chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Hypoaesthesia, Metabolic function test, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Pyrexia, Urine analysis, Vision blurred
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Amnesia, Blood test normal, Chest X-ray normal, Chest discomfort, Condition aggravated
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Dyspnoea, Fatigue, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Pyrexia, Tunnel vision, Urine analysis normal, Vaccination complication, Vision blurred
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 63.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Abdominal pain upper, Chest pain, Dizziness, Feeling abnormal, Headache
Clinical narrative: Case number PHHY2014US158781, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 547481) website on 28 Nov 2014. This report refers to a 63-year-old male patient. Concurrent conditions included Parkinson's disease, heart disease and diabetes. No concomitant medication was reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in 2013. A week after the vaccination, the patient experienced flu. In the hospital he was told that it was a new strain of flu. The outcome of the event was not reported. Seriousness was not reported. The case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 07 Oct 2014 and experienced events (see case: PHHY2014US158780).
Age: 63.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Retching, Tremor
Clinical narrative: Case number PHHY2014US158781, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 547481) website on 28 Nov 2014. This report refers to a 63-year-old male patient. Concurrent conditions included Parkinson's disease, heart disease and diabetes. No concomitant medication was reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in 2013. A week after the vaccination, the patient experienced flu. In the hospital he was told that it was a new strain of flu. The outcome of the event was not reported. Seriousness was not reported. The case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 07 Oct 2014 and experienced events (see case: PHHY2014US158780).
Age: 63.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Influenza
Clinical narrative: Case number PHHY2014US158781, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 547481) website on 28 Nov 2014. This report refers to a 63-year-old male patient. Concurrent conditions included Parkinson's disease, heart disease and diabetes. No concomitant medication was reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in 2013. A week after the vaccination, the patient experienced flu. In the hospital he was told that it was a new strain of flu. The outcome of the event was not reported. Seriousness was not reported. The case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 07 Oct 2014 and experienced events (see case: PHHY2014US158780).
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Eyelid oedema, Swollen tear duct
Clinical narrative: Case number PHHY2014US157895, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547915) website on 28 Nov 2014. This report refers to a 48-year-old female patient. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on 13 Oct 2014. On 14 Oct 2014, she experienced swollen right tear duct and swelling under eyes. She did not complaint about hives, itching, scratchy throat or difficulty breathing. The patient visited the emergency room. The outcome of the events was unknown. The events reported as non-serious. Seriousness assessment of the events (swollen right tear duct and swelling under eyes) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Abdominal discomfort, Abdominal pain, Death, Dyspnoea, Leukaemia
Clinical narrative: This spontaneous medically confirmed report (initial receipt 21-Nov-2014) concerns a 72 year-old male patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not reported) and pneumococcal vaccine (manufacturer and batch number not reported) on the same day. On an unspecified date, the patient experienced pain and tightness similar to gallbladder symptoms. The patient was seen by a physician and was determined to have enlarged spleen. The patient was sent to an oncologist and was diagnosed with leukemia on an unspecified date. The patient's spleen was surgically removed as it was continuing to enlarge. The patient never fully recovered from the surgery and experienced breathing problems and died on 07-Nov-2014, before leaving the hospital. The outcome was reported as deceased.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Splenectomy, Splenomegaly
Clinical narrative: This spontaneous medically confirmed report (initial receipt 21-Nov-2014) concerns a 72 year-old male patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not reported) and pneumococcal vaccine (manufacturer and batch number not reported) on the same day. On an unspecified date, the patient experienced pain and tightness similar to gallbladder symptoms. The patient was seen by a physician and was determined to have enlarged spleen. The patient was sent to an oncologist and was diagnosed with leukemia on an unspecified date. The patient's spleen was surgically removed as it was continuing to enlarge. The patient never fully recovered from the surgery and experienced breathing problems and died on 07-Nov-2014, before leaving the hospital. The outcome was reported as deceased.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Death, Discomfort, Dyspnoea, Gallbladder pain, Leukaemia
Clinical narrative: This spontaneous medically confirmed report (initial receipt 21-Nov-2014) concerns a 72 year-old male patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not reported) and pneumococcal vaccine (manufacturer and batch number not reported) on the same day. On an unspecified date, the patient experienced pain and tightness similar to gallbladder symptoms. The patient was seen by a physician and was determined to have enlarged spleen. The patient was sent to an oncologist and was diagnosed with leukemia on an unspecified date. The patient's spleen was surgically removed as it was continuing to enlarge. The patient never fully recovered from the surgery and experienced breathing problems and died on 07-Nov-2014, before leaving the hospital. The outcome was reported as deceased.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: 10/27/14 when shot was given a bolt of pain went from (L) shoulder down arm to (L) wrist. I indicated it hurt and was advised arm would be sore a few days. Had teeth chattering chills and fever that night and next day. Sore arm did not improve and began having pain when moving and extending it. 11/14 advised pharmacy. Physical therapy in progress.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Injection site pain, Pain in extremity, Pyrexia, X-ray
Clinical narrative: 10/27/14 when shot was given a bolt of pain went from (L) shoulder down arm to (L) wrist. I indicated it hurt and was advised arm would be sore a few days. Had teeth chattering chills and fever that night and next day. Sore arm did not improve and began having pain when moving and extending it. 11/14 advised pharmacy. Physical therapy in progress.
Age: 0.34
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 27-OCT-2014, an unspecified number of patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. Follow up information was received on 20-NOV-2014 from a registered nurse who was able to provide patient identification information, dates of administration, lot numbers and expiration dates for the reported incident of incorrect product storage. This case concerns a 4 month old male patient who on 27-OCT-2014 was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 27-OCT-2014, an unspecified number of patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. Follow up information was received on 20-NOV-2014 from a registered nurse who was able to provide patient identification information, dates of administration, lot numbers and expiration dates for the reported incident of incorrect product storage. This case concerns a 4 month old male patient who on 27-OCT-2014 was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 27-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. Follow up information was received on 20-NOV-2014 from a registered nurse who was able to provide patient identification information, dates of administration, lot numbers and expiration date for the reported incident of incorrect product storage. This case concerns a 6 month old male patient who on 27-OCT-2014 was vaccinated with a dose of improperly stored PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 27-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. Follow up information was received on 20-NOV-2014 from a registered nurse who was able to provide patient identification information, dates of administration, lot numbers and expiration date for the reported incident of incorrect product storage. This case concerns a 6 month old male patient who on 27-OCT-2014 was vaccinated with a dose of improperly stored PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Nodule, Pain
Clinical narrative: Itching around injection site, slight knottiness, some sharp pain, and then twinges of sharp pain over the next weeks and more general pain in the area of injection, continues to this day, certain movements of arm seem to cause pain or twinge in the injection area.
Age: 1.27
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Febrile convulsion, Urine analysis normal
Clinical narrative: Febrile seizure.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Pain in Left side of neck (on side of vaccine) when turned both left and right (more pain when turned to left); pain in Left shoulder when reaching across and placing hand on right arm.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Somnolence
Clinical narrative: Excessive sleepiness, unable to wake her up.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Dysarthria, Muscular weakness, Neuralgia, Pain, Paraesthesia
Clinical narrative: This spontaneous consumer report (initial receipt 21-Nov-2014) concerns a 61 year-old female patient. On an unspecified date "years ago", the patient received unspecified influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, shortly after receiving flu shot, she developed sudden 'tingliness' in her cheeks, fingers, legs, nose that was 'on and off for months'. The patient had 14 episodes of slurred speech and she went to the clinic three times. She had to use a walker due to lower limb muscle weakness. She stated that unspecified amount of time later, she developed the symptoms of chronic severe pain. She was diagnosed with painful relapsing remitting axonal sensory-motor neuropathy. She took gabapentin (4200 mg) to treat the pain which was effective but the patient developed low white blood cell count and stated that her white blood cell count was 3.6. The outcome was reported as not recovered. Reporter's comments: The reporter stated that her neurologist had told her that the condition was unrelated to flu vaccine but advised her not to receive flu vaccine in future.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Peripheral sensorimotor neuropathy, Walking aid user, White blood cell count decreased
Clinical narrative: This spontaneous consumer report (initial receipt 21-Nov-2014) concerns a 61 year-old female patient. On an unspecified date "years ago", the patient received unspecified influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, shortly after receiving flu shot, she developed sudden 'tingliness' in her cheeks, fingers, legs, nose that was 'on and off for months'. The patient had 14 episodes of slurred speech and she went to the clinic three times. She had to use a walker due to lower limb muscle weakness. She stated that unspecified amount of time later, she developed the symptoms of chronic severe pain. She was diagnosed with painful relapsing remitting axonal sensory-motor neuropathy. She took gabapentin (4200 mg) to treat the pain which was effective but the patient developed low white blood cell count and stated that her white blood cell count was 3.6. The outcome was reported as not recovered. Reporter's comments: The reporter stated that her neurologist had told her that the condition was unrelated to flu vaccine but advised her not to receive flu vaccine in future.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Myalgia
Clinical narrative: Myalgia, weaknrsss, unable to work.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pain
Clinical narrative: Patient developed diarrhea, aches and chills after receiving the second dose of flu vaccine for the season.  Vaccine was administered by an intern under the supervision of RPh.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Influenza like illness, Local swelling, Pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. An 86 year-old female patient received PREVNAR 13 (Lot number: unknown if J49845 or J49847, expiry date 21Mar2016, NDC: 00051971-02) at 0.5 ml single intramuscular in the arm (recommended vaccine for the patient age) on 18Nov2014. Medical history and concomitant medication were unknown. No other vaccine was administered besides PREVNAR 13 on the same day. The patient experienced pain, severe swelling arm, redness in the arm that was injected, fever, flu-like symptoms, almost cellulitis type swelling on unknown day in Nov2014. No emergency room treatment was required for the adverse event however there was a doctor visit as they wanted the doctor to look at the side effects. The outcome of the events was unknown. The Pfizer sales representative mentioned that the physician believed that the adverse events were caused by PREVNAR 13. Follow-up (25Nov2014) and FU (26Nov2014): New information reported from the same contactable physician via a Pfizer sales representative includes: patient details (age, gender, ethnicity), suspect product details (doubtful lot number, expiry date, NDC number, vaccination date, dose, frequency, anatomical location of vaccination, route of administration), absence of other vaccines given the same day, reaction date (event swelling was updated to severe swelling arm, events redness in the arm that was injected, fever, flu-like symptoms, almost cellulitis type swelling were added).
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. An 86 year-old female patient received PREVNAR 13 (Lot number: unknown if J49845 or J49847, expiry date 21Mar2016, NDC: 00051971-02) at 0.5 ml single intramuscular in the arm (recommended vaccine for the patient age) on 18Nov2014. Medical history and concomitant medication were unknown. No other vaccine was administered besides PREVNAR 13 on the same day. The patient experienced pain, severe swelling arm, redness in the arm that was injected, fever, flu-like symptoms, almost cellulitis type swelling on unknown day in Nov2014. No emergency room treatment was required for the adverse event however there was a doctor visit as they wanted the doctor to look at the side effects. The outcome of the events was unknown. The Pfizer sales representative mentioned that the physician believed that the adverse events were caused by PREVNAR 13. Follow-up (25Nov2014) and FU (26Nov2014): New information reported from the same contactable physician via a Pfizer sales representative includes: patient details (age, gender, ethnicity), suspect product details (doubtful lot number, expiry date, NDC number, vaccination date, dose, frequency, anatomical location of vaccination, route of administration), absence of other vaccines given the same day, reaction date (event swelling was updated to severe swelling arm, events redness in the arm that was injected, fever, flu-like symptoms, almost cellulitis type swelling were added).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Gait disturbance, Mobility decreased, Myalgia, Myositis, Tenderness
Clinical narrative: Initial unsolicited case received from a physician on 21 November 2014. An 11-year-old male patient received the following vaccines at 6:00 pm on 03 November 2014: a right deltoid injection of MENACTRA (lot number U4923BA) and a left deltoid injection of BOOSTRIX (lot number "4 (2) 424", other manufacturer). At 7:00 am the following morning, he awoke with severe muscle pain in the right leg, which was painful on palpation and prevented him from getting out of bed and walking. He was treated with ADVIL beginning on 04 November 2014 and symptoms improved; according to the reporter, the day after treatment (i.e. 05 November 2014) the patient was able to walk and only complained of pain on palpation. He was diagnosed with myositis. It was not reported if the patient was seen by a physician, or if the event had recovered. Documents held by sender: Initial report done in different language, translated on 28 November 2014.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Muscle tightness, Pain
Clinical narrative: CHILLS, COUGHING, HEADACHE, BODY ACHES, HANDS AND ARMS FELT LIKE THEY WERE ON FIRE, JAWS STARTED LOCKING UP, SINUS.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Sinus disorder, Skin burning sensation
Clinical narrative: CHILLS, COUGHING, HEADACHE, BODY ACHES, HANDS AND ARMS FELT LIKE THEY WERE ON FIRE, JAWS STARTED LOCKING UP, SINUS.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Sneezing, Vomiting
Clinical narrative: My wife (69 years old) and I (80 years old) got our flu shots in Sept. 2014 in a pharmacy operation. Since that time we both have had several bouts of nausea, some vomiting, weakness, and sneezing on and off since Sept. HAS THERE BEEN ANY REACTION TO THIS YEARS SERUM SIMILAR TO THIS? We have never had problems with previous years flu shots.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Dysphemia, Expressive language disorder, Speech disorder
Clinical narrative: Child received nasal spray flu vaccine and fell asleep shortly after. Immediately upon waking up the following morning, the child had extreme difficulty speaking and exibited a very pronounced stutter. Child previously had no trouble speaking and expressing herself in very fluent sentences with zero occurrences of stuttering whatsoever. The heavy and pronounced stutter lasted 2 weeks after which there was some improvement which has plateaued. After 6 weeks, she still stutters, but not as bad as the first 2 weeks.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh (injection site) warm, swollen, red and very painful to touch. It has been 32 days and her thigh is still red and slightly swollen but no longer painful.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Contusion, Full blood count abnormal, Herpes zoster, Platelet count decreased, Rash
Clinical narrative: On 11/24/14 came to office with rash of 2 days dx of herpes zoster treated with Acyclovir 200 mg/5 ml, 10 ml tid x 5 days. Returned to office 12/3/14 with history of bruising for 2 days-CBC revealed critically low platelet count-admitted to hospital.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza like illness, Oropharyngeal pain, Rhinorrhoea, Vaccination complication
Clinical narrative: Flu like symptoms came on suddenly. Sore throat, cough, runny nose, up-chuck. I went to pharmacy for medicine by time I returned home conditions worse. At 8PM she went to Emergency Room.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting, X-ray
Clinical narrative: Flu like symptoms came on suddenly. Sore throat, cough, runny nose, up-chuck. I went to pharmacy for medicine by time I returned home conditions worse. At 8PM she went to Emergency Room.
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of generalized urticaria in a patient who received FLUARIX TETRA (batch number ZE4G7, expiry date 19th June 2015). On 7th October 2014, the patient experienced FLUARIX TETRA. On 8th October 2014, 1 days after receiving FLUARIX TETRA, the patient experienced generalized urticaria. The patient was treated with prednisone and ATARAX (nos). On an unknown date, the outcome of the generalized urticaria was unknown. The reporter considered the generalized urticaria to be possibly related to FLUARIX TETRA. Additional information received: A patient received FLUARIX QIV on 07 October 2014 and then developed local urticaria on 08 October 2014 in the arm the patient received the vaccination. It then gradually became a generalized urticaria, the patient went to emergency room on 12 October 2014 and was prescribed Prednisone, ATARAX and "H2B".
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: (L) arm numbness, tingling, pain.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Electrocardiogram normal, Pyrexia, Tremor
Clinical narrative: 3 hours after vaccine administered patient experienced sharp chest pain went to ER, had fever of 100.2 and shakes. ER did EKG, everything was okay with heart. About 2 hours later patient was back to normal and discharged.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV2, MNQ, TDAP
Symptoms: Asthenia, Convulsion, Disorientation, Fall, Hyperhidrosis
Clinical narrative: 12:15 pm pt. was vaccinated 3-4 min. before w HPV, Tdap, MCV, Flu - pt has a loss of consciousness for seconds and drop off w hard sound in floor - pt. had apparently seizure movements 2-3 seconds and apparently disoriented, excessive sweat and pale recovery partial feeling was weakness. Was referred to ER for observation.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV2, MNQ, TDAP
Symptoms: Loss of consciousness, Pallor
Clinical narrative: 12:15 pm pt. was vaccinated 3-4 min. before w HPV, Tdap, MCV, Flu - pt has a loss of consciousness for seconds and drop off w hard sound in floor - pt. had apparently seizure movements 2-3 seconds and apparently disoriented, excessive sweat and pale recovery partial feeling was weakness. Was referred to ER for observation.
Age: 61.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right arm raised bump at injection site, tender to touch, warm 7 days after injection.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Activated partial thromboplastin time normal, Blood calcium normal, Blood test normal, Computerised tomogram head, Computerised tomogram normal
Clinical narrative: 56 year old man, no medication allergy, history of shellfish allergy, who developed lower lip tingling and numbness, dizziness, sweating, and headache twenty minutes after getting influenza vaccine. Symptoms resolved in 20 minutes. Emergency Dpt. evaluation was obtained. Brain CT Scan wo contrast and blood labs were negative. Neurology consultation thought stroke and TIA unlikely, and an allergic reaction to influenza vaccine most likely.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hyperhidrosis, Hypersensitivity, Hypoaesthesia oral
Clinical narrative: 56 year old man, no medication allergy, history of shellfish allergy, who developed lower lip tingling and numbness, dizziness, sweating, and headache twenty minutes after getting influenza vaccine. Symptoms resolved in 20 minutes. Emergency Dpt. evaluation was obtained. Brain CT Scan wo contrast and blood labs were negative. Neurology consultation thought stroke and TIA unlikely, and an allergic reaction to influenza vaccine most likely.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Metabolic function test, Paraesthesia oral
Clinical narrative: 56 year old man, no medication allergy, history of shellfish allergy, who developed lower lip tingling and numbness, dizziness, sweating, and headache twenty minutes after getting influenza vaccine. Symptoms resolved in 20 minutes. Emergency Dpt. evaluation was obtained. Brain CT Scan wo contrast and blood labs were negative. Neurology consultation thought stroke and TIA unlikely, and an allergic reaction to influenza vaccine most likely.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Prolonged, severe pain in the left deltoid muscle.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received flu shot on 11/24, came in 11/25 presenting w/ swollen, red and hot to touch left arm from elbow joint to approximately 4 inches up on arm. Advised to take ALEVE (she had at home) and BENADRYL, ice packs.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 48 hours after vaccine pt in for urgent ov with increased redness, warmth and swelling of B thighs L>R left thigh.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Onset of adverse reaction began on 10/25/14. Patient had an area of redness on her left inner arm. The site of the reaction was not on the site of injection. She did not complain of any pain or irritation.
Age: 1.27
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Mother noted erythema, exaggerated edema and tenderness of (R) thigh. Seen 11/21 elevated erythematic warm area at injection site. Treated for cellulitis and injection site reaction.
Age: 1.27
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Mother noted erythema, exaggerated edema and tenderness of (R) thigh. Seen 11/21 elevated erythematic warm area at injection site. Treated for cellulitis and injection site reaction.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Had severe pain at injection site > 2 wks after injection.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Patient received both vaccines in (R) arm, that evening she experienced pain. Upon waking she had a quarter size swelling as the day progressed it got larger. At the time she reported swelling (11/25/14) it was getting bigger.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injury
Clinical narrative: Neurological injury to right arm.
Age: 0.6
Sex: F
Vaccine: FLU4
Symptoms: Rash macular, Streptococcus test negative, Urticaria
Clinical narrative: IIV 4 given right anterior lateral thigh 12/3/14 at 1600. 1800 that same day noted whelps on back. BENADRYL oral given. No respiratory problems. No feeding problems. Small erythema macular rash trunk, face persistent to 12/4/14. ATARAX 2 mg/kg/day q6hr, consult allergist.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Contusion, Dizziness, Immediate post-injection reaction, Injection site pain
Clinical narrative: Nearly one month of L shoulder pain which started on 11/6 after receiving influenza vaccine at clinic. Patient normally looks away during a vaccine, but recalls thinking that she didn't feel the typical upper arm muscle squeeze before the injection. (demonstrates to me bunching up of the deltoid) Afterwards noticed that the shot was more painful and she felt a little lightheaded. Over 48hrs after injection, L shoulder pain increased significantly. Couldn't raise arm to wash hair. Had trouble getting dressed/undressed. Whole lateral side of shoulder hurt at rest and with movement. Also some of anterior upper arm. Developed bruise on shoulder as well. "It seemed higher than I'm used to injections being." (indicates area a little below acromion on lateral shoulder) Has been taking naproxen consistently, but symptoms have if anything worsened over Thanksgiving break. Went winter coat shopping with mother and wasn't able to try on coats without assistance. Motions with forward elevation, internal rotation and lateral elevation are painful. Trying to avoid these motions. Using heat pad with some relief. Not sure if naproxen is helping. Do not think joint itself is involved given painless passive ROM. Appears to have painful rotator cuff c/w sprain/tendonitis immediately following an influenza vaccination. Gave handout on rotator cuff injury from Patient Sports Medicine Advisor. Referral to PT for improvement in function and symptoms.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Nearly one month of L shoulder pain which started on 11/6 after receiving influenza vaccine at clinic. Patient normally looks away during a vaccine, but recalls thinking that she didn't feel the typical upper arm muscle squeeze before the injection. (demonstrates to me bunching up of the deltoid) Afterwards noticed that the shot was more painful and she felt a little lightheaded. Over 48hrs after injection, L shoulder pain increased significantly. Couldn't raise arm to wash hair. Had trouble getting dressed/undressed. Whole lateral side of shoulder hurt at rest and with movement. Also some of anterior upper arm. Developed bruise on shoulder as well. "It seemed higher than I'm used to injections being." (indicates area a little below acromion on lateral shoulder) Has been taking naproxen consistently, but symptoms have if anything worsened over Thanksgiving break. Went winter coat shopping with mother and wasn't able to try on coats without assistance. Motions with forward elevation, internal rotation and lateral elevation are painful. Trying to avoid these motions. Using heat pad with some relief. Not sure if naproxen is helping. Do not think joint itself is involved given painless passive ROM. Appears to have painful rotator cuff c/w sprain/tendonitis immediately following an influenza vaccination. Gave handout on rotator cuff injury from Patient Sports Medicine Advisor. Referral to PT for improvement in function and symptoms.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Swelling, Urticaria
Clinical narrative: PATIENT DESCRIBES PAIN, A WELT ABOUT 2 INCHES BY 2 INCHES IN DIAMETER, PUFFING OUT, NO ITCHING HOWEVER.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Myalgia and fever, chills plus pain/swelling around injection sites. Ibuprofen 600 mg once.
Age: 45.0
Sex: F
Vaccine: FLUC3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pt had extreme burning at injection site and around immediately after injection.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Death, Myocarditis infectious
Clinical narrative: Case number PHEH2014US024123, is an initial spontaneous report from a nurse received on 02 Dec 2014. This report refers to a 07 year old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date, after vaccination, she experienced myocardial infection and died 4 days after vaccination. Outcome of the event myocardial infection was not reported. Cause of death and causality of the events was not reported. Seriousness assessment of myocardial infection was upgraded based on the NVS-IMS list. No additional information was available.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Grand mal convulsion, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Patient was witnessed having a grand mal seizure in a classroom during her hospital orientation as a new employee. Seen in the ED where another seizure occurred, then admitted to the inpt unit. Keppra was started. Rec'd the flu shot 48 hrs prior to seizure...unknown if a precipitating factor. Treating doctors unaware of previous vaccination in Employee Health office.
Age: 54.0
Sex: F
Vaccine: IPV
Symptoms: Back pain, Injected limb mobility decreased, Injection site pain, Middle insomnia, Myalgia
Clinical narrative: Can't stretch/lift right arm above head. Unable to reach left side with right arm. Sharp lightning pains down right arm to elbow to leg and toe. And toward my neck and back. Sharp pain wake me up during the night. Need to sleep in chair to relieve pain. Pain occurs when sleeping on back, left or right side.
Age: 54.0
Sex: F
Vaccine: IPV
Symptoms: Neck pain, Nerve injury, Pain in extremity
Clinical narrative: Can't stretch/lift right arm above head. Unable to reach left side with right arm. Sharp lightning pains down right arm to elbow to leg and toe. And toward my neck and back. Sharp pain wake me up during the night. Need to sleep in chair to relieve pain. Pain occurs when sleeping on back, left or right side.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Full blood count, Hypoaesthesia, Injection site pain, Mammogram
Clinical narrative: Right upper arm, neck and arm pit hurt. A few days later she noticed swelling in the armpit that became progressively worse. She also had numbness and tingling in her right arm and hand.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Oedema peripheral, Paraesthesia
Clinical narrative: Right upper arm, neck and arm pit hurt. A few days later she noticed swelling in the armpit that became progressively worse. She also had numbness and tingling in her right arm and hand.
Age: 19.0
Sex: M
Vaccine: FLU4, HEPAB, MMR
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: PT recieved three vaccines in accordance with his readiness report. At the time of administration, the patient denied having any drug, food or latex allergies (verified with online medical systems) patient received his vaccines along with his classmates, was then instructed to standby in the clinic lobby until his entire class was completed. Time spent waiting was approximately 20-30min. Patient stated that he did not have any reactions until after 5pm. PT states had a itchy red rash covering his middle torso, upper right chest and right side of the neck. He denied any trouble breathing, any numbness or tingling to his extremities or any other abnormal feelings of being ill. Patient reported after sick call hours to the medical clinic he recieved the vaccines, and stated that the rash has gotten better but is still present. Patient was evaluated by the medical staff and the duty flight surgeon. Patient was released without limitations.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy
Clinical narrative: Left Axillary lymph node is swollen and below the injection site is red and warm.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling hot, Injection site pain, Lacrimation increased, Rhinorrhoea
Clinical narrative: Severe pain at the injection site for several days. Watery eyes, hot/cold chills and nasal drainage.
Age: 1.06
Sex: F
Vaccine: HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, swelling/redness in leg.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: A headache 1 hour after vaccination that progressively got worse throughout the day.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Bedridden, Confusional state, Disturbance in attention, Headache, Nausea
Clinical narrative: Feelings of severe nausea and headache. Bedridden with this for 10 days, mental confusion, lack of focus and clarity, completely different personality.  Contacted PCP for assistance.  ER visit for psychosis on 11/17/14.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Personality change, Psychotic disorder
Clinical narrative: Feelings of severe nausea and headache. Bedridden with this for 10 days, mental confusion, lack of focus and clarity, completely different personality.  Contacted PCP for assistance.  ER visit for psychosis on 11/17/14.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Cardiac stress test normal, Echocardiogram normal, Electrocardiogram normal, Musculoskeletal chest pain
Clinical narrative: Severe pain under both ears, down neck for about 2 hours, then pain moved to rib cage.  Both lasted until about 2:30, then just stopped.  Rested lying down most of the time.  Called doctor about 10 am.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Severe pain under both ears, down neck for about 2 hours, then pain moved to rib cage.  Both lasted until about 2:30, then just stopped.  Rested lying down most of the time.  Called doctor about 10 am.