chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood culture, C-reactive protein, Differential white blood cell count, Full blood count, Injection site pain
Clinical narrative: Pain and stiffness in left shoulder began 2 to 3 hours after vaccination and did not alleviate with movement or time. Patient then proceeded to seek medical help. Her Primary Care Physician then referred her to the an Orthopedic specialists.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Metabolic function test, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Red blood cell count
Clinical narrative: Pain and stiffness in left shoulder began 2 to 3 hours after vaccination and did not alleviate with movement or time. Patient then proceeded to seek medical help. Her Primary Care Physician then referred her to the an Orthopedic specialists.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate, Thyroid function test, X-ray
Clinical narrative: Pain and stiffness in left shoulder began 2 to 3 hours after vaccination and did not alleviate with movement or time. Patient then proceeded to seek medical help. Her Primary Care Physician then referred her to the an Orthopedic specialists.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Autoimmune neutropenia, Mouth ulceration, Neutrophil count decreased
Clinical narrative: Patient began developing oral ulcers.  She had recurrent oral ulcers throughout the fall and in December 2015 was diagnosed with autoimmune neutropenia.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Headache, Nausea, Pain
Clinical narrative: Headache, body aches, nausea x 4 days.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient has a red rash around her injection site about the size of a palm according to patient.  Maybe slightly warm to the touch.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Pt reported noticing a red area on arm; low grade fever that night (nothing above 100.7), achy, muscle aches, headache.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hyperhidrosis, Injection site erythema, Injection site paraesthesia, Injection site pruritus
Clinical narrative: Redness and swelling and warmth of left arm appropriately 1/3 of upper arm, injection site slightly swollen and tingling. Itchiness and rash noted on shoulders, trunk and back. Face red and slightly diaphoretic. Developed fever at during night at home.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pruritus, Pyrexia
Clinical narrative: Redness and swelling and warmth of left arm appropriately 1/3 of upper arm, injection site slightly swollen and tingling. Itchiness and rash noted on shoulders, trunk and back. Face red and slightly diaphoretic. Developed fever at during night at home.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Redness and swelling and warmth of left arm appropriately 1/3 of upper arm, injection site slightly swollen and tingling. Itchiness and rash noted on shoulders, trunk and back. Face red and slightly diaphoretic. Developed fever at during night at home.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Initially there was swelling, redness, itching and a hive at the site. Ice was applied and took 50mg Benadryl. The hive disappeared however the redness, swelling and temperature at the site increased. The next day the swelling was about 10cm diameter with heat to touch and pain radiating into shoulder joint and neck area.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth, Neck pain
Clinical narrative: Initially there was swelling, redness, itching and a hive at the site. Ice was applied and took 50mg Benadryl. The hive disappeared however the redness, swelling and temperature at the site increased. The next day the swelling was about 10cm diameter with heat to touch and pain radiating into shoulder joint and neck area.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red, whelps, itching on affected arm (L) and now on legs and trunk using hydrocortisone cream 1% and BENADRYL 25mg Q 6 hrs.
Age: 47.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chest X-ray, Electrocardiogram, Full blood count, Immune system disorder, Nasal congestion
Clinical narrative: Severe sore throat and nose stuffiness, Petechia on legs. Did blood test and sent home with antibiotics. On 8/20/2016 Platelets dropped to 9,000 and I was admitted into the hospital with severe immune problems.
Age: 47.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Oropharyngeal pain, Petechiae, Platelet count decreased
Clinical narrative: Severe sore throat and nose stuffiness, Petechia on legs. Did blood test and sent home with antibiotics. On 8/20/2016 Platelets dropped to 9,000 and I was admitted into the hospital with severe immune problems.
Age: 47.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Condition aggravated, Contusion, Ear pain, Ecchymosis, Haemoglobin normal
Clinical narrative: Severe sore throat and nose stuffiness, Petechia on legs. Did blood test and sent home with antibiotics. On 8/20/2016 Platelets dropped to 9,000 and I was admitted into the hospital with severe immune problems.
Age: 47.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Immune thrombocytopenic purpura, Oropharyngeal pain, Petechiae, Platelet count decreased, Pyrexia
Clinical narrative: Severe sore throat and nose stuffiness, Petechia on legs. Did blood test and sent home with antibiotics. On 8/20/2016 Platelets dropped to 9,000 and I was admitted into the hospital with severe immune problems.
Age: 47.0
Sex: F
Vaccine: MENB, MENB
Symptoms: White blood cell count increased
Clinical narrative: Severe sore throat and nose stuffiness, Petechia on legs. Did blood test and sent home with antibiotics. On 8/20/2016 Platelets dropped to 9,000 and I was admitted into the hospital with severe immune problems.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dyspnoea, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Large erythema at the site of the injection. it is itchy and hot. She denies any fever, chills, SOB.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area of swelling approximately 3 inches in diameter around injection site with significant pain, redness and hot to the touch. Area increased in severity on day two. On day three area remains the same but swelling has progressed to neck, face and eye on left side, same side as shot was received.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Swelling face
Clinical narrative: Area of swelling approximately 3 inches in diameter around injection site with significant pain, redness and hot to the touch. Area increased in severity on day two. On day three area remains the same but swelling has progressed to neck, face and eye on left side, same side as shot was received.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test, Cardiac monitoring, Dyspnoea, Eye irritation, Heart rate increased
Clinical narrative: Burning red eyes, drastically elevated heart rate, difficulty breathing.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ocular hyperaemia, Ultrasound Doppler
Clinical narrative: Burning red eyes, drastically elevated heart rate, difficulty breathing.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Eye irritation, Heart rate increased
Clinical narrative: Burning red eyes, drastically elevated heart rate, difficulty breathing.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test, Cardiac monitoring, Dyspnoea, Eye irritation, Heart rate increased
Clinical narrative: Pt returned on 10/6/16 at 4 pm and reported that she had to go to ER 2 hrs after vaccination. She had difficulty breathing, increased HR (140 in ER) eyes burning.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ocular hyperaemia, Ultrasound Doppler
Clinical narrative: Pt returned on 10/6/16 at 4 pm and reported that she had to go to ER 2 hrs after vaccination. She had difficulty breathing, increased HR (140 in ER) eyes burning.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Eye irritation, Heart rate increased
Clinical narrative: Pt returned on 10/6/16 at 4 pm and reported that she had to go to ER 2 hrs after vaccination. She had difficulty breathing, increased HR (140 in ER) eyes burning.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site swelling, Swelling
Clinical narrative: Patient reports swelling of injection site all the way down to elbow and also bruising in that arm. Also reports swelling in other parts of the body.
Age: 1.08
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Abasia, Decreased appetite, Gait disturbance, Injected limb mobility decreased, Irritability
Clinical narrative: Patient was not able to walk, step on his foot (where the injection has been made) for 4 days. He is limping until now.  Other symptoms are fussiness, lost of appetite.
Age: 1.08
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Abasia, Injection site movement impairment, Vaccination site pain
Clinical narrative: Patient was not able to walk, step on his foot (where the injection has been made) for 4 days. He is limping until now.  Other symptoms are fussiness, lost of appetite.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Respiratory tract congestion, Somnolence
Clinical narrative: Sleepy, congested achy.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: This customer complained about a pain at the shoulder area near her right armpit, it started on the same day she got the flu shot. She has not taken any medication for the pain except massaging her shoulder area every day. Pain has been getting less but she's still concerned about it. She felt that the pharmacist injected at a position higher than what it should be.
Age: 79.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site urticaria, Swelling, Urticaria, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Patient developed hives, swelling, and welts, including near the site of vaccination of one vaccine.  Patient was seen in the emergency department and monitored for several hours.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Erythema, Eye pruritus, Eye swelling
Clinical narrative: Almost immediately, child reported itchy/scratchy throat. Within 10 minutes he was coughing and had red eyes that were itchy. Within 30 minutes the child's skin color was bright red from head to toe, he experienced extreme itching all over his body, his skin temperature was hot, his eyes were swollen, and he complained of having trouble breathing. Two teaspoons of BENADRYL was given 1 hour after the injection. 1 1/2 hours after the injection the symptoms began to subside. 9 hours after the injection the child complained of a severe headache and had a low-grade fever (100.7).
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Ocular hyperaemia, Pruritus generalised, Pyrexia, Skin warm
Clinical narrative: Almost immediately, child reported itchy/scratchy throat. Within 10 minutes he was coughing and had red eyes that were itchy. Within 30 minutes the child's skin color was bright red from head to toe, he experienced extreme itching all over his body, his skin temperature was hot, his eyes were swollen, and he complained of having trouble breathing. Two teaspoons of BENADRYL was given 1 hour after the injection. 1 1/2 hours after the injection the symptoms began to subside. 9 hours after the injection the child complained of a severe headache and had a low-grade fever (100.7).
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Almost immediately, child reported itchy/scratchy throat. Within 10 minutes he was coughing and had red eyes that were itchy. Within 30 minutes the child's skin color was bright red from head to toe, he experienced extreme itching all over his body, his skin temperature was hot, his eyes were swollen, and he complained of having trouble breathing. Two teaspoons of BENADRYL was given 1 hour after the injection. 1 1/2 hours after the injection the symptoms began to subside. 9 hours after the injection the child complained of a severe headache and had a low-grade fever (100.7).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Left arm, where injection given in deltoid, is still sore after a period of 15 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyspnoea, Erythema, Pallor, Skin discolouration
Clinical narrative: Patient became pale with red speckles on his all around his face.  The periorbital area became dark purple.  He complained of mild shortness of breath within minutes of vaccine.  Oral allergy medication/Claritin was immediately given.  IM Benadryl on hand but care provider chose to wait and see how patient responded before upsetting him with another injection.  After 20 minutes, color had returned to normal and ease of breathing had returned. Breathing never became any more labored.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Nervous system disorder, Tenderness, X-ray abnormal
Clinical narrative: Patient reports tenderness in her arm and neck x 3 weeks. She states her dr did xrays and believes she has a nerve issue.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Headache, Insomnia, Pain in extremity
Clinical narrative: Very sore arm, upset stomach, insomnia, headache.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced swollen arm, hot to the touch, painful, rash around injection site, she called her doctor who informed her to apply ice and call in the morning if not better.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Electrocardiogram normal, Haematology test normal, Hypoaesthesia, Laboratory test normal
Clinical narrative: After receiving the FLUZONE vaccine, my arm was a little sore a few hour later and I took 650 mg of APAP. On 10/05 my arm was just a little sore all day but I did not take anything. On 10/6 at approximately 0330 AM, my arm was stinging (it felt like the needle was still in my arm which of course it wasn't) and sore. I just decided to take a 2.5 mg prescribed AMBIEN and fell back to sleep. At approximately 0515 or so, I woke up with both feet tingling severely and numb which went up to my knees although not as severe. My hands were also tingling severely and numb. Around my nose and nose was tingling and numb. It was a little difficult to swallow but my breathing was okay. I woke up my husband and we went to Hospital Emergency Department.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Paraesthesia, Urine analysis normal
Clinical narrative: After receiving the FLUZONE vaccine, my arm was a little sore a few hour later and I took 650 mg of APAP. On 10/05 my arm was just a little sore all day but I did not take anything. On 10/6 at approximately 0330 AM, my arm was stinging (it felt like the needle was still in my arm which of course it wasn't) and sore. I just decided to take a 2.5 mg prescribed AMBIEN and fell back to sleep. At approximately 0515 or so, I woke up with both feet tingling severely and numb which went up to my knees although not as severe. My hands were also tingling severely and numb. Around my nose and nose was tingling and numb. It was a little difficult to swallow but my breathing was okay. I woke up my husband and we went to Hospital Emergency Department.
Age: 91.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Injection site rash, Injection site warmth, Oedema peripheral, Rash
Clinical narrative: Rash starting from injection site on right arm extending down arm to wrist with heat and some edema.
Age: 91.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Rash starting from injection site on right arm extending down arm to wrist with heat and some edema.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Skin reaction
Clinical narrative: Localized cutaneous reaction. No evidence of cellulitis. Mild and resolving, through course prolonged (still present 2 weeks after).
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Congenital syphilitic osteochondritis, Dysphagia, Ear congestion, Laboratory test
Clinical narrative: Per patient: two days after the shot she woke up with phlegm in her throat, had a hard time swallowing, had a hoarse throat and her right ear felt "blocked inside". She went to her primary care clinic wondering if this was a reaction from the Zostavax vaccine she had received 2 days earlier. They told her it likely was not. Patient reported the phlegm cleared after a couple of days but the blocked feeling in her ear did not clear. She then went to her nephrologist who "ran labs" and confirmed that she had a flare of her Wegeners disease. She was started on Prednisone, Valtrex and omeprazole on the day of reporting.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Productive cough
Clinical narrative: Per patient: two days after the shot she woke up with phlegm in her throat, had a hard time swallowing, had a hoarse throat and her right ear felt "blocked inside". She went to her primary care clinic wondering if this was a reaction from the Zostavax vaccine she had received 2 days earlier. They told her it likely was not. Patient reported the phlegm cleared after a couple of days but the blocked feeling in her ear did not clear. She then went to her nephrologist who "ran labs" and confirmed that she had a flare of her Wegeners disease. She was started on Prednisone, Valtrex and omeprazole on the day of reporting.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Deafness unilateral, Ear discomfort, Granulomatosis with polyangiitis, Injection site erythema
Clinical narrative: Per patient: two days after the shot she woke up with phlegm in her throat, had a hard time swallowing, had a hoarse throat and her right ear felt "blocked inside". She went to her primary care clinic wondering if this was a reaction from the Zostavax vaccine she had received 2 days earlier. They told her it likely was not. Patient reported the phlegm cleared after a couple of days but the blocked feeling in her ear did not clear. She then went to her nephrologist who "ran labs" and confirmed that she had a flare of her Wegeners disease. She was started on Prednisone, Valtrex and omeprazole on the day of reporting.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paranasal sinus hypersecretion, Productive cough
Clinical narrative: Per patient: two days after the shot she woke up with phlegm in her throat, had a hard time swallowing, had a hoarse throat and her right ear felt "blocked inside". She went to her primary care clinic wondering if this was a reaction from the Zostavax vaccine she had received 2 days earlier. They told her it likely was not. Patient reported the phlegm cleared after a couple of days but the blocked feeling in her ear did not clear. She then went to her nephrologist who "ran labs" and confirmed that she had a flare of her Wegeners disease. She was started on Prednisone, Valtrex and omeprazole on the day of reporting.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, body aches, headache, vomiting, diarrhea.
Age: 1.0
Sex: M
Vaccine: HEP, MMRV, PNC13
Symptoms: Poor quality sleep, Pyrexia, Rash erythematous, Rhinorrhoea
Clinical narrative: Fever (100 - 102.8 F), runny nose, restless sleep, followed by red, raised rash on 10/03/2016.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site infection, Injection site pain
Clinical narrative: Information has been received from a registered pharmacist referring to a 68 year old male patient. The patient's pertinent medical history and drug reactions/allergies were reported as none. On 30-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L035687, expiration date 16-FEB-2017, 0.5 ml, once, intramuscular). Concomitant therapies included a dose of FLUZONE HIGH DOSE which administered in separate injection sites on the same day. On 01-OCT-2016, the patient developed pain at the PNEUMOVAX 23 injection site area that also looked infected. The patient went to an unspecified Emergency Room on the same day due to the reactions and was prescribed unspecified antibiotics as treatment. The patient was not admitted to the unspecified hospital that day. The patient went back to the unspecified Emergency Room on 03-OCT-2016 because it was spreading and getting worse. The patient was admitted to the unspecified hospital on 03-OCT-2016 and was diagnosed with cellulitis (on an unspecified date). The patient was currently still in the hospital. The outcome of cellulitis was reported as not recovered. The causality was not provided. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site cellulitis, Injection site infection, Injection site pain
Clinical narrative: Information has been received from a registered pharmacist referring to a 68 year old male patient. The patient's pertinent medical history and drug reactions/allergies were reported as none. On 30-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L035687, expiration date 16-FEB-2017, 0.5 ml, once, intramuscular). Concomitant therapies included a dose of FLUZONE HIGH DOSE which administered in separate injection sites on the same day. On 01-OCT-2016, the patient developed pain at the PNEUMOVAX 23 injection site area that also looked infected. The patient went to an unspecified Emergency Room on the same day due to the reactions and was prescribed unspecified antibiotics as treatment. The patient was not admitted to the unspecified hospital that day. The patient went back to the unspecified Emergency Room on 03-OCT-2016 because it was spreading and getting worse. The patient was admitted to the unspecified hospital on 03-OCT-2016 and was diagnosed with cellulitis (on an unspecified date). The patient was currently still in the hospital. The outcome of cellulitis was reported as not recovered. The causality was not provided. Additional information has been requested.
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: This case was reported by a consumer vial call center representative and described the occurrence of dizziness in a 71-year-old male patient who received Flu Seasonal QIV Dresden. The patient's past medical history included concussion (the patient suffered 13 years ago and this caused him to lose his sense of smell). On 7th September 2016, the patient received Influenza vaccine QUADRIVALENT. In September 2016, less than a day after receiving Influenza vaccine QUADRIVALENT, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to Influenza vaccine QUADRIVALENT. Additional details were provided as follows: The exact age at vaccination was not reported. The reporter's spouse go the 4 way flu shot at his primary care provider the day before reporting. On the date of reporting (less that 24 hours after vaccination), the patient had symptoms of acute dizziness. The patient felt that , the room was spin when he stood up. The patient never had the symptom before.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 50-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5S349, expiry date 31st May 2017). On 19th September 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 20th September 2016, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site redness, injection site pain, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site redness, injection site pain, injection site warmth and injection site swelling were recovering/resolving. The reporter considered the injection site redness, injection site pain, injection site warmth and injection site swelling to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was reported by an employee health nurse. The patient experienced redness, swelling, heat and soreness at the site of injection after vaccination with FLULAVAL QUADRIVALENT on left arm. The patient was not given any treatment recommendations at the time reporting. The employee health continued to follow up with the patient.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Eye irritation, Headache, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4Z27T, expiry date 25th June 2017. Concomitant products included PNEUMOVAX 23. On 23rd September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 23rd September 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced general body pain, fever, burning in eyes, headache and runny nose. On an unknown date, the outcome of the general body pain, fever, burning in eyes, headache and runny nose were not recovered/not resolved. The reporter considered the general body pain, fever, burning in eyes, headache and runny nose to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously not reported to anyone. The age at vaccination was not reported. The patient experienced headache, runny nose, burning eyes, fever and severe body aches after vaccination with FLUARIX QUADRIVALENT in left deltoid. This case is 1 of the 4 cases reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site redness in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site redness and injection site warmth. On an unknown date, the outcome of the injection site redness and injection site warmth were unknown. It was unknown if the reporter considered the injection site redness and injection site warmth to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The nurse sent out an email stating that she had at least 8 staff member that had local adverse reactions (redness and hot to the touch at the injection site) to FLUARIX QUADRIVALENT. The reporter did not have any additional details.
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Eye irritation, Headache, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 63-year-old male patient who received BOOSTRIX (batch number 9GE5D, expiry date 30th October 2017). Co-suspect products included FLUARIX QUADRIVALENT (batch number 4Z27T, expiry date 25th June 2017). Concomitant products included PNEUMOVAX 23. On 23rd September 2016, the patient received BOOSTRIX .5 ml and FLUARIX QUADRIVALENT .5ml. On 23rd September 2016, less than a day after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced general body pain, fever, burning in eyes, headache and runny nose. On an unknown date, the outcome of the general body pain, fever, burning in eyes, headache and runny nose were not recovered/not resolved. The reporter considered the general body pain, fever, burning in eyes, headache and runny nose to be related to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details were provided as follows: The case was previously not reported to anyone. The age at vaccination was not reported. The patient experienced headache, runny nose, burning eyes, fever, and severe body aches after vaccination with BOOSTRIX and FLUARIX QUADRIVALENT in left deltoid. This case is 1 of the 4 cases reported by the same reporter.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Product quality issue, Underdose
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3FK72, expiry date 15th May 2017). This case was associated with a product complaint. Co-suspect products included FLUARIX QUADRIVALENT (batch number 3FK72, expiry date 15th may 2017). On 10th August 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) and FLUARIX QUADRIVALENT. On 10th August 2016, an unknown time after receiving FLUARIX QUADRIVALENT and not applicable after receiving FLUARIX QUADRIVALENT, the patient experienced underdose. On an unknown date, the patient experienced injection site pain, pharmaceutical product complaint and injection site pain. On an unknown date, the outcome of the injection site pain, underdose, pharmaceutical product complaint and injection site pain were unknown. The reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. The reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reporter tried to administer a FLUARIX QUADRIVALENT vaccine in the left deltoid of the patient, she pushed the plunger and thought that she had pushed it down all the way. She indicated that she did experience some resistance when she first went to push the plunger but she thought that went away. She withdrew the needle and all of the medication was still in the syringe. The plunger appeared to only be partially depressed. She slightly pushed the plunger and noted that a little medication came out of the tip of the needle. This led to an underdose. She was unsure what the problem was but wanted to report it in case this situation was seen again. The reporter stated that she was an experienced user and had never experienced this before. She stated that it could be a problem with the needle she used or the syringe and was unable to sent back the syringe because she disposed of it in the sharps container. On the same day, the patient received another FLUARIX vaccine in the right arm. On 11th September 2016 (the day before reporting), the reporter talked with the patient and the patient stated that she had soreness at the injection site in both her left and right arms. Follow up information was received from QA department on 26th September 2016: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Eye irritation, Headache, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 16-year-old female patient who received BEXSERO (batch number 148901A, expiry date 30th September 2016). Co-suspect products included FLUARIX QUADRIVALENT (batch number 4Z27T, expiry date 25th June 2017). On 23rd September 2016, the patient received BEXSERO .5 ml and FLUARIX QUADRIVALENT .5 m. On 23rd September 2016, less than a day after receiving BEXSERO and FLUARIX QUADRIVALENT, the patient experienced general body pain, fever, burning in eyes, headache and runny nose. On an unknown date, the outcome of the general body pain, fever, burning in eyes, headache and runny nose were not recovered/not resolved. The reporter considered the general body pain, fever, burning in eyes, headache and runny nose to be related to BEXSERO and FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The caller reported that the patient experienced severe body aches after receiving vaccinations (BEXSERO in right deltoid and FLUARIX QUADRIVALENT in left deltoid). The patient was part of family and all patients reports same events. This case was one of the 4 cases reported by the same reporter.
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Eye irritation, Headache, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 35-year-old female patient who received BOOSTRIX (batch number 9GE5D, expiry date 30th October 2017. Co-suspect products included FLUARIX QUADRILALENT (batch number 4Z27T, expiry date 25th June 2017. Concomitant products included PNEUMOVAX 23. On 23rd September 2016, the patient received BOOSTRIX .5 ml and FLUARIX QUADRIVALENT .5 ml. On 23rd September 2016, less than day after receiving BOOSTRIX and FLUARIX QUADRIVALENT and less than day after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced general body pain, fever, burning in eyes, headache and runny nose. On an unknown date, the outcome of the general body pain, fever, burning in eyes, headache and runny nose were not recovered/not resolved. The reporter considered the general body pain, fever, burning in eyes, headache and runny nose to be related to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. The age at vaccination was not reported. Caller reports patient experienced severe body aches after receiving vaccinations (BOOSTRIX: right deltoid, FLUARIX: left deltoid). The patient was part of family and all patients reports same events. This case was one of the 4 cases reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Malaise, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 64-year-old male patient who received Flu Seasonal TIV Dresden. Co-suspect products included VALTREX unknown for herpes nos. On 12th September 2016, the patient received Influenza vaccine unspecified and VALTREX 1000 mg once daily (1000 mg dailey). On September 2016, 3 days after receiving Influenza vaccine unspecified and VALTREX, the patient experienced dizziness and sickness. In September 2016, the patient experienced tingling and numbness. The action taken with VALTREX was unknown. In September 2016, the outcome of dizziness and sickness were recovered/resolved. On an unknown date, the outcome of the tingling and numbness were not recovered/not resolved. It was unknown if the reporter considered the dizziness, sickness, tingling and numbness to be related to Influenza vaccine unspecified and VALTREX. Additional details were provided as follows: The patient was experiencing dizziness, sickness, tingling and numbness after receiving flu vaccine (unknown manufacturer) and generic VALTREX (unknown manufacturer).
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Swelling, pain and redness occurring 12-24 hours after administration.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Palpitations, Pruritus, Swollen tongue
Clinical narrative: Patient stated a few hours (early afternoon) developed tongue swelling, heart racing, itchiness on top of head. Reported to her PCP, and was seen in ER for BENADRYL and steroids (RX home steroids and BENADRYL) T/C to BD: no latex in cap on packaging. No BAND-AID used (gauze post vax) no gloves used, hand sani: alcohol 65%).
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Mild uncontrollable tremors to (L) hand noted in fingers. No other problems about 2 hrs after receiving flu vaccine.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Swelling
Clinical narrative: Raised, red rash- round 3" across at injection site.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date unspecified patients were vaccinated with improperly stored RECOMBIVAX HB I0X 3DS 00006487300 (dosing details were not reported) (lot # L033343 expiry date 13-SEP-2017, lot # L027733 expiry date: 13-SEP-2017, lot # L044694 expiry date 04-FEB-2018, lot # L040458 expiry date: 04-FEB-2018). No adverse effects were reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, heat.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in (L) shoulder and arm unable to lift arm properly, vaccine given at upper (L) arm nearest to shoulder.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large (55mm) red and warm area around vaccination site.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, warm arm, swollen. Started 10/5/16. Pt. already on prednisone taper dosing (started 10/5 for other issues) and steroid shot on (10/4/16).
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Discomfort, Inflammation, Joint range of motion decreased, Muscular weakness, Pain
Clinical narrative: Feels like rotator cuff injury. Weakness within the shoulder when raising shoulder to put shirt on. Discomfort wakes me up in the middle of the night. Has been a concern since vaccine was given a week ago. No skin RXN. The inflammation feels like it is under muscle in the bursa area. No fever or redness associated, only soreness and reduced range of motion.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Feels like rotator cuff injury. Weakness within the shoulder when raising shoulder to put shirt on. Discomfort wakes me up in the middle of the night. Has been a concern since vaccine was given a week ago. No skin RXN. The inflammation feels like it is under muscle in the bursa area. No fever or redness associated, only soreness and reduced range of motion.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: Feels like rotator cuff injury. Weakness within the shoulder when raising shoulder to put shirt on. Discomfort wakes me up in the middle of the night. Has been a concern since vaccine was given a week ago. No skin RXN. The inflammation feels like it is under muscle in the bursa area. No fever or redness associated, only soreness and reduced range of motion.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Myalgia, Pain
Clinical narrative: Muscle pain extremely. Can't still raise my left arm. Hurts to lift it up. Doctor believes it was injected too high. Deltoid (into Bursa sac).
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Muscle pain extremely. Can't still raise my left arm. Hurts to lift it up. Doctor believes it was injected too high. Deltoid (into Bursa sac).
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Limb discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Continued soreness and discomfort when raising my arm over shoulder level, even after over a week later. Discomfort when steering my car. Stiffness and pain extends past my elbow.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Continued soreness and discomfort when raising my arm over shoulder level, even after over a week later. Discomfort when steering my car. Stiffness and pain extends past my elbow.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Influenza, Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Patient came to pharmacy 10/4 at 4:15. He showed me a swollen, red, tender, warm right deltoid. It was "much better" than Saturday. He felt he was "hit by a truck, with malaise, body aches, flu symptoms".
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Patient came to pharmacy 10/4 at 4:15. He showed me a swollen, red, tender, warm right deltoid. It was "much better" than Saturday. He felt he was "hit by a truck, with malaise, body aches, flu symptoms".
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Arm very sore for about a week, bruise(for about a week). F.FT-Dx location too high (increased superior) in Deltoid (Bursa sac)
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: Sore/tenderness at site. Red and swollen. Very sore and discomfort when left arm.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Sore/tenderness at site. Red and swollen. Very sore and discomfort when left arm.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Sore/tenderness at site. Red and swollen. Very sore and discomfort when left arm.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: Soreness/Tenderness constantly - in left shoulder. Pain wakes me up about 2-4 in the morning. This feels more like joint pain. DIFF. DX: Too superior in Deltoid injection (in Bursa sac).
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Soreness/Tenderness constantly - in left shoulder. Pain wakes me up about 2-4 in the morning. This feels more like joint pain. DIFF. DX: Too superior in Deltoid injection (in Bursa sac).
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Soreness/Tenderness constantly - in left shoulder. Pain wakes me up about 2-4 in the morning. This feels more like joint pain. DIFF. DX: Too superior in Deltoid injection (in Bursa sac).
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling, redness on whole upper arm and warm.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Pain in extremity
Clinical narrative: Pain in arm, sore for at least a week. Couldn't rotate arm. Almost, numb feeling. Diff Dx: Injection too superior in deltoid knowing penetration and reaction of flu into bursa sac.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Impaired driving ability, Impaired work ability, Middle insomnia, Musculoskeletal pain
Clinical narrative: Pain in arm, sore for at least a week. Couldn't rotate arm. Almost, numb feeling. Diff Dx: Injection too superior in deltoid knowing penetration and reaction of flu into bursa sac.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in arm, sore for at least a week. Couldn't rotate arm. Almost, numb feeling. Diff Dx: Injection too superior in deltoid knowing penetration and reaction of flu into bursa sac.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Dyspnoea, Heart rate increased, Paraesthesia oral
Clinical narrative: A few min. after injection BP and pulse elevated, tingling around lips, difficulty breathing.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives/welts inside of arms/thighs both sides went to ER given BENADRYL/Steroids and cleared up in 1/2 hour.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient c/o shoulder soreness, difficulty in arm movement, some difficulty sleeping on shoulder. Thought it could be related to accident she was in or arthritis but wasn't sure. Said she never received shot in shoulder before. Concerned it has been 5 days.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Dyspnoea, Injection site erythema, Swelling
Clinical narrative: Approximately 10-15 mins after vaccine was administered participant came to nurse stating that her throat felt metallic, there was a red mark 2x3 noted to left deltoid. Swelling and difficulty breathing. EPIPEN administered to Lt. deltoid, 911 called, participant taken to local ER due to inability to sit up. She was given BENADRYL and discharge 2 hrs later.
Age: 10.0
Sex: M
Vaccine: FLUX
Symptoms: Discomfort, Erythema, Pain in extremity
Clinical narrative: After receiving the shot, my son develop a severe reaction, his whole arm was in pain and red. I took picture and video he has been in discomfort.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Lacrimation increased, Pain, Seasonal allergy
Clinical narrative: Local allergic reaction. Redness (diffuse but no induration) developed the evening vaccine was given in left arm. Local warmth and pain but she stated no induration. Erythema extended below injection site to above elbow. No SOB or other symptoms other than fatigue on evening of injection. Seasonal allergy rhinitis and watery eyes. No wheezing.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Local allergic reaction. Redness (diffuse but no induration) developed the evening vaccine was given in left arm. Local warmth and pain but she stated no induration. Erythema extended below injection site to above elbow. No SOB or other symptoms other than fatigue on evening of injection. Seasonal allergy rhinitis and watery eyes. No wheezing.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Peripheral swelling, Urticaria
Clinical narrative: Swollen hands, hives along both limbs, tingling tongue.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt's right arm was swollen, red, and hot to touch. Pt stated right arm was itchy. Recommended pt to take BENADRYL and MOTRIN/ADVIL or ALEVE. Recommended pt to contact her physician as soon as possible.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-SEP-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (with an expiration date on 10-SEP-2016; dose and lot # were not provided), subcutaneously. There were no adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 6 month old patient. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. Medical assistant reported that on 21-SEP-2016, the patient was vaccinated with a dose of PEDVAXHIB and PENTACEL at the same office visit. No adverse effects were reported. Additional information has been requested.