chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Pfizer Covid Vaccine 6m-4yr was mistakenly mixed with too little diluent. Medical Assistant only used .22ml diluent instead of 2.2ml diluent to mix the vaccine, so vaccine administered was concentrated too strong. Dose drawn up and administered was .2ml. Parent notified and watched child for any additional symptoms post vaccine, but did not report any between 12-6-22 and 12-9-22.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Wrong product administered
Clinical narrative: Patient/employee given the wrong vaccine - given Moderna series vaccine and not the booster as requested/scheduled. This was the patient's 4th round of the vaccine. The patient tolerated the vaccine well and there were no adverse reactions/events.
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: IT WAS DISCOVERED AFTER THE DOSE WAS GIVEN THAT THE VACCINE WAS PAST THE DISCARD DATE OF 10 WEEKS AT REFRIGERATION TEMPERATURES.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Dizziness, Fatigue, Influenza virus test, Nausea
Clinical narrative: fever, nausea, chills, body aches, dizziness and fatigue
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever, nausea, chills, body aches, dizziness and fatigue
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Unevaluable event
Clinical narrative: patient was administered two doses of GARDASIL before 2014. Caller reports that the patient is unsure if they received a third dose of GARDASIL 9; This spontaneous report was received from a medical assistant referring to currently 30-year-old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     Before 2014, on unspecified dates, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported).   At reporting time, the patient was unsure if they received a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) (interchange of vaccine products).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE information; HCP called in to report that a consumer received their first dose of GARDASIL 9 on 01/04/2018, and second dose on 02/28/2019. Caller reports the patient was administered a third dose of GARDASIL 9 on 11/15/2022. No further information provided to fur; This spontaneous report was received from a nurse and refers to an 11-year-old male patient. His medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 04-JAN-2018, the patient was vaccinated with 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U029623, expiration date: 26-OCT-2023 (strength, exact dose, site and route of administration were not provided) for prophylaxis. On 28-FEB-2019 and 15-NOV-2022, the patient received respectively second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration). No additional adverse event was reported.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: is HPV positive for type 16 and/or 18.; This spontaneous report was received from a consumer referring to her 25-year-old niece. Information regarding concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not provided.   On an unknown date, when the patient was an adolescent she was vaccinated with 2 or 3 dosed of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (lot#, expiration date, dose, route of administrations was not provided).   It was reported that currently, the patient was human papilloma virus positive for type 16 and/or 18. It was reported that final results to confirm were pending. It was unknown if the patient received treatment for the event. The outcome of the event was not reported.   Causality assessment was not provided.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Biopsy skin, Circumstance or information capable of leading to medication error, Dysgeusia, Feeding disorder, Feeling abnormal
Clinical narrative: lost blood through his stool; weight loss; feeling bad; tongue turning white; being unable to eat food because it tasted bad; being unable to eat food because it tasted bad; his arm is still hurting; he does not think he was given the correct vaccine; Consumer also states they did a biopsy of his back to see if he had cancer; This spontaneous report was received from Consumer and refers to himself, a 67-year-old (also reported as 68-year-old) male patient.  The patient's medical history was not reported. The patient's concurrent conditions included hepatitis C. Concomitant medications included metformin, vitamins, acetylsalicylic acid (ASPIRINE) and composition unspecified (PENTAZOLE).   On 29-SEP-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #T040202, expiration date: 11-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided).  On 01-OCT-2021, 2 days after this vaccine, he started feeling bad, he lost blood through his stool, experienced weight loss and he had to be given 2 units of iron. He also had a biopsy of his back to see if he had cancer. He went to the emergency room for these symptoms, and they referred him back to his primary care physician. He was given pain medication in the emergency room as treatment. He was also in and out of the emergency room and asked to see a specialist which was refused. He reported his tongue turning white and being unable to eat food because it tasted bad, and he had to spit it back out. His arm was still hurting and he got the vaccine over a year ago. He stated over and over that he did not think he was given the correct vaccine. He went to the doctor's office for a flu shot and signed for the flu shot. A young woman came in with 2 syringes and because he had Hepatitis C when he was 21 or 22 years old, he assumed the second shot was a Hepatitis C shot. The doctor's office forged his signature for the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shot as the young woman took his paperwork from him and when it was brought back to him it was different. He did not consent to receive a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shot. This shot almost killed him. He states he is trying to find a lawyer with the intent to sue the doctor's office for giving him the wrong vaccine that he did not consent to. At the time of reporting, the patient had not recovered from the event of feeling bad, lost blood through his stool, weight loss, biopsy of his back to see if he had cancer, his arm is still hurting. The outcome of tongue turning white, being unable to eat food because it tasted bad.   The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.   Upon internal review, the event lost blood through his stool was determined to be medically significant.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Haematochezia, Mineral supplementation, Pain in extremity, Tongue discolouration, Weight decreased
Clinical narrative: lost blood through his stool; weight loss; feeling bad; tongue turning white; being unable to eat food because it tasted bad; being unable to eat food because it tasted bad; his arm is still hurting; he does not think he was given the correct vaccine; Consumer also states they did a biopsy of his back to see if he had cancer; This spontaneous report was received from Consumer and refers to himself, a 67-year-old (also reported as 68-year-old) male patient.  The patient's medical history was not reported. The patient's concurrent conditions included hepatitis C. Concomitant medications included metformin, vitamins, acetylsalicylic acid (ASPIRINE) and composition unspecified (PENTAZOLE).   On 29-SEP-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #T040202, expiration date: 11-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided).  On 01-OCT-2021, 2 days after this vaccine, he started feeling bad, he lost blood through his stool, experienced weight loss and he had to be given 2 units of iron. He also had a biopsy of his back to see if he had cancer. He went to the emergency room for these symptoms, and they referred him back to his primary care physician. He was given pain medication in the emergency room as treatment. He was also in and out of the emergency room and asked to see a specialist which was refused. He reported his tongue turning white and being unable to eat food because it tasted bad, and he had to spit it back out. His arm was still hurting and he got the vaccine over a year ago. He stated over and over that he did not think he was given the correct vaccine. He went to the doctor's office for a flu shot and signed for the flu shot. A young woman came in with 2 syringes and because he had Hepatitis C when he was 21 or 22 years old, he assumed the second shot was a Hepatitis C shot. The doctor's office forged his signature for the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shot as the young woman took his paperwork from him and when it was brought back to him it was different. He did not consent to receive a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shot. This shot almost killed him. He states he is trying to find a lawyer with the intent to sue the doctor's office for giving him the wrong vaccine that he did not consent to. At the time of reporting, the patient had not recovered from the event of feeling bad, lost blood through his stool, weight loss, biopsy of his back to see if he had cancer, his arm is still hurting. The outcome of tongue turning white, being unable to eat food because it tasted bad.   The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.   Upon internal review, the event lost blood through his stool was determined to be medically significant.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: lost blood through his stool; weight loss; feeling bad; tongue turning white; being unable to eat food because it tasted bad; being unable to eat food because it tasted bad; his arm is still hurting; he does not think he was given the correct vaccine; Consumer also states they did a biopsy of his back to see if he had cancer; This spontaneous report was received from Consumer and refers to himself, a 67-year-old (also reported as 68-year-old) male patient.  The patient's medical history was not reported. The patient's concurrent conditions included hepatitis C. Concomitant medications included metformin, vitamins, acetylsalicylic acid (ASPIRINE) and composition unspecified (PENTAZOLE).   On 29-SEP-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #T040202, expiration date: 11-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided).  On 01-OCT-2021, 2 days after this vaccine, he started feeling bad, he lost blood through his stool, experienced weight loss and he had to be given 2 units of iron. He also had a biopsy of his back to see if he had cancer. He went to the emergency room for these symptoms, and they referred him back to his primary care physician. He was given pain medication in the emergency room as treatment. He was also in and out of the emergency room and asked to see a specialist which was refused. He reported his tongue turning white and being unable to eat food because it tasted bad, and he had to spit it back out. His arm was still hurting and he got the vaccine over a year ago. He stated over and over that he did not think he was given the correct vaccine. He went to the doctor's office for a flu shot and signed for the flu shot. A young woman came in with 2 syringes and because he had Hepatitis C when he was 21 or 22 years old, he assumed the second shot was a Hepatitis C shot. The doctor's office forged his signature for the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shot as the young woman took his paperwork from him and when it was brought back to him it was different. He did not consent to receive a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shot. This shot almost killed him. He states he is trying to find a lawyer with the intent to sue the doctor's office for giving him the wrong vaccine that he did not consent to. At the time of reporting, the patient had not recovered from the event of feeling bad, lost blood through his stool, weight loss, biopsy of his back to see if he had cancer, his arm is still hurting. The outcome of tongue turning white, being unable to eat food because it tasted bad.   The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.   Upon internal review, the event lost blood through his stool was determined to be medically significant.
Age: 0.75
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; HCP calling to report that GARDASIL 9 was administered via IM route to 9 month old patient.; This spontaneous report was received from a physician and refers to a 9-month-old female patient.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided  On 06-DEC-2022, the patient was vaccinated with with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at dose 0.5 milliliter once (lot #W011266 was verfied to be a valid number, expiration date reported and established as 05-SEP-2024), administered intramuscularly for prophylaxis (anatomical injection site and strength were not provided) (product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination failure, Viral titre decreased
Clinical narrative: the recent test showed low varicella titer.; This spontaneous report was received from a pharmacist and refers to a 32-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date (reported as unspecified years ago when the patient was young), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, dose description, lot #, expiry date and route of administration were not provided).  On an unknown date, the patient's recent test showed low varicella titer (vaccination failure). At the time of reporting, the outcome of the event was not reported.   The event was considered to be related to varicella virus vaccine live (oka/merck) (VARIVAX).
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: The administration of improperly stored VARIVAX.; This spontaneous report was received from a physician referring to a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 01-DEC-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), for prophylaxis (lot #W018830 had been verified to be a valid number; expiration date 14-JUN-2024, and upon internal validation established as the same date)(dosage, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported). The administered dose of the vaccine was stored at a temperature of -5 degrees Celsius (C), during a time frame of 12 hours, as recorded by a digital data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA003172:MSD
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Vaccine coordinator reporting the administration of improperly stored VARIVAX. See Temperature Excursion case 02298756. No PQC reported.   ?    Names of vaccines involved: VARIVAX (W018830 06/14/2024)         ?    Temperature: -5C         ?; This spontaneous report was received from a physician referring to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 01-DEC-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot #W018830 had been verified to be a valid number; expiration date  14-JUN-2024, and upon internal validation established as the same date) (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported). The administered dose of the vaccine was stored at a temperature of -5 degrees Celsius (C), during a time frame of 12 hours, as recorded by a digital data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA003157:MSD
Sex: U
Vaccine: RV5
Symptoms: Death
Clinical narrative: death; This spontaneous report was received from a consumer and refers to an infant patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally (strength, lot #, and expiry date were not provided), for prophylaxis (strength, dose, lot # and expiry date were not provided).  On an unknown date, the patient died. The cause of death was not provided, and it was unknown whether an autopsy was performed.   The causal relationship between the patient's death and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA001743:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got both his shot year ago, shingles now/ suspected vaccination failure; Has them right now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In December 2022, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 4-Dec-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient got both his shot a year ago and he had them right now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Bedridden, Extra dose administered, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: Had four shots and still got it/Suspected vaccination failure; Still got it in eye; Severe pain; Had four shots; in bed for 1 month; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 4th dose of Shingles vaccine, the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), bedridden, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and extra dose administered were unknown and the outcome of the bedridden was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, bedridden and pain to be related to Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 4-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had four shots and still got them in left eye. The was in bed for 1 month and still had severe pain. The reporter denied for the follow-up. Additional supportive information: The patient received four shots of Shingrix, which led extra dose administered. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Was vaccinated, got shingles/Suspected vaccination failure; Shingles on eye; Shingles on face; Horrible pain; Rash; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine, the patient experienced pain and rash. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown and the outcome of the pain and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, pain and rash to be related to Shingles vaccine.     Additional Information: GSK receipt date; 4-Dec-2022 Reporter's comment: The case was received from the patient interactive digital media. The patient stated that vaccine did not prevent shingles. The patient questioned whether it minimized them, she was vaccinated and got shingles on her face, and eye medications early, horrible pain, rash going 1 month. The reporter denuded for the follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Back calculation was done for onset date of horrible pain and rash asmper reported information.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product communication issue
Clinical narrative: never received a second Shingrix dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments:  This case was reported by patient's husband.  The patient stated that 2 years ago the patient received only one single dose of Shingrix. The patient stated received the shot in the arm. The patient was never informed that Shingrix was given in two doses series; hence, they never received a second Shingrix dose.  The patient declined consent for safety follow up with healthcare professional.  The patient declined to provide date of birth and age instead.  The patient declined to provide relatives information and age.  The patient could not provide Shingrix lot, expiration date information, dosage or route of administration. No additional information provided.  The reporter did not consent to follow up.  This case had been linked with US2022178660, US2022AMR179084, US2022AMR179087, US2022AMR179086 same reporter. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022178660:Same reporter US-GSK-US2022AMR179085:Same reporter US-GSK-US2022AMR179086:Same reporter US-GSK-US2022AMR179087:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product communication issue
Clinical narrative: 1st dose 2 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments:  This case was reported by the patient' brother.  The patient stated that 2 years ago the patient received only one single dose of Shingrix. The patient stated received the shot in the arm. The patient was never informed that Shingrix was given in two doses series; hence, they never received a second Shingrix dose.  The patient declined consent for safety follow up with healthcare professional.  The patient declined to provide date of birth and age instead.  The patient declined to provide relatives information and age.  The patient could not provide Shingrix lot, expiration date information, dosage or route of administration. No additional information provided.  The reporter did not consent to follow up.  This case had been linked with US2022178660, US2022AMR179084, US2022AMR179087, US2022AMR179086 same reporter. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022178660:Same reporter US-GSK-US2022AMR179084:Same reporter US-GSK-US2022AMR179086:Same reporter US-GSK-US2022AMR179087:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain of skin
Clinical narrative: Body aches; Chills; Headache; Painful skin; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced general body pain, chills, headache and skin pain. On an unknown date, the outcome of the general body pain, chills, headache and skin pain were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, headache and skin pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022178661   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix a year ago and reported body aches, chills, a headache and painful skin. The reporter would call back with lot/expiration date of vaccine given as well as the date of the first Shingrix vaccine after checking her patient chart. The reporter consented to follow up.  Additional Supportive Information: For tolerance of 2nd dose, refer case US2022178661.; Sender's Comments:  US-GSK-US2022178661:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia, Post herpetic neuralgia
Clinical narrative: Nerv pain same area when i had shingles; This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the post herpetic neuralgia was recovering/resolving.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.     Additional Information: GSK receipt date: 30-NOV-2022 Reporter's comment:  The case was reported via interactive digital media. The patient asked could vaccine trigger post Shingles nerve pain. The patient received Shingrix vaccine and 10 days after vaccine patient experienced nerve pain in same areas when he/she had Shingles not as bad and it was resolving. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received 3 Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on June 2021) and Shingrix (2nd dose received on September 2021).   In November 2022, the patient received the 3rd dose of Shingrix. In November 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received three doses of Shingrix vaccine. The patient wanted to know if this hurt him/her. Additional supportive information: The patient received extra dose of Shingrix in error, which led to extra dose administered. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: 12 hrs at 66.92 °F and  42 hrs 24 minutes at 65.6 °F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: The reporter reported that the Bexsero vaccine had a temperature excursion lasting 12 hours with maximum temperature of 66.92 Fahrenheit, and then a second excursion lasting 42 hours 24 minutes, with a maximum temperature of 65.6 Fahrenheit. The reporter reported that the vaccine was administered to the patient after the second excursion occurred. At the time of reporting, the reporter did not had patient specific identifiers. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The Bexsero vaccine temperature was exposed 66.92 Fahrenheit for 12 hours and 65.6 Fahrenheit for 42 hours and 24 minutes, which led to incorrect storage of drug. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022179395:same reporter US-GSK-US2022AMR179996:same reporter
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: 12 hrs at 66.92 °F and  42 hrs 24 minutes at 65.6 °F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: The reporter reported that the Bexsero vaccine had a temperature excursion lasting 12 hours with maximum temperature of 66.92 Fahrenheit, and then a second excursion lasting 42 hours 24 minutes, with a maximum temperature of 65.6 Fahrenheit. The reporter reported that the vaccine was administered to the patient after the second excursion occurred. At the time of reporting, the reporter did not had patient specific identifiers. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The Bexsero vaccine temperature was exposed upto 66.92 Fahrenheit for 12 hours and 65.6 Fahrenheit for 42 hours and 24 minutes which led to incorrect storage of drug. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR179995:same reporter US-GSK-US2022179395:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Impaired work ability, Loss of personal independence in daily activities, Pain
Clinical narrative: it hurts; Side effects Take you to bed; lost almost 2 weeks of work,; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, bedridden and activities of daily living impaired. On an unknown date, the outcome of the pain, bedridden and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain, bedridden and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 30-NOV-2022 Reporter's comment:  This case was reported by a patient via interactive digital media. The patient reported that it was tremendous, he/she got it and lost almost 2 weeks of work, it was horrible. The patient already his/her first vaccine shot, and he/she will go for the second one on December. The patient reported that it was hurt, and side effects take the bed for a few days. It was unknown If patient received any additional medication during the event. It was unknown if patient had any relevant medical history or any additional safety information. Additional supportive information:  Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Hand hurting; This case was reported by a consumer via interactive digital media and described the occurrence of pain in hand in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in hand. On an unknown date, the outcome of the pain in hand was recovered/resolved.   It was unknown if the reporter considered the pain in hand to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that his/her neighbor got shingles and she was crying from the pain and she stated that that it was hurts horrible. The patient stated that he/she went to get the shingles vaccine. After received shingles vaccine the patient experienced strong hurting in her hand which was lasted for few days. The patient reported that he/she hope he/she do not get it because it was horrible. Additional supportive information: Follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose before covid (early 2020); This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on early 2020 before Covid).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comment: The patient reported that he/she received Shingrix vaccine in early 2020 before Covid and he/she missed to receive the 2nd dose. The patient wanted to know that he/she need to start over or just he/she receive his/her second dose. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019, never got the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's comment: Pharmacist reported that a patient never got the 2nd dose. Reporter consented to follow up. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Swelling
Clinical narrative: small red bumps all over body; small itcy bumps all over body; bumpy rash; red rash; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2022, the patient received the 2nd dose of Shingrix (intramuscular). In November 2022, less than 2 weeks after receiving Shingrix, the patient experienced local swelling, itchy rash, papular rash and red rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the local swelling, itchy rash, papular rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the local swelling, itchy rash, papular rash and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments:  The patient received second dose of Shingrix.  The days later, the patient experienced small red itchy bumps all over body.  The patient went to healthcare professional who prescribed steroids.  The bumps have not resolved yet.  The education provided per content.  The medical information phone number was provided.  The adverse event was filed. The reporter did not consent to follow up.
Age: 1.33
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix was given instead of Infanrix; 16 months old was given Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GH32J, expiry date 29th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th November 2022, the patient received the 1st dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 29th November 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong 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: 29-NOV-2022 Reporter's Comment: The reporter called in to report that Boostrix was given to a patient instead of Infanrix.  The reporter gave details with regards to patients and vaccine.  The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. Additional Supportive Information: The 16 months patient received Boostrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago 0.5 ml intramuscularly).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK receipt date: 29-NOV-2022 Reporter's comment: The case was reported by the husband for her wife. The reporter stated that the patient got the first shingles vaccination several years ago around 3 years ago (exact date unknown) but failed to get her follow up shot. The patient asked was it okay to get 2nd dose or should she start the series over. Reporter was unable to provide any additional details. Reporter did not consent to follow up. Consent to contact HCP not given. Additional supportive information: Till the time of reporting patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case US2022178653 was identified as duplicate of US2022178654. The case US2022178654 would be voided, and all the future correspondence would be added in this case US2022178653 which stands as a case of record for this patient.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1 year old was given Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-NOV-2022 Reporter's comment:  The reporter stated that one year old patient was given Kinrix. It was unknown to reporter which dose in the DTaP series this was.  No additional information provided on call.  The reporter consented to follow up. Additional supportive information: One year old patient was received Kinrix, which led to inappropriate age at vaccine administration.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second shingrix vaccine today on 11/30/2022. He said he received his first shingrix dose 1 week and 7 months ago; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 7 months ago and 1 week ago).   On 30th November 2022, the patient received the 2nd dose of Shingrix. On 30th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 30-NOV-2022 Reporter's comment: The reporter was the patient and he reported that the he got his second shingrix vaccine today (the day of reporting). No further information was reported to the agent by the patient. The reporter did not consent to follow-up. Additional Supportive information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.