chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: a patient received a dose of Arexvy but it had been reconstituted with the wrong diluent,; a patient received a dose of Arexvy but it had been reconstituted with the wrong diluent,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number FK5AC, expiry date 23-MAR-2025) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: a patient received a dose of Arexvy but it had been reconstituted with the wrong diluent,) and inappropriate dose of vaccine administered (Verbatim: a patient received a dose of Arexvy but it had been reconstituted with the wrong diluent,). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-MAY-2024 The director of operations (other healthcare professional) called and requested on how to proceed after the patient received a dose of Arexvy but it had been reconstituted with the wrong diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked if the previous question was true what risks were present if a second dose was given and asked what would be the time frame that would be recommended in this scenario. They did clarify that there was a possibility that 1 patient out of 4 had been affected but were unsure as to whom and were also unsure about the vaccination date, stating it could have taken place between November 2023 and March 2024.  They provided data for the 4 patients and vaccine. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. This was 1 of the 4 cases, reported by the same reporter; Sender's Comments:  US-GSK-US2024060819:Same reporter / different patient US-GSK-US2024060821:Same reporter / different patient US-GSK-US2024060817:Same reporter / different patient
Sex: U
Vaccine: HIBV
Symptoms: Device connection issue, Incorrect dose administered, Product complaint, Syringe issue, Underdose
Clinical narrative: leaked out from the syringe connecting needle; leaked out from the syringe connecting needle; Product Complaint; Less than recommended dose administered/ if the patient got the vaccine most of it leaked out; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Hib (Hiberix) (batch number F45JY, expiry date 14-MAR-2026) for prophylaxis. This case was associated with a product complaint.   On 13-MAY-2024, the patient received the 3rd dose of Hiberix. On 13-MAY-2024, an unknown time after receiving Hiberix, the patient experienced incomplete dose administered (Verbatim: Less than recommended dose administered/ if the patient got the vaccine most of it leaked out). On an unknown date, the patient experienced syringe leak (Verbatim: leaked out from the syringe connecting needle), syringe connection issue (Verbatim: leaked out from the syringe connecting needle) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered, syringe leak, syringe connection issue and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 14-MAY-2024 The pharmacist calls because they had issues with Hiberix, the vaccine leaked out, they did not know if the patient got the vaccine, most of it leaked out from the syringe connecting needle, which led to incomplete dose administered. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: administered the adjuvant portion of the arexvy vaccine without the RSV vaccine component (lyophilized portion) obviously its not going to be efficacious; administered the adjuvant portion of the arexvy vaccine without the RSV vaccine component (lyophilized portion) obviously its not going to be efficacious; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 14-MAY-2024, the patient received Arexvy. On 14-MAY-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administered the adjuvant portion of the arexvy vaccine without the RSV vaccine component (lyophilized portion) obviously its not going to be efficacious) and inappropriate dose of vaccine administered (Verbatim: administered the adjuvant portion of the arexvy vaccine without the RSV vaccine component (lyophilized portion) obviously its not going to be efficacious). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-MAY-2024 Reporter reported that one of his or her site administered the adjuvant portion of the Arexvy vaccine without the RSV vaccine component (lyophilized portion), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Reporter said that obviously it was not going to be efficacious, and aske question that did they need to wait to be administered correct dilution of the product at a period of time or could they administered the dose at the time of reporting. Patient was not experiencing any side effects they left the clinic, and they realized it after that fact. The reporter did not consent to follow-up.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 3rd dose not received yet; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date) and Twinrix (received 2nd dose on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 3rd dose not received yet). 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: 14-MAY-2024 The Pharmacist reported that a patient received two doses of Twinrix and then had not seen for for four years. The reporter was asked to complete series they would just need to give them one more dose. The patient was not immunocompromised and had not received any other Hepatitis A or Hepatitis B vaccines since their initial 2 doses of Twinrix. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient got a first dose on December of this past year and didn't come in for his second dose in January; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (Patient received 1st dose of Twinrix in 01-DEC-2023 with batch number 7x224 and Expiry date 30-DEC-2025.).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Patient got a first dose on December of this past year and didn't come in for his second dose in January). 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: 15-MAY-2024 Pharmacist called and stated that the patient got a 1st dose of Twinrix on December 2023 and did not come in for his second dose of Twinrix in January. Till the time of reporting, the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product packaging issue, Product preparation issue
Clinical narrative: patients are only receiving the diluent for the Hiberix no separate vials; patients are only receiving the diluent for the Hiberix no separate vials; Product packaging issue/package insert laying over vial; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: patients are only receiving the diluent for the Hiberix no separate vials), inappropriate dose of vaccine administered (Verbatim: patients are only receiving the diluent for the Hiberix no separate vials) and product packaging issue (Verbatim: Product packaging issue/package insert laying over vial). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and product packaging issue were unknown.   Additional Information: GSK Receipt Date: 16-MAY-2024 The reporter reported that the Healthcare Medical group was now receiving the Hiberix vaccine that has a syringe with diluent and a medication/powder vial. In the past, we received the 2-vial packaging of Hiberix that we banded together for safety purposes. Since the transition, we have had multiple events reported where patients are only receiving the diluent for the Hiberix as the staff was not seeing the separate vial (various reasons, package insert laying over vial, etc.) which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered and product packaging issue. Was there a possibility that the packaging can be updated so the syringe and vial are joined/banded as in the 2 vial HIB packaging and a reminder inside of the package for reconstituting the medication. In the meantime, they would be re-educating, labeling all packages with a reminder to reconstitute and 1:1 education as needed.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: he had one shot on February 25th of 2022.According to reporter, the patient had not received the 2nd shot yet.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received 1st dose of Shingrix vaccine in 25-FEB-2022).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: he had one shot on February 25th of 2022.According to reporter, the patient had not received the 2nd shot yet.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2024 The reporter informed he/she had a patient interested in getting a vaccine of Shingrix, he had one shot on 25th February 2022. The patient had not received the 2nd shot yet. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. VAERS details reported for 1st dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 3rd July 2020 received 1st dose). Additional patient notes included Patient was immunocompetent.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2024 A pharmacist reported that there was an immunocompetent patient who received Shingrix first dose on 30 July 2020 and she had never received second dose.  The vaccine administration facility was the same as primary reporter. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hepatitis B administered 8 moths; Hepatitis B administered 3 moths; This spontaneous report has been received from a physician, regarding to a 3 months old, female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 23-JUN-1999, when the patient had days, she was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), then when the patient had 3 moths (Inappropriate schedule of product administration), she was vaccinated with the second dose, then when she had 8 moths (Inappropriate schedule of product administration), she was vaccinated wit the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB)(strength, dosage, route of administration, anatomical site of injection, vaccination scheme frequency, lot number and expiration date were not reported).; Sender's Comments:  US-009507513-2310USA011548:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2024) Negative; (May2024) Negative; (May2024) Positive, notes: testing positive for the past week. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 01May2024 to 05May2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got COVID in April 2024. I am on the recovery end.; I got COVID in April 2024. I am on the recovery end.; This is a spontaneous report received from a Consumer or other non HCP and a Nurse, Program ID.  A 41-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxil, reaction(s): "Drug allergy", notes: 10 MG TABLET. Vaccination history included: Flucelvax quad 2022-2023 (Dose number unknown), for IMMUNISATION.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "recovered" and all described as "I got COVID in April 2024. I am on the recovery end.".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever of 101/100; Headache; body aches; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15May2024 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 15May2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 15May2024, outcome "not recovered", described as "body aches"; HEADACHE (non-serious) with onset 16May2024, outcome "not recovered"; PYREXIA (non-serious) with onset 16May2024, outcome "not recovered", described as "fever of 101/100". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, pain. Additional information:Caller stated that she wanted to report some side effects her husband and her got the Covid and RSV shot. Both are sick. His fever is 101. He has a headache and body aches. The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400109351 same reporter/drug, different petients;
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Polycythaemia vera" (unspecified if ongoing); "Known allergies: Sulfate" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset Apr2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Apr2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 30Apr2024 to 04May2024. Clinical course: Patient took other medications within 2 weeks of Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Muscular weakness, Myalgia, Peripheral coldness
Clinical narrative: Cold feet; muscle aches; headache; exreme muscle weakness persisting for 7 days after injection; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 09May2024 at 11:00 as unk, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Phlebitis" (unspecified if ongoing); "type II diabetes" (unspecified if ongoing); "hyperparathyroid disease" (unspecified if ongoing); "depression" (unspecified if ongoing); "wheat allergy" (unspecified if ongoing); "Cats allergy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Erythromycin, reaction(s): "Hypersensitivity". The following information was reported: PERIPHERAL COLDNESS (non-serious) with onset 09May2024 at 19:00, outcome "recovering", described as "Cold feet"; MUSCULAR WEAKNESS (non-serious) with onset 09May2024 at 19:00, outcome "recovering", described as "exreme muscle weakness persisting for 7 days after injection"; HEADACHE (non-serious) with onset 09May2024 at 19:00, outcome "recovering"; MYALGIA (non-serious) with onset 09May2024 at 19:00, outcome "recovering", described as "muscle aches". Therapeutic measures were not taken as a result of peripheral coldness, myalgia, headache, muscular weakness. Additional information: The patient has not received other vaccines on the same date as the vaccine. The patient has not received other vaccines within 4 weeks prior to the vaccine. The patient was taking any other unspecified medications within 2 weeks of the event starting. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An adult female 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Pt alleges the immunization was given too high on the arm and she believes she has developed SIRVA
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Gaze palsy, Loss of consciousness, Muscle twitching, Seizure like phenomena
Clinical narrative: Pt had seizure like activity a few minutes after receiving vaccine. Eyes rolled back into her head and slight twitching. Episode lasted about a minute before patient came too. She did not want medical treatment and left on her on accord.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia, Rash, Rash pustular
Clinical narrative: Patient reported back to our pharmacy on 5/20 and was showing signs of what appeared to be a shingles infection. I referred her to her provider, she said that her pulmonologist suggested she get the vaccine so I referred her to him or her pcp. She had a pustular rash on left leg and numbness and tingling in her left arm and hand/fingers.
Age: 86.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: the patient received an extra dose due to the fact that the patient was unaware that they had all ready received the vaccine at a different pharmacy. patient has not reported any adverse effect to the pharmacy due to the additional dose yet and the doctor was contacted and made aware.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site, Sleep disorder
Clinical narrative: Pt is experiencing spasm-like pain (veracitis) during everyday-activities with her left arm. This pain occurs specifically when she is reaching up. She can no longer sleep with her arm underneath her pillow. She waited a few months until her annual checkup to let her doctor know about this pain, as she thought it would go away naturally. They suggested that the vaccine might have been given too high up.
Age: 18.0
Sex: M
Vaccine: HEP, MENB
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Hepatitis B was inadvertently given to patient. The patient had no symptoms or side effects from the inadvertent dose.
Age: 49.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Night sweats
Clinical narrative: Donor came in and presented with abnormal reaction to vaccine on 05/20/2024. Donor had redness, itching and swelling 1- 1 1/2 inches around vaccine site forming a large circle, along with some redness spreading 3 to 4 inches to anterior of right arm from vaccine site in the shape of a line about half an inch to an inch thick. Donor states that he had some night sweats Friday 05/17 and Saturday 05/18, night sweats stopped on 05/19 and donor states that he took Nyquil Saturday night to help sleep. Donor denies any other symptoms or illness. Donor called in on 05/20/2024 and confirmed after he went to see doctor and stated that he does have cellulitis and his doctor prescribed Prednisone for 5 days and Doxycycline for 10 days.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NO SYMPTOMS. ONLY HAD COVID 198 (PFIZER) FOR 6 MONTHS TO 5YR OLD ON HAND.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NO SYMPTOMS. ONLY HAD COVID 19 (PFIZER) FOR 6MO TO 5YR OLD. ON HAND.
Age: 50.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site warmth, Palpitations, Pruritus
Clinical narrative: Patient stopped by tonight and described an adverse event that occurred after his vaccination. He reported the next day Sunday he had a fever of 103, sweating, heart racing 127bpm, itching all over,. He did dr appt, took zyrtec for itching, execdrin then changed to tylenol for fever and itching, His fever broke later that day to 99. Today he is fever free and has redness and a little warm to the touch at injection site. He will stop by tomorrow to reevaluate the injection site to see if improving. He has had shingles previously.
Age: 50.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient stopped by tonight and described an adverse event that occurred after his vaccination. He reported the next day Sunday he had a fever of 103, sweating, heart racing 127bpm, itching all over,. He did dr appt, took zyrtec for itching, execdrin then changed to tylenol for fever and itching, His fever broke later that day to 99. Today he is fever free and has redness and a little warm to the touch at injection site. He will stop by tomorrow to reevaluate the injection site to see if improving. He has had shingles previously.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Eye pain, Flatulence
Clinical narrative: Unknown treatment. Addressed previous page.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Lethargy, Nausea, Pain in jaw
Clinical narrative: Unknown treatment. Addressed previous page.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Primary stabbing headache, Somnolence, Tremor
Clinical narrative: Unknown treatment. Addressed previous page.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: swelling distal joint fourth finger
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Patient went into Atrial Fibrillation that required hospitalization and an emergency room visit from 09/21/23, 09/23/23-09/24/23.
Age: 4.0
Sex: U
Vaccine: HEPA, PNC15, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/no PQC.; VAXNEUVANCE series was delayed as it was administered today outside of the recommended pediatric timeframe per prescribing information; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 17-MAY-2024, the patient was inadvertently vaccinated with an additional dose of hepatitis a vaccine, inactivated(VAQTA), an additional dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS), and the fourth dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) was delayed as it was administered today outside the recommended pediatric timeframe per the prescribing information (inappropriate schedule of product administration), (dose, route, anatomical location, lot number and expiration date were not reported for all suspect vaccines) all vaccines as prophylaxis. No additional adverse events reported.
Sex: U
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL was administered to at least four patients post excursion with no reported adverse event; Initial information received on 13-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves  4 patients of unknown age/gender patient who received punctured IPV (VERO) [IPOL] post excursion 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 patients received a  dose of suspect IPV (VERO), suspension for injection (lot W1B511M and expiry 08-SEP-2025; Lot: W1C751M, Expiration date: 18NOV20) (dose, strength: unknown) (poor quality product administered) (latency same day) via unknown route in unknown administration site for prophylactic vaccination (immunization).  Reportedly:- Two temperature excursions from two clinics. Please see details below. The first clinic temperature reached a minimum 34.38 F and the total excursion lasted 30 minutes. This excursion was due to an UNKNOWN cause. The punctured IPOL was administered to at least four patients post excursion. The patient specific information was not available at the time of the call. The 2nd clinic temperature reached 33.31 F and the total excursion lasted approximately 30 minutes due to a fridge malfunction. The punctured IPOL had not been administered post excursion.   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: MEN
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: administration of menquadfi to a patient subcutaneously instead of intramuscularly with no reported adverse event; Initial information was received on 13-May-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered subcutaneously instead of intramuscularly 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 an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot number, expiry date, strength, was unknown) via subcutaneous route in unknown administration site for Immunization and administration of menquadfi to a patient subcutaneously instead of intramuscularly with no reported adverse event (incorrect route of product administration) (Latency: same day). The information on the batch number was requested.  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: 26.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: a patient received a dose of YF-VAX intramuscularly instead of the intended subcutaneous route of administration with no reported adverse event; Initial information received on 14-May-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 26 years old female patient where patient received a dose of yellow fever vaccine - [YF-VAX] intramuscularly instead of the intended subcutaneous route of administration 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 typhoid vaccine (typhim) for Prophylactic vaccination.  On 13-May-2024, the patient received 0.5 ml dose of suspect yellow fever vaccine - US Solution for injection (lot- UK031AA and expiry- 31-Mar-2025) via intramuscular route in unknown administration site (Frequency- once, Strength- standard) for Immunisation (incorrect route 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.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: 3-month-old baby was only given the liquid component of PENTACEL without the lyophilized vaccine, with no reported adverse event; Initial information received on 15-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old male patient who was only given the liquid component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] without the lyophilized vaccine, 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 ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 14-May-2024, the patient was only given the liquid component of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection at dose 0.5 ml (lot UJ973AA; Expiration date:19-Nov-2024) via intramuscular route in the left thigh (left leg) without the lyophilized vaccine, with no reported adverse event (single component of a two-component product administered) (latency: on same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event
Clinical narrative: inadvertently administered PENTACEL liquid component only to patient with no reported adverse event; Initial information received on 15-May-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 6 months old and unknown gender patient who inadvertently administered diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] liquid component only to patient 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 diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (product preparation error)  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: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: giving a 5 year old an inadvertent dose of boostrix instead of kinrix; giving a 5 year old an inadvertent dose of boostrix instead of kinrix; Accidental underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: giving a 5 year old an inadvertent dose of boostrix instead of kinrix), inappropriate age at vaccine administration (Verbatim: giving a 5 year old an inadvertent dose of boostrix instead of kinrix) and accidental underdose (Verbatim: Accidental underdose). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and accidental underdose 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: 10-MAY-2024 The practical nurse called related to a medical assistant who gave a 5 year old patient an inadvertent dose of Boostrix vaccine instead of Kinrix vaccine. The patient was up to date with his vaccines. The nurse did not have vaccine lot number or expiration date at hand but agreed for follow up.  The vaccine administration facility was the same as primary reporter. The patient received Boostrix instead of Kinrix, which led to wrong vaccine administered and inappropriate age at vaccine administration, and accidental underdoes.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received three doses back in 2022 suppose to come back but came in today wanting the last fourth dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 26-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 20th May 2022), Twinrix (2nd dose received on 27th May 2022) and Twinrix (3rd dose received on 10th June 2022).   On an unknown date, the patient did not receive the 4th dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received three doses back in 2022 suppose to come back but came in today wanting the last fourth dose). 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: 14-MAY-2024 The reporter called to inquire how to proceed with Twinrix Series, was it too late for the fourth dose. The reporter reported that a patient was on the accelerated dosing schedule of Twinrix and received three doses back in 2022. The patient was supposed to come back but came on the day of reporting wanting the last fourth dose. Till the time of reporting, the patient did not receive the 4th dose of Twinrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given Influenza vaccine to early by mistake. No adverse reaction.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Cough, Headache, Hypertension
Clinical narrative: PATIENT REFERS THAT AFTER THE SECOND DOSE OF THE COVID VACCINE SHE KEEPS GETTING SICK CONSTANTLY. SHE REFERS THAT EVERY MONTH SHE CONTRACTS A DIFFERENT VIRUS THAT CAUSES SEVERE COUGH, WHOLE BODY DEBILITY AND OTHER RESPIRATORY PROBLEMS, SUCH AS SEVERE ASTHMA. SHE HAS BEEN EVALUATED AND TREATED BY A PNEUMOLOGIST WITHOUT ACHIEVING GETTING BETTER. ALSO, HER BLOOD PRESSURE HAS BEEN HIGH AND SHE REFERS HER MEDICATION IS NOT WORKING ANYMORE, HAVING HEADACHES CONSTANTLY.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of therapeutic response, Malaise, Respiratory disorder, Viral infection
Clinical narrative: PATIENT REFERS THAT AFTER THE SECOND DOSE OF THE COVID VACCINE SHE KEEPS GETTING SICK CONSTANTLY. SHE REFERS THAT EVERY MONTH SHE CONTRACTS A DIFFERENT VIRUS THAT CAUSES SEVERE COUGH, WHOLE BODY DEBILITY AND OTHER RESPIRATORY PROBLEMS, SUCH AS SEVERE ASTHMA. SHE HAS BEEN EVALUATED AND TREATED BY A PNEUMOLOGIST WITHOUT ACHIEVING GETTING BETTER. ALSO, HER BLOOD PRESSURE HAS BEEN HIGH AND SHE REFERS HER MEDICATION IS NOT WORKING ANYMORE, HAVING HEADACHES CONSTANTLY.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient was to receive Pfizer Comirnaty (2023-2024) 0.3ml IM; patient was administered Pfizer 6m-4y (2023-2024) 0.3ml, undiluted IM right deltoid by LPN; the event was discovered by nursing supervisor during routine chart audit and inventory count; notification of event escalated to nursing/department management and risk management for review
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Red, warm, large tender welt around vaccine site approx 2inx4in on deltoid, with a 1inch red streak extending from it towards axilla
Age: 1.17
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC15, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PHN inadvertently gave MMRV and Var. Patient was to receive MMR and Var. As soon as the mistake was caught PHN called her supervisor and reported the error. PHN immediately informed the father, who was present at the time of the vaccinations. PHN explained to the parent what to expect and the worst-case scenario. PHN called the local pediatrician, Dr., and asked questions about Tylenol and Motrin doses and times. Dr was very informative. PHN then reached out to the parent of the client and was able to inform parent of all that Dr. shared with the PHN. PHN then reached out to CDC about the double dose of Var. that the patient had received. CDC was able to educate the PHN on the double dose of Var. and then the PHN was able to inform the parent of the patient able the education that was received from CDC. By late afternoon on Monday 5/20/2024, PHN called the parent and the parent reported that the patient was doing great and denied any fever at his time. On the morning of Tuesday 5/21/2024, PHN called the parent and the parent again stated that the patient was doing great and denied any fever at this time.
Age: 1.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product preparation error
Clinical narrative: Powder part of the vaccine (ActHib) mixed with sterile water. Liquid part of vaccine (Dtap/IPV) not used. Patient only received the ActHib part of the vaccine
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Dyspnoea, Erythema, Pain, Pruritus, Swelling
Clinical narrative: day 1: pain, swelling; day 4: pain, swelling, itching, redness, shortness of breath; tx at ER for hives
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: day 1: pain, swelling; day 4: pain, swelling, itching, redness, shortness of breath; tx at ER for hives
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: Patient stated that her arm was hurting until  5/16 and then the pain went away and she started feeling heat all over and throughout her body. She attributes this to the vaccine and wanted it reported. Patient reported this info on 5/20 in the evening around 6:15PM. Patient stated she was going to the urgent care.
Age: 70.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Pyrexia, White blood cell count decreased
Clinical narrative: patient received both vaccines in the same arm and the next day went to the hospital emergency department.. she had a fever of about 101 and the white blood cell count was low.. she was not admitted and was released home the same day.. her primary doctor had her go for blood work 2 weeks later and the white blood cell count was back to normal.. patient did get the pfizer covid shot in the past and this was the first rsv shot she received
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Patient had arm pain starting at administration  and developed rash soon thereafter.  Later that day she noted that the arm was very sore and the pain radiated down the arm.  The pain has since subsided.  She could not place at what point the rash initially developed.  The arm still appears red and swollen at the injection site.  She states that it itches at times but it did not itch when she was in the pharmacy.  She did note that she thought that the redness had worsened since last night. We are now 7 days post immunization.
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Patient had arm pain starting at administration  and developed rash soon thereafter.  Later that day she noted that the arm was very sore and the pain radiated down the arm.  The pain has since subsided.  She could not place at what point the rash initially developed.  The arm still appears red and swollen at the injection site.  She states that it itches at times but it did not itch when she was in the pharmacy.  She did note that she thought that the redness had worsened since last night. We are now 7 days post immunization.