chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient was pharmacist. The patient experienced severe arm pain upon receiving a dose of Shingrix on 25th October 2019.  The reporter consented to follow up. The case has been linked with the case US2020071702 reported by same reporter for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injected limb mobility decreased, Injection site erythema, Injection site warmth
Clinical narrative: injection site reaction (very red and hot to the touch); injection site reaction (very red and hot to the touch); she couldnt lift her arm for a day after receiving her first shingrix; This case was reported by a pharmacist and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and injected limb mobility decreased. On an unknown date, the outcome of the injection site warmth, injection site erythema and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injected limb mobility decreased to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and had injection site reaction very red and hot to the touch and she could not lift her arm. The reporter at the time of reporting due for her second dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: a patient who is due for the second dose of Shingrix (patient will hit the 6 month mark within the next few days),; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient was due for the second dose of Shingrix and they were not sure how to proceed with completion of the series. It was likely that, due to COVID-19, the patient will receive the second dose late. This case has been linked with case US2020071754, reported for same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got both parts of the vaccination last July / got another outbreak; got another outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles twice before the vaccination).   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, between 8 and 10 months after receiving Shingrix, less than 9 months after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles twice before the vaccination. The patient got both parts of the vaccination last July.  The patient got another outbreak 2 days ago. The patient was taking valacyclovir. The patient wanted to know should consider a second 2 part vaccination with shingrix when it clears up? This case was considered as suspected vaccination failure since details regarding laboratory test for shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel as rough; This case was reported by a consumer and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient felt as rough. The patient was wondering would the second part of the shingles vaccine different then the first injection. Was the dosage the same as the first.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: very few patients experienced fever following Shingrix administration.; This case was reported by a other health professional via call center representative and described the occurrence of fever in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patients experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. very few patients experienced fever following Shingrix administration. lot number and expiration date not available.  No additional information was available. The reporter consented to follow up.  This case is 1 out of 4 cases reported by the same reporter.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain
Clinical narrative: severe abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced abdominal pain. On an unknown date, the outcome of the abdominal pain was not recovered/not resolved.   It was unknown if the reporter considered the abdominal pain to be related to Shingrix.  Additional information was provided as follows: The patient stated, it was reaction to the shot. The patient had to go to the emergency room. The patient wanted to put this in records for the side affect of these unsafe vaccines.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Peripheral coldness, Pyrexia
Clinical narrative: Temp 99; Shaking chills; Cold hands and feet; This case was reported by a physician and described the occurrence of fever in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2020AMR074958).   On 10th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced fever, chills and cold hands & feet. On an unknown date, the outcome of the fever, chills and cold hands & feet were recovered/resolved.   The reporter considered the fever, chills and cold hands & feet to be probably related to Shingrix.  Additional details were reported as follows: The symptoms started in the middle of the night during his sleep after getting the shot dose 2 on the 10th of March.  The patient reported waking up feeling fine in the am and took no medication.  The patient attributed the reaction to the vaccine as he had been advised they might occur by the pharmacist who gave him his 2nd dose.  The patient experienced only arm pain with dose 1 and no arm pain with dose 2.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This case was reported by a physician and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced only arm pain with dose 1. For tolerance after 2nd dose refer case US2020AMR074953.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: welt on her back; This case was reported by a consumer via call center representative and described the occurrence of welts in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient gets approximately 2 shingrix outbreaks per year). Previously administered products included Zostavax (previously received Zostavax).   On 10th January 2020, the patient received Shingrix. On 22nd April 2020, 103 days after receiving Shingrix, the patient experienced welts. On an unknown date, the outcome of the welts was unknown.   It was unknown if the reporter considered the welts to be related to Shingrix.  Additional details were provided as follows: The patient gets approximately 2 shingrix outbreaks per year. The patient had a welt on her back in the same place that she usually gets a shingles outbreak. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age
Clinical narrative: Circumstance or information capable of leading to medication error; Inappropriate age at vaccine administration; This case was reported by a physician via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 29-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error and inappropriate age at vaccine administration. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The vaccine has not been administered at the time of this report. A doctor reported that a 29 year old male with a history of Shingles may get Shingrix, and if administered might lead to circumstance or information capable of leading to medication error and inappropriate age at vaccine administration. This was a potential medication error.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Facial nerve disorder, Pain of skin, Paraesthesia
Clinical narrative: is experiencing "facial nerve issues" / first division of the trigeminal nerve up to his eye noted; burning on the left side of his face; scalp, and skin tenderness noted as well when shaving; tingling on the left side of his face; This case was reported by a physician via call center representative and described the occurrence of facial nerve disorder in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced facial nerve disorder, burning sensation in face, skin tenderness and tingling. On an unknown date, the outcome of the facial nerve disorder, burning sensation in face, skin tenderness and tingling were unknown.   It was unknown if the reporter considered the facial nerve disorder, burning sensation in face, skin tenderness and tingling to be related to Shingrix.  Additional details were provided as follows: The patient experienced "facial nerve issues, burning and tingling on the left side of his face, first division of the trigeminal nerve up to his eye, and scalp, and skin tenderness noted as well when shaving." Consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching
Clinical narrative: developed a twitch in the face; This case was reported by a pharmacist via call center representative and described the occurrence of twitching facial in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 15th May 2022) for prophylaxis.   On 10th January 2020, the patient received the 1st dose of Shingrix. In January 2020, 14 days after receiving Shingrix, the patient experienced twitching facial. In February 2020, the outcome of the twitching facial was recovered/resolved.   It was unknown if the reporter considered the twitching facial to be related to Shingrix.  Additional information was received as follows: The patient developed a twitch in the face that lasted for 10 days intermittently (near dimple area). The batch number of Shingrix was reported as 24k27, however upon review of sales data sheet it was corrected to 24KZ7. The reporter consented for follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dysstasia, Joint adhesion, Myalgia
Clinical narrative: knee was aching/stainless steel knee.; stainless steel knee; muscle aches; 29 year old patient received Shingrix; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2020, the patient received the 1st dose of Shingrix. In January 2020, 1 week after receiving Shingrix, the patient experienced muscle pain and difficulty in standing. On 13th March 2020, the patient experienced knee pain and knee adhesion. On an unknown date, the outcome of the muscle pain, difficulty in standing, knee pain and knee adhesion were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, difficulty in standing, knee pain and knee adhesion to be related to Shingrix.  Additional details were provided as follows: About a week after receiving Shingrix, the patient experienced muscles aches severely.  If she sits down for a few minutes she cannot get back up because of the muscle pain.  It was severely constant during the first month.  Every day was different. On the day of reporting, 52 days after receiving Shingrix, her knee was aching and she had a stainless steel knee. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: experienced pain at the injection site and surrounding area; experienced pain at the injection site and surrounding area; experienced muscle ache throughout the body; Headache; Shivering; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, headache, shivering and fever. On 16th March 2020, the patient experienced injection site pain and pain localized. On an unknown date, the outcome of the injection site pain and pain localized were recovered/resolved and the outcome of the muscle pain, headache, shivering and fever were recovering/resolving.   It was unknown if the reporter considered the injection site pain, pain localized, muscle pain, headache, shivering and fever to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine and Right after getting her dose she experienced pain at the injection site and surrounding area. By midnight patient experienced muscle ache throughout the body, headache, shivering, and low grade fever. The pain at the site of injection and surrounding area with dose 1 that lasted for couple days. The patient felt better at time of reporting. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: experienced pain at the injection site and surrounding area; experienced pain at the injection site and surrounding area; experienced muscle ache throughout the body; Headache; Shivering; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, headache, shivering and fever. On 16th March 2020, the patient experienced injection site pain and pain localized. On an unknown date, the outcome of the injection site pain and pain localized were recovered/resolved and the outcome of the muscle pain, headache, shivering and fever were recovering/resolving.   It was unknown if the reporter considered the injection site pain, pain localized, muscle pain, headache, shivering and fever to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine and Right after getting her dose she experienced pain at the injection site and surrounding area. By midnight patient experienced muscle ache throughout the body, headache, shivering, and low grade fever. The pain at the site of injection and surrounding area with dose 1 that lasted for couple days. The patient felt better at time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Intermittent Vertigo; This case was reported by a nurse via call center representative and described the occurrence of vertigo in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was not recovered/not resolved.   It was unknown if the reporter considered the vertigo to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, however it could be 59 or 60 years. The patient started to experience vertigo intermittently.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Outbreak of Shingles after receiving the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown 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 case details were reported as follows: The age at vaccination was not reported. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: had pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported., however it could be 60 or 61 years. The patient had pain at the injection site that lasted about a week.  The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Platelet count decreased
Clinical narrative: Platelets count has been dropping since receiving the vaccine/low platelets; This case was reported by a pharmacist via call center representative and described the occurrence of platelets decreased in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number ZM3D2, expiry date 3rd April 2022) for prophylaxis.   On 26th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th February 2020, immediately after receiving Shingrix, the patient experienced platelets decreased. On an unknown date, the outcome of the platelets decreased was not recovered/not resolved.   It was unknown if the reporter considered the platelets decreased to be related to Shingrix.  Additional case details were reported as follows: The patient's platelets count has been dropping since she received Shingrix.  Her normal platelet count was 220 which has dropped to 30 and then 20 in the last few weeks. The reporter consented to follow up. This case has been linked with US2020050262 and US2020050264, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were received as follows: This case was received via chat. The age group adult selected as per vaccine specification.  The patient received the second dose of Shingrix and was experiencing pain in the arm. The reporter did not consented to follow up.  The patient declined to share any details on the experience.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Coronavirus test negative, Erythema, Pyrexia
Clinical narrative: Bumps or red round blister all over his forehead and left side of the face; Bumps or red round blister all over his forehead and left side of the face; Been running a fever around 101.5; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. On 16th March 2020, 10 days after receiving Shingrix, the patient experienced fever. On 23rd March 2020, the patient experienced blister and erythema. On 22nd March 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the blister and erythema were not recovered/not resolved.   It was unknown if the reporter considered the fever, blister and erythema to be related to Shingrix.  Additional details were provided as follows: The patient had been running a fever around 101.5 degree F; Yesterday (22nd March 2020) was the last day with the fever. Today (23rd March 2020) he started noticing bumps or red round blister all over his forehead and left side of the face. He's been tested for coronavirus as well. Patient said all tests came out negative. Consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pain in extremity, Swelling
Clinical narrative: Redness an inch or two below the injection site; Swelling just below the injection site; Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose, for tolerance refer US2020AMR072170).   On 24th April 2020, the patient received the 2nd dose of Shingrix. On 24th April 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 26th April 2020, the patient experienced erythema and swelling. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, erythema and swelling were unknown.   It was unknown if the reporter considered the injection site pain, erythema and swelling to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix on right deltoid. After receiving Shingrix, the patient had experienced pain at the injection site and also had redness an inch or two below the injection site on Sunday that was painful to the touch. The patient was taking Tylenol to treat the pain. The reporter consented to follow up. This case is 1 of 3 cases reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified numbers of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not applicable. No specific patient was involved. The reporter reported that many patients experienced pain after receiving Shingrix.  The reporter consented to follow up. This case is 1 of 3 cases reported.
Sex: U
Vaccine: VARZOS
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: low grade fever; muscle weakness with 12 hours of getting their first shingrix vaccine; This case was reported by a non-health professional via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced fever and muscle weakness. On an unknown date, the outcome of the fever and muscle weakness were unknown.   It was unknown if the reporter considered the fever and muscle weakness to be related to Shingrix.  Additional details were reported as follows: Caller reported adverse event for a patient who got their Shingrix vaccination. Caller stated the patient developed a low grade fever and experienced muscle weakness with 12 hours of getting their fist shingrix vaccine. The reporter did not give consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: after receiving the Shingrix injection, they did not feel well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable. The reporter stated that she had heard other people say that after receiving the Shingrix injection, they did not feel well.  No additional information was provided. The reporter did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Nausea
Clinical narrative: Flu-like symptoms; chills; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th January 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, fatigue and nausea. On an unknown date, the outcome of the influenza-like symptoms, chills, fatigue and nausea were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills, fatigue and nausea to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in the left deltoid and experienced flu-like symptoms, nausea, fatigue and chills later that evening which lasted through the weekend. The reporter did not consent to follow up. The reporter declined to provide any medical doctor information.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 4 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 information was provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The nurse reported that the patient developed shingles 4 days after receipt of Shingrix. The reporter consented to follow up. No further details available from nurse at the time of reporting but she was agreeable to recontact.  Email address was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, 4 weeks 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 information was provided as follows: The age at the vaccination was not reported as patient could be 61 years or 62 years old at the time of vaccination. The patient received Shingrix in January and developed shingles about 4 weeks later. The reporter wanted recommendations for the 2nd dose. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site warmth
Clinical narrative: burning at injection site; heat at injection site; unable to lift arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number NG5N7, expiry date 1st April 2022) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 25th February 2020, 2 hrs after receiving Shingrix, the patient experienced injection site burning, injection site warmth and injected limb mobility decreased. On an unknown date, the outcome of the injection site burning, injection site warmth and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site burning, injection site warmth and injected limb mobility decreased to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in the left arm and felt heat at the injection site and that it burned at the injection site.   The patient was also not able to lift her arm.   Events had resolved. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months 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 information was received as follows: The case was reported by the husband of the patient. The patient received Shingrix on her left arm and experienced sore arm that had not resolved.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: fever; chills; aches; felt awful; This case was reported by a other health professional via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, chills, pain and feels awful. On an unknown date, the outcome of the fever, chills, pain and feels awful were resolved with sequelae.   It was unknown if the reporter considered the fever, chills, pain and feels awful to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Office manager called stating that her sister received her second dose of Shingrix about a year ago (probably in the morning) and began experiencing fever, chills, aches and felt awful in the afternoon because she had to go home from work. Within 24 hours the symptoms were gone. The lot number and expiration date not available.  Caller states that her sister wanted to report this but the clinic that she went to said not to bother. Clinic name was unknown.  The reporter consented to follow up. This case is 1 out of 3 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: experienced soreness in the arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced soreness in the arm. lot number and expiration date not available.  No additional information is available. The reporter consented to follow up.  This case is 1 out of 4 cases reported by the same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac flutter, Echocardiogram abnormal, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal
Clinical narrative: Fluttering; This case was reported by a consumer via call center representative and described the occurrence of heart fluttering in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced heart fluttering (serious criteria GSK medically significant). On an unknown date, the outcome of the heart fluttering was recovering/resolving.   It was unknown if the reporter considered the heart fluttering to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix and had fluttering. On an unknown date in 2020, the patient had Electrocardiogram, Echocardiogram, Electrocardiogram ambulatory test and result showed cardiac flutter. The reporter did not consented for follow up.      Lab Comments: On an unknown date in 2020, the patient had Electrocardiogram, Echocardiogram, Electrocardiogram ambulatory test and result showed cardiac flutter.
Age: 62.0
Sex: F
Vaccine: MENB
Symptoms: Asplenia, Product administered to patient of inappropriate age
Clinical narrative: the patient has asplenia; 62 year old female received a dose of Bexsero / may receive the 2nd dose; Inappropriate age at vaccine administration; This case was reported by a nurse via call center representative and described the occurrence of asplenia in a 62-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA63AA, expiry date 30th September 2021) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced asplenia (serious criteria GSK medically significant), off label use and inappropriate age at vaccine administration. On an unknown date, the outcome of the asplenia, off label use and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the asplenia to be related to Bexsero.  Additional information was received as follows: The patient received a dose of Bexsero at 62 age old and might receive the 2nd dose. No symptoms reported. The patient had Asplenia. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Neuropathy peripheral
Clinical narrative: Neuropathy; pain at the injection site; pain at the injection site on the right arm and goes to the right hip; This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), injection site pain and pain in hip. On an unknown date, the outcome of the neuropathy, injection site pain and pain in hip were recovering/resolving.   It was unknown if the reporter considered the neuropathy, injection site pain and pain in hip to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix on her right arm. The patient received Shingrix and had pain at the injection site on the right arm and goes to the right hip, also developed a neuropathy and had not recovered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: redness on top of her entire arm; arm was warm to touch; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHingrix (had original Shingles vaccines in the past.).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were unknown.   It was unknown if the reporter considered the erythema of extremities and skin warm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced redness on top of her entire arm, and it was warm to touch after getting the first dose of Shingrix vaccine. Patient stated she has had original Shingles vaccines in the past. The reporter consented to follow up. Caller did not provide any other details, caller disconnected prior to gathering any additional information.
Sex: U
Vaccine: MENB
Symptoms: Pain, Paraesthesia
Clinical narrative: Soreness; Tingling sensation; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. An adolescent patient of unspecified gender started to receive meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had a tingling sensation and soreness just after the vaccine was administered. The outcome of the events was unknown.   No follow-up attempts are needed. Information about Lot/Batch Number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Experienced severe pain at the injection site; This is a spontaneous report from contactable physician via a Pfizer Sales Representative. An elderly female patient (68 or 70 year old) received on an unknown date a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization. Medical history and concomitant medications were not reported. The patient experienced severe pain at the injection site that asked for almost a week after administration with vaccine. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: body aches and pains; Initial information received on 27-Apr-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a male patient who experienced body aches and pains (pain), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route for prophylactic vaccination.  On an unknown date, The patient developed a non-serious body aches and pains (pain) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab test reported.  Final diagnosis was body aches and pains.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported.  There will be no information available on the batch number for this case, currently.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient received mixture of the powder of the pentacel with the liquid of the quadracel, no AE; Initial information received on 29-Apr-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 6 months old patient received a 0.5 ml third dose of mixture of the powder of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ217AD, expiry date: 04-Apr-2021) with the liquid of the QUADRACEL, via an intramuscular route in the left thigh on 29-Apr-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting, the patient did not experienced any 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 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.