chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hairy cell leukaemia
Clinical narrative: Hairy Cell Leukemia; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, white blood cell went down), for COVID-19 immunization, reaction(s): "white blood cell went down"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: HAIRY CELL LEUKAEMIA (medically significant) with onset 17Nov2023, outcome "unknown", described as "Hairy Cell Leukemia". Therapeutic measures were taken as a result of hairy cell leukaemia.  Clinical Course: Reporter calling regarding her husband. Patient had no other conditions. Reporter clarified the side effect calling to report as Hairy Cell Leukemia which is very rare. She heard someone mention there was a possible connection to the vaccine, but is not sure. Outcome: When probed for outcome mentioned he is being seen for spinal treatment. Slowly his white blood cell went down after the vaccines. Confirmed her husband got the Pfizer Covid Vaccine and Pfizer Covid Booster. He got two Pfizer Covid Vaccines and the Booster. She was calling to see if as clarified there is assistance for the drug that is used to treat, Pentostatin, clarified the trade name is Nipent. Treatment: Six Chemo treatments. Reporter could not find vaccination card. Therefore, unable to provide date of getting the First and Second Covid Vaccine or the Covid Booster. Also, unable to provide lot/exp/ndc for any of the vaccines. Reiterated his white blood cell count slowly went down shortly afterwards; thinks it started after first dose, but does not have vaccination card to confirm the date. Regarding Concomitant Medications: Was on other medications, but declined to provide details. Patient had no Prior Vaccinations (within 4 weeks).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: thinks it(his white blood cell count slowly went down) started after first dose; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "thinks it(his white blood cell count slowly went down) started after first dose". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:Reporter calling regarding her husband. Patient had no other conditions. Slowly his white blood cell went down after the vaccines. Confirmed her husband got the Pfizer Covid Vaccine and Pfizer Covid Booster. He got two Pfizer Covid Vaccines and the Booster. Reporter could not find vaccination card. Therefore, unable to provide date of getting the First and Second Covid Vaccine or the Covid Booster. Also, unable to provide lot/exp/ndc for any of the vaccines. Reiterated his white blood cell count slowly went down shortly afterwards; thinks it started after first dose, but does not have vaccination card to confirm the date. Regarding Concomitant Medications: Was on other medications, but declined to provide details. Patient had no Prior Vaccinations (within 4 weeks). The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 10:15 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "MVP" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clavulanic acid, reaction(s): "allergies: Clavulanic acid"; Phenylpropanolamine, reaction(s): "Allergies: Phenylpropanolamine"; Ibuprofen, reaction(s): "Allergies: Ibuprofen". Vaccination history included: BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE (Vaccine administration time: 12:30 PM, lot unknown: Unable to locate or read the details, Vaccine location: Left arm)), administration date: 08Mar2023, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment from 12Mar2024 to 16Mar2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "type II diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment from 13Mar2024 to 21Mar2024).  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: have been vaccinated and has been taking Paxlovid for 4 days/this was their first time catching COVID; have been vaccinated and has been taking Paxlovid for 4 days/this was their first time catching COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have been vaccinated and has been taking Paxlovid for 4 days/this was their first time catching COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient called in to enroll in program. Patient stated they have been vaccinated and has been taking Paxlovid for 4 days because of the vaccination. The symptoms were mild and stated this was their first time catching COVID but their PTSD has had them in a panic the past few years in which patient thought they needed the medication immediately and paid out of pocket.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myositis
Clinical narrative: I am not able to function; myositis; This is a spontaneous report received from a Consumer or other non HCP.  An adult patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3 (Booster), Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2 , Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I am not able to function"; MYOSITIS (non-serious), outcome "unknown".  Additional information: Patient stated, "I developed myositis after my 4th COVID vaccine and need to report this adverse reaction and see if Pfizer can help me. I am not able to function. I believe this is a side effect that has been reported".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: made me quite ill; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "made me quite ill". Additional information: The patient was in bed for a couple of weeks  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: liquid component of pentacel was given to a patient and the hib component was not given with no reported adverse event; Initial information received on 15-Mar-2024 regarding an unsolicited valid non-serious case received via Nurse.  This case involves a 16-month-old female patient and the reporter stated liquid component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was given to a patient and the hib component was not given 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 Prophylactic vaccination.  On 08-Mar-2024, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ981AA, expiry date: 11-Feb-2025) via intramuscular route in the left thigh for Immunization and liquid component of pentacel was given to a patient and the hib component was not given with no reported ae (single component of a two-component product administered) (latency: same day)  Reportedly, Nurse called to find out how to further manage the situation wherein only the liquid component of PENTACEL was given to a patient and the HIB component was not given. Initially, the nurse said that they are suspecting 3 different patients. They don't know specifically who received the liquid component only since they only discovered that they have an extra HIB component when they were doing an inventory.  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: Headache
Clinical narrative: headache; Initial information received on 15-Mar-2024 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional.  This case involves an unknown age female patient who experienced headache after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (dosage, lot number, expiry, strength not reported) via unknown route in unknown administration site for Immunization. Information regarding batch number will be requested in this case  On an unknown date the patient developed headache (latency: Unknown) following the administration of Influenza Vaccine.  Action taken not applicable.  It was not reported that the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: medication error/an inappropriate use due to administration of expired ACTHIB with no reported adverse event; Initial information received on 15-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient and reporter reported that who had administration of expired HIB (PRP/T) VACCINE [ACT-HIB] 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, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap Vaccine) And Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) for Prophylactic vaccination.  On 06-Mar-2024, the patient received a expired dose 3 at a dose of 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength: standard, frequency: once, expiry date: 01-Mar-2024 and lot UJ833AA) via intramuscular route in the right thigh as Immunization (expired product administered) (same day latency).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Module of the 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: 13.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL was exposed to temperature excursion with Max/low temperature reached: 1.5C Duration out of labelled range: 15 hours and 43 minutes due to unknown reason and has been administered to patient with no reported adverse event; Initial information received on 15-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 years old female patient and it was reported that punctured IPV (VERO) [IPOL] was exposed to temperature excursion with Max/low temperature reached: 1.5C Duration out of labelled range: 15 hours and 43 minutes due to unknown reason and has been administered to 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP); measles vaccine, mumps vaccine, rubella vaccine (MMR; meningococcal vaccine A/C/Y/W CONJ (CRM197) (MENVEO) and varicella zoster vaccine (Varicella Vaccine) all for Prophylactic vaccination.  On 13-Mar-2024 the patient had been administered dose 1 of punctured IPV (VERO) (Suspension for injection) (lot: W1A191M; expiry date: 16-Feb-2025) which was exposed to temperature excursion with Max/low temperature reached: 1.5C Duration out of labelled range: 15 hours and 43 minutes due to unknown reason (poor quality product administered) (latency: same day) via unknown route in the left deltoid for Immunization.   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: UNK
Symptoms: No adverse event, Poor quality product administered, Product preparation error, Single component of a two-component product administered
Clinical narrative: diluent portion of Pentacel was given to a patient in the right thigh, without mixing it with the power Hib component with no reported adverse event; Initial information received on 18-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who received portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was given to a patient in the right thigh, without mixing it with the power hib component 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 13v (CRM197) (Prevnar 13) for Immunisation.  On 02-Feb-2024, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (Suspension for injection) lot UJ861AA,strength, expiry date was unknown via unknown route in the right thigh for Prophylactic vaccination (Immunization) and diluent portion of pentacel was given to a patient in the right thigh, without mixing it with the power hib component with no reported adverse event (poor quality 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: 0.58
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered a dose to a 7-month-old child with no reported adverse event; Initial information received on 21-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient whose nurse inadvertently administered a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] to her with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Mar-2024, the patient's nurse inadvertently administered 1 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE  to the patient (lot UT8111CA, expiry date: 01-Jun-2024) via intramuscular route in the left thigh as prophylactic vaccination with no reported adverse event (product administered to patient of inappropriate age) (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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Pruritus, Rash
Clinical narrative: Blisters appeared on injection site; Itching; Rash/rash "appears and disappears" and that he's got more of it on his scalp than he does on the rest of his body; Injection site got swollen; Injection site got red; This spontaneous case  was received on 18-Mar-2024, from other non-healthcare professional (consumer) via Company (reference number: SEQW24-00948), and concerned a 67-year-old, male patient.  The patient had no medical history. The patient's concomitant medications included unspecified supplements, reported as 'eight of them'. The patient's historical vaccines included two doses of Fluad Quadrivalent (influenza vaccine inact sag 4v), received on an unspecified date in 2021 and on an unspecified date in 2022, for unspecified indication, after which the patient experienced rash and itching. As reported, the patient was healthy.  On 11-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 371619 and expiry date was 30-Jun-2024.  On 01-Dec-2023, reported as six weeks after receiving Fluad Quadrivalent, the patient started having rash and itching, injection site got swollen, red and some blisters appeared on it.   On 02-Jan-2024, the patient started treatment with valaciclovir at a dose of 1 g twice a day, but it didn't help.  On an unspecified date in 2024, the patient visited the physician's office and doctor suggested a steroid injection, Kenalog (triamcinolone acetonide) 60 mg.  On 20-Feb-2024, the patient took steroid injection, Kenalog (triamcinolone acetonide) 60 mg.   On an unspecified date in 2024, although the patient still had the rash and the itching even though it was not as much of a rash at that point. The rash appeared and disappeared, and the patient got more of it on scalp than on the rest of body. When the patient took an antihistamine, it would quiet down.   At the time of initial reporting, the patient had not recovered from the events. As reported, symptoms persisted.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  This case is linked to the cases 202401671 and 202401672 (the same patient).  Company comment: A 67-year-old patient experienced pruritus and rash, as well as vaccination site blisters, swelling, and erythema six weeks after receiving the suspect product Fluad Quadrivalent. Based on implausible temporal relationship, causality for the reported events is assessed as not related.; Sender's Comments: A 67-year-old patient experienced pruritus and rash, as well as vaccination site blisters, swelling, and erythema six weeks after receiving the suspect product Fluad Quadrivalent. Based on implausible temporal relationship, causality for the reported events is assessed as not related.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site vesicles
Clinical narrative: Blisters appeared on injection site; Itching; Rash/rash "appears and disappears" and that he's got more of it on his scalp than he does on the rest of his body; Injection site got swollen; Injection site got red; This spontaneous case  was received on 18-Mar-2024, from other non-healthcare professional (consumer) via Company (reference number: SEQW24-00948), and concerned a 67-year-old, male patient.  The patient had no medical history. The patient's concomitant medications included unspecified supplements, reported as 'eight of them'. The patient's historical vaccines included two doses of Fluad Quadrivalent (influenza vaccine inact sag 4v), received on an unspecified date in 2021 and on an unspecified date in 2022, for unspecified indication, after which the patient experienced rash and itching. As reported, the patient was healthy.  On 11-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 371619 and expiry date was 30-Jun-2024.  On 01-Dec-2023, reported as six weeks after receiving Fluad Quadrivalent, the patient started having rash and itching, injection site got swollen, red and some blisters appeared on it.   On 02-Jan-2024, the patient started treatment with valaciclovir at a dose of 1 g twice a day, but it didn't help.  On an unspecified date in 2024, the patient visited the physician's office and doctor suggested a steroid injection, Kenalog (triamcinolone acetonide) 60 mg.  On 20-Feb-2024, the patient took steroid injection, Kenalog (triamcinolone acetonide) 60 mg.   On an unspecified date in 2024, although the patient still had the rash and the itching even though it was not as much of a rash at that point. The rash appeared and disappeared, and the patient got more of it on scalp than on the rest of body. When the patient took an antihistamine, it would quiet down.   At the time of initial reporting, the patient had not recovered from the events. As reported, symptoms persisted.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  This case is linked to the cases 202401671 and 202401672 (the same patient).  Company comment: A 67-year-old patient experienced pruritus and rash, as well as vaccination site blisters, swelling, and erythema six weeks after receiving the suspect product Fluad Quadrivalent. Based on implausible temporal relationship, causality for the reported events is assessed as not related.; Sender's Comments: A 67-year-old patient experienced pruritus and rash, as well as vaccination site blisters, swelling, and erythema six weeks after receiving the suspect product Fluad Quadrivalent. Based on implausible temporal relationship, causality for the reported events is assessed as not related.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: spikevax vaccine given 4 days after manufacturer expiration date. Ex date 3/21/24 dose given 3/35/24. no adverse reaction noted
Age: 69.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Note (patient request personal info not be included, Pfizer vaccine was the Comirnaty 2023-2024 seasonal dose and was the second of this specific dose  that the patient has had since >65 and >4 months since previous shot). Patient reported to the pharmacy 3/25/24 to pick up prescription and informed us that she had a reaction thought to be related to vaccination that was given last week on 3/20/24. Patient indicated that Friday morning 3/22/24 she developed a rash in the legs that then spread up to the bottom of her chin, the patient had hives develop with this rash along with itching, the neck area was the worst she indicated. On Saturday 3/21/24 patient went to urgent care and received a shot and was instructed to take Allegra and Benadryl, the patient has been doing that and the hives largely resolved 3/25/24 this morning, there is still some lingering redness with the rash in the neck region but at this time the patient has no complaints or concerns, following up with the patient in the coming days to confirm continued improvement, until complete resolution.
Age: 1.67
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Injection site erythema
Clinical narrative: Patient has a 2x2 red circle to left thigh
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Approximately 3 days after receiving the Spikevax covid vaccine, patient developed symptoms of "covid arm" with itchy, red, swollen arm around the injection site in the left deltoid. The following day the patient reported that the affected area appeared larger. Patient came in to the pharmacy to report the adverse reaction, and was counseled about the likelihood of the delayed allergic reaction, and what to watch for. Patient was advised to treat at home with cool compress, antihistamine, and Tylenol/ NSAID if necessary, but to call the pharmacy or doctor's office if it worsens or patient is concerned.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Extreme dizziness, nausea, vomiting, four and a half days after vaccine.  I am on day two of these symptoms.  I live alone and can't take myself to the hospital. I don't know which RSV I got. It was the one time dose.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Mobility decreased, Skin warm
Clinical narrative: My upper left arm started to get hotter and hotter, redder and redder and very uncomfortable.  It started out as about the size of a half dollar and as of 7:40 PM today is a huge red circle about the size of a large dinner plate.  Very hot to the touch and unable to raise my arm straight up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Blood test, Computerised tomogram, Echocardiogram, Electrocardiogram
Clinical narrative: After receiving a vaccination on 03/11/2024, I developed gradually developed a severe headache.  On the following Friday I noticed blurred vision, nausea which lasted 30 minutes.  On the following Monday night, 03/19/, the headache had become severe and a second episode took place involving partial blindness and inability to recognize objects due to blank areas.  This lasted slightly over one hour.  I went to bed and resolved to seek medical help in the morning.  I returned to the clinic and was directed to the ER.  I was given two CT scans, an MRI, electrocardiogram, multiple blood tests and an ultrasound "bubble test."  Diagnosis  was a Transient Ischemic Attack.  I underwent a brain stroke protocol and was discharged on Wednesday morning.  Follow up appointment is scheduled for March 29.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Nausea, Transient ischaemic attack, Vision blurred
Clinical narrative: After receiving a vaccination on 03/11/2024, I developed gradually developed a severe headache.  On the following Friday I noticed blurred vision, nausea which lasted 30 minutes.  On the following Monday night, 03/19/, the headache had become severe and a second episode took place involving partial blindness and inability to recognize objects due to blank areas.  This lasted slightly over one hour.  I went to bed and resolved to seek medical help in the morning.  I returned to the clinic and was directed to the ER.  I was given two CT scans, an MRI, electrocardiogram, multiple blood tests and an ultrasound "bubble test."  Diagnosis  was a Transient Ischemic Attack.  I underwent a brain stroke protocol and was discharged on Wednesday morning.  Follow up appointment is scheduled for March 29.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Eczema, Erythema, Pruritus, Psoriasis, Rash erythematous
Clinical narrative: Persistent red rash developed and developing resembling eczema or Plaque Psoriasis. Patches of red skin with extreme intermittent itching. Concurrent sites on : neck (both sides), both forearms, fingers both hands, torso (right side), and both shins. Persists three onths after vaccine 2 of Shingles Vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Migraine, Neck pain
Clinical narrative: EXTREME pain in side of neck then including base of head.  Dizziness, migraine headaches
Age: 50.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: The Vaccine was administered Inadvertently Intramuscularly instead of Subcutaneously
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Sensory loss, Spinal disorder
Clinical narrative: Patient's legs and feet became numb and started to lose feeling in both limbs on 2/5, so she went to the emergency room and they assumed it was something wrong with her spine and gave her a steroid to help with symptoms. She went back to the hospital on 2/8 when the steroid did not help and her left breast and left side went numb also. They diagnosed her with Guillain-Barre and she has remained hospitalized ever since. She is still hospitalized.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Eye pain, Eye swelling, Photosensitivity reaction
Clinical narrative: Eyes are swollen with excruciating pain, and severe photosensitivity.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Altered visual depth perception, Asthenopia, Eye pain, Eye swelling, Lacrimation increased
Clinical narrative: Eyes are swollen with excruciating pain, and severe photosensitivity.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Ophthalmological examination abnormal, Photophobia, Vision blurred
Clinical narrative: Eyes are swollen with excruciating pain, and severe photosensitivity.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized pain, swelling, erythema at injection site on day 2. Recommended ibuprofen, warm compresses and if not improvement in next 1-2 days return to clinic or sooner with any concerns.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial Swelling; reduced later on the weekend
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vulval disorder, Vulvovaginal pain
Clinical narrative: Painful lesions on vaginal folds lasting about two weeks.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Antibody test, Biopsy skin, Bone marrow failure, Haemophagocytic lymphohistiocytosis, Immunosuppressant drug therapy
Clinical narrative: This patient was eventually diagnosed with congenital HLH, bone marrow failure, and was treated with immunosuppressants, including steroids, etoposide, emapalumab, and is now 6 weeks away from receiving a bone marrow transplant. on 3/15, he developed a diffuse rash and was diagnosed with varicella, testing showed it was a strain likely linked to his prior live attenuated vaccination
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Rash, Varicella post vaccine, Varicella virus test positive
Clinical narrative: This patient was eventually diagnosed with congenital HLH, bone marrow failure, and was treated with immunosuppressants, including steroids, etoposide, emapalumab, and is now 6 weeks away from receiving a bone marrow transplant. on 3/15, he developed a diffuse rash and was diagnosed with varicella, testing showed it was a strain likely linked to his prior live attenuated vaccination
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Benign hydatidiform mole, Human chorionic gonadotropin, Maternal exposure before pregnancy, Ultrasound scan
Clinical narrative: Partial molar pregnancy
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to receive a Shingrix vaccine but received Arexvy instead.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient  complained about her arm being sore for weeks after her dose of Spikevax on 03/08. She said her arm hurts and she is now lacking mobility in her arm.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Laboratory test normal, Rash
Clinical narrative: Developed: RASH BODY MAINLY ON: CHEST, STOMACH, FACE 2/21/24 - 7 AM WENT TO DOCTOR: WAS PRESCRIBED: PREDNISONE 10 mg - 3 X DAILY FOR 5 DAYS NO FEVER
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Leukaemia, Malaise
Clinical narrative: POSSIBLE BLOOD CANCER FROM SHOTS. DEC. 2019 HAD ILLNESS DR. COULDNT INDENTIFY VERY SICK. KNEW NOT TO LAY DOWN - SYMPTOMS NOT DIAGNOSED AS COULD NOT KNOWN THEN: * GOT INJECTIONS, THEN BLOOD TESTS STARTED SHOWING HIGH BLOOD COUNT - TESTING THEN DONE (PV)  REVEALED LEUKEMIA IN DNA. HAVE BLOOD CANCER NOBODY IN FAMILY HAS PV OR LEUKEMIA - THEY SAID IT WAS GENETIC. BUT DNA TEST DONE ILLEGALLY BY DR - CHANGED DOCTORS NEVER GAVE PERMISSION FOR DNA TEST - NOTE ON ONE INJECTION THEY MISTAKENLY PUT RIGHT ARM ALL COID INJECTIONS WERE ON LEFT ARM.
Age: 60.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Monoplegia, Paraesthesia, Paralysis
Clinical narrative: Patient received 2 vaccinations on 10/28/23 and developed an adverse reaction to each vaccine starting with the covid shot (Left) arm. She developed partial paralysis and paresthesia that involved her left arm. The sensation travelled across her shoulders and continued through to her right arm and neck. She had some improvement, but, the symptoms are increasing again. She is under the care of the physician and has been referred to physical therapy.
Age: 15.0
Sex: U
Vaccine: HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE, no PQC; Product storage error; This spontaneous report was received from nurse practitioner, concerning a 15-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 25-OCT-2023, the patient was vaccinated with an out of temperature range of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (lot #W031980, has been verified to be valid, expiration date reported as 22-AUG-2024, but upon internal validation established as 06-OCT-2024)  (albumin status: recombinant human albumin) administered subcutaneously for prophylaxis (strength was not provided); and with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection,  (lot #1957405, has been verified to be valid, expiration date: 11-NOV-2025), administered intramuscularly for prophylaxis (strength was not provided).   The patient was vaccinated at public health clinic/hospital, purchased with public funds. No adverse event reported.   It was a single use vaccine, the operator of device was a healthcare professional, who was trained. The vaccine was not available for return/or evaluation.  The event was previously reported to manufacturer. The current location of vaccine was reported as used up/storage. The temperature excursion occur as a result of reading from a Digital Data Logger. The medication error occurred during storage in clinical practice.  This is one of the several cases created from the same source. ; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005578: US-009507513-2403USA005579:
Age: 13.0
Sex: U
Vaccine: HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE, no PQC; Product storage error; This spontaneous report was received from nurse practitioner, concerning a 13-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 25-OCT-2023, the patient was vaccinated with an out of temperature range of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (lot #W031980, has been verified to be valid, expiration date reported as 22-AUG-2024, but upon internal validation established as 06-OCT-2024)  (albumin status: recombinant human albumin) administered subcutaneously for prophylaxis (strength was not provided); and with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #1957405, has been verified to be valid, expiration date: 11-NOV-2025), administered intramuscularly for prophylaxis (strength was not provided).   The patient was vaccinated at public health clinic/hospital, purchased with public funds. No adverse event reported.   It was a single use vaccine, the operator of device was a healthcare professional, who was trained. The vaccine was not available for return/or evaluation.  The event was previously reported to manufacturer. The current location of vaccine was reported as used up/storage. The temperature excursion occur as a result of reading from a Digital Data Logger. The medication error occurred during storage in clinical practice.  This is one of the several cases created from the same source. ; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005578: US-009507513-2403USA005579:
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE details; administration about half of the vaccine was left in their respective vials; She reports the medical assistant drew up 0.5 mL from each vial but after administration there was 0.25 mL left in the MMR II vial and 0.2 mL left in the vial of VARIVAX; This spontaneous report was received from a registered nurse and refers to a 1-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 14-MAR-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # X013191 with expiration date 08-MAY-2025 and a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number reported as X025908, (dose, route, and anatomical location were not reported). The vaccines were reconstituted with sterile diluent(BAXTER STERILE DILUENT) lot number W036676 with expiration date 25-JUL-2024 for prophylaxis.  On the same date, while vaccination, the medical assistant administered both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX) and after administration about half of the vaccine was left in their respective vials (incorrect dose administered). The nurse reported that the medical assistant reported when she prepared the vaccines, she made sure the doses were correct. Nurse reported that the medical assistant drew up 0.5 mL from each vial but after administration there was 0.25 mL left in the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vial and 0.2 mL left in the vial of varicella virus vaccine live (oka/merck)(VARIVAX), (product preparation error). Nurse confirmed that no product breakage or any issue with the pre-filled diluent syringes that were used to reconstitute the vaccines. No additional adverse events were reported.  Lot number X025908 is an invalid lot number for varicella virus vaccine live (oka/merck).
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; received a dose of VAQTA one month before their doses were due.; This spontaneous report was received from an office manager and refers to a 14-year-old patient of unknown gender.  The patient's medical, concurrent conditions, previous drug allergies and reactions and concomitant therapies were not reported.  On 09-OCT-2023, the patient was vaccinated with the primary regimen of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 08-MAR-2024 (also reported as about 1 month prior to the booster due date), the patient was vaccinated with the booster dose of hepatitis a vaccine, inactivated (VAQTA) (inappropriate schedule of vaccine administered). No additional adverse events were reported.; Sender's Comments:  US-009507513-2403USA007673: US-009507513-2403USA007684: US-009507513-2403USA007685: US-009507513-2403USA007673:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; received a dose of VAQTA one month before their doses were due.; This spontaneous report was received from an office manager and refers to a 12-year-old patient of unknown gender.  The patient's medical, concurrent conditions, previous drug allergies and reactions and concomitant therapies were not reported.  On 09-OCT-2023, the patient was vaccinated with the primary regimen of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 08-MAR-2024 (also reported as about 1 month prior to the booster due date), the patient was vaccinated with the booster dose of hepatitis a vaccine, inactivated (VAQTA) (inappropriate schedule of vaccine administered). No additional adverse events were reported.  This is one of 4 reports from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; received a dose of VAQTA one month before their doses were due.; This spontaneous report was received from an office manager and refers to a 7-year-old patient of unknown gender.  The patient's medical, concurrent conditions, previous drug allergies and reactions and concomitant therapies were not reported.  On 09-OCT-2023, the patient was vaccinated with the primary regimen of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 08-MAR-2024 (also reported as about 1 month prior to the booster due date), the patient was vaccinated with the booster dose of hepatitis a vaccine, inactivated (VAQTA) (inappropriate schedule of vaccine administered). No additional adverse events were reported.  This is one of 4 reports from the same reporter.; Sender's Comments:  US-009507513-2403USA007673:
Age: 15.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: No additional AE; received their first dose of GARDASIL in May 2022 at the age of 15 years old. Patient received their second dose of GARDASIL 9 in November 2023.; received their first dose of GARDASIL in May 2022 at the age of 15 years old. Patient received their second dose of GARDASIL 9 in November 2023.; This spontaneous report was received from Physician and refers to a 15-year-old patient of unknown gender.  The patients' medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not reported.  On an unknown date in May 2022, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and on an unknown date in November 2023, was vaccinated with the second dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of vaccine administered, interchange of vaccine products). No additional adverse events were reported.