chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Rhinitis allergic, Skin burning sensation, Skin exfoliation, Skin lesion, Swelling of eyelid
Clinical narrative: Patient presented for the first time after 10/11/18 vaccinations on 11/01/2018 complaining of scattered, scaly rash all over trunk, chest wall, and legs. Office note states mother noticed a swollen area on left upper thigh approximately 1 or 2 days prior to this office visit.  The nurse's note states that the site was swollen, warm and tender to touch, without drainage. Patient was afebrile. The diagnoses for this date was pruritis, tinea corporis, and cutaneous abscess of left lower limb. Medications prescribed at this visit were Griseofulvin, Sulfamethazole-Trimethoprim, and topical Mupirocin. On 12/6/2018 patient returned to office complaining of bilateral eyelid swelling and eye pain. She was afebrile and denied cough. Medications continued were Griseofulvin and topical Ketoconazole 2% for the tinea rash. Zaditor and Cetirizine were also added.  She still complained that the left thigh abscess had not resolved and was referred to wound care with Dr. Office notes on 12/7/19 state that mother noticed lesion on left thigh 3 weeks prior to the office visit and stated that child did not have any pain at that time. Notes state the lesion on that date measured 1x1x1cm with serosanguineous drainage, red granulation, and subcutaneous tissue exposed. The wound was cleaned and dressed.  Child returned to pediatrician?s office on 2/7/19 with rash, cough and congestion. She was diagnosed with viral URI, hives, contact dermatitis, pruritis, left thigh abscess improved. She was prescribed Prednisolone 15mg/5ml twice daily for 5 days and Cetirizine 10 ml daily. Returned to Pediatrician?s office on 2/22/19 for skin peeling of hands and feet. Complained of burning skin. She was diagnosed with Eczema and Allergic Rhinitis. Patient was prescribed topical hydrocortisone 2.5% cream bid for 5-10 days and Children?s Loratadine 5ml once daily. Returned to Pediatrician 3/21/19 for congestion and ear pain. She had an ear infection and was prescribed Augmentin 600-42.9mg/5ml for 10 days. She returned to wound care on 4/10/19 complaining of left thigh pain at site of abscess for 3 weeks duration after bumping into an object. Wound care nurse reported that the abscess on left thigh had not healed since vaccines were given on 10/11/18. Wound had serous fluid and some tenderness. The wound was cleaned dressed and patient was referred for a surgical evaluation with Dr. 4/11/19 phone note from nurse practitioner stated that mother says the wound site was healed for months then started swelling again so she went back wound care to have it checked. She stated her allergies were also flaring again causing her eyes to swell. She was prescribed Zaditor eye drops and advised to continue Cetirizine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Urticaria, Viral upper respiratory tract infection, Wound treatment
Clinical narrative: Patient presented for the first time after 10/11/18 vaccinations on 11/01/2018 complaining of scattered, scaly rash all over trunk, chest wall, and legs. Office note states mother noticed a swollen area on left upper thigh approximately 1 or 2 days prior to this office visit.  The nurse's note states that the site was swollen, warm and tender to touch, without drainage. Patient was afebrile. The diagnoses for this date was pruritis, tinea corporis, and cutaneous abscess of left lower limb. Medications prescribed at this visit were Griseofulvin, Sulfamethazole-Trimethoprim, and topical Mupirocin. On 12/6/2018 patient returned to office complaining of bilateral eyelid swelling and eye pain. She was afebrile and denied cough. Medications continued were Griseofulvin and topical Ketoconazole 2% for the tinea rash. Zaditor and Cetirizine were also added.  She still complained that the left thigh abscess had not resolved and was referred to wound care with Dr. Office notes on 12/7/19 state that mother noticed lesion on left thigh 3 weeks prior to the office visit and stated that child did not have any pain at that time. Notes state the lesion on that date measured 1x1x1cm with serosanguineous drainage, red granulation, and subcutaneous tissue exposed. The wound was cleaned and dressed.  Child returned to pediatrician?s office on 2/7/19 with rash, cough and congestion. She was diagnosed with viral URI, hives, contact dermatitis, pruritis, left thigh abscess improved. She was prescribed Prednisolone 15mg/5ml twice daily for 5 days and Cetirizine 10 ml daily. Returned to Pediatrician?s office on 2/22/19 for skin peeling of hands and feet. Complained of burning skin. She was diagnosed with Eczema and Allergic Rhinitis. Patient was prescribed topical hydrocortisone 2.5% cream bid for 5-10 days and Children?s Loratadine 5ml once daily. Returned to Pediatrician 3/21/19 for congestion and ear pain. She had an ear infection and was prescribed Augmentin 600-42.9mg/5ml for 10 days. She returned to wound care on 4/10/19 complaining of left thigh pain at site of abscess for 3 weeks duration after bumping into an object. Wound care nurse reported that the abscess on left thigh had not healed since vaccines were given on 10/11/18. Wound had serous fluid and some tenderness. The wound was cleaned dressed and patient was referred for a surgical evaluation with Dr. 4/11/19 phone note from nurse practitioner stated that mother says the wound site was healed for months then started swelling again so she went back wound care to have it checked. She stated her allergies were also flaring again causing her eyes to swell. She was prescribed Zaditor eye drops and advised to continue Cetirizine.
Sex: U
Vaccine: HPV9
Symptoms: Neurological symptom
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of unspecified children of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with GARDASIL 9 (doses, frequencies, routes of administration and lot #s were not reported). On an unknown dates, the patients experienced neurological effects. The outcome of neurological effects was unknown. The causality assessment was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 1 ml dose of VAQTA was administered to one pediatric patient; No adverse effects reported; Information has been received from a medical assistant and refers to a  pediatric patient of unknown age and gender.      The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated intramuscularly with 1 ml adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # R002487, expiration date 21-APR-2019, for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received 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 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. The reporter stated that, when the patient received SHINGRIX, his arm hurt for weeks. The patient had recovered after some weeks. This case has been linked with case US2019GSK065527, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 65-year-old female patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pounding in head. On an unknown date, the outcome of the pounding in head was recovered/resolved. It was unknown if the reporter considered the pounding in head to be related to SHINGRIX. Additional details were provided as follows: In January 2019, the patient received 1st dose of SHINGRIX, and only had a pounding headache. The pounding headache resolved on an unknown date. For tolerance of 2nd dose, refer case number US2019060805.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 65-year-old female patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pounding in head. On an unknown date, the outcome of the pounding in head was recovered/resolved. It was unknown if the reporter considered the pounding in head to be related to SHINGRIX. Additional details were provided as follows: In January 2019, the patient received 1st dose of SHINGRIX, and only had a pounding headache. The pounding headache resolved on an unknown date. For tolerance of 2nd dose, refer case number US2019060805.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 65-year-old female patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pounding in head. On an unknown date, the outcome of the pounding in head was recovered/resolved. It was unknown if the reporter considered the pounding in head to be related to SHINGRIX. Additional details were provided as follows: In January 2019, the patient received 1st dose of SHINGRIX, and only had a pounding headache. The pounding headache resolved on an unknown date. For tolerance of 2nd dose, refer case number US2019060805.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received at the beginning of January 2019, refer case number US2019GSK064744). On 1st April 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2019, 1 days after receiving SHINGRIX, the patient experienced exhaustion, weakness, pain in arm and appetite absent. In April 2019, the patient experienced pounding in head, sleeplessness, shivering and general body pain. The patient was treated with ADVIL. Rechallenge with SHINGRIX was positive. On 3rd April 2019, the outcome of the exhaustion, weakness, pain in arm and appetite absent were recovered/resolved. In April 2019, the outcome of the pounding in head, sleeplessness and shivering were recovered/resolved. On an unknown date, the outcome of the general body pain was not recovered/not resolved. The reporter considered the pounding in head, sleeplessness, shivering, general body pain, exhaustion, weakness, pain in arm and appetite absent to be related to SHINGRIX. Additional details were provided as follows: On 1st April 2019, Monday morning, the patient received 2nd dose of SHINGRIX in left deltoid and by the evening, the patient had pounding headache, couldn't sleep, shivering, chills and body aches. On 2nd April 2019, Tuesday, the patient was feeling exhausted. She was in the for most of Tuesday due to being weak and fatigued. Her arm was very sore as if she had been beaten and she had no appetite. The patient received ADVIL for her head and body aches and by Wednesday morning, she started to feel better except her head still hurt. By Wednesday afternoon, her headache started to subside but she felt weak. At the day of reporting, the patient was better but was still having some body aches. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received at the beginning of January 2019, refer case number US2019GSK064744). On 1st April 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2019, 1 days after receiving SHINGRIX, the patient experienced exhaustion, weakness, pain in arm and appetite absent. In April 2019, the patient experienced pounding in head, sleeplessness, shivering and general body pain. The patient was treated with ADVIL. Rechallenge with SHINGRIX was positive. On 3rd April 2019, the outcome of the exhaustion, weakness, pain in arm and appetite absent were recovered/resolved. In April 2019, the outcome of the pounding in head, sleeplessness and shivering were recovered/resolved. On an unknown date, the outcome of the general body pain was not recovered/not resolved. The reporter considered the pounding in head, sleeplessness, shivering, general body pain, exhaustion, weakness, pain in arm and appetite absent to be related to SHINGRIX. Additional details were provided as follows: On 1st April 2019, Monday morning, the patient received 2nd dose of SHINGRIX in left deltoid and by the evening, the patient had pounding headache, couldn't sleep, shivering, chills and body aches. On 2nd April 2019, Tuesday, the patient was feeling exhausted. She was in the for most of Tuesday due to being weak and fatigued. Her arm was very sore as if she had been beaten and she had no appetite. The patient received ADVIL for her head and body aches and by Wednesday morning, she started to feel better except her head still hurt. By Wednesday afternoon, her headache started to subside but she felt weak. At the day of reporting, the patient was better but was still having some body aches. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received at the beginning of January 2019, refer case number US2019GSK064744). On 1st April 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2019, 1 days after receiving SHINGRIX, the patient experienced exhaustion, weakness, pain in arm and appetite absent. In April 2019, the patient experienced pounding in head, sleeplessness, shivering and general body pain. The patient was treated with ADVIL. Rechallenge with SHINGRIX was positive. On 3rd April 2019, the outcome of the exhaustion, weakness, pain in arm and appetite absent were recovered/resolved. In April 2019, the outcome of the pounding in head, sleeplessness and shivering were recovered/resolved. On an unknown date, the outcome of the general body pain was not recovered/not resolved. The reporter considered the pounding in head, sleeplessness, shivering, general body pain, exhaustion, weakness, pain in arm and appetite absent to be related to SHINGRIX. Additional details were provided as follows: On 1st April 2019, Monday morning, the patient received 2nd dose of SHINGRIX in left deltoid and by the evening, the patient had pounding headache, couldn't sleep, shivering, chills and body aches. On 2nd April 2019, Tuesday, the patient was feeling exhausted. She was in the for most of Tuesday due to being weak and fatigued. Her arm was very sore as if she had been beaten and she had no appetite. The patient received ADVIL for her head and body aches and by Wednesday morning, she started to feel better except her head still hurt. By Wednesday afternoon, her headache started to subside but she felt weak. At the day of reporting, the patient was better but was still having some body aches. The reporter did not consent to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Cough, Diarrhoea, Feeling cold, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 1st April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2019, 1 day after receiving SHINGRIX, the patient experienced feeling cold, influenza-like symptoms, weakness and diarrhea. On an unknown date, the patient experienced tremor and cough. On an unknown date, the outcome of the feeling cold, influenza-like symptoms, weakness, diarrhea and cough were unknown and the outcome of the tremor was recovered/resolved. It was unknown if the reporter considered the feeling cold, influenza-like symptoms, tremor, weakness, diarrhea and cough to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient stated that he woke up next day at 1 am with shaking and then it went away. Next day he woke up feeling cold, weak, flu like symptoms, and diarrhea. He was still experiencing this effect which come and go. A few days ago, he also developed a cough. The reporter consented to follow up. No further details were provided.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 1st April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2019, 1 day after receiving SHINGRIX, the patient experienced feeling cold, influenza-like symptoms, weakness and diarrhea. On an unknown date, the patient experienced tremor and cough. On an unknown date, the outcome of the feeling cold, influenza-like symptoms, weakness, diarrhea and cough were unknown and the outcome of the tremor was recovered/resolved. It was unknown if the reporter considered the feeling cold, influenza-like symptoms, tremor, weakness, diarrhea and cough to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient stated that he woke up next day at 1 am with shaking and then it went away. Next day he woke up feeling cold, weak, flu like symptoms, and diarrhea. He was still experiencing this effect which come and go. A few days ago, he also developed a cough. The reporter consented to follow up. No further details were provided.
Sex: U
Vaccine: PNC13
Symptoms: Limb discomfort
Clinical narrative: Arm felt a little bit heavy and then it was quickly fine; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative.  A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient's arm felt a little bit heavy and then it was quickly fine on an unspecified date. The patient recovered from the event on an unknown date.   Information on batch number has been requested
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Arm swelled and red 4 inch red circle. Ache and itchy. Lasted until April 2.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Body temperature increased, Seizure
Clinical narrative: increased temp w/in two hours of vaccines, parents unable to get temp to come down, parents brought pt to ED where seizure occurred. Seizure lasted 2-3 minutes, pt recovered after an hour.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Brain death, Brain injury, Brain scan abnormal, Crying, Dark circles under eyes
Clinical narrative: Woke up with a fever of 101, crying, diarrhea. Gave him a cool bath after changing him to get him clean/cool him down. He could not grab the water from the faucet, he missed it as if his hand wasn't going where his brain told to. Tried to give him water, he wouldn't drink any. He snuggled back to sleep, we transferred him to his crib. At 9am, he threw up in his sleep without even stirring, eyes had deep dark circles. We picked him up and he was limp. We took him to the ER where they said had severe brain damage. They treated him for sepsis.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Death, Diarrhoea, Hypophagia, Hypotonia, Pyrexia
Clinical narrative: Woke up with a fever of 101, crying, diarrhea. Gave him a cool bath after changing him to get him clean/cool him down. He could not grab the water from the faucet, he missed it as if his hand wasn't going where his brain told to. Tried to give him water, he wouldn't drink any. He snuggled back to sleep, we transferred him to his crib. At 9am, he threw up in his sleep without even stirring, eyes had deep dark circles. We picked him up and he was limp. We took him to the ER where they said had severe brain damage. They treated him for sepsis.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Sepsis, Vomiting
Clinical narrative: Woke up with a fever of 101, crying, diarrhea. Gave him a cool bath after changing him to get him clean/cool him down. He could not grab the water from the faucet, he missed it as if his hand wasn't going where his brain told to. Tried to give him water, he wouldn't drink any. He snuggled back to sleep, we transferred him to his crib. At 9am, he threw up in his sleep without even stirring, eyes had deep dark circles. We picked him up and he was limp. We took him to the ER where they said had severe brain damage. They treated him for sepsis.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness and warmth with mild edema at injection site that is the size of a orange after 48 hours.  It slowly increased in size from time of injection.  Instructed the patients mother to apply hydrocortisone cream to site BID, cool packs, and take benadryl routinely every 6 hours while symtpms are present.  Denies any SOB.  Instructed mother to call if worsens and prednisone may be sent into pharmacy.  The mother is outlining the diameter of the redness.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Dizziness, Rash, Rhinorrhoea
Clinical narrative: nasal drainage, dizziness, cough, beginning week after immunization,  rash started 12 days after immunization
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Chills, Dizziness, Headache
Clinical narrative: 06/09/2019: Follow up received, SHINGRIX NDC # 58160-0819-12. 04/11/2016: All in process quality checks for the lot number in question were satisfactory. The results indicated that the lot number, for this product and other reported products, as applicable, were manufactured in accordance with manufacturing site standard operating procedures. The lot met the requirements for market release. Additional information is not expected. I received vaccine at 3:00 pm on 4/10. At approximately 9:00 on the evening of the 4/10, I first developed sharp pain at injection site. As night progressed, I developed severe muscle aches, bone aches, joint aches over entire body, moderate fever with chills, severe headache, dizziness, chirping sound in ears which lasted 12 hours. These symptoms continued until today around 10 am. I am now about 70% improved.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia, Tinnitus
Clinical narrative: 06/09/2019: Follow up received, SHINGRIX NDC # 58160-0819-12. 04/11/2016: All in process quality checks for the lot number in question were satisfactory. The results indicated that the lot number, for this product and other reported products, as applicable, were manufactured in accordance with manufacturing site standard operating procedures. The lot met the requirements for market release. Additional information is not expected. I received vaccine at 3:00 pm on 4/10. At approximately 9:00 on the evening of the 4/10, I first developed sharp pain at injection site. As night progressed, I developed severe muscle aches, bone aches, joint aches over entire body, moderate fever with chills, severe headache, dizziness, chirping sound in ears which lasted 12 hours. These symptoms continued until today around 10 am. I am now about 70% improved.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: SHE BEGAN TO ITCH ALL OVER HER BODY THE NEXT DAY BUT REPORTED THAT SHE DID NOT HAVE A RASH.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 75-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster (The patient had a history of shingles outbreaks.). On an unknown date, the patient received the 1st dose of SHINGRIX and the 1st dose of SHINGRIX. On 31st March 2019, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the vaccination failure, shingles and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in late December 2018 or early January 2019. The patient received 2nd dose in late February or early March. The patient did not experienced any events after 1st dose. The patient experienced shingles on her tail bone and buttock 2 days after after receiving 2nd dose and shingles got resolved. The patient again experienced shingles in the same area. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a female patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 2nd August 2018, 14 days after receiving SHINGRIX, the patient experienced itchy rash and blister. On an unknown date, the outcome of the itchy rash and blister were not recovered/not resolved. The reporter considered the itchy rash and blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was administered the 1st dose of SHINGRIX. Within two weeks, she developed a rash on her face which had not dissipated before getting her 2nd dose on 31st October 2018. The rash will blister up, pop, then subside just to flare up again and they are itchy. The rash was restricted to her face. Her condition had not improved since her 2nd dose. She had seen her healthcare provider who was sending her to a skin doctor. Emergency room visit Required. The patient reported her pharmacy had been in contact with GSK about her case but could only provide the name and location of the pharmacy. The patient's health care professional.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 2nd dose of SHINGRIX. On 13th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. The patient was treated with Cortisone. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved. The reporter considered the pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The day after getting the vaccine, the patient couldn't move his arm because of the pain. The patient cannot sleep on that side. The patient visited his physician and had a cortisone shot on that arm but that was not helping. The reporter consented to follow up. The Patient was extremely irate and abusive on the phone as they could not tell him what to do or how long it would take for the event to go away.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash generalised, Rash pustular, Rash vesicular, Vaccination site reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 31st December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, generalized rash and pustule. On an unknown date, the outcome of the injection site rash, generalized rash and pustule were not recovered/not resolved. It was unknown if the reporter considered the injection site rash, generalized rash and pustule to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The reporter had no information of the patient. The patient received dose of SHINGRIX and experienced intermittent rash that look like chicken pox at vaccination site and other areas of the body, small pinpoint pustules. The reporter had no information on lot and expiration date.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 59-year-old male patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 1st dose of SHINGRIX. On 20th October 2018, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the patient experienced feelings of weakness. On an unknown date, the outcome of the erythema of extremities and feelings of weakness were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and feelings of weakness to be related to SHINGRIX. Additional details were reported as follows: The reporter was a patient. The patient received the SHINGRIX vaccine on left arm and developed redness at the injection site. The redness was the size of a baseball and increased in size from the shoulder to the elbow before going away. The patient stated that he also felt weak after receiving the vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Immediate post-injection reaction, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received the 1st dose of SHINGRIX. On 4th April 2019, immediately after receiving SHINGRIX, the patient experienced headache, pain, pain in arm, flu like symptoms and shivers. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the pain was not recovered/not resolved and the outcome of the pain in arm, flu like symptoms and shivers were recovering/resolving. It was unknown if the reporter considered the headache, pain, pain in arm, flu like symptoms and shivers 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 case was reported by the patient's sister who stated that the patient immediately started developing headache, achy and her arm was sore a little bit. The patient woke up in the middle of the night with shivers and flu like symptoms. The reporter stated that her sister was a private person and did not want to report the event.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received the 1st dose of SHINGRIX. On 4th April 2019, immediately after receiving SHINGRIX, the patient experienced headache, pain, pain in arm, flu like symptoms and shivers. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the pain was not recovered/not resolved and the outcome of the pain in arm, flu like symptoms and shivers were recovering/resolving. It was unknown if the reporter considered the headache, pain, pain in arm, flu like symptoms and shivers 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 case was reported by the patient's sister who stated that the patient immediately started developing headache, achy and her arm was sore a little bit. The patient woke up in the middle of the night with shivers and flu like symptoms. The reporter stated that her sister was a private person and did not want to report the event.
Age: 1.83
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, (10cm x 5cm) raised, painful 1/2 teaspoon of Benadryl was given with some ibuprofen. Called mom the next morning will come in @ 12:30 to get re-checked.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: Pt received vaccines in error. pt was here for check up today with sibling. After mom signed consent form she told medical assistant she wanted to step out of the exam room with the older sibling so the younger sibling can get the vaccines. mom ended up stepping out with the younger sibling so Patient received the four vaccines instead of just getting one. Dad was in the room when vaccines were given and did not identify the child as Patient the older sibling. The medical assistant realized the error and inform the doctor immediately and she spoke with the parents. called mom to check in the next day with pt. per mom pt is doing well, no side effects of vaccines.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Pain in extremity, Product administered at inappropriate site, Skin warm
Clinical narrative: Patient received Tdap vaccine on 4/9/19 at Clinic OB. Patient started having pain following day in the right arm with redness (16x10cm) warm to touch. Vaccine was not given in proper site. Way lower then deltoid, most likely give Sub Q. Pt followed up at our clinic since OB was gone. Patient was advised by Dr. to continue with ice and Tylenol as needed. A border was drawn around inflamed area. (App 16x10 cm). Patient will call us back if redness continues to spread. Clinic was contacted about reaction. Also advised to educate on proper admin site education.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Pt reported swelling at injection site that began on 4/11/19. She said was size of an egg but had gone down some by 4/12/19. Pharmacist answering the phone advised using an ice pack and ibuprofen for any discomfort.
Age: 1.67
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient now has seizures with fever. She has been sick numerous times prior to the vaccine and never had seizures and now when she has even a low grade fever (100) she seizes
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: had typical published/known side effects - tiredness, body aches, headache and fever of 101 for about 18 hours.  Arm was sore with rash developing 24 hours after injection.  But in day 7, a rash has spread out and down.  I have pictures if anyone wants.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: had typical published/known side effects - tiredness, body aches, headache and fever of 101 for about 18 hours.  Arm was sore with rash developing 24 hours after injection.  But in day 7, a rash has spread out and down.  I have pictures if anyone wants.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Facial paralysis, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a nurse via a company representative concerning her 14-year-old daughter. There was no information about the patient's medical history, drug reactions, allergies, concurrent conditions or concomitant medications to be reported. On an unspecified date in July 2018, the patient received her first dose of GARDASIL 9 (strength, dose, route, lot number and expiration date not reported) for prophylaxis. It was reported that the patient experienced Bell's palsy (facial paralysis) immediately after receiving the vaccination with GARDASIL 9. The outcome of the event was not reported. The causality between GARDASIL 9 and the event was not reported. Upon internal review, the event facial paralysis was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 18-MAR-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot number R002806, expiry date: 29-SEP-2019 (dose was not provided) for prophylaxis. The vaccine experienced temperature of 9 (also reported as 8.5) Celsius degrees for 25 minutes. There was previous temperature excursion: 12 hours in 20 Celsius degrees. Digital data logger was not involved. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Fatigue, Pain in extremity
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, contusion and fatigue. On an unknown date, the outcome of the pain in arm, contusion and fatigue were unknown. It was unknown if the reporter considered the pain in arm, contusion and fatigue to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The patient described his experience with his first dose of SHINGRIX in early 2018. The patient reported having pain in his arm that prevented him from golfing for 1 to 2 days, bruising and fatigue. The reporter did not agree to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: This case was reported by a via call center representative and described the occurrence of adverse drug reaction in a patient who received 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 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 details were provided as follows: The age at vaccination was not reported. The patient ask about how long the side effects typically lasts. The patient provided the details for the further follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site bruising, Injection site erythema, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received SHINGRIX. On 30th March 2019, several hours after receiving SHINGRIX the patient experienced headache and cold. On 1st April 2019, the patient experienced injection site bruising and injection site redness. The patient was treated with ADVIL. On an unknown date, the outcome of the headache, cold, injection site bruising and injection site redness were recovered/resolved. It was unknown if the reporter considered the headache, cold, injection site bruising and injection site redness to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's wife. The patient received the dose of SHINGRIX in the morning with her wife and that evening, he began to experience headache, started little cold at night. On 1st April 2019, 2 days after receiving SHINGRIX, it appeared black and blue at the injection site with redness. The dimension of injection site redness was 3 inches x 2 inches. All the symptoms were resolved at the time of reporting. The reporter did not provide the consent to follow up. The lot number was not available. This case has been linked with case US2019061251, reported for the patient's wife.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke within a few days of vaccination.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Angiogram, Aphasia, Blood test, Clumsiness, Computerised tomogram
Clinical narrative: Stroke within a few days of vaccination.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Echocardiogram, Gait disturbance, Hypoaesthesia, Nuclear magnetic resonance imaging, Thinking abnormal
Clinical narrative: Stroke within a few days of vaccination.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: On 4pm on 4/6/19 patient started to develop right sided facial numbness with difficulty walking up stairs (leg dragging). Patient had continued symptoms throughout the next 2 days with thought process was off, word finding difficulties, clumsy with right hand.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Angiogram, Aphasia, Blood test, Clumsiness, Computerised tomogram
Clinical narrative: On 4pm on 4/6/19 patient started to develop right sided facial numbness with difficulty walking up stairs (leg dragging). Patient had continued symptoms throughout the next 2 days with thought process was off, word finding difficulties, clumsy with right hand.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Echocardiogram, Gait disturbance, Hypoaesthesia, Nuclear magnetic resonance imaging, Thinking abnormal
Clinical narrative: On 4pm on 4/6/19 patient started to develop right sided facial numbness with difficulty walking up stairs (leg dragging). Patient had continued symptoms throughout the next 2 days with thought process was off, word finding difficulties, clumsy with right hand.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: Rash.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Pain
Clinical narrative: Have had Shingles 2 times already. Woke up this morning feeling like I have the flu-achy body and hurts to move.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Limited range of motion, pain, soreness at injection site continues after 6 mos.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Left Deltoid: red, rash, hot to the touch, hard at the injection site: states that it's itchy, muscle ache. Area of erythema is estimated to be the size of a half-dollar.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Left Deltoid: red, rash, hot to the touch, hard at the injection site: states that it's itchy, muscle ache. Area of erythema is estimated to be the size of a half-dollar.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Skin warm, Urticaria
Clinical narrative: Fever got as high as 101.1, welt continued to grow, red and warm to touch.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pain
Clinical narrative: Patient contacted local health unit on 4/8/19 in reference to HPV vaccine she received on 3/14/19. She states, "about a week after I got the shot, I noticed a small knot beneath the area where I got the shot. Concerned, I call my PCP and was informed that this was a common side effect reported after receiving HPV shot and it should disappear in within a week and a half but it hasn't and has gotten bigger, tender to touch and my right shoulder hurts and I can only move it to a certain point." Pt instructed to follow up with PCP and notify clinic. On 4/12/19, I spoke with patient again in reference to how she was doing and if she had seen her PCP. Pt verbalized, " Yes, I seen my PCP on 4/8/19, and they place me on an antibiotic. I've been on the antibiotic since Monday, 4/8/19 and the knot is completely gone."
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain
Clinical narrative: Left arm vaccine site increased on 4/12/19 to 4cm redness at site from 2cm redness on 4/11/19.  Pt. complains of itching and some pain. Right arm vaccine site increased to double the size of redness from 3 inches on 4/11/19 to 6 inches of redness on 4/12/19 also pt. complains of itching and pain at that site also. Dr. ordered benadryl and motrin and ice to site on 4/11/19 and to continue treating with Motrin, Benadryl and Ice along with Keflex 250 mg capsules, 2 capsules three times a day for 10 days. Will follow up on 4/16/19 unless s/s worsen prior.  May consider allergy referral before 2nd dose of Menveo.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Confusional state, Erythema, Pyrexia, Swelling
Clinical narrative: Fever, confusion, swelling, redness
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin discolouration
Clinical narrative: Pt developed redness, swelling and pain at the site of injection (arm). Pt seen at urgent care and felt to have a vaccine reaction. Parents insisted on antibiotics. Pt seen for F/U 2 wks after vaccine given-minimal discoloration remained (redness/purple).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Redness/Swelling/rash 4/11/19 at injection site. Pt. reports itching at the site, along with above rash/Swelling and Redness