chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain at the injection site). The outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-NOV-2024 The patient self-reported this case. The patient experienced pain at the injection site after receiving Arexvy.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in AUG-2020).   In MAR-2022, the patient received the 2nd dose of Shingrix. In MAR-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2024 The reporter reported that a patient received the first dose of Shingrix in AUG_2020 and 2nd dose in MAR-2022, which led to drug dose administration interval too long.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Extra Dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2FP37, expiry date 01-JUL-2025) for prophylaxis.   Previously administered products included Arexvy (received a dose year apart).   On 04-NOV-2024, the patient received the 2nd dose of Arexvy. On 04-NOV-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Extra Dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2024 The pharmacist stated a patient may have received an Arexvy dose twice, but a year apart (one may have been given last December and received a dose on the day of reporting) which led to extra dose administered. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix administration less than minimum Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number YA3NL) for prophylaxis.   Concurrent medical conditions included immunocompromised (immunocompromised due to Lupus) and systemic lupus erythematosus. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 12-APR-2023, the patient received the 2nd dose of Shingrix. On 12-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix administration less than minimum Interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 18-NOV-2024 The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of the vaccination scheduled. The reporter noticed in the database that a patient was given the shingles (Shingrix) vaccines only 6 days apart, the reporter asked was they in for a 2nd dose. The 1st dose of Shingrix vaccine was given on 06th April 2023, HCP did not share the lot number nor expiry date of 1st dose. For the vaccine (1st dose), this was administered on the same zip code that the HCP mentioned, for the second dose. The reporter reported that as he/she escalated this to 2nd line agent, the HCP mentioned to his/her coworker that the patient was immunocompromised due to lupus. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles 2 weeks after receiving the first dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: developed shingles 2 weeks after receiving the first dose of Shingrix). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 26-NOV-2024 The patient developed shingles 2 weeks after receiving the first dose of Shingrix.  The patient's outbreak was on the face and forehead.  The patient's initials and date of birth were not available.
Age: 50.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Oral pain
Clinical narrative: Oral pain in my palate; sensitive and painful; This spontaneous case was reported by a patient and describes the occurrence of ORAL PAIN (Oral pain in my palate; sensitive and painful) in a 50-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine for Flu.    No Medical History information was reported.   On 21-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 25-Nov-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced ORAL PAIN (Oral pain in my palate; sensitive and painful). At the time of the report, ORAL PAIN (Oral pain in my palate; sensitive and painful) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Needle issue, Soft tissue foreign body
Clinical narrative: issue with the threading on the diluent syringe/defective syringes/when pulled away the needle, the needle came off the syringe, and the needle stayed in the patient's arm; issue with the threading on the diluent syringe/defective syringes/when pulled away the needle, the needle came off the syringe, and the needle stayed in the patient's arm; This is a spontaneous report received from a Pharmacist from medical information team.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: LG9827, Expiration Date: Oct2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOREIGN BODY (medically significant), DEVICE CONNECTION ISSUE (medically significant), outcome "unknown" and all described as "issue with the threading on the diluent syringe/defective syringes/when pulled away the needle, the needle came off the syringe, and the needle stayed in the patient's arm".  Additional information included: Pharmacist calling about Abrysvo. She had a box and out of the box of 5, she had three Abrysvo vaccines that had to be damaged out since caller believes there is an issue with the threading on the diluent syringe. States they have already been thrown away since had needles on them. There was patient involvement with only one of the three defective syringes. Caller states that she was not the pharmacist that administered that one, it was a different pharmacist that gave the patient the injection and when pulled away the needle, the needle came off the syringe and the needle stayed in the patients arm, the needle had to be pulled out manually. States the last defective Abrysvo vaccine was from today and she did save the antigen vial with the adapter but discarded the adapter packaging and does not have the diluent syringe since it was discarded in the sharps container in case quality would like to retrieve.  Causality for "issue with the threading on the diluent syringe/defective syringes/when pulled away the needle, the needle came off the syringe, and the needle stayed in the patient's arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).; Sender's Comments: Based on the given information, the Company confirms that the event foreign body is unrelated to the suspected drug RSV VACCINE PROT.SUBUNIT PREF 2V and most likely due to the device connection issue of the device component of the suspect drug (device malfunction).
Sex: M
Vaccine: COVID19
Symptoms: Cold urticaria, Illness
Clinical narrative: sick for awhile; was in the cold/broke out in welts; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A child male patient received BNT162b2 (BNT162B2), as dose 2 (orange cap), 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 (When he was 9 or 10, DOSE 1 (ORANGE CAP), SINGLE), for covid-19 immunization, reaction(s): "seemed okay". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick for awhile"; COLD URTICARIA (non-serious), outcome "unknown", described as "was in the cold/broke out in welts". Additional information: When patient was 9 or 10, he got his first Pfizer covid vaccine dose and he seemed okay. With the second dose (she doesn't know if he was given the adult or kid dose) he had a bad reaction; he was sick for a while and then a month later, when he was in the cold, he broke out in welts. Thought it could be related to his scarf so the next time he was out, he didn't have the scarf and he broke out in welts again.  The third dose the following year, he got the kid dose and he seemed okay with it. Reporter (patient's mom) wonders if he had gotten the adult dose with the second vaccination and that's why he had the reaction. He is scheduled to get the vaccine today but reporter would like for him to get the dose for children 5-11 years. Last year, the doctor said he should get the adult dose so he didn't get anything.  She wishes the dose could be tailored to weight, immune system and not just age.    Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: PNC20
Symptoms: Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: Patient had flu like symptoms (fatigue,chills and body aches); This is a spontaneous report received from an Other HCP from a sales representative.  A 53-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Patient had flu like symptoms (fatigue,chills and body aches)". It was unknown if therapeutic measures were taken as a result of influenza like illness.  Additional information: It was unknown whether patient receive any other vaccines on the same date and any other vaccines within 4 weeks prior to the Prevnar 20 vaccine. It was unknown whether patient taking any other medications within 2 weeks of the event starting.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: achiness; sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 26Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 26Nov2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Nov2024, outcome "recovering", described as "sore arm"; PAIN (non-serious) with onset 27Nov2024, outcome "recovering", described as "achiness". Therapeutic measures were not taken as a result of pain in extremity, pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the vaccines for which you are reporting. The patient was taking other medications within 2 weeks of the event starting. Sore arm and achiness.  The reporter became aware of sore arm yesterday and achiness today.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: tired; achy; sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 15-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 26Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 15 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, in 2024 as dose number unknown, single; ZOLOFT. The following information was reported: PAIN (non-serious) with onset 27Nov2024, outcome "recovering", described as "achy"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2024, outcome "recovering", described as "sore arm"; FATIGUE (non-serious) with onset 27Nov2024, outcome "recovering", described as "tired". Therapeutic measures were not taken as a result of fatigue, pain, pain in extremity.  Additional Information: It was reported that the patient did not receive any other vaccines on the same date as the suspect vaccine.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322309 same reporter/patient, different dose;
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Neoplasm malignant, Seizure, Triple negative breast cancer
Clinical narrative: seizure; Stage 3 TNBC; now since vaccination I have Cancer Stage 4; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2023 at 13:30 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrogen peroxide, reaction(s): "Known allergies: hydrogen proxide". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SEIZURE (hospitalization, disability, life threatening) with onset 01Feb2023 at 00:45, outcome "not recovered"; TRIPLE NEGATIVE BREAST CANCER (disability, life threatening) with onset 17Feb2023, outcome "not recovered", described as "Stage 3 TNBC"; NEOPLASM MALIGNANT (medically significant) with onset 2023, outcome "not recovered", described as "now since vaccination I have Cancer Stage 4". The patient was hospitalized for seizure (hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: Mammogram: (Oct2022) normal. Therapeutic measures were not taken as a result of seizure, triple negative breast cancer. Clinical course: Patient stated that she received the vaccination on 28Jan2023 and on 17Feb2023 she was diagnosed with Stage 3 TNBC she had a normal mammogram in Oct2022. She said that, nothing else occurred between Oct2022 and Feb2023 except the Pfizer vaccination she received in Jan2023. She also had a seizure that put her in the hospital. Known allergies: Latex and hydrogen peroxide. Other medical history: HIV and now since vaccination she had Cancer Stage 4 now.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: developed nearly fatal lung problems; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 25-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG DISORDER (life threatening), outcome "unknown", described as "developed nearly fatal lung problems". Reporter had two children. One was 25 and the other was 22. They both were forced to take the two shots from Pfizer or Moderna in order to finish their last couple of quarters. Both developed nearly fatal lung problems.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: developed nearly fatal lung problems; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 22-year-old patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single; Unknown manufacturer (Pfizer or Moderna)), for COVID-19 immunisation. The following information was reported: LUNG DISORDER (life threatening), outcome "unknown", described as "developed nearly fatal lung problems". Reporter had two children. One was 25 and the other was 22. They both were forced to take the two shots from Pfizer or Moderna in order to finish their last couple of quarters. Both developed nearly fatal lung problems. The reporter stated fear of forever future spike protein effects and shortening their lives.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400154871 same reporter/events, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: HSV2 outbreaks; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES SIMPLEX (non-serious), outcome "unknown", described as "HSV2 outbreaks".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event
Clinical narrative: pregnant female patient received vaccine with no adverse event; Initial information received on 18-Nov-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age pregnant female patient who received influenza vaccine and diphtheria, tetanus and acellular pertussis vaccine with no adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The gestation period at time of event onset was 29 and half weeks approximately. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  Concomitant medications included Levothyroxine for Thyroid disorder.  On 12-Oct of an unknown year, the pregnant female patient received an unknown dose of suspect diphtheria, tetanus and acellular pertussis vaccine and an unknown dose of suspect influenza vaccine both of which are produced by unknown manufacturer (formulation; strength; lot number; expiry date not reported) via unknown route in unknown administration site for Immunisation with no adverse event (exposure during pregnancy) (latency: same day).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.  Reportedly, on 18-Oct of an unknown year, the patient received COVID booster and on 25-Nov of unknown year at 12:30 PM, the patient (35 and half weeks pregnant) received abrysvo in right upper arm and 5 days later baby lost the  heartbeat.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 0.75
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Started as a rash on face and chest then spread to whole body; Initial information received on 23-Nov-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 9-month-old female patient who had rash on face and chest then spread to whole body after receiving vaccine influenza USP trival A-B subvirion NO preservative vaccine.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 04-Nov-2024, the patient received a Dose 1 of 0.5 ml of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (unknown strength and expiry date) with lot u8465ca via unknown route in unknown administration site for prophylactic vaccination (immunization)  On 05-Nov-2024 the patient had started as a rash on face and chest then spread to whole body (rash) (Latency 1 day) following the administration of influenza USP trival A-B subvirion NO preservative vaccine.  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 Recovered / Resolved on 13-Nov-2024 for the event.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally given expired TDAP vaccine with no reported AE; Initial information received on 21-Nov-2024 regarding an unsolicited valid  non-serious case received from a unknown reporter.  This case involves an unknown age / gender patient who received expired diphtheria, tetanus and acellular pertussis vaccine with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Nov-2024, the patient received an unknown dose of expired diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (formulation, strength, lot number not reported and expiry date- 04-Nov-2024) via unknown route in unknown administration site as prophylactic vaccination (Immunization) with no reported adverse event (expired product administered) (latency- same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  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: 7.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of ipol, max/low temperature reached: 1.6°CDuration: 6 hours & 21 with no reported adverse event; IPOL administered after a temperature excursion. Temp too cold for over 6 hours. Temp excursion not found until 11/6/24; Initial information received on 06-Nov-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 years old female patient (27 kg) and reporter reported temperature excursion of IPV (VERO) [IPOL], max/low temperature reached: 1.6°cduration: 6 hours & 21 minutes due to human error with no reported adverse event and IPOL administered after a temperature excursion, temp too cold for over 6 hours with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Oct-2024, the patient received a dose of 0.5 ml once suspect IPV (VERO) Suspension for injection (lot X1C891M, expiry date-31-OCT-2026) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) which was exposed to temperature excursion, max/low temperature reached: 1.6°cduration: 6 hours & 21 minutes due to human error with no reported adverse event (product storage error) and it was administered after a temperature excursion, temp too cold for over 6 hours with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, there was no previous excursion. Human error was involved. Temperature excursion not found until 06-Nov-2024.  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.  Additional information was received on 20-Nov-2024: case was upgraded to valid. Event (poor quality product administered) added. Text amended accordingly.   ; Sender's Comments:  US-SA-2024SA353538:master case
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: act-hib without the diluent is a powder and she doesn't know how that would be administered. with no adverse event; Initial information received on 21-Nov-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case was linked to other case US-SA-2024SA350448.  This case involves an unknown age and unknown gender patient and reporter stated that HIB (PRP/T) vaccine [ACT-HIB] without the diluent is a powder and she doesn't know how that would be administered with no adverse event.  The patient's past medical history, medical treatment(s), concomitant meidctaions, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunization without the diluent is a powder and she doesn't know how that would be administered. mis discussed and emailed use of alternate diluents with no ae (product preparation error) (latency same day)  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Caller stated a patient was administered ACTHIB without the diluent. What are the next steps to be taken. Vaccine coordinator states that she just conveyed what was reported to her but she was confused too because Act-HIB without the diluent is a powder and she doesn't know how that would be administered. MIS discussed and emailed Use of alternate diluents. HCP and MIS also mentioned.   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-2024SA350448:02315085
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: pentacel; dtap-ipv and act-hib given as separate components as an alternate explanation for report wording with no reported ae; Initial information received on 21-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to 2024SA350428.  This case involves, the patient with unknown age and gender reportedly received the suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], dtap-ipv and act-hib were given as separate components as an alternate explanation for report wording with no reported adverse event.  On an unknown date, the patient with unknown age and gender reportedly received the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (unknown strength, dosage, expiry, lot number and route) in unknown administration site for prophylactic vaccination reporter reported pentacel; dtap-ipv and act-hib given were given as separate components as an alternate explanation for report wording with no reported adverse event (product preparation error) (unknown latency).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, PENTACEL;DTaP-IPV and Act-HIB given as separate components as an alternate explanation for report wording.  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-2024SA350428:02315085
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: affected vials of Ipol administered with no reported adverse event; Initial information received on 22-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA352904.  This case involves an unknown age and unknown gender patient who had affected vials of  IPV (VERO) [IPOL]administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant mediations and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect IPV (VERO) (Suspension for injection) strength, expiry date, lot number not reported via unknown route in unknown administration site for Immunization and affected vials of ipol administered with no reported adverse event (poor quality product administered) (latency: same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  Reportedly "Our refrigerator might have been held open too long which is why we had an excursion to only 8.1 C for 6 minutes.  I feel that 0.1 is not a huge excursion.  Both Tubersol and Ipol were open and were given afterwards before we realized this happened. Does this fall into that category of minor and brief?  Will I need to call these 3 patients back for re-administration?The caller says she is okay to make the decision on her own as to whether the products need re-dosing."   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-2024SA352904:02316237
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inadvertently administered FLUZONE HIGH-DOSE for a second time this season, with no reported adverse event; Initial information received on 22-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 76 years old female patient who was inadvertently administered influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] for a second time this season, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Nov-2024, the patient received 0.5 ml of influenza USP trival A-B high dose subvirion vaccine of Suspension for injection in pre-filled syringe (strength- unknown, expiry date- 30-Jun-2025 and lot U8524CA) via unknown route in unknown administration site. On 10-Oct-2024 she also received 0.5 ml of same vaccine (lot U8524CA) once via intramuscular route in the left deltoid as Immunization with no reported adverse event (inappropriate schedule of product administration) (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.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered FLUZONE NP and FLUZONE HD, that was not formulated for the 2024-2025 flu season, to five patients/ vaccines were already expired, with no reported adverse event; Initial information received on 22-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had inadvertently administered INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE (Fluzone Np) and Influenza Usp Trival A-B High Dose Subvirion Vaccine (Fluzone Hd), that was not formulated for the 2024-2025 flu season, to five patients/ vaccines were already expired, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Usp Trival A-B Subvirion Vaccine (Suspension for injection) lot number not reported via unknown route in unknown administration site and also received a  dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot number not reported via unknown route in unknown administration site for all Prophylactic vaccination (Immunization) (Expiry date: 30-Jun-2024) (dosage, strength was unknown for both the suspects) and inadvertently administered fluzone np and fluzone hd, that was not formulated for the 2024-2025 flu season, to five patients/ vaccines were already expired, with no reported adverse event (expired product administered) (latency: same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.   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: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: metallic taste in her mouth; Initial information received on 22-Nov-2024 regarding an unsolicited valid  non-serious case received from patient.  This case involves a 73 years old female patient who had metallic taste in her mouth after receiving vaccine influenza USP trival A-B high dose subvirion vaccine [fluzone HD].  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 21-Nov-2024, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (unknown strength,lot and expiry date) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed metallic taste in her mouth (dysgeusia) (unknown latency) following the administration of influenza USP trival A-B high dose subvirion vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Consumer reported she had FLUZONE HD injection 21NOV2024 and now has a metallic taste in her mouth. She ask ed if Fluzone HD contained mercury. She asked if the metallic taste is a side effect of Fluzone HD and saw nurse practitioner today who told her it was side effect of Fluzone HD. She stated nurse practitioner was seen today and told consumer that the taste was side effect of Fluzone HD. She was told to chew gum and it would resolve itself. She stated she cannot taste her food and is very upset because if she were eating something bad she would not even know it. She will see another HCP on 05-DEC-2024.   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.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Product storage error
Clinical narrative: fluzone hd & fluzone npreason: unknown max/low temperature reached: lowest: 2.3°c; highest: 27.9°c unsuitable product administered with no ae; Initial information received on 22-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves, an unknown age and unknown gender patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] and INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] reason: unknown max/low temperature reached: lowest: 2.3°c (degree Celsius); highest: 27.9°c unsuitable product administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE Suspension for injection in pre-filled syringe and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection (unknown strength, dosage, expiry, lot number and route) in unknown administration site for prophylactic vaccination reportedly reason: unknown max/low temperature reached: lowest: 2.3°c; highest: 27.9°c unsuitable product administered with no adverse event (poor quality product administered) (unknown latency).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Temperature excursion: negative disposition and product used. Previous Excursion were none. Human error unknown and yes the product was administered post-excursion to at least 1 patient.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Hypersensitivity
Clinical narrative: allergy; voice is froggy; Initial information received on 22-Nov-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who had allergy and voice is froggy after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed allergy (hypersensitivity) and voice is froggy (dysphonia) (unknown latency) following the administration of influenza vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.
Age: 0.33
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE PFS administered to a 4-month-old with no reported adverse event; Initial information received on 26-Nov-2024 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves a 4 month old female patient who received influenza USP trival A-B subvirion NO preservative vaccine [fluzone] 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 beyfortus [nirsevimab] and RotaTeq [rotavirus vaccine live reassort oral 5V]  On 25-Nov-2024, the patient received 0.5 ml of suspect luenza USP trival A-B subvirion NO preservative vaccine Suspension for injection of standard strength with lot UT8514JA and expiry date 30-Jun-2025 via unknown route in unknown administration site for Immunization with no reported adverse event (product administered to patient of inappropriate age) (Latency same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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: FLU3
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: extra dose of fluzone np was given to an 11-week pregnant patient with no other reported adverse event; extra dose of fluzone np was given to an 11-week pregnant patient with no other reported adverse event; Initial information received on 26-Nov-2024 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves an unknown age female patient who was exposed to vaccine influenza USP trival A-B subvirion NO preservative vaccine [fluzone] in context of extra dose of fluzone NP was given to an 11-week pregnant patient with no other reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported extra dose of fluzone NP was given to an 11-week pregnant patient with no other reported adverse event occurred at 11 Weeks of pregnancy.   The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy.  On 16-Sep-2024, the 11-week pregnant patient received a Dose 2  of suspect INFLU influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (unknown strength) with lot UT8423AA and expiry date 30-Jun-2025 via unknown route in unknown administration site. On 16-Sep-2024 she also received a dose of vaccine with an unknown batch number with no other reported adverse event (exposure during pregnancy) (extra dose administered) (Latency same day)   There were no information relevant prenatal testing after exposure included   Additionally, at time of reporting, the outcome of the pregnancy is 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: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Infant irritability, Pyrexia, Vaccination site pain
Clinical narrative: Provider spoke w/MOC. Per MOC pt has been at her USOH since vaccination. Denies fevers/excessive fussiness/pain at vaccination site.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: The patient came in saying her arm is still sore from 11/29. The administering technician did mention she felt she had trouble pushing on the plunger to administer the IMZ as if it was kind of stuck so had to push a bit harder.   Patient will be monitoring herself and let us know how things are going since its been less than a week. Possible defect syringe?
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haematoma, Wrong technique in product usage process
Clinical narrative: Patient came to the pharmacy today 12/3 and showed me her arm. She said the pharmacist was rough when he administered the vaccine and did not use an alcohol pad. The next morning she had a hematoma. Her cardiologist told her what the massive bruise was.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Gait disturbance, Sensory disturbance, Syncope
Clinical narrative: Fainted, could not gather strength to walk on own, hands felt "funny", and difficulty catching breath.