chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient (age and gender not reported) who was administered with a vaccine ACT-HIB (lot number, expiry date, dose, dose in series, route and site of administration was not reported). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique since the nurse has administered the ACTHIB vaccine diluted with sterile water instead of the supplied 0.4 percent saline. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 78 years old female patient who had vaccine for 2017 season that had expired, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Sep-2018, the patient received a first 0.5 ml once dose of suspect FLUZONE HIGH DOSE lot UI845AA via intramuscular route in the left deltoid (expiry 13-Apr-2018). It was a case of actual medication error due to expired vaccine used. (Other relevant tests included No lab test.) Final diagnosis was the patient was vaccinated with FLUZONE had for the 2017 season that had expired. It was not reported if the patient received a corrective treatment. It was unknown if patient had adverse event. 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 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.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. Linked case: 2018SA267494 (same reporter). This case involves a 67 years old male patient who received expired vaccine FLUZONE QIV. The patient's medical history and concomitant medications were not reported. On 21-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5899MA via intramuscular route in the left deltoid. It was a case of actual medication error due to expired vaccine used. It was unknown if patient experienced any adverse events following vaccination. 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 2001/83/EC 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.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a non-hcp (office staff). Linked case: 2018SA267493 (same reporter). This case involves a 22 years old female patient who received expired vaccine FLUZONE QIV. The patients medical history and concomitant medications were not reported. On 21-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5899MA via intramuscular route in the left deltoid. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Muscle spasms, Pyrexia
Clinical narrative: Fever, muscle cramps, sweats lasting 48 hours both days after the shots.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Received flu shot on 9/19/18 in (L) deltoid IM. On 9/20/18 at 8:00 AM experienced pain redness, heat at an area below where the shot was given. Employee put ice pack on it and took TYLENOL.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose, Chest pain, Dizziness, Dysarthria, Electrocardiogram
Clinical narrative: 5 minutes after receiving Flu vaccine, patient developed chest pain, body tingling, blotchy rash over body, slurred speech, feeling faint, racing heart beat.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations, Paraesthesia, Pregnancy test, Rash generalised, Rash macular
Clinical narrative: 5 minutes after receiving Flu vaccine, patient developed chest pain, body tingling, blotchy rash over body, slurred speech, feeling faint, racing heart beat.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pruritus, Tremor
Clinical narrative: Felt shaky, achy, itching, terrible chills and at first no fever.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Decreased appetite, Dizziness, Fatigue, Night sweats, Pyrexia
Clinical narrative: My wife received the seasonal flu shot and the shingles vaccine, on the same day. The type that will require a booster in about two months. 12 hours later she began experiencing fever, 100.2/F, fatigue/night sweats/ loss of appetite/dizziness. Going on for three days.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Erythema, Swelling
Clinical narrative: MOP reported excessive crying post vaccination and localized redness/swelling 2 hrs post vaccination.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Pyrexia, Seizure, Vomiting
Clinical narrative: Patient had headache, fever, sweats, and vomiting after receiving flu shot. Patient had also had seizure in ambulance patient had flu shot last year with no problem before.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies were not provided. On 13-SEP-2018, the patient was vaccinated with improperly stored PROQUAD lot # R001543 with an expiration date 15-JUL-2019 (dose, route of administration, anatomical location and albumin status were not reported). Other suspect therapy included sterile diluent (MERCK) lot# R002036 with an expiration date 03-AUG-2020 (dose, route of administration and anatomical location were not reported), which was stored appropriately. No adverse effect was reported. Administered vaccine experienced the temperature excursion from -14 to -10 degrees Celsius for 11 days. There was no previous temperature excursion. A digital data logger was involved. This is one of two reports received form the same reporter. Sender's Comments: US-009507513-1809USA012725.
Age: 0.33
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: This spontaneous report was received from a patient's father and refers to a 5-month-old female patient. The patient had no pertinent medical history, drug reactions or allergies and took no concomitant medications. On an unknown date in 2018 (reported as about two and a half weeks ago), when she was just over 4 months old, the patient was inadvertently vaccinated with PROQUAD (therapy type, dose, route and site of administration, lot# and expiration date were not provided) for prophylaxis. In September 2018 (reported as about week later), the patient experienced erratic fevers off and on that went as high as 102.4 degrees Fahrenheit. The reporter stated that he gave his daughter acetaminophen (TYLENOL). She was then seen by the physician on an unspecified date who prescribed an unspecified antibiotic on which did not help. They returned to the provider who then prescribed amoxicillin on an unspecified date. No laboratory diagnostics or studies were performed. The outcome of the event was reported as recovering. Causality assessment between the event and PROQUAD was not provided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a neonate patient reported as ''newborn'' of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-SEP-2018, the patient was vaccinated with RECOMBIVAX HB (dose, lot #, expiration date, site and route of administration were not reported) for prophylaxis. At the same time, the patient received in the same leg unspecified hepatitis B immune globulin (product administered at inappropriate site). No adverse effect were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 44 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 17-SEP-2018, the 44 year old patient inadvertently received a dose of PROQUAD lot # R001541 with expiration date of 15-JUL-2019, for prophylaxis (route and anatomical location were not reported), and a dose of sterile diluent (MERCK) lot # N030845  with expiration date of 12-JUN-2020 (route and indication were not reported). No adverse effects were reported.
Sex: M
Vaccine: FLU4, PPV
Symptoms: Haemoptysis, Intensive care, Loss of consciousness, Oxygen saturation decreased, Pneumonia
Clinical narrative: This initial spontaneous report was received on 25-SEP-2018 from a male patient who was currently in his 70's. When asked if he had any pertinent medical history or drug reactions/allergies, he replied "not that I know of." On 16-OCT-2017, the patient received PNEUMOVAX 23 at his local pharmacy for prevention of pneumonia (route and lot # not provided). He concomitantly received influenza FLUZONE. On 16-JUL-2018, the patient was driving his vehicle and he was coming to a stop in the road so he proceeded to put his foot on the break. The next thing he could recall was his body "completely shut down" and his car collided with and "T-boned" another driver on the road. He was immediately taken to the hospital the same day of the car accident (which was a Monday) and he was hospitalized in intensive care until he was released on the afternoon of 19-JUL-2018 (reported as later that week, until Thursday). He noted that just prior to the car accident ordeal, he was feeling some drowsiness related symptoms. The patient reported that he couldn't really recall anything about the accident itself after the collision occurred because he lost consciousness during the accident. While he was hospitalized, a physician who was treating the patient told him that he developed a case of pneumonia. The patient also mentioned that when he first got to the hospital, his "oxygen count was way down" and he had to be put on oxygen therapy, he was coughing up light mucous, and there were "particulates of blood and flesh" in the mucous (all considered symptoms of pneumonia). The patient also mentioned that when he was released from the hospital, his "feet looked black and blue" when he got home. The patient said he has an upcoming appointment with a cardiologist on 20-NOV-2018 to further evaluate his heart and lung health. The patient said that he received a letter from the other driver's attorney, suing him for the other driver's medical bills that incurred. The patient was requesting compensation for the remaining amount his insurance didn't cover because he felt that he got the PNEUMOVAX 23 to prevent pneumonia but he still ended up getting pneumonia anyway.  According to the patient, the pneumonia was the main factor that caused his body to abruptly shut down while driving, leading to his bad car accident. The patient said his present status was not recovered (however, loss of consciousness was considered resolved since patient reported these events). The patient did not specifically state whether he felt the events were related to PNEUMOVAX 23. Upon internal review, pneumonia and loss of consciousness were considered to be medically significant events. The patient did not provide consent for follow-up.
Sex: M
Vaccine: FLU4, PPV
Symptoms: Productive cough, Road traffic accident, Skin discolouration, Somnolence
Clinical narrative: This initial spontaneous report was received on 25-SEP-2018 from a male patient who was currently in his 70's. When asked if he had any pertinent medical history or drug reactions/allergies, he replied "not that I know of." On 16-OCT-2017, the patient received PNEUMOVAX 23 at his local pharmacy for prevention of pneumonia (route and lot # not provided). He concomitantly received influenza FLUZONE. On 16-JUL-2018, the patient was driving his vehicle and he was coming to a stop in the road so he proceeded to put his foot on the break. The next thing he could recall was his body "completely shut down" and his car collided with and "T-boned" another driver on the road. He was immediately taken to the hospital the same day of the car accident (which was a Monday) and he was hospitalized in intensive care until he was released on the afternoon of 19-JUL-2018 (reported as later that week, until Thursday). He noted that just prior to the car accident ordeal, he was feeling some drowsiness related symptoms. The patient reported that he couldn't really recall anything about the accident itself after the collision occurred because he lost consciousness during the accident. While he was hospitalized, a physician who was treating the patient told him that he developed a case of pneumonia. The patient also mentioned that when he first got to the hospital, his "oxygen count was way down" and he had to be put on oxygen therapy, he was coughing up light mucous, and there were "particulates of blood and flesh" in the mucous (all considered symptoms of pneumonia). The patient also mentioned that when he was released from the hospital, his "feet looked black and blue" when he got home. The patient said he has an upcoming appointment with a cardiologist on 20-NOV-2018 to further evaluate his heart and lung health. The patient said that he received a letter from the other driver's attorney, suing him for the other driver's medical bills that incurred. The patient was requesting compensation for the remaining amount his insurance didn't cover because he felt that he got the PNEUMOVAX 23 to prevent pneumonia but he still ended up getting pneumonia anyway.  According to the patient, the pneumonia was the main factor that caused his body to abruptly shut down while driving, leading to his bad car accident. The patient said his present status was not recovered (however, loss of consciousness was considered resolved since patient reported these events). The patient did not specifically state whether he felt the events were related to PNEUMOVAX 23. Upon internal review, pneumonia and loss of consciousness were considered to be medically significant events. The patient did not provide consent for follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 63-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included tachycardia. Concomitant products included NORVASC and metoprolol. On 17th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced heartbeats increased, increased blood pressure, injection site pain, influenza-like symptoms and fever. In April 2018, the outcome of the heartbeats increased, increased blood pressure, injection site pain, influenza-like symptoms and fever were recovered/resolved. It was unknown if the reporter considered the heartbeats increased, increased blood pressure, injection site pain, influenza-like symptoms and fever to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on an unknown arm. The patient experienced flu like symptoms, rapid heartbeat, fever, arm soreness at injection site and elevated blood pressure up to 160/90 mm Hg. The patient reported that he had to increase his doses of Metoprolol and NORVASC to counteract the rapid heartbeat and elevated blood pressure. The patient reported that all these experiences resolved within 2 to 3 days after SHINGRIX vaccination. The contact details of the physician were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The health care professional (HCP) reported quite a few people had experienced flu like symptoms after SHINGRIX vaccine. This adverse event was captured during re-listening to the call, HCP did not provide additional details or number of patients. This case is linked with case US2018169157, reported by the same reporter.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site macule, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 2nd dose of SHINGRIX. On 12th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 16th September 2018, the patient experienced injection site inflammation, injection site erythema and macular rash. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site inflammation, injection site erythema and macular rash were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site inflammation, injection site erythema and macular rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced soreness at the injection site on the day of the injection. The patient described soreness at the injection site as sore and tender. The soreness at the injection site was not as tender as on the day of reporting. However a day before the reporting date, the soreness at the injection site looked red and blotchy and inflamed.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received SHINGRIX (subcutaneous). On 12th September 2018, 1 hr after receiving SHINGRIX, the patient experienced injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling was recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient inadvertently received SHINGRIX via the subcutaneous route rather than indicated intramuscular route, which led to incorrect route of vaccine administration. One hour following vaccination, the patient experienced swelling at the injection site. On 14th September 2018, the patient visited her physician for swelling at the injection site. The reporter stated that the swelling was improved but not resolved, at the time of reporting. No lot number or expiry date was provided as SHINGRIX was administered at another facility.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site discoloration in a 55-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 2nd June 2018 15:22, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd June 2018, immediately after receiving SHINGRIX, the patient experienced injection site discoloration, injection site swelling, injection site erythema and injection site burning. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the injection site swelling, injection site erythema and injection site burning were recovered/resolved. It was unknown if the reporter considered the injection site discoloration, injection site swelling, injection site erythema and injection site burning to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in the left deltoid at approximately 3:22 PM and she reported that the area on the muscle turned darker in color and she felt a burning feeling with redness and puffiness at the injection site. The patient experienced discoloration at the injection site, approximately the size of a half dollar coin. The patient felt the vaccine liquid when she received the vaccine as though the liquid was between her skin and the muscle. The patient had since received the 2nd dose of SHINGRIX with no side effects, however, the site discoloration remained.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX (batch number 5737X, expiry date 23rd January 2021) for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 21 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was reported as follows: The patient received the vaccine in the left deltoid. The patient experienced shingles rash on the right side of her face after vaccination with SHINGRIX. Since 15th September 2018, the rash had worsened. As of the reporting date, the doctor had started the patient on VALTREX. No further details were provided.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) for prophylaxis. On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, couple of days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm and couple days after receiving the vaccine, the patient experienced pain in his left arm. The pain affected the patient's entire left arm, which was constant and never went away. The reported lot number (G41M2) for SHINGRIX did not exist and was updated to G47M2, according to sales database.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of diarrhea in a adult male patient who received SHINGRIX for prophylaxis. The patient's past medical history included rheumatoid arthritis. Concurrent medical conditions included thyroid disorder and acid reflux (esophageal). Concomitant products included HUMIRA, PEPCID and SYNTHROID. On 13th August 2018, the patient received SHINGRIX. On 14th August 2018, 1 days after receiving SHINGRIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved. It was unknown if the reporter considered the diarrhea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case was previously reported to the physician. The patient reported the day following the vaccination, he started to experience diarrhea for about a week before on 21st August 2018 it turned into loose, watery stools which continues to present day.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of pain in extremity (received on an unknown date see case US2018GSK175746). 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 and fever. On an unknown date, the outcome of the pain in arm and fever were unknown. It was unknown if the reporter considered the pain in arm and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 70 or 71 days. The patient recently had SHINGRIX vaccine and had worse pain in his arm than with the flu vaccine. The patient had a fever of 101 after SHINGRIX. This case has been linked to the US2018GSK175746, reported by the same reporter. Lab Comments: On an unknown date, the patient's body temprature was 101 degree F.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Chills, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 9th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than 9 months after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced generalized joint pain, headache, tiredness, knee arthritis, fever, chills and incomplete course of vaccination. The patient was treated with meloxicam. On an unknown date, the outcome of the generalized joint pain, headache, tiredness, knee arthritis, fever and chills were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the generalized joint pain, headache, tiredness, knee arthritis, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient called to inquire that it had been more than six months, and did she need to restart the series. The patient received 1st dose of SHINGRIX on right arm. The patient experienced fever, joint pain all over the body, chills, headaches, and tiredness, which lasted for total of 2 days. The patient also experienced inflammation and pain of the knee. The patient required a doctor's visit for the inflammation and pain in the knee. The patient was prescribed 7.5mg of Meloxicam. The patient recovered within 4 days from knee pain and inflammation. The patient continued to take Meloxicam for total of 2 weeks. Till the time of reporting, the patient did not receive the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The patient gave permission to contact her health care provider. The patient reported this event to her pharmacist, and her pharmacist has reported this event to VAERS. This was an accidental medication error associated with an adverse event.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Inflammation, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 9th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than 9 months after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced generalized joint pain, headache, tiredness, knee arthritis, fever, chills and incomplete course of vaccination. The patient was treated with meloxicam. On an unknown date, the outcome of the generalized joint pain, headache, tiredness, knee arthritis, fever and chills were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the generalized joint pain, headache, tiredness, knee arthritis, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient called to inquire that it had been more than six months, and did she need to restart the series. The patient received 1st dose of SHINGRIX on right arm. The patient experienced fever, joint pain all over the body, chills, headaches, and tiredness, which lasted for total of 2 days. The patient also experienced inflammation and pain of the knee. The patient required a doctor's visit for the inflammation and pain in the knee. The patient was prescribed 7.5mg of Meloxicam. The patient recovered within 4 days from knee pain and inflammation. The patient continued to take Meloxicam for total of 2 weeks. Till the time of reporting, the patient did not receive the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The patient gave permission to contact her health care provider. The patient reported this event to her pharmacist, and her pharmacist has reported this event to VAERS. This was an accidental medication error associated with an adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 30 days 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 pharmacist reported that a patient received the SHINGRIX vaccine and she had an outbreak of shingles a month after the first dose.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of watery diarrhea in a 4-month-old female patient who received ROTARIX lyophilized formulation (batch number G9HA5, expiry date 17th October 2019) for prophylaxis. On 10th September 2018 02:55, the patient received ROTARIX lyophilized formulation (oral) 1 ml. In September 2018, 1 day after receiving ROTARIX lyophilized formulation, the patient experienced watery diarrhea (serious criteria GSK medically significant). On 19th September 2018, the patient experienced rotavirus test positive. On an unknown date, the outcome of the watery diarrhea and rotavirus test positive were unknown. It was unknown if the reporter considered the watery diarrhea and rotavirus test positive to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: On 11 September 2018, the day after receiving ROTARIX vaccine, the patient developed watery diarrhea. On 17th September 2018, the patient was seen at healthcare professional (HCP) office for diarrhea. Nine days after receiving ROTARIX lyophilized formulation, the stool test was performed and came back positive for the Rotavirus. The batch number reported for ROTARIX Lyophilised formulation G9HAS, did not exist and was updated to G9HA5, as per sales data sheet.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received, patient did not have reactions after the 1st dose). In September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema 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 patient received her 2nd dose of SHINGRIX 2 days ago and was having redness and swelling at the injection site which was about a 2x3 inch diameter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days 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 health care professional reported that the patient developed Shingles 1 week after receiving the 1st dose of SHINGRIX. The health care professional did not have access to further information.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 28th July 2018, 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 patient received SHINGRIX vaccine in the left arm. The patient reported that the pain at the injection site lasted for approximately one month till 28th July 2018. The patient planned to follow up with her physician on an unknown date.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Vaccination complication
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a 77-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced adverse reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: On 17th September 2018 (Monday) or on 18th September 2018 (Tuesday), the patient received a dose of SHINGRIX vaccine subcutaneously instead of intramuscular route at a local pharmacy, which led to incorrect route of vaccine administration. The patient came in to report on Wednesday, with adverse reaction to SHINGRIX, which was based on that. The nurse stated that the office called GlaxoSmithKline (GSK) to make sure that, the dose was a valid dose and stated, they received a Medical letter from GSK about it. The reporter agreed for follow up. This case was linked to the case US2018171037, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Vaccination complication
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced adverse reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: On 17th September 2018 (Monday) or on 18th September 2018 (Tuesday), the patient received a dose of SHINGRIX vaccine subcutaneously instead of intramuscular route at a local pharmacy, which led to incorrect route of vaccine administration. The patient came in to report on Wednesday, with adverse reaction to SHINGRIX, which was based on that. The nurse stated that the office called GlaxoSmithKline (GSK) to make sure that, the dose was a valid dose and stated, they received a Medical letter from GSK about it. The reporter agreed for follow up. This case was linked to the case US2018171032, reported by the same reporter.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Product preparation issue, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 11-year-old male patient who received MENVEO for prophylaxis. On 4th August 2018, the patient received the 1st dose of MENVEO. On 4th August 2018, unknown after receiving MENVEO, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 5th August 2018, the patient experienced swelling arm, erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the swelling arm, erythema of extremities and itchy upper limbs were recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the swelling arm, erythema of extremities and itchy upper limbs to be related to MENVEO. Additional details were provided as follows: This case was reported by the patient's mother. The patient received only the liquid component of MENVEO to left arm. The liquid Men CYW-135 liquid component was not reconstituted with the lyophilized Men A component before administration, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The next day after receiving MENVEO, the patient experienced redness, swelling and itching on his left arm. The reporter stated that the patient's left arm was swollen and the bright redness was approximately 4 inches across his arm. The reporter stated that she called the patient's doctor to report this, however, the patient was not seen at the doctor's office.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of anaphylaxis in a patient who received Influenza vaccine Quadrivalent (unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown.  It was unknown if the reporter considered the anaphylaxis to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporting was stating the patient's previous history of anaphylaxis to an unknown influenza vaccine. The healthcare professional was unsure of brand name of Influenza vaccine administered in the past. The healthcare professional stated she was unsure if it was a GlaxoSmithKline product or the date anaphylaxis occurred. The healthcare professional provided no further information for patient or product.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Burning sensation, Drug hypersensitivity, Feeling hot, Hypersensitivity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced injection site erythema, burning sensation in joints, burning hip, fever, feeling hot, injection site swelling, allergy and documented hypersensitivity to administered drug. On an unknown date, the outcome of the injection site erythema, burning sensation in joints, burning hip, fever, feeling hot and injection site swelling were recovered/resolved and the outcome of the allergy and documented hypersensitivity to administered drug were unknown. It was unknown if the reporter considered the injection site erythema, burning sensation in joints, burning hip, fever, feeling hot, injection site swelling and allergy to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The caller was not aware of product. The caller relayed that the patient experienced fever (the patient's body temperature was recorded as 103 degrees F), joints aching, joints burning in her knees, elbows, and hips that felt flaming hot, injection site being red and the size of baseball. This case is linked with US2018158097 (same patient, different vaccine). Lab Comments: On an unknown date the patient's body temperature was recorded as 103 degree F.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced injection site erythema, burning sensation in joints, burning hip, fever, feeling hot, injection site swelling, allergy and documented hypersensitivity to administered drug. On an unknown date, the outcome of the injection site erythema, burning sensation in joints, burning hip, fever, feeling hot and injection site swelling were recovered/resolved and the outcome of the allergy and documented hypersensitivity to administered drug were unknown. It was unknown if the reporter considered the injection site erythema, burning sensation in joints, burning hip, fever, feeling hot, injection site swelling and allergy to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The caller was not aware of product. The caller relayed that the patient experienced fever (the patient's body temperature was recorded as 103 degrees F), joints aching, joints burning in her knees, elbows, and hips that felt flaming hot, injection site being red and the size of baseball. This case is linked with US2018158097 (same patient, different vaccine). Lab Comments: On an unknown date the patient's body temperature was recorded as 103 degree F.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of dizziness in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced dizziness and fever. On an unknown date, the outcome of the dizziness and fever were unknown. The reporter considered the dizziness to be related to SHINGRIX. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced dizziness and a low-grade fever. The reporter checked the vaccine information sheet (VIS) sheet which mentioned dizziness falls under severe allergic reaction. She thought the reaction was due to the vaccine. The reporter agreed for follow up.