chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. A 6-decade-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shingles. The patient was hospitalized for an afternoon and the doctors said that the vaccine could have definitely woke up the sleeping virus in the body. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. A 6-decade-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shingles. The patient was hospitalized for an afternoon and the doctors said that the vaccine could have definitely woke up the sleeping virus in the body. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dark circles under eyes, Eye swelling, Fatigue, Feeling of body temperature change
Clinical narrative: BOTH EYES ARE SWOLLEN/PUFFY/LEFT EYE MORE SWOLLEN; FACE WAS SWOLLEN (SWOLLEN CHEEKS); DARK RED COLOR AROUND EYES; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced both eyes are swollen/puffy/left eye more swollen. On 19-MAY-2021, the subject experienced face was swollen (swollen cheeks). On 19-MAY-2021, the subject experienced dark red color around eyes. On 19-MAY-2021, the subject experienced chest tightness. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from chest tightness, and had not recovered from both eyes are swollen/puffy/left eye more swollen, face was swollen (swollen cheeks), and dark red color around eyes. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Swelling face
Clinical narrative: BOTH EYES ARE SWOLLEN/PUFFY/LEFT EYE MORE SWOLLEN; FACE WAS SWOLLEN (SWOLLEN CHEEKS); DARK RED COLOR AROUND EYES; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced both eyes are swollen/puffy/left eye more swollen. On 19-MAY-2021, the subject experienced face was swollen (swollen cheeks). On 19-MAY-2021, the subject experienced dark red color around eyes. On 19-MAY-2021, the subject experienced chest tightness. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from chest tightness, and had not recovered from both eyes are swollen/puffy/left eye more swollen, face was swollen (swollen cheeks), and dark red color around eyes. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Erythema, Eye swelling, Swelling face
Clinical narrative: BOTH EYES ARE SWOLLEN/PUFFY/LEFT EYE MORE SWOLLEN; FACE WAS SWOLLEN (SWOLLEN CHEEKS); DARK RED COLOR AROUND EYES; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced both eyes are swollen/puffy/left eye more swollen. On 19-MAY-2021, the subject experienced face was swollen (swollen cheeks). On 19-MAY-2021, the subject experienced dark red color around eyes. On 19-MAY-2021, the subject experienced chest tightness. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from chest tightness, and had not recovered from both eyes are swollen/puffy/left eye more swollen, face was swollen (swollen cheeks), and dark red color around eyes. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Fatigue, Hypoaesthesia, Somnolence, Vision blurred
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Medium, Additional Details: Pt is a 16 yo male who came in for second dose pfizer vaccine on 05/18/21. His mother reported that the pt experienced redness and swelling of the left eye at 2am on 05/19/21. At 3am, the patient mother gave her son benadryl and ibuprofen. I called the patient at 11am on 05/19/21 to check up and he is currently sleeping with some swelling and redness present. He has made a doctor appointment later today.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Headache, Injection site erythema, Injection site swelling, Ocular hyperaemia
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Medium, Additional Details: Pt is a 16 yo male who came in for second dose pfizer vaccine on 05/18/21. His mother reported that the pt experienced redness and swelling of the left eye at 2am on 05/19/21. At 3am, the patient mother gave her son benadryl and ibuprofen. I called the patient at 11am on 05/19/21 to check up and he is currently sleeping with some swelling and redness present. He has made a doctor appointment later today.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Medium, Additional Details: Pt is a 16 yo male who came in for second dose pfizer vaccine on 05/18/21. His mother reported that the pt experienced redness and swelling of the left eye at 2am on 05/19/21. At 3am, the patient mother gave her son benadryl and ibuprofen. I called the patient at 11am on 05/19/21 to check up and he is currently sleeping with some swelling and redness present. He has made a doctor appointment later today.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cold sweat, Dizziness, Hypersensitivity, Muscle tightness
Clinical narrative: Throat closed up (anaphylaxis), itchiness, rash, migraine, dizziness,
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Migraine, Pruritus, Rash
Clinical narrative: Throat closed up (anaphylaxis), itchiness, rash, migraine, dizziness,
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Throat closed up (anaphylaxis), itchiness, rash, migraine, dizziness,
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Syncope, Vomiting
Clinical narrative: This is my first pregnancy. My estimated date of delivery is August 2021. I was to preface this by saying I have a history of passing out due to shots, examinations, blood tests, etc. So this might not have been because of the vaccine, but my own medical history of passing out. However, I do want to say I am 28 weeks pregnant, and ten minutes after receiving the vaccine, I fainted and then vomited. The EMT team was called, and the nurse practitioner on site examined me. They said that I was ok after monitoring me for about half and hour and checking my blood pressures four times. They also monitored my heart rate. I recovered fully after about an hour.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ADMINISTRATION ERROR:  Father claims that they went there on Monday to get the Pfizer vaccine and they ran out, and was scheduled to come back yesterday 5/19/21 and was administered the Moderna in error.    He then received the vaccine.  He is not as energetic as normal, lethargic, sitting, resting, no activity, very tired, sore arm, maybe low grade fever.     The facility did not tell them anything to do about giving him the wrong vaccine, father said very cavalier.  They told them to come back in 28 days on 6/16/21 for the 2nd vaccine of Moderna.   The facility supposedly reported the error.     Father states that the facility told him that the Moderna vaccine was going to be approved very shortly, there were no issues with it, they are all the same, and that he should not have any side effects, and to return to get the 2nd Moderna shot in 28 days.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Interchange of vaccine products, Lethargy, Pain in extremity
Clinical narrative: ADMINISTRATION ERROR:  Father claims that they went there on Monday to get the Pfizer vaccine and they ran out, and was scheduled to come back yesterday 5/19/21 and was administered the Moderna in error.    He then received the vaccine.  He is not as energetic as normal, lethargic, sitting, resting, no activity, very tired, sore arm, maybe low grade fever.     The facility did not tell them anything to do about giving him the wrong vaccine, father said very cavalier.  They told them to come back in 28 days on 6/16/21 for the 2nd vaccine of Moderna.   The facility supposedly reported the error.     Father states that the facility told him that the Moderna vaccine was going to be approved very shortly, there were no issues with it, they are all the same, and that he should not have any side effects, and to return to get the 2nd Moderna shot in 28 days.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dry mouth, Gait disturbance, Lichen sclerosus, Pain in extremity, Spinal stenosis
Clinical narrative: Lichen Sclerosus; spinal stenosis; trigger finger on the right hand; difficulty waking; dry mouth; My arm was sore after the pneumonia vaccine and the flu shot; This spontaneous report was received from a 86-year-old female patient via company, who was reporting on herself. Information regarding the patient's pertinent medical history, concurrent conditions, and concomitant therapies was not provided.  On an unknown date in 2020 (reported as "last year"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (formulation, dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). Additionally, it was reported that her arm was sore after the pneumonia vaccine and the influenza vaccine (reported as "flu shot ") (pain in extremity).  On an unknown date in 2020, the patient had Lichen Sclerosus, spinal stenosis, trigger finger on the right hand, difficulty waking (somnolence), and dry mouth, which started after the vaccination. The patient did not take any prescription medications.   Additionally, it was reported that the patient was allergic to an antibiotic that starts with an "e" and it caused her to have a severe long lasting headache but she cannot recall the name of the medication (class of product), but it was not reported if this happened before or after the vaccination.  The outcome of the events lichen sclerosus, pain in extremity, dry mouth, somnolence, trigger finger and spinal stenosis, and the causal relationship between the above-mentioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza vaccine were not provided.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Trigger finger
Clinical narrative: Lichen Sclerosus; spinal stenosis; trigger finger on the right hand; difficulty waking; dry mouth; My arm was sore after the pneumonia vaccine and the flu shot; This spontaneous report was received from a 86-year-old female patient via company, who was reporting on herself. Information regarding the patient's pertinent medical history, concurrent conditions, and concomitant therapies was not provided.  On an unknown date in 2020 (reported as "last year"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (formulation, dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). Additionally, it was reported that her arm was sore after the pneumonia vaccine and the influenza vaccine (reported as "flu shot ") (pain in extremity).  On an unknown date in 2020, the patient had Lichen Sclerosus, spinal stenosis, trigger finger on the right hand, difficulty waking (somnolence), and dry mouth, which started after the vaccination. The patient did not take any prescription medications.   Additionally, it was reported that the patient was allergic to an antibiotic that starts with an "e" and it caused her to have a severe long lasting headache but she cannot recall the name of the medication (class of product), but it was not reported if this happened before or after the vaccination.  The outcome of the events lichen sclerosus, pain in extremity, dry mouth, somnolence, trigger finger and spinal stenosis, and the causal relationship between the above-mentioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza vaccine were not provided.
Age: 5.0
Sex: M
Vaccine: DTAP, HPV4, MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: One of the patients was 5-year-old received a GARDASIL vaccine and meningococcal conjugate vaccine along with a DTAP; This spontaneous report has been received from unspecified reporter via company representative concerning a 5-year-old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included meningococcal vaccine conj and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP).   On an unknown date, the patient was incorrectly vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The reporter stated that they did not realize that the patient had received the wrong vaccine until the patient's mother had already left (product administered to patient of inappropriate age).
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Took expired Vivotif; Spontaneous report received on 11MAY2021.  A female consumer reported that she "took expired Vivotif" (PT: Expired product administered). The consumer was receiving oral Vivotif capsules (expiry date: Nov 2020) for typhoid. On 07MAY2021, she took expired Vivotif. She confirmed that she did not experience any reaction after taking Vivotif. She reported that she was on her dietary supplements along with Vivotif capsules. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Medical history was reported was as none.  Company comment: It was reported that a consumer took a dose of expired Vivotif (expired product administered) and did not experience any reaction. Vivotif was expired a few months before she took it. Considering the nature of the event, the causality of expired product administered is not applicable with vivotif.; Sender's Comments: It was reported that a consumer took a dose of expired Vivotif (expired product administered) and did not experience any reaction. Vivotif was expired a few months before she took it. Considering the nature of the event, the causality of expired product administered is not applicable with vivotif.
Sex: M
Vaccine: MENB
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: Dose was given at age 11 in error/ not give the second dose at age 11; This case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a 11-year-old 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 for prophylaxis.   Previously administered products included Bexsero (received 1st dose on an unknown date when he was 11 years old).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was given the 1st dose of Bexsero vaccine at the age of 11 by error. The health care provider had planned to give two doses when the patient would turn 16.  The patient did not receive the 2nd dose of Bexsero vaccine till the time of reporting, which led to incomplete course of vaccination. The patient received the 1st dose within the age range of the label; however, it was clear the vaccine was given to the patient in error by the provider's Medical Assistant. The physician did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a adult 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 hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received shingrix and experienced hives. The reporter reported to always check out the side effects before getting any vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: minor side effects with the second one / side effect / was / shivering; uncontrolled shaking of hands; This case was reported by a consumer via interactive digital media and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering and tremor of hands. On an unknown date, the outcome of the shivering and tremor of hands were recovered/resolved.   It was unknown if the reporter considered the shivering and tremor of hands to be related to Shingrix.  Additional details were provided as follows: The reporter had reported for himself/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had shivering. The patient stated that, he/she would not call it that because shivering would seem to have something to do with being cold. It was uncontrolled shaking of hands. The patient was trying to text and could not. The patient went to bed and he/she was fine the next day. The patient stated that, good thing about the vaccine was, it stayed protective above 85 percent for 4 years.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: got the shot and got it anyway/suspected vaccination failure; got the shot and got it anyway; Hope she is getting better with it now.; This case was reported by a consumer via media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling unwell. On an unknown date, the outcome of the vaccination failure, shingles and feeling unwell were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the Shingles shot and got it Shingles anyways. The reporter hoped that she was getting better with it till the time of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (for 25 years on head, eyes and throughout my body) and general body pain (for 25 years on head, eyes and throughout my body).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had shingles and the pain for 25 years which was on head, eyes and throughout body. It was considered chronic case. The patient stated that the shots didn't do anything but make the patient sick for three days.  The patient advised to consult with doctor. For tolerance of 2nd dose refer case US2021AMR104369.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104369:1st dose ,same patient,same event,same SP,Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: sick; 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (for 25 years on head, eyes and body) and pain (for 25 years). Previously administered products included Shingrix with an associated reaction of illness (1st dose received on an unknown date and experienced sickness refer case US2021AMR104366).   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 sickness. Rechallenge with Shingles vaccine was positive. 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 Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient said that Shingles shot did not do a thing for his/her but made sick for 3 days. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104366:1st dose ,same patient,same event,same SP,Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot when it first. Amen out. I now need it again,because I got them Aug 26 of last yr./ suspected vaccination failure; I had the shot when it first. Amen out. I now need it again,because I got them Aug 26 of last yr./ suspected vaccination failure; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In August 2020, 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 patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient said he/she needed the vaccine again, because patient got Shingles on 26th August 2020.  No vacation or nothing along with the epidemic of covid.  The patient was stuck in the house ,like a house plant. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. This case has been linked with US2021AMR104380 and US2021AMR104377, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104377:same reporter (1st folks case) US-GLAXOSMITHKLINE-US2021AMR104380:same repoter (2nd folks case)
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected Vaccination failure; had both doses of the vaccine two years ago - and the shingles last month; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and 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 and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had both doses of the vaccine two years ago and the shingles last month. The patient experienced shingles 3rd time. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088540:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; pretty bad case of them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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 reporter stated that his friend that has a pretty bad case of them even though he was vaccinated previously. This case was considered as suspected vaccination failure since the details dose number, time to onset and regarding laboratory confirmation of shingles not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the shot and still got Shingles.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, it was horrible. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: I got the vaccine and for two or three days had very tiny; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a elderly female 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 blister. On an unknown date, the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the blister to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient for herself. The age at vaccination was not reported. The patient currently was in her 80's and still did not had shingles. The patient's husband and aunt had shingles badly. The patient got the Shingles vaccine and for 2 or 3 days she had very tiny blisters here and there on her body. The patient felt glad to take the vaccine because she probably would have them as bad as others as she got older. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104871:Same reporter. Invalid-Hearsay case.
Sex: U
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This case was reported by a consumer via interactive digital media and described the occurrence of sore throat in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 48 hrs after receiving Shingrix, the patient experienced sore throat. On an unknown date, the outcome of the sore throat was unknown.   It was unknown if the reporter considered the sore throat to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of Shingrix and had some strong (unspecified) side effects for about 30 hours and then he/she got a sore throat about 48 hours after the dose. The reporter asked was that a possible side effect. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Neurological symptom
Clinical narrative: neurological event; had hard time walking; This case was reported by a physician via sales rep and described the occurrence of neurological symptom in a male 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 neurological symptom and walking difficulty. On an unknown date, the outcome of the neurological symptom and walking difficulty were unknown.   It was unknown if the reporter considered the neurological symptom and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a neurological event. The patient had hard time walking. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Anal incontinence, Diplegia, Fear, Gait inability, Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome; paralysis of her feet up to her waist; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 13th August 2020, the patient received Shingrix (intramuscular). On 1st September 2020, 19 days after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant). On 2nd September 2020, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome and paralysis were unknown.   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to Shingrix.  Additional detail: The patient received her Shingrix vaccine on 13 August 2020. By 01 September 2020 she developed paralysis of her feet up to her waist and lost the ability to walk. She also lost control of her bowel and bladder; she was terrified. She was rushed to the hospital on her island where they performed a lumbar puncture and then emergency airlifted her from that hospital  she was admitted for a week. She has required extensive treatment and physical therapy for her injury of Guillain Barre Syndrome on 02 September 2020.
Sex: F
Vaccine: VARZOS
Symptoms: Lumbar puncture, Paralysis, Urinary incontinence
Clinical narrative: Guillain Barre Syndrome; paralysis of her feet up to her waist; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 13th August 2020, the patient received Shingrix (intramuscular). On 1st September 2020, 19 days after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant). On 2nd September 2020, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome and paralysis were unknown.   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to Shingrix.  Additional detail: The patient received her Shingrix vaccine on 13 August 2020. By 01 September 2020 she developed paralysis of her feet up to her waist and lost the ability to walk. She also lost control of her bowel and bladder; she was terrified. She was rushed to the hospital on her island where they performed a lumbar puncture and then emergency airlifted her from that hospital  she was admitted for a week. She has required extensive treatment and physical therapy for her injury of Guillain Barre Syndrome on 02 September 2020.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Dyspnoea, Peripheral swelling, Vaccination site swelling
Clinical narrative: she was anaphylactic / ER Visit Required; difficulty breathing and she was rushed to the hospital / ER Visit Required; swollen arm at the vaccination site; This case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 64-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, 1 week after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), difficulty breathing (serious criteria other: Serious as per reporter) and swelling arm (serious criteria other: Serious as per reporter). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylaxis, difficulty breathing and swelling arm were recovered/resolved.   It was unknown if the reporter considered the anaphylaxis, difficulty breathing and swelling arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient had a swollen arm at the vaccination site and a week later she had difficulty breathing and she was rushed to the hospital.  The patient visited the emergency room. They gave the patient massive amounts of Benadryl and it took a full month for her to fully recover. The reporter did not consent to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered the liquid conjugate only (without the lyophilized portion); administered the liquid conjugate only (without the lyophilized portion); This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA391A, expiry date 20th July 2022) for prophylaxis.   On 13th May 2021, the patient received Menveo. On 13th May 2021, unknown after receiving Menveo, 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 details were provided as follows: The nurse practitioner administered only liquid conjugate of Menveo (without lyophilized portion) to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reported batch number AMXA391A was not found in sales data sheet, hence was updated to AMVA391A. No symptoms were reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; developed a sore throat; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-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, less than a year after receiving Shingrix, the patient experienced fever, chills, general body pain and sore throat. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved and the outcome of the sore throat was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, general body pain and sore throat to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient recently received Shingrix vaccine in her left arm. After getting the injection she developed the fever, chills and body aches. Those symptoms have resolved and afterwards she developed the sore throat and had not resolved till the time of reporting. The reporter declined to gave the health care professional information. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose / on 08/29/2019 and was unaware about getting the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th August 2019 intramuscularly in left deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not applicable to this report. Till the time of reporting the patient did not receive the 2nd dose of Shingrix , which led to incomplete course of vaccination. The patient was unaware about getting the second dose.  The patient inquired whether she should get a second dose or restart the vaccine. The reporter did not had full mailing address, name of the facility, email address to HCP. The reporter did not had lot number or expiration date. The reporter mentioned that, patient received the vaccine from pharmacy intramuscularly in left deltoid. The patient consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Lymphadenopathy, Myalgia
Clinical narrative: swollen lymph node on the left side of her neck (the size as that of a baseball); swelling and pain at the injection site; swelling and pain at the injection site; muscle aches; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th May 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, muscle pain and fatigue. On 15th May 2021, the patient experienced lymphadenopathy. On an unknown date, the outcome of the injection site pain, injection site swelling, muscle pain and fatigue were recovering/resolving and the outcome of the lymphadenopathy was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, muscle pain, fatigue and lymphadenopathy to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. The patient received the Shingrix and that evening, reported muscle aches and fatigue, as well as swelling and pain at the injection site. The next day of vaccination, the patient continued to experience fatigue and muscle aches and noted the swollen lymph node on the left side of her neck. The patient described the size as that of the baseball. Till the time of reporting, the events were improving, but not resolved. The lymph node swelling, however only reduced in size very small amount. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Had pain from her first Shingrix shot; This case was reported by a consumer via call center representative and described the occurrence of pain in a 50-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 pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had pain after receiving her first Shingrix shot (date of first shot was unknown). No lot or expiry date was available. The patient was offered Shingrix Product Information. The reporter consented to follow-up and recommended follow-up with her health care professional. For tolerance to the 2nd dose of Shingrix, refer case US2021AMR104820.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104820:Same reporter, same suspect, same patient (2nd dose)
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: kinrix given to a 19 month old; was due for 3rd dose of ipv and dtap / Kinrix was administered on 3/4/2021 as a 3rd dose in the series; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number yz97n, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTPa-IPV vaccine (Received 2nd dose on March 2020.).   On 4th March 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 4th March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: The patient received 3rd dose of Kinrix at 19 months of age which leads to inappropriate age at vaccination and inappropriate schedule of vaccine administered. Medical administrator called to inquire how should they continue with vaccination. Forget to ask for follow up, , however did collect contact information if necessary.