chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Malaise, Pallor, Unresponsive to stimuli
Clinical narrative: Patient received 2nd shingrix and prevnar 20.  At time of 1st shingrix, pt said she had a reaction to tetanus toxoids in 1982 which caused her to faint.  Patient tolerated 1st dose of shingrix fine, waited in IMZ room for 15 minutes after administration.  Immediately after immunization today, she stated she wasn't feeling  well, was lightheaded and dizzy.  I grabbed 2 cool packs for the patient and a wet cloth.  I asked another technician to get the blood pressure monitor and patient then dropped her head closed her eyes and stopped speaking to me.  I was tapping patient and yelling her name.  She was occasionally making some sounds.  I had another pharmacist call EMS.  Rescue squad arrived quickly.  When they arrived on scene, patient had started to respond, was speaking to me, eyes were open and her color was starting to return.  She left with the rescue squad for observation in the parking lot due to her coming to the store alone.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Pain in neck/ stiff neck, Pain in knees, back, thighs (much more than usual), nausea, headache
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pain in neck/ stiff neck, Pain in knees, back, thighs (much more than usual), nausea, headache
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra influenza vaccine. patient had one 09/18/23, 12/15/23, 2/19/24. patient was informed no reaction was reported by patient.
Age: 91.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received Arexvy on 10/19/23 and 01/04/24. Guidelines only recommend one dose.
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received Arexvy on 10/19/23 and 01/04/24. Guidelines only recommend one dose.
Age: 34.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms reported; Caller reported AE on behalf of patient who was administered a dose of PROQUAD on 12/27/2023 and is over the indicated age to receive PROQUAD. No symptoms reported. Obtained consent to contact HCP. MIR Filed. No additional AE/PQC.; This spontaneous report was received from a nurse on behalf a to a 34-year-old patient (gender was not provided). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-DEC-2023, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5ml/dose, administered subcutaneously for prophylaxis, lot number#  reported as W022943.date was not provided, but upon internal validation established as 06-APR-2024(strength was not provided). The reporter stated that it was over the indicated age to receive this vaccine (Product administered to patient of inappropriate age). No symptoms were reported.No Additional Adverse event.  Lot number#W022943 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). Lot number#W022943 is a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Maternal exposure before pregnancy, No adverse event
Clinical narrative: FBE called on behalf of a pharmacist to report a patient who only received one dose of GARDASIL 9. Patient received one dose of GARDASIL 9 "around ten years ago" as a teenager and never completed the dosing series. Patient is currently pregnant. No a; FBE called on behalf of a pharmacist to report a patient who only received one dose of GARDASIL 9. Patient received one dose of GARDASIL 9 "around ten years ago" as a teenager and never completed the dosing series. Patient is currently pregnant. No a; FBE called on behalf of a pharmacist to report a patient who only received one dose of GARDASIL 9. Patient received one dose of GARDASIL 9 "around ten years ago" as a teenager and never completed the dosing series. Patient is currently pregnant. No a; This prospective spontaneous pregnancy report was received from a pharmacist via a company representative, referring to a pregnant female patient of unknown age.The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2014 (reported as "around ten years ago, as a teenager"), the patient was vaccinated by a health professional with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and never completed the dosing series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  On an unknown date in 2024 (reported as "currently"), the patient was pregnant (Maternal exposure before pregnancy). No additional adverse events (AE) were reported. The last menstrual period (LMP), estimated due date (EDD) and the pregnancy outcome were not known.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE. No PQC.; Customer called to report an AE with MMRII. The caller said an expired dose of MMRII was administered to a patient on 2/12/2024. Confirmed with caller no other AE occurred and the product did not have any temperature excursions prior to administratio; This spontaneous report as received from a nurse and refers to a 12-month-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 12-FEB-2024 the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # W017556 and expiration date 07-JAN-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (expired product administered and no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Vomiting
Clinical narrative: started vomiting and felt dizzy; started vomiting and felt dizzy; started vomiting and felt dizzy / she says this happen to her with the first dose too; started vomiting and felt dizzy / she says this happen to her with the first dose too; This spontaneous report was received from an other healthcare professional via a company representative and refers to a 26-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route and site of administration were not provided) for prophylaxis.   On an unspecified date after the first dose, the patient experienced vomiting and felt dizzy. On an unknown date, the patient recovered from the events.  On an unknown date, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route and site of administration were not provided) for prophylaxis.  On an unspecified date reported as 5 minutes after the vaccination, the patient started vomiting and felt dizzy. She stayed 10 minutes in a chair and was resolve. The patient stated she did not have any other situation, felt fine and was gone. The outcome of the events was reported as recovered.  The causality assessment between the events and the suspect vaccine was not reported.
Age: 1.17
Sex: U
Vaccine: RV5, UNK
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects or symptoms reported; Medical assistant called to report an additional dose of VAXELIS, ROTATEQ, and Prevnar administered inadvertently to a 14-month-old patient.   No side effects or symptoms reported.   Caller granted permission to follow up.  No additional AE/no PQC.; This spontaneous report was received from a medical assistant and refers to a 14-month-old patient of unknown gender. The patient's medical history, and concurrent conditions were not reported. Concomitant medications included pneumococcal vaccine conj 7v (crm197) (PREVNAR) (described in the narrative below).   It was stated that on 16-FEB-2024, the patient was inadvertently vaccinated with an additional dose of: diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) (VAXELIS) (dose, formulation, route and site of administration not provided) lot #C5917AA, expiration date: 29-JUL-2024 for prophylaxis; rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, formulation, route and site of administration not provided), lot #X015248, expiration date: 10-DEC-2024 for prophylaxis (extra dose administered); and pneumococcal vaccine conj 7v (crm197) (PREVNAR) (concomitant vaccine).  No side effects or symptoms reported (no adverse event).
Sex: M
Vaccine: FLU4
Symptoms: Macule, Rash pruritic, Urticaria
Clinical narrative: rash pruritic; Macule; urticaria; rash; Initial information regarding unsolicited valid non-serious was received at our license partner ASTRAZENECA-SWE GSP-PCP under reference: US-AstraZeneca-2024A033068 via other-healthcare professional on 07-Feb-2024 and transmitted to Sanofi 13-Feb-2024.  A spontaneous report has been received from the regulatory authority (FDA). The report concerns a male patient of Unknown ethnic origin (age 1 year).   The patient's past and current medical history included bronchopulmonary dysplasia (ongoing). No concomitant products were reported.   The patient started treatment with Beyfortus (nirsevimab) (batch number(s) 2022832) Dose number in series 1, intramuscular, on 10-OCT-2023 and with Pasteur / Influenza (seasonal) (fluzone Quadrivalent) (influenza vaccine inact split 4v) (batch number(s) UT8055NA) Dose number in series 1, intramuscular, on 10-OCT-2023. No malfunction has been reported for BEYFORTUS.   On 14-OCT-2023, the patient experienced rash pruritic (preferred term: Rash pruritic), macule (preferred term: Macule), urticaria (preferred term: Urticaria) and rash (preferred term: Rash). It is unknown if any action was taken with Beyfortus (nirsevimab) and Pasteur / Influenza (seasonal) (fluzone Quadrivalent) (influenza vaccine inact split 4v). The patient recovered from the event(s) of rash pruritic, macule, urticaria and rash on an unspecified date.   The events were considered non-serious. Device Information: Combination Product Report: Yes Product As Reported: BEYFORTUS Common Device Name: Syringe Procode: FMF Product Role: Suspect
Sex: U
Vaccine: RSV
Symptoms: Insurance issue, Pulmonary hypertension
Clinical narrative: pulmonary hypertension; This serious case was reported by a consumer via interactive digital media and described the occurrence of pulmonary hypertension 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 pulmonary hypertension (Verbatim: pulmonary hypertension) (serious criteria GSK medically significant). The outcome of the pulmonary hypertension was not resolved.   It was unknown if the reporter considered the pulmonary hypertension to be related to Arexvy.     It was unknown if the company considered the pulmonary hypertension to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-FEB-2024 This case was reported by consumer via (AE monitoring) interactive digital media. The reporter was a patient. Patient was suffering from pulmonary hypertension severely after receiving the Arexvy vaccine, so patient could get something to help get that back under control it would help patient in the long run. Patient just not quite ready yet for the outcome. Patient said that medication was hard to come by right now and patient's insurance company was fighting with patient's doctor on a prescription that the doctor said. Patient mean it did not want to pay for it so patient's sitting out there with nothing. This case had been linked with the case US2024AMR021396, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR021396:Same reporter
Sex: M
Vaccine: RVX
Symptoms: Hyperchlorhydria
Clinical narrative: Stomach acidity; This non-serious case was reported by a consumer and described the occurrence of hyperacidity in a 87-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number NDC 58160-0848-11) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included irbesartan (Avapro).   On 15-JAN-2024, the patient received RSV vaccine. On 17-JAN-2024, 2 days after receiving RSV vaccine, the patient experienced hyperacidity (Verbatim: Stomach acidity). The outcome of the hyperacidity was not resolved.   It was unknown if the reporter considered the hyperacidity to be related to RSV vaccine.     It was unknown if the company considered the hyperacidity to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 10-FEB-2024 The patient self-reported this case.  This report was submitted via the online direct entry reporting system.  The patient used Avapro as concomitant product for hypertension, and it was ongoing. The patient experienced stomach acidity and it was ongoing. The patient reported that symptoms were treated. The consent to follow up granted.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise
Clinical narrative: felt sick; unable to do much for 24 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles several years ago and didn't want to repeat it). Previously administered products included Shingrix (got the 1st dose of vaccine last year and it was fine).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: felt sick) and activities of daily living impaired (Verbatim: unable to do much for 24 hours). The outcome of the feeling unwell was not reported and the outcome of the activities of daily living impaired was resolved (duration 24 hrs).   The reporter considered the feeling unwell and activities of daily living impaired to be possibly related to Shingrix.     The company considered the feeling unwell and activities of daily living impaired to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 07-FEB-2024 The patient self-reported this case. The patient felt sick after getting the second vaccine and were unable to do much for 24 hours. The reporter stated everyone handled it differently. The second one, as their grandma would say, knocked her into next week. The reporter stated that just be ready not to do much after each one, just in case. After their close friend developed shingles, they saw how painful it could really be. The patient lived a full life, and did not want shingles to get in the way. Follow-up was not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Respiratory symptom, Vaccination failure
Clinical narrative: suspected vaccination failure; symptoms of RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: symptoms of RSV). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection was not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.     It was unknown if the company considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-FEB-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient reported that he/she was a senior with a chronic condition. The patient had all the symptoms of RSV (respiratory syncytial virus infection) but physician will not see him/her. The patient enquired what he/she should do. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for RSV and laboratory confirmation regarding RSV were unknown at the time of reporting. This case is linked with US2024AMR021394, same reporter. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2024AMR021394:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: Very ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (For tolerance of the 1st dose refer linked case US2024AMR021147).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unwell (Verbatim: Very ill). Rechallenge with Shingrix was positive. The outcome of the unwell was not reported.   The reporter considered the unwell to be possibly related to Shingrix.     The company considered the unwell to be possibly related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR021147   Additional Information: GSK Receipt Date: 07-FEB-2024 This case was reported by a patient via interactive digital media. The patient received both Shingrix vaccines couple of years back and these shots made him or her very ill. The patient saw his or her old administrator sick as heck and how his skin looked so he or she choose to receive both vaccines. After patient's close friend developed shingles, he or she saw how painful it could really be. The patient wants a full life live, and he or she did not want shingles to get in the way. The reporter further stated that here his or her story on why he or she started a conversation with his or her physician about his or her shingles risk. The reporter thought that the event might had been related to the product. For tolerance of the 1st dose refer linked case US2024AMR021147, reported by the same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2024AMR021147:same patient, diffrent dose
Age: 19.0
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: titers didn't show anything; Engerix series last year with dose one on 8/8/2023 and the second dose on 9/18/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 20-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B pediatric) (batch number EM9E4) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b pediatrico).   On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On 18-SEP-2023, the patient received the 2nd dose of Engerix B pediatric. On 18-SEP-2023, not applicable after receiving Engerix B, Engerix B and Engerix B and an unknown time after receiving Engerix B pediatric, the patient experienced drug dose administration interval too long (Verbatim: Engerix series last year with dose one on 8/8/2023 and the second dose on 9/18/2023). On an unknown date, the patient experienced therapy non-responder (Verbatim:  titers didn't show anything). The outcome of the therapy non-responder and drug dose administration interval too long 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: 09-FEB-2024 The reporter called to inquired how to proceed with Engerix series. Reporter reported that patient completed the Engerix series in childhood. The patient was a pharmacy student, and the school asked the patient to get titers and the titers did not show anything. The patient restarted the Engerix series last year from reporting day with two doses, both were of pediatric doses due to the patient's 19 year of age. The reporter asked question that, the patient just turned 20 years old, what would be the dosing (pediatric or adult). The reporter did not consent to follow-up. The patient received 2nd dose of Engerix B pediatric, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: inadvertently administered Pediarix instead of Infanrix; patient had already received 3 prior doses have Pediarix.; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 77J49) for prophylaxis.   On 09-FEB-2024, the patient received the 4th dose of Pediarix. On 09-FEB-2024, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: inadvertently administered Pediarix instead of Infanrix) and extra dose administered (Verbatim: patient had already received 3 prior doses have Pediarix.). The outcome of the wrong vaccine administered and extra dose 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: 12-FEB-2024 The office manager reported 15 month old female patient was supposed to receive Infanrix vaccine but was inadvertently administered Pediarix instead which led to wrong vaccine administered. The patient had already received 3 prior doses have Pediarix which led to extra dose administered. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of an adult dose to a 5 year old male; administration of an adult dose to a 5 year old male; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 5-year-old male patient who received HAV (Havrix 1440 adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 13-JAN-2023, the patient received the 1st dose of Havrix 1440 adult. On 13-JAN-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: administration of an adult dose to a 5 year old male) and adult product administered to child (Verbatim: administration of an adult dose to a 5 year old male). The outcome of the overdose and adult product administered to child 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: 12-FEB-2024 The reporter contacted GSK via phone and inquired about Havrix and what information was available about the administration of an adult dose to a child patient, which led to overdose and adult product administered to child. They provided data about the vaccine, patient and event. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2024018938:reporter same/ same product
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the administration of an adult dose to a 3 year old male; the administration of an adult dose to a 3 year old male; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 3-year-old male patient who received HAV (Havrix 1440 adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 27-JAN-2023, the patient received the 1st dose of Havrix 1440 adult. On 27-JAN-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: the administration of an adult dose to a 3 year old male) and adult product administered to child (Verbatim: the administration of an adult dose to a 3 year old male). The outcome of the overdose and adult product administered to child 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: 12-FEB-2024 The reporter contacted GSK via phone and inquired about Havrix and what information was available about the administration of an adult dose to a child patient, which led to overdose and adult product administered to child. They provided data about the vaccine, patient and event. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2024018936:reporter same/ same product
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to pediatric patient; Adult dose given to pediatric patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 4-year-old male patient who received HAV (Havrix 1440 adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 13-SEP-2023, the patient received the 1st dose of Havrix 1440 adult. On 13-SEP-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: Adult dose given to pediatric patient) and adult product administered to child (Verbatim: Adult dose given to pediatric patient). The outcome of the overdose and adult product administered to child 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: 12-FEB-2024 A pharmacist inquired about Havrix and asked what information was available about the administration of an adult dose to a 4 year old patient, which led to overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hadn't received the 3rd dose; Late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 3-year-old male patient who received HBV (Engerix B) (batch number YG7YJ) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received 1st dose on 7th December 2021).   On 04-APR-2022, the patient received the 2nd dose of Engerix B. On an unknown date, the patient did not receive the 3rd dose of Engerix B. On 04-APR-2022, an unknown time after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 3rd dose). The outcome of the drug dose administration interval too long and incomplete course of vaccination 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:12-FEB-2024 The reporter reported that a patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Headache, Influenza like illness, Oral disorder
Clinical narrative: lesion had bubble; lesions on nose, chin and cheek bone; Lesion on lips; cold sores; lesion had pain; fatigue; headache; flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in February 2023).   In JUL-2023, the patient received the 2nd dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced blister (Verbatim: lesion had bubble), skin lesion (Verbatim: lesions on nose, chin and cheek bone), oral lesion (Verbatim: Lesion on lips), cold sores (Verbatim: cold sores), pain (Verbatim: lesion had pain), fatigue (Verbatim: fatigue), headache (Verbatim: headache) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the blister, skin lesion, oral lesion, cold sores, pain, fatigue, headache and influenza-like symptoms were not resolved.   It was unknown if the reporter considered the blister, skin lesion, oral lesion, cold sores, pain, fatigue, headache and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the blister, skin lesion, oral lesion, cold sores, pain, fatigue, headache and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-FEB-2024 The consumer reported that she received her first dose of Shingrix in February  and reported no adverse event after first dose. The patient received 2nd dose on July 2023 and 6 to 8 weeks after second dose she developed cold sores / lesions on multiple areas of her face that have not resolved. She gave locations of lesions as nose, lips, chin, and cheek bone. The patient stated that lesions occurred every month and when they start to resolve after 4 weeks a new batch of lesions develop and appear larger.  Lesions had bubbles and are painful.  The first batch of lesions she described was a size of half inch long and wide.  The latest occurrence of lesions she described sizes up to 3 inches long by 1 inch wide.  When new lesions occured they were accompanied with headache, fatigue, and flu like symptoms.  She stated that she was being disfigured by the lesions.  The patient reported that she had never gotten cold sores or herpes before getting the Shingrix vaccine. She had spoken to her physician. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pain, Skin lesion
Clinical narrative: lesion had bubble; lesions on nose, chin and cheek bone; Lesion on lips; cold sores; lesion had pain; fatigue; headache; flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in February 2023).   In JUL-2023, the patient received the 2nd dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced blister (Verbatim: lesion had bubble), skin lesion (Verbatim: lesions on nose, chin and cheek bone), oral lesion (Verbatim: Lesion on lips), cold sores (Verbatim: cold sores), pain (Verbatim: lesion had pain), fatigue (Verbatim: fatigue), headache (Verbatim: headache) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the blister, skin lesion, oral lesion, cold sores, pain, fatigue, headache and influenza-like symptoms were not resolved.   It was unknown if the reporter considered the blister, skin lesion, oral lesion, cold sores, pain, fatigue, headache and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the blister, skin lesion, oral lesion, cold sores, pain, fatigue, headache and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-FEB-2024 The consumer reported that she received her first dose of Shingrix in February  and reported no adverse event after first dose. The patient received 2nd dose on July 2023 and 6 to 8 weeks after second dose she developed cold sores / lesions on multiple areas of her face that have not resolved. She gave locations of lesions as nose, lips, chin, and cheek bone. The patient stated that lesions occurred every month and when they start to resolve after 4 weeks a new batch of lesions develop and appear larger.  Lesions had bubbles and are painful.  The first batch of lesions she described was a size of half inch long and wide.  The latest occurrence of lesions she described sizes up to 3 inches long by 1 inch wide.  When new lesions occured they were accompanied with headache, fatigue, and flu like symptoms.  She stated that she was being disfigured by the lesions.  The patient reported that she had never gotten cold sores or herpes before getting the Shingrix vaccine. She had spoken to her physician. The reporter did not consent to follow up.
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Kinrix - Extra dose of IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 12-FEB-2024, the patient received Kinrix. On 12-FEB-2024, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: Kinrix - Extra dose of IPV). The outcome of the extra dose 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: 13-FEB-2024 The reporter wanted to report that after administrating Kinrix a patient received mistakenly an extra dose of IPV, which led to extra dose administered. The reporter wanted to report this event a get a case number for documentation purpose. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd 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 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 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: Late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-FEB-2024  The pharmacist called to inform that a patient had received the 1st dose of Shingrix and had not received the 2nd dose yet, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Only diluent portion of Shingrix administered; Only diluent portion of Shingrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number HZ94D, expiry date 10-FEB-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent portion of Shingrix administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent portion of Shingrix administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-FEB-2024 The reporter was Medical Assistant. The reporter called to report that a patient was vaccinated with only diluent portion of Shingrix without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Lot and expiry date reported and documented. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Arexvy administered to a person under age 60; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-FEB-2024, the patient received Arexvy (injection). On 15-FEB-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy administered to a person under age 60). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 15-FEB-2024 A sales rep with was making a call on a pharmacy when the pharmacist mentioned he had provided Arexvy to a person under age 60.  He was told by his team that he needed to contact GSK and report the adverse event to them . The patient with below 60 years age received Arexvy, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Renal pain, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19; KIDNEYS HURT ON BOTH SIDES OF BACK. CONTINUED TO DRINK WATER AND TEAS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: shrimp allergy, and concurrent conditions included: hypo thyroid. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, and batch number were not reported) dose was not reported, administered on 12-APR-2021 to Right Arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 was treated with nirmatrelvir/ritonavir on 16-JAN-2024 (Dose series-1). On 22-JAN-2024, the patient experienced kidneys hurt on both sides of back and had continued to drink water and teas (Dose series:1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from kidneys hurt on both sides of back continued to drink water and teas, and the outcome of suspected covid-19 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: Litte reaction; This spontaneous case was reported by a consumer and describes the occurrence of NONSPECIFIC REACTION (Litte reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NONSPECIFIC REACTION (Litte reaction). At the time of the report, NONSPECIFIC REACTION (Litte reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  This case was identified during the RA inspection 2023 as part of the no patient identifier clean-up finding. All corrections and updates to the case have been made and the case is locked.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2021: Case unlocked on 15-Feb-2024 as a part of RA inspection 2023 to perform significant correction. Case upgraded as valid and classification of no patient identifier was removed.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Pulmonary fibrosis
Clinical narrative: pulmonary fibrosis; vaccine (Moderna and Pfizer) caused inflammation and got back into the oxygen full time, and before only use it for exertion; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY FIBROSIS (pulmonary fibrosis) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Pulmonary fibrosis.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY FIBROSIS (pulmonary fibrosis) (seriousness criterion medically significant) and CONDITION AGGRAVATED (vaccine (Moderna and Pfizer) caused inflammation and got back into the oxygen full time, and before only use it for exertion). At the time of the report, PULMONARY FIBROSIS (pulmonary fibrosis) and CONDITION AGGRAVATED (vaccine (Moderna and Pfizer) caused inflammation and got back into the oxygen full time, and before only use it for exertion) outcome was unknown.            Concomitant medication not reported.   Treatment medication not reported.  The patient had pulmonary fibrosis before the vaccinations, the vaccine (Moderna and Pfizer) caused inflammation and got back into the oxygen full time, and before only used it for exertion.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with relevant medical history of pulmonary fibrosis, who experienced the unexpected and serious (due to medically significant) event of Pulmonary fibrosis and the non-serious and unexpected event of Condition aggravated, which occurred on a date after an unspecified dose of mRNA-1273 vaccine. Co-suspect product included Tozinameran. As reported, the vaccine caused inflammation and patient got back into oxygen full time. He used it only for exertion before. No information disclosed about diagnostic tests performed and clinical course. Underlying pulmonary fibrosis can be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: it was reported that patient experienced: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (it was reported that patient experienced: COVID-19) in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Secondary progressive multiple sclerosis and Relapsing-remitting multiple sclerosis.    In October 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In November 2023, the patient experienced COVID-19 (it was reported that patient experienced: COVID-19). At the time of the report, COVID-19 (it was reported that patient experienced: COVID-19) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No Concomitant medications provided by the reporter. Patient current condition included Lesions and White matter disease. No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Stricture esophagus (Diagnosed 6 years ago. This was the reason patient can't swallow anything.) and Dilatation of esophagus (Surgery dilation of the esophagus and it helped to swallow, but swallowing food after chewing.). Previously administered products included for Product used for unknown indication: Pneumococcal conjugate 20 vaccine (The area where shot received up to elbow was red for two weeks.) on 12-Mar-2022 and Pneumococcal conjugate 20 vaccine on 12-Mar-2022. Past adverse reactions to the above products included Illness with Pneumococcal conjugate 20 vaccine; and Vaccination site erythema with Pneumococcal conjugate 20 vaccine. Concurrent medical conditions included Swallowing impaired (Can't swallow any pills, tablets, or capsules and is only able to take medication in liquid form.), Cough and Common cold. Concomitant products included PELARGONIUM SIDOIDES (UMCKA A) for Cough and Common cold.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of 300 milligram. At the time of the report, COVID-19 (Covid-19) outcome was unknown.            Patient weight was in between 107-110 pounds. Patient reported that she took all COVID vaccines up to date with Moderna vaccine. Patient experienced covid symptoms as regular cough and cold. Patient can't swallow any pills, tablets, or capsules and was only able to take medication in liquid form. Hence requested to come up with an alternate form of medication for Covid which was liquid or chewable.