chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: deep pain in his upper arm at the injection site that radiated down to forearm, upper arm was still very sore and feels tender to the touch; deep pain in his upper arm at the injection site that radiated down to forearm, upper arm was still very sore and feels tender to the touch; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional  This case involves a 42 years old female patient who experienced deep pain in his upper arm at the injection site that radiated down to forearm, upper arm was still very sore and feels tender to the touch (pain and vaccination site reaction), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Oct-2019 at around 2:30 pm, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in the right arm.  On an unknown date, the patient developed a deep pain in his upper arm at the injection site that radiated down to forearm, upper arm was still very sore and feels tender to the touch (pain and vaccination site reaction) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Other relevant tests not reported.      Final diagnosis was pain and vaccination site reaction.  It was not reported if the patient received a corrective treatment.  The patient was recovering from the events.
Sex: U
Vaccine: FLUR4
Symptoms: Upper respiratory tract infection
Clinical narrative: develop an upper respiratory infection; Initial information received on 23-Oct-2019 regarding an unsolicited valid non serious case received from a other health professional.  This case is linked to cases 2019SA301094 and 2019SA301095 (same reporter).  This case involves unknown demographic patient who experienced upper respiratory infection (upper respiratory tract infection), while patient received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non serious upper respiratory infection (upper respiratory tract infection) unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.   Other relevant tests were not reported.  Final diagnosis was upper respiratory infection.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.   Information on the batch number was requested.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: they gave her son Pentecal that was 6 days expired; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 12 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that they gave her son Pentecal that was 6 days expired (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 17-Oct-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported and expiry date: 10-Oct-2019 via intramuscular route in leg.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Headache, Injection site pain, Pain in extremity
Clinical narrative: About 2 hours after injection - 8PM - I went into shock and seizures. I had severe chills. Head hurt, jaw hurt, lips were tremering, and right arm had tremers - would not stop. Whole body felt funny like every organ was affected - breathing was tight - lungs affected - heart affected - Left arm developed severe pain from injection site on down, slowly eased off and stopped by 12PM
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in jaw, Seizure, Shock, Tremor
Clinical narrative: About 2 hours after injection - 8PM - I went into shock and seizures. I had severe chills. Head hurt, jaw hurt, lips were tremering, and right arm had tremers - would not stop. Whole body felt funny like every organ was affected - breathing was tight - lungs affected - heart affected - Left arm developed severe pain from injection site on down, slowly eased off and stopped by 12PM
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Cold sweat, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Influenza vaccine given at 14:18. Symptoms started at 14:30 - cold sweats, shortness of breath, chest pain, dizziness. Referred to ER. Had EKG done. Medications given: Duoneb, Solumedrol, Benadryl. Observed for 4 hours and then discharged home with prescription for prednisone.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Erythema, Headache, Neck pain
Clinical narrative: After about five minutes of administering flu vaccine Client started to cry stating her head and neck was hurting. Asked client to have a sit and asked her if she was having a hard time breathing. Client stated no. Client had erythema of her face.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, VARCEL
Symptoms: Erythema, Oedema, Pruritus, Urticaria
Clinical narrative: Urticaria - Diffuse Pruritis Erythema Significant Edema improved with Benadryl
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Limb discomfort, Urticaria
Clinical narrative: @ 3:30 Pt stated her arm felt funny. @ 8:30PM felt itchy (R) arm. Next morning had hives (R) arm. She was advised on phone to take Benadryl. If symptoms worsened she should go to ED.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Cough, Dyspnoea, Throat irritation
Clinical narrative: Cough, difficulty breathing, itchy throat burning in lungs
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Hypokinesia, Immediate post-injection reaction, Injection site pain, Migraine
Clinical narrative: Immediate pain in left upper arm that has continued to this day. The pain started radiating up to the left shoulder and left side of neck over the first 24-48 hours, and has caused increase in migraines from 1 every 2-3 weeks, to now a 14-day migraine and counting. My left upper arm is still sore to the touch. My neck and shoulder have spasms and my neck gets "stuck" when trying to do slow, gentle ROM.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Neck pain
Clinical narrative: Immediate pain in left upper arm that has continued to this day. The pain started radiating up to the left shoulder and left side of neck over the first 24-48 hours, and has caused increase in migraines from 1 every 2-3 weeks, to now a 14-day migraine and counting. My left upper arm is still sore to the touch. My neck and shoulder have spasms and my neck gets "stuck" when trying to do slow, gentle ROM.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza virus test negative, Vomiting
Clinical narrative: Headache, vomiting, chills continuous
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain in extremity
Clinical narrative: Experiencing left arm pain with bruising
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase increased, Basophil count decreased, Basophil percentage, Blood albumin decreased
Clinical narrative: Three days after receiving vaccines, patient reports malaise, leg pain, and headache.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin decreased, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase MB increased
Clinical narrative: Three days after receiving vaccines, patient reports malaise, leg pain, and headache.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Blood creatine phosphokinase increased, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium decreased
Clinical narrative: Three days after receiving vaccines, patient reports malaise, leg pain, and headache.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Blood urea normal, C-reactive protein increased, Carbon dioxide normal, Eosinophil count decreased, Eosinophil percentage decreased
Clinical narrative: Three days after receiving vaccines, patient reports malaise, leg pain, and headache.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Haematocrit normal, Haemoglobin normal, Headache, Influenza virus test negative, Laboratory test
Clinical narrative: Three days after receiving vaccines, patient reports malaise, leg pain, and headache.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Lymphocyte count normal, Lymphocyte percentage increased, Malaise, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased
Clinical narrative: Three days after receiving vaccines, patient reports malaise, leg pain, and headache.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Mean cell volume normal, Mean platelet volume normal, Monocyte count normal, Monocyte percentage increased, Neutrophil count decreased
Clinical narrative: Three days after receiving vaccines, patient reports malaise, leg pain, and headache.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Neutrophil percentage decreased, Pain in extremity, Platelet count normal, Protein total normal, Red blood cell count normal
Clinical narrative: Three days after receiving vaccines, patient reports malaise, leg pain, and headache.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Red blood cell nucleated morphology, Red cell distribution width, Red cell distribution width normal, Streptococcus test negative, White blood cell count decreased
Clinical narrative: Three days after receiving vaccines, patient reports malaise, leg pain, and headache.
Age: 90.0
Sex: M
Vaccine: FLUA3
Symptoms: Areflexia, Asthenia, Diarrhoea, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient experienced neck pain and diarrhea which then progressed to weakness.  On 10/16/19 daughter drove to hospital.  Patient was transferred to Medical Center. Patient with weakness starting in lower extremities, then upper extremities, areflexic bilateral upper and lower.   Dx w/Guillain-Barre Sysndrome.  Patient on ventilator support and receiving immunoglobulin
Age: 90.0
Sex: M
Vaccine: FLUA3
Symptoms: Mechanical ventilation, Muscular weakness, Neck pain
Clinical narrative: Patient experienced neck pain and diarrhea which then progressed to weakness.  On 10/16/19 daughter drove to hospital.  Patient was transferred to Medical Center. Patient with weakness starting in lower extremities, then upper extremities, areflexic bilateral upper and lower.   Dx w/Guillain-Barre Sysndrome.  Patient on ventilator support and receiving immunoglobulin
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Limb discomfort, Mobility decreased
Clinical narrative: Employee states when she received the vaccination she knew something wasn't right.  Stating when shot went in, she immediately felt it go around her shoulder, the next couple of days the pain kept getting worse not better.  By the weekend she was unable to raise her arm up a few inches, arm movement since the day of shot has not improved.  Range of motion is very limited, continued pain radiating down her arm, feels like it locks up and the releases to allow arm to move.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Vomiting
Clinical narrative: Vomiting, headache, shivers, sore at injection dite
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Exposure during pregnancy, Lethargy, Malaise, Premature labour
Clinical narrative: I felt ill two days following the injection: congestion, runny nose, lethargic, sluggish. I then went into preterm labor at 32 weeks gestation and delivered 5lbs 4 oz via emergency c-section. This was my first pregnancy.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Respiratory tract congestion, Rhinorrhoea, Sluggishness
Clinical narrative: I felt ill two days following the injection: congestion, runny nose, lethargic, sluggish. I then went into preterm labor at 32 weeks gestation and delivered 5lbs 4 oz via emergency c-section. This was my first pregnancy.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Dizziness, Dyspnoea exertional
Clinical narrative: At 12:30 p.m. on October 9, 2019, I received the flue vaccination.  Two hours after receiving vaccination, I became dizzy and head felt heavy for 24 hours.  I went to bed early due to discomfort.  The dizziness subsided with sleep.  The next day, I became short of breath after slight exertion,  This continued for the next 9 days.  After a week, (the last 3 days) I became better each day until I felt normal.   Normal by October 19.  II've never experienced this prior to this flu vaccintion.  My asthma is under control using Flovent and Flonase.
Age: 8.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Child went to the school nurses office 10/30/19 complaining of injection site itching.  The school nurse pulled the band-aid from 2 days ago off and saw that the child had a 5 1/2 x 3 1/2 red spot that was swollen and warm to the touch.  She called the child's parents to have them come get him from school and take him to the doctor.
Age: 8.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Child went to the school nurses office 10/30/19 complaining of injection site itching.  The school nurse pulled the band-aid from 2 days ago off and saw that the child had a 5 1/2 x 3 1/2 red spot that was swollen and warm to the touch.  She called the child's parents to have them come get him from school and take him to the doctor.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Oblong patch with increased color (Pink) without erythema, ecchymosis, or induration, non blanching 2cm width at the superior aspect surrounding the site of injection extends down the arm 9cm widens to 4 cm
Age: 85.0
Sex: M
Vaccine: FLUA3
Symptoms: Dry skin, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Patient reported a red rash that extended from the site of the vaccination approximately 3inches wide and 5 inches in length that extended from the flu shot site down towards the elbow. Rash was reddish and rough skin with itchiness, and small amount of pain when pressure was applied, felt slightly warm. This was noted in the morning of 10/8/2019 and was present for 3-4 days until it faded away over the course of a night. Patient took an antihistamine on the 2nd day which did not seem to help. Patient did not see his physician or seek medical assistance, reporting it to the nurse who provided the vaccine on 10/30/2019.
Age: 85.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site warmth
Clinical narrative: Patient reported a red rash that extended from the site of the vaccination approximately 3inches wide and 5 inches in length that extended from the flu shot site down towards the elbow. Rash was reddish and rough skin with itchiness, and small amount of pain when pressure was applied, felt slightly warm. This was noted in the morning of 10/8/2019 and was present for 3-4 days until it faded away over the course of a night. Patient took an antihistamine on the 2nd day which did not seem to help. Patient did not see his physician or seek medical assistance, reporting it to the nurse who provided the vaccine on 10/30/2019.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme minor, was diagnosed at the office on October 28th 2019.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Myalgia
Clinical narrative: Employee received second dose of the Hep B  vaccine at approx. 12pm. Employee had no adverse effects until later on that night at approx. 11pm. Employee states had chills, weakness, aches in the muscle and joints, back pain  and a fever of 102F. Employee states took 2 tab of Nyquil around 12am and a liquid fever reducer around 5am.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Employee received second dose of the Hep B  vaccine at approx. 12pm. Employee had no adverse effects until later on that night at approx. 11pm. Employee states had chills, weakness, aches in the muscle and joints, back pain  and a fever of 102F. Employee states took 2 tab of Nyquil around 12am and a liquid fever reducer around 5am.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to receive Pneumo 13, but was given Pneumo 23 by mistake.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Pruritus, Throat irritation
Clinical narrative: After the administration of the vaccine the patient was instructed to wait in the sitting area until cleared to leave. Before 15 minutes elapsed the  patient reported symptoms of itchy and clammy skin. He also reported having an itchy throat. Theses reactions took place 10 minutes after the vaccine was administered. I gave the patient 37.5mg  of Benadryl liquid. The patient reported feeling a little better. Due to the need to followup up with a physician I escorted the patient to the student health center where he was seen by a NP. At the health center vitals were taken (O2 sat was at 97, BP slightly elevated, Throat not swollen but red), solu-medrol was given, and a nasal cannula was utilized. The patient was stable before I left the health center. EMS was not called.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pustule
Clinical narrative: Patient developed a bump similar in appearance to a pimple directly over injection site. Not itchy or bothersome and went away on it's own.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient began experiencing swelling of the left arm at about 2 hours after the Pneumovax vaccine was administered. The patient indicates that she put ice on the affected area and took acetaminophen, but the swelling continued until the next day. She thought about going to the prescriber's office but it was sunday, so she called the pharmacy. The pharmacist in charge told her to continue with the ice applications on the area and to take diphenhydramine. On monday morning, the symptom was resolved, and she felt like nothing has happened.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Skin burning sensation, Skin warm
Clinical narrative: Patient stated her arm was extremely hot, burning, extremely swollen down to just above her elbow and sore- it hurt to even put a bed sheet over her arm. She also couldn't lift her arm over her head. These symptoms lasted for several days and have improved but she still has some lingering arm pain.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Vaccine given in afternoon.  Around 7pm pt reports arm became hot, swollen, red, itchy from armpit to elbow
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Pyrexia, Screaming, Tremor, Vomiting
Clinical narrative: vomiting, intermittent shaking & screaming, and Fever.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects were reported.; the patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. 01-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003868, expiration date 08-AUG-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 6 to 14 (7.2) degrees Fahrenheit for 2 hours. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; Inappropriate schedule of vaccine administered; This spontaneous report has been received from a registered nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 22-AUG-2006, the patient was administered a unspecified dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose number, dose, anatomical location, lot# and expiration date were not reported) subcutaneously for prophylaxis and on 01-SEP-2006, the patient received 1 dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose number, anatomical location, lot# and expiration date were not reported) subcutaneously for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: The patient received improperly stored VARIVAX; No adverse effect reported; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions and medical history were not reported. Their concomitant therapies included sterile diluent.     On an unknown date, the patient  was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019237, expiration date 19-FEB-2021 or lot# R019237, expiration date 04-JUL-202 (dose, route, frequency and vaccination site were not provided), for prophylaxis.     Temperature: -14°C to -10°C (-9.74 C) Previous temperature excursion? No Was call because of a "data logger''? Yes
Sex: F
Vaccine: PPV
Symptoms: Antibody test positive, Cough, Dyspnoea, Pneumonia
Clinical narrative: cough and shortness of breath last friday; cough and shortness of breath last friday; Positive for only one type of pneumonia and negative for all other types; was diagnosed with pneumonia/She still gets pneumonia 4 to 5 times a year; Drug indication: history of asthma; This spontaneous report was received from an approximately 67 year old female patient, who was a  physician assistant, referring to herself. The patient's concurrent conditions included crohn's disease, drug hypersensitivity to amoxicillin (+) clavulanate potassium (AUGMENTIN), meperidine hydrochloride (DEMEROL), morphine, latex sensitivity, and chesnuts and green peppers. Concomitant therapies included azithromycin (Z-PAK).   In 2014, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot number, expiration date, dose, strength and route were not reported) for history of asthma (drug used for unapproved indication).  In 2014, "shortly after" the vaccination, the patient was diagnosed with pneumonia and was placed on high dose of prednisone (manufacturer unknown). The reporter stated that she was still experiencing pneumonia 4 to 5 times per year. After that, in October 2019, reported as the last week, she had pneumonia titers which were positive for one type of pneumonia and negative for all other types. Therefore, on 16-OCT-2019, the patient was vaccinated with a second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot number, expiration date, dose, strength and route were not reported). Then on 18-OCT-2019, reported as the last friday, the patient experienced dyspnoea and cough. It was reported that the patient sought medical attention and started treatment with azithromycin (Z-PAK). At the reporting time, the outcome of the events was reported as not recovered/not resolved. The reporter did not assessed the causality between the events and the vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, the event pneumonia was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient was administered an improperly stored VARIVAX; No adverse effects.; This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.   On unknown date, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S021926 with expiration date on 15-JUL-2021 (dose, frequency, strength and route of administration were not reported) for prophylaxis.  Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit for 72 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Feel sick; This case was reported by a other health professional via Shingrix interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient felt sick after receiving Shingrix.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Chills, Pain in extremity
Clinical narrative: Sick to stomach; Back pain that spread to knees, feel, heels, and ankles; Back pain that spread to knees, feel, heels, and ankles; Back pain that spread to knees, feel, heels, and ankles; Chills; Lost 12 pounds; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th September 2019, less than a day after receiving Shingrix, the patient experienced chills and weight loss. On 30th September 2019, the patient experienced back pain, foot pain and knee pain. In October 2019, the patient experienced stomach discomfort. On an unknown date, the outcome of the back pain, foot pain, knee pain and weight loss were not recovered/not resolved and the outcome of the chills was resolved with sequelae and the outcome of the stomach discomfort was unknown.   It was unknown if the reporter considered the back pain, foot pain, knee pain, chills, weight loss and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient started having back pain that spread to his knees, feet, heels and ankles and had chills. He stated, this pain was ongoing and had progressed.  He also stated, he had been sick to his stomach since three days after the vaccine and lost 12 pounds of weight. Emergency room visit was required. The patient consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: Sick to stomach; Back pain that spread to knees, feel, heels, and ankles; Back pain that spread to knees, feel, heels, and ankles; Back pain that spread to knees, feel, heels, and ankles; Chills; Lost 12 pounds; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th September 2019, less than a day after receiving Shingrix, the patient experienced chills and weight loss. On 30th September 2019, the patient experienced back pain, foot pain and knee pain. In October 2019, the patient experienced stomach discomfort. On an unknown date, the outcome of the back pain, foot pain, knee pain and weight loss were not recovered/not resolved and the outcome of the chills was resolved with sequelae and the outcome of the stomach discomfort was unknown.   It was unknown if the reporter considered the back pain, foot pain, knee pain, chills, weight loss and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient started having back pain that spread to his knees, feet, heels and ankles and had chills. He stated, this pain was ongoing and had progressed.  He also stated, he had been sick to his stomach since three days after the vaccine and lost 12 pounds of weight. Emergency room visit was required. The patient consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site reaction, Wound
Clinical narrative: Flu like symptoms; Wound at injection site; Wound at injection site; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, injection site reaction and wound. On an unknown date, the outcome of the influenza-like symptoms, injection site reaction and wound were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site reaction and wound to be related to Shingrix.  Additional details were provided as follows: The reporting pharmacist was the spouse of the patient. The age at vaccination was not reported but it could be 61 years or 62 years. The patient received dose of Shingrix in the unknown arm. The patient experienced wound at injection site. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Dizziness, Headache, Injection site pain
Clinical narrative: Dizziness / Fainting feeling; Cold sweat; Headache; Chills at night / Shivering; Felt Restless; Tenderness at site of injection; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced injection site tenderness. On 21st October 2019, the patient experienced chills and restlessness. On 22nd October 2019, the patient experienced dizziness, cold sweat and headache. On an unknown date, the outcome of the chills, restlessness, dizziness, cold sweat, headache and injection site tenderness were unknown.   It was unknown if the reporter considered the chills, restlessness, dizziness, cold sweat, headache and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. Less than a day after vaccination, at night, the patient experienced chills and felt restless. One day after vaccination, the patient woke up next day at 5 am and experienced dizziness, cold sweat, fainting feeling, headache and shivering. No further details were provided. The reporter did not consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness
Clinical narrative: Dizziness / Fainting feeling; Cold sweat; Headache; Chills at night / Shivering; Felt Restless; Tenderness at site of injection; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced injection site tenderness. On 21st October 2019, the patient experienced chills and restlessness. On 22nd October 2019, the patient experienced dizziness, cold sweat and headache. On an unknown date, the outcome of the chills, restlessness, dizziness, cold sweat, headache and injection site tenderness were unknown.   It was unknown if the reporter considered the chills, restlessness, dizziness, cold sweat, headache and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. Less than a day after vaccination, at night, the patient experienced chills and felt restless. One day after vaccination, the patient woke up next day at 5 am and experienced dizziness, cold sweat, fainting feeling, headache and shivering. No further details were provided. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date 25th September 2021) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional detaikls were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist staed that, the patient had 2 epiosde of shingles after vaccination. The reporter unsure when the first case was, but they came in and said they develop shingles this weekend and it was ongoing. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site mass, Injection site rash, Injection site swelling
Clinical narrative: Injection site swelling with a hard knot; Injection site rash; Joint pain; Fever; Chills; Injection site swelling with a hard knot; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site swelling, injection site rash, joint pain, fever, chills and injection site lump. On an unknown date, the outcome of the injection site swelling, injection site rash, joint pain, fever, chills and injection site lump were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site rash, joint pain, fever, chills and injection site lump to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The caller was a patient who had first dose of Shingrix some time in left arm. The patient experienced injection site swelling with a hard knot, injection site rash, joint pain, fever and chills and that these events resolved in around 3 days. The reporter did not consent to follow-up. The caller declined to provide any demographics.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection site swelling with a hard knot; Injection site rash; Joint pain; Fever; Chills; Injection site swelling with a hard knot; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site swelling, injection site rash, joint pain, fever, chills and injection site lump. On an unknown date, the outcome of the injection site swelling, injection site rash, joint pain, fever, chills and injection site lump were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site rash, joint pain, fever, chills and injection site lump to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The caller was a patient who had first dose of Shingrix some time in left arm. The patient experienced injection site swelling with a hard knot, injection site rash, joint pain, fever and chills and that these events resolved in around 3 days. The reporter did not consent to follow-up. The caller declined to provide any demographics.
Age: 0.58
Sex: F
Vaccine: UNK
Symptoms: Erythema, Skin warm, Swelling, Urticaria
Clinical narrative: Hives; Little bit of redness; Swelling; Warmth; This case was reported by a nurse via call center representative and described the occurrence of hives in a 7-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 55GY9, expiry date 30th June 2020) for prophylaxis.   On 15th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 16th October 2019, 1 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced hives, erythema, swelling and skin warm. On 17th October 2019, the outcome of the hives, erythema, swelling and skin warm were recovered/resolved.   It was unknown if the reporter considered the hives, erythema, swelling and skin warm to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The patient received FluLaval Quadrivalent 2019-2020 season on unknown deltoid. In the evening the patient's parents noticed a line of hives going down the arm from the injection site. The hives were in a line. There was a little bit of redness, swelling and warmth to to the touch but not much. The patient was put to bed with no treatment and in the morning the hives had resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site scab, Injection site vesicles
Clinical narrative: Red injection site; Blistered injection site; The site is scabbed; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2021) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th August 2019, immediately after receiving Shingrix, the patient experienced injection site erythema, injection site blisters and injection site scab. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site blisters and injection site scab were unknown.   It was unknown if the reporter considered the injection site erythema, injection site blisters and injection site scab to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. The patient experienced a red, blistered injection site. The patient stated that the site was still red and scabbed. The reporter consented to follow up. The healthcare professional consented to follow up for this adverse event.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: arm weakness; This case was reported by a pharmacist via call center representative and described the occurrence of weakness of arms in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   On 26th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 26th April 2019, unknown after receiving Shingrix, the patient experienced weakness of arms. The patient was treated with steroids nos (Steroid Injection). On an unknown date, the outcome of the weakness of arms was not recovered/not resolved.   It was unknown if the reporter considered the weakness of arms to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in the right arm. The pharmacist reported that the patient was seen by her physician and was given a Steroid injection in her right arm. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional detauils were provided as follows: The age at vaccination was not reported. The age group of the patient selected as adult as per vaccine indication. No other details were provided. This case has been linked with case US2019192783, reported by same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Nausea, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine; Headache; Nausea; Low grade fever; This case was reported by a other health professional via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced headache, nausea and low grade fever. On 22nd October 2019, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the headache, nausea, low grade fever and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the headache, nausea and low grade fever to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the medical assistant. On 10th Se0tember 2019, the patient received 1st dose of Shingrix. The patient was inadvertently received a 2nd dose of Shingrix, which was earlier than recommended schedule, which led to shortening of the vaccination schedule. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Incorrect dose administered, Product preparation error
Clinical narrative: Diarrhea; Patient was administered only the liquid portion of the vaccine; Inappropriate dose of vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2019, the patient received the 1st dose of Shingrix. On 22nd October 2019, less than a day after receiving Shingrix, the patient experienced diarrhea, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the diarrhea, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional case details were reported as follows: The patient was administered only the liquid portion of the vaccine, which led to drug reconstitution and inappropriate dose of vaccine administered. The patient experienced diarrhea later that evening.  This case has been linked with case US2019193758, reported by the same reporter.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 months old infant recieved Adacel instead of pentacel/no ae; 15 months old infant recieved Adacel/no ae; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old male patient who experienced 15 months old infant recieved  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. instead of 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.  Concomitant medications included HIB VACCINE (HIB) for Immunisation; and POLIO VACCINE INACT (IPV) for Immunisation.  On an unknown date, the patient received a 4th dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6273AA via unknown route in the right thigh. On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.   It was unknown if any adverse event occurred.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: the Adacel experienced a temp excursion between 30-32 degrees/no AE; Adacel was administered to a 77 years 2 months old male patient/ no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA284333 (same reporter).  This case involves a 77 years old male patient who received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6202BA via intramuscular route in the right deltoid which was exposed to a temp excursion between 30-32 degrees.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUAD).  It was an actual medication error due to inappropriate age at vaccine administration and incorrect product storage.   At the time of report 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.