chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Heart rate increased, Pain
Clinical narrative: Tired; Fatigue; Body Aches; Fast Heartbeat; Headache; Dizziness; Shivering/Chills; Stomach Pain
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Patient experienced redness, swelling, tenderness, and blisters to the injection site.  Redness and swelling spreading down arm to elbow and across arm into arm pit.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Swelling
Clinical narrative: Patient experienced redness, swelling, tenderness, and blisters to the injection site.  Redness and swelling spreading down arm to elbow and across arm into arm pit.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: red, hot to touch, itchy, left arm
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site warmth, Pain
Clinical narrative: CLIENT CAME IN WITH COMPLAINTS OF PAIN, REDNESS, AND AREA BEING HOT TO TOUCH. CLIENT RECEIVED THE VACCINE ON 10-7-19, CLIENT REPORTED TO EMPLOYEE HEALTH ON 10-9-19. CLIENT SENT TO CLINIC (THE WORKPLACE) FOR FURTHER EVALUATION.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: CLIENT IN FOR FLU VACCINE SITE REDNESS, SITE WARM TO TOUCH. CLIENT SEEN BY DR. IN OFFICE AT TIME OF VISIT. CLIENT TOLD TO WATCH AND COME BACK BY IF PROBLEMS PERSIST.
Age: 7.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Influenza B virus test positive, Respiratory distress, Use of accessory respiratory muscles, Wheezing
Clinical narrative: On 19/7/19 patient presented to clinic in respiratory distress with wheezing and retractions. No history of Asthma. Improved after nebulizer treatment with Duoneb.
Age: 2.25
Sex: M
Vaccine: DTAP
Symptoms: Face oedema, Swelling face
Clinical narrative: Facial edema, swollen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: C/O left upper arm swelling, non tender. 3/4 inch warm area.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Sore bicep/tricep muscle in arm with injection site.  2 inch rash on bicep 3 inches below injection site.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Erythema of eyelid, Pruritus
Clinical narrative: itchy, redness on face and eyelids
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Dysphagia, Pharyngeal swelling, Streptococcus test negative, Throat irritation
Clinical narrative: Throat started to become scratchy then by 6pm bought Benadryl . throat very swollen swallowing difficult but not inhibiting eating or breathing
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Diarrhoea
Clinical narrative: Patient start experiencing diarrhea at midnight and it lasted all night on 10/11/19
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Blood culture, Chest X-ray, Cough, Haematemesis, Laboratory test
Clinical narrative: Vomiting, Hematemesis, Coughing, Ocular Hyperemia
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Urine analysis, Vomiting
Clinical narrative: Vomiting, Hematemesis, Coughing, Ocular Hyperemia
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: Noticed a blister on site of injection a day after receiving the vaccine.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal swelling, Respiratory distress
Clinical narrative: Pt called complaining of shortness of breath after the flu shot, presented to the clinic in mild respiratory distress, no stridor or wheezing noted but did complain of fullness in the throat.  Given Albuterol Neb treatment with dramatic improvement noted.  Also received Solumedrol IV push.  Admitted to Observation for overnight to monitor.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE KNOWN
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: UNKNOWN
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Neck pain, Vaccination site induration
Clinical narrative: Swelling of right upper arm, painful, warm to the touch. Also has pain into the neck. Hard "ball" in the upper arm at site of vaccination
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site nodule
Clinical narrative: Swelling of right upper arm, painful, warm to the touch. Also has pain into the neck. Hard "ball" in the upper arm at site of vaccination
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Nausea, Pallor, Vomiting
Clinical narrative: Within 5 minutes after vaccination, patient's nurse stated that the patient was losing consciousness and color in her face.  Rescue was called immediately.  Patient was vomiting and felt nauseas while waiting for rescue but regained consciousness.  Rescue arrived within 15 minutes and checked vitals.  Patient stated that she wanted to go home and didn't want to go to hospital for further evaluation.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injection site pain, Mobility decreased
Clinical narrative: Client presented for flu vaccination at her worksite on 9/19/2019. On 10/7/2019 email received from HR at client's company asking for someone to call client regarding symptoms she was still having from her flu shot. TC to client and she stated that she had "normal" pain at the injection site for two days but then the pain spread into her shoulder, armpit and back side of her shoulder. Her shoulder has become increasingly difficult to move. She had not sought medical attention but agreed after talking with us.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion
Clinical narrative: Bruise at shoulder.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Fatigue, Pyrexia, Skin warm
Clinical narrative: Increased redness and warmth medial aspect of left arm, redness started on Tuesday.  Wednesday tactile fever ,chills and fatigue, are of redness 50% of upper arm
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; patient was inadvertently administered a dose of GARDASIL 9, on 9/9/2019, that had been improperly stored.; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent history, concomitant therapies and drug allergy or reactions were not reported.       On 09-SEP-2019, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1581027, expiration date: 03-JUN-2021; dose and route were not reported) for prophylaxis, that had been improperly stored (improper storage of product in use). No adverse effect was reported.   The administrated vaccine experienced the following temperature excursion: temperature: 60 Fahrenheit (F) for 8 hours 25 minutes. Previous temperature excursions: above 47 degree Fahrenheit/9 degree Celsius (46.6 F) for 2 hours 45 minutes. The call was due to a data logger.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. No information regarding patient's gender, concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. On 04-SEP-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # S002874, expiration date 29-JAN-2021, for prophylaxis (exact dose, route of administration and injection site were not provided). The vaccine was reconstituted with properly stored sterile diluent. The vaccine was exposed to a temperature from 6 to 14 degrees Fahrenheit (F) for 50 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of several reports from the same reporter; Sender's Comments:  US-009507513-1909USA005231: US-009507513-1909USA005078: US-009507513-1909USA005124: US-009507513-1909USA005119: US-009507513-1909USA005129: US-009507513-1909USA005134: US-009507513-1909USA005139: US-009507513-1909USA005220: US-009507513-1909USA005231: US-009507513-1909USA005365: US-009507513-1909USA005375: US-009507513-1909USA005424: US-009507513-1909USA005468:
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: post herpetic neurlagia; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported.  On or about 15-OCT-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, frequency, route and site of administration, lot# and expiration date were not reported) in a pharmacy by a pharmacist, for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the patient experienced post herpetic neuralgia and was treated by a healthcare professional for the event. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, 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 outcome of the event was not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: shingles (herpes zoster); This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 10-NOV-2015, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), pt suffered pain and swelling to his right ankle and foot. Pt was thereby diagnosed with shingles/herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), pt 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), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of singles/herpes zoster was considered to be disabling.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Patient was received improperly stored varivax; This spontaneous report as received from a nurse refers to a patient of unknown age and gender.    The patient's medical history, past drugs, allergies and reactions were not reported. Concomitant therapies included sterile diluent. On 19-JUL-2019 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S002874, expiry date: 29-JAN-2021) for prophylaxis. The diluent was used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 7.64 Fahrenheit (F) for a time frame of 20 minutes. There was previous temperature excursion was 19.34 Fahrenheit for 34 minutes. Data logger was involved (product storage error).  The outcome of product storage error and no adverse event was unknown.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pt had swelling and redness from injection site and full upper arm area. counseled pt to take benadryl  and ibuprofen and ice and to seek medical attention if gets worse or not better with medication, I contact Dr.'s office and reported incident with staff at mds and faxed pts immunization record over to office
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Tinnitus
Clinical narrative: A couple of hours after I received the Flu shot my ear had a very loud and severe tinnitus attack that lasted about a minute.  The severity lessened: however, that night it was loud and annoying enough to prevent sleep.  Since then it has become milder but it has not dissipated as of 10/11/*19 11:45 a.m.    I plan to get an appointment with and ENT since I have had chronic ear issues.   I could not find the exact match in the drop down list.   there was a date on the bottom on the information sheet 08/07/2015 Not sure what this is for.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Full blood count, Metabolic function test, Seizure, Somnolence
Clinical narrative: About 15 minutes after the vaccines the patient became drowsy and had a seizure.  Water, bedside blood glucose, comfort and blood draw was initiated.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Patient immediately after injection started to have hives around the injection area redness and swelling. We immediately administered Benadryl 4mL and patient was observed for 15 minutes
Age: 76.0
Sex: M
Vaccine: FLUR4
Symptoms: Rash, Skin irritation
Clinical narrative: A day after the patient received the vaccine, they noticed irritation and a light rash not localized to the injection site. Patient consulted their doctor who suggested the events could be related to the immunization.
Age: 23.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood calcium normal
Clinical narrative: 3 hours after receiving the vaccines (as noted) she had a syncopal episode. She also experienced headache and myalgias.  EMS was called to her home at 1257, and they arrived at 1308.  she refused transport to nearest ED. She remained at home with her husband.  the next morning, she no longer had myalgias, or any dizziness. She had persistent headache at the time of this report, which is 27 hours after vaccine administration.
Age: 23.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Blood creatinine normal, Blood potassium normal, Blood sodium normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: 3 hours after receiving the vaccines (as noted) she had a syncopal episode. She also experienced headache and myalgias.  EMS was called to her home at 1257, and they arrived at 1308.  she refused transport to nearest ED. She remained at home with her husband.  the next morning, she no longer had myalgias, or any dizziness. She had persistent headache at the time of this report, which is 27 hours after vaccine administration.
Age: 23.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Headache, Myalgia, Protein total normal, Syncope, White blood cell count increased
Clinical narrative: 3 hours after receiving the vaccines (as noted) she had a syncopal episode. She also experienced headache and myalgias.  EMS was called to her home at 1257, and they arrived at 1308.  she refused transport to nearest ED. She remained at home with her husband.  the next morning, she no longer had myalgias, or any dizziness. She had persistent headache at the time of this report, which is 27 hours after vaccine administration.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patient received improperly stored VARlVAX; This spontaneous report was received from a medical assistance and refers to a currently 4-year-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medically history provided.  On 10-SEP-2019, the patient received a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot number: S003864, expiration date: 08-AUG-2020 (dose, indication and route of administration were not provided). The improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (recombinant human albumin) (PROQUAD) was reconstituted with properly stored sterile diluent. No adverse effect reported.  The administrated doses of the vaccines were exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.7 F) for 30 minutes. There was no previous temperature excursion. Data logger was involved.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: The Patient had a routine Papanicolau (PAP) smear which was "positive" and she was considered "high risk" and "needed a colposcopy"; This spontaneous report was received from a nurse via a company representative referring to a 25 years old female patient. The patient's concurrent condition was not reported; pertinent medical history, drug reactions/allergies and concomitant medication were unknown by the reporter.    On an unspecified date in 2012, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength and dose not reported; lot number and expiration date were unknown) intramuscularly as prophylaxis. The patient said that she did receive a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength and dose not reported; lot number and expiration date were unknown) on an unspecified date which the nurse did not have any documentation of the second dose. On an unspecified date in September 2019 (reported as last week), the patient had a routine papanicolaou (PAP) smear which was positive (smear cervix abnormal) and she was considered as high risk and needed a colposcopy. It was unknown if other studies were performed. After the routine PAP, the patient sought medical attention. At the reporting time, the outcome of the event was reported as unknown. The causality between smear cervix abnormal and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)  was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; patient was administered an expired dose of MMRII; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 12-SEP-2019, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) via subcutaneous route, lot # N023142, expiration date 24-AUG-2019 (exact dose and injection site were not reported) for prophylaxis. The suspected vaccine was reconstituted with properly stored and non-expired sterile diluent. There was no adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: the patient was treated for postherpetic trigeminal neuralgia; the patient was treated for zoster; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-MAY-2015, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a pharmacy for or the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's vaccination, the patient was treated by a physician zoster and postherpetic trigeminal neuralgia. As a direct and proximate result of patient's vaccination, she 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 reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The outcome of the events was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: unspeified patient who was pregnant received dose of Gradasil 9; no adverse effect; This spontaneous prospective pregnancy report was received from a nurse regarding a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. The nurse stated that on an unspecified date the patient who was pregnant vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiry date were not reported) for prophylaxis (exposure during pregnancy). No adverse effects reported and there was no product confusion. The last menstrual period and estimate date of delivery was unknown. The pregnancy outcome was outcome pending. The out come of events was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-AUG-2019, the patient was vaccinated with an improperly stored  dose of varicella virus vaccine live (oka/merck)(VARIVAX)  lot # S005078 expiration date 19-FEB-2019 or lot # R019237 expiration date 04-JUL-2020 (strength, dose, frequency and anatomical location were not provided) for prophylaxis. The reporter had not clear which lot # was given to the patient, since both lot # had temperature excursion. The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent. The administered doses of the vaccines were stored with the temperature  between -14 degrees centigrades to -10 degrees centigrades (mainly at -9.74 degrees centigrades), the time frame was unknown by reporter. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering
Clinical narrative: Blisters in mouth; This case was reported by a pharmacist via call center representative and described the occurrence of blistering of mouth in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number N99P3, expiry date 19th October 2021) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced blistering of mouth. On an unknown date, the outcome of the blistering of mouth was unknown.   It was unknown if the reporter considered the blistering of mouth to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced blisters in mouth. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching all over body; This case was reported by a nurse via call center representative and described the occurrence of generalized pruritus in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was recovered/resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. Four months before the reporting date ago, the patient received Shingrix. Within 24 hours of receiving the vaccination, the patient experienced itching all over her body which resolved within a day. The reporter was a nurse with the health department. She would not provide any additional details. She was going to have the physician call Glaxosmithkline to provide the details.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash described as little patch of blisters; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) for prophylaxis.   On 10th September 2019, the patient received the 2nd dose of Shingrix .5 ml. In September 2019, less than a week after receiving Shingrix, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was unknown.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on the right arm. The patient presented rash on the opposite arm within 3 days of receiving the vaccination. The rash presented on the left arm 2 inches down from the arm pit area on the under side of the arm. The rash was described as a little patch of blisters.  The reporter consented to follow up.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: given 12 to 15 patients expired dose of Fluzone High Dose/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves 12 to 15 patients (demographics unknown) was given expired dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] VACCINE lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a 72 year old male received a dose of fluzone quadrivalent in error instead of fluzone high dose/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 72 years old male patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in error instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Urinary incontinence
Clinical narrative: had an episode where patient wet his pants; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 8 years old male patient who had an episode where he wet his pants (urinary incontinence), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Sep-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6654A via intramuscular route in the left arm.  On an unknown date, the patient developed a non-serious had an episode where patient wet his pants (urinary incontinence) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was had an episode where patient wet his pants.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown.  Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was given to a 21 month old baby/No AE; Fluzone HD was given to a 21 month old baby/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21 months old male patient who received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines administered.   On 02-Oct-2019, the patient received 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Frequency = once) lot UJ249AA, expiry-30-04-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Hypersensitivity, Paraesthesia oral, Pharyngeal swelling, Pyrexia
Clinical narrative: tongue was itching; tongue was tingling; couldn't swallow; throat was swelling; allergic reaction to the ingredients of Fluzone HD vaccine; slight fever; throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 68 years old female patient who experienced tongue was itching (tongue pruritus), tongue was tingling (paraesthesia oral), couldn't swallow (dysphagia), throat was swelling (pharyngeal swelling), allergic reaction to the ingredients of Fluzone HD vaccine (allergy to vaccine), slight fever (pyrexia) and throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue (oropharyngeal discomfort), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation received a couple weeks ago, patient got sick from that shot but that is typical with the second shot. She had fever and chills.  On 02-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ253AA via unknown route in the right arm.  On an unknown date, the patient developed a non-serious tongue was itching (tongue pruritus), tongue was tingling (paraesthesia oral), couldn't swallow (dysphagia), throat was swelling (pharyngeal swelling), allergic reaction to the ingredients of Fluzone HD vaccine (allergy to vaccine), slight fever (pyrexia) and throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue (oropharyngeal discomfort) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue, slight fever, allergic reaction to the ingredients of Fluzone HD vaccine, throat was swelling, couldn't swallow, tongue was tingling and tongue was itching.   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) 3, 4mg tablets.  On an unknown date, the patient was Recovered from throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue, allergic reaction to the ingredients of Fluzone HD vaccine, throat was swelling, couldn't swallow, tongue was tingling and tongue was itching and not recovered from slight fever.  Information on the batch number was requested.  Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Sensation of foreign body, Tongue discomfort, Tongue pruritus
Clinical narrative: tongue was itching; tongue was tingling; couldn't swallow; throat was swelling; allergic reaction to the ingredients of Fluzone HD vaccine; slight fever; throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 68 years old female patient who experienced tongue was itching (tongue pruritus), tongue was tingling (paraesthesia oral), couldn't swallow (dysphagia), throat was swelling (pharyngeal swelling), allergic reaction to the ingredients of Fluzone HD vaccine (allergy to vaccine), slight fever (pyrexia) and throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue (oropharyngeal discomfort), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation received a couple weeks ago, patient got sick from that shot but that is typical with the second shot. She had fever and chills.  On 02-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ253AA via unknown route in the right arm.  On an unknown date, the patient developed a non-serious tongue was itching (tongue pruritus), tongue was tingling (paraesthesia oral), couldn't swallow (dysphagia), throat was swelling (pharyngeal swelling), allergic reaction to the ingredients of Fluzone HD vaccine (allergy to vaccine), slight fever (pyrexia) and throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue (oropharyngeal discomfort) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue, slight fever, allergic reaction to the ingredients of Fluzone HD vaccine, throat was swelling, couldn't swallow, tongue was tingling and tongue was itching.   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) 3, 4mg tablets.  On an unknown date, the patient was Recovered from throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue, allergic reaction to the ingredients of Fluzone HD vaccine, throat was swelling, couldn't swallow, tongue was tingling and tongue was itching and not recovered from slight fever.  Information on the batch number was requested.  Documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dtap was given expired 2 weeks ago to a patient who is 15 months old; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old patient (gender unknown) who received expired dose of vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site On an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  Documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient received ActHIB that was prepared with sterile water instead of the proper diluent/no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA276702 same reporter.  This case involves a 12 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] that was prepared with sterile water instead of the proper diluent.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Aug-2019, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UI905AAA via unknown route in the right thigh (The lot of the diluent found by itself is: lot U6057AA expiry 24 Oct 2019.).  It was a case of actual medication error due to Wrong solution used in drug reconstitution.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient received ActHIB that was prepared with sterile water instead of the proper diluent/no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA276700 same reporter.  This case involves a 2 years old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] that was prepared with sterile water instead of the proper diluent.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Aug-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI905AAA via unknown route in the right thigh (The lot of the diluent found by itself is: lot U6057AA expiry 24Oct2019.).  It was a case of actual medication error due to Wrong solution used in drug reconstitution.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: FLUX, IPV, MMR, TDAP, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4yo patient inadvertently received Adacel instead of Daptacel, no AE; 4yo patient inadvertently received Adacel instead of Daptacel, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (other).  This case involves a 4 years old female patient who inadvertently received a 0.5 ml fifth dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and site of administration were not reported) instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] via intramuscular route on 25-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and INFLUENZA VACCINE (INFLUENZA VACCINE).  It was an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event, Product administered at inappropriate site
Clinical narrative: Adacel was administered to a patient in the back of the arm in the subcutaneous area/NO AE; Adacel was administered to a patient in the back of the arm in the subcutaneous area/no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient who was administered with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) via subcutaneous route in the back of the arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to vaccine administered at inappropriate site and inappropriate route of vaccination.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.