chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX. Concurrent medical conditions included shingles (10 years ago) and seasonal allergy. Concomitant products included atenolol, NASACORT, Probiotic, vitamin D and ELIQUIS. On 19th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 19th mMy 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, headache and nightmare. On 20th May 2018, the patient experienced feelings of weakness, shaky feelings, influenza-like symptoms and fever. The patient was treated with TYLENOL. On 19th May 2018, the outcome of the injection site pain was recovered/resolved. On 20th May 2018, the outcome of the nightmare was recovered/resolved. On 21st May 2018, the outcome of the general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, feelings of weakness, shaky feelings, influenza-like symptoms, fever and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, feelings of weakness, shaky feelings, influenza-like symptoms, headache and nightmare to be related to SHINGRIX. The reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The patient experienced pain at injection site during the injection. By the evening of the day of vaccination, at around 9 pm, the patient experienced headache, body ache, difficulty sleeping, had a nightmare, had runny and stuffy nose and felt nauseated. One day after vaccination, the patient experienced feelings of weakness, shaky feelings, influenza-like symptoms and fever. The patient reported that this contented through Sunday, 20th May 2018 and she also felt weak and shaky and could not shower or attend church. The patient had a fever of 101 degree F and she took TYLENOL to treat this. The patient had flu like symptoms that lasted all day Sunday and that she went to bed Sunday night at 8:30 pm. When she awoke Monday, 21st May 2018 in the morning, the symptoms had resolved, she felt fine and was able to go to work. The patient was unable to provided full demographics for pharmacy or for her physician. The contact details of the physician was provided.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Musculoskeletal pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivers in a 51-year-old male patient who received SHINGRIX (batch number ZY3X4, expiry date April 2019). Concomitant products included Omeprazole, LEXAPRO and Toprol. On 17th May 2018, the patient received SHINGRIX (intramuscular). On 18th May 2018,1 days after receiving SHINGRIX, the patient experienced shivers, shoulder pain, pain and influenza-like symptoms. On an unknown date, the outcome of the shivers, shoulder pain, pain and influenza-like symptoms were recovering/resolving. It was unknown if the reporter considered the shivers, shoulder pain, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The next day after vaccination, the patient experienced shivers at night and flu like symptoms which included achiness, shoulder hurts. The patient said that he was feeling better today but he was still having symptoms.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Creatinine urine increased, Fatigue, Injection site bruising, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 74-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (experienced in 2000, 2015 and 2017, which were very tiny and smaller than a quarter in size). Concomitant products included amlodipine, Levothyroxine, simvastatin, Aspirin and Valsartan HCT. On 2nd May 2018, the patient received the 1st dose of SHINGRIX .5ml. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site bruising. On 3rd May 2018, the patient experienced urinary tract infection, fatigue, fever and shivering. On 4th May 2018, the patient experienced creatinine urine increased. On 16th May 2018, the patient experienced tremor. The patient was treated with MACROBID and ALEVE. On 3rs May 2018, the outcome of the fatigue and shivering were recovered/resolved. On an unknown date, the outcome of the urinary tract infection was unknown and the outcome of the injection site erythema, fever, tremor and injection site bruising were recovered/resolved and the outcome of the creatinine urine increased was not recovered/not resolved. The reporter considered the urinary tract infection, injection site erythema, fatigue, fever, shivering, creatinine urine increased, tremor and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness and bruising feeling at the injection site on her first day. Those symptoms resolved by the end of the weekend. On 3rd May 2018, 1 day after vaccination, at around 2 to 3:00 PM, the patient thought she was not able to get to her car after an event, because she experienced a wave of tiredness that came over her. She got home and stated shivering and she felt like she had a fever with exhaustion and body fatigue. This went on for a couple of hours and around 8:00 PM, the symptoms resolved. The following day on 4th May 2018, the patient had labs done. On 6th May 2018, the patient's labs came back and she had a urinary tract infection and the patient was put on MACROBED and she finished the medication on 16th May 2018. On 16th May 2018, 14 days after vaccination, the patient started to shutter and shake and could barely brush her teeth. She also had a fever of 102 degree F. She claims that her fever was more significant on 16th may 2018 and it lasted longer. She took ALEVE for her fever. On 22nd May 2018, the patient had additional lab work and they would like for her to have an ultrasound done because her lab work was screwy and her creatinine and kidney levels were elevated and worse now. The contact details of the physician was provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test abnormal, Loss of personal independence in daily activities, Pyrexia, Renal function test abnormal, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 74-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (experienced in 2000, 2015 and 2017, which were very tiny and smaller than a quarter in size). Concomitant products included amlodipine, Levothyroxine, simvastatin, Aspirin and Valsartan HCT. On 2nd May 2018, the patient received the 1st dose of SHINGRIX .5ml. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site bruising. On 3rd May 2018, the patient experienced urinary tract infection, fatigue, fever and shivering. On 4th May 2018, the patient experienced creatinine urine increased. On 16th May 2018, the patient experienced tremor. The patient was treated with MACROBID and ALEVE. On 3rs May 2018, the outcome of the fatigue and shivering were recovered/resolved. On an unknown date, the outcome of the urinary tract infection was unknown and the outcome of the injection site erythema, fever, tremor and injection site bruising were recovered/resolved and the outcome of the creatinine urine increased was not recovered/not resolved. The reporter considered the urinary tract infection, injection site erythema, fatigue, fever, shivering, creatinine urine increased, tremor and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness and bruising feeling at the injection site on her first day. Those symptoms resolved by the end of the weekend. On 3rd May 2018, 1 day after vaccination, at around 2 to 3:00 PM, the patient thought she was not able to get to her car after an event, because she experienced a wave of tiredness that came over her. She got home and stated shivering and she felt like she had a fever with exhaustion and body fatigue. This went on for a couple of hours and around 8:00 PM, the symptoms resolved. The following day on 4th May 2018, the patient had labs done. On 6th May 2018, the patient's labs came back and she had a urinary tract infection and the patient was put on MACROBED and she finished the medication on 16th May 2018. On 16th May 2018, 14 days after vaccination, the patient started to shutter and shake and could barely brush her teeth. She also had a fever of 102 degree F. She claims that her fever was more significant on 16th may 2018 and it lasted longer. She took ALEVE for her fever. On 22nd May 2018, the patient had additional lab work and they would like for her to have an ultrasound done because her lab work was screwy and her creatinine and kidney levels were elevated and worse now. The contact details of the physician was provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan, Urinary tract infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 74-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (experienced in 2000, 2015 and 2017, which were very tiny and smaller than a quarter in size). Concomitant products included amlodipine, Levothyroxine, simvastatin, Aspirin and Valsartan HCT. On 2nd May 2018, the patient received the 1st dose of SHINGRIX .5ml. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site bruising. On 3rd May 2018, the patient experienced urinary tract infection, fatigue, fever and shivering. On 4th May 2018, the patient experienced creatinine urine increased. On 16th May 2018, the patient experienced tremor. The patient was treated with MACROBID and ALEVE. On 3rs May 2018, the outcome of the fatigue and shivering were recovered/resolved. On an unknown date, the outcome of the urinary tract infection was unknown and the outcome of the injection site erythema, fever, tremor and injection site bruising were recovered/resolved and the outcome of the creatinine urine increased was not recovered/not resolved. The reporter considered the urinary tract infection, injection site erythema, fatigue, fever, shivering, creatinine urine increased, tremor and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness and bruising feeling at the injection site on her first day. Those symptoms resolved by the end of the weekend. On 3rd May 2018, 1 day after vaccination, at around 2 to 3:00 PM, the patient thought she was not able to get to her car after an event, because she experienced a wave of tiredness that came over her. She got home and stated shivering and she felt like she had a fever with exhaustion and body fatigue. This went on for a couple of hours and around 8:00 PM, the symptoms resolved. The following day on 4th May 2018, the patient had labs done. On 6th May 2018, the patient's labs came back and she had a urinary tract infection and the patient was put on MACROBED and she finished the medication on 16th May 2018. On 16th May 2018, 14 days after vaccination, the patient started to shutter and shake and could barely brush her teeth. She also had a fever of 102 degree F. She claims that her fever was more significant on 16th may 2018 and it lasted longer. She took ALEVE for her fever. On 22nd May 2018, the patient had additional lab work and they would like for her to have an ultrasound done because her lab work was screwy and her creatinine and kidney levels were elevated and worse now. The contact details of the physician was provided.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Influenza like illness, Injection site cellulitis, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received SHINGRIX (batch number NR4Z4, expiry date 11th October 2020). On 21st May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, influenza-like symptoms, injection site warmth and injection site cellulitis. On an unknown date, the outcome of the extensive swelling of vaccinated limb, influenza-like symptoms, injection site warmth and injection site cellulitis were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, influenza-like symptoms, injection site warmth and injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on unknown arm. The health care professional reported that the patient experienced flulike symptoms that subsided but also had swelling of the arm about 6 into 4 inches. The health care professional was worried as it could be a cellulitis. The health care professional reported that the patient was experiencing number localized reactions only after receiving the 2nd dose. The health care professional did not have any patient information or lot number or expiry date.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX (batch number 32GR4 ?, expiry date 4th July 2020,GSK note: the reported lot number did not match with any GSK lot number). On 18th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 18th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovering/resolving. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. After receiving SHINGRIX, the patient experienced difficulty moving arm. The reported batch number of SHINGRIX (32GR4) did not exist in the sales database and was updated to 32GR4 ?
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On 17th May 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The event redness at injection site lasted for 7 days after vaccine administered. No other details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sale rep and described the occurrence of pain in arm in a adult 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 pain in arm and sickness. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the pain in arm and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist reported that he had a number of patients who had complained about being sick for a week after vaccination with SHINGRIX. The patients were also reporting arm pain. The pharmacist was questioning about whether these patients would return for a second dose.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site discolouration, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX. On 18th May 2018, 19:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site induration, injection site warmth, injection site itching and injection site discoloration. On 18th May 2018, the patient experienced joint pain, tiredness, weakness and muscle pain. On an unknown date, the outcome of the joint pain, weakness, muscle pain, injection site pain, injection site swelling, injection site erythema, injection site induration, injection site itching and injection site discoloration were recovering/resolving and the outcome of the tiredness and injection site warmth were recovered/resolved. The reporter considered the joint pain, tiredness, weakness and muscle pain to be almost certainly related to SHINGRIX. The reporter considered the injection site pain, injection site swelling, injection site erythema, injection site induration, injection site warmth, injection site warmth, injection site itching and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: On the same evening after receiving SHINGRIX, the patient began feeling very tired, developed joint pain, muscle pain and weakness and was asleep by 8:30 pm. The following day (on 19th May 2018), the muscle pain, joint pain and weakness were improving and she felt better, and again, at around 6:00 pm, the muscle and joint pain and tiredness recurred, and she again was in bed by 8:30 pm and slept 12 hours which was very unusual for her. On 20th May 2018, she felt much better and did not have the recurrence of her symptoms and did not have to go to bed early because of the tiredness. She received her injection on her left deltoid, and experienced pain, swelling, redness, and skin hot to touch at injection site. Presently, the site was hard, about 3 inches in diameter and discolored, but not black and blue. At the time of reporting, she stated that the injection site was improving and was now itchy. She was inquiring if the same thing would happen with the 2nd dose of SHINGRIX. Reviewed the PI including adverse reactions, how often they might occur with 2nd dose, and reviewed information from the clinical trials. The patient denied any fever or chills. The patient was planning to received the 2nd injection in a timely manner. She just wanted to be prepared on what to expect. The patient had denied permission to contact her physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX. On 18th May 2018, 19:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site induration, injection site warmth, injection site itching and injection site discoloration. On 18th May 2018, the patient experienced joint pain, tiredness, weakness and muscle pain. On an unknown date, the outcome of the joint pain, weakness, muscle pain, injection site pain, injection site swelling, injection site erythema, injection site induration, injection site itching and injection site discoloration were recovering/resolving and the outcome of the tiredness and injection site warmth were recovered/resolved. The reporter considered the joint pain, tiredness, weakness and muscle pain to be almost certainly related to SHINGRIX. The reporter considered the injection site pain, injection site swelling, injection site erythema, injection site induration, injection site warmth, injection site warmth, injection site itching and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: On the same evening after receiving SHINGRIX, the patient began feeling very tired, developed joint pain, muscle pain and weakness and was asleep by 8:30 pm. The following day (on 19th May 2018), the muscle pain, joint pain and weakness were improving and she felt better, and again, at around 6:00 pm, the muscle and joint pain and tiredness recurred, and she again was in bed by 8:30 pm and slept 12 hours which was very unusual for her. On 20th May 2018, she felt much better and did not have the recurrence of her symptoms and did not have to go to bed early because of the tiredness. She received her injection on her left deltoid, and experienced pain, swelling, redness, and skin hot to touch at injection site. Presently, the site was hard, about 3 inches in diameter and discolored, but not black and blue. At the time of reporting, she stated that the injection site was improving and was now itchy. She was inquiring if the same thing would happen with the 2nd dose of SHINGRIX. Reviewed the PI including adverse reactions, how often they might occur with 2nd dose, and reviewed information from the clinical trials. The patient denied any fever or chills. The patient was planning to received the 2nd injection in a timely manner. She just wanted to be prepared on what to expect. The patient had denied permission to contact her physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX. On 18th May 2018, 19:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site induration, injection site warmth, injection site itching and injection site discoloration. On 18th May 2018, the patient experienced joint pain, tiredness, weakness and muscle pain. On an unknown date, the outcome of the joint pain, weakness, muscle pain, injection site pain, injection site swelling, injection site erythema, injection site induration, injection site itching and injection site discoloration were recovering/resolving and the outcome of the tiredness and injection site warmth were recovered/resolved. The reporter considered the joint pain, tiredness, weakness and muscle pain to be almost certainly related to SHINGRIX. The reporter considered the injection site pain, injection site swelling, injection site erythema, injection site induration, injection site warmth, injection site warmth, injection site itching and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: On the same evening after receiving SHINGRIX, the patient began feeling very tired, developed joint pain, muscle pain and weakness and was asleep by 8:30 pm. The following day (on 19th May 2018), the muscle pain, joint pain and weakness were improving and she felt better, and again, at around 6:00 pm, the muscle and joint pain and tiredness recurred, and she again was in bed by 8:30 pm and slept 12 hours which was very unusual for her. On 20th May 2018, she felt much better and did not have the recurrence of her symptoms and did not have to go to bed early because of the tiredness. She received her injection on her left deltoid, and experienced pain, swelling, redness, and skin hot to touch at injection site. Presently, the site was hard, about 3 inches in diameter and discolored, but not black and blue. At the time of reporting, she stated that the injection site was improving and was now itchy. She was inquiring if the same thing would happen with the 2nd dose of SHINGRIX. Reviewed the PI including adverse reactions, how often they might occur with 2nd dose, and reviewed information from the clinical trials. The patient denied any fever or chills. The patient was planning to received the 2nd injection in a timely manner. She just wanted to be prepared on what to expect. The patient had denied permission to contact her physician.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site pain, injection site swelling, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site rash, injection site pain, injection site swelling and injection site erythema were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site rash, injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered SHINGRIX on the left arm subcutaneously rather than intramuscularly, which led to incorrect route of vaccination. The patient also experienced a rash which was red, swollen and painful at the injection site as bad reaction. The side effects had resolved but no additional details was available. The clinic claimed that they reported this adverse event information but the sales representative said that she discovered on the reporting date that they did not report it to the proper channels.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Condition aggravated, Erythema, Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pimples in a 56-year-old female patient who received SHINGRIX (batch number B334Y ?, expiry date 17th October 2020). Concurrent medical conditions included pimples, pruritus and erythema. Concomitant products included VALTREX. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5. On 24th May 2018, 1 days after receiving SHINGRIX, the patient experienced pimples, erythema, pruritus, rash and condition aggravated. On an unknown date, the outcome of the pimples, erythema and pruritus were not recovered/not resolved and the outcome of the rash and condition aggravated were unknown. The reporter considered the pimples, erythema, pruritus, rash and condition aggravated to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The health care professional (HCP) reported that the patient had a red, itchy pimple on her back prior to receiving SHINGRIX but was taking VALTREX for it and it did go down. However, the patient then got SHINGRIX and the rash reappeared. The HCP did not think this was due to the vaccine because patient had these symptoms prior to the vaccine and it was getting better but they got worse after getting the vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Culture, Erythema, Skin lesion
Clinical narrative: Patient presented with finger lesions (raised white blisters on a red base) (6-7 blisters) on 3rd finger left hand. Culture sent to Laboratory-results pending. Patient treated with Famciclovir 500mg 1 PO TID #15. There was a very faint pink stripe noted up arm.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site warmth and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The case was reported by medical assistant via click to chat. The age at vaccination was not reported. The health care professional reported that the patient received vaccine subcutaneously, which led to inappropriate route of vaccination. The health care professional might have also reported the adverse event by phone but no last name or contact details were provided via chat and was unable to verify if this was reported by the same health care professional or not.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Laboratory test, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received SHINGRIX. Previously administered products included SHINGRIX (no adverse event). In April 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms and swelling arm. On an unknown date, the outcome of the fever, influenza-like symptoms and swelling arm were recovered/resolved. The reporter considered the fever, influenza-like symptoms and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever of 100.8 for 24 hours. She also experienced a swollen arm, with the swelling size of 3 inches by 2 inches, the patient also experienced overall flu like symptoms. She did not require hospitalization. She did not require hospitalization. The adverse event was filed as reported. No additional details provided by the representative.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX. In May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness, erythema of extremities and pain in arm. On an unknown date, the outcome of the injection site erythema and erythema of extremities were recovered/resolved and the outcome of the injection site tenderness and pain in arm were unknown. It was unknown if the reporter considered the injection site erythema, injection site tenderness, erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered SHINGRIX 6 days before the reporting date. The patient reported redness and tenderness at injection site and on arm 5 days after receiving the vaccine. The patient has had redness lasting about 7 days (discrepant information). Clarification had been requested for correct onset time and duration. The physician was not too concerned and she was following up with patient again on the reporting date. She would call back after connecting with the patient. The reporter agreed to be contacted for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of numbness in hand in a 79-year-old 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 numbness in hand, muscle pain and tingling of extremity. On an unknown date, the outcome of the numbness in hand, muscle pain and tingling of extremity were not recovered/not resolved. It was unknown if the reporter considered the numbness in hand, muscle pain and tingling of extremity to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported the patient was seen by him after receiving SHINGRIX vaccine. The patient experienced numbness and tingling of both hands, and general muscle aches.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX. The patient's past medical history included shingles. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site itching and injection site lump. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were unknown and the outcome of the injection site lump was recovering/resolving. The reporter considered the injection site erythema, injection site warmth and injection site lump to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site itching to be related to SHINGRIX. Additional details were provided as follow: The pharmacist reported the adverse event on behalf of the patient. The age at vaccination was not reported. The patient received SHINGRIX in the right arm. The reporter stated that the patient received the SHINGRIX vaccine and later that evening or the next day she felt a knot at the injection site. The reporter stated that the patient experienced an injection site reaction that he described as a circular red area around the injection site that was warm to touch and the diameter was the size of a grapefruit. The reporter stated that he told the patient to monitor the redness and aid that the patient came into the pharmacy 2 days after receiving SHINGRIX to show the injection site and told the reporter that she did not think that the area was getting larger. The reporter stated that the patient might have experienced itchiness at the injection site, but the reporter could not remember. The reporter stated that he would be following up with the patient soon.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 68-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site itching and injection site pain. On 22nd May 2018, the patient experienced fever, general body pain and headache. On an unknown date, the outcome of the injection site induration, injection site erythema, injection site itching and injection site pain. On 22nd May 2018, the patient experienced fever, general body pain and headache. On an unknown date, the outcome of the injection site induration, injection site erythema, injection site itching and injection site pain were not recovered/not resolved and the outcome of the fever, general body pain and headache were recovering/resolving. The reporter considered the injection site induration, injection site erythema, injection site itching, injection site pain, fever, general body pain and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The HCP was a retail pharmacist. The healthcare professional (HCP) stated that patient developed a headache, fever, and body soreness within 24 hours of receiving the SHINGRIX vaccine. Since then those symptoms were resolving at the time of reporting. The patient had also developed a hard, red, itchy, painful area that was 3 inches in diameter on the patients right arm 2 and 1/2 inches below the injection site. The HCP stated that the patient not had any interventions or sought any medical treatment other than to call the pharmacy. The HCP recommended the patient that call her MD, but patient declined.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 68-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site itching and injection site pain. On 22nd May 2018, the patient experienced fever, general body pain and headache. On an unknown date, the outcome of the injection site induration, injection site erythema, injection site itching and injection site pain. On 22nd May 2018, the patient experienced fever, general body pain and headache. On an unknown date, the outcome of the injection site induration, injection site erythema, injection site itching and injection site pain were not recovered/not resolved and the outcome of the fever, general body pain and headache were recovering/resolving. The reporter considered the injection site induration, injection site erythema, injection site itching, injection site pain, fever, general body pain and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The HCP was a retail pharmacist. The healthcare professional (HCP) stated that patient developed a headache, fever, and body soreness within 24 hours of receiving the SHINGRIX vaccine. Since then those symptoms were resolving at the time of reporting. The patient had also developed a hard, red, itchy, painful area that was 3 inches in diameter on the patients right arm 2 and 1/2 inches below the injection site. The HCP stated that the patient not had any interventions or sought any medical treatment other than to call the pharmacy. The HCP recommended the patient that call her MD, but patient declined.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient arm swollen very large, intense redness and itching - afraid the skin will deteriorate. Advised antihistamine, cold pack, TYLENOL.
Age: 60.0
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Back pain, Chest pain, Herpes zoster, Rash
Clinical narrative: Patient has active Shingles outbreak. Symptoms of rash and pain began about 10 days after receiving SHINGRIX and PREVNAR. Patient is immunocompromised. Sought treatment from Dr. who prescribed Valacyclovir 1g TID.
Age: 60.0
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Herpes zoster, Immunodeficiency, Pain, Rash
Clinical narrative: Patient has active Shingles outbreak. Symptoms of rash and pain began about 10 days after receiving SHINGRIX and PREVNAR. Patient is immunocompromised. Sought treatment from Dr. who prescribed Valacyclovir 1g TID.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain
Clinical narrative: Initial minor soreness at shot site. Pain intensified, moving into shoulder and neck. Approximately 6-7 hours later, pain increased considerably in the shoulder as well as the neck region (trapezius). Finally, the pain. Gradually subsided after taking 800 mg ibuprofen.
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, MMRV, PNC13
Symptoms: Crying, Influenza virus test negative, Irritability, Malaise, Pyrexia
Clinical narrative: She took vaccination at 11 AM, she slept 12, woke up at 5 PM with 40 degrees C. Very high temperature and crying all night, looking very sick. She stayed with high fever despite using 120 ml gram TYLENOL and cool shower. The baby temperature went down on the third day. This is the third day and baby look sick with eyes really sick and irritable and without energy.
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, MMRV, PNC13
Symptoms: Urine analysis normal
Clinical narrative: She took vaccination at 11 AM, she slept 12, woke up at 5 PM with 40 degrees C. Very high temperature and crying all night, looking very sick. She stayed with high fever despite using 120 ml gram TYLENOL and cool shower. The baby temperature went down on the third day. This is the third day and baby look sick with eyes really sick and irritable and without energy.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Mobility decreased, Muscle strain
Clinical narrative: Round red circle and tenderness on arm at site of shot; severe lower back and muscle strain making necessary to stay in bed all day; Could not lift or bend  for 2-3days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Pyrexia
Clinical narrative: Injection was given 05/30/2018. Patient came in 06/01/2018 to show reaction. The reaction was approximately 5 inches in diameter, redness, and blistering area 1.5 inches in diameter near a small BANDAID covering the injection site. Patient's daughter reported the reaction began 05/31/2018 and her mother was in the hospital on that day with fever when she noticed the reacton.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood culture negative, Chest X-ray normal, Chills, Culture urine negative, Dizziness
Clinical narrative: Patient received vaccination at Pharmacy on 5/31/2018, and within a twenty four hour period developed a fever, chills, myalgia, shivers, dizziness and sought medication attention.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient received vaccination at Pharmacy on 5/31/2018, and within a twenty four hour period developed a fever, chills, myalgia, shivers, dizziness and sought medication attention.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Myalgia, Product quality issue, Pyrexia
Clinical narrative: Patient received vaccination at Pharmacy on 5/31/2018, and within a twenty four hour period developed a fever, chills, myalgia, shivers, dizziness and sought medication attention.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Paraesthesia, Pruritus, Rash
Clinical narrative: Patient came back to the pharmacy today and said he thought he was having a reaction to the shingles vaccination. He showed me a rash on his right forearm that he described as extremely uncomfortable, itchy and said it had a strange tingling sensation that concentrated on his arm but would radiate around his body. He also said the same rash was starting to develop on his scalp.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Hyperaesthesia, Myalgia
Clinical narrative: Pain in arm muscle and shoulder joint. Worse symptoms after 1 1/2 weeks, by third week is improving. Some fatigue and skin sensitivity.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site joint pain, Injection site joint swelling, Injection site pain, Injection site swelling, X-ray limb
Clinical narrative: Patient came to the pharmacy on 05/31 (26 days after getting immunized), that he has left shoulder joint pain and it is swollen. He spoke to the RPh on duty, that his left shoulder top started hurting a couple of days/ within a week of getting the shot. RPh told him if it was painful & swollen, he can take Ibuprofen, Advil, or Tylenol and put some ice on the swollen shoulder. Per Rph pt refused to take those meds he recommended to alleviate pain but instead told him he had went to dr to have an xray & gave the RPh the rejection from insurance that they won't pay for the vaccine that was given to him on 05/05/18.
Age: 52.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Back pain, Injection site pain, Insomnia, Mobility decreased, Pain
Clinical narrative: Stabbing arm pain in left deltoid radiating to fingers and between shoulders. The stabbing pain occurs when the muscle is stretched otherwise it is a dull pain similar to a bruise. Unable to sleep on left side due to pain. Unable to lift overhead without pain.
Age: 52.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Stabbing arm pain in left deltoid radiating to fingers and between shoulders. The stabbing pain occurs when the muscle is stretched otherwise it is a dull pain similar to a bruise. Unable to sleep on left side due to pain. Unable to lift overhead without pain.
Age: 52.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Stabbing arm pain in left deltoid radiating to fingers and between shoulders. The stabbing pain occurs when the muscle is stretched otherwise it is a dull pain similar to a bruise. Unable to sleep on left side due to pain. Unable to lift overhead without pain.
Age: 52.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Back pain, Injection site pain, Insomnia, Mobility decreased, Pain
Clinical narrative: Stabbing arm pain in left deltoid radiating to fingers and between shoulders. The stabbing pain occurs when the muscle is stretched otherwise it is a dull pain similar to a bruise. Unable to sleep on left side to pain. Unable to lift overhead without pain.
Age: 52.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Stabbing arm pain in left deltoid radiating to fingers and between shoulders. The stabbing pain occurs when the muscle is stretched otherwise it is a dull pain similar to a bruise. Unable to sleep on left side to pain. Unable to lift overhead without pain.
Age: 52.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Stabbing arm pain in left deltoid radiating to fingers and between shoulders. The stabbing pain occurs when the muscle is stretched otherwise it is a dull pain similar to a bruise. Unable to sleep on left side to pain. Unable to lift overhead without pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: 5/30/2018: 2 am chills, 8 am nausea, muscle pain, tiredness, dizzy, throwing up, warmth, redness and swelling at injection site, very sore to the touch. After throwing up at 9am I felt a little better, continued to feel better as day went on...there is still redness, pain on touch, warmth and swelling at injection site 3 days later- 6/2/18.