chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (as a 15 years old in 1970). 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 injection site pain and muscle pain. On an unknown date, the outcome of the injection site pain and muscle pain were recovered/resolved. It was unknown if the reporter considered the injection site pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced strong pain at injection site and muscle aches for a week or so. At the time of reporting the patient was in fair condition for his age, side effects were almost all gone and said that he hopes this works because the side effects were worse than he remember with shingles as a 15 year old brought on by bad jelly fish sting and he survived and he also said that this information hopefully works on the SHINGRIX research. This case has been linked with case US2018GSK158157, (same patient for 2nd dose) reported by the same reporter.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Feeling cold, Headache, Myalgia, Pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received BEXSERO (batch number ABX657AA, expiry date 1st April 2019) for prophylaxis. Co-suspect products included MENACTRA for prophylaxis. Previously administered products included MENACTRA (received a previous dose with no issues years before the time of reporting). On 20th August 2018, the patient received the 1st dose of BEXSERO .5 ml and MENACTRA. On 20th August 2018, less than a day after receiving BEXSERO, the patient experienced pain, feeling cold, headache, myalgia and wakefulness. On an unknown date, the outcome of the pain, feeling cold, headache, myalgia and wakefulness were not recovered/not resolved. It was unknown if the reporter considered the pain, feeling cold, headache, myalgia and wakefulness to be related to BEXSERO. Additional details were provided as follows: The reporter already reported this to VAERS. The age at vaccination was not reported. The patient received a dose of BEXSERO at the same time as MENACTRA. On 20th August 2018, the patient received BEXSERO and MENACTRA and had significant pain that night radiating down to her wrist and up to the right side of her face. The patient was having a cold sensation in her throat and a headache, she also had significant myalgias that kept her awake all night. The patient was back in their office on yesterday (on the day of reporting) for the complaints and they were still not resolved at the time of reporting. The reporter agreed to contact for follow up. It was unknown if the reporter considered the radiating pain, feeling cold, headache, myalgia and wakefulness to be related to MENACTRA.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Poor quality sleep
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received BEXSERO (batch number ABX657AA, expiry date 1st April 2019) for prophylaxis. Co-suspect products included MENACTRA for prophylaxis. Previously administered products included MENACTRA (received a previous dose with no issues years before the time of reporting). On 20th August 2018, the patient received the 1st dose of BEXSERO .5 ml and MENACTRA. On 20th August 2018, less than a day after receiving BEXSERO, the patient experienced pain, feeling cold, headache, myalgia and wakefulness. On an unknown date, the outcome of the pain, feeling cold, headache, myalgia and wakefulness were not recovered/not resolved. It was unknown if the reporter considered the pain, feeling cold, headache, myalgia and wakefulness to be related to BEXSERO. Additional details were provided as follows: The reporter already reported this to VAERS. The age at vaccination was not reported. The patient received a dose of BEXSERO at the same time as MENACTRA. On 20th August 2018, the patient received BEXSERO and MENACTRA and had significant pain that night radiating down to her wrist and up to the right side of her face. The patient was having a cold sensation in her throat and a headache, she also had significant myalgias that kept her awake all night. The patient was back in their office on yesterday (on the day of reporting) for the complaints and they were still not resolved at the time of reporting. The reporter agreed to contact for follow up. It was unknown if the reporter considered the radiating pain, feeling cold, headache, myalgia and wakefulness to be related to MENACTRA.
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of gastrointestinal disorder in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced gastrointestinal disorder and pain in arm. On an unknown date, the outcome of the gastrointestinal disorder and pain in arm were unknown. It was unknown if the reporter considered the gastrointestinal disorder and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was taken based on the product indication as no other patient details were provided. The reporter mentioned that, one female patient experienced gastrointestinal issues for 3 days after the second dose, but she also mentioned that this same thing could happen when patients experience shingles so she was not concerned. The patient also reported that her arm did hurt with the 2nd injection. This case has been linked with case US2018GSK152348 reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). Concurrent medical conditions included pain. Concomitant products included OXYCONTIN. On 21st August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced feeling unwell and feeling abnormal. On an unknown date, the outcome of the feeling unwell and feeling abnormal were unknown. It was unknown if the reporter considered the feeling unwell and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she was not the healthiest person in the world. She lived in pain and took a low dose of oxycodone to eliminate pain. The patient had her SHINGRIX shot a day before date of reporting and she felt sicker than a dog. She felt drugged. The patient wanted to know if this was known side effect. If yes how long would this dead feeling last. This case was linked with A0807245A, reported for the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: This case was reported by a nurse and described the occurrence of itchy upper limbs in a female patient who received SHINGRIX for prophylaxis. On 17th August 2018, the patient received SHINGRIX. On 21st August 2018, 4 days after receiving SHINGRIX, the patient experienced itchy upper limbs. On 22nd August 2018, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the itchy upper limbs, erythema of extremities and pain in arm were unknown. It was unknown if the reporter considered the itchy upper limbs, erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 1 pm, the patient received SHINGRIX. On the day of reporting, 5 days after receiving SHINGRIX, the patient had noticed a large red area on upper arm. The patient started to experience itching on the day before reporting. The patient said that he did not came up until the date of reporting. The patient cannot found any literature to support this information.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 63-year-old female 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 pain in arm and feeling unwell. On an unknown date, the outcome of the pain in arm and feeling unwell were unknown. The reporter considered the pain in arm and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however it could be 62 or 63 years old. The reporter stated that the patient was one of their nurses at her clinic. She said that the nurse had a very sore arm and did not feel well after the shot. The reporter said that the nurse did not want to get 2nd dose in series. The patient felt that her experience was related to vaccine.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a 54-year-old male patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 7 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: About a week after receiving SHINGRIX, the patient experienced rash. The patient visited office on 22nd August 2018 and the doctor confirmed it was mild case of Shingles.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Migraine
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of migraine in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included migraine (under control using INDERAL). In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced migraine. On an unknown date, the outcome of the migraine was not recovered/not resolved. It was unknown if the reporter considered the migraine to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX four days before the date of reporting and had experienced severe migraines every day since. The patient stated that he understood headaches were a common side effect for the injection. The patient asked that how long reaction typically continued following the injection and was it unwise to took the booster shot if he continued to experience migraines.
Sex: F
Vaccine: MENB
Symptoms: Dermatitis, Injection site reaction
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site reaction in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site reaction and dermatitis. On an unknown date, the outcome of the injection site reaction and dermatitis were unknown. It was unknown if the reporter considered the injection site reaction and dermatitis to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that she had a patient that had reaction to BEXSERO at the injection site and all over the face. The doctor believed it may had been related to BEXSERO.
Sex: U
Vaccine: VARZOS
Symptoms: Reactogenicity event
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of reactogenicity event in an unspecified number of adult patients 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 reactogenicity event. On an unknown date, the outcome of the reactogenicity event was unknown. It was unknown if the reporter considered the reactogenicity event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported that he administered many doses of SHINGRIX to his patients. The reporter reported that, not withstanding the reactogenicity he had observed in his use of SHINGRIX with his patients. The reporter saw the benefit risk profile of SHINGRIX as favorable. This case has been linked with US2018148543, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported that the patients have usually been okay with the first dose but experienced flu like symptoms for 2 to 3 days with the second dose. This case has been linked with US2018GSK154782, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. 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 provided as follows: This case was reported by an Office Manager who was also the patient. The age at vaccination was not reported. On an unknown date, the patient received the 1st dose of SHINGRIX. Ten weeks after receiving the 1st dose, the patient received the 2nd dose of SHINGRIX. The patient experienced fever (body temperature greater than 103 degree F) for 2 days. The fever lasted for 2 days. The reporter did not agree for follow up. Lab Comments: On an unknown date, the patient's body temperature was recorded greater than 103 degree F.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient said that her arm blew up after receiving the SHINGRIX. The nurse did not remember the patient's initials and did not know her date of both as well. The nurse did not agree to follow up.
Sex: M
Vaccine: RAB
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received Rabies Vaccine for prophylaxis. On an unknown date, the patient received the 3rd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced fever and myalgia. The patient was treated with ALEVE. On an unknown date, the outcome of the fever and myalgia were unknown. The reporter considered the fever and myalgia to be possibly related to Rabies Vaccine. Additional details were provided as follows: It was unknown if the patient started Rabies vaccine prior or post exposure to the infection. The age at vaccination was not reported. The physician reported that, his son experienced a fever (body temperature: 103 degree F) and myalgia. After consulting with one of the Advisory Committee on Immunization Practices (ACIP) voting member, the physician discovered that this could occur with the rabies vaccine. The patient was advised to take some ALEVE after the 4th dose. The patient was able to complete the 4 dose series. The reporter did not agree to follow up. Lab Comments: On unknown date, the patient's body temperature was recorded as 103 degree F.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: 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 pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (received the 1st dose on an unknown date. Refer case US2018089348). On 20th August 2018 20:00, the patient received the 2nd dose of SHINGRIX. On 20th August 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 21st August 2018, the patient experienced fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the fever was not recovered/not resolved. 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 patient received the 2nd dose of SHINGRIX on 20th August 2018 and experienced arm soreness in the arm where he received the shot. The soreness presented a few hours after the shot. He said his arm was a little more achy than it was the first time. On the day of reporting, in the morning he experienced a fever of 100 degrees F. The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (also experienced chills and pain, refer the case US2018107212). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain, headache, muscle pain and feeling bad. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, pain, headache, muscle pain and feeling bad were unknown. It was unknown if the reporter considered the fever, pain, headache, muscle pain and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient had awful reactions and again had fever, aches, headache, and muscle pain. The reporter stated that had the same side effects. The patient was in bed all day but feel like turned the corner. This was 1 of 2 cases, reported by the same reporter for same patient.
Sex: M
Vaccine: VARZOS
Symptoms: 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 adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (also experienced chills and pain, refer the case US2018107212). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain, headache, muscle pain and feeling bad. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, pain, headache, muscle pain and feeling bad were unknown. It was unknown if the reporter considered the fever, pain, headache, muscle pain and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient had awful reactions and again had fever, aches, headache, and muscle pain. The reporter stated that had the same side effects. The patient was in bed all day but feel like turned the corner. This was 1 of 2 cases, reported by the same reporter for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fatigue in an unspecified numbers of adult patients who received SHINGRIX(batch number Y24KE, expiry date 11th October 2020) 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 fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Couple of people in our office felt very fatigued and very run down for a day or two" following vaccination with SHINGRIX. This case has been linked with US2018153831, reported via same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Feeling of body temperature change, Injection site pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (as a 15 years old in 1970). Previously administered products included SHINGRIX with an associated reaction of injection site pain (received 1st dose on an unspecified date, for tolerance refer case US2018GSK152189). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced injection site pain, general body pain, chest pain, pain in arm and feeling hot and cold. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, general body pain, chest pain, pain in arm and feeling hot and cold were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain, chest pain, pain in arm and feeling hot and cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced sore at injection site, body aches, chest and left arm pain after a week or so, from the lasts couple of weeks the patient body was experiencing temperature being hot to cold. Less than a year, after receiving the SHINGRIX the patient body being hot to cold like what a women experience with metaphase. At the time of reporting the patient was in fair condition for his age, side effects were almost all gone and said that he hopes this works because the side effects were worse than he remember with shingles as a 15 year old brought on by bad jelly fish sting and he survived and he also said that this information hopefully works on the SHINGRIX research. This case has been linked with case US2018GSK152189, (same patient for 1st dose) reported by the same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (as a 15 years old in 1970). Previously administered products included SHINGRIX with an associated reaction of injection site pain (received 1st dose on an unspecified date, for tolerance refer case US2018GSK152189). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced injection site pain, general body pain, chest pain, pain in arm and feeling hot and cold. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, general body pain, chest pain, pain in arm and feeling hot and cold were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain, chest pain, pain in arm and feeling hot and cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced sore at injection site, body aches, chest and left arm pain after a week or so, from the lasts couple of weeks the patient body was experiencing temperature being hot to cold. Less than a year, after receiving the SHINGRIX the patient body being hot to cold like what a women experience with metaphase. At the time of reporting the patient was in fair condition for his age, side effects were almost all gone and said that he hopes this works because the side effects were worse than he remember with shingles as a 15 year old brought on by bad jelly fish sting and he survived and he also said that this information hopefully works on the SHINGRIX research. This case has been linked with case US2018GSK152189, (same patient for 1st dose) reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza, Injection site pain, Listless, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of listless in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced listless, fever, injection site pain and influenza. On an unknown date, the outcome of the listless, fever, injection site pain and influenza were recovered/resolved. It was unknown if the reporter considered the listless, fever, injection site pain and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 83 or 84 years. Within approximately two hours after receiving SHINGRIX, the patient experienced pain at the injection site. The evening after receiving SHINGRIX, the patient began to feel listless like he had a mild flu, and a low-grade fever. All of the symptoms were resolved within two to three days. The reporter gave permission to contact their physician. The reporter was unable to provide additional information. This case has been linked with cases US2018153593 and US2018153589, reported by same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Dizziness, Frequent bowel movements
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in April 2018 experienced sore arm ( please refer case US2018154156)). On 22nd August 2018, the patient received the 2nd dose of SHINGRIX. On 22nd August 2018, several hours after receiving SHINGRIX, the patient experienced upset stomach, frequent bowel movements and diarrhea. On 23rd August 2018, the patient experienced fever, shivering, headache and dizziness. On an unknown date, the outcome of the upset stomach, shivering, headache, dizziness, frequent bowel movements and diarrhea were recovered/resolved and the outcome of the fever was recovering/resolving. It was unknown if the reporter considered the upset stomach, fever, shivering, headache, dizziness, frequent bowel movements and diarrhea to be related to SHINGRIX. Additional details were reported as follows: At 17:00, the patient received SHINGRIX in left arm. The couple of hours after receiving SHINGRIX vaccine, the patient experienced stomach upset in the form of increased number of bowel movements, which the patient called a running stomach. On the next morning after receiving SHINGRIX, the patient felt a light headache and dizziness by the afternoon the patient experienced fever recorded as 39.7 degree C and shivering.  At the time of reporting, all symptoms resolved except fever, which was 38.2 degree C. The patient did not experience any of these symptoms after the 1st dose, but only sore arm. The contact details of the physician was provided.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in April 2018 experienced sore arm ( please refer case US2018154156)). On 22nd August 2018, the patient received the 2nd dose of SHINGRIX. On 22nd August 2018, several hours after receiving SHINGRIX, the patient experienced upset stomach, frequent bowel movements and diarrhea. On 23rd August 2018, the patient experienced fever, shivering, headache and dizziness. On an unknown date, the outcome of the upset stomach, shivering, headache, dizziness, frequent bowel movements and diarrhea were recovered/resolved and the outcome of the fever was recovering/resolving. It was unknown if the reporter considered the upset stomach, fever, shivering, headache, dizziness, frequent bowel movements and diarrhea to be related to SHINGRIX. Additional details were reported as follows: At 17:00, the patient received SHINGRIX in left arm. The couple of hours after receiving SHINGRIX vaccine, the patient experienced stomach upset in the form of increased number of bowel movements, which the patient called a running stomach. On the next morning after receiving SHINGRIX, the patient felt a light headache and dizziness by the afternoon the patient experienced fever recorded as 39.7 degree C and shivering.  At the time of reporting, all symptoms resolved except fever, which was 38.2 degree C. The patient did not experience any of these symptoms after the 1st dose, but only sore arm. The contact details of the physician was provided.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product container issue, Skin laceration
Clinical narrative: Initial unsolicited report received from nurse on 15-Aug-2018. This case involves a female patient (age unknown) who stabbed her hand while taking green cap of vaccine PENTACEL. (Batch number C5264AA, expiration date 29-Oct-2018), on an unknown date. The patients medical history and concomitant medications were not reported. It was reported that on unknown date, 8 individual doses of PENTACEL have broken, nurse went to take little green cap off it and it shattered in her hand, the bottom shattered and stabbed her hand. Description of complaint: Supervisor calling to report that in total 8 individual doses of PENTACEL have broken. This particular time, today, the nurse went to take the little green cap off it and it shattered in her hand. The bottom shattered and stabbed her hand. Other vials, sometimes it separates at the neck. Sometimes when the nurses pull the vials out the box the bottom falls out. Some have holes in the base or around the shoulder, looks like it had been shot with little holes in it, leaving no liquid inside. Lab data and corrective treatment were not reported. Outcome of the event was unknown. List of documents held by sender- none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Initial pregnancy information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a 32 years old female patient who received extra dose of ADACEL while she was pregnant. Gestation period: first dose at 27.2 weeks pregnant (6 months) and second dose again 4 weeks later at 31.2 weeks (7 months) pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 29-Jun-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5798AB. On an unknown date she also received a 0.5 ml dose of the same vaccine lot 5N2YG. It was a case of actual medication error due to extra dose administered and Vaccine exposure during pregnancy. ADACEL was given twice in 4 weeks. No AE symptoms stated or known. 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.
Sex: F
Vaccine: FLUX
Symptoms: Lichen planus
Clinical narrative: Initial unsolicited report received from the literature on 21-Aug-2018. This case is linked with related cases- 2018SA237245, 2018SA237231, 2018SA237250, 2018SA237248, 2018SA237249, 2018SA237247, for same influenza vaccine, same literature article. The following is the abstract from the article- Lichen planus (LP) and lichenoid drug eruptions (LDEs) uncommonly occur after vaccination, especially for hepatitis B and influenza. The key initiating event that leads to the development of post immunization LP or LDE is not well understood. There have been prior reports of an association between several vaccines and LP. In this study, we aim to characterize and review cases of LP and LDE after vaccination from the Vaccine Adverse Event Reporting System (VAERS) national database. Information on vaccine associated LP and LDE was retrieved from the database (July 1990 to November 2014) to examine the frequency of LP or LDE after vaccination. Hepatitis B, influenza, and herpes zoster vaccines were the 3 most commonly associated vaccines. Patients with LP or LDE were significantly older compared to the reported adverse events (AEs) overall (P<.001). The median age of onset for LP and LDE was 47 years. The median time of onset of AEs was 14 days. It is important to obtain recent vaccination history in patients presenting with new-onset LP or LDE. This case involves a 73 years old female patient who experienced lichen planus, while she received vaccine INFLUENZA VACCINE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious lichen planus 19 days following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was reported that patient was seen and followed up by dermatologists or physicians. Other relevant tests included- Histologic confirmation of lichen planus- yes. Final diagnosis was lichen planus. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for lichen planus. List of documents held by sender- none.; Sender's Comments: This case concerns an elderly patient who presented with lichen planus after vaccination with Influenza Vaccine (unknown manufacturer). The time to onset, allergic history and confirmation of the etiology is not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two-months old patient who was accidently administered with a 0.5 ml dose of QUADRACEL (lot number: C5222AA, expiry date, dose in series was not reported) via intramuscular route in the right thigh on 13-Aug-2018 instead of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PREVENAR for Immunisation; and ROTARIX for Immunisation. It was also a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. 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 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. List of documents held by sender: none
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial unsolicited report received from physician on 21-Aug-2018. This case involves a patient who was vaccinated with IMOVAX RABIES. (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to Caller states a patient went off schedule for his IMOVAX vaccine post exposure and received injection on day 0 and day 7 but missed day 3 (inappropriate schedule of vaccine administered). It was unknown whether patient experienced any adverse event following 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 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: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Musculoskeletal discomfort, Paraesthesia
Clinical narrative: Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 48 years old male patient who experienced pulling in his right shoulder, numbness and tingling down his right arm whenever he moved neck up/down to the left side, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Jun-2018 at 04:30 PM, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI856AB via intramuscular route in the right deltoid. On 12-Aug-2018 at 12:00 PM, the patient developed a non-serious pulling in his right shoulder, numbness, tingling down his right arm whenever he moved neck up/down to the left side, one month 27 days 19 hours 30 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant tests were not reported. Final diagnosis was pulling in his right shoulder, numbness and tingling down his right arm whenever he moved neck up/down to the left side. It was not reported if the patient received a corrective treatment. On an unknown date, the patient was recovered from the events. List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial unsolicited report received from Consumer on 21-Aug-2018. This case involves an 18-years female patient (also reported as 11-years old) who received an extra dose of MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunisation; and HPV VACCINE for Immunisation. The patient received a 0.5ml first, second and inadvertently received third dose of MENACTRA (Batch number: U5984AC) via intramuscular route in right deltoid on 04-Sep-2012, 29-Aug-2017 and 17-Aug-2018 respectively. It was a case of actual medication error due to extra dose administered. It was unknown whether patient experienced any adverse event following 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 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.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old male patient who had received D-TAP/ IPOL diluent (lot number: 2030999) but not ACTHIB (lot number: C5456AA, expiry date: 18-Dec-2018), while he received a third dose of PENTACEL in left thigh on 22-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE and PREVNAR 13 for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was unknown if any adverse event was 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 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. Documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old male patient who received 0.5 ml dose of suspect PENTACEL (lot number, route and site of administration were not reported) on 22-Aug-2018 too early. The patient also received a dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number, route and site of administration were not reported) on 26-Apr-2018. Concomitant medications included PROQUAD for Immunisation; and PREVNAR 13 for Immunisation. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was reported that the patient was not due for his fourth dose until 16-May-2021. It was unknown if any adverse event was 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 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. List of the documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: This case involves a six months old male patient who was vaccinated with a 0.5 ml expired dose of vaccine PENTACEL (Batch number: C5389AA, expiration date: 17-Jul-2018, route: intramuscular and site of administration was not reported) on 23-Aug-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse event following 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 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.
Sex: U
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Product storage error
Clinical narrative: Based on information received on 24-Aug-2018, the report previously considered as non-valid and became valid: because 37 patients involved in this case (initially reported as multiple children's). Initial unsolicited report received from Consumer/ Non-Healthcare Professional in the on 23-Aug-2018. This case involves 37 children patients who were vaccinated with a dose of vaccines PENTACEL and ADACEL. (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due temperature excursions which was reached -0.33C for 30 minutes for their PENTACEL and ADACEL(incorrect product storage). It was unknown whether patient experienced any adverse event following vaccination. It had been request that the reporter sent "something to fill out" to provide all children details. 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 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. Follow-up information received from a non-healthcare professional in the on 24-Aug-2018. Number of patients updated. List of documents held by sender: none.