chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 21-JUL-2016 (reported as today), the patient was vaccinated with and expired dose of ZOSTAVAX (lot # L011529, expiration date: 03-JUL-2016, 0.65 ml, subcutaneous) (expired product administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL 9 (lot # L043213, expiry date 28-AUG-2017) that was improperly stored. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of VARIVAX (lot # L048467, expiry date 17-FEB-2017) that were improperly stored. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Immediate post-injection reaction, Pain, Rash, Skin warm
Clinical narrative: Immediate onset-severe pain when touched. Approximately 24 hr. post vaccine-rash over 25% of upper arm, warm to the touch, erythema.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: Sore arm, hurting all over, swelling.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Electromyogram, Imaging procedure, Injection site pain
Clinical narrative: Initial unsolicited report received from other company (Pfizer) via consumer (Manufacturer Report Number: 2016318227) on 13 July 2016. This case involves a 75-year-old male patient who received a 0.5 ml injection of TDAP (batch number, expiry date, route of administration was not reported) in deltoid and 0.5ml injection of PREVENAR 13 (batch number, expiry date, route of administration was not reported) in deltoid on 02 September 2015 at 10:33 A.M. Patient had medical history of diabetes. At the time of report the patient had metformin 500 mg twice a day for diabetes as concomitant medication. On 02 September 2015, same day following the vaccination, the patient had experienced that could not sleep on left arm, having a lot of pain and no attention, pain was migrating up through his left side of neck up into his head, feeling a slight discomfort and experiencing some growth going out of his chest 4 days afterwards. It was also reported that patient was sent to tetanus shot by podiatrist because patient had hurt big toe. It was reported that patient had pain through whole body when injected with Prevnar 13. Lab data and corrective treatment were not reported. Outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Blood test, Discomfort, Headache, Injection site pain, Mass
Clinical narrative: Initial unsolicited report received from other company (Pfizer) via consumer (Manufacturer Report Number: 2016318227) on 13 July 2016. This case involves a 75-year-old male patient who received a 0.5 ml injection of TDAP (batch number, expiry date, route of administration was not reported) in deltoid and 0.5ml injection of PREVENAR 13 (batch number, expiry date, route of administration was not reported) in deltoid on 02 September 2015 at 10:33 A.M. Patient had medical history of diabetes. At the time of report the patient had metformin 500 mg twice a day for diabetes as concomitant medication. On 02 September 2015, same day following the vaccination, the patient had experienced that could not sleep on left arm, having a lot of pain and no attention, pain was migrating up through his left side of neck up into his head, feeling a slight discomfort and experiencing some growth going out of his chest 4 days afterwards. It was also reported that patient was sent to tetanus shot by podiatrist because patient had hurt big toe. It was reported that patient had pain through whole body when injected with Prevnar 13. Lab data and corrective treatment were not reported. Outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Monoplegia, Neck pain, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from other company (Pfizer) via consumer (Manufacturer Report Number: 2016318227) on 13 July 2016. This case involves a 75-year-old male patient who received a 0.5 ml injection of TDAP (batch number, expiry date, route of administration was not reported) in deltoid and 0.5ml injection of PREVENAR 13 (batch number, expiry date, route of administration was not reported) in deltoid on 02 September 2015 at 10:33 A.M. Patient had medical history of diabetes. At the time of report the patient had metformin 500 mg twice a day for diabetes as concomitant medication. On 02 September 2015, same day following the vaccination, the patient had experienced that could not sleep on left arm, having a lot of pain and no attention, pain was migrating up through his left side of neck up into his head, feeling a slight discomfort and experiencing some growth going out of his chest 4 days afterwards. It was also reported that patient was sent to tetanus shot by podiatrist because patient had hurt big toe. It was reported that patient had pain through whole body when injected with Prevnar 13. Lab data and corrective treatment were not reported. Outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Sleep disorder, X-ray
Clinical narrative: Initial unsolicited report received from other company (Pfizer) via consumer (Manufacturer Report Number: 2016318227) on 13 July 2016. This case involves a 75-year-old male patient who received a 0.5 ml injection of TDAP (batch number, expiry date, route of administration was not reported) in deltoid and 0.5ml injection of PREVENAR 13 (batch number, expiry date, route of administration was not reported) in deltoid on 02 September 2015 at 10:33 A.M. Patient had medical history of diabetes. At the time of report the patient had metformin 500 mg twice a day for diabetes as concomitant medication. On 02 September 2015, same day following the vaccination, the patient had experienced that could not sleep on left arm, having a lot of pain and no attention, pain was migrating up through his left side of neck up into his head, feeling a slight discomfort and experiencing some growth going out of his chest 4 days afterwards. It was also reported that patient was sent to tetanus shot by podiatrist because patient had hurt big toe. It was reported that patient had pain through whole body when injected with Prevnar 13. Lab data and corrective treatment were not reported. Outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Discomfort, Headache, Neck pain, Neoplasm skin, Pain
Clinical narrative: Initial unsolicited report received from other company (Pfizer) via consumer (Manufacturer Report Number: 2016318227) on 13 July 2016. This case involves a 75-year-old male patient who received a 0.5 ml injection of TDAP (batch number, expiry date, route of administration was not reported) in deltoid and 0.5ml injection of PREVENAR 13 (batch number, expiry date, route of administration was not reported) in deltoid on 02 September 2015 at 10:33 A.M. Patient had medical history of diabetes. At the time of report the patient had metformin 500 mg twice a day for diabetes as concomitant medication. On 02 September 2015, same day following the vaccination, the patient had experienced that could not sleep on left arm, having a lot of pain and no attention, pain was migrating up through his left side of neck up into his head, feeling a slight discomfort and experiencing some growth going out of his chest 4 days afterwards. It was also reported that patient was sent to tetanus shot by podiatrist because patient had hurt big toe. It was reported that patient had pain through whole body when injected with Prevnar 13. Lab data and corrective treatment were not reported. Outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP, PNC13, TDAP, PNC13, TDAP
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Initial unsolicited report received from other company (Pfizer) via consumer (Manufacturer Report Number: 2016318227) on 13 July 2016. This case involves a 75-year-old male patient who received a 0.5 ml injection of TDAP (batch number, expiry date, route of administration was not reported) in deltoid and 0.5ml injection of PREVENAR 13 (batch number, expiry date, route of administration was not reported) in deltoid on 02 September 2015 at 10:33 A.M. Patient had medical history of diabetes. At the time of report the patient had metformin 500 mg twice a day for diabetes as concomitant medication. On 02 September 2015, same day following the vaccination, the patient had experienced that could not sleep on left arm, having a lot of pain and no attention, pain was migrating up through his left side of neck up into his head, feeling a slight discomfort and experiencing some growth going out of his chest 4 days afterwards. It was also reported that patient was sent to tetanus shot by podiatrist because patient had hurt big toe. It was reported that patient had pain through whole body when injected with Prevnar 13. Lab data and corrective treatment were not reported. Outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Eyelid pain, Herpes zoster, Ocular hyperaemia, Pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX at a dose of 0.65 ml, once subcutaneously (injection site, lot# and expiration date were not provided). On an unspecified date, following the administration of ZOSTAVAX, the patient developed a "mild rash" on his face. The patient sought medical attention in the pharmacy. At the time of reporting, the outcome of mild rash was unknown. The causality assessment between the event and ZOSTAVAX was not reported. Follow up information was received from the reporting pharmacist on 01-JUN-2016. The 64 year-old patient did not have known drug allergies, no pertinent medical history and no concomitant medications. On 05-MAY-2016, the patient was vaccinated in the left arm with ZOSTAVAX (lot # L039126, expiration date: of 08-JAN-2017). In the evening of 08-MAY-2016, the patient noticed a mild rash on the right side of his face. The mild rash first developed on the patient's right temple and spread to his right forehead above his right eyebrow and "close to his right eyelid". On 16-MAY-2016, the patient visited his primary care physician, who referred him to an ophthalmologist, who discovered a large amount of "debris" in the patient's eye and diagnosed the patient with shingles. No laboratory diagnostic studies were performed. The patient was treated with acyclovir tablets, 800 mg, 5 times daily for 10 days and prednisolone 1% ophthalmic drops (1 drop to right eye twice a day). At the time of the report (reported as presently), most of the lesions had cleared up and the patient was recovering. The patient did not have pain, but he had general sensitivity in the affected area. There was no impairment of vision. Follow up information was received from the reporting pharmacist on 21-JUL-2016. The currently 65 year-old patient did not have a prior history of Herpes Zoster (HZ) and there was no recent exposure to chickenpox or HZ. The first dose of ZOSTAVAX was administered at 01:00 post meridiem (PM) on 05-MAY-2016 and it was purchased with a private funds. The patient required a doctor visit. The patient recovered, on an unknown date in approximately 2016. The event of shingles was considered as medically significant, as the patient required medical intervention. Additional information have been requested. Reporter's and patient's demographics, product information, event outcome and seriousness and narrative were updated.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular, Secretion discharge, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX at a dose of 0.65 ml, once subcutaneously (injection site, lot# and expiration date were not provided). On an unspecified date, following the administration of ZOSTAVAX, the patient developed a "mild rash" on his face. The patient sought medical attention in the pharmacy. At the time of reporting, the outcome of mild rash was unknown. The causality assessment between the event and ZOSTAVAX was not reported. Follow up information was received from the reporting pharmacist on 01-JUN-2016. The 64 year-old patient did not have known drug allergies, no pertinent medical history and no concomitant medications. On 05-MAY-2016, the patient was vaccinated in the left arm with ZOSTAVAX (lot # L039126, expiration date: of 08-JAN-2017). In the evening of 08-MAY-2016, the patient noticed a mild rash on the right side of his face. The mild rash first developed on the patient's right temple and spread to his right forehead above his right eyebrow and "close to his right eyelid". On 16-MAY-2016, the patient visited his primary care physician, who referred him to an ophthalmologist, who discovered a large amount of "debris" in the patient's eye and diagnosed the patient with shingles. No laboratory diagnostic studies were performed. The patient was treated with acyclovir tablets, 800 mg, 5 times daily for 10 days and prednisolone 1% ophthalmic drops (1 drop to right eye twice a day). At the time of the report (reported as presently), most of the lesions had cleared up and the patient was recovering. The patient did not have pain, but he had general sensitivity in the affected area. There was no impairment of vision. Follow up information was received from the reporting pharmacist on 21-JUL-2016. The currently 65 year-old patient did not have a prior history of Herpes Zoster (HZ) and there was no recent exposure to chickenpox or HZ. The first dose of ZOSTAVAX was administered at 01:00 post meridiem (PM) on 05-MAY-2016 and it was purchased with a private funds. The patient required a doctor visit. The patient recovered, on an unknown date in approximately 2016. The event of shingles was considered as medically significant, as the patient required medical intervention. Additional information have been requested. Reporter's and patient's demographics, product information, event outcome and seriousness and narrative were updated.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Ophthalmic herpes zoster, Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX at a dose of 0.65 ml, once subcutaneously (injection site, lot# and expiration date were not provided). On an unspecified date, following the administration of ZOSTAVAX, the patient developed a "mild rash" on his face. The patient sought medical attention in the pharmacy. At the time of reporting, the outcome of mild rash was unknown. The causality assessment between the event and ZOSTAVAX was not reported. Follow up information was received from the reporting pharmacist on 01-JUN-2016. The 64 year-old patient did not have known drug allergies, no pertinent medical history and no concomitant medications. On 05-MAY-2016, the patient was vaccinated in the left arm with ZOSTAVAX (lot # L039126, expiration date: of 08-JAN-2017). In the evening of 08-MAY-2016, the patient noticed a mild rash on the right side of his face. The mild rash first developed on the patient's right temple and spread to his right forehead above his right eyebrow and "close to his right eyelid". On 16-MAY-2016, the patient visited his primary care physician, who referred him to an ophthalmologist, who discovered a large amount of "debris" in the patient's eye and diagnosed the patient with shingles. No laboratory diagnostic studies were performed. The patient was treated with acyclovir tablets, 800 mg, 5 times daily for 10 days and prednisolone 1% ophthalmic drops (1 drop to right eye twice a day). At the time of the report (reported as presently), most of the lesions had cleared up and the patient was recovering. The patient did not have pain, but he had general sensitivity in the affected area. There was no impairment of vision. Follow up information was received from the reporting pharmacist on 21-JUL-2016. The currently 65 year-old patient did not have a prior history of Herpes Zoster (HZ) and there was no recent exposure to chickenpox or HZ. The first dose of ZOSTAVAX was administered at 01:00 post meridiem (PM) on 05-MAY-2016 and it was purchased with a private funds. The patient required a doctor visit. The patient recovered, on an unknown date in approximately 2016. The event of shingles was considered as medically significant, as the patient required medical intervention. Additional information have been requested. Reporter's and patient's demographics, product information, event outcome and seriousness and narrative were updated.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vitreous floaters
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX at a dose of 0.65 ml, once subcutaneously (injection site, lot# and expiration date were not provided). On an unspecified date, following the administration of ZOSTAVAX, the patient developed a "mild rash" on his face. The patient sought medical attention in the pharmacy. At the time of reporting, the outcome of mild rash was unknown. The causality assessment between the event and ZOSTAVAX was not reported. Follow up information was received from the reporting pharmacist on 01-JUN-2016. The 64 year-old patient did not have known drug allergies, no pertinent medical history and no concomitant medications. On 05-MAY-2016, the patient was vaccinated in the left arm with ZOSTAVAX (lot # L039126, expiration date: of 08-JAN-2017). In the evening of 08-MAY-2016, the patient noticed a mild rash on the right side of his face. The mild rash first developed on the patient's right temple and spread to his right forehead above his right eyebrow and "close to his right eyelid". On 16-MAY-2016, the patient visited his primary care physician, who referred him to an ophthalmologist, who discovered a large amount of "debris" in the patient's eye and diagnosed the patient with shingles. No laboratory diagnostic studies were performed. The patient was treated with acyclovir tablets, 800 mg, 5 times daily for 10 days and prednisolone 1% ophthalmic drops (1 drop to right eye twice a day). At the time of the report (reported as presently), most of the lesions had cleared up and the patient was recovering. The patient did not have pain, but he had general sensitivity in the affected area. There was no impairment of vision. Follow up information was received from the reporting pharmacist on 21-JUL-2016. The currently 65 year-old patient did not have a prior history of Herpes Zoster (HZ) and there was no recent exposure to chickenpox or HZ. The first dose of ZOSTAVAX was administered at 01:00 post meridiem (PM) on 05-MAY-2016 and it was purchased with a private funds. The patient required a doctor visit. The patient recovered, on an unknown date in approximately 2016. The event of shingles was considered as medically significant, as the patient required medical intervention. Additional information have been requested. Reporter's and patient's demographics, product information, event outcome and seriousness and narrative were updated.
Age: 20.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner and  refers to a 20 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. The patient became pregnant with estimated  last menstrual period (LMP) of 11-APR-2016 and estimated date of delivery (EDD) of 16-JAN-2017. It was reported that on 18-JUL-2016, the pregnant patient was vaccinated with VARIVAX lot # L004653, expiration date: 11-FEB-2017, 0.5 ml. The nurse practitioner reported that VARIVAX  was administered intramuscularly. Initial exposure to VARIVAX was at 14 weeks. There was no adverse effects reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner and  refers to a 20 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. The patient became pregnant with estimated  last menstrual period (LMP) of 11-APR-2016 and estimated date of delivery (EDD) of 16-JAN-2017. It was reported that on 18-JUL-2016, the pregnant patient was vaccinated with VARIVAX lot # L004653, expiration date: 11-FEB-2017, 0.5 ml. The nurse practitioner reported that VARIVAX  was administered intramuscularly. Initial exposure to VARIVAX was at 14 weeks. There was no adverse effects reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Blister, Cough, Pruritus, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, cough and drainage, began to break out in blisters, itching.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Dizziness postural, Nausea, Pain, Paraesthesia
Clinical narrative: Tingling in extremities, slight nausea, dizziness upon standing. Symptoms progressed to mid-grade fever, aches and joint pain, vomiting.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: Tingling in extremities, slight nausea, dizziness upon standing. Symptoms progressed to mid-grade fever, aches and joint pain, vomiting.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV9, MNQ, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Child in for immunizations. Nurse inadvertently drew up and administered Dtap instead of Tdap. No adverse events or problems noted with patient.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Musculoskeletal stiffness, Obstructive airways disorder, Pharyngeal oedema
Clinical narrative: Got shot on Tuesday, Friday develop reaction neck stiffness, airway closing, throat swelling, could not swallow saliva. Was seen Saturday (ER visit) sent home. Hospitalized x 1 day (Monday).
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Streptococcus test negative, Throat tightness
Clinical narrative: Started with sore throat, felt like throat was closing. Started getting feverish feeling and body aches.
Sex: U
Vaccine: PNC13
Symptoms: Pain, Pulmonary oedema
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The patient experienced lung swelling and pain on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 0.42
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RVX
Symptoms: Reaction to preservatives
Clinical narrative: This is a spontaneous report from a contactable nurse. A 1-year-old female patient received PREVNAR 13 at 0.5 ml single, polio vaccine (unknown manufacturer), hepatitis B vaccine (unknown manufacturer), rotavirus vaccine (unknown manufacturer), DTP (unknown manufacturer), Hib (unknown manufacturer) all administered in Jan2016. Relevant medical history and concomitant medications were not reported. The patient had no drug allergies. The patient reacted badly to a vaccine series of medications in Jan2016 and as result she was hospitalized. The nurse reported that the patient may have been hospitalized numerous times after this occurrence but she was unaware of exactly when. The patient was recovering from the event. The nurse reported that they could not determine which medication the patient reacted badly to however when she was at the hospital they were able to determine that she reacted specifically to the preservatives in multi-dose vials. They will now look for vaccines that are preservative free in the single dose vials.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Febrile convulsion, Pyrexia
Clinical narrative: Fever leading to febrile sz x2 and cellulitis of arm.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Patient described symptoms as being the injection site arm was in extreme pain, had bright red spot at the injection site, and fever/chills in the evening. Patient took VICODIN to help sleep due to the extreme pain. Did not complain of any difficulties breathing and red spot did not increase since the time of administration until the morning of 7/24/16 where patient came back to pharmacy to ask for more recommendations.
Age: 60.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site pain, Joint stiffness
Clinical narrative: Pain in right shoulder, stiffness in bilateral knees and wrists.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm red, swollen and painful down to elbow.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Pt was given an expired vaccine. Vaccine expired on 07/14/2016.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Gait disturbance, Nausea, Pallor, Vomiting
Clinical narrative: Pt exhibited pale skin, with uneasy gait. Pt sat down in chair. Pt complained of nausea and light headedness. Pt requested water. Approximately 4min after receiving vaccines, proceeded to vomit. 30 min after vaccination, pt stated he was feeling 'good'.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Headache began 12 hours after vaccination. Woke up the next morning with fever that continued to increase throughout the day up to 103, nausea, diarrhea, muscle aches, malaise that continued through the evening.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Headache began 12 hours after vaccination. Woke up the next morning with fever that continued to increase throughout the day up to 103, nausea, diarrhea, muscle aches, malaise that continued through the evening.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Left shoulder pain radiating to elbow, anti-inflammatories prescribed.
Age: 0.19
Sex: F
Vaccine: HBHEPB, PPV
Symptoms: Injection site mass, Injection site swelling, Lethargy, Pyrexia, Somnolence
Clinical narrative: Lethargic, unable to stay awake, swollen lump at shot sites on thighs, feverish.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: She developed a rash around injection site. Area is flat and red. It was limited to within 2 inches around the injection site.  The entire area appeared swollen.  Then, she went to the doctor on Friday, 7/22/16.  The doctor prescribed doxycycline for the rash. When she came to the pharmacy Friday, the reaction had not worsened or improved.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: She developed a rash around injection site. Area is flat and red. It was limited to within 2 inches around the injection site.  The entire area appeared swollen.  Then, she went to the doctor on Friday, 7/22/16.  The doctor prescribed doxycycline for the rash. When she came to the pharmacy Friday, the reaction had not worsened or improved.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: Administered 2 vaccines. Patient became hot, nauseous and lightheaded.
Age: 75.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, Intentional product misuse, Wound
Clinical narrative: A report has been received from a pharmacist via Pfizer concerning a female patient. The patient's medical history included venous insufficiency, falls and psoriasis. The patient's concurrent diseases included penicillin allergy and sulfa allergy. Concomitant medications included carvedilol, fexofenadine hydrochloride, simvastatin, torsemide, warfarin sodium, prednisone for rheumatoid arthritis and unspecified. On an unknown date the patient started receiving nasal FLUMIST (intranasal) with unknown dose for unknown indication and oral XELJANZ lot: 36117, 10 mg, daily (5 mg, two times) for rheumatoid arthritis, started on 15-Jan-2016. The patient experienced wound/chronic wound (preferred term:wound) and she was administered thousands of dose of FLUMIST - misuse (preferred term:intentional product misuse). The action taken of FLUMIST was unknown. Tofacitinib was continued. At the time of reporting, the event of wound/chronic wound was improving and the outcome of the event of administered thousands of dose of FLUMIST - misuse was unknown. The event of administered thousands of dose of FLUMIST - misuse was considered as serious with the serious criteria of important medical event by company physician. The event of wound/chronic wound was considered as non-serious by company physician. Sender's Comments: The report concerns a 75 years old female patient who experienced intentional product misuse while on FLUMIST. It was reported that the patient administered thousands of doses of FLUMIST. There is missing information on the indication and dosing of the suspect drug, concurrent diseases, circumstances and results of the event.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Microscopic polyangiitis
Clinical narrative: Microscopic polyangiitis.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of passed out in a 18-year-old female patient who received BEXSERO (batch number 154101A, expiry date 31st May 2017). On 20th July 2016, the patient received BEXSERO .5 ml. On 20th July 2016, less than a day after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was recovering/resolving. It was unknown if the reporter considered the passed out to be related to BEXSERO. Additional details were received as follows: The patients received a dose of BEXSERO in their left arm. The reporter stated that, the patient passed out after the vaccination. No other information was provided. This case has been linked with case US2016GSK106551, reported by the same reporter.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Alopecia, Colonoscopy normal, Dermatologic examination normal, Diarrhoea, Gastroenteritis viral
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hair loss in a 20-year-old female patient who received BEXSERO (batch number W149001A, expiry date 30th September 2016). On 12th April 2016, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced hair loss (serious criteria other: As per reporter), injection site erythema, injection site pain, stomach virus, diarrhea and nausea. On an unknown date, the outcome of the hair loss, injection site erythema and injection site pain were recovering/resolving and the outcome of the stomach virus, diarrhea and nausea were unknown. It was unknown if the reporter considered the hair loss, injection site erythema, injection site pain, stomach virus, diarrhea and nausea to be related to BEXSERO. Additional details were received as follows: The reporter stated that, the patient experienced hair loss, stomach virus-like symptoms, diarrhea, nausea and localized redness and pain at injection site. The patient was taken to the emergency room. No other vaccines were administered with BEXSERO. The dermatology testing was done for hair loss and colonoscopy was performed, which showed no abnormal findings. No further information was reported regarding the event.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hair loss in a 20-year-old female patient who received BEXSERO (batch number W149001A, expiry date 30th September 2016). On 12th April 2016, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced hair loss (serious criteria other: As per reporter), injection site erythema, injection site pain, stomach virus, diarrhea and nausea. On an unknown date, the outcome of the hair loss, injection site erythema and injection site pain were recovering/resolving and the outcome of the stomach virus, diarrhea and nausea were unknown. It was unknown if the reporter considered the hair loss, injection site erythema, injection site pain, stomach virus, diarrhea and nausea to be related to BEXSERO. Additional details were received as follows: The reporter stated that, the patient experienced hair loss, stomach virus-like symptoms, diarrhea, nausea and localized redness and pain at injection site. The patient was taken to the emergency room. No other vaccines were administered with BEXSERO. The dermatology testing was done for hair loss and colonoscopy was performed, which showed no abnormal findings. No further information was reported regarding the event.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Headache, Nausea, Vomiting
Clinical narrative: Significant headache, abdominal pain, nausea, vomiting x 3.
Age: 48.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Electrocardiogram normal, Electroencephalogram normal, Neurological symptom, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Recurring spells oflightheadedness to the point of presyncope; tingling sensation in hands. Sx occurring several times per day. Cardiac testing done - normal. Referred to neurol - MRI did not show demyelination, but neurologist thought this was a neurologic response to yellow fever vaccine.
Age: 48.0
Sex: F
Vaccine: YF
Symptoms: Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Presyncope
Clinical narrative: Recurring spells oflightheadedness to the point of presyncope; tingling sensation in hands. Sx occurring several times per day. Cardiac testing done - normal. Referred to neurol - MRI did not show demyelination, but neurologist thought this was a neurologic response to yellow fever vaccine.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness at injection site.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash
Clinical narrative: Reaction started the next morning, rash and arm swelled. Pt went to ER on Wed 6/22/16.
Age: 31.0
Sex: F
Vaccine: YF
Symptoms: Body temperature increased, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Temperature to 101 degrees, severe headache, myalgias, nausea and vomiting. Sx resolved with TYLENOL 48 hr after onset.
Age: 6.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Loss of consciousness
Clinical narrative: I gave an HPV vaccine, within one minute, her body jerked and she passed out, I layed her down. Within 30 seconds, she was awake.
Age: 65.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient bitten by unvaccinated cat on 6/22/16. Received rabies immune globulin + vaccine series 6/27, 6/30, 7/4 and 7/11. Patient received final vaccine in series on 7/11. Presented to ED approx. 5 hrs later with rash & itching at injection site. No acute symptoms causing distress. Prescribed prednisone 30mg x 2 days, 20mg x 3 days, then 10mg daily x 3 days. Also prescribed famotidine 20mg po BID x 5 days. Patient followed up with PCP on 7/14/16. Reported improvements in rash & itching. Pt requested DC of prednisone which was okay'd by PCP with instructions to restart if symptoms returned.
Age: 65.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Biopsy skin, Laboratory test, Urticaria
Clinical narrative: Patient bitten by unvaccinated cat on 6/22/16. Received rabies immune globulin + vaccine series 6/27, 6/30, 7/4 and 7/11. Patient received final vaccine in series on 7/11. Presented to ED approx. 5 hrs later with rash & itching at injection site. No acute symptoms causing distress. Prescribed prednisone 30mg x 2 days, 20mg x 3 days, then 10mg daily x 3 days. Also prescribed famotidine 20mg po BID x 5 days. Patient followed up with PCP on 7/14/16. Reported improvements in rash & itching. Pt requested DC of prednisone which was okay'd by PCP with instructions to restart if symptoms returned.
Age: 48.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Vaccination site haemorrhage
Clinical narrative: Left shoulder pain, along with shoulder stiffness; progressed throughout the day. Suspect bleed at site of vaccination. Treated with factor infusion of RECOMBINATE 1480 IU vials x2 given IV push x1.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: Pt finished receiving vaccines. Pt had a vasovagal response.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling and redness on the arm.
Age: 1.02
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Diet refusal, Irritability, Pyrexia, Screaming
Clinical narrative: Vomiting, high fever 102.5, screaming, extremely sleepy, diarrhea, refusing to eat or drink. Extreme fussiness and irritability.
Age: 1.02
Sex: M
Vaccine: HEP
Symptoms: Somnolence, Stomach scan, Vomiting
Clinical narrative: Vomiting, high fever 102.5, screaming, extremely sleepy, diarrhea, refusing to eat or drink. Extreme fussiness and irritability.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Crying, Injection site bruising, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: About 2 hours after shot was given his leg got Red hot injection site aka leg. He was very cranky and crying and the next day his injection site was bruised with hard lumps, cranky baby.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site warmth, Irritability
Clinical narrative: About 2 hours after shot was given his leg got Red hot injection site aka leg. He was very cranky and crying and the next day his injection site was bruised with hard lumps, cranky baby.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: Went to emergency department due to redness on arm and was told she developed cellulitis. Was prescribed Bactrim DS 7/19, then cephalexin 7/20 followed by an injection of rocephin at the ER on a subsequent visit.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Dizziness, Injection site pain, Injection site swelling, Pain in extremity, Pallor
Clinical narrative: 3 hrs after getting the vaccine, she developed significant Right arm pain. She felt faint, had blurry vision, and looked pale to others. She lay down with resolution of symptoms. Continued to have pain and mild swelling of her Right deltoid muscle at visit 3 days ago.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Vision blurred
Clinical narrative: 3 hrs after getting the vaccine, she developed significant Right arm pain. She felt faint, had blurry vision, and looked pale to others. She lay down with resolution of symptoms. Continued to have pain and mild swelling of her Right deltoid muscle at visit 3 days ago.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Swollen area the size of her fist.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pain, swelling, redness, hardness around injection site, still ongoing 5 days later, but is slowly improving. Severe arm and shoulder pain, couldn't use arm for a full day. Fever, chills, nausea, headache, bodyache started 22 hours after injection and lasted about a day. Treated with motrin and ice, still healing.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Mobility decreased, Musculoskeletal pain, Nausea, Pain
Clinical narrative: Pain, swelling, redness, hardness around injection site, still ongoing 5 days later, but is slowly improving. Severe arm and shoulder pain, couldn't use arm for a full day. Fever, chills, nausea, headache, bodyache started 22 hours after injection and lasted about a day. Treated with motrin and ice, still healing.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain, swelling, redness, hardness around injection site, still ongoing 5 days later, but is slowly improving. Severe arm and shoulder pain, couldn't use arm for a full day. Fever, chills, nausea, headache, bodyache started 22 hours after injection and lasted about a day. Treated with motrin and ice, still healing.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Nausea
Clinical narrative: 07/21/16: nausea, vomiting; 07/22/16: body aches, headache, nausea, chills/cold, hot feeling, fever; 07/23/16: nausea, vomited 1 time; Ongoing headache today since 07/21/16.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: 07/21/16: nausea, vomiting; 07/22/16: body aches, headache, nausea, chills/cold, hot feeling, fever; 07/23/16: nausea, vomited 1 time; Ongoing headache today since 07/21/16.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Abasia, Feeling abnormal, Muscle spasms, Muscular weakness
Clinical narrative: Spasm of pelvic area, weakness in legs, pt could not walk. She described it as a funny feeling. She was taken into the pharmacy area, sat down, and her blood pressure was recorded (140's/90's). She felt better almost immediately. She stated she does have hypertension, does not have diabetes or kidney problems. She was given water to drink. She sat for a while, then her husband picked her up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Mobility decreased
Clinical narrative: Developed pain and redness at injection site 1 day after injection. Also with decreased mobility of arm until 7/20. Redness all the way down her upper (L) arm. No blistering, pustules or fever. Treated with antibiotics to cover possibility of cellulitis. Questionable esponse to antibiotics, so may actually have a hypersensitivity reaction to a component of TRUMENBA.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Abdominal pain upper, Allergy test positive, Autism spectrum disorder, Food allergy, Gluten sensitivity
Clinical narrative: Date and time close to occurrence - Patient lost most words he knew following vaccination and high temperature. Developed stomach pains and was tested for food allergies. 9/18/2015 test showed allergy to soy bean, vanilla, broccoli, Apple, dairy, cinnamon, gluten, lactose, onion.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Lactose intolerance, Milk allergy, Pyrexia
Clinical narrative: Date and time close to occurrence - Patient lost most words he knew following vaccination and high temperature. Developed stomach pains and was tested for food allergies. 9/18/2015 test showed allergy to soy bean, vanilla, broccoli, Apple, dairy, cinnamon, gluten, lactose, onion.
Age: 38.0
Sex: M
Vaccine: JEVX, SMALL
Symptoms: Injection site discharge, Rash, Rash erythematous, Vaccination site rash
Clinical narrative: Reddish bumps on forearms and legs, (R) shoulder immunization site weeping, also a rash on the skin portion where bandages were used to cover the vaccination site.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Abnormal behaviour, Irritability, Pyrexia, Rash
Clinical narrative: High fever lasting more than 3 days; rash on face, arms, legs, chest; irritable mood, sudden change in demeanor that lasted over a week!
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Foaming at mouth, Mouth haemorrhage, Muscle spasms, Pulmonary haemorrhage
Clinical narrative: Child was cramping and diarrhea initially..then red foam from his mouth and lungs.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse via company representative referring to a female patient in her late 60's. The patient's concurrent conditions and pertinent medical history were reported. In July 2011 (reported as "5 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, lot #, expiration date and route were not reported). Concomitant therapies were not reported. In approximately January 2012 (reported as after "6 months" of received a dose of ZOSTAVAX), the patient developed severe shingles (unspecified location) and was hospitalized. During hospitalization the patient received unspecified treatment. On unknown date, the patient was discharged from the hospital and she had since fully recovered. No product quality complaint was involved. Additional information has been requested.