chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Tremor
Clinical narrative: Case number PHHY2015US012489, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553500) on 06 JAN 2015. This report refers to a 39 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on 18 OCT 2011. On same day after vaccination she experienced fever, shaking, extreme pain in joints and large muscle groups. She also experienced extreme fatigue and she was unable to stand alone, unable to complete adis alone and unable to feed herself. The outcome of the events were reported as complete recovery. The events were reported as non-serious and causality of the events was not reported.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Eye pain, Headache
Clinical narrative: Case number PHHY2015US012679, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553603) on 06 JAN 2015. This report refers to a 48 years old male patient. His medical history includes failed back surgery, lumbar stenosis, vacuum disk phenomenon, degenerative disk disease, post laminectomy syndrome, possible arachnoiditis. His concomitant medications included fentanyl 25 mg patch and gabapentin 300 mg. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) intramuscularly on 10 NOV 2014. On same day after vaccination, he experienced headache which was left sided behind left eye to back of the head on his left and described as entire rear of head and aforementioned locations with little relief from OCT treatment. Narco treatment was helpful. The outcome of the event was reported as  condition unchanged by 14 NOV 2014. The events was reported as non-serious and causality of the event was not reported.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Induration, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2015US012505, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 553686) website on 06 JAN 2015. This report refers to a 72-year-old female patient. Current conditions included diabetes and increased blood pressure. On an unknown date, she was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) along with pneumococcal vaccine (other manufacturer, batch number: not reported). On an unknown date after vaccination she experienced swelling from elbow to top of arm, area red, hard and painful and she felt ill. On 14 NOV 2014, she still had redness but she felt better. The outcome of the events reported as recovered. The event reported as non-serious. The causality of the event was not reported.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Insomnia, Musculoskeletal pain, Pain in extremity, X-ray
Clinical narrative: Case number PHHY2015US012513, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 553728) website on 06 JAN 2015. This report refers to a 46-year-old female patient. Concomitnat drugs included daily vitamins, Vit B12, Vit D, calcium and fish oil. On 30 OCT 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On 31 OCT 2014, after vaccination she experienced pain in left shoulder. It was reported that the pain continued to worsen over two weeks and her entire arm aches by the end of the day. She had difficulty in sleeping and performing many tasks which needed use of her left arm. She saw a chiropractor and orthopedic doctor and underwent X-ray (result: not reported). The outcome of the events reported as not recovered. The event reported as non-serious. The causality of the event was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Computerised tomogram, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: My husband told me I hardly remember 6 bottles plasma. Nerve test, CT spinal tap, lots more. IVIG bottle each day. Guillain-Barre syndrome.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Memory impairment, Nerve stimulation test, Nuclear magnetic resonance imaging, Transfusion
Clinical narrative: My husband told me I hardly remember 6 bottles plasma. Nerve test, CT spinal tap, lots more. IVIG bottle each day. Guillain-Barre syndrome.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Dyskinesia, Dyspnoea, Fall, Feeling abnormal
Clinical narrative: My husband told me I hardly remember 6 bottles plasma. Nerve test, CT spinal tap, lots more. IVIG bottle each day. Guillain-Barre syndrome.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Heart rate abnormal, Immunoglobulin therapy, Laboratory test, Lumbar puncture abnormal
Clinical narrative: My husband told me I hardly remember 6 bottles plasma. Nerve test, CT spinal tap, lots more. IVIG bottle each day. Guillain-Barre syndrome.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pruritus, Seizure, Walking aid user
Clinical narrative: My husband told me I hardly remember 6 bottles plasma. Nerve test, CT spinal tap, lots more. IVIG bottle each day. Guillain-Barre syndrome.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Dizziness, Headache, Heart rate increased, Pain in extremity
Clinical narrative: Case number PHEH2016US001753, is an initial spontaneous report received from a consumer on 19 Jan 2016. This report refers to a 52 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157802) intramuscularly on 04 Nov 2015. On the same day within minutes after the vaccination, the patient experienced rapid heart rate, difficulty breathing, headache, dizziness, injection site swelling and pain. Outcome of the events was reported as complete recovery on 04 Nov 2015. Seriousness and causality of the events were not reported. Seriousness of the events heart rate increase, dizziness and dyspnea was upgraded to serious (medically significant) based on the available information in the source document. Following an internal review done on 01 Feb 2016 for the data received on 19 Jan 2016: Non serious events heart rate increase, dizziness and dyspnea upgraded to serious events (medically significant).
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Peripheral swelling
Clinical narrative: Case number PHEH2016US001753, is an initial spontaneous report received from a consumer on 19 Jan 2016. This report refers to a 52 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157802) intramuscularly on 04 Nov 2015. On the same day within minutes after the vaccination, the patient experienced rapid heart rate, difficulty breathing, headache, dizziness, injection site swelling and pain. Outcome of the events was reported as complete recovery on 04 Nov 2015. Seriousness and causality of the events were not reported. Seriousness of the events heart rate increase, dizziness and dyspnea was upgraded to serious (medically significant) based on the available information in the source document. Following an internal review done on 01 Feb 2016 for the data received on 19 Jan 2016: Non serious events heart rate increase, dizziness and dyspnea upgraded to serious events (medically significant).
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate increased, Injection site pain
Clinical narrative: Case number PHEH2016US001753, is an initial spontaneous report received from a consumer on 19 Jan 2016. This report refers to a 52 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157802) intramuscularly on 04 Nov 2015. On the same day within minutes after the vaccination, the patient experienced rapid heart rate, difficulty breathing, headache, dizziness, injection site swelling and pain. Outcome of the events was reported as complete recovery on 04 Nov 2015. Seriousness and causality of the events were not reported. Seriousness of the events heart rate increase, dizziness and dyspnea was upgraded to serious (medically significant) based on the available information in the source document. Following an internal review done on 01 Feb 2016 for the data received on 19 Jan 2016: Non serious events heart rate increase, dizziness and dyspnea upgraded to serious events (medically significant).
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling
Clinical narrative: Case number PHEH2016US001753, is an initial spontaneous report received from a consumer on 19 Jan 2016. This report refers to a 52 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157802) intramuscularly on 04 Nov 2015. On the same day within minutes after the vaccination, the patient experienced rapid heart rate, difficulty breathing, headache, dizziness, injection site swelling and pain. Outcome of the events was reported as complete recovery on 04 Nov 2015. Seriousness and causality of the events were not reported. Seriousness of the events heart rate increase, dizziness and dyspnea was upgraded to serious (medically significant) based on the available information in the source document. Following an internal review done on 01 Feb 2016 for the data received on 19 Jan 2016: Non serious events heart rate increase, dizziness and dyspnea upgraded to serious events (medically significant).
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3, FLUX
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain
Clinical narrative: Per patient, vaccine administered in right shoulder, started with discomfort that same day and symptoms became worse through the night and next morning. Unable to lift move arm (Pt. is left handed). Limited movement and pain was persistent until pt. visited family Dr. and was prescribed a cortisone injection (Buttock). Within 4 weeks after injection, pain and limited movement returned and pt made another visit to his Dr. who then put him on an oral anti-inflammatory.  Pt. is still having pain despite taking the oral prednisone. Pain is worse at night and upon rising in morning.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3, FLUX
Symptoms: Injection site pain
Clinical narrative: Per patient, vaccine administered in right shoulder, started with discomfort that same day and symptoms became worse through the night and next morning. Unable to lift move arm (Pt. is left handed). Limited movement and pain was persistent until pt. visited family Dr. and was prescribed a cortisone injection (Buttock). Within 4 weeks after injection, pain and limited movement returned and pt made another visit to his Dr. who then put him on an oral anti-inflammatory.  Pt. is still having pain despite taking the oral prednisone. Pain is worse at night and upon rising in morning.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal discomfort
Clinical narrative: Per patient, vaccine administered in right shoulder, started with discomfort that same day and symptoms became worse through the night and next morning. Unable to lift move arm (Pt. is left handed). Limited movement and pain was persistent until pt. visited family Dr. and was prescribed a cortisone injection (Buttock). Within 4 weeks after injection, pain and limited movement returned and pt made another visit to his Dr. who then put him on an oral anti-inflammatory.  Pt. is still having pain despite taking the oral prednisone. Pain is worse at night and upon rising in morning.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: Information has been received from a pharmacist via Pfizer refers to an approximately 67 year old male patient. The patient's concurrent condition included wheezing and shortness of breath, gastroesophageal reflux disease, blood pressure disorder, thyroid function abnormal and hypertension. On 23-JAN-2014 (also reported as 16 months ago) the patient was vaccinated with a dose of PNEUMOVAX 23 (1 injection, lot#, expiration date, strength and route unknown). Concomitant therapies included PROAIR, omeprazole, metoprolol, levothyroxine sodium, furosemide and clopidogrel (the reporter was not quite sure why the patient was taking clopidogrel, other than the fact that it was an anticoagulant). The pharmacist reported lack of effect of PNEUMOVAX 23, as since the vaccination, the patient had experienced pneumonia 3 times during 2014 to 2015. Unspecified outpatient treatment was given for the event of pneumonia. The patient had been hospitalized on an unknown date. It was unknown if the patient was hospitalized for the pneumonia or not. Outcome of the event was unknown. The reporter considered the event to be not related to PNEUMOVAX 23. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: HEP, TD
Symptoms: Headache, Rash
Clinical narrative: Rash and headache. Benadryl in cream.
Age: 1.13
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Eye movement disorder, Hypotonia, Unresponsive to stimuli
Clinical narrative: While sitting in high chair, became limp and unresponsive for appproximately 30 seconds. Eyes rolled back in head. No movement of limbs. Seemed normal immediately after.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Redness, warmth, and tenderness at site of injection in right triceps. No fevers or drainage. Area of injection was indurated and tender. Treated with Keflex to cover for cellulitis as unsure if it was this or an allergy.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Cellulitis, Culture wound negative, Erythema
Clinical narrative: 1/29/2016 17:05 EST 16 YEARS OLD MALE PRESENT FOR REDNESS ON LEFT ARM AFTER BEEN GIVEN THE HPV SHOT GIVEN 12/11/15 AT 4:24PM. Culture Wound (Order): Cellulitis, Stat collect, *Est. Requested Draw Date and T 1/29/2016, Cellulitis of left upper extremity, To be done at Lab: Final - 01 February 2016 8:50 EST - No growth. Pre - 31 January 2016 9:56 EST - No growth. GS - 30 January 2016 5:21 EST -  No White Blood Cells. No organisms seen. No epithelial cells. TREATMENT: MUPIROCIN TOPICAL 3 TIMES DAILY FOR 10 DAYS. CLINDAMYCIN 300MG 1 CAP PO Q6HR FOR 10 DAYS. MOM TO BE NOTIFIED TO FOLLOW UP IN 1-2 WEEKS.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Impaired work ability, Injected limb mobility decreased, Pain in extremity
Clinical narrative: I received the shot in my right upper arm that morning. Just thought I would be sore from vaccine (TDAP). It is has only continued to worsen. The mobility of my right arm is minimal with severe pain. There is no comfortable position with a constant pain. Minimal rotation and reaching ability. I worry as it is effecting my job and seems I can find no relief.  Very concerning.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Swelling, erythema, tenderness, warm to touch.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Lethargy, Local swelling, Rhinorrhoea, Tinnitus
Clinical narrative: Ringing in the ears, Headache, Lethargy, Swollen neck, Runny nose.
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Neck pain
Clinical narrative: Pain/burning on left side where shot was administered to shoulder/neck area.
Age: 84.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Area is red, swollen. Above is bruised (she had 2 shots- where the Prevnar 13 was given. She indicated it was not where the Tdap was given). Recommend that she mention it to her primary care (also indicated it was itching a little now- 2/1/16.  Shot was given on Thursday 1/28/16 and she said it started on the next day). Told her to keep me inform.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Lymphadenopathy, White blood cell count
Clinical narrative: Vaccine PCV13 - Shoulder joint pain and swelling of lymph nodes at the base of the neck both on the side of the inject (left). After two weeks red steaks along left clavicle. Naproxen-didn't help, Cephalexin - too early to tell.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Erythematous rash appeared ~10 days after vaccine administration "a few inches" below the injection site.  Rash lasted ~3 days then disappeared.  Rash did not require treatment.  Patient did not report rash until after symptoms resolved.
Sex: F
Vaccine: HEPA, YF
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from a nurse on 22 January 2016. This case involves female patient (age not reported) who was vaccinated with a dose of Yellow fever (batch number, route and site of administration not reported) and a dose of Hep a (batch number, route and site of administration not reported) on the same day on an unspecified date. The patient's medical history includes annual vaccination with flu vaccine without any adverse event and concomitant medications were not reported. On an unspecified date in 1997, following the vaccination, the patient had experienced Guillain-Barre syndrome. Laboratory data and corrective treatment were not reported. The outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event Guillain-Barre syndrome. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Anticonvulsant drug level decreased, Aphasia, Brain scan normal, Condition aggravated
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A 68-years-old female patient received PREVNAR 13 (NDC number: 000051971-05), via an unspecified route of administration in the right arm on 31Dec2015 at 0.5 ml single. Medical history included ongoing seizure; hurt her left leg from an unknown date and unknown if ongoing. The patient had x-ray of head a long time before when first began having seizures, maybe 30 years before, which showed black spot on left side of her head. It didn't go all the way down into her brain, hadn't grown, no explanation why it was there. Thought to be the cause of her seizures. The patient previously took PREVNAR 13 about 10 years before and experienced no adverse event. Concomitant medication included DILANTIN for seizure. Patient used to be on 200 mg in the morning and 200 mg in the evening until about six months before when she had her phenytoin level checked and it was too high. At that time, she decreased her dose to 100mg one in the morning and 200 mg at night. On 01Jan2016 at 18:00 the patient had seizure which the patient believed was due to the PREVNAR 13. They were at a friend's house, her friend knew she was having a seizure because she grabbed the card table she was eating off of, was shaking it, and her friend could not get reporter's hand off of it. Has history of accident in which she hurt her left leg. Thought she hurt it again during the seizure as it was still sore. They called the ambulance to take her to emergency room, where she spent 18 hours. The patient was happy enough to walk to the ambulance to go. While at hospital, they attempted to release her on three different occasions. They started to release her the first time, but she couldn't walk so they kept her. Next time they told her she was free to go, she couldn't speak so they kept her. Next time they said they were keeping her for more tests, did EKG and heart ultrasound, which came back fine on 02Jan2016. An head scan on 02Jan2016 was normal. The patient also had lab work on the same date, including phenytoin level, which showed she had no phenytoin in her system because she had been without her phenytoin for 18 hours. After this seizure, she increased her phenytoin (NDC: 0071036924, Lot: M38474, EXP: July2017) to 200 mg in the morning and 200 mg in the evening. The patient recovered with sequel from seizure on the same date. The patient was blacked out for 4 days; she does not really remember things that happened after she got the vaccine on 31Dec2015, with outcome of recovered on 04Jan2016. During the emergency room visit the patient couldn't walk and couldn't talk; she couldn't remember at what point visit these happened, but they resolved completely.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Echocardiogram normal, Electrocardiogram normal, Limb injury, Loss of consciousness, Memory impairment
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A 68-years-old female patient received PREVNAR 13 (NDC number: 000051971-05), via an unspecified route of administration in the right arm on 31Dec2015 at 0.5 ml single. Medical history included ongoing seizure; hurt her left leg from an unknown date and unknown if ongoing. The patient had x-ray of head a long time before when first began having seizures, maybe 30 years before, which showed black spot on left side of her head. It didn't go all the way down into her brain, hadn't grown, no explanation why it was there. Thought to be the cause of her seizures. The patient previously took PREVNAR 13 about 10 years before and experienced no adverse event. Concomitant medication included DILANTIN for seizure. Patient used to be on 200 mg in the morning and 200 mg in the evening until about six months before when she had her phenytoin level checked and it was too high. At that time, she decreased her dose to 100mg one in the morning and 200 mg at night. On 01Jan2016 at 18:00 the patient had seizure which the patient believed was due to the PREVNAR 13. They were at a friend's house, her friend knew she was having a seizure because she grabbed the card table she was eating off of, was shaking it, and her friend could not get reporter's hand off of it. Has history of accident in which she hurt her left leg. Thought she hurt it again during the seizure as it was still sore. They called the ambulance to take her to emergency room, where she spent 18 hours. The patient was happy enough to walk to the ambulance to go. While at hospital, they attempted to release her on three different occasions. They started to release her the first time, but she couldn't walk so they kept her. Next time they told her she was free to go, she couldn't speak so they kept her. Next time they said they were keeping her for more tests, did EKG and heart ultrasound, which came back fine on 02Jan2016. An head scan on 02Jan2016 was normal. The patient also had lab work on the same date, including phenytoin level, which showed she had no phenytoin in her system because she had been without her phenytoin for 18 hours. After this seizure, she increased her phenytoin (NDC: 0071036924, Lot: M38474, EXP: July2017) to 200 mg in the morning and 200 mg in the evening. The patient recovered with sequel from seizure on the same date. The patient was blacked out for 4 days; she does not really remember things that happened after she got the vaccine on 31Dec2015, with outcome of recovered on 04Jan2016. During the emergency room visit the patient couldn't walk and couldn't talk; she couldn't remember at what point visit these happened, but they resolved completely.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Seizure, Skull X-ray abnormal
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A 68-years-old female patient received PREVNAR 13 (NDC number: 000051971-05), via an unspecified route of administration in the right arm on 31Dec2015 at 0.5 ml single. Medical history included ongoing seizure; hurt her left leg from an unknown date and unknown if ongoing. The patient had x-ray of head a long time before when first began having seizures, maybe 30 years before, which showed black spot on left side of her head. It didn't go all the way down into her brain, hadn't grown, no explanation why it was there. Thought to be the cause of her seizures. The patient previously took PREVNAR 13 about 10 years before and experienced no adverse event. Concomitant medication included DILANTIN for seizure. Patient used to be on 200 mg in the morning and 200 mg in the evening until about six months before when she had her phenytoin level checked and it was too high. At that time, she decreased her dose to 100mg one in the morning and 200 mg at night. On 01Jan2016 at 18:00 the patient had seizure which the patient believed was due to the PREVNAR 13. They were at a friend's house, her friend knew she was having a seizure because she grabbed the card table she was eating off of, was shaking it, and her friend could not get reporter's hand off of it. Has history of accident in which she hurt her left leg. Thought she hurt it again during the seizure as it was still sore. They called the ambulance to take her to emergency room, where she spent 18 hours. The patient was happy enough to walk to the ambulance to go. While at hospital, they attempted to release her on three different occasions. They started to release her the first time, but she couldn't walk so they kept her. Next time they told her she was free to go, she couldn't speak so they kept her. Next time they said they were keeping her for more tests, did EKG and heart ultrasound, which came back fine on 02Jan2016. An head scan on 02Jan2016 was normal. The patient also had lab work on the same date, including phenytoin level, which showed she had no phenytoin in her system because she had been without her phenytoin for 18 hours. After this seizure, she increased her phenytoin (NDC: 0071036924, Lot: M38474, EXP: July2017) to 200 mg in the morning and 200 mg in the evening. The patient recovered with sequel from seizure on the same date. The patient was blacked out for 4 days; she does not really remember things that happened after she got the vaccine on 31Dec2015, with outcome of recovered on 04Jan2016. During the emergency room visit the patient couldn't walk and couldn't talk; she couldn't remember at what point visit these happened, but they resolved completely.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle spasms, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Severe pain at site, down arm and in shoulder. Finger also have pain. Pain at night cramping in arm - lost range of motion in arm. 2-visits to family Dr. X-Rays. Physical therapy. MRI. Visit to orthopaedic Dr two visits.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray
Clinical narrative: Severe pain at site, down arm and in shoulder. Finger also have pain. Pain at night cramping in arm - lost range of motion in arm. 2-visits to family Dr. X-Rays. Physical therapy. MRI. Visit to orthopaedic Dr two visits.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 58-years-old female patient received PREVNAR 13, via an unspecified route of administration in the left arm on 17Sep2015 at single dose. The patient medical history and concomitant medications were not reported. The patient could not move arm and as they were giving it to her the pain hurt so bad all the way on 17Sep2015 with outcome of not recovered; frozen shoulder on an unspecified date with outcome of  unknown. Reporter stated that she went to her doctor for a checkup and received PREVNAR 13. As they were giving it on 17Sep2015 the pain hurt so bad all the way to her wrist. Stated she can't move her left arm. She has been to an orthopedist, physical therapy and is now seeing a chiropractor. The pain and not being able to move her arm were noticed immediately after the vaccine and have both gotten worse. She stated that she does not want to receive the product again. On 28Oct2015 her primary care provider told her she had a frozen shoulder and treated it with steroids.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Periarthritis
Clinical narrative: This is a spontaneous report from a contactable consumer. A 58-years-old female patient received PREVNAR 13, via an unspecified route of administration in the left arm on 17Sep2015 at single dose. The patient medical history and concomitant medications were not reported. The patient could not move arm and as they were giving it to her the pain hurt so bad all the way on 17Sep2015 with outcome of not recovered; frozen shoulder on an unspecified date with outcome of  unknown. Reporter stated that she went to her doctor for a checkup and received PREVNAR 13. As they were giving it on 17Sep2015 the pain hurt so bad all the way to her wrist. Stated she can't move her left arm. She has been to an orthopedist, physical therapy and is now seeing a chiropractor. The pain and not being able to move her arm were noticed immediately after the vaccine and have both gotten worse. She stated that she does not want to receive the product again. On 28Oct2015 her primary care provider told her she had a frozen shoulder and treated it with steroids.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at site, down arm and lost range of motion in arm. Visit - family Dr. (Wife has same reaction).
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Please see attached 2 pages.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Grunting, Loss of consciousness, Seizure like phenomena, Syncope
Clinical narrative: She fainted and while she was passed out it looked as if she was having a seizure, her body was jerking around and she made a weird sound like a grunting. I'd say the whole episode from fainting to awake and calmed down lasted at least 3-4 minutes.
Age: 0.18
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient given Rotarix vaccine IM instead of oral. Induration at sight, no redness.  Given Rotarix orally after error realized.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Oral herpes, Pyrexia, Sluggishness, Throat irritation
Clinical narrative: Started to feel sluggish, ill that evening 1/26/16. The next day scratchy throat. On 1/28/16 ran fever of 102.7 ill started to get fever blisters around lips. Had fever until 1/30/16.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Coordination abnormal, Demyelinating polyneuropathy, Electromyogram abnormal, Gait disturbance, Hypoaesthesia
Clinical narrative: Within 1-3 weeks: numbness feet, hands, tingle, irritable bowel. Then blurred vision, numbness in face. Poor gait, coordination. Diagnosed w/chronic sensory demyelination polyneuropathy.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Irritable bowel syndrome, Paraesthesia, Peripheral sensory neuropathy, Vision blurred
Clinical narrative: Within 1-3 weeks: numbness feet, hands, tingle, irritable bowel. Then blurred vision, numbness in face. Poor gait, coordination. Diagnosed w/chronic sensory demyelination polyneuropathy.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Death, Dyspnoea, Obstructive airways disorder, Oropharyngeal pain, Pharyngeal abscess
Clinical narrative: Developed fever next day then 3 days later developed sore throat - was seen in an Urgent Care - negative for strep. Two days later had difficulty breathing and expired in the ED of a large retropharyngeal abscess occluding airway - grew strep anginosus.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Developed fever next day then 3 days later developed sore throat - was seen in an Urgent Care - negative for strep. Two days later had difficulty breathing and expired in the ED of a large retropharyngeal abscess occluding airway - grew strep anginosus.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Confusional state, Dizziness, Nausea, Palpitations, Vomiting
Clinical narrative: Two hours after receiving the vaccine, she experienced heart palpitations, dizziness, confusion, nausea, and vomiting which lasted two days.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Culture, Incisional drainage, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and pain at the site of injection, was treated in the Urgent care twice for drainage. Pt then went to ER when the fluid reaccumulated, and required I&D in the OR. On oral antibiotics presently and receiving wound care at home with packing.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Clostridium test negative, Diarrhoea, Feeling abnormal, Immunosuppressant drug level
Clinical narrative: Fever up to 101.4, shakes, chills, and feeling poorly.  He also have 2 very loose watery stools.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Procalcitonin increased, Pyrexia, Tremor, White blood cell count increased
Clinical narrative: Fever up to 101.4, shakes, chills, and feeling poorly.  He also have 2 very loose watery stools.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Musculoskeletal stiffness, Nausea
Clinical narrative: Nausea, leg stiffness with difficulty walking for 2 days, beginning on day of vaccine administration or early next morning. Symptoms are now resolving. Patient did not seek medical attention for these complaints.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: Nausea, leg stiffness with difficulty walking for 2 days, beginning on day of vaccine administration or early next morning. Symptoms are now resolving. Patient did not seek medical attention for these complaints.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Musculoskeletal stiffness, Pruritus
Clinical narrative: A 24 year old woman received MassBiologics Td vaccine (Lot# A080A) in the left deltoid on 9/16/15 for wound prophylaxis.  The following day she reported she felt warm to the touch and developed itching, swelling, and pain at the injection site.  Two days after the immunization (9/18/15), she contacted her health care provider to report these symptoms along with expansion of the pruritus to her hand as well as hand stiffness.  Following the adverse event, she took ibuprofen 600mg orally.  The patient was offered an evaluation by her health care provider, but she declined. Sender's Comments: This adverse event is assessed as non-serious and labeled, as injection site reactions including pain, pruritus, and swelling are described in the product labeling, as is pyrexia (which may have caused the patient to feel "warm to the touch").  It is possible the reported hand stiffness was due to musculoskeletal stiffness (reaction described in the package insert) or was secondary to the swelling in the affected limb, but this is unable to be confirmed as the patient declined an evaluation by the provider on the day the symptoms were reported.  MassBiologics performed a follow up with the health care provider on two occasions as summarized below: Follow-up on 10/14/15:  The reporter informed that the patient did not visit the physician since the adverse event and that the clinic had not heard from the patient since she last called to report the event. The reporter also mentioned that the patient was scheduled for a visit on the 29th of October. Follow-up on 10/30/15:  The reporter informed that the patient had failed to keep her appointment at the physician's office. Patient's recovery status is unknown. All attempts to obtain additional information have been unsuccessful.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Skin warm
Clinical narrative: A 24 year old woman received MassBiologics Td vaccine (Lot# A080A) in the left deltoid on 9/16/15 for wound prophylaxis.  The following day she reported she felt warm to the touch and developed itching, swelling, and pain at the injection site.  Two days after the immunization (9/18/15), she contacted her health care provider to report these symptoms along with expansion of the pruritus to her hand as well as hand stiffness.  Following the adverse event, she took ibuprofen 600mg orally.  The patient was offered an evaluation by her health care provider, but she declined. Sender's Comments: This adverse event is assessed as non-serious and labeled, as injection site reactions including pain, pruritus, and swelling are described in the product labeling, as is pyrexia (which may have caused the patient to feel "warm to the touch").  It is possible the reported hand stiffness was due to musculoskeletal stiffness (reaction described in the package insert) or was secondary to the swelling in the affected limb, but this is unable to be confirmed as the patient declined an evaluation by the provider on the day the symptoms were reported.  MassBiologics performed a follow up with the health care provider on two occasions as summarized below: Follow-up on 10/14/15:  The reporter informed that the patient did not visit the physician since the adverse event and that the clinic had not heard from the patient since she last called to report the event. The reporter also mentioned that the patient was scheduled for a visit on the 29th of October. Follow-up on 10/30/15:  The reporter informed that the patient had failed to keep her appointment at the physician's office. Patient's recovery status is unknown. All attempts to obtain additional information have been unsuccessful.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: Urticara and erythema.
Age: 38.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: After taking the first dose 2 days ago (1/30/16) and today (2nd dose of vaccine), experienced diarrhea within 2-4 hours of taking the pill.  Stomach cramping as well, with 2nd dose today causing more severe effects, with more episodes.  Only one episode on 1/30, so didn't report immediately, but second pill creating multiple episodes of diarrhea today, so I called the doctor and decided to report it.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient's left deltoid was red, hot and swollen at injection site which was about 3 cm in diameter. The swelling around the red went out 4-5 cm beyond that in diameter. The area was very itchy. The patient stated that she never had a reaction like this before with TDaP.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Constant Pain, Swelling, and Redness at and around injection site i.e. left upper arm near deltoid area.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: Evening of injection-"whole upper arm sore and a little swollen. The next day, Thursday 1/28/16, my arm continued to swell and I had a low grade fever in the afternoon.  When I got up on Friday morning, 1/30/16, I had a low grade fever of 102.8 and my arm was swollen, extremely painful and had a red rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness at site. Treated with cephalexin 250mg/5ml 6mL TID x 10.
Age: 32.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Nausea, diaphoresis.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Redness on upper left arm, blood spot similar to a small bruise (1/4 inch in diameter). Pt counseled to do cold compress/MOTRIN/BENADRYL. If no improvement seek medical attention. No rash or hives or resp issue.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling, Swelling, Tenderness
Clinical narrative: Left arm swelling 1-27-16. Axilla swelling started 1-28-16. Chest wall tender/firm starting 1-29-16.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Rash at injection site spreading to chest well, self-limited. No anaphylactic reaction. Diphenhydramine 50 mg PRN.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site pain, Injection site pruritus, Rash
Clinical narrative: Skin rash and redness, tenderness, itching, and pain at injection site.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Skin rash. Hydrocortisone small amount prn.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Impaired work ability, Malaise, Pyrexia
Clinical narrative: On 11/3 she started to feel ill. On 11/4 took off work with a stated (undocumented) fever and remained off work on the 5th and 6th. She did not see a physician but she was told she might have an allergic reaction.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, VARCEL
Symptoms: Dyskinesia, Fall, Moaning, Pain, Tremor
Clinical narrative: Patient received the following vaccines today, Meningococcal, Varicella, Influenza, and GARDASIL 9. After the last injection, GARDASIL 9, patient stated "Ouch, that one hurt," and then fell backwards onto the table. Patient started to have movements, and head shaking, along with moaning. Provider notified, vitals taken, EMS notified at 12:25PM. Patient was monitored until EMS arrived at 12:29PM. Patient was then transported to MC via 911.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Mucosal inflammation
Clinical narrative: Mother states 1 day after flumist she noticed sores, some coming out of nose that lasted for approximately 1 week and then went away.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Mucosal inflammation
Clinical narrative: About 1 day after flumist was given, developed sores inside the nose that lasted for around one week.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Blister, Neuralgia, Pain in extremity
Clinical narrative: Severe debilitating lower back pain and 2 weeks later a dime sized blistering pusey rash over and in the left eyebrow along with sciatic nerve pain in left leg (glutes) up to the knee. Result of shingles vaccination????
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pustular
Clinical narrative: Severe debilitating lower back pain and 2 weeks later a dime sized blistering pusey rash over and in the left eyebrow along with sciatic nerve pain in left leg (glutes) up to the knee. Result of shingles vaccination????
Age: 33.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: None.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Palpitations, Throat irritation
Clinical narrative: Case number PHEH2016US002218, is an initial spontaneous report received from a healthcare professional on 27 Jan 2016. This report refers to a 51 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 158102) intramuscularly on 22 Jan 2016. On the same day 20 to 25 minutes after vaccination, she experienced heart palpitations and discomfort in throat. Outcome of the events was reported as complete recovery on 22 Jan 2016. Seriousness and causality of the events were not reported. seriousness of the events palpitations and discomfort was upgraded to medically significant based on the information available in the source document.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat irritation
Clinical narrative: Case number PHEH2016US002218, is an initial spontaneous report received from a healthcare professional on 27 Jan 2016. This report refers to a 51 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 158102) intramuscularly on 22 Jan 2016. On the same day 20 to 25 minutes after vaccination, she experienced heart palpitations and discomfort in throat. Outcome of the events was reported as complete recovery on 22 Jan 2016. Seriousness and causality of the events were not reported. seriousness of the events palpitations and discomfort was upgraded to medically significant based on the information available in the source document.
Age: 73.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Fatigue, Feeling abnormal, Headache, Middle insomnia, Mobility decreased
Clinical narrative: 1 week after getting shot, 2 weeks of bad headaches, fatigue, woke up during the night and I couldn't hardly turn over because of pain. Pain when raising arms, weakness and pain in legs. It has been 5 months since the shot and I am in a lot of pain everyday. My whole life has changed. Some days I get up feeling like I have been beat with a bat. Never had this before the PREVNAR 13 shot. I hope this is not permanent.
Age: 73.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: 1 week after getting shot, 2 weeks of bad headaches, fatigue, woke up during the night and I couldn't hardly turn over because of pain. Pain when raising arms, weakness and pain in legs. It has been 5 months since the shot and I am in a lot of pain everyday. My whole life has changed. Some days I get up feeling like I have been beat with a bat. Never had this before the PREVNAR 13 shot. I hope this is not permanent.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: After HPV9 and MCV4 vaccine was given pt started feeling lightheaded and dizzy. Had pt lay on floor with legs up and ice applied to neck. She laid there for about 5 minutes then sat in chair. TP skin test was given, patient felt the same symptoms again. Had her lay on floor again for 5  minutes then she felt better.
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt says her arm has been hurting her since the shot. She can lift it but it is painful to lift too high she says she has tingling going down her arm and to her fingers.
Age: 16.0
Sex: F
Vaccine: FLUN4, MNQ
Symptoms: Rash macular, Respiratory tract congestion
Clinical narrative: Congestion and splotchy rash.
Age: 40.0
Sex: M
Vaccine: FLU3, HEP, PPV
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: 1/30/16 presented to ER for swelling to the proximal posterior (L)UE approximately 24-48 hours after receiving vaccination at that site. Approximately 40 hours after receiving vaccination developed diffuse myalgias, chills, fatigue, and diaphoresis. (2-1-15) -> (L) arm tenderness remains tender w/palpable hard swelling on (L) posterior upper arm dense erythema extends along triceps through medial upper arm down just past elbow. Full ROM of elbow no appreciable swelling of forearm or hand. Continue w/BENADRYL, ice and elevation.
Age: 40.0
Sex: M
Vaccine: FLU3, HEP, PPV
Symptoms: Metabolic function test, Myalgia, Tenderness
Clinical narrative: 1/30/16 presented to ER for swelling to the proximal posterior (L)UE approximately 24-48 hours after receiving vaccination at that site. Approximately 40 hours after receiving vaccination developed diffuse myalgias, chills, fatigue, and diaphoresis. (2-1-15) -> (L) arm tenderness remains tender w/palpable hard swelling on (L) posterior upper arm dense erythema extends along triceps through medial upper arm down just past elbow. Full ROM of elbow no appreciable swelling of forearm or hand. Continue w/BENADRYL, ice and elevation.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On 26-JAN-2016 the patient was administered improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017) (dosage, strength and route unknown) (temperature 30 degree Fahrenheit, time frame 4 hours). There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.