chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient reported that later that night developed redness, swelling, and pain on anterior portion of upper left arm with extension onto his chest. Rash and redness, swelling, and pain.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Patient reported that later that night developed redness, swelling, and pain on anterior portion of upper left arm with extension onto his chest. Rash and redness, swelling, and pain.
Age: 46.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema
Clinical narrative: Patient received PPSV23 on 10/20/2015 in right upper deltoid. Patient developed redness in right upper arm, which started spreading to lower arm on 10/23/2015. No pain reported. Came as walk-in to clinic on 10/23/2015 and per exam, no confluence or warmth of red sites. Diagnosed with cellulitis s/p PNEUMOVAX.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, these patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L020015 with expiration date on 16-AUG-2017, dose and route unknown) (incorrect product storage). No adverse effects were reported. No product quality complaint was filed. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from an approximately 71 year old female consumer, reporting on herself. The patient's medical history and concurrent conditions were not reported. On an unspecified date in 2011, the patient was vaccinated with unidentified pneumococcal vaccine (manufacturer unknown) 1 shot, subcutaneous, (lot# and expiration date were not reported). Concomitant therapy was not reported. The consumer wanted to know the safety of pneumococcal vaccine (manufacturer unknown), as she was concerned about side effects, she stated that on an unknown date in 2011, she experienced peripheral swelling and pain in extremity, reported as "swelling and pain in her arm". The patient did not seek for medical attention. The outcome of peripheral swelling and pain in extremity was reported as recovered on an unspecified date. This is one of two reports received from the same reporter. Additional information is not expected since there is not contact details.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented with redness, itching, hive-like reaction at injection site in right arm. Patient reported he started itching, burning, redness, and swelling at site. Patient experienced brief shortness of breath but resolved. No fever or chills were reported by patient. Dyspnea.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site urticaria
Clinical narrative: Patient presented with redness, itching, hive-like reaction at injection site in right arm. Patient reported he started itching, burning, redness, and swelling at site. Patient experienced brief shortness of breath but resolved. No fever or chills were reported by patient. Dyspnea.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and urticaria pruritus.
Age: 36.0
Sex: F
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Skin rash. Loratadine 10 mg once.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Sensory disturbance
Clinical narrative: Nurse gave her the shot which seemed a little high on her arm.  As soon as needle went in, she could feel it in the top of her fingers in left hand.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Nurse gave her the shot which seemed a little high on her arm.  As soon as needle went in, she could feel it in the top of her fingers in left hand.
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician assistant referring to a currently 5 year old female patient. The patient's concurrent conditions included atopic dermatitis and gelatin, tree nut and food allergy. On an unknown date the patient was vaccinated with VARIVAX (lot number, dose and route were unknown). Concomitant medications were unspecified. On an unknown date the patient experienced urticaria. The outcome of urticaria was unknown. The causality between the event and VARIVAX was unknown. This case is linked with 1510USA008399, referring to the same patient. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 01/02/16: Headache, nausea, flu-like feeling, significant tiredness, transient shooting pain to right shoulder joint at time of injection. 01/03/16 - present: Flu-like symptoms (especially rhinitis); significant tiredness; injection site (redness, swelling, hardness, mild rash and itchiness).
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: 01/02/16: Headache, nausea, flu-like feeling, significant tiredness, transient shooting pain to right shoulder joint at time of injection. 01/03/16 - present: Flu-like symptoms (especially rhinitis); significant tiredness; injection site (redness, swelling, hardness, mild rash and itchiness).
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: 01/02/16: Headache, nausea, flu-like feeling, significant tiredness, transient shooting pain to right shoulder joint at time of injection. 01/03/16 - present: Flu-like symptoms (especially rhinitis); significant tiredness; injection site (redness, swelling, hardness, mild rash and itchiness).
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site joint pain, Injection site pruritus, Injection site rash, Injection site swelling, Nausea
Clinical narrative: 01/02/16: Headache, nausea, flu-like feeling, significant tiredness, transient shooting pain to right shoulder joint at time of injection. 01/03/16 - present: Flu-like symptoms (especially rhinitis); significant tiredness; injection site (redness, swelling, hardness, mild rash and itchiness).
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rhinitis
Clinical narrative: 01/02/16: Headache, nausea, flu-like feeling, significant tiredness, transient shooting pain to right shoulder joint at time of injection. 01/03/16 - present: Flu-like symptoms (especially rhinitis); significant tiredness; injection site (redness, swelling, hardness, mild rash and itchiness).
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram, Febrile convulsion, Nuclear magnetic resonance imaging
Clinical narrative: Prolonged, Atypical Febrile seizure.  Transported via Ambulance to emergency room.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Conjunctivitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: On 12/4/15 around 8 PM parent noted large area of erythema at site and pt c/o pain.  12/5/15 am no pain but 12 x 7.5 cm area of erythma, slight induration, warm to touch, mild swelling along Left Upper Arm at site of Influenza vaccine injection.  Also dx w/conjunctivitis of right eye.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: On 12/4/15 around 8 PM parent noted large area of erythema at site and pt c/o pain.  12/5/15 am no pain but 12 x 7.5 cm area of erythma, slight induration, warm to touch, mild swelling along Left Upper Arm at site of Influenza vaccine injection.  Also dx w/conjunctivitis of right eye.
Sex: M
Vaccine: HEP
Symptoms: Alopecia, Arthralgia, Autoimmune disorder, Blood test abnormal, Connective tissue disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a adult male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult and ENGERIX B adult. In August 2013, the patient received the 1st dose of ENGERIX B adult. On an unknown date, the patient received the 2nd dose of ENGERIX B adult and the 3rd dose of ENGERIC B adult. On an unknown date, an unknown time after receiving ENGERIX B adult and ENGERIX B adult and 30 days after receiving ENGERIX B adult, the patient experienced autoimmune disorder (serious criteria GSK medically significant), gastritis, vitamin B12 deficiency, hair loss, itchy skin, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity. On an unknown date, the outcome of the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss, itchy skin, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity were unknown. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss and itchy skin to be almost certainly related to ENGERIX B adult. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss and itchy skin to be almost certainly related to ENGERIX B adult. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity to be almost certainly related to ENGERIX B adult. Additional details were received as follows: In August 2013, the patient received 1st dose of ENGERIX B adult. After receiving 1st dose of ENGERIX B adult, the patient experienced hair loss and itching of skin. After receiving the 2nd dose of ENGERIX B adult, the patient experienced worsening of the hair loss and itching of skin. On an unknown date, 1 month after receiving 3rd dose of ENGERIX B adult, the patient experienced rheumatological disorders in his left knee and neurological disorders such as pain in his neck and spinal cord (symptoms similar to cancerous mellitus). In the winter of 2015, the rheumatological disorder spread to both knees and elbows. In July 2015, it was determined that the patient might have a connective tissue disorder in these joints. On an unknown date, patient underwent blood test and it was confirmed that the patient had an autoimmune disorder in the form of a B12 deficiency and gastritis. The patient also experienced numbness, shooting pain and spasticity in his hands. The patient believed that these events were caused by the autoimmune disorder. The patient had denied permission to contact their physician.
Sex: M
Vaccine: HEP
Symptoms: Gastritis, Hypoaesthesia, Muscle spasticity, Neck pain, Nervous system disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a adult male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult and ENGERIX B adult. In August 2013, the patient received the 1st dose of ENGERIX B adult. On an unknown date, the patient received the 2nd dose of ENGERIX B adult and the 3rd dose of ENGERIC B adult. On an unknown date, an unknown time after receiving ENGERIX B adult and ENGERIX B adult and 30 days after receiving ENGERIX B adult, the patient experienced autoimmune disorder (serious criteria GSK medically significant), gastritis, vitamin B12 deficiency, hair loss, itchy skin, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity. On an unknown date, the outcome of the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss, itchy skin, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity were unknown. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss and itchy skin to be almost certainly related to ENGERIX B adult. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss and itchy skin to be almost certainly related to ENGERIX B adult. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity to be almost certainly related to ENGERIX B adult. Additional details were received as follows: In August 2013, the patient received 1st dose of ENGERIX B adult. After receiving 1st dose of ENGERIX B adult, the patient experienced hair loss and itching of skin. After receiving the 2nd dose of ENGERIX B adult, the patient experienced worsening of the hair loss and itching of skin. On an unknown date, 1 month after receiving 3rd dose of ENGERIX B adult, the patient experienced rheumatological disorders in his left knee and neurological disorders such as pain in his neck and spinal cord (symptoms similar to cancerous mellitus). In the winter of 2015, the rheumatological disorder spread to both knees and elbows. In July 2015, it was determined that the patient might have a connective tissue disorder in these joints. On an unknown date, patient underwent blood test and it was confirmed that the patient had an autoimmune disorder in the form of a B12 deficiency and gastritis. The patient also experienced numbness, shooting pain and spasticity in his hands. The patient believed that these events were caused by the autoimmune disorder. The patient had denied permission to contact their physician.
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity, Pruritus, Rheumatic disorder, Spinal pain, Vitamin B12 decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a adult male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult and ENGERIX B adult. In August 2013, the patient received the 1st dose of ENGERIX B adult. On an unknown date, the patient received the 2nd dose of ENGERIX B adult and the 3rd dose of ENGERIC B adult. On an unknown date, an unknown time after receiving ENGERIX B adult and ENGERIX B adult and 30 days after receiving ENGERIX B adult, the patient experienced autoimmune disorder (serious criteria GSK medically significant), gastritis, vitamin B12 deficiency, hair loss, itchy skin, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity. On an unknown date, the outcome of the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss, itchy skin, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity were unknown. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss and itchy skin to be almost certainly related to ENGERIX B adult. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss and itchy skin to be almost certainly related to ENGERIX B adult. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity to be almost certainly related to ENGERIX B adult. Additional details were received as follows: In August 2013, the patient received 1st dose of ENGERIX B adult. After receiving 1st dose of ENGERIX B adult, the patient experienced hair loss and itching of skin. After receiving the 2nd dose of ENGERIX B adult, the patient experienced worsening of the hair loss and itching of skin. On an unknown date, 1 month after receiving 3rd dose of ENGERIX B adult, the patient experienced rheumatological disorders in his left knee and neurological disorders such as pain in his neck and spinal cord (symptoms similar to cancerous mellitus). In the winter of 2015, the rheumatological disorder spread to both knees and elbows. In July 2015, it was determined that the patient might have a connective tissue disorder in these joints. On an unknown date, patient underwent blood test and it was confirmed that the patient had an autoimmune disorder in the form of a B12 deficiency and gastritis. The patient also experienced numbness, shooting pain and spasticity in his hands. The patient believed that these events were caused by the autoimmune disorder. The patient had denied permission to contact their physician.
Sex: M
Vaccine: HEP
Symptoms: Vitamin B12 deficiency
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a adult male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult and ENGERIX B adult. In August 2013, the patient received the 1st dose of ENGERIX B adult. On an unknown date, the patient received the 2nd dose of ENGERIX B adult and the 3rd dose of ENGERIC B adult. On an unknown date, an unknown time after receiving ENGERIX B adult and ENGERIX B adult and 30 days after receiving ENGERIX B adult, the patient experienced autoimmune disorder (serious criteria GSK medically significant), gastritis, vitamin B12 deficiency, hair loss, itchy skin, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity. On an unknown date, the outcome of the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss, itchy skin, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity were unknown. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss and itchy skin to be almost certainly related to ENGERIX B adult. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss and itchy skin to be almost certainly related to ENGERIX B adult. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity to be almost certainly related to ENGERIX B adult. Additional details were received as follows: In August 2013, the patient received 1st dose of ENGERIX B adult. After receiving 1st dose of ENGERIX B adult, the patient experienced hair loss and itching of skin. After receiving the 2nd dose of ENGERIX B adult, the patient experienced worsening of the hair loss and itching of skin. On an unknown date, 1 month after receiving 3rd dose of ENGERIX B adult, the patient experienced rheumatological disorders in his left knee and neurological disorders such as pain in his neck and spinal cord (symptoms similar to cancerous mellitus). In the winter of 2015, the rheumatological disorder spread to both knees and elbows. In July 2015, it was determined that the patient might have a connective tissue disorder in these joints. On an unknown date, patient underwent blood test and it was confirmed that the patient had an autoimmune disorder in the form of a B12 deficiency and gastritis. The patient also experienced numbness, shooting pain and spasticity in his hands. The patient believed that these events were caused by the autoimmune disorder. The patient had denied permission to contact their physician.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Mid-lower LBP radiating down both legs. Numbness and paresthesias lower legs. Gait imbalance and weakness. Neurologist diagnosed Guillain Barre. On 10/31/14, patient presented to this primary care office with complaints that are listed on the VAERS form. She consulted her neurosurgeon and was referred to a neurologist/pain specialist. Dr. evaluated patient and diagnosed Guillain Barre likely related to the influenza vaccine received in this office on 10/7/14. It was our understanding that he had completed the VAERS form along with his diagnosis. Patient subsequently transferred to a primary care physician who practices within the same network as did the neurologist and neurosurgeon. Neurologist has since relocated, but patient's current records should be available through her current primary care physician, or through the former office of the neurologist listed on the VAERS form. Prior to her transfer to her current primary care physician, this office sent her entire record accumulated during the six months she was a patient here from 8/12/14 - 1/23/15. We have not heard  from her until her recent request for completion of the VAERS form which we were happy to do.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Mid-lower LBP radiating down both legs. Numbness and paresthesias lower legs. Gait imbalance and weakness. Neurologist diagnosed Guillain Barre. On 10/31/14, patient presented to this primary care office with complaints that are listed on the VAERS form. She consulted her neurosurgeon and was referred to a neurologist/pain specialist. Dr. evaluated patient and diagnosed Guillain Barre likely related to the influenza vaccine received in this office on 10/7/14. It was our understanding that he had completed the VAERS form along with his diagnosis. Patient subsequently transferred to a primary care physician who practices within the same network as did the neurologist and neurosurgeon. Neurologist has since relocated, but patient's current records should be available through her current primary care physician, or through the former office of the neurologist listed on the VAERS form. Prior to her transfer to her current primary care physician, this office sent her entire record accumulated during the six months she was a patient here from 8/12/14 - 1/23/15. We have not heard  from her until her recent request for completion of the VAERS form which we were happy to do.
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Initial unsolicited report received from a nurse on 04 November 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE INTRADERMAL QUADRIVALENT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's  medical history and concomitant medications were not reported. On an unspecified date in 2014, following the vaccination, the patient had developed cellulitis of upper arm. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: cellulitis of upper arm. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Headache, Hypoaesthesia, Immediate post-injection reaction, Injection site pain
Clinical narrative: Received injection early Aug. 2015 immediately felt pain in left arm. For approx. 1 week (L) arm felt "dead" in AM and could not lift arm in morning. Pain/stiffness/loss in mobility/hurts to sleep on left side/experiencing continued pain, stiffness, headaches/effecting neck. Treatment Pilates, PT, chiropractor, massage. Pain continues/radiating pain at injection site too.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal discomfort, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Received injection early Aug. 2015 immediately felt pain in left arm. For approx. 1 week (L) arm felt "dead" in AM and could not lift arm in morning. Pain/stiffness/loss in mobility/hurts to sleep on left side/experiencing continued pain, stiffness, headaches/effecting neck. Treatment Pilates, PT, chiropractor, massage. Pain continues/radiating pain at injection site too.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, X-ray
Clinical narrative: Received injection early Aug. 2015 immediately felt pain in left arm. For approx. 1 week (L) arm felt "dead" in AM and could not lift arm in morning. Pain/stiffness/loss in mobility/hurts to sleep on left side/experiencing continued pain, stiffness, headaches/effecting neck. Treatment Pilates, PT, chiropractor, massage. Pain continues/radiating pain at injection site too.
Age: 38.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Chest pain, Chills, Dyspnoea, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: This is a spontaneous report from the non-clinical study program. A 38-year-old female contactable consumer (unknown ethnicity) reported that received PREVNAR 13, at single dose, on 09Nov2015. Relevant medical history included type 2 diabetes mellitus. Concomitant medications were unknown. The patient experienced injection site reaction with itching immediately after injection on 09Nov2015. Treatment was received (antibiotic, antihistamine). The patient recovered from the adverse event. On 09Nov2015, the patient experienced also chills, vision problem, and nausea; while on 10Nov2015, she developed fever of 101 Fahrenheit, shortness of breath and cellulitis at injection site. Hospitalization was required. Diagnosis was cellulitis. Electrocardiogram (EKG) was performed. Treatment was received for the events (antibiotic for fever, chills, ZOFRAN for nausea and clindamycin, and ROCEPHIN for cellulitis at injection site). No treatment was received for vision problem. The patient recovered from these events. On an unspecified date, in Nov2015, the consumer reported that had chest pain and she was certain she was about to die. Clinical outcome and seriousness criteria of these events were unknown. Follow-up (23Dec2015): New information reported from the same contactable consumer includes: patient details, reaction data and case seriousness changed from non-serious to serious.
Age: 38.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injection site cellulitis, Injection site pruritus, Injection site reaction, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from the non-clinical study program. A 38-year-old female contactable consumer (unknown ethnicity) reported that received PREVNAR 13, at single dose, on 09Nov2015. Relevant medical history included type 2 diabetes mellitus. Concomitant medications were unknown. The patient experienced injection site reaction with itching immediately after injection on 09Nov2015. Treatment was received (antibiotic, antihistamine). The patient recovered from the adverse event. On 09Nov2015, the patient experienced also chills, vision problem, and nausea; while on 10Nov2015, she developed fever of 101 Fahrenheit, shortness of breath and cellulitis at injection site. Hospitalization was required. Diagnosis was cellulitis. Electrocardiogram (EKG) was performed. Treatment was received for the events (antibiotic for fever, chills, ZOFRAN for nausea and clindamycin, and ROCEPHIN for cellulitis at injection site). No treatment was received for vision problem. The patient recovered from these events. On an unspecified date, in Nov2015, the consumer reported that had chest pain and she was certain she was about to die. Clinical outcome and seriousness criteria of these events were unknown. Follow-up (23Dec2015): New information reported from the same contactable consumer includes: patient details, reaction data and case seriousness changed from non-serious to serious.
Age: 38.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Visual impairment
Clinical narrative: This is a spontaneous report from the non-clinical study program. A 38-year-old female contactable consumer (unknown ethnicity) reported that received PREVNAR 13, at single dose, on 09Nov2015. Relevant medical history included type 2 diabetes mellitus. Concomitant medications were unknown. The patient experienced injection site reaction with itching immediately after injection on 09Nov2015. Treatment was received (antibiotic, antihistamine). The patient recovered from the adverse event. On 09Nov2015, the patient experienced also chills, vision problem, and nausea; while on 10Nov2015, she developed fever of 101 Fahrenheit, shortness of breath and cellulitis at injection site. Hospitalization was required. Diagnosis was cellulitis. Electrocardiogram (EKG) was performed. Treatment was received for the events (antibiotic for fever, chills, ZOFRAN for nausea and clindamycin, and ROCEPHIN for cellulitis at injection site). No treatment was received for vision problem. The patient recovered from these events. On an unspecified date, in Nov2015, the consumer reported that had chest pain and she was certain she was about to die. Clinical outcome and seriousness criteria of these events were unknown. Follow-up (23Dec2015): New information reported from the same contactable consumer includes: patient details, reaction data and case seriousness changed from non-serious to serious.
Age: 38.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Chest pain, Chills, Dyspnoea, Injection site cellulitis, Nausea
Clinical narrative: This is a spontaneous report from the non-clinical study program. A 38-year-old female contactable consumer (unknown ethnicity) reported that received PREVNAR 13, at single dose, on 09Nov2015. Relevant medical history included type 2 diabetes mellitus. Concomitant medications were unknown. The patient experienced injection site reaction with itching immediately after injection on 09Nov2015. Treatment was received (antibiotic, antihistamine). The patient recovered from the adverse event. On 09Nov2015, the patient experienced also chills, vision problem, and nausea; while on 10Nov2015, she developed fever of 101 Fahrenheit, shortness of breath and cellulitis at injection site. Hospitalization was required. Diagnosis was cellulitis. Electrocardiogram (EKG) was performed. Treatment was received for the events (antibiotic for fever, chills, ZOFRAN for nausea and clindamycin, and ROCEPHIN for cellulitis at injection site). No treatment was received for vision problem. The patient recovered from these events. On an unspecified date, in Nov2015, the consumer reported that had chest pain and she was certain she was about to die. Clinical outcome and seriousness criteria of these events were unknown. Follow-up (23Dec2015): New information reported from the same contactable consumer includes: patient details, reaction data and case seriousness changed from non-serious to serious.
Age: 38.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pruritus, Pyrexia, Visual impairment
Clinical narrative: This is a spontaneous report from the non-clinical study program. A 38-year-old female contactable consumer (unknown ethnicity) reported that received PREVNAR 13, at single dose, on 09Nov2015. Relevant medical history included type 2 diabetes mellitus. Concomitant medications were unknown. The patient experienced injection site reaction with itching immediately after injection on 09Nov2015. Treatment was received (antibiotic, antihistamine). The patient recovered from the adverse event. On 09Nov2015, the patient experienced also chills, vision problem, and nausea; while on 10Nov2015, she developed fever of 101 Fahrenheit, shortness of breath and cellulitis at injection site. Hospitalization was required. Diagnosis was cellulitis. Electrocardiogram (EKG) was performed. Treatment was received for the events (antibiotic for fever, chills, ZOFRAN for nausea and clindamycin, and ROCEPHIN for cellulitis at injection site). No treatment was received for vision problem. The patient recovered from these events. On an unspecified date, in Nov2015, the consumer reported that had chest pain and she was certain she was about to die. Clinical outcome and seriousness criteria of these events were unknown. Follow-up (23Dec2015): New information reported from the same contactable consumer includes: patient details, reaction data and case seriousness changed from non-serious to serious.
Age: 61.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative
Clinical narrative: On 9/30, DOH was notified by an out-of-state health services company that a nurse had reused syringes for multiple persons earlier that day at an employee influenza vaccination clinic where the health services company had been contracted. The nurse contracted by the health services company brought three multiple-dose vials of vaccine that were intended for another event (and stored in her personal fridge without temp monitoring). The nurse reported using two syringes she found among her supplies to administer vaccine to 67 employees of the business. She reported wiping the syringes with alcohol and using a new needle for each of the 67 persons. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult participants. Participants were offered blood-borne pathogen testing (hep B, hep C, HIV), hepatitis B vaccine, and flu vaccine.
Age: 61.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: On 9/30, DOH was notified by an out-of-state health services company that a nurse had reused syringes for multiple persons earlier that day at an employee influenza vaccination clinic where the health services company had been contracted. The nurse contracted by the health services company brought three multiple-dose vials of vaccine that were intended for another event (and stored in her personal fridge without temp monitoring). The nurse reported using two syringes she found among her supplies to administer vaccine to 67 employees of the business. She reported wiping the syringes with alcohol and using a new needle for each of the 67 persons. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult participants. Participants were offered blood-borne pathogen testing (hep B, hep C, HIV), hepatitis B vaccine, and flu vaccine.
Age: 61.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage
Clinical narrative: On 9/30, DOH was notified by an out-of-state health services company that a nurse had reused syringes for multiple persons earlier that day at an employee influenza vaccination clinic where the health services company had been contracted. The nurse contracted by the health services company brought three multiple-dose vials of vaccine that were intended for another event (and stored in her personal fridge without temp monitoring). The nurse reported using two syringes she found among her supplies to administer vaccine to 67 employees of the business. She reported wiping the syringes with alcohol and using a new needle for each of the 67 persons. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult participants. Participants were offered blood-borne pathogen testing (hep B, hep C, HIV), hepatitis B vaccine, and flu vaccine.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abasia, Blood test normal, Erythema, Gait disturbance, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her sister. A 70-years-old female patient received the first dose of PREVNAR 13, via an unspecified route of administration on her left arm in Nov2015 at 0.5 ml, single. Medical history included ongoing tardive dyskinesia. Concomitant medication included clonazepam (unknown manufacturer) 2mg three times a day and clonidine (unknown manufacturer) three times a day both for tardive dyskinesia. The patient experienced redness that spread almost down to the bend of the patient arm, her arm was swollen, hot swollen, she could not walk/she was only functioning 26% in her walk/she had non ability to walk, she was dragging her right foot all on an unspecified date in 2015. On 28Nov2015 the reporter took the patient to the doctor who gave her anti-inflammatory and Cephalexin for redness that spread almost down to the bend of the patient arm, her arm was swollen, hot swollen. A couple of days later, the patient could not walk and she was so bad that the reporter had to take her to the emergency room and mentioned that patient was bad enough that they thought maybe she had a stroke because of the way she could not walk and she was dragging her right foot. So, they did a scan and all kind of blood works and all those test came back pathologically okay and further added that they could not rule out the vaccine. The reporter mentioned that the consumer had to use the walker and mentioned that at the patient's age doctor told reporter that patient should be functioning at 86% at her age in her walking ability and the patient was only functioning 26% in her walk and that was at the time when she was in the emergency room. The reporter wanted to know if this was usual or unusual because she knew little bit of redness around the injection site was not unusual but the patient's whole arm down to the bend of her arm to elbow was very red and swollen and on that day reporter took patient to the doctor. The reporter mentioned that the redness and everything has gone away and mentioned that the patient was still experiencing the non-ability to walk, she has to use a walker. The outcome of she was dragging her right foot was unknown.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Peripheral swelling, Scan normal, Skin warm, Walking aid user
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her sister. A 70-years-old female patient received the first dose of PREVNAR 13, via an unspecified route of administration on her left arm in Nov2015 at 0.5 ml, single. Medical history included ongoing tardive dyskinesia. Concomitant medication included clonazepam (unknown manufacturer) 2mg three times a day and clonidine (unknown manufacturer) three times a day both for tardive dyskinesia. The patient experienced redness that spread almost down to the bend of the patient arm, her arm was swollen, hot swollen, she could not walk/she was only functioning 26% in her walk/she had non ability to walk, she was dragging her right foot all on an unspecified date in 2015. On 28Nov2015 the reporter took the patient to the doctor who gave her anti-inflammatory and Cephalexin for redness that spread almost down to the bend of the patient arm, her arm was swollen, hot swollen. A couple of days later, the patient could not walk and she was so bad that the reporter had to take her to the emergency room and mentioned that patient was bad enough that they thought maybe she had a stroke because of the way she could not walk and she was dragging her right foot. So, they did a scan and all kind of blood works and all those test came back pathologically okay and further added that they could not rule out the vaccine. The reporter mentioned that the consumer had to use the walker and mentioned that at the patient's age doctor told reporter that patient should be functioning at 86% at her age in her walking ability and the patient was only functioning 26% in her walk and that was at the time when she was in the emergency room. The reporter wanted to know if this was usual or unusual because she knew little bit of redness around the injection site was not unusual but the patient's whole arm down to the bend of her arm to elbow was very red and swollen and on that day reporter took patient to the doctor. The reporter mentioned that the redness and everything has gone away and mentioned that the patient was still experiencing the non-ability to walk, she has to use a walker. The outcome of she was dragging her right foot was unknown.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abasia, Asthenia, Blood test, Computerised tomogram, Gait disturbance
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her sister. A 70-years-old female patient received the first dose of PREVNAR 13, via an unspecified route of administration on her left arm in Nov2015 at 0.5 ml, single. Medical history included ongoing tardive dyskinesia. Concomitant medication included clonazepam (unknown manufacturer) 2mg three times a day and clonidine (unknown manufacturer) three times a day both for tardive dyskinesia. The patient experienced redness that spread almost down to the bend of the patient arm, her arm was swollen, hot swollen, she could not walk/she was only functioning 26% in her walk/she had non ability to walk, she was dragging her right foot all on an unspecified date in 2015. On 28Nov2015 the reporter took the patient to the doctor who gave her anti-inflammatory and Cephalexin for redness that spread almost down to the bend of the patient arm, her arm was swollen, hot swollen. A couple of days later, the patient could not walk and she was so bad that the reporter had to take her to the emergency room and mentioned that patient was bad enough that they thought maybe she had a stroke because of the way she could not walk and she was dragging her right foot. So, they did a scan and all kind of blood works and all those test came back pathologically okay and further added that they could not rule out the vaccine. The reporter mentioned that the consumer had to use the walker and mentioned that at the patient's age doctor told reporter that patient should be functioning at 86% at her age in her walking ability and the patient was only functioning 26% in her walk and that was at the time when she was in the emergency room. The reporter wanted to know if this was usual or unusual because she knew little bit of redness around the injection site was not unusual but the patient's whole arm down to the bend of her arm to elbow was very red and swollen and on that day reporter took patient to the doctor. The reporter mentioned that the redness and everything has gone away and mentioned that the patient was still experiencing the non-ability to walk, she has to use a walker. The outcome of she was dragging her right foot was unknown.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Ultrasound scan, Walking aid user
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her sister. A 70-years-old female patient received the first dose of PREVNAR 13, via an unspecified route of administration on her left arm in Nov2015 at 0.5 ml, single. Medical history included ongoing tardive dyskinesia. Concomitant medication included clonazepam (unknown manufacturer) 2mg three times a day and clonidine (unknown manufacturer) three times a day both for tardive dyskinesia. The patient experienced redness that spread almost down to the bend of the patient arm, her arm was swollen, hot swollen, she could not walk/she was only functioning 26% in her walk/she had non ability to walk, she was dragging her right foot all on an unspecified date in 2015. On 28Nov2015 the reporter took the patient to the doctor who gave her anti-inflammatory and Cephalexin for redness that spread almost down to the bend of the patient arm, her arm was swollen, hot swollen. A couple of days later, the patient could not walk and she was so bad that the reporter had to take her to the emergency room and mentioned that patient was bad enough that they thought maybe she had a stroke because of the way she could not walk and she was dragging her right foot. So, they did a scan and all kind of blood works and all those test came back pathologically okay and further added that they could not rule out the vaccine. The reporter mentioned that the consumer had to use the walker and mentioned that at the patient's age doctor told reporter that patient should be functioning at 86% at her age in her walking ability and the patient was only functioning 26% in her walk and that was at the time when she was in the emergency room. The reporter wanted to know if this was usual or unusual because she knew little bit of redness around the injection site was not unusual but the patient's whole arm down to the bend of her arm to elbow was very red and swollen and on that day reporter took patient to the doctor. The reporter mentioned that the redness and everything has gone away and mentioned that the patient was still experiencing the non-ability to walk, she has to use a walker. The outcome of she was dragging her right foot was unknown.
Age: 62.0
Sex: M
Vaccine: TTOX
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm.
Age: 35.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: On 9/30, DOH was notified by an out-of-state health services company that a nurse had reused syringes for multiple persons earlier that day at an employee influenza vaccination clinic where the health services company had been contracted. The nurse contracted by the health services company brought three multiple-dose vials of vaccine that were intended for another event (and stored in her personal fridge without temp monitoring). The nurse reported using two syringes she found among her supplies to administer vaccine to 67 employees of the business. She reported wiping the syringes with alcohol and using a new needle for each of the 67 persons. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult participants. Participants were offered blood-borne pathogen testing (hep B, hep C, HIV), hepatitis B vaccine, and flu vaccine.
Age: 35.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: On 9/30, DOH was notified by an out-of-state health services company that a nurse had reused syringes for multiple persons earlier that day at an employee influenza vaccination clinic where the health services company had been contracted. The nurse contracted by the health services company brought three multiple-dose vials of vaccine that were intended for another event (and stored in her personal fridge without temp monitoring). The nurse reported using two syringes she found among her supplies to administer vaccine to 67 employees of the business. She reported wiping the syringes with alcohol and using a new needle for each of the 67 persons. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult participants. Participants were offered blood-borne pathogen testing (hep B, hep C, HIV), hepatitis B vaccine, and flu vaccine.
Age: 35.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Wrong technique in product usage process
Clinical narrative: On 9/30, DOH was notified by an out-of-state health services company that a nurse had reused syringes for multiple persons earlier that day at an employee influenza vaccination clinic where the health services company had been contracted. The nurse contracted by the health services company brought three multiple-dose vials of vaccine that were intended for another event (and stored in her personal fridge without temp monitoring). The nurse reported using two syringes she found among her supplies to administer vaccine to 67 employees of the business. She reported wiping the syringes with alcohol and using a new needle for each of the 67 persons. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult participants. Participants were offered blood-borne pathogen testing (hep B, hep C, HIV), hepatitis B vaccine, and flu vaccine.