chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles really are bad, I got the 1st part of the shingles vaccine and got a really bad case of them; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles really are bad, I got the 1st part of the shingles vaccine and got a really bad case of them). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that shingles really were bad, he/she got the 1st part of the shingles vaccine and got really bad case of them. The reporter mentioned that he/she not getting the second part of the vaccine.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I received a shingrix shot in 2019. When am due for another shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I received a shingrix shot in 2019. When am due for another shot). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 21-FEB-2025 The reporter reported that the patient received a Shingrix shot in 2019. The patient asked when he/she due for another shot. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Heart rate decreased
Clinical narrative: Low heart rate afterwards; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of heart rate low in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced heart rate low (Verbatim: Low heart rate afterwards). The outcome of the heart rate low was not reported.   It was unknown if the reporter considered the heart rate low to be related to Shingrix.     It was unknown if the company considered the heart rate low to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-FEB-2025 This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine and had low hear rate afterwards.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site discharge, Injection site erosion, Injection site pruritus, Injection site reaction
Clinical narrative: still in the open sore stage/oozing lesions developed at injection site; injection site started to itch (Pruritus); received first shingrix shot and had a shingles breakout at the injection site/oozing lesions developed at front and back right shoulder and righ arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erosion in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ankylosing spondylitis. Concomitant products included certolizumab pegol (Cimzia).   On 11-OCT-2024, the patient received the 1st dose of Shingrix (injection, right deltoid) .5 ml. In OCT-2024, 5 days after receiving Shingrix, the patient experienced injection site erosion (Verbatim: still in the open sore stage/oozing lesions developed at injection site), injection site itching (Verbatim: injection site started to itch (Pruritus)) and shingles (Verbatim: received first shingrix shot and had a shingles breakout at the injection site/oozing lesions developed at front and back right shoulder and righ arm). The outcome of the injection site erosion, injection site itching and shingles were not resolved.   It was unknown if the reporter considered the injection site erosion, injection site itching and shingles to be related to Shingrix.     It was unknown if the company considered the injection site erosion, injection site itching and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JAN-2025 The patient received Shingrix. The patient did not know the lot number of the vaccine that was administered. The patient reported that 2 days after getting the vaccine, injection site started to itch (Pruritus) (Symptomatic) The patient also reported he had a shingles breakout at the injection site that was still in the open sore stage The patient reported 5 days after getting the vaccine oozing lesions developed at injection site, front and back right shoulder, and right arm (Symptomatic). The patient reported that his symptoms had not resolved completely, stating that his skin still itches (Pruritus) and 2 lesions remain oozing at the time of reporting. The patient wanted to know if he should get the 2nd shot or continue to wait for the sores to go away.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: no record of her getting a dose 3; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (1st dose received in 2023) and Hepatitis B vaccine (2nd dose received one a month later of 1st dose).   On an unknown date, the patient did not receive the 3rd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: no record of her getting a dose 3). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 07-FEB-2025 The patient states she got the hepatitis b vaccine years ago.  The patient was not sure how long ago, not sure if she completed series, and was not sure of manufacturer. Fast forward, pharmacist states she found in records that in 2023 patient got an initial dose of Hepatitis B then got one a month later but there was no record of her getting a dose 3, which led incomplete course of vaccination.  The reported consented to follow up. Pharmacist did not know if the Hepatitis B the patient received was Engerix B or not.
Sex: F
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This serious case was reported by a nurse via call center representative and described the occurrence of guillain barre syndrome in a 60-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Arexvy.     The company considered the guillain barre syndrome to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 12-FEB-2025 The reporter was a GlaxoSmithKline representative who was reporting on behalf of an healthcare professional (nurse practitioner).  The reporter had asked the representative if Arexvy could caused Guillain-Barre Syndrome.  The reporter had a 60 year old female patient who developed Guillain-Barre Syndrome after receiving unknown vaccines. It was uncertain if the vaccine had been Arexvy.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which, due to the following criteria (missing medical history, concurrent conditions, laboratory data, clinical details) is considered unrelated to GSK vaccine Arexvy.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: administration of a 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 93kk4, expiry date 31-JAN-2027) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th Oct 2024) and Shingrix (2nd dose received on 11th Dec 2024).   On 17-FEB-2025, the patient received the 3rd dose of Shingrix. On 17-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: administration of a 3rd dose of Shingrix). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 17-FEB-2025 The reporter called to request safety information as the immunocompetent patient received 3rd dose of Shingrix, which led to extra dose administered. The vaccine administration facility was the same as primary reporter.
Age: 70.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she was due for a Second dose a few months later and a third dose 6 months after that initial. She just came in for her Second dose,; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received HAB (Twinrix) (batch number 04774) for prophylaxis.   Previously administered products included Twinrix (1st dose received in Sep 2024).   On 17-FEB-2025, the patient received the 2nd dose of Twinrix. On 17-FEB-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: she was due for a Second dose a few months later and a third dose 6 months after that initial. She just came in for her Second dose,). The outcome of the drug dose administration interval too long was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-FEB-2025 The reporter called to inquire about a patient who they administered a Twinrix vaccine back in September, she was due for a second dose a few months later and a third dose 6 months after that initial. However she came in for her second dose late, so, they were not sure that she should come in for her third dose in a month and keep the 6 months after the 1st one or they should wait a while after the second dose. The patient received 2nd dose longer than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: An 84 years old female patient received a dose of Shingrix after the vaccine had a temperature excursion at an unknown temperature for 72 hours.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 93KK4, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: An 84 years old female patient received a dose of Shingrix after the vaccine had a temperature excursion at an unknown temperature for 72 hours.). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 19-FEB-2025 A Pharmacy Manager called to report that they administered Shingrix to a patient after a temperature excursion which led to product storage error.  The Shingrix vaccine was exposed to an unknown temperature for 72 hours.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a two year old patient was administered a Kinrix dose; patient was intended to be administered a diphtheria, tetanus, pertussis, and polio vaccines separately, but by mistake it was administered a kinrixdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included Diphtheria vaccine toxoid (Diphtheria) for prophylaxis, Tetanus vaccine toxoid (Tetanus vaccine) for prophylaxis, Pertussis vaccine for prophylaxis and Polio vaccine for prophylaxis.   On 04-FEB-2025, the patient received Kinrix. On an unknown date, the patient received Diphtheria, Tetanus vaccine, Pertussis vaccine and Polio vaccine. On 04-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a two year old patient was administered a Kinrix dose) and wrong vaccine administered (Verbatim: patient was intended to be administered a diphtheria, tetanus, pertussis, and polio vaccines separately, but by mistake it was administered a kinrixdose). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-FEB-2025 The reporter reported that a two year old patient was intended to be administered a diphtheria, tetanus, pertussis, and polio vaccines separately, but by mistake it was administered a Kinrix dose which led to inappropriate age at vaccine administration and wrong vaccine administered. Reporter needs advise on this situation. Vaccination date and patient demographics were obtained, no vaccine detail was provided from the reporter end.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Pyrexia
Clinical narrative: Onset of headache and fever like  symptoms overnight after shot
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Blood culture, Chest X-ray normal, Coronavirus test positive, Haemoglobin normal, Influenza virus test negative
Clinical narrative: 24 hours after administration Urticarial reaction and elevation WBC 30
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Platelet count normal, SARS-CoV-2 test negative, Streptococcus test negative, Urticaria, White blood cell count increased
Clinical narrative: 24 hours after administration Urticarial reaction and elevation WBC 30
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 17.0
Sex: M
Vaccine: HEP, MENB
Symptoms: Chills, Pain, Seizure, Vomiting
Clinical narrative: reported he is shivering, vomiting, and has body aches, convuslsions started around 12:00pm
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 22.0
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test negative, Therapeutic response decreased
Clinical narrative: she was not successfully immunized (low titers) after 2 prior doses of this vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a female 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 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced therapeutic response decreased (Verbatim: she was not successfully immunized (low titers) after 2 prior doses of this vaccine). The outcome of the therapeutic response decreased was not applicable.   Additional Information: GSK Receipt Date : 21-FEB-2025 Pharmacist passed an inquiry from a physician about the possibility of a patient to receive a third dose of Shingrix because she was not successfully immunized (low titers) after 2 prior doses of this vaccine.  He mentioned that he did not have any more data of the patient, just mentioned her gender.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Urticaria
Clinical narrative: I broke out in itchy hives all over my body several hours after receiving the vaccine.  It's my secon day of Prednisone and I'm still itching from head to toe.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 31.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. Pregnant and due 5/3/25
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: receive a 1 mL dose of Havrix instead of the 0.5 mL dose..; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 12-month-old patient who received HAV (Havrix) for prophylaxis.   Concurrent medical conditions included idiopathic thrombocytopenia.   On 19-FEB-2025, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced overdose (Verbatim: receive a 1 mL dose of Havrix instead of the 0.5 mL dose..). The outcome of the overdose was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-FEB-2025 On 24/Feb/2025, a pharmacist called to inform about a vaccine error about Havrix, they had a 12-month-old patient received a 1 mL dose of Havrix instead of the 0.5 mL dose, which led to overdose. Also, reporter mentioned that the patient had idiopathic thrombocytopenia as a preexisting condition.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 43.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 36.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 18.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Antinuclear antibody, C-reactive protein increased, Full blood count normal, Metabolic function test normal, Urticaria
Clinical narrative: patient has been seen 3 times in our office.  1st visit in our office- patient has hives treated with loratadine and medrol dose pak  Seen next at her dermatologist office and steroids repeated  2nd visit  at our office - persistent symptoms there was a concern with secondary infection and was treated antibiotics.  Normal cbc, cmp, and ANA is pending.  3rd visit at our office now a month after initial symptoms she is having rash and now joint pain.   NSAIDs presecribed.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Antinuclear antibody positive, Arthralgia, Biopsy skin, Blood test, Chills
Clinical narrative: patient has been seen 3 times in our office.  1st visit in our office- patient has hives treated with loratadine and medrol dose pak  Seen next at her dermatologist office and steroids repeated  2nd visit  at our office - persistent symptoms there was a concern with secondary infection and was treated antibiotics.  Normal cbc, cmp, and ANA is pending.  3rd visit at our office now a month after initial symptoms she is having rash and now joint pain.   NSAIDs presecribed.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Swelling, Ultrasound Doppler
Clinical narrative: patient has been seen 3 times in our office.  1st visit in our office- patient has hives treated with loratadine and medrol dose pak  Seen next at her dermatologist office and steroids repeated  2nd visit  at our office - persistent symptoms there was a concern with secondary infection and was treated antibiotics.  Normal cbc, cmp, and ANA is pending.  3rd visit at our office now a month after initial symptoms she is having rash and now joint pain.   NSAIDs presecribed.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Joint swelling, Pain, Rash, Urticaria
Clinical narrative: patient has been seen 3 times in our office.  1st visit in our office- patient has hives treated with loratadine and medrol dose pak  Seen next at her dermatologist office and steroids repeated  2nd visit  at our office - persistent symptoms there was a concern with secondary infection and was treated antibiotics.  Normal cbc, cmp, and ANA is pending.  3rd visit at our office now a month after initial symptoms she is having rash and now joint pain.   NSAIDs presecribed.
Age: 27.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 33.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Acid base balance normal, Acute kidney injury, Anion gap, Arthralgia, Bacterial test negative
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Basophil count normal, Basophil percentage, Bilirubin urine, Blood calcium normal, Blood chloride normal
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase normal, Blood creatinine normal, Blood glucose normal, Blood lactic acid normal, Blood potassium normal
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood sodium normal, Blood urea normal, Blood urine present, Carbon dioxide normal, Chromaturia
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Decreased appetite, Dysuria, Ear pain, Eosinophil count normal
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Eosinophil percentage, Glomerular filtration rate normal, Glucose urine absent, Haematocrit normal, Haemoglobin normal
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypertension, Hypophagia, Immature granulocyte count, Influenza A virus test negative
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza B virus test negative, Insomnia, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Middle ear effusion, Migraine
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Monocyte count increased, Monocyte percentage increased, Muscle strain, Musculoskeletal pain, Myalgia
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Myositis, Nausea, Neck pain, Neutrophil count normal, Neutrophil percentage
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Nitrite urine absent, Pain, Pain in jaw, Palpitations, Platelet count normal
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Protein urine absent, Red blood cell count normal, Red blood cells urine, Red cell distribution width normal, Renal function test normal
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative, Specific gravity urine abnormal, Tachycardia, Temporomandibular pain and dysfunction syndrome, Tenderness
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis abnormal, Urine ketone body absent, Urobilinogen urine, White blood cell count normal, White blood cells urine negative
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: pH urine normal
Clinical narrative: Patient presents with concern for reaction to her shingles vaccine.  The patient got her second dose of shingles vaccine yesterday.  She notes that yesterday evening development of headache, diffuse myalgias and bodyaches, nausea poor appetite.  There has been no fever.  There has been no cough congestion no infectious symptoms.  The patient notes pain to her right ear as well as both TMJs.  She notes pain essentially to her entire body.  She has tried sumatriptan hand for the headache as well as ibuprofen.  She was advised to come to the ICC for evaluation.   Later in the discussion she also notes that she has had dysuria since this morning as well as dark-colored urine.
Age: 10.0
Sex: M
Vaccine: HPV9, UNK
Symptoms: Dizziness
Clinical narrative: After he received both vaccines he felt like passing out had to go back in the room and drink juice and water. Went home, woke up in the morning feeling dizzy almost passed out in the shower. His sister has been having dizzy spells and headaches for a long time and now I'm wondering if it's from the HPV shot she got a while back.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 22.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: gave the patient the immunization, went to document through the Immunization clinic and when I changed the immunization to the high dose flu, it popped up a box that stated that the patient had already completed the series, when looking back in the immunization history, the patient had received a high dose flu shot at pharmacy on 10/04/2024. Called Seqirus Inc. and was told that there is nothing in the guidelines to say that taking 2 vaccines in 1 season is harmful to the patient.
Age: 27.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received twinrix 6 months ago and skipped the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included twinrix adult (patient receive 1st dose on 5th September 2024, with batch number 4DS4N and expiry 25th September, 2026).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: received twinrix 6 months ago and skipped the 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-FEB-2025 Other HCP had a question regarding the Twinrix vaccine. Reported had a patient who got his First dose in September and reporter knew that Twinrix was given 0,1 and 6 months.  However he was after 6 months, wanted to have the Second dose and in this case, reporter asked do they give him 2 more doses or just give 1 dose? Till the time of reporting patient did not receive 2nd dose of Twinrix which led to incomplete course of vaccination. This case is 1 of 2 cases reported by same reporter.; Sender's Comments:  US-GSK-US2025023096:Same reporter different patient
Age: 30.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 35.0
Sex: F
Vaccine: FLU3, RSV, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Magnetic resonance imaging joint, Osteonecrosis
Clinical narrative: One week after injections, I noted in my diary left shoulder pain and a bruise. I attributed the pain and bruise to moving some furniture but now think that the injection may have been responsible. Subsequently, in 2025, I was diagnosed by an orthopedic surgeon with Avascular Necrosis in that shoulder that involved my Humeral Head.  There was no other explanation for that development.
Age: 37.0
Sex: F
Vaccine: FLU3, RSV, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Cognitive disorder, Mobility decreased, Pain in extremity
Clinical narrative: His arm was in intense pain for a couple of days and he wasn't physically able to grip anything or squeeze with that hand. Even cognitively he was really off for a couple of days. No treatment given aside from symptomatic cares at home and monitoring.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 6.0
Sex: F
Vaccine: DTAP, FLU3, HEP
Symptoms: Extra dose administered
Clinical narrative: Patient was given Hepatitis B vaccine that was not needed.
Vaccine: COVID19
Symptoms: Mass, Unevaluable event
Clinical narrative: unspecified mass; body does not work the same; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up.  No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified mass and body does not work the same. (dose series 1).  The doctors found a mass in my body, and know have to get it removed. Patient do not have the money to get it removed because patient was  not working . Ever sense patient got the Covid-19 vaccine, body does not work the same. They are not looking for  money, just for someone to help with this. The action taken with janssen covid-19 vaccine was not applicable.  The outcome of unspecified mass and body does not work the same was not reported.  This report was associated with a product quality complaint: Product Complaint 90000351091.  This report was serious (other medically important condition).; Sender's Comments: V0:  Mass. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions