he thinks ITA could have been misdiagnosed or patient was showing signs of a more significant stroke.  Emergency Surgery was performed 1 blood clot had caused a lot of damage they would have to adapt with colostomy bag or remove damaged area.  The family elected to remove damaged area.  3 of the 7 blood clots were removed. Operating doctor advised condition would worsen and eventually become terminal expected 10-24 months, most likely 10 months at best.  consulted with pt  Neurologist confirmed prior stroke Ct Scan and Blood Work and Labs were all within range of a prior stroke. She prescribed Clopidogrel 75mg once daily (alternatively aspirin plus dipyridamole), and Atorvastatin 20-80mg. said it's hard to say when the second or third stroke occurred other than that it waas before now, said to log his signs they would fluxuate over then next several months.  He continues to decline
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Life expectancy shortened, Memory impairment, Pain in extremity, Speech disorder
Clinical narrative: October 22, 2022 at work in office became dizzy, showed signs of struggling to talk, slurred Speach, and collapsed.  Taken by Ambulance doctors determined he had suffered ITA without dementia most likely from his excessive high blood pressure. specialist would follow up to find medication to lower the blood pressure. October 22, 2022 at work in office became dizzy, showed signs of struggling to talk, slurred Speech, and collapsed.  Taken by Ambulance doctors determined he had suffered ITA without dementia most likely from his excessive high blood pressure. specialist would follow up to find medication to lower the blood pressure.  Referred to neurologist.  December 23, 2022 after hours on toilet he began to haemorrhage, rushed to hospital diagnosis was intestinal thrombosis requiring emergency surgery, Dr said patient appeared to confused, had difficulty remembering things, distracted, incoherent at times was complaining of pain in arms, elbows and fingers definite behavior change he thinks ITA could have been misdiagnosed or patient was showing signs of a more significant stroke.  Emergency Surgery was performed 1 blood clot had caused a lot of damage they would have to adapt with colostomy bag or remove damaged area.  The family elected to remove damaged area.  3 of the 7 blood clots were removed. Operating doctor advised condition would worsen and eventually become terminal expected 10-24 months, most likely 10 months at best.  consulted with pt  Neurologist confirmed prior stroke Ct Scan and Blood Work and Labs were all within range of a prior stroke. She prescribed Clopidogrel 75mg once daily (alternatively aspirin plus dipyridamole), and Atorvastatin 20-80mg. said it's hard to say when the second or third stroke occurred other than that it waas before now, said to log his signs they would fluxuate over then next several months.  He continues to decline
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Thrombectomy, Thrombosis, Transient ischaemic attack
Clinical narrative: October 22, 2022 at work in office became dizzy, showed signs of struggling to talk, slurred Speach, and collapsed.  Taken by Ambulance doctors determined he had suffered ITA without dementia most likely from his excessive high blood pressure. specialist would follow up to find medication to lower the blood pressure. October 22, 2022 at work in office became dizzy, showed signs of struggling to talk, slurred Speech, and collapsed.  Taken by Ambulance doctors determined he had suffered ITA without dementia most likely from his excessive high blood pressure. specialist would follow up to find medication to lower the blood pressure.  Referred to neurologist.  December 23, 2022 after hours on toilet he began to haemorrhage, rushed to hospital diagnosis was intestinal thrombosis requiring emergency surgery, Dr said patient appeared to confused, had difficulty remembering things, distracted, incoherent at times was complaining of pain in arms, elbows and fingers definite behavior change he thinks ITA could have been misdiagnosed or patient was showing signs of a more significant stroke.  Emergency Surgery was performed 1 blood clot had caused a lot of damage they would have to adapt with colostomy bag or remove damaged area.  The family elected to remove damaged area.  3 of the 7 blood clots were removed. Operating doctor advised condition would worsen and eventually become terminal expected 10-24 months, most likely 10 months at best.  consulted with pt  Neurologist confirmed prior stroke Ct Scan and Blood Work and Labs were all within range of a prior stroke. She prescribed Clopidogrel 75mg once daily (alternatively aspirin plus dipyridamole), and Atorvastatin 20-80mg. said it's hard to say when the second or third stroke occurred other than that it waas before now, said to log his signs they would fluxuate over then next several months.  He continues to decline
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Induration, Musculoskeletal stiffness, Pruritus, Pustule, Skin warm
Clinical narrative: Patient came to pharmacy to show his arm. His arm had a small white pus filled as small as a dot. It is hot and hard to touch.  The area is painful and slightly itchy. In addition, patient also said that his neck seems to be tense. I told the patient to go home and place an ice pack over the area to help with the inflammation and take ibuprofen if he doesn't have any problem  with it. However if it doesn't get better by the next day, I recommend patient to go to ER or urgent care to get it check up on.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Tenderness
Clinical narrative: Patient came to pharmacy to show his arm. His arm had a small white pus filled as small as a dot. It is hot and hard to touch.  The area is painful and slightly itchy. In addition, patient also said that his neck seems to be tense. I told the patient to go home and place an ice pack over the area to help with the inflammation and take ibuprofen if he doesn't have any problem  with it. However if it doesn't get better by the next day, I recommend patient to go to ER or urgent care to get it check up on.
Age: 13.0
Sex: M
Vaccine: PNC20
Symptoms: No adverse event, Product administration error, Product packaging confusion, Wrong product administered
Clinical narrative: Patient presented for well child check with mother and agreed to HPV vaccine. Vis given and consent obtained. Vaccine retrieved from refrigerator and administered without difficulty or complaint. Patient proceeded to lab. Upon documentation of vaccine within five minutes of administration, unable to locate lot number. Lot number searched and discovered Prevnar20 had been administered instead of HPV. These two vaccines are stored next to each other and are the same shape box and blue in color. Patient & mother are still in building and brought back to exam room. Nurse informed mother and patient of error and apologized to both, questions answered, VIS for pneumococcal was given. Offered for patient to remain until provider finished with current patient. Mother declines as she has a dental appointment for her other child soon. The patient denies symptoms or complaints. They are offered the HPV vaccine and decide to an appointment in one week and leave. The patient was asymptomatic upon discharge. Provider, manager, DON and risk management informed. RN has requested remedial vaccine education. RN has separated the vaccines so as not to be stored directly next to each other. The physician did follow up with patient?s family later in the same day via phone.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Fatigue, Inflammation, Injection site erythema, Injection site pain
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Large rash with raised bumps started day after vaccination and spread down arm and across chest, patient showed me rash on forearm (in the bend of the elbow and 4-5 inches down the arm). Looked inflamed, red, raised bumps throughout. Reported itching and patient has tried hydrocortisone cream OTC and poison ivy itch releif spray. Counseled to try taking some benadryl, continuing with the cream(s), and contact their PCP if not getting better in another day
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Lethargy, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Large rash with raised bumps started day after vaccination and spread down arm and across chest, patient showed me rash on forearm (in the bend of the elbow and 4-5 inches down the arm). Looked inflamed, red, raised bumps throughout. Reported itching and patient has tried hydrocortisone cream OTC and poison ivy itch releif spray. Counseled to try taking some benadryl, continuing with the cream(s), and contact their PCP if not getting better in another day
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Large rash with raised bumps started day after vaccination and spread down arm and across chest, patient showed me rash on forearm (in the bend of the elbow and 4-5 inches down the arm). Looked inflamed, red, raised bumps throughout. Reported itching and patient has tried hydrocortisone cream OTC and poison ivy itch releif spray. Counseled to try taking some benadryl, continuing with the cream(s), and contact their PCP if not getting better in another day
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Severe
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Infection, Productive cough, Sputum discoloured
Clinical narrative: Systemic: back ache, shingles, and secondary infection coughing green mucus-Severe
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Lymph Node Swelling-Medium
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Joint Pain-Medium
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Dermatitis allergic, Erythema, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: she got a injection 08/19/24 , it was fully ok while she stayed in pharmacy. As per saying, she did not have any reaction. This morning 08/22/24 she came, and told me that got redness around neck and arms. It started about 2 days alter. she saying that it may get from arexvy shot, but she was not sure about it. She did not have any reaction in her injection site, but only rash in her neck , arms and legs, Other Vaccines:  VaccineTypeBrand: arexvy; Manufacturer: glaxosmithkline; LotNumber: 29z7e; Route: im; BodySite: left arm delotoid; Dose: ; VaxDate: UNKNOWN
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site vesicles
Clinical narrative: Site: Bruising at Injection Site-Mild, Additional Details: patient showed a blister adjacent to vaccine site. he states that its at the vaccine site. vaccine area is bruised and the blister is probably 1 inch away the buised site., Other Vaccines:  VaccineTypeBrand: boostrix; Manufacturer: glaxosmithkline; LotNumber: 5yb5g; Route: intramuscular; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 53.0
Sex: M
Vaccine: PNC20
Symptoms: Joint swelling, Limb discomfort
Clinical narrative: Systemic: pt said his right arm is feeling heavy and he is having swelling in his right knee-Medium, Additional Details: pt said his right arm feels heavy and his right knee is experiencing swelling. I spoke to him on phone and adressed his concerns and told him to reach out to his dr asap for further instruction being friday afternoon and the weekend coming
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Erythema, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fever-Medium, Additional Details: PATIENT RETURNED TO PHARMACY ON 08/23 345PM WITH COMPLAINT OF FEVER/SHOULDER SWEELING AND REDNESS. SWELLING AND REDNESS IS VISIBLE. PATIENT'S FEVER SUBSIDED. COUNSELED PATIENT TO USE BENADRY AROUND TH CLOCK AND TO CONTACT MD IF REDNESS/SWELLING DOESN'T SUBSIDE., Other Vaccines:  VaccineTypeBrand: PREVNAR; Manufacturer: PFIZER; LotNumber: HP7364; Route: IM; BodySite: L DELTOID; Dose: ; VaxDate: UNKNOWN
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fever-Medium, Additional Details: PATIENT RETURNED TO PHARMACY ON 08/23 345PM WITH COMPLAINT OF FEVER/SHOULDER SWEELING AND REDNESS. SWELLING AND REDNESS IS VISIBLE. PATIENT'S FEVER SUBSIDED. COUNSELED PATIENT TO USE BENADRY AROUND TH CLOCK AND TO CONTACT MD IF REDNESS/SWELLING DOESN'T SUBSIDE., Other Vaccines:  VaccineTypeBrand: PREVNAR; Manufacturer: PFIZER; LotNumber: HP7364; Route: IM; BodySite: L DELTOID; Dose: ; VaxDate: UNKNOWN
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Seizure, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: FAINTED, SEIZURE FOR 5-8 SECONDS, EMS CALLED, PARENTS CALLED, PT WENT TO HOSPITAL FOR EVALUATION.  LATER THAT DAY, PARENTS STATED DAUGHER IS DOING WELL AND HOME APROXIMATELY 3 HOURS AFTER INCIDENT