chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: FLUA3
Symptoms: Erythema, Immediate post-injection reaction, Swelling, Urticaria
Clinical narrative: Patient immediately developed a large, raised, red welt about the size of a quarter. Patient was not experiencing any relief from the swelling but experienced no pain or itching at 10:54a diphenhydramine 25 mg one by mouth once was administered with water. The patient then waited tell 11:06a to go to their doctor's office in which they had seen their physician and the physician noted no significant change in condition but for the patient to monitor the situation and alert both pharmacy and doctor if any change in condition occurred.
Age: 0.75
Sex: M
Vaccine: UNK
Symptoms: Fluid intake reduced, Hypophagia, Malaise, Mobility decreased
Clinical narrative: Patient was sick for three days and slept for those three days. He recieved the vaccination on a thursday and didnt come back around tp normal until that monday. He didnt eat, drink, or move for those three days. All he did was sleep
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: By the morning of 9-22-19, there was a red hot welt around the injection site. It was about four and a half inches long and about  3 inches wide. It was not symmetrical. It itches a lot.  That morning I returned to the pharmacy to see if this was a normal expected reaction. I showed the pharmacist my arm. The pharmacist said I could use something to stop the itching and that I should report this as a n adverse reaction.  It is now the evening of 9-24-19 and my arm  is still red and itches, but not nearly as bad as it was. I continue to use something for the itching.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Headache, Neck pain, Pain in extremity, Syncope
Clinical narrative: patient reported feeling fine during and immediately after vaccine, after signing for vaccine as she was walking to her cart the patient felt lightheaded and dizzy, patient asked to sit down, as patient was resting she starting feeling a pain in her neck and up her arm, patient also said that she had a headache after vaccine.  - paramedics checked patient out - vitals were normal and they believe that she just had an episode of syncope -patient refused to go to the hospital  -checked in with patient at 4:00pm and she was resting at home and feeling better
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Nausea, Pruritus, Rash
Clinical narrative: On Sept 24th at approximately  2:15 pm Staff patient received Flulaval flu vaccine with Lot # 60442 Manufactured by GSK with Expiration date 6-30-20 Pre-filled vaccine was given IM via Left Arm. At approximately 2:20 pm she complained  to the stahat she is hot and itching.  Staff was assesses by 2 RN's After few minutes mild rashes was noted to neck region and scattered mild rash on the posterior trunk and mild redness to left arm noted.  NO Shortness of breath during the assessment . Staff was alert and oriented and ambulatory. Staff Was referred to urgent care. Per RN of Urgent care patient was noted with nausea and vomiting.  Was given oxygen therapy and was referred to hospital for further treatment
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: On Sept 24th at approximately  2:15 pm Staff patient received Flulaval flu vaccine with Lot # 60442 Manufactured by GSK with Expiration date 6-30-20 Pre-filled vaccine was given IM via Left Arm. At approximately 2:20 pm she complained  to the stahat she is hot and itching.  Staff was assesses by 2 RN's After few minutes mild rashes was noted to neck region and scattered mild rash on the posterior trunk and mild redness to left arm noted.  NO Shortness of breath during the assessment . Staff was alert and oriented and ambulatory. Staff Was referred to urgent care. Per RN of Urgent care patient was noted with nausea and vomiting.  Was given oxygen therapy and was referred to hospital for further treatment
Age: 4.0
Sex: M
Vaccine: MMR, TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse events noted. Pt was administered Td vs DT which was ordered.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Conjunctivitis, Dysphonia, Oropharyngeal pain
Clinical narrative: patient began having raspy voice/sore throat approximately 4 hours after receiving vaccine He also had conjunctivitis-like symptoms in both eyes which he did not have prior to receiving vaccine
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash & UrticariaPruritus
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia, Tremor
Clinical narrative: 1 shot - body shaking , fever 2 shot - no reaction  2nd vaccine was not available several months  Got shingles - 7-12-2019
Age: 6.0
Sex: U
Vaccine: DTAPHEPBIP, FLU4, HEPA, MMRV
Symptoms: Malaise, Vomiting
Clinical narrative: -Following the vaccination, client became ILL + had a Emesis. at no time was the clients breathing compromised. I assisted with a Emesis bucket + cool compresses to the client forehead. The Emesis was full of food + other liquids.  -TX: I Made sure Client was safe at all time + did take vitals, following (Vitals: 2:30 114/68, 64, 20, 97.8/ 2:45 110/64, 68, 18, 97.6 LOC: A&O x 3.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Patient came to the pharmacy on September 24, 2019 at approximately 11:15 AM and stated that he had a reaction from the Shingrix vaccine he received. He brought pictures of his break out- pictures showed patient's arm with red, blistering spots. Pictures were of patient's arms, but patient stated he also had blistering spots on both legs. Patient stated he went to his primary care provider where they gave him a prescription for an antiviral and the blistering spots have since cleared. The primary care provider instruction him not to receive the 2nd dose of the Shingrix vaccine.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Narrative: Symptoms: Seizures Treatment: SODIUM CHLORIDE ONCE NS x 1 liter
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Hive x1 at injection site approximately 24 hrs after injection given; treated with Benadryl & cool compress.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever Swelling arms, red and warm area, pain both arms.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Skin warm
Clinical narrative: Fever Swelling arms, red and warm area, pain both arms.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: Raised area of redness over (R) upper arm. Blotchy skin over UES, upper chest - no frank hives
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Full blood count, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: body aches; chills; low grade fever; swelling at injection site; left shoulder to left elbow was warm; vomiting; elevated white cell count of 14.8; neutrophil count at 92; lymphocyte count low at 3.0; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a male patient who received Men B NVS (Bexsero) (batch number ABX778AA, expiry date 31st July 2020) for prophylaxis.   On 7th August 2019, the patient received Bexsero (intramuscular). On 7th August 2019, 1 hr after receiving Bexsero, the patient experienced general body pain, chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased, neutrophil count increased and lymphocyte count decreased. On an unknown date, the outcome of the general body pain was resolved with sequelae and the outcome of the chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased, neutrophil count increased and lymphocyte count decreased were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased and neutrophil count increased to be related to Bexsero. The reporter considered the lymphocyte count decreased to be unrelated to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that about an hour after the dose, the patient experienced body aches, chills, low grade fever, swelling at injection site, left shoulder to left elbow felt warm and then 4 hours after dose experienced vomiting. The patient 7 hours after the dose, was seen in clinic and had CBC lab which showed elevated white count at 14.8, neutrophils at 92 and low lymphocyte count at 3.0. Casualty for the event lymphocyte count decreased was reported as No. Clarification has been raised for the causality since no reply received the case has been closed.
Sex: M
Vaccine: MENB, MENB
Symptoms: Lymphocyte count, Neutrophil count, Pain, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: body aches; chills; low grade fever; swelling at injection site; left shoulder to left elbow was warm; vomiting; elevated white cell count of 14.8; neutrophil count at 92; lymphocyte count low at 3.0; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a male patient who received Men B NVS (Bexsero) (batch number ABX778AA, expiry date 31st July 2020) for prophylaxis.   On 7th August 2019, the patient received Bexsero (intramuscular). On 7th August 2019, 1 hr after receiving Bexsero, the patient experienced general body pain, chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased, neutrophil count increased and lymphocyte count decreased. On an unknown date, the outcome of the general body pain was resolved with sequelae and the outcome of the chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased, neutrophil count increased and lymphocyte count decreased were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased and neutrophil count increased to be related to Bexsero. The reporter considered the lymphocyte count decreased to be unrelated to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that about an hour after the dose, the patient experienced body aches, chills, low grade fever, swelling at injection site, left shoulder to left elbow felt warm and then 4 hours after dose experienced vomiting. The patient 7 hours after the dose, was seen in clinic and had CBC lab which showed elevated white count at 14.8, neutrophils at 92 and low lymphocyte count at 3.0. Casualty for the event lymphocyte count decreased was reported as No. Clarification has been raised for the causality since no reply received the case has been closed.
Sex: M
Vaccine: MENB, MENB
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: body aches; chills; low grade fever; swelling at injection site; left shoulder to left elbow was warm; vomiting; elevated white cell count of 14.8; neutrophil count at 92; lymphocyte count low at 3.0; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a male patient who received Men B NVS (Bexsero) (batch number ABX778AA, expiry date 31st July 2020) for prophylaxis.   On 7th August 2019, the patient received Bexsero (intramuscular). On 7th August 2019, 1 hr after receiving Bexsero, the patient experienced general body pain, chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased, neutrophil count increased and lymphocyte count decreased. On an unknown date, the outcome of the general body pain was resolved with sequelae and the outcome of the chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased, neutrophil count increased and lymphocyte count decreased were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased and neutrophil count increased to be related to Bexsero. The reporter considered the lymphocyte count decreased to be unrelated to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that about an hour after the dose, the patient experienced body aches, chills, low grade fever, swelling at injection site, left shoulder to left elbow felt warm and then 4 hours after dose experienced vomiting. The patient 7 hours after the dose, was seen in clinic and had CBC lab which showed elevated white count at 14.8, neutrophils at 92 and low lymphocyte count at 3.0. Casualty for the event lymphocyte count decreased was reported as No. Clarification has been raised for the causality since no reply received the case has been closed.
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Injection site swelling, Lymphocyte count decreased, Neutrophil count increased, Pain
Clinical narrative: body aches; chills; low grade fever; swelling at injection site; left shoulder to left elbow was warm; vomiting; elevated white cell count of 14.8; neutrophil count at 92; lymphocyte count low at 3.0; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a male patient who received Men B NVS (Bexsero) (batch number ABX778AA, expiry date 31st July 2020) for prophylaxis.   On 7th August 2019, the patient received Bexsero (intramuscular). On 7th August 2019, 1 hr after receiving Bexsero, the patient experienced general body pain, chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased, neutrophil count increased and lymphocyte count decreased. On an unknown date, the outcome of the general body pain was resolved with sequelae and the outcome of the chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased, neutrophil count increased and lymphocyte count decreased were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased and neutrophil count increased to be related to Bexsero. The reporter considered the lymphocyte count decreased to be unrelated to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that about an hour after the dose, the patient experienced body aches, chills, low grade fever, swelling at injection site, left shoulder to left elbow felt warm and then 4 hours after dose experienced vomiting. The patient 7 hours after the dose, was seen in clinic and had CBC lab which showed elevated white count at 14.8, neutrophils at 92 and low lymphocyte count at 3.0. Casualty for the event lymphocyte count decreased was reported as No. Clarification has been raised for the causality since no reply received the case has been closed.
Sex: M
Vaccine: MENB, MENB
Symptoms: Pyrexia, Skin warm, Vomiting, White blood cell count increased
Clinical narrative: body aches; chills; low grade fever; swelling at injection site; left shoulder to left elbow was warm; vomiting; elevated white cell count of 14.8; neutrophil count at 92; lymphocyte count low at 3.0; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a male patient who received Men B NVS (Bexsero) (batch number ABX778AA, expiry date 31st July 2020) for prophylaxis.   On 7th August 2019, the patient received Bexsero (intramuscular). On 7th August 2019, 1 hr after receiving Bexsero, the patient experienced general body pain, chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased, neutrophil count increased and lymphocyte count decreased. On an unknown date, the outcome of the general body pain was resolved with sequelae and the outcome of the chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased, neutrophil count increased and lymphocyte count decreased were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, low grade fever, injection site swelling, skin warm, vomiting, white blood cell count increased and neutrophil count increased to be related to Bexsero. The reporter considered the lymphocyte count decreased to be unrelated to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that about an hour after the dose, the patient experienced body aches, chills, low grade fever, swelling at injection site, left shoulder to left elbow felt warm and then 4 hours after dose experienced vomiting. The patient 7 hours after the dose, was seen in clinic and had CBC lab which showed elevated white count at 14.8, neutrophils at 92 and low lymphocyte count at 3.0. Casualty for the event lymphocyte count decreased was reported as No. Clarification has been raised for the causality since no reply received the case has been closed.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Alopecia
Clinical narrative: Patient said she experienced hair loss after getting the Shingrix shot
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: patient reported swelling of the injection arm and hand.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: pt reported swelling, redness, pain of injection arm
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pain, Vertigo
Clinical narrative: I started with a headache and strong body aches that disturbed my sleep the night of the vaccine. The next day I experienced continued headaches and bothersome dizziness, like vertigo. Dizziness and headaches continued into the third day, the tapered off the fourth day after the injection. I stayed in bed a lot for a couple days because of the side effects.
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Confusional state, Disturbance in attention, Headache, Insomnia, Pain
Clinical narrative: Headache.  Body ache.  Feverish feeling.   Insomnia.  Racing/confusing thoughts.  Trouble concentrating.
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, Tachyphrenia
Clinical narrative: Headache.  Body ache.  Feverish feeling.   Insomnia.  Racing/confusing thoughts.  Trouble concentrating.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Patient reported the arm where both vaccines were injected was very tender to touch, and warm.  Patient felt weak the following couple of days and had fever 101.   On 09/23/19 she felt better but injection site was still sore.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse effect; A 28 week pregnant female patient received GARDASIL 9 on 11-SEP-2019; This spontaneous prospective pregnancy report was received from a medical assistant via a company representative referring to a female patient of unknown age who were 28 weeks pregnant. There was no information about patient's concomitant medications, past drug reactions, allergies or pertinent medical history. Her last menstrual period was in 28-FEB-2019.   On 11-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose number, dose route, anatomical site of vaccination, lot number and expiration date were not reported) (exposure during pregnancy). In addition, no adverse effect was reported.    At the moment of the report, the pregnancy was on going.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient received improperly stored Varivax; This spontaneous report was received from a medical assistant and refers to a 14-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S002874 and expiration date 29-JAN-2021 (dose and route of administration were not reported) for prophylaxis. The temperature was from 6°F to 14°F (10.2 F, multiple) for 50 minutes. There was no previous temperature excursion reported. Digital data logger was involved. Concomitant therapies included properly stored sterile diluent. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005231: US-009507513-1909USA005223: US-009507513-1909USA005220: US-009507513-1909USA005078: US-009507513-1909USA005119: US-009507513-1909USA005124: US-009507513-1909USA005129: US-009507513-1909USA005134: US-009507513-1909USA005139: US-009507513-1909USA005365: US-009507513-1909USA005525: US-009507513-1909USA005424: US-009507513-1909USA005468:
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Sudden hearing loss, Tinnitus
Clinical narrative: sudden hearing loss and significant tinnitus where she was ultimately diagnosed with sudden idiopathic hearing loss of right ear; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 01-JUN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after received zoster vaccine live (ZOSTAVAX), the patient suffered sudden hearing loss and significant tinnitus where she was ultimately diagnosed with sudden idiopathic hearling loss or right ear. It was also specified that the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. At the time of reporting, the outcome of the event was not recovered. The event sudden hearing loss was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  The event sudden hearing loss was considered medically significant.   The sudden hearing loss was considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequent to the patient's vaccination with zoster vaccine live (ZOSTAVAX), the patient was treated by a physician for shingles. It was also specified that the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 30-SEP-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated at a medical center for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was considered as not recovered. The lawyer considered herpes zoster to be related to zoster vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Myositis, Peripheral swelling, Ultrasound scan, Urine analysis
Clinical narrative: Her "calves started swelling and then progressively got worse"/While admitted was diagnosed with Myositis; This spontaneous report has been received from a pharmacist who is also the patient's father referring to a 14 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies. Concomitant therapies included loratadine (CLARITIN) and cetirizine hydrochloride (ZYRTEC).       On 07-AUG-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly, for prophylaxis (lot # and expiration date were not reported).     On 30-AUG-2019, the patient's calves started swelling and progressively got worse, therefore, the patient went to the physician's office, then to urgent care and finally, on 07-SEP-2019, was hospitalized. On an unspecified date in September 2019, an ultrasound of calves, unspecified blood work, and urianalysis tests were taken but no results were provided. Afterwards, while being hospitalized, the patient was diagnosed with myositis and received furosemide (LASIX) intravenously for 3 days, as well as fluid and sodium restrictions. On 11-SEP-2019 (reported as 5 days later), the patient recovered from the event and was discharged from hospital.  The reporter's causality assessment between myositis and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Age: 1.08
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; received improperly stored PEDVAXHIB; This spontaneous report was received from a nurse refers to a 13 month old male patient. The patient's medical history, concurrent conditions, historical drugs, drug reactions/ allergies and concomitant medications were not reported. On 06-SEP-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # S000353 and expiration date 09-OCT-2021 (strength, dose, frequency and route not reported) for prophylaxis (product storage error). Storage temperature was reported as above 47 degree Fahrenheit (F) (47.4 F) with timeframe of 23 hours. There was no previous temperature excursion. The call was made because of a data logger. No adverse effects reported. No product quality complaint (PQC) present.  This is one of three reports received from the same reporter.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; received improperly stored PEDVAXHIB; This spontaneous report was received from a nurse refers to a 4 month old male patient. The patient's medical history, concurrent conditions, historical drugs, drug reactions/ allergies and concomitant medications were not reported. On 09-SEP-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # S000353 and expiration date 09-OCT-2021 (strength, dose, frequency and route not reported) for prophylaxis (product storage error). Storage temperature was reported as above 47 degree Fahrenheit (F) (47.4 F) with timeframe of 23 hours. There was no previous temperature excursion. The call was made because of a data logger. No adverse effects reported. No product quality complaint (PQC) present.  This is one of three reports received from the same reporter.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza, Nephrotic syndrome, Peripheral swelling
Clinical narrative: patient was hospitalized again and was again diagnosed with nephrotic syndrome; patient developed "swollen legs". The patient was hospitalized at unknown facility in an unspecified city/state on 22-AUG-2012 with flu and was diagnosed with nephrotic syndrome; patient developed "swollen legs". The patient was hospitalized at unknown facility in an unspecified city/state on 22-AUG-2012 with flu and was diagnosed with nephrotic syndrome; This spontaneous report was received from a physician via a company representative regarding a 12 years old female patient. Patient's past medical history and drug reactions/allergies were reported as unknown. Concomitant medications included diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA).   On 25-JUL-2012, the patient received first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), intramuscular for prevention of certain HPV related cancers (dose, lot# and expiry dates were not reported).   On 02-AUG-2012, the patient developed "swollen legs". The patient was hospitalized at unknown facility in an unspecified city/state on 22-AUG-2012 with flu and was diagnosed with nephrotic syndrome. On 03-JAN-2013, the patient received 2nd dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) and received 3rd dose on 26-APR-2013. On 13-MAY-2013, the patient was hospitalized again and was again diagnosed with nephrotic syndrome.   On unspecified dates, the patient recovered from the events nephrotic syndrome and flu. On an unknown date in 2017, the patient recovered from the event nephrotic syndrome. Causality of the events were not reported.  It was reported that the patient was suffering an incapacity due to being hospitalized and diagnosed with Nephrotic syndrome twice (disability).   Upon internal review, the event "Nephrotic syndrome" was determined to be medically significant.
Sex: M
Vaccine: MMR
Symptoms: Allergy to vaccine, Dyspnoea, Hypersensitivity, Mumps antibody test negative
Clinical narrative: her son had trouble breathing; severe allergic reaction; negative titers to mumps; This spontaneous report was received from a consumer, referring to her son, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions or allergies were not reported.     On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, anatomical injections site, lot # and expiration date were not disclosed).         Afterwards, on an unknown date, the patient experienced trouble breathing (dyspnea) and had other unspecified but severe allergic reaction (allergy to vaccine). The patient's mother also reported that her son had negative titers to mumps (mumps antibody test negative) after receiving the vaccine.  At the time of this report, the outcome of dyspnoea, mumps antibody test negative and allergy to vaccine was unknown.    The event of allergy to vaccine was considered to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). However, the causality assessment between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the events dyspnea and mumps test negative, was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Ataxia
Clinical narrative: Ataxia; This spontaneous report was received from a physician via a company representative refers to a 13 year old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On an unknown date, (reported as: approximately 5 days after vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient experienced ataxia. The outcome of ataxia was reported as recovered/resolved, on an unknown date. The causality of event was not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: an improperly stored dose of Pedvax was administered to the patient; no adverse effects; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, previous drug reactions or allergies, and concurrent conditions were not disclosed.  On an unknown date, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (strength, dose, route of administration, anatomical injection site were not disclosed), lot # N024570 and expiration date 01-MAY-2020.  It was reported that this vaccine had been on a temperature excursion and was stored below 36 °F (32.1 °F) during 8 hours; but it was also noted that there had not been a previous temperature excursion.  At the time of this report, there were no adverse events reported. Digital data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Ear pain, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: cellulitis; post herpetic neuralgia; left ear pain; recurrent outbreaks of herpes zoster dermatitis; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 18-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered painful rash on right arm and has been diagnosed with recurrent outbreaks of herpes zoster dermatitis, left ear pain, cellulitis and post herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events recurrent outbreaks of herpes zoster dermatitis, left ear pain, cellulitis and post herpetic neuralgia was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events recurrent outbreaks of herpes zoster dermatitis, left ear pain, cellulitis and post herpetic neuralgia to be disability.  Upon internal review, the event cellulitis was determined to be medically significant event.
Age: 76.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Incomplete course of vaccination
Clinical narrative: facial pain radiating to eye, ear and Rsideof the face; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of facial pain in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced facial pain and incomplete course of vaccination. The patient was treated with antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the facial pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the facial pain to be related to Shingrix.  Additional details were provided as follows: The patient had vaccine and experienced facial pain radiating to eye ear and right side of face. The patient took antiviral pill which alleviated the sx. At the time of reporting did not receive the 2nd dose, which led to incomplete course of vaccination. The patient asked whether it is safe to have the follow up vaccine suggested after 6 months.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included foot pain and breast cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in the right arm. The patient experienced sore arm for few days after receiving 1st dose of Shingrix. The reporter consented to follow up. This case has been linked with case US2019168158 reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Headache, Inappropriate schedule of product administration, Injection site discomfort
Clinical narrative: Injection Site Redness; Injection Site Swelling; Injection Site Warmth; Injection Site Pain; Injection Site Itching; It was tender but then worsened; Couldn't sleep; Slight discomfort at injection site; Inappropriate Schedule of Vaccine; Fever; Chills; Headache; Knots in the muscle that moved throughout the muscle area; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number B4772, expiry date 20th November 2021) for prophylaxis.   Previously administered products included Zostavax and Shingrix (received 1st dose in May 2018).   On 13th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 13th September 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 14th September 2019, the patient experienced injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness and injection site discomfort. In September 2019, the patient experienced fever, chills, headache and muscle mass. On an unknown date, the outcome of the injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness, fever, chills, headache, muscle mass, injection site discomfort and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness, fever, chills, headache, muscle mass and injection site discomfort to be related to Shingrix.  Additional details were reported as follows: On 13th September 2019, the patient received the 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The patient stated that had redness, swelling, warmth, pain and itching at the site. The area was about 4 x 6 and the whole upper arm. The patient stated that it was tender but then worsened , it was painful to lay on and she could not sleep. The patient also had fever, chills and headache. The patient also saw knots in the muscle that moved throughout the muscle area. On the time of reporting the patient still had slight discomfort, itching and warmth at the site. The patient has not reported the event to the physician because everything she read is her events were common. The patient wondered if the events to the second dose had anything to do with the fact that she was so late receiving the second dose.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Insomnia
Clinical narrative: Injection Site Redness; Injection Site Swelling; Injection Site Warmth; Injection Site Pain; Injection Site Itching; It was tender but then worsened; Couldn't sleep; Slight discomfort at injection site; Inappropriate Schedule of Vaccine; Fever; Chills; Headache; Knots in the muscle that moved throughout the muscle area; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number B4772, expiry date 20th November 2021) for prophylaxis.   Previously administered products included Zostavax and Shingrix (received 1st dose in May 2018).   On 13th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 13th September 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 14th September 2019, the patient experienced injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness and injection site discomfort. In September 2019, the patient experienced fever, chills, headache and muscle mass. On an unknown date, the outcome of the injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness, fever, chills, headache, muscle mass, injection site discomfort and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness, fever, chills, headache, muscle mass and injection site discomfort to be related to Shingrix.  Additional details were reported as follows: On 13th September 2019, the patient received the 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The patient stated that had redness, swelling, warmth, pain and itching at the site. The area was about 4 x 6 and the whole upper arm. The patient stated that it was tender but then worsened , it was painful to lay on and she could not sleep. The patient also had fever, chills and headache. The patient also saw knots in the muscle that moved throughout the muscle area. On the time of reporting the patient still had slight discomfort, itching and warmth at the site. The patient has not reported the event to the physician because everything she read is her events were common. The patient wondered if the events to the second dose had anything to do with the fact that she was so late receiving the second dose.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle mass, Pyrexia, Tenderness
Clinical narrative: Injection Site Redness; Injection Site Swelling; Injection Site Warmth; Injection Site Pain; Injection Site Itching; It was tender but then worsened; Couldn't sleep; Slight discomfort at injection site; Inappropriate Schedule of Vaccine; Fever; Chills; Headache; Knots in the muscle that moved throughout the muscle area; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number B4772, expiry date 20th November 2021) for prophylaxis.   Previously administered products included Zostavax and Shingrix (received 1st dose in May 2018).   On 13th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 13th September 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 14th September 2019, the patient experienced injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness and injection site discomfort. In September 2019, the patient experienced fever, chills, headache and muscle mass. On an unknown date, the outcome of the injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness, fever, chills, headache, muscle mass, injection site discomfort and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness, fever, chills, headache, muscle mass and injection site discomfort to be related to Shingrix.  Additional details were reported as follows: On 13th September 2019, the patient received the 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The patient stated that had redness, swelling, warmth, pain and itching at the site. The area was about 4 x 6 and the whole upper arm. The patient stated that it was tender but then worsened , it was painful to lay on and she could not sleep. The patient also had fever, chills and headache. The patient also saw knots in the muscle that moved throughout the muscle area. On the time of reporting the patient still had slight discomfort, itching and warmth at the site. The patient has not reported the event to the physician because everything she read is her events were common. The patient wondered if the events to the second dose had anything to do with the fact that she was so late receiving the second dose.