chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities, fatigue, muscle pain and headache. On an unknown date, the outcome of the erythema of extremities, fatigue, muscle pain and headache were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, fatigue, muscle pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX a few weeks before the date of reporting. In 2018, the patient experienced red arm, severe headache, fatigue and muscle aches which lasted over a week. The patient had been advised not to get the 2nd dose of SHINGRIX. The patient did not wish to provide additional information as her pharmacy had already reported her reactions to the health department. The patient wanted to know how much protection did she have from one dose of SHINGRIX.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 26th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, injection site pain and injection site swelling. The patient was treated with Anti Inflammatory Drug (Nos). On 31st May 2018, the outcome of the injection site rash, injection site erythema, injection site pain and injection site swelling were recovered/resolved. The reporter considered the injection site rash, injection site erythema, injection site pain and injection site swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The healthcare professional (HCP) stated that the patient had an injection site reaction 12 hours after receiving SHINGRIX vaccine. The HCP reported that the patient had a red rash, swelling, and pain located on her right deltoid, arm area where the vaccine was administered. The HCP stated that the patient had this reaction for 5 days, then the reaction fully resolved. The HCP stated that the patient had a low threshold for pain. The HCP was a retail pharmacist stated patient's husband called to report site reaction in the next morning, patient was recommended to rest, apply ice, and take anti-inflammatories for injection site reaction. The HCP was unsure if patient did any of those interventions. The HCP stated that she was unsure if the patient had her second dose as recommended due to the injection site reaction.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Hypersensitivity, Incomplete course of vaccination, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction, swollen arm, erythema of extremities and fatigue. SHINGRIX was discontinued. On an unknown date, the outcome of the allergic reaction, swollen arm, erythema of extremities and fatigue were unknown. It was unknown if the reporter considered the allergic reaction, swollen arm, erythema of extremities and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The other health professional reported that, she had a patient who had a strong reaction to the first shot. The swollen red arm and fatigue. She wanted to know how efficacious was the vaccine if she only gets one shot. Her primary care thought she might be allergic so they recommended her to not get the second dose. No additional information was reported.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Erythema, Fatigue, Incomplete course of vaccination, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 77-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date unknown) for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 2 days after receiving SHINGRIX, the patient experienced swelling arm, fatigue, erythema of extremities and mental distress. On 22nd May 2018, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the swelling arm and fatigue were recovered/resolved and the outcome of the erythema of extremities was recovering/resolving and the outcome of the mental distress and incomplete course of vaccination were unknown. The reporter considered the swelling arm, fatigue, erythema of extremities and mental distress to be related to SHINGRIX. Additional details was received as follows: The patient received SHINGRIX in left deltoid. The health care professional (HCP) was not able to provide the expiration date of the SHINGRIX. The HCP also said this experience was very mentally and emotionally stressful for the patient. The HCP stated that the patient's physician told patient to not to receive 2nd dose of the series, which was sounded like the patient would not finish the series, which led to incomplete course of vaccination. The patient visited physician for these adverse events.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Aura, Brain operation, Panic reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of aura in a 57-year-old female patient who received BOOSTRIX for prophylaxis. Co-suspect products included LAMICTAL unknown for epilepsy. Concurrent medical conditions included epilepsy. Concomitant products included CLARITIN, IMODIUM and ZOCOR. On 25th May 2018, the patient received BOOSTRIX .5 ml. On an unknown date, the patient started LAMICTAL (oral) 500 mg once daily (500 mg daily). On 25th May 2018, 9 hrs after receiving BOOSTRIX and unknown after starting LAMICTAL, the patient experienced aura. LAMICTAL was continued with no change. On an unknown date, the outcome of the aura was recovered/resolved. The reporter considered the aura to be almost certainly related to BOOSTRIX and LAMICTAL. Additional information was received as follows: The patient had surgery to had piece of brain removed for epilepsy treatment. The patient was using multivitamin and PROTONIX as concomitant product. The patient stated that she had a history of epilepsy and states that she had not any seizure activity in 34 years. Nine hours after receiving the vaccine, the patient stated that she had aura and she had it again about 2 hours after first experience. The patient panicked because she usually gets aura prior to having a seizure. The patient did not experienced, however, had a seizure, but rather it was a chemical reaction. The patient had the product information (PI) and stated that read the ingredients, but asks if thiomersal was one of the ingredients in BOOSTRIX. The patient stated that thiomersal was known to cause seizures. The patient informed that she could not find any mention of thiomersal in the PI but suggested that she had her health care professional (HCP) call our medical information department. The call center representative mentioned that the patient uses LAMICTAL as preventative treatment for her epilepsy so it was listed as a suspect product. The patient did not feel that the LAMICTAL was what caused her symptoms. The patient's primary care physician was aware of her symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a elderly female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. Concomitant products included Venlafaxine and Estradiol Patch. On 29th May 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced blister. On an unknown date, the outcome of the blister was not recovered/not resolved. The reporter considered the blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called about one of her patients at her pharmacy that received the SHINGRIX vaccine at her pharmacy. The floater pharmacist gave the injection to the patient on that day. The patient called over this past weekend and said that she had some blisters on her upper arm on both arms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Headache, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 9th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th June 2018, 2 days after receiving SHINGRIX, the patient experienced papular rash. In June 2018, the patient experienced headache, pain in joint involving hand, back pain and fever. The patient was treated with Cortisone (Nos) and BENDARYL. On 11th June 2018, the outcome of the headache, pain in joint involving hand, back pain and fever were recovered/resolved. On an unknown date, the outcome of the papular rash was recovering/resolving. The reporter considered the headache, pain in joint involving hand, back pain, fever and papular rash to be possibly related to SHINGRIX. Additional details were reported as follows: At 14:00, the patient received SHINGRIX vaccine on the left arm. The next day (Sunday), she woke up with a headache, joints of fingers on both hands hurting, back pain, and fever. She said that she was in bed all day. By Monday, all of these symptoms had resolved however she had a bumpy rash (2 days after receiving SHINGRIX) on her cheek. She used cortisone on the rash and it started to improve. On 12th June 2018 (Tuesday), she noticed that, the rash had spread to her forehead. She took BENADRYL and by Wednesday it had improved, but it was still visible. She planned to see a dermatologist. The reporter gave permission for her physician to be contacted and provided contact details for the same. This case was one of the 5 cases reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 9th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th June 2018, 2 days after receiving SHINGRIX, the patient experienced papular rash. In June 2018, the patient experienced headache, pain in joint involving hand, back pain and fever. The patient was treated with Cortisone (Nos) and BENDARYL. On 11th June 2018, the outcome of the headache, pain in joint involving hand, back pain and fever were recovered/resolved. On an unknown date, the outcome of the papular rash was recovering/resolving. The reporter considered the headache, pain in joint involving hand, back pain, fever and papular rash to be possibly related to SHINGRIX. Additional details were reported as follows: At 14:00, the patient received SHINGRIX vaccine on the left arm. The next day (Sunday), she woke up with a headache, joints of fingers on both hands hurting, back pain, and fever. She said that she was in bed all day. By Monday, all of these symptoms had resolved however she had a bumpy rash (2 days after receiving SHINGRIX) on her cheek. She used cortisone on the rash and it started to improve. On 12th June 2018 (Tuesday), she noticed that, the rash had spread to her forehead. She took BENADRYL and by Wednesday it had improved, but it was still visible. She planned to see a dermatologist. The reporter gave permission for her physician to be contacted and provided contact details for the same. This case was one of the 5 cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of ringing in ears in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unchanged. It was unknown if the reporter considered the ringing in ears to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 62 years or 63 years. It was unknown to the reporter if there was a previous medical history of ringing in the ears. The patient received SHINGRIX 2 to 6 months before the date of reporting at another retail pharmacy, and since the first dose had been experiencing ringing in his ears that was still ongoing. The pharmacist did not having any vaccine information from the 1st dose. The previous pharmacy had no record of administration. The patient presented for 2nd dose of SHINGRIX to a retail pharmacy. The date of first dose administration was unknown, onset of ringing in ears was unknown, interventions or MD/ER treatment were unknown. The pharmacist stated she did talk to patient about starting a B Complex to assist with ringing in the ears, unknown if patient followed this intervention recommendation. The pharmacist stated not knowing many adverse event question answers due to her pharmacy was not the administering location. Additionally, the patient only shared limited details.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 21st February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st February 2018, less than a day after receiving SHINGRIX, the patient experienced chills and fever. On 22nd February 2018, the patient experienced lethargy. On 22nd February 2018, the outcome of the chills, lethargy and fever were recovered/resolved. The reporter considered the chills, lethargy and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX after lunch in the right arm. On the same day, at the night the patient experienced low fever and chills. The patient experienced lethargy the day after receiving the SHINGRIX and it resolved by end of that day. The suspect vaccine lot number and expiry date was not available. For tolerance after the 2nd dose of SHINGRIX, refer case US2018GSK111503. This case is one of the 5 cases, reported by the same reporter.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Erythema, Feeling abnormal, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 82-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included high blood pressure (Diagnosed prior to receiving the vaccine) and high cholesterol (Diagnosed prior to receiving the vaccine). Concomitant products included lisinopril and lovastatin. On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities, local swelling, itching, stomach ache, pain in arm and swelling arm. The action taken with SHINGRIX was unknown. On an unknown date, the outcome of the erythema of extremities, local swelling, itching, pain in arm and swelling arm were not recovered/not resolved and the outcome of the stomach ache was recovered/resolved. The reporter considered the erythema of extremities, local swelling, itching, pain in arm and swelling arm to be almost certainly related to SHINGRIX. The reporter considered the stomach ache to be unlikely related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included Vitamins. The patient's arm was red, sore, had swelling, itches and feels kind of funny (like she can feel something in there, maybe a lump). She stated that she also had a stomach ache but thought it was from something else. The reporter provided her with the appropriate adverse event information from the PI and suggested that she call her physician about her symptoms and for recommendations. Obtain permission to contact MD.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 82-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included high blood pressure (Diagnosed prior to receiving the vaccine) and high cholesterol (Diagnosed prior to receiving the vaccine). Concomitant products included lisinopril and lovastatin. On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities, local swelling, itching, stomach ache, pain in arm and swelling arm. The action taken with SHINGRIX was unknown. On an unknown date, the outcome of the erythema of extremities, local swelling, itching, pain in arm and swelling arm were not recovered/not resolved and the outcome of the stomach ache was recovered/resolved. The reporter considered the erythema of extremities, local swelling, itching, pain in arm and swelling arm to be almost certainly related to SHINGRIX. The reporter considered the stomach ache to be unlikely related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included Vitamins. The patient's arm was red, sore, had swelling, itches and feels kind of funny (like she can feel something in there, maybe a lump). She stated that she also had a stomach ache but thought it was from something else. The reporter provided her with the appropriate adverse event information from the PI and suggested that she call her physician about her symptoms and for recommendations. Obtain permission to contact MD.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Night sweats, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 27th February 2018, the patient received the 1st dose of SHINGRIX  (intramuscular). On 27th February 2018, less than a day after receiving SHINGRIX , the patient experienced chills, night sweats and fever. On an unknown date, the outcome of the chills, night sweats and fever were recovered/resolved. The reporter considered the chills, night sweats and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine at around 1:00 PM in the left arm. The same day, at night, the patient experienced fever, chills, and night sweats which resolved that night. The suspect vaccine lot number and expiry date was not available. For tolerance after the 2nd dose of SHINGRIX, refer case US2018GSK111482. This case is one of the 5 cases, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 29th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 29th May 2018, less than a day after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved. The reporter considered the chills to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine in the left arm before the lunch. The same day, at night, the patient experienced chills. The symptoms resolved at that night.  The suspect vaccine lot number and expiry date was not available. This case is one of the 5 cases, reported by the same reporter. The caller stated that they administered about 70 SHINGRIX doses in their pharmacy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle reaction in a 55-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On 9th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site muscle reaction, injection site muscle pain, injection site warmth, injection site induration, injection site erythema and injection site swelling. The patient was treated with Analgesics. On an unknown date, the outcome of the injection site muscle reaction, injection site muscle pain, injection site warmth, injection site induration, injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site muscle reaction, injection site muscle pain, injection site warmth, injection site induration, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) stated that, the patient experienced redness and swelling at injection site, muscle pain and muscle stiffness at the injection site as well as hardness at the injection site. The HCP states that, the patient also had the injection site area which was warm to the touch. The patient had been taking over the counter (OTC) analgesics, which was not helping any of these symptoms. Till the time of reporting the patient was experiencing these symptoms and symptoms had not resolved. No further information was provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle reaction in a 55-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On 9th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site muscle reaction, injection site muscle pain, injection site warmth, injection site induration, injection site erythema and injection site swelling. The patient was treated with Analgesics. On an unknown date, the outcome of the injection site muscle reaction, injection site muscle pain, injection site warmth, injection site induration, injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site muscle reaction, injection site muscle pain, injection site warmth, injection site induration, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) stated that, the patient experienced redness and swelling at injection site, muscle pain and muscle stiffness at the injection site as well as hardness at the injection site. The HCP states that, the patient also had the injection site area which was warm to the touch. The patient had been taking over the counter (OTC) analgesics, which was not helping any of these symptoms. Till the time of reporting the patient was experiencing these symptoms and symptoms had not resolved. No further information was provided.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Seizure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of seizures in a 53-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. The patient's past medical history included seizure. Concomitant products included gabapentin and valproic acid (Divalproex). On 29th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced seizures (serious criteria GSK medically significant and other: as per reporter). On an unknown date, the outcome of the seizures was unknown. The reporter considered the seizures to be unrelated to SHINGRIX. Additional information was received as follows: The concomitant drugs included anti depressant and anti anxiety medications. The health care professional (HCP) reported the patient had a pre-existing seizure condition since childhood that was controlled on divalproex.  After the patient experienced the seizures, the divalproex dose was adjusted and event was in control at the time of reporting. The reporter didn't feel that the vaccine caused the seizures to reoccur. The reporter did not have a too much information available. This was the information received from the pharmacy tech. The patient required emergency room visit. This was all the information available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (refer linked case US2018GSK110733). On 11th June 2018, the patient received the 2nd dose of SHINGRIX 50 mcg/mg. On 11th June 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain and fever. On 13th June 2018, the outcome of the influenza-like symptoms, general body pain and fever were recovered/resolved. The reporter considered the influenza-like symptoms, general body pain and fever to be probably related to SHINGRIX. Additional details were provided as follows: The patient experienced flu like symptoms (body aches with temperature). This case has been linked with US2018GSK110733, reported by the same reporter for same patient for the adverse events experienced after receiving 1st dose.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced red spot, silver dollar size, painful still in pain 2 days later at injection site. On 13th June 2018, the patient returned to report.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Extensive swelling of vaccinated limb, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, pain in arm and skin warm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm and skin warm were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The reporter said that, on a Tuesday (unknown date), the patient received SHINGRIX. On Friday, the patient's arm was wet and swollen from arm down to hip, which led to extensive swelling of vaccinated limb. It felt like it was on fire and hurt. The patient felt like the medicine was going in when receiving SHINGRIX. The reported agreed to be followed up.
Sex: M
Vaccine: VARZOS
Symptoms: 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 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 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 reported. The patient received SHINGRIX at outside of reporter's office and experienced fever. The reporter had limited information.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included allergy to chemicals and mercury sensitivity. On 28th February 2018, the patient received SHINGRIX. In February 2018, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased, pain in arm and discomfort. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm and discomfort were not recovered/not resolved. It was unknown if the reporter considered the injected limb mobility decreased, pain in arm and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient was on no medication. The patient received SHINGRIX in Left arm. Within 24 hours, the patient noticed that her arm was feeling restricted in its normal fluid motion and in fact her muscle that received the shot was constricted and could not be moved without pain and limitation. The patient reported that, her exercise routines through her local health club were totally impacted. Even with having several manipulations (massage and physical therapy adjustments) into the 2nd month of these restrictions, and doing some exercises to help restore her normal arm motion and reduced discomfort. The patient continued to experience residual arm movement on her left side. The patient was asking further information to identify if SHINGRIX had contain mercury thimerosal and or formaldehyde.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of headache in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 29th May 2018, the patient received the 2nd dose of SHINGRIX. On 30th May 2018, 1 days after receiving SHINGRIX, the patient experienced headache, feeling unwell, chills, fever, muscle pain, fatigue, stomach discomfort, decreased appetite and pain in arm. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, feeling unwell, chills, fever, muscle pain, fatigue, stomach discomfort, decreased appetite and pain in arm were unknown. It was unknown if the reporter considered the headache, feeling unwell, chills, fever, muscle pain, fatigue, stomach discomfort, decreased appetite and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 30th May 2018, in the morning,  the patient woke up feeling ill and experienced a bad headache, chills, slight fever (the patient's body temperature was recorded as 100.4 degree F), muscle aches, and was extremely fatigued. The patient's stomach was somewhat unsettled and she did not have much of an appetite and had soreness in arm that she had expected. The patient had been taking Advil, on the day of reporting, to keep these symptoms at bay, which had been helpful, although she was still feeling washed out and tired. The patient searched SHINGRIX side effects and noted that others had experienced similar side effects based on information on the SHINGRIX website. The patient wanted to officially report these events as part of her Pfizer obligation to do so, but also to help get the word out to help the research continue with this important vaccine relative to the population that experiences these adverse events. The patient was not sure if there was any other information she could provide that might be of additional use. However, the patient agreed to be contacted for any need of additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of headache in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 29th May 2018, the patient received the 2nd dose of SHINGRIX. On 30th May 2018, 1 days after receiving SHINGRIX, the patient experienced headache, feeling unwell, chills, fever, muscle pain, fatigue, stomach discomfort, decreased appetite and pain in arm. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, feeling unwell, chills, fever, muscle pain, fatigue, stomach discomfort, decreased appetite and pain in arm were unknown. It was unknown if the reporter considered the headache, feeling unwell, chills, fever, muscle pain, fatigue, stomach discomfort, decreased appetite and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 30th May 2018, in the morning,  the patient woke up feeling ill and experienced a bad headache, chills, slight fever (the patient's body temperature was recorded as 100.4 degree F), muscle aches, and was extremely fatigued. The patient's stomach was somewhat unsettled and she did not have much of an appetite and had soreness in arm that she had expected. The patient had been taking Advil, on the day of reporting, to keep these symptoms at bay, which had been helpful, although she was still feeling washed out and tired. The patient searched SHINGRIX side effects and noted that others had experienced similar side effects based on information on the SHINGRIX website. The patient wanted to officially report these events as part of her Pfizer obligation to do so, but also to help get the word out to help the research continue with this important vaccine relative to the population that experiences these adverse events. The patient was not sure if there was any other information she could provide that might be of additional use. However, the patient agreed to be contacted for any need of additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of chest pain in a female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX. On 7th June 2018, 3 days after receiving SHINGRIX, the patient experienced chest pain and chest discomfort. On an unknown date, the outcome of the chest pain and chest discomfort were unknown. It was unknown if the reporter considered the chest pain and chest discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the initial dose of SHINGRIX on in her left arm and was reported as fine. However, the patient reported pain and discomfort in her left chest cavity. Both PA-C (reporter) and the physician were not sure if what the patient was experiencing was a result of SHINGRIX, but want to report the event.
Sex: U
Vaccine: MENB
Symptoms: Injection site cellulitis, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in an unspecified number of patient who received BEXSERO (batch number unknown, expiry date 2018) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site cellulitis, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site cellulitis was unknown and the outcome of the injection site swelling and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site cellulitis, injection site swelling and injection site pain to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not applicable. The patients had swelling and cellulitis like bumps around the injection site and pain.  She said that it did resolve without any serious issues. She did not give me any patient name.
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Tremor, Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of tremor limb in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included PREVNAR 13 for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml and PREVNAR 13. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced tremor limb and vomiting. On an unknown date, the outcome of the tremor limb and vomiting were recovered/resolved. It was unknown if the reporter considered the tremor limb and vomiting to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX in the deltoid muscle of upper left arm and PREVNAR 13 on right arm. The patient experienced shaking of the right arm. The patient's adverse events were ceased and the patient was symptom free in about a day. The patient did not contact the physician immediately, but she reported these adverse events about one month post vaccination, when the patient was being seen by the physician for another reason. The physician questioned whether the patient should receive her 2nd dose of SHINGRIX or not. The reporter agreed to be followed up.
Sex: U
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of white blood cell increased in a adult patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included lymphocytic leukemia (chronic). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was unknown. It was unknown if the reporter considered the white blood cell increased to be related to SHINGRIX. Additional details were provided as follows: The patient's age group was taken based on the product indication as no other patient details were provided. The physician who adminsitered the vaccine to the reporting healthcare professional, stated another patient also discovered their WBC count increased after SHINGRIX vaccination. No additional information was provided. This case has been linked with case US2018103115, reported by the same reporter. Lab Comments: On an unspecified dates, before receiving the SHINGRIX, white blood cell (WBC) count was normal and WBC was increased after receiving the SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient's age group was taken based on the product indication as no other patient details were provided. The age at the vaccination was not reported. The reporter said a patient was given SHINGRIX last month and was reporting a case of the shingles at the time of reporting. The reporter was directed to speak with Medical Information via the SHINGRIX GlaxoSmithKline response center. The sales rep would follow up with the reporter for more information.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Middle insomnia
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of injection site erythema in a male patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIOX, the patient experienced injection site erythema, injection site swelling, injection site itching and nocturnal awakening. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching and nocturnal awakening were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching and nocturnal awakening to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date was unknown by the reporter. The patient experienced red swollen and itchy arm after being vaccinated with SHINGRIX. The patient also reported that this had been waking him up at night and was not able to clarify further. No further information was provided.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 71-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Baby ASA and citalopram. On 20th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 9 days after receiving SHINGRIX, the patient experienced shingles, pruritus and rash. The patient was treated with hydrocortisone and Antibacterial Soap. On an unknown date, the outcome of the shingles, pruritus and rash were recovering/resolving. It was unknown if the reporter considered the shingles, pruritus and rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The patient was experienced itching, rash and spots on his left hip and buttocks. On 14th June 2018, the patient had an already scheduled physician appointment and was diagnosed that day as mild case of shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain and fever. On an unknown date, the outcome of the influenza-like symptoms, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced Flu-like symptoms (body aches with temperature). This case has been linked with case US2018GSK106051, reported by the same reporter for same patient for the events experienced after receiving 2nd dose of SHINGRIX.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 25th January 2018, the patient received the 1st dose of SHINGRIX. On 25th January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient reported that she experienced pain on her injection site. For tolerance to the 2nd dose refer case US2018107300, reported by the same reporter for the same patient.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 28th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash and injection site pain. On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site rash and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced a small rash and pain at the injection site after the first dose of SHINGRIX in February 2018. For tolerance to the 2nd dose of SHINGRIX vaccine, refer case US2018106483 for same patient.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Night sweats, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 56-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (received 1st dose on 27th February 2018, additionally experienced night sweats and fever, for tolerance refer case US2018107293). On 1st June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced chills, night sweat and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, night sweat and fever were unknown. It was unknown if the reporter considered the chills, night sweat and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine at around 2:00 PM. The patient experienced these events which were similar in intensity after the 1st dose of SHINGRIX. The suspect vaccine lot number and expiry date was not available. This case is one of the 5 cases, reported by the same reporter.