chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: RVX
Symptoms: Incorrect route of product administration
Clinical narrative: gave Rotarix incorrectly as an injection, further clarified to be IM injection; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 2-month-old female patient who received Rotavirus vaccine for prophylaxis.   On 08-MAY-2024, the patient received Rotavirus vaccine (intramuscular). On 08-MAY-2024, an unknown time after receiving Rotavirus vaccine, the patient experienced inappropriate route of vaccination (Verbatim: gave Rotarix incorrectly as an injection, further clarified to be IM injection). The outcome of the inappropriate route of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-MAY-2024 The nurse reported another nurse at the clinic gave Rotarix incorrectly as an injection which was further clarified to be IM (intramuscular) injection, which led to an inappropriate route of vaccination. The specialist inadvertently overlooked requesting LOT and expiration of administered dose.  No further details were provided on call, but nurse consents to follow up from safety.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: only gave the diluent/incorrect preparation; gave an Arexvy vaccine but only gave the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 68-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number PS2CK) for prophylaxis.   On 21-MAY-2024, the patient received the 1st dose of Arexvy. On 21-MAY-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: only gave the diluent/incorrect preparation) and inappropriate dose of vaccine administered (Verbatim: gave an Arexvy vaccine but only gave the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 22-MAY-2024 The pharmacist reported that the patient had received 1st dose Arexvy vaccine. The reporter reported that he/she had a facility but only gave the diluent which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consent the follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: female patient received her 1st dose of Twinrix over 10 years ago and didn't get any additional doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received over 10 years ago).   On an unknown date, the patient did not received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: female patient received her 1st dose of Twinrix over 10 years ago and didn't get any additional doses). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-MAY-2024 and 22-MAY-2024 The reporter mentioned that a patient missed a dose (of Twinrix). Upon callback to the reporter for Medical Information inquiry he stated that patient received her 1st dose of Twinrix over 10 years ago. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: sister should have received Kinrix but received DTaP; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a female patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, an unknown time after receiving DTaP vaccine, the patient experienced wrong vaccine administered (Verbatim: sister should have received Kinrix but received DTaP). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2024 The medical assistant reported female patient was inadvertently administered DTaP instead of Kinrix, which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter. This case had been link with US2024059782, reported by the same reporter.; Sender's Comments:  US-GSK-US2024059782:Same reporter different patient
Age: 0.67
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong Product Used; Unapproved Age; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 8-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Previously administered products included DTaP (had received a total two DTaP doses) and IPV (had received a total two IPV doses).   On 24-APR-2024, the patient received Kinrix. On 24-APR-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Wrong Product Used) and inappropriate age at vaccine administration (Verbatim: Unapproved Age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-MAY-2024 The nurse reported that a patient was inadvertently administered Kinrix instead of Vaxelis , which led to wrong vaccine administered. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: only the diluent portion of Arexvy had been administered to a 71 year old female; only the diluent portion of Arexvy had been administered to a 71 year old female; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 429P7, expiry date 23-NOV-2026) for prophylaxis.   On 22-MAY-2024, the patient received the 1st dose of Arexvy. On 22-MAY-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate dose of vaccine administered (Verbatim: only the diluent portion of Arexvy had been administered to a 71 year old female). On an unknown date, the patient experienced inappropriate preparation of medication (Verbatim: only the diluent portion of Arexvy had been administered to a 71 year old female). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 22-MAY-2024 The other health professional (medical assistant) asked about how to proceed after only the diluent portion of Arexvy had been administered to a 71 year old female patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Medical information was provided but the health care professional did not seem content with that and solicited information on how to contact the Centers for Disease Control.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consented to follow up.
Sex: U
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Inappropriate reconstitution technique; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced wrong technique in product usage process (Verbatim: Inappropriate reconstitution technique). The outcome of the wrong technique in product usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAY-2024 The pharmacist states that nursing had been withdrawing the diluent for Priorix out of the supplied prefilled syringes and using another syringe to inject the diluent to reconstitute Priorix, which led to Wrong technique in product usage process. This case was linked with US2023077256 and US2020AMR215994, reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023077256:Same reporter US-GLAXOSMITHKLINE-US2020AMR215994:Same reporter
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient received a dose of Hiberix that had expired on 15-May-2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received Hib (Hiberix) (expiry date 15-MAY-2024) for prophylaxis.   On 22-MAY-2024, the patient received Hiberix. On 22-MAY-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: patient received a dose of Hiberix that had expired on 15-May-2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2024 The pharmacist reported that earlier that day the patient received an expired dose of Hiberix vaccine, which led to expired vaccine used. The reporter asked for information available for administration of Hiberix after it had already expired The vaccine administration facility was the same as primary reporter. The reporter consent to follow-up
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: planning on giving Havrix to a patient,first dose of Hepatitis A was given to the patient in 2014; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A (received 1st dose in 2014).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incomplete course of vaccination (Verbatim: planning on giving Havrix to a patient,first dose of Hepatitis A was given to the patient in 2014). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2024 The pharmacist called to inform that they were planning on giving Havrix to a patient, but the patient said they had a different Hepatitis A vaccine a couple years ago. According to the reporter, the first dose of Hepatitis A was given to the patient back in 2014 and also, the reporter didn't know which was the brand of the first Hepatitis A dose the patient received. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Hepatitis A, which led to incomplete course of vaccination.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration out of age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number MZ379, expiry date 25-JAN-2025) for prophylaxis.   On 17-MAY-2024, the patient received the 1st dose of Kinrix. On 17-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration out of age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAY-2024 The caller informed that they just wanted to verify if it was invalid or valid, and any harm that would be caused to the child. The caller reported that they administered Kinrix vaccine to a 4 months old patient, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expiry dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HBV (Engerix B) (batch number YM444, expiry date 22-MAY-2024) for prophylaxis.   On 23-MAY-2024, the patient received Engerix B. On 23-MAY-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expiry dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-MAY-2024 The vaccine had an expiration date of 22nd May 2024 it was given to a 3 years old, and the reporter was just trying to found out if they need to repeat that dose or if there was any grace period since it was 11 hours pass since expiration., which led to expire vaccine use. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: patient received expired dose of priorix; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 46-year-old female patient who received MMR (Priorix) (batch number GX27P, expiry date 11-MAY-2024) for prophylaxis.   On 22-MAY-2024, the patient received Priorix. On 22-MAY-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: patient received expired dose of priorix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAY-2024 A medical assistant reported that unfortunately a patient was given one of the expired Priorix vaccines yesterday which led to expired vaccine used and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: HIBV
Symptoms: Exposure via skin contact, Injury associated with device, Needle issue, Product complaint, Underdose
Clinical narrative: needle remained in the patient's thigh; patient did not get the full dose; the reconstituted product leaked onto the skin of the patient,; Exposure via skin contact; The luerlock component on the syringes have been breaking off easily; Pharmaceutical product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a infant female patient who received Hib (Hiberix) (batch number Y24T9, expiry date 14-MAR-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: needle remained in the patient's thigh), incomplete dose administered (Verbatim: patient did not get the full dose), accidental exposure while administering drug (Verbatim: the reconstituted product leaked onto the skin of the patient,), exposure via skin contact (Verbatim: Exposure via skin contact), syringe issue (Verbatim: The luerlock component on the syringes have been breaking off easily) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the accidental needle stick was not reported and the outcome of the incomplete dose administered, accidental exposure while administering drug, exposure via skin contact, syringe issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the accidental needle stick to be related to Hiberix.     It was unknown if the company considered the accidental needle stick to be related to Hiberix.   Additional Information: GSK receipt date: 23-MAY-2024 The reporter complaint regarding the Hiberix vial / syringe presentation.  The luerlock component on the syringes have been breaking off easily all of the products were of the same lot, but not from the same box.  The number of syringes involved was 6 or 7.  Because of that, for one syringe, the needle remained in the patient's thigh, the reconstituted product leaked onto the skin of the patient, and the patient did not get the full dose, which led incomplete dose administered, accidental exposure while drug administration and exposure via skin contact. During preparation for administration and during administration, the fault detected.  The syringes were from partial use, end of pack, beginning of the pack. (The reporter stated it varied). The mixing/shaking performed after reconstitution, Rolled back and forth The vial held upside-down when the vaccine was being withdrawn. The product was administered in all patients but one in which it was partially administered. Experienced user laking Between the luer lock of the syringe and needle. There was no product to return nor are there any pictures to return to GSK. The suspect products have been discarded.
Age: 59.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second Late Dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received HAB (Twinrix) (batch number 429JJ, expiry date 01-APR-2026) for prophylaxis.   Previously administered products included Twinrix (on 13th July 2015 received 1st dose.).   On 17-MAY-2024, the patient received the 2nd dose of Twinrix. On 17-MAY-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Second Late Dose). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAY-2024 A nurse reported to asking can help me figure out the next dosage for a patient for the Twinrix.  So, she was given one, back in 2015 and she had administered one on 17 May, so, initially we were going to do the fast track but he/she had noted that she had one back in 2015 so the reporter not sure if he/she should give the last dose within a month or in 6 months for the second dose. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Deafness bilateral, Ear congestion, Hypoacusis, Meniere's disease, Nasal congestion
Clinical narrative: Bilateral Meniere's Disease/had lost 60 percent hearing in both ears; left nostril was congested; This serious case was reported by a consumer via call center representative and described the occurrence of meniere's disease in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-MAY-2024, the patient received Arexvy (intramuscular, left arm). On 10-MAY-2024, 1 days after receiving Arexvy, the patient experienced nasal congestion (Verbatim: left nostril was congested). On 22-MAY-2024, the patient experienced meniere's disease (Verbatim: Bilateral Meniere's Disease/had lost 60 percent hearing in both ears) (serious criteria GSK medically significant). The patient was treated with xylometazoline hydrochloride (Nasal Spray Ii). The outcome of the meniere's disease was not resolved and the outcome of the nasal congestion was resolved.   It was unknown if the reporter considered the meniere's disease and nasal congestion to be related to Arexvy.     It was unknown if the company considered the meniere's disease and nasal congestion to be related to Arexvy.   Additional Information: GSK Receipt date: 28-MAY-2024 The patient self-reported. She received the Arexvy vaccine in her left arm on 09 May 2024 and on next day her left nostril was congested.  Reporter called her HCP who referred her to an ENT and the ENT told her to use nasal spray for the congestion. Reporter reported that the congestion then settled in her ears.  On 22 May 2024 the personal assistant in the ENT practice told her she had lost 60 percent hearing in both ears, and it was Bilateral Meniere's disease.  Reporter wanted to know if this was a result of the Arexvy vaccine, and will it go away. Reporter went back to the ENT to see the physician and she state that she would feel better if an actual Doctor saw her ears.  Reporter reported that she was told by the personal assistant who saw her last week to call the drug company to see if hearing loss with the Arexvy vaccine had then observed.  Reporter reported that she was not looking to sue anyone, she just wants her hearing back.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Product contamination physical
Clinical narrative: I suspect that's what caused my daughter's health issues; some of the foreign particle Moderna vaccines were recalled; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (I suspect that's what caused my daughter's health issues) and PRODUCT CONTAMINATION PHYSICAL (some of the foreign particle Moderna vaccines were recalled) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. 3004215 and 3004219) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I suspect that's what caused my daughter's health issues) and PRODUCT CONTAMINATION PHYSICAL (some of the foreign particle Moderna vaccines were recalled). At the time of the report, IMMUNISATION REACTION (I suspect that's what caused my daughter's health issues) and PRODUCT CONTAMINATION PHYSICAL (some of the foreign particle Moderna vaccines were recalled) outcome was unknown.            No concomitant medication was reported.  Patient's family was away around the time that some of the foreign particle Moderna vaccines were recalled. Reporter suspects that's what caused patient's health issues.  No treatment medication was reported.  Reason for no investigation was reported as: The patient's mother is emailing about the vaccine batches used for her daughter's vaccinations, stating they were received around the time of the Moderna product recalls. The case was forwarded to the Drug Safety team and an Argus number was assigned. A review of Quality Events for CMO batch 3004215 and 3004219 was performed. There have been no Market Actions taken for batch 3004215 and 3004219. This batch has not been associated with a recall to date. This complaint will be closed with no further investigation recommended.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2024: Live follow-up received contains non-significant information (reference ID's added). On 17-May-2024: No new information received. On 19-May-2024: Non-significant follow-up received: reference numbers were added. On 20-May-2024: Non-significant follow-up received: reference number added. On 27-May-2024: Significant follow-up received in which case updated from invalid to valid and Rationale for no investigation was added into QC Comment field.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: when putting the needle on the hub part, the syringe breaks and when trying to give the vaccine the vaccine squirts through to the blue hub; when putting the needle on the hub part, the syringe breaks and when trying to give the vaccine the vaccine squirts through to the blue hub; This is a spontaneous report received from a Nurse.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "when putting the needle on the hub part, the syringe breaks and when trying to give the vaccine the vaccine squirts through to the blue hub".  Causality for "when putting the needle on the hub part, the syringe breaks and when trying to give the vaccine the vaccine squirts through to the blue hub" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: it was unknown if the product was given to the patient.
Age: 70.0
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.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Mar2024 as dose 2, single (Lot number: HN0478) at the age of 70 years, in right arm for covid-19 immunisation; BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Lot number: HH7595), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asplenia" (unspecified if ongoing); "high blood pressure (controlled)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid as treatment from 19May2024 to 24May2024.
Age: 68.0
Sex: M
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.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid 19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid 19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid 19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid 19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid 19 vaccine (DOSE 5 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid 19 vaccine (DOSE 6 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid 19 vaccine (DOSE 7 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 16May2024 to 21May2024.  Clinical course: Symptoms subsided after 5day paxlovid treatment, but head cold like symptoms returned at day 10. The patient had no known allergies.
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: arm was swollen/it is swollen; where they gave me the shot and it is sore/ very sore spot/soreness; significant lump where they gave me the shot/size of them looks like a golf ball under my skin; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old male patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), on 24May2024 at 11:15 as dose number unknown, single (Lot number: Unknown) at the age of 63 years intramuscular, in right arm for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 24May2024, outcome "not recovered", described as "significant lump where they gave me the shot/size of them looks like a golf ball under my skin"; VACCINATION SITE PAIN (non-serious) with onset 24May2024, outcome "not recovered", described as "where they gave me the shot and it is sore/ very sore spot/soreness"; VACCINATION SITE SWELLING (non-serious) with onset 26May2024, outcome "not recovered", described as "arm was swollen/it is swollen". Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling which included putting ice on it.  Additional information: The patient had the Pfizer shot (Prevnar 20 last Friday, the 24th, in his right arm, dominant arm) and has a pretty significant lump where they gave him the shot and it is sore, now he can move his arm but it is a very sore spot, almost like a size of them looks like a golf ball under his skin. He reported that his arm was swollen when they gave him the shot. The soreness started immediately. He did not notice the swelling up until the 26May2024 or 27May2024. It still swollen and sore at the time of the report. He put ice on it to see if that would help and thinks it may have helped but it is still there and still underneath where they gave him the shot. It is hard, like a golf ball, still swollen. Treatment for the event was reported as "no". The patient was thinking the swelling would have gone by now, but it is sore to touch if he presses on it, it is sore, and it is swollen. So, there is some adverse reaction. He wanted to make sure that he did not need to do anything for it, there is a doctor or anything else because now he is out of town in REDACTED and he just wanted to make someone aware on their side in case anything else happens so that they have a record of this.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergy; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male 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 included: "Drug allergy" (unspecified if ongoing), notes: Unknown drug. The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunisation. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergy".  Batch/lot number is not provided, and it cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11May2024 as dose 1, single at the age of 57 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (non-serious) with onset May2024, outcome "not recovered", described as "COVID-19 treatment".  It was further reported that the patient started to take Paxlovid on 16May2024.    No follow-up attempts are possible.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Neoplasm progression
Clinical narrative: slowed the growth down but now it's other systems in his body that's being affected; really sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male 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 included: "pituitary tumor", start date: 2009 (ongoing); "Inaudible failure" (ongoing), notes: Inaudible failure. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series complete.), for COVID-19 immunization.  The following information was reported: NEOPLASM PROGRESSION (non-serious), outcome "unknown", described as "slowed the growth down but now it's other systems in his body that's being affected"; ILLNESS (non-serious), outcome "unknown", described as "really sick".  Additional information: Reporter stated, "My husband's really sick. He has pituitary tumor, and he has a (inaudible) failure. We're still able to be somewhat independent. We did get all the Pfizer COVID shots. It's non-Cancerous. It's an endocrine disease that unfortunately he got. Reporter was asked if husband became sick before or after receiving the Pfizer COVID vaccine and responded it was long after. He was diagnosed in 2009. So, this has been ongoing for a long time. He had surgery. They couldn't get it all. He had radiation that didn't help, (inaudible). That slowed the growth down but now it's other systems in his body that's being affected but its slow. It's a slow growth."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 11.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: excursion for 21 minutes on fridge, temp. was 34.31° C/vaccine was given with no reported adverse event; excursion for 21 minutes on fridge, temp. was 34.31° C/vaccine was given with no reported adverse event; Initial information received on 24-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient (170 cm and 52.163 kg) and reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated) (IPV (VERO))/ 21 minutes on fridge, temp. was 34.31° C/vaccine was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Mar-2024, the patient received 0.5 ml (Booster) dose of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: WIC751M) (expiry date, strength: unknown) via intramuscular route in the left deltoid for immunization.  On an unknown date, the reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated)/ 21 minutes on fridge, temp. was 34.31° C/vaccine was given with no reported adverse event (product storage error) (unknown latency).  On 20-MAR-2024, the reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated)/ 21 minutes on fridge, temp. was 34.31° C/vaccine was given 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: 34.0
Sex: M
Vaccine: DTAPIPV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administrator states pt was given quadracel in error, they were supposed to get ADACEL with no reported adverse event; Initial information received on 24-May-2024 (with live follow-up information received on 28-May-2024) regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 34 years old male patient who was administered Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine [Quadracel (VERO)] in error, they were supposed to get Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received (dose and units unspecified) of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine (Solution for injection) (lot U7908AA, expiry date: 03-Oct-2025; strength not reported) via unknown route in unknown administration site for Immunization, in error, they were supposed to get Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, with no reported adverse event (wrong 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: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Infant irritability
Clinical narrative: experienced 3 to 4 hours of inconsolable fussiness; Initial information received on 24-May-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4-month-old female patient who experienced 3 to 4 hours of inconsolable fussiness 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 Pneumococcal Vaccine CONJ 15V (CRM197) (Vaxneuvance); and Rotavirus Vaccine Live Reassort Oral 5V (Rotateq) (both for Immunization)  On 21-Mar-2024, the patient received a dose 1 (0.5 ml 1x (once)) with formulation Suspension for injection of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine via intramuscular route on left leg(lot UK015AA, expiration date: 31-May-2025) (with an unknown strength) for Immunization.  On 21-MAR-2024 the patient experienced 3 to 4 hours of inconsolable fussiness (infant irritability) (latency: same day)following the administration of Diptheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine.  Action taken was not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: guillain barre syndrome; Initial information received on 24-May-2024 regarding an unsolicited valid serious case received from a pharmacist.  This case involves an unknown age female patient who experienced Guillain barre syndrome after receiving vaccine 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 an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunisation.  Information on the batch number was requested.  On an unknown date the patient developed guillain barre syndrome (guillain-barre syndrome) (unknown latency) following the administration of Influenza Vaccine.   Reportedly, The pharmacist received an inquiry from a family medical doctor about a patient who developed Guillain Barre Syndrome (GBS) after receiving a flu vaccine (the particular brand/product was not known). The specific timing of the patient's development of GBS after flu vaccine was not known.  Seriousness criteria: This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event guillain barre syndrome.; Sender's Comments: Sanofi company comment dated 28-May-2024: This case involves an unknown age female patient who experienced Guillain barre syndrome after receiving vaccine Influenza Vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: HEP, UNK
Symptoms: Incomplete course of vaccination
Clinical narrative: She received two of three doses of HBV recombinant vaccine (unknown formulation) at zero and one month; Drug used for unapproved indication; This literature marketed information has been received from the authors in a published article title as stated below and refers to a 1-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions, Concomitant therapies were not reported. The patient had currently 67-years.   On an unknown date, the patient was vaccinated with 2 of 3 doses (first at 0 months old and the second at 1-month old) of hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, lot #, expiry date, and route of administration were not provided) intramuscular injection, administered for prophylaxis.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports from the same literature.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have COVID; I have COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE (had received all immunizations)), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I have COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information : The patient had all immunizations including the omicron variant. Patient had COVID for almost two weeks. Patient was still suffering from it. Patient was given paxlovid and patient can tell that it sucks. Burning diarrhea, metallic taste even the water tastes like patient was sucking on old pennies. Patient was told that if Patient contracted COVID, the vaccines would make it easier and short lived. Not the case.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400071273 same patient, different drug and events;
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Muscle fatigue, Pyrexia, Rash
Clinical narrative: Chills, fever, lethargic, muscle fatigue, rash on sides of neck, sides of face & chin area
Age: 22.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received her initial doses of MMR and Varicella on 05/20/2024. She was administered both vaccines again on 05/29/2024, earlier than the 28 days interval between doses. Patient has not reported any symptoms.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Fall, Seizure, Syncope
Clinical narrative: Syncope and had a seizure after the fallinn  to the floor.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Per system patient was due for tdap and our provider like us to administer before he comes in if pt is due also per standing orders which allows us to give vaccinations. Before administering I asked pt if she was sure she didn't receive it at another clinic and she stated she hadn't.  Per our system there was nothing in the patient's chart or in the immunizations record there was no previous records on there until after administering the vaccine my second verified then double checked on her side and she saw that it was given in 2023.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: PT PRESENTED TO THE PHARMACY 5/31/24 AND SHOWED LARGE, RED, RASH ON RIGHT ARM BELOW THE DELTOID. SHE DESCRIBED IT AS SHOWING UP THE DAY AFTER VACCINE ADMINISTRATION AND HAD NOT IMPROVED. SLIGHTLY RAISED AND WARM TO TOUCH. PT WAS ENCOURAGED TO CONTACT PCP AND PHARMACY CONTACTED PCP. BENADRYL WAS RECOMMENDED BUT SHE PREFERRED LORATADINE.
Age: 26.0
Sex: F
Vaccine: PNC20
Symptoms: Chest discomfort, Dyspnoea, Hypersensitivity, Throat irritation
Clinical narrative: Pt left facility after receiving PNUCN20 (Prevnar 20) (Pneumococcal conjugate, 20 valent) then returned to clinic as she stated she began to feel chest tightness, difficulty breathing and scratchy throat on her drive home. Upon arrival to clinic LVN asked for MD assistance due to report of allergic reaction, MD assessed pt, 50 mg IM benadryl were given and EMS transport was called to take pt to emergency room.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: After the vaccination on 10/2 i developed tinnitus. The date is not exact but went 1/26/2024 to an Audiology appointment. I have a high pitched buzz in both ears. It came on so quickly.
Age: 33.0
Sex: M
Vaccine: IPV, TDAP, TYP, YF
Symptoms: Syncope
Clinical narrative: pt experienced syncope after administering the fourth of four vaccines today.
Age: 10.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was administered Kinrix out of age range.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient asked to get her Covid booster. I checked chart and saw that she had her last dose in 9/29/2023. On the vaccine informed consent form I misread her current age (63) instead of 65. Patient did not report any reactions , has not listed any known allergies/reaction to vaccines in the past and has indicated Diabetes as a disease state. *The current CDC guidelines indicate the Covid booster for anyone 65 and older as long as it has been 4 months or more since the last dose. *