chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Feeling drunk, Injection site urticaria, Product complaint
Clinical narrative: Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group selected as an adult as the patient was employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the Glaxosmithkline response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 5 of 9 linked cases reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Feeling drunk, Injection site urticaria, Product complaint
Clinical narrative: Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were priovided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group selected as an adult as the patient was employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the Glaxosmithkline response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 6 of 9 linked cases reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Feeling drunk, Injection site urticaria, Product complaint
Clinical narrative: Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group selected as an adult, as the patient reported as employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the glaxosmithkline response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 7 of 9 linked cases reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Feeling drunk, Injection site urticaria, Product complaint
Clinical narrative: Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group was selected as an adult as the patient was employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 8 of 9 linked cases reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Feeling drunk, Injection site urticaria, Product complaint, Vomiting
Clinical narrative: Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Vomiting; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema, vomiting and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, vomiting, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema, vomiting and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group of the patient selected as an adult, because the patient was reported as employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck, vomitting and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the glaxosmithkline response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 3 of 9 linked cases reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Vaccine extremely painful; Normal swelling at site; Headache; Arm  is painful; Numbness and tingling to my finger tips; Tingling to my finger tips; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On 2nd October 2019, immediately after receiving Shingrix, the patient experienced injection site pain and injection site swelling. In October 2019, the patient experienced headache, pain in arm, numbness in fingers and tingling of extremity. On an unknown date, the outcome of the injection site pain, pain in arm, numbness in fingers and tingling of extremity were not recovered/not resolved and the outcome of the injection site swelling and headache were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, headache, pain in arm, numbness in fingers and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The vaccine was extremely painful to the patient. Soon after, the patient experienced normal swelling at site and headache an hour later. Less than a week after receiving the Shingrix, the patients arm was painful and experiencing numbness and tingling to finger tips. At the evening of reporting date, the patient was still experiencing numb, tingling and pain.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Vaccine extremely painful; Normal swelling at site; Headache; Arm  is painful; Numbness and tingling to my finger tips; Tingling to my finger tips; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On 2nd October 2019, immediately after receiving Shingrix, the patient experienced injection site pain and injection site swelling. In October 2019, the patient experienced headache, pain in arm, numbness in fingers and tingling of extremity. On an unknown date, the outcome of the injection site pain, pain in arm, numbness in fingers and tingling of extremity were not recovered/not resolved and the outcome of the injection site swelling and headache were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, headache, pain in arm, numbness in fingers and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The vaccine was extremely painful to the patient. Soon after, the patient experienced normal swelling at site and headache an hour later. Less than a week after receiving the Shingrix, the patients arm was painful and experiencing numbness and tingling to finger tips. At the evening of reporting date, the patient was still experiencing numb, tingling and pain.
Age: 0.25
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Intensive care, Malaise, Near death experience, Pertussis
Clinical narrative: Pertussis; Very sick; This case was reported by a consumer via interactive digital media and described the occurrence of pertussis in a 3-month-old male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced pertussis (serious criteria hospitalization, GSK medically significant and life threatening) and sickness (serious criteria hospitalization). On an unknown date, the outcome of the pertussis and sickness were unknown.   It was unknown if the reporter considered the pertussis and sickness to be related to DTPa vaccine.  Additional details were provided as follows: The patient was exposed to a 5 year old who they said had bronchitis.  The patient was very sick.  The patient was diagnosed with pertussis in emergency room after swan test. The patient was not old enough to receive the 2nd dose of DTP vaccine, thus immunity was not good. The patient almost died and was 10 days in intensive care unit (ICU). At the age of 6 months the patient was with suction machine. It was reported that,the 5 year old tested for pertussis and had no bronchitis. The patient's parents did not believe in vaccinations.      Lab Comments: on an unknown date patient underwent swan test.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: red spot expanding to the size of a grapefruit; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was recovered/resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient had red spot expanding to the size of a grapefruit also occurred following 1st dose Shingrix at an unspecified date, but not flu-like symptoms. The reporter consented to follow up. The reporter did not collect the date or vaccine details of 1st Shingrix dose. For tolerances of 2nd dose, refer case US2019179897 and linked with US2019179912, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: sore shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of musculoskeletal pain (patient received 1st dose on an unknown date, refer case US2019AMR184141 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shoulder soreness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shoulder soreness was unknown.   It was unknown if the reporter considered the shoulder soreness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's partner. The age at vaccination was not reported. The age group was not reported but selected as adult as per vaccine indication. The patient experienced sore shoulder after receiving Shingrix. This case has been linked to US2019169168 and US2019AMR176794, reported by the same reporter.
Age: 64.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; Fever; Chills; Severe achiness; This case was reported by a nurse via sales rep and described the occurrence of fever in a 64-year-old patient who received Herpes zoster (Shingrix) (batch number 7D9C3, expiry date unknown), (batch number P2275, expiry date unknown), (batch number 454S2, expiry date unknown) and (batch number YA724, expiry date unknown) for prophylaxis.   On 12th July 2019, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever, chills, pain and fatigue. On an unknown date, the outcome of the fever, chills and pain were recovered/resolved and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the fever, chills, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The reporter was not sure which one was the correct batch number, because both appeared on separate screens. The patient experienced fever, chills, severe achiness that lasted for 10 to 14 days. The patient experienced fatigue, 2 months before the date of reporting it started to lessen.  Till the time of reporting, the symptoms were not cleared and the patient had to miss work due to it.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Full blood count, Headache, Magnetic resonance imaging, Nausea
Clinical narrative: Nausea; Vomiting; dull headache/ headache became worse; This case was reported by a consumer via call center representative and described the occurrence of headache aggravated in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in November 2017), hysterectomy (in 2001) and migraine. Previously administered products included Valaciclovir with an associated reaction of headache (received in November 2017).   On 26th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th September 2019, 1 days after receiving Shingrix, the patient experienced headache aggravated. On 30th September 2019, the patient experienced nausea and vomiting. The patient was treated with excedrin unknown, paracetamol (Tylenol) and ibuprofen (Advil). On an unknown date, the outcome of the headache aggravated, nausea and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the headache aggravated, nausea and vomiting to be related to Shingrix.  Additional case details were provided as follows: The patient reporter for herself. The patient did not know the manufacturer of Valacyclovir which she received in November 2017. She mentions that, she experienced headache after taking the Valacyclovir and had to go to the emergency room. She had MRI (Nuclear magnetic resonance imaging) and blood work done at the hospital. She was discharged the same day from hospital.  The patient received Shingrix in right arm The patient experienced dull headache on 27th, 28th and 29th Septemebr 2019.  On 30th September 2019, her headache became worse. The headache was worse on waking up.  On the same day, she also experienced nausea and vomiting. The headache, nausea and vomiting were on an on and off basis. The headache was still present till the date of reporting. She had tried taking Tylenol, Excedrin and Advil and nothing had helped her. The patient messaged her doctor about her experience and was waiting to hear back from the doctor. The patient consented to follow up.  No further details were provided.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting; dull headache/ headache became worse; This case was reported by a consumer via call center representative and described the occurrence of headache aggravated in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in November 2017), hysterectomy (in 2001) and migraine. Previously administered products included Valaciclovir with an associated reaction of headache (received in November 2017).   On 26th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th September 2019, 1 days after receiving Shingrix, the patient experienced headache aggravated. On 30th September 2019, the patient experienced nausea and vomiting. The patient was treated with excedrin unknown, paracetamol (Tylenol) and ibuprofen (Advil). On an unknown date, the outcome of the headache aggravated, nausea and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the headache aggravated, nausea and vomiting to be related to Shingrix.  Additional case details were provided as follows: The patient reporter for herself. The patient did not know the manufacturer of Valacyclovir which she received in November 2017. She mentions that, she experienced headache after taking the Valacyclovir and had to go to the emergency room. She had MRI (Nuclear magnetic resonance imaging) and blood work done at the hospital. She was discharged the same day from hospital.  The patient received Shingrix in right arm The patient experienced dull headache on 27th, 28th and 29th Septemebr 2019.  On 30th September 2019, her headache became worse. The headache was worse on waking up.  On the same day, she also experienced nausea and vomiting. The headache, nausea and vomiting were on an on and off basis. The headache was still present till the date of reporting. She had tried taking Tylenol, Excedrin and Advil and nothing had helped her. The patient messaged her doctor about her experience and was waiting to hear back from the doctor. The patient consented to follow up.  No further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, 42 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 information received were as follows: The age at vaccination was not reported. The customer stated that one of his friends received the first dose of the Shingrix vaccine. About 6 weeks after receiving Shingrix, the patient was diagnosed with shingles. Additional information not provided.  Address not provided.  The reporter did not consent to follow-up.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Feeling hot, Influenza like illness, Pain, Pyrexia
Clinical narrative: Red spot also described as hot; Redness; Flu-like symptoms; achy; having low energy; fever; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash erythematous (received 1st dose on unknown date, refer case US2019AMR184103).   On 27th September 2019, the patient received the 2nd dose of Fluarix Tetra 2019-2020 season (intramuscular) and the 2nd dose of Shingrix. In September 2019, less than a week after receiving Fluarix Tetra 2019-2020 season and Shingrix, the patient experienced influenza-like symptoms, energy decreased and fever. On 27th September 2019, the patient experienced red rash and feeling of warmth. On an unknown date, the patient experienced pain. Rechallenge with Shingrix was positive. In September 2019, the outcome of the red rash and influenza-like symptoms were recovered/resolved. On 30th September 2019, the outcome of the fever and feeling of warmth were recovered/resolved. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the energy decreased was unknown.   It was unknown if the reporter considered the red rash, influenza-like symptoms, pain, energy decreased, fever and feeling of warmth to be related to Fluarix Tetra 2019-2020 season and Shingrix.  Additional information received were as follows: The patient received 2nd dose Shingrix in her right arm and Fluarix quadrivalent in her left arm and had red spot appeared on her right arm approximately 12 hours following vaccination. Red spot also described as hot. Within 24 hours following vaccination, caller reports the size of red spot was now the size of a grapefruit and still hot. The patient experiencing mild flu-like symptoms described as feeling feverish, achy, and having low energy. All symptoms last approximately 2 days and were resolved. The reporter consented to follow up.  The caller was a GlaxoSmithKline employee who did not work for the field. The GlaxoSmithKline employee was the patient. This report 1 of 3 reported by same reporter.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red spot also described as hot; Redness; Flu-like symptoms; achy; having low energy; fever; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash erythematous (received 1st dose on unknown date, refer case US2019AMR184103).   On 27th September 2019, the patient received the 2nd dose of Fluarix Tetra 2019-2020 season (intramuscular) and the 2nd dose of Shingrix. In September 2019, less than a week after receiving Fluarix Tetra 2019-2020 season and Shingrix, the patient experienced influenza-like symptoms, energy decreased and fever. On 27th September 2019, the patient experienced red rash and feeling of warmth. On an unknown date, the patient experienced pain. Rechallenge with Shingrix was positive. In September 2019, the outcome of the red rash and influenza-like symptoms were recovered/resolved. On 30th September 2019, the outcome of the fever and feeling of warmth were recovered/resolved. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the energy decreased was unknown.   It was unknown if the reporter considered the red rash, influenza-like symptoms, pain, energy decreased, fever and feeling of warmth to be related to Fluarix Tetra 2019-2020 season and Shingrix.  Additional information received were as follows: The patient received 2nd dose Shingrix in her right arm and Fluarix quadrivalent in her left arm and had red spot appeared on her right arm approximately 12 hours following vaccination. Red spot also described as hot. Within 24 hours following vaccination, caller reports the size of red spot was now the size of a grapefruit and still hot. The patient experiencing mild flu-like symptoms described as feeling feverish, achy, and having low energy. All symptoms last approximately 2 days and were resolved. The reporter consented to follow up.  The caller was a GlaxoSmithKline employee who did not work for the field. The GlaxoSmithKline employee was the patient. This report 1 of 3 reported by same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Fever; Aches / Pains; Chills / Shivering; Swelling at injection site; Felt like flu; Very tired; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th September 2019, less than a day after receiving Shingrix, the patient experienced fever, pain, chills, injection site swelling, influenza-like symptoms and tiredness. On an unknown date, the outcome of the fever, pain, chills, injection site swelling and influenza-like symptoms were recovered/resolved and the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the fever, pain, chills, injection site swelling, influenza-like symptoms and tiredness to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix into left deltoid. The patient experienced fever, chills and shivering, aches, pains and swelling at injection site. All adverse events were better on the reporting date. The patient felt like flu and was still very tired.  The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; Aches / Pains; Chills / Shivering; Swelling at injection site; Felt like flu; Very tired; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th September 2019, less than a day after receiving Shingrix, the patient experienced fever, pain, chills, injection site swelling, influenza-like symptoms and tiredness. On an unknown date, the outcome of the fever, pain, chills, injection site swelling and influenza-like symptoms were recovered/resolved and the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the fever, pain, chills, injection site swelling, influenza-like symptoms and tiredness to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix into left deltoid. The patient experienced fever, chills and shivering, aches, pains and swelling at injection site. All adverse events were better on the reporting date. The patient felt like flu and was still very tired.  The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Chills; Fever; Headache; Vomiting; Diarrhea; Body aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included adalimumab (Humira).   On 1st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st October 2019, less than a day after receiving Shingrix, the patient experienced chills, fever, headache, vomiting, diarrhea and general body pain. On an unknown date, the outcome of the chills, fever, headache, vomiting, diarrhea and general body pain were recovering/resolving.   It was unknown if the reporter considered the chills, fever, headache, vomiting, diarrhea and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was on Humira and received Shingrix on left deltoid and experience fever, chills, headache, vomiting, diarrhea, and body aches. She was feeling much better at the time of reporting. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Chills; Fever; Headache; Vomiting; Diarrhea; Body aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included adalimumab (Humira).   On 1st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st October 2019, less than a day after receiving Shingrix, the patient experienced chills, fever, headache, vomiting, diarrhea and general body pain. On an unknown date, the outcome of the chills, fever, headache, vomiting, diarrhea and general body pain were recovering/resolving.   It was unknown if the reporter considered the chills, fever, headache, vomiting, diarrhea and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was on Humira and received Shingrix on left deltoid and experience fever, chills, headache, vomiting, diarrhea, and body aches. She was feeling much better at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Pain in the right arm; Swelling in the right arm; Difficulty moving the arm for a week/Difficulty lifting the arm for a week / Difficulty raising her arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past). Previously administered products included shingles vaccine (had the previous Shingles vaccine in the past).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site swelling and injected limb mobility decreased were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling and injected limb mobility decreased to be related to Shingrix.  Additional information received were as follows: The patient woke up at middle of night with swelling and pain in the right arm. She had difficulty moving and lifting the arm for a week. After a week it was getting better, but she was still having difficulty raising her arm.  No further details were provided, caller disconnected call prior to gathering any further information.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Feeling drunk, Injection site urticaria, Product complaint, Vomiting
Clinical narrative: Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Vomiting; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema, vomiting and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, vomiting, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema, vomiting and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck, vomitting and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 1 of 9 linked cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles 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, less than a week 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 group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received dose of shingrix a few months ago. The health care professional reported that, within 1 week after vaccination with dose of Shingrix, the patient developed a case of shingles. The health care professional did not provide the patient details or original vaccination date and stated that, it was a few months ago.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Pruritus
Clinical narrative: Forehead was itchy; Inappropriate age at vaccine administration; This case was reported by a consumer via call center representative and described the occurrence of pruritus facial in a 22-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pruritus facial and inappropriate age at vaccine administration. On an unknown date, the outcome of the pruritus facial and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the pruritus facial to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the 1st dose of Shingrix, forehead of patient was itchy. The patient received the vaccine at less than 50 years of age, which led to inappropriate age at vaccine administration. The reporter did not provide any additional information and did not consent to follow-up. This case was considered as medication error with harm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling; Numbness in fingers; This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2021) for prophylaxis.   On 4th October 2019, the patient received Shingrix (intramuscular) .5 ml. On 4th October 2019, less than a day after receiving Shingrix, the patient experienced tingling of extremity and numbness in fingers. On an unknown date, the outcome of the tingling of extremity and numbness in fingers were unknown.   It was unknown if the reporter considered the tingling of extremity and numbness in fingers to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix about 2 hours ago in left deltoid. The patient started experiencing tingling and numbness in fingers of the left arm and now it was also on the fingers of the right hand. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: Nausea intermittently / Intermittent nausea; Chills; This case was reported by a physician via call center representative and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2019, the patient received Shingrix. On 2nd October 2019, 1 days after receiving Shingrix, the patient experienced nausea and chills. On an unknown date, the outcome of the nausea was not recovered/not resolved and the outcome of the chills was recovering/resolving.   It was unknown if the reporter considered the nausea and chills 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. It was 3rd day after the vaccine and the patient was still having chills and nausea intermittently. Overall the patient was feeling much better than the evening of 2nd October 2019, but still had intermittent nausea. This information was received via chat and the reporter was unresponsive to questions for adverse events.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Herpes zoster
Clinical narrative: ear pain; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3EE55, expiry date 11th December 2021) for prophylaxis.   Concomitant products included amitriptyline.   On 27th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced ear pain. The patient was treated with valaciclovir hydrochloride (Valtrex), naproxen and gabapentin. On an unknown date, the outcome of the shingles and ear pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and ear pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that she developed shingles on her head, neck, and ears 3 days after dose 1 of Shingrix.   The patient went to the emergency department due to the ear pain and was diagnosed with shingles.   The patient was prescribed Valtrex 1 gram three times daily, Naproxyn, and gabapentin and then sent home. The reporter consented to follow up. There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and it was reported as not recovered/ not resolved.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Blister, Neuralgia, Post herpetic neuralgia, Pruritus
Clinical narrative: ear pain; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3EE55, expiry date 11th December 2021) for prophylaxis.   Concomitant products included amitriptyline.   On 27th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced ear pain. The patient was treated with valaciclovir hydrochloride (Valtrex), naproxen and gabapentin. On an unknown date, the outcome of the shingles and ear pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and ear pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that she developed shingles on her head, neck, and ears 3 days after dose 1 of Shingrix.   The patient went to the emergency department due to the ear pain and was diagnosed with shingles.   The patient was prescribed Valtrex 1 gram three times daily, Naproxyn, and gabapentin and then sent home. The reporter consented to follow up. There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and it was reported as not recovered/ not resolved.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Varicella zoster virus infection, Viral test positive
Clinical narrative: ear pain; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3EE55, expiry date 11th December 2021) for prophylaxis.   Concomitant products included amitriptyline.   On 27th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced ear pain. The patient was treated with valaciclovir hydrochloride (Valtrex), naproxen and gabapentin. On an unknown date, the outcome of the shingles and ear pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and ear pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that she developed shingles on her head, neck, and ears 3 days after dose 1 of Shingrix.   The patient went to the emergency department due to the ear pain and was diagnosed with shingles.   The patient was prescribed Valtrex 1 gram three times daily, Naproxyn, and gabapentin and then sent home. The reporter consented to follow up. There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and it was reported as not recovered/ not resolved.