chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dizziness, Feeling cold, Headache, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included loratadine (Claritin), ferrous sulfate (Ferrous Sulphate), folic acid, indapamide, psyllium husk (Metamucil), metformin hydrochloride (Metformin), ramipril, ranitidine hydrochloride, spironolactone, ascorbic acid (Vitamin C) and metoprolol succinate (Toprol Xl). On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th June 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever. On an unknown date, the outcome of the shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever were recovered/resolved. It was unknown if the reporter considered the shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitant products included multivitamins. The patient received SHINGRIX in the left arm. The patient experienced pain in the left arm. The patient reported this to her pharmacy and it was reported to the VAERS.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included loratadine (Claritin), ferrous sulfate (Ferrous Sulphate), folic acid, indapamide, psyllium husk (Metamucil), metformin hydrochloride (Metformin), ramipril, ranitidine hydrochloride, spironolactone, ascorbic acid (Vitamin C) and metoprolol succinate (Toprol Xl). On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th June 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever. On an unknown date, the outcome of the shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever were recovered/resolved. It was unknown if the reporter considered the shivering, dizziness, pain in arm, malaise, headache, feeling cold and fever to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitant products included multivitamins. The patient received SHINGRIX in the left arm. The patient experienced pain in the left arm. The patient reported this to her pharmacy and it was reported to the VAERS.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Feeling abnormal, Full blood count, Herpes zoster, Malaise
Clinical narrative: Acute febrile illness that started on date of vaccine (Friday 6/29/18). About 30-45 minutes after the injection she started noting left arm pain and upper shoulder pain. It primarily was along the left side but it did cross over the spine to the other side minimally. She felt it to be more stiff and pain with movement of her head. She had a headache. She then noted she had a fever of the weekend. She took a couple ibuprofen about two hours ago and she has a documented fever of 101 today (Monday 7/2/18) in the clinic. She also noted a small rash on the palmer side of her hand by her thumb. She is having some pain in the arm and the rash is described as burning and painful. It is not itchy. She denies having any other symptoms except she feels weak and wobbly when she walks. She is very fatigued. since has noted body aches and soreness into her neck. She also notes a fever and chills. Over the next 4 weeks she developed a progressive illness that included maculopapular rash on the legs, low grade fever, fatigue, polyarthralgia, joint swelling/stiffness, and headache. Her sed rate and CRP were high. GCA was suspected and she was started on prednisone on July 26. Temporal artery biopsy on July 27 did not show evidence of GCA or vasculitis. Dermatologist saw her on 7/28 and concluded that her skin rash was most likely a vaccine reaction that could be related to a vasculitis syndrome. Her symptoms improved on prednisone.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Neuralgia, Pyrexia
Clinical narrative: Acute febrile illness that started on date of vaccine (Friday 6/29/18). About 30-45 minutes after the injection she started noting left arm pain and upper shoulder pain. It primarily was along the left side but it did cross over the spine to the other side minimally. She felt it to be more stiff and pain with movement of her head. She had a headache. She then noted she had a fever of the weekend. She took a couple ibuprofen about two hours ago and she has a documented fever of 101 today (Monday 7/2/18) in the clinic. She also noted a small rash on the palmer side of her hand by her thumb. She is having some pain in the arm and the rash is described as burning and painful. It is not itchy. She denies having any other symptoms except she feels weak and wobbly when she walks. She is very fatigued. since has noted body aches and soreness into her neck. She also notes a fever and chills. Over the next 4 weeks she developed a progressive illness that included maculopapular rash on the legs, low grade fever, fatigue, polyarthralgia, joint swelling/stiffness, and headache. Her sed rate and CRP were high. GCA was suspected and she was started on prednisone on July 26. Temporal artery biopsy on July 27 did not show evidence of GCA or vasculitis. Dermatologist saw her on 7/28 and concluded that her skin rash was most likely a vaccine reaction that could be related to a vasculitis syndrome. Her symptoms improved on prednisone.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Biopsy artery normal, Burning sensation, C-reactive protein increased
Clinical narrative: Acute febrile illness that started on date of vaccine (Friday 6/29/18). About 30-45 minutes after the injection she started noting left arm pain and upper shoulder pain. It primarily was along the left side but it did cross over the spine to the other side minimally. She felt it to be more stiff and pain with movement of her head. She had a headache. She then noted she had a fever of the weekend. She took a couple ibuprofen about two hours ago and she has a documented fever of 101 today (Monday 7/2/18) in the clinic. She also noted a small rash on the palmer side of her hand by her thumb. She is having some pain in the arm and the rash is described as burning and painful. It is not itchy. She denies having any other symptoms except she feels weak and wobbly when she walks. She is very fatigued. since has noted body aches and soreness into her neck. She also notes a fever and chills. Over the next 4 weeks she developed a progressive illness that included maculopapular rash on the legs, low grade fever, fatigue, polyarthralgia, joint swelling/stiffness, and headache. Her sed rate and CRP were high. GCA was suspected and she was started on prednisone on July 26. Temporal artery biopsy on July 27 did not show evidence of GCA or vasculitis. Dermatologist saw her on 7/28 and concluded that her skin rash was most likely a vaccine reaction that could be related to a vasculitis syndrome. Her symptoms improved on prednisone.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Gait disturbance, Headache, Injection site pain
Clinical narrative: Acute febrile illness that started on date of vaccine (Friday 6/29/18). About 30-45 minutes after the injection she started noting left arm pain and upper shoulder pain. It primarily was along the left side but it did cross over the spine to the other side minimally. She felt it to be more stiff and pain with movement of her head. She had a headache. She then noted she had a fever of the weekend. She took a couple ibuprofen about two hours ago and she has a documented fever of 101 today (Monday 7/2/18) in the clinic. She also noted a small rash on the palmer side of her hand by her thumb. She is having some pain in the arm and the rash is described as burning and painful. It is not itchy. She denies having any other symptoms except she feels weak and wobbly when she walks. She is very fatigued. since has noted body aches and soreness into her neck. She also notes a fever and chills. Over the next 4 weeks she developed a progressive illness that included maculopapular rash on the legs, low grade fever, fatigue, polyarthralgia, joint swelling/stiffness, and headache. Her sed rate and CRP were high. GCA was suspected and she was started on prednisone on July 26. Temporal artery biopsy on July 27 did not show evidence of GCA or vasculitis. Dermatologist saw her on 7/28 and concluded that her skin rash was most likely a vaccine reaction that could be related to a vasculitis syndrome. Her symptoms improved on prednisone.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint stiffness, Joint swelling, Laboratory test normal, Musculoskeletal stiffness, Neck pain
Clinical narrative: Acute febrile illness that started on date of vaccine (Friday 6/29/18). About 30-45 minutes after the injection she started noting left arm pain and upper shoulder pain. It primarily was along the left side but it did cross over the spine to the other side minimally. She felt it to be more stiff and pain with movement of her head. She had a headache. She then noted she had a fever of the weekend. She took a couple ibuprofen about two hours ago and she has a documented fever of 101 today (Monday 7/2/18) in the clinic. She also noted a small rash on the palmer side of her hand by her thumb. She is having some pain in the arm and the rash is described as burning and painful. It is not itchy. She denies having any other symptoms except she feels weak and wobbly when she walks. She is very fatigued. since has noted body aches and soreness into her neck. She also notes a fever and chills. Over the next 4 weeks she developed a progressive illness that included maculopapular rash on the legs, low grade fever, fatigue, polyarthralgia, joint swelling/stiffness, and headache. Her sed rate and CRP were high. GCA was suspected and she was started on prednisone on July 26. Temporal artery biopsy on July 27 did not show evidence of GCA or vasculitis. Dermatologist saw her on 7/28 and concluded that her skin rash was most likely a vaccine reaction that could be related to a vasculitis syndrome. Her symptoms improved on prednisone.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Acute febrile illness that started on date of vaccine (Friday 6/29/18). About 30-45 minutes after the injection she started noting left arm pain and upper shoulder pain. It primarily was along the left side but it did cross over the spine to the other side minimally. She felt it to be more stiff and pain with movement of her head. She had a headache. She then noted she had a fever of the weekend. She took a couple ibuprofen about two hours ago and she has a documented fever of 101 today (Monday 7/2/18) in the clinic. She also noted a small rash on the palmer side of her hand by her thumb. She is having some pain in the arm and the rash is described as burning and painful. It is not itchy. She denies having any other symptoms except she feels weak and wobbly when she walks. She is very fatigued. since has noted body aches and soreness into her neck. She also notes a fever and chills. Over the next 4 weeks she developed a progressive illness that included maculopapular rash on the legs, low grade fever, fatigue, polyarthralgia, joint swelling/stiffness, and headache. Her sed rate and CRP were high. GCA was suspected and she was started on prednisone on July 26. Temporal artery biopsy on July 27 did not show evidence of GCA or vasculitis. Dermatologist saw her on 7/28 and concluded that her skin rash was most likely a vaccine reaction that could be related to a vasculitis syndrome. Her symptoms improved on prednisone.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Red blood cell sedimentation rate increased, Streptococcus test negative
Clinical narrative: Acute febrile illness that started on date of vaccine (Friday 6/29/18). About 30-45 minutes after the injection she started noting left arm pain and upper shoulder pain. It primarily was along the left side but it did cross over the spine to the other side minimally. She felt it to be more stiff and pain with movement of her head. She had a headache. She then noted she had a fever of the weekend. She took a couple ibuprofen about two hours ago and she has a documented fever of 101 today (Monday 7/2/18) in the clinic. She also noted a small rash on the palmer side of her hand by her thumb. She is having some pain in the arm and the rash is described as burning and painful. It is not itchy. She denies having any other symptoms except she feels weak and wobbly when she walks. She is very fatigued. since has noted body aches and soreness into her neck. She also notes a fever and chills. Over the next 4 weeks she developed a progressive illness that included maculopapular rash on the legs, low grade fever, fatigue, polyarthralgia, joint swelling/stiffness, and headache. Her sed rate and CRP were high. GCA was suspected and she was started on prednisone on July 26. Temporal artery biopsy on July 27 did not show evidence of GCA or vasculitis. Dermatologist saw her on 7/28 and concluded that her skin rash was most likely a vaccine reaction that could be related to a vasculitis syndrome. Her symptoms improved on prednisone.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Feeling abnormal, Headache, Induration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 51-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 16th July 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous) .5 ml. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, fever, bone pain, headache, general body pain and intramuscular formulation administered by other route. On 18th July 2018, the outcome of the fever, bone pain, headache and general body pain were recovered/resolved. On 22nd July 2018, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site erythema were recovered/resolved. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, fever, bone pain, headache and general body pain to be related to SHINGRIX. Additional information was reported as follows: On the same night after vaccination with the 2nd dose of SHINGRIX, the patient began to experience fever, aching where she stated that every bone in her body hurt. The patient also experienced headache and severe local symptoms at the vaccination arm that included swelling, redness and it was very painful. The diameter specified for the injection site redness and swelling was approximately 6 to 8 inches. The patient was inadvertently administered the 2nd dose of SHINGRIX, by subcutaneous route instead of intramuscular, which led to intramuscular formulation administered by other route. The events fever, body aches and headache resolved within 2 days, however the local injection site events remained for 5 to 6 days.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 51-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 16th July 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous) .5 ml. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, fever, bone pain, headache, general body pain and intramuscular formulation administered by other route. On 18th July 2018, the outcome of the fever, bone pain, headache and general body pain were recovered/resolved. On 22nd July 2018, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site erythema were recovered/resolved. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, fever, bone pain, headache and general body pain to be related to SHINGRIX. Additional information was reported as follows: On the same night after vaccination with the 2nd dose of SHINGRIX, the patient began to experience fever, aching where she stated that every bone in her body hurt. The patient also experienced headache and severe local symptoms at the vaccination arm that included swelling, redness and it was very painful. The diameter specified for the injection site redness and swelling was approximately 6 to 8 inches. The patient was inadvertently administered the 2nd dose of SHINGRIX, by subcutaneous route instead of intramuscular, which led to intramuscular formulation administered by other route. The events fever, body aches and headache resolved within 2 days, however the local injection site events remained for 5 to 6 days.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bone pain, Erythema, Extensive swelling of vaccinated limb, Headache, Incorrect route of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 51-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 16th July 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous) .5 ml. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, fever, bone pain, headache, general body pain and intramuscular formulation administered by other route. On 18th July 2018, the outcome of the fever, bone pain, headache and general body pain were recovered/resolved. On 22nd July 2018, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site erythema were recovered/resolved. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, fever, bone pain, headache and general body pain to be related to SHINGRIX. Additional information was reported as follows: On the same night after vaccination with the 2nd dose of SHINGRIX, the patient began to experience fever, aching where she stated that every bone in her body hurt. The patient also experienced headache and severe local symptoms at the vaccination arm that included swelling, redness and it was very painful. The diameter specified for the injection site redness and swelling was approximately 6 to 8 inches. The patient was inadvertently administered the 2nd dose of SHINGRIX, by subcutaneous route instead of intramuscular, which led to intramuscular formulation administered by other route. The events fever, body aches and headache resolved within 2 days, however the local injection site events remained for 5 to 6 days.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 51-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 16th July 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous) .5 ml. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, fever, bone pain, headache, general body pain and intramuscular formulation administered by other route. On 18th July 2018, the outcome of the fever, bone pain, headache and general body pain were recovered/resolved. On 22nd July 2018, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site erythema were recovered/resolved. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, fever, bone pain, headache and general body pain to be related to SHINGRIX. Additional information was reported as follows: On the same night after vaccination with the 2nd dose of SHINGRIX, the patient began to experience fever, aching where she stated that every bone in her body hurt. The patient also experienced headache and severe local symptoms at the vaccination arm that included swelling, redness and it was very painful. The diameter specified for the injection site redness and swelling was approximately 6 to 8 inches. The patient was inadvertently administered the 2nd dose of SHINGRIX, by subcutaneous route instead of intramuscular, which led to intramuscular formulation administered by other route. The events fever, body aches and headache resolved within 2 days, however the local injection site events remained for 5 to 6 days.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 51-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 16th July 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous) .5 ml. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, fever, bone pain, headache, general body pain and intramuscular formulation administered by other route. On 18th July 2018, the outcome of the fever, bone pain, headache and general body pain were recovered/resolved. On 22nd July 2018, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site erythema were recovered/resolved. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, fever, bone pain, headache and general body pain to be related to SHINGRIX. Additional information was reported as follows: On the same night after vaccination with the 2nd dose of SHINGRIX, the patient began to experience fever, aching where she stated that every bone in her body hurt. The patient also experienced headache and severe local symptoms at the vaccination arm that included swelling, redness and it was very painful. The diameter specified for the injection site redness and swelling was approximately 6 to 8 inches. The patient was inadvertently administered the 2nd dose of SHINGRIX, by subcutaneous route instead of intramuscular, which led to intramuscular formulation administered by other route. The events fever, body aches and headache resolved within 2 days, however the local injection site events remained for 5 to 6 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Erythematous papular, wheal-like rash 5 - 10 cm in diameter all over body. Started 12 hours after receiving PROQUAD and QUADRACEL. Treated with BENADRYL and steroids.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Rash erythematous, Rash papular, Urticaria
Clinical narrative: Erythematous papular, wheal-like rash 5 - 10 cm in diameter all over body. Started 12 hours after receiving PROQUAD and QUADRACEL. Treated with BENADRYL and steroids.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles five days later. Acyclovir 800 and Lidocaine to treat this from the provider. Healing well only a few lesions at the this time but healing.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Asthenia, Chills, Erythema, Fatigue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash, thirst, weakness, tiredness, injection site pain, neck pain and fever. On an unknown date, the outcome of the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever were recovered/resolved. It was unknown if the reporter considered the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced rash, pain at injection site that went up to the neck area, low grade fever, weakness, tired throughout whole body and she was thirst.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Headache, Initial insomnia, Injected limb mobility decreased, Injection site pain, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash, thirst, weakness, tiredness, injection site pain, neck pain and fever. On an unknown date, the outcome of the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever were recovered/resolved. It was unknown if the reporter considered the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced rash, pain at injection site that went up to the neck area, low grade fever, weakness, tired throughout whole body and she was thirst.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Limb discomfort, Neck pain, Pain in extremity, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash, thirst, weakness, tiredness, injection site pain, neck pain and fever. On an unknown date, the outcome of the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever were recovered/resolved. It was unknown if the reporter considered the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced rash, pain at injection site that went up to the neck area, low grade fever, weakness, tired throughout whole body and she was thirst.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash, thirst, weakness, tiredness, injection site pain, neck pain and fever. On an unknown date, the outcome of the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever were recovered/resolved. It was unknown if the reporter considered the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced rash, pain at injection site that went up to the neck area, low grade fever, weakness, tired throughout whole body and she was thirst.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash, Thirst
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash, thirst, weakness, tiredness, injection site pain, neck pain and fever. On an unknown date, the outcome of the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever were recovered/resolved. It was unknown if the reporter considered the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced rash, pain at injection site that went up to the neck area, low grade fever, weakness, tired throughout whole body and she was thirst.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Injection site pain, Neck pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash, thirst, weakness, tiredness, injection site pain, neck pain and fever. On an unknown date, the outcome of the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever were recovered/resolved. It was unknown if the reporter considered the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced rash, pain at injection site that went up to the neck area, low grade fever, weakness, tired throughout whole body and she was thirst.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Chills, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash, thirst, weakness, tiredness, injection site pain, neck pain and fever. On an unknown date, the outcome of the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever were recovered/resolved. It was unknown if the reporter considered the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced rash, pain at injection site that went up to the neck area, low grade fever, weakness, tired throughout whole body and she was thirst.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Insomnia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash, thirst, weakness, tiredness, injection site pain, neck pain and fever. On an unknown date, the outcome of the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever were recovered/resolved. It was unknown if the reporter considered the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced rash, pain at injection site that went up to the neck area, low grade fever, weakness, tired throughout whole body and she was thirst.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash, thirst, weakness, tiredness, injection site pain, neck pain and fever. On an unknown date, the outcome of the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever were recovered/resolved. It was unknown if the reporter considered the rash, thirst, weakness, tiredness, injection site pain, neck pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced rash, pain at injection site that went up to the neck area, low grade fever, weakness, tired throughout whole body and she was thirst.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac stress test normal, Chest pain, Electrocardiogram normal, Headache, Injection site pain
Clinical narrative: Headache, pain in left arm, and chest.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test
Clinical narrative: Headache, pain in left arm, and chest.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Headache, Pain in extremity
Clinical narrative: Headache, pain in left arm, and chest.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date without any side effects). On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On 1st August 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, sweating, burning sensation, diarrhea, chills and headache. On 2nd August 2018, the patient experienced swelling arm and extremities hot feeling of. On an unknown date, the outcome of the fatigue, sweating, swelling arm, extremities hot feeling of, chills and headache were not recovered/not resolved and the outcome of the burning sensation and diarrhea were unknown. It was unknown if the reporter considered the fatigue, sweating, burning sensation, swelling arm, extremities hot feeling of, diarrhea, chills and headache to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the right deltoid. Immediately after receiving the SHINGRIX, the patient experienced burning sensation of the arm and one hour after receiving the SHINGRIX, the patient experienced diarrhoea. One day after receiving the SHINGRIX, the patient experienced swelling arm and arm hot.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Chills, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date without any side effects). On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On 1st August 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, sweating, burning sensation, diarrhea, chills and headache. On 2nd August 2018, the patient experienced swelling arm and extremities hot feeling of. On an unknown date, the outcome of the fatigue, sweating, swelling arm, extremities hot feeling of, chills and headache were not recovered/not resolved and the outcome of the burning sensation and diarrhea were unknown. It was unknown if the reporter considered the fatigue, sweating, burning sensation, swelling arm, extremities hot feeling of, diarrhea, chills and headache to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the right deltoid. Immediately after receiving the SHINGRIX, the patient experienced burning sensation of the arm and one hour after receiving the SHINGRIX, the patient experienced diarrhoea. One day after receiving the SHINGRIX, the patient experienced swelling arm and arm hot.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hyperhidrosis, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date without any side effects). On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On 1st August 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, sweating, burning sensation, diarrhea, chills and headache. On 2nd August 2018, the patient experienced swelling arm and extremities hot feeling of. On an unknown date, the outcome of the fatigue, sweating, swelling arm, extremities hot feeling of, chills and headache were not recovered/not resolved and the outcome of the burning sensation and diarrhea were unknown. It was unknown if the reporter considered the fatigue, sweating, burning sensation, swelling arm, extremities hot feeling of, diarrhea, chills and headache to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the right deltoid. Immediately after receiving the SHINGRIX, the patient experienced burning sensation of the arm and one hour after receiving the SHINGRIX, the patient experienced diarrhoea. One day after receiving the SHINGRIX, the patient experienced swelling arm and arm hot.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 73-year-old female patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. On 4th August 2018 04:25, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema, local swelling, pain localized, skin warm and pain in arm. On an unknown date, the outcome of the localized erythema, local swelling, pain localized and skin warm were unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the localized erythema, local swelling, pain localized, skin warm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right arm. The patient initially developed a dime size area that was red, swollen, hot and painful. At the time of reporting, the area was the size of a silver dollar. The patient also had pain that went down her arm but now it was just in the silver dollar area. The reporter was transferred to the medical information department.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 73-year-old female patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. On 4th August 2018 04:25, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema, local swelling, pain localized, skin warm and pain in arm. On an unknown date, the outcome of the localized erythema, local swelling, pain localized and skin warm were unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the localized erythema, local swelling, pain localized, skin warm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right arm. The patient initially developed a dime size area that was red, swollen, hot and painful. At the time of reporting, the area was the size of a silver dollar. The patient also had pain that went down her arm but now it was just in the silver dollar area. The reporter was transferred to the medical information department.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning a patient pf unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 intramuscularly, lot # M047519 and expiration date 04-AUG-2018 (dose and frequency were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning a patient pf unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 intramuscularly, lot # M047519 and expiration date 04-AUG-2018 (dose and frequency were not reported) for prophylaxis. No adverse effects were reported.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Skin warm, Swelling
Clinical narrative: Spreading Red rash, swelling, increased local temperature, itching.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Viral titre decreased
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 20 year old non pregnant female patient. The patient did not have pertinent medical history, drug reactions, allergies and concomitant medications. On 01-MAY-2001, the patient was vaccinated with her first dose of VARIVAX followed by her second dose on 02-DEC-2009 which was reconstituted with sterile diluent (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) indicated for varicella prevention. The patient's titers of VARIVAX was performed on 31-JUL-2018 as a school requirement, which showed that she was "low positive" for varicella titers, described as "108.4(units not reported), with a reference range of greater than 164 (units not reported) for normal positive results" (viral titre decreased). The patient sought medical attention by reviewing the results with her physician and no treatment was given for the adverse events. The outcome of viral titre decreased was reported as not resolved. The reporter did not assess the causal relationship between viral titre decreased with VARIVAX.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-JAN-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On an unknown date in 2015, the patient was treated by a physician for her painful symptoms and was diagnosed with herpes zoster or shingles. The outcome of the events is unknown. The patient suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or approximately 04-SEP-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 08-SEP-2016, the patient was treated by a physician for shingles, and was prescribed acyclovir for management of his symptoms. The outcome of the events is unknown. The patient suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.