chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: has  test originally/she was exposed; has test originally/she was exposed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "has  test originally/she was exposed". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Additional information: Patient had  test originally in the mail the expiration date was 28Jan2023 (unspecified). Patient was wondering if she could still use it because she was exposed.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I seem to have had an extraordinarily positive response to my COVID vaccine(s); in fact, I believe it cured me of a horrific skin infection I've had for most of my life.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Horrific skin infection" (unspecified if ongoing), notes: I've had for most of my life. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I seem to have had an extraordinarily positive response to my COVID vaccine(s); in fact, I believe it cured me of a horrific skin infection I've had for most of my life.". The event "i seem to have had an extraordinarily positive response to my covid vaccine(s); in fact, i believe it cured me of a horrific skin infection i've had for most of my life." required physician office visit.  Additional information: Patient tried to report the miraculous improvements to local doctors, but they are apathetic towards the connection to the vaccine. Still, patient's skin radically changed exactly 10 days after the first vaccine and has never stopped improving since.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: Chronic Urticaria/break out in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Ever since taking all the COVID Vaccines I have developed Chronic Urticaria), for COVID-19 immunization, reaction(s): "Chronic Urticaria". The following information was reported: URTICARIA CHRONIC (non-serious), outcome "not recovered", described as "Chronic Urticaria/break out in hives".  Additional Information: Patient told this would resolve in time but patient's last booster was Sep2022. Will this indeed resolve, and will future vaccines cause the same issue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300239563 same patient, different dose/event;
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of daptacel with no reported adverse event; Initial information received on 27-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who received an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] 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 Hepatitis B Vaccine, Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) both for Prophylactic vaccination..  On 26-Jun-2023, the patient received expired dose 0.5 ml (dose 2) Once (1X) of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (strength not reported) (lot C5893AA; Expiration Date :21-Jun-2023) via intramuscular route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency; on same day) Caller reports that the first dose of the dtap series came from a combination from a combination vaccine.  Action taken : not applicable.  Outcome :  Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of pentacel with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 1 years old male patient who had received an expired dose of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant vaccinations included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13); and hepatitis A vaccine both for Prophylactic vaccination (immunization).  On 26-Jun-2023, the patient received 0.5 mL dose 3 of expired suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (lot: UJ671AA; Expiry date: 13-May-2023) via unknown route in the left thigh for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event received an expired dose of pentacel with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered with no reported adverse event; Initial information was received on 28-Jun-2023 regarding an unsolicited valid non-serious case from an other health professional.  This case involves 3 years old female patient who received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/HIB(PRP/T) vaccine [Pentacel (vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and hepatitis B vaccine for Prophylactic vaccination (immunisation).  On 27-Oct-2020, the patient received a dose 3 of expired suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/HIB(PRP/T) vaccine (lot number: UJ015AAA, expiration date: 26-Oct-2023) via intramuscular route in the left lateral thigh for immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  outcome was Unknown for the event expired vaccine administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received ADACEL on 6/16/23 and then the same vaccines administered 6/27/23 with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA201354.  This case involves a 11 years old male patient who received diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] on 16-Jun-2023 and then the same vaccines were administered on 27-Jun-2023 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 meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Prophylactic vaccination.  On 27-Jun-2023, the patient received a dose of 0.5 ml (dose 1) once of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: u7624aa; expiry date: 06-Feb-2024; strength: standard) via intramuscular route in the right arm for Immunisation.  On 27-Jun-2023 the patient received adacel however the same vaccines were administered 16-Jun-2023 with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  It was reported, "Caller transferred from Medical assistant asking what further steps need to be taken after a patient received ADACEL AND MENQUADFI yesterday. The patient had received Menquadfi and another tdap vaccine 11 days prior at a different location. Caller states that they don't know if the patient received Adacel."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: they have mistakenly administered an expired Daptacel to a patient, with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a 1 years old male patient and it was reported they have mistakenly administered an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] to a 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 HIB vaccine CONJ (TET TOX) (ACTHIB); and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) both for Prophylactic vaccination..  On 30-JUN-2023, the patient was mistakenly administered an expired dose (Dose 4) of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] Suspension for injection (batch/lot number: C5893AA; expiry date: 21-Jun-2023; strength: standard; frequency: once) via intramuscular route in the left thigh for immunization, with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: received only the liquid, DTaP-IPV portion of the PENTACEL product with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 15 months old male patient who had received only the liquid, DTAP-IPV portion of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] product 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 hepatitis A vaccine (Hepatitis A vaccine) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 30-Jun-2023, the patient received only the liquid, DTAP-IPV portion of a standard total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ840AA, expiry date: 16-Feb-2024) via intramuscular route in left leg for Immunization with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, Caller asks what's the medication or ingredient in the PENTACEL's vial (diluent) and powder? Another staff member, stated the reason they ask is because it was administered separately instead of together and to 2 different patients. Should they repeat the dose? Should they wait? Is there any harm in the patient receiving a partial or inactive dose?   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA203212:01674842
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: received only the lyophilized component,Hib portion of the PENTACEL product, with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 1-year-old male patient who had received only the lyophilized component,hib portion of the pentacel product, with no reported adverse event after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 30-Jun-2023, the patient received a total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot: UJ840AA) via intramuscular route in unknown administration site for Immunization.  On 30-Jun-2023 the patient had event of received only the lyophilized component,hib portion of the pentacel product, with no reported adverse event (single component of a two-component product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  It was unknown if any lab data/tests available.  Action taken with diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine (Pentacel (Vero)) was not applicable.  Outcome: unknown.    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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of Daptacel was administered to a patient, with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient where expired dose diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] was administered to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 28-Jun-2023, the patient received 0.5 ml (once) dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (Strength = standard, batch number- C5893AA) via unknown route in unknown administration site (expiration date: not provided) for Immunisation.  On 28-Jun-2023 the patient got expired dose of daptacel was administered to a patient, with no reported adverse event (expired product administered) (latency- same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient who received TENIVAC that was expired on 24Jun2023 and was administered today, the 30Jun2023 with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 51 years old female patient received diphtheria-2/tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that was expired on 24jun2023 and was administered today, the 30jun2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Jun-2023, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus-5 Adsorbed Toxoids No Preservative Adult (strength: not reported; expiry date: 30Jun-2023 and  lot U7092AA) via intramuscular route in the right deltoid for Immunization and received was expired vaccine with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: giving the liquid component of the Pentacel to a child/lyophilized component wasn't mixed with the liquid component, with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 years old male patient who was given the liquid component of the diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] / lyophilized component wasn't mixed with the liquid 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 Prophylactic vaccination (immunization).  On 30-Jun-2023, the patient received 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ678AA (Act-Hib); Expiry date: 09-sep- 2023; Batch number: U7311AA (DTAP-IPV), Expiry date: 09-sep- 2023) via intramuscular route in left leg for Immunization, only given the liquid component of the pentacel to a child/ lyophilized component wasn't mixed with the liquid component, with no reported adverse event (product preparation error) (same day latency).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event giving the liquid component of the pentacel to a child/ lyophilized component wasn't mixed with the liquid component, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: that they administered an expired dose of MENACTRA vaccine over the weekend with no reported adverse event; Initial information received on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient and it was reported that they administered an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] over the weekend with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, they administered an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] Solution for injection (batch/lot number, expiry date, strength, dose, route: not reported) in unknown administration site for prophylactic vaccination (immunization) over the weekend with no reported adverse event (expired product administered) (latency: same day). Information on the batch number was requested.  Reportedly, Pharmacist (vaccine specialist) called because another pharmacist from a sister pharmacy reported that they administered an expired dose of MENACTRA vaccine over the weekend. Caller is requesting guidance on re-vaccination.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: UNK
Symptoms: Accidental exposure to product, Medication error, No adverse event
Clinical narrative: one of her nurses just got a little pentacel splashed in her eye, she rinsed it out with water with no reported adverse event; Initial information received on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a female patient of unknown age and it was reported one of her nurses just got a little diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] splashed in her eye, she rinsed it out with water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, one of her nurses just got a little diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] Suspension for injection (batch/lot number, expiry date: not reported) splashed in her eye, she rinsed it out with water with no reported adverse event (accidental exposure to product) (latency: same day). Information on the batch number was requested.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Pain
Clinical narrative: headache; blister on left arm near elbow; Body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-JUN-2023, the patient received the 1st dose of Shingrix (left arm). In JUN-2023, several hours after receiving Shingrix, the patient experienced general body pain (Verbatim: Body aches) and headache (Verbatim: headache). On 29-JUN-2023, the patient experienced blister (Verbatim: blister on left arm near elbow). The patient was treated with paracetamol (Tylenol). In JUN-2023, the outcome of the headache was resolved. The outcome of the general body pain and blister were not resolved.   It was unknown if the reporter considered the general body pain, headache and blister to be related to Shingrix.     It was unknown if the company considered the general body pain, headache and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-JUN-2023 The patient self-reported this case. The patient stated that she experienced headache (resolved) and body aches, hours later.  The patient took Tylenol. She stated that on the day of reporting noticed a blister on left arm near elbow.  The blister hurts and it was half size of a bean, and it had water inside.  The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: Suffering from Chronic Lymphoedema for 40 years but after 3 days she got the 1st shot of the Moderna vaccine it went away; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Suffering from Chronic Lymphoedema for 40 years but after 3 days she got the 1st shot of the Moderna vaccine it went away) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Lymphoedema (Chronic Lymphoedema for 40 years).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Suffering from Chronic Lymphoedema for 40 years but after 3 days she got the 1st shot of the Moderna vaccine it went away) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Suffering from Chronic Lymphoedema for 40 years but after 3 days she got the 1st shot of the Moderna vaccine it went away) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Patient received a Moderna Covid shot 3 years ago. Treatment information was not reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information about patient 5th out of 10 infant patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:Same reporter, master case
Age: 60.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain
Clinical narrative: burning from Tetanus Shot; Initial information received on 29-Jun-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 60 years old female patient who experienced burning from tetanus shot after receiving vaccine Tetanus Toxoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Tetanus Toxoid produced by unknown manufacturer formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).Information on the batch number was requested.  On an unknown date the patient developed a non-serious burning from tetanus shot (vaccination site pain) (unknown latency) following the administration of Tetanus Toxoid.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (burning from Tetanus Shot).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event burning from tetanus shot.; Sender's Comments:  US-SA-2023SA201969:
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: SADDLE PULMONARY EMBOLISM ACUTE PULMONARY EMBOLISM
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; Temperature: 70F; This spontaneous report was received from a pharmacist and a nurse, referred to a 4-year-old patient of unknown gender. Information about the patient's pertinent medical history, concomitant medications, and drug reactions/allergies was not provided.  On 02-MAR-2023, doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot# W025273, expiration date: 10-AUG-2024) experienced a temperature excursion of 70 Fahrenheit (F) for 9 minutes with no previous temperature excursion. It was not known if digital data logger was involved. On 07-JUN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, lot #W025273, expiration date: 10-AUG-2024, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) (Product storage error). No symptoms were reported. No further adverse event (AE) details and no product quality complaints (PQCs) were reported.  This case is one of multiple reports from the same reporter.
Sex: F
Vaccine: RAB
Symptoms: Asthma, Condition aggravated
Clinical narrative: Flare up of asthma not any worse that it usually is; Case reference number US-BN-2023-000327 is a spontaneous case report initially received from a consumer (reference number: USBAV23-0234) on 09-Feb-2023 and concerns a female patient of unknown age.  The patient's relevant medical history and concomitant medication details were not provided.  On 07-Feb-2023, the patient was vaccinated with the first dose of RabAvert (batch number not provided) at an unknown dose, site or route of administration for post exposure to rabies.   On an unspecified date, reported as two days after RabAvert dose, the patient experienced a flare up of asthma. As reported, it was not any worse than it usually was and the patient has not used any steroid at that point and could hold on for two weeks or so.  At the time of the initial report, the outcome of the event 'flare up of asthma not any worse that it usually was' was unknown.  The reporter assessed the event 'flare up of asthma not any worse that it usually was' as non-serious and as not related to RabAvert vaccine.   Additional information received from Bavarian Nordic on 10-Feb-2023 included local case ID.; Reporter's Comments: A female patient of unknown age experienced flare up of asthma, two days after she was vaccinated with the first dose of RabAvert, at an unknown dose, site or route of administration for post exposure to rabies. Reportedly, it was not any worse than it usually was and the patient has not used any steroid at that point. Asthma is unlisted according to insert for Rabipur. The outcome was unknown. Causal relationship is conservatively assessed as related to suspect product due to plausible temporal relationship however the underlying condition is strongly confounding causality assessment. The case is non-serious.; Sender's Comments: A female patient of unknown age experienced flare up of asthma, two days after she was vaccinated with the first dose of RabAvert, at an unknown dose, site or route of administration for post exposure to rabies. Reportedly, it was not any worse than it usually was and the patient has not used any steroid at that point. Asthma is unlisted according to insert for Rabipur. The outcome was unknown. Causal relationship is conservatively assessed as related to suspect product due to plausible temporal relationship however the underlying condition is strongly confounding causality assessment. The case is non-serious.
Sex: U
Vaccine: RAB
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis event; Case reference number US-BN-2023-000328 is a spontaneous case report initially received from a consumer on 22-Feb-2023 and concerns a patient of unknown age and gender.  The patient's relevant medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of the rabies vaccine (rabies virus (inactivated, strain flury LEP); (batch number: not provided)) at an unknown dose, site, or route of administration for post-exposure rabies immunization. The reporter could not advise whether the patient received RabAvert or Imovax.   On an unspecified date, an unknown amount of time after the rabies vaccine, the patient experienced an anaphylaxis event.  At the time of this report, the outcome of the event was unknown.  The reporter did not provide a seriousness or causality assessment for the event. Additionally, the event of 'anaphylaxis' was assessed as serious, due to medically significance.   No further information was provided.; Reporter's Comments: A patient of unknown age and gender was vaccinated with a dose of an unspecified rabies vaccine, at an unknown dose, site, or route of administration for post-exposure rabies immunization. On an unspecified date, an unknown amount of time after the rabies vaccine, the patient experienced a serious event of anaphylaxis (medical significance). Anaphylactic reaction is listed for rabies vaccine according to the insert. The patient's relevant medical history and concomitant medication details were not provided. The outcome of the event was unknown. Since the evaluation did not find enough evidence to completely exclude a contributory role of the suspect vaccine to the development of the event, the anaphylactic reaction has been considered as related to rabies vaccine. This case is considered as serious due to medical significance.; Sender's Comments: A patient of unknown age and gender was vaccinated with a dose of an unspecified rabies vaccine, at an unknown dose, site, or route of administration for post-exposure rabies immunization. On an unspecified date, an unknown amount of time after the rabies vaccine, the patient experienced a serious event of anaphylaxis (medical significance). Anaphylactic reaction is listed for rabies vaccine according to the insert. The patient's relevant medical history and concomitant medication details were not provided. The outcome of the event was unknown. Since the evaluation did not find enough evidence to completely exclude a contributory role of the suspect vaccine to the development of the event, the anaphylactic reaction has been considered as related to rabies vaccine. This case is considered as serious due to medical significance.
Sex: U
Vaccine: SMALLMNK
Symptoms: Chlamydial infection, Gonorrhoea
Clinical narrative: Gonorrhea and chlamydia; Gonorrhea and chlamydia; Case reference number US-BN-2023-001123 is a spontaneous case report initially received from a other health professional (reference number: USBAV23-0781) on 20-Jun-2023 and concerns a patient of unknown demographics.   The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (batch number not provided), at unknown dose, route and anatomical site of administration, for an unknown indication.  On an unspecified date, an unknown amount of time after the first dose of Jynneos, the patient experienced gonorrhea and chlamydia.  On an unspecified date, an unknown amount of time after the first dose of Jynneos, the patient was coming in for the second dose of monkey pox vaccine, as reported, and also asked for sexually transmitted disease (STD) treatment for gonorrhea and chlamydia.  At the time of initial report, the outcome of the events 'gonorrhea' and 'chlamydial infection' was unknown.  The reporter assessed the events 'gonorrhea' and 'chlamydial infection' as non-serious. However, the events 'gonorrhea' and 'chlamydial infection' were assessed as serious due to the seriousness criteria of medical significance. Causality assessment was not provided for the reported events.  Additional information received from Bavarian Nordic on 21-Jun-2023 included the local case ID.; Reporter's Comments: A patient of unknown demographics received the first dose of Jynneos, via unknown route and site of administration. An unknown amount of time later, before receiving the second dose of Jynneos, the patient developed gonorrhea and chlamydial infection (serious, medically significant events). Gonorrhoea and chlamydial infection are unlisted per the insert for Jynneos. The patient's medical history and concomitant medications were not reported. Considering that gonorrhoea and chlamydia are sexually transmitted diseases, a causal relationship is deemed biologically implausible. The events are assessed as not related to Jynneos.; Sender's Comments: A patient of unknown demographics received the first dose of Jynneos, via unknown route and site of administration. An unknown amount of time later, before receiving the second dose of Jynneos, the patient developed gonorrhea and chlamydial infection (serious, medically significant events). Gonorrhoea and chlamydial infection are unlisted per the insert for Jynneos. The patient's medical history and concomitant medications were not reported. Considering that gonorrhoea and chlamydia are sexually transmitted diseases, a causal relationship is deemed biologically implausible. The events are assessed as not related to Jynneos.
Sex: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound scan
Clinical narrative: DEEP VEIN THROMBOSIS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total administered on JUL-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On unspecified date in JUL-2022, the patient experienced deep vein thrombosis(DVT) diagnosed in Emergency Room (ER) (ultrasound). Acute DVT in ER in NOV-2022, several more indicated, ultrasound. Patient woke up on 11-NOV-2022 with a swollen foot, looks like that to date, won't go away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000288257.; Sender's Comments: V0: 20230673585- deep vein thrombosis. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about patient 6 out of 10 patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:Master case