chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 27th June 2018, the patient received SHINGRIX (intramuscular) 50 mcg/mg. On 27th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, pain and pain in arm. On 28th June 2018, the patient experienced headache, extremities hot feeling of, erythema of extremities, swelling arm and feeling bad. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On 30th June 2018, the outcome of the headache, pain and feeling bad were recovered/resolved. On an unknown date, the outcome of the injection site pain, extremities hot feeling of, erythema of extremities, swelling arm and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, headache, extremities hot feeling of, erythema of extremities, swelling arm, pain, pain in arm and feeling bad to be related to SHINGRIX. Additional details were provided as follow:Wednesday, the patient experienced pain when given the SHINGRIX and on the same day in afternoon several hours after receiving SHINGRIX, her arm was sore for the remainder of the day. Less than a day after receiving SHINGRIX, the patient developed aches. On 28th June 2018 Thursday, 1 day after receiving SHINGRIX, when the patient awoke, she felt bad all over and in night she developed a severe headache and experienced swelling and redness on her arm and was hot to touch. On 29th June 2018 Saturday, when the patient awoke in morning, she felt better except her sore arm. The patient's husband actually noticed the swelling and redness on her arm. By Saturday night it had worsened but all other symptoms resolved. The patient's arm was redder and really hot to the touch and the area was much larger. Sunday morning it felt better but by that evening, it was larger and worse than on Saturday evening. As of today in the reporting date, it was not better. On 30th June 2018, in afternoon, the patient consulted with her pharmacist, who told her to put ice on it which did not help. Then on Saturday night the patient called a nurse who told her to put a warm compress on it.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Balance disorder, Bronchitis, Chest X-ray abnormal, Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivers in a 74-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included peritoneal dialysis (at home daily), blood pressure high and type ii diabetes mellitus. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On 25th June 2018, less than a day after receiving SHINGRIX the patient experienced shivers, erythema and pain. On 26th June 2018, the patient experienced pain ankle, leg pain, cough, sputum discolored, bronchitis and influenza-like symptoms. On an unknown date, the patient experienced balance difficulty. On an unknown date, the outcome of the shivers, erythema, pain ankle, pain and influenza-like symptoms were recovered/resolved and the outcome of the leg pain was unknown and the outcome of the balance difficulty, cough, sputum discolored and bronchitis were not recovered/not resolved. It was unknown if the reporter considered the shivers, erythema, pain ankle, leg pain, balance difficulty, cough, sputum discolored, bronchitis, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was friend of patient who received SHINGRIX on last Monday. The patient experienced soreness and redness at the sight that has resolved. The patient also experienced shivering that night and the next day after receiving SHINGRIX the patient  developed a bad cough with green sputum. 1 day after receiving SHINGRIX, the patient was seen by his physician and a chest xray ruled out pneumonia, he was diagnosed with Bronchitis and given Ceftaline antibiotic, but that was not helping the friend reports. At the time of reporting, the patient experienced terrible pain in his ankles, knees and legs that are like shooting pains that get worse with walking and she states it is affecting his balance when walking. The caller was friend of the patient. She was calling to provide doctor's information with permission to contact them.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Erythema, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivers in a 74-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included peritoneal dialysis (at home daily), blood pressure high and type ii diabetes mellitus. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On 25th June 2018, less than a day after receiving SHINGRIX the patient experienced shivers, erythema and pain. On 26th June 2018, the patient experienced pain ankle, leg pain, cough, sputum discolored, bronchitis and influenza-like symptoms. On an unknown date, the patient experienced balance difficulty. On an unknown date, the outcome of the shivers, erythema, pain ankle, pain and influenza-like symptoms were recovered/resolved and the outcome of the leg pain was unknown and the outcome of the balance difficulty, cough, sputum discolored and bronchitis were not recovered/not resolved. It was unknown if the reporter considered the shivers, erythema, pain ankle, leg pain, balance difficulty, cough, sputum discolored, bronchitis, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was friend of patient who received SHINGRIX on last Monday. The patient experienced soreness and redness at the sight that has resolved. The patient also experienced shivering that night and the next day after receiving SHINGRIX the patient  developed a bad cough with green sputum. 1 day after receiving SHINGRIX, the patient was seen by his physician and a chest xray ruled out pneumonia, he was diagnosed with Bronchitis and given Ceftaline antibiotic, but that was not helping the friend reports. At the time of reporting, the patient experienced terrible pain in his ankles, knees and legs that are like shooting pains that get worse with walking and she states it is affecting his balance when walking. The caller was friend of the patient. She was calling to provide doctor's information with permission to contact them.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Sputum discoloured
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivers in a 74-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included peritoneal dialysis (at home daily), blood pressure high and type ii diabetes mellitus. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On 25th June 2018, less than a day after receiving SHINGRIX the patient experienced shivers, erythema and pain. On 26th June 2018, the patient experienced pain ankle, leg pain, cough, sputum discolored, bronchitis and influenza-like symptoms. On an unknown date, the patient experienced balance difficulty. On an unknown date, the outcome of the shivers, erythema, pain ankle, pain and influenza-like symptoms were recovered/resolved and the outcome of the leg pain was unknown and the outcome of the balance difficulty, cough, sputum discolored and bronchitis were not recovered/not resolved. It was unknown if the reporter considered the shivers, erythema, pain ankle, leg pain, balance difficulty, cough, sputum discolored, bronchitis, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was friend of patient who received SHINGRIX on last Monday. The patient experienced soreness and redness at the sight that has resolved. The patient also experienced shivering that night and the next day after receiving SHINGRIX the patient  developed a bad cough with green sputum. 1 day after receiving SHINGRIX, the patient was seen by his physician and a chest xray ruled out pneumonia, he was diagnosed with Bronchitis and given Ceftaline antibiotic, but that was not helping the friend reports. At the time of reporting, the patient experienced terrible pain in his ankles, knees and legs that are like shooting pains that get worse with walking and she states it is affecting his balance when walking. The caller was friend of the patient. She was calling to provide doctor's information with permission to contact them.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dry mouth, Fatigue, Injection site bruising, Injection site swelling
Clinical narrative: his case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included viral infection (hospitalised to rule out stroke, about one year ago from the date of reporting). Concurrent medical conditions included diabetes. Concomitant products included doxycycline and levocetirizine hydrochloride (Levocetirizine). On 4th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, dry mouth, appetite lost, injection site bruising and tiredness. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site swelling and injection site bruising were recovered/resolved and the outcome of the dry mouth, appetite lost and tiredness were not recovered/not resolved. The reporter considered the injection site swelling and injection site bruising to be related to SHINGRIX. The reporter considered the dry mouth and tiredness to be possibly related to SHINGRIX. The reporter considered the appetite lost to be unrelated to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who is a nurse practitioner. She experienced swelling at the site of injection to about twice normal size as well as bruising.  She used ice packs and those resolved within about 10 days. The patient also stated that, since the injection, she had noted increased tiredness, loss of appetite and dry mouth. The patient was concerned whether the symptoms are similar to what she had experienced about an year ago when she was hospitalized for possible stroke and was finally diagnosed with a viral infection. The patient was unsure if these symptoms are related to the SHINGRIX vaccine.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 84-year-old male patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, several hours after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and pruritus. The patient was treated with topical steroid nos (Steroid Cream). On 8th May 2018, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the injection site erythema and pruritus were recovered/resolved. The reporter considered the injection site swelling to be possibly related to SHINGRIX. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. The reporter considered the pruritus to be unlikely related to SHINGRIX. Additional details were provided as follows: The patient experienced redness at the injection site which took about a week to subside. It did not hinder him in any way. The patient also experienced itching on legs and arms, which was treated with a steroid cream prior to receipt of vaccine, so likely predated the vaccine.
Sex: U
Vaccine: MENB
Symptoms: Back pain, Chills, Diarrhoea, Lethargy, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a adult patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced fever, lethargy, diarrhea, myalgia, chills and back pain. The patient was treated with ibuprofen (Motrin) and paracetamol (Tylenol). On an unknown date, the outcome of the fever, lethargy, diarrhea, myalgia, chills and back pain were recovered/resolved. It was unknown if the reporter considered the fever, lethargy, diarrhea, myalgia, chills and back pain to be related to BEXSERO. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The doctor reported she had the patient who suffered from fever and chills, diarrhea, myalgia and was lethargic for 2 days following the vaccination. The exact date of the vaccination or the date when the adverse events began was unknown.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a adult patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced fever, lethargy, diarrhea, myalgia, chills and back pain. The patient was treated with ibuprofen (Motrin) and paracetamol (Tylenol). On an unknown date, the outcome of the fever, lethargy, diarrhea, myalgia, chills and back pain were recovered/resolved. It was unknown if the reporter considered the fever, lethargy, diarrhea, myalgia, chills and back pain to be related to BEXSERO. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The doctor reported she had the patient who suffered from fever and chills, diarrhea, myalgia and was lethargic for 2 days following the vaccination. The exact date of the vaccination or the date when the adverse events began was unknown.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Erythema, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. Concurrent medical conditions included shingles and neuropathy in head. On 28th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th June 2018, less than a day after receiving SHINGRIX, the patient experienced headache and pain in arm. On 29th June 2018, the patient experienced influenza-like symptoms, erythema, weakness, fever, chills, nausea and skin discoloration. The patient was treated with ibuprofen, medication unknown (Ice Pack (Nos)), prednisone and benadryl (nos) (Benadryl). On 30th June 2018, the outcome of the influenza-like symptoms, headache, pain in arm, weakness, fever, chills and nausea were recovered/resolved. On an unknown date, the outcome of the erythema and skin discoloration were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, erythema, pain in arm, weakness, fever, chills, nausea and skin discoloration to be related to SHINGRIX. Additional details were received as follows: On the vaccination day, at 2:00, the patient experienced headache. On the next day at 2:00, the patient experienced flu like symptoms which were described as weakness, fever, chills, nausea, and spending 3/4th of the day in bed. The patient took Ibuprofen every 8 hours for flu like symptoms. The patient used Ice for left arm pain. The reporter noted a purple reddish circle appeared closer to her left shoulder and purple, reddish circle to her lower arm. On 29th June 2018, the reporter saw her physician and was prescribed Prednisone, 50mg of Benadryl, and instructed to continue using ice. The reporter provided lot number 3AF9F, but noted the last letter could also be an 'E', could not specify. However, the batch number was corrected to 3AF9E as per the sales database. The first name of the pharmacist who administered the vaccine was unknown. The details of the physician was provided.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. Concurrent medical conditions included shingles and neuropathy in head. On 28th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th June 2018, less than a day after receiving SHINGRIX, the patient experienced headache and pain in arm. On 29th June 2018, the patient experienced influenza-like symptoms, erythema, weakness, fever, chills, nausea and skin discoloration. The patient was treated with ibuprofen, medication unknown (Ice Pack (Nos)), prednisone and benadryl (nos) (Benadryl). On 30th June 2018, the outcome of the influenza-like symptoms, headache, pain in arm, weakness, fever, chills and nausea were recovered/resolved. On an unknown date, the outcome of the erythema and skin discoloration were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, erythema, pain in arm, weakness, fever, chills, nausea and skin discoloration to be related to SHINGRIX. Additional details were received as follows: On the vaccination day, at 2:00, the patient experienced headache. On the next day at 2:00, the patient experienced flu like symptoms which were described as weakness, fever, chills, nausea, and spending 3/4th of the day in bed. The patient took Ibuprofen every 8 hours for flu like symptoms. The patient used Ice for left arm pain. The reporter noted a purple reddish circle appeared closer to her left shoulder and purple, reddish circle to her lower arm. On 29th June 2018, the reporter saw her physician and was prescribed Prednisone, 50mg of Benadryl, and instructed to continue using ice. The reporter provided lot number 3AF9F, but noted the last letter could also be an 'E', could not specify. However, the batch number was corrected to 3AF9E as per the sales database. The first name of the pharmacist who administered the vaccine was unknown. The details of the physician was provided.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Body temperature, Chills, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. Concurrent medical conditions included shingles and neuropathy in head. On 28th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th June 2018, less than a day after receiving SHINGRIX, the patient experienced headache and pain in arm. On 29th June 2018, the patient experienced influenza-like symptoms, erythema, weakness, fever, chills, nausea and skin discoloration. The patient was treated with ibuprofen, medication unknown (Ice Pack (Nos)), prednisone and benadryl (nos) (Benadryl). On 30th June 2018, the outcome of the influenza-like symptoms, headache, pain in arm, weakness, fever, chills and nausea were recovered/resolved. On an unknown date, the outcome of the erythema and skin discoloration were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, erythema, pain in arm, weakness, fever, chills, nausea and skin discoloration to be related to SHINGRIX. Additional details were received as follows: On the vaccination day, at 2:00, the patient experienced headache. On the next day at 2:00, the patient experienced flu like symptoms which were described as weakness, fever, chills, nausea, and spending 3/4th of the day in bed. The patient took Ibuprofen every 8 hours for flu like symptoms. The patient used Ice for left arm pain. The reporter noted a purple reddish circle appeared closer to her left shoulder and purple, reddish circle to her lower arm. On 29th June 2018, the reporter saw her physician and was prescribed Prednisone, 50mg of Benadryl, and instructed to continue using ice. The reporter provided lot number 3AF9F, but noted the last letter could also be an 'E', could not specify. However, the batch number was corrected to 3AF9E as per the sales database. The first name of the pharmacist who administered the vaccine was unknown. The details of the physician was provided.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site scar, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. Concurrent medical conditions included shingles and neuropathy in head. On 28th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th June 2018, less than a day after receiving SHINGRIX, the patient experienced headache and pain in arm. On 29th June 2018, the patient experienced influenza-like symptoms, erythema, weakness, fever, chills, nausea and skin discoloration. The patient was treated with ibuprofen, medication unknown (Ice Pack (Nos)), prednisone and benadryl (nos) (Benadryl). On 30th June 2018, the outcome of the influenza-like symptoms, headache, pain in arm, weakness, fever, chills and nausea were recovered/resolved. On an unknown date, the outcome of the erythema and skin discoloration were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, erythema, pain in arm, weakness, fever, chills, nausea and skin discoloration to be related to SHINGRIX. Additional details were received as follows: On the vaccination day, at 2:00, the patient experienced headache. On the next day at 2:00, the patient experienced flu like symptoms which were described as weakness, fever, chills, nausea, and spending 3/4th of the day in bed. The patient took Ibuprofen every 8 hours for flu like symptoms. The patient used Ice for left arm pain. The reporter noted a purple reddish circle appeared closer to her left shoulder and purple, reddish circle to her lower arm. On 29th June 2018, the reporter saw her physician and was prescribed Prednisone, 50mg of Benadryl, and instructed to continue using ice. The reporter provided lot number 3AF9F, but noted the last letter could also be an 'E', could not specify. However, the batch number was corrected to 3AF9E as per the sales database. The first name of the pharmacist who administered the vaccine was unknown. The details of the physician was provided.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Middle insomnia, Nausea, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 77-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included zolpidem tartrate (Ambien). On 6th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th April 2018, 1 days after receiving SHINGRIX, the patient experienced vomiting and nausea. In April 2018, the patient experienced shivering. On an unknown date, the outcome of the shivering, vomiting and nausea were recovered/resolved. The reporter considered the shivering and nausea to be related to SHINGRIX. It was unknown if the reporter considered the vomiting to be related to SHINGRIX. Additional details were provided as follows: The patient independently decided to walk-in to her retail pharmacy and ask for the vaccine. The patient had many vaccinations previously as related to her past work with the Peace Corps in the 1960's and had never had any reactions to any vaccination except to the SHINGRIX dose. The patient did not have other vaccinations that same day or within 4 weeks prior. The patient received SHINGRIX left upper arm (left deltoid) and she could not provide further dosing specifics. The patient had a dose of SHINGRIX in the series and then woke up in the middle of night with uncontrollable shivering which lasted for a while but she did not know exactly for what period of time the shivering lasted. The patient then went back to sleep, and that next morning of the day following the first dose, the patient had nausea and vomiting for about six hours, the patient felt fine by the next day. The patient agreed to contact her HCP (healthcare professional). The patient said her HCP would not mind that she got the vaccine but was not yet aware that she received it or of the reaction. The patient did not know the name of the pharmacist who administered the vaccination and assumes she was administered whatever the standard SHINGRIX dose might be. The patient did not take any of the nights following the first dose of Shingrix, because she only used it as needed when she was at high altitudes, and her home was close to sea level.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site induration, injection site lump, injection site itching, fever and woozy. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site lump, injection site itching, fever and woozy were recovered/resolved and the outcome of the injection site swelling was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, injection site lump, injection site itching, fever and woozy to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their patient received the a dose of SHINGRIX vaccine. On that same day, the patient experienced a large red swollen bump at the injection site. It was the size of half a dollar. The pharmacist saw the patient's arm where the vaccine was given and the patient also said that the muscle underneath the injection site was like a hard knot, the patient felt woozy, the injection site was light pink, the injection site was itching and the patient had a low grade fever of 99.1 degree F. On 1st July 2018, the patient's fever was 100.1 degree F.  The pharmacist said that on Sunday the patient returned and the red swollen bump was the size of a baseball, It increased in size. The patient also said that the hardening at the injection site seems to hardened even more. All event were resolved only remaining adverse event was the golf-ball sized swelling which had significantly improved in size.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site induration, injection site lump, injection site itching, fever and woozy. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site lump, injection site itching, fever and woozy were recovered/resolved and the outcome of the injection site swelling was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, injection site lump, injection site itching, fever and woozy to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their patient received the a dose of SHINGRIX vaccine. On that same day, the patient experienced a large red swollen bump at the injection site. It was the size of half a dollar. The pharmacist saw the patient's arm where the vaccine was given and the patient also said that the muscle underneath the injection site was like a hard knot, the patient felt woozy, the injection site was light pink, the injection site was itching and the patient had a low grade fever of 99.1 degree F. On 1st July 2018, the patient's fever was 100.1 degree F.  The pharmacist said that on Sunday the patient returned and the red swollen bump was the size of a baseball, It increased in size. The patient also said that the hardening at the injection site seems to hardened even more. All event were resolved only remaining adverse event was the golf-ball sized swelling which had significantly improved in size.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 70-year-old male patient who received SHINGRIX for prophylaxis.  On 25th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th June 2018, 1 days after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On 27th June 2018, the patient experienced raised rash. On 1st July 2018, the outcome of the injection site swelling, raised rash and injection site pain were recovered/resolved.  It was unknown if the reporter considered the injection site swelling, raised rash and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The next day after vaccination, the patient experienced soreness and swollen at the injection site. The symptoms lasted for about 5 days before resolving. His saw his physician for a different reason on 29th June 2018 and since he was there had his physician look at the reaction.  They physician recommended not getting the 2nd dose since the reaction had lasted so long. He had not decided if he would get the 2nd dose or not. The patient had denied permission to contact their physician.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a adult patient who received SHINGRIX for prophylaxis. On 30th May 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, 17 days after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The health care professional reported that the patient experienced large itchy rash after 2.5 weeks. The rash had lasted 2 weeks and continues to spread and which was worsening. The rash was located on his arms and left back area. The patient wanted to remain anonymous and had not followed up with his family doctor at this time. As per case description the latency was reported 2 nad half weeks but as per event onset date (18th June 2018), the latency was 19 days. Clarification has been raised.
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of genital herpes in a female patient who received SHINGRIX for prophylaxis. On 22nd April 2018, the patient received the 1st dose of SHINGRIX. On 22nd April 2018, immediately after receiving SHINGRIX the patient experienced genital herpes. The patient was treated with Antiviral. On an unknown date, the outcome of the genital herpes was unknown. It was unknown if the reporter considered the genital herpes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient immediately had an outbreak of genital herpes which was treated with antivirals. The health care professional called to ask if we had any reports of patients having an outbreak of HSV-2 (genital herpes) after the administration of SHINGRIX. The health care professional did state that the patient received her 2nd dose of SHINGRIX on the day before reporting (on 1st July 2018) but so far, the patient had not contacted the health care professional that she had another outbreak of genital herpes yet after the 2nd dose of SHINGRIX. No further information was provided. The health care professional was calling us from home, and not from her work location, so she did not have any additional details to provide at the time of the call.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Hypoaesthesia, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced numbness of upper extremities, vomiting, diarrhea, pain in arm, tingling of extremity and incorrect storage of drug. On an unknown date, the patient experienced nausea. On an unknown date, the outcome of the numbness of upper extremities, vomiting, diarrhea, pain in arm, tingling of extremity and incorrect storage of drug were unknown and the outcome of the nausea was unknown. It was unknown if the reporter considered the numbness of upper extremities, vomiting, diarrhea, pain in arm, tingling of extremity and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) also stated that the SHINGRIX vaccine might have undergone a temperature excursion prior to administration, which led to incorrect storage of vaccine. The HCP was not sure what the temperature was of the SHINGRIX vaccine and she was going to check her data logger and make sure it fell within their extended stability data for SHINGRIX. When asked for additional information, the HCP stated she would have to call back since she did not have time to provide any additional data at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced numbness of upper extremities, vomiting, diarrhea, pain in arm, tingling of extremity and incorrect storage of drug. On an unknown date, the patient experienced nausea. On an unknown date, the outcome of the numbness of upper extremities, vomiting, diarrhea, pain in arm, tingling of extremity and incorrect storage of drug were unknown and the outcome of the nausea was unknown. It was unknown if the reporter considered the numbness of upper extremities, vomiting, diarrhea, pain in arm, tingling of extremity and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) also stated that the SHINGRIX vaccine might have undergone a temperature excursion prior to administration, which led to incorrect storage of vaccine. The HCP was not sure what the temperature was of the SHINGRIX vaccine and she was going to check her data logger and make sure it fell within their extended stability data for SHINGRIX. When asked for additional information, the HCP stated she would have to call back since she did not have time to provide any additional data at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Insomnia, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of raised rash in a 69-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On 1st June 2018, less than a year after receiving SHINGRIX, the patient experienced pruritus. On 1st July 2018, the patient experienced raised rash. On an unknown date, the patient experienced cough and sleeplessness. On an unknown date, the outcome of the raised rash and pruritus were not recovered/not resolved and the outcome of the cough and sleeplessness were unknown. It was unknown if the reporter considered the raised rash, cough, pruritus and sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The health care professional said that the patient stated that they had experienced hacking cough that started after administration of SHINGRIX and this hacking cough is keeping the patient up at night. At the date of reporting, pharmacy said that the patient went into the pharmacy today to show her this side effects. The pharmacist said that the bumps were in his right hand and on his back. The patient did not mentioned any other issues to the pharmacist. The patient had not reported this reaction to his physician.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on 5th or 6th April 2018. The patient experienced soreness in her arm. In 2018, the event was resolved. This is 1 of 2 cases, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on 5th or 6th April 2018. The patient experienced soreness in her arm. In 2018, the event was resolved. This is 1 of 2 cases, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (see the case for 1st dose US2018118584). On 2nd July 2018, the patient received the 2nd dose of SHINGRIX. On 3rd July 2018, 1 days after receiving SHINGRIX, the patient experienced headache, upset stomach and fever. On an unknown date, the outcome of the headache, upset stomach and fever were not recovered/not resolved. It was unknown if the reporter considered the headache, upset stomach and fever to be related to SHINGRIX. Additional details were provided as follows: The patient was woke up with headache, upset stomach and fever. The patient's body temperature was recorded as close to 100 degree F. The patient had denied permission to contact their physician. This is 1 of 2 cases reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (see the case for 1st dose US2018118584). On 2nd July 2018, the patient received the 2nd dose of SHINGRIX. On 3rd July 2018, 1 days after receiving SHINGRIX, the patient experienced headache, upset stomach and fever. On an unknown date, the outcome of the headache, upset stomach and fever were not recovered/not resolved. It was unknown if the reporter considered the headache, upset stomach and fever to be related to SHINGRIX. Additional details were provided as follows: The patient was woke up with headache, upset stomach and fever. The patient's body temperature was recorded as close to 100 degree F. The patient had denied permission to contact their physician. This is 1 of 2 cases reported by the same reporter.
Sex: M
Vaccine: MEN
Symptoms: Fatigue, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, 1 day after receiving Meningococcal B vaccine, the patient experienced fever, influenza-like symptoms and fatigue. On an unknown date, the outcome of the fever, influenza-like symptoms and fatigue were unknown. It was unknown if the reporter considered the fever, influenza-like symptoms and fatigue to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter called to inquire as to how to find out if her son would be allergic to the 1st series dose of an unknown Meningococcal Group B Vaccine which he received at his physician's office because he had a really high fever the next day after having had the vaccination. The vaccine dose might had been a 1st dose of BEXSERO but could have instead been a TRUMENBA dose. The patient's vaccination paperwork references a 2 serogroup B meningococcal vaccine, and the words BEXSERO and TRUMENBA  were referenced on the paperwork. She did not know for certain the manufacturer or brand name of the meningococcal vaccine he was administered. She then inquired as to how to know if her son was allergic to BEXSERO. The product information (PI) for Bexsero was discussed during the call, and she was referred to discuss her inquiry with the patient's prescribing healthcare professional and to discuss which unknown manufacturer and to determine which vaccine product the patient was previously administered with the healthcare professional. She thought the patient's fever caused the fatigue and the flu-like symptoms because when she described that when someone had a fever they feel like they had the flu.  No further information beyond what was documented above was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patients experienced pain and erythema. On an unknown date, the outcome of the pain and erythema were recovered/resolved. It was unknown if the reporter considered the pain and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The healthcare professional (HCP) reported that he typically saw the patients got pain and redness, 24 to 36 hours after they receive SHINGRIX which went away 4 to 5 days later. The patient had denied permission to contact their physician. Did not speak to HCP, but spoke to a representative in inside sales but HCP stated that they did not want to be called back and did not want to provide any additional information. The HCP was making a general statement of what he had seen when administered SHINGRIX.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Immediate post-injection reaction, Influenza like illness, Malaise, Migraine
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 53-year-old male patient who received SHINGRIX for prophylaxis.  The patient's past medical history included migraine and cold sores. Concurrent medical conditions included attention deficit/hyperactivity disorder. Concomitant products included acyclovir, atorvastatin calcium (Atorvastatin), bupropion hydrochloride (Bupropion), lansoprazole, losartan potassium (Losartan) and metformin hydrochloride (Metformin). On 8th May 2018, the patient received the 1st dose of SHINRIX. On 8th May 2018, immediately after receiving SHINGRIX, the patient experienced influenza-like symptoms, loss of energy and feeling unwell. On 13th May 2018, the patient experienced scalp pain. On an unknown date, the patient experienced migraine. On an unknown date, the outcome of the influenza-like symptoms, scalp pain, migraine, loss of energy and feeling unwell were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, scalp pain, migraine, loss of energy and feeling unwell to be related to SHINGRIX. Additional information was received as follows: The patient did not feel so great immediately after receiving the SHINGRIX and he felt flu like symptoms with no energy. The patient stopped the acyclovir which he was taking for migraines, he had no migraines and no cold sores. The patient had denied permission to contact their physician. This case has been linked to the case US2018GSK124064, reported by the same reporter.