chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16-year-old patient was inadvertently administered FLUBLOK with no reported adverse event; Initial information received on 28-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an Influenza Trivalent Recombinant Vaccine [Flublok TIV] was administered to a 16-year-old patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 26-Oct-2024, the patient received a dose of 0.5 ml of suspect Influenza Trivalent Recombinant Vaccine (Solution for injection) lot U8432AA, Expiry date: 30-Apr-2025, strength was unknown via intramuscular route in the left deltoid for Immunization and flublok was administered to a 16-year-old patient with no reported adverse event (product administered to patient of inappropriate age) (latency : same day)."  Reportedly "This situation is reported as a misuse as per local labelling due to administering dose of FLUBLOK to a patient whose age is not approved for in prescribing information."   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: 4.0
Sex: U
Vaccine: TD
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of TENIVAC to a 4-year-old patient with no reported adverse event; Initial information received on 28-Oct-2024 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves a 4 years old and unknown gender patient who received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] 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 4 year old patient received an unknown dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, RN (registered nurse) declined to provide information of the patient and administered dose.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Exposure via skin contact, Needle issue, No adverse event, Underdose
Clinical narrative: the patient received a partial injection with no adverse event; accidental exposure as the needle hub came off and the vaccine sprayed out onto the patient with no adverse event; Initial information received on 28-OCT-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was administered partial injection with no adverse event and accidental exposure as the needle hub came off and the vaccine sprayed out onto the patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE  Suspension for injection (unknown strength, dosage, expiry,lot number and route) in unknown administration site for prophylactic vaccination was administered partial injection with no adverse event (medication error) and accidental exposure as the needle hub came off and the vaccine sprayed out onto the patient with no adverse event (accidental exposure to product) (unknown latency).  Reportedly, Nurse stated 4 month old was being administered PENTACEL and moved. The needle hub came off and the vaccine sprayed out onto the patient and the patient received a partial injection.   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: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL (Punctured) Reason: power outage Max/low temperature reached: 11.9 C Duration: 2 hrs and 14 mins Previous Excursion? YESOn 03OCT - max 9.2 C for 21 mins On 27SEP -  max 8.3 C for 5 mins/product was administarted with no reported adverse event; Initial information received on 28-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who had administrated IPV (VERO) [IMOVAX POLIO](punctured) reason: power outage max/low temperature reached: 11.9 c duration: 2 hrs and 14 mins previous excursion? yeson 03oct - max 9.2 c for 21 mins on 27sep -  max 8.3 c for 5 mins/product was administarted with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect IPV (VERO) (suspension for injection) lot W1C751M, Expiry date: 18-Nov-2025, strength was unknown via unknown route in unknown administration site for Immunization and ipol (punctured) reason: power outage max/low temperature reached: 11.9 c duration: 2 hrs and 14 mins previous excursion? yeson 03oct - max 9.2 c for 21 mins on 27sep -  max 8.3 c for 5 mins/product was administarted with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly "Human error? NO Administered? YES. Sometime after 27SEP  Does extended stability data cover the excursion? NO.Nurse stated they had a provider gave a patient IPOL that was exposed to an excursion with a negative disposition."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Administered post excursion? Yes, the products have been administered post excursion since they recently discovered the excursion with no reported adverse event; Initial information received on 29-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA315643 (Master case).  This case involves an unknown age female patient who was administered IPV (VERO) [IMOVAX POLIO] post excursion? yes, the products have been administered post excursion since they recently discovered the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect IPV (VERO) (suspension for injection) lot X1C891M, Expiry date: 20-Oct-2026, strength was unknown via unknown route in unknown administration site for Immunization and administered post excursion? yes, the products have been administered post excursion since they recently discovered the excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly "The remaining inquiries were submitted to PV since the products were not supported by the extended stability information post excursion and had been administered to patients.Max/low temperature reached: 13 Duration: 6 hours Previous Excursion? No Human error? UNKNOWN.6 patients have received IPOL 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.; Sender's Comments:  US-SA-2024SA315643:Master
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: the products have been administered post excursion since they recently discovered the excursion with no reported adverse event; Initial information received on 29-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA315643 (Master case).  This case involves an unknown age female patient who was administered IPV (VERO) [IMOVAX POLIO] since they recently discovered the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect IPV (VERO) (suspension for injection) lot X1C891M, Expiry date: 20-Oct-2026, strength was unknown via unknown route in unknown administration site for Immunization and administered post excursion since they recently discovered the excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, Max/low temperature reached: 13 Duration: 6 hours Previous Excursion was none. Human error was unknown.6 patients have received IPOL 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.; Sender's Comments:  US-SA-2024SA315643:master case
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: the products have been administered post excursion since they recently discovered the excursion with no reported adverse event; Initial information received on 29-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA315643 (Master case).  This case involves an unknown age male patient who was administered IPV (VERO) [IMOVAX POLIO] since they recently discovered the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect IPV (VERO) (suspension for injection) lot X1C891M, Expiry date: 20-Oct-2026, strength was unknown via unknown route in unknown administration site for Immunization and administered post excursion since they recently discovered the excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, Max/low temperature reached: 13 Duration: 6 hours Previous Excursion was none. Human error was unknown.6 patients have received IPOL 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.; Sender's Comments:  US-SA-2024SA315643:master case
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: patients received Fluzone Hd that was not to be used according to Vaxserve's determination about a shipping excursion with no reported adverse event; Initial information received on 29-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] that was not to be used according to vaxserve's determination about a shipping excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of Suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot U8524DA, Expiry date: 30-Jun-2025, strength was unknown via unknown route in unknown administration site for Immunization and patients received fluzone hd that was not to be used according to vaxserve's determination about a shipping excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly "Pharmacy manager asking if a FLUZONE HD needs to be readministered.She stated it experienced a shipping temperature excursion and Vaxserve instructed them not to use the product as a result.However, the caller is asking if it was administered, do they need to give it again."   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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Immune thrombocytopenia, Myocarditis
Clinical narrative: Shingles, Myocarditis, ITP
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: pain everywhere; nausea; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-OCT-2024, the patient received the 1st dose of Shingrix (left arm). In OCT-2024, 3 hrs after receiving Shingrix, the patient experienced general body pain (Verbatim: pain everywhere), nausea (Verbatim: nausea) and headache (Verbatim: headache). The outcome of the general body pain, nausea and headache were unknown.   It was unknown if the reporter considered the general body pain, nausea and headache to be related to Shingrix.     It was unknown if the company considered the general body pain, nausea and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-OCT-2024 The reporter was the patient who received her Shingrix the day before reporting. She reported that headache, nausea, and pain everywhere which started 3 hours after the dose. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 37-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 11-JAN-2024).   On 12-SEP-2024, the patient received the 2nd dose of Engerix B. On 12-SEP-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: inappropriate schedule of vaccine). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 21-OCT-2024 The reporter did not consent to follow-up. The patient received 2nd dose of Engerix-B later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired Flulaval vaccine from last season was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 39pf2, expiry date 30-JUN-2024) for prophylaxis.   On 18-OCT-2024, the patient received FluLaval Quadrivalent 2023-2024 season. On 18-OCT-2024, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced expired vaccine used (Verbatim: expired Flulaval vaccine from last season was administered to a patient). 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: 21-OCT-2024 The reporter called to report an expired Flulaval vaccine from last season was administered to a patient, which led to expired vaccine used. The reporter consented to follow up via email.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Maladministration of Engerix-B After the Expiration Date; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 35-year-old female patient who received HBV (Engerix B) (batch number ZY7D9, expiry date 12-AUG-2024) for prophylaxis.   On 24-OCT-2024, the patient received the 3rd dose of Engerix B. On 24-OCT-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Maladministration of Engerix-B After the Expiration Date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 25-OCT-2024 Pharmacist reported that a patient received by error Engerix-B after the expiration, which led to expired vaccine used. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix vaccine was administer to two patients of 2 YO; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 25A2S, expiry date 19-JAN-2026) for prophylaxis.   On 04-SEP-2024, the patient received the 1st dose of Boostrix. On 04-SEP-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix vaccine was administer to two patients of 2 YO). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 25-OCT-2024 The reporter called about that he/she guessed a mistake that was made by a staff member, they had given a Tdap (Boostrix) to two-year-old, they were set of twins, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2024133101, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024133101:Same reporter/Different patient
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the administration of Kinrix to a 27 month-old patient; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 27-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 16-OCT-2024, the patient received Kinrix. On 16-OCT-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: the administration of Kinrix to a 27 month-old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-OCT-2024 A physician reported the administration of Kinrix to a 27 month-old patient, which led to inappropriate age at vaccine administration and patient had not reported adverse reactions. The reporter mentioned that Kinrix was given as catch-up dose for the Dtap series.  The physician asked for recommendations on this situation. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Extra dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 28-Nov-2023).   On 22-OCT-2024, the patient received the 2nd dose of Arexvy. On 22-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 25-OCT-2024 The reporter reported the following that he/she had a question regarding the Arexvy vaccine, he/she was wondering, asked any data like if a patient would receive 2 of the vaccines about a year apart. The reporter just wanted to confirm for the Arexvy vaccine, was that's a onetime dose. During the conversation, she also asked about any side effects for a duplicate dose, we asked her if this was related to a patient and she agree to this.  The reporter provided patient information and she mentioned that the 2nd dose was administer in a different place that her zip code (the vaccine was administered in a pharmacy). The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: AREXVY second dose administration; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose in 2023).   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: AREXVY second dose administration). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 25-OCT-2024 Anonymous female member of the public called to mention that last year received a first dose of Arexvy and this year received another, which led to extra dose administered. The reporter asked if there would be any issue about this. The anonymous female member of the public said that the healthcare provider gave this phone number to call us.  Anonymous female member of the public did not provide reactive consent for follow-up from Safety Department, neither provides any detail about specific vaccine detail, vaccination date or other patient demographics information. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: not received a second or third dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received 1st dose on 14-MAY-2024).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: not received a second or third 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: 25-OCT-2024 The reporter was asking about a patient that received a 1st dose of Engerix-B in May twenty-twenty four and had not received a second or third dose.  The reporter asked if they had any guidance about this. The reporter provided vaccination date and patient demographics reactively, did not provide any vaccine detail (lot number/expiration date).  No further information was provided from the Anonymous Healthcare provider end in this call. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Engerix-B , which led to incomplete course of vaccination.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a elderly male patient who received HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis.   On 24-OCT-2024, the patient received the 1st dose of Engerix B. On 24-OCT-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose given). 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: 25-OCT-2024 The patient received their Engerix-B but the dose had expired, which led to expired vaccine used. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Incomplete dose/received half dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 23-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 495MK, expiry date 30-JUN-2025) for prophylaxis.   On 25-OCT-2024, the patient received FluLaval 2024-2025 season. On 25-OCT-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced underdose (Verbatim: Incomplete dose/received half dose). The outcome of the underdose 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: 25-OCT-2024 A medical assistant called to inform that earlier that day he/she administered a vaccine, but he/she was not able to give the full dose and he/she only gave half a dose, which led to underdose. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 3 days; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-JUN-2024, 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: Sore arm for 3 days). The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-OCT-2024 The pharmacist stated that she received her Shingrix dose and referred having normal sore arm for 3 days after. No other information or permission to follow up was gathered since healthcare professional was in hurry.  The health care professional is at the same time the patient of this case.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Neck pain, Pain in extremity
Clinical narrative: chills; pain on the neck; pain on the arm of injection; difficulty breathing; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2024, the patient received the 1st dose of Shingrix (unknown arm). In OCT-2024, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: chills), neck pain (Verbatim: pain on the neck), pain in arm (Verbatim: pain on the arm of injection) and difficulty breathing (Verbatim: difficulty breathing). The outcome of the chills, neck pain, pain in arm and difficulty breathing were not resolved.   It was unknown if the reporter considered the chills, neck pain, pain in arm and difficulty breathing to be related to Shingrix.     It was unknown if the company considered the chills, neck pain, pain in arm and difficulty breathing to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-OCT-2024 The patient self-reported this case for himself. The patient received the first Shingrix vaccine one week ago (from the date of reporting).  The patient was experiencing chills, difficulty breathing, pain on the arm, pain on the neck.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered the DTaP-IPV portion only of a PENTACEL vaccine with no reported adverse event; Initial information received on 11-Oct-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3 months old male patient who received only dtap-ipv portion of a Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine [Pentacepentacel vaccine with no reported adverse event.  Concomitant medications included [Rotavirus vaccine live oral 1v (Rotarix); Pneumococcal Vaccine; And Hepatitis B Vaccine For Immunisation].  On 07-Oct-2024, the patient received a dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine, Powder and suspension for injection ( lot : UK024AA and expiry date :unknown) via intramuscular route in unknown administration site for Immunization.  On 07-OCT-2024 the patient received dtap-ipv portion only of a pentacel vaccine with no reported adverse event (single component of a two-component product administered) (latency: 1 day) following the administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine.  Information regarding expiration date corresponding to the one at time of event occurrence 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.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Administered post-excursion? Yes, the products have been administered post excursion since they recently discovered the excursion with no reported adverse event; Initial information received on 29-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA315643 (Master case).  This case involves an unknown age and unknown gender patient who was administered IPV (VERO) [IMOVAX POLIO] post-excursion? yes, the products have been administered post excursion since they recently discovered the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect IPV (VERO) (suspension for injection) lot X1C891M , Expiry date: 20-Oct-2026, strength was unknown via unknown route in unknown administration site for Immunization and administered post-excursion? yes, the products have been administered post excursion since they recently discovered the excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly "Previous Excursion? No. Human error? UNKNOWN . 6 patients have received IPOL post excursion.these products were supported by the extended stability information post excursion. The remaining inquiries were submitted to PV since the products were not supported by the extended stability information post excursion and had been administered to patients."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA315643:Master case
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Impaired work ability, Magnetic resonance imaging, Sleep disorder, Tinnitus
Clinical narrative: I had received 3 Pfizer vaccines in 2021 . Marc , April and December. Tinnitus began May 2021. Have my Covid vaccine card as well .
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Chest X-ray, Chromosomal analysis, Echocardiogram, Electroencephalogram abnormal, Gene sequencing
Clinical narrative: Admission to hospital due to infantile spasms that were confirmed to be seizures. No further vaccines are permitted for patient until cleared by Neurology.  Mom did inform us that she had taken Mucinex (no decongestant) on 10/28 and 10/29, and she is breastfeeding.  Patient was given Rotateq at 2mo and 4mo, then Rotarix at 6mo.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Infantile spasms, Magnetic resonance imaging head, Metabolic function test, Seizure
Clinical narrative: Admission to hospital due to infantile spasms that were confirmed to be seizures. No further vaccines are permitted for patient until cleared by Neurology.  Mom did inform us that she had taken Mucinex (no decongestant) on 10/28 and 10/29, and she is breastfeeding.  Patient was given Rotateq at 2mo and 4mo, then Rotarix at 6mo.
Age: 1.3
Sex: F
Vaccine: MMRV
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Mother called office 11/8/24 8:15 AM to report rash on pt's abdomen & back. Rash small red, slightly raised dots. No other sx.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination site bruising, Vaccination site mass
Clinical narrative: The patient came in on 11/10/24 and reported having a bruise and a lump near vaccine site. I didn't feel the area but saw a small bruise. She had received the vaccine on 10/28/24.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Balance disorder, Blood test normal, Computerised tomogram head normal, Gait inability
Clinical narrative: Intense vertigo attacks began on December 14th. These attacks lasted anywhere from seconds to a a minute. Loss of balance, gait, and sensitivity to sounds became permanent with differing levels of intensity. Sudden, loud sounds with a deep and high pitch timbre would trigger these vertigo spells, like clapping, deep voice yelling, and vibraphone sounds. Vestibular migraines have occurred multiple times a week, neck stiffness, shaking and tremors, and constant tinnitus every day, all day long. I took a hearing and tympanometry test, which resulted normal; Blood tests which resulted normal; was referred to an ENT and received a  CT scan - results normal, and then finally was referred to a neurologist and received an MRI which resulted normal. I was diagnosed with 3PD - Persistent Postural Perceptual Dizziness and was prescribed SSRI Xoloft, which was not effective. I have since stopped taking the prescription. My issue has been unresolved.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperacusis, Magnetic resonance imaging normal, Musculoskeletal stiffness, Persistent postural-perceptual dizziness, Tinnitus
Clinical narrative: Intense vertigo attacks began on December 14th. These attacks lasted anywhere from seconds to a a minute. Loss of balance, gait, and sensitivity to sounds became permanent with differing levels of intensity. Sudden, loud sounds with a deep and high pitch timbre would trigger these vertigo spells, like clapping, deep voice yelling, and vibraphone sounds. Vestibular migraines have occurred multiple times a week, neck stiffness, shaking and tremors, and constant tinnitus every day, all day long. I took a hearing and tympanometry test, which resulted normal; Blood tests which resulted normal; was referred to an ENT and received a  CT scan - results normal, and then finally was referred to a neurologist and received an MRI which resulted normal. I was diagnosed with 3PD - Persistent Postural Perceptual Dizziness and was prescribed SSRI Xoloft, which was not effective. I have since stopped taking the prescription. My issue has been unresolved.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Tympanometry normal, Vertigo, Vestibular migraine
Clinical narrative: Intense vertigo attacks began on December 14th. These attacks lasted anywhere from seconds to a a minute. Loss of balance, gait, and sensitivity to sounds became permanent with differing levels of intensity. Sudden, loud sounds with a deep and high pitch timbre would trigger these vertigo spells, like clapping, deep voice yelling, and vibraphone sounds. Vestibular migraines have occurred multiple times a week, neck stiffness, shaking and tremors, and constant tinnitus every day, all day long. I took a hearing and tympanometry test, which resulted normal; Blood tests which resulted normal; was referred to an ENT and received a  CT scan - results normal, and then finally was referred to a neurologist and received an MRI which resulted normal. I was diagnosed with 3PD - Persistent Postural Perceptual Dizziness and was prescribed SSRI Xoloft, which was not effective. I have since stopped taking the prescription. My issue has been unresolved.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Central nervous system mass, Leiomyosarcoma, Pelvic mass, Positron emission tomogram abnormal, Tumour excision
Clinical narrative: Aggressive leiomyosarcoma
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, fatigue, aches, cough
Age: 95.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Malaise
Clinical narrative: About 15 mins post vaccination the pt started reporting "feeling not right". She stated that she was having chest pains and that she felt tight in the chest. She also stated that she felt like she was having trouble breathing. Pt remained alert and was speaking the entire interaction. EMS was called per patient request and pt was transported into their care.
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Cardiac arrest, Cardioversion, Catheterisation cardiac, Chest X-ray, Computerised tomogram
Clinical narrative: Ventricular Fibrillation leading to cardiac arrest, AED administered, intubation, 15-day hospitalization, implantation of Internal Cardioverter Fibrillator.
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Endotracheal intubation, Implantable defibrillator insertion, Ventricular fibrillation
Clinical narrative: Ventricular Fibrillation leading to cardiac arrest, AED administered, intubation, 15-day hospitalization, implantation of Internal Cardioverter Fibrillator.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Headache, Injection site pain, Nausea
Clinical narrative: Woke up at 3 am with pain at injection site, headache, body aches in shoulders and backs of legs, nausea, and raised temperature (97.4 after taking Tylenol).
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Woke up at 3 am with pain at injection site, headache, body aches in shoulders and backs of legs, nausea, and raised temperature (97.4 after taking Tylenol).
Age: 70.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given pediatric dose of Hepatitis B vaccine instead of adult dose.  No adverse reaction patient returned to get adult dose per Dr.
Age: 24.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pyrexia, Retching, Vomiting
Clinical narrative: High fever (102°F) starting at midnight the day after, vomiting and dry heaves starting at 2 AM
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: injection administered  high on left arm.  It felt like it was administered into a hard part of my shoulder.  I had a sore arm, as usual, for a flu shot following in the next several days. Instead of resolving, it became more painful over the course of the next week.  it is now difficult to hold weight in that arm, especially above my chest level; for example putting groceries away in a high cupboard.  Brushing my hair, and taking off my shirt is very painful.
Age: 44.0
Sex: F
Vaccine: CHIK, HEPA, JEV1, TYP
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: Client starting feeling "bad" 5 days after vaccines. She had flu vaccine the day before and had been ok. Tuesday, 10/22/2024 she felt fatigue, body aches, headache and developed post auricular lymphadenopathy on the right side. She had lymphadenopathy on left lower neck and shoulder area. Client was seen by ENT who felt she was developing a strong immune reaction to vaccines and put her on antibiotics. When she returned to our clinic on 11/08/2024 she did not have post auricular lymphadenopathy but  lymphadenopathy on left lower neck/shoulder. Client stated she was feeling much better.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: While at office appt, pt agreed to have his influenze vaccine after being asked by nursing staff. After patient was given vaccine, staff were completing charting and noted that patient had already received an influenze vaccine on 9/26/24. Pt notified on 11/8/24. Pt denied any symptoms or concerns at that time.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site scab
Clinical narrative: Developed red, itchy, bumps where patient received 18 month vaccines (DTaP and Hep A) on 10/28/24.  Hives remained local on LT without spreading and had started to scab over.  Denies streaking or warm to touch.  Referred to Allergist.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Influenza
Clinical narrative: Flu symptoms for 48 hours
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given too soon
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Hypotonia, Injection site haemorrhage, Tachycardia
Clinical narrative: Patient was sitting in chair, saw small amount of blood on the bandaid and then felt dizzy, eyes closed and she went limp in chair. She was sweating, no cyanosis or seizure. She awoke < 1 minute later. Initial vital signs showed some tachycardia and mildly low blood pressure: these were back to normal < 15 minutes later.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Discomfort, Injection site swelling, Lymphadenopathy, Malaise, Migraine
Clinical narrative: The day after vaccine administration, patient began to feel unwell. She started to experience the following symptoms: Right arm pain, swelling at the sight and beneath her arm around her gland.  In the next days she started to experience radiating pain up and down her right arm and experiencing migraine headaches which started from 10/20 - 11/8 when she finally reported to the Employee Health department.  At this time of the report she was still having issues raising her arm above her head. She continues taking Ibuprofin and Acetominophen for discomfort and will start with a heating pack to relieve some tension in the arm. The site of the injection was appropriately given for an IM injection. We will evaluate patient's progress throughout the week to determine next steps in her care. At this time she is not experiencing any facial drop or loss of strength in her extremities.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Muscle tightness, Pain, Pain in extremity
Clinical narrative: The day after vaccine administration, patient began to feel unwell. She started to experience the following symptoms: Right arm pain, swelling at the sight and beneath her arm around her gland.  In the next days she started to experience radiating pain up and down her right arm and experiencing migraine headaches which started from 10/20 - 11/8 when she finally reported to the Employee Health department.  At this time of the report she was still having issues raising her arm above her head. She continues taking Ibuprofin and Acetominophen for discomfort and will start with a heating pack to relieve some tension in the arm. The site of the injection was appropriately given for an IM injection. We will evaluate patient's progress throughout the week to determine next steps in her care. At this time she is not experiencing any facial drop or loss of strength in her extremities.