chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Influenza like illness, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. 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 influenza-like symptoms, dizziness, headache, fever and nausea. On an unknown date, the outcome of the influenza-like symptoms, dizziness, headache, fever and nausea were unknown. It was unknown if the reporter considered the influenza-like symptoms, dizziness, headache, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The insurance plan told to reporter that she can pay for SHINGRIX at pharmacy and take it to her doctor's office at hospital across the street from the pharmacy to get injection at her doctor's office. The reporter's doctor agreed and the reporter did not had to have an appointment. They said her to come to office and nurse would do injection as soon the reporter got the medicine. The patient experienced flu like symptoms, dizziness, headache, fever and nausea after the 1st shot at pharmacy so she did not want to sit in a pharmacy with those symptoms again. The patient was so glad that she thought that she could get injection at doctor's office especially since the patient also read that the pharmacist often missed the deltoid muscle. Today, the patient called to verify that pharmacy would sell her the medicine through insurance and explained that she would be taking it across the street to get injection at her doctor's office at the hospital clinic. The pharmacist said that they could not sell it to the patient as she could get in an accident driving across street or medicine could get hot. So the patient was not going to let the pharmacist inject so may had to be forced into not getting the 2nd  shot because of fear of getting it again at pharmacist. The patient asked that why drug plan and her doctor planned to do work. The pharmacist said they had to do injection that they are not allowed to sell her the medicine to take to her doctor. The patient inquired what can be done to get shot from doctor's office if pharmacists refused to sell it.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. 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 shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician said that he saw the patient one week post SHINGRIX vaccination with shingles. The physician described the outbreak as being in 2 dermatomes. The patient received the vaccine at a pharmacy and not in his office. The physician agreed for contact on follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. 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 injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The physician reported pain, redness and swelling in 2 or 3 patients that had received SHINGRIX vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoscopy, Chills, Fatigue, Headache, Insomnia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 9th May 2018). On 15th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia, headache, fatigue, nausea, shivering, autoscopic phenomena and insomnia. On an unknown date, the outcome of the myalgia, headache, fatigue, nausea, shivering, autoscopic phenomena and insomnia were unknown. It was unknown if the reporter considered the myalgia, headache, fatigue, nausea, shivering, autoscopic phenomena and insomnia to be related to SHINGRIX. Additional details were provided as follows: The patient experienced reactogenicity greater than with dose 1 and believed these symptoms were related to the vaccine. She was experiencing out of body feeling which was unusual for her. She was feeling better on the day of reporting morning and anticipated continuation of improvement in symptoms. She preferred not to be contacted for follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 9th May 2018). On 15th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia, headache, fatigue, nausea, shivering, autoscopic phenomena and insomnia. On an unknown date, the outcome of the myalgia, headache, fatigue, nausea, shivering, autoscopic phenomena and insomnia were unknown. It was unknown if the reporter considered the myalgia, headache, fatigue, nausea, shivering, autoscopic phenomena and insomnia to be related to SHINGRIX. Additional details were provided as follows: The patient experienced reactogenicity greater than with dose 1 and believed these symptoms were related to the vaccine. She was experiencing out of body feeling which was unusual for her. She was feeling better on the day of reporting morning and anticipated continuation of improvement in symptoms. She preferred not to be contacted for follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes virus infection, Herpes zoster, Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of herpes virus infection in a adult patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced herpes virus infection, shingles, malaise, fever, pain and rash. On an unknown date, the outcome of the herpes virus infection, shingles, malaise, fever, pain and rash were unknown. It was unknown if the reporter considered the herpes virus infection, shingles, malaise, fever, pain and rash to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine 1 week ago and presented to me with malaise low grade fever and painful rash right flank clinically suspicious for shingles. The skin biopsy was performed for which results showed Herpesvirus infection. It was advised if ever reported and if possible it was coincidence. The patient also asking if she should get the follow up vaccination in a few months.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Viral test positive
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of herpes virus infection in a adult patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced herpes virus infection, shingles, malaise, fever, pain and rash. On an unknown date, the outcome of the herpes virus infection, shingles, malaise, fever, pain and rash were unknown. It was unknown if the reporter considered the herpes virus infection, shingles, malaise, fever, pain and rash to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine 1 week ago and presented to me with malaise low grade fever and painful rash right flank clinically suspicious for shingles. The skin biopsy was performed for which results showed Herpesvirus infection. It was advised if ever reported and if possible it was coincidence. The patient also asking if she should get the follow up vaccination in a few months.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix (subcutaneous) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not agree for the follow up. The patient experienced severe redness and swelling at the injection sight in the back of the arm. The patient received Shingrix subcutaneously, which led to inappropriate route of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of local reaction in a adult patient who received SHINGRIX for prophylaxis. 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 local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not provided, but was selected adult as per the vaccine indication. The physician stated that he saw larger local reactions in patients who received SHINGRIX vaccines versus other vaccines, but he felt that was due to the SHINGRIX adjuvant. The physician did not agree for follow up.
Sex: M
Vaccine: MNQ
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a male patient who received Meningitis ACWY vaccine (potential MENVEO) for prophylaxis. On an unknown date, the patient received Meningitis ACWY vaccine (potential MENVEO) at an unknown dose. On an unknown date, unknown after receiving Meningitis ACWY vaccine (potential MENVEO), the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown. It was unknown if the reporter considered the upset stomach to be related to Meningitis ACWY vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her son (patient) got sick on his stomach after receiving vaccine. The reporter stated that if she found out earlier that the patient would get it because of this shot then she would be suing.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received SHINGRIX for prophylaxis. 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 extensive swelling of vaccinated limb, injection site erythema, general body pain and fever. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, general body pain and fever were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced large red swollen injection site greater than 100 mm in size, body aches and low grade fever.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of activities of daily living impaired in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the activities of daily living impaired to be related to Shingrix. Additional details were provided as follows: This case was reported by the registered nurse for her coworker. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient was unable to do activities over the weekend after receiving Shingrix. The reporting nurse had encouraged the patient to report what they experienced, however due to limited information unable to identify duplicate cases. This case has been linked with US2018GSK152035, reported by same reporter. The reporter did not agree to be followed up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Feeling hot, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 73-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pyrexia (achiness, along with her feet feeling hot after 1st dose received in May 2018, refer case US2018147867). On 13th August 2018, the patient received the 2nd dose of Shingrix. On 13th August 2018, less than a day after receiving Shingrix, the patient experienced general body pain, fever, hot feeling in feet and feeling cold. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, fever, hot feeling in feet and feeling cold were unknown. It was unknown if the reporter considered the general body pain, fever, hot feeling in feet and feeling cold to be related to Shingrix. Additional details reported as follows: The evening of vaccination, the patient began to experience feeling hot and cold, with fever and aching all over. This case has been linked with US2018147868, reported by same reporter and linked with case US2018147867 for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Cranial nerve disorder, Eye symptom, Headache, Pyrexia, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a adult female patient who received Shingrix for prophylaxis. 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 fever, eye symptom, cranial nerve disorder, headache and rash. On an unknown date, the outcome of the fever, eye symptom, cranial nerve disorder, headache and rash were unknown. It was unknown if the reporter considered the fever, eye symptom, cranial nerve disorder, headache and rash to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the healthy individual (patient) who developed symptoms of ophthalmic -1st division of the 5th cranial nerve, fever, headache and rash. The reporter agreed to contact for the follow up.
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a male patient who received Bexsero for prophylaxis. On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, less than a year after receiving Bexsero, 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 unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Bexsero. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Bexsero about a month an half ago from the date of reporting. The patient experienced pain at injection and unable to move arm. The reporter did not agree to contact on follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Paraesthesia, Rash, Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of hives in a 57-year-old male patient who received Shingrix for prophylaxis. In August 2018, the patient received the 1st dose of Shingrix. In August 2018, less than a day after receiving Shingrix, the patient experienced hives, tingling, rash, headache and fatigue. On an unknown date, the outcome of the hives, tingling, rash, headache and fatigue were unknown. It was unknown if the reporter considered the hives, tingling, rash, headache and fatigue to be related to Shingrix. Additional details were reported as follows: At 5:30 pm on Tuesday, the patient received Shingrix vaccine in an unknown arm. By the next morning, the patient developed a tingling and then rash under the arm, which spread to the same side torso. The physician told the patient that it looked like hives. It was not sure if it was resolved. The patient also had usual' symptoms of headache and fatigue, as described by the physician. The physician reported this adverse event to VAERS as well. The physician believed that these reactions were as a result of Shingrix vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (refer case US2018147888). On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, general body pain, chills, injection site warmth and joint pain. On an unknown date, the outcome of the injection site pain, injection site swelling, general body pain, chills, injection site warmth and joint pain were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, general body pain, chills, injection site warmth and joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient received her 2nd SHINGRIX dose on 7th August 2018 at the doctor's office and the patient experienced a pain as the needle was injected. The patient experienced a sore arm which was hot to the touch and the injection site appeared swollen. The patient also experienced an achy feeling all over with joint pain. The patient reported being chilled, and needed a hot water bottle and wrapped in blankets to alleviate, the patient also reported shaking from being so chilled. The events began to improve a few days later, and at day 5 post injection events had resolved. This case has been linked with case US2018147888 reported by the same reporter for the same patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (refer case US2018147888). On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, general body pain, chills, injection site warmth and joint pain. On an unknown date, the outcome of the injection site pain, injection site swelling, general body pain, chills, injection site warmth and joint pain were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, general body pain, chills, injection site warmth and joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient received her 2nd SHINGRIX dose on 7th August 2018 at the doctor's office and the patient experienced a pain as the needle was injected. The patient experienced a sore arm which was hot to the touch and the injection site appeared swollen. The patient also experienced an achy feeling all over with joint pain. The patient reported being chilled, and needed a hot water bottle and wrapped in blankets to alleviate, the patient also reported shaking from being so chilled. The events began to improve a few days later, and at day 5 post injection events had resolved. This case has been linked with case US2018147888 reported by the same reporter for the same patient.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal discomfort, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received Shingrix (batch number 27K24, expiry date 22nd February 2021) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 29th June 2018,for tolerance see case US2018148542). On 14th August 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th August 2018, less than a day after receiving Shingrix, the patient experienced injection site pain and drug dose administration interval too short. On 15th August 2018, the patient experienced muscle soreness. The patient was treated with Advil. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and muscle soreness were recovering/resolving and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the injection site pain and muscle soreness to be related to Shingrix. Additional details were provided as follows: This case was previously reported to the doctor. The patient stated that he was called back to get his 2nd dose 30 days after the first dose of Shingrix. The patient returned to the facility yesterday (the day before reporting) on 14th August 2018, 45 days after the first, and was given the 2nd dose of Shingrix, which led to shortening of vaccination schedule. On the day of reporting, the patient woke up with muscle soreness of his neck and shoulders. The patient was taking Advil for the soreness and had reported it to his physician, who referred him to GSK on the early dose. The healthcare professional information not asked. This case has been linked with case US2018148542 (same patient), reported by the same reporter.
Age: 55.0
Sex: F
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 adult female patient who received Shingrix for prophylaxis. In April 2018, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix in unknown arm. In 2018, the patient experienced pain in her injection arm which was resolved after a couple of nights. This case is linked with the case US2018146936 (case reported for 2nd dose).
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in an unspecified number of the adult patients who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, several hours after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The Director of Operations for a large physician group reports that the physicians state that most recipients of Shingrix report injection site pain a few hours after vaccination that lasts several days. This case has been linked with case US2018147861, reported by same reporter.
Sex: U
Vaccine: DTAP, RVX
Symptoms: Kawasaki's disease
Clinical narrative: This case was reported in a literature article and described the occurrence of Kawasaki's disease in a infant subject who received Rotavirus vaccine for prophylaxis. On an unknown date, less than a month after receiving Rotavirus vaccine and DTPa vaccine, the subject developed Kawasaki's disease. Serious criteria included GSK medically significant. The outcome of Kawasaki's disease was unknown. It was unknown if the investigator considered the Kawasaki's disease to be related to Rotavirus vaccine and DTPa vaccine. Additional information was provided. This case was reported in a literature and described the occurrence of Kawasaki disease in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus (RV) vaccine (either RV1 or RV5) and unspecified diphtheria-tetanus-pertussis (DTaP) vaccine (manufacturer unknown for both) for prophylaxis. The patient was part of study that evaluated the short-term risk of adverse events associated with rotavirus vaccine (RV) in infants, overall and by vaccine formulation (three-dose pentavalent, RV5; two-dose monovalent, RV1). The patient was a newborn between 2006 and 2014. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received 1 dose of unspecified rotavirus vaccine concurrently with 1 dose of DTaP vaccine (administration route and site unspecified for DTaP; batch number not provided for both). [In this study, RV and DTaP follow similar dosing schedules, with recommended doses at 2, 4, and 6 months (except for the two-dose RV1 which does not have a 6-month dose) with doses at least 4 weeks apart]. The age of vaccination was not provided. On an unspecified date, during 30 days post-vaccination, the patient developed Kawasaki disease. The treatment was unknown. The outcome of the event was not provided. The author did not comment on relationship between the event of Kawasaki disease and unspecified DTaP vaccine and unspecified rotavirus vaccine. The author stated "we did not demonstrate an association between RV and serious adverse events, and the safety was comparable between the two RV formulations, though many events were rare. RV may be associated with a small increased risk of otitis media, but further research is necessary to confirm this association.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a adult patient who received Shingrix for prophylaxis. 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, malaise and injection site pain. On an unknown date, the outcome of the pain, malaise and injection site pain were unknown. It was unknown if the reporter considered the pain, malaise and injection site pain to be related to Shingrix. Additional details were provided as follows: The patient had reported experiencing malaise, feeling achy and that the vaccine was painful. Five out of 3 patients experienced the same events.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a adult patient who received Shingrix for prophylaxis. 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, malaise and injection site pain. On an unknown date, the outcome of the pain, malaise and injection site pain were unknown. It was unknown if the reporter considered the pain, malaise and injection site pain to be related to Shingrix. Additional details were provided as follows: The patient had reported experiencing malaise, feeling  achy and that the vaccine was painful. Five out of 3 patients experienced the same events.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovering/resolving. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional also stated during the report that there had been several patients that had commonly reported "not feeling well" after receiving SHINGRIX. This case was linked to the case US2018148548, reported by the same reporter for different patient.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a adult male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown dose). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The reporting physician was the patient. The patient experienced a fever of 102 degree F for 2 days. The physician mentioned the adverse event as an aside and did not provide further details about lot number and vaccination dates. Lab Comments: On an unknown date, the patient did laboratory test.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported via webform. The age at vaccination was not reported. The age group was not provided, but was captured adult as per vaccine indication. Apparently the reporter had multiple cases of Shingles in the past and it had been reported to VAERS already. The reporter was asking, did the GlaxoSmithKline (GSK) have a recommendation on such a scenario. The reporter had seen in the studies, most patients did receive the second dose but she wanted to confirm. This case was already reported to VAERS. No additional information was provided. This case has been linked to the US2018146907, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: 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 64-year-old male patient who received Shingrix for prophylaxis. On 23rd May 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional information was reported as follows: The patient experienced pain in arm, where the patient commented that the second dose hurted a little more when injected as compared to the first dose. This case was linked to case US2018149465, reported by the same reporter for the same patient for the tolerence of 2nd dose.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 87-year-old male patient who received Shingrix for prophylaxis. In June 2018, the patient received the 1st dose of Shingrix. In June 2018, 1 days after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain and fatigue were recovered/resolved. It was unknown if the reporter considered the injection site muscle pain and fatigue to be related to Shingrix. Additional details were provided as follows: In early June 2018, the patient received 1st dose of Shingrix. In 2018, the patient experienced muscle pain close to the injection site. One day after receiving Shingrix on the following day, the patient also felt wiped out with fatigue after receiving Shingrix. For tolerance to 2nd dose refer linked case US2018149466. This case has been linked with US2018149464, reported by the same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 78-year-old female patient who received Shingrix for prophylaxis. In June 2018, the patient received the 1st dose of Shingrix. In June 2018, 1 day after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced muscle pain, localized erythema and pain upon movement. On an unknown date, the outcome of the muscle pain and fatigue were recovered/resolved and the outcome of the localized erythema was not recovered/not resolved and the outcome of the pain upon movement was unknown. It was unknown if the reporter considered the muscle pain, fatigue, localized erythema and pain upon movement to be related to Shingrix. Additional details were provided as follows: In early June 2018, the patient received 1st dose of Shingrix. Less than a year after receiving Shingrix, the patient experienced muscle pain close to the injection site. The patient hurt a little bit when she raised her arm up and around. The patient also experienced redness close to the injection site, that quickly disappeared. The patient also felt wiped out with fatigue on the following day after receiving the injection with both injections. The patient said that her symptoms were not exactly where she got the injection, but slightly below, like three inches below her band aid from the shot. For tolerance to 2nd dose refer linked case US2018149464. This case has been linked with US2018149466 and US2018GSK153538, reported by the same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose, refer case US2018147863). On 13th August 2018 15:00, the patient received the 2nd dose of Shingrix. In August 2018, less than a day after receiving Shingrix, the patient experienced fever, pain in arm and injection site pain. The patient was treated with Tylenol. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, pain in arm and injection site pain were unchanged. It was unknown if the reporter considered the fever, pain in arm and injection site pain to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in left arm. He took Tylenol to help with the fever on the day before reporting night and on the day of reporting morning. As per the patient his condition was still unchanged. The patient had denied permission to contact their physician. No further details were provided.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 55-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included breast cancer. Concomitant products included Shingrix. On 31st July 2018, the patient received the 2nd dose of Shingrix (intramuscular). In July 2018, less than a month after receiving Shingrix, the patient experienced swelling arm. On 31st July 2018, the patient experienced pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingrix. Additional details were reported as follows: This case was previously reported to the physician. The patient age at vaccination could be 55 or 56 years old. The patient received Shingrix in left arm. The patient received Shingrix in appropriate muscle and immediately experienced soreness at the injection site and at the top of her left arm. The patient also experienced swelling in her left arm. However, it was not as severe as the swelling that occurred after the 1st dose of Shingrix. The swelling and soreness after the 2nd dose only lasted for 2-3 days. This case was previously reported by the patient. This case linked with case US2018147996, reported by same reporter for the same patient.
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 elderly male patient who received SHINGRIX for prophylaxis. 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination can be 69 or 70 years. The sore arm lasted for a couple of days. This case was linked with case US20181493969 (2nd dose), reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after receiving 1st dose, see case US2018GSK148175). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced local injection site pain lasting 2 days. The reporter agreed to be contacted for follow up.
Sex: F
Vaccine: PNC13
Symptoms: Contusion
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient  [Age: 85, Unit: Unknown] received on an unknown date a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. The patient after vaccination experienced on an unknown date severe bruising. Outcome was unknown.
Sex: U
Vaccine: HPVX, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves 04 year old male patient who received HPV VACCINE, MENACTRA and 0.5 ml ADACEL frequency once, lot 54B74, expiry date 14 Sep 2020 instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, MMR VACCINE, KENDIX on 16 Aug 2018.                   It was a case of actual medication error due to Wrong vaccine administered. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Vaccine administered on 8/18/18. Patient first reported on 8/21/18. On 8/18/18 patient had a injection site mild rash. Patient then reported on 8/26/18. Injection site rash did not improve. Dark red about 1 inch diameter. Not tender to touch, not a raised bump, not warm to touch. Painful only sometime.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pruritus generalised, Somnolence
Clinical narrative: Headache, itching throughout the body and sleepiness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Musculoskeletal stiffness, Neck pain, Odynophagia, Pain
Clinical narrative: I am having extreme neck pain. My neck is frozen. Can't turn head from side to side or up and down. Any movement at all is causing me pain. Having a difficult time swallowing due pain. Need help getting in and out of bed intermittently.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: The patient, my mother, got the shingles vaccine 8/14 and babysat my son, 6 months old, the same day. Then 12 days later, 8/25, my son developed chicken pox. My son is cared for exclusively at my home by myself and my husband. In the month of August at the time he contracted chicken pox he had no contact with anyone with chicken pox or shingles; no other contact with children, or other sick contact;  he is not in day care or with a sitter on a daily basis. He had not been outside our home other than the visit with my mother and one trip to the pediatrician for vaccines and check up. He got his vaccines 8/20/2018, so the incubation period for the chicken pox virus to be acquired there is too short (5 days). Otherwise, my son and I went to church with no sick contacts and grocery store once in the incubation period before his rash broke out. In the store he is in a backpack carrier without contact with carts etc. I am currently pregnant and never had the chicken pox, so this is of great concern to my family. Fortunately, I had been vaccinated in the past for chicken pox while working in the hospital.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Culture throat negative, Rash, Streptococcus test
Clinical narrative: Sand paper like rash on torso, back, chest, neck, upper arm. Pt states it started the weekend after the injection. Date of onset is not exact as he did not tell his parents immediately.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Redness and swelling at injection site, dizziness, fever, nausea. Symptoms began about 24 hours after I received the injection. I took Ibuprofen, iced the injection site and slept. The symptoms seem to have subsided although I am still a bit weak (time now is 9 am on 8/27/18). There were no adverse effects with the first vaccine in the series.