chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 65-year-old male patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 11-JUN-2015, at the age of 64 years old (also reported as 54 years old, conflicting information), the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at a pharmacy for prophylaxis. As a result of his receipt or zoster vaccine live (ZOSTAVAX), on 06-JAN-2016, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), he had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions he requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that he will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, he requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. He also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. He has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Intercepted product administration error
Clinical narrative: pain at the injection site; Intercepted drug administration error; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and intercepted drug administration error. On an unknown date, the outcome of the injection site pain and intercepted drug administration error were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vacination was not provided. The age group of the patient was not reported but selected as an adult as per vaccine indication The , patient received 1st dose of Shingrix and experienced injection site pain. The reporter reported that, after vaccination with 1st dose, the nurse asked to return for 2nd dose in 1 month. The patient would called to doctor office and reschedule for at least two months for 2nd dose of Shingrix, which led to intercepted drug administration error.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Can the Shingrix vaccine cause itching all over?; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced itching all over after vaccination. The patient asked could the Shingrix vaccine cause itching all over.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: have a rash that is red and spreading 7 days after my first vaccine; This case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided a follows: The age at vaccination was not reported. The patient reported that, till the time of reporting had red rash, which was red and was spread 7 days after vaccination. The patient asked is that normal.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Peripheral coldness, Peripheral swelling
Clinical narrative: Headache; has a arm swollen; elevated temperature; Her hands and feet are cold.; This case was reported by a consumer via patient support programs and described the occurrence of headache in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced headache, swelling arm, body temperature increased and cold extremities. On an unknown date, the outcome of the headache, swelling arm, body temperature increased and cold extremities were unknown.   It was unknown if the reporter considered the headache, swelling arm, body temperature increased and cold extremities to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination experienced swollen arm, headache and elevated temperature, hand and foot were cold. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain, Injection site reaction, Sensitive skin
Clinical narrative: Injection site be sore; very sore and sensitive; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a few months ago, refer case US2020AMR041766).   On 3rd March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site discomfort. On an unknown date, the outcome of the injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site pain and injection site discomfort to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not reported. The reporter asked how long should injection site be sore. The patient sttaed that, was concerned because it was vert sore and sensitive. For the tolerence of 1st  dose refer case US2020AMR041766, reported by same reporter for the same patient
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: first shot hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix a few months ago and experienced pain. For the tolerence of 2nd dose refer case US2020AMR041761, reported by same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: not feeling well after getting the shingrix vaccine; This case was reported by a other health professional via other manufacturer and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) unknown for prophylaxis.   Concurrent medical conditions included psoriatic arthritis.   On an unknown date, the patient received Shingrix at an unknown dose. On 23rd January 2019, the patient started Xeljanz (oral) 11 mg at an unknown frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. The action taken with Xeljanz was unknown. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient was not felt well after receiving Shingrix vaccine. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced flu symptoms after vaccination and asked if could take ibuprofen.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: experienced chills; experienced fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that the patient experienced fever and chills after vaccination. The reporter asked because of the Coronavirus is it safe to get the booster shot or should I delay. The reporter asked if experience these side effects does it compromise immune system making more vulnerable to getting Coronavirus.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain
Clinical narrative: pain; redness; This case was reported by a consumer and described the occurrence of pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2020, the patient received the 1st dose of Shingrix. On 16th March 2020, less than a day after receiving Shingrix, the patient experienced pain and injection site erythema. On an unknown date, the outcome of the pain and injection site erythema were unknown.   It was unknown if the reporter considered the pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine at local pharmacy. The patient received 1st dose of Shingrix 4 hours ago on he day of reporting. The patient stated that, after vaccination had pain and injection site erythema. The patient was told that she might get a fever from the shot. The patient advised to took tylenol or advil for fever for 2 to 3 days.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: headache; aches; Flu like aches; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, general body pain and influenza-like symptoms. On an unknown date, the outcome of the headache, general body pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the headache, general body pain and influenza-like symptoms to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. after vaccination, the patient experienced headache, general body pain and influenza-like symptoms. The patient asked how long these symptoms would last.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Feeling hot, Headache
Clinical narrative: felt lightheaded/Felt faint; Felt hot/slowly feeling warm; Headache; Chills; deep achy muscle left side leg & upper arm pain; Achy muscle pain; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2020AMR040645).   On 18th February 2020, the patient received the 2nd dose of Shingrix. On 18th February 2020, less than a day after receiving Shingrix, the patient experienced fatigue. On 19th February 2020, the patient experienced muscle pain, light-headed feeling, feeling hot, headache, chills and leg pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the muscle pain, feeling hot, headache, chills and leg pain were unknown and the outcome of the fatigue and light-headed feeling were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fatigue, light-headed feeling, feeling hot, headache, chills and leg pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist was retired and the patient reporting for herself. The patient received Shingrix and felt fatigue, it resolved in 4 hours.  The patient felt lightheaded, then reported slowly feeling warm, she felt hot, had to sit due to feeling faint she reported that it resolved for a short time and then progressed to fatigue and chills, that alternated. Then she stated she had a headache after a 2 hour nap, deep achy muscle left side leg & upper arm pain.  She took Tylenol. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: felt lightheaded/Felt faint; Felt hot/slowly feeling warm; Headache; Chills; deep achy muscle left side leg & upper arm pain; Achy muscle pain; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2020AMR040645).   On 18th February 2020, the patient received the 2nd dose of Shingrix. On 18th February 2020, less than a day after receiving Shingrix, the patient experienced fatigue. On 19th February 2020, the patient experienced muscle pain, light-headed feeling, feeling hot, headache, chills and leg pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the muscle pain, feeling hot, headache, chills and leg pain were unknown and the outcome of the fatigue and light-headed feeling were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fatigue, light-headed feeling, feeling hot, headache, chills and leg pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist was retired and the patient reporting for herself. The patient received Shingrix and felt fatigue, it resolved in 4 hours.  The patient felt lightheaded, then reported slowly feeling warm, she felt hot, had to sit due to feeling faint she reported that it resolved for a short time and then progressed to fatigue and chills, that alternated. Then she stated she had a headache after a 2 hour nap, deep achy muscle left side leg & upper arm pain.  She took Tylenol. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Subcutaneous route; Swollen arm; Redness, hot and a bump in the injection site; Redness, hot and a bump in the injection site; Redness, hot and a bump in the injection site; This case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) and (batch number 477z77, expiry date 7th February 2021) for prophylaxis.   On 21st February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. In February 2020, less than a week after receiving Shingrix, the patient experienced swelling arm, injection site erythema, injection site warmth and injection site swelling. On 21st February 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the swelling arm, injection site erythema, injection site warmth, injection site swelling and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the swelling arm, injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient experienced swelling arm, injection site erythema, injection site warmth and injection site swelling after vaccination. The patient received the second dose of Shingrix by the subcutaneous route, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia, Retching
Clinical narrative: chills; fever; nausea; dry heaves; headache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2020 10:00, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd March 2020 21:30, 11 hrs 30 min after receiving Shingrix, the patient experienced chills and fever. In March 2020, the patient experienced nausea, dry heaves and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, fever, nausea, dry heaves and headache were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, nausea, dry heaves and headache to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient received 2nd dose of Shingrix around 10 am on day before reporting. Around 9:30 PM she started having chills and a fever. Around 1 AM, 15 hrs. after vaccination the patient started having nausea with dry heaves, and ton day of reporting, she has a headache. She took her temperature about 2 hours after having Tylenol and she had a fever of 100.1 degree Fahrenheit. The reporter consented to follow up. The outcome of the events were reported as not recovered/not resolved in the database however in source document, it was mentioned as recovering/resolving, so kept as reported in database.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: experienced swelling after Shingrix /.....I am swollen; This case was reported by a consumer via call center representative and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced swelling after Shingrix. The patient did not consent to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema
Clinical narrative: headache; redness at the injection site; This case was reported by a physician via call center representative and described the occurrence of headache in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced headache and injection site erythema. On an unknown date, the outcome of the headache and injection site erythema were unknown.   It was unknown if the reporter considered the headache and injection site erythema to be related to Shingrix.  Additional information was provided as follows: The batch number and expiration dates were not provided as the reporter did not have the information. The patient received Shingrix and experienced headache and redness at the injection site.  The reporter asked if the patient could receive the second dose. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: flu like symptoms; sneezing; sniffles; body aches; fever; fatigue; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th December 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue. On 29th December 2019, the outcome of the influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the left arm. After vaccination, the patient experienced  influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue. The reporter consented to follow up with physician on an unknown date.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Sneezing
Clinical narrative: flu like symptoms; sneezing; sniffles; body aches; fever; fatigue; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th December 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue. On 29th December 2019, the outcome of the influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the left arm. After vaccination, the patient experienced  influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue. The reporter consented to follow up with physician on an unknown date.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: he had a bad reaction to the Shingrix vaccine 3-5 days after having it; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 3 days after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was recovered/resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient had a bad reaction to the Shingrix vaccine 3 to 5 days after having it. The reporter said she would not provide any additional details about the report and that her physician would have to be the one to do that.  The reporter did not consent to follow up. This case is 1 out of 5 cases reported by the same reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 18 IN. BY 8 IN. RED SWOLLEN AREA AROUND INJECTION SITE. HOT TO TOUCH. PATIENT STATES THAT IT DOES NOT HURT BUT ITCHES.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a practice manager (also reported as administrator) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications or medical history provided. On 10-MAR-2020, the patient was inadvertently administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # S021322, expiration date 09-JUL-2021 (formulation, strength, exact dose, route of administration were not provided) for prophylaxis. The vaccine was exposed to -8.3 degrees Celsius for 24 minutes. No additional adverse event was reported. Digital data logger was involved.
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: VOMITING; This spontaneous case was received from a nurse on 04-Apr-2019. It describes a female patient who experienced vomiting after the administration of Vivotif for an unknown indication.   Case report: The consumer experienced vomiting 10 hours after taking the third dose of Vivotif and again she vomited 2 hours after taking the fourth dose.  Action taken with Vivotif was dosage maintained.   The consumer had recovered from the event vomiting.  Company's Comment: In this case, it was reported that the consumer had vomiting following intake of vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had vomiting following intake of vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Foreign body in throat, Oesophageal injury
Clinical narrative: FELT LIKE IT BRUISED HIS ESOPHAGUS; DOSE WAS STUCK IN THE ESOPHAGUS OR THROAT FOR ABOUT 1.5 HOURS; COULD NOT GET THE PILL TO GO DOWN; This spontaneous case (PVX2019-828) was received from a consumer on 08-Apr-2019. It describes a 50-year-old adult male consumer who "could not get the pill to go down", "dose was stuck in the esophagus or throat for about 1.5 hours", and "felt like it bruised his esophagus" while taking of Vivotif for an unknown indication.   Case report: The consumer reported that he had a little bit of trouble when he took his first dose of Vivotif on 06-Apr-2019. He could not get the pill to go down and it was stuck in his esophagus or throat for about 1.5 hours, he had to eat and drink warm water, to help it go down. He felt like it bruised his esophagus. However, on 07-Apr-2019 he was fine.  Action taken with Vivotif with the event "felt like it bruised his esophagus" was unknown while with respect to the events "could not get the pill to go down" and "dose was stuck in the esophagus or throat for about 1.5 hours" was not applicable.  The clinical outcome of the events "felt like it bruised his esophagus", "dose was stuck in the esophagus or throat for about 1.5 hours", and "could not get the pill to go down" was resolved.  Company's Comment: In this case, it was reported that the male consumer "could not get the pill to go down", "dose was stuck in the esophagus or throat for about 1.5 hours", and "felt like it bruised his esophagus" following intake of first dose of vivotif. The events appear to be incidental finding and hence, the causality of the events is not related with Vivotif vaccine. ; Sender's Comments: Company's Comment: In this case, it was reported that the male consumer "could not get the pill to go down", "dose was stuck in the esophagus or throat for about 1.5 hours", and "felt like it bruised his esophagus" following intake of first dose of vivotif. The events appear to be incidental finding and hence, the causality of  the events is not related with Vivotif vaccine.
Sex: U
Vaccine: TYP
Symptoms: Abdominal discomfort
Clinical narrative: STOMACH DISCOMFORT; This spontaneous case (PVX2019-910) was received from a nurse on 17-Apr-2019 for two consumers.   Based on the information obtained from the nurse, two individual case safety reports PVX201904-000300 (PVX2019-910; consumer 1) and PVX201904-000301 (PVX2019-910; consumer 2) were created and cross-linked in the database.  This case report describes an adult consumer who experienced stomach discomfort, after the administration of Vivotif for an unknown indication.  Case report: The consumer experienced stomach discomfort after taking Vivotif. The consumer took only two doses.  Action taken with Vivotif was dosage discontinued.  The clinical outcome of the event stomach discomfort was unknown.  Company's Comment: In this case, it was reported that the consumer experienced stomach discomfort, after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal discomfort is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced stomach discomfort, after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal discomfort is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201904-000300:
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Suspected vaccination failure; shingles, extremely mild case; itching; blister; RASH; pain for 10 days; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and tofacitinib citrate (Xeljanz) for ulcerative colitis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2019, the patient received the 2nd dose of Shingrix and Xeljanz (oral) 10 mg twice daily (20 mg daily). On an unknown date, unknown after receiving Shingrix and less than 4 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pruritus, blister and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). The action taken with Xeljanz was unknown. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and blister were unknown and the outcome of the pain was recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus, blister and rash to be related to Shingrix and Shingrix.  Additional details were received as follows: The patient received Shingrix vaccine, on the same day as starting xeljanz therapy.  The patient reported that, after starting the therapy everything was good, she felt good and things were flowing.  The patient then developed shingles, an extremely mild case. She was unsure of start date for shingles symptoms. The patient had pain for 10 days prior to itching and formation of blister.  The physician started valtrex prescription about 6 days ago of the reporting date but rash was still present. The patient received last dose of xeljanz on 10th February 2020. No additional information provided. This case was considered as suspected vaccination failure, since the details regarding time to onset and laboratory confirmation for herpes zoster were not provided.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles, extremely mild case; itching; blister; RASH; pain for 10 days; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and tofacitinib citrate (Xeljanz) for ulcerative colitis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2019, the patient received the 2nd dose of Shingrix and Xeljanz (oral) 10 mg twice daily (20 mg daily). On an unknown date, unknown after receiving Shingrix and less than 4 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pruritus, blister and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). The action taken with Xeljanz was unknown. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and blister were unknown and the outcome of the pain was recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus, blister and rash to be related to Shingrix and Shingrix.  Additional details were received as follows: The patient received Shingrix vaccine, on the same day as starting xeljanz therapy.  The patient reported that, after starting the therapy everything was good, she felt good and things were flowing.  The patient then developed shingles, an extremely mild case. She was unsure of start date for shingles symptoms. The patient had pain for 10 days prior to itching and formation of blister.  The physician started valtrex prescription about 6 days ago of the reporting date but rash was still present. The patient received last dose of xeljanz on 10th February 2020. No additional information provided. This case was considered as suspected vaccination failure, since the details regarding time to onset and laboratory confirmation for herpes zoster were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: How long can I expect my fever to last after my 2nd shingrix shot yesterday?; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know how long could he/she expect the fever to last after 2nd shingles shot. This was 1 of the 5 cases, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: headache; tired; muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced headache, fatigue and myalgia. On an unknown date, the outcome of the headache, fatigue and myalgia were not recovered/not resolved.   It was unknown if the reporter considered the headache, fatigue and myalgia to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know how long did the symptoms such as tired, muscle pain and headache stay usually after having 2nd Shingrix injection. This was 1 of the 5 cases, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Vertigo, Vestibular neuronitis
Clinical narrative: Can this injection cause vertigo; Or vestibular neuritis?; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vertigo and vestibular neuronitis. On an unknown date, the outcome of the vertigo and vestibular neuronitis were unknown.   It was unknown if the reporter considered the vertigo and vestibular neuronitis to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient wanted to know whether shinrix vaccine can cause vertigo and vestibular neuronitis. No other information was reported.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site reaction, Pain
Clinical narrative: pt had injection site reaction.  Red/soreness     referred pt  pcp if problem persists.   I contacted PCP office and made them aware of the situation.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Received erythema left upper arm
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to an approximately 62-year-old female patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in October 2013, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at county health department for prophylaxis. As a result of her receipt or zoster vaccine live (ZOSTAVAX), on an unknown date in March 2014, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse effect reported.; patient received VARN AX via intramuscular route; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 22-FEB-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection via an intramuscular way (exact dose, frequency, lot# and expiration date were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (manufacturer unknown). No additional adverse effect was reported.
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Rash
Clinical narrative: NAUSEA; TRUNCAL RASH; DIARRHEA; This spontaneous case was received from a physician on 13-Jun-2019. It describes a female consumer who had nausea, diarrhea, and truncal rash, after the administration of Vivotif for an unknown indication.  Case report: The consumer took the last dose of Vivotif on 08-Jun-2019. In between the dosing, she had nausea, diarrhea, and truncal rash.   She had no known immunocompromising condition.  Action taken with Vivotif was dosage maintained.  The consumer had been recovering from the diarrhea, while the clinical outcome of the events nausea and truncal rash was unknown.  Company's Comment: In this case, it was reported that had nausea, diarrhea, and truncal rash, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, diarrhea, and rash are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that had nausea, diarrhea, and truncal rash, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, diarrhea, and rash are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Feeling abnormal, Incomplete course of vaccination
Clinical narrative: STOMACH ACHE/ ABDOMINAL PAIN/ ABDOMINAL CRAMPS/ FELT LIKE SHE HAD BEEN POISONED; This spontaneous case report (PVX2019-2062) was received from a consumer on 09-Aug-2019. It described a 60-year-old female consumer who reported "stomach ache/ abdominal pain/ abdominal cramps/ felt like she had been poisoned" (PT: Abdominal pain), after the administration of oral Vivotif for typhoid fever prophylaxis.   Case report: The consumer took first dose of Vivotif on 06-Aug-2019. On the same day, she experienced stomach ache/abdominal pain and abdominal cramps. Also, she felt like she had been poisoned. Her physician told her to stop taking remaining doses of Vivotif. Moreover, she had no prior history of abdominal pain and cramps.  Action taken with Vivotif was vaccine discontinued.  The consumer had been recovering from the reported event.  Company's Comment: In this case, it was reported that the consumer experienced "stomach ache/abdominal pain/abdominal cramps/felt like she had been poisoned". There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, abdominal pain is labeled as per CCDS. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced "stomach ache/abdominal pain/abdominal cramps/felt like she had been poisoned" . There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, abdominal pain is labeled as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: VOMITED THE THIRD DOSE; This spontaneous case (PVX2019-2255) was received from a consumer on 04-Sep-2019. It described a female consumer, who "vomited the third dose" (PT: Vomiting), while being on Vivotif capsule for an unknown indication.  Case report: The consumer took the Vivotif doses on 27-Aug-2019, 29-Aug-2019, 31-Aug-2019, and 02-Sep-2019, respectively. She threw up the third dose on 31-Aug-2019 and saw the capsule in the vomit. She stated that she did not vomit after taking the fourth dose on 02-Sep-2019.  Action taken with Vivotif with respect to the event was dosage maintained.  The consumer had recovered from the reported event.  Company's Comment: In this case, it was reported that a female consumer "vomited the third dose". There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, vomiting is labeled as per CCDS. ; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer  "vomited the third dose". There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, vomiting is labelled as per CCDS.