chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Metabolic function test, Presyncope, Rash, Syncope, Troponin
Clinical narrative: Patient felt weak and developed generalized rash on 10/21/2020 AM.  Patient's husband text patient's sign and symptoms and photo of skin rash.  Benadryl and Medrol dose pack oral were prescribed.  Patient had a vasovagal event at home 10/21/2020 in the afternoon after taken first 4mg  Medrol dose.  Patient had a video telemedicine with provider in the afternoon.  Patient was alert and orient sitting in the house.  Patient subsequently was brought to local ER by husband in the early evening, and received epinephrin, diphenhydramine  and methylprednisonlone sod succ (SOLUMEDROL) and IV fluid.  Patient discharged home with ER diagnosis acute allergic reaction, initial enounter and syncope and collapse.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling, Vaccine positive rechallenge
Clinical narrative: Localized swelling, remarkable. That responded to oral Benadryl. Swelling happened about 4 hours into IM injection into left thigh. Had a similar reaction last year too following  flu vaccination, which was given IM to left thigh . last year though the swelling happened about 24 ouhrs into the shot. So this year the reaction occurred quicker but swelling was slightly lesser.
Age: 1.67
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Mobility decreased, Pain
Clinical narrative: Patient had Dtap and phemonia shot. He can?t move his legs. Won?t walk at all.  Is in pain when I try change diaper.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Erythema, Urticaria
Clinical narrative: pt returned to office aafter receiving his 4 year vaccines. he was alert, slightly dyspneic and with redness of his entire face and body with a few hives on cheek and arm. no stridor. no wheezing. he was given Claritin 10 mg, Benadryl 18.75 mg, Epi 0.15 mg and prednisolone 30 mg. within a few minutes, his breathing normalized, the redness improved and he was more talkative. 911 called to transport pt to the ED, where he was monitored for a few hours and sent home. Will refer to allergist for allergy testing
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased
Clinical narrative: temps 100 - 100.8 since gettings PCV13 on 11/17.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Within a few minutes into the vaccination she broke out in hives. generalized. No respiratory distress. Pulse ox at 98%. Though we drew up epinephrine given no respiratory distress or any other systemic symptoms and also slowly the hives started to fade away, we did not have to administer epinephrine. However given she will need another preschool booster need to determine if it is safe to do any more boosters. Did receive Heamophilus influenza dose (#4) same day but would think the allergic reaction likely was from  Daptacel.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Skin burning sensation
Clinical narrative: Righ palm burning with blisters
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Injection site erythema, Injection site swelling, Peripheral swelling, Swollen tongue
Clinical narrative: Initial reported symptoms: (almost 2 hours after the shot) redness and swelling in injection arm spreading downwards and upwards on to neck, tongue numbness Initial Treatment: Patient took a Claritin at advice of a physician she works for. Patient then later took a Benadryl and an unknown other medication pill and went home.  Next day: Tongue swelling, arm swollen more Next day treatment: unknown  Third day: Tongue back to numb, redness and swelling around site "oreo-sized" Third day treatment: unknown
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Extreme Exhaustion, headache;, and shivers.  Began about 10 hours after vaccination.  This was the second shingles vaccination.  First one was About 60 days prior.  Zero adverse effects experienced with first vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Hypotension, Pyrexia, Syncope, White blood cell count
Clinical narrative: FevER - Chills - FAiNtNG - Low B.P. HospitALIZAtion - HospitAL 11-11-2020 11-12-2020 11-13-2020 WBC > 38
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure decreased, Loss of consciousness, Myalgia, Platelet count increased, Pyrexia
Clinical narrative: FevER - Chills - FAiNtNG - Low B.P. HospitALIZAtion - HospitAL 11-11-2020 11-12-2020 11-13-2020 WBC > 38
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Sinusitis, White blood cell count increased
Clinical narrative: FevER - Chills - FAiNtNG - Low B.P. HospitALIZAtion - HospitAL 11-11-2020 11-12-2020 11-13-2020 WBC > 38
Sex: U
Vaccine: PNC13
Symptoms: Feeling abnormal, Peripheral swelling, Pyrexia
Clinical narrative: Leg swelling, fever 100 - 101, fussy x 2 days.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Injection site pain, Injection site pruritus, Peripheral swelling
Clinical narrative: Can send you photos if needed - had swelling & redness of the (L) arm that involved 2/3 of the upper extremity - pain & itching at the site. No reaction on right. Started 11/13 and progressed to 11/15 started on prednisone.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Irritability, Pyrexia
Clinical narrative: Fever 100.8 @ 4 hours after shot and repeat 100.4. Cranky / fussy but no site swelling / redness
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines were administered after temperature excursion; This spontaneous report was received from an officer manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 13-NOV-2020, the patients were vaccinated with improperly stored doses of: - measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S001332 has been verified to be a valid lot number, expiration reported as 20-JAN-2021, but upon internal validation established as 14-JAN-2021) albumin status rHA, dose 0.5 ml; - measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T019422 has been verified to be a valid lot number, expiration reported as 20-DEC-2021, but upon internal validation established as 02-DEC-2021, albumin status rHA) dose 0.5 ml; (lot # T016145 has been verified to be a valid lot number, expiration reported as 20-NOV-2021, but upon internal validation established as 07-NOV-2021, dose was not reported); lot # T010288, expiration date 20-SEP-2021, albumin status rHA (dose was not reported); - varicella virus vaccine live (oka/merck) (VARIVAX) lot # T006346, expiration date 20-FEB-2022, dose 0.5 ml; lot # S015460, expiration date 20-MAY-2021 (dose was not reported). All the vaccines were administered for prophylaxis (routes of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 15 to 46 (28.2) degrees Fahrenheit for 8 hours and 20 minutes. Data logger was involved. There were previous excursions reported (unspecified).
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: deep joint pain in a shoulder; two separate patients that received the Pneumovax 23 from the same lot, and they both had intense arm pain beyond what we expect from vaccines; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T016159, expiration date not reported but after lot validation established as: 28-FEB-2022 (dose and route of administration were not reported), administered in deltoid, for prophylaxis.  On an unknown date, the patient experienced intense arm pain beyond what was expected from vaccines and deep joint pain in the shoulder. She was treated with antibiotics but was still complaining of deep joint pain.  The outcome of the event of deep joint pain in shoulder was not recovered/not resolved. The outcome of the event of intense arm pain beyond what was expected from vaccines was unknown. The causal relationship between the events and vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related.  This is one of two cases received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: T016159; expirationdate: 28-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA010012:
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; malaise; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, fever and malaise. On an unknown date, the outcome of the pain in arm, fever and malaise were unknown.   It was unknown if the reporter considered the pain in arm, fever and malaise to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The reporter stated that her babysitter had an adverse reaction to Shingrix. Permission to follow up denied.
Age: 1.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Blood disorder
Clinical narrative: Blood disorder; This case was reported by a consumer via interactive digital media and described the occurrence of blood disorder in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included MMR (MEASLES/MUMPS/RUBELLA) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and MMR (MEASLES/MUMPS/RUBELLA). On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced blood disorder. On an unknown date, the outcome of the blood disorder was unknown.   It was unknown if the reporter considered the blood disorder to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient got a blood disorder after her 12 month flu shot and MMR. This case is one of the 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225504:same reporter US-GLAXOSMITHKLINE-US2020AMR225505:same reporter US-GLAXOSMITHKLINE-US2020AMR225503:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: knot at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site nodule in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In October 2020, less than 2 months after receiving Shingrix, the patient experienced injection site nodule. On an unknown date, the outcome of the injection site nodule was unknown.   It was unknown if the reporter considered the injection site nodule to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experinced little knot trying to form following Shingrix administration.  Sometimes rubbing the area seems to help.  Sometimes when she massages the area it calms down and go down.  Most of these events occurred in the last two weeks. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222240:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: severe shingles on the right side from the neck to the ankle; fever of 103; first dose of the Shingrix vaccine on around 01/2018 / second dose late at around 05/2019; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee replacement.   In January 2018, the patient received the 1st dose of Shingrix. In May 2019, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, fever and drug dose administration interval too long. On an unknown date, the outcome of the shingles, fever and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received first dose of the Shingrix vaccine on around  January 2018  She had to undergo a right knee replacement surgery for a pre-existing condition around December 2018 and two days after the surgery she had severe shingles on the right side from the neck to the ankle with fever of 103 degree F. The second dose received  around May 2019 which led to drug dose administration interval too long.  The reporter did not consent to follow-up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: Diarrhea; Weakness; Muscle pain; Shivering; Headache; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 2nd dose of Shingrix. On 11th November 2020, less than a day after receiving Shingrix, the patient experienced weakness, muscle pain, shivering and headache. On 12th November 2020, the patient experienced diarrhea. On an unknown date, the outcome of the weakness, muscle pain, shivering, headache and diarrhea were unknown.   It was unknown if the reporter considered the weakness, muscle pain, shivering, headache and diarrhea to be related to Shingrix.  Additional information was provided as follows: The patient experienced weakness, muscle pain, shivering, headache and diarrhea after receiving the 2nd dose of Shingrix. No additional information was provided. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: pneumonia; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via social media.  This case involves a female patient (age unspecified) who had pneumonia after she received INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and the patient ended up in the hospital for this event.  The doctor said that he did not wonder patient had got so sick and he did not recommend the flu shot at all. They do make many sick, especially the elderly and those with weakened immune system.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of the event was unknown.  The information on lot number was requested for this case.; Sender's Comments: This poorly documented case from social media concerns a female patient who had pneumonia after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: the vaccine "squirted out" instead of going through the needle with no AE; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient whose vaccine "squirted out" instead of going through the needle (needle issue) with no adverse event, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ471AB and expiration date 30-Jun-2020] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE to an employee and the vaccine "squirted out" instead of going through the needle (needle issue) with no adverse event.   Final diagnosis was needle issue.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Not Applicable.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pustule, Rash erythematous
Clinical narrative: redness on her arm; there was a raised red lump and a fan shaped red rash; there was a raised red lump and a fan shaped red rash; Initial information was received on 21-Oct-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional.  This case involves a female patient who experienced redness on her arm (erythema), there was a raised red lump (mass) and a fan shaped red rash(rash erythematous), after she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included flu shot which the patient received last year and she was tired for four days (Fatigue) and her arm ached (Pain in extremity).  The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via subcutaneous route instead of muscular in an unknown administration site.  On an unknown date, the patient developed a non-serious redness on her arm(erythema), there was a raised red lump (mass) and a fan shaped red rash(rash erythematous) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (latency: unknown).   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for all the events.  There will be no information available on the batch number for this case.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Medical Assistant did not realize that the Pentacel had to be reconstituted and mixed with a powder in order for a complete dose to be received with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information(Reference number- 00345628) and transmitted to Sanofi on 04-Nov-2020.  This case involves a three months old male patient who was administered with the liquid portion (0.5 mL) of the DTAP/IPV DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ224AAA and expiration date 23-Apr-2021) via intramuscular route in the right thigh for prophylactic vaccination on 27-Oct-2020 as the medical assistant did not realize that the vaccine had to be reconstituted and mixed with a powder in order for a complete dose to be received (product preparation issue).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of actual medication error due to inappropriate reconstitution technique (latency on the same day).  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.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Mouth swelling
Clinical narrative: Patient said she started feeling swelling in mouth and was having shortness of breath.  She called her Doctor who prescribed her a steroid.  After 2 days she said the symptoms subsided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: pain and good fourth  of site shows redness and swollen
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Blood calcium normal, Blood chloride normal, Blood cholesterol normal, Blood creatine phosphokinase normal, Blood creatinine normal
Clinical narrative: 78y/o F received Flu Vaccine on 9/17/20. (Pt previously received flu vaccines in 2014, 2015, 2017, 2018 with no note of any reactions). Pt with PMHx notable for HTN, presented to ED on 9/27/20. Symptoms started as soon as she woke up, around 9 AM on the day of presentation. She experienced numbness in the right foot first, then left foot shortly after. Numbness continues to persist and progresses upwards to her legs and thighs. She also reports falling onto her buttocks this morning as she was leaving the house to go to the hospital. She states her legs "just gave out". No head injury, syncope, lightheadedness, or dizziness associated with the fall. No slurred speech, vision changes, urinary or bowel incontinence, or weakness or numbness of upper extremities, or lumbar pain. She states she had the flu vaccination on 9/17 and experienced mild headache and myalgias afterwards, which quickly resolved with Tylenol. No other recent respiratory or gastrointestinal illness. No camping/hiking trips or sick contacts. No fevers/chills, nausea/vomiting, cough, rhinorrhea, shortness of breath, chest pain, abdominal pain, diarrhea, urinary symptoms.  Investigations:  CSF showed 0 WBC with 57 protein.  Non-contrast MRI of the spine showed no acute pathology.   Impression:  Acute onset symmetric sensorimotor neuropathy.  Likely GBS based on the clinical presentation.   -No respiratory involvement this admission, breathing on RA comfortably  -Received 5 days IVIG in hospital By 10/16/20 the patient is back to 95% of baseline.  She has been advised to have no further influenza vaccination.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Blood magnesium normal, Blood phosphorus decreased, Blood potassium normal, Blood sodium normal
Clinical narrative: 78y/o F received Flu Vaccine on 9/17/20. (Pt previously received flu vaccines in 2014, 2015, 2017, 2018 with no note of any reactions). Pt with PMHx notable for HTN, presented to ED on 9/27/20. Symptoms started as soon as she woke up, around 9 AM on the day of presentation. She experienced numbness in the right foot first, then left foot shortly after. Numbness continues to persist and progresses upwards to her legs and thighs. She also reports falling onto her buttocks this morning as she was leaving the house to go to the hospital. She states her legs "just gave out". No head injury, syncope, lightheadedness, or dizziness associated with the fall. No slurred speech, vision changes, urinary or bowel incontinence, or weakness or numbness of upper extremities, or lumbar pain. She states she had the flu vaccination on 9/17 and experienced mild headache and myalgias afterwards, which quickly resolved with Tylenol. No other recent respiratory or gastrointestinal illness. No camping/hiking trips or sick contacts. No fevers/chills, nausea/vomiting, cough, rhinorrhea, shortness of breath, chest pain, abdominal pain, diarrhea, urinary symptoms.  Investigations:  CSF showed 0 WBC with 57 protein.  Non-contrast MRI of the spine showed no acute pathology.   Impression:  Acute onset symmetric sensorimotor neuropathy.  Likely GBS based on the clinical presentation.   -No respiratory involvement this admission, breathing on RA comfortably  -Received 5 days IVIG in hospital By 10/16/20 the patient is back to 95% of baseline.  She has been advised to have no further influenza vaccination.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Blood thyroid stimulating hormone decreased, Blood triglycerides increased, Blood urea normal, Buttock injury, CSF glucose normal
Clinical narrative: 78y/o F received Flu Vaccine on 9/17/20. (Pt previously received flu vaccines in 2014, 2015, 2017, 2018 with no note of any reactions). Pt with PMHx notable for HTN, presented to ED on 9/27/20. Symptoms started as soon as she woke up, around 9 AM on the day of presentation. She experienced numbness in the right foot first, then left foot shortly after. Numbness continues to persist and progresses upwards to her legs and thighs. She also reports falling onto her buttocks this morning as she was leaving the house to go to the hospital. She states her legs "just gave out". No head injury, syncope, lightheadedness, or dizziness associated with the fall. No slurred speech, vision changes, urinary or bowel incontinence, or weakness or numbness of upper extremities, or lumbar pain. She states she had the flu vaccination on 9/17 and experienced mild headache and myalgias afterwards, which quickly resolved with Tylenol. No other recent respiratory or gastrointestinal illness. No camping/hiking trips or sick contacts. No fevers/chills, nausea/vomiting, cough, rhinorrhea, shortness of breath, chest pain, abdominal pain, diarrhea, urinary symptoms.  Investigations:  CSF showed 0 WBC with 57 protein.  Non-contrast MRI of the spine showed no acute pathology.   Impression:  Acute onset symmetric sensorimotor neuropathy.  Likely GBS based on the clinical presentation.   -No respiratory involvement this admission, breathing on RA comfortably  -Received 5 days IVIG in hospital By 10/16/20 the patient is back to 95% of baseline.  She has been advised to have no further influenza vaccination.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: CSF protein increased, CSF white blood cell count negative, Carbon dioxide normal, Computerised tomogram head normal, Fall
Clinical narrative: 78y/o F received Flu Vaccine on 9/17/20. (Pt previously received flu vaccines in 2014, 2015, 2017, 2018 with no note of any reactions). Pt with PMHx notable for HTN, presented to ED on 9/27/20. Symptoms started as soon as she woke up, around 9 AM on the day of presentation. She experienced numbness in the right foot first, then left foot shortly after. Numbness continues to persist and progresses upwards to her legs and thighs. She also reports falling onto her buttocks this morning as she was leaving the house to go to the hospital. She states her legs "just gave out". No head injury, syncope, lightheadedness, or dizziness associated with the fall. No slurred speech, vision changes, urinary or bowel incontinence, or weakness or numbness of upper extremities, or lumbar pain. She states she had the flu vaccination on 9/17 and experienced mild headache and myalgias afterwards, which quickly resolved with Tylenol. No other recent respiratory or gastrointestinal illness. No camping/hiking trips or sick contacts. No fevers/chills, nausea/vomiting, cough, rhinorrhea, shortness of breath, chest pain, abdominal pain, diarrhea, urinary symptoms.  Investigations:  CSF showed 0 WBC with 57 protein.  Non-contrast MRI of the spine showed no acute pathology.   Impression:  Acute onset symmetric sensorimotor neuropathy.  Likely GBS based on the clinical presentation.   -No respiratory involvement this admission, breathing on RA comfortably  -Received 5 days IVIG in hospital By 10/16/20 the patient is back to 95% of baseline.  She has been advised to have no further influenza vaccination.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Glycosylated haemoglobin normal, Guillain-Barre syndrome, Haematocrit normal, Haematuria, Haemoglobin normal
Clinical narrative: 78y/o F received Flu Vaccine on 9/17/20. (Pt previously received flu vaccines in 2014, 2015, 2017, 2018 with no note of any reactions). Pt with PMHx notable for HTN, presented to ED on 9/27/20. Symptoms started as soon as she woke up, around 9 AM on the day of presentation. She experienced numbness in the right foot first, then left foot shortly after. Numbness continues to persist and progresses upwards to her legs and thighs. She also reports falling onto her buttocks this morning as she was leaving the house to go to the hospital. She states her legs "just gave out". No head injury, syncope, lightheadedness, or dizziness associated with the fall. No slurred speech, vision changes, urinary or bowel incontinence, or weakness or numbness of upper extremities, or lumbar pain. She states she had the flu vaccination on 9/17 and experienced mild headache and myalgias afterwards, which quickly resolved with Tylenol. No other recent respiratory or gastrointestinal illness. No camping/hiking trips or sick contacts. No fevers/chills, nausea/vomiting, cough, rhinorrhea, shortness of breath, chest pain, abdominal pain, diarrhea, urinary symptoms.  Investigations:  CSF showed 0 WBC with 57 protein.  Non-contrast MRI of the spine showed no acute pathology.   Impression:  Acute onset symmetric sensorimotor neuropathy.  Likely GBS based on the clinical presentation.   -No respiratory involvement this admission, breathing on RA comfortably  -Received 5 days IVIG in hospital By 10/16/20 the patient is back to 95% of baseline.  She has been advised to have no further influenza vaccination.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, High density lipoprotein normal, Hypertensive urgency, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: 78y/o F received Flu Vaccine on 9/17/20. (Pt previously received flu vaccines in 2014, 2015, 2017, 2018 with no note of any reactions). Pt with PMHx notable for HTN, presented to ED on 9/27/20. Symptoms started as soon as she woke up, around 9 AM on the day of presentation. She experienced numbness in the right foot first, then left foot shortly after. Numbness continues to persist and progresses upwards to her legs and thighs. She also reports falling onto her buttocks this morning as she was leaving the house to go to the hospital. She states her legs "just gave out". No head injury, syncope, lightheadedness, or dizziness associated with the fall. No slurred speech, vision changes, urinary or bowel incontinence, or weakness or numbness of upper extremities, or lumbar pain. She states she had the flu vaccination on 9/17 and experienced mild headache and myalgias afterwards, which quickly resolved with Tylenol. No other recent respiratory or gastrointestinal illness. No camping/hiking trips or sick contacts. No fevers/chills, nausea/vomiting, cough, rhinorrhea, shortness of breath, chest pain, abdominal pain, diarrhea, urinary symptoms.  Investigations:  CSF showed 0 WBC with 57 protein.  Non-contrast MRI of the spine showed no acute pathology.   Impression:  Acute onset symmetric sensorimotor neuropathy.  Likely GBS based on the clinical presentation.   -No respiratory involvement this admission, breathing on RA comfortably  -Received 5 days IVIG in hospital By 10/16/20 the patient is back to 95% of baseline.  She has been advised to have no further influenza vaccination.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Low density lipoprotein normal, Magnetic resonance imaging spinal normal, Mean cell volume normal, Muscular weakness, Myalgia
Clinical narrative: 78y/o F received Flu Vaccine on 9/17/20. (Pt previously received flu vaccines in 2014, 2015, 2017, 2018 with no note of any reactions). Pt with PMHx notable for HTN, presented to ED on 9/27/20. Symptoms started as soon as she woke up, around 9 AM on the day of presentation. She experienced numbness in the right foot first, then left foot shortly after. Numbness continues to persist and progresses upwards to her legs and thighs. She also reports falling onto her buttocks this morning as she was leaving the house to go to the hospital. She states her legs "just gave out". No head injury, syncope, lightheadedness, or dizziness associated with the fall. No slurred speech, vision changes, urinary or bowel incontinence, or weakness or numbness of upper extremities, or lumbar pain. She states she had the flu vaccination on 9/17 and experienced mild headache and myalgias afterwards, which quickly resolved with Tylenol. No other recent respiratory or gastrointestinal illness. No camping/hiking trips or sick contacts. No fevers/chills, nausea/vomiting, cough, rhinorrhea, shortness of breath, chest pain, abdominal pain, diarrhea, urinary symptoms.  Investigations:  CSF showed 0 WBC with 57 protein.  Non-contrast MRI of the spine showed no acute pathology.   Impression:  Acute onset symmetric sensorimotor neuropathy.  Likely GBS based on the clinical presentation.   -No respiratory involvement this admission, breathing on RA comfortably  -Received 5 days IVIG in hospital By 10/16/20 the patient is back to 95% of baseline.  She has been advised to have no further influenza vaccination.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Nitrite urine absent, Peripheral sensorimotor neuropathy, Platelet count increased, Urine analysis abnormal, Urine leukocyte esterase
Clinical narrative: 78y/o F received Flu Vaccine on 9/17/20. (Pt previously received flu vaccines in 2014, 2015, 2017, 2018 with no note of any reactions). Pt with PMHx notable for HTN, presented to ED on 9/27/20. Symptoms started as soon as she woke up, around 9 AM on the day of presentation. She experienced numbness in the right foot first, then left foot shortly after. Numbness continues to persist and progresses upwards to her legs and thighs. She also reports falling onto her buttocks this morning as she was leaving the house to go to the hospital. She states her legs "just gave out". No head injury, syncope, lightheadedness, or dizziness associated with the fall. No slurred speech, vision changes, urinary or bowel incontinence, or weakness or numbness of upper extremities, or lumbar pain. She states she had the flu vaccination on 9/17 and experienced mild headache and myalgias afterwards, which quickly resolved with Tylenol. No other recent respiratory or gastrointestinal illness. No camping/hiking trips or sick contacts. No fevers/chills, nausea/vomiting, cough, rhinorrhea, shortness of breath, chest pain, abdominal pain, diarrhea, urinary symptoms.  Investigations:  CSF showed 0 WBC with 57 protein.  Non-contrast MRI of the spine showed no acute pathology.   Impression:  Acute onset symmetric sensorimotor neuropathy.  Likely GBS based on the clinical presentation.   -No respiratory involvement this admission, breathing on RA comfortably  -Received 5 days IVIG in hospital By 10/16/20 the patient is back to 95% of baseline.  She has been advised to have no further influenza vaccination.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: White blood cell count increased
Clinical narrative: 78y/o F received Flu Vaccine on 9/17/20. (Pt previously received flu vaccines in 2014, 2015, 2017, 2018 with no note of any reactions). Pt with PMHx notable for HTN, presented to ED on 9/27/20. Symptoms started as soon as she woke up, around 9 AM on the day of presentation. She experienced numbness in the right foot first, then left foot shortly after. Numbness continues to persist and progresses upwards to her legs and thighs. She also reports falling onto her buttocks this morning as she was leaving the house to go to the hospital. She states her legs "just gave out". No head injury, syncope, lightheadedness, or dizziness associated with the fall. No slurred speech, vision changes, urinary or bowel incontinence, or weakness or numbness of upper extremities, or lumbar pain. She states she had the flu vaccination on 9/17 and experienced mild headache and myalgias afterwards, which quickly resolved with Tylenol. No other recent respiratory or gastrointestinal illness. No camping/hiking trips or sick contacts. No fevers/chills, nausea/vomiting, cough, rhinorrhea, shortness of breath, chest pain, abdominal pain, diarrhea, urinary symptoms.  Investigations:  CSF showed 0 WBC with 57 protein.  Non-contrast MRI of the spine showed no acute pathology.   Impression:  Acute onset symmetric sensorimotor neuropathy.  Likely GBS based on the clinical presentation.   -No respiratory involvement this admission, breathing on RA comfortably  -Received 5 days IVIG in hospital By 10/16/20 the patient is back to 95% of baseline.  She has been advised to have no further influenza vaccination.
Age: 34.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Arthralgia, Arthritis, Erythema, Feeling abnormal, Impaired work ability
Clinical narrative: The first sign I noticed was severe and ?brain fog?.  After that my joints and tendons became red, swollen, inflamed and it had become too painful for me to perform my jobs at work. I took a 6 day round of prednisone and once I finished taking the steroids the inflammation returned and it has spread to my elbows. My elbows are in pain and they are dark red. I also see some inflammation in my knees and few and there is some redness.
Age: 34.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Joint swelling, Laboratory test abnormal, Monocyte count increased
Clinical narrative: The first sign I noticed was severe and ?brain fog?.  After that my joints and tendons became red, swollen, inflamed and it had become too painful for me to perform my jobs at work. I took a 6 day round of prednisone and once I finished taking the steroids the inflammation returned and it has spread to my elbows. My elbows are in pain and they are dark red. I also see some inflammation in my knees and few and there is some redness.
Age: 46.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: it's been Hot to the touch for 3 days, on my left upper arm - its  elevated, tender and rock hard
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Patient states he has had periodic pain that sometimes will radiate down arm.  He has stated that he gets shooting pain if he raises his arm up in certain directions.  He was asked about the area and he described it as normal coloration but is sensitive to touch and pressure.  He started getting more concerned as pain sometimes radiates to neck area.  He said it started out at just typical soreness but has gotten worse over the last 2+ months.  He has not been seen by a medical professional as of day of reporting (11/17/20).  We suggested that it be evaluated for potential treatment.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching in left arm, chest, and both hands. Pt states SX started @2130 on 17NOV2020
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Dyspnoea, Erythema, Eye disorder, Injection site erythema, Injection site swelling
Clinical narrative: Injection at 2:11p,m Home at 2:15pm Noticed quick onset of redness, fever at 225pm Tylenol given at 230pm Generalized redness: face, chest, abdomen:  Facial Swelling more pronounced could barely open eyes: 2:56pm Injection site  Left leg very swollen and red to the point that pants were tight almost couldn't remove Headed to E.R. 3:02pm Hives/Shortness of Breath 3:10pm Registered/Triaged in the ER at 3:25pm  Epi given at 3:45 (roughly) Patient was put under observation and symptoms started to subside at 5p.m. Patient was discharged at 823 p.m
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Pyrexia, Swelling face, Urticaria
Clinical narrative: Injection at 2:11p,m Home at 2:15pm Noticed quick onset of redness, fever at 225pm Tylenol given at 230pm Generalized redness: face, chest, abdomen:  Facial Swelling more pronounced could barely open eyes: 2:56pm Injection site  Left leg very swollen and red to the point that pants were tight almost couldn't remove Headed to E.R. 3:02pm Hives/Shortness of Breath 3:10pm Registered/Triaged in the ER at 3:25pm  Epi given at 3:45 (roughly) Patient was put under observation and symptoms started to subside at 5p.m. Patient was discharged at 823 p.m
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Anaphylactic reaction, Erythema, Throat tightness, Tongue discolouration, Urticaria
Clinical narrative: Injection at 2:11p,m Home at 2:15pm Noticed quick onset of redness, fever at 225pm Tylenol given at 230pm Generalized redness: face, chest, abdomen:  Facial Swelling more pronounced could barely open eyes: 2:56pm Injection site  Left leg very swollen and red to the point that pants were tight almost couldn't remove Headed to E.R. 3:02pm Hives/Shortness of Breath 3:10pm Registered/Triaged in the ER at 3:25pm  Epi given at 3:45 (roughly) Patient was put under observation and symptoms started to subside at 5p.m. Patient was discharged at 823 p.m
Age: 0.5
Sex: M
Vaccine: RV1
Symptoms: Abnormal behaviour, Dyspnoea, Lethargy, Vomiting
Clinical narrative: Threw up twice in his sleep, trouble breathing and so lethargic we could barely wake him out of his vomit, he is an otherwise hard to get to sleep baby and his behavior was left field.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: no additional adverse events; nurse administered an expired ROTATEQ to a 6-month-old patient; This spontaneous report as received from a licensed vocational nurse refers to a 6 month old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On 27-OCT-2020, the patient was inadvertently administered an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # S001101 has been verified to be a valid lot number, expiration date: 21-OCT-2020, dose not reported). No additional adverse events were reported.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Intensive care, Mechanical ventilation, Paralysis, Pneumonia bacterial
Clinical narrative: Guillain Barre syndrome (GBS); Patient was paralyzed; On a ventalator and had a trach put in he developed septic pneumonia; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a consumer or non-health care professional (patient's brother) via social media.  This case involves male patient (age unspecified) who experienced Guillain barre syndrome (GBS) (Guillain-barre syndrome) who was paralyzed (paralysis) and on a ventilator and had a trach put in he developed septic pneumonia (pneumonia bacterial), while he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain barre syndrome (GBS) (Guillain-barre syndrome), paralyzed (paralysis) and on a ventilator and had a trach put in he developed septic pneumonia (pneumonia bacterial), (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant and life-threatening. The patient was hospitalized for these events.  It was reported that which Guillain-barre syndrome attacks the nerves and patient was in intensive care unit (ICU) for 6 weeks.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Event outcome was unknown for all reported events.  There will be no information available on batch number for this case.; Sender's Comments: This case concern social media case which involves a male patient (age unspecified) who presented with Guillain-barre syndrome, paralysis and pneumonia bacterial after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations and other alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Sepsis, Tracheostomy
Clinical narrative: Guillain Barre syndrome (GBS); Patient was paralyzed; On a ventalator and had a trach put in he developed septic pneumonia; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a consumer or non-health care professional (patient's brother) via social media.  This case involves male patient (age unspecified) who experienced Guillain barre syndrome (GBS) (Guillain-barre syndrome) who was paralyzed (paralysis) and on a ventilator and had a trach put in he developed septic pneumonia (pneumonia bacterial), while he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain barre syndrome (GBS) (Guillain-barre syndrome), paralyzed (paralysis) and on a ventilator and had a trach put in he developed septic pneumonia (pneumonia bacterial), (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant and life-threatening. The patient was hospitalized for these events.  It was reported that which Guillain-barre syndrome attacks the nerves and patient was in intensive care unit (ICU) for 6 weeks.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Event outcome was unknown for all reported events.  There will be no information available on batch number for this case.; Sender's Comments: This case concern social media case which involves a male patient (age unspecified) who presented with Guillain-barre syndrome, paralysis and pneumonia bacterial after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations and other alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.