chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Activated partial thromboplastin time normal, C-reactive protein normal, Differential white blood cell count, Full blood count normal, Joint swelling
Clinical narrative: Patient developed palpable purpura and joint swelling consistent with IgA vasculitis (formerly known as Henoch Schonlein Pupura). No treatment required. He will require weekly follow up to assess blood pressure and development of proteinuria to screen for renal involvment
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Metabolic function test normal, Palpable purpura, Prothrombin time normal, Red blood cell sedimentation rate normal, Vasculitis
Clinical narrative: Patient developed palpable purpura and joint swelling consistent with IgA vasculitis (formerly known as Henoch Schonlein Pupura). No treatment required. He will require weekly follow up to assess blood pressure and development of proteinuria to screen for renal involvment
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Eye pruritus, Hyperhidrosis, Swelling face
Clinical narrative: He developed profuse sweating, his eyes got really itchy, and he felt like his face was getting swollen.  He had no hives and no trouble breathing.  I had him take Benadryl. He did fine.
Age: 55.0
Sex: M
Vaccine: MMR
Symptoms: Exercise electrocardiogram, Pyrexia, Tachycardia
Clinical narrative: Tachycardia at rest >120 BPM, fever 99 Fahrenheit, SPO2 92%.  Relieved without medication after 8 hours.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: Patient broke out in raised, itchy blister type rash on injected arm and slightly on other arm. Started a couple days after vaccination .
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: PATIENT STATES HE EXPERIENCED ITCHING AT THE INJECTION SITE APPROXIMATELY 9 HOURS AFTER RECEIVING THE VACCINTATION (THE SAME DAY).  THE NEXT MORNING HE HAD REDNESS AROUND THE INJECTION SITE AND REDNESS ON HIS INNER UPPER ARM THAT MOVED DOWN HIS ARM TOWARD HIS ELBOW. THAT AREA WAS WARM TO THE TOUCH AND HAD TWO BLISTER-LIKE AREAS ABOUT THE SIZE OF A QUARTER-DOLAR.  PATIENT TOOK ONE DOSE OF ORAL BENADRYL ANOUT 24 HOURS AFTER HIS INJECTION, AND A SECOND DOSE OF BENADRYL ABOUT 6 HOURS LATER. OUTCOME STILL PENDING.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: The patient said the next day after the shot her entire arm 3 to 4 inches above and below the injection site were bright red and hot to the touch.  The patient went to the doctor on 4/15/19 and was diagnosed with cellulitis in the area and prescribed Cephalexin 500mg 1 capsule 3 times daily for 7 days and a Methylprednisolone 4mg pack.  The treatment cleared up the infection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Gingival swelling, Headache
Clinical narrative: Burning pain at injection site immediately. When awoke next morning, weak, nausea, fatigue, headache, muscle aches, muscle spasms and horrible chills all day.  Swolen gums noted that night when I tried to brush my teeth.   Chills subsided by 9 p.m. that day but nausea, weakness, headache, muscle aches continued for 3 more days and swolen gums for about 10 days.  I?m still dealing with fatigue 3 months later.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscle spasms, Myalgia, Nausea
Clinical narrative: Burning pain at injection site immediately. When awoke next morning, weak, nausea, fatigue, headache, muscle aches, muscle spasms and horrible chills all day.  Swolen gums noted that night when I tried to brush my teeth.   Chills subsided by 9 p.m. that day but nausea, weakness, headache, muscle aches continued for 3 more days and swolen gums for about 10 days.  I?m still dealing with fatigue 3 months later.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Skin plaque, Urticaria
Clinical narrative: Generalized red lacy rash on trunk, back, abdomen, upper thighs. Urticaria like plaques on left AC fossa, left wrist, upper lip, nose
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Insomnia, Pain
Clinical narrative: chills,shivers,bad aches all over,not sure about a fever but low grade if any,-NO treatment, just tired next day due to no sleep and weak.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia, Pruritus, Rash
Clinical narrative: Patient came in to tell me that she was diagnosed with shingles by a physician 10 days after she got the shingles shot. She said that she also had shingles after the Zostavax shot.  She had all of the symptoms that accompany shingles, including rash, tingling and itching.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Injection site pain
Clinical narrative: Left upper arm pain up shoulder, Back + Down arm since the shot. Aleve relieves pain temporarily.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Pain in extremity, Peripheral swelling, Vaccination site induration
Clinical narrative: Lt arm pain 4/9, morning 5/10 reports entire Lt  upper arm swollen, red, painful, seen 5/15 & swelling nearly resolved, has 4 cm firm knot  with redness at vaccines site, recommend warm compress
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site nodule
Clinical narrative: Lt arm pain 4/9, morning 5/10 reports entire Lt  upper arm swollen, red, painful, seen 5/15 & swelling nearly resolved, has 4 cm firm knot  with redness at vaccines site, recommend warm compress
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Neck mass, Tenderness
Clinical narrative: On 5/3/19 pt noticed a new lump on the (L) side of  her neck that was tender. She was seen at urgent  care and was told that it was possibly from the  Tdap shot. She was prescribed prednisone. Within the day she started the prednisone, the lump  was gone.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Influenza like illness, Pain, Pyrexia
Clinical narrative: Patient reports flu-like symptoms: body aches, low grade fever, sweats - starting the evening the vaccine was given and fully resolved by the next morning.
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Expired product administered
Clinical narrative: 51 year old male patient received expired Adacel, no adverse event; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA126034 (same reporter).  This case involves a 51 years old male patient who received  0.5 ml of expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5656AA/U6565AA) via intramuscular route in the right arm, on 04-May-2019. The vaccine was expired on 02-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 51 year old male patient received expired Adacel, no adverse event; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA126034 (same reporter).  This case involves a 51 years old male patient who received  0.5 ml of expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5656AA/U6565AA) via intramuscular route in the right arm, on 04-May-2019. The vaccine was expired on 02-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Arm Pain/ strong ache; pain in the muscle of his upper arm/ back muscle; Back pain; Fatigue; Fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd February 2019, the patient received the 1st dose of Shingrix. On 22nd February 2019, 3 hrs after receiving Shingrix, the patient experienced fever, chills, pain in arm, fatigue, muscle pain and back pain. On an unknown date, the outcome of the fever, chills and fatigue were recovered/resolved and the outcome of the pain in arm, muscle pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, pain in arm, fatigue, muscle pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient received many shots being in the military, but this shot was the most painful. The patient received Shingrix on left arm. It was reported that three to four hours after receiving Shingrix the patient experienced fever, chills, arm pain, and extreme fatigue that lasted approximately for two days.  At the time of reporting, the patient still had pain in the muscle of his upper arm, along with painful back muscles and felt as if he pulled a muscle or something. It was reported that when he woke up in the morning, it was painful when he rolled over onto his arm.  The patient also experienced pain when lifting the objects with his arm or moving it a certain way and described the arm pain as a strong ache.  It was reported that the patient would not receive the 2nd dose of Shingrix until his arm pain goes away. The reporter did not consent to follow up. This case was linked with case US2019GSK086801 (Reporter mother's case) reported by the same reporter. The outcome reported for fever, chills, fatigue in the structured field of XML is recovered/resolved with sequel) instead of " Recovered/Resolved (outcome uploaded in Argus).  The outcome reported for arm pain and back pain in the structured field of XML is recovering/resolving instead of Not Recovered/Not Resolved (outcome uploaded in Argus).
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chills, Fatigue, Myalgia, Pain
Clinical narrative: Arm Pain/ strong ache; pain in the muscle of his upper arm/ back muscle; Back pain; Fatigue; Fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd February 2019, the patient received the 1st dose of Shingrix. On 22nd February 2019, 3 hrs after receiving Shingrix, the patient experienced fever, chills, pain in arm, fatigue, muscle pain and back pain. On an unknown date, the outcome of the fever, chills and fatigue were recovered/resolved and the outcome of the pain in arm, muscle pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, pain in arm, fatigue, muscle pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient received many shots being in the military, but this shot was the most painful. The patient received Shingrix on left arm. It was reported that three to four hours after receiving Shingrix the patient experienced fever, chills, arm pain, and extreme fatigue that lasted approximately for two days.  At the time of reporting, the patient still had pain in the muscle of his upper arm, along with painful back muscles and felt as if he pulled a muscle or something. It was reported that when he woke up in the morning, it was painful when he rolled over onto his arm.  The patient also experienced pain when lifting the objects with his arm or moving it a certain way and described the arm pain as a strong ache.  It was reported that the patient would not receive the 2nd dose of Shingrix until his arm pain goes away. The reporter did not consent to follow up. This case was linked with case US2019GSK086801 (Reporter mother's case) reported by the same reporter. The outcome reported for fever, chills, fatigue in the structured field of XML is recovered/resolved with sequel) instead of " Recovered/Resolved (outcome uploaded in Argus).  The outcome reported for arm pain and back pain in the structured field of XML is recovering/resolving instead of Not Recovered/Not Resolved (outcome uploaded in Argus).
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm Pain/ strong ache; pain in the muscle of his upper arm/ back muscle; Back pain; Fatigue; Fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd February 2019, the patient received the 1st dose of Shingrix. On 22nd February 2019, 3 hrs after receiving Shingrix, the patient experienced fever, chills, pain in arm, fatigue, muscle pain and back pain. On an unknown date, the outcome of the fever, chills and fatigue were recovered/resolved and the outcome of the pain in arm, muscle pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, pain in arm, fatigue, muscle pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient received many shots being in the military, but this shot was the most painful. The patient received Shingrix on left arm. It was reported that three to four hours after receiving Shingrix the patient experienced fever, chills, arm pain, and extreme fatigue that lasted approximately for two days.  At the time of reporting, the patient still had pain in the muscle of his upper arm, along with painful back muscles and felt as if he pulled a muscle or something. It was reported that when he woke up in the morning, it was painful when he rolled over onto his arm.  The patient also experienced pain when lifting the objects with his arm or moving it a certain way and described the arm pain as a strong ache.  It was reported that the patient would not receive the 2nd dose of Shingrix until his arm pain goes away. The reporter did not consent to follow up. This case was linked with case US2019GSK086801 (Reporter mother's case) reported by the same reporter. The outcome reported for fever, chills, fatigue in the structured field of XML is recovered/resolved with sequel) instead of " Recovered/Resolved (outcome uploaded in Argus).  The outcome reported for arm pain and back pain in the structured field of XML is recovering/resolving instead of Not Recovered/Not Resolved (outcome uploaded in Argus).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: fever; arm swelling/arm swelled up; arm pain; arm red; arm hot; welt/ arm welts; Blood glucose increased; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced fever, swelling arm, pain in arm, erythema of extremities, skin warm, welts and blood glucose increased. On an unknown date, the outcome of the fever, swelling arm, pain in arm, erythema of extremities, skin warm, welts and blood glucose increased were recovering/resolving.   It was unknown if the reporter considered the fever, swelling arm, pain in arm, erythema of extremities, skin warm, welts and blood glucose increased to be related to Shingrix.  Additional details were provided as follows: The patient had a shingles shot and had a reaction to it. The patient was worried if it could happened again. The age at vaccination was not reported. Later that day of vaccination, less than a day, the patient's arm swelled up and had a fever, that night, the patient could not lay on his arm. It was very painful. On Thursday, Friday, Saturday and Sunday, the arm became more red and swollen. Less than a week, after receiving Shingrix, the patient experienced urticaria and skin warm. The welt was 6 to 7 inches long. After 2 days on Monday, of vaccination, it started to feel better. Less than a week, the patient's sugar rose as well. In April 2019, the patient's lab test was done and result for blood sugar level was increased. This case has been linked to US2019AMR068953, US2019AMR068949, US2019AMR068954 reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood glucose increased, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: fever; arm swelling/arm swelled up; arm pain; arm red; arm hot; welt/ arm welts; Blood glucose increased; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced fever, swelling arm, pain in arm, erythema of extremities, skin warm, welts and blood glucose increased. On an unknown date, the outcome of the fever, swelling arm, pain in arm, erythema of extremities, skin warm, welts and blood glucose increased were recovering/resolving.   It was unknown if the reporter considered the fever, swelling arm, pain in arm, erythema of extremities, skin warm, welts and blood glucose increased to be related to Shingrix.  Additional details were provided as follows: The patient had a shingles shot and had a reaction to it. The patient was worried if it could happened again. The age at vaccination was not reported. Later that day of vaccination, less than a day, the patient's arm swelled up and had a fever, that night, the patient could not lay on his arm. It was very painful. On Thursday, Friday, Saturday and Sunday, the arm became more red and swollen. Less than a week, after receiving Shingrix, the patient experienced urticaria and skin warm. The welt was 6 to 7 inches long. After 2 days on Monday, of vaccination, it started to feel better. Less than a week, the patient's sugar rose as well. In April 2019, the patient's lab test was done and result for blood sugar level was increased. This case has been linked to US2019AMR068953, US2019AMR068949, US2019AMR068954 reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: fever; arm swelling/arm swelled up; arm pain; arm red; arm hot; welt/ arm welts; Blood glucose increased; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced fever, swelling arm, pain in arm, erythema of extremities, skin warm, welts and blood glucose increased. On an unknown date, the outcome of the fever, swelling arm, pain in arm, erythema of extremities, skin warm, welts and blood glucose increased were recovering/resolving.   It was unknown if the reporter considered the fever, swelling arm, pain in arm, erythema of extremities, skin warm, welts and blood glucose increased to be related to Shingrix.  Additional details were provided as follows: The patient had a shingles shot and had a reaction to it. The patient was worried if it could happened again. The age at vaccination was not reported. Later that day of vaccination, less than a day, the patient's arm swelled up and had a fever, that night, the patient could not lay on his arm. It was very painful. On Thursday, Friday, Saturday and Sunday, the arm became more red and swollen. Less than a week, after receiving Shingrix, the patient experienced urticaria and skin warm. The welt was 6 to 7 inches long. After 2 days on Monday, of vaccination, it started to feel better. Less than a week, the patient's sugar rose as well. In April 2019, the patient's lab test was done and result for blood sugar level was increased. This case has been linked to US2019AMR068953, US2019AMR068949, US2019AMR068954 reported by same reporter.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Rash erythematous
Clinical narrative: broke out in a rash mainly over his mid-to-upper back and chest area; Initial information received on 09-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 months old male patient who experienced broke out in a rash mainly over his mid-to-upper back and chest area, while he received vaccines ROTATEQ, PREVNAR and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-May-2019, the patient received a third dose of suspect 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5590AA, expiry date: 31-Oct-2019, via unknown route in unknown administration site, a dose of suspect PREVNAR lot number not reported via unknown route in unknown administration site and a dose of suspect ROTATEQ lot number not reported via unknown route in unknown administration site.  On 07-May-2019, the patient developed a non-serious broke out in a rash mainly over his mid-to-upper back and chest area (rash) 5-10 minutes following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Other relevant tests were not reported.  Final diagnosis was broke out in a rash mainly over his mid-to-upper back and chest area.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from the event.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Rash
Clinical narrative: broke out in a rash mainly over his mid-to-upper back and chest area; Initial information received on 09-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 months old male patient who experienced broke out in a rash mainly over his mid-to-upper back and chest area, while he received vaccines ROTATEQ, PREVNAR and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-May-2019, the patient received a third dose of suspect 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5590AA, expiry date: 31-Oct-2019, via unknown route in unknown administration site, a dose of suspect PREVNAR lot number not reported via unknown route in unknown administration site and a dose of suspect ROTATEQ lot number not reported via unknown route in unknown administration site.  On 07-May-2019, the patient developed a non-serious broke out in a rash mainly over his mid-to-upper back and chest area (rash) 5-10 minutes following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Other relevant tests were not reported.  Final diagnosis was broke out in a rash mainly over his mid-to-upper back and chest area.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from the event.  List of documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fall, Haemorrhage, Loss of consciousness, Pain in jaw, Skin laceration
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of passed out in a 18-year-old female patient who received BEXSERO (batch number ABX751AA, expiry date unknown) for prophylaxis. On 25th April 2019, the patient received the 1st dose of BEXSERO. On 25th April 2019, less than a minute after receiving BEXSERO, the patient experienced passed out (serious criteria hospitalization and GSK medically significant), fall, laceration of face and jaw pain. On an unknown date, the outcome of the passed out, fall, laceration of face and jaw pain were unknown. It was unknown if the reporter considered the passed out, fall, laceration of face and jaw pain to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in the office. The patient did not receive any other vaccines at that visit. The patient was sitting on the exam table and less than 1 minute after receiving the BEXSERO, the patient passes out and fell face first onto the floor. The patient had no warning signs or symptoms. The patient never had a reaction to previous vaccines per mom. The patient had a chin laceration and complained of jaw pain. Emergency medical services (EMS) was called. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fall, Loss of consciousness, Pain in jaw, Skin laceration
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of passed out in a 18-year-old female patient who received BEXSERO (batch number ABX751AA, expiry date unknown) for prophylaxis. On 25th April 2019, the patient received the 1st dose of BEXSERO. On 25th April 2019, less than a minute after receiving BEXSERO, the patient experienced passed out (serious criteria hospitalization and GSK medically significant), fall, laceration of face and jaw pain. On an unknown date, the outcome of the passed out, fall, laceration of face and jaw pain were unknown. It was unknown if the reporter considered the passed out, fall, laceration of face and jaw pain to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in the office. The patient did not receive any other vaccines at that visit. The patient was sitting on the exam table and less than 1 minute after receiving the BEXSERO, the patient passes out and fell face first onto the floor. The patient had no warning signs or symptoms. The patient never had a reaction to previous vaccines per mom. The patient had a chin laceration and complained of jaw pain. Emergency medical services (EMS) was called. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Claustrophobia, Dizziness, Dry mouth, Erythema
Clinical narrative: The morning after receiving the vaccination, the patient felt light headed, dizzy, required assistance from bathroom to bedroom. She experienced weakness in her legs and collapsed. After 10 seconds on the ground she gasped and had a loss of consciousness for about 30 seconds.  she remained in bed until 1300 sleeping most of the time. she also reported pain, redness, myalgia, fatigue, headache, and shivering.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fall, Fatigue, Gaze palsy, Headache, Hypersomnia
Clinical narrative: The morning after receiving the vaccination, the patient felt light headed, dizzy, required assistance from bathroom to bedroom. She experienced weakness in her legs and collapsed. After 10 seconds on the ground she gasped and had a loss of consciousness for about 30 seconds.  she remained in bed until 1300 sleeping most of the time. she also reported pain, redness, myalgia, fatigue, headache, and shivering.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness, Muscular weakness, Myalgia, Nausea, Pain
Clinical narrative: The morning after receiving the vaccination, the patient felt light headed, dizzy, required assistance from bathroom to bedroom. She experienced weakness in her legs and collapsed. After 10 seconds on the ground she gasped and had a loss of consciousness for about 30 seconds.  she remained in bed until 1300 sleeping most of the time. she also reported pain, redness, myalgia, fatigue, headache, and shivering.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Circulatory collapse, Dizziness, Dyspnoea, Erythema
Clinical narrative: The morning after receiving the vaccination, the patient felt light headed, dizzy, required assistance from bathroom to bedroom. She experienced weakness in her legs and collapsed. After 10 seconds on the ground she gasped and had a loss of consciousness for about 30 seconds.  she remained in bed until 1300 sleeping most of the time. she also reported pain, redness, myalgia, fatigue, headache, and shivering.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Gait disturbance, Headache, Hypersomnia, Loss of consciousness
Clinical narrative: The morning after receiving the vaccination, the patient felt light headed, dizzy, required assistance from bathroom to bedroom. She experienced weakness in her legs and collapsed. After 10 seconds on the ground she gasped and had a loss of consciousness for about 30 seconds.  she remained in bed until 1300 sleeping most of the time. she also reported pain, redness, myalgia, fatigue, headache, and shivering.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Myalgia, Pain
Clinical narrative: The morning after receiving the vaccination, the patient felt light headed, dizzy, required assistance from bathroom to bedroom. She experienced weakness in her legs and collapsed. After 10 seconds on the ground she gasped and had a loss of consciousness for about 30 seconds.  she remained in bed until 1300 sleeping most of the time. she also reported pain, redness, myalgia, fatigue, headache, and shivering.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: The patient has been experiencing bilateral thigh pain since the vaccination was administered.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: headache, body aches, nausea, all just started this evening
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Rash generalised, Urticaria
Clinical narrative: Thigh swelled and had large red mark for several days after the shot. This evening, he developed a full-body rash/hives and a slight fever. It spread quickly so we had to take him to the ER.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Myalgia, Pyrexia, Rash
Clinical narrative: After receiving the vaccine the patient experienced the typical soreness in the right arm, but then had a fever (>100 degrees F), shivering, muscle aches, and a rash.  The patient says they tried calling the ER but could not get through.  The patient said 5/15/19 was when they felt much better although there is still a rash.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Musculoskeletal stiffness
Clinical narrative: Pt states that he had a stiff neck for a total of three months
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEP, HIBV
Symptoms: C-reactive protein, Full blood count, Injection site joint movement impairment, Injection site reaction, Subcutaneous emphysema
Clinical narrative: refusal to move left hip joint, subcutaneous emphysema on imaging (pelvic XR) about 2 inches caudal to injection side with evidence of tracking, no site swelling, erythema or irritation visible
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEP, HIBV
Symptoms: X-ray of pelvis and hip abnormal
Clinical narrative: refusal to move left hip joint, subcutaneous emphysema on imaging (pelvic XR) about 2 inches caudal to injection side with evidence of tracking, no site swelling, erythema or irritation visible
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pain, Pain of skin
Clinical narrative: Body aches the following day after immunization.  Skin and muscles hurt when touched.  Some dizziness.   Feeling similar to when you come down with the flu.   Took 2 Tylenol for pain.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: First night, patient had significant pain up and down the arm.  Originally it was thought it could be an allergic reaction because it was swollen and responded to diphenhydramine.  However, it stopped responding  to that medication and was still hurting.  Patient is now stating that there is significant shoulder and neck pain that started this morning.  Her arm has been stiff since the injection.  We thought if it was an allergic reaction it would have subsided by now, but the pain is still there and she believes that the injection may have been given too high on her arm.
Sex: M
Vaccine: MMR
Symptoms: Serology negative
Clinical narrative: Negative antibody serologic testing; This spontaneous report as received from a physician refers to a 40 year old male patient.    On 13-MAY-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1 for prophylaxis.       On 13-MAY-2019, 1 day after onset of therapy the patient experienced serology negative.    The outcome of serology negative is unknown.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: had a fever after received Gardasil second dose; This spontaneous report was received from a pharmacist via company representative refers to an adult female (early 20's) patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (lot number, expiry date unspecified).  On an unknown date, in her early 20's the patient had fever after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) second dose of HPV vaccination series. The outcome of pyrexia was resolved. Reporter's causality was not provided.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: Muscle pain; tiredness; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2019, the patient received the 1st dose of Shingrix. On 17th April 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, tiredness and muscle pain. On an unknown date, the outcome of the injection site pain, tiredness and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tiredness and muscle pain to be related to Shingrix.  Additional details were provided as follows:  The patient received 1st dose of shingrix shot two days ago from the date of reporting and experienced muscle soreness around shot area. The patient felt a little tired the next morning. The reporter did not consent to follow-up with your physician at this time unless side effect lingers.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Condition aggravated, Fall, Fatigue
Clinical narrative: Muscle weakness; Tired/ Fatigue; Loss of balance; Weakness; feels like just got over the flu; unable to control urination; Condition aggravated; Fall; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2019080542). Concurrent medical conditions included urinary incontinence (it was under control on Flomax). Concomitant products included tamsulosin hydrochloride (Flomax).   On 4th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 5th May 2019, 1 days after receiving Shingrix, the patient experienced muscle weakness, fatigue, balance difficulty, weakness, influenza like illness, urinary incontinence, condition aggravated and fall. On 6th May 2019, the outcome of the balance difficulty, influenza like illness, urinary incontinence, condition aggravated and fall were recovered/resolved. On an unknown date, the outcome of the muscle weakness, fatigue and weakness were not recovered/not resolved.   It was unknown if the reporter considered the muscle weakness, fatigue, balance difficulty, weakness, influenza like illness, urinary incontinence, condition aggravated and fall to be related to Shingrix.  Additional details were provided as follows: The patient was diagnosed with urinary incontinence prior to receiving the Shingrix vaccine, but it was under control on Flomax. On Saturday, the patient received Shingrix on left arm and approximately 24 hours after receiving the vaccine he began to feel muscle weakness, fatigue, tired loss of balance due to weakness, and unable to control urination. The patient fell over a couple of times and his wife had to help him get up. He said he could not catch himself. At the day of reporting, the symptoms had resolved except he feels weak and tired. The patient said that on the day of reporting he feels like he just got over the flu. The reporter consented to follow up. The reporter gave permission for his physician to be contacted. No additional information was reported.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Muscular weakness, Urinary incontinence
Clinical narrative: Muscle weakness; Tired/ Fatigue; Loss of balance; Weakness; feels like just got over the flu; unable to control urination; Condition aggravated; Fall; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2019080542). Concurrent medical conditions included urinary incontinence (it was under control on Flomax). Concomitant products included tamsulosin hydrochloride (Flomax).   On 4th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 5th May 2019, 1 days after receiving Shingrix, the patient experienced muscle weakness, fatigue, balance difficulty, weakness, influenza like illness, urinary incontinence, condition aggravated and fall. On 6th May 2019, the outcome of the balance difficulty, influenza like illness, urinary incontinence, condition aggravated and fall were recovered/resolved. On an unknown date, the outcome of the muscle weakness, fatigue and weakness were not recovered/not resolved.   It was unknown if the reporter considered the muscle weakness, fatigue, balance difficulty, weakness, influenza like illness, urinary incontinence, condition aggravated and fall to be related to Shingrix.  Additional details were provided as follows: The patient was diagnosed with urinary incontinence prior to receiving the Shingrix vaccine, but it was under control on Flomax. On Saturday, the patient received Shingrix on left arm and approximately 24 hours after receiving the vaccine he began to feel muscle weakness, fatigue, tired loss of balance due to weakness, and unable to control urination. The patient fell over a couple of times and his wife had to help him get up. He said he could not catch himself. At the day of reporting, the symptoms had resolved except he feels weak and tired. The patient said that on the day of reporting he feels like he just got over the flu. The reporter consented to follow up. The reporter gave permission for his physician to be contacted. No additional information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a physician via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced small rash after receiving Shingrix vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Body aches; Nauseated; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included urinary incontinence (it was under control with Flomax). Concomitant products included tamsulosin hydrochloride (Flomax).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced general body pain and nausea. On an unknown date, the outcome of the general body pain and nausea were recovered/resolved.   It was unknown if the reporter considered the general body pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with urinary incontinence prior to receiving the Shingrix vaccine, but it was under control on Flomax. The patient received Shingrix on left arm and experienced body aches and felt nauseated. These symptoms lasted for less than 24 hours. For tolerance to the 2nd dose of Shingrix, refer case US2019GSK086539. No additional information was reported. The reporter consented to follow up. The reporter gave permission for his physician to be contacted.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Malaise, Pain in extremity, Swelling
Clinical narrative: Swelling; Not  Feeling Well; pink mark at injection site; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, 1 day after receiving Shingrix, the patient experienced swelling, pain in arm, feeling unwell and injection site discoloration. In May 2019, the outcome of the swelling and feeling unwell were recovered/resolved. On an unknown date, the outcome of the pain in arm and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the swelling, pain in arm, feeling unwell and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: Last Thursday or Friday, the patient received Shingrix on right arm. The next day, the patient experienced swelling, sore arm, pink mark at injection site, and was not feeling well. The patient felt better within 24 hours, swelling went down within 36 hours, arm was still a little bit sore, but the pink mark had not disappeared till the time of reporting. The reporter reported that the pink mark as diffused or spreading out a little bit. The reporter consented to follow up. In Argus core outcome of the events swelling and feeling unwell were recovered/resolved, however in source document the outcome of this events were reported as recovered/resolved with sequel.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Appetite disorder, Asthenia, Headache, Influenza like illness, Lethargy
Clinical narrative: night sweats; low grade fever; not good appetite/ appetite does not seem to be very good; headaches; low energy/feels with low energy; lethargic; leg weakness; achy/ overall achy feeling; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 22nd April 2019, 3 hrs after receiving Shingrix, the patient experienced lower extremities weakness of, pain and influenza-like symptoms. On an unknown date, the patient experienced night sweat, low grade fever, appetite disorder, headache, energy decreased and lethargy. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the lower extremities weakness of, pain, influenza-like symptoms, night sweat, low grade fever, appetite disorder, headache, energy decreased and lethargy were not recovered/not resolved.   It was unknown if the reporter considered the lower extremities weakness of, pain, influenza-like symptoms, night sweat, low grade fever, appetite disorder, headache, energy decreased and lethargy to be related to Shingrix.  Additional details were provided as follows: The patient reported received the first Shingrix vaccine. Three hours after the vaccine he started experiencing the following symptoms: leg weakness, overall achy feeling, flu-like symptoms. The patient also experienced night sweats and low grade fever (up to 102 degrees) for the past 2 weeks. The patient had low grade fever was not as high anymore, but he still had it. The patient appetite does not seem to be very good. The patient was also having mild headaches, feels with low energy and lethargic. The patient said that all the symptoms come and goes in waves during the day. The patient had visited his physician twice since he started having these symptoms. The physician had given him steroid shots. The reporter consented to follow up.      Lab Comments: In 2019, body temperature was up to 102.