chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Weight bearing difficulty
Clinical narrative: Extremely irritable and unable to weight bear on vaccinated leg. Leg became limp and she would scream if we touched it.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Complaints of pain radiating down the arm.  Not just site reaction.  Pain continued for longer than 1 week.
Age: 85.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Erythema
Clinical narrative: Patient went to the doctor because her arm turned red to the elbow.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm is red, swollen, hot to the touch, sore.
Age: 20.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Fall, Feeling hot, Headache, Migraine, Syncope
Clinical narrative: Pt stood up was standing with her father and she felt hot and fainted, falling to the floor, no one witnessed her hitting her head, she was asked about her head and said she didnt hit it, we offered cold packs but she said she was fine, sat in chair for another 15 minutes felt fine and went home.  Next day she had to go to ER twice for migraines/headaches.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Insomnia, Limb mass, Local swelling, Peripheral swelling
Clinical narrative: Patient reported feeling a lump in her left arm about 2 hours after vaccines. This progressed to a red, itchy rash that started on the inside of her arm and spread outward. The left side of her chest and arm was swollen from top down to forearm. She had trouble sleeping. I observed her left arm to be swollen and her elbow to be bright red.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient reported feeling a lump in her left arm about 2 hours after vaccines. This progressed to a red, itchy rash that started on the inside of her arm and spread outward. The left side of her chest and arm was swollen from top down to forearm. She had trouble sleeping. I observed her left arm to be swollen and her elbow to be bright red.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hot flush, Postmenopause, Vaginal haemorrhage
Clinical narrative: Hot Flashes through the day, and on 10/03/16 started vaginal bleeding as if having a Mens period. Have not had a Mens period in 15 years.
Age: 60.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: FEVER 101.5 ACHY HEADACHE.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, redness at injection site.
Age: 44.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dizziness
Clinical narrative: Pt. felt very dizzy for about 10 minutes. Had eyes closed for most of the time.
Age: 78.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain
Clinical narrative: Shoulder sore in area of injection.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Raised red welts radiating around injection site. Not painful or itchy.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Pt was given Fluarix Quadrivalent PFS (36+mos) to left deltoid IM on 09/26/2016. Pt returned with mother on 09/28.  Mother stated pt developed redness/warmth at injection site and surrounding areas starting on 09/26.  Pt then developed itching on 09/28. Pt treated with Keflex 250 mg/5 ml x 10 days.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: Patient reported developing itchy hives and rash all over body. Reported to pharmacy on day 3 but still having symptoms. Reporting to Dr tomorrow.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: Significant swelling, redness, and tenderness of right arm where Pneumovax was administered IM. Fluzone Quadrivalent was also administered in the same arm. Significant swelling of both upper and lower extremity. Warm to touch. Symptoms appeared soon after receiving vaccine. Per pharmacist advice, patient has been treating with intermittent ice pack and acetaminophen. Symptoms have not improved or worsened as of 10/2/2016.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Anaphylactic reaction, Autonomic nervous system imbalance
Clinical narrative: Anaphylaxis.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Asthma, Autonomic nervous system imbalance, Eczema
Clinical narrative: Asthma, eczema.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: The patients arm was swollen not the site of injection but the whole arm was swollen and pt complains that her arm hurts when she tries to lift the arm up straight , there is area where she has some redness on the upper arm but not the injection site.
Age: 47.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Axillary pain, Lymph node pain
Clinical narrative: Patient said that her armpits/lymphnodes are sore and tender to the touch.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Feeling hot, Flushing, Hyperhidrosis, Presyncope
Clinical narrative: Patient stated she was feeling warm at 5:51PM and rather sit on cool floor, then feeling clammy, sweaty, flushed face, so she layed down at 5:53PM. She was coherent entire time of Near syncope stating this is "routine reaction post shots and doctor is aware". I provided smelling salt and orange juice. She refused further medical treatment. She returned to feeling much better and "normal" self she stated at 6:09PM and stood up at 6:15PM with no problems or concerns.
Age: 51.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Chills, Fatigue, Impaired work ability, Influenza, Pain
Clinical narrative: Full blown flu - fever, chills, body aches, fatigue, etc. for 5 - 7 days. Required doctor visit in order to avoid patients - so I was off work.
Age: 51.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Pyrexia
Clinical narrative: Full blown flu - fever, chills, body aches, fatigue, etc. for 5 - 7 days. Required doctor visit in order to avoid patients - so I was off work.
Age: 62.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SITE OF INJECTION WAS VERY HOT, RED AND RAISED.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: Patient reported pain in arm on 10/1/16.  She then returned to pharmacy 10/2/16, and said pain was still present. Pharmacist looked at arm and the arm was red from just under the armpit region to 1 to 2 inches about elbow.  The arm was felt to be warm to the touch. Patient also reported her arm was not moving well.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: 9-30/16 received PNEUMOVAX 23 in right deltoid. 9-30/16 Pt. noticed swelling and redness in upper arm near injection site in the evening. 10-1/16 Pt. noted pain at and around injection site with redness progressing towards the bicep. 10/2 swelling and redness fully extended and redness fully extended to lower bicep, w/continuing pain. The redness near the injection site has resolved. The pt. notes some tingling in her lower right arm.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Myalgia
Clinical narrative: 9-30-16 Received FLUZONE HD influenza vaccine. 10-1-16 Redness appeared in an area of 1 inch by 1 1/2 inch that is painful to touch, at the injection site. There is no notable muscle soreness with normal ambulatory.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: The night after her vaccine she developed pain in top of shoulder and up neck. Arm was extremely sore. TYLENOL helped some.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Patient had an allergic reaction-hives all over the body, itching, rash. Went to ER twice 9/30/16 and 10/2/16. Got oral prednisone, diphenhydramine and famotidine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient got to FLUZONE HD for the first time on 9/30/16. Since the vaccination, her (R) arm became swollen (hard), red, hot, and mildly itchy. This has been spreading in the deltoid muscle area for the last 2 days - Advised to take BENADRYL and call MD.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Throat irritation, Upper-airway cough syndrome
Clinical narrative: On 10/1/16, patient noticed injection site reaction (mild) on right upper arm. Patient reported a lump under the skin, redness and warm to the touch. Patient also reported scratchy throat and post-nasal drip.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling to right arm that is going down.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient was administered a FLUAD vaccine at the Pharmacy - after the wait she headed out after grabbin some milk at the cooler - felt dizzy and got into the car after the purchase, she passed out at the wheel while driving out of the Pharmacy and had to call 911 - after about 45 mins of observation left for home - her husband drove her.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Eye swelling, Gingival swelling, Pain, Pain in extremity
Clinical narrative: Swelling - throat, tongue, eyes, gums. Ears ringing. Body pain; arms-back-legs.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swollen tongue, Tinnitus
Clinical narrative: Swelling - throat, tongue, eyes, gums. Ears ringing. Body pain; arms-back-legs.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a physician referring to a 16 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were unknown. On 31-AUG-2016, the patient was vaccinated with GARDASIL 9 (dose, route, lot # and expiration date were unknown). The patient then informed the staff on 13-SEP-2016 that she tested positive for pregnancy. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. The pregnancy outcome was pending. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patients arm was red, hard, hot itchy in a 3 inch circle. Patient went to Dr and received antibiotics.
Age: 75.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Pruritus, Rash
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program [IBCC (Inbound Call Center for HCPs)]. A 75-years-old male patient started to receive PREVNAR 13) via an unspecified route of administration in Left  Arm on 04Jan2016  at 0.5ml, single for immunisation.  Medical history included ongoing hypertension and blood cholesterol abnormal since years, muscle disorder, dyspepsia, heart burn, neuropathy peripheral, nervousness, headache, pain or headaches.  Concomitant medication included tramadol, pravastatin, amlodipine, irbesartan, clonazepam, omeprazole, acetylsalicylic acid (ASPIRIN), cyclobenzaprine.  The patient felt like just had it/ the feeling of the shot where he got it comes and goes on 04Jan2016 with outcome of not recovered , stinging sensation/still hurts on Jan2016 with outcome of not recovered, broke out in red welts all over trunk, arms, boobs, and back (urticaria)  on Jan2016 with outcome of recovered. Therapeutic measures includes local lotion.
Age: 75.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Erythema, Injection site pain, Urticaria
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program [IBCC (Inbound Call Center for HCPs)]. A 75-years-old male patient started to receive PREVNAR 13) via an unspecified route of administration in Left  Arm on 04Jan2016  at 0.5ml, single for immunisation.  Medical history included ongoing hypertension and blood cholesterol abnormal since years, muscle disorder, dyspepsia, heart burn, neuropathy peripheral, nervousness, headache, pain or headaches.  Concomitant medication included tramadol, pravastatin, amlodipine, irbesartan, clonazepam, omeprazole, acetylsalicylic acid (ASPIRIN), cyclobenzaprine.  The patient felt like just had it/ the feeling of the shot where he got it comes and goes on 04Jan2016 with outcome of not recovered , stinging sensation/still hurts on Jan2016 with outcome of not recovered, broke out in red welts all over trunk, arms, boobs, and back (urticaria)  on Jan2016 with outcome of recovered. Therapeutic measures includes local lotion.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Herpes zoster, Hypoacusis, Rash, Visual impairment
Clinical narrative: Information has been received on 15-AUG-2016 from a 76 year old male consumer. The patient's medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. On 14-MAR-2016, the patient developed shingles. The patient had a rash on the right side of his face which affected his sight in the right eye and he lost 75% of his hearing in his right ear. The patient received unspecified treatment and an unspecified blood test was performed. The patient reported he recovered sometime within the last month. The patient reported that he saw a legal advertisement to obtain financial compensation for medical bills incurred for patients who developed shingles after receiving the vaccine. Follow-up was received from a physician on 29-SEP-2016. The patient had no prior history of herpes zoster. On 10-JAN-2013, the pt was vaccinated with ZOSTAVAX (lot # not reported). The physician answered "no" when asked if there was a rash at the injection site or elsewhere within 42 days of vaccination. Date of herpes zoster onset was 09-FEB-2016. The pt had no recent exposure to herpes zoster or chickenpox. When asked what dermatomes were involved, the physician checked of V1 and V2 for facial region/trigeminal nerve. Maximum temperature was 99.1. The physician reported the pt experienced zoster keratoconjunctivitis. There were no diagnostic tests performed. The patient recovered. Upon internal review, zoster keratoconjunctivitis was considered medically significant. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Body temperature increased, Herpes zoster, Hypoacusis, Ophthalmic herpes zoster
Clinical narrative: Information has been received on 15-AUG-2016 from a 76 year old male consumer. The patient's medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. On 14-MAR-2016, the patient developed shingles. The patient had a rash on the right side of his face which affected his sight in the right eye and he lost 75% of his hearing in his right ear. The patient received unspecified treatment and an unspecified blood test was performed. The patient reported he recovered sometime within the last month. The patient reported that he saw a legal advertisement to obtain financial compensation for medical bills incurred for patients who developed shingles after receiving the vaccine. Follow-up was received from a physician on 29-SEP-2016. The patient had no prior history of herpes zoster. On 10-JAN-2013, the pt was vaccinated with ZOSTAVAX (lot # not reported). The physician answered "no" when asked if there was a rash at the injection site or elsewhere within 42 days of vaccination. Date of herpes zoster onset was 09-FEB-2016. The pt had no recent exposure to herpes zoster or chickenpox. When asked what dermatomes were involved, the physician checked of V1 and V2 for facial region/trigeminal nerve. Maximum temperature was 99.1. The physician reported the pt experienced zoster keratoconjunctivitis. There were no diagnostic tests performed. The patient recovered. Upon internal review, zoster keratoconjunctivitis was considered medically significant. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Visual impairment
Clinical narrative: Information has been received on 15-AUG-2016 from a 76 year old male consumer. The patient's medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. On 14-MAR-2016, the patient developed shingles. The patient had a rash on the right side of his face which affected his sight in the right eye and he lost 75% of his hearing in his right ear. The patient received unspecified treatment and an unspecified blood test was performed. The patient reported he recovered sometime within the last month. The patient reported that he saw a legal advertisement to obtain financial compensation for medical bills incurred for patients who developed shingles after receiving the vaccine. Follow-up was received from a physician on 29-SEP-2016. The patient had no prior history of herpes zoster. On 10-JAN-2013, the pt was vaccinated with ZOSTAVAX (lot # not reported). The physician answered "no" when asked if there was a rash at the injection site or elsewhere within 42 days of vaccination. Date of herpes zoster onset was 09-FEB-2016. The pt had no recent exposure to herpes zoster or chickenpox. When asked what dermatomes were involved, the physician checked of V1 and V2 for facial region/trigeminal nerve. Maximum temperature was 99.1. The physician reported the pt experienced zoster keratoconjunctivitis. There were no diagnostic tests performed. The patient recovered. Upon internal review, zoster keratoconjunctivitis was considered medically significant. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Back pain, Blood urine present, Decreased appetite, Fatigue, Insomnia
Clinical narrative: Extreme arm pain at injection site.  Kidney pain and bleeding, fatigue, chills, nausea, difficulty eating, loss of appetite.  Pale.  Low body temperature. Many doctor visits over two months.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain in extremity, Protein urine present
Clinical narrative: Extreme arm pain at injection site.  Kidney pain and bleeding, fatigue, chills, nausea, difficulty eating, loss of appetite.  Pale.  Low body temperature. Many doctor visits over two months.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Body temperature decreased, Chills, Decreased appetite, Eating disorder, Fatigue
Clinical narrative: Extreme arm pain at injection site.  Kidney pain and bleeding, fatigue, chills, nausea, difficulty eating, loss of appetite.  Pale.  Low body temperature. Many doctor visits over two months.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Haemorrhage, Injection site pain, Nausea, Pallor, Renal pain
Clinical narrative: Extreme arm pain at injection site.  Kidney pain and bleeding, fatigue, chills, nausea, difficulty eating, loss of appetite.  Pale.  Low body temperature. Many doctor visits over two months.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not reported. The patient had no drug allergies. On 17-SEP-2016, the patient was vaccinated with ZOSTAVAX (dose and route were unknown, lot# L044530, expiration date 09-FEB-2017. On an unspecified date in September 2016, the patient experienced injection site swelling, injection site warmth and injection site erythema. The patient did not seek medical attention, however, treatment with BENADRYL was given for the events. No lab diagnostics studies were performed. The patient did not recover from the events. No product quality complaint (PQC) was involved. The primary reporter did not provided the causal relationship between ZOSTAVAX and the events. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not reported. The patient had no drug allergies. On 17-SEP-2016, the patient was vaccinated with ZOSTAVAX (dose and route were unknown, lot# L044530, expiration date 09-FEB-2017. On an unspecified date in September 2016, the patient experienced injection site swelling, injection site warmth and injection site erythema. The patient did not seek medical attention, however, treatment with BENADRYL was given for the events. No lab diagnostics studies were performed. The patient did not recover from the events. No product quality complaint (PQC) was involved. The primary reporter did not provided the causal relationship between ZOSTAVAX and the events. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Secretion discharge
Clinical narrative: This spontaneous report was received from a pharmacist referring to his 54 years old female wife. The patient's medical history, drug reactions and allergies were not reported. On 18-SEP-2016 at 14:30, the patient was vaccinated with ZOSTAVAX (concentration, dose, lot # and expiration date were not provided) on the left arm. Concomitant medications included bupropion hydrochloride, SYNTHROID and QYSMIA. On 20-SEP-2016 at 20:15, the patient experienced injection site (back of left arm a few inches above elbow) and red, itchy, painful to touch, welt forming. Early next morning the welt area blistered, by 15:00, the blister was weeping and a 3/16" crater formed. No product quality complaint was involved. The outcome of the events was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist referring to his 54 years old female wife. The patient's medical history, drug reactions and allergies were not reported. On 18-SEP-2016 at 14:30, the patient was vaccinated with ZOSTAVAX (concentration, dose, lot # and expiration date were not provided) on the left arm. Concomitant medications included bupropion hydrochloride, SYNTHROID and QYSMIA. On 20-SEP-2016 at 20:15, the patient experienced injection site (back of left arm a few inches above elbow) and red, itchy, painful to touch, welt forming. Early next morning the welt area blistered, by 15:00, the blister was weeping and a 3/16" crater formed. No product quality complaint was involved. The outcome of the events was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist referring to his 54 years old female wife. The patient's medical history, drug reactions and allergies were not reported. On 18-SEP-2016 at 14:30, the patient was vaccinated with ZOSTAVAX (concentration, dose, lot # and expiration date were not provided) on the left arm. Concomitant medications included bupropion hydrochloride, SYNTHROID and QYSMIA. On 20-SEP-2016 at 20:15, the patient experienced injection site (back of left arm a few inches above elbow) and red, itchy, painful to touch, welt forming. Early next morning the welt area blistered, by 15:00, the blister was weeping and a 3/16" crater formed. No product quality complaint was involved. The outcome of the events was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist referring to his 54 years old female wife. The patient's medical history, drug reactions and allergies were not reported. On 18-SEP-2016 at 14:30, the patient was vaccinated with ZOSTAVAX (concentration, dose, lot # and expiration date were not provided) on the left arm. Concomitant medications included bupropion hydrochloride, SYNTHROID and QYSMIA. On 20-SEP-2016 at 20:15, the patient experienced injection site (back of left arm a few inches above elbow) and red, itchy, painful to touch, welt forming. Early next morning the welt area blistered, by 15:00, the blister was weeping and a 3/16" crater formed. No product quality complaint was involved. The outcome of the events was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pruritus in a 57-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7KK33, expiry date 30th April 2017). Concurrent medical conditions included hay fever, latex allergy and sensitivity to some detergents. On 19th September 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT .5 ml. On 20th September 2016, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced pruritus, hives and rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the pruritus, hives and rash were recovering/resolving. The reporter considered the pruritus, hives and rash to be probably related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This patient had allergy to some detergents. The patient experienced itching, rash and hives on both arms, knees, upper thighs, upper neck and face after vaccination with FLULAVAL QUADRIVALENT. The patient was treated with 50 mg of BENADRYL.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pruritus in a 57-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7KK33, expiry date 30th April 2017). Concurrent medical conditions included hay fever, latex allergy and sensitivity to some detergents. On 19th September 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT .5 ml. On 20th September 2016, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced pruritus, hives and rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the pruritus, hives and rash were recovering/resolving. The reporter considered the pruritus, hives and rash to be probably related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This patient had allergy to some detergents. The patient experienced itching, rash and hives on both arms, knees, upper thighs, upper neck and face after vaccination with FLULAVAL QUADRIVALENT. The patient was treated with 50 mg of BENADRYL.
Age: 43.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chills, Muscular weakness, Nausea, Pyrexia, Tremor
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rhabdomyolysis in a 43-year-old male patient who received FLUARIX QUADRIVALENT (batch number C54L3, expiry date 30th June 2016). On 17th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 18th September 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), nausea (serious criteria hospitalization), weakness of upper extremities (serious criteria hospitalization), tremor (serious criteria hospitalization), fever (serious criteria hospitalization) and chills (serious criteria hospitalization). On an unknown date, the outcome of the rhabdomyolysis, nausea, weakness of upper extremities, tremor, fever and chills were recovering/resolving. The reporter considered the rhabdomyolysis, nausea, weakness of upper extremities, tremor, fever and chills to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on the left deltoid. On 18th September 2016, the patient went to urgent care with fever, nausea, chills, tremors and upper extremity weakness. They attributed the symptoms to the FLUARIX QUADRIVALENT. On 19th September 2016, the patient went to his primary care physician, because he felt that the symptoms were worsening. Again physician thought that it was due to his FLUARIX QUADRIVALENT and sent the patient home. On 21st September 2016, the patient went to the emergency room and was admitted with a diagnosis of Rhabdomyolysis. The reporter did not know how long the patient was admitted for. The patient was at home and was recovering.
Age: 43.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chills, Muscular weakness, Nausea, Pyrexia, Rhabdomyolysis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rhabdomyolysis in a 43-year-old male patient who received FLUARIX QUADRIVALENT (batch number C54L3, expiry date 30th June 2016). On 17th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 18th September 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), nausea (serious criteria hospitalization), weakness of upper extremities (serious criteria hospitalization), tremor (serious criteria hospitalization), fever (serious criteria hospitalization) and chills (serious criteria hospitalization). On an unknown date, the outcome of the rhabdomyolysis, nausea, weakness of upper extremities, tremor, fever and chills were recovering/resolving. The reporter considered the rhabdomyolysis, nausea, weakness of upper extremities, tremor, fever and chills to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on the left deltoid. On 18th September 2016, the patient went to urgent care with fever, nausea, chills, tremors and upper extremity weakness. They attributed the symptoms to the FLUARIX QUADRIVALENT. On 19th September 2016, the patient went to his primary care physician, because he felt that the symptoms were worsening. Again physician thought that it was due to his FLUARIX QUADRIVALENT and sent the patient home. On 21st September 2016, the patient went to the emergency room and was admitted with a diagnosis of Rhabdomyolysis. The reporter did not know how long the patient was admitted for. The patient was at home and was recovering.
Age: 43.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Tremor
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rhabdomyolysis in a 43-year-old male patient who received FLUARIX QUADRIVALENT (batch number C54L3, expiry date 30th June 2016). On 17th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 18th September 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), nausea (serious criteria hospitalization), weakness of upper extremities (serious criteria hospitalization), tremor (serious criteria hospitalization), fever (serious criteria hospitalization) and chills (serious criteria hospitalization). On an unknown date, the outcome of the rhabdomyolysis, nausea, weakness of upper extremities, tremor, fever and chills were recovering/resolving. The reporter considered the rhabdomyolysis, nausea, weakness of upper extremities, tremor, fever and chills to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on the left deltoid. On 18th September 2016, the patient went to urgent care with fever, nausea, chills, tremors and upper extremity weakness. They attributed the symptoms to the FLUARIX QUADRIVALENT. On 19th September 2016, the patient went to his primary care physician, because he felt that the symptoms were worsening. Again physician thought that it was due to his FLUARIX QUADRIVALENT and sent the patient home. On 21st September 2016, the patient went to the emergency room and was admitted with a diagnosis of Rhabdomyolysis. The reporter did not know how long the patient was admitted for. The patient was at home and was recovering.
Age: 6.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Redness started at injection site 9/28/16,left arm with erythema above deltoid down to elbow, warm, taut on lateral surface, soft in medial surface. Diagnosis of cellulitis and prescribed Cephalexin 250/50 10ml TID for 10days.
Age: 6.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site warmth, Skin tightness
Clinical narrative: Redness started at injection site 9/28/16,left arm with erythema above deltoid down to elbow, warm, taut on lateral surface, soft in medial surface. Diagnosis of cellulitis and prescribed Cephalexin 250/50 10ml TID for 10days.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Pain, Vomiting
Clinical narrative: Vomiting; followed by diarrhea about 4 hours later which continued for about 12 hours; body aches begging at around 20 hours after the vaccine lasting for 12 hours.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Immediate post-injection reaction, Influenza like illness, Malaise
Clinical narrative: Initial unsolicited report received from a consumer on 20 September 2016. This case involves a 75-year-old female patient who was vaccinated with a dose Fluzone HD (batch number: unknown, expiration date, dose, site and route of administration were not reported) on 01 October 2015. Patient's Illness at time of vaccination was denied, pre-existing physician diagnosed allergies, birth defects, and medical conditions included diabetes. Any other vaccinations within 4 weeks of vaccinations was denied. Concomitant medications were not reported. On 01 October 2015, almost immediately following the vaccination, the patient had flu like symptoms including aches, fatigue, was sick for a month with deep cough, had fever (didn't remember how high it got), On an unknown date following the vaccination, patient felt she got RSV (Respiratory syncytial virus) from the vaccination. It was reported that patient required emergency room or doctor visit. it was also reported that patient required multiple visits to the doctor. Lab data and corrective treatment was not reported. On unknown date, patient recovered from the events. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Respiratory syncytial virus infection
Clinical narrative: Initial unsolicited report received from a consumer on 20 September 2016. This case involves a 75-year-old female patient who was vaccinated with a dose Fluzone HD (batch number: unknown, expiration date, dose, site and route of administration were not reported) on 01 October 2015. Patient's Illness at time of vaccination was denied, pre-existing physician diagnosed allergies, birth defects, and medical conditions included diabetes. Any other vaccinations within 4 weeks of vaccinations was denied. Concomitant medications were not reported. On 01 October 2015, almost immediately following the vaccination, the patient had flu like symptoms including aches, fatigue, was sick for a month with deep cough, had fever (didn't remember how high it got), On an unknown date following the vaccination, patient felt she got RSV (Respiratory syncytial virus) from the vaccination. It was reported that patient required emergency room or doctor visit. it was also reported that patient required multiple visits to the doctor. Lab data and corrective treatment was not reported. On unknown date, patient recovered from the events. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 20-Sep-2016. This case involves a (age and gender not reported) patient who was intramuscularly vaccinated with FLUZONE in 2015 and DAPTACEL in 2016 (batch number, expiry date, dose, dose in series and site of administration were not reported for both vaccines). Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medication was not reported. On an unspecified date, following the vaccination patient had experienced cellulitis. Patient required emergency room/doctor visit. Laboratory investigation were not reported. Patient received antibiotics as corrective treatment. It was also reported that patient was scrub down the injection site with betadine prior to administration. Patient was recovered from the event on an unknown date. Upon internal review, case was considered as serious due to important medical event: cellulitis. List of the documents held by sender: none. Sender's Comments: Cellulitis is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE but listed with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This is poorly documented case However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Mobility decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Metal or copper taste in mouth, pain in shoulder and neck, unable to raise arm without hurting, not being able to lift anything and very ache all over.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Migraine, Vaccination site swelling, Vaccination site warmth
Clinical narrative: On the day after she received the flu shot, the patient reports that her left arm became red, warm, swollen and itchy around the site of the vaccination.  She also had a migraine and vomiting on that day.  She went to employee health and was told to report her symptoms to the flu hotline number.  On 9/21 when patient called the hotline, the red area was the size of her palm.  It was not yet resolving or worsening. She was going to make an appt with her doctor.  Phone message left to check on symptoms on 9/27.  Patient has not returned my phone call.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: On the day after she received the flu shot, the patient reports that her left arm became red, warm, swollen and itchy around the site of the vaccination.  She also had a migraine and vomiting on that day.  She went to employee health and was told to report her symptoms to the flu hotline number.  On 9/21 when patient called the hotline, the red area was the size of her palm.  It was not yet resolving or worsening. She was going to make an appt with her doctor.  Phone message left to check on symptoms on 9/27.  Patient has not returned my phone call.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Abasia, Balance disorder, Blood test, Chest pain, Dizziness
Clinical narrative: Dizziness, trouble breathing, balance cant walk, chest pains, very bad headache, vomiting, rapid heart beat, felt my throat was closing. Face felt flushing.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Flushing, Headache, Heart rate increased, Throat tightness
Clinical narrative: Dizziness, trouble breathing, balance cant walk, chest pains, very bad headache, vomiting, rapid heart beat, felt my throat was closing. Face felt flushing.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting, X-ray
Clinical narrative: Dizziness, trouble breathing, balance cant walk, chest pains, very bad headache, vomiting, rapid heart beat, felt my throat was closing. Face felt flushing.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports a history of reactions to vaccinations.  She had an abscess post MMR in 1994 that required a surgical procedure.  She also had a significant local reaction to the Pneumovax, date unknown.  She has had allergy testing and is not allergic to eggs.  She cannot wear contacts, because it makes her eyes red and swollen.  She wonders if she may be allergic to thimerosol, but has not been tested for it.  Patient reports a raised, red, warm 10cm area around injection site that lasted 5-6 days before resolving on its own. Symptoms began a day or 2 after the flu vaccination.  Patient did receive a thimerosol free vaccine, as requested.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching about the face.  Denied any other symptoms including chest pain, SOB or difficulty swallowing.  Pt was given oral Benadryl and observed.  Epi was available but not given.  Sxs resolved over time.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Injection site hypoaesthesia, Injection site swelling, Malaise
Clinical narrative: Arm swelled at injection site, felt numb and patient was dizzy and not feeling well.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint swelling, Pain, Skin warm, Tenderness
Clinical narrative: Swelling in left arm through forearm, pain and tenderness as well as warm to touch. patient had no other complaints, no redness. Onset 9/26/16 in am Pt came in 9/30/16 approx 9:30am. MD office notified and Pt was prescribed MEDROL dosepak.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Warm to touch; tender, red and puffy. 5cm wide and 4.5cm down arm. No fever in patient.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation
Clinical narrative: Right arm swelling an inflammation. (Right Deltoid PNEUMOVAX23).
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Vaccination site cellulitis, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red, swollen area where pt was vaccinated and warm and hard to touch--looks like a cellulitis.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Sore lump on collarbone. Spoke to nurse at hospital, said its a swollen lymph node from reaction from shot. Said to put heat on it.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Pain, Vertigo
Clinical narrative: Severe headache, body aches, vertigo/dizziness.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site hypoaesthesia, Injection site pain, Pain
Clinical narrative: Numbness in area of injection and sharp shooting pain and increased, prolonged numbness in upper arm when raised overhead. Symptoms ongoing and increasing at this time (10/3/2016). Also, aching in injection location and headache experienced on day 1 after flu shot (same as last year). Note: Flu shot mandatory for continued employment.
Age: 14.0
Sex: M
Vaccine: HPVX
Symptoms: Seizure
Clinical narrative: Seizure for 10 - 15 seconds.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Pt. had swelling of throat/trouble breathing about 20 minutes after vaccine administration. She took BENADRYL and reaction subsided.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Autism spectrum disorder, Regressive behaviour, Vaccination complication
Clinical narrative: We have reason to believe that our son had a reaction to vaccines that were given to him about 1.5 years old (2013). The symptoms were him regressing on his milestones.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis, Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Bell's Palsy in a 51-year-old female patient who received FLUARIX TETRA (batch number L2DR5, expiry date 7th May 2017). Concomitant products included VALTREX. On 12th September 2016, the patient received the 1st dose of FLUARIX TETRA (intramuscular). On 17th September 2016, 5 days after receiving FLUARIX TETRA, the patient experienced Bell's Palsy (serious criteria GSK medically significant), lip swelling, numb lips, numbness facial, tingling lips, tingling and viral infection. On an unknown date, the outcome of the Bell's Palsy, lip swelling, numb lips, numbness facial, tingling lips, tingling and viral infection were unknown. Additional details were provided as follows: After vaccination, the patient's lip were swollen and she also experienced numbness and tingling in her face. Pharmacist told the patient that it would be unlikely the flu shot. The patient went to emergency care and they told her it was caused by virus and it was Bell's Palsy. It was unknown if the reporter considered the Bell's Palsy, lip swelling, numb lips, numbness facial, tingling lips, tingling and viral infection to be related to FLUARIX TETRA.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Viral infection
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Bell's Palsy in a 51-year-old female patient who received FLUARIX TETRA (batch number L2DR5, expiry date 7th May 2017). Concomitant products included VALTREX. On 12th September 2016, the patient received the 1st dose of FLUARIX TETRA (intramuscular). On 17th September 2016, 5 days after receiving FLUARIX TETRA, the patient experienced Bell's Palsy (serious criteria GSK medically significant), lip swelling, numb lips, numbness facial, tingling lips, tingling and viral infection. On an unknown date, the outcome of the Bell's Palsy, lip swelling, numb lips, numbness facial, tingling lips, tingling and viral infection were unknown. Additional details were provided as follows: After vaccination, the patient's lip were swollen and she also experienced numbness and tingling in her face. Pharmacist told the patient that it would be unlikely the flu shot. The patient went to emergency care and they told her it was caused by virus and it was Bell's Palsy. It was unknown if the reporter considered the Bell's Palsy, lip swelling, numb lips, numbness facial, tingling lips, tingling and viral infection to be related to FLUARIX TETRA.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of anaphylactic reaction in a adult female patient who received FLUARIX TETRA. On 16th September 2016, the patient received FLUARIX TETRA (intramuscular). On 16th September 2016, less than a day after receiving FLUARIX TETRA, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). The patient was treated with BENADRYL and SOLUMEDROL. On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. The reporter considered the anaphylactic reaction to be related to FLUARIX TETRA. Additional details were provided as follows: The sales representative reported on behalf of a health care professional. The age at vaccination was not reported. The patient received FLUARIX TETRA on the unknown arm. The patient was nurse therefore self monitored. The other health care professional had lot number if needed. This was 1 of the 3 cases reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discharge, Injection site erythema, Injection site vesicles
Clinical narrative: Blisters with erythema at site of injection and oozing still 5 days later. Dr. prescribed him Cephalexin 500 mg two twice daily number 40.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Itching and progressively got worse. IM site looks good. No swelling, redness noted. Faint rash noted on right arm and back and right plank.