chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: RASH, ITCHING, UNKNOWN IF RELATED TO VACCINE OR HOTEL STAY.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: CSF cell count normal, CSF oligoclonal band, CSF virus no organisms observed, Enterovirus test negative, Herpes simplex serology negative
Clinical narrative: Lower extremity weakness noticed on 12/05/15, 6 days following 6 month immunizations including flu. Diagnosed with longitudinal transverse myelitis from C4-T2. Infectious etiologies mostly ruled out at time of report. NMO and oligoclonal bands still pending. Responding quite well symptomatically on day 3 of steroid burst. Considering IVIG.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Human rhinovirus test positive, Muscular weakness, Myelitis transverse, Polymerase chain reaction, West Nile virus test negative
Clinical narrative: Lower extremity weakness noticed on 12/05/15, 6 days following 6 month immunizations including flu. Diagnosed with longitudinal transverse myelitis from C4-T2. Infectious etiologies mostly ruled out at time of report. NMO and oligoclonal bands still pending. Responding quite well symptomatically on day 3 of steroid burst. Considering IVIG.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: RASH, ITCHING UNKNOWN IF RELATED TO VACCINE OR HOTEL STAY.
Age: 1.27
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Electroencephalogram normal, Febrile convulsion, Influenza virus test, Streptococcus test, Viral test
Clinical narrative: Complex Febrile Seizure lasting 12 minutes. Admission to the hospital, EEG that came back normal.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction, Skin lesion
Clinical narrative: Pt. developed a rash with lesions at injection site.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: *PATIENT recieved a FLU shot back on 10/30/2015. Patient came back in on 12/10/2015 (41 days later) and claims her arm is still sore and she thinks it may have something to do with the FLU shot. She initially claimed that the medicine went into her muscle and that she did not feel right. When it was explained to her that it is in fact an INTRAMUSCULAR INJECTION, she then claimed that perhaps it was injected "TOO HIGH" on her arm. She and her husband appeared to be looking for some sort of compensation. Pharmacist on duty (me) looked at her arm and there NO SIGNS of swelling or infection whatsoever. Patient was advised to see her MD and this could be unrelated to the FLU shot but patient insisted that she felt the FLU shot is responsible for her shoulder being sore.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient came in a couple days after the shot with swelling and redness (about 3 inches in diameter) closer to her bicep (about 4 inches below injection site). Patient reported having a similar reaction to an influenza shot, which went away.  I recommended that she took Benadryl and to seek urgent care if it gets any worse. Patient told me afterwards that she went to the hospital.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Injection site pain, Malaise, Pain
Clinical narrative: Initially malaise & general aches, subsequently fever >101F, greater pain, felt like I would pass out during evening even with head between knees, soreness at injection location. Still weak next morning, mostly recovered in 24 hrs except slight weakness and site of injection.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initially malaise & general aches, subsequently fever >101F, greater pain, felt like I would pass out during evening even with head between knees, soreness at injection location. Still weak next morning, mostly recovered in 24 hrs except slight weakness and site of injection.
Sex: U
Vaccine: MENB
Symptoms: Blindness unilateral
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of loss of vision in a adolescent patient who received BEXSERO (batch number 146101, expiry date April 2016). On 9th April 2015, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced loss of vision (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of vision was unknown. It was unknown if the reporter considered the loss of vision to be related to BEXSERO. Additional details were provided as follows: The patient was 11 or 15 years old. The patient experienced loss of vision in left eye. This case was linked to case US2015GSK173020 (same reporter).
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Mobility decreased, Swelling
Clinical narrative: Information has been received from a pharmacist referring to an 84 year old female patient with high blood pressure. The patient had no drug allergies. The patient received a dose of PREVNAR on 07-AUG-2015. On 07-DEC-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K009876 with expired date 19-MAR-2016, 0.5 ml, intramuscular) in the arm. Concomitant therapies included some unspecified high blood pressure medications. On the same day (overnight), the patient developed "excruciating pain" (from injection site to elbow), redness and swelling. The patient applied ice to arm and took ADVIL. No lab tests were performed. The patient visited the pharmacy for medical attention. The reporter stated that she planned to contact the patient's primary care physician about experience and treatment options. The events were considered as significant disability by the patient as she could not move her arm at all. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 15cm round raised warm area of induration without discharge at site of injection 1 week after administration.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Mother of patient called at 846 am 12-10-15, stating swelling in left leg "size of tennis ball" and warm to touch. Pain in leg. No fever. No limp. Seen by physician at 250 pm 12-10-15. 14cm x 7 cm. KEFLEX and BENADRYL started.
Age: 47.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Burning sensation, Injection site erythema, Injection site pain
Clinical narrative: Patient reported injection site pain erythema starting approximately 2 hrs post injection. She then developed burning sensation at the site that radiate down to radial wrist. Burning with pain have persisted.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood test, Computerised tomogram, Injection site mass, Injection site rash, Scan
Clinical narrative: (One) lump appeared below where shot was administered that appeared 2 day)  after vaccine. When lump disappeared after ER visit on Sat; On Monday 2  4inch radius rash appeared that last 4 1/2 weeks.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Urine analysis
Clinical narrative: (One) lump appeared below where shot was administered that appeared 2 day)  after vaccine. When lump disappeared after ER visit on Sat; On Monday 2  4inch radius rash appeared that last 4 1/2 weeks.
Age: 21.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Asthenia, Chills, Fatigue, Myalgia, Pain
Clinical narrative: Achy, feverish, myalgias and shivering over the course of approximately 5 hours, at which point pt. slept for the night. Upon awakening today, continues with fatigue and weakness, no fever.
Age: 21.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Pyrexia
Clinical narrative: Achy, feverish, myalgias and shivering over the course of approximately 5 hours, at which point pt. slept for the night. Upon awakening today, continues with fatigue and weakness, no fever.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Blood pressure fluctuation, Dizziness, Erythema, Headache, Mobility decreased
Clinical narrative: Had PREVNAR 13 on 11/09/15. Days after immunization noted swelling, redness, pain, itchiness, tightness with moving arm, no heat or ice were effective. Took extra loratadine (20 mg) - no effect. States BP also up/down since then. Reported headache on 11/12 worse than normal. Has had headaches for the last over a year and had work up for that. But today it is worse and even got dizzy when leaned down. Denies fever, chill. Ibuprofen 600 mg TID.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Had PREVNAR 13 on 11/09/15. Days after immunization noted swelling, redness, pain, itchiness, tightness with moving arm, no heat or ice were effective. Took extra loratadine (20 mg) - no effect. States BP also up/down since then. Reported headache on 11/12 worse than normal. Has had headaches for the last over a year and had work up for that. But today it is worse and even got dizzy when leaned down. Denies fever, chill. Ibuprofen 600 mg TID.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Feeling cold, Vomiting
Clinical narrative: Vomiting, severe chills and feeling cold "felt awful".
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Has local reaction on left deltoid c/w warm, erythema, swelling, firmness. No evidence of secondary infection/cellulitis. No systemic reaction.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Flu shot - Friday am arm was red and swollen by Sat PM. Went to urgent care on Sun AM. Arm was swelling from shoulder to elbow. Patient was given TYLENOL and BENADRYL. Allergy doctor is following up: possible allergy to vaccine.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient reported swelling of arm below injection site and increased temperature of skin on arm. She took BENADRYL and symptoms resolved after a few hours.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K007826, expiration date 03-FEB-2016) (dosage, strength and route not reported). There was no concomitant medication reported. No adverse symptoms was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. There was no concomitant medication reported. On unknown dates the patients received doses of improperly stored ZOSTAVAX (lot # L011533, expiration date 03-JUL-2016) (dosage, strength and route not reported). There was no concomitant medication reported. No adverse effects was reported. This is one of two cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. There was no concomitant medication reported. On unknown dates the patients received doses of improperly stored VARIVAX (Merck) (lot # L001335, expiration date 13-JAN-2016; lot # L021215, expiration date 10-JUN-2017; lot # K005428, expiration date 15-APR-2016) (dosage, strength and route not reported). There was no concomitant medication reported. No adverse effects was reported. This is one of two cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On unspecified dates the patient received two doses of GARDASIL (lot#, dose and route not reported). The healthcare worker reported that the patient was present in the office to received the final dose in the series (on the reporting day, 09-DEC-2015) and it was likely that the patient would get a dose of GARDASIL 9 (lot#, dose and route not reported) to complete the series (interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. On unknown dates, the unspecified patients were administered improperly stored doses of VARIVAX (Merck) (lot reported as L026411, expiry date 15-FEB-2017; lot L020004, expiry date 02-JUN-2017). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood test, Groin pain, Musculoskeletal pain, Myalgia
Clinical narrative: This spontaneous report has been received from a male patient of unknown age, who was reporting on himself. The patient's pertinent medical history and drug reactions or allergies were not reported. On 28-SEP-2014, the patient was vaccinated with an unknown dose of ZOSTAVAX (route, lot # and expiry date were not reported). On an unknown date in September 2014, the patient was vaccinated with an unknown dose of PNEUMOVAX 23 (route, lot # and expiry date were not reported) (secondary suspect therapy also reported as concomitant). Concomitant medications included unspecified blood pressure medication. On 28-SEP-2014, the patient experienced extreme muscle, hip and shoulder pain, as well as a deep pain in his groin area. The patient sought medical attention and, on an unknown date, he was hospitalized. While hospitalized, the patient was given intravenous steroids and oral prednisone (manufacturer unknown) at unknown doses and frequency to relieve symptoms. On an unknown date, the patient recovered and he was "free of symptoms" for about one year. On an unknown date in 2015, he had a recurrence of the same symptoms and he was sent to the same hospital. During the second hospitalization, he was given oral prednisone (manufacturer unknown) at an unknown dose and frequency. Magnetic resonance imaging (MRI) and blood test were performed on an unknown date (results were not reported). The patient was hospitalized for 4 days (it was unspecified if it referred to the first or the second hospitalization). The outcome of muscle, hip, shoulder and groin pain (started in 2015) was reported as not recovered. The relatedness between muscle, hip, shoulder and groin pain (started in 28-SEP-2014 and in 2015) and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report has been received from a male patient of unknown age, who was reporting on himself. The patient's pertinent medical history and drug reactions or allergies were not reported. On 28-SEP-2014, the patient was vaccinated with an unknown dose of ZOSTAVAX (route, lot # and expiry date were not reported). On an unknown date in September 2014, the patient was vaccinated with an unknown dose of PNEUMOVAX 23 (route, lot # and expiry date were not reported) (secondary suspect therapy also reported as concomitant). Concomitant medications included unspecified blood pressure medication. On 28-SEP-2014, the patient experienced extreme muscle, hip and shoulder pain, as well as a deep pain in his groin area. The patient sought medical attention and, on an unknown date, he was hospitalized. While hospitalized, the patient was given intravenous steroids and oral prednisone (manufacturer unknown) at unknown doses and frequency to relieve symptoms. On an unknown date, the patient recovered and he was "free of symptoms" for about one year. On an unknown date in 2015, he had a recurrence of the same symptoms and he was sent to the same hospital. During the second hospitalization, he was given oral prednisone (manufacturer unknown) at an unknown dose and frequency. Magnetic resonance imaging (MRI) and blood test were performed on an unknown date (results were not reported). The patient was hospitalized for 4 days (it was unspecified if it referred to the first or the second hospitalization). The outcome of muscle, hip, shoulder and groin pain (started in 2015) was reported as not recovered. The relatedness between muscle, hip, shoulder and groin pain (started in 28-SEP-2014 and in 2015) and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Cellulitis, Dysphagia, Erythema, Injection site swelling, Throat irritation
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of allergic reaction in a child patient who received BOOSTRIX. Concomitant products included MENVEO. On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced allergic reaction, itchy throat, swallowing difficult, injection site swelling and erythema. On an unknown date, the outcome of the allergic reaction, itchy throat, swallowing difficult, injection site swelling and erythema were unknown. It was unknown if the reporter considered the allergic reaction, itchy throat, swallowing difficult, injection site swelling and erythema to be related to BOOSTRIX. Additional details were received as follows: The patient had received BOOSTRIX and MENVEO in the same arm (unknown deltoid). The patient experienced an allergic reaction, swollen deltoid, red streak down the arm, itchy throat and trouble swallowing. The reporter did not have patient information or any further information. Follow-up information received on 4th December 2015: This case was identified as a duplicate of case PHEH2015US020022. The case PHEH2015US020022 would be deleted and the present case would be kept as the case of record. The duplicate case received included the following information: The patient details were updated. On 30th September 2015, the patient received BOOSTRIX (batch number 9NA32, intramuscularly) .5 ml and the 1st dose of MENVEO (batch number A15032, intramuscularly) .5 ml, both in the left deltoid. On 1st October 2015, 1 days after receiving BOOSTRIX and MENVEO, the patient was seen in urgent care for left arm redness and swelling of the throat. On 2nd October 2015, the patient was seen in the emergency room for increased redness of left arm and numbness to upper left extremity down to hand with some paresthesias. The events were considered to be life threatening and clinically significant/intervention required. The events were possibly related to MENVEO. The patient did not underwent any laboratory tests. At the time of reporting, the events were resolved.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dysphagia, Erythema, Hypersensitivity, Hypoaesthesia, Injection site erythema
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of allergic reaction in a child patient who received BOOSTRIX. Concomitant products included MENVEO. On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced allergic reaction, itchy throat, swallowing difficult, injection site swelling and erythema. On an unknown date, the outcome of the allergic reaction, itchy throat, swallowing difficult, injection site swelling and erythema were unknown. It was unknown if the reporter considered the allergic reaction, itchy throat, swallowing difficult, injection site swelling and erythema to be related to BOOSTRIX. Additional details were received as follows: The patient had received BOOSTRIX and MENVEO in the same arm (unknown deltoid). The patient experienced an allergic reaction, swollen deltoid, red streak down the arm, itchy throat and trouble swallowing. The reporter did not have patient information or any further information. Follow-up information received on 4th December 2015: This case was identified as a duplicate of case PHEH2015US020022. The case PHEH2015US020022 would be deleted and the present case would be kept as the case of record. The duplicate case received included the following information: The patient details were updated. On 30th September 2015, the patient received BOOSTRIX (batch number 9NA32, intramuscularly) .5 ml and the 1st dose of MENVEO (batch number A15032, intramuscularly) .5 ml, both in the left deltoid. On 1st October 2015, 1 days after receiving BOOSTRIX and MENVEO, the patient was seen in urgent care for left arm redness and swelling of the throat. On 2nd October 2015, the patient was seen in the emergency room for increased redness of left arm and numbness to upper left extremity down to hand with some paresthesias. The events were considered to be life threatening and clinically significant/intervention required. The events were possibly related to MENVEO. The patient did not underwent any laboratory tests. At the time of reporting, the events were resolved.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site swelling, Paraesthesia, Pharyngeal oedema, Throat irritation
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of allergic reaction in a child patient who received BOOSTRIX. Concomitant products included MENVEO. On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced allergic reaction, itchy throat, swallowing difficult, injection site swelling and erythema. On an unknown date, the outcome of the allergic reaction, itchy throat, swallowing difficult, injection site swelling and erythema were unknown. It was unknown if the reporter considered the allergic reaction, itchy throat, swallowing difficult, injection site swelling and erythema to be related to BOOSTRIX. Additional details were received as follows: The patient had received BOOSTRIX and MENVEO in the same arm (unknown deltoid). The patient experienced an allergic reaction, swollen deltoid, red streak down the arm, itchy throat and trouble swallowing. The reporter did not have patient information or any further information. Follow-up information received on 4th December 2015: This case was identified as a duplicate of case PHEH2015US020022. The case PHEH2015US020022 would be deleted and the present case would be kept as the case of record. The duplicate case received included the following information: The patient details were updated. On 30th September 2015, the patient received BOOSTRIX (batch number 9NA32, intramuscularly) .5 ml and the 1st dose of MENVEO (batch number A15032, intramuscularly) .5 ml, both in the left deltoid. On 1st October 2015, 1 days after receiving BOOSTRIX and MENVEO, the patient was seen in urgent care for left arm redness and swelling of the throat. On 2nd October 2015, the patient was seen in the emergency room for increased redness of left arm and numbness to upper left extremity down to hand with some paresthesias. The events were considered to be life threatening and clinically significant/intervention required. The events were possibly related to MENVEO. The patient did not underwent any laboratory tests. At the time of reporting, the events were resolved.
Age: 55.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Cervical radiculopathy, Injection site erythema, Injection site swelling, Neuralgia
Clinical narrative: This spontaneous report was received from a physician referring to a 55 year old female patient. Patient had no pertinent medical history. The patient had sulfa allergy. On 01-DEC-2015 the patient was vaccinated with VARIVAX (Merck) (lot # K007980), 1 shot via subcutaneous route. The patient was not on any concomitant medications. On 03-DEC-2015 (also reported as 48 hours after receiving VARIVAX (Merck), the patient experienced pain, redness and swelling with varicella-like lesion. On the same day the patient also experienced C7 nerve root radiculopathy. The patient sought medical attention by contacting the physician. No lab tests were performed. The patient received treatment with prednisone (manufacturer unknown) and unspecified antibiotics and pain medication. The action taken with the vaccine was not applicable. The outcome of the events was reported as not recovered/not resolved. The relatedness of the event with VARIVAX (Merck) was not provided. No further information provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Cervical radiculopathy, Erythema, Pain, Rash vesicular, Swelling
Clinical narrative: This spontaneous report was received from a physician referring to a 55 year old female patient. Patient had no pertinent medical history. The patient had sulfa allergy. On 01-DEC-2015 the patient was vaccinated with VARIVAX (Merck) (lot # K007980), 1 shot via subcutaneous route. The patient was not on any concomitant medications. On 03-DEC-2015 (also reported as 48 hours after receiving VARIVAX (Merck), the patient experienced pain, redness and swelling with varicella-like lesion. On the same day the patient also experienced C7 nerve root radiculopathy. The patient sought medical attention by contacting the physician. No lab tests were performed. The patient received treatment with prednisone (manufacturer unknown) and unspecified antibiotics and pain medication. The action taken with the vaccine was not applicable. The outcome of the events was reported as not recovered/not resolved. The relatedness of the event with VARIVAX (Merck) was not provided. No further information provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Asthenia, Blood test, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: Initial unsolicited report received from Consumer (patient's wife) on 27-Nov-2015. This case was linked to case 2015SA200301 (same reporter and same vaccine). This case involves 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date and route of administration were not reported) in left arm on 09-Nov-2015. Medical history and concomitant medications were not reported. It was reported that patient had received flu shot last year without complications. On 10-Nov-2015, next day after vaccination, patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. He went to the clinic on 13-Nov-2015 because of the pain. Patient had small amount of fluid in one lobe of his lung. He also had trouble while moving and sleeping and had been exhausted and weak. The patient had an EKG and chest x-ray. He was told that he had a small amount of fluid in one lobe of his lung and was prescribed an antibiotic. Patient has been back to the doctor and his lungs are now clear. Patient was recovered from the event edema lung and not recovered from all other reported events. Upon internal review, case was considered as serious due to important medical event: edema lung. Documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Pneumonia, Pyrexia
Clinical narrative: Initial unsolicited report received from Consumer (patient's wife) on 27-Nov-2015. This case was linked to case 2015SA200301 (same reporter and same vaccine). This case involves 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date and route of administration were not reported) in left arm on 09-Nov-2015. Medical history and concomitant medications were not reported. It was reported that patient had received flu shot last year without complications. On 10-Nov-2015, next day after vaccination, patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. He went to the clinic on 13-Nov-2015 because of the pain. Patient had small amount of fluid in one lobe of his lung. He also had trouble while moving and sleeping and had been exhausted and weak. The patient had an EKG and chest x-ray. He was told that he had a small amount of fluid in one lobe of his lung and was prescribed an antibiotic. Patient has been back to the doctor and his lungs are now clear. Patient was recovered from the event edema lung and not recovered from all other reported events. Upon internal review, case was considered as serious due to important medical event: edema lung. Documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Initial unsolicited report received from Consumer (patient's wife) on 27-Nov-2015. This case was linked to case 2015SA200301 (same reporter and same vaccine). This case involves 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date and route of administration were not reported) in left arm on 09-Nov-2015. Medical history and concomitant medications were not reported. It was reported that patient had received flu shot last year without complications. On 10-Nov-2015, next day after vaccination, patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. He went to the clinic on 13-Nov-2015 because of the pain. Patient had small amount of fluid in one lobe of his lung. He also had trouble while moving and sleeping and had been exhausted and weak. The patient had an EKG and chest x-ray. He was told that he had a small amount of fluid in one lobe of his lung and was prescribed an antibiotic. Patient has been back to the doctor and his lungs are now clear. Patient was recovered from the event edema lung and not recovered from all other reported events. Upon internal review, case was considered as serious due to important medical event: edema lung. Documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Asthenia, Chest X-ray abnormal, Electrocardiogram, Fatigue, Insomnia
Clinical narrative: Initial unsolicited report received from Consumer (patient's wife) on 27-Nov-2015. This case was linked to case 2015SA200301 (same reporter and same vaccine). This case involves 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date and route of administration were not reported) in left arm on 09-Nov-2015. Medical history and concomitant medications were not reported. It was reported that patient had received flu shot last year without complications. On 10-Nov-2015, next day after vaccination, patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. He went to the clinic on 13-Nov-2015 because of the pain. Patient had small amount of fluid in one lobe of his lung. He also had trouble while moving and sleeping and had been exhausted and weak. The patient had an EKG and chest x-ray. He was told that he had a small amount of fluid in one lobe of his lung and was prescribed an antibiotic. Patient has been back to the doctor and his lungs are now clear. Patient was recovered from the event edema lung and not recovered from all other reported events. Upon internal review, case was considered as serious due to important medical event: edema lung. Documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity, Pulmonary oedema, Pyrexia
Clinical narrative: Initial unsolicited report received from Consumer (patient's wife) on 27-Nov-2015. This case was linked to case 2015SA200301 (same reporter and same vaccine). This case involves 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date and route of administration were not reported) in left arm on 09-Nov-2015. Medical history and concomitant medications were not reported. It was reported that patient had received flu shot last year without complications. On 10-Nov-2015, next day after vaccination, patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. He went to the clinic on 13-Nov-2015 because of the pain. Patient had small amount of fluid in one lobe of his lung. He also had trouble while moving and sleeping and had been exhausted and weak. The patient had an EKG and chest x-ray. He was told that he had a small amount of fluid in one lobe of his lung and was prescribed an antibiotic. Patient has been back to the doctor and his lungs are now clear. Patient was recovered from the event edema lung and not recovered from all other reported events. Upon internal review, case was considered as serious due to important medical event: edema lung. Documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Asthenia, Electrocardiogram, Fatigue, Insomnia, Mobility decreased
Clinical narrative: Initial unsolicited report received from Consumer (patient's wife) on 27-Nov-2015. This case was linked to case 2015SA200301 (same reporter and same vaccine). This case involves 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date and route of administration were not reported) in left arm on 09-Nov-2015. Medical history and concomitant medications were not reported. It was reported that patient had received flu shot last year without complications. On 10-Nov-2015, next day after vaccination, patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. He went to the clinic on 13-Nov-2015 because of the pain. Patient had small amount of fluid in one lobe of his lung. He also had trouble while moving and sleeping and had been exhausted and weak. The patient had an EKG and chest x-ray. He was told that he had a small amount of fluid in one lobe of his lung and was prescribed an antibiotic. Patient has been back to the doctor and his lungs are now clear. Patient was recovered from the event edema lung and not recovered from all other reported events. Upon internal review, case was considered as serious due to important medical event: edema lung. Documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Pain in extremity, Pulmonary oedema, Pyrexia, X-ray
Clinical narrative: Initial unsolicited report received from Consumer (patient's wife) on 27-Nov-2015. This case was linked to case 2015SA200301 (same reporter and same vaccine). This case involves 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date and route of administration were not reported) in left arm on 09-Nov-2015. Medical history and concomitant medications were not reported. It was reported that patient had received flu shot last year without complications. On 10-Nov-2015, next day after vaccination, patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. He went to the clinic on 13-Nov-2015 because of the pain. Patient had small amount of fluid in one lobe of his lung. He also had trouble while moving and sleeping and had been exhausted and weak. The patient had an EKG and chest x-ray. He was told that he had a small amount of fluid in one lobe of his lung and was prescribed an antibiotic. Patient has been back to the doctor and his lungs are now clear. Patient was recovered from the event edema lung and not recovered from all other reported events. Upon internal review, case was considered as serious due to important medical event: edema lung. Documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Asthenia, Blood test, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: Initial unsolicited report received from a consumer (patient's wife) on 30 November 2015. This case is linked with 2015SA204038. This case involves an 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number, route and site of administration were not reported) on 9 November 2015. Last year the patient received a flu shot without any problem. The patient's medical history was not reported. Concomitant medication was not reported. On 10 November 2015, next day following the vaccination, the patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. On an unspecified date, small amount of fluid in one lobe of his lung. He has had trouble moving and sleeping. The patient has been exhausted and weak. On 13 November 2015, the patient went to clinic because of the pain. Laboratory investigation includes, Electrocardiogram (EKG) and chest x-ray result was not reported. On an unspecified date, the patient received antibiotics as a corrective treatment. On an unspecified date, the patient was recovered from fluid in one lobe of lung; however the outcome of the other event was not reported. Upon internal review, company assessed the event of fluid in one lobe of his lung as serious and important medical event. List of documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Pneumonia, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer (patient's wife) on 30 November 2015. This case is linked with 2015SA204038. This case involves an 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number, route and site of administration were not reported) on 9 November 2015. Last year the patient received a flu shot without any problem. The patient's medical history was not reported. Concomitant medication was not reported. On 10 November 2015, next day following the vaccination, the patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. On an unspecified date, small amount of fluid in one lobe of his lung. He has had trouble moving and sleeping. The patient has been exhausted and weak. On 13 November 2015, the patient went to clinic because of the pain. Laboratory investigation includes, Electrocardiogram (EKG) and chest x-ray result was not reported. On an unspecified date, the patient received antibiotics as a corrective treatment. On an unspecified date, the patient was recovered from fluid in one lobe of lung; however the outcome of the other event was not reported. Upon internal review, company assessed the event of fluid in one lobe of his lung as serious and important medical event. List of documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Initial unsolicited report received from a consumer (patient's wife) on 30 November 2015. This case is linked with 2015SA204038. This case involves an 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number, route and site of administration were not reported) on 9 November 2015. Last year the patient received a flu shot without any problem. The patient's medical history was not reported. Concomitant medication was not reported. On 10 November 2015, next day following the vaccination, the patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. On an unspecified date, small amount of fluid in one lobe of his lung. He has had trouble moving and sleeping. The patient has been exhausted and weak. On 13 November 2015, the patient went to clinic because of the pain. Laboratory investigation includes, Electrocardiogram (EKG) and chest x-ray result was not reported. On an unspecified date, the patient received antibiotics as a corrective treatment. On an unspecified date, the patient was recovered from fluid in one lobe of lung; however the outcome of the other event was not reported. Upon internal review, company assessed the event of fluid in one lobe of his lung as serious and important medical event. List of documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Asthenia, Chest X-ray abnormal, Electrocardiogram, Fatigue, Insomnia
Clinical narrative: Initial unsolicited report received from a consumer (patient's wife) on 30 November 2015. This case is linked with 2015SA204038. This case involves an 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number, route and site of administration were not reported) on 9 November 2015. Last year the patient received a flu shot without any problem. The patient's medical history was not reported. Concomitant medication was not reported. On 10 November 2015, next day following the vaccination, the patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. On an unspecified date, small amount of fluid in one lobe of his lung. He has had trouble moving and sleeping. The patient has been exhausted and weak. On 13 November 2015, the patient went to clinic because of the pain. Laboratory investigation includes, Electrocardiogram (EKG) and chest x-ray result was not reported. On an unspecified date, the patient received antibiotics as a corrective treatment. On an unspecified date, the patient was recovered from fluid in one lobe of lung; however the outcome of the other event was not reported. Upon internal review, company assessed the event of fluid in one lobe of his lung as serious and important medical event. List of documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity, Pulmonary oedema, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer (patient's wife) on 30 November 2015. This case is linked with 2015SA204038. This case involves an 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number, route and site of administration were not reported) on 9 November 2015. Last year the patient received a flu shot without any problem. The patient's medical history was not reported. Concomitant medication was not reported. On 10 November 2015, next day following the vaccination, the patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. On an unspecified date, small amount of fluid in one lobe of his lung. He has had trouble moving and sleeping. The patient has been exhausted and weak. On 13 November 2015, the patient went to clinic because of the pain. Laboratory investigation includes, Electrocardiogram (EKG) and chest x-ray result was not reported. On an unspecified date, the patient received antibiotics as a corrective treatment. On an unspecified date, the patient was recovered from fluid in one lobe of lung; however the outcome of the other event was not reported. Upon internal review, company assessed the event of fluid in one lobe of his lung as serious and important medical event. List of documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Asthenia, Electrocardiogram, Fatigue, Insomnia, Mobility decreased
Clinical narrative: Initial unsolicited report received from a consumer (patient's wife) on 30 November 2015. This case is linked with 2015SA204038. This case involves an 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number, route and site of administration were not reported) on 9 November 2015. Last year the patient received a flu shot without any problem. The patient's medical history was not reported. Concomitant medication was not reported. On 10 November 2015, next day following the vaccination, the patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. On an unspecified date, small amount of fluid in one lobe of his lung. He has had trouble moving and sleeping. The patient has been exhausted and weak. On 13 November 2015, the patient went to clinic because of the pain. Laboratory investigation includes, Electrocardiogram (EKG) and chest x-ray result was not reported. On an unspecified date, the patient received antibiotics as a corrective treatment. On an unspecified date, the patient was recovered from fluid in one lobe of lung; however the outcome of the other event was not reported. Upon internal review, company assessed the event of fluid in one lobe of his lung as serious and important medical event. List of documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Pain in extremity, Pulmonary oedema, Pyrexia, X-ray
Clinical narrative: Initial unsolicited report received from a consumer (patient's wife) on 30 November 2015. This case is linked with 2015SA204038. This case involves an 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number, route and site of administration were not reported) on 9 November 2015. Last year the patient received a flu shot without any problem. The patient's medical history was not reported. Concomitant medication was not reported. On 10 November 2015, next day following the vaccination, the patient's arm was hurt and he had a low fever. Two days later, his fever escalated and his arm pain was severe. On an unspecified date, small amount of fluid in one lobe of his lung. He has had trouble moving and sleeping. The patient has been exhausted and weak. On 13 November 2015, the patient went to clinic because of the pain. Laboratory investigation includes, Electrocardiogram (EKG) and chest x-ray result was not reported. On an unspecified date, the patient received antibiotics as a corrective treatment. On an unspecified date, the patient was recovered from fluid in one lobe of lung; however the outcome of the other event was not reported. Upon internal review, company assessed the event of fluid in one lobe of his lung as serious and important medical event. List of documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cerebrovascular accident, Computerised tomogram, Culture, Electroencephalogram, Hand-eye coordination impaired
Clinical narrative: Altered mental status and generalized weakness found to have severe Guillain-Barre Syndrome.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Incontinence, Laboratory test, Lethargy, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: Altered mental status and generalized weakness found to have severe Guillain-Barre Syndrome.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Visual impairment
Clinical narrative: Altered mental status and generalized weakness found to have severe Guillain-Barre Syndrome.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Electromyogram abnormal, Guillain-Barre syndrome, Mental status changes
Clinical narrative: Altered mental status and generalized weakness found to have severe Guillain-Barre Syndrome.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Whole arm is painful. Problem to lift the arm.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Per child's mother, child developed fever, itching and body rashes to face and arms the next day following his receiving Flumist dose during clinic.