chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Brain operation, Decreased appetite, Erythema, Feeling abnormal, Lyme disease
Clinical narrative: Meningioma benign; Lyme disease; Itchy; Had no appetite; Had very red shoulders, chest and back; Sore muscles; This spontaneous report has been received from a 73 year old male patient concerning himself, via Pfizer. The patient's concurrent conditions included a penicillin allergy which he developed when he was a child (he was about 10 years old at that time) and he had not had any penicillin since. He had not ever had an anaphylactic response to anything. His medical history and concomitant therapies were not reported.  In October 2016 (also reported as about 5 years ago), on a Friday afternoon, and recommended at yearly check-up, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in the left arm for prophylaxis (dose, route of administration, lot number and expiration date were not provided).   The patient stated that he had a pretty good response to the vaccine at the doctor's office, then that night he went out to dinner and had a few drinks at a wedding party. He stated that the next day, which was Saturday, he had sore muscles (myalgia), was itchy (pruritus), had no appetite, and had very red shoulders, chest and back (erythema); and he felt worse as the day went on. Moreover, He stated that he was at a wedding and did go to the wedding reception, but probably should not have with the way he was feeling. He also stated that he was recovering better by the next morning, so it only really lasted for about 1 day.   In approximately 2017 (reported as about 4 years ago), the patient experienced lyme disease, and eventually it went away.  On an unknown date, the patient experienced meningioma noncancerous (meningioma benign). In October 2019 (reported as 2 years ago), he had a brain surgery. For the meningioma noncancerous, the patient had magnetic resonance imaging (MRI) since then; the last one was in December 2020 and it was perfect.   The relationship between all the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.  Upon internal review, meningioma benign and lyme disease were determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Magnetic resonance imaging, Meningioma benign, Myalgia, Pruritus
Clinical narrative: Meningioma benign; Lyme disease; Itchy; Had no appetite; Had very red shoulders, chest and back; Sore muscles; This spontaneous report has been received from a 73 year old male patient concerning himself, via Pfizer. The patient's concurrent conditions included a penicillin allergy which he developed when he was a child (he was about 10 years old at that time) and he had not had any penicillin since. He had not ever had an anaphylactic response to anything. His medical history and concomitant therapies were not reported.  In October 2016 (also reported as about 5 years ago), on a Friday afternoon, and recommended at yearly check-up, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in the left arm for prophylaxis (dose, route of administration, lot number and expiration date were not provided).   The patient stated that he had a pretty good response to the vaccine at the doctor's office, then that night he went out to dinner and had a few drinks at a wedding party. He stated that the next day, which was Saturday, he had sore muscles (myalgia), was itchy (pruritus), had no appetite, and had very red shoulders, chest and back (erythema); and he felt worse as the day went on. Moreover, He stated that he was at a wedding and did go to the wedding reception, but probably should not have with the way he was feeling. He also stated that he was recovering better by the next morning, so it only really lasted for about 1 day.   In approximately 2017 (reported as about 4 years ago), the patient experienced lyme disease, and eventually it went away.  On an unknown date, the patient experienced meningioma noncancerous (meningioma benign). In October 2019 (reported as 2 years ago), he had a brain surgery. For the meningioma noncancerous, the patient had magnetic resonance imaging (MRI) since then; the last one was in December 2020 and it was perfect.   The relationship between all the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.  Upon internal review, meningioma benign and lyme disease were determined to be medically significant.
Age: 1.25
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE; the vaccines went through the temperature excursion on 16-FEB-2021; This spontaneous report refers to a 15-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-FEB-2021, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, lot # T024286, expiration date: 15-JUL-2022 (formulation, strength, dose, frequency, route of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) 0.5 mL, lot # S032825, expiration date: 16-OCT-2021 (formulation, strength, dose, frequency, route of administration were not reported), both for prophylaxis. On 16-FEB-2021, the doses of the vaccines were exposed to temperature excursion at -10 Celsius degrees (C) for 1 hour 15 minutes. There was no information about previous temperature excursion. The call was not due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE information; the vaccines went through the temperature excursion on 16-FEB-2021; This spontaneous report refers to a 4-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-FEB-2021, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, lot # T024286, expiration date: 15-JUL-2022 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. On 16-FEB-2021, the dose of the vaccine was exposed to temperature excursion at -10 Celsius degrees (C) for 1 hour 15 minutes. There was no information about previous temperature excursion. The call was not due to digital data logger. No additional adverse event was reported.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: her sister had the same "severe respiratory reaction" to the vaccine that she experienced; This spontaneous report was received from a consumer concerning her sister, a female patient of unknown age. Prior, the patient's sister experienced a severe respiratory reaction after vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) ( case 1308USA014995). No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported), as vaccination. According to the reporter, the patient had the same "severe respiratory reaction" (hypersensitivity) to the vaccine that she experienced.  At the time of the report, the outcome of hypersensitivity was unknown. The causal relationship between the aforementioned event and the suspect vaccine was related.  This is one of the two cases from the same source.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Cardiac disorder, Cerebrovascular accident, Facial paralysis, Herpes zoster
Clinical narrative: stroke; Heart attack; Facial paralysis; Herpes zoster; Postherpetic neuralgia; Cardiac issues; Balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 03-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster, post-herpetic neuralgia, stroke (cerebrovascular accident), cardiac issues (cardiac disorder), heart attack (myocardial infarction), balance problems (balance disorder), and facial paralysis. The outcome of the events was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events cerebrovascular accident, myocardial infarction, and facial paralysis were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Myocardial infarction, Post herpetic neuralgia
Clinical narrative: stroke; Heart attack; Facial paralysis; Herpes zoster; Postherpetic neuralgia; Cardiac issues; Balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 03-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster, post-herpetic neuralgia, stroke (cerebrovascular accident), cardiac issues (cardiac disorder), heart attack (myocardial infarction), balance problems (balance disorder), and facial paralysis. The outcome of the events was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events cerebrovascular accident, myocardial infarction, and facial paralysis were determined to be medically significant.
Age: 0.75
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; Inappropriate age at vaccine administration; This spontaneous report was received from a nurse and refers to a 9 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 15-MAR-2021, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021827, expiration date 25-JUN-2022 (strength, dose, route and frequency were not reported); along with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S031482, expiration date 07-OCT-2021 (strength, dose, route and frequency were not reported) for prophylaxis. The nurse reported no adverse reactions.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; Patient was administered improperly stored PROQUAD on 03/12/2021.; This spontaneous report has been received from a nurse, concerning a 4 years old patient of unknown gender.  The patient's past medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 12-MAR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin (rHA) (PROQUAD) (product storage error) (strength, dosage, anatomical location or route of administration were not provided) lot # T025221 with expiration date on 19-JAN-2022, for prophylaxis. The storage temperature was -12°C for a time frame of 6 hours and 30 minutes. There was no previous temperature excursion. No additional adverse event (AE) was reported. Digital data logger was involved. The outcome of product storage error was unknown.  This is one of several reports received from the same reporter.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reports no additional AE.; Caller states a dose was administered today, 3/15/2021 after the labeled expiry of 3/12/2021.; This spontaneous report was received from a registered nurse, referring to a 4-months-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not provided.   On 15-MAR-2021, the patient was vaccinated with an expired dose (expired product administered) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered at a dose of 2 milliliter (mL), as prophylaxis (formulation, strength, vaccination scheme frequency, route of administration and anatomical site of vaccination were not provided; lot number 1660956, which has been verified to be valid, expiration date reported and validated as 12-MAR-2021). No additional adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: hurts; she could not even lift the arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis (diagnosed years ago, taking treatment with celebrex for years). Concomitant products included celecoxib (Celebrex).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and mobility decreased. On an unknown date, the outcome of the pain and mobility decreased were unknown.   It was unknown if the reporter considered the pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient works at a hospital as a director and she was not a healthcare professional. The patient had Shingrix 1st dose in December 2018 and 2nd in March 2019. The patient stated regarding shingles shot that it hurts to where she could not even lift the arm. The reporter did not consent to contact primary healthcare professional. The reporter consented to follow-up. Note: It was not clear after which dose the events occurred.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Pain never goes away; Nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a 83-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (in last 5 year the patient had Shingles 3 time in the same place that was left shoulder and neck). Previously administered products included shingles vaccine with an associated reaction of herpes zoster (received after the second bought of and shortly after that the patient got another bought of shingles, same shoulder). Concurrent medical conditions included post zoster pain and nerve injury.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and nerve damage. On an unknown date, the outcome of the pain and nerve damage were not recovered/not resolved.   It was unknown if the reporter considered the pain and nerve damage to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. About a year later after 1st dose, the patient received the new Shingles vaccine.  No new boughts of shingles but the nerve damage was still there.  The pain had never gone away it was like having permanent case of shingles.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased
Clinical narrative: Feeling unwell/was sick and in bed for 3 days.; This case was reported by a consumer via other manufacturer and described the occurrence of mobility decreased in a 73-year-old 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, unknown after receiving Shingrix, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient was in bed for 3 days after receiving shingrix vaccine and then she was fine. The reporter consented to follow up. For tolerances for 2nd dose, refer case US2021AMR043127.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR043127:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: felt like I had the flu for a day; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingles vaccine (had single shot version first with no problems) and Shingles vaccine with an associated reaction of influenza like illness (1st dose received on an unknown date, for tolerance refer linked case US2021AMR048213).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group at vaccination was not reported but was captured as an adult as per vaccine indication. The patient felt like the flu for a day after vaccination. The patient already had Shingles in past and never want again. For tolerence with 1st dose refer case US2021AMR048213; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR048213:same reporter 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: she was a little sick after the two dose Shingrix shot / Strong reaction/ was sick a couple of days; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma (diagnosed 15 years ago). Concomitant products included vitamin d, triamcinolone (Nasacort), fexofenadine and budesonide + formoterol fumarate (Symbicort).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting vitamin d and Nasacort, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The patient had 2 doses of Shingrix and was a little sick for couple of days. The patient got pretty hard, strong reaction after that one. No further information was provided.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Lymphadenopathy, Night sweats, Pain in extremity
Clinical narrative: Headache; Swollen neck lymph node; Night sweats; My rm was extremely painful; This case was reported by a consumer via call center representative and described the occurrence of night sweat in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On 16th February 2021, the patient received the 2nd dose of Shingles vaccine. In February 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm. On 25th February 2021, the patient experienced night sweat. On 26th February 2021, the patient experienced headache and lymphadenopathy cervical. On an unknown date, the outcome of the night sweat, headache and lymphadenopathy cervical were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the night sweat, headache, lymphadenopathy cervical and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporting case for him/herself. After receiving Shingles vaccine, the patient had night sweats, headache and swollen neck lymph node. The patient's rm was extremely painful for four days, then sorta of for two more. The reporter did not consent to follow up. The patient was scheduled for first covid vaccine on 02nd March 2021.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blister, Chills, Fatigue, Malaise
Clinical narrative: blister; Chills; fatigue; upset stomach; generally feel miserable; This case was reported by a consumer and described the occurrence of blister in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2021 14:00, the patient received the 1st dose of Shingrix. In February 2021, 14 hrs after receiving Shingrix, the patient experienced blister, chills, fatigue, upset stomach and feeling unwell. On an unknown date, the outcome of the blister, chills, fatigue, upset stomach and feeling unwell were unknown.   It was unknown if the reporter considered the blister, chills, fatigue, upset stomach and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient was reporting case for herself. On 26th February 2021, at 4 am, 14 hours after receiving Shingrix, the patient woke up with a blister. The patient also had chills, fatigue, upset stomach and generally felt miserable. The patient wanted to report this and asked if she should be concerned.
Age: 0.5
Sex: F
Vaccine: FLUX
Symptoms: White blood cell count increased
Clinical narrative: elevated blood cell count; This case was reported by a consumer via other manufacturer and described the occurrence of white blood cell count increased in a 6-month-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 7th January 2021, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 7th January 2021, unknown after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced white blood cell count increased. On an unknown date, the outcome of the white blood cell count increased was unknown.   It was unknown if the reporter considered the white blood cell count increased to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The reporter reported that, the patient received her flu shot and experienced white blood cell count was elevated. No lot or expiration date was known. The reporter denied for consent follow up. Note- The patient's date of birth is mentioned and vaccination date was provided as 7th Jan 2020 which seems discrepant. Therefore the date of vaccination was 7th Jan 2021 conservatively.; Sender's Comments: T202005981:
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 69-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, several weeks after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu vaccine in October (unspecified year) and after few weeks experienced shingles from his belly button around the middle of his back.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe (batch number Unknown, expiry date unknown) for prophylaxis.   On an unknown date, 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 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 Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age of the patient at vaccination was not reported. The nurse practitioner stated that one of his two sons, age unknown, received a dose of Bexsero on an unknown date. At an unknown time, after the dose of Bexsero was administered, he experienced pain at the injection site. On an unknown date, approximately 2 weeks after the start of the pain at injection site, the pain at injection site resolved. No other information stated by the reporter due to limited time. All other information was unknown. The reporter consented to follow up. This case was linked with other cases US2021AMR061888 and US2021AMR061889; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061888:Same reporter. Patient #2. US-GLAXOSMITHKLINE-US2021AMR061889:Same reporter. Patient #3.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site / worst shot that he ever got; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe (batch number Unknown, expiry date unknown) for prophylaxis.   On an unknown date, 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 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 Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. The nurse practitioner states that his other son, age unknown, received a dose of Bexsero on an unknown date. At an unknown time, after the dose of Bexsero was administered, he experienced pain at the injection site. On an unknown date, approximately 2 weeks after the start of the pain at injection site, the pain at injection site resolved. The patient stated that the Bexsero was the worst shot that he ever got. No other information stated by the reporter due to limited time. All other information is unknown. The reporter consented to follow up. This case was linked with US2021AMR061883 and US2021AMR061889; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061883:Same reporter. Patient #1. US-GLAXOSMITHKLINE-US2021AMR061889:Same reporter. Patient #3.
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Had severe arm pain; Had severe / swelling at the injection site; Caused her not to be able to play tennis / physical therapy would be needed; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) 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 an unknown date, 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 pain in arm, injection site swelling and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, injection site swelling and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain in arm, injection site swelling and activities of daily living impaired to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. Post vaccination the patient had severe arm pain and swelling at the injection site. The pain and swelling caused the patient not to be able to play tennis.  The patient's mother stated that physical therapy would be needed for the pain and swelling. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061888:Same reporter. Patient #2. US-GLAXOSMITHKLINE-US2021AMR061883:Same reporter. Patient #1.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I had the Shingles on my back and in my eyes / came back in my eyes worst this time nothing on my back but it's murder in my eyes; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles on back) and ophthalmic herpes zoster.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had the Shingles on back and in eyes. The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient received 2nd dose of Shingrix and shingles in eyes worst nothing on back but it was murder in my eyes. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; What a big mistake we both made / We end up giving the shingles to ourselves; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were reported as follows: This case was reported by patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient experienced shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown. This case has been linked with the case US2021AMR063242, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063242:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Thought I was well protected. Wrong!!!!! / heading into my 3rd month of pain & suffering; Thought I was well protected. Wrong!!!!! / heading into my 3rd month of pain & suffering; I am heading into my 3rd month of pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that the patient has taken the first vaccination that came out. A couple of years before the date of reporting, the patient took the two new vaccine's that came out. The patient experienced shingles and stated that the patient was heading into my 3rd month of pain and suffering. The patient stated that the patient was wrong that patient was well protected. This case was considered to be a suspected vaccination failure case, as the details regarding being laboratory confirmation for shingles was unknown. This case has been linked with the case US2021AMR063296, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063296:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took the shot and still got shingles/ Suspected vaccination failure; Shingles / Horrible; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine and still got shingles which was horrible for months. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Vaccination failure
Clinical narrative: Got the vaccine and broke out immediately/ Suspected vaccination failure; Broke out immediately; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were reported as follows: The age at vaccination was not reported. The patient had shingles vaccine and broke out immediately and get them several times a year. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 4 family members got shingles. 8 got shingrex vaccine/ Suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult 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 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 Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. Eight family members of patient received Shingrix vaccine. After receiving Shingrix vaccine, the patient experienced shingles.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. This case was 1 of the 4 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063309:Same reporter US-GLAXOSMITHKLINE-US2021AMR063310:Same reporter US-GLAXOSMITHKLINE-US2021AMR063311:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Me to / Thought I was well protected. Wrong!!!!!/ Suspected Vaccination Failure; Me to / Thought I was well protected. Wrong!!!!!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were provided as follows: The age at vaccination was not reported. The patient experienced shingles and thought was well protected after receiving vaccine but was wrong. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. This case has been linked with the case US2021AMR063266, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063266:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Illness, Vomiting
Clinical narrative: quite sick / lasted days / ended up in ER; headache / lasted days / ended up in ER; vomiting / lasted days / ended up in ER; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult 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 sickness, headache and vomiting. On an unknown date, the outcome of the sickness, headache and vomiting were unknown.   It was unknown if the reporter considered the sickness, headache and vomiting to be related to Shingrix.   Additional details were reported as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the Shingrix vaccine and did not have a serious allergic reaction. The patient reported that he/she became quite sick with headache and vomiting that lasted days and patient ended up in the emergency room. This case is linked with US2021063407, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021063407:Same country, Same product
Sex: U
Vaccine: VARZOS
Symptoms: Syringe issue
Clinical narrative: during the administration of Shingrix the syringe leak; This case should be considered invalid because the amount of leakage is not specified also the replacement dose was not mentioned.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Hyperaesthesia, Joint swelling, Lymphadenopathy, Pain
Clinical narrative: Swelling in her lower left arm, as well as her glands; Swelling in her lower left arm; felt a Sensitivity under her left arm pit. / felt like a "nerve sensitivity"/ Sensitivity in lower left arm, as well as glands; Sensitivity under her left arm pit/ felt like a "nerve sensitivity", and it only hurt when she stretched her left arm; Muscle Aches in her left arm; This case was reported by a consumer and described the occurrence of swollen glands in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2021AMR043313).   On 27th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 27th January 2021, less than a day after receiving Shingrix, the patient experienced myalgia upper extremities. On 29th January 2021, the patient experienced increased skin sensitivity and axillary pain. On 15th February 2021, the patient experienced swollen glands and swelling arm. On 1st February 2021, the outcome of the myalgia upper extremities was recovered/resolved. On an unknown date, the outcome of the swollen glands, swelling arm and increased skin sensitivity were not recovered/not resolved and the outcome of the axillary pain was unknown.   The reporter considered the swollen glands, swelling arm, increased skin sensitivity and myalgia upper extremities to be related to Shingrix. It was unknown if the reporter considered the axillary pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received the 2nd dose of Shingrix in left arm and she experienced muscle aches in her left arm for five days. Approximately 2 days after receiving the vaccine, the patient felt a sensitivity under her left arm pit which felt like a nerve sensitivity, and it only hurt when she stretched her left arm.  Till the time of reporting, the patient was experiencing sensitivity and swelling in her lower left arm, as well as her glands.  The patient was referred to a physician. The reporter did not consent to follow up. All information was not available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR043313:1st dose, same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Swelling in her lower left arm, as well as her glands; Swelling in her lower left arm; felt a Sensitivity under her left arm pit. / felt like a "nerve sensitivity"/ Sensitivity in lower left arm, as well as glands; Sensitivity under her left arm pit/ felt like a "nerve sensitivity", and it only hurt when she stretched her left arm; Muscle Aches in her left arm; This case was reported by a consumer and described the occurrence of swollen glands in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2021AMR043313).   On 27th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 27th January 2021, less than a day after receiving Shingrix, the patient experienced myalgia upper extremities. On 29th January 2021, the patient experienced increased skin sensitivity and axillary pain. On 15th February 2021, the patient experienced swollen glands and swelling arm. On 1st February 2021, the outcome of the myalgia upper extremities was recovered/resolved. On an unknown date, the outcome of the swollen glands, swelling arm and increased skin sensitivity were not recovered/not resolved and the outcome of the axillary pain was unknown.   The reporter considered the swollen glands, swelling arm, increased skin sensitivity and myalgia upper extremities to be related to Shingrix. It was unknown if the reporter considered the axillary pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received the 2nd dose of Shingrix in left arm and she experienced muscle aches in her left arm for five days. Approximately 2 days after receiving the vaccine, the patient felt a sensitivity under her left arm pit which felt like a nerve sensitivity, and it only hurt when she stretched her left arm.  Till the time of reporting, the patient was experiencing sensitivity and swelling in her lower left arm, as well as her glands.  The patient was referred to a physician. The reporter did not consent to follow up. All information was not available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR043313:1st dose, same reporter