chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Echocardiogram normal, Hypersensitivity
Clinical narrative: Initial unsolicited report received from consumer on 28 October 2016. This case involves 77-year-old male patient who was vaccinated with a dose of Fluzone HD (batch number, expiry date, and site of administration was not reported) intramuscularly on 20 October 2016. Illness at time of vaccination reported as none and pre-existing physician diagnosed allergies, birth defects, a medical condition was reported as allergic to contrast dye. Concomitant medication was not reported. On 20 October 2016, 1.5 hour following the vaccination, patient began having difficulty breathing, gasping for air and in next morning he was still having breathing difficulties and went to the emergency room. On an unspecified date following vaccination patient reported that similar reaction many years ago when patient had dye injected for a test and was allergic to a component of it. On an unspecified date patient was hospitalized and released after 2 days. Lab data reported as echocardiogram was negative. It was reported that stress test scheduled for 31 October 2016. Corrective treatment was not reported. Patient was not recovered from events. It was reported that still having breathing difficulties, but not as severe. List of documents held by sender: none. Sender's Comments: INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Time to onset is compatible with the role of the vaccine. However investigation result to identify the culprit antigen and any other etiology would be helpful to assess this case further.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 28 October 2016. This case involves an 87-year-old male patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI697AB, expiry date: 06 May 2017, dose and dose in series were not reported) intramuscularly in the right arm on 27 October 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergies (NKA). Illness at the time of vaccination was reported as chronic kidney disease (CKD). Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 28 October 2016, one day following the vaccination, it was reported that the patient felt weak in legs. The patient was vaccinated with FLUZONE HD in last year. The patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a adult female patient who received FLUARIX. On an unknown date, the patient received FLUARIX. On an unknown date, 10 min after receiving FLUARIX, the patient experienced cellulitis (serious criteria GSK medically significant), redness and skin warm. The patient was treated with ibuprofen, ALLEGRA and medication unknown, medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the cellulitis, redness and skin warm were recovered/resolved. It was unknown if the reporter considered the cellulitis, redness and skin warm to be related to FLUARIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine on unknown arm. The reporter stated that the patient developed a reaction distal to the injection site, but in the injected arm. She stated the reaction looked like cellulitis because it was red and hot. The event went away after about a day and the patient felt better. The patient requested that medical information called her about using in pregnant women. The patient stated that she had read the package label and was aware of the center for disease control (CDC) recommendation, but was looking for any additional information.
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pneumonia
Clinical narrative: This spontaneous report has been received from a pharmacist via company representative regarding a female patient of unknown age. The patient's concurrent condition includes asthma. Concomitant medications were unknown. On 22-JUL-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L022262, Expiration date: 05-NOV-2016). Other suspect therapies included TDAP (manufacturer unknown) administered on the same day. On an unknown date in 2016, the patient experienced pneumonia. On 25-OCT-2016, the patient was admitted to an unspecified hospital for 5 days for the treatment of pneumonia. The patient had since recovered from pneumonia on an unknown date in 2016. The causality was not reported. Upon internal review, pneumonia was determined to be medically significant. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Began with swelling at injection site...initially approximately the size of a golf ball, progressing over next 2 days to approximately the size of a baseball...site was hot to the touch and red and painful.  Swelling began to dissipate on 5th day and after approximately 10 days was pretty much back to normal with the exception of minor itching.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Chills, Dyspnoea, Electrocardiogram abnormal, Laboratory test
Clinical narrative: Chills/fever beginning Saturday afternoon, progressed to body aches and respiratory symptoms by Saturday night.  Symptoms continued until I presented at urgent care with shortness of breath and EKG changes on 10/27/2016.  I was transported by ambulance to the emergency room where I was admitted for 4 days with pneumonia and EKG changes.  Discharge on 10/30/2016 with numerous at-home medications and follow-up appointments.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pneumonia, Pyrexia, Respiratory symptom
Clinical narrative: Chills/fever beginning Saturday afternoon, progressed to body aches and respiratory symptoms by Saturday night.  Symptoms continued until I presented at urgent care with shortness of breath and EKG changes on 10/27/2016.  I was transported by ambulance to the emergency room where I was admitted for 4 days with pneumonia and EKG changes.  Discharge on 10/30/2016 with numerous at-home medications and follow-up appointments.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest pain, Computerised tomogram, Headache, Pyrexia
Clinical narrative: Headache, chest pain - 5 min and did not return, 1.5 degree fever, and vomiting.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound liver, Ultrasound scan, Vomiting
Clinical narrative: Headache, chest pain - 5 min and did not return, 1.5 degree fever, and vomiting.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, slight swelling and tenderness to upper right arm where Hepatitis A (HAVRIX) injection had been administered.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain, Sleep disorder
Clinical narrative: Arm red at site of injection.  Large area on upper arm.  Hot to touch, painful - patient woke from sleep with pain.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Intense sore/dull pain in upper arm.  After a few days it continued.  One year later nothing has changed.  I have delayed getting a flu shot this year because I'm uncertain if I want to have the shot in the same arm and if additional adverse effects might happen.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Nervousness, Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 26-Oct-2016. This case involves a 61-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number expiry date, dose strength, form, frequency, route of administration were not reported) on an unknown date. Patient's medical history included cyst on her spine. Concomitant medications included teriflunomide for multiple sclerosis. Concurrent conditions included cyst on the spine and multiple sclerosis. On 17-Oct-2016 unspecified days post vaccination the patient reported that her arm was sore and she had fever and body aches. The patient also reported that she was experiencing feeling shaky on and off over the past few weeks. Laboratory investigations included MRI scan on an unspecified date which revealed cyst getting larger and a surgery was planned for the same. Corrective treatment was not reported. At the time of the report the patient had recovered from the events fever, body aches and sore arm while the outcome of the event "feeling shaky on and off" was not recovered. List of documents held by the sender: None.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lethargy, Pyrexia, Skin warm, Tremor
Clinical narrative: Initial unsolicited report received from a nurse (LPN) on 27-Oct-2016. This case involves a 94-year-old female patient who was vaccinated with FLUZONE HD (lot number: UI689AA, expiration date: 26-Apr-2017, dose in series, site of administration not reported) intramuscularly in left arm on 19-Oct-16. Illness at the time of vaccination was reported as unknown and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy. Concomitant medication was not reported. On 20-Oct-2016, one day after the vaccination, patient had warm skin, headache, shaky and lethargic with a fever of 101F. Patient required ER/doctor visit. The patient's laboratory and corrective treatment were not reported. It was reported that all symptoms were resolved on 27-Oct-2016. (The outcome was also reported as not recovered). List of the documents held by sender: none.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm swelling and redness.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complains of left arm pain, with limited range of motion along with pain when arm is touched. No redness or swelling at injection site.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, X-ray
Clinical narrative: Complaints of left arm pain.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Patient stated that she was having weakness/numbness/tingling of the legs. She went to her PCP office and was diagnosed with Guillain-Barre. She has been taking TYLENOL which has been helping with the pain. Spoke to patient 11/4/2016 and symptoms were diminishing/gone.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure increased, Chills, Dizziness, Fatigue, Myalgia
Clinical narrative: My mother got this shot then several hours later started with arm pain, then chills. Nausea, dizziness and her blood pressure continuously had risen until at 930 pm she had a seizure as of 12 noon on 11/08/2016 she complains of nausea, muscle aches, fatigue, sleepiness and chills. She should NOT have had this shot and by her records and the insert of this medication the doctor should have known this!
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain in extremity, Seizure, Somnolence
Clinical narrative: My mother got this shot then several hours later started with arm pain, then chills. Nausea, dizziness and her blood pressure continuously had risen until at 930 pm she had a seizure as of 12 noon on 11/08/2016 she complains of nausea, muscle aches, fatigue, sleepiness and chills. She should NOT have had this shot and by her records and the insert of this medication the doctor should have known this!
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aphasia, Crying, Dyskinesia, Headache
Clinical narrative: Beginning the early morning hours of September 30, 2014 my son began screaming and grabbing his head. Over the next few days he continued screaming, having 3-4 HOUR long crying fits, lost most of his speech, started flapping his arms, jumping off of high and dangerous things, spinning, and had obviously new sensory and speech issues. He was shortly thereafter diagnosed with Sensory Processing Disorder and Expressive-Receptive Language Disorder and the onset of symptoms was within a week of MMR vaccine. It took over a year before the 3-4 hour long sensory related tantrums subsided to being under 2 hours long as we worked through his new sensory processing disorder. He was nearly 4 before he learned to talk enough to help ask for the sensory needs to prevent the long meltdowns and he was just over age 4 before he regained the speech he lost after the MMR vaccine.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Laboratory test, Language disorder, Screaming, Sensory processing disorder, Speech disorder
Clinical narrative: Beginning the early morning hours of September 30, 2014 my son began screaming and grabbing his head. Over the next few days he continued screaming, having 3-4 HOUR long crying fits, lost most of his speech, started flapping his arms, jumping off of high and dangerous things, spinning, and had obviously new sensory and speech issues. He was shortly thereafter diagnosed with Sensory Processing Disorder and Expressive-Receptive Language Disorder and the onset of symptoms was within a week of MMR vaccine. It took over a year before the 3-4 hour long sensory related tantrums subsided to being under 2 hours long as we worked through his new sensory processing disorder. He was nearly 4 before he learned to talk enough to help ask for the sensory needs to prevent the long meltdowns and he was just over age 4 before he regained the speech he lost after the MMR vaccine.
Age: 86.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports swelling, redness, and itching in area near where the immunization was administered. The adverse reaction began 6 days after the immunization, prior to the patient said the area was sore.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dyspnoea, Fall, Urticaria
Clinical narrative: JOINT PAIN, hives, shortness breathe, falling.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient came in with hot, red, swollen arm; same arm as the one vaccinations given. She went to ER and was diagnosed with cellulitis, given antibiotics and released.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pityriasis rosea, Rash
Clinical narrative: Patient received the Flu shot and the next day had a small rash on her abdomen. The rash grew to cover her entire torso and chest. She has seen several physicians and is being treated for pityriasis rosea. Treated with steroids and other topical medication.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Pain in left shoulder joint, difficulty raising arm, lifting even small amount of weight.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursitis
Clinical narrative: Pain in left shoulder joint, difficulty raising arm, lifting even small amount of weight.
Age: 20.0
Sex: U
Vaccine: FLUX, MENB
Symptoms: Blood ketone body, Malaise
Clinical narrative: This is a spontaneous report from a contactable nurse, via a Pfizer sales representative. A 20-year-old patient of an unspecified ethnicity and gender received TRUMENBA first dose at single dose, and first dose of  influenza vaccine both via an unspecified route of administration on an unspecified date for immunization. Medical history included diabetes mellitus.  The patient's concomitant medications were not reported.  The patient felt sick after receiving the two vaccinations and later developed ketones on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age, race, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient had an allergic reaction to the vaccine on an unspecified date. Outcome was unknown.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Limb discomfort, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age and race received  PREVNAR 13, via an unspecified route of administration in Sep2016 at single dose for immunisation.  The patient medical history and the patient's concomitant medications were not reported.  The patient experienced arm discomfort, she cannot use her right arm properly. The outcome was reported as unknown.  She went to doctor and he gave her muscle relaxant.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Influenza like illness, Myalgia, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable office manager, reporting for herself, via a Pfizer sales representative. This 65 year-old female patient received PREVNAR 13 via an unspecified route of administration in the left arm on 01Nov2016 at 0.5 ml single for routine vaccination. The patient medical history and concomitant medications were not reported. No other vaccines were administered the same day. On an unspecified day in Nov2016 the patient felt achy, arm was killing her, she also experienced flu like symptoms, muscle ache, she felt crappy. The patient recovered on an unspecified day in Nov2016.
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is spontaneous report from a contactable nurse practitioner reporting for herself via a Pfizer sales representative. This  female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration at 0.5 ml single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced all over body aches on an unspecified date after the vaccination from which she recovered after 24-48 hours.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC13, VARZOS
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received PREVNAR 13, on an unknown date in 2016 at 0.5 ml single for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2016 the patient experienced joint pain, muscle pain and she couldn't move neck left or right. She stated that the muscle around her neck was bad and she couldn't turn it left or right. She went to the hospital and got a shot for a muscle relaxant. She was not admitted to the hospital, she was treated in the emergency room. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Bone pain, Discomfort, Fatigue, Headache
Clinical narrative: This 65 year-old female patient received for immunization a single dose of PREVNAR 13 (lot M05077) intramuscular in the left deltoid on 30Aug2016 and an unspecified flu shot in the right deltoid on an unspecified date.  The patient medical history was not reported.  There were no concomitant medications. It was reported pneumococcal 13-val conj vac (dipht crm197 protein) was administered in an unusual manner: the administrator (a medical assistant) put the needle into the deltoid muscle in the left arm of the patient and with the open palm of the hand slammed the plunger into the arm. The medical assistant did not wipe the area of the injection with alcohol and did not put a Band-Aid on it after the injection. It was also reported that the vaccine suspension was pale yellow in color and it looked like a lot of stuff. On 30Aug2016 the patient experienced fatigue, aching in her left deltoid where received the injection, she had mild headache, aching all over and she had joints and bone pain, pain, trouble in falling asleep because it was uncomfortable. It was reported that when, after the vaccination, the patient went home, she was overwhelmed by significant fatigue and also had aching in her left deltoid where received the injection. For the next three to four days she had a mild headache, aching all over and she had joints and bone pain. It seemed like it coursed through her whole body twice over weeks. She mentioned that the pain bothered her in sleeping too. She had trouble in falling asleep because it was uncomfortable and she woke up in the early hours like 3 to 4 AM. She had informed her doctor about this and the pain was slowly getting better and it was coming and going. She underwent to two physical therapy sessions regarding this pain, she was also taking ibuprofen tablet oral 600 mg at least two per day to help with this pain and her fatigue was improving week by week. The patient underwent to shoulder X-ray to check and to make sure whether a piece of needle or anything else was there in her shoulder considering how violently she was injected, but there was no foreign body in her muscle or bones. The bone was fine and there were no signs of arthritis or anything else that could cause pain in her shoulder. The patient mentioned that she was not fully recovered; she was still getting physical therapies and she was recovering, but she still had pain. The pain was ongoing but in the last 2 weeks it has been settled just in the left deltoid area at the injection site and left shoulder.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Inadequate aseptic technique in use of product, Initial insomnia, Injection site pain, Liquid product physical issue, Pain
Clinical narrative: This 65 year-old female patient received for immunization a single dose of PREVNAR 13 (lot M05077) intramuscular in the left deltoid on 30Aug2016 and an unspecified flu shot in the right deltoid on an unspecified date.  The patient medical history was not reported.  There were no concomitant medications. It was reported pneumococcal 13-val conj vac (dipht crm197 protein) was administered in an unusual manner: the administrator (a medical assistant) put the needle into the deltoid muscle in the left arm of the patient and with the open palm of the hand slammed the plunger into the arm. The medical assistant did not wipe the area of the injection with alcohol and did not put a Band-Aid on it after the injection. It was also reported that the vaccine suspension was pale yellow in color and it looked like a lot of stuff. On 30Aug2016 the patient experienced fatigue, aching in her left deltoid where received the injection, she had mild headache, aching all over and she had joints and bone pain, pain, trouble in falling asleep because it was uncomfortable. It was reported that when, after the vaccination, the patient went home, she was overwhelmed by significant fatigue and also had aching in her left deltoid where received the injection. For the next three to four days she had a mild headache, aching all over and she had joints and bone pain. It seemed like it coursed through her whole body twice over weeks. She mentioned that the pain bothered her in sleeping too. She had trouble in falling asleep because it was uncomfortable and she woke up in the early hours like 3 to 4 AM. She had informed her doctor about this and the pain was slowly getting better and it was coming and going. She underwent to two physical therapy sessions regarding this pain, she was also taking ibuprofen tablet oral 600 mg at least two per day to help with this pain and her fatigue was improving week by week. The patient underwent to shoulder X-ray to check and to make sure whether a piece of needle or anything else was there in her shoulder considering how violently she was injected, but there was no foreign body in her muscle or bones. The bone was fine and there were no signs of arthritis or anything else that could cause pain in her shoulder. The patient mentioned that she was not fully recovered; she was still getting physical therapies and she was recovering, but she still had pain. The pain was ongoing but in the last 2 weeks it has been settled just in the left deltoid area at the injection site and left shoulder.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Sleep disorder, Wrong technique in product usage process, X-ray limb normal
Clinical narrative: This 65 year-old female patient received for immunization a single dose of PREVNAR 13 (lot M05077) intramuscular in the left deltoid on 30Aug2016 and an unspecified flu shot in the right deltoid on an unspecified date.  The patient medical history was not reported.  There were no concomitant medications. It was reported pneumococcal 13-val conj vac (dipht crm197 protein) was administered in an unusual manner: the administrator (a medical assistant) put the needle into the deltoid muscle in the left arm of the patient and with the open palm of the hand slammed the plunger into the arm. The medical assistant did not wipe the area of the injection with alcohol and did not put a Band-Aid on it after the injection. It was also reported that the vaccine suspension was pale yellow in color and it looked like a lot of stuff. On 30Aug2016 the patient experienced fatigue, aching in her left deltoid where received the injection, she had mild headache, aching all over and she had joints and bone pain, pain, trouble in falling asleep because it was uncomfortable. It was reported that when, after the vaccination, the patient went home, she was overwhelmed by significant fatigue and also had aching in her left deltoid where received the injection. For the next three to four days she had a mild headache, aching all over and she had joints and bone pain. It seemed like it coursed through her whole body twice over weeks. She mentioned that the pain bothered her in sleeping too. She had trouble in falling asleep because it was uncomfortable and she woke up in the early hours like 3 to 4 AM. She had informed her doctor about this and the pain was slowly getting better and it was coming and going. She underwent to two physical therapy sessions regarding this pain, she was also taking ibuprofen tablet oral 600 mg at least two per day to help with this pain and her fatigue was improving week by week. The patient underwent to shoulder X-ray to check and to make sure whether a piece of needle or anything else was there in her shoulder considering how violently she was injected, but there was no foreign body in her muscle or bones. The bone was fine and there were no signs of arthritis or anything else that could cause pain in her shoulder. The patient mentioned that she was not fully recovered; she was still getting physical therapies and she was recovering, but she still had pain. The pain was ongoing but in the last 2 weeks it has been settled just in the left deltoid area at the injection site and left shoulder.
Age: 38.0
Sex: F
Vaccine: FLUR3
Symptoms: Dizziness, Fatigue, Pruritus
Clinical narrative: Itching, fatigue, dizziness, afebrile.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Was given dose for children 6-35 months which is incorrect age group.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Headache, Insomnia, Tremor
Clinical narrative: Severe Headache, Chills, Shaking, considered going to ER, but took OTC meds and waited/watched. Unable to sleep, and Mild Headache persists today. (11/8/2016, reported at 120PM).
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hyporesponsive to stimuli, Hypotonia, Laboratory test normal, Pallor
Clinical narrative: After waking up in the morning baby became limp, pale and has low reaction, for about 10-15 minutes.
Age: 64.0
Sex: F
Vaccine: TTOX
Symptoms: Activities of daily living impaired, Quality of life decreased, Wheelchair user
Clinical narrative: The tetanus shot completely destroyed my life. I am in a wheelchair. I cannot take care of myself.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Hallucination, Headache, Lethargy, Nervous system disorder
Clinical narrative: Difficulty breathing, neurological issues, headache, lethargy, and hallucinations.
Age: 65.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Redness and swelling of left deltoid. Minimal warmth to the touch. Full ROM.
Age: 65.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness and swelling of left deltoid. Minimal warmth to the touch. Full ROM.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became swollen (height of a golf ball, area the size of a soft ball), red, and hot to touch.
Age: 27.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Haemoglobin decreased, Unresponsive to stimuli
Clinical narrative: After administration of vaccines pt became unresponsive with heart rate in 40's. EMS was called and pt transported to ER.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Lymphocyte count normal, Monocyte count increased, Neutrophil count increased, Pyrexia
Clinical narrative: Headache and fever.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: After receiving a routine flu shot, I began to feel extreme pain in the effected shoulder, which continued to get worse for the following week. I experienced severe pain and limited mobility. Upon returning to doctor I was administered a cortisone shot which helped ease the pain.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Neck pain
Clinical narrative: Swelling and redness on the injection with severe pain radiating toward the left side of neck to left lower arm. Left axillary lymphadenopathy.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Headache, Neck pain, Viral infection, White blood cell count increased
Clinical narrative: Case number PHEH2016US028706, is an initial spontaneous report received from a consumer on 31 Oct 2016. This report refers to a 46 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch  number: not reported) at a dose of 0.5 ml intramuscularly on 10 Oct 2016. On 20 Oct 2016, reported as 10 days after vaccination the patient experienced muscle pain in back, neck and headache. The patient went to  the hospital and her white cell count was up (results unspecified). She was treated with vancomycin. She stayed in the hospital for a day and her diagnosed was viral unknown. The outcome of the event viral infection was reported as condition improving and of other events was not reported. The causality of the events was not reported.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness, Meningococcal infection, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a adolescent patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant), meningococcal infection (serious criteria GSK medically significant) and influenza-like symptoms. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal infection and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO. The reporter considered the influenza-like symptoms to be almost certainly related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The batch number was unknown. In 2016, the patient received BEXSERO in unknown arm and experienced flu-like symptoms that she described as feeling like she had developed meningococcal disease. This case was considered as suspected vaccination failure, since the exact time to onset for the event and laboratory confirmation of the infection was not provided. In 2016, the events got resolved.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore arm lasting longer than a week.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: FLUARIX given in left deltoid per RN at 3:50 P.M. At 3:55 PM patient c/o itching at injection site with whelping rash noted below shoulder. Cold compress applied. Patient employee.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Injection site bruising, Peripheral swelling, Skin warm
Clinical narrative: Stated she had a severe headache and still does (11/08/2016). Arm is swollen and red and hot. There is a bruise at injection site.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Haematoma, Rash erythematous, Vaccination complication
Clinical narrative: FLAT, RED RASH ON INSIDE OF ARM COVERING 1/2 OF LENGTH OF ARM. AT BOTTOM OF RASH 2IN DIAMETER LUMP OR POCKET OF FLUID. NO ITCH, PAIN OR HEAT. NOTHING AROUND INJECTION SITE.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood test, Cold sweat, Dehydration, Electrocardiogram
Clinical narrative: In the evening, I began feeling weak and feverish. Through the night I had cold sweats and aches. The following day at 9:30 a.m., I passed out at work and was transported to the emergency room via ambulance. I was told I was dehydrated and had a UTI (of which I had no symptoms previously).
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Loss of consciousness, Pain, Pyrexia, Urinary tract infection, Urine analysis
Clinical narrative: In the evening, I began feeling weak and feverish. Through the night I had cold sweats and aches. The following day at 9:30 a.m., I passed out at work and was transported to the emergency room via ambulance. I was told I was dehydrated and had a UTI (of which I had no symptoms previously).
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient c/o burning as soon as vaccine was administered. Patient called facility 30 minutes later, said injection site was swollen, red, and hot. Nurse advised her to apply cool compress, take MOTRIN, monitor for 24 hours and call back with any worsening changes. Patient called on 11/7/16, said swelling had gone down, reported bruising at injection site.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Dizziness, Headache, Hypopnoea
Clinical narrative: Severe headache, chills, HR 141, fever of 104, dizziness, weakness, rapid, shallow breathing.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory rate increased
Clinical narrative: Severe headache, chills, HR 141, fever of 104, dizziness, weakness, rapid, shallow breathing.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death
Clinical narrative: Death.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Fatigue, Influenza like illness, Pain, Peripheral swelling
Clinical narrative: FLU LIKE SYMPTOMS, BODY ACHES, EXTREME FATIGUE, SWOLLEN AND RED ARM FROM ELBOW TO SHOULDER. Symptoms lasted for three days.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Feeling jittery, Local swelling, Myalgia, Vomiting
Clinical narrative: Chills, myalgias, jittery feeling, vomiting, local swelling.  Symptoms lasted for 12 hours.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Abdominal X-ray, Emotional distress, Irritability, Pyrexia, Ultrasound abdomen normal
Clinical narrative: Pt. developed  fever of 102.2 and was irritable later in the day after receiving vaccines.  Fever lasted 4 days and pt. was very irritable and inconsolable for most of the 4 days.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: X-ray normal
Clinical narrative: Pt. developed  fever of 102.2 and was irritable later in the day after receiving vaccines.  Fever lasted 4 days and pt. was very irritable and inconsolable for most of the 4 days.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Family noticed a large area of redness around the site of the influenza vaccination.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Chills, Dysstasia, Headache
Clinical narrative: Between 8:00 PM and 8:00 AM experienced the following: severe nausea and vomiting, chills and shivering, room spinning, severe headache, weakness, couldn't stand, walk or sleep, extreme arm pain.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Nausea, Pain in extremity, Vertigo, Vomiting
Clinical narrative: Between 8:00 PM and 8:00 AM experienced the following: severe nausea and vomiting, chills and shivering, room spinning, severe headache, weakness, couldn't stand, walk or sleep, extreme arm pain.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Skin on arm red and hot, some swelling.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Nausea, Urticaria, Vertigo
Clinical narrative: 14:15 client C/O feeling nauseated, flushed, and head was swimming. BP 158/97 P 98 R 20 alert and oriented x 3. Face was flushed, hives on cheeks and forehead. BP repeated 173/103. Declined transport to emergency room.
Age: 44.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: The patient's boss called into the pharmacy to state that her employee received her flu and Tdap shot at the pharmacy on Sunday 10/23/16 and still has a red, sore, warm and painful arm where the vaccine was administered.
Age: 0.17
Sex: M
Vaccine: RV1, RV1
Symptoms: Enema administration, Gastrointestinal sounds abnormal, Intussusception, Syncope, Ultrasound abdomen abnormal
Clinical narrative: Vomiting, hyperactive bowel sounds. Pt later went to ER for worsening condition the next day. Pt then went to different hospital and was given an enema, which caused pt to have syncopal episode. Pt then diagnosed with intussusception.
Age: 0.17
Sex: M
Vaccine: RV1, RV1
Symptoms: Vomiting
Clinical narrative: Vomiting, hyperactive bowel sounds. Pt later went to ER for worsening condition the next day. Pt then went to different hospital and was given an enema, which caused pt to have syncopal episode. Pt then diagnosed with intussusception.
Age: 0.17
Sex: M
Vaccine: RV1, RV1
Symptoms: Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Vomiting, hyperactive bowel sounds. Pt later went to ER for worsening condition the next day. Pt then went to different hospital and was given an enema, which caused pt to have syncopal episode. Pt then diagnosed with intussusception.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt states she had a hive one to two inches below injection site and itchy hives covering her body.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PT HAD SEVERE PAIN IN ARM AND SHE COULD NOT EVEN LIFT HER ARM. SHE WENT TO DOCTOR TO REPORT IT TO HIM. SHE HAD SEVERE PAIN AND IMMOBILITY THAT LASTED FOR DAYS. SHE HAS FLU SHOT EVERY YEAR AND NEVER HAD ANY REACTION UNTIL THIS YEAR.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, discomfort at injection site.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Pyrexia
Clinical narrative: High fever, dizziness.
Age: 82.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The daughter of the patient called pharmacy late Monday (11/07/2016) after stating her mother had received vaccines from us on 11/02/2016. She stated the arm where PREVNAR-13 was administered was swollen the size of a baseball and the back side of the arm where ZOSTAVAX was administered was red and itching. Staff advised the daughter to contact the prescribing physician, due to the length of time of the swelling. The pharmacist administering the vaccines stated that the patient insisted on receiving both vaccines in the same arm.
Age: 45.0
Sex: F
Vaccine: HEP, HEPA, MMRV, MNQ, VARCEL, HEP, HEPA, MEN, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: NONE.
Age: 45.0
Sex: F
Vaccine: HEP, HEPA, MMRV, MNQ, VARCEL, HEP, HEPA, MEN, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: NONE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site rash
Clinical narrative: Rash to inoculation sites on Bilateral Thighs.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature, Chest discomfort, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Her left arm was sore and she woke up in the middle of the night and put an ice pack on it. Her arm was swollen and hot and this lasted through Sunday night. She had a temperature Saturday 101 F but was gone on Sunday. Saturday she had a tightening in the chest lasted into the night and then Sunday morning she did not have chest tightness. Tuesday night she is now fine no problems.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizzy spell lasting for about 1 minute while out gardening - so bad patient had to stay down on hands and knees on the ground for it pass.
Age: 73.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Blood test, Headache, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Headache, Extreme pain at the injection site moving down to the wrist; Red splotchy rash below injection site, Nausea, Vomiting, Neck stiffness.
Age: 73.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Nausea, Pain in extremity, Rash macular, Vomiting
Clinical narrative: Headache, Extreme pain at the injection site moving down to the wrist; Red splotchy rash below injection site, Nausea, Vomiting, Neck stiffness.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Dysphonia, Dyspnoea, Nasal congestion
Clinical narrative: SHORTNESS OF BREATH, STUFFY NOSE, HOARSENESS VOICE AND HIP PAIN.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Condition aggravated, Injection site erythema, Mood altered, Pyrexia
Clinical narrative: Redness at injection site, fever, mood change, behavior change, relapse in progress of understanding/grasp/mood/behavior. We're 2 weeks post shots, and he's still in a relapse. He's not the same person he was before he had his shots...like his autism is worse.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Autism, Condition aggravated, Injection site erythema, Pyrexia
Clinical narrative: Redness at injection site, fever, mood change, behavior change, relapse in progress of understanding/grasp/mood/behavior. We're 2 weeks post shots, and he's still in a relapse. He's not the same person he was before he had his shots...like his autism is worse.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Haemoglobin normal, Petechiae, Platelet count normal, White blood cell count normal
Clinical narrative: Petechial rash in arms and chest, no symptoms, no fever, no vesicles, no evident bleeding.
Age: 56.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient had swelling in administration arm and high fever of 103.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular, Urticaria
Clinical narrative: Flu vaccines given at 8:40A at 9:12A noted red blotches and welts. Given BENADRYL .04ml at 9:15A. EMS called and arrived at 9:25A.
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: R Shoulder developed 3cm pruritic, eurythmic area of vaccine w/in 10 min of administration.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Choking, Dysphagia, Local swelling, Nocturnal dyspnoea
Clinical narrative: Swelling entire neck-hard to swallow-cannot breath at night, feels like choking. Seen in clinic a few days later and had improved with BENADRYL. No rash, no hives, no swelling oropharynx. Add non-sedating antihistamine, continue prednisone BENDRYL HB.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Upon receipt of vaccine Pt. reported immediate burning (more than normal). During evening hours arm soreness became worse. Pt. had difficult time lifting arm over head which continues to date. No treatment sought.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Nuclear magnetic resonance imaging, Pain in extremity, Swelling, Ultrasound scan
Clinical narrative: Very painful left arm immediately swelling.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: X-ray limb
Clinical narrative: Very painful left arm immediately swelling.
Age: 34.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain
Clinical narrative: Soreness that gradually became more like a sharp pain when lifting or rotating arm. Symptoms have been present for a month. Patient has been moving arm to keep limber, taking Ibuprofen/ALEVE around the clock, and using hot and cold compresses.
Age: 34.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness that gradually became more like a sharp pain when lifting or rotating arm. Symptoms have been present for a month. Patient has been moving arm to keep limber, taking Ibuprofen/ALEVE around the clock, and using hot and cold compresses.
Age: 55.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large, red, hot, painful, bruising on left arm to elbow.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: Patient complains of shoulder and muscle pain. Needed a cortisone injection.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pyrexia, Skin warm, Swelling, Tenderness
Clinical narrative: Patient received flu shot 11/6/16, seen in office today for erythema and swelling. Sister reports patient had slight fever last night. Today patient presents with erythema and swelling over left deltoid extending to elbow, scapula, neck, and across chest reaching to sternum with irregular borders. Area is very hot to the touch and tender. Patient started on cephalexin 250 mg/5 ml, 6.75 ml tid for 10 days.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Ear pain, Headache, Myalgia, Vomiting
Clinical narrative: Headache started about 4:00 p.m. Muscle aches and ears hurting - 9:00 p.m. Diarrhea and throwing up at 4:00 a.m. took TYLENOL, ADVIL and PEPTO BISMOL.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Muscular weakness
Clinical narrative: 10/10 - 12N lasting until 5pm 10/11. Weakness thighs and calves. Received Flu shot 10/6. No other symptoms or weakness. Felt weak when standing.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt got flu shot at pharmacy on 10/29/16 developed swelling and redness to injection site next day. Seen in our office 10/31/16 swelling/redness measured 4 x 10 cm.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Mydriasis
Clinical narrative: Pt received FLUZONE then began having diaphoresis, dizziness, SOB, and dilated pupils. EMS called. Pt refused transport to ED. F/U call on 11/4/16 pt states no further complications.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient got really big bruise around injection site - after 10 days still she has almost 6 inches long bruise on her left upper arm. It does hurt her to touch.