chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Computerised tomogram head normal, Electrocardiogram normal, Injection site pain, Joint noise
Clinical narrative: Acute pain of left shoulder; Dysfunction of left rotator cuff; Adverse effect of vaccine, subsequent encounter; LOC (loss of consciousness); We discussed that the loss of consciousness with urinary incontinence is likely related to the severe pain. She had a similar LOC with severe back pain. 03/27/2019: She was definitely fine" before the shingles vaccination. Looking back she states that chronology of events: shingles vaccination (was painful when administered); Then it was okay but started to hurt after about a few hours; She was in pain in the left shoulder and arm; "crackling sounds" with moving the arm; then it got worse: stabbing, aching and intense "and it did not let up." She felt she passed out due to the pain and she had urinated in the bed; she called 911, was seen in the, ER: All the time it was the left arm that was "hurting so bad" in the area of the shot and around the area up the shoulder areas; It was not red then. It was hard for her to move her left shoulder. She was in pain in the left shoulder and arm; "crackling sounds" with moving the arm; 03/27/2019: She was seen in the emergency department for left arm pain. She had a shingles vaccination that same day (earlier in the afternoon). Examination did not show skin or bone deformity of the left arm; CT scan of the head showed no stroke; lab did not show concerning results; red blood cell count was decreased with no overt bleeding; EKG did not show acute changes; thought to be related to shingles vaccination; lidocaine cream, acetaminophen, follow up with PCP recommended. The left upper arm severe pain started to get better the next day; Since then she has been feeling better with left shoulder pain (6/10) and more so with pressing on the area. Left shoulder limitation in ROM. She has not been able to do some home tests without pain. She feels that she is a little weaker because of that. Her left hand grasps remains good though her other range of motion of the elbows, wrists, fingers remain good. The right upper extremity is unaffected. She is not able to brush her hair and do left UE tasks a little better but not back to normal due to pain. No breathing problems, no chest wall pain. She states she has known rotator cuff problems in the past but was not symptomatic before the shot; she has known spine osteoarthritis and back pain. She follows with physician therapy for this regarding no loss of consciousness with incontinence of urine, she states that she had something similar when she had severe back pain. She has pulmonary artery hypertension. She is on: LETAIRIS 10 mg tab Take 1 tab by mouth one time daily.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Laboratory test normal, Loss of consciousness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Acute pain of left shoulder; Dysfunction of left rotator cuff; Adverse effect of vaccine, subsequent encounter; LOC (loss of consciousness); We discussed that the loss of consciousness with urinary incontinence is likely related to the severe pain. She had a similar LOC with severe back pain. 03/27/2019: She was definitely fine" before the shingles vaccination. Looking back she states that chronology of events: shingles vaccination (was painful when administered); Then it was okay but started to hurt after about a few hours; She was in pain in the left shoulder and arm; "crackling sounds" with moving the arm; then it got worse: stabbing, aching and intense "and it did not let up." She felt she passed out due to the pain and she had urinated in the bed; she called 911, was seen in the, ER: All the time it was the left arm that was "hurting so bad" in the area of the shot and around the area up the shoulder areas; It was not red then. It was hard for her to move her left shoulder. She was in pain in the left shoulder and arm; "crackling sounds" with moving the arm; 03/27/2019: She was seen in the emergency department for left arm pain. She had a shingles vaccination that same day (earlier in the afternoon). Examination did not show skin or bone deformity of the left arm; CT scan of the head showed no stroke; lab did not show concerning results; red blood cell count was decreased with no overt bleeding; EKG did not show acute changes; thought to be related to shingles vaccination; lidocaine cream, acetaminophen, follow up with PCP recommended. The left upper arm severe pain started to get better the next day; Since then she has been feeling better with left shoulder pain (6/10) and more so with pressing on the area. Left shoulder limitation in ROM. She has not been able to do some home tests without pain. She feels that she is a little weaker because of that. Her left hand grasps remains good though her other range of motion of the elbows, wrists, fingers remain good. The right upper extremity is unaffected. She is not able to brush her hair and do left UE tasks a little better but not back to normal due to pain. No breathing problems, no chest wall pain. She states she has known rotator cuff problems in the past but was not symptomatic before the shot; she has known spine osteoarthritis and back pain. She follows with physician therapy for this regarding no loss of consciousness with incontinence of urine, she states that she had something similar when she had severe back pain. She has pulmonary artery hypertension. She is on: LETAIRIS 10 mg tab Take 1 tab by mouth one time daily.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell count decreased, Rotator cuff syndrome, Urinary incontinence, Vaccination complication
Clinical narrative: Acute pain of left shoulder; Dysfunction of left rotator cuff; Adverse effect of vaccine, subsequent encounter; LOC (loss of consciousness); We discussed that the loss of consciousness with urinary incontinence is likely related to the severe pain. She had a similar LOC with severe back pain. 03/27/2019: She was definitely fine" before the shingles vaccination. Looking back she states that chronology of events: shingles vaccination (was painful when administered); Then it was okay but started to hurt after about a few hours; She was in pain in the left shoulder and arm; "crackling sounds" with moving the arm; then it got worse: stabbing, aching and intense "and it did not let up." She felt she passed out due to the pain and she had urinated in the bed; she called 911, was seen in the, ER: All the time it was the left arm that was "hurting so bad" in the area of the shot and around the area up the shoulder areas; It was not red then. It was hard for her to move her left shoulder. She was in pain in the left shoulder and arm; "crackling sounds" with moving the arm; 03/27/2019: She was seen in the emergency department for left arm pain. She had a shingles vaccination that same day (earlier in the afternoon). Examination did not show skin or bone deformity of the left arm; CT scan of the head showed no stroke; lab did not show concerning results; red blood cell count was decreased with no overt bleeding; EKG did not show acute changes; thought to be related to shingles vaccination; lidocaine cream, acetaminophen, follow up with PCP recommended. The left upper arm severe pain started to get better the next day; Since then she has been feeling better with left shoulder pain (6/10) and more so with pressing on the area. Left shoulder limitation in ROM. She has not been able to do some home tests without pain. She feels that she is a little weaker because of that. Her left hand grasps remains good though her other range of motion of the elbows, wrists, fingers remain good. The right upper extremity is unaffected. She is not able to brush her hair and do left UE tasks a little better but not back to normal due to pain. No breathing problems, no chest wall pain. She states she has known rotator cuff problems in the past but was not symptomatic before the shot; she has known spine osteoarthritis and back pain. She follows with physician therapy for this regarding no loss of consciousness with incontinence of urine, she states that she had something similar when she had severe back pain. She has pulmonary artery hypertension. She is on: LETAIRIS 10 mg tab Take 1 tab by mouth one time daily.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Macule, Pain, Skin warm
Clinical narrative: Patient came in and received her second dose of SHINGRIX on 4/10/19 (1st dose was 1/23/19). Patient came into pharmacy on 4/12 and presented with a red, round spot on her arm that was warm and sore. This spot was about 4 inches below injection site.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood test, Headache, Influenza virus test, Neck pain, Urine analysis
Clinical narrative: Complained of severe headaches and neck pain.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Viral test
Clinical narrative: Complained of severe headaches and neck pain.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: Complained of severe headaches and neck pain.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pregnant patient received VARIVAX; No adverse effects; This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age.      No pertinent medical history. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On an unknown date the patient became pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) were not reported.  On an unknown date, the pregnant patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. The pregnancy outcome was pending.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 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 details were provided as follows: The reporter was the patient. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The SHINGRIX made the patient sick.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Dizziness, Dysstasia, Eye pain, Eye swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On 1st April 2019, the patient received SHINGRIX. On 1st April 2019, less than a day after receiving SHINGRIX, the patient experienced fever, headache, dizziness, nausea, general body pain, swelling arm, pain in arm, difficulty in standing and bedridden. On 2nd April 2019, the patient experienced eye swelling and eye pain. On an unknown date, the outcome of the fever, swelling arm and pain in arm were recovering/resolving and the outcome of the headache and nausea were not recovered/not resolved and the outcome of the dizziness, general body pain, difficulty in standing, bedridden, eye swelling and eye pain were unknown. It was unknown if the reporter considered the fever, headache, dizziness, nausea, general body pain, swelling arm, pain in arm, difficulty in standing, bedridden, eye swelling and eye pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not provided. The patient developed fever, which lasted for 3 hours straight. The patient was unable to stand or get out of the bed for the day. At the time of reporting, the patients arm was inflamed and in extreme pain yesterday and was still very sore but can be touched. The patient would like to know what was to be done and was concerning about getting the second shot since the patient had such bad reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Inflammation, Nausea, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On 1st April 2019, the patient received SHINGRIX. On 1st April 2019, less than a day after receiving SHINGRIX, the patient experienced fever, headache, dizziness, nausea, general body pain, swelling arm, pain in arm, difficulty in standing and bedridden. On 2nd April 2019, the patient experienced eye swelling and eye pain. On an unknown date, the outcome of the fever, swelling arm and pain in arm were recovering/resolving and the outcome of the headache and nausea were not recovered/not resolved and the outcome of the dizziness, general body pain, difficulty in standing, bedridden, eye swelling and eye pain were unknown. It was unknown if the reporter considered the fever, headache, dizziness, nausea, general body pain, swelling arm, pain in arm, difficulty in standing, bedridden, eye swelling and eye pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not provided. The patient developed fever, which lasted for 3 hours straight. The patient was unable to stand or get out of the bed for the day. At the time of reporting, the patients arm was inflamed and in extreme pain yesterday and was still very sore but can be touched. The patient would like to know what was to be done and was concerning about getting the second shot since the patient had such bad reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On 1st April 2019, the patient received SHINGRIX. On 1st April 2019, less than a day after receiving SHINGRIX, the patient experienced fever, headache, dizziness, nausea, general body pain, swelling arm, pain in arm, difficulty in standing and bedridden. On 2nd April 2019, the patient experienced eye swelling and eye pain. On an unknown date, the outcome of the fever, swelling arm and pain in arm were recovering/resolving and the outcome of the headache and nausea were not recovered/not resolved and the outcome of the dizziness, general body pain, difficulty in standing, bedridden, eye swelling and eye pain were unknown. It was unknown if the reporter considered the fever, headache, dizziness, nausea, general body pain, swelling arm, pain in arm, difficulty in standing, bedridden, eye swelling and eye pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not provided. The patient developed fever, which lasted for 3 hours straight. The patient was unable to stand or get out of the bed for the day. At the time of reporting, the patients arm was inflamed and in extreme pain yesterday and was still very sore but can be touched. The patient would like to know what was to be done and was concerning about getting the second shot since the patient had such bad reaction.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 64-year-old patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (about 2 years before the reporting time). On 5th April 2019, the patient received the 1st dose of SHINGRIX. On 7th April 2019, 2 days after receiving SHINGRIX, the patient experienced pain in arm, muscle pain and fatigue. On 8th April 2019, the patient experienced red rash and vesicular rash. In April 2019, the patient experienced rash and pain in arm. On an unknown date, the outcome of the rash, pain in arm, muscle pain, fatigue, pain in arm, red rash and vesicular rash were unknown. It was unknown if the reporter considered the rash, pain in arm, muscle pain, fatigue, pain in arm, red rash and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The patient had the expected achy arm. The patient had general muscle ache and fatigue before the day of reporting with the increased sore arm the patient at the time of reporting had a very red rash. This rash like area was about 2 inches below from the injection site going down about 6 inches below in a linear fashion. The reporter advised to get the 2nd dose in 3 months.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 64-year-old patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (about 2 years before the reporting time). On 5th April 2019, the patient received the 1st dose of SHINGRIX. On 7th April 2019, 2 days after receiving SHINGRIX, the patient experienced pain in arm, muscle pain and fatigue. On 8th April 2019, the patient experienced red rash and vesicular rash. In April 2019, the patient experienced rash and pain in arm. On an unknown date, the outcome of the rash, pain in arm, muscle pain, fatigue, pain in arm, red rash and vesicular rash were unknown. It was unknown if the reporter considered the rash, pain in arm, muscle pain, fatigue, pain in arm, red rash and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The patient had the expected achy arm. The patient had general muscle ache and fatigue before the day of reporting with the increased sore arm the patient at the time of reporting had a very red rash. This rash like area was about 2 inches below from the injection site going down about 6 inches below in a linear fashion. The reporter advised to get the 2nd dose in 3 months.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Headache, Influenza like illness, Malaise
Clinical narrative: flu- like symptoms; chills; headache; feeling bad; Sick; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Flu Seasonal TIV Quebec (Flulaval) for prophylaxis.   On an unknown date, the patients received Flulaval. On an unknown date, unknown after receiving Flulaval, the patients experienced influenza-like symptoms, chills, headache, feeling bad and sickness. On an unknown date, the outcome of the influenza-like symptoms, chills, headache, feeling bad and sickness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, headache, feeling bad and sickness to be related to Flulaval.  Additional details were provided as follows: The age at vaccination was not applicable for this report. These symptoms occurred more frequently when vaccine was co-administered with Shingrix, than when the Flu vaccine was given alone. The reporter cannot quantify and had no further patient or product details. The reporter did not consent to follow-up. This case has been linked with case US2019063821, reported by same reporter.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: minor swelling at injection site; redness at injection site; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   In December 2018, the patient received the 1st dose of Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Flu vaccine.  Additional details were provided as follows: After receiving flu vaccine the patient experienced injection site swelling, injection site erythema, injection site pain. Did not consent to follow-up. This case has been linked to case US2019060766 reported by same reporter.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: minor swelling at injection site; redness at injection site; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   In December 2018, the patient received the 1st dose of Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Flu vaccine.  Additional details were provided as follows: After receiving flu vaccine the patient experienced injection site swelling, injection site erythema, injection site pain. Did not consent to follow-up. This case has been linked to case US2019060766 reported by same reporter.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Condition aggravated, Eczema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: minor swelling at injection site; redness at injection site; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   In December 2018, the patient received the 1st dose of Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Flu vaccine.  Additional details were provided as follows: After receiving flu vaccine the patient experienced injection site swelling, injection site erythema, injection site pain. Did not consent to follow-up. This case has been linked to case US2019060766 reported by same reporter.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Tooth disorder
Clinical narrative: minor swelling at injection site; redness at injection site; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   In December 2018, the patient received the 1st dose of Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Flu vaccine.  Additional details were provided as follows: After receiving flu vaccine the patient experienced injection site swelling, injection site erythema, injection site pain. Did not consent to follow-up. This case has been linked to case US2019060766 reported by same reporter.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included eczema (eczema outbreaks). In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX the patient experienced injection site swelling, injection site erythema, injection site pain, eczema and her tooth needed pulled. The patient stated that, the events occurred are Similar to other vaccine injections, like the flu vaccine. Did not consent to follow-up. This case has been linked to case US2019GSK066587 reported by same reporter.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included eczema (eczema outbreaks). In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX the patient experienced injection site swelling, injection site erythema, injection site pain, eczema and her tooth needed pulled. The patient stated that, the events occurred are Similar to other vaccine injections, like the flu vaccine. Did not consent to follow-up. This case has been linked to case US2019GSK066587 reported by same reporter.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Condition aggravated, Eczema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included eczema (eczema outbreaks). In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX the patient experienced injection site swelling, injection site erythema, injection site pain, eczema and her tooth needed pulled. The patient stated that, the events occurred are Similar to other vaccine injections, like the flu vaccine. Did not consent to follow-up. This case has been linked to case US2019GSK066587 reported by same reporter.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Tooth disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included eczema (eczema outbreaks). In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, eczema and tooth disorder to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX the patient experienced injection site swelling, injection site erythema, injection site pain, eczema and her tooth needed pulled. The patient stated that, the events occurred are Similar to other vaccine injections, like the flu vaccine. Did not consent to follow-up. This case has been linked to case US2019GSK066587 reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Contusion
Clinical narrative: This case was reported by a medical representative via call center representative and described the occurrence of axillary lump in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced axillary lump and contusion. On an unknown date, the outcome of the axillary lump and contusion were unknown. It was unknown if the reporter considered the axillary lump and contusion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient over 60 years of age received SHINGRIX and experienced a lump under her arm in the armpit area with bruising. No other specifics were known. The nurse did not want to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Pyrexia, Skin lesion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old male patient who received SHINGRIX (batch number X5XY4, expiry date unknown) for prophylaxis. The patient's past medical history included shingles (the patient had shingles lesions 25 years ago.). On 3rd March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, 26 days after receiving SHINGRIX, the patient experienced shingles, injection site pain, fever and skin lesion. The patient was treated with ibuprofen. On an unknown date, the outcome of the shingles and skin lesion were unknown and the outcome of the injection site pain and fever were recovered/resolved. It was unknown if the reporter considered the shingles, injection site pain, fever and skin lesion to be related to SHINGRIX. Additional details were provided as follows: At the time of reporting, the expiry date of SHINGRIX was not reported. The patient received 1st dose of SHINGRIX 31 days ago. The patient experienced high grade fever of 101 F, few days after the infection and which resolved after about 3 to 4 days. The patient experienced injection site pain which lasted for about 10 days. 4 to 5 days ago, the patient developed lesions on his face, that looks like shingles lesions.
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Product administered to patient of inappropriate age, Therapy non-responder, Underdose
Clinical narrative: titers were drawn and show low to no response; Underdose; Underdose; Underdose; wrong vaccine administered; wrong vaccine administered; wrong vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis and HBV (Engerix B pediatric) (batch number 5R52M, expiry date 3rd October 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric, the 2nd dose of Engerix B pediatric and the 3rd dose of Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B pediatric and less than a year after receiving Engerix B pediatric, the patient experienced therapy non-responder, underdose, underdose, underdose, adult use of a child product, adult use of a child product and adult use of a child product. On an unknown date, the outcome of the therapy non-responder, underdose, underdose, underdose, adult use of a child product, adult use of a child product and adult use of a child product were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B pediatric, Engerix B pediatric and Engerix B pediatric.  Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date for 3rd dose of Engerix B pediatric was reported. The adult patient received Engerix B pediatric, which led to underdose and adult use of a child product. The reporter reported that, hepatitis B antibody titer was drawn, and showed low to no response, which led to therapy non-responder.      Lab Comments: On an unknown date, lab test was performed
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody, Product administered to patient of inappropriate age, Therapy non-responder, Underdose
Clinical narrative: Therapy non-responder; wrong vaccine administration; Underdose; wrong vaccine administration; Underdose; wrong vaccine administration; Underdose; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis and HBV (Engerix B pediatric) (batch number 5R52M, expiry date 3rd October 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric, the 2nd dose of Engerix B pediatric and the 3rd dose of Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B pediatric and Engerix B pediatric, the patient experienced therapy non-responder, adult use of a child product, underdose, adult use of a child product, underdose, adult use of a child product and underdose. On an unknown date, the outcome of the therapy non-responder, adult use of a child product, underdose, adult use of a child product, underdose, adult use of a child product and underdose were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B pediatric, Engerix B pediatric and Engerix B pediatric.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported the patient received Engerix-B series in pediatric doses, instead of adult doses, which led to adult use of a child product, underdose. The healthcare professional noted titers were drawn and show low to no response.      Lab Comments: On an unknown date, the lab test was performed.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site erythema, Injection site pruritus, Injection site swelling, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. The patient's past medical history included heartbeats increased (she had a history of rapid heartbeat with other immunizations). On 26th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, feeling unwell, injection site erythema, nausea, fever, heartbeats increased, injection site itching and generalized muscle aches. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the injection site swelling, feeling unwell, injection site erythema, nausea, fever and heartbeats increased were recovered/resolved and the outcome of the injection site itching and generalized muscle aches were unknown. It was unknown if the reporter considered the injection site swelling, feeling unwell, injection site erythema, nausea, fever, heartbeats increased, injection site itching and generalized muscle aches to be related to SHINGRIX. Additional details were provided as follows: The caller who was the office manager for physician office. The patient received SHINGRIX in the left arm and experienced arm swelling and redness the same day and nausea that night. She noted she felt sick had a low-grade fever the next day, her muscles ached all over, which she took ADVIL and TYLENOL for alternating. She experienced rapid heartbeat about 3 hours after the shot. She still has itching and swelling the size of a 50 cent piece at the site. She noted the redness and swelling had gotten to a 3 inch circular area. All other issues have resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. The patient's past medical history included heartbeats increased (she had a history of rapid heartbeat with other immunizations). On 26th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, feeling unwell, injection site erythema, nausea, fever, heartbeats increased, injection site itching and generalized muscle aches. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the injection site swelling, feeling unwell, injection site erythema, nausea, fever and heartbeats increased were recovered/resolved and the outcome of the injection site itching and generalized muscle aches were unknown. It was unknown if the reporter considered the injection site swelling, feeling unwell, injection site erythema, nausea, fever, heartbeats increased, injection site itching and generalized muscle aches to be related to SHINGRIX. Additional details were provided as follows: The caller who was the office manager for physician office. The patient received SHINGRIX in the left arm and experienced arm swelling and redness the same day and nausea that night. She noted she felt sick had a low-grade fever the next day, her muscles ached all over, which she took ADVIL and TYLENOL for alternating. She experienced rapid heartbeat about 3 hours after the shot. She still has itching and swelling the size of a 50 cent piece at the site. She noted the redness and swelling had gotten to a 3 inch circular area. All other issues have resolved.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 29th March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the influenza-like symptoms was recovering/resolving. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient received SHINGRIX on an unknown arm. The patient experienced sore arm, which lasted for a couple of days. The soreness reducing with each day. The patient states that most recently, her arm was tender to touch. The patient had flu symptoms, that are recovered 85 to 90 percent. The patient did not consent to follow up with physician. This is 1 of the 2 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Erythema, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On 6th April 2019, the patient received SHINGRIX. On 7th April 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness, upset stomach, shivering, headache, pain in arm, swelling and erythema. On 8th April 2019, the outcome of the influenza-like symptoms, tiredness, upset stomach, shivering and headache were recovered/resolved. On an unknown date, the outcome of the pain in arm, swelling and erythema were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, tiredness, upset stomach, shivering, headache, pain in arm, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms, arm soreness, tiredness, upset stomach, shivering, headache, swelling and redness. The arm pain, swelling and redness had not resolved. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On 6th April 2019, the patient received SHINGRIX. On 7th April 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness, upset stomach, shivering, headache, pain in arm, swelling and erythema. On 8th April 2019, the outcome of the influenza-like symptoms, tiredness, upset stomach, shivering and headache were recovered/resolved. On an unknown date, the outcome of the pain in arm, swelling and erythema were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, tiredness, upset stomach, shivering, headache, pain in arm, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms, arm soreness, tiredness, upset stomach, shivering, headache, swelling and redness. The arm pain, swelling and redness had not resolved. The patient consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Malaise, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of no adverse event (in July 2018, the patient received 1st dose). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th December 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, fever, malaise, pain and pain in arm. On 10th December 2018, the patient experienced knee pain and buttock pain. On an unknown date, the outcome of the influenza-like symptoms, chills, fever, malaise, pain and pain in arm were recovered/resolved and the outcome of the knee pain and buttock pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, fever, malaise, pain, pain in arm, knee pain and buttock pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX in left arm. The patient experienced flu like symptoms consisting of chills, fever, achiness and malaise. The patient also reported arm soreness. Approximately 7 to 10 days later, the patient experienced pain under her right buttock and behind the right knee. The patient had an ultrasound and a blood clot was ruled out. At time of reporting, the symptoms associated with the buttock and knee pain were intermittent and unresolved. The patient did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Ultrasound scan normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of no adverse event (in July 2018, the patient received 1st dose). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th December 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, fever, malaise, pain and pain in arm. On 10th December 2018, the patient experienced knee pain and buttock pain. On an unknown date, the outcome of the influenza-like symptoms, chills, fever, malaise, pain and pain in arm were recovered/resolved and the outcome of the knee pain and buttock pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, fever, malaise, pain, pain in arm, knee pain and buttock pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX in left arm. The patient experienced flu like symptoms consisting of chills, fever, achiness and malaise. The patient also reported arm soreness. Approximately 7 to 10 days later, the patient experienced pain under her right buttock and behind the right knee. The patient had an ultrasound and a blood clot was ruled out. At time of reporting, the symptoms associated with the buttock and knee pain were intermittent and unresolved. The patient did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue 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, unknown after receiving SHINGRIX, the patient experienced fatigue and myalgia. On an unknown date, the outcome of the fatigue and myalgia were unknown. It was unknown if the reporter considered the fatigue and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional did not wish to provide date of birth, lot, expiry date of vaccine from 1st dose. After the 1st dose, the patient did not have any problems other than fatigue and myalgia.