chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/no PQC.; HCP reporting that VARIVAX was administered after it experienced a supported temperature excursion. No side effects were reported. No additional information provided. No additional AE/no PQC.         ?    Names of vaccines involved (including lot/e; This spontaneous report was received from Other Health Professional and refers to a 17-year-old patient of unknown gender,   The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 11-OCT-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided).  On 11-OCT-2023, HCP reported that VARIVAX was administered after it experienced a supported temperature excursion (Temperature: -9 C for 4 hours, 30 minutes). No side effects were reported. No additional information provided. No additional AE/no PQC.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE; adverse event regarding an expired dose of PNEUMOVAX 23 that was administered to a patient; This spontaneous report as received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 11-OCT-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (0.5 mL, lot #U035117 was valid for formulation prefilled syringe, expiration date 18-AUG-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). Nurse confirmed that the patient involved had not reported any symptoms or medical concerns related to the administration of the expired dose. No additional information provided regarding this adverse event. No additional adverse event (AE)/product quality complaint (PQC) reported (No adverse event).
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No side effects were reported/ No additional AE; HCP reporting that VARIVAX was administered after it experienced a supported temperature excursion. No side effects were reported. No additional information provided. No additional AE/no PQC.         ?    Names of vaccines involved (including lot/e; This spontaneous report was received from a Nurse Practitioner and refers to a 15-year-old patient.  The patient's medical history, concurrent conditions were not provided. Concomitant medications included sterile diluent (manufacturer unknown).   On 11-OCT-2023, the patient was vaccinated with a improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of  0.5 ml, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) following a temperature excursion of minus 9 degree Celsius for 4 hours, 30 minutes (Improper storage of product in use). No side effects were reported.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Abdominal pain upper, Eye contusion, Eye swelling, Headache, Palpitations
Clinical narrative: faint; Heart palpitations; headache; stomachache; brusing and swelling on sight; eye brusing/brusing and swelling on sight; This serious case was reported by a consumer and described the occurrence of faint in a 56-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis.   Concomitant products included thyroid bovine and buprenorphine hydrochloride + naloxone hydrochloride (Suboxone).   On 03-OCT-2023, the patient received Shingles vaccine and COVID 19 VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced faint (Verbatim: faint) (serious criteria GSK medically significant), palpitation (Verbatim: Heart palpitations), headache (Verbatim: headache), stomach pain (Verbatim: stomachache), eye swelling (Verbatim: brusing and swelling on sight) and eye contusion (Verbatim: eye brusing/brusing and swelling on sight).  The outcome of the faint, palpitation, headache, stomach pain, eye swelling and eye contusion were not resolved.   It was unknown if the reporter considered the faint, palpitation, headache, stomach pain, eye swelling and eye contusion to be related to Shingles vaccine.     It was unknown if the company considered the faint, palpitation, headache, stomach pain, eye swelling and eye contusion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-OCT-2023 The reporter stated that patient administered the shingles vaccine of unspecified manufacturer. The patient dated heart palpitation, fainted, headache, stomachache and brushing and swelling on sight. All the reported symptoms were ongoing. The patient also got the covid shot too. The symptoms were not treated. The expiry date of shingles vaccine was unknown. It was unknown if the company considered the faint, palpitation, headache, stomach pain, eye swelling and eye contusion to be related to Covid 19 vaccine.  The reporter did not consented to contact.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Syncope
Clinical narrative: faint; Heart palpitations; headache; stomachache; brusing and swelling on sight; eye brusing/brusing and swelling on sight; This serious case was reported by a consumer and described the occurrence of faint in a 56-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis.   Concomitant products included thyroid bovine and buprenorphine hydrochloride + naloxone hydrochloride (Suboxone).   On 03-OCT-2023, the patient received Shingles vaccine and COVID 19 VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced faint (Verbatim: faint) (serious criteria GSK medically significant), palpitation (Verbatim: Heart palpitations), headache (Verbatim: headache), stomach pain (Verbatim: stomachache), eye swelling (Verbatim: brusing and swelling on sight) and eye contusion (Verbatim: eye brusing/brusing and swelling on sight).  The outcome of the faint, palpitation, headache, stomach pain, eye swelling and eye contusion were not resolved.   It was unknown if the reporter considered the faint, palpitation, headache, stomach pain, eye swelling and eye contusion to be related to Shingles vaccine.     It was unknown if the company considered the faint, palpitation, headache, stomach pain, eye swelling and eye contusion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-OCT-2023 The reporter stated that patient administered the shingles vaccine of unspecified manufacturer. The patient dated heart palpitation, fainted, headache, stomachache and brushing and swelling on sight. All the reported symptoms were ongoing. The patient also got the covid shot too. The symptoms were not treated. The expiry date of shingles vaccine was unknown. It was unknown if the company considered the faint, palpitation, headache, stomach pain, eye swelling and eye contusion to be related to Covid 19 vaccine.  The reporter did not consented to contact.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Death, Malaise, Mobility decreased, Upper respiratory tract infection
Clinical narrative: had a stroke; upper respiratory infection; sick; in bed; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced stroke (Verbatim: had a stroke) (serious criteria death and GSK medically significant), upper respiratory tract infection (Verbatim: upper respiratory infection) (serious criteria death), sickness (Verbatim: sick) (serious criteria death) and bedridden (Verbatim: in bed) (serious criteria death).  The reported cause of death was stroke, upper respiratory tract infection, sickness and bedridden.   It was unknown if the reporter considered the stroke, upper respiratory tract infection, sickness and bedridden to be related to Shingrix.     It was unknown if the company considered the stroke, upper respiratory tract infection, sickness and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 This case was reported by a patient via interactive digital media. It was reported that the patient was sick in bed with upper respiratory infection and side effects from Shingrix vaccine. The reporter stated that the only person he knew had a stroke afterwards and died within two years of complications. The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Stroke; Upper respiratory tract infection; Sickness; Bedridden
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Diarrhea; Her arm hurt really bad; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 29EY3, expiry date 28-JUN-2024) for prophylaxis.   Concurrent medical conditions included allergy (Cephalexin, Morphine, Codeine and Sulfa albendazole). Concomitant products included alprazolam.   On 01-JUN-2023, the patient received the 1st dose of Shingrix (right deltoid). On 01-JUN-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Her arm hurt really bad). On an unknown date, the patient experienced diarrhea (Verbatim: Diarrhea).  The outcome of the pain in arm was resolved (duration 3 days) and the outcome of the diarrhea was not resolved.   The reporter considered the pain in arm and diarrhea to be possibly related to Shingrix.     The company considered the pain in arm and diarrhea to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 31-AUG-2023 The patient was self-reported this case. The reporter reported that she received Shingrix vaccine and on same day she experienced arm hurt really bad for 3 days. The patient experienced diarrhea before receiving 2nd dose of Shingrix vaccine. The reporter consented to follow up.   Follow information received on 05-OCT-2023 It was reported that patient received 2nd dose on 30th August 2023 on left deltoid with batch number 7L777 and expiry date 22 August 2025. The patient had allergies with Cephalexin which caused GI upset and diarrhea, Morphine which caused itching, Codeine which caused nausea, vomiting and Sulfa albendazole which caused nausea, vomiting. It was reported that the clinic was unaware of the adverse events occurred after 1st dose. Summary of changes: Patient tab, product tab, event tab and narrative was updated.; Sender's Comments:  US-GSK-US2023AMR122939:
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: hives on her torso; Itching; Painful arm/ sore arm; This non-serious case was reported by a consumer via patient support programs and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-SEP-2023, the patient received Shingrix and Arexvy. On 12-SEP-2023, less than a day after receiving Shingrix and Arexvy, the patient experienced hives (Verbatim: hives on her torso), pruritus (Verbatim: Itching) and pain in arm (Verbatim: Painful arm/ sore arm).  The outcome of the hives, pruritus and pain in arm were not resolved.   It was unknown if the reporter considered the hives, pruritus and pain in arm to be related to Shingrix and Arexvy.     It was unknown if the company considered the hives, pruritus and pain in arm to be related to Shingrix and Arexvy.   Additional Information: GSK receipt date: 04-OCT-2023 This report was submitted via the online direct entry reporting system.  The patient called in complaining of a sore arm, hives on her torso, and itching.  She stated it had been about 30 days since she received both her second dose of Shingrix and the Arexvy shot.                                 Reason for no Batch or Lot number of Arexvy was unwilling to provide. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: issued an expired drug; This non-serious case was reported by a physician via patient support programs and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 05-OCT-2023, the patient received Boostrix. On 05-OCT-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: issued an expired drug).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 5-Oct-2023 The case was received from the physician via (digital services) patient support programs. The reporter unwilling to provide reason for no batch or lot number of Boostrix. The reporter consented to follow-up. The patient received an expired dose of Boostrix, which led to expired vaccine used.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: body aches the next day; tiredness; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on 23rd March 2021, refer case US2023109506).   On 18-JUN-2021, the patient received the 2nd dose of Shingrix. On 19-JUN-2021, 1 days after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches the next day) and tiredness (Verbatim: tiredness).  Rechallenge with Shingrix was positive. The outcome of the general body pain and tiredness were resolved (duration 24 hrs).   It was unknown if the reporter considered the general body pain and tiredness to be related to Shingrix.     It was unknown if the company considered the general body pain and tiredness to be related to Shingrix.   Linked case(s) involving the same patient:  US2023109506   Additional Information: GSK Receipt date: 11-AUG-2023 The reporter was the wife of the patient. After the patient received the second dose, the patient experienced the same events, tiredness and body aches the next day which lasted for 24 hours. The reporter consented to follow up.   Follow up information received on 03-OCT-2023 Summary of changes: reporter details and  event details were updated.
Sex: U
Vaccine: RSV
Symptoms: Cough
Clinical narrative: Still has a bad cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough 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 cough (Verbatim: Still has a bad cough).  The outcome of the cough was not resolved.   It was unknown if the reporter considered the cough to be related to Arexvy.     It was unknown if the company considered the cough to be related to Arexvy.   Additional Information: GSK Receipt date: 03-OCT-2023 This case was reported by patient via (open field AE monitoring) interactive digital media. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Hypersensitivity, Pruritus, Swelling
Clinical narrative: itching; swelling; Allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 28-SEP-2023, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pruritus (Verbatim: itching), swelling (Verbatim: swelling) and allergic reaction (Verbatim: Allergic reaction).  The patient was treated with benadryl (nos) (Benadryl). The outcome of the pruritus, swelling and allergic reaction were resolved (duration 1 week).   It was unknown if the reporter considered the pruritus, swelling and allergic reaction to be related to RSV vaccine.     It was unknown if the company considered the pruritus, swelling and allergic reaction to be related to RSV vaccine.   Additional Information: GSK Receipt date: 05-OCT-2023 This case was reported by patient via interactive digital media. A reporter reported that a patient had the RSV shot last Thursday and had itching and swelling for 1 week. The patient thought was an allergic reaction he/she need to know the ingredients and also benadyrl did not do anything to help the patient. Follow up was not possible, as no contact details were available.
Age: 1.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was incorrectly given to a 16 month old male instead of Infanrix; Kinrix was incorrectly given to a 16 month old male instead of Infanrix; This non-serious case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix was incorrectly given to a 16 month old male instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: Kinrix was incorrectly given to a 16 month old male instead of Infanrix).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt date: 03-OCT-2023 A reporter reported that Kinrix was incorrectly given to a patient instead of Infanrix, it was human error and the staff will be educated. Kinrix was incorrectly given to a 16 month old male instead of Infanrix which led to Wrong vaccine administered and Inappropriate age at vaccine administration. The reporter did not agree to follow up from GSK.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site vesicles
Clinical narrative: experienced non painful blisters around injection site; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site blisters in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75BFS, expiry date 28-JAN-2025) for prophylaxis.   On 02-OCT-2023, the patient received Arexvy. On 03-OCT-2023, 1 days after receiving Arexvy, the patient experienced injection site blisters (Verbatim: experienced non painful blisters around injection site).  The outcome of the injection site blisters was resolving.   It was unknown if the reporter considered the injection site blisters to be related to Arexvy.     It was unknown if the company considered the injection site blisters to be related to Arexvy.   Additional Information: GSK Receipt date: 05-OCT-2023 The reporter reported that patient received Arexvy vaccine in pharmacy and day after vaccination patient had non painful blisters around injection site. The reporter spoke with the patient on the morning of reporting day and patient told that the blisters had subsided some. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Every time he gets his Shingles vaccine, he gets a couple of month's relief from his PHN; This non-serious case was reported by a nurse via sales rep and described the occurrence of unexpected therapeutic effect in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gallbladder disease (surgeon diagnosed patient with gallbladder disease), shingles (Shingles and surgery both occurred years before he came into their practice/care) and gallbladder removal (had an unnecessary gallbladder removal at the original sight of his Shingles). Concurrent medical conditions included post herpetic neuralgia (the patient suffered for many years from significant postherpetic neuralgia-PHN) and pain. Concomitant products included gabapentin and valaciclovir hydrochloride (Valtrex).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: Every time he gets his Shingles vaccine, he gets a couple of month's relief from his PHN).  The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter mentioned that every time patient got Shingles vaccine, he got a couple of month's relief from his PHN. The reporter did not mentioned whether he was referring to Shingrix. They asked how many times they thought he'd gotten the vaccine, however they did not track that in their office and recommended they spoke to the pharmacy. The patient took Gabapentin for pain and they experimented with Valtrex during flare ups. The patient would be barred from getting more than 2 shots both by the pharmacy and insurance. They discussed this at length with manager and local GSK Agent. They all agreed that this was not an adverse event. However, because it was an unexpected and/or unusual outcome, it should be reported Again, this was all the substantive information. The reporter consented to follow up.
Age: 12.0
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: gave a Boostrix vaccine that was expired by 10 days; This non-serious case was reported by a nurse and described the occurrence of expired vaccine used in a 12-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: gave a Boostrix vaccine that was expired by 10 days). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 04-OCT-2023 The reporter gave a Boostrix vaccine that was expired by 10 days, which led to expired vaccine used. The reporter asked if they have to re-vaccinate this patient.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, HIBV, MENB, MNQ, RV1
Symptoms: Intercepted product storage error, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; This non-serious case was reported by a other health professional and described the occurrence of intercepted product storage error in a patient who received DTPa (Infanrix) (batch number A5573, expiry date 13-JUL-2025) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis, DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis, HAV (Havrix) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis, HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis, Hib (Hiberix) (batch number G3453, expiry date 12-NOV-2024) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number 9C2KP, expiry date 31-DEC-2024) for prophylaxis, Men B NVS (Bexsero) (batch number 2X955, expiry date 31-JAN-2026) for prophylaxis and Rota (Rotarix lyophilized formulation) (batch number Y4NG3, expiry date 03-OCT-2025) for prophylaxis.   On an unknown date, the patient did not receive Infanrix .5 ml, Pediarix .5 ml, Kinrix .5 ml, Havrix .5 ml, Engerix B .5 ml, Hiberix .5 ml, Menveo .5 ml, Bexsero .5 ml and Rotarix lyophilized formulation .5 ml. On an unknown date, an unknown time after receiving Infanrix, Pediarix, Kinrix, Havrix, Engerix B, Hiberix, Menveo, Bexsero and Rotarix lyophilized formulation, the patient experienced intercepted product storage error (Verbatim: Product temperature excursion issue).  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: 4-Oct-2023 The pharmacy technician reaching out to GlaxoSmithKline to inquired about a temperature excursion and to verify validation of stability. There were several GlaxoSmithKline vaccines that were affected. Excursion started on 30th September 2023 at 7:21 pm 8.0 C thru 1st October 2023 11:55 pm reaching 28.5C. The several GlaxoSmithKline vaccines had temperature excursion and all medications had been removed to recommended storage and quarantined, which led to intercepted product storage error.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not received another dose; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of incomplete course of vaccination in a 15-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (1st dose received on January 2023) and Pediarix (2nd dose received on 9th February 2023).   On an unknown date, the patient did not receive the 3rd dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incomplete course of vaccination (Verbatim: Did not received another 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: 05-OCT-2023 The reporter reported that the 15 months old patient missed a dose of Pediarix due to his or her mom no showed at a 1 year old appointment. The reporter stated that the patient did not had any symptoms. Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: was uncomfortable for the patient; This non-serious case was reported by a consumer via call center representative and described the occurrence of discomfort in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-JUN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced discomfort (Verbatim: was uncomfortable for the patient).  The outcome of the discomfort was not reported.   It was unknown if the reporter considered the discomfort to be related to Shingrix.     It was unknown if the company considered the discomfort to be related to Shingrix.   Linked case(s) involving the same patient:  US2023135770   Additional Information: GSK Receipt Date: 03-OCT-2023 Reporter was the daughter calling on behalf of her father who was a male patient that received Shingrix vaccine. The reporter informed about Shingrix vaccine and went ahead and told this agent about various adverse events. The reporter stated that the 1st dose of Shingrix was received 5-JUN-2023 and it was uncomfortable for the patient. Reporter had no information about lot, expiry, location of administration, route of administration to provide. No information was provided about this dose. The 2nd vaccine was given on 22-AUG-2023 and 3rd one was on 31-AUG-2023. These vaccinations were given at 3 different pharmacies and there was only one pharmacy that was known. The reporter did not consent to follow up. The consent to follow up with healthcare professional was declined per a phone. The reporter was advised to contact his healthcare professional for further instructions. For the tolerance of later dose, refer case - US2023135770.; Sender's Comments:  US-GSK-US2023135770:3rd dose, same reporter
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction, received an expired flu vaccine
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient inadvertently received a 2nd dose of Prevnar20 his first being sometime in April. Patient only complained of redness and soreness at the injection site that has since resolved.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Nausea
Clinical narrative: Before 12 o'clock and within 30 minutes I started feeling achey,  the aches intensified all afternoon, followed by the chills, and by 4 o'clock I was wrapped up in  blankets on the couch. My hands were freezing cold and I was shaking uncontrollably.  At 5 o'clock while walking upstairs to bed, I became nauseated and began to pass out. I fell to the ground and kept my head down until the feeling passed.  My heart was racing and pounding. My husband helped to bed, my heart rate was 93 and it continued racing well into the evening. (my heart rate usually runs 60's) I continued feeling nauseated on/off during the evening. I was fine in the morning, just tired. Today, I am tired, however, I am fine.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Palpitations, Syncope, Tremor
Clinical narrative: Before 12 o'clock and within 30 minutes I started feeling achey,  the aches intensified all afternoon, followed by the chills, and by 4 o'clock I was wrapped up in  blankets on the couch. My hands were freezing cold and I was shaking uncontrollably.  At 5 o'clock while walking upstairs to bed, I became nauseated and began to pass out. I fell to the ground and kept my head down until the feeling passed.  My heart was racing and pounding. My husband helped to bed, my heart rate was 93 and it continued racing well into the evening. (my heart rate usually runs 60's) I continued feeling nauseated on/off during the evening. I was fine in the morning, just tired. Today, I am tired, however, I am fine.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Pain, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: Body aches, fatigue, headache, runny nose which lasted about 8 days.  The fatigue has improved moderately but not completely.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Rash, Rash macular, Rash papular
Clinical narrative: Macular papular rash with halos surrounding starting on anterior thighs, spreading to B arms, anterior chest and neck
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms.  Received an expired flu vaccine
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Fatigue, Pruritus, Skin warm
Clinical narrative: Redness spreading out over large area, itching, fatigue, very hot to the touch. Started almost 24 hours after administration
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced injection site reaction of swelling and redness. This came about the day after injection and lasted near a week, slowly resolving.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Contusion, Skin induration, Skin warm
Clinical narrative: Pt is reporting  very large bruising (3.5-4 inch bruise) across arm, it is hot to the touch and feels like there is a scab (hard spot) beneath the skin. Pt has an appointment scheduled wit h the doctor on Monday 10/16/2023
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Patient received the shot and had no immediate symptoms, but developed a very sore upper arm/shoulder that did not resolve. He described 10/10 pain when lifting his arm. He did not report thise to us until nearly a month after the vaccine, when he was picking up a steroid dose pack for the pain. He said the steroid resolved his pain completely when we checked in with him about a week after he picked up the steroid.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity, Swelling
Clinical narrative: From individual  "10/12/23, I administered 2 vaccines to patient. She called the pharmacy approximately 4 hours after receiving Shingrix and Flulaval and is reporting arm pain, swelling, and decreased range of motion with the left arm that she received the vaccines in. I administered both vaccines in the left arm after palpating the acromion process and placed both vaccines 2 finger widths below this landmark. The 1st vaccine was given 2 finger widths below the acromion process in the deltoid and the second shot was separated by the first by 1 inch. I informed the patient that I would be reporting this adverse event and that should would be contacted by management/a supervisor per her request."
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DA5C3, expiry date 09-MAY-2026) for prophylaxis.   On 02-OCT-2023, the patient received Arexvy. On 02-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 03-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist stated that only the adjuvant portion of Arexvy was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via postal.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Hyperhidrosis, Malaise
Clinical narrative: Vaccine was given at 1130am, at 1132 employee reported she was feeling short of breath, she was diaphoretic and her face and neck were bright red in color. SHe sat in chair, placed fan with cool air facing her. CHecked Blood pressure 147/87, HR 100, Sats 98%, reassess blood pressure in 3 minutes blood pressure 132/78, HR 92, Sats 98%. Reports she was feeling better and returned to work. at 1500 she reports feeling back to normal. The following day employee sent email stating she wazs not feeling well and had went to her provider. Provider suggested to fill out adverse raction form.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Feeling hot, Head injury, Loss of consciousness, Malaise
Clinical narrative: Rec'd vaccine on 10.5.23.  Later that night had malaise, felt hot and significant leg cramps bilaterally.  States occasionally gets cramps but usually only in one leg,  Also states on 10/7 experienced 2 episodes where she "blacked out" momentarily. States it was a long enough episode where she hit her head on a cabinet. States had similar episodes 5 years ago and never had them checked out.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms
Clinical narrative: Rec'd vaccine on 10.5.23.  Later that night had malaise, felt hot and significant leg cramps bilaterally.  States occasionally gets cramps but usually only in one leg,  Also states on 10/7 experienced 2 episodes where she "blacked out" momentarily. States it was a long enough episode where she hit her head on a cabinet. States had similar episodes 5 years ago and never had them checked out.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Injection site cellulitis, Injection site pain, Pyrexia, Swelling
Clinical narrative: Suspected cellulitis at site of injection. Symptoms include pain at injection site, swelling, redness, slight fever. TX cephalexin 500mg
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Provider and patient's mother both requested for the patient to receive the flu vaccine.  The Med Aid gave the flu vaccine and as she was documenting the administration she realized he had already had a flu vaccine on 10/2/2023.  The patient was observed in clinic for approximately 15 minutes.  The patient tolerated the dose well and had no adverse side effects while in the clinic.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in sn unapproved storage unit
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 77.0
Sex: M
Vaccine: FLU4, FLUA4
Symptoms: Wrong product administered
Clinical narrative: Patient received Fluad in the left deltoid  and then received by mistake flulaval in the right arm.  Patient did not have any reaction and was cought by the pharmacist after the patient returned home.  The patient returned to the pharmacy and received Arexvy in the right arm an inch from the other.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 1.17
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently gave the 12+ series
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Chills, headaches, muscle aches. Treatment - nsaids
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4, PNC20, RSV
Symptoms: Urticaria
Clinical narrative: hives in the upper arms area
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient stated that when she received the vaccine she felt pain in her arm like a "waterfall effect".  Patient experienced continued pain after the inject with a pain scale of 9.  Patient stated on (10/11/23) that the pain has lessened but she has pain when she raises her left arm into the air at the shoulder.  Patient reports pain is now about a 5.  Patient stated that she did not have any swelling or redness at the injection site or arm.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Sex: F
Vaccine: FLU4
Symptoms: Overdose
Clinical narrative: Two doses of Fluarix in the same day; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) (batch number 9CE79, expiry date 30-JUN-2024) for prophylaxis.   On 02-OCT-2023, the patient received Fluarix Tetra 2023-2024 season. On 02-OCT-2023, an unknown time after receiving Fluarix Tetra 2023-2024 season, the patient experienced overdose (Verbatim: Two doses of Fluarix in the same day). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-OCT-2023 The nurse reported that two doses of Fluarix were administered to a patient in the same day which led to overdose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Lymphadenopathy, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: swollen lymph node; her arm is sore; Consumer reports she is 38 years of age; This non-serious case was reported by a consumer via call center representative and described the occurrence of swollen lymph nodes in a 38-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 28-SEP-2023, the patient received Shingrix and Flu vaccine. On 28-SEP-2023, an unknown time after receiving Shingrix and not applicable after receiving Flu vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: Consumer reports she is 38 years of age). On an unknown date, the patient experienced swollen lymph nodes (Verbatim: swollen lymph node) and pain in arm (Verbatim: her arm is sore).  The outcome of the swollen lymph nodes, pain in arm and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the swollen lymph nodes and pain in arm to be related to Shingrix and Flu vaccine.     It was unknown if the company considered the swollen lymph nodes and pain in arm to be related to Shingrix and Flu vaccine.   Additional Information: GSK Receipt date: 03-OCT-2023 The patient self-reported his case. The reporter reported that she had a flu vaccine (unknown manufacturer/name) and a Shingrix vaccination on same day. The patient stated that she had a swollen lymph node in one of her arms, she went to urgent care on 2nd October 2023 and the provider confirmed a swollen lymph node was present on her arm.  Patient reported that her arm was sore, especially when moved. The reporter did not consent to follow up. No further information was provided. The reporter reported that she was 38 years old at the time of reporting, which led to inappropriate age at vaccine administration.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Asthma, Cough
Clinical narrative: severe asthma; cough; This non-serious case was reported by a physician via sales rep and described the occurrence of asthma in a 68-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-SEP-2023, the patient received Arexvy. On 20-SEP-2023, 1 days after receiving Arexvy, the patient experienced cough (Verbatim: cough). On 26-SEP-2023, the patient experienced asthma (Verbatim: severe asthma). The outcome of the asthma and cough were unknown.   It was unknown if the reporter considered the asthma and cough to be related to Arexvy.     It was unknown if the company considered the asthma and cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-OCT-2023 The reporter stated after administration of Arexvy vaccine, following day he experienced a cough. One week later he was diagnosed with severe asthma. In structural field event onset date was reported as 18Sep2023 which was before vaccine administration date. According to narrative patient experienced event following day of vaccine administration that was on 20Sep2023. Hence according to narrative event onset date was captured (20Sep2023). The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, Incorrect dose administered, Product preparation issue
Clinical narrative: received 2 doses of menveo today on accident; received 2 doses of menveo today on accident; mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient; mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient; 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 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA985A) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number 9C2KP, expiry date 31-DEC-2024) for prophylaxis.   On 04-OCT-2023, the patient received Menveo. On 03-OCT-2023, the patient received Menveo. On 03-OCT-2023, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient) and inappropriate dose of vaccine administered (Verbatim: mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient). On 04-OCT-2023, the patient experienced accidental overdose (Verbatim: received 2 doses of menveo today on accident) and extra dose administered (Verbatim: received 2 doses of menveo today on accident).  The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, accidental overdose and extra dose administered were unknown.   Additional Information: GSK Receipt date: 03-OCT-2023 and 04-OCT-2023 A HCP states a nurse mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient.  The reporter states that he/she had a patient who received 2 doses of menveo today on accident.  The reporter asked are there any adverse effects other than what is listed that he/she need to review with patient since he received a double dose. The patient received 2 doses of menveo today on accident which led to accidental overdose and extra dose administered. Nurse mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: received 4th dose of Kinrix instead of Infanrix; 14 months old received Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 14-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Previously administered products included Infanrix (1st dose received on 20 September 2022), Infanrix (2nd dose received on 23 November 2022) and Infanrix (3rd dose received on 23 January 2023).   On 02-OCT-2023, the patient received Kinrix. On 02-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: received 4th dose of Kinrix instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: 14 months old received Kinrix).  The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration 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: 04-OCT-2023 The healthcare professional requested data on the interchangeability of Kinrix and Infanrix. The healthcare professional reported that Infanrix was administered on 20 September 2022 as 1st dose, 23 November 2022 as 2nd dose, 23 January 2023 as 3rd dose and Kinrix was administered on 02 October 2023 as 4th or Booster dose instead of Infanrix which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.