chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: three days of fevers; three days of / myalgias.; This case was reported by a physician and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were recovered/resolved.   It was unknown if the reporter considered the fever and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In October 2019, the patient received 1st dose of Shingrix. After this, she had three days of fevers and myalgias.  The events were resolved. For tolerance to 2nd dose refer linked case US2020AMR197673, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197673:same patient (2nd dose)
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Rash, Rash pruritic, Urticaria
Clinical narrative: Itchy rash; rash/hives on front and back torso / Large patches; rash/hives on front and back torso; Itchy and warm; This case was reported by a other health professional via sales rep and described the occurrence of itchy rash in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   On 24th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season .5 ml. On 26th September 2020, 2 days after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced itchy rash, rash, hives and feeling of warmth. On an unknown date, the outcome of the itchy rash, rash, hives and feeling of warmth were unknown.   The reporter considered the itchy rash, rash, hives and feeling of warmth to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. Rash or hives on front and back torso. Has happened before with other vaccines. Rash appeared on 26th September 2020. Large patches still had rash. Using lotion to sooth. Itchy and warm. Thought it was related to vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Haematology test normal, Inflammatory marker increased, Myalgia
Clinical narrative: fevers (up to 102.4F) / defervesces in about 2-3 days; myalgias; arthralgias; chills; and night sweats every 3-4 weeks; Labs drawn / show elevated acute inflammatory markers; transiently low white blood cell counts; This case was reported by a physician and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in October 2019. please refer the case US2020AMR197667).   In January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, myalgia, arthralgia, chills, night sweat, inflammatory marker increased and white blood cell count low. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, myalgia, arthralgia, chills, night sweat, inflammatory marker increased and white blood cell count low were unknown.   It was unknown if the reporter considered the fever, myalgia, arthralgia, chills, night sweat, inflammatory marker increased and white blood cell count low to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The second vaccination in January 2020. Since then, she's had fevers (up to 102.4F), myalgias, arthralgias, chills, and night sweats every 3 to 4 weeks.  Labs drawn during the fevers show elevated acute inflammatory markers which are normal when she's asymptomatic as well as transiently low white blood cell counts. She defervesces in about 2 to 3 days and feels fine in between. So far, extensive heme/onc, infectious disease, and rheumatologic evaluations have been negative although some labs were pending. She had no personal or family history of periodic fever syndromes.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197667:same patient (2nd dose)
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats, Pyrexia, Rheumatological examination, White blood cell count decreased
Clinical narrative: fevers (up to 102.4F) / defervesces in about 2-3 days; myalgias; arthralgias; chills; and night sweats every 3-4 weeks; Labs drawn / show elevated acute inflammatory markers; transiently low white blood cell counts; This case was reported by a physician and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in October 2019. please refer the case US2020AMR197667).   In January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, myalgia, arthralgia, chills, night sweat, inflammatory marker increased and white blood cell count low. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, myalgia, arthralgia, chills, night sweat, inflammatory marker increased and white blood cell count low were unknown.   It was unknown if the reporter considered the fever, myalgia, arthralgia, chills, night sweat, inflammatory marker increased and white blood cell count low to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The second vaccination in January 2020. Since then, she's had fevers (up to 102.4F), myalgias, arthralgias, chills, and night sweats every 3 to 4 weeks.  Labs drawn during the fevers show elevated acute inflammatory markers which are normal when she's asymptomatic as well as transiently low white blood cell counts. She defervesces in about 2 to 3 days and feels fine in between. So far, extensive heme/onc, infectious disease, and rheumatologic evaluations have been negative although some labs were pending. She had no personal or family history of periodic fever syndromes.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197667:same patient (2nd dose)
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: everyone in the school fell I'll; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patients 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The school faculty and students get the shot. Nearly everyone in the school fell I'll.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 1st dose of Shingrix. In July 2020, 8 hrs after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experiencing flu-like symptoms beginning 8 hours after administration and lasting approximately 48 hours. Limited information was available. The reporter consented to follow up. For tolerances of 2nd dose refer case US2020197294, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020197294:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: shot site itches; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2020, the patient received the 2nd dose of Shingrix. On 4th October 2020, 4 days after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingles vaccine and had injection site itching. The reporter asked was this normal.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: not felt good; This case was reported by a consumer via other manufacturer and described the occurrence of malaise in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 16th September 2020, the patient received Influenza vaccine Quadrivalent unspecified season. On 17th September 2020, 1 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient received Flu vaccine and had malaise. The reporter mentioned that it might related to flu shot.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had injection site pain. The reporter asked was it common to had pain at the injection site for 4 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Blister, Breast pain, Flank pain
Clinical narrative: diagnosis of shingles; blisters in her mouth; cold sores in her mouth; cold sores/ were painful; skin became painful on the right arm where she received the injection; painful/ axilla,; painful/ flank; painful/ breast; painful/ back; developed blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix. On 15th September 2020, 2 days after receiving Shingrix, the patient experienced shingles, blistering of mouth, cold sore mouth and pain. In September 2020, the patient experienced skin pain, axillary pain, flank pain, breast pain, back pain and blister. On an unknown date, the outcome of the shingles and skin pain were unknown and the outcome of the blistering of mouth, cold sore mouth and blister were recovered/resolved and the outcome of the pain, axillary pain, flank pain, breast pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blistering of mouth, cold sore mouth, pain, skin pain, axillary pain, flank pain, breast pain, back pain and blister to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that got the 1st dose of Shingrix on her right arm. The patient stated that 2 days after vaccination, developed cold sores in mouth that were painful. The patient said that after the blisters in mouth resolved, her skin became painful on the right arm where she received the injection, as well as her axilla, flank, breast and part of her back. Following the pain on her skin listed, she also developed blisters, which had since resolved, but the pain remains till the time of reporting. The patient had 2 virtual visits and was given the diagnosis of shingles. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes, Oral mucosal blistering, Pain, Pain of skin
Clinical narrative: diagnosis of shingles; blisters in her mouth; cold sores in her mouth; cold sores/ were painful; skin became painful on the right arm where she received the injection; painful/ axilla,; painful/ flank; painful/ breast; painful/ back; developed blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix. On 15th September 2020, 2 days after receiving Shingrix, the patient experienced shingles, blistering of mouth, cold sore mouth and pain. In September 2020, the patient experienced skin pain, axillary pain, flank pain, breast pain, back pain and blister. On an unknown date, the outcome of the shingles and skin pain were unknown and the outcome of the blistering of mouth, cold sore mouth and blister were recovered/resolved and the outcome of the pain, axillary pain, flank pain, breast pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blistering of mouth, cold sore mouth, pain, skin pain, axillary pain, flank pain, breast pain, back pain and blister to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that got the 1st dose of Shingrix on her right arm. The patient stated that 2 days after vaccination, developed cold sores in mouth that were painful. The patient said that after the blisters in mouth resolved, her skin became painful on the right arm where she received the injection, as well as her axilla, flank, breast and part of her back. Following the pain on her skin listed, she also developed blisters, which had since resolved, but the pain remains till the time of reporting. The patient had 2 virtual visits and was given the diagnosis of shingles. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Acne, Blister, Blister rupture, Decreased appetite
Clinical narrative: went to the doctor / received the shingles diagnosis; blister broke; very painful and increases in pain every day; no appetite; is nauseated; malaise all over her body; blister came back with a circular red area around; flu like symptoms; Valacyclovir made her sick to her stomach; developed a pimple near the blister; blister on the arm / fluid filled blister on her left forearm /blister came back with a circular red area around; This case was reported by a consumer via call center representative and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number YZ325, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for shingles.   On 25th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Valacyclovir at an unknown dose and frequency. On 26th September 2020, 1 days after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced blister. On 1st October 2020, the patient experienced pimples. On an unknown date, the patient experienced shingles, blister rupture, pain, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach. The patient was treated with topical antibiotic (nos) (Antibiotic Cream (Nos)). Valacyclovir was discontinued. On an unknown date, the outcome of the blister was not recovered/not resolved and the outcome of the shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach were unknown.   It was unknown if the reporter considered the blister, shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema and influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the upset stomach to be related to Valacyclovir.  Additional details were provided as follows: The patient received Shingrix in her upper left arm and had blister on the arm, went to the doctor and received the shingles diagnosis. The patient developed a fluid filled blister on her left forearm. The blister broke and the blister came back with a circular red area around the blister.  The patient still had the blister and it was very painful and increases in pain every day.  The patient was seen by her MD who stated that it was possibly Shingles and prescribed Valacyclovir and an antibiotic cream.  The patient developed a pimple near the blister, but it has not developed into a blister.  The patient also had no appetite, nauseated, and was experiencing malaise all over her body and flu like symptoms.  The patient received Valacyclovir made her sick to her stomach, so she stopped taking it. The reporter did not consent to follow up. The reporter reported FAQ regarding side effects, referred caller to physician and to provide MI contact physician.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Influenza like illness, Malaise, Nausea
Clinical narrative: went to the doctor / received the shingles diagnosis; blister broke; very painful and increases in pain every day; no appetite; is nauseated; malaise all over her body; blister came back with a circular red area around; flu like symptoms; Valacyclovir made her sick to her stomach; developed a pimple near the blister; blister on the arm / fluid filled blister on her left forearm /blister came back with a circular red area around; This case was reported by a consumer via call center representative and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number YZ325, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for shingles.   On 25th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Valacyclovir at an unknown dose and frequency. On 26th September 2020, 1 days after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced blister. On 1st October 2020, the patient experienced pimples. On an unknown date, the patient experienced shingles, blister rupture, pain, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach. The patient was treated with topical antibiotic (nos) (Antibiotic Cream (Nos)). Valacyclovir was discontinued. On an unknown date, the outcome of the blister was not recovered/not resolved and the outcome of the shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach were unknown.   It was unknown if the reporter considered the blister, shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema and influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the upset stomach to be related to Valacyclovir.  Additional details were provided as follows: The patient received Shingrix in her upper left arm and had blister on the arm, went to the doctor and received the shingles diagnosis. The patient developed a fluid filled blister on her left forearm. The blister broke and the blister came back with a circular red area around the blister.  The patient still had the blister and it was very painful and increases in pain every day.  The patient was seen by her MD who stated that it was possibly Shingles and prescribed Valacyclovir and an antibiotic cream.  The patient developed a pimple near the blister, but it has not developed into a blister.  The patient also had no appetite, nauseated, and was experiencing malaise all over her body and flu like symptoms.  The patient received Valacyclovir made her sick to her stomach, so she stopped taking it. The reporter did not consent to follow up. The reporter reported FAQ regarding side effects, referred caller to physician and to provide MI contact physician.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: went to the doctor / received the shingles diagnosis; blister broke; very painful and increases in pain every day; no appetite; is nauseated; malaise all over her body; blister came back with a circular red area around; flu like symptoms; Valacyclovir made her sick to her stomach; developed a pimple near the blister; blister on the arm / fluid filled blister on her left forearm /blister came back with a circular red area around; This case was reported by a consumer via call center representative and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number YZ325, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for shingles.   On 25th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Valacyclovir at an unknown dose and frequency. On 26th September 2020, 1 days after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced blister. On 1st October 2020, the patient experienced pimples. On an unknown date, the patient experienced shingles, blister rupture, pain, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach. The patient was treated with topical antibiotic (nos) (Antibiotic Cream (Nos)). Valacyclovir was discontinued. On an unknown date, the outcome of the blister was not recovered/not resolved and the outcome of the shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach were unknown.   It was unknown if the reporter considered the blister, shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema and influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the upset stomach to be related to Valacyclovir.  Additional details were provided as follows: The patient received Shingrix in her upper left arm and had blister on the arm, went to the doctor and received the shingles diagnosis. The patient developed a fluid filled blister on her left forearm. The blister broke and the blister came back with a circular red area around the blister.  The patient still had the blister and it was very painful and increases in pain every day.  The patient was seen by her MD who stated that it was possibly Shingles and prescribed Valacyclovir and an antibiotic cream.  The patient developed a pimple near the blister, but it has not developed into a blister.  The patient also had no appetite, nauseated, and was experiencing malaise all over her body and flu like symptoms.  The patient received Valacyclovir made her sick to her stomach, so she stopped taking it. The reporter did not consent to follow up. The reporter reported FAQ regarding side effects, referred caller to physician and to provide MI contact physician.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Blister rupture, Erythema, Furuncle, Pain of skin
Clinical narrative: went to the doctor / received the shingles diagnosis; blister broke; very painful and increases in pain every day; no appetite; is nauseated; malaise all over her body; blister came back with a circular red area around; flu like symptoms; Valacyclovir made her sick to her stomach; developed a pimple near the blister; blister on the arm / fluid filled blister on her left forearm /blister came back with a circular red area around; This case was reported by a consumer via call center representative and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number YZ325, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for shingles.   On 25th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Valacyclovir at an unknown dose and frequency. On 26th September 2020, 1 days after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced blister. On 1st October 2020, the patient experienced pimples. On an unknown date, the patient experienced shingles, blister rupture, pain, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach. The patient was treated with topical antibiotic (nos) (Antibiotic Cream (Nos)). Valacyclovir was discontinued. On an unknown date, the outcome of the blister was not recovered/not resolved and the outcome of the shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach were unknown.   It was unknown if the reporter considered the blister, shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema and influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the upset stomach to be related to Valacyclovir.  Additional details were provided as follows: The patient received Shingrix in her upper left arm and had blister on the arm, went to the doctor and received the shingles diagnosis. The patient developed a fluid filled blister on her left forearm. The blister broke and the blister came back with a circular red area around the blister.  The patient still had the blister and it was very painful and increases in pain every day.  The patient was seen by her MD who stated that it was possibly Shingles and prescribed Valacyclovir and an antibiotic cream.  The patient developed a pimple near the blister, but it has not developed into a blister.  The patient also had no appetite, nauseated, and was experiencing malaise all over her body and flu like symptoms.  The patient received Valacyclovir made her sick to her stomach, so she stopped taking it. The reporter did not consent to follow up. The reporter reported FAQ regarding side effects, referred caller to physician and to provide MI contact physician.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Discharge, Erythema, Pain
Clinical narrative: went to the doctor / received the shingles diagnosis; blister broke; very painful and increases in pain every day; no appetite; is nauseated; malaise all over her body; blister came back with a circular red area around; flu like symptoms; Valacyclovir made her sick to her stomach; developed a pimple near the blister; blister on the arm / fluid filled blister on her left forearm /blister came back with a circular red area around; This case was reported by a consumer via call center representative and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number YZ325, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for shingles.   On 25th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Valacyclovir at an unknown dose and frequency. On 26th September 2020, 1 days after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced blister. On 1st October 2020, the patient experienced pimples. On an unknown date, the patient experienced shingles, blister rupture, pain, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach. The patient was treated with topical antibiotic (nos) (Antibiotic Cream (Nos)). Valacyclovir was discontinued. On an unknown date, the outcome of the blister was not recovered/not resolved and the outcome of the shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach were unknown.   It was unknown if the reporter considered the blister, shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema and influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the upset stomach to be related to Valacyclovir.  Additional details were provided as follows: The patient received Shingrix in her upper left arm and had blister on the arm, went to the doctor and received the shingles diagnosis. The patient developed a fluid filled blister on her left forearm. The blister broke and the blister came back with a circular red area around the blister.  The patient still had the blister and it was very painful and increases in pain every day.  The patient was seen by her MD who stated that it was possibly Shingles and prescribed Valacyclovir and an antibiotic cream.  The patient developed a pimple near the blister, but it has not developed into a blister.  The patient also had no appetite, nauseated, and was experiencing malaise all over her body and flu like symptoms.  The patient received Valacyclovir made her sick to her stomach, so she stopped taking it. The reporter did not consent to follow up. The reporter reported FAQ regarding side effects, referred caller to physician and to provide MI contact physician.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: red rash all over her body; welts on both her ankles/itchy welt; ankles which were itchy; diagnosed with chicken pox; red / at the injection site; rash / at the injection site / radiated like a line all the way down to her left wrist; itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chickenpox (chicken pox in first grade).   On 21st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd September 2020, 1 days after receiving Shingrix, the patient experienced chickenpox, injection site erythema, injection site rash and injection site itching. On 24th September 2020, the patient experienced welts and localized itching. On 25th September 2020, the patient experienced red rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the chickenpox, injection site erythema, injection site rash, injection site itching, welts, localized itching and red rash were unknown.   It was unknown if the reporter considered the chickenpox, injection site erythema, injection site rash, injection site itching, welts, localized itching and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in her left deltoid intramuscularly and had red, rash and itching at the injection site which radiated like a line all the way down to her left wrist. The patient had welts on both her ankles which were itchy and red rash all over her body and went to the Emergency room, where she was diagnosed with chicken pox.  The patient was started on a 5 day course of steroid which completed. The itching had stopped but she continues to had the rash all over her body. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Urticaria, Varicella
Clinical narrative: red rash all over her body; welts on both her ankles/itchy welt; ankles which were itchy; diagnosed with chicken pox; red / at the injection site; rash / at the injection site / radiated like a line all the way down to her left wrist; itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chickenpox (chicken pox in first grade).   On 21st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd September 2020, 1 days after receiving Shingrix, the patient experienced chickenpox, injection site erythema, injection site rash and injection site itching. On 24th September 2020, the patient experienced welts and localized itching. On 25th September 2020, the patient experienced red rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the chickenpox, injection site erythema, injection site rash, injection site itching, welts, localized itching and red rash were unknown.   It was unknown if the reporter considered the chickenpox, injection site erythema, injection site rash, injection site itching, welts, localized itching and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in her left deltoid intramuscularly and had red, rash and itching at the injection site which radiated like a line all the way down to her left wrist. The patient had welts on both her ankles which were itchy and red rash all over her body and went to the Emergency room, where she was diagnosed with chicken pox.  The patient was started on a 5 day course of steroid which completed. The itching had stopped but she continues to had the rash all over her body. The reporter consented to follow up.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Dizziness, Feeling of body temperature change, Headache, Pain in extremity
Clinical narrative: her left arm hurt; feeling of hot flash and cold flash; headache; lightheadedness; vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 22-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 25th February 2020 03:00, the patient received the 1st dose of Bexsero. On 25th February 2020 04:00, 1 hr after receiving Bexsero, the patient experienced pain in arm, feeling hot and cold, headache, light headedness, vomiting and diarrhea. On 26th February 2020 02:00, the outcome of the pain in arm, feeling hot and cold, headache, light headedness, vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the pain in arm, feeling hot and cold, headache, light headedness, vomiting and diarrhea to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero in her left arm around 3 pm and around 4 pm started to had diarrhea, vomiting, lightheadedness, headache, feeling of hot flash and cold flash and her left arm hurt and by around 2 am the next day all the adverse events had resolved. The reporter consented to follow up.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: her left arm hurt; feeling of hot flash and cold flash; headache; lightheadedness; vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 22-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 25th February 2020 03:00, the patient received the 1st dose of Bexsero. On 25th February 2020 04:00, 1 hr after receiving Bexsero, the patient experienced pain in arm, feeling hot and cold, headache, light headedness, vomiting and diarrhea. On 26th February 2020 02:00, the outcome of the pain in arm, feeling hot and cold, headache, light headedness, vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the pain in arm, feeling hot and cold, headache, light headedness, vomiting and diarrhea to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero in her left arm around 3 pm and around 4 pm started to had diarrhea, vomiting, lightheadedness, headache, feeling of hot flash and cold flash and her left arm hurt and by around 2 am the next day all the adverse events had resolved. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash was red and spread on / arms and legs being / similar to a bad sunburn; This case was reported by a pharmacist via call center representative and described the occurrence of red rash in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number G4HX3, expiry date 13th May 2022) for prophylaxis.   On 3rd October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 5th October 2020, 2 days after receiving Shingrix, the patient experienced red rash. On 6th October 2020, 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 details were provided as follows: The age at vaccination was not reported, but could be 68 or 69 years. The patient received the 1st dose of Shingrix in left deltoid. The patient developed a rash on 5th October 2020. The rash was red and spread on patient's arms and legs being very similar to a bad sunburn (patient's description), the rash was not itchy and patient had no trouble breathing. The reporter on the day of reporting contacted patient and patient confirmed the rash had cleared. The reporter called to request information for an adverse event and safety of a second dose for the patient  The reporter consented to follow up..
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, No adverse event, Product appearance confusion, Wrong product administered
Clinical narrative: pediatric patient received FluZone High Dose rather than standard FluZone QIV .5ml dose, no AE; pediatric patient received FluZone High Dose rather than standard FluZone QIV .5ml dose, no AE; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves pediatric patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date not reported) and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]  (0.5 ml, lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination in September. (PT: wrong product administered, overdose).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered and overdose (Same day latency).They reported error was made due to product (syringes and box) looking very similar.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Hemiparesis
Clinical narrative: Weakness in right side of body for 2 days, swollen eyes for one day.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Injection site erythema, Injection site macule, Injection site pain, Joint range of motion decreased
Clinical narrative: Mild transient dizziness after injection. Lt shoulder pain, erythematous macular lesion over shoulder, approximately 2.5 ". Pain with lifting shoulder > 45 degrees noted the next evening after the injection.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Eye patch application, Illness, Magnetic resonance imaging brain, Strabismus, Vomiting
Clinical narrative: Episodes of vomiting begain on 7/2/2020 - resolved after several days. Esotropia of left eye then moving to right eye over time starting 7/8/2020 and has continued requiring patching of both eyes.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Influenza like illness, Urinary incontinence
Clinical narrative: Dizziness, Weakness, Urinary incontinence, headache, flu like symptoms
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: next day- soreness with red skin distal to injection site but still above elbow. second day- 99.8 temp (self reports 97 her normal). swelling between injection site and elbow - patient took APAP otc for symptoms third day- swelling progressed, itch developed - patient continued APAP and began otc hydrocortisone cream for symptoms 6th day- yellowish/bruising skin 1 week- still has intermittent fever
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: next day- soreness with red skin distal to injection site but still above elbow. second day- 99.8 temp (self reports 97 her normal). swelling between injection site and elbow - patient took APAP otc for symptoms third day- swelling progressed, itch developed - patient continued APAP and began otc hydrocortisone cream for symptoms 6th day- yellowish/bruising skin 1 week- still has intermittent fever
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Hypoaesthesia
Clinical narrative: Patient reported having difficulty breathing and face numbness after giving a pneumovax-23 vaccine.  An adult epinephrine 0.3 mg was given in left thigh and 911 was called. Patient felt better after the injection.  Patient delivered to hospital for further monitoring
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Within a few hours after the injection  I felt pain and tenderness at the injectin site, whole body ache and about 12 hours later, I was suffering from a low grade fever.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Malaise, Seizure
Clinical narrative: Patient said he wasn't feeling well immediately after the injection. Patient began sweating and passed out. Patient then convulsed. 911 was immediately called. While awaiting EMS, patient woke up, and was alert and oriented. EMS responded and did not transport to ER. Family came and picked up patient. EMS advised to call doctor.
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Feeling abnormal, Injection site bruising, Injection site erythema, Injection site inflammation, Injection site oedema
Clinical narrative: Patient when into store 10/08 with a lot of pain, redness, and fluid build up around her elbow area on her right arm - the arm she was given Pneumovax in. She reported fever-like symptoms and feeling very badly the night of the shot, followed by "severe" pain in the arm. The injection site looked completely normal, no redness or swelling at all. The arm was certainly inflamed and red around the elbow area and it did not seem like a normal reaction to Rph or floater that was here. She was still reporting pain on the "distressing level" today. I referred her up to the walk in clinic, and she said she'd go straight there.    The physician at urgent care stated The reaction should resolve itself.  I spoke with patient today and she stated the swelling had gone down and the area was starting to bruise.  She already had an appointment with her primary physician scheduled for today and she will discuss the reaction with them later today.
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injection site pain
Clinical narrative: Patient when into store 10/08 with a lot of pain, redness, and fluid build up around her elbow area on her right arm - the arm she was given Pneumovax in. She reported fever-like symptoms and feeling very badly the night of the shot, followed by "severe" pain in the arm. The injection site looked completely normal, no redness or swelling at all. The arm was certainly inflamed and red around the elbow area and it did not seem like a normal reaction to Rph or floater that was here. She was still reporting pain on the "distressing level" today. I referred her up to the walk in clinic, and she said she'd go straight there.    The physician at urgent care stated The reaction should resolve itself.  I spoke with patient today and she stated the swelling had gone down and the area was starting to bruise.  She already had an appointment with her primary physician scheduled for today and she will discuss the reaction with them later today.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pt is reporting an arm that is still sore over a month later , with finger tingles
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth, Peripheral swelling
Clinical narrative: 10:35 received Flu vaccine L deltoid.  She states 20 minutes later her arm was becoming swollen with reddened skin and it felt hot to her.  These symptoms continued to develop over time with the emergence of a slight rash on both arms, and a hive on the Right arm and on her back.  Then she became itchy on her arms and across her brow, and in her throat.  She then went to the Emergency Room at 13:54.  She was examined and treated with Benedryl and Pepcid.  She returned to Employee Health after her ED visit and the rash and itching had subsided.  At 9:50 on 10/7/20 patient was seen again in Employee Health.  Her Left deltoid area was red, hot, and indurated in an area of 70 mm.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Skin warm, Throat irritation, Urticaria
Clinical narrative: 10:35 received Flu vaccine L deltoid.  She states 20 minutes later her arm was becoming swollen with reddened skin and it felt hot to her.  These symptoms continued to develop over time with the emergence of a slight rash on both arms, and a hive on the Right arm and on her back.  Then she became itchy on her arms and across her brow, and in her throat.  She then went to the Emergency Room at 13:54.  She was examined and treated with Benedryl and Pepcid.  She returned to Employee Health after her ED visit and the rash and itching had subsided.  At 9:50 on 10/7/20 patient was seen again in Employee Health.  Her Left deltoid area was red, hot, and indurated in an area of 70 mm.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site pain, Sleep disorder
Clinical narrative: Employee received Fluzone Quadrivalent flu vaccine on 09/24/2020 (2 weeks ago). She has been having pain and inflammation in her left upper arm since that time. She has pain with left arm internal and external rotation only. No pain with flexion, extension, abduction or adduction and no pain at rest. Her pain wakes her up at night when she rolls onto her left arm. Her pain is localized to anterior bicep region. She has full ROM of her left shoulder. She denies any numbness, tingling or radiating pain. She was started on a Medrol Dose pack and will follow-up at clinic in 1 week.