chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pain, Skin discolouration, Vomiting
Clinical narrative: made us both sick; we had weakness; we had chills; we had body aches; This case was reported by a consumer and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for tolerance of 1st dose refer case US2020AMR044287).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, weakness, chills and general body pain. On an unknown date, the outcome of the sickness, weakness, chills and general body pain were unknown.   It was unknown if the reporter considered the sickness, weakness, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix and had weakness, chills, body aches and sickness. This is 1 of the 4 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: I have fever; I have body aches; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2020, the patient received the 2nd dose of Shingrix. On 11th March 2020, 1 days after receiving Shingrix, the patient experienced fever, general body pain and headache. On an unknown date, the outcome of the fever, general body pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain and headache to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. On the day of reporting the patient experienced fever, body aches, headache and enquired for how long should it last?
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 1s dose of Shingrix and experienced arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypersensitivity.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after vaccinaion experienced arm pain. The consented to follow up. For tolerence of 2nd dose refer case US2020044415, reported by same reporter. This was 1 of 3 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Wound infection
Clinical narrative: Infection in a leg wound; Some soreness; This case was reported by a other health professional via interactive digital media and described the occurrence of wound infection 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 wound infection (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the wound infection and pain were recovered/resolved.   It was unknown if the reporter considered the wound infection and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient received the 1st dose and was told to receive the 2nd dose after 2-6 months. The patient had some soreness lasting a couple of days. The patient would be going on a biologic once an infection in a leg wound clears up and wanted to know if he/she should get second shot of Shingrix before starting biologic. The patient asked was it better to get next dose at 2 months or wait a little longer.  Note: it was unknown if the patient had leg wound infection before or after 1st dose of Shingrix. Follow up information had been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Hyperpyrexia
Clinical narrative: had a very high fever (108 degrees) / such a high fever; I was too weak to take a tepid bath or go down the stairs to get Tylenol; had a bad headache; This case was reported by a consumer via call center representative and described the occurrence of hyperpyrexia in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced hyperpyrexia (serious criteria GSK medically significant), weakness and headache. On an unknown date, the outcome of the hyperpyrexia was not recovered/not resolved and the outcome of the weakness and headache were unknown.   It was unknown if the reporter considered the hyperpyrexia, weakness and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 64 years or 65 years. The patient had a very high fever (108 degree F). The patient stated it was during the night. The patient was too weak to take a tepid bath or go down the stairs to get Tylenol. Less than a week after vaccination, the patient experienced had a bad headache which the patient stated as looks like a common side affect. The patient's body temperature was 101 degree F at the time of reporting. As per advice, the patient would call the doctor's office and let them know about the fever.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (refer case US2020AMR042490).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, more than a week after receiving Shingrix, the patient experienced muscle pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced muscle pain after 2nd dose of Shingrix. This case has been linked to US2020AMR042539, reported by the same reporter.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia
Clinical narrative: Bilateral numbness from the waist down; Developed the shingles rash and was diagnosed with shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tingling of extremity.   On 12th February 2020, the patient received the 1st dose of Shingrix. On 14th February 2020, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced numbness. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the numbness was unknown.   It was unknown if the reporter considered the shingles and numbness to be related to Shingrix.  Additional details were reported as follows: The reporter stated that patient was sent to the pharmacy by the Health Care Professional to took Shingrix vaccine because he was having tingling in the four extremities. The patient received 1st dose of vaccine and developed the shingles rash and was diagnosed with shingles. The patient still had shingles at the time of reporting. The patient also had bilateral numbness from the waist. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Aches; Sore arm at injection site; This case was reported by a nurse via call center representative and described the occurrence of pain in a 65-years-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain and injection site pain. On an unknown date, the outcome of the pain and injection site pain were recovered/resolved.   It was unknown if the reporter considered the pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The patient experienced aches and sore arm at injection site for 36 hours.  The patient did not experience hives. The reporter consented to follow up. This case has been linked to US2020056774 and US2020AMR057294, reported by the same reporter.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Apnoea, Blood culture negative, Bronchopulmonary dysplasia, Culture urine negative, Cyanosis
Clinical narrative: Excessive sleepiness and refusal to feed -- about 12 hrs later, family called and referred to ER, noted hypothermia, treated for suspected sepsis, but cultures remained negative, Had an episode during feed the next am on the hospital floor of cyanosis and apnea, successful code, transferred to PICU, temps eventually improved, some low sats, Pulmonary consult obtained, CLD of preterm infant suspected
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Food refusal, Full blood count normal, Hypothermia, Intensive care, Oxygen saturation decreased
Clinical narrative: Excessive sleepiness and refusal to feed -- about 12 hrs later, family called and referred to ER, noted hypothermia, treated for suspected sepsis, but cultures remained negative, Had an episode during feed the next am on the hospital floor of cyanosis and apnea, successful code, transferred to PICU, temps eventually improved, some low sats, Pulmonary consult obtained, CLD of preterm infant suspected
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Sepsis, Somnolence, Urine analysis normal
Clinical narrative: Excessive sleepiness and refusal to feed -- about 12 hrs later, family called and referred to ER, noted hypothermia, treated for suspected sepsis, but cultures remained negative, Had an episode during feed the next am on the hospital floor of cyanosis and apnea, successful code, transferred to PICU, temps eventually improved, some low sats, Pulmonary consult obtained, CLD of preterm infant suspected
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Emotional distress, Hypophagia, Irritability, Staring
Clinical narrative: Fussiness/inconsolable for at least 1 hour at 7pm that night, gave Tylenol.  Crying subsided but for the next 15 hours she would only stare off to the side when awake, not responding to mom.  Barely eating.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Fussiness/inconsolable for at least 1 hour at 7pm that night, gave Tylenol.  Crying subsided but for the next 15 hours she would only stare off to the side when awake, not responding to mom.  Barely eating.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Culture throat negative, Decreased appetite, Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: Fever, adenopathy, listless and fatigue with decreased appetite for 3+ days. Presenting at clinic with: Right tender anterior cervical node.  Size: 2cm and Left non-tender anterior cervical node.  Size: 2cm.  R/o strep: Throat culture negative for rapid strep, culture came back negative as well.  Treatment: Symptom support, return to care if worsens.  Patient has not called or returned to care for continued c/o as of today of report.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Fever, adenopathy, listless and fatigue with decreased appetite for 3+ days. Presenting at clinic with: Right tender anterior cervical node.  Size: 2cm and Left non-tender anterior cervical node.  Size: 2cm.  R/o strep: Throat culture negative for rapid strep, culture came back negative as well.  Treatment: Symptom support, return to care if worsens.  Patient has not called or returned to care for continued c/o as of today of report.
Sex: F
Vaccine: PPV, UNK
Symptoms: Erythema, Lymph node pain, Urticaria
Clinical narrative: lymph node was sore; reddish purlpe welt; This spontaneous report was received from a pharmacist and refers to a 45-year-old female patient. The patient's concurrent conditions included allergy to penicillin, fluconazole, metronidazole benzoate (FLAGYL) and minocycline. The patient's medical history and concomitant therapies were not reported.  On 23-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot # S033516, expiry date 29-JUN-2021 (exact dose was not reported), indication was reported as asthmatic.  On 24-MAR-2020, the patient experienced a reddish purple "welt" near her bicep and her lymph node was sore. No treatment was given for the events.  The outcome of the events was reported as not recovered. The causality assessment was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient stated that he received his second dose of GARDASIL 9 "about 6 weeks after the first dose, not 8 weeks like it is recommended.; No adverse symptoms reported.; This spontaneous report was received from a patient of unknown age and gender reporting on herself. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location,lot # and expiration date were unknown) for prophylaxis. Additionally, the patient stated that he received his second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) about 6 weeks after the first dose, not 8 weeks like it is recommended. No adverse symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles (herpes zoster).  As a direct and proximate result of the used of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would 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 would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Herpes zoster, Rash
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 18-APR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered a rash and discomfort around the left chest which traveled anteriorly towards the breastbone and posteriorly over the shoulder blade; then, the patient was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, symptoms had resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX) vaccination, he sustained severe and permanent personal injuries. Further, patient 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 of zoster vaccine live (ZOSTAVAX) vaccine, he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).  Reporter considered herpes zoster to be a disabling event.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site was sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. After the first dose of the Shingrix vaccine the injection site was sore. The reporter did not consent to follow up. For tolerance of 2nd dose refer case US2020053227.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: had every side effect listed after their Shingrix injection; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The patient was reporter's friend. The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient had every side effect listed after their Shingrix injection, but there were no further details. The reporter did not wish to provide any demographics, other than this statement. The reporter did not consent to follow up. This case had been linked to the case US2020053243, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: had reaction with first dose; This case was reported by a consumer and described the occurrence of adverse drug reaction 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 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 age group was not reported, but was selected adult as per vaccine indication. The patient had reaction with first dose lasting for 2 days. The reporter requesting consent to follow up. For tolerance of 2nd dose refer case US2020AMR053971.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza like illness, Malaise, Somnolence
Clinical narrative: had reaction with first dose; This case was reported by a consumer and described the occurrence of adverse drug reaction 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 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 age group was not reported, but was selected adult as per vaccine indication. The patient had reaction with first dose lasting for 2 days. The reporter requesting consent to follow up. For tolerance of 2nd dose refer case US2020AMR053971.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 65 or 66 years. The patient experienced sore arm after receiving 1st dose of Shingrix. Consent to follow up was provided. For tolerance with 2nd dose of Shingrix refer case US2020AMR012880. The patient did not experienced rash (which was red bumps) after 1st dose of Shingrix.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Hyperaesthesia, Hypoaesthesia, Lacrimation increased, Ocular discomfort
Clinical narrative: suspects optical Shingles; right eye became very sensitive; Watery eye; eye sensation as having a headache in the eye / Tender to touch; Sensitivity extended on right side of face near cheek; eye sensitivity to light; numbness around eye down to cheek; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th March 2020, 3 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye discomfort, watering eyes and eye pain. In March 2020, the patient experienced hyperesthesia, photophobia and numbness facial. On an unknown date, the outcome of the ophthalmic herpes zoster, eye pain, photophobia and numbness facial were not recovered/not resolved and the outcome of the eye discomfort was recovering/resolving and the outcome of the watering eyes and hyperesthesia were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, eye discomfort, watering eyes, eye pain, hyperesthesia, photophobia and numbness facial to be related to Shingrix.  Additional details were provided as follows: The patient was a pharmacist and reported receiving 2nd dose of Shingrix in left deltoid.  On 12th March 2020, the patient's right eye became very sensitive and she suspects optical shingles. Her eye started watering and becoming bothersome.  The patient also described eye sensation as having a headache in the eye.  Sensitivity became worse as the day went on.  At night, the patient's eye became worse in that it became tender to touch as if lightly pressing on a bruise.  Sensitivity extended on right side of face near cheek and upper jaw.  The patient used an ice pack last night to help relieve sensitivity. The patient reported eye sensitivity to light and numbness around eye down to cheek.  Her symptoms are not too painful. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Photophobia, Tenderness
Clinical narrative: suspects optical Shingles; right eye became very sensitive; Watery eye; eye sensation as having a headache in the eye / Tender to touch; Sensitivity extended on right side of face near cheek; eye sensitivity to light; numbness around eye down to cheek; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th March 2020, 3 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye discomfort, watering eyes and eye pain. In March 2020, the patient experienced hyperesthesia, photophobia and numbness facial. On an unknown date, the outcome of the ophthalmic herpes zoster, eye pain, photophobia and numbness facial were not recovered/not resolved and the outcome of the eye discomfort was recovering/resolving and the outcome of the watering eyes and hyperesthesia were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, eye discomfort, watering eyes, eye pain, hyperesthesia, photophobia and numbness facial to be related to Shingrix.  Additional details were provided as follows: The patient was a pharmacist and reported receiving 2nd dose of Shingrix in left deltoid.  On 12th March 2020, the patient's right eye became very sensitive and she suspects optical shingles. Her eye started watering and becoming bothersome.  The patient also described eye sensation as having a headache in the eye.  Sensitivity became worse as the day went on.  At night, the patient's eye became worse in that it became tender to touch as if lightly pressing on a bruise.  Sensitivity extended on right side of face near cheek and upper jaw.  The patient used an ice pack last night to help relieve sensitivity. The patient reported eye sensitivity to light and numbness around eye down to cheek.  Her symptoms are not too painful. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a physician via call center representative and described the occurrence of fever in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient started with fever 24 hours after receiving 1st dose of Shingrix. The healthcare professional would like to know if the fever was attributable to the vaccine or could it be associated with Coronavirus. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Within 5 minutes of receiving the vaccine, patient passed out face first in the store.  He woke up almost immediately after hitting the floor.  Said he was fine when he woke up, only felt a little dizzy before he passed out.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Muscular weakness, Myalgia
Clinical narrative: patient states night of vaccine (3/31) she had cold chills, On 4/1 she felt "chilly cold" all day and had upper leg muscle pain/weakness
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Full body hives and dyspnea. Received an IM dose of Solumedrol at PCP office on Monday 3/30/20.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Fever &  body aches for approximately 24-36 hours post-injection. Site tenderness also.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Dermatitis diaper, Frequent bowel movements, Pyrexia
Clinical narrative: Increase stooling onset 3/23/2020 several times a day initially fever after vaccines now with diaper rash
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Chills, Diarrhoea, Myalgia
Clinical narrative: CHILLS; MYALGIA; ABDOMINAL CRAMPING; DIARRHOEA; This spontaneous case report was extracted through VAERS database (775021-1) on 01-Feb-2019. The case was reported by a consumer via health authority. The report describes a 49-year-old male consumer who had diarrhea, abdominal cramping, myalgia, and chills following the intake of oral Vivotif (lot no: 3003215) for an unknown indication.  The consumer had colon cancer at the age of 48 and he had surgical cured in Jun 2016. The consumer was also allergic to injection, tree nuts, peanuts, grass and weeds. He received also AIT Shots (allergy shot).  The consumer's concomitant medication included fish oil.  It was reported that the consumer took the first dose of Vivotif on 18-Sep-2019. All the four doses were taken. On 26-Sep-2019, he had diarrhea, abdominal cramping, myalgia and chills.  The action taken with Vivotif with respect to the events diarrhea, abdominal cramping, myalgia, and chills was not applicable.  The clinical outcome of the events diarrhea, abdominal cramping, myalgia, and chills was not resolved.  Company's Comment: In this case, it was reported that the consumer had diarrhea, abdominal cramping, myalgia and chills after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea, abdominal cramping, myalgia, and chills 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 the consumer had diarrhea, abdominal cramping, myalgia and chills after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea, abdominal cramping, myalgia, and chills are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Chills, Hypersensitivity, Hypoaesthesia oral, Immediate post-injection reaction, Malaise
Clinical narrative: ALLERGIC REACTION; TONGUE AND THROAT WENT NUMB; IMMEDIATE REACTION TO VACCINE; TONGUE AND THROAT WENT NUMB; CHILLS; MALAISE; This spontaneous case report was extracted through VAERS database (804348-1) on 21-Jun-2018. The case was reported by a consumer. It describes a 49-year-old female consumer who experienced the events chills, malaise, allergic reaction, tongue and throat went numb, and immediate reaction to vaccine, after the administration of oral Vivotif (lot no: 3003239) for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 28-Feb-2019 and had an immediate reaction of vaccine, including chills and malaise. Her tongue and throat went numb. She took two dose of Benadryl (diphenhydramine) from which events got resolved somewhat. She contacted to primary care physician (PCP) and she was informed to immediately discontinue vaccine. She was prescribed prednisone, but she did not feel better.  Action taken with Vivotif was dosage discontinued.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported a female consumer experienced the events chills, malaise, allergic reaction, tongue and throat went numb, and immediate reaction to vaccine, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events "chills, malaise, allergic reaction, tongue and throat went numb". Hence, the causality of the events with Vivotif is assessed as possible. The causality for the event "immediate reaction to vaccine" is assessed as not related as vivotif is an oral vaccine. ; Sender's Comments: Company's Comment: In this case, it was reported a female consumer experienced the events chills, malaise, allergic reaction, tongue and throat went numb, and immediate reaction to vaccine, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events "chills, malaise, allergic reaction, tongue and throat went numb" . Hence, the causality of the events with Vivotif is assessed as possible. The causality for the event "immediate reaction to vaccine" is assessed as not related as vivotif is a oral vaccine.
Sex: F
Vaccine: TYP
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: ALLERGIC REACTION; TONGUE AND THROAT WENT NUMB; IMMEDIATE REACTION TO VACCINE; TONGUE AND THROAT WENT NUMB; CHILLS; MALAISE; This spontaneous case report was extracted through VAERS database (804348-1) on 21-Jun-2018. The case was reported by a consumer. It describes a 49-year-old female consumer who experienced the events chills, malaise, allergic reaction, tongue and throat went numb, and immediate reaction to vaccine, after the administration of oral Vivotif (lot no: 3003239) for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 28-Feb-2019 and had an immediate reaction of vaccine, including chills and malaise. Her tongue and throat went numb. She took two dose of Benadryl (diphenhydramine) from which events got resolved somewhat. She contacted to primary care physician (PCP) and she was informed to immediately discontinue vaccine. She was prescribed prednisone, but she did not feel better.  Action taken with Vivotif was dosage discontinued.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported a female consumer experienced the events chills, malaise, allergic reaction, tongue and throat went numb, and immediate reaction to vaccine, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events "chills, malaise, allergic reaction, tongue and throat went numb". Hence, the causality of the events with Vivotif is assessed as possible. The causality for the event "immediate reaction to vaccine" is assessed as not related as vivotif is an oral vaccine. ; Sender's Comments: Company's Comment: In this case, it was reported a female consumer experienced the events chills, malaise, allergic reaction, tongue and throat went numb, and immediate reaction to vaccine, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events "chills, malaise, allergic reaction, tongue and throat went numb" . Hence, the causality of the events with Vivotif is assessed as possible. The causality for the event "immediate reaction to vaccine" is assessed as not related as vivotif is a oral vaccine.
Sex: F
Vaccine: TYP
Symptoms: Chills, Diarrhoea, Hypersomnia, Malaise, Nausea
Clinical narrative: ACHY; SLEPT ALL DAY AND NIGHT; HAD A BAD REACTION; CHILLS; VERY SICK; NAUSEA; VOMITING; DIARRHOEA; This spontaneous case report (819160-1) was extracted through VAERS database on 27-Sep-2019. The case was reported by a consumer via health authority. This report described a 57-year-old female consumer who developed diarrhea (PT: Diarrhoea), vomiting (PT: Vomiting), nausea (PT: Nausea), chills (PT: Chills), achy (PT: Pain), very sick (PT: Malaise), slept all day and night (PT:  Hypersomnia), and had a bad reaction (PT: vaccination complication), while being on oral Vivotif for an unknown indication.  Case report: The consumer took first dose of Vivotif on 27-May-2019. After taking first dose, she had a bad reaction and very watery diarrhea which was resolved with Imodium (loperamide). There was no reaction after the second dose of Vivotif. On 31-May-2019, she took the third dose and woke up very sick on Saturday. Later, she had severe diarrhea, vomiting, severe nausea, chills, achy and slept all day and night. Also, she was basically out of it for 12 hours. It was reported that she could not take her last dose of Vivotif.  Medical history included mild asthma, borderline elevated cholesterol, urge incontinence, environmental allergies, and allergies to cat hair and dust mites.  Concomitant medications included oxybutynin CR (5 mg; once daily), Zyrtec (cetirizine; 10 mg; once daily), and multivitamin.  Action taken with Vivotif with respect to reported events was unknown.  The consumer had recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer experienced diarrhea, vomiting, nausea, chills, achy, very sick, slept all day and night, and had a bad reaction after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events.  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 the consumer experienced diarrhea, vomiting, nausea, chills, achy, very sick, slept all day and night, and had a bad reaction after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events.  Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Pain, Vomiting
Clinical narrative: ACHY; SLEPT ALL DAY AND NIGHT; HAD A BAD REACTION; CHILLS; VERY SICK; NAUSEA; VOMITING; DIARRHOEA; This spontaneous case report (819160-1) was extracted through VAERS database on 27-Sep-2019. The case was reported by a consumer via health authority. This report described a 57-year-old female consumer who developed diarrhea (PT: Diarrhoea), vomiting (PT: Vomiting), nausea (PT: Nausea), chills (PT: Chills), achy (PT: Pain), very sick (PT: Malaise), slept all day and night (PT:  Hypersomnia), and had a bad reaction (PT: vaccination complication), while being on oral Vivotif for an unknown indication.  Case report: The consumer took first dose of Vivotif on 27-May-2019. After taking first dose, she had a bad reaction and very watery diarrhea which was resolved with Imodium (loperamide). There was no reaction after the second dose of Vivotif. On 31-May-2019, she took the third dose and woke up very sick on Saturday. Later, she had severe diarrhea, vomiting, severe nausea, chills, achy and slept all day and night. Also, she was basically out of it for 12 hours. It was reported that she could not take her last dose of Vivotif.  Medical history included mild asthma, borderline elevated cholesterol, urge incontinence, environmental allergies, and allergies to cat hair and dust mites.  Concomitant medications included oxybutynin CR (5 mg; once daily), Zyrtec (cetirizine; 10 mg; once daily), and multivitamin.  Action taken with Vivotif with respect to reported events was unknown.  The consumer had recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer experienced diarrhea, vomiting, nausea, chills, achy, very sick, slept all day and night, and had a bad reaction after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events.  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 the consumer experienced diarrhea, vomiting, nausea, chills, achy, very sick, slept all day and night, and had a bad reaction after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events.  Hence, the causality of the events with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Dizziness, Nausea, Pyrexia, Sluggishness
Clinical narrative: SLUGGISH; DIZZY; FEVERISH; NAUSEATED; This spontaneous case report (828373-1) was extracted through VAERS database on 06-Dec-2019. The case was reported by a consumer via health authority. The report described a 34-year-old male consumer who felt dizzy (PT: Dizziness), feverish (PT: Pyrexia), sluggish (PT: Sluggishness) and nauseated (PT: Nausea) while being on oral Vivotif (lot number: 3003279) for an unknown indication.  Case report: The consumer took third dose of Vivotif on 11-Aug-2019. Following the third dose of Vivotif the consumer felt dizzy, feverish, sluggish, and nauseated on 12-Aug-2019.  Medical history included HIV (human immunodeficiency virus).  Concomitant medication included Genvoya tablet (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; 150 mg/150 mg/200 mg/10 mg).   Action taken with Vivotif with respect to the reported events was unknown.  The consumer had recovered from the reported events.  Company Comment: A consumer took the third Vivotif dose, on the next day felt dizziness, feverish, sluggishness, and nauseated. Consumer recovered from all of the events. Considering the potential of Vivotif to cause nausea, dizziness, and fever, the causality of all these events is assessed as possible with Vivotif. The role of Vivotif cannot be ruled out for sluggishness as Vivotif can cause tiredness and malaise, and the causality of sluggishness is assessed as possible. The event sluggishness is unlabelled as per CCDS.; Sender's Comments: A consumer took the third Vivotif dose and on the next day felt dizziness, feverish, sluggishness, and nauseated. Consumer recovered from all of the events. Considering the potential of Vivotif to cause nausea, dizziness, and fever, the causality of all these events is assessed as possible with Vivotif. The role of Vivotif cannot be ruled out for sluggishness as Vivotif can cause tiredness and malaise, and the causality of sluggishness is assessed as possible. The event sluggishness is unlabelled as per CCDS.
Sex: F
Vaccine: FLU3, TYP, VARCEL, YF
Symptoms: Erythema, Neck pain, Pain, Swelling
Clinical narrative: PAIN IN LEFT SIDE OF NECK; PAIN; REDNESS; SWELLING; This spontaneous case report (838045-1) was extracted through VAERS database on 06-Dec-2019. The case was reported by a consumer via health authority. The report described a 76-year-old female consumer who had pain (PT: Pain), redness (PT: Erythema), swelling (PT: Swelling) and pain in left side of neck (PT: Neck pain), while being on Vivotif, Fluzone (influenza virus vaccine), Varivax (varicella virus vaccine live) and YF-Vax (yellow fever vaccine) for unknown indications.  Case report: The consumer took a dose of Vivotif on 01-Oct-2019, along with Fluzone, Varivax and YF-Vax. She developed pain, redness, and swelling on 01-Oct-2019 and pain in the left side of the neck on 02-Oct-2019. She was using her left to pick up solid item and felt water drops on her left hand.  The consumer's past medical history included arthritis.  Allergy included codeine allergy.  Concomitant medication included simvastatin and Effexor (venlafaxine).  Action taken with Vivotif, Fluzone, Varivax and YF-Vax with respect to the reported events was unknown.  The consumer had not recovered from the reported events.  Company Comment: A consumer had Vivotif dose and then developed pain, erythema, swelling and pain in left side of neck. Consumer also had Fluzone vaccine (on right arm), Varivax vaccine, and yellow fever vaccine along with Vivotif. Vivotif is an oral vaccine and the causality of all of the events is assessed as unlikely with Vivotif and could be explained by all other vaccines she took along with Vivotif.; Sender's Comments: A consumer had Vivotif dose and then developed pain, erythema, swelling and pain in left side of neck. Consumer also had Fluzone vaccine (on right arm), Varivax vaccine, and yellow fever vaccine along with Vivotif. Vivotif is an oral vaccine and the causality of all of the events is assessed as unlikely with Vivotif and could be explained by all other vaccines she took along with Vivotif.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Pain
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.