chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at site of injection.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site abscess, Mass, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: PAIN BEGAN ON NOVEMBER 2ND, AND BY NOVEMBER 6TH, I NOTICED I COULD FEEL A LUMP.  I CONTACTED MY PCP AND WAS TREATED FOR CELLULITIS.  A FEW DAYS LATER I CALLED MY PCP BECAUSE THE ANTIBIODIC WASN'T HELPING.  AN MRI SHOWED THAT I HAD AN ABSCESS 3 INCHES LONG AND AN INCH THICK.  I SAW AN ORTHOPEDIC SURGEON ON NOV. 11TH, AND HAD SURGERY ON NOV. 12TH TO REMOVE THE ABSCESS.  I KNOW HAVE A 3-4 INCH INCISION HEALING ON MY LEFT SHOULDER.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pathology test, Shoulder operation
Clinical narrative: PAIN BEGAN ON NOVEMBER 2ND, AND BY NOVEMBER 6TH, I NOTICED I COULD FEEL A LUMP.  I CONTACTED MY PCP AND WAS TREATED FOR CELLULITIS.  A FEW DAYS LATER I CALLED MY PCP BECAUSE THE ANTIBIODIC WASN'T HELPING.  AN MRI SHOWED THAT I HAD AN ABSCESS 3 INCHES LONG AND AN INCH THICK.  I SAW AN ORTHOPEDIC SURGEON ON NOV. 11TH, AND HAD SURGERY ON NOV. 12TH TO REMOVE THE ABSCESS.  I KNOW HAVE A 3-4 INCH INCISION HEALING ON MY LEFT SHOULDER.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Impaired work ability, Injection site pain, Muscular weakness
Clinical narrative: Reported muscle weakness, fatigue, severe soreness at site of injection. Out of work for 4 days. Course of adverse event 4 days.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Severe muscle pain, fatigue, redness swelling at site of injection for greater than 1 week.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site nodule, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Fever, knot/nodule at injection site, swollen hands and feet, rash on hands, feet, wrists.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Bedridden, Mobility decreased, Musculoskeletal stiffness, Vaccination site pain, Vaccination site swelling
Clinical narrative: Right arm (where vaccine was given) and whole back swole up, and got stiff and store. Could not move and was bedridden for 8 days.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Severe pain in entire arm where flu shot was given with weakness.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Activities of daily living impaired, Headache, Vertigo positional
Clinical narrative: Vertigo during the night when turning over from one side to another. I have never in my life had vertigo, so i did not know what it was. It is now 11/15/15 and I still have it at night, albeit not as intense as initial, AND I have it during the day when I turn my head side to side or up/down - affecting my work (presentations and meetings).
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Tremor, Vomiting
Clinical narrative: Patient reported body shaking/tremors, and nausea/vomiting until approximately 1am. Pt received shot about noon and said symptoms started about 5 hours later.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Lymph node pain, Lymphadenopathy, Neck pain, Pain, Tenderness
Clinical narrative: Very large Swollen lymph nodes around collar bone with pain whenever it is touched or if I move my left arm or turn my neck to that side. Pain/tenderness going up into neck.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Patient had some swelling (lump) at deltoid injection site that appeared to have resolved/lessened in about 10 minutes. No difficulty breathing or other side effects in 25-30 minutes of monitoring. This report is precautionary.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Patient received Prevnar 13 on 11/11/15.  24 hours later, she called & reported being spacey in the head and having a headache.  She said she was also running fever and had chills.  I told her to take Tylenol and if the fever did not start coming down, to go to the E.R.  The next morning, she reported that she felt normal 2 hours later, after taking the Tylenol and everything was well.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Eye irritation, Feeling abnormal, Oropharyngeal pain
Clinical narrative: Started with a sore throat and followed shortly by burning eyes.   A few hours later my throat became not only sore but swollen and I started to get aches and pains in my legs and back.  When I got up about 07:00 AM the throat was normal as the soreness and swelling had gone away and most of the aches had subsided.  However I did feel weak and did not feel normal until about 02:00 PM.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Pharyngeal oedema
Clinical narrative: Started with a sore throat and followed shortly by burning eyes.   A few hours later my throat became not only sore but swollen and I started to get aches and pains in my legs and back.  When I got up about 07:00 AM the throat was normal as the soreness and swelling had gone away and most of the aches had subsided.  However I did feel weak and did not feel normal until about 02:00 PM.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Laboratory test, Mobility decreased, Myalgia, Paraesthesia
Clinical narrative: Unable to left arm away from body, extreme pain in arm muscle.  Unable to use arm for daily functions, occasional tingling down arm to finger tips.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: Unable to left arm away from body, extreme pain in arm muscle.  Unable to use arm for daily functions, occasional tingling down arm to finger tips.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Day after vaccination patient experienced soreness in both arms. Per patient felt like she was punched in arm 100 times. Initially, pain predominantly in Adacel (right) arm. Then alternated back & forth between right & left arm. She has been on Motrin tid since day after vaccination. Patient complains of pain when she crosses arms and states she cannot lift arms above shoulders. No redness, no warmness & no swelling per patient. About 2 to 2 and 1/2 wks after vaccination she went to ER as PCP was out of town. She was told to continue Motrin and give it a few more days. More recently as symptoms are still present her doctor is recommending XRay or MRI to check for muscle involvement or damage.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Haemorrhage, Syncope
Clinical narrative: Subsequent to IM injection on deltoid, patient had minor bleeding which soon stopped. As patient was rising from chair, he fainted and fell from chair. His mother caught him as he fell. It did not appear to be a bad fall. Patient regained consciousness right away. The fainting was brief. Patient was monitored for about 30 minutes during which time he was stable with no complaints.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Headache for 2 days (as of today) no ibuprofen, acetaminophen etc. taken as I read they could suppress immune making ability.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pink or red below inj site 11-9->11-13-15 hot/swollen. Less in color 11-14-15.
Age: 89.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vaccination complication
Clinical narrative: My shot reacted from a pneumonia shot. I end up in the hospital 5 days. It messed my whole body up.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Patient developed large lump around injection site that was hard, painful, and warm to the touch. Lump continued to get larger over days after vaccination. Diagnosed by patient's doctor as cellulitis.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain
Clinical narrative: Pt received flu and pneumonia at same time at same arm on 10/8/15. Pt is suffering still from pain and cannot move freely with that arm been more than 10 days.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Site of injection itchy, red and large red wheal surrounded injection site (approx 3") when I saw it 6 days later. Advised pt to go to Dr's. Dr advised BENADRYL tabs and HC cream OTC.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Pt given vaccine 11/12/15 in afternoon. Pt called and reported redness, swelling, pain, warm to touch on afternoon of 11/13/15. Pt counseled to monitor and to call if symptoms worsen. Pt came to pharmacy on 11/15/15 in the morning. Redness "still" extended through entire upper arm. Pt thought swelling had improved some. Redness stretched from shoulder to elbow. Pt was going to consult her doctor.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Axillary pain, Erythema, Neck pain, Pruritus
Clinical narrative: 2 days post vaccination pt developed a sore neck. 6 days post vaccination pt developed large itchy, red area on arm and had soreness under arm. Advised topical hydrocortisone and cool compress. Pt on medication.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: On Wednesday, started rash, left abdomen. Has "shooting pains" occasionally, "starts and stops". Will se Dr tomorrow.
Age: 20.0
Sex: F
Vaccine: FLUC3
Symptoms: Flushing, Oral mucosal blistering, Pyrexia, Urticaria
Clinical narrative: Fever the following day along with hives and flushing blisters in mouth and throat two days after received vaccination. Patient went to Emergency Room and placed on oral steroids.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Still feels sore. No movement issue now.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, painful itchy at injection site.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Culture urine, Cystitis, Dehydration, Diarrhoea
Clinical narrative: Headaches dDiarrhea for several hrs. bladder UTI as a result of dehydration. Went to walk in clinic after symptoms persisted. Chills.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Urinary tract infection
Clinical narrative: Headaches dDiarrhea for several hrs. bladder UTI as a result of dehydration. Went to walk in clinic after symptoms persisted. Chills.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from a healthcare professional via Pfizer (manufacturer report number: 2015377806), referring to a currently 18 year old male patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date, at least a year ago, the patient was vaccinated with GARDASIL 9 (manufacturer unknown) (dose, route, lot#, expiration date were not reported). On an unknown date the patient fainted when he received GARDASIL 9 (manufacturer unknown). The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site induration, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 61-year-old female patient who received FLULAVAL (batch number C92E7, expiry date 30th June 2016). On 2nd October 2015, the patient received FLULAVAL .5 ml. On 2nd October 2015, less than a day after receiving FLULAVAL, the patient experienced erythema and injection site tenderness. On 3rd October 2015, the patient experienced injection site induration, pain in arm and injection site paresthesia. On an unknown date, the outcome of the injection site induration, pain in arm, erythema, injection site tenderness and injection site paresthesia were recovering/resolving. The reporter considered the injection site induration and pain in arm to be probably related to FLULAVAL. The reporter considered the erythema, injection site tenderness and injection site paresthesia to be related to FLULAVAL. Additional details were provided as follows: The case was previously reported to a doctor. The patient herself was a physician. The injection site of the vaccine was not reported. On 3rd October 2015, 1 day after receiving FLULAVAL, the patient experienced 3 x 3 cm induration medial to the injection site, arm pain and injeciton site paresthesia. It was unclear whether erythema occurred at injection site or other location than injection site. This case has been linked to other two patients for experiencing induration after receiving the vaccine from the same vial (see cases US2015142209 and US2015142212).
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Injection site induration, Injection site pain, Injection site paraesthesia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 61-year-old female patient who received FLULAVAL (batch number C92E7, expiry date 30th June 2016). On 2nd October 2015, the patient received FLULAVAL .5 ml. On 2nd October 2015, less than a day after receiving FLULAVAL, the patient experienced erythema and injection site tenderness. On 3rd October 2015, the patient experienced injection site induration, pain in arm and injection site paresthesia. On an unknown date, the outcome of the injection site induration, pain in arm, erythema, injection site tenderness and injection site paresthesia were recovering/resolving. The reporter considered the injection site induration and pain in arm to be probably related to FLULAVAL. The reporter considered the erythema, injection site tenderness and injection site paresthesia to be related to FLULAVAL. Additional details were provided as follows: The case was previously reported to a doctor. The patient herself was a physician. The injection site of the vaccine was not reported. On 3rd October 2015, 1 day after receiving FLULAVAL, the patient experienced 3 x 3 cm induration medial to the injection site, arm pain and injeciton site paresthesia. It was unclear whether erythema occurred at injection site or other location than injection site. This case has been linked to other two patients for experiencing induration after receiving the vaccine from the same vial (see cases US2015142209 and US2015142212).
Age: 63.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pain in extremity
Clinical narrative: This case has been linked to other two patients for experiencing induration after receiving the vaccine from the same vial (see cases US2015142208 and US2015142212). This case was reported by a pharmacist via call center representative and described the occurrence of induration in a 63-year-old male patient who received FLULAVAL (batch number C92E7, expiry date 30th June 2016). On 2nd October 2015, the patient received FLULAVAL (intramuscular). On 3rd October 2015, 1 days after receiving FLULAVAL, the patient experienced erythema and injection site pain. In October 2015, the patient experienced induration. On an unknown date, the outcome of the induration, erythema and injection site pain were not recovered/not resolved. The reporter considered the induration to be probably related to FLULAVAL. The reporter considered the erythema and injection site pain to be related to FLULAVAL. Additional details were provided as follows: This case was previously reported to a doctor. The patient himself was a healthcare professional. The reported injection site for FLULAVAL vaccine was left deltoid. In October 2015, less than a week after receiving the vaccine, the patient experienced induration. On 3rd October 2015, the patient experienced erythema, tenderness and arm pain. It was unclear whether erythema and induration occurred at injection site or other location than injection site. No other details were reported at the time of reporting.
Age: 63.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Erythema, Induration, Injection site pain, Pain in extremity, Tenderness
Clinical narrative: This case has been linked to other two patients for experiencing induration after receiving the vaccine from the same vial (see cases US2015142208 and US2015142212). This case was reported by a pharmacist via call center representative and described the occurrence of induration in a 63-year-old male patient who received FLULAVAL (batch number C92E7, expiry date 30th June 2016). On 2nd October 2015, the patient received FLULAVAL (intramuscular). On 3rd October 2015, 1 days after receiving FLULAVAL, the patient experienced erythema and injection site pain. In October 2015, the patient experienced induration. On an unknown date, the outcome of the induration, erythema and injection site pain were not recovered/not resolved. The reporter considered the induration to be probably related to FLULAVAL. The reporter considered the erythema and injection site pain to be related to FLULAVAL. Additional details were provided as follows: This case was previously reported to a doctor. The patient himself was a healthcare professional. The reported injection site for FLULAVAL vaccine was left deltoid. In October 2015, less than a week after receiving the vaccine, the patient experienced induration. On 3rd October 2015, the patient experienced erythema, tenderness and arm pain. It was unclear whether erythema and induration occurred at injection site or other location than injection site. No other details were reported at the time of reporting.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Limb discomfort, Musculoskeletal discomfort
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of delayed type hypersensitivity in a 12-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 27th October 2015, the patient received FLUARIX QUADRIVALENT (injection). On 31st October 2015, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On 1st November 2015, the patient experienced myositis (serious criteria hospitalization) and mobility decreased. On 4th November 2015, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the delayed type hypersensitivity, gastrointestinal bleeding and myositis were recovering/resolving and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the delayed type hypersensitivity, gastrointestinal bleeding, myositis and mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 31st October 2015, the patient went to the urgent care and was misdiagnosed (exact details of diagnosis not provided) and then went to emergency room on 1st November 2015. On 1st November 2015, the patient experienced myositis on his whole upper left side. He could not raise his left arm and was admitted to hospital that day. On 4th November 2015, he had the gastrointestinal bleed and was transferred to another hospital where he had a scope and 2 blood transfusions. The patient was hospitalised from 1st November 2015 to 8th November 2015.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: C-reactive protein increased, Flank pain, Joint range of motion decreased, Musculoskeletal pain, Myositis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of delayed type hypersensitivity in a 12-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 27th October 2015, the patient received FLUARIX QUADRIVALENT (injection). On 31st October 2015, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On 1st November 2015, the patient experienced myositis (serious criteria hospitalization) and mobility decreased. On 4th November 2015, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the delayed type hypersensitivity, gastrointestinal bleeding and myositis were recovering/resolving and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the delayed type hypersensitivity, gastrointestinal bleeding, myositis and mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 31st October 2015, the patient went to the urgent care and was misdiagnosed (exact details of diagnosis not provided) and then went to emergency room on 1st November 2015. On 1st November 2015, the patient experienced myositis on his whole upper left side. He could not raise his left arm and was admitted to hospital that day. On 4th November 2015, he had the gastrointestinal bleed and was transferred to another hospital where he had a scope and 2 blood transfusions. The patient was hospitalised from 1st November 2015 to 8th November 2015.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Nausea, Neck pain, Nuclear magnetic resonance imaging abnormal, Pyrexia, Type III immune complex mediated reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of delayed type hypersensitivity in a 12-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 27th October 2015, the patient received FLUARIX QUADRIVALENT (injection). On 31st October 2015, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On 1st November 2015, the patient experienced myositis (serious criteria hospitalization) and mobility decreased. On 4th November 2015, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the delayed type hypersensitivity, gastrointestinal bleeding and myositis were recovering/resolving and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the delayed type hypersensitivity, gastrointestinal bleeding, myositis and mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 31st October 2015, the patient went to the urgent care and was misdiagnosed (exact details of diagnosis not provided) and then went to emergency room on 1st November 2015. On 1st November 2015, the patient experienced myositis on his whole upper left side. He could not raise his left arm and was admitted to hospital that day. On 4th November 2015, he had the gastrointestinal bleed and was transferred to another hospital where he had a scope and 2 blood transfusions. The patient was hospitalised from 1st November 2015 to 8th November 2015.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of delayed type hypersensitivity in a 12-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 27th October 2015, the patient received FLUARIX QUADRIVALENT (injection). On 31st October 2015, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On 1st November 2015, the patient experienced myositis (serious criteria hospitalization) and mobility decreased. On 4th November 2015, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the delayed type hypersensitivity, gastrointestinal bleeding and myositis were recovering/resolving and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the delayed type hypersensitivity, gastrointestinal bleeding, myositis and mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 31st October 2015, the patient went to the urgent care and was misdiagnosed (exact details of diagnosis not provided) and then went to emergency room on 1st November 2015. On 1st November 2015, the patient experienced myositis on his whole upper left side. He could not raise his left arm and was admitted to hospital that day. On 4th November 2015, he had the gastrointestinal bleed and was transferred to another hospital where he had a scope and 2 blood transfusions. The patient was hospitalised from 1st November 2015 to 8th November 2015.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Back pain, C-reactive protein increased, Chest pain, Endoscopy gastrointestinal abnormal, Gastrointestinal haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of delayed type hypersensitivity in a 12-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 27th October 2015, the patient received FLUARIX QUADRIVALENT (injection). On 31st October 2015, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On 1st November 2015, the patient experienced myositis (serious criteria hospitalization) and mobility decreased. On 4th November 2015, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the delayed type hypersensitivity, gastrointestinal bleeding and myositis were recovering/resolving and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the delayed type hypersensitivity, gastrointestinal bleeding, myositis and mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 31st October 2015, the patient went to the urgent care and was misdiagnosed (exact details of diagnosis not provided) and then went to emergency room on 1st November 2015. On 1st November 2015, the patient experienced myositis on his whole upper left side. He could not raise his left arm and was admitted to hospital that day. On 4th November 2015, he had the gastrointestinal bleed and was transferred to another hospital where he had a scope and 2 blood transfusions. The patient was hospitalised from 1st November 2015 to 8th November 2015.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Gastrointestinal viral infection, Haemoglobin decreased, Hallucination, Injection site rash, Mobility decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of delayed type hypersensitivity in a 12-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 27th October 2015, the patient received FLUARIX QUADRIVALENT (injection). On 31st October 2015, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On 1st November 2015, the patient experienced myositis (serious criteria hospitalization) and mobility decreased. On 4th November 2015, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the delayed type hypersensitivity, gastrointestinal bleeding and myositis were recovering/resolving and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the delayed type hypersensitivity, gastrointestinal bleeding, myositis and mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 31st October 2015, the patient went to the urgent care and was misdiagnosed (exact details of diagnosis not provided) and then went to emergency room on 1st November 2015. On 1st November 2015, the patient experienced myositis on his whole upper left side. He could not raise his left arm and was admitted to hospital that day. On 4th November 2015, he had the gastrointestinal bleed and was transferred to another hospital where he had a scope and 2 blood transfusions. The patient was hospitalised from 1st November 2015 to 8th November 2015.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Musculoskeletal pain, Myositis, Nausea, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of delayed type hypersensitivity in a 12-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 27th October 2015, the patient received FLUARIX QUADRIVALENT (injection). On 31st October 2015, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On 1st November 2015, the patient experienced myositis (serious criteria hospitalization) and mobility decreased. On 4th November 2015, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the delayed type hypersensitivity, gastrointestinal bleeding and myositis were recovering/resolving and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the delayed type hypersensitivity, gastrointestinal bleeding, myositis and mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 31st October 2015, the patient went to the urgent care and was misdiagnosed (exact details of diagnosis not provided) and then went to emergency room on 1st November 2015. On 1st November 2015, the patient experienced myositis on his whole upper left side. He could not raise his left arm and was admitted to hospital that day. On 4th November 2015, he had the gastrointestinal bleed and was transferred to another hospital where he had a scope and 2 blood transfusions. The patient was hospitalised from 1st November 2015 to 8th November 2015.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased, Tenderness, Transfusion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of delayed type hypersensitivity in a 12-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 27th October 2015, the patient received FLUARIX QUADRIVALENT (injection). On 31st October 2015, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On 1st November 2015, the patient experienced myositis (serious criteria hospitalization) and mobility decreased. On 4th November 2015, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the delayed type hypersensitivity, gastrointestinal bleeding and myositis were recovering/resolving and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the delayed type hypersensitivity, gastrointestinal bleeding, myositis and mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 31st October 2015, the patient went to the urgent care and was misdiagnosed (exact details of diagnosis not provided) and then went to emergency room on 1st November 2015. On 1st November 2015, the patient experienced myositis on his whole upper left side. He could not raise his left arm and was admitted to hospital that day. On 4th November 2015, he had the gastrointestinal bleed and was transferred to another hospital where he had a scope and 2 blood transfusions. The patient was hospitalised from 1st November 2015 to 8th November 2015.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Type IV hypersensitivity reaction, White blood cell count increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of delayed type hypersensitivity in a 12-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 27th October 2015, the patient received FLUARIX QUADRIVALENT (injection). On 31st October 2015, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On 1st November 2015, the patient experienced myositis (serious criteria hospitalization) and mobility decreased. On 4th November 2015, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the delayed type hypersensitivity, gastrointestinal bleeding and myositis were recovering/resolving and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the delayed type hypersensitivity, gastrointestinal bleeding, myositis and mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 31st October 2015, the patient went to the urgent care and was misdiagnosed (exact details of diagnosis not provided) and then went to emergency room on 1st November 2015. On 1st November 2015, the patient experienced myositis on his whole upper left side. He could not raise his left arm and was admitted to hospital that day. On 4th November 2015, he had the gastrointestinal bleed and was transferred to another hospital where he had a scope and 2 blood transfusions. The patient was hospitalised from 1st November 2015 to 8th November 2015.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Endoscopy, Gastrointestinal haemorrhage, Mobility decreased, Myositis, Transfusion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of delayed type hypersensitivity in a 12-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 27th October 2015, the patient received FLUARIX QUADRIVALENT (injection). On 31st October 2015, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On 1st November 2015, the patient experienced myositis (serious criteria hospitalization) and mobility decreased. On 4th November 2015, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the delayed type hypersensitivity, gastrointestinal bleeding and myositis were recovering/resolving and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the delayed type hypersensitivity, gastrointestinal bleeding, myositis and mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 31st October 2015, the patient went to the urgent care and was misdiagnosed (exact details of diagnosis not provided) and then went to emergency room on 1st November 2015. On 1st November 2015, the patient experienced myositis on his whole upper left side. He could not raise his left arm and was admitted to hospital that day. On 4th November 2015, he had the gastrointestinal bleed and was transferred to another hospital where he had a scope and 2 blood transfusions. The patient was hospitalised from 1st November 2015 to 8th November 2015.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of delayed type hypersensitivity in a 12-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9Z429, expiry date 30th June 2016). On 27th October 2015, the patient received FLUARIX QUADRIVALENT (injection). On 31st October 2015, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On 1st November 2015, the patient experienced myositis (serious criteria hospitalization) and mobility decreased. On 4th November 2015, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the delayed type hypersensitivity, gastrointestinal bleeding and myositis were recovering/resolving and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the delayed type hypersensitivity, gastrointestinal bleeding, myositis and mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 31st October 2015, the patient went to the urgent care and was misdiagnosed (exact details of diagnosis not provided) and then went to emergency room on 1st November 2015. On 1st November 2015, the patient experienced myositis on his whole upper left side. He could not raise his left arm and was admitted to hospital that day. On 4th November 2015, he had the gastrointestinal bleed and was transferred to another hospital where he had a scope and 2 blood transfusions. The patient was hospitalised from 1st November 2015 to 8th November 2015.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Itchy, rash (small raised bumps, red) and hives where scratched on neck and chest. (Note: also extreme soreness in arm where vaccine administered).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Pain
Clinical narrative: Unable to move my arm, unable to take shirt off by myself. Severe pain took ibuprofen but didn't help much.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: My arm was very sore and I can not raise it without severe pain. I also have problems laying on it without pain.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dyspnoea, Eye swelling, Fatigue, Peripheral swelling
Clinical narrative: Swelling in face, eyes and throat. Swelling continued several 12-14 hours with difficulty in breathing. Administered cold compresses to face. Other symptoms continued up to a week: Swelling in arm. General weakness and tiredness.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pharyngeal oedema, Swelling face
Clinical narrative: Swelling in face, eyes and throat. Swelling continued several 12-14 hours with difficulty in breathing. Administered cold compresses to face. Other symptoms continued up to a week: Swelling in arm. General weakness and tiredness.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Rash in area of arm where vaccine was administered. Was not painful and did not spread.
Age: 29.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site pain, Rash
Clinical narrative: Sore Arm at injection site. Rash on Shoulder, Torso, and Neck.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Pruritus generalised, Rash
Clinical narrative: Patient developed a hard lump about 2" wide and redness about 5 1/2" long around the injection site when I measured it 11/13/15 approximately 1pm. She also experienced whole body itchiness for the past few days. She went seen employees medical team and was advised to take BENADRYL. She has been using it ever since and when I called her today, she said the rash is more contained.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Injection site pain, Musculoskeletal pain
Clinical narrative: Pain around the rotating left shoulder. Missed work the first two days after the shot. Patient has been using the adhesive tape to wrap around the upper arm to give support. Complaint still pain even a mark after or up to today date.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Fatigue, Malaise, Nausea, Vomiting
Clinical narrative: Client reports that at 10 days post vaccination he became "sick" sx included nausea, vomited and fatigue - denied fever. States missed a week of work, but "I'm fine now." Injection site without any visible redness or blistering.
Age: 26.0
Sex: F
Vaccine: ANTH, YF
Symptoms: Fatigue, Headache, Myalgia, Neutropenia, Night sweats
Clinical narrative: Onset of fatigue, night sweats/fever, headache, myalgias in 2010. Diagnosis of neutropenia, unknown cause. Concerned that anthrax and yellow fever immunizations received in 2003, 2004 may have caused illness. Causality assessment provided. Causality "unrelated".
Age: 26.0
Sex: F
Vaccine: ANTH, YF
Symptoms: Pyrexia
Clinical narrative: Onset of fatigue, night sweats/fever, headache, myalgias in 2010. Diagnosis of neutropenia, unknown cause. Concerned that anthrax and yellow fever immunizations received in 2003, 2004 may have caused illness. Causality assessment provided. Causality "unrelated".
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Syncope
Clinical narrative: Upon receiving subQ injection pt fainted. Blood pressure was very low, taken to hospital within 20 min. Given IV fluids, was able to drive back home on her own within 2 hours from hospital.
Age: 35.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Rash, Somnolence
Clinical narrative: Pt states she is experiencing rash on chest. Pt states she feels drowsy after taking oral typhoid capsules.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm got red, swollen, and painful. Went to doctor on 11/14/15 and received antibiotics and pain meds to treat diagnosis of cellulitis.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Oral herpes, Pain, Pyrexia
Clinical narrative: Fever, fever blisters, malaise, achiness onset the morning after receiving the Zostavax injection.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives developed the evening of vaccination and continued into the following date.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Cough, Headache, Nausea
Clinical narrative: Very weak nausea body aches chills cough headache.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Very weak nausea body aches chills cough headache.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Headache, Poor quality sleep
Clinical narrative: Daughter called and reported that patient did not sleep well.  Chills, redness of upper arm and Headache.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TD
Symptoms: Pallor, Syncope
Clinical narrative: Patient went pale and fainted after receiving 3 IM injections and the Flu Mist.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in upper left arm when raising above shoulder level. Pain when sleeping on left arm. Pain has not diminished over the course of 18 days. Unable to raise left arm to remove clothing without severe pain.
Age: 1.6
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Abdominal pain upper, Flushing, Irritability, Lethargy, Pain
Clinical narrative: Patient developed a mild fever Saturday night (flushed cheeks, very cranky), which developed and maintained though Monday morning. Tylenol brought the fever down but it would spike again as soon as the Tylenol wore off. He also complained of body aches (legs/feet/head) and said his belly hurt. Also developed runny nose and lethargy.
Age: 1.6
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Patient developed a mild fever Saturday night (flushed cheeks, very cranky), which developed and maintained though Monday morning. Tylenol brought the fever down but it would spike again as soon as the Tylenol wore off. He also complained of body aches (legs/feet/head) and said his belly hurt. Also developed runny nose and lethargy.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Flatulence, Headache, Insomnia
Clinical narrative: Headache, stomach ache, gas, unable to sleep.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site joint movement impairment, Injection site pain, Pain in extremity
Clinical narrative: Left shoulder pain which radiates to left arm elbow and hand with decrease range of motion of left shoulder.
Sex: U
Vaccine: HPVX
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Several years ago, the patient received a series of human papillomavirus (HPV) vaccines which interchanged GARDASIL and CERVARIX. It was unspecified how many doses of each vaccine were administered and what the dates of administration were (dose, route and lot# were also not reported). No symptoms were reported. Additional information is not expected since the medical assistant did not want to be contacted regarding this report and she did not want to provide further information.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency and route were not reported) (lot# K010215 and expiration date 05-MAY-2017) and confirmed not GARDASIL. M-M-R II and (PNEUMOVAX 23 appeared on the product list, because stability questions were asked about these products and no doses of improperly stored M-M-R II and PNEUMOVAX 23 were administered. No adverse effects were reported. No Product Quality Product (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency and route were not reported) (lot# K010215 and expiration date 05-MAY-2017) and confirmed not GARDASIL. M-M-R II and PNEUMOVAX 23 appeared on the product list, because stability questions were asked about these products and no doses of improperly stored M-M-R II and PNEUMOVAX 23 were administered. No adverse effects were reported. No Product Quality Product (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chronic obstructive pulmonary disease, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness pain and swelling (L) upper arm and is extremely sore. Received DECADRON 4mg IM. Started MEDROL Dose Pak 4 mg pack as directed, PEPCID 20 mg, 1 tab at office visit and then daily.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patients were vaccinated with improperly stored multiple unspecified doses of (Oka/Merck) VARIVAX 017145; expiry: 13-MAY-2017, L006383; expiry: 25-FEB-2017 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.