chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test abnormal, Dysstasia, Inflammation, Mobility decreased, Myalgia
Clinical narrative: Slight inflammation; Woke up screaming due to extreme muscle pain that was excruciating; Pain is in her legs, arms and hands / Described the pain as a burning like someone is stabbing her; Can't sit, stand or get up due to the pain; Can't sit, stand or get up due to the pain; Woke up screaming due to extreme muscle pain that was excruciating; This case was reported by a consumer via call center representative and described the occurrence of inflammation in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020 17:00, the patient received the 2nd dose of Shingrix. On 24th January 2020 23:00, 6 hrs after receiving Shingrix, the patient experienced inflammation, muscle pain, pain in extremity, difficulty in standing, mobility decreased and screaming. The patient was treated with diclofenac, tramadol, gabapentin, cannabis oil (Cbd Oil) and paracetamol (Tylenol). On an unknown date, the outcome of the inflammation, muscle pain, pain in extremity, difficulty in standing, mobility decreased and screaming were not recovered/not resolved.   It was unknown if the reporter considered the inflammation, muscle pain, pain in extremity, difficulty in standing, mobility decreased and screaming to be related to Shingrix.    Additional details were provided as follows: The patient received Shingrix in the left arm. By 11:00 PM that evening, the patient woke up screaming due to extreme muscle pain that was excruciating. She claimed that the pain was in her legs, arms and hands and she was in absolute misery. The patient reported she used to walk 3 miles per day prior to the shot and now she could not sit, stand or get up due to the pain. The patient went to the hospital and emergency room but was not admitted. They did blood work and saw slight inflammation. The patient described the pain as a burning like someone was stabbing her. They gave her Tramadol for pain, Diclofenac for inflammation, Gabapentin to calm her nerves and CBD oil but none of the treatments did anything for her condition.  She also used Tylenol. The patient consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Screaming
Clinical narrative: Slight inflammation; Woke up screaming due to extreme muscle pain that was excruciating; Pain is in her legs, arms and hands / Described the pain as a burning like someone is stabbing her; Can't sit, stand or get up due to the pain; Can't sit, stand or get up due to the pain; Woke up screaming due to extreme muscle pain that was excruciating; This case was reported by a consumer via call center representative and described the occurrence of inflammation in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020 17:00, the patient received the 2nd dose of Shingrix. On 24th January 2020 23:00, 6 hrs after receiving Shingrix, the patient experienced inflammation, muscle pain, pain in extremity, difficulty in standing, mobility decreased and screaming. The patient was treated with diclofenac, tramadol, gabapentin, cannabis oil (Cbd Oil) and paracetamol (Tylenol). On an unknown date, the outcome of the inflammation, muscle pain, pain in extremity, difficulty in standing, mobility decreased and screaming were not recovered/not resolved.   It was unknown if the reporter considered the inflammation, muscle pain, pain in extremity, difficulty in standing, mobility decreased and screaming to be related to Shingrix.    Additional details were provided as follows: The patient received Shingrix in the left arm. By 11:00 PM that evening, the patient woke up screaming due to extreme muscle pain that was excruciating. She claimed that the pain was in her legs, arms and hands and she was in absolute misery. The patient reported she used to walk 3 miles per day prior to the shot and now she could not sit, stand or get up due to the pain. The patient went to the hospital and emergency room but was not admitted. They did blood work and saw slight inflammation. The patient described the pain as a burning like someone was stabbing her. They gave her Tramadol for pain, Diclofenac for inflammation, Gabapentin to calm her nerves and CBD oil but none of the treatments did anything for her condition.  She also used Tylenol. The patient consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain, Arthralgia, Asthenia, Chills, Crying
Clinical narrative: explosive diarrhea; her chest and ribs are tender; lost four pounds; and back are tender; gripping horrid pain in her stomach; vomited; could hardly walk; fatigue/Exhaustion; chills; joint aches; red blotches on arm; rash; her arm was a little red; body aches/pain; fever; weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever and weakness. On 12th March 2020, the patient experienced stomach pain, vomiting and walking difficulty. On 16th March 2020, the patient experienced explosive diarrhea, chest tenderness, weight loss and back pain. On an unknown date, the outcome of the fatigue, chills, joint pain, red blotches and rash were recovering/resolving and the outcome of the erythema, stomach pain, vomiting and walking difficulty were recovered/resolved and the outcome of the general body pain, fever, weakness, explosive diarrhea, chest tenderness, weight loss and back pain were unknown.   It was unknown if the reporter considered the fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever, weakness, stomach pain, vomiting, walking difficulty, explosive diarrhea, chest tenderness, weight loss and back pain to be related to Shingrix.  Additional case details were reported as follows: The received Shingrix the day after her arm was a little red but that this has resolved.  She stated that the following day she experienced chills, fever, body aches and weakness.  The patient said that on Thursday she had a gripping horrid pain in her stomach.  The patient said she vomited profusely as if her insides were coming out.  The patient said she could hardly walk as she was seeing starts.  The patient said that the pain lasted a long time but that was has now resolved.  The patient said that all of the previously reported symptoms have subsided. On 16th March 2020 in the morning she had the runs and had explosive diarrhea, her chest, ribs and back are tender. She said that so far, she has lost four pounds from the ordeal. This is 1 of the 4 linked cases reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Dizziness, Hypersomnia, Muscle spasms, Pain
Clinical narrative: explosive diarrhea; her chest and ribs are tender; lost four pounds; and back are tender; gripping horrid pain in her stomach; vomited; could hardly walk; fatigue/Exhaustion; chills; joint aches; red blotches on arm; rash; her arm was a little red; body aches/pain; fever; weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever and weakness. On 12th March 2020, the patient experienced stomach pain, vomiting and walking difficulty. On 16th March 2020, the patient experienced explosive diarrhea, chest tenderness, weight loss and back pain. On an unknown date, the outcome of the fatigue, chills, joint pain, red blotches and rash were recovering/resolving and the outcome of the erythema, stomach pain, vomiting and walking difficulty were recovered/resolved and the outcome of the general body pain, fever, weakness, explosive diarrhea, chest tenderness, weight loss and back pain were unknown.   It was unknown if the reporter considered the fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever, weakness, stomach pain, vomiting, walking difficulty, explosive diarrhea, chest tenderness, weight loss and back pain to be related to Shingrix.  Additional case details were reported as follows: The received Shingrix the day after her arm was a little red but that this has resolved.  She stated that the following day she experienced chills, fever, body aches and weakness.  The patient said that on Thursday she had a gripping horrid pain in her stomach.  The patient said she vomited profusely as if her insides were coming out.  The patient said she could hardly walk as she was seeing starts.  The patient said that the pain lasted a long time but that was has now resolved.  The patient said that all of the previously reported symptoms have subsided. On 16th March 2020 in the morning she had the runs and had explosive diarrhea, her chest, ribs and back are tender. She said that so far, she has lost four pounds from the ordeal. This is 1 of the 4 linked cases reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pallor, Vomiting, Weight decreased
Clinical narrative: explosive diarrhea; her chest and ribs are tender; lost four pounds; and back are tender; gripping horrid pain in her stomach; vomited; could hardly walk; fatigue/Exhaustion; chills; joint aches; red blotches on arm; rash; her arm was a little red; body aches/pain; fever; weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever and weakness. On 12th March 2020, the patient experienced stomach pain, vomiting and walking difficulty. On 16th March 2020, the patient experienced explosive diarrhea, chest tenderness, weight loss and back pain. On an unknown date, the outcome of the fatigue, chills, joint pain, red blotches and rash were recovering/resolving and the outcome of the erythema, stomach pain, vomiting and walking difficulty were recovered/resolved and the outcome of the general body pain, fever, weakness, explosive diarrhea, chest tenderness, weight loss and back pain were unknown.   It was unknown if the reporter considered the fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever, weakness, stomach pain, vomiting, walking difficulty, explosive diarrhea, chest tenderness, weight loss and back pain to be related to Shingrix.  Additional case details were reported as follows: The received Shingrix the day after her arm was a little red but that this has resolved.  She stated that the following day she experienced chills, fever, body aches and weakness.  The patient said that on Thursday she had a gripping horrid pain in her stomach.  The patient said she vomited profusely as if her insides were coming out.  The patient said she could hardly walk as she was seeing starts.  The patient said that the pain lasted a long time but that was has now resolved.  The patient said that all of the previously reported symptoms have subsided. On 16th March 2020 in the morning she had the runs and had explosive diarrhea, her chest, ribs and back are tender. She said that so far, she has lost four pounds from the ordeal. This is 1 of the 4 linked cases reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Chills
Clinical narrative: explosive diarrhea; her chest and ribs are tender; lost four pounds; and back are tender; gripping horrid pain in her stomach; vomited; could hardly walk; fatigue/Exhaustion; chills; joint aches; red blotches on arm; rash; her arm was a little red; body aches/pain; fever; weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever and weakness. On 12th March 2020, the patient experienced stomach pain, vomiting and walking difficulty. On 16th March 2020, the patient experienced explosive diarrhea, chest tenderness, weight loss and back pain. On an unknown date, the outcome of the fatigue, chills, joint pain, red blotches and rash were recovering/resolving and the outcome of the erythema, stomach pain, vomiting and walking difficulty were recovered/resolved and the outcome of the general body pain, fever, weakness, explosive diarrhea, chest tenderness, weight loss and back pain were unknown.   It was unknown if the reporter considered the fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever, weakness, stomach pain, vomiting, walking difficulty, explosive diarrhea, chest tenderness, weight loss and back pain to be related to Shingrix.  Additional case details were reported as follows: The received Shingrix the day after her arm was a little red but that this has resolved.  She stated that the following day she experienced chills, fever, body aches and weakness.  The patient said that on Thursday she had a gripping horrid pain in her stomach.  The patient said she vomited profusely as if her insides were coming out.  The patient said she could hardly walk as she was seeing starts.  The patient said that the pain lasted a long time but that was has now resolved.  The patient said that all of the previously reported symptoms have subsided. On 16th March 2020 in the morning she had the runs and had explosive diarrhea, her chest, ribs and back are tender. She said that so far, she has lost four pounds from the ordeal. This is 1 of the 4 linked cases reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Gait disturbance, Musculoskeletal chest pain
Clinical narrative: explosive diarrhea; her chest and ribs are tender; lost four pounds; and back are tender; gripping horrid pain in her stomach; vomited; could hardly walk; fatigue/Exhaustion; chills; joint aches; red blotches on arm; rash; her arm was a little red; body aches/pain; fever; weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever and weakness. On 12th March 2020, the patient experienced stomach pain, vomiting and walking difficulty. On 16th March 2020, the patient experienced explosive diarrhea, chest tenderness, weight loss and back pain. On an unknown date, the outcome of the fatigue, chills, joint pain, red blotches and rash were recovering/resolving and the outcome of the erythema, stomach pain, vomiting and walking difficulty were recovered/resolved and the outcome of the general body pain, fever, weakness, explosive diarrhea, chest tenderness, weight loss and back pain were unknown.   It was unknown if the reporter considered the fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever, weakness, stomach pain, vomiting, walking difficulty, explosive diarrhea, chest tenderness, weight loss and back pain to be related to Shingrix.  Additional case details were reported as follows: The received Shingrix the day after her arm was a little red but that this has resolved.  She stated that the following day she experienced chills, fever, body aches and weakness.  The patient said that on Thursday she had a gripping horrid pain in her stomach.  The patient said she vomited profusely as if her insides were coming out.  The patient said she could hardly walk as she was seeing starts.  The patient said that the pain lasted a long time but that was has now resolved.  The patient said that all of the previously reported symptoms have subsided. On 16th March 2020 in the morning she had the runs and had explosive diarrhea, her chest, ribs and back are tender. She said that so far, she has lost four pounds from the ordeal. This is 1 of the 4 linked cases reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Rash, Rash macular, Vomiting
Clinical narrative: explosive diarrhea; her chest and ribs are tender; lost four pounds; and back are tender; gripping horrid pain in her stomach; vomited; could hardly walk; fatigue/Exhaustion; chills; joint aches; red blotches on arm; rash; her arm was a little red; body aches/pain; fever; weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever and weakness. On 12th March 2020, the patient experienced stomach pain, vomiting and walking difficulty. On 16th March 2020, the patient experienced explosive diarrhea, chest tenderness, weight loss and back pain. On an unknown date, the outcome of the fatigue, chills, joint pain, red blotches and rash were recovering/resolving and the outcome of the erythema, stomach pain, vomiting and walking difficulty were recovered/resolved and the outcome of the general body pain, fever, weakness, explosive diarrhea, chest tenderness, weight loss and back pain were unknown.   It was unknown if the reporter considered the fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever, weakness, stomach pain, vomiting, walking difficulty, explosive diarrhea, chest tenderness, weight loss and back pain to be related to Shingrix.  Additional case details were reported as follows: The received Shingrix the day after her arm was a little red but that this has resolved.  She stated that the following day she experienced chills, fever, body aches and weakness.  The patient said that on Thursday she had a gripping horrid pain in her stomach.  The patient said she vomited profusely as if her insides were coming out.  The patient said she could hardly walk as she was seeing starts.  The patient said that the pain lasted a long time but that was has now resolved.  The patient said that all of the previously reported symptoms have subsided. On 16th March 2020 in the morning she had the runs and had explosive diarrhea, her chest, ribs and back are tender. She said that so far, she has lost four pounds from the ordeal. This is 1 of the 4 linked cases reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Weight decreased
Clinical narrative: explosive diarrhea; her chest and ribs are tender; lost four pounds; and back are tender; gripping horrid pain in her stomach; vomited; could hardly walk; fatigue/Exhaustion; chills; joint aches; red blotches on arm; rash; her arm was a little red; body aches/pain; fever; weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever and weakness. On 12th March 2020, the patient experienced stomach pain, vomiting and walking difficulty. On 16th March 2020, the patient experienced explosive diarrhea, chest tenderness, weight loss and back pain. On an unknown date, the outcome of the fatigue, chills, joint pain, red blotches and rash were recovering/resolving and the outcome of the erythema, stomach pain, vomiting and walking difficulty were recovered/resolved and the outcome of the general body pain, fever, weakness, explosive diarrhea, chest tenderness, weight loss and back pain were unknown.   It was unknown if the reporter considered the fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever, weakness, stomach pain, vomiting, walking difficulty, explosive diarrhea, chest tenderness, weight loss and back pain to be related to Shingrix.  Additional case details were reported as follows: The received Shingrix the day after her arm was a little red but that this has resolved.  She stated that the following day she experienced chills, fever, body aches and weakness.  The patient said that on Thursday she had a gripping horrid pain in her stomach.  The patient said she vomited profusely as if her insides were coming out.  The patient said she could hardly walk as she was seeing starts.  The patient said that the pain lasted a long time but that was has now resolved.  The patient said that all of the previously reported symptoms have subsided. On 16th March 2020 in the morning she had the runs and had explosive diarrhea, her chest, ribs and back are tender. She said that so far, she has lost four pounds from the ordeal. This is 1 of the 4 linked cases reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: explosive diarrhea; her chest and ribs are tender; lost four pounds; and back are tender; gripping horrid pain in her stomach; vomited; could hardly walk; fatigue/Exhaustion; chills; joint aches; red blotches on arm; rash; her arm was a little red; body aches/pain; fever; weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever and weakness. On 12th March 2020, the patient experienced stomach pain, vomiting and walking difficulty. On 16th March 2020, the patient experienced explosive diarrhea, chest tenderness, weight loss and back pain. On an unknown date, the outcome of the fatigue, chills, joint pain, red blotches and rash were recovering/resolving and the outcome of the erythema, stomach pain, vomiting and walking difficulty were recovered/resolved and the outcome of the general body pain, fever, weakness, explosive diarrhea, chest tenderness, weight loss and back pain were unknown.   It was unknown if the reporter considered the fatigue, chills, joint pain, red blotches, rash, erythema, general body pain, fever, weakness, stomach pain, vomiting, walking difficulty, explosive diarrhea, chest tenderness, weight loss and back pain to be related to Shingrix.  Additional case details were reported as follows: The received Shingrix the day after her arm was a little red but that this has resolved.  She stated that the following day she experienced chills, fever, body aches and weakness.  The patient said that on Thursday she had a gripping horrid pain in her stomach.  The patient said she vomited profusely as if her insides were coming out.  The patient said she could hardly walk as she was seeing starts.  The patient said that the pain lasted a long time but that was has now resolved.  The patient said that all of the previously reported symptoms have subsided. On 16th March 2020 in the morning she had the runs and had explosive diarrhea, her chest, ribs and back are tender. She said that so far, she has lost four pounds from the ordeal. This is 1 of the 4 linked cases reported by the same reporter.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; a 12 month old patient received first dose in VARIVAX innnunization series that was improperly stored.; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 13-MAR-2020, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S024362 with expiration date of 06-AUG-2021, for prophylaxis (strength, dose, anatomical site of injection and route of administration were not reported). Varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (STERILE DILUENT MRK).     No symptoms were reported (no adverse event).  It was stated that the vaccines underwent a temperature excursion of 38.1°F (degrees Fahrenheit) for 20.7 hours (product storage error). No previous temperature excursion was done. The call was because of a "data logger".  Follow-up information indicated the initial aware date of the case was 19-MAR-2020. Therefore, case # US-009507513-2003USA007926 is being deleted from our files on Varicella virus vaccine live (oka/merck) (VARIVAX) and the date is amended and information is consolidated into case US-009507513-2003USA009793.; Sender's Comments:  US-009507513-2003USA007926:
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye pain, Headache, Neuralgia, Pain, Sensitive skin
Clinical narrative: Sensitive nerve endings; Sensitive Skin; Sore eyes; Headache; Body ache; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of neuralgia (1st dose received on an unknown date, refer case US2020039220 ).   On 24th February 2020, the patient received the 2nd dose of Shingrix. On 25th February 2020, 1 days after receiving Shingrix, the patient experienced nerve pain, sensitive skin, sore eye, headache and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nerve pain, sensitive skin, sore eye, headache and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, sensitive skin, sore eye, headache and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. On 29th February 2020, the patient experienced again same sensitive nerve endings, sensitive skin, sore eyes, headache, and body ache with lower severity. No further details were provided. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 12-months-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 08-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.  It has been determined that case # 2004USA000223 was initially distributed with an aware date of 25-MAR-2020 however it was determined that the correct aware date was 24-MAR-2020, Therefore, case # 2004USA000223 is being deleted from our files and the case was consolidated into case # 2004USA001041 with correct aware date of 24-MAR-2020.   This is an amended report. The aware date was changed from 25-MAR-2020 to 24-MAR-2020.
Sex: F
Vaccine: TYP
Symptoms: Urinary tract infection
Clinical narrative: Urinary infection; Spontaneous report received on 09DEC2019 via company which was forwarded to Emergent on 10DEC2019.  A pharmacist reported that a female consumer developed urinary infection (PT: Urinary tract infection), while being on oral Vivotif capsule for typhoid. The consumer took two doses of Vivotif and developed urinary infection. The pharmacist advised the consumer to stop taking Vivotif and reported that consumer must start on 5-day antibiotic dosage quickly. Action taken with Vivotif with respect to the reported event was drug discontinued. Outcome of the reported event was unknown at the time of report.  Company Comment: A consumer who took two doses of Vivotif developed urinary infection. The consumer was advised to stop taking Vivotif and to start on five-day course of antibiotic soon. Further details of the event and information on consumer's medical history was limited. Considering the infectious pathogenesis of urinary infection, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer who took two doses of Vivotif developed urinary infection. The consumer was advised to stop taking Vivotif and to start on five day course of antibiotic soon. Further details of the event and information on consumer's medical history was limited. Considering the infectious pathogenesis of urinary infection, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: The patient has had abnormal papanicolau; has tested positive for HPV; This spontaneous report has been received from a physician via a company representative referring to a 51 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.         On an unknown date, the patient had abnormal papanicolau test (smear cervix abnormal) and tested positive for human papilloma virus (HPV) (human papilloma virus test positive). At the reporting time. The outcome of smear cervix abnormal and human papilloma virus test positive was unknown. The causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Neurological symptom, Tinnitus, Vertigo
Clinical narrative: tinnitus; vertigo; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 24-MAY-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered severe ringing and buzzing in the ears, dizziness, severe headaches and neurological issues, and was diagnosed with tinnitus and vertigo. As a direct and proximate result of the company's defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of vertigo and tinnitus was reported as not resolved.  The causal relationship of the events was reported as related to zoster vaccine live (ZOSTAVAX). The reporter considered vertigo and tinnitus to be disabling events.
Sex: U
Vaccine: HPV9, MMR, UNK, VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored doses of GARDASIL9, MMRII, and VARlVAX may have been administered; no adverse effects reported; This spontaneous report was received from an office manager concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, the patient were vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# R020200 expiration date 05-MAY-2021, lot# R024259 expiration date 30-MAY-2021 and lot# 1614898 expiration date 15-NOV-2021; Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot# R030810 expiration date 24-OCT-2020, lot# S005251 expiration date 20-FEB-2021 and lot# S014807 expiration date 13-MAY-2021; and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# S019583 expiration date 25-JUN-2021 and lot# reported as S0006018 expiration date 27-FEB-2021 (dose and route of administration were not provided) for prophylaxis             Digital data logger registered a temperature excursion of 12.3 Celsius degrees and -1 Celsius degree (for varicella virus vaccine live (Oka/Merck) (VARIVAX)), along 2 hours 25 minutes in refrigerator, and 2 hours 15 minutes in the freezer.  Lot Number S0006018 is NOT valid for varicella virus vaccine live (Oka/Merck) (VARIVAX). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; evaluationvalue - Patient / Device: N/A / 2993
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE information was provided; a patient was administered an expired MMR II on vaccine on 3/15/2020 and an expired VARIVAX vaccine on 3/31/2020; a patient was administered an expired MMR II on vaccine on 3/15/2020 and an expired VARIVAX vaccine on 3/31/2020; Information has been received from a licensed practical nurse via a field representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications was not provided.      On 15-MAR-2020, the patient was administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose, route were unknown; lot # R008031 and expiration date 18-MAR-2020) for prophylaxis. On 31-MAR-2020, the patient was administered with an expired varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route were unknown; lot # R009409 and expiration date 30-MAR-2020) for prophylaxis (expired product administered; inappropriate schedule of product administration). The sterile diluent that was used to reconstitute the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) was not expired. No additional adverse events was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella zoster pneumonia
Clinical narrative: Varicella Pneumonia; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for varicella pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event varicella pneumonia was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, varicella pneumonia was determined to be medically significant.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: Travelling to country next week after starting Vivotif; Took unrefrigerated dose of Vivotif; Spontaneous report received on 13DEC2019.  A female consumer reported that she "took unrefrigerated dose of Vivotif" (PT: Product storage error) and was "travelling to country next week after starting Vivotif" (PT: Inappropriate schedule of product administration). She was scheduled on Vivotif for immunization. On 10DEC2019, the consumer took the first dose of Vivotif and then left it out of refrigerator until she took the second dose on 12DEC2019. It was reported that she was going to country next week. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer took an unrefrigerated dose of Vivotif (Incorrect product storage) and was also travelling to country a week after starting Vivotif (Inappropriate schedule of product administration). Vivotif course should be completed at least one week before travelling. Considering the nature of the events, the causality of both the events is assessed as not related to Vivotif.; Sender's Comments: A consumer took an unrefrigerated dose of Vivotif (Incorrect product storage) and was also travelling to country a a week after starting Vivotif (Inappropriate schedule of product administration). Vivotif course should be completed at least one week before travelling. Considering the nature of the events, the causality of both the events is assessed as not related to Vivotif.