chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Nausea, Neck pain
Clinical narrative: This spontaneous report was received from a 62 year old female patient and refers to herself. The patient had an allergy to morphine (manufacturer unknown) and methadone. The patient's pertinent medical history was not reported. On 04-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX, 1 vial in the unspecified arm (strength, lot # and expiration date were not provided). The patient was vaccinated in an unspecified pharmacy by an unspecified pharmacist. The patient took unspecified medications. On 04-NOV-2015, the patient's arm (the one that received the vaccine) began to feel hot and swell. This arm continued to "hurt" her until pain in this arm prevented him from lifting her arm above the waist. She also became nauseous and got a headache. The pain in her arm extended up to her neck. The patient called the pharmacist who administered ZOSTAVAX, and was told to take BENADRYL as a treatment (unspecified dose). At the time of the report, the patient's arm was still tender to touch. The patient sought medical attention via calling the pharmacist. The outcome of the events was reported as recovering (also reported as "all of these symptoms lasted for 3 days"). The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports concerning the same patient. Additional information is not expected as there was no correspondence contact provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a 62 year old female patient and refers to herself. The patient had an allergy to morphine (manufacturer unknown) and methadone. The patient's pertinent medical history was not reported. On 04-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX, 1 vial in the unspecified arm (strength, lot # and expiration date were not provided). The patient was vaccinated in an unspecified pharmacy by an unspecified pharmacist. The patient took unspecified medications. On 04-NOV-2015, the patient's arm (the one that received the vaccine) began to feel hot and swell. This arm continued to "hurt" her until pain in this arm prevented him from lifting her arm above the waist. She also became nauseous and got a headache. The pain in her arm extended up to her neck. The patient called the pharmacist who administered ZOSTAVAX, and was told to take BENADRYL as a treatment (unspecified dose). At the time of the report, the patient's arm was still tender to touch. The patient sought medical attention via calling the pharmacist. The outcome of the events was reported as recovering (also reported as "all of these symptoms lasted for 3 days"). The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports concerning the same patient. Additional information is not expected as there was no correspondence contact provided.
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Blood urine present, Haematuria, Urine analysis abnormal
Clinical narrative: Case number PHEH2015US022720, is an initial spontaneous report from a pharmacist received on 03 Nov 2015. This report refers to a 57 years old female patient. Medical history and concomitant medications were not reported, The patient was vaccinated with FLUCELVAX (batch number: 173906) intramuscular on 01 May 2015. On 02 May 2015 the patient complained of hematuria which was recovered on the same day. The seriousness and causality of the event was not reported. Seriousness assessment of hematuria was upgraded based on information in the source document.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Beta haemolytic streptococcal infection, Caesarean section, Exposure during pregnancy, Oropharyngeal pain, Polymerase chain reaction positive
Clinical narrative: Mother case: Case number PHHY2015US146922 is an initial literature report received on 02 Nov 2015. The author described 3 cases of Respiratory Syncytial Virus (RSV) infection diagnosed at a center during winter 2014. This report refers to a 21 year old female patient who was pregnant (primigravida). She had no history of asthma or smoking. Her medical history was complicated by mild aortic coarctation and a cognitive delay. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) when she was pregnant. She sought treatment at the outpatient clinic at week 32 of gestation with a three day history of sore throat, congestion and fever. At her initial visit, she was afebrile with stable vital signs and was therefore discharged to her home with empiric oseltamivir. A throat culture specimen was positive for group A streptococcus and a nasopharyngeal aspirate was positive for RSV by viral Polymerase Chain Reaction (PCR). The patient was treated with penicillin 500 mg twice a day for 10 days for the group A streptococcus infection without any further complications. At 39 weeks of gestation, she underwent an uncomplicated primary cesarean delivery of a 2,855 grams female infant with Apgar scores of 9 at 1 and 5 minutes. The infant was admitted to the newborn nursery and was discharged home with the mother on postoperative day 4. Action taken with empiric oseltamivir and penicillin were not known. The events outcome was not reported. The events RSV infection and streptococcal Group A infection was upgraded as medically significant based on the information available in the source documents. The author concluded the article stating that RSV infection might pose a substantial risk for hospitalization and further complications in pregnant women and the infection was likely worsened in the setting of baseline pulmonary disease such as asthma and tobacco use. The author also stated that the cases presented demonstrated the wide spectrum of maternal disease and emphasized the potential for maternal benefit of an RSV vaccine administered during pregnancy.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract congestion, Streptococcus test positive
Clinical narrative: Mother case: Case number PHHY2015US146922 is an initial literature report received on 02 Nov 2015. The author described 3 cases of Respiratory Syncytial Virus (RSV) infection diagnosed at a center during winter 2014. This report refers to a 21 year old female patient who was pregnant (primigravida). She had no history of asthma or smoking. Her medical history was complicated by mild aortic coarctation and a cognitive delay. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) when she was pregnant. She sought treatment at the outpatient clinic at week 32 of gestation with a three day history of sore throat, congestion and fever. At her initial visit, she was afebrile with stable vital signs and was therefore discharged to her home with empiric oseltamivir. A throat culture specimen was positive for group A streptococcus and a nasopharyngeal aspirate was positive for RSV by viral Polymerase Chain Reaction (PCR). The patient was treated with penicillin 500 mg twice a day for 10 days for the group A streptococcus infection without any further complications. At 39 weeks of gestation, she underwent an uncomplicated primary cesarean delivery of a 2,855 grams female infant with Apgar scores of 9 at 1 and 5 minutes. The infant was admitted to the newborn nursery and was discharged home with the mother on postoperative day 4. Action taken with empiric oseltamivir and penicillin were not known. The events outcome was not reported. The events RSV infection and streptococcal Group A infection was upgraded as medically significant based on the information available in the source documents. The author concluded the article stating that RSV infection might pose a substantial risk for hospitalization and further complications in pregnant women and the infection was likely worsened in the setting of baseline pulmonary disease such as asthma and tobacco use. The author also stated that the cases presented demonstrated the wide spectrum of maternal disease and emphasized the potential for maternal benefit of an RSV vaccine administered during pregnancy.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Caesarean section, Culture throat positive, Exposure during pregnancy, Oropharyngeal pain, Pharyngitis streptococcal
Clinical narrative: Mother case: Case number PHHY2015US146922 is an initial literature report received on 02 Nov 2015. The author described 3 cases of Respiratory Syncytial Virus (RSV) infection diagnosed at a center during winter 2014. This report refers to a 21 year old female patient who was pregnant (primigravida). She had no history of asthma or smoking. Her medical history was complicated by mild aortic coarctation and a cognitive delay. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) when she was pregnant. She sought treatment at the outpatient clinic at week 32 of gestation with a three day history of sore throat, congestion and fever. At her initial visit, she was afebrile with stable vital signs and was therefore discharged to her home with empiric oseltamivir. A throat culture specimen was positive for group A streptococcus and a nasopharyngeal aspirate was positive for RSV by viral Polymerase Chain Reaction (PCR). The patient was treated with penicillin 500 mg twice a day for 10 days for the group A streptococcus infection without any further complications. At 39 weeks of gestation, she underwent an uncomplicated primary cesarean delivery of a 2,855 grams female infant with Apgar scores of 9 at 1 and 5 minutes. The infant was admitted to the newborn nursery and was discharged home with the mother on postoperative day 4. Action taken with empiric oseltamivir and penicillin were not known. The events outcome was not reported. The events RSV infection and streptococcal Group A infection was upgraded as medically significant based on the information available in the source documents. The author concluded the article stating that RSV infection might pose a substantial risk for hospitalization and further complications in pregnant women and the infection was likely worsened in the setting of baseline pulmonary disease such as asthma and tobacco use. The author also stated that the cases presented demonstrated the wide spectrum of maternal disease and emphasized the potential for maternal benefit of an RSV vaccine administered during pregnancy.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Polymerase chain reaction positive, Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract congestion
Clinical narrative: Mother case: Case number PHHY2015US146922 is an initial literature report received on 02 Nov 2015. The author described 3 cases of Respiratory Syncytial Virus (RSV) infection diagnosed at a center during winter 2014. This report refers to a 21 year old female patient who was pregnant (primigravida). She had no history of asthma or smoking. Her medical history was complicated by mild aortic coarctation and a cognitive delay. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) when she was pregnant. She sought treatment at the outpatient clinic at week 32 of gestation with a three day history of sore throat, congestion and fever. At her initial visit, she was afebrile with stable vital signs and was therefore discharged to her home with empiric oseltamivir. A throat culture specimen was positive for group A streptococcus and a nasopharyngeal aspirate was positive for RSV by viral Polymerase Chain Reaction (PCR). The patient was treated with penicillin 500 mg twice a day for 10 days for the group A streptococcus infection without any further complications. At 39 weeks of gestation, she underwent an uncomplicated primary cesarean delivery of a 2,855 grams female infant with Apgar scores of 9 at 1 and 5 minutes. The infant was admitted to the newborn nursery and was discharged home with the mother on postoperative day 4. Action taken with empiric oseltamivir and penicillin were not known. The events outcome was not reported. The events RSV infection and streptococcal Group A infection was upgraded as medically significant based on the information available in the source documents. The author concluded the article stating that RSV infection might pose a substantial risk for hospitalization and further complications in pregnant women and the infection was likely worsened in the setting of baseline pulmonary disease such as asthma and tobacco use. The author also stated that the cases presented demonstrated the wide spectrum of maternal disease and emphasized the potential for maternal benefit of an RSV vaccine administered during pregnancy.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Streptococcus test positive
Clinical narrative: Mother case: Case number PHHY2015US146922 is an initial literature report received on 02 Nov 2015. The author described 3 cases of Respiratory Syncytial Virus (RSV) infection diagnosed at a center during winter 2014. This report refers to a 21 year old female patient who was pregnant (primigravida). She had no history of asthma or smoking. Her medical history was complicated by mild aortic coarctation and a cognitive delay. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) when she was pregnant. She sought treatment at the outpatient clinic at week 32 of gestation with a three day history of sore throat, congestion and fever. At her initial visit, she was afebrile with stable vital signs and was therefore discharged to her home with empiric oseltamivir. A throat culture specimen was positive for group A streptococcus and a nasopharyngeal aspirate was positive for RSV by viral Polymerase Chain Reaction (PCR). The patient was treated with penicillin 500 mg twice a day for 10 days for the group A streptococcus infection without any further complications. At 39 weeks of gestation, she underwent an uncomplicated primary cesarean delivery of a 2,855 grams female infant with Apgar scores of 9 at 1 and 5 minutes. The infant was admitted to the newborn nursery and was discharged home with the mother on postoperative day 4. Action taken with empiric oseltamivir and penicillin were not known. The events outcome was not reported. The events RSV infection and streptococcal Group A infection was upgraded as medically significant based on the information available in the source documents. The author concluded the article stating that RSV infection might pose a substantial risk for hospitalization and further complications in pregnant women and the infection was likely worsened in the setting of baseline pulmonary disease such as asthma and tobacco use. The author also stated that the cases presented demonstrated the wide spectrum of maternal disease and emphasized the potential for maternal benefit of an RSV vaccine administered during pregnancy.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes virus infection, Pain, Pyrexia
Clinical narrative: Good evening. Was made application of the product ZOSTAVAX suspension for subcutaneous injection on August 24, 2015. On November 9, 2015 I developed herpes. I never had anything herpes. I have all affected skin photos. What is the offers to be taken? I am very concerned about the occurrence. I have a fever, pain in the region of injuries, general discomfort. Which provides that you guys will take? whom should I look for in my city.
Age: 37.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Myalgia, Pain, Pain in extremity, Sleep disorder
Clinical narrative: After few days initial soreness was not improving increased muscle pain in upper arm radiating into hand decreased ability to lift constant pain even when not moving pain while sleeping disrupting sleep or using shooting pain with fast movement down arm.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headache Nausea Dizziness.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt called the clinic noting his vaccine injection site was hot, red and tender on Nov 11. The symptoms continued even after trialing at home therapies such as Tylenol and ice. The pt presented in the clinic on Nov 13th and was seen and treated for cellulitis.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Rash around injection site.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site area redness, swelling, warmth, itching at site.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site paraesthesia, Injection site warmth, Pain, Paraesthesia, Rash
Clinical narrative: A rash about 5x2 appeared on arm at site of vaccine along with small bumps.  Two days later a rash appeared on arms, back.  This rash then kept spreading up my back and chest onto my neck.  Besides itching the rash tingles like pins and needles.  When the arm tingles so does the rash on my back, shoulders and neck.  The rash at the site of the vaccine left after about three days, but the site still tingles plus it radiates heart sometimes.  Doctor had me put on over the counter steroid cream once a day plus over the counter itch creams.  In a week since the creams weren't working she put me on a steroid pack, plus more over the counter steroid creams and itch creams.  A week later she put me on a 10mg steroid, seven days full strength, and then half strength for three days.  A month has now passed and the rash is still itching, stinging, and red; however it appears to not be spreading any more.  It is on my back, shoulders, chest around collar bone, and all around my neck.  My allergist on November 9, 2015 put me on Singulair, Allegra, and over the counter moisturizers.  Eight days have passed and the rash is no better, but st least it is no longer spreading.  I just want to know if there have been any other complaints of this happening to other people and are there any known cures.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Rash pruritic, Vaccination site rash
Clinical narrative: A rash about 5x2 appeared on arm at site of vaccine along with small bumps.  Two days later a rash appeared on arms, back.  This rash then kept spreading up my back and chest onto my neck.  Besides itching the rash tingles like pins and needles.  When the arm tingles so does the rash on my back, shoulders and neck.  The rash at the site of the vaccine left after about three days, but the site still tingles plus it radiates heart sometimes.  Doctor had me put on over the counter steroid cream once a day plus over the counter itch creams.  In a week since the creams weren't working she put me on a steroid pack, plus more over the counter steroid creams and itch creams.  A week later she put me on a 10mg steroid, seven days full strength, and then half strength for three days.  A month has now passed and the rash is still itching, stinging, and red; however it appears to not be spreading any more.  It is on my back, shoulders, chest around collar bone, and all around my neck.  My allergist on November 9, 2015 put me on Singulair, Allegra, and over the counter moisturizers.  Eight days have passed and the rash is no better, but st least it is no longer spreading.  I just want to know if there have been any other complaints of this happening to other people and are there any known cures.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever and vomiting.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Arm red from elbow to shoulder, very swollen, hot, couldn't move it. 102.5 fever, chills.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Arm red from elbow to shoulder, very swollen, hot, couldn't move it. 102.5 fever, chills.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Cellulitis, Chills, Erythema, Headache
Clinical narrative: Arm red from elbow to shoulder, very swollen, hot, couldn't move it. 102.5 fever, chills.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Inflammation, Influenza virus test, Injected limb mobility decreased, Malaise, Peripheral swelling
Clinical narrative: Arm red from elbow to shoulder, very swollen, hot, couldn't move it. 102.5 fever, chills.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Arm red from elbow to shoulder, very swollen, hot, couldn't move it. 102.5 fever, chills.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Heart rate increased
Clinical narrative: Rapid Heart Beat.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Ear pain, Eye irritation, Gait disturbance, Incision site erythema
Clinical narrative: 10/29 eyes burn, ears ache, neck stiff, shoulders ache. 10/30 above plus knees warm and achy, incisions hot, red and itch above and below elbows itchy (no rash) -> ache all over; hurt to move, difficult to walk, red spots on thighs: BENADRYL q 4 hours started, hydrocor. 2.5% knees continue sl. edematous. 10/31 knees less achy, redness, body achy, continue BENADRYL. Ankle (R) edema starting. 11/1 (R) ankle 2+ times size - diff to walk 11/2-3-4 less edema - not gone.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Incision site pruritus, Joint warmth, Musculoskeletal pain, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: 10/29 eyes burn, ears ache, neck stiff, shoulders ache. 10/30 above plus knees warm and achy, incisions hot, red and itch above and below elbows itchy (no rash) -> ache all over; hurt to move, difficult to walk, red spots on thighs: BENADRYL q 4 hours started, hydrocor. 2.5% knees continue sl. edematous. 10/31 knees less achy, redness, body achy, continue BENADRYL. Ankle (R) edema starting. 11/1 (R) ankle 2+ times size - diff to walk 11/2-3-4 less edema - not gone.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pruritus, Rash, Rash erythematous, Skin warm
Clinical narrative: 10/29 eyes burn, ears ache, neck stiff, shoulders ache. 10/30 above plus knees warm and achy, incisions hot, red and itch above and below elbows itchy (no rash) -> ache all over; hurt to move, difficult to walk, red spots on thighs: BENADRYL q 4 hours started, hydrocor. 2.5% knees continue sl. edematous. 10/31 knees less achy, redness, body achy, continue BENADRYL. Ankle (R) edema starting. 11/1 (R) ankle 2+ times size - diff to walk 11/2-3-4 less edema - not gone.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Local swelling, Rash, Skin discolouration, Swelling face
Clinical narrative: Swelling of jaw line and neck black and blue along jaw line, rash, swelling of lips and tongue.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: Swelling of jaw line and neck black and blue along jaw line, rash, swelling of lips and tongue.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Flushing
Clinical narrative: 11/06/15 Pt. called at about 1500 - said her face got flushed and hot, and she had some erythema of her neck and chest, but no trouble breathing or swallowing.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphonia, Fatigue, Headache, Nasopharyngitis
Clinical narrative: Itching, hoarseness, headache, cold symptoms, fatigue - felt like I was going to faint after shot. Saw stars.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Photopsia, Pruritus
Clinical narrative: Itching, hoarseness, headache, cold symptoms, fatigue - felt like I was going to faint after shot. Saw stars.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reports pain in arm starting 15 min after she arrived home. She had pain throughout her body the night of 11-2-15 and day of 11-3-15. Patient states on 11-4-15 site is feeling better. Did not have any rash, fever, swelling or SOB.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: Pt. receive vaccination on 10/28/15 came back next day, arm where vaccination was given is swollen, red, and inflamed. Pt. also said it's hot and a little painful. Recommended ice pack/BENADRYL after 5 days almost recovered.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Cellulitis of left arm. Tx with Rocephin IM and KEFLEX (po) pain, swelling, heat, streaking 4 in 24 h.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Heart rate increased, Nausea, Pain
Clinical narrative: Patient claimed she had nausea, vomiting, aches all over, very bad chills. She called 3rd shift pharmacist around midnight and informed him that she had gone to hospital for treatment.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient claimed she had nausea, vomiting, aches all over, very bad chills. She called 3rd shift pharmacist around midnight and informed him that she had gone to hospital for treatment.
Age: 0.8
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Urticaria
Clinical narrative: Hives, dizziness, BP 112/70-gave BENADRYL 50mg IM x 1
Age: 36.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Skin irritation, Tuberculin test, Urticaria
Clinical narrative: Skin irritation, hives.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: 101.2 fever, joint pain, could not turn head, HA.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: Lightheaded, dizziness/vertigo, fatigue.
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Pruritus generalised, Pyrexia, Throat irritation
Clinical narrative: Throat started itching about 20 mins after, then the roof of mouth to a full body itching feeling. Took BENADRYL itching went away to only return in the mouth. Fever of 101.5, and weakness feeling even after 24 hrs.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever, chills, headache, muscle aches.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose, Blood thyroid stimulating hormone, Chest discomfort, Electrocardiogram normal, Injection site hypoaesthesia
Clinical narrative: GARDASIL 9 given at 1:50 pm, blood drawn at 1:55. Patient complained to lab that arm where shot was given felt numb. 2:00 patient passed out in subwait area. Oxygen placed, nausea and vomited. Vitals stable, had some chest tightness. EKG done, results normal. Went home with mother.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Nausea, Vomiting
Clinical narrative: GARDASIL 9 given at 1:50 pm, blood drawn at 1:55. Patient complained to lab that arm where shot was given felt numb. 2:00 patient passed out in subwait area. Oxygen placed, nausea and vomited. Vitals stable, had some chest tightness. EKG done, results normal. Went home with mother.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pain in extremity
Clinical narrative: Patient states she is having pain from shoulder to elbow, across her back an inch below her waist, and down both thighs to her knees - this was reported on 11/7/15 - vaccine administered on 10/15/15.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Persistent headache.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Rash and itchy all over body. Seen at urgent care. Given steroid shot and prednisone 40 mg.
Sex: F
Vaccine: HPV9
Symptoms: Tonic clonic movements
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative refers to a three female patients of an unknown age. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patients were vaccinates with GARDASIL 9. On an unknown date the patient experienced tonic clonic movements was unknown. The reporter did not provide the relatedness of the event with GARDASIL 9. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: ZOSTAVAX immunization: Soreness, burning, redness, and swelling at the site of injection.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: (R) upper arm (entirely) swollen, not red, (+) tender sensitivity to touch, (+) fever.
Age: 1.79
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Erythema, Induration
Clinical narrative: Redness and induration.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Autonomic nervous system imbalance, Chronic fatigue syndrome, Colitis ulcerative, Colonoscopy abnormal, Dizziness
Clinical narrative: Dizziness, passing out, heart palpitations. No treatment, I was told this was normal for girls my age. Was never told it could be from the HPV vaccine.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Injection site mass, Loss of consciousness, Mass excision, Orthostatic hypotension, Palpitations
Clinical narrative: Dizziness, passing out, heart palpitations. No treatment, I was told this was normal for girls my age. Was never told it could be from the HPV vaccine.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Soft tissue sarcoma, Tilt table test positive
Clinical narrative: Dizziness, passing out, heart palpitations. No treatment, I was told this was normal for girls my age. Was never told it could be from the HPV vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, redness, swelling, approximately 4in in diameter at injection site.
Age: 39.0
Sex: M
Vaccine: FLUC3
Symptoms: Local swelling, Lymphadenopathy, Peripheral swelling, Swelling face
Clinical narrative: Right arm swelling. Facial and neck swelling. Lymph node swelling.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-AUG-2015, the patient received a dose of M-M-R II (lot#, expiration date, dose and route of administration were not reported) that was inadvertently reconstituted with improperly stored sterile diluent (dose one, lot# reported as L016272, expiration date 24-FEB-2018, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant/healthcare worker refers to a patient of unknown demographics. On 13-NOV-2015, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 (Lot#K007824 and expiry date: 05-NOV-2015). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On 05-NOV-2015, the patient was inadvertently vaccinated with an expired dose of VARIVAX (Merck) (Lot # J012380; expiration date 03-OCT-2015) (dose and route not provided). This was supported. No adverse effects were reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Received quadrivalent influenza vaccine mid-October 2015 in upper right arm. Started noticing itching and redness in stick area. Wheels/welts appeared, in addition to redness, on or about November 2, 2015.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site inflammation, Injection site swelling, Mobility decreased
Clinical narrative: Had PREVNAR Vaccine - adverse reaction, red and inflamed at injection site. Very swollen at the injection site. Pt felt fatigued. Was not able to move arm.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rash pruritic, Urticaria
Clinical narrative: Flu vaccine received at 10:30 am 11/4. By 5 pm she felt itchy "hive like" bumps on chin. Rash progressed to confluent areas on face and neck. By 11/9 itching and pain so severe, no relief with BENADRYL that she went to ED for IV steroids.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: PA from hospital called store and told Rph that pt admitted w/Guillain Barre to fill out VAERS. PA complied.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: Lightheaded, dizziness/vertigo, fatigue.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Went to doctor because rash appeared at the injection site from when he received his ZOSTAVAX injection on 11-9-15.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Periarthritis, Peripheral coldness
Clinical narrative: Patient has been in twice, complains about shoulder soreness, not able to move arm without pain. Also says it is cold in morning only left shoulder.
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Erythema, Urticaria, Wheezing
Clinical narrative: Hives, redness, trouble breathing, wheezing 30 minutes post vaccine treatment - personal inhaler, personal Epi pen x 1.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient reported large, dark bruise from injection site down to elbow. Bruise noticed Friday 11/6, roughtly. Got worse then today (11/9) gotten a little better.
Age: 0.28
Sex: F
Vaccine: RV5
Symptoms: Anorectal discomfort, Diarrhoea, Vomiting
Clinical narrative: Infant presented with diarrhea x 12 hours started 24 hours after ROTATEQ vaccination with irritation to anus and surrounding tissue, and vomiting bile x3 approx. 36 hours after vaccination.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Rash erythematous, Rash generalised
Clinical narrative: Rash - face, neck, trunk, buttocks, groin, hands, and feet. Red raised with some blistering between fingers and toes.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Symptoms woke patient in the night, day after receiving injection. Redness spans 9 cm by 7 cm and is warm to the touch. Swollen as well. Painful to move the arm. Treated for cellulitis with KEFLEX 500mg BID x 10 days.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: Severe shaking chills lasting 5 hours and sweats and low fever of 99.2F. Starting about 12 hours after the injection.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Was given flu shot, later that night was reddened, warm, and painful. Redness measured 3cm x 3cm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site pain, Injection site rash, Local reaction
Clinical narrative: Developed acute local reaction with rash approx 15x10 cm in area of injection site. Extremely uncomfortable and painful. This is from PREVNAR.
Age: 22.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Limb injury, Loss of consciousness
Clinical narrative: Patient went unconscious after receiving these vaccine, hit his hand twice and went to ER to be checked out.
Age: 59.0
Sex: F
Vaccine: FLUR3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: A female subject, received FLUBLOK Intramuscular on an unknown date at a pharmacy. The subject developed bumps and redness around the injection site for a time after the shot. The pharmacist did speak with the subject the next day and said upon looking at her arm, it looked good and the subject said she was fine. At the time of the report, the outcome for the events was complete recovery. Concomitant medications were not reported. The company's assessment of the causal relationship between bumps around the injection site FLUBLOK is a possible relationship and between redness around the injection site and FLUBLOK is a possible relationship. In summary, this case report does not change the known safety profile of FLUBLOK.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Localized pain at injection site without evidence of muscle atrophy. Possible SIRVA (R) deltoid.
Age: 81.0
Sex: F
Vaccine: FLUC3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Possible celluliltis of right arm. Patient came in Sunday am with large part of upper arm red and hot. MD was called and started dicloxacillin 250 4x/day for 1 week with follow up on Monday.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: At 1410 gave Tdap, MENVEO in RA, HPV9 LA arm, FLUMIST. 1415 noted hives (R) arm down to wrist. No breathing issues. Dr notified assessed BENADRYL given 5 ml 125mg po - hives better discharge 230.
Age: 79.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Very sore arm hurts when moved. Nurse gave both shots in right arm still very sore 7 weeks later.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Paraesthesia oral, Rash, Rash erythematous
Clinical narrative: Rash on legs- 1 wk no itching more like red spots headache 1 week - Took TYLENOL. Tingling around mouth.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Abdominal distension, Arthralgia, Catheterisation cardiac normal, Chest discomfort
Clinical narrative: On November 4, 2015 I had the ZOSTAVAX injection. On Fri. 11/06 and 11/07 I started having slight upset stomach with a fullness feeling. Then on Sunday 11/8 starting having a heaviness feeling to chest area. And by Monday 11/09 the heaviness of chest area was joined by joint pain in left shoulder and left elbow and area between the two was a heavy feeling then on to left hand being numb. Also early Monday morning had fever then chills. About noon on Monday had a bout of nausea. About 8 p.m. Monday night decided it was time of the ER. Was admitted to the Hospital on Tuesday morning 11/10. Had a heart catheterization, all by-pass grafts are still working great, no other blockage. So Wed. 11/11 a CT scan was done. All look the same as last CT scan done 4 or months before. So with that we determined that the problem was caused by the ZOSTAVAX shot.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Computerised tomogram normal, Nausea, Pyrexia
Clinical narrative: On November 4, 2015 I had the ZOSTAVAX injection. On Fri. 11/06 and 11/07 I started having slight upset stomach with a fullness feeling. Then on Sunday 11/8 starting having a heaviness feeling to chest area. And by Monday 11/09 the heaviness of chest area was joined by joint pain in left shoulder and left elbow and area between the two was a heavy feeling then on to left hand being numb. Also early Monday morning had fever then chills. About noon on Monday had a bout of nausea. About 8 p.m. Monday night decided it was time of the ER. Was admitted to the Hospital on Tuesday morning 11/10. Had a heart catheterization, all by-pass grafts are still working great, no other blockage. So Wed. 11/11 a CT scan was done. All look the same as last CT scan done 4 or months before. So with that we determined that the problem was caused by the ZOSTAVAX shot.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain
Clinical narrative: On November 4, 2015 I had the ZOSTAVAX injection. On Fri. 11/06 and 11/07 I started having slight upset stomach with a fullness feeling. Then on Sunday 11/8 starting having a heaviness feeling to chest area. And by Monday 11/09 the heaviness of chest area was joined by joint pain in left shoulder and left elbow and area between the two was a heavy feeling then on to left hand being numb. Also early Monday morning had fever then chills. About noon on Monday had a bout of nausea. About 8 p.m. Monday night decided it was time of the ER. Was admitted to the Hospital on Tuesday morning 11/10. Had a heart catheterization, all by-pass grafts are still working great, no other blockage. So Wed. 11/11 a CT scan was done. All look the same as last CT scan done 4 or months before. So with that we determined that the problem was caused by the ZOSTAVAX shot.
Age: 76.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Very sore arm hurts when moved. Nurse gave both shots in left arm still hurts 7 weeks later.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
Clinical narrative: Left arm with 6cm by 8 cm area of erythema without fluctuance noted. Area is tender and warm to touch, location of vaccine is 2cm above area of redness. No lymphadenopathy noted. Dx: cellulitis tx = BACTRIM DS 1 tab BID x 10d.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: On 11/8/15 spoke with client. Stated left arm (upper) became reddened around shot site. Left upper arm very sore. States redness and soreness resolved on its own within 3 days. Did not see practitioner. Received influenza vaccination 10/20/15.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Contusion, Erythema, Pruritus
Clinical narrative: 1 week (7 days) after receiving vaccine developed 3" x 2" localized redness/erythema and itching. Has had 5/8" wide bruise since the day after the injection.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Migraine, Neck pain, Vertigo, Vision blurred
Clinical narrative: Migraine headaches for 2 weeks without any relief. Have taken ibuprofen, aspirin. Even tried SUDAFED and nasal spray simply saline. No relief. Headache 7/10-> 8/10. Neck pain (R) side. Shot taken on 10/26. on Wednesday 11/4 vertigo started and has continued. Blurred vision on 10/27 and comes and goes. Father had Meniere disease.
Age: 31.0
Sex: F
Vaccine: FLUR3
Symptoms: Anaphylactic reaction, Dyspnoea, Feeling hot, Flushing, Pruritus
Clinical narrative: This is an initial report of a serious adverse event, received on 04Nov2015, for Protein Sciences FLUBLOK. Subject, a 31 year old female received FLUBLOK intramuscular on 03Nov2015. On 03Nov2015, the same day as receiving FLUBLOK at a clinic, (lot # 550653F, expiration date: 14Jan2016), the subject experienced breathing difficulties-anaphylaxis after the administration of the vaccine. The subject received an EPIPEN dose at the clinic and was sent to the emergency room (ER). Per the reporter, the subject was sent home from the ER after 3 1/2 hours and was doing better with some itching and feeling warm all over. On 06Nov2015 additional information received reported that the subject received EPIPEN at the clinic and in the ER. In the ER patient also received intravenous (IV) BENADRYL 50 mg, IV ranitidine 50 mg and IV SOLUMEDROL 125 mg. The subject was sent home with a prescription for EPIEPENS and oral BENADRYL as needed. On 05Nov2015, the subject went back to the clinic and had treatment for continued sensation of itching and being warm and flushed. She received IV BENADRYL 50 mg and IV ranitidine 50 mg and prednisone in a tapering dose. No additional AE information provided by reporter. The events were considered serious due to the subject's report of an emergency room visit. The outcome of the event of breathing difficulties-anaphylaxis was resolved. The outcome for the event of itching and warm all over was not resolved. Laboratory and/or other relevant test results were not reported. Concomitant medications were not reported.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient experienced neck pain following flu shot on the next day. Arms and legs began hurting and has continued for 2 weeks. No fever.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, Injected limb mobility decreased, Neck pain, Pain in extremity, Sleep disorder
Clinical narrative: After injection 9-9-15, arm continually got increasingly sore until 10-12-15 I couldn't move my right arm without nerve/shock pains shooting down my arm and back of neck. Lost several hours of sleep each night. Physical therapy, electrodes, ultrasound, heat, cold still being treated biceps-tendonitis - shot went in tendon instead of muscle.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Tendonitis
Clinical narrative: After injection 9-9-15, arm continually got increasingly sore until 10-12-15 I couldn't move my right arm without nerve/shock pains shooting down my arm and back of neck. Lost several hours of sleep each night. Physical therapy, electrodes, ultrasound, heat, cold still being treated biceps-tendonitis - shot went in tendon instead of muscle.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Vaccination site pain
Clinical narrative: Left upper arm pain at vaccine site 15" after, increased, radiated to upper back for 2 weeks - improving.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Headache, muscle ache, nausea.
Sex: U
Vaccine: VARZOS
Symptoms: Chemotherapy, Neoplasm malignant
Clinical narrative: This spontaneous report was received from a healthcare student referring to a patient of unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date in November 2014, reported as "one year ago", the patient was vaccinated with ZOSTAVAX, (dose, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, in 2015, reported as "recently", the patient developed unspecified cancer and received unspecified chemotherapy. At the time of reporting, the outcome of cancer was unknown. The reporter did not assess the relatedness between cancer and ZOSTAVAX. Upon internal review, the event of unspecified cancer was considered serious as other important medical event. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram abnormal, Hypersensitivity, Local swelling, Neck mass, Peripheral swelling
Clinical narrative: Swelling of neck - CAT scan revealed mass - please contact patient's PCP with any questions. Still experiencing swelling in arm and neck - probable allergic reaction.
Age: 79.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Decreased appetite, Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: Starting a few hours after pneumonia shot pt started having significant pain and swelling of entire (R) arm. Pt was unable to move arm and entire underside of arm filled with fluid such that skin was distended approx. 1 inch beyond normal. Pt also had fever, loss of appetite x 1 wk. As swelling subsided, pt's entire arm began itching. Pain unrelieved by pain reliever (unknown med name/dose).