chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 09-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 17-AUG-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 09-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 10-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 11-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 15-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 16-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 17-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 18-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Rash, Rash erythematous
Clinical narrative: Non-itchy rash over torso, abdomen, arms & amp; legs; I broke out in red / solid red across her abdomen; This case was reported by a consumer via call center representative and described the occurrence of rash in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2020, 2 days after receiving SHINGRIX and an unknown time after starting ZYRTEC, the patient experienced rash and erythema. The patient was treated with cetirizine hydrochloride (ZYRTEC). On an unknown date, the outcome of the rash and erythema were unknown.   It was unknown if the reporter considered the rash and erythema to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left arm intramuscularly and two days later she broke out in red, non-itchy rash over torso, abdomen, arms and legs. It was solid red across her abdomen. The patient had an online chat with her provider who said it was an allergic reaction. The patient had no itching or difficulty breathing and took ZYRTEC for 2 days and the red rash resolved.
Sex: M
Vaccine: HEPAB
Symptoms: Injection site haemorrhage
Clinical narrative: some blood came out of his arm; This case was reported by a pharmacist and described the occurrence of injection site hemorrhage in a 43-year-old male patient who received TWINRIX for prophylaxis.   On an unknown date, the patient received the 2nd dose of TWINRIX (intramuscular). On an unknown date, less than a day after receiving TWINRIX, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the injection site hemorrhage was unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to TWINRIX.  Additional details were provided as follows: The age at vaccination was not reported. The patient received TWINRIX about a week ago and reported when he got home after receipt of the vaccine and removed the band-aid and some blood came out of his arm. The patient then bled a little more and was worried he may not have gotten a proper dose of the vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: I am allergic to the flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of allergy 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 allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine and had allergy. The patient stated that cannot ever had another one.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: L. arm soreness; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient experienced some soreness in the left arm after receiving the 1st dose of Shingrix. The reporter did not consent to follow up. For the tolerance of 2nd dose, refer the case- US2020192546.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Malaise, Pyrexia
Clinical narrative: very weak; Fever; I feel Terrible; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on unknown date).   On 24th September 2020, the patient received the 2nd dose of Shingrix. On 24th September 2020, less than a day after receiving Shingrix, the patient experienced fever and feeling unwell. On 25th September 2020, the patient experienced weakness. On an unknown date, the outcome of the fever, feeling unwell and weakness were unknown.   It was unknown if the reporter considered the fever, feeling unwell and weakness to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated 2nd dose of Shingrix. After vaccination patient felt terrible. The patient had fever on vaccination day and had felt very weak next day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed mood, Diarrhoea, Fatigue, Feelings of worthlessness, Haematochezia
Clinical narrative: feeling tired; feeling of melancholy was described as a feeling of rejection / escalated following both injections.; stomach issues / as a feeling of / being hungover / though she didn't drink alcohol; feeling of rejection; The blood in the stool presented after the 1st dose; stomach issues / described as a feeling of motion sickness; loose stool; headache; This case was reported by a consumer via call center representative and described the occurrence of blood in stool in a 60-year-old female patient who received SHINGRIX for prophylaxis.   On 30th July 2020, the patient received the 1st dose of SHINGRIX. On 31st July 2020, 1 days after receiving SHINGRIX, the patient experienced headache. In August 2020, the patient experienced blood in stool (serious criteria GSK medically significant), motion sickness and loose stools. On an unknown date, the patient experienced tiredness, feeling blue, hangover effect and feelings of worthlessness. On an unknown date, the outcome of the blood in stool was unknown and the outcome of the headache, tiredness, feeling blue, hangover effect, motion sickness, loose stools and feelings of worthlessness were recovered/resolved.   It was unknown if the reporter considered the blood in stool, headache, tiredness, feeling blue, hangover effect, motion sickness, loose stools and feelings of worthlessness to be related to SHINGRIX.  Additional details were provided as follows: The received SHINGRIX in left arm.  The patient experienced the same symptoms. The headache and feeling tired presented the day after the vaccination. A feeling of melancholy was described as a feeling of rejection. She was supposed to see her doctor for a physical and then was told she would not see her doctor but would receive the vaccine by a nurse. It left her feeling rejected and that feeling escalated following both injections. The stomach issues were described as a feeling of motion sickness or being hungover even though she didn't drink alcohol. The blood in the stool presented after the 1st dose only. The loose stool presented after both.  The stomach issues presented 2 to 3 days following both vaccines.  The reporter consent to follow up. For tolerance to 2nd dose refer linked case US2020193793, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020193793:same patient (2nd dose)
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hangover, Headache, Motion sickness
Clinical narrative: feeling tired; feeling of melancholy was described as a feeling of rejection / escalated following both injections.; stomach issues / as a feeling of / being hungover / though she didn't drink alcohol; feeling of rejection; The blood in the stool presented after the 1st dose; stomach issues / described as a feeling of motion sickness; loose stool; headache; This case was reported by a consumer via call center representative and described the occurrence of blood in stool in a 60-year-old female patient who received SHINGRIX for prophylaxis.   On 30th July 2020, the patient received the 1st dose of SHINGRIX. On 31st July 2020, 1 days after receiving SHINGRIX, the patient experienced headache. In August 2020, the patient experienced blood in stool (serious criteria GSK medically significant), motion sickness and loose stools. On an unknown date, the patient experienced tiredness, feeling blue, hangover effect and feelings of worthlessness. On an unknown date, the outcome of the blood in stool was unknown and the outcome of the headache, tiredness, feeling blue, hangover effect, motion sickness, loose stools and feelings of worthlessness were recovered/resolved.   It was unknown if the reporter considered the blood in stool, headache, tiredness, feeling blue, hangover effect, motion sickness, loose stools and feelings of worthlessness to be related to SHINGRIX.  Additional details were provided as follows: The received SHINGRIX in left arm.  The patient experienced the same symptoms. The headache and feeling tired presented the day after the vaccination. A feeling of melancholy was described as a feeling of rejection. She was supposed to see her doctor for a physical and then was told she would not see her doctor but would receive the vaccine by a nurse. It left her feeling rejected and that feeling escalated following both injections. The stomach issues were described as a feeling of motion sickness or being hungover even though she didn't drink alcohol. The blood in the stool presented after the 1st dose only. The loose stool presented after both.  The stomach issues presented 2 to 3 days following both vaccines.  The reporter consent to follow up. For tolerance to 2nd dose refer linked case US2020193793, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020193793:same patient (2nd dose)
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Near death experience, Pneumonia
Clinical narrative: flu shot while in the hospital with pneumonia. It made it worse.i almost died; This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia aggravated in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included pneumonia.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pneumonia aggravated (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the pneumonia aggravated was unknown.   It was unknown if the reporter considered the pneumonia aggravated to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient was given the flu shot while in the hospital with pneumonia. It made it worse and the patient almost died. The patient would not get another one and had not been sick. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: pain; red skin; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in a 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 and skin red. On an unknown date, the outcome of the pain and skin red were unknown.   It was unknown if the reporter considered the pain and skin red to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The patient had pain and red skin after the Shingles shot.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: injection site is still sore; injection site is still hot to the touch; injection site is still red; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 24th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The Shingrix was administered in right arm.  The patient also had flu vaccine administered in left arm that on the same day. The patient's injection site (right arm) was sore, hot to the touch and red at the time of reporting.  The reporter asked how long would this last.  He or she was told to expect soreness for 2-3 days. Patient's right arm was really red and sore at the time of reporting. Patient did not have lot number of Shingrix that was administered to her.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2020, the patient received the 1st dose of Shingrix. On 28th September 2020, 14 days 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 at vaccination was not reported.  The age group was not reported but was selected as adult as per vaccine indication. The patient was vaccinated with 1st dose of Shingrix 2 weeks ago and experinced Shingles. The reporter did not consent to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Pneumonia
Clinical narrative: had pneumonia; was sick; This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia 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, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pneumonia (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the pneumonia and sickness were unknown.   It was unknown if the reporter considered the pneumonia and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that last time took the flu vaccine, the patient was sick all winter, had pneumonia and everything. The patient would think to take chances.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Rash at the injection site; Red rash at the injection site; Itchy, red rash at the injection site; This case was reported by a consumer via interactive digital media 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, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site rash, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site rash, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. After the first Shingrix shot, the patient broke into an itchy, red rash at the injection site.  The patient questioned of they should get the second shot.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Arthropathy, Muscular weakness, Myalgia
Clinical narrative: pain and weakness in my left elbow joint and in the muscles above and below the elbow/Sore elbow joint; weakness in my left elbow joint and in the muscles above and below the elbow/weak elbow joint; pain and weakness in my left elbow joint and in the muscles above and below the elbow; weakness in my left elbow joint and in the muscles above and below the elbow; This case was reported by a consumer and described the occurrence of joint pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than 2 weeks after receiving Shingrix, the patient experienced joint pain, joint disorder, muscle pain and muscle weakness. On an unknown date, the outcome of the joint pain, joint disorder, muscle pain and muscle weakness were unknown.   It was unknown if the reporter considered the joint pain, joint disorder, muscle pain and muscle weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in good health. The patient received the first Shingrix shot on 21st September 2020 in my left arm. Ever since the patient experienced continuous pain and weakness in the left elbow joint and in the muscles above and below the elbow. The patient contacted his primary care physician but did not seemed alarmed. The patient questioned what was going on and should he be concerned.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Fot the flu / when I took the flu shot/Suspected Vaccination failure; Flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 and influenza were unknown.   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 case was reported by patient itself. The patient received flu shot and had flu. 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.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Eye pain, Hyperaesthesia, Paraesthesia, Photopsia
Clinical narrative: Right eye / tenderness; Right eye rash; Flashers in eye / sees flashes of light and dark; Red rash in a band around his head; Pins and needles feeling on left lower ribcage, feels like electric shock bolt of pain; Ribcage is red but no rash; lower left ribcage he has touch sensitivity like 1000 needles; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Occurred 13-14 years ago from the date of reporting) and pins and needles (experienced 1 month before injection date, 2-4 yearly episodes).   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, 1 week after receiving Shingrix, the patient experienced red rash, pins and needles, erythema and touch sensitivity increased. On 21st September 2020, the patient experienced eye tenderness, rash and flashing lights. On an unknown date, the outcome of the red rash, pins and needles, erythema, touch sensitivity increased, eye tenderness, rash and flashing lights were unknown.   It was unknown if the reporter considered the red rash, pins and needles, erythema, touch sensitivity increased, eye tenderness, rash and flashing lights to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not have lot number and expiry date. 1 week after Shingrix the patient developed a red rash in a band around his head.  He had pins and needles feeling on left lower ribcage.  His ribcage was red but no rash.  On lower left ribcage the patient had touch sensitivity like 1000 needles, it felt like electric shock bolt of pain that comes and goes quickly. The patient also experienced right eye rash and tenderness.  He had flashers in eye where he seen flashes of light and dark it goes on and off for 15-20 minutes then goes away.  Eye flashes had been lasted for 2 days. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Right eye / tenderness; Right eye rash; Flashers in eye / sees flashes of light and dark; Red rash in a band around his head; Pins and needles feeling on left lower ribcage, feels like electric shock bolt of pain; Ribcage is red but no rash; lower left ribcage he has touch sensitivity like 1000 needles; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Occurred 13-14 years ago from the date of reporting) and pins and needles (experienced 1 month before injection date, 2-4 yearly episodes).   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, 1 week after receiving Shingrix, the patient experienced red rash, pins and needles, erythema and touch sensitivity increased. On 21st September 2020, the patient experienced eye tenderness, rash and flashing lights. On an unknown date, the outcome of the red rash, pins and needles, erythema, touch sensitivity increased, eye tenderness, rash and flashing lights were unknown.   It was unknown if the reporter considered the red rash, pins and needles, erythema, touch sensitivity increased, eye tenderness, rash and flashing lights to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not have lot number and expiry date. 1 week after Shingrix the patient developed a red rash in a band around his head.  He had pins and needles feeling on left lower ribcage.  His ribcage was red but no rash.  On lower left ribcage the patient had touch sensitivity like 1000 needles, it felt like electric shock bolt of pain that comes and goes quickly. The patient also experienced right eye rash and tenderness.  He had flashers in eye where he seen flashes of light and dark it goes on and off for 15-20 minutes then goes away.  Eye flashes had been lasted for 2 days. The reporter consented to follow up.
Sex: M
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Extensive Lymph Swelling; This case was reported by a other health professional via call center representative and described the occurrence of lymphadenopathy in a child male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular). On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was unknown.   It was unknown if the reporter considered the lymphadenopathy to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported the patient had extensive lymph swelling, which led to lymphadenopathy. No further information was available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site pain
Clinical narrative: felt burn; pain; bruise; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 14th September 2020, the patient received the 1st dose of Shingrix. On 14th September 2020, immediately after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site bruising and pain. On 17th September 2020, the patient experienced injection site burning. On 17th September 2020, the outcome of the injection site bruising was recovered/resolved. On an unknown date, the outcome of the injection site burning was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising, injection site burning and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administrated 1st dose of Shingrix.  The vaccine was administrated on her left arm and she felt burn when the vaccine was injection. Then she felt pain and still having it. Three days after the administration bruise appear.  The same day the flu vaccine was administrated but in her right. arm.  The reporter did not consent to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Coumadin.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   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. Pharmacist reported the patient experienced soreness after 1st dose of Shingrix.  The reporter consented to follow up. For tolerance in 2nd dose of Shingrix refer case US2020AMR193446.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR193446:Same patient, 2nd dose
Age: 61.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Shivering; possible fever (feeling hot); Severe headache; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concomitant products included bupropion hydrochloride (Wellbutrin) and sertraline hydrochloride (Zoloft).   On 23rd September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 23rd September 2020 10:00, the patient received Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 23rd September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after starting Wellbutrin, the patient experienced shivering, fever, headache and pain in arm. On 24th September 2020, the outcome of the shivering, fever, headache and pain in arm were recovered/resolved.   It was unknown if the reporter considered the shivering, fever, headache and pain in arm to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional information was provided as follows: The patient experienced shivering, a possible fever, severe headache and a sore arm after the 2nd dose of Shingrix, he also had administered the Flu vaccine at the same time. The patient also mentioned that, he had started taking Zoloft and Wellbutrin as new medications. The reporter did not consetnt to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pain
Clinical narrative: fluish [flu-like].; sore; feeling pretty poor [malaise]; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced influenza like illness, pain and malaise. On an unknown date, the outcome of the influenza like illness, pain and malaise were not recovered/not resolved.   It was unknown if the reporter considered the influenza like illness, pain and malaise to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient felt pretty poor (malaise), sore, and fluish (flu-like) after vaccination. The reporter declined to provide any further information for safety report.