chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age, Underdose
Clinical narrative: a 63 year-old patient received Engerix-B pediatric formulation as a first dose; a 63 year-old patient received Engerix-B pediatric formulation as a first dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 63-year-old male patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   On 23-FEB-2024, the patient received the 1st dose of Engerix B pediatric. On 23-FEB-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: a 63 year-old patient received Engerix-B pediatric formulation as a first dose) and adult use of a child product (Verbatim: a 63 year-old patient received Engerix-B pediatric formulation as a first dose). 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: 29-FEB-2024 Medical assistant reported that the adult patient received Engerix B pediatric formulation as a first dose, which led to underdose and adult use of child product. The reporter consented to follow-up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: A patient received an expired Menveo 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 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA764A, expiry date 31-DEC-2023) for prophylaxis.   On 29-FEB-2024, the patient received Menveo .5 ml. On 29-FEB-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: A patient received an expired Menveo vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-FEB-2024 The reporter was a Medical Assistant.   The reporter stated a patient received an expired Menveo vaccine, which led to expired vaccine used. The reporter did not consent to follow-up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Product administration error, Wrong product administered
Clinical narrative: inadvertent use of kinrix in a 4 months baby; kinrix maladministration instead of pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   Previously administered products included Dtap (already received 2 doses of Dtaps on an unknown date) and Ipv (received 2 doses of IPV vaccine on an unknown date).   On 27-NOV-2023, the patient received Kinrix. On 27-NOV-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertent use of kinrix in a 4 months baby) and wrong vaccine administered (Verbatim: kinrix maladministration instead of pediarix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 29-FEB-2024 The practice manager reported that the patient received Kinrix instead of Pediarix below than the recommended age limit, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient took dose 1 of Shingrix vaccine in Sept. of 2021 but didn't get 2nd 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient took dose 1 of Shingrix vaccine in Sept. of 2021 but didn't get 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: RA Receipt Date: 01-MAR-2024 The reporter inquired that the patient did not get 2nd dose of Shingrix and asked if they should restart the series. The reporter ended chat unable to capture any vaccine, patient, or healthcare professional details. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administration of only the Shingrix adjuvant; administration of only the Shingrix adjuvant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administration of only the Shingrix adjuvant) and inappropriate dose of vaccine administered (Verbatim: administration of only the Shingrix adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: RA receipt date: 01-MAR-2024 A Pharmacist contacted (PRIVACY) via phone on Shingrix inquiring about Boostrix and what information was available about any information about the administration of only the Shingrix adjuvant. They gave partial information about the event. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix stored at minus 2.8C for 50 minutes; 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 female patient who received DTPa (Reduced antigen) (Boostrix) (batch number MX2V9, expiry date 03-MAY-2026) for prophylaxis.   On 29-FEB-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix stored at minus 2.8C for 50 minutes). The outcome of the incorrect storage of drug 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: 01-MAR-2024  A medical assistant reported to request stability data for Boostrix stored at minus 2.8 degree Celsius for 50 minutes and administered to 5 different patient which led to incorrect storage of drug.  The reporter consented to follow up. This is 3 of 5 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024027787:Different patient US-GSK-US2024027788:Different patient US-GSK-US2024027790:Different patient US-GSK-US2024027791:Different patient
Age: 65.0
Sex: F
Vaccine: MNQ
Symptoms: Asplenia, Product administered to patient of inappropriate age
Clinical narrative: Potential administration at inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 65-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Potential administration at inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 04-MAR-2024 The reporter called to ask if a 65-year-old patient could receive a dose of Menveo, since the patient needed a meningitis vaccine and the only product available in the facility was Menveo, which led to inappropriate age at vaccine administration. The reporter mentioned that the patient did not have a spleen. The dose had not been administered at the moment of the call.
Age: 1.92
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expiration date of the vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 23-month-old patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 04-MAR-2024, the patient received Infanrix. On 04-MAR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expiration date of the 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: 04-MAR-2024 Nurse called to inform a dose of Infanrix was given one day after the expiration date of the vaccine which led to expired vaccine used. She requested information about this subject.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: 2 doses of Arexvy administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (expiry date 03-JUL-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 14-DEC-2023, the patient received the 2nd dose of Arexvy. On 14-DEC-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: 2 doses of Arexvy administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 05-MAR-2024 Pharmacist reported due to vaccine recorded not being uploaded to the reporting system a patient received two doses of Arexvy which led to extra dose administered.
Sex: U
Vaccine: COVID19, FLU4
Symptoms: Chills, Cough, Fatigue, Myalgia, Pyrexia
Clinical narrative: myalgia; low grade fever; chills; fatigue; runny nose; coughing; Initial information received on 05-Mar-2024 regarding an unsolicited valid non-serious courtesy case received via consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who had runny nose, coughing, myalgia, low grade fever, chills and fatigue while receiving elasomeran [Spikevax] and influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rosuvastatin; and omeprazole.  On an unknown date in Nov-2023, the patient received a 1 DF (dosage form) dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength, expiry date: unknown) (lot: U8201FA) via unknown route in unknown administration site for prophylactic vaccination (immunization) and dose 5 of an unknown dose of suspect SPIKEVAX injection not produced by Sanofi Pasteur (strength, lot number, expiry date: unknown) via intramuscular route in unknown administration site for covid-19 prophylaxis.  On 30-Nov-2023 the patient had events of runny nose (rhinorrhoea) and coughing (cough) (unknown latency) following the administration of influenza quadrival A-B vaccine and spikevax.  On 30-Nov-2023 at 07:00 hours, the patient had events of myalgia and low grade fever (pyrexia), chills and fatigue (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE and (SPIKEVAX.  Action taken: not applicable.  The patient was treated with Paracetamol (Tylenol) from 30-Nov-2023 to 02-Dec-2023 for Fever and Myalgia, at a dose of UNK UNK, prn.  It was not reported if the patient received a corrective treatment for the events runny nose, coughing, chills, fatigue.  Outcome: Recovering / Resolving for the events runny nose, coughing, was Recovered / Resolved on 03-Dec-2023 for the events myalgia, low grade fever, chills and fatigue.
Sex: U
Vaccine: COVID19, FLU4
Symptoms: Rhinorrhoea
Clinical narrative: myalgia; low grade fever; chills; fatigue; runny nose; coughing; Initial information received on 05-Mar-2024 regarding an unsolicited valid non-serious courtesy case received via consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who had runny nose, coughing, myalgia, low grade fever, chills and fatigue while receiving elasomeran [Spikevax] and influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rosuvastatin; and omeprazole.  On an unknown date in Nov-2023, the patient received a 1 DF (dosage form) dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength, expiry date: unknown) (lot: U8201FA) via unknown route in unknown administration site for prophylactic vaccination (immunization) and dose 5 of an unknown dose of suspect SPIKEVAX injection not produced by Sanofi Pasteur (strength, lot number, expiry date: unknown) via intramuscular route in unknown administration site for covid-19 prophylaxis.  On 30-Nov-2023 the patient had events of runny nose (rhinorrhoea) and coughing (cough) (unknown latency) following the administration of influenza quadrival A-B vaccine and spikevax.  On 30-Nov-2023 at 07:00 hours, the patient had events of myalgia and low grade fever (pyrexia), chills and fatigue (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE and (SPIKEVAX.  Action taken: not applicable.  The patient was treated with Paracetamol (Tylenol) from 30-Nov-2023 to 02-Dec-2023 for Fever and Myalgia, at a dose of UNK UNK, prn.  It was not reported if the patient received a corrective treatment for the events runny nose, coughing, chills, fatigue.  Outcome: Recovering / Resolving for the events runny nose, coughing, was Recovered / Resolved on 03-Dec-2023 for the events myalgia, low grade fever, chills and fatigue.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of pentacel was inadvertently administered with no reported adverse event; Initial information received from on 04-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who had expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Mar-2024, the patient received a, expired dose 2 with dosage 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (lot UJ844AA, Expiry: 02-Mar-2024, with unknown strength) via intramuscular route in the left thigh as prophylactic vaccination with no reported adverse event (expired 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: 21.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: expired TYPHIM VI used with no reported adverse event; Initial information received on 06-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 21 years old male patient who had expired Typhoid Vi polysaccharide vaccine [Typhim VI] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact 3V (VERO) (IPOL [polio vaccine inact 3V (VERO)]) for Prophylactic vaccination.  On 06-Mar-2024, the patient received an expired dose 1 of suspect Typhoid Vi polysaccharide vaccine Solution for injection (strength- standard) at a dose of  0.5 mL total (lot V1A231M, expiry date- 04-MAR-2024) via intramuscular route in the  Intradeltoid NOS (not otherwise specified) for immunization with no reported adverse event (expired product administered) (latency- same day).  Nurse Director called to inquire if an expired TYPHIM VI vaccine dose should be repeated if given to a patient.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority 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: RVX, VARZOS
Symptoms: Illness, Nasopharyngitis
Clinical narrative: sick; slight cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 02-FEB-2024, the patient received the 1st dose of Shingles vaccine (unknown arm) and RSV vaccine (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine and RSV vaccine, the patient experienced sickness (Verbatim: sick) and cold (Verbatim: slight cold). The outcome of the sickness and cold were not reported.   It was unknown if the reporter considered the sickness and cold to be related to Shingles vaccine and RSV vaccine.     It was unknown if the company considered the sickness and cold to be related to Shingles vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by the patient via interactive digital media. The patient stated that he/she got the shingles shot and stated second one in few months. They said after the first he/she would get sick, and the patient did, it was like slight cold. The patient stated that if he/she did not get the second one, then the first would have been no good. The patient stated that second shot would made him/her sick, only worse.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Felt like someone shot a ton of bricks into my shoulder; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shoulder pain (Verbatim: Felt like someone shot a ton of bricks into my shoulder). The outcome of the shoulder pain was not reported.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.     It was unknown if the company considered the shoulder pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-Mar-2024 This case was reported by the patient via interactive digital media. The patient stated that he/she felt like someone shot a ton of brick into him/her shoulder, but thought that he/she was fine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: got sick; ran a high temperature; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles three times prior to getting the shot, the third time it was so bad) and pain (pain with shingles was so bad that there was no explanation for it). Additional patient notes included did not had any adverse effects with the first Shingles shot.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got sick) and high temperature (Verbatim: ran a high temperature). The outcome of the sickness and high temperature were not reported.   It was unknown if the reporter considered the sickness and high temperature to be related to Shingles vaccine.     It was unknown if the company considered the sickness and high temperature to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a patient via (social media) interactive digital media. The patient got sick and ran a high temperature with the second Shingles shot. The reporter mentioned, it was nowhere as bad as shingles so everyone needs to get the shots. The patient had shingles three times prior to getting the shot and he/she just kept thinking that he/she would not had them again.  The reporter would not wish them on his/her worse enemy.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Fatigue
Clinical narrative: Joint pain; Tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: Joint pain) and tiredness (Verbatim: Tiredness). The outcome of the joint pain and tiredness were not reported.   It was unknown if the reporter considered the joint pain and tiredness to be related to Arexvy.     It was unknown if the company considered the joint pain and tiredness to be related to Arexvy.   Additional Information: RA receipt date: 01-MAR-2024 This case was reported by a patient via (PRIVACY) interactive digital media. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Pruritus, Rash
Clinical narrative: itching; rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 2 days after receiving Arexvy, the patient experienced pruritus (Verbatim: itching) and rash (Verbatim: rash). The outcome of the pruritus and rash were not reported.   It was unknown if the reporter considered the pruritus and rash to be related to Arexvy.     It was unknown if the company considered the pruritus and rash to be related to Arexvy.   Additional Information: RA Receipt Date: 01-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The reporter asked, what about itching and rash 2 days after injection.
Sex: U
Vaccine: RSV
Symptoms: Insomnia
Clinical narrative: could not sleep; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of insomnia in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 29-FEB-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced insomnia (Verbatim: could not sleep). The outcome of the insomnia was not reported.   It was unknown if the reporter considered the insomnia to be related to Arexvy.     It was unknown if the company considered the insomnia to be related to Arexvy.   Additional Information: RA Receipt Date: 01-MAR-2024  This case was reported by a patient via (Open field AE monitoring) interactive digital media. The reporter stated that they had shot yesterday (day before reporting) and could not sleep.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: exposed to temperature below freezing negative; 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 2-year-old female patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   On an unknown date, the patient received the 1st dose of Infanrix. On 29-FEB-2024, an unknown time after receiving Infanrix, the patient experienced incorrect storage of drug (Verbatim: exposed to temperature below freezing negative). The outcome of the incorrect storage of drug 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: 04-MAR-2024 It was reported that Infanrix was exposed to temperature below freezing negative. Patient was administered the frozen product which led to incorrect storage of drug. This case is linked with US2024028549 ,same reporter.; Sender's Comments:  US-GSK-US2024028549:2 of 2 report
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: child was given a Fluzone high-dose by mistake with no adverse event; Initial information received on 06-Mar-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves Child and unknown gender patient who was given a influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] by mistake 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 child patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, dose, form, expiry not reported) via unknown route in unknown administration site as prophylactic vaccination by mistake with no adverse event (product administered to patient of inappropriate age) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority 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: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; inadvertently administered ROTATEQ that was involved in a supported below range TE; This spontaneous report was received from a License Vocational Nurse (LVN) referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On 01-MAR-2024, the patient was vaccinated with the second vial of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, oral, lot # 1968393, expiration date: 24-MAY-2024 (strength was not provided) for prophylaxis.  It was reported that the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was involved in a supported below range temperature (product storage error). No symptomatic adverse events were reported.   The temperature excursion was fr 1 hours 3 minutes 0 seconds with a temperature of -2.2°C
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Off label use
Clinical narrative: HCP called to report that a first dose of GARDASIL 9 was given off label to an 8 yr old patient; No adverse effects were reported; This spontaneous report was received from a pharmacist doctor and refers to an 8-year-old patient of unknown gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.       On an unknown date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 milliliter for prophylaxis (lot #, expiration date and route were not reported)  (off label use). No other adverse effects (no adverse event) and not product quality complain were reported.    Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Agitation, Back pain, Herpes zoster, Insomnia, Rash
Clinical narrative: my third week of another attack / Suspected vaccination failure; my third week of another attack; rash; back pain; difficulty sleeping; agitation; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included varicella zoster vaccine (patient got the first Shingles vaccine and later had a mild case of shingles). Concurrent medical conditions included constipation.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: my third week of another attack / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: my third week of another attack), rash (Verbatim: rash), back pain (Verbatim: back pain), difficulty sleeping (Verbatim: difficulty sleeping) and agitation (Verbatim: agitation). The outcome of the vaccination failure was unknown and the outcome of the shingles, back pain, difficulty sleeping and agitation were not resolved and the outcome of the rash was resolving.   It was unknown if the reporter considered the vaccination failure, shingles, rash, back pain, difficulty sleeping and agitation to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, rash, back pain, difficulty sleeping and agitation to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2024 This case was reported by the patient via interactive digital media. The patient stated that they got both new two dose of vaccine. The patient was in third week of another attack. The patient stated that the rash was going slowly away but still had back pain and difficulty sleeping. The reporter stated that pain pills had caused constipation and had other medical problems he/she was dealing with. The patient stated that he/she was hoping to get rid of back pain and agitation. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: my third week of another attack / Suspected vaccination failure; my third week of another attack; rash; back pain; difficulty sleeping; agitation; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included varicella zoster vaccine (patient got the first Shingles vaccine and later had a mild case of shingles). Concurrent medical conditions included constipation.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: my third week of another attack / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: my third week of another attack), rash (Verbatim: rash), back pain (Verbatim: back pain), difficulty sleeping (Verbatim: difficulty sleeping) and agitation (Verbatim: agitation). The outcome of the vaccination failure was unknown and the outcome of the shingles, back pain, difficulty sleeping and agitation were not resolved and the outcome of the rash was resolving.   It was unknown if the reporter considered the vaccination failure, shingles, rash, back pain, difficulty sleeping and agitation to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, rash, back pain, difficulty sleeping and agitation to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2024 This case was reported by the patient via interactive digital media. The patient stated that they got both new two dose of vaccine. The patient was in third week of another attack. The patient stated that the rash was going slowly away but still had back pain and difficulty sleeping. The reporter stated that pain pills had caused constipation and had other medical problems he/she was dealing with. The patient stated that he/she was hoping to get rid of back pain and agitation. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: I got Gillian Breaue from shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: I got Gillian Breaue from shot) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2024 This case was reported by the patient via interactive digital media. The patient stated that he/she got the gillian breau from shot.
Sex: M
Vaccine: MEN
Symptoms: Delirium, Headache, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: delirious episodes; tingling on both arms; pain on both arms; walking in his sleep; talking in his sleep; feeling pain in the neck; hives on his chest; very high fever of 102 to 103; severe headache; Initial information received on 04-Mar-2024 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who experienced delirious episodes, tingling on both arms, pain on both arms, walking in his sleep, talking in his sleep, feeling pain in the neck, hives on his chest, very high fever of 102 to 103 and severe headache after receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Feb-2024, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation.  On 24-Feb-2024 the patient developed delirious episodes (delirium), tingling on both arms (paraesthesia), pain on both arms (pain in extremity), walking in his sleep (somnambulism), talking in his sleep (sleep talking), feeling pain in the neck (neck pain), hives on his chest (urticaria), very high fever of 102 to 103 (pyrexia) and severe headache (headache) (latency- 5 days) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.   Action taken- not applicable.  The patient was treated with ibuprofen for pyrexia and loratadine (claritine) for Urticaria.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.  Seriousness criteria- Medically significant for delirium; Sender's Comments: Sanofi Company Comment dated 07-Mar-2024: This case involves an unknown age male patient who experienced delirious episodes, tingling on both arms, pain on both arms, walking in his sleep, talking in his sleep, feeling pain in the neck, hives on his chest, very high fever of 102 to 103 and severe headache after receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: M
Vaccine: MEN
Symptoms: Pyrexia, Sleep talking, Somnambulism, Urticaria
Clinical narrative: delirious episodes; tingling on both arms; pain on both arms; walking in his sleep; talking in his sleep; feeling pain in the neck; hives on his chest; very high fever of 102 to 103; severe headache; Initial information received on 04-Mar-2024 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who experienced delirious episodes, tingling on both arms, pain on both arms, walking in his sleep, talking in his sleep, feeling pain in the neck, hives on his chest, very high fever of 102 to 103 and severe headache after receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Feb-2024, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation.  On 24-Feb-2024 the patient developed delirious episodes (delirium), tingling on both arms (paraesthesia), pain on both arms (pain in extremity), walking in his sleep (somnambulism), talking in his sleep (sleep talking), feeling pain in the neck (neck pain), hives on his chest (urticaria), very high fever of 102 to 103 (pyrexia) and severe headache (headache) (latency- 5 days) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.   Action taken- not applicable.  The patient was treated with ibuprofen for pyrexia and loratadine (claritine) for Urticaria.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.  Seriousness criteria- Medically significant for delirium; Sender's Comments: Sanofi Company Comment dated 07-Mar-2024: This case involves an unknown age male patient who experienced delirious episodes, tingling on both arms, pain on both arms, walking in his sleep, talking in his sleep, feeling pain in the neck, hives on his chest, very high fever of 102 to 103 and severe headache after receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal, Headache
Clinical narrative: Reports received 1st COvid vaccine this AM, approx 25 minutes later developed chest pain that persists. Reports headache and shortness of breath. Diagnosis management comments: Patient is a 59-year-old, developed chest pain shortness of breath about 25 minutes after receiving the Covid vaccine, she has no additional symptoms including no rash no signs of angioedema, on exam there is no wheezing no increased respiratory effort no hypoxemia.  Patient has high blood pressure and is overweight otherwise no significant cardiac risk factors.  Work-up including 2 troponins EKG labs are benign.  Chest x-ray is unremarkable.  I think this is less likely ACS and more likely some sort of postvaccine reaction, possibly anxiety, however she has been monitored here for 3 hours, symptoms have resolved.  Her repeat trop is higher than her originial but still well within the normal range; I discussed this finding with cardiology, Dr, advises if clinical scenario is not overall suggested of ACS and patient is asymptomatic this is unlikely a concerning finding and therefore in this patient's case I think she can be safely discharged.  She was advised however if her pain returns or she develops additional symptoms she should return immediately for evaluation.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: Reports received 1st COvid vaccine this AM, approx 25 minutes later developed chest pain that persists. Reports headache and shortness of breath. Diagnosis management comments: Patient is a 59-year-old, developed chest pain shortness of breath about 25 minutes after receiving the Covid vaccine, she has no additional symptoms including no rash no signs of angioedema, on exam there is no wheezing no increased respiratory effort no hypoxemia.  Patient has high blood pressure and is overweight otherwise no significant cardiac risk factors.  Work-up including 2 troponins EKG labs are benign.  Chest x-ray is unremarkable.  I think this is less likely ACS and more likely some sort of postvaccine reaction, possibly anxiety, however she has been monitored here for 3 hours, symptoms have resolved.  Her repeat trop is higher than her originial but still well within the normal range; I discussed this finding with cardiology, Dr, advises if clinical scenario is not overall suggested of ACS and patient is asymptomatic this is unlikely a concerning finding and therefore in this patient's case I think she can be safely discharged.  She was advised however if her pain returns or she develops additional symptoms she should return immediately for evaluation.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse advent, wrong dose given
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Feeling cold, Feeling hot
Clinical narrative: She got her vaccine, she had no symptoms at all until about 8:00 PM.  Then she started to feel like she was getting a fever, and then a while after that she started shivering and could not get warm despite having a heavy comforter on.  Her husband got her a heating pad and then started having aches and nausea, and slept for 24 hours and waking only occasionally with severe pain in her joints.  Her husband noted that she had a 4" hive in the area of the vaccine, raised hive.  It was very much like the flu, but she never got diarrhea or vomiting.  This went on for 24 hours.  The next day she had loose stools, but not diarrhea.  She then went into itching last night and is now taking Benadryl.  The Benadryl seems to be helping the itching.  The symptoms are starting to subside as far as the aches and pains and took an Imodium yesterday so she did not get dehydrated, and then the itching started last night.  The area of the arm is red, but there are no hives there, but she does have the itching.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Influenza like illness, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: She got her vaccine, she had no symptoms at all until about 8:00 PM.  Then she started to feel like she was getting a fever, and then a while after that she started shivering and could not get warm despite having a heavy comforter on.  Her husband got her a heating pad and then started having aches and nausea, and slept for 24 hours and waking only occasionally with severe pain in her joints.  Her husband noted that she had a 4" hive in the area of the vaccine, raised hive.  It was very much like the flu, but she never got diarrhea or vomiting.  This went on for 24 hours.  The next day she had loose stools, but not diarrhea.  She then went into itching last night and is now taking Benadryl.  The Benadryl seems to be helping the itching.  The symptoms are starting to subside as far as the aches and pains and took an Imodium yesterday so she did not get dehydrated, and then the itching started last night.  The area of the arm is red, but there are no hives there, but she does have the itching.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pruritus
Clinical narrative: She got her vaccine, she had no symptoms at all until about 8:00 PM.  Then she started to feel like she was getting a fever, and then a while after that she started shivering and could not get warm despite having a heavy comforter on.  Her husband got her a heating pad and then started having aches and nausea, and slept for 24 hours and waking only occasionally with severe pain in her joints.  Her husband noted that she had a 4" hive in the area of the vaccine, raised hive.  It was very much like the flu, but she never got diarrhea or vomiting.  This went on for 24 hours.  The next day she had loose stools, but not diarrhea.  She then went into itching last night and is now taking Benadryl.  The Benadryl seems to be helping the itching.  The symptoms are starting to subside as far as the aches and pains and took an Imodium yesterday so she did not get dehydrated, and then the itching started last night.  The area of the arm is red, but there are no hives there, but she does have the itching.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: redness at injection site and itching that started 2 days after the injection on 3/8/24
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Two blisters on right breast
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Nodule
Clinical narrative: A nodule appeared after vaccination. We did not think anything of it at the time but it has now been 9 months and the nodule is still present and hurts at times.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise, Pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient received varicella vaccine on 2/28/24. Reports varicella-like rash on 3/10/24. Describes rash as itchy red lesions - about 20 scattered on face, torso, arms, legs. Denies crusting, discharge, scabbing. Reports associated body aches and malaise but denies any other signs or symptoms at this time.