chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 18-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL 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 1104 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: RV5
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 11-FEB-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to three temperature excursions, one for a sum of 24 hours with a lowest temperature recorded as -1 degree C; other for a sum of 48 hours with a lowest temperature recorded as 1 degree C and the last one for a sum of 72 hours with a highest temperature recorded as 9 degree 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 complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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 04-FEB-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to three temperature excursion, one for a sum of 216 hours with a lowest temperature recorded as 34 degree F (1.111111111 degree C); other for a sum of 24 hours with a lowest temperature recorded as 33 degree F (0.555555556 degree C) and another for a sum of 144 hours with a lowest temperature recorded as 31 degree F (-0.555555556 degree 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 complain involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Redness, swelling, warmth of right upper arm.
Sex: U
Vaccine: RV5
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 orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to two temperature excursions, one for a sum of 24 hours with a lowest temperature recorded as 33 degree F (0.555555556 degree C); and other for a sum of 136 hours with a lowest temperature recorded as 34 degree F (1.111111111). 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 complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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 19-JAN-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to three temperature excursions, one for a sum of 144 hours with the lowest temperature recorded as 31 degrees F (-0.555555556 degrees C); and other for a sum of 24 hours with a lowest temperature recorded as 33 degrees F (0.555555556 degrees C); and another for a sum of 216 hours with a lowest temperature recorded as 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 complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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 17-NOV-2014, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to three temperature excursions, one for a sum of 192 hours with a lowest temperature recorded as 34 degree F (1.111111111 degree C); other for a sum of 24 hours with a lowest temperature recorded as 33 degree F (0.555555556 degree C); and another for a sum of 144 hours with a lowest temperature recorded as 31 degree F (-0.555555556 degree 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 complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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 29-JUL-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to three temperature excursions, one for a sum of 144 hours with a lowest temperature recorded as 31 degrees F; (-0.555555556 degrees C), other for a sum of 24 hours with a lowest temperature recorded as 33 degrees F (0.555555556); and another for a sum of 240 hours with a lowest temperature recorded as 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 complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. On an unknown date (reported as "more than 2 years ago"), the patient was vaccinated with ZOSTAVAX (19400 plaque-forming units (PFU), lot number, dose and route were unknown). In approximately 2014 (reported as "about 2 years ago"), the patient experienced alopecia. The patient had been treated by an unspecified healthcare provider beginning on an unspecified date. The reporter did not know if the patient's condition improved or worsened. The patient's alopecia had not resolved as of 26-OCT-2016. The causality between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
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 condition or concomitant therapies were not reported. On 11-DEC-2014, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to two temperature excursions, one for a sum of 48 hours with a lowest temperature recorded as 1 degree C and other for a sum of 72 hours with a highest temperature recorded as 9 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 complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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 15-APR-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to four temperature excursions, one for a sum of 48 hours with a lowest temperature recorded as 1 degree C; other for a sum of 72 hours with a highest temperature recorded as 9 degrees C; another for a sum of 24 hours with a lowest temperature recorded as -1 degree C, and the last one for a sum of 48 hours with a lowest temperature recorded as 0 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 complain involved. 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: This spontaneous report was received on 12-OCT-2016 from a licensed practical nurse who reported that multiple unspecified patients (gender and age not specified) received improperly stored vaccines on either 11-OCT-2016 or 12-OCT-2016. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On 11-OCT-2016 or 12-OCT-2016, the patients received improperly stored GARDASIL 9 (Lot number M023169, expiration date 13-JUN-2018). Temperature was reported as 34.8 degrees Fahrenheit. Time frame was reported as 5 hours 22 minutes. The vaccines were reported as administered. There was no previous temperature excursion. The Call was because of data logger. No adverse effects was reported. No additional information was available. No product quality complaint involved. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: RV5
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 12-FEB-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to four temperature excursion, one for a sum of 48 hours with a lowest temperature recorded as 1 degree C; other for a sum of 72 hours with a highest temperature recorded as 9 degree C; another for a sum of 24 hours with a lowest temperature recorded as -1 degree C; and the last one for a sum of 16 hours with a lowest temperature recorded as 0 degree 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 complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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 09-SEP-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to four temperature excursions, one for a sum of 24 hours with a lowest temperature recorded as -1 degree C; other for a sum of 48 hours with a lowest temperature recorded as 0 degree C; another for a sum of 48 hours with a lowest temperature recorded as 1 degree C, and the last one for a sum of 72 hours with a highest temperature recorded as 9 degree 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 complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapies were not reported. On 30-AUG-2016, the patient was administered a dose of PNEUMOVAX 23 injection (lot#, expiration date, dose and route unknown, in arm). While administering, the vaccine sprayed out of the syringe barrel and the patient did not received a completed dose. The pharmacist confirmed that the PNEUMOVAX 23 vaccine did not make skin contact with either pharmacist or the patient. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 12-OCT-2016 from a licensed practical nurse who reported that multiple unspecified patients (gender and age not specified) received improperly stored vaccines on either 11-OCT-2016 or 12-OCT-2016. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On 11-OCT-2016 or 12-OCT-2016, the patients received improperly stored ROTATEQ (Lot number M007298, expiration date 19-NOV-2017) (Lot number M007298, expiration date 19-NOV-2017). Temperature was reported as 34.8 degrees Fahrenheit. Time frame was reported as 5 hours 22 minutes. The vaccines were reported as administered. There was no previous temperature excursion. The Call was because of data logger. No adverse effects was reported. No additional information was available. No product quality complaint involved. This is one of several reports received from same reporter. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 12-OCT-2016 from a licensed practical nurse who reported that multiple unspecified patients (gender and age not specified) received improperly stored vaccines on either 11-OCT-2016 or 12-OCT-2016. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On 11-OCT-2016 or 12-OCT-2016, the patients received improperly stored RECOMBIVAX (Lot number M029233, expiration date 09-AUG-2018). Temperature was reported as 34.8 degrees Fahrenheit. Time frame was reported as 5 hours 22 minutes. The vaccines were reported as administered. There was no previous temperature excursion. The Call was because of data logger. No adverse effects was reported. No additional information was available. No product quality complaint involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number, dose and route were unknown). On an unknown date the patient experienced pain. The patient was still experiencing pain 5 months after the vaccine was administered. At the time of report, the outcome of the pain was unknown. The causality between the event and PNEUMOVAX 23 was unspecified. No PQC was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number, dose and route were unknown). On an unknown date the patient experienced pain. The pain was so severe that she was given a TORADOL injection and prednisone to treat the pain. The outcome and causality of the event was not provided. No PQC was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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 23-MAR-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP2-2015. This vaccine was improperly stored exposed to three temperature excursions, one for a sum of 144 hours with a lowest temperature recorded as 31 degrees F (-0.555555556); other for a sum of 24 hours with a lowest temperature recorded as 33 degrees F (0.555555556 degrees C); and another for a sum of 216 hours with a lowest temperature recorded as 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 complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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 11-SEP-2014, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to two temperature excursions, one for a sum of 168 hours with the lowest temperature recorded as 34 degrees F (1.111111111 degrees C); and other for a sum of 24 hours with a lowest temperature recorded as 33 degrees F (0.555555556 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 complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Nuclear magnetic resonance imaging, Rotator cuff syndrome
Clinical narrative: The vaccine was injected in a location on the arm close to the shoulder socket, above the correct location where the vaccination should have been administered.  This resulted in tearing of the tendons/ligaments in the shoulder. Treatment consisted of several steroid injections and 6 months of continuous physical therapy.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Hypoaesthesia, Peripheral coldness, Rash pruritic, Tremor
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 19 Oct 2016. This case involves a 70-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose: not reported) by intramuscular route in left deltoid on 12 Oct 2015. Patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to Sulfa and PCN (penicillin). On 12 Oct 2015, by the evening same day following the vaccination, the patient reported having severe shaking, chills, numbness in her fingers and toes, and had a burning sensation in her hands. On 13 Oct 2015, one day following vaccination in the morning , she woke up with bumps on her head and widespread over her body, the bumps were raised and itchy, but not red and felt crumby the whole second day. The patient's lab tests was reported as none. Corrective treatment was not reported. On 13 Oct 2015, in the morning the numbness in the fingers and toes subsided, on 14 Oct 2015, by day 3 following vaccination, all other symptoms had cleared and patient recovered from all the events. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Chills, Feeling abnormal, Hypoaesthesia, Rash generalised
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 19 Oct 2016. This case involves a 70-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose: not reported) by intramuscular route in left deltoid on 12 Oct 2015. Patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to Sulfa and PCN (penicillin). On 12 Oct 2015, by the evening same day following the vaccination, the patient reported having severe shaking, chills, numbness in her fingers and toes, and had a burning sensation in her hands. On 13 Oct 2015, one day following vaccination in the morning , she woke up with bumps on her head and widespread over her body, the bumps were raised and itchy, but not red and felt crumby the whole second day. The patient's lab tests was reported as none. Corrective treatment was not reported. On 13 Oct 2015, in the morning the numbness in the fingers and toes subsided, on 14 Oct 2015, by day 3 following vaccination, all other symptoms had cleared and patient recovered from all the events. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash pruritic, Tremor
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 19 Oct 2016. This case involves a 70-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose: not reported) by intramuscular route in left deltoid on 12 Oct 2015. Patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to Sulfa and PCN (penicillin). On 12 Oct 2015, by the evening same day following the vaccination, the patient reported having severe shaking, chills, numbness in her fingers and toes, and had a burning sensation in her hands. On 13 Oct 2015, one day following vaccination in the morning , she woke up with bumps on her head and widespread over her body, the bumps were raised and itchy, but not red and felt crumby the whole second day. The patient's lab tests was reported as none. Corrective treatment was not reported. On 13 Oct 2015, in the morning the numbness in the fingers and toes subsided, on 14 Oct 2015, by day 3 following vaccination, all other symptoms had cleared and patient recovered from all the events. List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Pruritus, Rash generalised
Clinical narrative: Information has been received from a 74 year old female consumer referring to herself. The patient's concurrent condition included bipolar, blood pressure abnormal, cough and acid reflux. Concomitant therapy included FLUZONE (reported as FLOZONE), donepezil, cough medication (unknown by reporter) and acid reflux medication (unknown by reporter). The patient did not have drug reactions. On 27-SEP-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot# unknown) intravenously. On 28-SEP-2016, within 24 hours of having ZOSTAVAX administered, the patient experienced an intense rash with properties of hives. It was also reported that they resembled "small measles" and run from the patient's torso down to thighs. The patient sought unspecified medical attention and unspecified treatment was given for the events. Lung examination was performed (result unknown). The outcome of the events was unknown. Causality was not provided. Additional information is not expected as there was no consent for follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, FLU3, VARZOS
Symptoms: Incorrect route of drug administration, Pulmonary physical examination, Rash, Rash morbilliform, Urticaria
Clinical narrative: Information has been received from a 74 year old female consumer referring to herself. The patient's concurrent condition included bipolar, blood pressure abnormal, cough and acid reflux. Concomitant therapy included FLUZONE (reported as FLOZONE), donepezil, cough medication (unknown by reporter) and acid reflux medication (unknown by reporter). The patient did not have drug reactions. On 27-SEP-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot# unknown) intravenously. On 28-SEP-2016, within 24 hours of having ZOSTAVAX administered, the patient experienced an intense rash with properties of hives. It was also reported that they resembled "small measles" and run from the patient's torso down to thighs. The patient sought unspecified medical attention and unspecified treatment was given for the events. Lung examination was performed (result unknown). The outcome of the events was unknown. Causality was not provided. Additional information is not expected as there was no consent for follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, FLU3, VARZOS
Symptoms: Rash morbilliform, Urticaria
Clinical narrative: Information has been received from a 74 year old female consumer referring to herself. The patient's concurrent condition included bipolar, blood pressure abnormal, cough and acid reflux. Concomitant therapy included FLUZONE (reported as FLOZONE), donepezil, cough medication (unknown by reporter) and acid reflux medication (unknown by reporter). The patient did not have drug reactions. On 27-SEP-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot# unknown) intravenously. On 28-SEP-2016, within 24 hours of having ZOSTAVAX administered, the patient experienced an intense rash with properties of hives. It was also reported that they resembled "small measles" and run from the patient's torso down to thighs. The patient sought unspecified medical attention and unspecified treatment was given for the events. Lung examination was performed (result unknown). The outcome of the events was unknown. Causality was not provided. Additional information is not expected as there was no consent for follow up.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Dysphagia
Clinical narrative: Dysphagia.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood test, Computerised tomogram, Fontanelle bulging, Pyrexia, Ultrasound scan
Clinical narrative: Fever over 101° and bulging fontanelle. He was sent to hospital after being evaluated at multicare, where they accused me of shaking him instead of taking responsibility for the adverse effects of the vaccines. He had ultrasounds done on his head and got a CT scan at the hospital.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain, Pain in extremity, Spinal X-ray
Clinical narrative: Constant aching pain from shot area, traveling to whole arm, shoulder and neck.  On scale from 1 to 10 would said 9 being extreme pain, still to this day 11/1/2016.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Increasing shoulder pain near injection site with decreasing range of pain free motion.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Induration, Urticaria
Clinical narrative: Initial unsolicited report received from a non health care professional (office staff) on 20 Oct 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE INTRADERMAL QUADRIVALENT (batch number, expiration date, dose, site and route were not reported) on an unspecified date. Patient medical history and concomitant medication was not reported. On an unspecified date, post vaccination; the patient experienced hard red welt under the skin. Lab data and corrective treatment was not reported. The patient was not yet recovered from the events (reported as still having events six weeks after administration). List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016463882) on 20-Oct-2016. This case involves a male patient (age not reported) who was vaccinated with INFLUENZA VACCINE (FLU VACCINE) (batch number, expiry date, dose, dose in series, route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, unknown timeframe following the vaccination, patient developed allergy. Lab test and corrective treatment was not reported. The outcome of the events was not reported. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Cough
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016462433)  on 20-OCT-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date ("two-three days ago"), following the vaccination patient experienced coughing like crazy. Lab data was not reported. Corrective treatment included Robitussin (it was reported that patient received expired dose of Robitussin with expiry date of APR-2016). The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a consumer on 19 October 2016. This case involves a female patient (age not reported) vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (Batch number, expiration date, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient experienced severe pain in the shoulder. Laboratory examinations were not reported. Corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 21 Oct 2016. Manufacturer control number: 2016464978. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, route, expiry date, dose and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, after vaccination the patient had developed tenderness in her arm at the injection site with flu shot. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash starting on back and spreading to extremities and right side of face; no fever or other reported symptoms; advised to call/see pediatrician to ensure related to immunizations.
Age: 35.0
Sex: F
Vaccine: JEV1
Symptoms: Insomnia, Joint range of motion decreased, Pain in extremity
Clinical narrative: After receiving Japanese Encephalitis vaccine, severe pain level 10. Loss of range of motion. Loss of strength in left arm. Loss of sleep due to pain in arm radiating to elbow during sleep. Pain radiates up to shoulder when carrying or lifting weight of 15 or more pounds. Followed up with Doctor at Clinic on 13 September 2016.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Child had fever of 102, given Tylenol, fever now down to 100.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Pt had redness/inflammation/pain at site that was getting worse over two days. Per provider pt did not require an exemption.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Heart rate increased
Clinical narrative: Headache, dizziness, fast heartbeat.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Headache, Laboratory test normal, Neuropathy peripheral, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial unsolicited report received from a consumer on 20 October 2016. This case involves a 50 year old male patient, who was vaccinated with a dose of FLUZONE Quadrivalent (batch number: UI440AD, expiry date: 14 August 2016, dose, dose in series, form and site of administration were not reported) via intramuscularly on 11 September 2015. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Patient's medical history and Concomitant medications were not reported. On 11 September 2015, same time following the vaccination, the patient developed tinnitus with continuous anxiety for 6-8 months. On an unknown date, following the vaccination, the patient developed peripheral neuropathy and a persistent low grade headache. It was reported that the patient had gone to ear, nose and tongue (ENT) doctor and to a neurologist for MRI, performed lab and other tests which were all in normal range. The patient required a doctor visit. Corrective treatment included Tylenol. On an unspecified date, the patient had recovered from headache and the outcome for all other events was not recovered/not resolved. List of documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: Initial unsolicited report received from a consumer on 20 October 2016. This case involves a 50 year old male patient, who was vaccinated with a dose of FLUZONE Quadrivalent (batch number: UI440AD, expiry date: 14 August 2016, dose, dose in series, form and site of administration were not reported) via intramuscularly on 11 September 2015. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Patient's medical history and Concomitant medications were not reported. On 11 September 2015, same time following the vaccination, the patient developed tinnitus with continuous anxiety for 6-8 months. On an unknown date, following the vaccination, the patient developed peripheral neuropathy and a persistent low grade headache. It was reported that the patient had gone to ear, nose and tongue (ENT) doctor and to a neurologist for MRI, performed lab and other tests which were all in normal range. The patient required a doctor visit. Corrective treatment included Tylenol. On an unspecified date, the patient had recovered from headache and the outcome for all other events was not recovered/not resolved. List of documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: Computerised tomogram, Urinary tract infection
Clinical narrative: Case number PHEH2016US027834, is an initial spontaneous report received from a consumer on 25 Oct 2016. This report refers to a 45 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX (batch number: not reported) at a dose of 0.5 ml intramuscularly on 10 Oct 2016. On 13 Oct 2016 (reported as in the same week), the patient experienced urinary tract infection. The patient had computer tomography (CT) scan (results unspecified) and was on antibiotics (unspecified) for his infection. The outcome of the event was reported as condition improving. The seriousness of the event was reported as serious (medically significant and disability) by the consumer. The causality of the event was not reported.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Drug administered at inappropriate site
Clinical narrative: Information has been received from a pharmacist referring to a male patient of unknown age. No relevant medical history or concurrent conditions were reported. On 18-DEC-2015, the patient was vaccinated with ZOSTAVAX 19400 plaque forming unit (PFU) (subcutaneous; lot#, expiration date and dose were not reported) and a dose of influenza virus vaccine inactivated (unspecified) at an unspecified pharmacy. The ZOSTAVAX was administered on the back underside of the patient's arm by his elbow (product use issue). The reporter stated that the patient came to the pharmacy for another flu shot. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Haematoma, Joint swelling, Skin warm
Clinical narrative: Oct 21, 2016, nurse called to spoke to RPH that HS. Patient got a flu shot the day before and developed a distal (not localized) swelling at wrist area. Warm to touch/red, no fever, the redness started the night of the flu shot and was more so the next day, the nurse contacted the doctor. Pt was ok (contact him on 10/14 and 10/25).
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Reports swelling of arm to elbow, unable move-redness-took ALEVE and BENADRYL and applied ice which helped.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling, tenderness (4" in diameter) of left arm at site of injection.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Injection site reaction
Clinical narrative: Pt. has prolonged pain and weakness in his should at site of vaccine.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Received the flu shot on 10/7/16. On 10/21/16-Became symptomatic for Bell's Palsy. (She was prescribed Prednisone and Acyclovir).
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling of right arm from elbow up no redness/ pain. Symptoms currently being relieved w/ice.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Immediate post-injection reaction, Nodule, Pain, Peripheral swelling
Clinical narrative: Pt bled freely and immediately a large knot came up on her arm. Pressure was applied and bleeding was stopped. Ice was applied to her arm to help w/swelling. Called today pt ok just sore.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: Pt requested preservative free flu shot and while getting vaccine ready. I picked up pediatric box instead of adult flu shot.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Since vaccination patient reports arm pain that has persisted even with day to day activity.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site joint movement impairment, Pain in extremity
Clinical narrative: PREVNAR 13 arm hurt for 5 days. Ice on spot for 2 days and unable to move elbow those days.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient contacted me reporting soreness in the back of her arm and shoulder, appearing one week after flu vaccine. It is relieved when taking ibuprofen but after 3 weeks she is concerned. Advised to seek medical evaluation.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site paraesthesia, Musculoskeletal stiffness, Nasopharyngitis, Pain in extremity
Clinical narrative: Left arm stiffness & soreness, fever, exhaustion Thursday evening (10/27) to Sunday 10/30. Thursday night 10/27 aching and left arm tingling from left upper central arm to fingertips x 4 days, decreased to localized tingling in center of upper left arm on 11/1/16; cold symptoms 10/30-present.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Left arm stiffness & soreness, fever, exhaustion Thursday evening (10/27) to Sunday 10/30. Thursday night 10/27 aching and left arm tingling from left upper central arm to fingertips x 4 days, decreased to localized tingling in center of upper left arm on 11/1/16; cold symptoms 10/30-present.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Joint swelling, Peripheral swelling, Skin warm
Clinical narrative: Patient came in with swollen left thigh and knee and was hot to the touch. The whole thigh was swollen. No fever.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Rash macular
Clinical narrative: Rash, slight swelling at injection site on left arm, blotches with redness.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: 12 hrs after receiving vaccine, he began to have hives and itching to left arm and left side of abdomen. Was at home and took BENADRYL 50mg. Saw NP on 10/26/16 with one 5x3cm whelp on left arm. Told to use topical steroid and oral antihistamine.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest pain, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal disorder
Clinical narrative: 3 days post PNEUMOVAZ 23 entire top of arm is red, swollen, hot, sore. Decrease function of arm/hand (left). Complaining of chest pain on and off since vaccination. I recommend pt go to ER.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: 3 days post PNEUMOVAZ 23 entire top of arm is red, swollen, hot, sore. Decrease function of arm/hand (left). Complaining of chest pain on and off since vaccination. I recommend pt go to ER.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall
Clinical narrative: Became light headed and fell out of chair face first.
Age: 14.0
Sex: M
Vaccine: FLUX, HPVX
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, exhaustion, fever.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis
Clinical narrative: Employee called from doctor office (pcp) to report to us that the patient had a cellulitis infection in the arm that the immunizations were administered in.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Shot was given much higher on my arm than normal.  Since then, I have been in pain and unable to sleep on that side or lift my arm without hurting.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Reported prolonged soreness in arm after injection. Lasted several weeks.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Fibromyalgia, Neck pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of neck pain in a 17-year-old female patient who received BEXSERO. Concomitant products included MENVEO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, 14 days after receiving BEXSERO, the patient experienced neck pain (serious criteria other: as per reporter), fatigue (serious criteria other: as per reporter) and fibromyalgia (serious criteria other: as per reporter). On an unknown date, the outcome of the neck pain, fatigue and fibromyalgia were recovered/resolved. The reporter considered the neck pain, fatigue and fibromyalgia to be related to BEXSERO. Additional details were reported as follows: This case was previously reported to a doctor. The age at vaccination was not reported. About 2 and a half weeks after receiving BEXSERO, the patient experienced the noted side effects. The patient was seen at the local emergency room, but it was not known by the sales representative if the patient was admitted. The sales representative stated about a meningococcal quadrivalent product, which was believed to be MENVEO. The reporter was not sure when the MENVEO was received by the patient. All the questions were asked but limited information was provided by the representative.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm has been very sore since administration. She is still having pain and difficulty moving her arm in certain positions. She is seeing her PCP for follow up.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Chest pain, Pain in extremity
Clinical narrative: The evening after getting the vaccine started having pain in armpit that radiated down arm to fingertips.  Woke up in night with pain on left side of chest from sternum to lateral side.
Age: 41.0
Sex: F
Vaccine: FLUR3
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Skin discolouration
Clinical narrative: After injection light rash appeared on both arms with bumps. Itching on right shoulder above where vaccine was given. Face itching a little, face already pink but got a little darker pink.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: PATIENT WAS GIVEN FLU 3+YRS PATIENT WAS ONLY 2YRS 10M AT TIME OF VACCINATION. THERE WAS NO ADVERSE REACTION TO THE DOSE.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: PATIENT WAS VACCINATED WITH FLU 3+ AND WAS ONLY 2Y 10M AT THE TIME OF THE VACCINATION THERE WAS NO ADVERSE REACTION TO THIS DOSE.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Right shoulder stiffness and pain. rRduction in range of motion for 2+ weeks.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Medication error, No adverse event
Clinical narrative: KINRIX was given to patient. There was no adverse reaction to the patient.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Prolonged soreness in arm after injection, ongoing.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Pain in extremity
Clinical narrative: Prolonged soreness in arm. Her arm is still sore. She also stated that she had a white patchy area over injection site.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Chest X-ray, Dyspnoea, Hyperhidrosis, Oxygen saturation decreased, Urticaria
Clinical narrative: Patient returned to office less than 5 minutes after receiving a flu vaccine with diffuse urticaria and SOB and wheezing and diaphoresis. Chest exam with decreased O2 and wheezing. Given EPIPEN in office and 1 dose of CLARITIN with immediate improvement in symptoms. Taken to ER for observation and further eval.