chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PNC, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Received PNEUMOVAX and PREVNAR concomitantly today; This spontaneous report was received from a pharmacist concerning a 67-year-old female patient. There was no information reported about the patient's medical history, drug reactions/allergies, concomitant medications or concurrent conditions.  It was reported that on 29-SEP-2020, the patient was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) syringe injection; lot number: T009743, expiration date reported as: 27-JAN-2022, and one dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) injection, lot number: DF1307, expiration date reported as: August 2022) both administered concomitantly as prophylaxis (duplicate therapy with same active substance); dosage regimen, anatomical injection site and route of administration were not reported.  The caller wanted to know about timing for subsequent pneumococcal vaccines administration and the possible sequalae or adverse events. At the reporting time, the patient was not experiencing any side effects. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009743; expirationdate: 27-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: he was unsure whether the physician administered the vaccine in the past; he was unsure whether the physician administered the vaccine in the past; This spontaneous report was received from a consumer concerning a male patient of an unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, the patient was vaccinated with another dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis   as he stated he was unsure whether the physician administered the vaccine in the past.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: Accidentally left Vivotif unrefrigerated for three days and then took two doses of unrefrigerated Vivotif on consecutive days; Accidentally left Vivotif unrefrigerated for three days and then took two doses of unrefrigerated Vivotif on consecutive days; Spontaneous report received on 24AUG2020.  Based on the information obtained from the female consumer two individual case safety reports 20000452SP (wife) and 20000453SP (husband) were created and cross-linked in the database.  The female consumer reported that she "accidentally left Vivotif unrefrigerated for three days and then took two doses of unrefrigerated Vivotif on consecutive days" (PT: Product storage error/Inappropriate schedule of product administration). She was receiving Vivotif (lot number: 3003320 and expiry date: Nov 2020) for immunization. She stated that Vivotif was left unrefrigerated for three days (Tuesday to Friday) at 72-degree Fahrenheit. She put back Vivotif in the refrigerator on Friday. Later, she took two unrefrigerated doses of Vivotif on consecutive days that was on 22AUG2020 and 23AUG2020, respectively. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer accidentally left Vivotif unrefrigerated for three days and then took two doses of unrefrigerated Vivotif on consecutive days (product storage error, inappropriate schedule of product administration). Vivotif should always be stored in the refrigerator at the recommended temperatures and should be taken every other day. The causality of product storage error, and inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the events which were due to human error.; Sender's Comments: A consumer accidentally left Vivotif unrefrigerated for three days and then took two doses of unrefrigerated Vivotif on consecutive days (product storage error, inappropriate schedule of product administration). Vivotif should always be stored in the refrigerator at the recommended temperatures and should be taken every other day. The causality of product storage error, and inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the events which were due to human error.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Consumed one dose of Vivotif which was left unrefrigerated for three days; Spontaneous report received on 24AUG2020.  Based on the information obtained from the female consumer two individual case safety reports 20000452SP (wife) and 20000453SP (husband) were created and cross-linked in the database.  The female consumer reported that her husband "consumed one dose of Vivotif which was left unrefrigerated for three days" (PT: Product storage error). He was receiving Vivotif (lot number: 3003320 and expiry date: Nov 2020) for immunisation. She reported that Vivotif was left unrefrigerated for three days (Tuesday to Friday) at 72-degree Fahrenheit. She put back Vivotif in the refrigerator on Friday. On 24AUG2020, her husband took one dose of the unrefrigerated Vivotif. She also informed that her husband took only one dose of Vivotif so far. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer consumed one dose of Vivotif which was left unrefrigerated for three days (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperatures. The causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.; Sender's Comments: It was reported that a consumer consumed one dose of Vivotif which was left unrefrigerated for three days (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperatures. The causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient experienced pain after shingrix vaccine. The reporter asked, could aspirin be used for shingrix pain.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: pain; 2019 after her first dose of Shingrix in July/second dose of Shingrix as January 2020 /shingles that began in the 3rd week of August, 2020; shingles that began in the 3rd week of August, 2020; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles outbreak (average per 2 year)). Previously administered products included Zostavax (received Zostavax vaccine several years ago).   In July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In January 2020, the patient received the 2nd dose of Shingrix. On 23rd August 2020, between 1 and 2 years after receiving Shingrix and between 6 and 8 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. The patient was treated with acyclovir and gabapentin. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient 2 doses of shingrix and experienced shingles. The patient had history of chronic shingles (average per 2 days). The patient had received Zostavax several years ago and did not diminish number of shingles outbreak. After 1st shingrix vaccination, patient experienced atleast one outbreak in 2019. The reporter mentioned that, patient had recently recovered from case of shingles that experienced in 3rd week of August. At the day of reporting, patient started to experience shingles. The patient was treated with acyclovir and during outbreaks and gabapectin for pain. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190572:1st dose
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: pain; 2019 after her first dose of Shingrix in July/second dose of Shingrix as January 2020 /shingles that began in the 3rd week of August, 2020; shingles that began in the 3rd week of August, 2020; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles outbreak (average per 2 year)). Previously administered products included Zostavax (received Zostavax vaccine several years ago).   In July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In January 2020, the patient received the 2nd dose of Shingrix. On 23rd August 2020, between 1 and 2 years after receiving Shingrix and between 6 and 8 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. The patient was treated with acyclovir and gabapentin. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient 2 doses of shingrix and experienced shingles. The patient had history of chronic shingles (average per 2 days). The patient had received Zostavax several years ago and did not diminish number of shingles outbreak. After 1st shingrix vaccination, patient experienced atleast one outbreak in 2019. The reporter mentioned that, patient had recently recovered from case of shingles that experienced in 3rd week of August. At the day of reporting, patient started to experience shingles. The patient was treated with acyclovir and during outbreaks and gabapectin for pain. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190572:1st dose
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: at least one outbreak in 2019 after her first dose of Shingrix; pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Chronic Shingles outbreaks and Zostavax (received zostavax several years ago).   In July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, between 5 and 7 months after receiving Shingrix, the patient experienced shingles and pain. The patient was treated with acyclovir and gabapentin. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were as follows: The patient received 1st dose of shingrix and experienced shingles and pain. The patient received zostavax vaccine several years ago and did not dimish the number of shingle outbreaks. The patient was treated with aciclovir and gabapectin for pain during the shingles outbreak. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR192427:2nd dose
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: at least one outbreak in 2019 after her first dose of Shingrix; pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Chronic Shingles outbreaks and Zostavax (received zostavax several years ago).   In July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, between 5 and 7 months after receiving Shingrix, the patient experienced shingles and pain. The patient was treated with acyclovir and gabapentin. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were as follows: The patient received 1st dose of shingrix and experienced shingles and pain. The patient received zostavax vaccine several years ago and did not dimish the number of shingle outbreaks. The patient was treated with aciclovir and gabapectin for pain during the shingles outbreak. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR192427:2nd dose
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: The two times i took flu shots i contracted the flu/ Suspected vaccination failure; Flu; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported The patient received flu shot and experienced flu. No other information was reported. The case was linked to case US2020AMR193666, reported by same reporter. This case was considered as suspected vaccination failure as details regarding exact time to onset for target disease and laboratory confirmation were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR193666:same reporter
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Mild injection site reaction of pain; Mild injection site reaction of pain and redness; This case was reported by a nurse and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hypothyroidism. Concurrent medical conditions included penicillin allergy. Concomitant products included levothyroxine sodium (Synthroid).   On 22nd January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were as follows: It was reported that 51 years female patient recived the shingrix vaccine on 22nd January,2020 in left deltoid, and experienced some reaction at the injection site that is injection site pain and injection site redness both abated 3-4 days post injection. It was reported that patient was using Synthroid 50mcg dose concomitantly. Patient had hyperthyroid in past, and currently she has PCN allergy. This case has been linked with US2020AMR193708 this case. The reporter consented to follow up.  Note: The Synthroid's daily dose of 50mcg was removed from the structured fields to allow the e VAERS PADER report to be ack.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Injection site pain; Injection site redness; Body wide myalgias (in back and lower legs); Shivering; Take a 1.5 hour nap during the day; Dose 1 in series on 22Jan2020 / dosage #2 was 23Sep2020; This case was reported by a nurse and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hypothyroidism. Concurrent medical conditions included penicillin allergy. Concomitant products included levothyroxine sodium (Synthroid).   On 23rd September 2020, the patient received the 2nd dose of Shingrix. On 23rd September 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 24th September 2020, the patient experienced injection site pain, injection site erythema, myalgia, shivering and somnolence. On an unknown date, the outcome of the drug dose administration interval too long, injection site pain, injection site erythema, myalgia, shivering and somnolence were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, myalgia, shivering and somnolence to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that 51 years female patient recived the 2nd shingrix vaccine on 23rd September 2020 in left deltoid, and experienced body wide myalgias (especially in back and lower legs), injection site redness and pain, and shivering. Also patient mentioned that she was able to complete myhernormal routine-exercise, work, caring for home, however she had to take a 1.5 hour nap during the day which is uncharacteristic for her. It was reported that patient was using Synthroid 50mcg dose concomitantly. Patient had hyperthyroid in past, and currently she has PCN allergy. This case has been linked with US2020AMR193698 The reporter consented to follow up.  Note: The Synthroid's daily dose of 50mcg was removed from the structured fields to allow the e VAERS PADER report to be ack.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Injection site pain; Injection site redness; Body wide myalgias (in back and lower legs); Shivering; Take a 1.5 hour nap during the day; Dose 1 in series on 22Jan2020 / dosage #2 was 23Sep2020; This case was reported by a nurse and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hypothyroidism. Concurrent medical conditions included penicillin allergy. Concomitant products included levothyroxine sodium (Synthroid).   On 23rd September 2020, the patient received the 2nd dose of Shingrix. On 23rd September 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 24th September 2020, the patient experienced injection site pain, injection site erythema, myalgia, shivering and somnolence. On an unknown date, the outcome of the drug dose administration interval too long, injection site pain, injection site erythema, myalgia, shivering and somnolence were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, myalgia, shivering and somnolence to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that 51 years female patient recived the 2nd shingrix vaccine on 23rd September 2020 in left deltoid, and experienced body wide myalgias (especially in back and lower legs), injection site redness and pain, and shivering. Also patient mentioned that she was able to complete myhernormal routine-exercise, work, caring for home, however she had to take a 1.5 hour nap during the day which is uncharacteristic for her. It was reported that patient was using Synthroid 50mcg dose concomitantly. Patient had hyperthyroid in past, and currently she has PCN allergy. This case has been linked with US2020AMR193698 The reporter consented to follow up.  Note: The Synthroid's daily dose of 50mcg was removed from the structured fields to allow the e VAERS PADER report to be ack.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: headache /waking up in the morning with a headache / headaches that come and go; low grade fever / highest fever/ with a reading of 101.2 F; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 10th September 2020, less than a day after receiving Shingrix, the patient experienced headache. In September 2020, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine the patient developed a headache that day. The patient developed headache was not severe the first few days and occurred in the evenings towards 10 pm when going to bed. The patient reported waking up in the morning with a headache once in a while.  The patient reported still experiencing headaches that come and go and that they now occur throughout the day. For relief he may use Tylenol, Aspirin or Advil. If headache is minor, consumer reports not using a pain reliever. Headaches have not resolved. Around 14th or 15th September 2020, The patient reported developing a low grade fever, and recorded taking temperature on the 15th September 2020 at 9:45 PM and having a low-grade fever. The patient reported the highest fever was 17th September 2020 at 6:50 PM with a reading of 101.2 F. The patient reports ever since then that temperature recordings have been below 98.6 F. Fever reportedly resolved. The reporter consent to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Hyperhidrosis, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: headache /waking up in the morning with a headache / headaches that come and go; low grade fever / highest fever/ with a reading of 101.2 F; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 10th September 2020, less than a day after receiving Shingrix, the patient experienced headache. In September 2020, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine the patient developed a headache that day. The patient developed headache was not severe the first few days and occurred in the evenings towards 10 pm when going to bed. The patient reported waking up in the morning with a headache once in a while.  The patient reported still experiencing headaches that come and go and that they now occur throughout the day. For relief he may use Tylenol, Aspirin or Advil. If headache is minor, consumer reports not using a pain reliever. Headaches have not resolved. Around 14th or 15th September 2020, The patient reported developing a low grade fever, and recorded taking temperature on the 15th September 2020 at 9:45 PM and having a low-grade fever. The patient reported the highest fever was 17th September 2020 at 6:50 PM with a reading of 101.2 F. The patient reports ever since then that temperature recordings have been below 98.6 F. Fever reportedly resolved. The reporter consent to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Night sweats, Pyrexia
Clinical narrative: headache /waking up in the morning with a headache / headaches that come and go; low grade fever / highest fever/ with a reading of 101.2 F; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 10th September 2020, less than a day after receiving Shingrix, the patient experienced headache. In September 2020, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine the patient developed a headache that day. The patient developed headache was not severe the first few days and occurred in the evenings towards 10 pm when going to bed. The patient reported waking up in the morning with a headache once in a while.  The patient reported still experiencing headaches that come and go and that they now occur throughout the day. For relief he may use Tylenol, Aspirin or Advil. If headache is minor, consumer reports not using a pain reliever. Headaches have not resolved. Around 14th or 15th September 2020, The patient reported developing a low grade fever, and recorded taking temperature on the 15th September 2020 at 9:45 PM and having a low-grade fever. The patient reported the highest fever was 17th September 2020 at 6:50 PM with a reading of 101.2 F. The patient reports ever since then that temperature recordings have been below 98.6 F. Fever reportedly resolved. The reporter consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on her legs; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) and (batch number 4MT3A, expiry date May 2022) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 19th September 2020, 24 hrs after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist was reporting a patient describing a rash on her legs beginning 24 hours after receiving her first dose of Shingrix. The pharmacist reported the patient's rash has not recovered and the patient will seek medical advice from her doctor.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Swelling, Vaccination failure
Clinical narrative: minor discomfort; small raised area remain; July 2018, first Shingrix dose/Nov 2018 the patient received second Shingrix dose. /Feb/Mar 2020 the patient developed shingles; shingles across back, chest and under left arm; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 957J3, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 49R72, expiry date unknown) for prophylaxis.   Previously administered products included Zostavax (received zostavax years ago (past medical history)).   In July 2018, the patient received the 1st dose of Shingrix. In November 2018, the patient received the 2nd dose of Shingrix. In February 2020, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced discomfort and swelling. On an unknown date, the outcome of the vaccination failure, discomfort and swelling were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, discomfort and swelling to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received 2 doses of Shingrix and in february or march 2020 experienced shingles across back, chest and left upper left arm and discomfort. The reporter mentioned that at the time of reporting shingles has greatly improved and patient was still experiencing minor discomfort and small raised area remain. The patient had received zostavax years ago for past medical history. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Documented hypersensitivity to administered product, Dyspnoea, Swelling
Clinical narrative: Difficulty breathing; Puffed up; Medical history incudes allergy to sucrose; This case was reported by a physician via call center representative and described the occurrence of difficulty breathing in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included allergy (patient had allergy to sucrose on unknown date).   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, unknown after receiving Shingrix, the patient experienced documented hypersensitivity to administered product. On an unknown date, the patient experienced difficulty breathing and swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the difficulty breathing and swelling were recovered/resolved and the outcome of the documented hypersensitivity to administered product was unknown.   It was unknown if the reporter considered the difficulty breathing and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccinated with 1st dose of Shingri from healthcare provider. After an unknown amount of time following the vaccine the patient stated he puffed up and began to had difficulty breathing, self treated with Benadryl and self administering nebulizer treatments. The events were resolved without seeking medical help. The patients medical history incudes allergy to sucrose but sucrose is listed as an ingredient in the Shingrix vaccine which led to documented hypersensitivity to administered product. The reporter consent to follow up.
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Cough, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Flu-like Symptoms; Fever of 101 to 102 degrees; Chills; Fatigue; Dizziness; Headache; Vomiting; Coughing; Sneezing; Diarrhea; Sick; This case was reported by a consumer via call center representative and described the occurrence of flu-like symptoms in a 65-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On 10th February 2020, the patient received Havrix adult. On 11th February 2020, 1 days after receiving Havrix adult, the patient experienced flu-like symptoms, fever, chills, fatigue, dizziness, headache, vomiting, cough, sneezing, diarrhea and sickness. On 14th March 2020, the outcome of the flu-like symptoms, fever, chills, fatigue, dizziness, headache, vomiting, cough, sneezing, diarrhea and sickness were recovered/resolved.   The reporter considered the flu-like symptoms, fever, chills, fatigue, dizziness, headache, vomiting, cough, sneezing, diarrhea and sickness to be related to Havrix adult.  Additional details were as follows: The patient was vaccinated with Havrix on left arm. On next day after vaccination patient experienced flu-like symptoms and she was sick with fever of 101 to 102 degree F, chills, fatigue, dizziness, headache, vomiting, coughing, sneezing, and diarrhea. The patient stated that symptoms lasted until 14th March 2020 and now did not had any of those symptoms. The reporter stated she was going to call MERCK and report that she had the same symptoms with their Hepatitis A vaccine. The patient stated that symptoms were the result of the vaccines for Hepatitis A she received manufactured by GSk and MERCK. The reporter consent to follow up.
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Illness, Influenza like illness, Pyrexia, Sneezing
Clinical narrative: Flu-like Symptoms; Fever of 101 to 102 degrees; Chills; Fatigue; Dizziness; Headache; Vomiting; Coughing; Sneezing; Diarrhea; Sick; This case was reported by a consumer via call center representative and described the occurrence of flu-like symptoms in a 65-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On 10th February 2020, the patient received Havrix adult. On 11th February 2020, 1 days after receiving Havrix adult, the patient experienced flu-like symptoms, fever, chills, fatigue, dizziness, headache, vomiting, cough, sneezing, diarrhea and sickness. On 14th March 2020, the outcome of the flu-like symptoms, fever, chills, fatigue, dizziness, headache, vomiting, cough, sneezing, diarrhea and sickness were recovered/resolved.   The reporter considered the flu-like symptoms, fever, chills, fatigue, dizziness, headache, vomiting, cough, sneezing, diarrhea and sickness to be related to Havrix adult.  Additional details were as follows: The patient was vaccinated with Havrix on left arm. On next day after vaccination patient experienced flu-like symptoms and she was sick with fever of 101 to 102 degree F, chills, fatigue, dizziness, headache, vomiting, coughing, sneezing, and diarrhea. The patient stated that symptoms lasted until 14th March 2020 and now did not had any of those symptoms. The reporter stated she was going to call MERCK and report that she had the same symptoms with their Hepatitis A vaccine. The patient stated that symptoms were the result of the vaccines for Hepatitis A she received manufactured by GSk and MERCK. The reporter consent to follow up.
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Flu-like Symptoms; Fever of 101 to 102 degrees; Chills; Fatigue; Dizziness; Headache; Vomiting; Coughing; Sneezing; Diarrhea; Sick; This case was reported by a consumer via call center representative and described the occurrence of flu-like symptoms in a 65-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On 10th February 2020, the patient received Havrix adult. On 11th February 2020, 1 days after receiving Havrix adult, the patient experienced flu-like symptoms, fever, chills, fatigue, dizziness, headache, vomiting, cough, sneezing, diarrhea and sickness. On 14th March 2020, the outcome of the flu-like symptoms, fever, chills, fatigue, dizziness, headache, vomiting, cough, sneezing, diarrhea and sickness were recovered/resolved.   The reporter considered the flu-like symptoms, fever, chills, fatigue, dizziness, headache, vomiting, cough, sneezing, diarrhea and sickness to be related to Havrix adult.  Additional details were as follows: The patient was vaccinated with Havrix on left arm. On next day after vaccination patient experienced flu-like symptoms and she was sick with fever of 101 to 102 degree F, chills, fatigue, dizziness, headache, vomiting, coughing, sneezing, and diarrhea. The patient stated that symptoms lasted until 14th March 2020 and now did not had any of those symptoms. The reporter stated she was going to call MERCK and report that she had the same symptoms with their Hepatitis A vaccine. The patient stated that symptoms were the result of the vaccines for Hepatitis A she received manufactured by GSk and MERCK. The reporter consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 424A7, expiry date 18th April 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 424A7, expiry date 18th April 2021) for prophylaxis.   On 8th November 2018, the patient received the 1st dose of Shingrix (intramuscular). On 24th January 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 7th September 2020, 669 days after receiving Shingrix, 592 days after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with acyclovir. On 22nd September 2020, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: After receiving 2 doses of Shingrix, the patient had a shingles outbreak. The patient assisted to reporters place of work to request something for the shingles outbreak the patient had developed over Labor Day.  The patient was given Acyclovir to treat the outbreak and since patient has not returned it was assumed patient has recovered.  The consented to follow up. This case was considered as suspected vaccination failure, since the details regarding the completion of laboratory confirmation for herpes zoster was not provided. The batch number of Shingrix was reported as I24A7 and 4Z4A7, which was corrected to 424A7 as per sales data sheet.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Rash, Vaccination failure, Varicella virus test
Clinical narrative: rash consisting of spots in back, left hand, right arm, and under both breasts; feeling uncomfortable; first dose of Shingrix on February 14, 2020 and second dose May 28, 2020/Today, consumer went to doctor's office and was diagnosed with shingles; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number not known, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st shingles vaccine 10 years ago).   On 14th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd September 2020, 222 days after receiving Shingrix and 118 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced rash and discomfort. On an unknown date, the outcome of the vaccination failure and discomfort were unknown and the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and discomfort to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The patient received 2 doses of shingrix and experienced shingles, rash consisting of spots in back, left hand, right arm, and under both breasts. On 21st September 2020, patient visited ER as she felt uncomfortable. The ER prescribed cream which did not helped. On 23rd September 2020, consumer went to doctor's office and was diagnosed with shingles. Blood-work was performed to confirm shingles diagnosis and awaiting laboratory results.  The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm is sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 weeks 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: This case is reported by the husband of the patient. The patient experienced pain in arm after the 1st dose of Shingrix. The patient had received the 2nd dose in her left arm. The reporter mentioned that the arm was still hurting, 2 weeks after the vaccination that is until the date of reporting. The reporter did not consent to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Eye pain, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: fever; pain behind the eyes; headache; nausea; swelling in the arm; fatigue; pain at the injection site; This case was reported by a physician via call center representative and described the occurrence of fever in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 17th September 2020, the patient received the 2nd dose of Bexsero. On 18th September 2020, 1 days after receiving Bexsero, the patient experienced fever, pain behind eyes, headache, nausea, swelling arm, fatigue and injection site pain. On 18th September 2020, the outcome of the fever, pain behind eyes, headache, nausea, swelling arm, fatigue and injection site pain were recovered/resolved.   It was unknown if the reporter considered the fever, pain behind eyes, headache, nausea, swelling arm, fatigue and injection site pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient started with fever, pain behind the eyes, headache, nausea, swelling in the arm, fatigue and pain at the injection site but they all were transient and by the afternoon they were gone (as reported)but at the afternoon they were gone.  The reporter consent to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: fever; pain behind the eyes; headache; nausea; swelling in the arm; fatigue; pain at the injection site; This case was reported by a physician via call center representative and described the occurrence of fever in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 17th September 2020, the patient received the 2nd dose of Bexsero. On 18th September 2020, 1 days after receiving Bexsero, the patient experienced fever, pain behind eyes, headache, nausea, swelling arm, fatigue and injection site pain. On 18th September 2020, the outcome of the fever, pain behind eyes, headache, nausea, swelling arm, fatigue and injection site pain were recovered/resolved.   It was unknown if the reporter considered the fever, pain behind eyes, headache, nausea, swelling arm, fatigue and injection site pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient started with fever, pain behind the eyes, headache, nausea, swelling in the arm, fatigue and pain at the injection site but they all were transient and by the afternoon they were gone (as reported)but at the afternoon they were gone.  The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: lay in bed trembling and shaking; This case was reported by a consumer via call center representative and described the occurrence of tremor in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tremor. On an unknown date, the outcome of the tremor was recovered/resolved.   It was unknown if the reporter considered the tremor to be related to Shingrix.  Additional details were provided as follows: The patient was either age 54 or 55 received both shots of Shingrix. The second shot her cousin lay in bed with trembling and shaking with the covers over. This case has been linked with case US2020AMR193653, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020191504:same reporter