chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: test positive; test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: CJ5342) for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 at 14:30 as dose 1, single (Lot number: EL3246), in left arm, on 20Feb2021 at 14:30 as dose 2, single (Lot number: EN9581), in left arm, on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 31Mar2022 at 16:20 as dose 4 (booster), single (Lot number: FJ9943), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL SUCCINATE; ALENDRONATE; ATORVASTATIN. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 08Oct2022, outcome "unknown" and all described as "test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: I tested positive for covid 08Oct2022. Clinical course: 16Oct2022: she found this article today; It would have been so reassuring for them- had they not gotten covid a month after the bivalent booster. 12Sep2022- Received Pfizer bivalent. She tested positive for covid 08Oct2022. Her only symptom was nasal congestion. However since 12Oct she had no sense of smell. As a result she cannot taste anything. Her tongue does sense sweet, bitter, salty, etc. Her prescribed medications had remained the same since even before her first covid shot. Metoprolol succinate 25 mg daily tablet daily at bedtime. Alendronate 70 mg- 1 tablet weekly. Atorvastatin 10 mg- 1 tablet daily.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-1 test, Vaccination failure
Clinical narrative: test positive; test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: CJ5342) for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 at 14:30 as dose 1, single (Lot number: EL3246), in left arm, on 20Feb2021 at 14:30 as dose 2, single (Lot number: EN9581), in left arm, on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 31Mar2022 at 16:20 as dose 4 (booster), single (Lot number: FJ9943), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL SUCCINATE; ALENDRONATE; ATORVASTATIN. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 08Oct2022, outcome "unknown" and all described as "test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: I tested positive for covid 08Oct2022. Clinical course: 16Oct2022: she found this article today; It would have been so reassuring for them- had they not gotten covid a month after the bivalent booster. 12Sep2022- Received Pfizer bivalent. She tested positive for covid 08Oct2022. Her only symptom was nasal congestion. However since 12Oct she had no sense of smell. As a result she cannot taste anything. Her tongue does sense sweet, bitter, salty, etc. Her prescribed medications had remained the same since even before her first covid shot. Metoprolol succinate 25 mg daily tablet daily at bedtime. Alendronate 70 mg- 1 tablet weekly. Atorvastatin 10 mg- 1 tablet daily.
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Asthenia, COVID-19, Paranasal sinus discomfort, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 13:15 as dose 5 (booster), single (Lot number: GH9644) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 at 10:30 as dose 1, single (Lot number: EL3248), in left arm, on 01Feb2021 at 12:00 as dose 2, single (Lot number: EL9265), in left arm, on 10Sep2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05May2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Known allergies: Pecans" (unspecified if ongoing), notes: Known allergies: Pecans. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Feb2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (paxlovid) were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 13:15 as dose 5 (booster), single (Lot number: GH9644) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 at 10:30 as dose 1, single (Lot number: EL3248), in left arm, on 01Feb2021 at 12:00 as dose 2, single (Lot number: EL9265), in left arm, on 10Sep2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05May2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Known allergies: Pecans" (unspecified if ongoing), notes: Known allergies: Pecans. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Feb2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (paxlovid) were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Specialist transferred physician who is requesting guidance on use of MMRII after a 21 month old patient experienced an unspecified rash. She states that she has already swabbed the "measle like rash." She also states that the patient had a fever. Sh; fever; This spontaneous report was received from a physician and refers to a 21-month-old patient of an unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) both for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided for both); and with hepatitis a vaccine, (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided). On the same day, the patient experienced unspecified rash, she swabbed the "measle like rash" and also experienced a fever. The outcome of the events was nor provided. Relatedness between the events and suspect vaccines was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient had no symptoms or adverse effects following the dose; VARIVAX was administered following a temperature excursion; This spontaneous report was received from a business professional and refers to a 26-year-old patient. The patient's concurrent conditions and medical history were not provided.    On 23-SEP-2022,the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml once, lot # W012164, expiration date 12-APR-2024 (route of administration was not provided) for prophylaxis. The vaccine was stored at a temperature of 25 Fahrenheit (F) degrees for 1 hour 30 minutes. There was no previous excursion. The patient had no symptoms or adverse effects following the dose. The patient concomitantly received diluent (DILUENT MRK), which was properly stored.
Sex: M
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no additional AE; Customer reported that when a nurse tried to administer GARDASIL 9 to a patient, the patient moved and some of the medication leaked out. Agent filed this AE for the patient and precautionary AE filed in case 02254778 for potential nurse exposure to; This spontaneous report was received from a customer and refers to a 12-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 23-SEP-2022, nurse tried to administer hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection 0.5 ml intramuscularly, lot # 1775808, expiration date 20-AUG-2023 to the patient, the patient moved and some of the vaccine leaked out (incomplete dose administered). No additional adverse events were reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event; GARDASIL 9 was accidentally administered to 5 year old patient due to name error; This spontaneous report has been received from a nurse, referring to a 5-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.   On 05-OCT-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml once (strength, route, anatomical site of administration, lot number, and expiration date were not reported) as prophylaxis. It was accidentally administered to the 5-year-old patient due to name error. The reporter stated that vaccine was intended for 15-year-old patient with similar name (product administered to patient of inappropriate age). No additional information provided. No additional AE reported (no adverse event). No PQC reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE occurred; an expired dose of PROQUAD was administered to the patient on 9/6/2022; This spontaneous report was received from a Licensed Practical Nurse concerning to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human Albumin (rHA), 1 dose, lot #U007505, expiration date: 04-SEP-2022 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (expired product administered).  No other adverse events occurred (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Depression, Neuropathy peripheral, Post herpetic neuralgia
Clinical narrative: neuropathy; post-herpetic neuralgia; anxiety; depression; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose,  lot #, expiry date, and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   On an unknown date, the pt experienced post-herpetic neuralgia, neuropathy, anxiety, and depression. As a result of these symptoms, the pt was seen and treated by medical provider.  As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had sustained severe and permanent personal injuries, including but not limited to: serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt also had suffered and incurred damages, including medical related expenses, the loss of accumulations; and other economic and non-economic damages as a result of these injuries.  By the time of this report, the pt had not recovered from shingles. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of neuropathy was considered to be medically significant.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Hypoaesthesia, Laboratory test normal, Tremor
Clinical narrative: tingling sensation on her finger and toes; numbness on hands and feet; tremor and shaking on her legs; This spontaneous report was received from a Pharmacist and refers to a 12-year-old female, who was the pharmacist's daughter. The patient's concurrent conditions and medical history were not reported.   On 11-AUG-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1775811, expiration date: 07-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided); and  meningococcal vaccine a/c/y/w conj (crm197) (MENVEO), (strength, formulation, lot #, expiry date, route of administration, and indication were not provided).  On 15-OCT-2022, the patient received a dose of influenza vaccine inact split 3v (FLULAVAL), 12 hours later, the patient developed tingling sensation on her finger and toes (Paraesthesia of fingers), numbness on hands and feet (Numbness of extremities), tremor and shaking on her legs (Tremor). Her body was also shaking. The patient went to an Emergency Room, saw a physician and received unspecified lab tests and all were normal. The patient was discharged and was not admitted. She did recover for most symptoms except some numbness on her left leg but it goes away after she stands up.   The causal relationship between numbness on paresthesia of fingers, numbness of extremities, tremor  and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Age: 0.25
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE reported; female patient was administered a pediatric dose of VAQTA at a younger age than recommended; This spontaneous report has been received from a non-health care professional and refers to a 12-week-old female patient.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  20-OCT-2022, the 12 weeks old patient was vaccinated with  first dose of hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5 ml, lot #CN3GS upon internal validation was found not valid for  hepatitis a vaccine, inactivated (VAQTA) expiration date reported: 19-NOV-2023,  administered for prophylaxis (vaccination scheme and route of administration were not provided)at a younger age than recommended within the prescribing information (Inappropriate age at vaccine administration). No additional adverse event were reported.
Age: 1.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; Year Old Patient was administered BOOSTRIX, MENCATRA and GARDASIL9; This spontaneous report was received from an office manager and a physician and refers to an 1-year-old female patient.  The patient's medical history was not reported.   On 18-OCT-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, lot #1775811, expiration date: 07-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided); also vaccinated with  diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (BOOSTRIX) and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) (product administered to patient of inappropriate age). At the reporting time, no adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No other AE occurred; An expired dose was administered to a patient; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 24-OCT-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose (lot number 1742417 has been verified to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and validated as 14-OCT-2022) administered orally as prophylaxis (exact dose was not provided) (Expired product administered).  No other adverse event (AE) occurred and the vaccine did not experience any temperature excursions.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Crying, Mobility decreased, Musculoskeletal disorder, Musculoskeletal stiffness
Clinical narrative: back pain unbearable took me to hospital; major life stress/cried screamed couldn't function more stress; one sore on finger worst experience; lost use if left arm and hand; my hand still stiff; Crying; Screaming; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced back pain (serious criteria hospitalization), stress, skin ulcer, mobility decreased, limbs stiffness, crying and screaming. On an unknown date, the outcome of the back pain, stress, skin ulcer and mobility decreased were recovered/resolved and the outcome of the limbs stiffness was not recovered/not resolved and the outcome of the crying and screaming were unknown.   It was unknown if the reporter considered the back pain, stress, skin ulcer, mobility decreased, limbs stiffness, crying and screaming to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. Patient had 2 shots, and had stress back pain unbearable, which made patient for hospitalization for few days. Patient had one sore on finger lasted six months, also had lost use left arm and hand. Patient cried screamed due to could not function more stress in hand and stiffness. Additional supportive information: Note: It was unknown after which dose number patient experienced events so only one suspect kept with blank dose number.; Sender's Comments:  US-GSK-US2022AMR151161:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Screaming, Skin ulcer, Stress
Clinical narrative: back pain unbearable took me to hospital; major life stress/cried screamed couldn't function more stress; one sore on finger worst experience; lost use if left arm and hand; my hand still stiff; Crying; Screaming; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced back pain (serious criteria hospitalization), stress, skin ulcer, mobility decreased, limbs stiffness, crying and screaming. On an unknown date, the outcome of the back pain, stress, skin ulcer and mobility decreased were recovered/resolved and the outcome of the limbs stiffness was not recovered/not resolved and the outcome of the crying and screaming were unknown.   It was unknown if the reporter considered the back pain, stress, skin ulcer, mobility decreased, limbs stiffness, crying and screaming to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. Patient had 2 shots, and had stress back pain unbearable, which made patient for hospitalization for few days. Patient had one sore on finger lasted six months, also had lost use left arm and hand. Patient cried screamed due to could not function more stress in hand and stiffness. Additional supportive information: Note: It was unknown after which dose number patient experienced events so only one suspect kept with blank dose number.; Sender's Comments:  US-GSK-US2022AMR151161:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/In 2017 got the Shingrix vaccine, in 2021 and 2022 got shingles; Got Shingles for the 2nd and 3rd times; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Pfizer Covid vaccine  with an associated reaction of herpes zoster (as a side effect of 2nd Pfizer Covid vaccine, the patient developed shingles).   On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR152123   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The six month later the shingles, the patient got the Shingrix vaccine in 2017 and during 2021 and again in 2022 (about 8 months later), the patient got shingles for the 2nd and 3rd times. The patient was prescribed Valacyclovir which worked, until the shingles showed up again. The patient asked that did they want to test the patient's blood to find out why the vaccine did not work on him/her. The case was linked with case US2022AMR152123, reported by same reporter for different product. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2022AMR152123:Same Reporter/patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shots didn't work/ Suspected vaccination failure; shots didn't work; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-Oct-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter reported that it was good for other, but the patient shots did not work. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact detail were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: my mom had the shots and ended up with shingles/suspected vaccination failure; shingles / has them now; 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. On an unknown date, several years after receiving 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.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The reporter stated that, although the shots were effective, they were not 100 percent. The patient had the shingles shots and still ended up with shingles. The patient had shingles now, having got the Shingles shot several years ago from reporting.  The reporter further stated that, she was going through exact experience and he/she was miss hugging her. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2022AMR151921, reported by the same reporter. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR151921:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: many people had the shots and ended up with shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: This case was reported by a reporter via interactive digital media. The reporter stated that, although the shots were effective, they were not 100 percent. The reporter stated that he/she knew several people, that had the shots and still ended up with shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2022AMR151913, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR151913:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on Dec2021, 2nd dose after 10 months; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on December 2021).   On 14th October 2022, the patient received the 2nd dose of Shingles vaccine. On 14th October 2022, unknown after receiving Shingles vaccine, 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: 17-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient went last Friday and received 2nd dose of Shingles vaccine. The patient stated that the girl who gave him/her dose and said that it was okay that he/she waited for 10 months between the 1st and 2nd dose. The reporter reported he/she now saw on GlaxoSmithKline website that should have Gotten. Additional supportive information: The patient received 2nd dose of Shingrix later than recommended time frame, which led to lengthening of vaccination schedule. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discomfort, Pain
Clinical narrative: Discomfort; The shot and follow-up worth every ache; This case was reported by a consumer via interactive digital media and described the occurrence of injection site discomfort 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 injection site discomfort and pain. On an unknown date, the outcome of the injection site discomfort and pain were unknown.   It was unknown if the reporter considered the injection site discomfort and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-Oct-2022 Reporter's Comment:  This case was reported by a patient via interactive digital media. The patient received the shingles shot. The patient experienced discomfort around the shot that was nothing to the misery that was shingles.  The shot and the follow up was much milder and worth every ache. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: Arm is swollen; Red rash; Hot to touch; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced swelling arm, red rash and skin warm. On an unknown date, the outcome of the swelling arm, red rash and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, red rash and skin warm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine over 24 hours ago (before the reporting time) and arm was swollen with a red rash that was hot to touch. The patient asked should he/she be concerned. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the vaccine site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had no side effects except soreness at the vaccine site for one day. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had one shot in 2018, and another today; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (first dose was received in October 2018).   On 17th October 2022, the patient received the 2nd dose of Shingles vaccine. On 17th October 2022, unknown after receiving Shingles vaccine, 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: 17-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received first shot and another was received on the day of reporting.  The patient was asking do he/she need another one. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient thought he/she had a rash from the Shingrix vaccination. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Exposed, below freezing, administered; 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 Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The pharmacy resident reported that Flulaval which was exposed to temperature below freezing (24.4 Fahrenheit) was administered to 5 employees. The vaccine administration facility was the same as primary reporter. The reporter did not had any other details but agreed to follow-up via email only. The reporter consented to follow-up. This is one of five linked cases reported by same reporter for different patients. Additional supportive information: The patient received Flulaval after temperature excursions, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR152067:Same reporter US-GSK-US2022151428:Same reporter US-GSK-US2022AMR152066:Same reporter US-GSK-US2022AMR152068:Same reporter US-GSK-US2022AMR152066:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Exposed, below freezing, administered; 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 Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The pharmacy resident reported that Flulaval which was exposed to temperature below freezing (24.4 Fahrenheit) was administered to 5 employees. The vaccine administration facility was the same as primary reporter. The reporter did not had any other details but agreed to follow-up via email only. The reporter consented to follow-up. This is one of five linked cases reported by same reporter for different patients. Additional supportive information: The patient received Flulaval after temperature excursions, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR152067:Same reporter US-GSK-US2022151428:Same reporter US-GSK-US2022AMR152068:Same reporter US-GSK-US2022AMR152065:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Exposed, below freezing, administered; 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 Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The pharmacy resident reported that Flulaval which was exposed to temperature below freezing (24.4 Fahrenheit) was administered to 5 employees. The vaccine administration facility was the same as primary reporter. The reporter did not had any other details but agreed to follow-up via email only. The reporter consented to follow-up. This is one of five linked cases reported by same reporter for different patients. Additional supportive information: The patient received Flulaval after temperature excursions, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR152068:Same reporter US-GSK-US2022AMR152066:Same reporter US-GSK-US2022AMR152065:Same reporter US-GSK-US2022151428:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Exposed, below freezing, administered; 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 Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The pharmacy resident reported that Flulaval which was exposed to temperature below freezing (24.4 Fahrenheit) was administered to 5 employees. The vaccine administration facility was the same as primary reporter. The reporter did not had any other details but agreed to follow-up via email only. The reporter consented to follow-up. This is one of five linked cases reported by same reporter for different patients. Additional supportive information: The patient received Flulaval after temperature excursions, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR152067:Same reporter US-GSK-US2022AMR152066:Same reporter US-GSK-US2022AMR152065:Same reporter US-GSK-US2022151428:Same reporter US-GSK-US2022AMR152065:Same reporter US-GSK-US2022AMR152066:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the diluent; Administered only the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 3BD9E, expiry date 6th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-Oct-2022 Reporter's comment: The nurse reported that they were uncertain of which patient might had received this vaccination as it occurred between 23rd October 2021 and 5th November 2021. The patient's information asked but not available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: The patient was administered only diluent component of Shingrix without using the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Boostrix administered instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Previously administered products included Dtap (On an unknown date the patient received 3 doses of Dtap.).   On 17th October 2022, the patient received Boostrix. On 17th October 2022, unknown after receiving Boostrix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: The reporter stated that Boostrix was given instead of Infanrix on 17th October 2022. The reporter also mentioned the Patient had previously had 3 doses of Dtap.  The reporter gave consent to follow up. Additional Supportive Information: The patient had boostrix instead of Infanrix which leads to wrong vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient does not come before the six months for the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th April 2022).   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: 17-Oct-2022 Reporter's comment: The registered pharmacist had a chat and a question about Shingrix dosing. The registered pharmacist asked what happened if the patient did not come before the six months for the second dose, did the patient needed to repeat the first dose. The reporter consented for follow-up via postal. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on Nov2021, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 29-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in November 2021).   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: 17-OCT-2022 Reporter's Comment: The reporter reported that , the patient had not received dose 2 of Shingrix as of yet.  No reactions were reported. The reporter consented to follow up via e-mail. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 1st dose a few years ago, recently given second; This case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received few years ago prior to the reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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: Reporter's Comment: The vaccine field representative reported on behalf of a provider who was reported that the patient received a first dose of Shingrix vaccine a couple, or a few years ago and just recently received the second dose of Shingrix vaccine. The field representative initially stated that the provider said first dose of the series was received about 10 years ago, and then the field representative was attempted to clarify whether vaccine given was Zostavax or Shingrix, but the provider thought it was a shingrix dose given a few years ago. The provider was in rush and the representative was unable to clarify further. The provider was unaware of this was being reported to safety, and the representative did not ask the provider whether safety had permission to follow up. The reporter did consent to follow up Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.