chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPVX
Symptoms: Death
Clinical narrative: Information has been received from a reporter via social media concerning eight patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients received HPV vaccine (manufacturer unknown) (lot#, expire date, dose and route unknown). On unknown dates, the patients died. It was unknown if autopsy was done. The relationship between the events and vaccine was not confirmed. Upon internal review, death was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected because of lack of privately contactable information for the reporter. This is a new safety report and has been created due to safety report "US-009507513-1610JPN011009" having been created with the incorrect primary source country code. Unfortunately our system is not fully ICH-E2B (R2) compliant, so US-009507513-1610JPN011009 is being nullified and we have created this new safety report ID to reflect the correct country code. US-009507513-1610JPN011009 is now listed as an E2B Report Duplicate.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 38-year-old female patient who received FLULAVAL QUADRIVALENT (batch number Y9H77, expiry date April 2017). Concurrent medical conditions included shellfish allergy, drug allergy (DARVOCET), drug allergy (MONISTAT) and food allergy (seasoning and other food allergies nonspecified). On 12th October 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular). On an unknown date, the dose was an unknown dose. On 12th October 2016, 3 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb (serious criteria other: as per reporter), injection site pain (serious criteria other: as per reporter), injection site erythema (serious criteria other: as per reporter), injection site itching (serious criteria other: as per reporter) and injection site warmth (serious criteria other: as per reporter). The patient was treated with BENADRYL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site itching and injection site warmth were recovering/resolving. The reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site itching and injection site warmth to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: At 13:00 hours, the patient received FLULAVAL QUADRIVALENT on the right deltoid. The patient experienced itching, remarkable swelling at injection site beginning at 4 to 6 PM her whole arm swelled including swelling in elbow area, aches and pains in whole arm. The patient was medicated with BENADRYL twice. The patient still had local swelling, redness and fever at injection site and the swollen area is the size of navel orange.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 38-year-old female patient who received FLULAVAL QUADRIVALENT (batch number Y9H77, expiry date April 2017). Concurrent medical conditions included shellfish allergy, drug allergy (DARVOCET), drug allergy (MONISTAT) and food allergy (seasoning and other food allergies nonspecified). On 12th October 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular). On an unknown date, the dose was an unknown dose. On 12th October 2016, 3 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb (serious criteria other: as per reporter), injection site pain (serious criteria other: as per reporter), injection site erythema (serious criteria other: as per reporter), injection site itching (serious criteria other: as per reporter) and injection site warmth (serious criteria other: as per reporter). The patient was treated with BENADRYL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site itching and injection site warmth were recovering/resolving. The reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site itching and injection site warmth to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: At 13:00 hours, the patient received FLULAVAL QUADRIVALENT on the right deltoid. The patient experienced itching, remarkable swelling at injection site beginning at 4 to 6 PM her whole arm swelled including swelling in elbow area, aches and pains in whole arm. The patient was medicated with BENADRYL twice. The patient still had local swelling, redness and fever at injection site and the swollen area is the size of navel orange.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Pt fainted after receiving a flu vaccine injection, feel to floor, hitting her forehead on the floor.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and redness around injection sight.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Flat red rash appears on patient's right side of her neck with complaint of itchiness approximately 5-10 mins following administration of influenza vaccine. Denies any other sign or symptoms including difficulty breathing, wheezing, chest pain, & palpitation. Vital sign #1 @0943 am: BP-138/78, HR-86 R-16. @9:49 am patient was given one time dose of diphenhydramine HCL 25mg PO by registered nurse (RN).  RN observed patient x 30 mins, symptoms of rash on neck improved and no other symptoms noted.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Amnesia, Asthenia, Confusional state, Speech disorder, Stupor
Clinical narrative: Stupor, confusion, weakness, memory loss, speech difficulty.
Age: 45.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: An expired Tdap vaccine was inadvertently administered to this client. No adverse events reported by client.
Sex: M
Vaccine: PPV
Symptoms: Splenectomy
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 60 year old male patient. the patient's medical history and concurrent conditions were not known. On an unknown date in January 2015, the patient was vaccinated with PNEUMOVAX 23 (lot # K006681). On an unknown date in January 2015 (reported as "at the same time" of vaccination), the patient had splenectomy. The reporter did not know if PNEUMOVAX 23 was given before or after the splenectomy and did not know why the patient had a splenectomy. The patient was hospitalized at an unspecified facility for the splenectomy for an unspecified amount of time. The outcome of the event splenectomy was unknown. The reporter did not provide the causality between the event and the suspect therapy. The event splenectomy was considered as serious due to hospitalization. Upon internal review the event splenectomy was considered as serious (medically significant). Additional information is not expected as the reporter does not want to be contacted.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a child patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a Licensed Vocational Nurse (LVN). The age at vaccination was not reported. The batch number of FLUARIX QUADRIVALENT was unknown. The nurse reported that she was aware of two patients that experienced swelling and redness at their injection site. Limited information was provided by the nurse. No further information was available. This was 1 of the 2 cases reported by the same reporter.
Age: 7.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Drug administered to patient of inappropriate age, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 7-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9A7JS, expiry date unknown). Co-suspect products included DTPa (INFANRIX) (batch number LY27Z, expiry date unknown). Concomitant products included SINGULAIR, ALLEGRA and Flonase. On 14th September 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml and the 1st dose of INFANRIX (intramuscular). On 14th September 2016, not applicable after receiving FLUARIX QUADRIVALENT and an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. On 16th September 2016, the patient experienced injection site warmth, injection site swelling and fever. On an unknown date, the outcome of the injection site warmth, injection site swelling and fever were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the injection site warmth, injection site swelling and fever to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the fever to be related to INFANRIX. Additional details were provided as follows: The patient received FLUARIX on Right thigh. The patient received INFANRIX on Left thigh at the age of 7 years, which led to inappropriate age at vaccine administration. The swelling and warm to touch at the injection site was on the side of the FLUARIX and not the INFANRIX. The nurse reported that the physician believed that the side effects listed above were from the FLUARIX, not the INFANRIX. Two days after receiving FLUARIX QUADRIVALENT and INFANRIX, the patient experienced fever. The reported lot number (9A7J5) for FLUARIX did not exist and was updated to 9A7JS as per the sales database. The reported lot number (LY272) for INFANRIX did not exist and was updated to LY27Z as per the sales database.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of tingling of extremity in a 59-year-old female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced tingling of extremity, numbness of upper extremities and muscle pain. On an unknown date, the outcome of the tingling of extremity and muscle pain were unknown and the outcome of the numbness of upper extremities was not recovered/not resolved. It was unknown if the reporter considered the tingling of extremity, numbness of upper extremities and muscle pain to be related to FLUARIX QUADRIVALENT. Additional detains were provided as follows: The age at vaccination was not reported. The patient experienced tingling of extremity, numbness of upper extremities and muscle pain in left arm after receiving FLUARIX QUADRIVALENT on left deltoid. No other information was provided by the reporter.
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative, who reported same event for the four patients. This is the first of four reports. A male patient (age range reported as 50-70) receive a single dose of PREVNAR 13, on an unspecified date as vaccination. The patient medical history and concomitant medications were not reported. On an unknown date, few days after vaccination, the patient complained of soreness between the elbow and shoulder. There was redness as well. The outcome of the events was unknown.  Sender's Comments: Linked Report(s): US-PFIZER INC-2016487683 same reporter/drug/event, different patient;US-PFIZER INC-2016487681 same reporter/drug/event, different patient; US-PFIZER INC-2016487682 same reporter/drug/event, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative, who reported same event for the four patients . This is the second of four reports. A female patient (age range reported as 50-70) receive a single dose of PREVNAR 1 , on an unspecified date as vaccination. The patient medical history and concomitant medications were not reported.  On an unknown date, few days after vaccination, the patient complained of soreness between the elbow and shoulder. There was redness as well.The outcome of the events was unknown; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016487623 same reporter/drug/event, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative, who reported same event for the four patients . This is the third of four reports. A female patient (age range reported as 50-70) receive a single dose of PREVNAR 13 , on an unspecified date as vaccination. The patient medical history and concomitant medications were not reported.  On an unknown date, few days after vaccination, the patient complained of soreness between the elbow and shoulder. There was redness as well.The outcome of the events was unknown; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016487623 same reporter/drug/event, different patient
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative, who reported same event for the four patients . This is the fourth of four reports. A female patient (age range reported as 50-70) receive a single dose of PREVNAR 13 , on an unspecified date as vaccination. The patient medical history and concomitant medications were not reported.  On an unknown date, few days after vaccination, the patient complained of soreness between the elbow and shoulder. There was redness as well.The outcome of the events was unknown; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016487623 same reporter/drug/event, different patient.
Sex: U
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site hives in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site hives. On an unknown date, the outcome of the injection site hives was unknown. It was unknown if the reporter considered the injection site hives to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received FLUARIX QUADRIVALENT on left arm and presented hives on same arm. The reporter declined to proceed with Safety report.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence on injection site rash in a 5-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9A7JS, expiry date unknown). Concomitant products included MIRALAX, ZYRTEC and Multivitamin. On 3rd October 2016, the patient received 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 3rd October 2016, less that a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site rash and injection site warmth. In October 2016, the outcome of the injection site rash and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site rash and injection site warmth to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on left arm. On 5th October 2016, the patient was seen in the office. This was 1 of the 2 cases reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site hives in a female patient who received FLUARIX QUADRIVALENT (batch number B5592, expiry date 20th June 2017). On 11th October 2016, the patient received FLUARIX QUADRIVLENT .5 ml. On 11th October 2016, less than a day after receiving FLUARIX QUADRIVLENT, the patient experienced injection site hives. The patient was treated with hydrocortisone and BENADRYL. In October 2016, the outcome of the injection site hives was recovered/resolved. It was not reported if the reporter considered the injection site hives to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced localized hives on left deltoid after receiving FLUARIX QUADRIVLENT. It had resolved 3 to 4 hours after putting hydrocortisone on the site and taking BENADRYL.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: Facial, trunkal macular itchy rash that lasted 4+ days.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Pain
Clinical narrative: My shoulder - left one where they administered it  - is sore and stiff. It has lasted for two and a half weeks so far and it still a low-grade pain when at rest and moving. And some movements are particularly painful.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pruritus, Rash macular, Skin warm
Clinical narrative: Patient states that arm was hot to the touch, itching, painful, red splotches running down arm from where injection site was. Patient reports no fever.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Immediate post-injection reaction, Seizure like phenomena, Syncope
Clinical narrative: SEIZURE-LIKE ACTIVITY AND FAINTING IMMEDIATELY UPON SYRINGE WITHDRAWAL. PT COMMENTED THEY "FELT FUNNY" AND "NOT OK" BEFORE PARTIALLY COLLAPSING. PT WAS ASSISTED TO FLOOR, FELT BETTER AFTER ABOUT 5 MINUTES, AND WAS MONITORED FOR 5 MORE MINUTES BEFORE BEING ALLOWED TO DEPART.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bone pain, Neck pain, Pain in extremity
Clinical narrative: Patient says that she had right arm pain from Pneumonia vaccine that turned into bone pain that radiated up her clavicle into her neck. Advised patient to see MD as this is not a normal vaccine reaction.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Severe shoulder pain, headache, stiff neck body aches.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Cellulitis, Induration, Musculoskeletal stiffness, Pruritus, Skin warm
Clinical narrative: The area is warm to the touch, area is the size of her whole hand almost touches her elbow, area is pink, itchy, hard in the center. Stiff, only painful if touch. PT. later went to walk-in clinic and was diagnosed with cellulitis. Antibiotic prescribed. (cephalexin).
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Tenderness
Clinical narrative: The area is warm to the touch, area is the size of her whole hand almost touches her elbow, area is pink, itchy, hard in the center. Stiff, only painful if touch. PT. later went to walk-in clinic and was diagnosed with cellulitis. Antibiotic prescribed. (cephalexin).
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Ataxia, Cerebellar ataxia, Headache, Nausea, Nuclear magnetic resonance imaging normal
Clinical narrative: Fever, sorethroat and headache. 10/19: fever resolved, headache persisted, nausea/vomiting; later same day with ataxia, worsening and seen on 10/20, MRI negative; persisted with ataxia and vomiting; admitted for either post-viral cerebellar ataxia or post-vaccine cerebellar ataxia.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Fever, sorethroat and headache. 10/19: fever resolved, headache persisted, nausea/vomiting; later same day with ataxia, worsening and seen on 10/20, MRI negative; persisted with ataxia and vomiting; admitted for either post-viral cerebellar ataxia or post-vaccine cerebellar ataxia.
Age: 6.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, MMRV
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling, erythema and warmth at vaccine site (Left Deltoid).
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Pruritus, Rash, Rash papular, Rash vesicular, Viral rash
Clinical narrative: Viral disease characterized by exanthema. Lesions look c/w varicella despite the fact that child was immunized. Other viral exanthems on ddx include coxsackie, however pt recently. Recovered from suspected hand/foot/mouth and these lesions do not appear on palms or soles.   Disease characterized by exanthema. Was seen in clinic seven months after Varicella Vaccine for a rash on back and spread to trunk some popular and vesicular lesion in nature. Patient was itching. No confirmed diagnosis of Varicella but rash similar.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Peripheral swelling, Pyrexia
Clinical narrative: Arm swelling, site redness, Fever.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pruritus, Skin warm
Clinical narrative: High dose influenza caused bruising, warm to touch, itching x2days 2nd day of symptoms, started MEDROL DOSEPAK and advised to take BENADRYL prn.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Axillary mass, Limb discomfort, Peripheral swelling
Clinical narrative: Slight swelling, discomfort in injection arm. Knot in arm pit of injected arm.
Age: 31.0
Sex: F
Vaccine: FLU4, MMR, VARCEL, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient given mmr, var and flu vaccine on 10/19/2016. On 10/21/2016 patient reported she is 8 weeks pregnant.
Age: 31.0
Sex: F
Vaccine: FLU4, MMR, VARCEL, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient given mmr, var and flu vaccine on 10/19/2016. On 10/21/2016 patient reported she is 8 weeks pregnant.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red raised band developed about 4-5 inches below where vaccine was administered.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Feeling abnormal, Pruritus, Urticaria
Clinical narrative: Pt felt itchy and developed hives around 7 pm and took one ZYRTEC PO when he felt that his mouth felt weird.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Deltoid area was painful after injection but not unusually severe. The area has continued to be intermittently painful on movement since the injection 3 1/2 weeks ago.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Injection site swelling
Clinical narrative: Swelling of arm at site of injection (40x50cm).  Swelling went down some but was still present 2 days later so student returned to clinic and was seen by a Nurse Practitioner.  Swelling was going down, advised to take Ibuprofen or Acetaminophen and use ice for discomfort and to return to clinic if further discomfort.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Nausea, Pruritus generalised
Clinical narrative: Nausea, diarrhea, and headache started 11 hours after injection and lasted approx. 24 hours. Started itching everywhere about 19 hours after injection and has been itching since (about one week) was worse the first day, but getting better. Has been taking BENADRYL everyday since injection.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Ankylosing spondylitis, Arthralgia, Back pain, Blood test, HLA-B*27 positive
Clinical narrative: Both hands extreme joint pain. Lathered them in over the counter arthritis cream and took Advil. Started making arrangements to see a doctor 10+ pain scale.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: Both hands extreme joint pain. Lathered them in over the counter arthritis cream and took Advil. Started making arrangements to see a doctor 10+ pain scale.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Injection site reaction
Clinical narrative: The patient experienced an injection site reaction on her right arm. She first recognized the reaction on 10/20 (the morning after she received the vaccine). Between 10/20/16 and 10/21/16, the size of the reaction area grew significantly. We referred her to the Student Health Center on campus and she was evaluated by a physician. She was prescribed a short course of hydrocortisone for the inflammation and was told to monitor the site. She will follow up with the Health Center if it worsens.
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist.   A female patient of an unspecified age and ethnicity received  PREVNAR 13 (Lot # M06899, Expiry Date Mar2017), via an unspecified route of administration  at 0.5 ml, single on 11Oct2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced broke out into rash at injection site on 17Oct2016 with outcome of unknown.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist.   A 65-year-old female patient received PREVNAR 13 (Lot # N16562, Expire Date Oct2017, NDC number 00005-1971-01), intramuscular at 0.5 ml, single in the left arm on 13Oct2016 for immunisation. The patient medical history was not reported. Concomitant medication included FLUZONE (Lot # UI659AA , Expire Date 29Mar2017), intramuscular at 1DF single in the right arm on 13Oct2016 for immunisation.  On 14Oct2016, the patient experienced severe bruising in the area, swelling, redness, significant pain. No treatment received. The outcome of the events was unknown.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: The patient experienced a mild injection site reaction on her left arm. She noticed the reaction on 10/21/16. She will use an ice pack and acetaminophen and monitor the site. If it worsens, she will go to the Student Health Center.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Swelling at and below injection site.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site but no redness or swelling.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Vomiting
Clinical narrative: On 10/13/2016 client reported raised, reddened, slightly warm to touch spot where varicella shot given 2 days prior. Also reported slight fever and emesis. Instructed client to email picture of site to Public Health Nurse, and to put heat on affected area. Picture showed reddened area at shot site and chain-like reddened areas distal to central redness. Instructed client to use Tylenol as needed.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 6x8cm in diameter, red and warm to touch on the right thigh. Appropriate injection site. No treatment. PT was in office 10/21/2016 @ 2pm.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactoid reaction
Clinical narrative: Symptoms of anaphylaxis.  Had to be transported via ambulance to the hospital.  She was admitted.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: Symptoms of anaphylaxis.  Had to be transported via ambulance to the hospital.  She was admitted.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Skin warm, Tenderness
Clinical narrative: TENDERNESS, WARMTH TO TOUCH.
Age: 75.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient noticed some soreness in her right arm on evening of 10/20. on 10/21 it was a large red area, hot to the touch and itching. She was going to take benedryl.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: TENDERNESS, WARMTH TO TOUCH. REDNESS.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient came in with swollen, red, warm lump at injection site that spread down the arm slightly. Patient stated that her arm was sore and that these symptoms occurred this morning when she woke up. No other systemic signs were noted by the patient. The redness has not spread anymore.
Age: 70.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Migraine
Clinical narrative: First-time migraine headache.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Pain
Clinical narrative: Increased pain same day of shot, following day pain worse, difficulty moving left shoulder, to MD 10/21/2016- stated  influenza vaccine injection to bursae, vs. deltoid. Given cortisone injection 10/21/2016.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Erythema, Local reaction, Pain
Clinical narrative: Significant large local reaction with temp to 100.2. Fair amount of pain. Started as mild redness and quickly progressed to intense erythema. There was no obvious drainage. Pain also noted.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Lethargy
Clinical narrative: Dizziness, lethargy, no fever.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Lethargy, Pain
Clinical narrative: I was unable to use/lift my left arm for 48 hours. Pain lasted for 3 days. Felt lethargic for 48 hours.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Influenza virus test negative, Myalgia, Pyrexia
Clinical narrative: Fever to 101.8, chills, myalgias.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain over R shoulder at injection site.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Erythema, Pain, Swelling
Clinical narrative: Swelling, bright redness, soreness, bruising.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted while signing at counter after flu shot was administered.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: 101.2 degree Fever, Chills, Shaking, Aching. Still symptomatic 10/21/2016 at 3:20PM.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: PATIENT HAS NEVER HAD AN ISSUE WITH A FLU SHOT, BUT SHE JUST TURNED 65 AND GOT THE HIGH DOSE FOR THE FIRST TIME. RETURNED TO THE PHARMACY 3 DAYS AFTER INJECTION WITH A LARGE RED WELT ON UPPER INNER ARM. WARM TO THE TOUCH NO MARK OR REDNESS AT INJECTION SITE. STATES THAT THE INJECTION ITSELF WAS MORE PAINFUL THAN USUAL, AND IT WAS VERY SORE THE FIRST 2 DAYS. STATES THAT IT ISN'T SORE ANY LONGER, BUT THE REDNESS AND WARMNESS STILL PERSISTS. DENIES FEVER CHILLS OR ANY OTHER HEALTH CONCERN AT THIS TIME.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling at injection site, red skin on arm, severe itching.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient experience arm pain, swelling, hot to touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Nausea, Pain, Peripheral swelling
Clinical narrative: Patient reported swelling down her arm that she described as "welts". she also complained of headache, nausea, body ache, and fatigue for 48 hours after immunization.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient reported swelling down her arm that she described as "welts". she also complained of headache, nausea, body ache, and fatigue for 48 hours after immunization.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient described an injection site reaction that has been progressively getting worse.  Started as a smaller red circle around injection site that has grown to about a 2 inch diameter.  Patient described it as being soft and now has gotten hard and itches.  Has been getting progressively worse over last 2 days since date of injection.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Bladder pain, Dysuria, Sneezing
Clinical narrative: Woke up to sneezing and later in afternoon pain & burning in bladder. Will need to call doctor to get an antibiotic possible bladder infection.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Pharyngeal oedema, Tenderness, Vomiting
Clinical narrative: Pt states she started feeling like her throat was swelling and she also had N/V. Pt stated that her whole L arm was painful to touch. This all occurred two hours after the injection was given.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Lethargy, Pyrexia
Clinical narrative: Lethargic, 101.9 fever.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and burning at injection site and down injected limb.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Redness, swelling and burning at injection site and down injected limb.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Paraesthesia
Clinical narrative: Patient felt shortness of breath and "tingling", he then drove to urgent care and from there he was treated and then taken to Hospital by ambulance.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, headache, runny nose, cough every time that I got that vaccine.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abdominal pain upper, Hyperhidrosis, Injection site erythema, Injection site pruritus, Local swelling
Clinical narrative: 1am- pt reports sweating and vomiting, stomach ache, and feet hurting. At 6am all symptoms improved. At time of conversation 5pm pt reported redness/pink color at injection site (top) with local minor swelling. Pt stated itchiness at injection site which was reduced with a lotion applied. Pt denies any difficulty breathing or respiratory problems. Pt states currently feeling fine and was recommended to take a ZRYTEC daily to reduce any potential residue itchiness. Pt was advise to seek emergency medical service if sweating and vomiting return.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Vomiting
Clinical narrative: 1am- pt reports sweating and vomiting, stomach ache, and feet hurting. At 6am all symptoms improved. At time of conversation 5pm pt reported redness/pink color at injection site (top) with local minor swelling. Pt stated itchiness at injection site which was reduced with a lotion applied. Pt denies any difficulty breathing or respiratory problems. Pt states currently feeling fine and was recommended to take a ZRYTEC daily to reduce any potential residue itchiness. Pt was advise to seek emergency medical service if sweating and vomiting return.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives all over body.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site rash
Clinical narrative: Pt developed rash from injection site down to her elbow that encircled her arm. Stated she had a very difficult time moving her right arm.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warm to the touch at injection site.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Headache, Migraine, Nausea, Pyrexia
Clinical narrative: Nausea, diarrhea, headache and fever and next day migraine, nausea, fever and rash.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Nausea, diarrhea, headache and fever and next day migraine, nausea, fever and rash.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness, Electrocardiogram normal, Headache, Pyrexia
Clinical narrative: Lightheadedness, headache, mild fever (Temp 100.6).
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt had round mark around administration site. It turned brown and then a week later it turned red and started itching/burning.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling itching starting at injection site and moving down arm, currently about two inches from elbow. Possible cellulitis?
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Contracted Shingles.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient reported swelling, redness, warmth and slight itching in area where vaccine was administered. This was observed when she came in to pharmacy the next day and was instructed to go visit urgent care.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Rash, Rash erythematous, Rash macular
Clinical narrative: My fingers started tingling with mild pain. I noticed little white spots on my hands & fingers. My finger started hurting really bad, like I had smashed my fingers. I started to get a blotchy red rash on my hand and very fine red rash on my arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: High fever body aches sore arm.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Dizziness, Palpitations, Vertigo, Vomiting
Clinical narrative: Heart palpitations , vertigo , dizziness , vomiting , feeling faint , extremely confused.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV, TD
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at injection site. Some pain and discomfort. Pain subsided but redness is moving to the right side of left arm to muscle area and swelling is still present.
Age: 28.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Adverse event, Seizure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of seizure in a patient who received FLUARIX QUADRIVALENT (batch number NY5J4, expiry date 30th June 2017). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and adverse event. On an unknown date, the outcome of the seizure and adverse event were unknown. It was unknown if the reporter considered the seizure and adverse event to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter informed this report via GSK click-to-chat. The patient received the FLUARIX QUADRIVALENT had suffered an adverse reaction, including seizures. No further information was reported regarding the event.
Age: 28.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Computerised tomogram, Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of seizure in a patient who received FLUARIX QUADRIVALENT (batch number NY5J4, expiry date 30th June 2017). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and adverse event. On an unknown date, the outcome of the seizure and adverse event were unknown. It was unknown if the reporter considered the seizure and adverse event to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter informed this report via GSK click-to-chat. The patient received the FLUARIX QUADRIVALENT had suffered an adverse reaction, including seizures. No further information was reported regarding the event.
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Activities of daily living impaired, Coeliac disease
Clinical narrative: This spontaneous report was received from a Nurse via a company representative referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. In March 2014, the patient was vaccinated with a dose of GARDASIL (Dose, route, lot # and expiration date were not provided). In April 2014 (reported as a month later), the patient lost her ability to walk and play sports and was home-bound and could not go to school. In November 2015, the patient was diagnosed with coeliac disease. It was stated that the patient was placed on a "special diet" and that 2 weeks after she started the diet she was fine and back to normal. At the time of reporting, the outcome of abasia was unknown. The causality assessment between the events and GARDASIL was not provided. Upon internal review, coeliac disease was determined to be medically significant. Additionally, abasia was determined to be medically significant and disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This spontaneous report was received from an administrator via company representative concerning a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (strength, dose, lot# and expiration date were not provided) subcutaneously. There were no concomitant medications reported. On an unknown date, the patient experienced Bell's Palsy. The patient was to an unspecified hospital for which she was hospitalized and received treatment during an unknown length of time. Also, it was reported that an unspecified treatment was given to the patient for the event of facial paralysis. No product quality complain was involved. At the reporting time, the patient was fully recovered, since an unknown date, from the event of facial paralysis. The causality between ZOSTAVAX and the event of facial paralysis was not assessed. The reporter considered that the event of facial paralysis was not life threatening. However, upon internal review, the event of facial paralysis was considered to be medically significant. Additional information is not expected as the reporter did not consent for follow up attempts.
Sex: M
Vaccine: VARCEL
Symptoms: Apgar score normal, Caesarean section, Congenital anomaly, Foetal exposure during pregnancy
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a currently 27 days old male patient. The patient's concurrent conditions and concomitant medications were not reported. On 09-DEC-2015, the patient's mother was vaccinated with VARIVAX lot # L015048 with expiry date of 29-APR-2017, and the patient had a transplacental exposure. Mother's lab data included: On 09-MAR-2016, ultrasound scan at 12 weeks of pregnancy was normal. On 19-APR-2016 (at 19 weeks of pregnancy), maternal serum alpha-fetoprotein screening (MSAFP) was negative. On 27-APR-2016, ultrasound scan at 19 weeks and on 03-JUN-2016, ultrasound scan at 24 weeks of pregnancy were normal. At 39 weeks gestation, the patient's mother had a Cesarean section (captured in 1602USA001176) and the patient was born with a weight of 4167.37 grams and a length of 21 inches. The patient was born with a congenital anomaly. The infant's APGAR scores were 8 at one minute and 9 at five minutes. The outcome of congenital anomaly was unknown. Causality was not provided by the reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 48-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7FF3N, expiry date 30th June 2017. On 29th September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) 0.5 ml. On 29th September 2016, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and injection site pain. On an unknown date, the outcome of the pain in arm and injection site pain were not recovered/not resolved. The reporter considered the pain in arm and injection site pain to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: It was reported that the patient experienced pain (10/10) radiated down her arm to her elbow. Then the pain moved down the arm to align with the middle finger. The pain subsided in the lower arm but continues in the upper arm above the elbow to the injection site. Pain was 3/10. But, if patient raised her arm pain was 10/10.
Sex: M
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received Seasonal influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Seasonal Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. In prior years from vaccines (unknown manufacturers) the reporter experiencing sickness. The reporter was unable to provide complete details of events.
Sex: F
Vaccine: FLU4
Symptoms: Hypotension, Nausea, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nausea in a female patient who received FLUARIX QUADRIVALENT (batch number ZG3S5, expiry date 30th June 2017). On 8th October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced nausea, vomiting and hypotension. On an unknown date, the outcome of nausea, vomiting and hypotension were unknown. It was unknown if the reporter considered the nausea, vomiting and hypotension 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 for this report. The other health professional stated that she would call back with details regarding the other two adverse events. This case has been linked with case US2016GSK149943 and US2016GSK149945 as reported by the same reporter.