chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up
Clinical narrative: The physician reported her niece spit out a dose of ROTATEQ; The physician reported her niece spit out a dose of ROTATEQ; No adverse effects were reported.; This spontaneous report was received from a physician referring to her niece a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route (strength, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The physician reported her niece spit out a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) on an unspecified date. No adverse effects were reported.        At the time of the report, the outcome of infantile spitting up, was unknown. The physician did not mention the causality assessment between the event and Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Facial pain, Headache, Herpes zoster
Clinical narrative: suffered and was diagnosed with painful shingles on her face as well as persistent headaches and balance problems all caused by Zostavax.; suffered and was diagnosed with painful shingles on her face as well as persistent headaches and balance problems all caused by Zostavax.; suffered and was diagnosed with painful shingles on her face as well as persistent headaches and balance problems all caused by Zostavax.; This initial spontaneous report was received on 11-OCT-2019, from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 17-MAY-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2012 (also reported as "within two or three weeks of receiving zoster vaccine live (ZOSTAVAX)"), the patient suffered and was diagnosed with painful shingles on her face as well as persistent headaches and balance problems all caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) vaccine, mental an emotional distress due to  resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work, severe, 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. At the time of the report, the outcome of balance disorder, headache and herpes zoster was not recovered. The reporter considered herpes zoster, balance disorder and headache to be related to Zoster Vaccine Live (ZOSTAVAX).  The events balance disorder, headache and herpes zoster were considered to be disabling.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; incorrect product storage; This spontaneous report was received from a licensed practical nurse referring to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported.  Since 01-OCT-2019, the patients were vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose number, route and anatomical location were not provided) lot # R002510, expiration date on 25-JAN-2020 and a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose number, route and anatomical location were not provided) lot # R020672, expiration date on 18-JUL-2020 for prophylaxis.  The vaccines were stored in temperature of 6°F (Fahrenheit degrees) to 14°; 6.4°F for 11 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No adverse events; This spontaneous report was received from a Medical Assistant and refers to an unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported.  On unspecified date, the patients were vaccinated with a dose of improperly stored Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23)  lot # S018405, expiration date on 28-MAR-2021 (strength, dose number, route and anatomical location were not provided) for prophylaxis.   The vaccine was stored in temperature below 32°Fahrenheit degrees/0°Celsius degrees (31.3°F) for 1 cycle. Digital data logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient received an improperly stored dose of ROTATEQ on 10/03/2019; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 03-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R026391 and expiration date 09-JUL-2020 (strength, dose, frequency and anatomical location were unknown) for prophylaxis (product storage error).  The administered dose of the vaccine was stored with the temperature of 32.9 degrees Fahrenheit, for 3 hours and 40 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient was given an improperly stored dose of MMR II; This spontaneous report as received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.   On 23-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R030808 and expiration date 24-OCT-2020 (strength, dose, frequency and anatomical location were unknown) for prophylaxis (product storage error). The administered dose of the vaccine was stored with the temperature of 10.3 degrees centigrades, for 39 hours and 33 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. 3 to 4 percent of the patients who received the Shingrix at reporter's facility, experienced flu-like symptoms, that lasted for 1 day after receiving the 2nd dose of the series. No further details were provided during the call. The reporter consented to follow up. This case had been linked to the case US2019185181, reported by the same reporter.
Sex: U
Vaccine: UNK, UNK
Symptoms: Hypersensitivity
Clinical narrative: allergy; This case was reported by a physician via other manufacturer and described the occurrence of allergy in a patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2011-12 season) for prophylaxis.   Co-suspect products included sumatriptan succinate (Imitrex) unknown for product used for unknown indication.   Concurrent medical conditions included adhesive tape allergy (Gets skin tear and itching with adhesive tapes), drug allergy (Bactrim allergy to severe heartburn, increased rash, shakes), drug allergy (Bees allergy to Hives) and drug allergy (Cleocin allergy to diarrhea, Flagyl allergy to diarrhea, Flexeril allergy to itching, Heparin allergy to PF4 And SRA Positive Dx, Imitrex allergy to makes want to crawl out of skin, Keflex allergy to itching, Lisinopril allergy to severe hypotension, Rifadin allergy to GI upset, Seroquel allergy to extreme sleepiness, Valium allergy to mental status change).   On an unknown date, the patient received Influenza vaccine unspecified 2011-12 season at an unknown dose and Imitrex at an unknown dose and frequency. On an unknown date, less than a year after receiving Influenza vaccine unspecified 2011-12 season and unknown after starting Imitrex, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Influenza vaccine unspecified 2011-12 season and Imitrex.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's contact information was available. The reporter was the prescribing healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Limb discomfort, Magnetic resonance imaging, Magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Arms very sore; Bursitis in left shoulder; Small rotator cuff tear; Congestion in right arm; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 8th May 2019 in the left arm). Concomitant products included Flu unspecified (Flu vaccine).   On 31st August 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Flu vaccine, the patient experienced pain in arm, shoulder bursitis, rotator cuff tear and arm discomfort. The patient was treated with antiinflammatory/antirheumatic products (Antiinflammatory Drug (Unknown)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the shoulder bursitis, rotator cuff tear and arm discomfort were unknown.   It was unknown if the reporter considered the pain in arm, shoulder bursitis, rotator cuff tear and arm discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in the right arm and flu vaccine in the unknown thigh. The patient had massage, acupuncture, chiropractor, PT therapies and MRI, Xray test. The patient had antiinflammatory drugs as a treatment medication. The patient stated that, the MRI finally showed small rotator cuff tear(not clearly related to shingrix vaccine), and bursitis in the left shoulder, which never had before the shot and which did not explain the identical pain and congestion in the right arm. The patient reported that, after almost 18 months of therapy, both arms were better, but it was long, painful and costly experience. The patient stated that, most of the treatments were not covered by insurance.      Lab Comments: lab test performed on an unknown date
Sex: F
Vaccine: VARZOS
Symptoms: Rotator cuff syndrome, X-ray
Clinical narrative: Arms very sore; Bursitis in left shoulder; Small rotator cuff tear; Congestion in right arm; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 8th May 2019 in the left arm). Concomitant products included Flu unspecified (Flu vaccine).   On 31st August 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Flu vaccine, the patient experienced pain in arm, shoulder bursitis, rotator cuff tear and arm discomfort. The patient was treated with antiinflammatory/antirheumatic products (Antiinflammatory Drug (Unknown)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the shoulder bursitis, rotator cuff tear and arm discomfort were unknown.   It was unknown if the reporter considered the pain in arm, shoulder bursitis, rotator cuff tear and arm discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in the right arm and flu vaccine in the unknown thigh. The patient had massage, acupuncture, chiropractor, PT therapies and MRI, Xray test. The patient had antiinflammatory drugs as a treatment medication. The patient stated that, the MRI finally showed small rotator cuff tear(not clearly related to shingrix vaccine), and bursitis in the left shoulder, which never had before the shot and which did not explain the identical pain and congestion in the right arm. The patient reported that, after almost 18 months of therapy, both arms were better, but it was long, painful and costly experience. The patient stated that, most of the treatments were not covered by insurance.      Lab Comments: lab test performed on an unknown date
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling; Redness; Warmth; Tenderness; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 46-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number Y5X93, expiry date 30th June 2020) for prophylaxis.   On 3rd October 2019, the patient received FluLaval Tetra 2019-2020 season. On an unknown date, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site tenderness to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received dose of Flulaval Quadrivalent season 2019-2020 in left deltoid. The nurse stated that, the patient received vaccine from different vial of same batch number. The reporter did not link this case to product complaint. The reporter did not consent to follow up. This case was 1 of 5 linked cases reported by same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HT5J, expiry date 26th January 2022) for prophylaxis.   On 20th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in the left deltoid, since almost 90% of the doses they administered in the pharmacy were given in left deltoid. However, he did not have the documentation in front of him during this call and could not confirm for sure. The patient experienced flu like symptoms, that lasted a week. The patient was afraid to get the 2nd dose. The reporter consented to follow up. This case had been linked to the case US2019185189, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Insomnia, Pyrexia
Clinical narrative: Fever; Fartigue; Soreness at injection site; Difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced fever, fatigue, injection site pain and difficulty sleeping. On an unknown date, the outcome of the fever, fatigue, injection site pain and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the fever, fatigue, injection site pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix yesterday of reporting date and was experiencing fever, fatigue, soreness at injection site and difficulty sleeping. No further details were provided. The reporter did not want to provide his address.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash below injection site; Injection site pain; This case was reported by a physician via call center representative and described the occurrence of injection site rash in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site rash and injection site pain. On an unknown date, the outcome of the injection site rash and injection site pain were unknown.   It was unknown if the reporter considered the injection site rash and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 54 or 55 years. The reporter stated that the patient developed injection site pain and a rash below the injection site. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Exposure via skin contact, Occupational exposure to product
Clinical narrative: Blisters around the eye; Some medication gets on skin; Occupational exposure while preparing product for administration; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than an hour after receiving Shingrix, the patient experienced blister, exposure via skin contact and occupational exposure while preparing product for administration. On an unknown date, the outcome of the blister, exposure via skin contact and occupational exposure while preparing product for administration were unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that while pulling stickers off the vial of Shingrix, some of the medication gets on skin, which led to exposure via skin contact and occupational exposure while preparing product for administration and also had Blisters around the eye the blisters started to appear around the time of preparing Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Nausea, Pyrexia, Rash
Clinical narrative: Fever; Headache; Stomach ache; Nausea; Rash on chest, stomach and arms; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, headache, stomach pain, nausea and rash. On an unknown date, the outcome of the fever, headache, stomach pain, nausea and rash were recovered/resolved.   It was unknown if the reporter considered the fever, headache, stomach pain, nausea and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient  stated that within few hours of getting the first dose of Shingrix she experienced fever, headache, stomach ache and nausea that lasted for total of 2 days. The patient also experienced a rash that was most prominent on chest and stomach and also present on her arms. The patient did not consent to follow up.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: the patient received some of the vaccine, no AE; the syringe detached like it was defected, no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist  This case involves a 3 years old patient who received some of the dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number, expiry dates were not reported) via unknown route in unknown site of administration, on an unknown date due to the syringe detached, like it was defected.  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 underdose. It was also a case of syringe issue. The issue with the syringe occurred while she was administering the vaccine  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: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: allergic reaction; local reactions-erythema; swelling in the left leg; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who experienced allergic reaction (hypersensitivity), local reactions-erythema (erythema) and swelling in the left leg (swelling), while he received vaccines HEPATITIS A and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 04-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot: UJ223AA, expiry date: 30-Jun-2020, via intramuscular route in the left thigh.  On an unknown date, the patient had allergic reaction (hypersensitivity), local reactions-erythema (erythema) and swelling in the left leg (swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Lab data was not reported.  Final diagnosis was hypersensitivity, erythema and swelling.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for all the events.  List of document held by sender: none.
Age: 57.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 57-year-old female patient received Daptacel instead of Adacel by a nurse/no AE; a 57-year-old female patient received Daptacel instead of Adacel by a nurse/no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 57 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication.   On 30-Sep-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA via intramuscular route in the right arm.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was unknown whether patient experienced any delayed adverse reaction.  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.  List of documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Shortness of breath; body fatigue; low grade fever; 57 year old male patient received Fluzone High-Dose; 57 year old male patient received Fluzone High-Dose; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a physician and nurse via Sales Representative.  This case was linked to cases 2019SA280604 and 2019SA280605 (same reporter).  This case involves a 57 years old male patient who experienced shortness of breath (dyspnoea), body fatigue (fatigue) and low grade fever (pyrexia), while he 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.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious shortness of breath (dyspnoea), body fatigue (fatigue) and low grade fever (pyrexia) within 24 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that an ambulance took him to the hospital. Hospital personnel told patient his symptoms were due to his flu shot.  It was also a case of Inappropriate age at vaccine administration and overdose.  Other relevant tests not reported.  Final diagnosis was low grade fever, body fatigue and shortness of breath.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for low grade fever, body fatigue and shortness of breath.  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.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: hives; Initial information received on 08-Oct-2019 regarding an unsolicited valid serious case received from a physician and nurse via sales representative.  This case is linked to cases 2019SA280603 and 2019SA280604 (same reporter).  This case involves a 85 years old female patient who experienced hives (urticaria) and, 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.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed hives (urticaria) within 24 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for these events.  Other relevant tests not reported.   Final diagnosis was hives.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for hives.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: mild flu; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves unknown demographic patient who experienced mild flu (influenza), while he/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.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious mild flu (influenza) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that spouse received Fluzone HD about 2 weeks ago. Caller reports no adverse reaction, but does express some concern about lack of protection against the second B flu strain (B/Phuket) not included in the Fluzone HD. Caller reports receiving Fluzone HD the past couple of years and having contracted a "mild flu for bout 2-3 days" while in the tropics during the winter.  Final diagnosis was mild flu.   It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome is reported as Recovered for mild flu.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 15.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 years old patient received the Flublok / no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff).  This case involves a 15 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date unknown) 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 case due to inappropriate age at vaccine administration.  It was reported that patient that received the Flublok last year that was 15 years old.  At the time of reporting no adverse reaction 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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: she received her shipment of Flublok out of range and it was administered to patient, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to case 2019SA281974 (same reporter).  This case involves a 69 years old patient who received 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1941, Exp. Date 30-Jun-2020) via intramuscular route in the left arm on 07-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage.  At the time of reporting, no adverse reactions were 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.  List of documents held by sender: none.
Age: 7.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 years old was administered Flublok, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA281991 (same reporter).  This case involves a seven years old patient (gender not reported) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Exp. 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 case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse reactions were 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.
Age: 87.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: shipment of Flublok received late and the stability of the vaccine could not be verified, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA282000 and 2019SA282001 (same reporter).  This case involves a 87 years old male patient who received a dose vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1941, Exp. Date 30-Jun-2020) via unknown route in unknown administration site on an unknown date (reported as yesterday) by mistake.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage.  Patient had no adverse reaction.  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.  List of documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 years old recieved Flublock yesterday, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA282006 and 2019SA282007 (same reporter).  This case involves a five years old patient (gender not reported) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date (reported as yesterday).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse reactions were 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.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Syringe issue
Clinical narrative: Liquid leaked from the side of the product during administration, no AE; Liquid leaked from the side of the product during administration, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 55 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe) lot QFAA1912, Exp. Date 28-Jun-2020 via intramuscular route in the left deltoid on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine underdose and syringe leak.  It was reported that they gave a patient Flublok yesterday but it started leaking while giving vaccine to patient.  At the time of reporting, no adverse reactions were reported (symptoms- None 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.  List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11 years old was administered Flublok, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA281959 (same reporter).  This case involves a 11 years old patient (gender not reported) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Exp. 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 case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse reactions were 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: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: pediatric patient who received about half of the Fluzone Quad 0.5; Initial information received on 10-Oct-2019 and additional information on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves pediatric patient who received about half of the 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number not reported via unknown route.  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 vaccine underdose.  It was unknown if any adverse event occurred.  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
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site nerve damage, Injection site pain, Injection site reaction
Clinical narrative: On 10-17-19 patient came in to report vaccine injury associated with injection given on 9-28-19.  She said she experienced much more pain and a "crackling" sound at the time of the injection.  She reported a much larger red and swollen area than after her first dose of Shingrix.  She also complains of numbness or tingling down her arm and into her hand. Her MD told her the needle likely hit a nerve but recommended no further treatment.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Paraesthesia
Clinical narrative: On 10-17-19 patient came in to report vaccine injury associated with injection given on 9-28-19.  She said she experienced much more pain and a "crackling" sound at the time of the injection.  She reported a much larger red and swollen area than after her first dose of Shingrix.  She also complains of numbness or tingling down her arm and into her hand. Her MD told her the needle likely hit a nerve but recommended no further treatment.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Urticaria
Clinical narrative: Hives and chills lasting  for extended period (still has them as of today 10-17-19).
Age: 46.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pruritus, Skin lesion
Clinical narrative: mildly pruritic erythematous lesions to left shoulder abdommen, arms and back beginning yesterday. some w/ vesicles
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Small area of erythema under the bandaid found by the patient 13 hours after administration.  Within the next 24 hours, erythema had spread to area (3 in x 5 in) across the arm, was hot to touch and swollen.  Patient sought medical care at an urgent care center.  Celullitis was diagnosed.  Keflex 500mg capsules prescribed (1 cap QID) for 7 days along with probiotics.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Feeding disorder
Clinical narrative: dizziness, upset stomach, all-over weakness, unable to eat anything all day
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Localized reaction:  Area on the arm was very red, swollen, hot to touch, painful.  Mom gave him benadryl but it did not help the symptoms
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Injection site scar, Pyrexia, Screaming
Clinical narrative: Inconsolable scream and crying, high fever, nursing strike, scar at injection site (left thigh)
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Skin induration, Skin tightness
Clinical narrative: When giving child a bath on the night of 10/16/17, mother noticed large red area and swelling that started at injection site and went down around 2-3 inches on the arm. Mother reports the skin feels hard and tight. Does not bother the child at all.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient states shortly after receiving the vaccination, she was unable raise her left shoulder and has been in pain. She was seen by her PCP who prescribed her some steroids and Norco to help relieve the pain. She still is unable to raise her left shoulder.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Intense shivering lasting about 3 minutes (7:00 pm the night of the injection), fatigue, muscle pain occurring the next day 910/17/2019), pain at injection site starting shortly after injection and continueing in to today (10/17/2019)
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Autonomic nervous system imbalance, Blood test, Dehydration, Dizziness
Clinical narrative: extreme fatigue and lethargy, memory loss, low blood pressure, dizziness, rapid dehydration, symptoms similar to dysautonomia
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Hypotension, Lethargy
Clinical narrative: extreme fatigue and lethargy, memory loss, low blood pressure, dizziness, rapid dehydration, symptoms similar to dysautonomia
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: headache slight and nausea slight