chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patients were administered pediatric doses of Engerix-B.; adult patients were administered pediatric doses of Engerix-B.; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HBV (Engerix B pediatric) (batch number FP9TJ, expiry date 24-MAR-2025) for prophylaxis.   On 07-MAR-2024, the patient received Engerix B pediatric. On 07-MAR-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patients were administered pediatric doses of Engerix-B.) and adult use of a child product (Verbatim: adult patients were administered pediatric doses of Engerix-B.). The outcome of the underdose and adult use of a child product 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-05-APR-2024 The nurse reported that the adult patient received the pediatric dose of Engerix B vaccine which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. This case is 1 of the 3 cases reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024043623:Same reporter / different patient US-GSK-US2024043622:Same reporter/ diffrerent patient
Age: 68.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Administered a dose of Bexsero on 12 April 2024 , which had an expiration date of 31 March 2024; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 68-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 12-APR-2024, the patient received Bexsero. On 12-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Administered a dose of Bexsero on 12 April 2024 , which had an expiration date of 31 March 2024). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-APR-2024 The pharmacy technician reported that the patient was administered a dose of Bexsero which had an expiration date of 31 March 2024, which led to expired vaccine used. The reporter chatted in to ask if the patient will need to be revaccinated. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose of Shingrix on 05-FEB-2024 by error/ extra dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 07-MAY-2018) and Shingrix (received 2nd dose on 04-AUG-2018).   On 05-FEB-2024, the patient received the 3rd dose of Shingrix. On 05-FEB-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a third dose of Shingrix on 05-FEB-2024 by error/ extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-APR-2024 The patient's husband reported this case. He stated that his wife (patient) received a third dose of Shingrix by error, which led to an extra dose administered. The reporter did not consent to follow-up. This case is linked with US2024048876, reported by the same reporter.; Sender's Comments:  US-GSK-US2024048876:SAME REPORTER
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue
Clinical narrative: developed more fatigue than usual; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fatigue.   On 01-APR-2024, the patient received the 2nd dose of Shingrix (intramuscular). In APR-2024, more than 2 weeks after receiving Shingrix, the patient experienced fatigue (Verbatim: developed more fatigue than usual). The outcome of the fatigue was not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.   It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-APR-2024 The patient self reported this case. The patient stated she took the 2nd Shingrix vaccine and did not develop any symptoms until 14 days later. The reporter stated she only developed more fatigue than usual. The reporter would not give any information except for the date and the adverse event. Very minimal information was given. The reporter stated she would call back with more details after going to see her healthcare professional. The adverse event filed with minimal information. The permission for follow up was not granted.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: did not return for the second 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 44-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2015).   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: did not return for the second 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: 16-APR-2024 The patient did not return for the second dose. No exact vaccination date or lot number reported for the first dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to an incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose has not been administered 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 38-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2022). Concurrent medical conditions included immune system disorder.   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: Second dose has not been administered yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-APR-2024 The pharmacist reported that they have a patient with the recommended 2 to 6 months for her 2nd dose. The patient was unaware that she needed a 2nd dose of Shingrix. The pharmacist was wondering do they have to restart the regimen or could they give her one dose. The health care professional unable to provide batch/lot number. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to an incomplete course of vaccination.  The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: After first shot of Shingrix, patient totally forgot the second shot.; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first shot 2 to 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: After first shot of Shingrix, patient totally forgot the second shot.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-APR-2024  The field representative sent message about Shingrix: After first shot of Shingrix, the patient totally forgot the second shot. 2 to 3 years after first shot, the reporter asked does the patient need to start with first shot again. The vaccine administration facility was the same as primary reporter. That was a vCRM message no other detail was provided. The reporter consented to follow up. VAERS details provided for 1st dose.  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Alcohol test false positive
Clinical narrative: the patient had a patch and when the patch was removed on the 30th, it was positive for alcohol; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of alcohol test false positive in a 41-year-old male patient who received HAB (Twinrix) (batch number H7RF2) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number NR5DX) for prophylaxis.   On 15-MAR-2024, the patient received Twinrix and Boostrix. On 30-MAR-2024, 15 days after receiving Twinrix and Boostrix, the patient experienced alcohol test false positive (Verbatim: the patient had a patch and when the patch was removed on the 30th, it was positive for alcohol). The outcome of the alcohol test false positive was unknown.   It was unknown if the reporter considered the alcohol test false positive to be related to Twinrix, Twinrix Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the alcohol test false positive to be related to Twinrix, Twinrix Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device.   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: 17-APR-2024 A reporter called and informed that a patient had received Boostrix and Twinrix and according to reporter, the patient had a patch and when the patch was removed on the 30th, it was positive for alcohol. According to reporter, the patient mentioned that he had not consumed alcohol. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose 1 of Shingrix about 3 years ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   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: received dose 1 of Shingrix about 3 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-APR-2024 The reporter stated she received dose 1 of Shingrix about 3 years ago. She asked how effective will the vaccine be if she gets her second dose. Referred to healthcare professional . Medical information phone number offered with website information provided. Till the tome of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Tenderness
Clinical narrative: tender arm /arm was still a little sore; Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In DEC-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: tender arm /arm was still a little sore) and shingles (Verbatim: Shingles). The outcome of the pain in arm was not resolved and the outcome of the shingles was not reported.   It was unknown if the reporter considered the pain in arm and shingles to be related to Shingrix.     It was unknown if the company considered the pain in arm and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2024 The reporter called and stated that she had shingles vaccine about three months ago and her arm was still sore and tender, though not as bad as it was at one point.  This was her first dose in the series and she not yet had second dose.  The reporter was called to ask if this was common to still had arm soreness after several months.  She asked to remain anonymous.  The reporter stated that she was at work and had to get back, was unable to obtain any further information.  The reporter stated she would call back later.  The patient called to informed the following about Shingrix that she got it about 3 months ago, and her arm was still a little tender, shingles, arm was still a little sore from it 3 months later.  Because she had to get the 2nd dose. The patient said that she was uncertain if vaccine had been received in 28th December 2023 or 29th December 2023. The country of consumer was not confirmed during the call, as caller abruptly ended it. No further details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site pain
Clinical narrative: she developed pain at the injection site; Pain under left armpit; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-APR-2024, the patient received the 1st dose of Shingrix (left arm). In APR-2024, 24 hrs after receiving Shingrix, the patient experienced injection site pain (Verbatim: she developed pain at the injection site) and axillary pain (Verbatim: Pain under left armpit). The outcome of the injection site pain was not resolved and the outcome of the axillary pain was not reported.   It was unknown if the reporter considered the injection site pain and axillary pain to be related to Shingrix.     It was unknown if the company considered the injection site pain and axillary pain to be related to Shingrix.   Additional Information: GSK receipt date: 17-APR-2024 The reporter reported that the patient received Shingrix vaccine and within 24hours after, she developed pain at injection site and under left armpit. Spoke per content referred to health care professional. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: they administered Shingrix but fridge was out of temperature; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number G3P43, expiry date 31-JUL-2024) for prophylaxis.   On 28-FEB-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: they administered Shingrix but fridge was out of temperature). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 18-APR-2024 The pharmacist reported that, they administered Shingrix, but fridge was out of temperature, digital thermometer was giving random temperatures like below 0, vaccine was exposed to minus 2.2 Celsius supposedly which led to incorrect storage of drug. The vaccine was not frozen, no discoloration, it was crystal clear, did not had particles or anything that shows signs of damage. The patient did not feel anything unusual.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix is given via IM instead of SC injection; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 28-year-old female patient who received MMR (Priorix) (batch number L322P, expiry date 01-AUG-2024) for prophylaxis.   On 18-APR-2024, the patient received Priorix (intramuscular). On 18-APR-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix is given via IM instead of SC injection). The outcome of the subcutaneous injection formulation administered by other route 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: 18-APR-2024 The pharmacist asked for information about side effects if Priorix was given via intramuscular instead of subcutaneous injection which led to subcutaneous injection formulation administered by other route. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix stored out of range; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 2y, expiry date 17-MAY-2026) for prophylaxis.   On 17-APR-2024, the patient received Shingrix. On 17-APR-2024, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Shingrix stored out of range). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt date: 18-APR-2024 The reporter stated she went to one of their clinical sites on 16 April 2024 and discovered that vaccine fridge was set on coldest setting and the temperature was reading at minus 4 Celsius. She stated that facility had not documented a temperature recording since 05 April 2024, so she was unsure how long the temperature was out of range. There was a dose of Shingrix administered to patient which led to incorrect storage of drug. At the time of reporting, the dose had not been repeated. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024050075:same reporter US-GSK-US2024050076:Same reporter US-GSK-US2024050074:same reporter US-GSK-US2024050072:same reporter US-GSK-US2024050073:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: some of her pts got the first dose 7 years ago and have not gotten the 2nd; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 7 years ago from reporting).   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: some of her pts got the first dose 7 years ago and have not gotten the 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-APR-2024 The pharmacist asked did a patient had to restart the Shingrix series if they had not completed it within 2 to 6 months. The pharmacist reported, some of her patients got the 1st dose 7 years ago and had not gotten the 2nd which led to incomplete course of vaccination.  The pharmacist was wondering how to proceed with that. The vaccine administration facility was the same as primary reporter. VAERS details was reported for 1st dose.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Overdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number dc49g, expiry date 30-JUN-2024) for prophylaxis.   On 03-APR-2024, the patient received FluLaval Quadrivalent 2023-2024 season. On 03-APR-2024, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced accidental overdose (Verbatim: Overdose). The outcome of the accidental overdose 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: 18-APR-2024 The nurse reported that, the patient accidently got 2 doses of Flulaval with same lot and expiration date on the same day which led to accidental overdose.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: the child had only received the adjuvant without the antigen; the child had only received the adjuvant without the antigen; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 15-APR-2024, the patient received Menveo. On 15-APR-2024, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: the child had only received the adjuvant without the antigen). On an unknown date, the patient experienced inappropriate preparation of medication (Verbatim: the child had only received the adjuvant without the antigen). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-APR-2024 The reporter was the mother of the patient. The reporter reported that, the patient received what they believed was a Menveo vaccination.  The reporter received a phone call from the physician's office reporting that the patient had only received the adjuvant without the antigen which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  She went back on 18th April 2024 and received the appropriate dose.  The vaccine administration facility was the same as primary reporter.
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: After been inquired if a Patient got administered an expired vaccine,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-week-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 7D7RY, expiry date 25-FEB-2024) for prophylaxis.   On 07-APR-2024, the patient received the 1st dose of Rotarix lyophilized formulation. On 07-APR-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: After been inquired if a Patient got administered an expired vaccine,). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-APR-2024 The reporter was clinic Coordinator. The reporter was trying to see if there was extended expiration date on a Rotarix vaccine. After been inquired if a patient got administered an expired vaccine. The patient received expired vaccine of Roatrix, which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a physician via other company Sanofi and also from attorney. Documents were received in the form of legal documents and concerned a 64 year old female of unknown race and ethnicity.  The patient's height, and weight were not reported. The patient's concurrent conditions included: atopic dermatitis. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, Dose in Series 1, start therapy date were not reported for COVID-19 prophylaxis. Age at the time of vaccination was 64 year old. Non-company suspect drugs included: dupilumab (solution for injection, subcutaneous, batch number was not reported) 300 mg, 1 time every 2 weeks, from 06-SEP-2023 for atopic dermatitis. No concomitant medications were reported.  Legal documents included: It was reported that she was prescribed with Dupixent (dupilumab) because she developed antihistamine after she took the COVID vaccine and then had a rash from the COVID19 vaccine it was unknown if the patient experienced any additional symptoms/event. There were no lab details/results available. It was not reported if the patient received a corrective treatment for the event (had a rash from COVID vaccines). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable; and action taken with dupilumab was not reported. The outcome of rash was not reported. This report was non-serious.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Hib part of PENTACEL reconstitued with a Merck diluent with no reported adverse event; Initial information received on 17-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient and reporter reported hib part of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] reconstitued with a merck diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Apr-2024, the patient received 0.5 ml total of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ971AA) (Expiry date: 05-Nov-2024) (strength: standard) (Frequency: once) via unknown route in unknown administration site for immunization.  On 10-Apr-2024, the reporter reported hib part of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] reconstitued with a merck diluent with no reported adverse event (product preparation error) (latency: same day).  It was reported, Nurse inquired regarding stability data of the Hib part of PENTACEL reconstitued with a Merck diluent and asked for recommendations on how to proceed.  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: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: reports that ACT-HIB was reconstituted with sterile water and administered to a patient with no reported adverse event; reports that ACT-HIB was reconstituted with sterile water and administered to a patient with no reported adverse event; Initial information received on 17-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who was administered HIB (PRP/T) Vaccine [ACT-HIB] which was reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Apr-2024, the patient received a 0.5 ml dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as Immunization was reconstituted with sterile water with no reported adverse event (product preparation error) and (poor quality product administered) (Latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: FLU4, HEPA, IPV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reactions.  Pfizer Covid vaccine that was given was being kept in freezer at -25 C. per manufacturer vaccine is non viable.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, MENB, RV5, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 4 month old female given Trumenba vaccine instead of the Prevnar 20 vaccine. No known reactions at this time.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, MENB, RV5, MENB
Symptoms: Product administered to patient of inappropriate age, Vomiting, Wrong product administered
Clinical narrative: 4 month old female given Trumenba vaccine instead of the Prevnar 20 vaccine. No known reactions at this time.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient stated she had , " nausea, vomiting, and some dizziness" about 7 hours post administration of vaccine. Patient stated , "it resolved other than some nausea by the next day".
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired. No adverse effects noted.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine dose administered was expired. No adverse effects noted.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Mobility decreased, Pain, Swelling
Clinical narrative: redness, swelling, soreness, unable to move arm. Treatment: Detox bath, benadryl
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A reconciliation of immunizations was done prior to administering  HPV vaccine today in the clinic.  It showed that patient still needed his second and final HPV vaccine.  After immunization was administered today a new outside immunization needing reconciling showed up in EMR.  This was actually another HPV vaccine that he had received at Hospital departmenton 4/25/23.  Since this showed up after administration patient actually received a third HPV today.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Renal function test abnormal
Clinical narrative: Abnormal renal labs
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Sore throat, cough
Age: 59.0
Sex: F
Vaccine: FLU4, RSV, VARZOS
Symptoms: Injection site bruising, Injection site nodule, Injection site swelling
Clinical narrative: Bruise and raised knot on right deltoid (less than 1 inch above injection site).  Was not aware of it before injection and patient did not know if it was present before receiving vaccines.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash vesicular
Clinical narrative: Patient experienced a zoster like rash after getting Shingrix vaccine and had pain in her arm which could not be determined if it was from the vaccine or another cause
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 4/24 10pm Sister asked RN to check her left upper arm. Area was warm, red with rash measuring 6.0 cm x 7.5 cm , second area below first 3.2cm x 3.5cm. Sister stated area painful and itchy at times. Covid vaccine was given in left deltoid on Monday.   4/25 APNP note: 1. Erythema at injection site of COVID-19 vaccine Mild erythema and warmth along with itching to the left upper arm after receiving covid19 vaccine on 4/22/24. She does not appear to have cellulitis or significant allergic reaction. We discussed applying ice as needed, hydrocortisone 2.5% cream BID, and loratadine 10 mg PO daily prn. She will be monitored by nursing staff and they will update if symptoms persist or worsen.    4/27 Nurses note:  LUE with puffiness particularly above elbow. Has raised region ~ 0.75 cm diameter from s/p vaccination, has appearance of reversed "button" band-aide: ie center raised. Skin uniform in color, pink. Denies itching or pain (has chronic shoulder pain). Stated that scheduled hydrocortisone cream that was applied earlier was effective. L arm was measured for tubigrip on PM shift. Size D sleeve cut but Sister declined application at this time. Will wait until morning. Declined intervention for arm (ice/elevation). Strong radial pulse, able to use hands/fingers effectively and efficiently with normal/baseline dexterity. -
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: 4/24 10pm Sister asked RN to check her left upper arm. Area was warm, red with rash measuring 6.0 cm x 7.5 cm , second area below first 3.2cm x 3.5cm. Sister stated area painful and itchy at times. Covid vaccine was given in left deltoid on Monday.   4/25 APNP note: 1. Erythema at injection site of COVID-19 vaccine Mild erythema and warmth along with itching to the left upper arm after receiving covid19 vaccine on 4/22/24. She does not appear to have cellulitis or significant allergic reaction. We discussed applying ice as needed, hydrocortisone 2.5% cream BID, and loratadine 10 mg PO daily prn. She will be monitored by nursing staff and they will update if symptoms persist or worsen.    4/27 Nurses note:  LUE with puffiness particularly above elbow. Has raised region ~ 0.75 cm diameter from s/p vaccination, has appearance of reversed "button" band-aide: ie center raised. Skin uniform in color, pink. Denies itching or pain (has chronic shoulder pain). Stated that scheduled hydrocortisone cream that was applied earlier was effective. L arm was measured for tubigrip on PM shift. Size D sleeve cut but Sister declined application at this time. Will wait until morning. Declined intervention for arm (ice/elevation). Strong radial pulse, able to use hands/fingers effectively and efficiently with normal/baseline dexterity. -
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Fever, rhinorrhea, activity change
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Covid vaccine administered was expired. No adverse effects noted.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: severe itching from my head to my ankles
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Angiocardiogram, Laboratory test, Myocardial infarction, Thrombosis
Clinical narrative: Myocardial Infarction due by thrombosis causing full occlusion of RCA
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram head normal, Electrocardiogram, Full blood count normal, Gait disturbance
Clinical narrative: Sudden loss of balance while walking, staggering, leaning to the left. Next day leg muscle weakness. Weakness and difficulty with balance lasted 6 days.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Metabolic function test normal, Muscular weakness, Thyroid function test normal, Urine analysis normal
Clinical narrative: Sudden loss of balance while walking, staggering, leaning to the left. Next day leg muscle weakness. Weakness and difficulty with balance lasted 6 days.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Immunization not to be given to patients 7 and over.  No side effect, s/s of any problems noted.  Student discharged w/o incident.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Lymphadenopathy, Pain
Clinical narrative: Fever, stomach ache and diarrhea , body ache, tingling feeling on both hands, headache, painful arm, enlarged lymph nodes on the side of the vaccine site. The symptoms lasted for almsot five days.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Fever, stomach ache and diarrhea , body ache, tingling feeling on both hands, headache, painful arm, enlarged lymph nodes on the side of the vaccine site. The symptoms lasted for almsot five days.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Local reaction
Clinical narrative: Patient developed local site reaction.  Arm turned red below site of injection and began to spread starting the day after injection.  Patient described arm as itching and burning.  Patient has had adverse reaction to Shingrix injection previously.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash pustular, Scab
Clinical narrative: LARGE PUSTULAR RASH IN GROIN AREA. SCABBED OVER NOW BUT ITCHING.
Age: 1.42
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient came to this facility to receive 2nd menvo dose. The nurse informed mother of patient of vaccine that is to be administered, all vaccine questions were asked, vaccine was administered to patient.  Patient and mother left after their appointment. After leaving the patient and mother returned due to realizing that the patient had already received this vaccine in a different city at a different location. Provider notified, no concerns and no harm was done to patient.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Eyelid ptosis, Facial paralysis, Miller Fisher syndrome, Ophthalmoplegia, Speech disorder
Clinical narrative: notice symptoms right facial paralysis, speech, right eyes ptosis and paralysis. of  April 7th, 2024 after return from travel abroad   anx. concern regarding flu vacc receive in 3/02/2024 was admitted to hospital on 04/09/2024 and discharged ons 04/22/2024 Seen neurology, diag with Miller Fisher Syndrome during hospital admission
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Exposure via skin contact, No adverse event
Clinical narrative: after the vaccines were administered the vaccine roll over her skin with no reported AE; after the vaccines were administered the vaccine roll over her skin with no reported AE; Initial information received on 19-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient and it was reported that after the Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] and HIB (PRP/T) Vaccine [ACT-HIB] were administered the vaccine roll over her skin with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Apr-2024, the patient had received (dose and units unknown) (dose: 4) of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot number, strength and expiry date not reported) via unknown route in unknown administration site and on the same day the patient also received (dose and units unknown) (dose: 4) of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot number, strength and expiry date not reported) via unknown route in unknown administration site; both for immunization. Batch number was requested for this case.  On 18-Apr-2024 (latency same day) it was reported that after the HIB (PRP/T) Vaccine and Diphtheria-15/Tetanus/5 AC Pertussis Vaccine were administered the vaccine roll over her skin with no reported adverse event (accidental exposure to product) (exposure via skin contact).   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: 62.0
Sex: M
Vaccine: PPV
Symptoms: Spinal pain
Clinical narrative: Patient described "spinal pain" after administration of the vaccine. patient reported resolution of pain after 5 minutes without intervention (occurred during office visit).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: DVT's in leg
Age: 1.33
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received duplicate varicella vaccines on the same day unintentionally. Received both the Proquad combo vaccine and the Varivax. No side effects noted at time of this report since administration (4/29/24)
Age: 70.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Blood glucose decreased, Loss of consciousness
Clinical narrative: Patient said blood sugar dropped and he passed out.  EMS was called, gave glucose after noting BS was at approximately 40.  No hospitalization or ER visit or ambulance ride.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Hypersensitivity, Pain, Skin warm
Clinical narrative: Allergic reaction, warm to touch, some bruising , pain and sore.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Heart rate increased, Pain in extremity, Skin reaction
Clinical narrative: Allergic reaction, warm to touch, some bruising , pain and sore.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Hypersensitivity, Pain, Skin warm
Clinical narrative: PT EXPERIENCED REDNESS, SWELLING, HEAT AND PAIN IN THE ARM.  SHE SAID SHE ALSO EXPERIENCED A RAPID HEART RATE AND "HAD TO TAKE AN ADDITIONAL BLOOD PRESSURE TABLET.  SHE CONTACTED A NURSE PRACTITIONER VIA PHONE AND APPLIED A WARM COMPRESS TO THE AREA AND THE REACTION IS STILL VISIBLE BUT GETTING BETTER.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Heart rate increased, Pain in extremity, Skin reaction
Clinical narrative: PT EXPERIENCED REDNESS, SWELLING, HEAT AND PAIN IN THE ARM.  SHE SAID SHE ALSO EXPERIENCED A RAPID HEART RATE AND "HAD TO TAKE AN ADDITIONAL BLOOD PRESSURE TABLET.  SHE CONTACTED A NURSE PRACTITIONER VIA PHONE AND APPLIED A WARM COMPRESS TO THE AREA AND THE REACTION IS STILL VISIBLE BUT GETTING BETTER.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given Moderna booster in office today.  This was administered 1 day after the "best used by date" on the outside of the package.  Use by date was 4/24/24, and the vaccines was administered on 4/25/24.  Moderna has been contacted regarding the vaccine administration and we are awaiting their answer on how to proceed with the patient.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Single component of a two-component product administered
Clinical narrative: one component, ActHIB, of Pentacel was administered.
Age: 5.0
Sex: F
Vaccine: FLU4, HEPA, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reactions noted. Pfizer vaccine given was stored in -25 C.  Per manufacturer vaccine is non viable..
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Electric shock sensation, Facial pain, Paraesthesia, Pruritus, Rash
Clinical narrative: One week after receiving my first Shingrix vaccine (3/11/24) I began feeling a tingling sensation on the left side of my face. This progressed to itching, random electric shock sensations, and finally, by Friday 3/15/24 I had a bright red, raised, hot rash on the left side of my face. Intense itching and pain with any touch continued for 3 days. The most painful spots were around the left side of my left eye and the area just in front of my left ear (even the inside of my left ear itched). The rash slowly moved across my face to the right side, with a particularly sensitive spot at the top of my right cheekbone. The heat and itching subsided, but the painful areas around my left eye, the front of my left ear and the top of my right cheekbone remained sensitive for several weeks. I had small lesions scattered over my left face that scabbed over (and eventually fell off).  This process has repeated itself 4 times now, each episode being milder than the previous one (every week or 2). During the second "round" I experienced electrical shocks over my scalp on the left side of my head.I am due for my second Shingrix vaccine on 5/3/24 , and I will definitely NOT be getting it!
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash papular, Skin lesion, Skin warm
Clinical narrative: One week after receiving my first Shingrix vaccine (3/11/24) I began feeling a tingling sensation on the left side of my face. This progressed to itching, random electric shock sensations, and finally, by Friday 3/15/24 I had a bright red, raised, hot rash on the left side of my face. Intense itching and pain with any touch continued for 3 days. The most painful spots were around the left side of my left eye and the area just in front of my left ear (even the inside of my left ear itched). The rash slowly moved across my face to the right side, with a particularly sensitive spot at the top of my right cheekbone. The heat and itching subsided, but the painful areas around my left eye, the front of my left ear and the top of my right cheekbone remained sensitive for several weeks. I had small lesions scattered over my left face that scabbed over (and eventually fell off).  This process has repeated itself 4 times now, each episode being milder than the previous one (every week or 2). During the second "round" I experienced electrical shocks over my scalp on the left side of my head.I am due for my second Shingrix vaccine on 5/3/24 , and I will definitely NOT be getting it!
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blindness unilateral, Magnetic resonance imaging, Optic ischaemic neuropathy, Visual field tests
Clinical narrative: Upon waking up on Dec 12, I was unable to see out of the top half of my left eye. I was diagnosed with NAION on Dec 15th .  I am still unable to see out of my left eye .
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired. No adverse effects noted.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired. No adverse effects noted.