chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Hyperaesthesia, Influenza like illness
Clinical narrative: Sore arm at vaccination site for 5 days. 16 hours after vaccination woke up with strong flu-like symptoms: joints sore, skin sensitive, headache, muscles sore, felt slightly feverish (not measured).   18 hours: started to cook breakfast but got too nauseous to continue. 20 hours: ate 1 slice of plain bread and 2 ibuprofen. 21 hours: the symptoms got better. For the next 3 days I took 1 aspirin plus 1 ibuprofen 3 times per day for headache. Tiredness throughout this period.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Sore arm at vaccination site for 5 days. 16 hours after vaccination woke up with strong flu-like symptoms: joints sore, skin sensitive, headache, muscles sore, felt slightly feverish (not measured).   18 hours: started to cook breakfast but got too nauseous to continue. 20 hours: ate 1 slice of plain bread and 2 ibuprofen. 21 hours: the symptoms got better. For the next 3 days I took 1 aspirin plus 1 ibuprofen 3 times per day for headache. Tiredness throughout this period.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient is complaining of left arm soreness that has lasted for over a month after administration of SHINGRIX. She stated that it is still sore to the touch and hurts to lay on that arm while sleeping. She also stated that the pain sometimes radiates up to the shoulder.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient came back into the pharmacy tonight and her arm was red and slightly swollen from the shoulder to near the elbow. I advised her to go get seen by urgent care so they could give her something for the reaction.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Patient experienced burning and redness at site of injection initially. Vaccine was almost a month ago and patient is experiencing continued burning and a lump at the injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had swollen, red and felt warm at the site of injection from the evening of giving the vaccine. Patient also felt very fatigued for next day or two but started feeling back to normal after that.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Chills started about 13 hours after vaccine was given. Swollen, itchy, rash, 4 x 4 inches at injection sight appeared on 5/16/18.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Autonomic nervous system imbalance, Condition aggravated, Herpes virus infection, Herpes zoster
Clinical narrative: Within 3 days herpetiform lesions reported by pt. This followed about day 6 herpes zoster outbreak right (time crunch ) L2-4 dermatone. Heightened autonomic sx flare
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient said she developped cellulitis on the site and was seen by her physician.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nasopharyngitis, Ocular hyperaemia, Pyrexia
Clinical narrative: Fever 101-101.5. Headache. Shivering. Cold. Bloodshot eyes.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Malaise
Clinical narrative: Flu like symptoms....headache, chills, aches, fatigue, malaise. Began day after vaccine and subsided by the 3rd day.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Flu like symptoms....headache, chills, aches, fatigue, malaise. Began day after vaccine and subsided by the 3rd day.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptoms..headache, chills, aches, fatigue..started day after shot and subsided 3 days post shot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Pt experienced swelling of the upper arm (injection site swelling about palm size). It lasts for 1 week.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site discomfort, Injection site erythema, Injection site inflammation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after received SHINGRIX, the patient experienced erythema, arm discomfort, inflammation localized, skin warm, pain in arm and wrong injection technique. The patient was treated with clindamycin. On an unknown date, the outcome of the erythema, arm discomfort, inflammation localized, skin warm, pain in arm and wrong injection technique were unknown. It was unknown if the reporter considered the erythema, arm discomfort, inflammation localized, skin warm and pain in arm to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received SHINGRIX through a bandaid, which led to wrong injection technique. The injection didn't hurt but the delivery was hugely uncomfortable. Soon afterwards patient's arm got very pink, hot and uncomfortable. It was not at the injection site but about an itch away. The inflammation spread to a large area over patient's upper arm and was very warm to the touch. It didn't itch, nor did the patient get sick, but the nurse practitioner had her take clindamycin for 7 days. The patient's arm was still tender but most of the inflammation was gone. The patient was assuming a fiber or particle of that shielded through which the nurse injected was injection into patent's arm. The patient's issue was with the pharmacy not. The patient could not get the pharmacy to stop this corporate decision to putting the Band-Aid on after the injection rather than going through it. Inject through a shield and wanted to let GlaxoSmithKline know how their product was being misused to the disadvantage of the customer or patient. The reporter was asking GlaxoSmithKline might want or need to have a chat with corporate of the pharmacy where the patient received the vaccine. The reporter stated that they would go to the same pharmacy for her husband's injection since she had checked and they did not inject through something that can be delivered in to his arm.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Limb discomfort, Pain in extremity, Skin warm, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after received SHINGRIX, the patient experienced erythema, arm discomfort, inflammation localized, skin warm, pain in arm and wrong injection technique. The patient was treated with clindamycin. On an unknown date, the outcome of the erythema, arm discomfort, inflammation localized, skin warm, pain in arm and wrong injection technique were unknown. It was unknown if the reporter considered the erythema, arm discomfort, inflammation localized, skin warm and pain in arm to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received SHINGRIX through a bandaid, which led to wrong injection technique. The injection didn't hurt but the delivery was hugely uncomfortable. Soon afterwards patient's arm got very pink, hot and uncomfortable. It was not at the injection site but about an itch away. The inflammation spread to a large area over patient's upper arm and was very warm to the touch. It didn't itch, nor did the patient get sick, but the nurse practitioner had her take clindamycin for 7 days. The patient's arm was still tender but most of the inflammation was gone. The patient was assuming a fiber or particle of that shielded through which the nurse injected was injection into patent's arm. The patient's issue was with the pharmacy not. The patient could not get the pharmacy to stop this corporate decision to putting the Band-Aid on after the injection rather than going through it. Inject through a shield and wanted to let GlaxoSmithKline know how their product was being misused to the disadvantage of the customer or patient. The reporter was asking GlaxoSmithKline might want or need to have a chat with corporate of the pharmacy where the patient received the vaccine. The reporter stated that they would go to the same pharmacy for her husband's injection since she had checked and they did not inject through something that can be delivered in to his arm.
Sex: M
Vaccine: VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after received SHINGRIX, the patient experienced erythema, arm discomfort, inflammation localized, skin warm, pain in arm and wrong injection technique. The patient was treated with clindamycin. On an unknown date, the outcome of the erythema, arm discomfort, inflammation localized, skin warm, pain in arm and wrong injection technique were unknown. It was unknown if the reporter considered the erythema, arm discomfort, inflammation localized, skin warm and pain in arm to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received SHINGRIX through a bandaid, which led to wrong injection technique. The injection didn't hurt but the delivery was hugely uncomfortable. Soon afterwards patient's arm got very pink, hot and uncomfortable. It was not at the injection site but about an itch away. The inflammation spread to a large area over patient's upper arm and was very warm to the touch. It didn't itch, nor did the patient get sick, but the nurse practitioner had her take clindamycin for 7 days. The patient's arm was still tender but most of the inflammation was gone. The patient was assuming a fiber or particle of that shielded through which the nurse injected was injection into patent's arm. The patient's issue was with the pharmacy not. The patient could not get the pharmacy to stop this corporate decision to putting the Band-Aid on after the injection rather than going through it. Inject through a shield and wanted to let GlaxoSmithKline know how their product was being misused to the disadvantage of the customer or patient. The reporter was asking GlaxoSmithKline might want or need to have a chat with corporate of the pharmacy where the patient received the vaccine. The reporter stated that they would go to the same pharmacy for her husband's injection since she had checked and they did not inject through something that can be delivered in to his arm.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Product quality issue, Rash erythematous, Rash generalised
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a 15-month old male patient who received INFANRIX (batch number Y5475m expiry date unknown). This case was associated with a product complaint. On 23rd April 2018, the patient received INFANRIX. On an unknown date, less than a month after receiving INFANRIX, the patient experienced injection site rash, injection site erythema, generalized rash and pharmaceutical product complaint. On an unknown date, the outcome of the injection site rash, injection site erythema, generalized rash and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site rash, injection site erythema and generalized rash to be related to INFANRIX. Additional details were provided as follows: The nurse reported that the patient experienced a red rash at injection site that was larger than usual and a systemic rash (rash over body). In total 13 patients received INFANRIX with the same lot number but only 3 patients including this patient experienced reactions. The vaccine was administered at the 15 to 18 month visit. The patient's mother stated earlier the week of 5th May 2018, that the rash was till there and thought it was possible due to an allergy to ranch dressing. According to the treating physician the adverse events reported were not due to the INFANRIX but thought it was a normal reaction to DTAP. The nurse reported that they had 40 more doses from this lot number and she was not sure if they should use so she had sat them aside in the refrigerator until she hears from GlaxoSmithKline (GSK). The nurse was informed that there had not been a recall on this lot but that investigation would be carried out. The reporter had return the one vial from the lot for investigation. The reported agreed to contact on follow up. This case has been linked with case US2018GSK080169 and US2018GSK080192, reported by the same reporter.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction, Product quality issue, Rash erythematous, Rash generalised
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a 15-month-old female patient who received INFANRIX (batch number Y5475, expiry date unknown). This case was associated with a product complaint. On 19th April 2018, the patient received INFANRIX. On an unknown date, less than a month after receiving INFANRIX, the patient experienced injection site rash, injection site erythema, generalized rash and pharmaceutical product complaint. On an unknown date, the outcome of the injection site rash, injection site erythema, generalized rash and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site rash, injection site erythema and generalized rash to be related to INFANRIX. Additional details were provided as follows: The nurse reported that the patient experienced a red rash at injection site that was larger than usual and a systemic rash (rash over body). In total 13 patients received INFANRIX with the same lot number but only 3 patients including this patient experienced reactions. The vaccine was administered at the 15 to 18 month visit. According to the treating physician the adverse events reported were not due to the INFANRIX but thought it was a normal reaction to DTap. The nurse reported that they had 40 more doses from this lot number and she was not sure if they should use so she had sat them aside in the refrigerator until she hears from GlaxoSmithKline (GSK). The nurse was informed that there had not been a recall on this lot but that investigation would be carried out. The reporter had return the one vial from the lot for investigation. The reported agreed to contact on follow up. This case has been linked with cases US2018GSK080169 and US2018GSK080194, reported by the same reporter.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: 56 yo Male states he was in his usual state of health until he had a routine primary care appointment yesterday and received a pneumonia vaccine to his left deltoid. He states shortly after getting home he began having general body aches and nausea and vomiting.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Lethargy, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever, lethargy, headache, tremor and chills. On an unknown date, the outcome of the fever, lethargy, headache, tremor and chills were recovered/resolved. The reporter considered the fever, lethargy, headache, tremor and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported via GlaxoSmithKline field based Medical Science Liaison (MSL) who received by an email. The patient experienced fever (body temperature was recorded as 101 degree F), chills, shaking, headache and lethargy for the next 2 days after the vaccination. No further details were provided in the email communication from the reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Influenza like illness, Injected limb mobility decreased, Lethargy
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX. Concomitant products included atorvastatin. On 4th may 2018 03:00, the patient received the 2nd dose of SHINGRIX. On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache, appetite lost, influenza-like symptoms and pain. On 4th May 2018 08:00, the patient experienced lethargy. In May 2018, the patient experienced injected limb mobility decreased. In May 2018, the outcome of the pain in arm, headache, lethargy, appetite lost, influenza-like symptoms, pain in injected limb mobility decreased were recovered/resolved. The reporter considered the pain in arm, headache, lethargy, appetite lost, influenza-like symptoms, pain and injected limb mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The reporter was a GlaxoSmithKline employee. The reporter was at a meeting last night before the late of reporting, where the patient at the meeting mentioned that she had the experienced sore arm that lasted for 2 days. The patient reported that, after receiving the second dose of SHINGRIX it was painful and that she had a hard time moving because of the pain that she had on the same side where she received her shot. The patient also stated that, the side effects were even more severe than that experienced after vaccination with the first dose. Five hours after the vaccination the patient experienced lethargy. The patient stated that she felt lethargic at the point when she went to bed at 8:00 pm, the same night after vaccination, she slept all night and felt flu like symptoms. This case was linked with case US2018081702, reported by the same reporter for the same patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX. Concomitant products included atorvastatin. On 4th may 2018 03:00, the patient received the 2nd dose of SHINGRIX. On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache, appetite lost, influenza-like symptoms and pain. On 4th May 2018 08:00, the patient experienced lethargy. In May 2018, the patient experienced injected limb mobility decreased. In May 2018, the outcome of the pain in arm, headache, lethargy, appetite lost, influenza-like symptoms, pain in injected limb mobility decreased were recovered/resolved. The reporter considered the pain in arm, headache, lethargy, appetite lost, influenza-like symptoms, pain and injected limb mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The reporter was a GlaxoSmithKline employee. The reporter was at a meeting last night before the late of reporting, where the patient at the meeting mentioned that she had the experienced sore arm that lasted for 2 days. The patient reported that, after receiving the second dose of SHINGRIX it was painful and that she had a hard time moving because of the pain that she had on the same side where she received her shot. The patient also stated that, the side effects were even more severe than that experienced after vaccination with the first dose. Five hours after the vaccination the patient experienced lethargy. The patient stated that she felt lethargic at the point when she went to bed at 8:00 pm, the same night after vaccination, she slept all night and felt flu like symptoms. This case was linked with case US2018081702, reported by the same reporter for the same patient.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in a 64-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date unknown). The patient's past medical history included diabetes. On 23rd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional information was reported as follows: This case was reported by a administrator. The patient had soreness for a period beyond 5 days. The reporter did not make any conclusion on the causality of the event the product. The reporter did not make any conclusion on the causality of the event and the product. It was not sure if the reporter agreed to follow up for this case.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Ear pain, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of ear pain in a 50-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date unknown). On 23rd April 2018, the patient received the 1st dose of SHINGRIX. On 24th April 2018, 1 days after receiving SHINGRIX, the patient experienced ear pain, neck pain, shoulder pain and axillary pain. On an unknown date, the patient experienced mobility decreased. On an unknown date, the outcome of the ear pain, neck pain, shoulder pain, axillary pain and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the ear pain, neck pain, shoulder pain, axillary pain and mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The patient experienced pain located from behind her ear back of neck to her shoulders and under her armpit. Less than a month after receiving the vaccination, the patient was unable to lift her arm. Till the time of reporting the events were still present but not that severe. The patient went to seek medical attention and was suggested she not get the second dose. The reporter did not comment anything on the causality of the event and the product. This case was linked with case US2018GSK082128 and case US2018GSK081371, reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX. Concomitant products included atorvastatin. On 22nd February 2018, the patient received the 1st dose of SHINGRIX 50 mcg/mg. On 22nd February 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. In February 2018, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The reporter was a GlaxoSmithKline employee. The reporter was at a meeting a night before the date of reporting, where the patient at the meeting mentioned that she had the experienced sore arm at the injection site that lasted for 5 days. The patient also stated that this event was more severe as compared to the 2nd time when she experienced the events. This case was linked with case US2018GSK087986 (dose 2), reported by the same reporter for the same patient.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash was unknown and the outcome of the pruritus was recovered/resolved. It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in a last week of reporting date. The vaccine was not administered at the reporter's pharmacy, so she did not have many details about the vaccination. On 5th May 2018, the patient came to the pharmacy, so she did not have many details about the vaccination. On 5th May 2018, the patient came to the pharmacy with the rash from shoulder to wrist on arm where the patient received SHINGRIX. The rash was initially itching, but by the time the patient went to the pharmacy, the itching had resolved.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, chills, swelling and fatigue. On an unknown date, the outcome of the fever, chills, swelling and fatigue were unknown. It was unknown if the reporter considered the fever, chills, swelling and fatigue to be related to SHINGRIX. Additional details were received as follows: The reporter spoke about some of the side effects. The reporter stated that he had fever, chills, swelling and fatigue for example he had experienced, within 14 hours of vaccination. This was all of the information that the reporter knew.
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood glucose increased in a adult female patient who received SHINGRIX. On 7th May 2018, the patient received SHINGRIX. On 7th May 2018, less than a day after receiving SHINGRIX, the patient experienced blood glucose increased On an unknown date, the outcome of the blood glucose increased was unknown. The reporter considered the blood glucose increased to be unrelated to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. On 7th May 2018 12:00, the patient received SHINGRIX. The patient noted her blood glucose number was high (300 units not reported). The patient insisted that, the SHINGRIX vaccine had nothing to do with high blood glucose, but her eating a candy bar did. The reporter did not wish to continue the report. No additional information was provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Memory impairment, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX. Concurrent medical conditions included osteoarthritis, rheumatoid arthritis and sulfonamide allergy. Concomitant products included acyclovir, Levothyroxine, methotrexate and hydrocortisone. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 4th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and rash. On 5th May 2018, the patient experienced tiredness, memory impairment and feeling abnormal. SHINGRIX was discontinued. On 6th May 2018, the outcome of the injection site pain, tiredness, memory impairment and feeling abnormal were recovered/resolved. On an unknown date, the outcome of the rash was recovering/resolving. The reporter considered the injection site pain, rash, tiredness, memory impairment and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The patient reported this case for herself. On the next day after vaccination, the patient noted soreness at site of injection and rash on her back, arm and down the side of her leg and groin area. One day after vaccination, the patient woke up and did not feel right in that she could not remember things and was very tired. The patient had lunch and went back to bed to rest. The patient also reported that, during her conversations with her husband, she had difficulty remembering things. On 6th May 2018, the patient was back to felt normal and that some of the rash still remained. The patient used hydrocortisone cream to treat the rash. The patient would not be getting the 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of inflammation localized in a female patient who received SHINGRIX. On 4th May 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced inflammation localized and erythema of extremities. On an unknown date, the outcome of the inflammation localized and erythema of extremities were unknown. It was unknown if the reporter considered the inflammation localized and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient's arm had been inflamed and red since. The reporter indicated that she was going to advise the patient to take some ibuprofen. Only pharmacist's first name and telephone number was provided. The reporter called the pharmacy but the pharmacist who left the message was not available. The reporter was able to obtain the pharmacy address.
Sex: M
Vaccine: 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 male patient who received SHINGRIX. On an unknown date, the patient received 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 unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. While line at the pharmacy to get SHINGRIX dose the reporter stated that the man (patient) in front of her noted he had SHINGRIX shot and had a sore arm. No further detail was available. This case has been linked with case US2018080703, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental overdose, Erectile dysfunction, Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site warmth in a 64-year-old male patient who received SHINGRIX. Co-suspect products included SHINGRIX. On 4th May 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) 1 ml and SHINGRIX (intramuscular) 1 ml. On 4th May 2018, not applicable after receiving SHINGRIX and less than a day after receiving SHINGRIX, the patient experienced injection site warmth, injection site erythema, injection site wheal, injection site swelling, inappropriate route of vaccination and accidental overdose. In May 2018, the patient experienced erection failure. On an unknown date the outcome of the injection site warmth, injection site erythema, injection site wheal, injection site swelling, erection failure, inappropriate route of vaccination and accidental overdose were unknown. It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site wheal, injection site swelling and erection failure to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The SHINGRIX vaccine was initially administered subcutaneously under the tricep in the fatty part of the left arm, which led to inappropriate route of vaccination and then administered a second time an hour later intramuscularly about an inch from the first injections, which led to accidental overdose. The injection site was hot and there was a welt. The health care professional called medical information and described the previously reported weld as a red, raised, hot spot. Less than a week after receiving SHINGRIX, the patient experienced erection failure.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site warmth in a 64-year-old male patient who received SHINGRIX. Co-suspect products included SHINGRIX. On 4th May 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) 1 ml and SHINGRIX (intramuscular) 1 ml. On 4th May 2018, not applicable after receiving SHINGRIX and less than a day after receiving SHINGRIX, the patient experienced injection site warmth, injection site erythema, injection site wheal, injection site swelling, inappropriate route of vaccination and accidental overdose. In May 2018, the patient experienced erection failure. On an unknown date the outcome of the injection site warmth, injection site erythema, injection site wheal, injection site swelling, erection failure, inappropriate route of vaccination and accidental overdose were unknown. It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site wheal, injection site swelling and erection failure to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The SHINGRIX vaccine was initially administered subcutaneously under the tricep in the fatty part of the left arm, which led to inappropriate route of vaccination and then administered a second time an hour later intramuscularly about an inch from the first injections, which led to accidental overdose. The injection site was hot and there was a welt. The health care professional called medical information and described the previously reported weld as a red, raised, hot spot. Less than a week after receiving SHINGRIX, the patient experienced erection failure.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of erythema in a 61-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced erythema, swelling, pain and malaise. On an unknown date, the outcome of the erythema, swelling, pain and malaise were recovered/resolved. The reporter considered the erythema, swelling, pain and malaise to be related to SHINGRIX. Additional details were provided as follows: The case was reported by licensed practical nurse (LPN). The age at vaccination was not reported, but it could be either 61 or 62 year old. The reporter had the limited information.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received BOOSTRIX (batch number 9PD92, expiry date 30th May 2020). On 1st May 2018, the patient received BOOSTRIX (intramuscular). On 1st May 2018, less than a day after receiving BOOSTRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to BOOSTRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient received BOOSTRIX in the right arm. The patient experienced soreness at the injection site along with a round, red area around the injection site approximately 2 x 2 cm in area.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Injected limb mobility decreased, Injection site pain, Myalgia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included BCG Vaccine. On 16th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, injected limb mobility decreased, chest pain and muscle pain. In April 2018, the outcome of the injected limb mobility decreased was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the chest pain and muscle pain were unchanged. The reporter considered the injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased, chest pain and muscle pain to be related to SHINGRIX. Additional information was reported as follows: In March 2018, the patient received the Tuberculosis shot in her left forearm. The patient reported that, the injection site hurt when the SHINGRIX vaccine was being administered in the left deltoid. Within two to three hours after receiving the vaccination the patient also began to experience pain in the top muscle of her back and pain in her chest under the collar bone. By the third day of vaccination, the patient was able to move her arm but it was still painful. It took a week, after the vaccination before she was able to lift her arm over her head. The patient had aches, especially after any type of exercise till the date of reporting. The patient noticed this discomfort because she exercised a lot. She stopped in to her physician's office on the day of reporting and asked the nurse if this was normal. The patient was told it is not and that she should put a hot pack on her arm. The patient gave permission for her physician to be contacted and provided information for the same.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain x 2 1/2 months.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site reaction in a adult patient who received SHINGRIX. On 2nd May 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site reaction, injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site reaction, injection site erythema, injection site swelling and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site reaction, injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed injection site reaction including injection site swelling, injection site redness and injection site pruritus. The reaction size was like a quarter diameter (25 cents coin). On 4th May 2018, the symptoms were still present. It was unknown if the reporter agree to follow up with GSK.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Feeling hot, Hyperhidrosis, Lymph node pain, Musculoskeletal pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of adverse reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction, neck pain, shoulder pain, general body pain, lymph node pain, feeling of warmth and sweating. On an unknown date, the outcome of the adverse reaction, neck pain, shoulder pain, general body pain, lymph node pain, feeling of warmth and sweating were unknown. It was unknown if the reporter considered the adverse reaction, neck pain, shoulder pain, general body pain, lymph node pain, feeling of warmth and sweating to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient experienced systemic reactions. The reporter was agreed to FU from GSK.
Sex: U
Vaccine: VARZOS
Symptoms: Neck pain, Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of adverse reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction, neck pain, shoulder pain, general body pain, lymph node pain, feeling of warmth and sweating. On an unknown date, the outcome of the adverse reaction, neck pain, shoulder pain, general body pain, lymph node pain, feeling of warmth and sweating were unknown. It was unknown if the reporter considered the adverse reaction, neck pain, shoulder pain, general body pain, lymph node pain, feeling of warmth and sweating to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient experienced systemic reactions. The reporter was agreed to FU from GSK.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes virus infection, Herpes zoster, Influenza like illness, Influenza virus test negative
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles, herpes virus infection, feeling bad, general body pain, fever and influenza-like symptoms. On an unknown date, the outcome of the shingles, herpes virus infection, rash, feeling bad, general body pain, fever and influenza-like symptoms were unknown. It was unknown if the reporter considered the shingles, herpes virus infection, rash, feeling bad, general body pain, fever and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. A few days after the shot, the patient felt badly. Extreme body aches started one morning and that evening the patient had 101 degree fever. The following day the patient still felt fluish. The patient went to physician and she tested for the flu. It was negative, all the symptoms seemed like flu (101 temperature at that night). Next day the Shingle outbreaks started. It had been three weeks and the patient had 5 shingle rashes and more than 10 Herpes outbreaks. The patient was asking what might help his condition. This case was considered as suspected vaccination failure as the time to onset and primary vaccination schedule completion were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles, herpes virus infection, feeling bad, general body pain, fever and influenza-like symptoms. On an unknown date, the outcome of the shingles, herpes virus infection, rash, feeling bad, general body pain, fever and influenza-like symptoms were unknown. It was unknown if the reporter considered the shingles, herpes virus infection, rash, feeling bad, general body pain, fever and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. A few days after the shot, the patient felt badly. Extreme body aches started one morning and that evening the patient had 101 degree fever. The following day the patient still felt fluish. The patient went to physician and she tested for the flu. It was negative, all the symptoms seemed like flu (101 temperature at that night). Next day the Shingle outbreaks started. It had been three weeks and the patient had 5 shingle rashes and more than 10 Herpes outbreaks. The patient was asking what might help his condition. This case was considered as suspected vaccination failure as the time to onset and primary vaccination schedule completion were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a nurse and described the occurrence of headache in a 84-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml. On 1st May 2018, less than a year after receiving SHINGRIX, the patient experienced headache, shoulder pain and neck pain. In May 2018, the outcome of the headache, shoulder pain and neck pain were recovered/resolved. It was unknown if the reporter considered the headache, shoulder pain and neck pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX. On 2nd May 2018, the patient received SHINGRIX. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site itching, injection site warmth and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site itching, injection site warmth and injection site erythema were unknown. The reporter considered the extensive swelling of vaccinated limb, injection site itching, injection site warmth and injection site erythema to be possibly related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. On 4th May 2018, the patient experienced injection site swelling with diameter more than 100 mm, itching, warm and redness. Duration of adverse events were reported as 3 days, however event outcome were reported as Unknown.