chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: reaction to being administered with Fluzone High-Dose Quadrivalent; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 68-year-old female patient who experienced reaction to being administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (vaccination complication).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ479AA, expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious reaction to being administered with fluzone high-dose quadrivalent (vaccination complication) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Event outcome was unknown at the time of report.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: warmth, pain and little red bumps at the injection site; pain at the injection site; little red bumps at the site; itching at the site; warmth at the injection site; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 74-years-old male patient who had warmth, pain and little red bumps at the injection site (vaccination site inflammation) and itching at the site (vaccination site pruritus), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications were not reported.  On 25-Sep-2020, the patient received a dose of 0.7 mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ487AB, expiry date-30-Jun-2020) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date in 2020, the patient developed a non-serious warmth, pain and little red bumps at the injection site (vaccination site inflammation) with symptoms of warmth at the injection site (vaccination site warmth) and pain at the injection site (vaccination site pain) four days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date in 2020, the patient developed a non-serious little red bumps at the site (vaccination site erythema) symptom of (vaccination site inflammation) and itching at the site (vaccination site pruritus) two weeks following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratories details reported.  It was not reported if the patient received any corrective treatment.  Outcome of events was unknown at the time of reporting.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Skin warm, Swelling, Vaccination site inflammation
Clinical narrative: mild reaction area from the neck to the elbow on the left arm being swollen; mild reaction described as the area from the neck to the elbow on the left arm being red and hot; mild reaction described as the area from the neck to the elbow on the left arm being red and hot; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 67-year-old female patient who had mild reaction described as the area from the neck to the elbow on the left arm being red, swollen, and hot (extensive swelling of vaccinated limb, inflammation and vaccination site reaction), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations and family history were not provided.  No concomitant medications given.  On 06-Oct-2020, the patient received a dose of 0.7 mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ482AA, expiry date 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On 07-Oct-2020, the patient developed non-serious mild reaction described as the area from the neck to the elbow on the left arm being red, swollen, and hot (extensive swelling of vaccinated limb, inflammation and vaccination site reaction) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the patient was not recovered from the events.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: mild reaction area from the neck to the elbow on the left arm being swollen; mild reaction described as the area from the neck to the elbow on the left arm being red and hot; mild reaction described as the area from the neck to the elbow on the left arm being red and hot; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 67-year-old female patient who had mild reaction described as the area from the neck to the elbow on the left arm being red, swollen, and hot (extensive swelling of vaccinated limb, inflammation and vaccination site reaction), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations and family history were not provided.  No concomitant medications given.  On 06-Oct-2020, the patient received a dose of 0.7 mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ482AA, expiry date 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On 07-Oct-2020, the patient developed non-serious mild reaction described as the area from the neck to the elbow on the left arm being red, swollen, and hot (extensive swelling of vaccinated limb, inflammation and vaccination site reaction) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the patient was not recovered from the events.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: She said she got the Fluzone  65+ vaccine and not the Fluzone Quadrivalent with no adverse event; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a female patient of unknown age she said she got the fluzone  65+ vaccine and not the influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] (product dispensing error) (formulation, strength, dose, frequency, batch number, expiration date and route of administration were unknown) for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to inappropriate schedule of vaccine administered (latency unknown).  At the time of reporting, no adverse event was reported.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 year old female patient was administered DAPTACEL, they are aware that the cut-off is 6 years old with no adverse event; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional.  This case involves a 7-year-old female patient was administered diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel], they are aware that the cut-off was 6 years old (off label use) on 26-Oct-2020. (formulation, dosing frequency and strength were unknown) (lot number: C5643BA and expiry date: 17-JUL-2021) at 0.5 ml via intramuscular route in the left deltoid site for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included polio vaccine inact 3v (vero) (Ipol).  This was an actual off label use case due to inappropriate schedule of vaccine administered (latency unknown).  At the time of reporting, no adverse event was reported.  No further relevant information was reported.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: states that a patient received two doses of Fluzone high dose 29 days apart. One on 25-Sep-2020 and one on 23-Oct-2020 with no adverse event; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 79-year-old male patient received two doses of influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] 29 days apart. one on 25-sep-2020 and one on 23-oct-2020 (inappropriate schedule of product administration). (formulation, dosing frequency and strength were unknown) (lot number: UJ512AB and expiry date: 30-Jun-2021) at 0.7 ml via intramuscular route in unknown administration site for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  This was an actual medication error case due to inappropriate schedule of vaccine administered (latency unknown).  At the time of reporting, no adverse event was reported.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, No adverse event
Clinical narrative: Patient received vaccine on 11/19/2020 from the reporter who is the organization's Employee Health Nurse, no initial sign of adverse reaction at time of injection. Patient reported her arm felt "itchy" when going to bed that night. Received a call this morning at 11:15am from the employee and supervisor reporting that there was about a nickel sized area of redness at the insertion site on her left arm and then about 2 cm below the insertion site there was a roughly 5 cm x 3 cm area of erythema that was hot, raised, and itchy.
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus
Clinical narrative: Patient received vaccine on 11/19/2020 from the reporter who is the organization's Employee Health Nurse, no initial sign of adverse reaction at time of injection. Patient reported her arm felt "itchy" when going to bed that night. Received a call this morning at 11:15am from the employee and supervisor reporting that there was about a nickel sized area of redness at the insertion site on her left arm and then about 2 cm below the insertion site there was a roughly 5 cm x 3 cm area of erythema that was hot, raised, and itchy.
Sex: F
Vaccine: VARZOS
Symptoms: Burning mouth syndrome, Burning sensation, Erythema, Oral candidiasis, Taste disorder
Clinical narrative: States at 1:30am after the vaccination, she woke up with a severe migraine, blurred vision to where she couldn't see, her body had heat wave with the shakes where the inside of her body felt overheated but her outer body was cold. Her vision was so blurry so she laid back down and when she woke up she had fever of 101, her arm where the injection was is super tight, warm and hurts extremely bad so she went to the emergency room on 11/19/20 around 10. When getting the injection she states the nurse stuck her the first time and said she don't want to hurt her and removed that needle and got another needled and re stuck her again.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Joint stiffness, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Patient c/o of severe pain 10/10 left arm immediately after vaccine given. She had stiffness of left arm causing her to miss work. I believe  she stated she had fever, chills and severe pain of left arm. After 2 weeks the ;left arm pain remains a 6-7/10
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient c/o of severe pain 10/10 left arm immediately after vaccine given. She had stiffness of left arm causing her to miss work. I believe  she stated she had fever, chills and severe pain of left arm. After 2 weeks the ;left arm pain remains a 6-7/10
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: soreness of arm lasting more than 2 months. radiating pain but no tingling or numbness. soreness radiates to hand.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Palpitations, Tachycardia
Clinical narrative: Tachycardia/Palpitations. Did not occur at pharmacy. Occurred later in the day at home and patient went to the ED.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient is reported "shooting pain that radiates towards neck and down arm" for right arm where prevnar 13 injection provided. She states that she is unable to lift right arm above her head.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Injection site pain
Clinical narrative: Patient came in for 2nd dose of Shingrix at pharmacy on 11/20/20 and reported left arm soreness in deltoid area that began the same dame as vaccine administration (09/09/20) and has persisted since then. Patient received his first Shingles vaccination in the right arm and his yearly flu shot in the left arm on 09/09/20. Patient said the pain was from his Shingles shot, but the Immunization Registry has the Afluria documented as being given in the left arm. It is most painful when he lays on his arm at night. Patient also reported feeling fatigued and achy for about three days after getting the vaccines, which I explained to him was a normal response to the Shingrix vaccine. I encouraged the patient to check in with his provider to determine the source of his shoulder pain (if vaccine administration-related or other) and recommended acetaminophen OTC and ice in the mean time to help.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: slight nausea, chills, low grade fever, extreme body aches, headache
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting within 2 hours of injection, vomited x3 , treated effectively with zofran, no further symptoms or treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: pt presented following am with area of 3" long x 2.5" wide swelling. it was 2" below injection site. Warm to touch, raised and painful
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient repports breaking out in hives the evening of her flu shot. She reports that her arms, legs and trunk were affected. She reports itching as if she was exposed to fiberglass. Patient took Benadryl that evening and on 11/20 reported that the hives had subsided.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Shivers, fever, body aches, headache. All last about 36 hrs.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Full blood count normal, Headache, Lip discolouration, Loss of consciousness
Clinical narrative: Around 7:30pm the night after vaccine, patient was standing in bathroom and complained of abdominal pain and headache. She called for mom and when mom saw patient she looked very pale and lips were white. She then lost consciousness. Mom caught her and carried her to bed. She began to try to arouse her, estimates that she was unconscious for ~1 minute. No seizure like activity or movement of extremities.  Once she came to, mom took to ER for evaluation.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test normal, Pallor, Unresponsive to stimuli, Urine analysis normal
Clinical narrative: Around 7:30pm the night after vaccine, patient was standing in bathroom and complained of abdominal pain and headache. She called for mom and when mom saw patient she looked very pale and lips were white. She then lost consciousness. Mom caught her and carried her to bed. She began to try to arouse her, estimates that she was unconscious for ~1 minute. No seizure like activity or movement of extremities.  Once she came to, mom took to ER for evaluation.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Heart rate increased, Pain, Pyrexia
Clinical narrative: Mild fever, body ache,weak increased heartbeat
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Fatigue, Hypertension, Laboratory test normal, Pain in extremity
Clinical narrative: I rec the senior high dose flu shot. Around the evening time I started feeling weak and my arm was sore  so I went to sleep. Woke up at 2 am and heart was pounding and I was feeling very fatigued also feeling like I could not get out of bed and so I sat on the floor. I did the not have the strength to get up so I woke my husband up at 6am and we went to the ER. ER stated I had high blood pressure and labs came back clear.
Sex: F
Vaccine: FLUX
Symptoms: Palpitations
Clinical narrative: I rec the senior high dose flu shot. Around the evening time I started feeling weak and my arm was sore  so I went to sleep. Woke up at 2 am and heart was pounding and I was feeling very fatigued also feeling like I could not get out of bed and so I sat on the floor. I did the not have the strength to get up so I woke my husband up at 6am and we went to the ER. ER stated I had high blood pressure and labs came back clear.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Cervical spinal cord paralysis, Cough, Cytogenetic analysis abnormal, Ear infection, Electroencephalogram abnormal
Clinical narrative: Within hours of the shot, patient became sick. She had a runny nose, cough, eventually diagnosed with an ear infection etc. However, the most severe reaction to the shot  that we witnessed was on January 14th. She had a severe seizure that mimicked that of a stroke (although tests later ruled out a stroke); her entire left side of the body was paralyzed from her face down to her feet. Her body was extremely stiff, unable to move and patient was completely nonresponsive. She was nonresponsive for almost 15 minutes but breathing. Her left side of the body was stiff and her face was stuck in the drooping down position like you would see in an elderly stroke victim.   We saw the physician on 1/16 (as soon as we could get in) and he referred us to see the neurologist. Since January, we have been under the care of this doctor. After many tests (will be described below) patient has been diagnosed with epilepsy and focial seizures. They occur nearly every two weeks at this current time. She continues to get paralysis in her limbs and neck and has many ticks following a seizure.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Epilepsy, Facial paralysis, Hemiplegia, Magnetic resonance imaging normal, Malaise
Clinical narrative: Within hours of the shot, patient became sick. She had a runny nose, cough, eventually diagnosed with an ear infection etc. However, the most severe reaction to the shot  that we witnessed was on January 14th. She had a severe seizure that mimicked that of a stroke (although tests later ruled out a stroke); her entire left side of the body was paralyzed from her face down to her feet. Her body was extremely stiff, unable to move and patient was completely nonresponsive. She was nonresponsive for almost 15 minutes but breathing. Her left side of the body was stiff and her face was stuck in the drooping down position like you would see in an elderly stroke victim.   We saw the physician on 1/16 (as soon as we could get in) and he referred us to see the neurologist. Since January, we have been under the care of this doctor. After many tests (will be described below) patient has been diagnosed with epilepsy and focial seizures. They occur nearly every two weeks at this current time. She continues to get paralysis in her limbs and neck and has many ticks following a seizure.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Mobility decreased, Musculoskeletal stiffness, Partial seizures, Rhinorrhoea, Seizure
Clinical narrative: Within hours of the shot, patient became sick. She had a runny nose, cough, eventually diagnosed with an ear infection etc. However, the most severe reaction to the shot  that we witnessed was on January 14th. She had a severe seizure that mimicked that of a stroke (although tests later ruled out a stroke); her entire left side of the body was paralyzed from her face down to her feet. Her body was extremely stiff, unable to move and patient was completely nonresponsive. She was nonresponsive for almost 15 minutes but breathing. Her left side of the body was stiff and her face was stuck in the drooping down position like you would see in an elderly stroke victim.   We saw the physician on 1/16 (as soon as we could get in) and he referred us to see the neurologist. Since January, we have been under the care of this doctor. After many tests (will be described below) patient has been diagnosed with epilepsy and focial seizures. They occur nearly every two weeks at this current time. She continues to get paralysis in her limbs and neck and has many ticks following a seizure.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Tic, Unresponsive to stimuli
Clinical narrative: Within hours of the shot, patient became sick. She had a runny nose, cough, eventually diagnosed with an ear infection etc. However, the most severe reaction to the shot  that we witnessed was on January 14th. She had a severe seizure that mimicked that of a stroke (although tests later ruled out a stroke); her entire left side of the body was paralyzed from her face down to her feet. Her body was extremely stiff, unable to move and patient was completely nonresponsive. She was nonresponsive for almost 15 minutes but breathing. Her left side of the body was stiff and her face was stuck in the drooping down position like you would see in an elderly stroke victim.   We saw the physician on 1/16 (as soon as we could get in) and he referred us to see the neurologist. Since January, we have been under the care of this doctor. After many tests (will be described below) patient has been diagnosed with epilepsy and focial seizures. They occur nearly every two weeks at this current time. She continues to get paralysis in her limbs and neck and has many ticks following a seizure.
Age: 1.17
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash, Rash macular
Clinical narrative: patients mom states that a few days later  there was a rash on his legs and arms  , flat macular rash , no fever , no pain , no trouble walking or sleeping , now resolved
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Pain and firmness at site with decreased ROM  SIRVA Injury
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Blood glucose normal, Dizziness, Face injury, Headache, Loss of consciousness
Clinical narrative: patient was administered FluMist without incident. After that he was watching his father and brother get the injection and he passed out.  He was standing and he hit his chin on the edge of the table.  He was only blacked out for a few seconds but 911 was called due to hitting his chin in the table. When he awoke he said he was dizzy and head was throbbing. He was A&Ox3 and responding to questions.  Father stated he has very high anxiety and history of panic attacks.   5:10pm BP=160/92 , P=96.  5:20pm BP=168/106 P=66. No meds were given.  EMT's arrived and assessed. Blood sugar=92. Pt went to ED for evaluation and was diagnosed as vasovagal and his chin was fine, no further injury.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Headache, Heart rate increased, Nausea, Retching
Clinical narrative: Nausea for 24 hours with dry heaves; headache; shakes; increase in blood pressure and heartrate
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Nausea for 24 hours with dry heaves; headache; shakes; increase in blood pressure and heartrate
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red warm swollen 2.0x2.5cm on right thigh
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Headache, Lymphadenopathy, Oropharyngeal pain, Pyrexia
Clinical narrative: STOMACH PAIN; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; SWOLLEN GLANDS; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; FEVER; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; SORE THROAT; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; VOMITING; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; HEADACHE; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; A spontaneous report has been received from a consumer via the regulatory authority concerning a 11 year old male patient with height of 145 centimetres and with weight of 43 kilograms.    The patient's past and current medical history included allergy to nuts (ongoing). No concomitant products were reported.    On 30-Oct-2020, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal) 1 dosage form, nasal.     On 30-Oct-2020, the patient experienced stomach pain (preferred term: Abdominal pain upper), swollen glands (preferred term: Lymphadenopathy), fever (preferred term: Pyrexia), sore throat (preferred term: Oropharyngeal pain), vomiting (preferred term: Vomiting) and headache (preferred term: Headache).     At the time of reporting, the event of stomach pain, swollen glands, fever, sore throat, vomiting and headache was improving.     The events were considered serious (important medical event) by the reporter.; Sender's Comments: Abdominal pain upper, lymphadenopathy, oropharyngeal pain and vomiting are not listed in the company core data sheet of Q/LAIV (Fluenz). Pyrexia has been associated with use of LAIV in children but not in adults. The events could be in connection. Due to limited information on indication of the suspect drug, onset date and outcome of the event, possible risk factors, circumstances surrounding the event, aetiological and diagnostic workup, concurrent diseases, concomitant medications and medical history, it is not possible to make a conclusive assessment of the causal relationship of the events and suspect drug
Sex: M
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: STOMACH PAIN; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; SWOLLEN GLANDS; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; FEVER; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; SORE THROAT; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; VOMITING; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; HEADACHE; vomited within an hour, very bad headache, feverish, sore tummy, sore throat, swollen glands; A spontaneous report has been received from a consumer via the regulatory authority concerning a 11 year old male patient with height of 145 centimetres and with weight of 43 kilograms.    The patient's past and current medical history included allergy to nuts (ongoing). No concomitant products were reported.    On 30-Oct-2020, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal) 1 dosage form, nasal.     On 30-Oct-2020, the patient experienced stomach pain (preferred term: Abdominal pain upper), swollen glands (preferred term: Lymphadenopathy), fever (preferred term: Pyrexia), sore throat (preferred term: Oropharyngeal pain), vomiting (preferred term: Vomiting) and headache (preferred term: Headache).     At the time of reporting, the event of stomach pain, swollen glands, fever, sore throat, vomiting and headache was improving.     The events were considered serious (important medical event) by the reporter.; Sender's Comments: Abdominal pain upper, lymphadenopathy, oropharyngeal pain and vomiting are not listed in the company core data sheet of Q/LAIV (Fluenz). Pyrexia has been associated with use of LAIV in children but not in adults. The events could be in connection. Due to limited information on indication of the suspect drug, onset date and outcome of the event, possible risk factors, circumstances surrounding the event, aetiological and diagnostic workup, concurrent diseases, concomitant medications and medical history, it is not possible to make a conclusive assessment of the causal relationship of the events and suspect drug
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given via intramuscular route instead of subcutaneously; This spontaneous report was received from a registered nurse and refers to an adult patient of an unknown age and gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and patient's pertinent medical history was not provided.  On an unknown date, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) (formulation, dose, dose #, strength, frequency, lot # and expiration date were unknown) for prophylaxis, intramuscularly, not subcutaneously (subcutaneous injection formulation administered by other route). No product quality complaint (PQC) was involved.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: 17 people were given vaccines during improperly stored; This spontaneous report as received from a Licensed Practical Nurse refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 02-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(rHA, recombinant human albumin) lot # S035110, expiration date: 03-MAY-2021, 0.5 milliliter (dosing schedule and route of administration were not reported) for prophylaxis. Administered dose of vaccine was exposed to the temperatures: -13.9 Celsius degrees (C) to -14.7 Celsius degrees, in the following time frames: -14 C to -10 C (-13.9 C): for 30 minutes; -14 C to -10 C (-14.2 C) for 15 minutes; -14 C to -10 C (-14.7 C) for 20 minutes and -14 C to -10 C (-14.6 C) for 5 minutes, as recorded by digital data logger.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: There are no additional AEs; MA calling with a dose of expired MMR-II administered inadvertently.; This spontaneous report was received from a registered medical assistant 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.  On 13-NOV-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dosage form, lot # R031681, expiration date 01-NOV-2020 (route of administration and anatomical location were not provided), for prophylaxis. There was no adverse event reported.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Joint range of motion decreased, Pain in extremity, Sleep disorder
Clinical narrative: the patient is waking up most nights with sporadic pain in her left arm; the patient is waking up most nights with sporadic pain in her left arm; the patient has no range of motion when this occurs; This spontaneous report was received from a nurse and refers to a 14-year-old not pregnant female patient. No information regarding the patient's concurrent condition, past medical history, concomitant medications and drug reactions or allergies was provided.  On 23-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter dose administered intramuscularly (lot number and expiration date were not reported). At the time of administration, the patient reported no adverse events.  The patient's mother contacted the reporter on an unspecified date in 2020 (reported as later) and reported that starting in late September 2020, the patient experienced "waking up most nights with sporadic pain in her left arm" and also reported the patient had "no range of motion when this occurs". The nurse stated she had no additional information regarding the event.  The outcome of the events was reported as not recovered/not resolved. The causal relationship was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD was improperly stored fuen administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not reported.  On 17-NOV-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) ( lot # T025506, expiration date 23-JAN-2022), 0.5 milliliter for prophylaxis (Anatomical location was not provided).     Temperature: 22.8 °F for a time frame of 13 hours and 25 minutes. Previous temperature excursion were of 17.4 °F for 31 minutes and 30 seconds. Digital data logger was involved.
Age: 55.0
Sex: F
Vaccine: FLUX, TTOX, VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included TETANUS SHOT for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and TETANUS SHOT. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season and unknown after receiving TETANUS SHOT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: Age at vaccination was not reported. The patient received an unspecified tetanus shot a few years ago and an unknown flu shot a few months ago and having a sore arm afterwards that lasted a day or two. The reporter did not consent to follow-up.  This case has been linked with the case US2020223100 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223100:same reporter
Age: 55.0
Sex: F
Vaccine: FLUX, TTOX, VARZOS
Symptoms: Limb discomfort
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included TETANUS SHOT for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and TETANUS SHOT. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season and unknown after receiving TETANUS SHOT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: Age at vaccination was not reported. The patient received an unspecified tetanus shot a few years ago and an unknown flu shot a few months ago and having a sore arm afterwards that lasted a day or two. The reporter did not consent to follow-up.  This case has been linked with the case US2020223100 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223100:same reporter
Age: 55.0
Sex: F
Vaccine: FLUX, TTOX, VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm discomfort; This case was reported by a consumer via call center representative and described the occurrence of arm discomfort in a 55-year-old female patient who received Herpes zoster (Shingrix). Previously administered products included tetanus shot and flu shot.   On 10th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th November 2020, 2 hrs after receiving Shingrix, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix and it had been close to two hours and she was experiencing some arm discomfort.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR223706:same reporter
Age: 55.0
Sex: F
Vaccine: FLUX, TTOX, VARZOS
Symptoms: Limb discomfort
Clinical narrative: arm discomfort; This case was reported by a consumer via call center representative and described the occurrence of arm discomfort in a 55-year-old female patient who received Herpes zoster (Shingrix). Previously administered products included tetanus shot and flu shot.   On 10th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th November 2020, 2 hrs after receiving Shingrix, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix and it had been close to two hours and she was experiencing some arm discomfort.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR223706:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Rash papular
Clinical narrative: developed a few recurrent papules / small papules on her back; This case was reported by a physician via sales rep and described the occurrence of papular rash in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 20th October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 24th October 2020, 4 days after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was unknown.   It was unknown if the reporter considered the papular rash to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received either Fluarix or FluLaval on 20th October 2020, and developed a few recurrent papules on 24th October 2020, at the same location where she had a bout of herpes zoster post-Shingrix administration over a year ago. Be advised that the  Herpes zoster event post-Shingrix was previously reported to GSK so that is not a new event to report. Patient stated that the recurrent papules post-influenza vaccination in October 2020 has not been physician diagnosed, just a new event that she was self-aware of as she is able to feel these small papules on her back. Reporter/patient does not know if the flu vaccine is the cause but noted that was the flu vaccine was the only new event. She plans on seeing her physician soon to get a diagnosis. This case has been linked with case US2019AMR193464, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR193464:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: chills; muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced chills and muscle pain. On an unknown date, the outcome of the chills and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the chills and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received 1st Shingrix vaccine about 24 hours ago and experiencing chills and muscle aches. The patient asked how long does this typically last.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Nausea 3 weeks after injection; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient asked can Shingrix give nausea 3 weeks after injection.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Received a 3rd dose in error; sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter stated that, the patient received a 3rd dose of Shingrix in error, which led to extra dose administered.   Follow-up information received from pharmacist on 17th November 2020 : The patient's demographics were updated. On 30rd March 2018, the patient received 1st dose of Shingrix and on 20th September 2018, patient received 2nd dose of shingrix. Order sent to pharmacy for vaccine administration by MD office. The patient reported pharmacy for vaccine stating it was his 1st dose. Access was temporarily unavailable and pharmacy did not check patient's chart for previous vaccination. Pharmacy records were in an old pharmacy system not easily visible or retrieved. Then vaccine was administered to patient. During documentation process it was discovered that the patient had previously received 2 doses of vaccine in 2018. On 29th October 2020, the patient received 0.5ml of 3rd dose of Shingrix, intramuscularly. On an unknown date, less than a month after receiving vaccine, the patient experienced pain in arm for 3 days. It was unknown if the reporter considered the pain in arm to be related to Shingrix The VAERS details were updated. The patient and provider was notified about medication error and patient reported no harm.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Nerve pain in her mouth and teeth; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, between 1 and 2 weeks after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   The reporter considered the nerve pain to be unrelated to Shingrix.  Additional details were provided as follows: The reporter stated that her mother received her first dose of Shingrix in right arm. The reporter stated that 1.5 to 2 weeks later the patient developed nerve pain in her mouth and teeth.  The patient had gone to the physician about this pain, and the physician stated it was not related to the Shingrix vaccine. The reporter stated that the pain had decreased, but still had not resolved. The reporter did not consent to follow up.