chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; the patients were vaccinated with improperly stored doses; Information was received from the vaccine coordinator and refers to 4 patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date in 2019, between 16-APR-2019 and 02-MAY-2019, the patients were vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis, lot number R021084 with expiration date on 14-JUN-2021 (strength, dose number, anatomical location and route of administration were not reported).  No adverse effects were reported.  The temperature was of 35.2 degrees Celsius (°C) for a timeframe of 30 minutes with a previous temperature excursion of 32.7 °C for 7 hours and 30 minutes. The temperature excursion was called because a digital data logger.  This is a non-valid case due to lack of patient identifiers.  On 03-FEB-2019, a phone call was placed to the primary reporter (physician assistant). A request was made for patient identifiers, lot and vaccine received and enquired about dates. Additional information has been requested.  On 03-FEB-2019, a returned telephone call was received from the primary reporter, who requested additional information to assist him in his research on patient information. Additional information has been requested.  Follow up information was received from the vaccine coordinator referring to an approximately 1-year-old female patient on 05-FEB-2020.  On 01-MAY-2019, the patient was vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB).  This case was previously considered as non- valid due to lack of patient identifiers. However, on receiving the patient's initials, date of birth and gender, this case was determined as valid.  This is one of the several reports received from the same reporter.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; the patients were vaccinated with improperly stored doses; Information was received from the vaccine coordinator and refers to 4 patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date in 2019, between 16-APR-2019 and 02-MAY-2019, the patients were vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis, lot number R021084 with expiration date on 14-JUN-2021 (strength, dose number, anatomical location and route of administration were not reported).  No adverse effects were reported.  The temperature was of 35.2 degrees Celsius (°C) for a timeframe of 30 minutes with a previous temperature excursion of 32.7 °C for 7 hours and 30 minutes. The temperature excursion was called because a digital data logger.  This is a non-valid case due to lack of patient identifiers.  On 03-FEB-2019, a phone call was placed to the primary reporter (physician assistant). A request was made for patient identifiers, lot and vaccine received and enquired about dates. Additional information has been requested.  On 03-FEB-2019, a returned telephone call was received from the primary reporter, who requested additional information to assist him in his research on patient information. Additional information has been requested.  Follow up information was received from the vaccine coordinator referring to an approximately 1-year-old female patient on 05-FEB-2020.  On 02-MAY-2019, the patient was vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB).  This case was previously considered as non- valid due to lack of patient identifiers. However, on receiving the patient's initials, date of birth and gender, this case was determined as valid.  This is one of the several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Pain
Clinical narrative: body ache; weakness; dizziness; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hyperthyroidism and palpitation.   On 28th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced general body pain, weakness and dizziness. On an unknown date, the outcome of the general body pain, weakness and dizziness were recovered/resolved.   It was unknown if the reporter considered the general body pain, weakness and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after vaccination with 1st dose of shingrix, the patient had severe body ache, dizziness and weakness which disappeared after 2 days. The patient stated that, could not determine if Shingrix was the reason for adverse events following vaccination. The patient would likely to return for second dose
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: body pain; headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain and headache. On an unknown date, the outcome of the general body pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and headache 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 selected as adult as per the vaccine indication. The patient experienced general body pain and headache after receiving Shingrix. The reporter wanted to know what could he/she take to relieve the body pain and headache.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Pain
Clinical narrative: I feel achy; feel unsteady; This case was reported by a consumer via call center representative and described the occurrence of pain in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, 7 days after receiving Shingrix, the patient experienced pain and unsteadiness. On an unknown date, the outcome of the pain and unsteadiness were not recovered/not resolved.   It was unknown if the reporter considered the pain and unsteadiness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 68 years old. The patient experienced achy and unsteady after receiving 2nd dose of Shingrix. The reporter wanted to know long after injection can general symptoms show.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: considerable pain in the left at muscle; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (1st dose received on an unknown date , refer linked case US2020AMR015711).   On 27th January 2020, the patient received the 2nd dose of Shingrix. On 27th January 2020, less than a day after receiving Shingrix, the patient experienced muscle pain. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle 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 selected as an adult as per the vaccine indication. The patient experienced pain in the left at muscle after receiving 2nd dose of Shingrix, which was not relieved with Tylenol.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: rash on the lower part of chin; This case was reported by a nurse via sales rep and described the occurrence of vesicular rash 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 vesicular rash. The patient was treated with valaciclovir hydrochloride (Valtrex) and prednisone. On an unknown date, the outcome of the vesicular rash was recovered/resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The patient received Shingrix and experienced rash on the lower part of chin. The reporter stated that, it looked like shingles but not confirmed.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: feeling ackey all over; feeling very fatigued; This case was reported by a other health professional via sales rep and described the occurrence of general body pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received in November 2019 and felt fatigue, refer case US2020AMR017459).   On 29th January 2020, the patient received the 2nd dose of Shingrix. On 29th January 2020, less than a day after receiving Shingrix, the patient experienced general body pain and fatigue. On an unknown date, the outcome of the general body pain and fatigue were unknown.   The reporter considered the general body pain and fatigue to be possibly related to Shingrix.  Additional information was provided as follows: The patient received a dose of Shingrix on the left arm. The patient felt ackey all over and very fatigued. The patient thought it may be due to the vaccine. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Pain, Pruritus
Clinical narrative: ichy; sore; uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tremor (mild tremor) and red face. Previously administered products included Cortisone (years ago) and Epinephrine (years ago). Concomitant products included simvastatin, etanercept (Enbrel) and potassium nos (Potassium).   On 12th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix and an unknown time after starting simvastatin, the patient experienced pruritus, pain and discomfort. On an unknown date, the outcome of the pruritus, pain and discomfort were unknown.   It was unknown if the reporter considered the pruritus, pain and discomfort to be related to Shingrix.  Additional details were received as follows: The patient after vaccination experienced little achy, sore and uncomfortable. The patient consented to follow up. For tolerance to 2nd dose, refer case US2020012242.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Hives; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 6-year-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   On 24th January 2020, the patient received Kinrix. In January 2020, less than a week after receiving Kinrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Kinrix.  Additional details were reported as follows: The patient experienced hives after receiving Kinrix vaccine. The reporter wanted to know whether patient could receive Boostrix vaccine in future. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age of the patient about 60 years old. The age at vaccination was not reported. The medical assistant reported that, 2 weeks ago from the date of reporting, the patient received 2nd dose of Shingrix and developed shingles outbreaks. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, within a day of vaccination, the patient experienced injection site pain. The injection site pain resolved within 2 days. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness in the injection site; Swelling in the injection site; Myalgia in the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th November 2021) for prophylaxis.   On 22nd January 2020, the patient received the 1st dose of Shingrix. On 24th January 2020, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site muscle pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site muscle pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site erythema, injection site swelling and injection site muscle pain after receiving 1st dose of Shingrix. Consented to follow up was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Arm pain; Muscle soreness around the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient still experienced arm pain and muscle soreness around the injection site. The patient did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: rash at injection site; pain at injection site; This case was reported by a physician via sales rep and described the occurrence of injection site rash 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 injection site rash and injection site pain. On an unknown date, the outcome of the injection site rash was unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site rash and injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. After receiving the Shingrix vaccine, the patient developed a rash at the injection site. The patient also developed pain at the injection site that has lasted for 1.5months. The reporter did not have any additional details regarding the event or the patient. This case has been linked to US2020015870, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Sounding like she has a case of Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HT5J, expiry date 26th January 2022) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix .5 ml. In January 2020, less than 3 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, but it could be 72 or 73 years old. The patient received vaccine in left deltoid. The patient received 1st dose of Shingrix vaccine. As per reporter the patient had possible Shingles at the time of reporting. The reporter was concerned whether that was just a coincidence or there was increased risk for triggering an outbreak with the immunization. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: left arm sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included coxarthritis (received hip replacements). Previously administered products included Shingrix (1st dose received on an unknown date and did not experience any side effects). Concurrent medical conditions included finger arthritis.   In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient received 2nd dose of Shingrix either on 8th or 9th January 2020 on left arm. Later that night, the patient's left arm became sore. Till the time of reporting, the patient's arm was sore and she could hardly lay on that arm. The patient stated that she had a physician's appointment on friday of the reporting week to have her arm checked out and stated that she would be getting an x-ray on the left arm. The patient required emergency visit. The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles after the 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9235B, expiry date 29th November 2021) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient developed shingles. The reported lot number (L9235B) for Shingrix did not exist and was updated to 9235B, according to sales datasheet. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Hardness at injection site; Redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included rheumatoid arthritis.   On 25th January 2020, the patient received the 2nd dose of Shingrix. On 26th January 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema. On 30th January 2020, the patient experienced injection site induration. On an unknown date, the outcome of the injection site erythema and injection site induration were recovering/resolving.   It was unknown if the reporter considered the injection site erythema and injection site induration to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient was around 70 years of age. The reporter stated that the patient received the second dose of Shingrix and noted an area of redness at the injection site approximately 1 inch in diameter. Five days after receiving vaccination, the area of redness now felt hard, and was approximately 2 inches by 5 inches in diameter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chest discomfort, Respiratory disorder
Clinical narrative: complained of an upper respiratory and chest tightness; Upper respiratory tightness; This case was reported by a nurse via call center representative and described the occurrence of chest tightness 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 chest tightness and upper respiratory disorder. On an unknown date, the outcome of the chest tightness and upper respiratory disorder were unknown.   It was unknown if the reporter considered the chest tightness and upper respiratory disorder to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient complained of an upper respiratory and chest tightness with the first dose of the Shingrix vaccine. The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Headache, Injection site erythema
Clinical narrative: Fever Chills Joint pain Headache,  injection site (left arm) red, swollen and sore Stomach pain
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever Chills Joint pain Headache,  injection site (left arm) red, swollen and sore Stomach pain
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; the patient was administered an improperly stored dose of VARIVAX; This spontaneous report has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical condition and concurrent condition were not reported.  On 21-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot# R020651with expiration date: 18-JUL-2020; dose, strength, frequency and route unknown) for prophylaxis. The sterile diluent (STERILE DILUENT) was properly stored. There was no additional event.   The vaccine was stored under 6 Fahrenheit (F) to 14F (13.6F) for 8 hours and 14 minutes. There was no previous temperature excursion. The digital data logger was involved.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Urticaria
Clinical narrative: i noticed hives near the area of the shot; experienced headaches; tiredness; This case was reported by a consumer via call center representative and described the occurrence of hives in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache and tiredness. On 27th January 2020, the patient experienced hives. On an unknown date, the outcome of the hives, headache and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the hives, headache and tiredness to be related to Shingrix.  Additional details were provided as follows:  The patient experienced hives near the area of the shot of receiving 1st dose of Shingrix. The patient experienced headaches and tiredness all week. The reporter wanted to know does this mean he/she was allergic and should not get second shot. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Fall, Hypoaesthesia, Rib fracture, Sensory loss
Clinical narrative: lost feeling in both feet; both feet numbing /Numbing of the hands; i fell fractured a rib; fell; This case was reported by a consumer via call center representative and described the occurrence of loss of sensation in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced loss of sensation, hypoesthesia, rib fracture and fall. On an unknown date, the outcome of the loss of sensation, hypoesthesia, rib fracture and fall were unknown.   It was unknown if the reporter considered the loss of sensation, hypoesthesia, rib fracture and fall to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported but it could be 54 years old. The patient experienced lost feeling in both feet and hands numbness. The patient feet  was being numb, fell and fractured a rib.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: feeling pain in the area of my gluteus; felt muscle pain all over my body; This case was reported by a consumer and described the occurrence of generalized muscle aches in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received in August 2019, refer linked case US2020AMR015673).   On 23rd January 2020, the patient received the 2nd dose of Shingrix. On 24th January 2020, 1 days after receiving Shingrix, the patient experienced generalized muscle aches. On 25th January 2020, the patient experienced buttock pain. On an unknown date, the outcome of the generalized muscle aches was recovered/resolved and the outcome of the buttock pain was not recovered/not resolved.   It was unknown if the reporter considered the generalized muscle aches and buttock 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 selected as adult as per the vaccine indication. The patient experienced muscle pain all over body, then it subsided. On Saturday 2 days after receiving vaccination, the patient started feeling pain in the area of gluteus. On Monday the patient  was still feeling this pain.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Dizziness, Headache, Herpes zoster, Impaired driving ability
Clinical narrative: got the shingles shot in December and then got the shingles; got the shingles; has dizziness; trouble driving; rash; extreme pain in his head and neck; extreme pain in his head and neck; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   In December 2019, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, dizziness, driving ability disturbed, rash, headache and neck pain. On an unknown date, the outcome of the vaccination failure, shingles, dizziness, driving ability disturbed, rash, headache and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, dizziness, driving ability disturbed, rash, headache and neck pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's brother. It was reported that the patient had survived two bouts of cancer The reporter asked help to recover from the bad reaction to the shingles shot. The patient got the shingles shot in December and then got the shingles and has been battling to get back to health. The patient experienced rash and extreme pain in his head and neck. The patient experienced dizziness and was having trouble driving.  The patient underwent cat scan, has been sent to the ear physician but they said no ear infection.  The physician recommend to underwent MRI scan. This case was considered as suspected vaccination failure since the laboratory confirmation and time to onset regarding shingles was not provided.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Rash, Vaccination failure
Clinical narrative: got the shingles shot in December and then got the shingles; got the shingles; has dizziness; trouble driving; rash; extreme pain in his head and neck; extreme pain in his head and neck; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   In December 2019, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, dizziness, driving ability disturbed, rash, headache and neck pain. On an unknown date, the outcome of the vaccination failure, shingles, dizziness, driving ability disturbed, rash, headache and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, dizziness, driving ability disturbed, rash, headache and neck pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's brother. It was reported that the patient had survived two bouts of cancer The reporter asked help to recover from the bad reaction to the shingles shot. The patient got the shingles shot in December and then got the shingles and has been battling to get back to health. The patient experienced rash and extreme pain in his head and neck. The patient experienced dizziness and was having trouble driving.  The patient underwent cat scan, has been sent to the ear physician but they said no ear infection.  The physician recommend to underwent MRI scan. This case was considered as suspected vaccination failure since the laboratory confirmation and time to onset regarding shingles was not provided.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Heart rate irregular, Pain
Clinical narrative: his rate rate has elevated; soreness and body aches presented last night; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix. On 28th January 2020, less than a day after receiving Shingrix, the patient experienced general body pain. On 29th January 2020, the patient experienced heart rate irregular. On an unknown date, the outcome of the general body pain and heart rate irregular were recovering/resolving.   It was unknown if the reporter considered the general body pain and heart rate irregular to be related to Shingrix.  Additional information was provided as follows: The patient experienced soreness and body aches. On the day of reporting, the patient's heart rate was elevated. It went up to 110 beats per minute then down and then up to 160 beats per minute and then down again. The reporter consented to follow up. The outcome of events were reported as recovering/ resolving in the database however in source document, it was mentioned as not recovered/ not resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R774, expiry date 19th January 2021) for prophylaxis.   On 20th January 2020, the patient received Shingrix (intramuscular). On 21st January 2020, 1 days after receiving Shingrix, the patient experienced shingles. Rechallenge with Shingrix was negative. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: This case reported by the nurse practitioner student. The patient went to the health care professional's office the next day after vaccination with outbreak of shingles. The reporter did not know if the patient was still experiencing the outbreak.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: swelled twice the original size; aching for 2 weeks following the first shot; redness for 2 weeks following the first shot; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced swelling arm, pain and erythema. On an unknown date, the outcome of the swelling arm was unknown and the outcome of the pain and erythema were recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain and erythema to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but it could be 52 or 53 years old. The patient received 1st dose of Shingrix. The patient expereinced adverse reactions such as the patient's arm swelled twice the original size, the patient also experienced aching and redness for 2 weeks. The reporter wanted to know, should patient receive the second dose. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Fatigue, Hypersomnia, Loss of consciousness
Clinical narrative: blacked out; Fatigue; fell; Dizziness; requiring more sleep than normal; This case was reported by a pharmacist via sales rep and described the occurrence of blackout in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Shingrix. On 12th January 2020, 3 days after receiving Shingrix, the patient experienced blackout (serious criteria GSK medically significant), fatigue, fall, dizziness and sleep excessive. On an unknown date, the outcome of the blackout, fatigue, fall, dizziness and sleep excessive were unknown.   It was unknown if the reporter considered the blackout, fatigue, fall, dizziness and sleep excessive to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient felt fatigued, requiring more sleep than normal. The patient fall in the bathroom and blacked out. The patient also experienced dizziness. The field representative received an email and called in the information that the pharmacy sent to the representative. The reporter consented to follow up.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Daptacel vaccine that expired on 1/30/2020.  Patient has not had an adverse effects, but will need to be revaccinated.  I called patients mother, patient has an appointment on 2/20/2020 and will receive Daptacel vaccine at that time.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness, swelling , warm to touch. pain from injection site to elbow area. reported to er on the third day for noted symptoms. diagnosed with cellulitis to left upper arm.  prescription given for clindamycin hcl , 2 capsules every 6 hours.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: went to get second  shingles shot broke out on left cheek and side of nose below eye and lip and gum on that side
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Acute zonal occult outer retinopathy, Bartonella test negative, Borrelia test negative, Central vision loss, Dengue virus test negative
Clinical narrative: Retinitis, AZOOR, Retinal vasculitis, loss of central and peripheral vision left eye.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Retinal vasculitis, Retinitis, Viral test negative, Visual field defect
Clinical narrative: Retinitis, AZOOR, Retinal vasculitis, loss of central and peripheral vision left eye.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Gait inability, Nausea, Pyrexia
Clinical narrative: chills and shivering, fever, nausea, light-headed -  off and on for 8 hours.   About 1/2  hour with symptoms severe enough that patient could not walk and had to lay down on the floor to keep from falling.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: Swelling and soreness at site of injection, headache, extreme shivering No medical treatment sought By next morning headache was milder and shivering had stopped sometime during the night, injection site was sore for about 3 days
Age: 5.0
Sex: M
Vaccine: HEPA, HEPA, IPV, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: CLIENT WAS VACCINED WITH AN ADULT DOSE OF HEPATITIS A AND THEN VACCINATED WITH A PEDIATRIC DOSE OF HEPATITIS A ON THE SAME DAY AND IN THE SAME VACCINE SITE.  NO ADVERSE REACTION NOTED.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Soreness and swelling at injection site, shivering No medical treatment sought Except for sore arm, side effects were gone next day
Age: 11.0
Sex: F
Vaccine: DT
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt was received Dtap when they should have received Tdap. The Dtap the pt received was also expired by three days. There was no adverse affects with the patient. I was informed to fill this form out. The date of injection was 1/29/2020. Pt came back in for updated immunization.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Influenza A virus test negative, Influenza B virus test, Influenza like illness, Influenza virus test negative
Clinical narrative: INFLUENZA LIKE SYMPTOMS INCLUDING BODY ACHES, FEVER (MEASURED 101.4), AND ELEVATED BLOOD PRESSURE (MEASURED 163/88).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: INFLUENZA LIKE SYMPTOMS INCLUDING BODY ACHES, FEVER (MEASURED 101.4), AND ELEVATED BLOOD PRESSURE (MEASURED 163/88).
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Cyanosis, Dehydration, Diarrhoea, Dyskinesia
Clinical narrative: On March 30, 2018, My husband and I both recall his immediate reaction, because we went out to eat right after the Dr.'s appointment, and my 4 year old was acting berzerk, not his usual calm demeanor.  IN his car seat he wiggled arched his back and was trying to get out, and then for the next 5 hours he thrashed, climbed up chairs, walls, flailed, flopped, was emotional and crying, fussy, irritable and his eyes were glazed over. He seemed out of his mind.  After so may emotions he was exhausted and slept the rest of the afternoon and night. He was a little slower in his reactions the next day, and  the day after starting to get back to himself, but since then his changed from a very easy calm child and toddler to a wild constantly fidgeting and moving one. His personality changed.  Around 3 weeks later on April  26, 2018  my 4 year old had severe diarrhea for about 3 days. Friday night to Sunday.  On April 29,  2018 he was watching cartoons and  looked strange to me I went to look closer and he had blue lips, blue hands, arms, and feet. BLUE! I tried arousing him, he was lethargic and not very responsive, his eyes were glossed over and sort of in a stare. I called 911.  The  paramedics came and too noticed something wrong. His oxygen was low and his vitals were off so went to the ER.  (I told them he had a DTap shot about 3-4 weeks ago. But they said he was mildly dehydrated. They couldn't tell me why he had turned blue.  They didn't keep him for a stay or give him an IV, they sent us home in about 3 hours.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Emotional disorder, Fatigue, Glassy eyes, Hyporesponsive to stimuli, Immediate post-injection reaction
Clinical narrative: On March 30, 2018, My husband and I both recall his immediate reaction, because we went out to eat right after the Dr.'s appointment, and my 4 year old was acting berzerk, not his usual calm demeanor.  IN his car seat he wiggled arched his back and was trying to get out, and then for the next 5 hours he thrashed, climbed up chairs, walls, flailed, flopped, was emotional and crying, fussy, irritable and his eyes were glazed over. He seemed out of his mind.  After so may emotions he was exhausted and slept the rest of the afternoon and night. He was a little slower in his reactions the next day, and  the day after starting to get back to himself, but since then his changed from a very easy calm child and toddler to a wild constantly fidgeting and moving one. His personality changed.  Around 3 weeks later on April  26, 2018  my 4 year old had severe diarrhea for about 3 days. Friday night to Sunday.  On April 29,  2018 he was watching cartoons and  looked strange to me I went to look closer and he had blue lips, blue hands, arms, and feet. BLUE! I tried arousing him, he was lethargic and not very responsive, his eyes were glossed over and sort of in a stare. I called 911.  The  paramedics came and too noticed something wrong. His oxygen was low and his vitals were off so went to the ER.  (I told them he had a DTap shot about 3-4 weeks ago. But they said he was mildly dehydrated. They couldn't tell me why he had turned blue.  They didn't keep him for a stay or give him an IV, they sent us home in about 3 hours.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Lethargy, Oxygen saturation decreased, Personality change, Staring
Clinical narrative: On March 30, 2018, My husband and I both recall his immediate reaction, because we went out to eat right after the Dr.'s appointment, and my 4 year old was acting berzerk, not his usual calm demeanor.  IN his car seat he wiggled arched his back and was trying to get out, and then for the next 5 hours he thrashed, climbed up chairs, walls, flailed, flopped, was emotional and crying, fussy, irritable and his eyes were glazed over. He seemed out of his mind.  After so may emotions he was exhausted and slept the rest of the afternoon and night. He was a little slower in his reactions the next day, and  the day after starting to get back to himself, but since then his changed from a very easy calm child and toddler to a wild constantly fidgeting and moving one. His personality changed.  Around 3 weeks later on April  26, 2018  my 4 year old had severe diarrhea for about 3 days. Friday night to Sunday.  On April 29,  2018 he was watching cartoons and  looked strange to me I went to look closer and he had blue lips, blue hands, arms, and feet. BLUE! I tried arousing him, he was lethargic and not very responsive, his eyes were glossed over and sort of in a stare. I called 911.  The  paramedics came and too noticed something wrong. His oxygen was low and his vitals were off so went to the ER.  (I told them he had a DTap shot about 3-4 weeks ago. But they said he was mildly dehydrated. They couldn't tell me why he had turned blue.  They didn't keep him for a stay or give him an IV, they sent us home in about 3 hours.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Vital signs measurement
Clinical narrative: On March 30, 2018, My husband and I both recall his immediate reaction, because we went out to eat right after the Dr.'s appointment, and my 4 year old was acting berzerk, not his usual calm demeanor.  IN his car seat he wiggled arched his back and was trying to get out, and then for the next 5 hours he thrashed, climbed up chairs, walls, flailed, flopped, was emotional and crying, fussy, irritable and his eyes were glazed over. He seemed out of his mind.  After so may emotions he was exhausted and slept the rest of the afternoon and night. He was a little slower in his reactions the next day, and  the day after starting to get back to himself, but since then his changed from a very easy calm child and toddler to a wild constantly fidgeting and moving one. His personality changed.  Around 3 weeks later on April  26, 2018  my 4 year old had severe diarrhea for about 3 days. Friday night to Sunday.  On April 29,  2018 he was watching cartoons and  looked strange to me I went to look closer and he had blue lips, blue hands, arms, and feet. BLUE! I tried arousing him, he was lethargic and not very responsive, his eyes were glossed over and sort of in a stare. I called 911.  The  paramedics came and too noticed something wrong. His oxygen was low and his vitals were off so went to the ER.  (I told them he had a DTap shot about 3-4 weeks ago. But they said he was mildly dehydrated. They couldn't tell me why he had turned blue.  They didn't keep him for a stay or give him an IV, they sent us home in about 3 hours.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Large area of redness, spreading around inner thigh and almost to the back of thigh. Swollen and warm to the touch.