chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-JUN-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 3 times with the following lowest recorded temperatures: 34F (1.11 Celsius degrees) for 88 hours, 32 F (0 Celsius degrees) for 40 hours and 33 F (0.555 Celsius degrees) for 40 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 29-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 "10PK 0.5mL SD-PFS LLokwTip 10Pk" and  lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius)for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 08-JUL-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVls 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 24 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 06-AUG-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX "10 Single DS 0.5 ml LVls 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 48 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 24-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-MAR-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-JUL-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 3 times with the following lowest recorded temperatures: 34F (1.11 Celsius degrees) for 88 hours, 32 F (0 Celsius degrees) for 152 hours and 33 F (0.55 Celsius degrees) for 40 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # J014855, expiration date 01-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour, the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 304, 59 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 08-SEP-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVls 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 72 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 15-FEB-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 "10PK 0.5mL SD-PFS LLokwTip 10Pk" and lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius)for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 24, 34, and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 176, 48 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 24-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient (encounter key # 448029) of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 21-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 06-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 0.55 degrees C for 488 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 26-DEC-2014, the patient was vaccinated with an improperly stored dose of (23-valent) PNEUMOVAX 0.5 ml (VIs 10 SDV) (Lot number K007822, expiration date 15-AUG-2015), dose, route and anatomical location were not provided. There was no concomitant medication provided. On unknown dates, the (23-valent) PNEUMOVAX had temperature excursions for 48, 24 and 2220 hours, with the highest recorded temperature of 46.8 F (8.2 Celsius), 47.5 F (8.6 Celsius) and 59.9 F (15.5 Celsius) respectively. The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reaction/allergies and concomitant medications was not reported. On 21-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion of 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 13-OCT-2014, the patient was vaccinated with an improperly stored dose of (23-valent) PNEUMOVAX 0.5 ml (VIs 10 SDV) (Lot number K007822, expiration date 15-AUG-2015), single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the (23-valent) PNEUMOVAX had a temperature excursion for 312 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported and "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has ben received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored RECOMBIVAX HB (lot # L006231, expiration date 06-OCT-2016, lot # reported as L0136959, expiration date 12-MAR-2018, lot # L045117, expiration date 06-OCT-2018, lot # M001578, expiration date 21-NOV-2018, lot # L027733, expiration date 13-SEP-2017; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored GARDASIL 9 (lot # M007764, expiration date 30-JAN-2018, lot # M009378, expiration date 23-APR-2018; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-NOV-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 5 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 152, 30, -1.111111111 and R; 184, 29, -1.666666667 and R; 112, 33, 0.555555556 and R; 344, 31, -0.555555556 and R; 224, 32, 0 and R. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 23-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10 PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 504 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Joint injection, Joint range of motion decreased, Pain in extremity, Sleep disorder
Clinical narrative: Sore arm second day, November 22, 2015. December 7 limited range of motion. December 18, 2015, Dr injected cortisone into shoulder. X ray showed no sign of arthritis. March 16, 2016, second cortisone shot by P.A. continued soreness. Cannot sleep on left side. Limited activities.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray limb normal
Clinical narrative: Sore arm second day, November 22, 2015. December 7 limited range of motion. December 18, 2015, Dr injected cortisone into shoulder. X ray showed no sign of arthritis. March 16, 2016, second cortisone shot by P.A. continued soreness. Cannot sleep on left side. Limited activities.
Age: 42.0
Sex: M
Vaccine: MMR, HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of neuropathy peripheral in a 42-year-old male patient who received ENGERIX B adult (batch number XR9GF, expiry date 8th October 2018). On 1st September 2016, the patient received the 3rd dose of ENGERIX B adult (intramuscular). In September 2016, less than a week after receiving ENGERIX B adult, the patient experienced neuropathy peripheral, burning sensation, pins and needles and numbness. On an unknown date, the outcome of the neuropathy peripheral, burning sensation, pins and needles and numbness were unknown. It was unknown if the reporter considered the neuropathy peripheral, burning sensation, pins and needles and numbness to be related to ENGERIX B adult. Additional details were provided as follows: This case was previously reported to a doctor. At 11:30, the patient received ENGERIX B adult in his right deltoid. Within four days after receiving the ENGERIX B adult, the patient experienced peripheral neuropathy in his tongue, lips, both arms and hands as well as both legs and feet. In 2016, less than year, after receiving ENGERIX B adult, the patient also experienced numbness, tingling, burning and a pins and needles sensation. On 6th October 2016, the patient went to his physician, because of what he was experiencing which involved an electromyogram (EMG) and blood work test. The reporter indicated that the patient faxed to her office a VAERS report outlining the adverse events. The reporter was unable to provide any further details and the VAERS report did not have a reference number.
Age: 42.0
Sex: M
Vaccine: MMR, HEP, HEP
Symptoms: Blood test, Burning sensation, Electromyogram, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of neuropathy peripheral in a 42-year-old male patient who received ENGERIX B adult (batch number XR9GF, expiry date 8th October 2018). On 1st September 2016, the patient received the 3rd dose of ENGERIX B adult (intramuscular). In September 2016, less than a week after receiving ENGERIX B adult, the patient experienced neuropathy peripheral, burning sensation, pins and needles and numbness. On an unknown date, the outcome of the neuropathy peripheral, burning sensation, pins and needles and numbness were unknown. It was unknown if the reporter considered the neuropathy peripheral, burning sensation, pins and needles and numbness to be related to ENGERIX B adult. Additional details were provided as follows: This case was previously reported to a doctor. At 11:30, the patient received ENGERIX B adult in his right deltoid. Within four days after receiving the ENGERIX B adult, the patient experienced peripheral neuropathy in his tongue, lips, both arms and hands as well as both legs and feet. In 2016, less than year, after receiving ENGERIX B adult, the patient also experienced numbness, tingling, burning and a pins and needles sensation. On 6th October 2016, the patient went to his physician, because of what he was experiencing which involved an electromyogram (EMG) and blood work test. The reporter indicated that the patient faxed to her office a VAERS report outlining the adverse events. The reporter was unable to provide any further details and the VAERS report did not have a reference number.
Age: 42.0
Sex: M
Vaccine: MMR, HEP, HEP
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of neuropathy peripheral in a 42-year-old male patient who received ENGERIX B adult (batch number XR9GF, expiry date 8th October 2018). On 1st September 2016, the patient received the 3rd dose of ENGERIX B adult (intramuscular). In September 2016, less than a week after receiving ENGERIX B adult, the patient experienced neuropathy peripheral, burning sensation, pins and needles and numbness. On an unknown date, the outcome of the neuropathy peripheral, burning sensation, pins and needles and numbness were unknown. It was unknown if the reporter considered the neuropathy peripheral, burning sensation, pins and needles and numbness to be related to ENGERIX B adult. Additional details were provided as follows: This case was previously reported to a doctor. At 11:30, the patient received ENGERIX B adult in his right deltoid. Within four days after receiving the ENGERIX B adult, the patient experienced peripheral neuropathy in his tongue, lips, both arms and hands as well as both legs and feet. In 2016, less than year, after receiving ENGERIX B adult, the patient also experienced numbness, tingling, burning and a pins and needles sensation. On 6th October 2016, the patient went to his physician, because of what he was experiencing which involved an electromyogram (EMG) and blood work test. The reporter indicated that the patient faxed to her office a VAERS report outlining the adverse events. The reporter was unable to provide any further details and the VAERS report did not have a reference number.
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cough, Pneumothorax
Clinical narrative: He rec'd the Pr 13 pneumonia vaccine and 23 h later he coughed for over 2 hrs and continue to cough for year.
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cough
Clinical narrative: He rec'd the Pr 13 pneumonia vaccine and 23 h later he coughed for over 2 hrs and continue to cough for year.
Age: 38.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Injection site reaction, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Employee rec'd influenza vaccine in (L) deltoid, that evening developed stiff shoulder and couldn't move arm. Three weeks later and still having pain and stiffness in shoulder at inj. site.
Age: 38.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Employee rec'd influenza vaccine in (L) deltoid, that evening developed stiff shoulder and couldn't move arm. Three weeks later and still having pain and stiffness in shoulder at inj. site.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Impaired work ability, Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: 15 min. approx. after flu vaccine I started getting a long pain on left arm making mobility painful and limited. On 10/11 went to U.C. about the pain. They referred me to E.R. for ultra sound. On 10/13 went to my primary and scheduled physical therapy. Starting Therapy 10/24/16.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity, Ultrasound scan, Vaccination complication
Clinical narrative: 15 min. approx. after flu vaccine I started getting a long pain on left arm making mobility painful and limited. On 10/11 went to U.C. about the pain. They referred me to E.R. for ultra sound. On 10/13 went to my primary and scheduled physical therapy. Starting Therapy 10/24/16.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 43-year-old female patient who received BOOSTRIX. Concomitant products included NOVOLOG. On 26th September 2016, the patient received BOOSTRIX. In September 2016, less than a week after receiving BOOSTRIX, the patient experienced injected limb mobility decreased, injection site pain and joint range of motion decreased. On an unknown date, the outcome of the injected limb mobility decreased and joint range of motion decreased were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain and joint range of motion decreased to be related to BOOSTRIX. Additional details were provided as follows: The case was previously reported to a health department. The following two days after vaccination, the patient experienced really bad pain at the injection site and unable to move the arm where the vaccine injected. The pain subsided about a week later. However, the patient had no range of motion in her arm that received the vaccine. She could not drive because she could not raise her arm diagonally. The patient filled out some paperwork at the pharmacy to report it. She did not see any medication attention yet. The patient did not have the lot and the expiration date of the vaccine she received.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Impaired driving ability, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 43-year-old female patient who received BOOSTRIX. Concomitant products included NOVOLOG. On 26th September 2016, the patient received BOOSTRIX. In September 2016, less than a week after receiving BOOSTRIX, the patient experienced injected limb mobility decreased, injection site pain and joint range of motion decreased. On an unknown date, the outcome of the injected limb mobility decreased and joint range of motion decreased were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain and joint range of motion decreased to be related to BOOSTRIX. Additional details were provided as follows: The case was previously reported to a health department. The following two days after vaccination, the patient experienced really bad pain at the injection site and unable to move the arm where the vaccine injected. The pain subsided about a week later. However, the patient had no range of motion in her arm that received the vaccine. She could not drive because she could not raise her arm diagonally. The patient filled out some paperwork at the pharmacy to report it. She did not see any medication attention yet. The patient did not have the lot and the expiration date of the vaccine she received.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 39-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4Z27T, expiry date 25th June 2017). On 19th October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT .5 ml. On 20th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were not recovered/not resolved. The reporter considered the injection site erythema, injection site pain and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced redness, pain and swelling at injection site after receiving FLUARIX QUADRIVALENT on right deltoid. On 20th October 2016, the site was approximately the size of a quarter. On 21st October 2016, the site was approximately size of orange. The reporter advised the patient to see her physician. Emergency room visit was required. The representative also noted that the flu vaccine was given off site at the business location.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 39-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4Z27T, expiry date 25th June 2017). On 19th October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT .5 ml. On 20th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were not recovered/not resolved. The reporter considered the injection site erythema, injection site pain and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced redness, pain and swelling at injection site after receiving FLUARIX QUADRIVALENT on right deltoid. On 20th October 2016, the site was approximately the size of a quarter. On 21st October 2016, the site was approximately size of orange. The reporter advised the patient to see her physician. Emergency room visit was required. The representative also noted that the flu vaccine was given off site at the business location.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Induration, Myalgia, Skin warm, Swelling
Clinical narrative: Very swollen, hard, very warm, painful muscle. Reported to dr who ordered z-pak but I didn't take it. Cool compresses but no relief. Had same symptoms for a week.
Age: 21.0
Sex: M
Vaccine: FLU4, SMALL
Symptoms: C-reactive protein, Echocardiogram, Electrocardiogram, Myocarditis, Troponin
Clinical narrative: Myopericarditis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Headache, 3 inch red tender itchy injection site. 3 days later soreness in arm pit.
Age: 0.42
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain lower, Asthenia, Headache, Malaise, Myalgia
Clinical narrative: Racing heart, lower abdominal pain, weakness, muscle aches, nausea, headache.
Age: 0.42
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Palpitations
Clinical narrative: Racing heart, lower abdominal pain, weakness, muscle aches, nausea, headache.
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Localised infection, Pain in extremity
Clinical narrative: Patient complained of arm pain from shoulder to elbow. She was instructed to seek medical attention. She was diagnosed with an infection and is currently on medication to treat.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: I woke up to severe pain in left shoulder from the shot which was left arm right below the shoulder. Pain persists today in waves on and off. This is over a month later. Sometimes I cannot move my left arm for the amount of pain. I got the free flu shot at pharmacy, not totally sure of the time but my Medicare record should show all the information, and who gave me the shot.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Sudden infant death syndrome
Clinical narrative: Apparent SIDS in ED 10/26/16 AM co-sleeper may have been in use.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient states she has not been able to move her flu vaccine arm (left deltoid) since flu shot; decreased mobility reported 10/21/16 to pharmacy.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Injection site cellulitis
Clinical narrative: Cellulitis at inj. site. RX with AUGMENTIN. 2" area of redness noted after vaccine given within 1 hour.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient develop hives on her face and a 2.5 x 1 cm raised area to the left deltoid under the injection site. Benadryl was given, hives cleared but left arm continued to swell. 10/29/16 the left arm swelling was very pronounced, red and warm with pain on palpation and ROM. 10/30/16 Patient visited the ER and was given ABX (Keflex) for a dx of cellulitis.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Urticaria
Clinical narrative: Patient develop hives on her face and a 2.5 x 1 cm raised area to the left deltoid under the injection site. Benadryl was given, hives cleared but left arm continued to swell. 10/29/16 the left arm swelling was very pronounced, red and warm with pain on palpation and ROM. 10/30/16 Patient visited the ER and was given ABX (Keflex) for a dx of cellulitis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Asthenia, Blood test, Chills
Clinical narrative: Baby would take in a bottle of Enfamil Gentlease and would vomit the entire bottle shortly after. He would vomit sporadically through out the night. He had a bowel movement at 6:00Am 10/27 we thought he was getting better because his fever broke. Later in the day the fever came back he was sweaty had the chills and extremely pale. He had no wet diapers and would refuse a bottle, we also tried pedialyte which he vomited. He was taken to hospital at 6:00 Pm 10/27 and by then he was dry heaving, had a fever, very pale, had no energy to cry while nurses tried to find a vein for an IV. X Ray showed he had intussusception radiologist gave the baby an air enema which opened the intestines back up. He stayed through out the night and was discharged the next day. Between 5:00pm 10/26 and being admitted to the hospital 10/27 at 6:00pm he had only been able to keep down two ounces of formula. It should be noted that two weeks before baby started vomiting we thought he had severe colic and just spit up a lot and would scream for no reason.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Diet refusal, Enema administration, Hyperhidrosis, Infantile spitting up
Clinical narrative: Baby would take in a bottle of Enfamil Gentlease and would vomit the entire bottle shortly after. He would vomit sporadically through out the night. He had a bowel movement at 6:00Am 10/27 we thought he was getting better because his fever broke. Later in the day the fever came back he was sweaty had the chills and extremely pale. He had no wet diapers and would refuse a bottle, we also tried pedialyte which he vomited. He was taken to hospital at 6:00 Pm 10/27 and by then he was dry heaving, had a fever, very pale, had no energy to cry while nurses tried to find a vein for an IV. X Ray showed he had intussusception radiologist gave the baby an air enema which opened the intestines back up. He stayed through out the night and was discharged the next day. Between 5:00pm 10/26 and being admitted to the hospital 10/27 at 6:00pm he had only been able to keep down two ounces of formula. It should be noted that two weeks before baby started vomiting we thought he had severe colic and just spit up a lot and would scream for no reason.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Pallor, Pyrexia, Retching, Screaming
Clinical narrative: Baby would take in a bottle of Enfamil Gentlease and would vomit the entire bottle shortly after. He would vomit sporadically through out the night. He had a bowel movement at 6:00Am 10/27 we thought he was getting better because his fever broke. Later in the day the fever came back he was sweaty had the chills and extremely pale. He had no wet diapers and would refuse a bottle, we also tried pedialyte which he vomited. He was taken to hospital at 6:00 Pm 10/27 and by then he was dry heaving, had a fever, very pale, had no energy to cry while nurses tried to find a vein for an IV. X Ray showed he had intussusception radiologist gave the baby an air enema which opened the intestines back up. He stayed through out the night and was discharged the next day. Between 5:00pm 10/26 and being admitted to the hospital 10/27 at 6:00pm he had only been able to keep down two ounces of formula. It should be noted that two weeks before baby started vomiting we thought he had severe colic and just spit up a lot and would scream for no reason.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ultrasound abdomen, Urine analysis, Urine output decreased, Vomiting, X-ray abnormal
Clinical narrative: Baby would take in a bottle of Enfamil Gentlease and would vomit the entire bottle shortly after. He would vomit sporadically through out the night. He had a bowel movement at 6:00Am 10/27 we thought he was getting better because his fever broke. Later in the day the fever came back he was sweaty had the chills and extremely pale. He had no wet diapers and would refuse a bottle, we also tried pedialyte which he vomited. He was taken to hospital at 6:00 Pm 10/27 and by then he was dry heaving, had a fever, very pale, had no energy to cry while nurses tried to find a vein for an IV. X Ray showed he had intussusception radiologist gave the baby an air enema which opened the intestines back up. He stayed through out the night and was discharged the next day. Between 5:00pm 10/26 and being admitted to the hospital 10/27 at 6:00pm he had only been able to keep down two ounces of formula. It should be noted that two weeks before baby started vomiting we thought he had severe colic and just spit up a lot and would scream for no reason.
Age: 63.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Drug administered at inappropriate site, Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Two vaccines injected at same site - site is too low for IM injection in deltoid (approx 3 " below).  Area  became red, hot, very swollen and tender.  Over next 24 hours symptoms spread to an area of redness, swelling and tenderness approximately 8" long and 6" wide around upper arm.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Pain, Palpitations, Pyrexia
Clinical narrative: Body aches, low grade fever, chills, heart racing, stomach ache.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported received flu shot now has tenderness, itching, and swelling to injection site 1.5in x 1.5in Acetaminophen 325mg, diphenhydramine 25mg night, loradamed 10mg day, hydrocortisone 1% prn for symptom and comfort control per package directions. Follow up with physician.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching & pain from axial to proximal right forearm.
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Immediate post-injection reaction, Pain, Peripheral swelling, Pruritus
Clinical narrative: Received flu shot 10/26/16 4 PM had pain immediately got MOTRIN within a few hours had redness on arm, swelling, pain, and itching. Maximum swelling on 10/28/16. 10/29/16 less redness, no pain, less swelling.
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Received flu shot 10/26/16 4 PM had pain immediately got MOTRIN within a few hours had redness on arm, swelling, pain, and itching. Maximum swelling on 10/28/16. 10/29/16 less redness, no pain, less swelling.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: 10/26/16 received Flu vaccine 4pm pain from swelling and blotchy face -> by 7pm pain itching redness and swelling to arm 10/28/16 max swelling and redness 10/29/16 No pain less redness less swelling.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: 10/26/16 received Flu vaccine 4pm pain from swelling and blotchy face -> by 7pm pain itching redness and swelling to arm 10/28/16 max swelling and redness 10/29/16 No pain less redness less swelling.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: 9 days after flu vaccine, developed numbness of (L) arm, worse as day progresses.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site oedema
Clinical narrative: Local erythema and edema of (L) thigh.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Erythema, Induration, Local reaction, Nodule
Clinical narrative: She experienced severe local reaction of erythema, edema, induration and nodule with peripheral vesicles and minor erosion where the band aid made contact. The site was limited to her upper left arm, primarily deltoid. Her arm was painful to move but maintained function. She treated it with ice and NSAIDS, although states she can only tolerate lower doses. She also had severe pain that was improved on NSAIDS. Onset was one day after receipt. Symptoms fully resolved in about a week. She did not take pictures.