chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced allergic reaction, tremor, malaise and chills. On 23rd June 2018, the patient experienced fever, myalgia, headache, shoulder pain and nausea. On an unknown date, the outcome of the allergic reaction, tremor, malaise and chills were recovering/resolving and the outcome of the fever, myalgia, headache, shoulder pain and nausea were recovered/resolved. It was unknown if the reporter considered the allergic reaction, tremor, malaise and chills to be related to SHINGRIX. The reporter considered the fever, myalgia, headache, shoulder pain and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist and master of public health (MPH). The MPH was the patient's wife. The patient received SHINGRIX in left arm. On 23rd June 2018, at 22:40, several hours after vaccination, the patient experienced myalgia, febrile symptoms (fever), headache, left shoulder pain and nausea. The patient experienced an overall illness and category 3 allergic reaction with chills, malaise, and shakiness. The patient experienced those symptoms over time and by 26th June 2018 was feeling better. These adverse events were previously reported to the physician. The healthcare professional did not have any further information.  This case has been linked to the US2018115063, reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced allergic reaction, tremor, malaise and chills. On 23rd June 2018, the patient experienced fever, myalgia, headache, shoulder pain and nausea. On an unknown date, the outcome of the allergic reaction, tremor, malaise and chills were recovering/resolving and the outcome of the fever, myalgia, headache, shoulder pain and nausea were recovered/resolved. It was unknown if the reporter considered the allergic reaction, tremor, malaise and chills to be related to SHINGRIX. The reporter considered the fever, myalgia, headache, shoulder pain and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist and master of public health (MPH). The MPH was the patient's wife. The patient received SHINGRIX in left arm. On 23rd June 2018, at 22:40, several hours after vaccination, the patient experienced myalgia, febrile symptoms (fever), headache, left shoulder pain and nausea. The patient experienced an overall illness and category 3 allergic reaction with chills, malaise, and shakiness. The patient experienced those symptoms over time and by 26th June 2018 was feeling better. These adverse events were previously reported to the physician. The healthcare professional did not have any further information.  This case has been linked to the US2018115063, reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Hypersensitivity, Injection site pain, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced allergic reaction, tremor, malaise and chills. On 23rd June 2018, the patient experienced fever, myalgia, headache, shoulder pain and nausea. On an unknown date, the outcome of the allergic reaction, tremor, malaise and chills were recovering/resolving and the outcome of the fever, myalgia, headache, shoulder pain and nausea were recovered/resolved. It was unknown if the reporter considered the allergic reaction, tremor, malaise and chills to be related to SHINGRIX. The reporter considered the fever, myalgia, headache, shoulder pain and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist and master of public health (MPH). The MPH was the patient's wife. The patient received SHINGRIX in left arm. On 23rd June 2018, at 22:40, several hours after vaccination, the patient experienced myalgia, febrile symptoms (fever), headache, left shoulder pain and nausea. The patient experienced an overall illness and category 3 allergic reaction with chills, malaise, and shakiness. The patient experienced those symptoms over time and by 26th June 2018 was feeling better. These adverse events were previously reported to the physician. The healthcare professional did not have any further information.  This case has been linked to the US2018115063, reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced allergic reaction, tremor, malaise and chills. On 23rd June 2018, the patient experienced fever, myalgia, headache, shoulder pain and nausea. On an unknown date, the outcome of the allergic reaction, tremor, malaise and chills were recovering/resolving and the outcome of the fever, myalgia, headache, shoulder pain and nausea were recovered/resolved. It was unknown if the reporter considered the allergic reaction, tremor, malaise and chills to be related to SHINGRIX. The reporter considered the fever, myalgia, headache, shoulder pain and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist and master of public health (MPH). The MPH was the patient's wife. The patient received SHINGRIX in left arm. On 23rd June 2018, at 22:40, several hours after vaccination, the patient experienced myalgia, febrile symptoms (fever), headache, left shoulder pain and nausea. The patient experienced an overall illness and category 3 allergic reaction with chills, malaise, and shakiness. The patient experienced those symptoms over time and by 26th June 2018 was feeling better. These adverse events were previously reported to the physician. The healthcare professional did not have any further information.  This case has been linked to the US2018115063, reported by the same reporter.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cough, Influenza like illness, Oropharyngeal pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old male patient who received SHINGRIX (batch number ZN22Z, expiry date unknown) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, sore throat, cold, shivering, cough, facial swelling, fatigue and erythematous rash. In June 2018, the outcome of the shivering, facial swelling and fatigue were recovered/resolved. On an unknown date, the outcome of the shingles, cough and erythematous rash were recovering/resolving and the outcome of the sore throat and cold were recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. The reporter considered the sore throat, cold, shivering, cough, facial swelling, fatigue and erythematous rash to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX vaccine on the left arm. Later on the same night of vaccination with SHINGRIX, the patient experienced sore throat that lasted until Sunday. The patient stated that he experienced a rash next to the injection site that looked like shingles. The patient also stated that the rash was red and it was 1 and 3/4 inch and had decreased to 3/4 inch at the time of reporting. The patient also experienced extreme fatigue and severe coughing spells following the vaccination. The reporter provided the contact details of physician and stated that he did not have the address of the healthcare professional. The patient did not have the expiry date for SHINGRIX, but was able to provide the lot number. The reported batch number ZN2Z7 of SHINGRIX does not exists in the sales database, so the batch number ZN2Z7 was replaced with ZN22Z.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Cough, Fatigue, Herpes zoster, Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old male patient who received SHINGRIX (batch number ZN22Z, expiry date unknown) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, sore throat, cold, shivering, cough, facial swelling, fatigue and erythematous rash. In June 2018, the outcome of the shivering, facial swelling and fatigue were recovered/resolved. On an unknown date, the outcome of the shingles, cough and erythematous rash were recovering/resolving and the outcome of the sore throat and cold were recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. The reporter considered the sore throat, cold, shivering, cough, facial swelling, fatigue and erythematous rash to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX vaccine on the left arm. Later on the same night of vaccination with SHINGRIX, the patient experienced sore throat that lasted until Sunday. The patient stated that he experienced a rash next to the injection site that looked like shingles. The patient also stated that the rash was red and it was 1 and 3/4 inch and had decreased to 3/4 inch at the time of reporting. The patient also experienced extreme fatigue and severe coughing spells following the vaccination. The reporter provided the contact details of physician and stated that he did not have the address of the healthcare professional. The patient did not have the expiry date for SHINGRIX, but was able to provide the lot number. The reported batch number ZN2Z7 of SHINGRIX does not exists in the sales database, so the batch number ZN2Z7 was replaced with ZN22Z.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nasopharyngitis, Oropharyngeal pain, Rash erythematous, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old male patient who received SHINGRIX (batch number ZN22Z, expiry date unknown) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, sore throat, cold, shivering, cough, facial swelling, fatigue and erythematous rash. In June 2018, the outcome of the shivering, facial swelling and fatigue were recovered/resolved. On an unknown date, the outcome of the shingles, cough and erythematous rash were recovering/resolving and the outcome of the sore throat and cold were recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. The reporter considered the sore throat, cold, shivering, cough, facial swelling, fatigue and erythematous rash to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX vaccine on the left arm. Later on the same night of vaccination with SHINGRIX, the patient experienced sore throat that lasted until Sunday. The patient stated that he experienced a rash next to the injection site that looked like shingles. The patient also stated that the rash was red and it was 1 and 3/4 inch and had decreased to 3/4 inch at the time of reporting. The patient also experienced extreme fatigue and severe coughing spells following the vaccination. The reporter provided the contact details of physician and stated that he did not have the address of the healthcare professional. The patient did not have the expiry date for SHINGRIX, but was able to provide the lot number. The reported batch number ZN2Z7 of SHINGRIX does not exists in the sales database, so the batch number ZN2Z7 was replaced with ZN22Z.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Atrial fibrillation, Heart rate increased, Nausea, Pain
Clinical narrative: Severe pain in arm, 4 days severe nausea and dry heaves and constipation still occurring. Auto immune severe symptoms pain and swelling in kidney. Still occurring. Difficulty in walking about 10 days. Just slight now. Also sweating from the shot. I had 2 doctor visits DR and Dr. Also had to call an ambulance to go to hospital. Will be going to my rheumatologist MD for more tests.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe pain in arm, 4 days severe nausea and dry heaves and constipation still occurring. Auto immune severe symptoms pain and swelling in kidney. Still occurring. Difficulty in walking about 10 days. Just slight now. Also sweating from the shot. I had 2 doctor visits DR and Dr. Also had to call an ambulance to go to hospital. Will be going to my rheumatologist MD for more tests.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune disorder, Blood pressure increased, Constipation, Decreased appetite, Gait disturbance
Clinical narrative: Severe pain in arm, 4 days severe nausea and dry heaves and constipation still occurring. Auto immune severe symptoms pain and swelling in kidney. Still occurring. Difficulty in walking about 10 days. Just slight now. Also sweating from the shot. I had 2 doctor visits DR and Dr. Also had to call an ambulance to go to hospital. Will be going to my rheumatologist MD for more tests.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperhidrosis, Kidney enlargement, Nausea, Pain in extremity, Renal pain
Clinical narrative: Severe pain in arm, 4 days severe nausea and dry heaves and constipation still occurring. Auto immune severe symptoms pain and swelling in kidney. Still occurring. Difficulty in walking about 10 days. Just slight now. Also sweating from the shot. I had 2 doctor visits DR and Dr. Also had to call an ambulance to go to hospital. Will be going to my rheumatologist MD for more tests.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Retching
Clinical narrative: Severe pain in arm, 4 days severe nausea and dry heaves and constipation still occurring. Auto immune severe symptoms pain and swelling in kidney. Still occurring. Difficulty in walking about 10 days. Just slight now. Also sweating from the shot. I had 2 doctor visits DR and Dr. Also had to call an ambulance to go to hospital. Will be going to my rheumatologist MD for more tests.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Feeling abnormal, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of arthritic pains in a 74-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020) for prophylaxis. On 21st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced arthritic pains. On an unknown date, the outcome of the arthritic pains was not recovered/not resolved. It was unknown if the reporter considered the arthritic pains to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced arthritic pain since getting the vaccine in her knees, hips and shoulders. The pain has gotten worse since then. No further information was provided by the reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of arthritic pains in a 74-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020) for prophylaxis. On 21st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced arthritic pains. On an unknown date, the outcome of the arthritic pains was not recovered/not resolved. It was unknown if the reporter considered the arthritic pains to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced arthritic pain since getting the vaccine in her knees, hips and shoulders. The pain has gotten worse since then. No further information was provided by the reporter.
Age: 30.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Blood creatine phosphokinase increased, Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 30-year-old male patient who received BOOSTRIX for prophylaxis.  On 22nd June 2018, the patient received BOOSTRIX. On 26th June 2018, 4 days after receiving BOOSTRIX, the patient experienced chills, generalized muscle aches, weakness generalized and fatigability generalized. On an unknown date, the outcome of the chills, generalized muscle aches, weakness generalized and fatigability generalized were not recovered/not resolved. The reporter considered the chills, generalized muscle aches, weakness generalized and fatigability generalized to be probably related to BOOSTRIX. Additional details were provided as follows: The reporter did not have access to lot number and expiration date at the time of call.  The reporting nurse practitioner stated that this was generalized symptoms which had progressively gotten worse, and that there were no local injection site symptoms.
Age: 30.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 30-year-old male patient who received BOOSTRIX for prophylaxis.  On 22nd June 2018, the patient received BOOSTRIX. On 26th June 2018, 4 days after receiving BOOSTRIX, the patient experienced chills, generalized muscle aches, weakness generalized and fatigability generalized. On an unknown date, the outcome of the chills, generalized muscle aches, weakness generalized and fatigability generalized were not recovered/not resolved. The reporter considered the chills, generalized muscle aches, weakness generalized and fatigability generalized to be probably related to BOOSTRIX. Additional details were provided as follows: The reporter did not have access to lot number and expiration date at the time of call.  The reporting nurse practitioner stated that this was generalized symptoms which had progressively gotten worse, and that there were no local injection site symptoms.
Age: 30.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 30-year-old male patient who received BOOSTRIX for prophylaxis.  On 22nd June 2018, the patient received BOOSTRIX. On 26th June 2018, 4 days after receiving BOOSTRIX, the patient experienced chills, generalized muscle aches, weakness generalized and fatigability generalized. On an unknown date, the outcome of the chills, generalized muscle aches, weakness generalized and fatigability generalized were not recovered/not resolved. The reporter considered the chills, generalized muscle aches, weakness generalized and fatigability generalized to be probably related to BOOSTRIX. Additional details were provided as follows: The reporter did not have access to lot number and expiration date at the time of call.  The reporting nurse practitioner stated that this was generalized symptoms which had progressively gotten worse, and that there were no local injection site symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash, Skin lesion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 59-year-old female patient who received SHINGRIX (batch number 27K24, expiry date February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 16th June 2018, the patient received the 2nd dose of SHINGRIX. On 3rd July 2018, 17 days after receiving SHINGRIX, the patient experienced herpes zoster. On 4th July 2018, the patient experienced tingling sensation. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the herpes zoster and tingling sensation were unknown.  The reporter considered the herpes zoster to be unlikely related to SHINGRIX. It was unknown if the reporter considered the tingling sensation to be related to SHINGRIX. Additional details were provided as follows: It was unknown if patient has a prior history of herpes zoster. On 3rd July 2018, the patient went to the urgent care clinic complaining of a breakout on her abdomen. The physician suspected this as herpes zoster and gave her Valtrex for treatment. On 5th July 2018, the patient contacted her pharmacist and stated that she has tingling on her face and arm.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 59-year-old female patient who received SHINGRIX (batch number 27K24, expiry date February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 16th June 2018, the patient received the 2nd dose of SHINGRIX. On 3rd July 2018, 17 days after receiving SHINGRIX, the patient experienced herpes zoster. On 4th July 2018, the patient experienced tingling sensation. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the herpes zoster and tingling sensation were unknown.  The reporter considered the herpes zoster to be unlikely related to SHINGRIX. It was unknown if the reporter considered the tingling sensation to be related to SHINGRIX. Additional details were provided as follows: It was unknown if patient has a prior history of herpes zoster. On 3rd July 2018, the patient went to the urgent care clinic complaining of a breakout on her abdomen. The physician suspected this as herpes zoster and gave her Valtrex for treatment. On 5th July 2018, the patient contacted her pharmacist and stated that she has tingling on her face and arm.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, PPV, RV5, PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 6 month old patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. The nurse reported that on 05-JUL-2018, the patient was inadvertently administered PNEUMOVAX 23 (lot # R009162, expiration date 06-JAN-2020) at a dose of 1 injection, intramuscularly for prophylaxis instead of PREVENAR 13 as planned. No adverse effects reported. No additional information provided.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, PPV, RV5, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 6 month old patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. The nurse reported that on 05-JUL-2018, the patient was inadvertently administered PNEUMOVAX 23 (lot # R009162, expiration date 06-JAN-2020) at a dose of 1 injection, intramuscularly for prophylaxis instead of PREVENAR 13 as planned. No adverse effects reported. No additional information provided.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 68-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included shingles (experienced 10-11 years before the day reporting). On 20th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th June 2018, 1 day after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms, feeling unwell, tiredness, pain and pain in arm. On an unknown date, the patient experienced injection site discoloration, sore mouth, facial puffiness and oral redness. In June 2018, the outcome of the fever, influenza-like symptoms, feeling unwell, tiredness, pain and pain in arm were recovered/resolved. On an unknown date, the outcome of the injection site discoloration was recovered/resolved and the outcome of the sore mouth, facial puffiness and oral redness were not recovered/not resolved. It was unknown if the reporter considered the injection site discoloration, fever, influenza-like symptoms, feeling unwell, tiredness, pain, pain in arm, sore mouth, facial puffiness and oral redness to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she had the dose SHINGRIX vaccine and on that same day she experienced fever and did'nt feel well with flu like symptoms, tired, achy, mark on her arm, soreness on her arm where she received the vaccine for 2 to 3 days. A few days after the vaccination, she started noticing a slight sore, redness on the side of her mouth. She also noticed that her cheek was puffy on that same side. The patient was calling on her doctor. She was concerned that they seem similar to the symptoms she had when getting shingles 10 to 11 years ago. The patient was not certain, nor have had diagnosis of shingles. This case was linked with case US2018117587, reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site discolouration, Malaise, Oral mucosal erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 68-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included shingles (experienced 10-11 years before the day reporting). On 20th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th June 2018, 1 day after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms, feeling unwell, tiredness, pain and pain in arm. On an unknown date, the patient experienced injection site discoloration, sore mouth, facial puffiness and oral redness. In June 2018, the outcome of the fever, influenza-like symptoms, feeling unwell, tiredness, pain and pain in arm were recovered/resolved. On an unknown date, the outcome of the injection site discoloration was recovered/resolved and the outcome of the sore mouth, facial puffiness and oral redness were not recovered/not resolved. It was unknown if the reporter considered the injection site discoloration, fever, influenza-like symptoms, feeling unwell, tiredness, pain, pain in arm, sore mouth, facial puffiness and oral redness to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she had the dose SHINGRIX vaccine and on that same day she experienced fever and did'nt feel well with flu like symptoms, tired, achy, mark on her arm, soreness on her arm where she received the vaccine for 2 to 3 days. A few days after the vaccination, she started noticing a slight sore, redness on the side of her mouth. She also noticed that her cheek was puffy on that same side. The patient was calling on her doctor. She was concerned that they seem similar to the symptoms she had when getting shingles 10 to 11 years ago. The patient was not certain, nor have had diagnosis of shingles. This case was linked with case US2018117587, reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral pain, Pain, Pain in extremity, Pyrexia, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 68-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included shingles (experienced 10-11 years before the day reporting). On 20th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th June 2018, 1 day after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms, feeling unwell, tiredness, pain and pain in arm. On an unknown date, the patient experienced injection site discoloration, sore mouth, facial puffiness and oral redness. In June 2018, the outcome of the fever, influenza-like symptoms, feeling unwell, tiredness, pain and pain in arm were recovered/resolved. On an unknown date, the outcome of the injection site discoloration was recovered/resolved and the outcome of the sore mouth, facial puffiness and oral redness were not recovered/not resolved. It was unknown if the reporter considered the injection site discoloration, fever, influenza-like symptoms, feeling unwell, tiredness, pain, pain in arm, sore mouth, facial puffiness and oral redness to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she had the dose SHINGRIX vaccine and on that same day she experienced fever and did'nt feel well with flu like symptoms, tired, achy, mark on her arm, soreness on her arm where she received the vaccine for 2 to 3 days. A few days after the vaccination, she started noticing a slight sore, redness on the side of her mouth. She also noticed that her cheek was puffy on that same side. The patient was calling on her doctor. She was concerned that they seem similar to the symptoms she had when getting shingles 10 to 11 years ago. The patient was not certain, nor have had diagnosis of shingles. This case was linked with case US2018117587, reported by the same reporter.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Arthritis, Lymph node pain, Lymph node palpable, Lymphadenopathy
Clinical narrative: On day 12: Nasal congestion, painful lymphadenopathy in neck, jaw and pre-auricular area (palpable and tender), mild sore throat, mild fever (except for lymphadenopathy, the rest of the symptoms have almost subsided); in addition: arthritis and arthralgia (left wrist, and interphalangeal joints of right 3rd and 4th fingers) on day 17, which are still ongoing. Treatment: TYLENOL, cetirizine.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: On day 12: Nasal congestion, painful lymphadenopathy in neck, jaw and pre-auricular area (palpable and tender), mild sore throat, mild fever (except for lymphadenopathy, the rest of the symptoms have almost subsided); in addition: arthritis and arthralgia (left wrist, and interphalangeal joints of right 3rd and 4th fingers) on day 17, which are still ongoing. Treatment: TYLENOL, cetirizine.
Age: 45.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Diarrhoea, Flank pain, Headache, Nausea, Vomiting
Clinical narrative: Nausea began 10 1/2 hours after receiving vaccine; 24 hours after vaccine - vomiting, diarrhea, headache and right side flank pain.
Age: 9.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: Patient needed Tdap which was verbally told to medical assistant. Medical assistant placed order for vaccine approval in computer which was mistakenly signed thinking it was Tdap but it was Td, which was administered to patient. Reporter documented that it would be helpful if the vaccine in computer had the actual component initials (i.e. for HAVRIX it could say HAVRIX (Hep A) instead of just HAVRIX).
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever, movement described as "convulsions" by daycare provider. No other physical signs of illness on exam. No other seizure like activity. Fever abated within 24-48hr.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Eyelid ptosis, Facial paralysis, Immediate post-injection reaction, Ocular discomfort
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative and refers to a 51-year-old male patient (the reporter's husband). The patient's concurrent conditions were not reported. On an unspecified date in October 2016, the patient developed shingles in the cornea of the left eye. The field representative reported that the patient saw an unspecified physician and was treated with acyclovir 800 mg 5 times daily, and 1% prednisone eye drops 4 times daily. On an unspecified date, the patient was taken down to a maintenance dose of acyclovir 800 mg once daily and 1% prednisone eye drops once daily. On 08-JUN-2017, the patient was vaccinated with ZOSTAVAX (lot # M034764, expiration date: 26-OCT-2017, dose and route of administration were not reported) for regular immunization. On 08-JUN-2017, immediately after administration of ZOSTAVAX, the patient started to experience pressure in the eye and the shingles returned in the cornea again. The patient visited an unspecified physician who put the patient back on the higher dose of acyclovir 800 mg 5 times daily and 1% prednisone eye drops 4 times daily. On an unspecified date, the patient was seen by an unspecified physician, who lowered the dose of the acyclovir to 800mg once daily and discontinued the prednisone eye drops. On an unspecified date, the shingles in the eye started getting worse and the patient was treated with acyclovir 800 mg once daily and 1% prednisone eye drops 4 times daily. At the time of reporting, the patient was feeling better, but he could not tolerate the light, his vision was blurry and his eye and face were droopy (onset date not reported). The outcome of facial paralysis and eyelid ptosis was unknown. The outcome of ophthalmic herpes zoster was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the events of ophthalmic herpes zoster and facial paralysis were considered to be medically significant.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Photophobia, Vision blurred
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative and refers to a 51-year-old male patient (the reporter's husband). The patient's concurrent conditions were not reported. On an unspecified date in October 2016, the patient developed shingles in the cornea of the left eye. The field representative reported that the patient saw an unspecified physician and was treated with acyclovir 800 mg 5 times daily, and 1% prednisone eye drops 4 times daily. On an unspecified date, the patient was taken down to a maintenance dose of acyclovir 800 mg once daily and 1% prednisone eye drops once daily. On 08-JUN-2017, the patient was vaccinated with ZOSTAVAX (lot # M034764, expiration date: 26-OCT-2017, dose and route of administration were not reported) for regular immunization. On 08-JUN-2017, immediately after administration of ZOSTAVAX, the patient started to experience pressure in the eye and the shingles returned in the cornea again. The patient visited an unspecified physician who put the patient back on the higher dose of acyclovir 800 mg 5 times daily and 1% prednisone eye drops 4 times daily. On an unspecified date, the patient was seen by an unspecified physician, who lowered the dose of the acyclovir to 800mg once daily and discontinued the prednisone eye drops. On an unspecified date, the shingles in the eye started getting worse and the patient was treated with acyclovir 800 mg once daily and 1% prednisone eye drops 4 times daily. At the time of reporting, the patient was feeling better, but he could not tolerate the light, his vision was blurry and his eye and face were droopy (onset date not reported). The outcome of facial paralysis and eyelid ptosis was unknown. The outcome of ophthalmic herpes zoster was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the events of ophthalmic herpes zoster and facial paralysis were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2015, the patient was treated at a dermatology facility for symptoms of a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, but the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2015, the patient was treated by a physician for symptoms of a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 28-AUG-2012, the patient was inoculated at a pharmacy with ZOSTAVAX for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route of administration, site of administration and lot number were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2014, the patient was treated by a physician, for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 09-JUL-2018 from a lawyer regarding a case in litigation. A male patient, age unspecified, was inoculated with ZOSTAVAX on 21-OCT-2015 at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain of herpes zoster. In 2016 the patient was treated at a hospital for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, 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, pain, suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 09-JUL-2018 from a lawyer regarding a case in litigation. A male patient, age unspecified, was inoculated with ZOSTAVAX in 2014 by a physician as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain of herpes zoster. In 2015 the patient was treated at a physician office for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, 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, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient brings this action for personal injuries and damages suffered as a result of being inoculated with the ZOSTAVAX. The patient was inoculated with the ZOSTAVAX for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. In 2006, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route by a physician, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. On or about 01-OCT-2015, the patient was treated by a physician, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided.  In 2013, the patient was inoculated with ZOSTAVAX by a physician at a healthcare facility for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 20-NOV-2015, the patient was treated by the physician, at the healthcare facility, for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.