chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; HCP reported that an expired PNEUMOVAX 23 vaccine was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-OCT-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (lot number W021636 has been verified to be a valid lot number, expiration date reported and validated as 01-OCT-2023) (expired product administered) for prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided). No additional adverse event/PQC was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC; HCP called to report PROQUAD was administered to a 17 yo patient.; This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot#, strength, expiry date, route of administration and anatomical location were not provided) for prophylaxis (product administered to patient of inappropriate age). No signs, symptoms or adverse effects have been reported from the administration of vaccine.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: exhibiting symptoms of POTS post unspecified GARDASIL vaccination; This spontaneous report was received from a medical assistant and refers to a female patient of 12-years-old by reporting time. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (dose, dose number, lot number, expiration date, vaccination scheme, frequency and route of administration were not provided) or with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administer for prophylaxis (dose, dose number, lot number, expiration date, vaccination scheme, frequency and route of administration were not provided).  On an unknown date, the patient exhibiting symptoms of postural orthostatic tachycardia syndrome (POTS) post unspecified quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination. The patient was currently undergoing testing at an unspecified facility, the healthcare provider (HCP) stated that she would await correspondence and testing results and then provide the requested information back to the company. The outcome of the event POTS was not provided.  The causal relationship between the event POTS and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA003523:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for patient who received improperly stored PROQUAD on 04OCT2023. No side effects reported. No other medical information known. Operator of Device was a Healthcare Professional. HCP permission to contact obtained. See addition; This spontaneous report was received from a healthcare professional (HCP) and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # X018582 has been confirmed as valid, expiration date: 05-JAN-2025 (dose and route of administration were not provided) administered for prophylaxis. The vaccine underwent temperature excursion that same date, with a minimum temperature of -9.8 degree Celsius in a time frame of 12 minutes (product storage error). No previous temperature excursion and additional side effects were reported (no adverse event).  This is one of 7 reports received from the same reporter.; Sender's Comments:  US-009507513-2310USA007934:
Sex: M
Vaccine: RV5
Symptoms: Adenovirus test positive, Rotavirus test positive, Weight gain poor
Clinical narrative: infant not gaining weight appropriately; HCP called to report that a 2-month-old infant has tested positive for the Rota Virus today, 10/19/2023. HCP reports that the infant was given his first and only vaccination with ROTATEQ on 9/21/2023. The baby's stool w; adenovirus test positive; This spontaneous report was received from Other Health Professional and refers to a 13-week-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies included iron.  On 21-SEP-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2mls/once, lot #1933912, expiration date 21-APR-2024, administered orally for prophylaxis (strength was not provided).  An infant was unable to gain weight and on 18-OCT-2023 was hospitalized. A 2-month-old infant has tested positive for the Rota Virus and adenovirus on 19-OCT-2023. The infant has had no other signs or symptoms and was not premature. The infant was started on an iron supplementation today on 19-OCT-2023, but is not taking any other medications, or supplements. The outcome of weight gain decreased was unknown and the outcome of rotavirus test positive and adenovirus test positive was not recovered. Action taken was not applicable.  The causal relationship between all of the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Neutropenia, Rash
Clinical narrative: during prolonged neutropenia; development of a dermatome rash; Contraindicated product; This spontaneous report was received from physician and referred to a child of unknown gender. The patient was enrolled in the Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. The patient's medical history included varicella zoster virus serology positive, and skin lesion. Information about the patient's concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccine with varicella virus vaccine live (oka/merck) (VARIVAX) injection; or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (reported as VZV Oka vaccine) for prophylaxis (strength, dose description, lot #, expiry date, anatomical site of vaccination and route of administration were not provided) (Contraindicated product administered).  On an unknown date, the patient developed a dermatome rash during prolonged neutropenia. At the time of reporting, the outcome of the event dermatome rash, prolonged neutropenia was not known. The causal relationship between dermatome rash, prolonged neutropenia and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown. The causal relationship between dermatome rash, prolonged neutropenia and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.   Upon internal review, the event prolonged neutropenia was determined to be medically significant.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; Medical Assistant calling to report an adverse event regarding misuse of ROTATEQ.  Medical Assistant stated that a patient was administered their first dose of ROTATEQ at age 6 months and 7 days.  Medical Assistant stated that the patient has not rec; Incorrect dose administered; This spontaneous report was received from a medical assistant refers to a 6-month-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 0.5 milliliter (lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis (incorrect dose administered).   It was reported that the patient was administered their first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at age 6 months and 7 days (product administered to patient of inappropriate age). Medical Assistant stated that the patient has not received their first or seconds doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at the recommended age intervals, and the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) dose that was given today, 23-OCT-2023, was the patient's first dose. Medical Assistant confirmed that the patient involved has not reported any medical concerns or symptoms related to being administered the ROTATEQ dose beyond the recommended age intervals. Medical Assistant stated that the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) dose was administered due to an error in processing the patient in their care. No additional adverse event reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist called and stated that a patient received their 1st dose of MMR II on 9/28/2023 and then received their 2nd dose too early on 10/16/2023. Caller stated patient has not reported any symptoms. No additional AE/no PQC.; No additional AE; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-SEP-2023, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 16-OCT-2023, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Gastrointestinal disorder
Clinical narrative: Stomach Problems; 12 Year Old Received Heplisav-B; Initial Report Received on 05-Jul-2023  A registered pharmacist reported that a 12-year-old male patient (race and ethnicity unknown) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed stomach problems.   Medical history and concomitant medications at the time of vaccination were not reported.   On 09-Aug-2022, the patient received the first dose of HEPLISAV-B vaccine (Lot # 937233; expiration date 11-Mar-2023; NDC # 43528-003-05) intramuscularly in the left arm (deltoid) from a pharmacist.   On an unspecified date in Sep-2022, after having been vaccinated with HEPLISAV-B, the patient experienced stomach problems.   The reporter confirmed that the event was discovered since the patient was going for his second injection of HEPLISAV-B.  The patient's parent was notified. No adverse reactions were reported. The reporting pharmacist was not aware of the patient experiencing stomach problems in Sep-2022. No additional information was provided.  Company Comment:  The  company assessed the event as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received Heplisav-B Inadverently As Third Dose 6 Weeks After Second Dose Engerix; Received Heplisav-B Inadverently As Third Dose 6 Weeks After Second Dose Engerix; Initial Report Received on 06-Jul-2023  A medical assistant reported that a 56-year-old male patient (race and ethnicity unknown), received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the third dose in the series, 6 weeks after the second dose.  Medical history and allergies at the time of vaccination were not reported. No adverse reactions to previous vaccines were reported.  Allergies at the time of vaccination included amoxicillin, Vicodin, and trimethoprim.   On 14-Jul-2021, the patient received a dose of Engerix (no details provided).   On 23-Mar-2023, the patient received a dose of Recombivax (no details provided).  On 04-May-2023, the patient received HEPLISAV-B vaccine (Lot # 941588; expiration date 31-Aug-2025, NDC # 43528-003-05) as the third dose in the series, 6 weeks after the second dose with Recombinvax. No adverse reactions were reported.  No additional information was provided.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pruritus
Clinical narrative: chills; headache; facial itching; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of chills in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included cetirizine hydrochloride (Zyrtec).   On 15-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On 15-OCT-2023, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: chills), headache (Verbatim: headache) and pruritus facial (Verbatim: facial itching). The patient was treated with fexofenadine hydrochloride (Allegra) and ibuprofen. The outcome of the chills and headache were not resolved and the outcome of the pruritus facial was resolved.   The reporter considered the chills, headache and pruritus facial to be related to Shingrix.     The company considered the chills, headache and pruritus facial to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter reported that after receiving Shingrix vaccine patient had chills, headache and facial itching. The reporter reported that the patient used Zyrtec, OTC vitamins. The reporter reported that the facial itching was resolved after taking Allegra. Patient also took ibuprofen as per need for headache and chills. The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Cough, Oxygen saturation decreased, Product use in unapproved indication, Productive cough
Clinical narrative: phlegm; coughing; very low blood oxygen; Drug use for unapproved indication; This non-serious case was reported by a consumer and described the occurrence of phlegm in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes and bronchitis (developed bronchitis). Concomitant products included semaglutide (Rybelsus).   On 19-SEP-2023, the patient received Arexvy. On 19-SEP-2023, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved indication (Verbatim: Product use in unapproved indication). On 29-SEP-2023, the patient experienced phlegm (Verbatim: phlegm), cough (Verbatim: coughing) and oxygen saturation decreased (Verbatim: very low blood oxygen). The outcome of the phlegm, cough and oxygen saturation decreased were not resolved and the outcome of the drug use in unapproved indication was unknown.   It was unknown if the reporter considered the phlegm, cough and oxygen saturation decreased to be related to Arexvy.     It was unknown if the company considered the phlegm, cough and oxygen saturation decreased to be related to Arexvy.   Additional Information: GSK receipt date: 16-Oct-2023 The reporter reported seriousness for phlegm, coughing and very low blood oxygen was intervention required. The reporter consented to follow-up. The patient received a dose of Arexvy for bronchitis, which led to drug use for unapproved indication.
Sex: F
Vaccine: RVX
Symptoms: Injection site reaction
Clinical narrative: Delayed injection site reaction following injection; Drug use for unapproved indication; This non-serious case was reported by a consumer and described the occurrence of injection site reaction in a 69-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number 35AD3) for prophylaxis.   Concurrent medical conditions included necrosis. Concomitant products included cefalexin (Keflex).   On 24-SEP-2023, the patient received RSV vaccine. On 24-SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced drug use for unapproved indication (Verbatim: Drug use for unapproved indication). On 30-SEP-2023, the patient experienced injection site reaction (Verbatim: Delayed injection site reaction following injection). The outcome of the injection site reaction was not resolved and the outcome of the drug use for unapproved indication was unknown.   It was unknown if the reporter considered the injection site reaction to be related to RSV vaccine.     It was unknown if the company considered the injection site reaction to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 16-OCT-2023 This report was submitted via the online direct entry reporting system. The patient was not pregnant. The reporter seriousness for Delayed injection site reaction following injection: Intervention required. The patient received RSV for the indication Necrotic tissue, which led to drug use for unapproved indication.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: FluLaval was in a cooler with the temp log reading  minus 1.6 Celsius; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number E5MN5, expiry date 30-JUN-2024) for prophylaxis.   On 14-OCT-2023, the patient received FluLaval Quadrivalent. On an unknown date, an unknown time after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug (Verbatim: FluLaval was in a cooler with the temp log reading  minus 1.6 Celsius). 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: 18-OCT-2023 The pharmacist reported that he had some FluLaval that was in a cooler with the temp log reading minus 1.6 Celsius. The vaccine was injected and the reporter wonder if need to revaccinate those individuals. 64 patients received the vaccine from the cooler reading minus 1.6 Celsius which led to incorrect storage of drug. The pharmacists reported that he had 185 doses, that had not been injected. The reporter consented to follow up via postal.    The vaccine administration facility is the same as primary reporter. The Healthcare professional stated she would rather provide patient demographics at follow up. This case is linked with US2023AMR148062, same reporter.; Sender's Comments:  US-GSK-US2023AMR148062:Original Case : US2023144281
Sex: F
Vaccine: FLUR3, RSV
Symptoms: Fatigue, Headache
Clinical narrative: experienced fatigue with the first 12 hours of administration; experienced severe headache with the first 12 hours of administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of fatigue in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE RHA 3V (BACULOVIRUS) (FLUBLOK) for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm) and FLUBLOK (unknown arm). On an unknown date, less than a day after receiving Arexvy, the patient experienced fatigue (Verbatim: experienced fatigue with the first 12 hours of administration) and headache (Verbatim: experienced severe headache with the first 12 hours of administration). The outcome of the fatigue and headache were not reported.   It was unknown if the reporter considered the fatigue and headache to be related to Arexvy.     It was unknown if the company considered the fatigue and headache to be related to Arexvy.   Additional Information: GSK receipt date: 16-Oct-2023 A healthcare provider informed of an adverse event when she received Arexvy concomitantly with Flublok.  Both given in the same arm, about an inch apart.  She experienced severe headache and fatigue with the first 12 hours of administration. The follow-up could not be possible as no contact details were available. It was unknown if the reporter considered the fatigue and headache to be related to Flublok.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Injection site mass, Pain, Pruritus, Skin warm
Clinical narrative: I have a big lump at injection site; warm too touch; sore; itchy; tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site lump 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 injection site lump (Verbatim: I have a big lump at injection site), skin warm (Verbatim: warm too touch), pain (Verbatim: sore), pruritus (Verbatim: itchy) and tiredness (Verbatim: tiredness). The outcome of the injection site lump, skin warm, pain, pruritus and tiredness were not reported.   It was unknown if the reporter considered the injection site lump, skin warm, pain, pruritus and tiredness to be related to Arexvy.     It was unknown if the company considered the injection site lump, skin warm, pain, pruritus and tiredness to be related to Arexvy.   Additional Information: GSK receipt date: 16-Oct-2023 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient had received Arexvy and had big lump at injection site, warm too touch, sore, itchy and tiredness. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: patient given diluent; patient given diluent; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 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 preparation of medication (Verbatim: patient given diluent) and inappropriate dose of vaccine administered (Verbatim: patient given diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-OCT-2023 The reporter stated that there was mixing error and patient was given diluent of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not agreed to follow up.
Sex: U
Vaccine: RSV
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site reaction 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 injection site reaction (Verbatim: Injection site reaction). The outcome of the injection site reaction was not reported.   It was unknown if the reporter considered the injection site reaction to be related to Arexvy.  It was unknown if the company considered the injection site reaction to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2023 The patient took Arexvy shot and experienced injection site reaction.  The reporter said that they watched it for a couple of days. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Gaze palsy, Influenza like illness, Mobility decreased
Clinical narrative: Headache; was in bed; Experienced chills; Body aches; Flu-like symptoms; Feeling lousy; Sensation of a needle stick; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 7s7mf, expiry date 27-SEP-2025) for prophylaxis.   On 09-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On 09-OCT-2023, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: Headache) and bedridden (Verbatim: was in bed). In OCT-2023, the patient experienced shivers (Verbatim: Experienced chills), general body pain (Verbatim: Body aches), influenza-like symptoms (Verbatim: Flu-like symptoms), feeling bad (Verbatim: Feeling lousy) and paresthesia (Verbatim: Sensation of a needle stick). On 11-OCT-2023, the outcome of the bedridden was resolved (duration 2 days). The outcome of the headache, shivers, general body pain, influenza-like symptoms, feeling bad and paresthesia were resolved.   It was unknown if the reporter considered the headache, bedridden, shivers, general body pain, influenza-like symptoms, feeling bad and paresthesia to be related to Shingrix.     It was unknown if the company considered the headache, bedridden, shivers, general body pain, influenza-like symptoms, feeling bad and paresthesia to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-OCT-2023 The patient was self-reported this case. The reporter reported that the she received Shingrix vaccine on a Monday at 5:30 pm and By 9 pm that same evening she experienced headache and went to bed and was in bed until Wednesday.  The reporter stated that exactly one week later the she was playing tennis and experienced the sensation of a needle stick in her left arm where she was vaccinated with Shingrix.  The patient reports she feeling lousy throughout the day.   She experienced chills, flu-like symptoms, headache and body aches.   Tuesday morning she took a COVID test which results negative.   The reporter reported that by the end of day Tuesday all symptoms was resolved. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: Headache; was in bed; Experienced chills; Body aches; Flu-like symptoms; Feeling lousy; Sensation of a needle stick; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 7s7mf, expiry date 27-SEP-2025) for prophylaxis.   On 09-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On 09-OCT-2023, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: Headache) and bedridden (Verbatim: was in bed). In OCT-2023, the patient experienced shivers (Verbatim: Experienced chills), general body pain (Verbatim: Body aches), influenza-like symptoms (Verbatim: Flu-like symptoms), feeling bad (Verbatim: Feeling lousy) and paresthesia (Verbatim: Sensation of a needle stick). On 11-OCT-2023, the outcome of the bedridden was resolved (duration 2 days). The outcome of the headache, shivers, general body pain, influenza-like symptoms, feeling bad and paresthesia were resolved.   It was unknown if the reporter considered the headache, bedridden, shivers, general body pain, influenza-like symptoms, feeling bad and paresthesia to be related to Shingrix.     It was unknown if the company considered the headache, bedridden, shivers, general body pain, influenza-like symptoms, feeling bad and paresthesia to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-OCT-2023 The patient was self-reported this case. The reporter reported that the she received Shingrix vaccine on a Monday at 5:30 pm and By 9 pm that same evening she experienced headache and went to bed and was in bed until Wednesday.  The reporter stated that exactly one week later the she was playing tennis and experienced the sensation of a needle stick in her left arm where she was vaccinated with Shingrix.  The patient reports she feeling lousy throughout the day.   She experienced chills, flu-like symptoms, headache and body aches.   Tuesday morning she took a COVID test which results negative.   The reporter reported that by the end of day Tuesday all symptoms was resolved. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: COVID19, FLUX, RSV
Symptoms: Contusion, Erythema, Injection site haemorrhage, Muscle swelling
Clinical narrative: The entire deltoid area is also red in addition; Swelling of right deltoid area; Bruise on his arm; Blood came out of the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 61-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7X7A5, expiry date 01-FEB-2025) and (batch number 95K2R, expiry date 07-FEB-2026) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On 10-OCT-2023, the patient received Arexvy (intramuscular, right deltoid). On 10-OCT-2023, the patient received Influenza vaccine (left arm) and COVID 19 VACCINE (left arm). On 10-OCT-2023, immediately after receiving Arexvy and not applicable after receiving Influenza vaccine, the patient experienced injection site hemorrhage (Verbatim: Blood came out of the injection site). On 11-OCT-2023, the patient experienced localized erythema (Verbatim: The entire deltoid area is also red in addition), muscle swelling (Verbatim: Swelling of right deltoid area) and bruising of arm (Verbatim: Bruise on his arm). The outcome of the injection site hemorrhage, localized erythema, muscle swelling and bruising of arm were not resolved.   It was unknown if the reporter considered the injection site hemorrhage, localized erythema, muscle swelling and bruising of arm to be related to Arexvy. It was unknown if the reporter considered the localized erythema, muscle swelling and bruising of arm to be related to Influenza vaccine.     It was unknown if the company considered the injection site hemorrhage, localized erythema, muscle swelling and bruising of arm to be related to Arexvy. It was unknown if the company considered the localized erythema, muscle swelling and bruising of arm to be related to Influenza vaccine.  Additional Information: GSK Receipt Date: 16-OCT-2023 The pharmacist reported that a patient received Arexvy vaccine (lyophilized antigen lot number 7X7A5 and  adjuvant lot number 95K2R). The pharmacist stated when he removed the needle after the injection, blood came out of the injection site, and then the following day the patient had a bruise on his arm the size of a tennis ball. The entire deltoid area was also red in addition to swollen. This was still (till the time of reporting) ongoing.  The patient also received influenza and Covid-19 vaccines on the same day, but these were administered in the left arm. Time to onset of localized erythema, muscle swelling and bruising of arm was 1 day with Arexvy, Influenza and Covid-19 vaccines. It was unknown if the company considered the localized erythema, muscle swelling and bruising of arm to be related to Covid-19 vaccine. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: would like the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received first dose on 8-SEP-2022 ).   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: would like the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date:16-OCT-2023 The pharmacist called to inquire how to proceed with the Shingrix Series. The pharmacist reported a patient received the first dose of Shingrix on 08-SEP-2022 and would like the second dose. The reporter asked if the patient could get the second dose or they need to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling cold, Headache, Pain
Clinical narrative: felt like a needle was still on patient's arm; started with chills; body aches/pain; headache; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included the patient was not immunocompromised.   On 02-OCT-2023, the patient received the 1st dose of Shingrix. On 04-OCT-2023, 2 days after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches/pain) and headache (Verbatim: headache). In OCT-2023, the patient experienced feeling abnormal (Verbatim: felt like a needle was still on patient's arm) and chills (Verbatim: started with chills). In OCT-2023, the outcome of the feeling abnormal and chills were resolved. The outcome of the general body pain and headache were resolved.   It was unknown if the reporter considered the general body pain, headache, feeling abnormal and chills to be related to Shingrix.     It was unknown if the company considered the general body pain, headache, feeling abnormal and chills to be related to Shingrix.   Additional Information: GSK Receipt date: 16-OCT-2023 The patient over 50 years, received Shingrix first dose. On Wednesday (4th October 2023) the patient started with body aches, pains and headache. The patient played tennis one week later and she felt like a needle was still on her arm and started with chills and pain again. The patient was now okay. The reporter did not consent to follow up.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: patient inadvertently received BEXSERO instead of  MENVEO; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 17-OCT-2023, the patient received Bexsero. On 17-OCT-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient inadvertently received BEXSERO instead of  MENVEO). The outcome of the wrong vaccine administered 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: 17-Oct-2023 The reporter was a medical assistant (MA).   The reporter gave consent for follow up. The patient received Bexsero instead of Menveo, which led to wrong vaccine administered.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 16th August 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-OCT-2023 The pharmacist reported that patient had not yet received the second dose, though he was there in pharmacy waiting to receive it.  The pharmacist was in a hurry and declined to provide any further information. The Vaccine Administration Facility is the same as Primary Reporter. No further details available.   The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. VAERS details pertains to 1st dose of Twinrix in product tab
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: she returned to the clinic complaining of numbness; tingling in her left 4th and 5th fingers; This non-serious case was reported by a other health professional via call center representative and described the occurrence of numbness in fingers in a 44-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) (batch number 7Z423, expiry date 30-JUN-2024) for prophylaxis.   On 17-OCT-2023, the patient received Fluarix Tetra 2023-2024 season (injection, left deltoid) .5 ml. On 17-OCT-2023, 1 hr after receiving Fluarix Tetra 2023-2024 season, the patient experienced numbness in fingers (Verbatim: she returned to the clinic complaining of numbness) and tingling of extremity (Verbatim: tingling in her left 4th and 5th fingers). The outcome of the numbness in fingers and tingling of extremity were not resolved.   It was unknown if the reporter considered the numbness in fingers and tingling of extremity to be related to Fluarix Tetra 2023-2024 season.     It was unknown if the company considered the numbness in fingers and tingling of extremity to be related to Fluarix Tetra 2023-2024 season.   Additional Information: GSK receipt date: 17-Oct-2023 Nurse practice reported that working at GlaxoSmithKline Clinic giving FLUARIX 2023-2024 SEASON Vaccines.  One hour after administering a vaccine, she returned to the clinic complaining of numbness and tingling in her left 4th and 5th fingers.   The reporter reported that the symptoms 4 hours after administration and symptoms had not resolved.   Vaccine was not listed in SF look up menu.   IT Ticket had been placed and escalated.   The reporter consented to follow-up.
Sex: U
Vaccine: FLU4
Symptoms: Intercepted product storage error
Clinical narrative: 185 doses, incorrectly stored vaccines that have not been injected; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient did not receive FluLaval Quadrivalent. On an unknown date, an unknown time after receiving FluLaval Quadrivalent, the patient experienced intercepted product storage error (Verbatim: 185 doses, incorrectly stored vaccines that have not been injected). The outcome of the intercepted product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2023 The pharmacist reported that he had some FluLaval that was in a cooler with the temp log reading minus 1.6 Celsius. The vaccine was injected and the reporter wonder if need to revaccinate those individuals. 64 patients received the vaccine from the cooler reading minus 1.6 Celsius. The pharmacists reported that he had 185 doses, that had not been injected which led to intercepted product storage error. The reporter consented to follow up via postal.    The vaccine administration facility is the same as primary reporter. The Healthcare professional stated she would rather provide patient demographics at follow up. This case is linked with US2023144281, same reporter.; Sender's Comments:  US-GSK-US2023144281:Original Case : US2023144281
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose of Kinrix was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31-JAN-2022) for prophylaxis.   On 01-JUN-2022, the patient received Kinrix. On 01-JUN-2022, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose of Kinrix 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: 18-Oct-2023 The practice manager consented to follow-up via email. The patient received an expire dose of Kinrix, which led to expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received a dose of Twinrix expired on September 22nd 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 48-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 14-OCT-2023, the patient received Twinrix. On 14-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: received a dose of Twinrix expired on September 22nd 2023). 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: 18-OCT-2023 The pharmacist reported on October 18th 2023 that female patient received a dose of Twinrix expired on September 22nd 2023 which led to expired vaccine used. The did not consent to follow up. The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never came back for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received the first dose of Shingrix on 17-MAR-2023).   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: never came back for the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2023 The pharmacist reported that a patient received the first dose of Shingrix back on 17-MAR-2023 and never came back for the second dose. The pharmacist called to inquire if the patient need to restart the series. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: difficult to walk; about pain on both legs; This non-serious case was reported by a physician via call center representative and described the occurrence of walking difficulty in a 87-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-SEP-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced walking difficulty (Verbatim: difficult to walk) and leg pain (Verbatim: about pain on both legs). The outcome of the walking difficulty and leg pain were not resolved.   It was unknown if the reporter considered the walking difficulty and leg pain to be related to Arexvy.   It was unknown if the company considered the walking difficulty and leg pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter was a Medical Doctor who contacted GlaxoSmithKline representative stating a patient received Arexvy and called the clinic on 16th October 2023 to complain about pain on both legs and difficult to walk.  The reporter did not know when the symptoms started.  According to the patient, she felt fine on the morning and then the symptoms return in the afternoon.  The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned an 8 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 73 years old. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, involving the same patient is linked to 20231055739.