chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Blood urine absent, C-reactive protein normal, CSF glucose normal, CSF protein decreased, Calcium ionised normal
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Carbon dioxide normal, Chromaturia, Computerised tomogram head normal, Gait inability, Glucose urine absent
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Haematocrit normal, Haemoglobin normal, Hypotonia, Irritability, Lethargy
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Lymphocyte count normal, Lymphocyte percentage increased, Magnetic resonance imaging brain normal, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Mean cell volume decreased, Mean platelet volume normal, Neutrophil count normal, Neutrophil percentage decreased, Nitrite urine absent
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: PCO2 decreased, PO2 increased, Platelet count increased, Posture abnormal, Protein total normal
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Protein urine absent, Red blood cell count normal, Red cell distribution width increased, Scan with contrast normal, Specific gravity urine normal
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Urine bilirubin decreased, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, White blood cell count normal
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: pH urine normal
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 35.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Syncope
Clinical narrative: Within one minute of receiving vaccines I fainted for 1-5 seconds. I responded to the nurse practitioner trying to wake me and within another minute fainted again. I responded to her a second time and was able to regain consciousness.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site pruritus
Clinical narrative: patient had flu shot on 10-14-19 --patient states a day or 2 later her arm became itchy and she started scratching it.  A large area on her arm became black and blue--it extended from the shot down to the elbow.  I advised her to call her doctor to let them know what happened and I advised her she should be seen by physician today.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, redness, swelling approximately 3 inches wide and 4 inches long distal to injection site.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site cellulitis, Injection site reaction, Skin warm, Tenderness
Clinical narrative: patient had a large red area of erythema, warm and tenderness, spreading down arm, on lateral and medial site for several days past injection. Shingrix and Pneumovax administered in the same arm
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patients parent sent a picture of the patients arm 12 hours after it was given.  Arm was swollen from the injection site to the elbow and very red.  Pictures sent the following day after the vaccine showed noticeable improvement in the redness and swelling. Patients mother denies any fever or respiratory symptoms
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Influenza like illness, Laboratory test, Muscle spasms, Muscular weakness
Clinical narrative: per patient statement: severe flu-like sx's, severe back muscle spasms, left leg (entire leg) numbness and weakness
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: SWELLING IN ARM, REDNESS AND WARM TO THE TOUCH. MAY BE CELLULITIS AND PATIENT WILL SEEK MEDICAL TREATMENT
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient wife called pharmacy to report patient had a painful rash about 2-3 inches under arm that started at patients armpit and came around to the top of his arm. Patient reported that it was not swollen and started the day after the injection was given. Patient called back 3 days later to report that the rash had started to go down.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Neck pain, Sleep disorder
Clinical narrative: patient had tenderness by the time he got home, then increase in dull aching pain from the elbow to left side of his neck. Patient tried tylenol every 4 hours to help with pain.  He tried a heating pad and this did not help. Patient having to sleep on back instead of left side due to pain, so he has not been sleeping well. Pain has been interfering with doing things.  Patient had some soft tissue firness in 2 places in his left upper arm.  Patient instructed to take tylenol arthritis 2 tablets every 8 hours or just twice a day. Patient to apply cold packs to left upper arm for at lease 30 minutes every 2 hours while awake.
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus
Clinical narrative: patient developed all over itching with no hives 1 hour after vaccine was given
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in jaw
Clinical narrative: Exp date June 30, 2020. Complaint of R. Jaw pain, moderate to severe.  Aleve and topical heat for treatment. Resolved to mild discomfort after one week
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis in Left Arm after injection of vaccine
Age: 42.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt received the 1st dose of varivax and 2nd dose of MMR less than 28 days from pts first dose of MMR ( live).  PT has not reported any adverse events however the timing was less than 28 days and the shots will need to be redone per ACIP recommendations.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia
Clinical narrative: exquisite muscle pain associated with some loss of strength in legs; tx with 600 mg ibuprofen q 6 hours in 1st 24 hours, then q 8 hours next day
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal ulcer, Oral herpes
Clinical narrative: Patient states that she has begun to experience sores in the inside of her nose. This is her second shot and during the first one she also got very sick (nausea  and vomiting)  and she thinks the cold sores with her second shot may be related to Shingrix. Researched in Clinical Pharmacology and no previous reports. Referred patient to contact her Rheumatologist or her PCP.
Age: 73.0
Sex: F
Vaccine: FLUR4
Symptoms: Irritability, Mood swings, Peripheral swelling, Skin reaction
Clinical narrative: Patient's left arm became red and swollen approximately softball diameter size.  Also, patient had mood swing (became irritable and is still showing signs almost a week later).
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects noted; Improperly stored VARIVAX; Information has been received from a medical assistant referring to a female patient of unknown age. Information about concurrent condition and medical history was not provided. Concomitant therapies included properly stored sterile diluent.  On 30-SEP-2019, the patient was vaccinated with improperly stored (temperature: -12.3 degree Celsius. Time frame: 6.05 hours) varicella virus vaccine live (Oka/Merck)  (VARIVAX) (lot#S011951, expiration date reported as 16-APR-2019 but upon internal review determined to be 16-APR-2021; strength, dose, frequency, route were not reported) for prophylaxis. No adverse effects were noted. There was no previous temperature excursion.  This one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1910USA007211: US-009507513-1910USA007203: US-009507513-1910USA007189: US-009507513-1910USA007200: US-009507513-1910USA007348: US-009507513-1910USA007375:
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored doses administered; no adverse event; This spontaneous report has been received from a Health Care Professional concerning to a 13-years-old male patient.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 24-SEP-2019, the patient received a improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (albumin status of recombinant human albumin (rHA) (M-M-R II) (dose number, dose and anatomical location were not reported) intramuscularly for prophylaxis (lot#: R028382, expiration date: 10-MAR-2020) (product storage error). The temperature excursion was due to a data logger. No adverse events were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Patient reports she received the shingles vaccine a few days ago and had a reaction to it. she states she has loose bowel movements and felt very fatigued.; Patient reports she received the shingles vaccine a few days ago and had a reaction to it. she states she has loose bowel movements and felt very fatigued.; Patient reports she received the shingles vaccine a few days ago and had a reaction to it. she states she has loose bowel movements and felt very fatigued.; This spontaneous report was received from a consumer through Agency via pharmacy refers to a female patient of approximately 83 years old. The patient's concurrent condition and medical history were unknown. The patient's concomitant therapy included rivaroxaban (XARELTO). On an unknown date in 2019 (reported as a few days ago), the patient was vaccinated with varicella virus vaccine live (oka/merck) (Manufacturer Unknown) (dose, frequency, anatomical location, lot # and expiration date unknown) for prophylaxis. On an unknown date in 2019, the patient had reaction to it (vaccination complication). The patient also stated that she experienced loose bowel movements (diarrhea) and felt very fatigued. The outcome of vaccination complication, diarrhea and fatigue was reported as unknown (It was also reported that the patient was finally feeling better on 17-OCT-2019). The causal relationship of the events with varicella virus vaccine live (oka/merck) (Manufacturer Unknown) was not provided.
Sex: U
Vaccine: DTAPIPVHIB, FLUX, HEPA, PNC13
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient was supposed to receive hepatitis A and influenza vaccines. Instead, a flu shot was given along with Pentacel and Prevnar 13. / no AE; The patient received the fourth dose of Pentacel on 01Jul2019. The dose that was given in error today was therefore an extra dose/ no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 18-month-old patient who was supposed to receive HEPATITIS A VACCINE and INFLUENZA VACCINEs Instead, a flu shot was given along with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVNAR 13] (lot number, exp date, dosing details not reported on 03-Oct-2019.  Past vaccination included fourth dose of Pentacel on 01Jul2019.   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 wrong vaccine administered and extra dose administered.   It was reported that The patient had received the fourth dose of Pentacel . The dose that was given in error today was therefore an extra dose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX, UNK
Symptoms: Pain in extremity
Clinical narrative: arm still feels sore; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown demographics, who experienced arm still feels sore (pain in extremity), while he/she received vaccine INFLUENZA VACCINE and while treated with TOFACITINIB CITRATE [XELJANZ XR].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started taking XELJANZ XR (TOFACITINIB CITRATE) 11 mg (with an unknown batch number).   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient's arm still felt sore (pain in extremity) (Unknown latency) following the administration of INFLUENZA VACCINE and TOFACITINIB CITRATE.  It was reported that he was not experiencing any other symptoms such as weakness, malaise, fever, flu like symptoms, advised the patient to report the soreness to the pharmacy where the vaccine was administered as well as his doctor if the pain does not improve in a few days, patient stated he was still able to exercise and has range of motion, no bruising or swelling.  Lab data was not reported.  Final diagnosis was pain in extremity.   It was not reported if the patient received a corrective treatment.  Action taken with TOFACITINIB CITRATE (XELJANZ XR) was not reported.  The patient outcome was reported as not recovered for pain in extremity (still very sore).  There will be no information available on the batch number for this case.  List of documents held by the sender: none
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublok vaccine to her 13 year old child/no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 11-year-old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number QFAA1905 via unknown route.  It was of actual medication error case due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  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.
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13 years old received Flublok immunization/no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA287209 (same reporter).  This case involves 13-year-old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  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 QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route.  It was of actual medication error case due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  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.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 other children received Flublok immunization/no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA287163 (same reporter).  This case involves two Child patients who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  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 QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route.  It was of actual medication error case due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  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.
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: diagnosed with cellulitis; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was tender; some local reaction/all the way from shoulder to elbow; Initial information received on 17-Oct-2019 regarding an unsolicited valid serious case received from a physician.  This case involves a 4 years old male patient who experienced diagnosed with cellulitis (cellulitis), while he received vaccine 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 MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) in the right arm.  On 15-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ269AA via intramuscular route in the left arm.  On 15-Oct-2019, The patient developed a serious diagnosed with cellulitis (cellulitis) along with associated symptoms little local reaction but by the morning the arm was red, swollen, hot, tender (vaccination site inflammation, vaccination site erythema, vaccination site swelling, vaccination site pain, vaccination site warmth), some local reaction/all the way from shoulder to elbow (skin reaction) same day following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. These events were assessed as medically significant.  Patient required visit to physician office on 16-Oct-2019.  Final diagnosis was diagnosed with cellulitis.   The patient was treated with CEFALEXIN SODIUM (CEPHALEXIN [CEFALEXIN SODIUM]) orally.  The patient outcome is reported as Recovering / Resolving for the events; Sender's Comments: Patient was diagnosed with cellulitis same day after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: diagnosed with cellulitis; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was tender; some local reaction/all the way from shoulder to elbow; Initial information received on 17-Oct-2019 regarding an unsolicited valid serious case received from a physician.  This case involves a 4 years old male patient who experienced diagnosed with cellulitis (cellulitis), while he received vaccine 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 MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) in the right arm.  On 15-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ269AA via intramuscular route in the left arm.  On 15-Oct-2019, The patient developed a serious diagnosed with cellulitis (cellulitis) along with associated symptoms little local reaction but by the morning the arm was red, swollen, hot, tender (vaccination site inflammation, vaccination site erythema, vaccination site swelling, vaccination site pain, vaccination site warmth), some local reaction/all the way from shoulder to elbow (skin reaction) same day following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. These events were assessed as medically significant.  Patient required visit to physician office on 16-Oct-2019.  Final diagnosis was diagnosed with cellulitis.   The patient was treated with CEFALEXIN SODIUM (CEPHALEXIN [CEFALEXIN SODIUM]) orally.  The patient outcome is reported as Recovering / Resolving for the events; Sender's Comments: Patient was diagnosed with cellulitis same day after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Patient complains of a "lump" on her arm after administration of the flu vaccine - distal to the deltoid where the vaccine was confirmed to be administered. Called the manufacturer, common "induration" site reaction, although may not be related because of the location. Video footage shows proper administration.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Angiogram, Chest X-ray, Electrocardiogram, Erythema, Fibrin D dimer increased
Clinical narrative: Redness, warmth, pain, swelling from LEFT lateral neck to wrist. Significant pain in arm. Palpitations.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Pain in extremity, Palpitations, Skin warm, Swelling
Clinical narrative: Redness, warmth, pain, swelling from LEFT lateral neck to wrist. Significant pain in arm. Palpitations.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound Doppler
Clinical narrative: Redness, warmth, pain, swelling from LEFT lateral neck to wrist. Significant pain in arm. Palpitations.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise, Myalgia
Clinical narrative: Morning after vaccination patient noticed swelling and redness in the area of the injection site.  Red area became the diameter of a baseball 3-4 inches around. Red area still apparent 4 days after vaccination although patient reports it has gotten better. Patient reported normal reaction: Malaise/muscle aches the day after but that didn't persist beyond 24 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Patient c/o chills, body aches, low grade fever and nausea. Symptoms treated with Tylenol and warm compress.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Discomfort, Injection site erythema, Injection site swelling, Pain
Clinical narrative: red, swollen are around injection site. swelling spread all the way down the arm. Skin blistered and peeled off on that arm as well. Pain and discomfort lasted 3 weeks according to the patient
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin exfoliation
Clinical narrative: red, swollen are around injection site. swelling spread all the way down the arm. Skin blistered and peeled off on that arm as well. Pain and discomfort lasted 3 weeks according to the patient
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Joint stiffness, Pain in jaw
Clinical narrative: 10 minutes after receiving vaccine felt jaw pain and tightening to the point patient could not open her mouth.  At that time,  patient took liquid Benadryl, one teaspoon .  Slowly symptoms began to subside.  Patient began to manually open and close her jaw.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Infantile spitting up, Injection site erythema, Injection site pain, Irritability
Clinical narrative: fussiness and flailing abut as in pain Left thigh  erythema beyond injection site spitting up
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: PATIENT CLAIMS ENTIRE LEFT UPPER ARM RED AND SWOLLEN, FEVER/CHILLS, NAUSEA, HEADACHE, AND NUMBNESS IN HER LEFT THIGH
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: PATIENT CLAIMS ENTIRE LEFT UPPER ARM RED AND SWOLLEN, FEVER/CHILLS, NAUSEA, HEADACHE, AND NUMBNESS IN HER LEFT THIGH
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Insomnia, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Injection was very painful; unusual   The injection was given Too high on the arm into the rotator cuff As the days went on the pain got much worse.   Pain down arm, shoulder and into clavicle area   Can't sleep at night due to severe pain.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Injection was very painful; unusual   The injection was given Too high on the arm into the rotator cuff As the days went on the pain got much worse.   Pain down arm, shoulder and into clavicle area   Can't sleep at night due to severe pain.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chest pain, Immediate post-injection reaction, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Injection was very painful; unusual   The injection was given Too high on the arm into the rotator cuff As the days went on the pain got much worse.   Pain down arm, shoulder and into clavicle area   Can't sleep at night due to severe pain.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Insomnia, Joint range of motion decreased, Pain, Pain in extremity, Radiculopathy
Clinical narrative: Injection was very painful; unusual   The injection was given Too high on the arm into the rotator cuff As the days went on the pain got much worse.   Pain down arm, shoulder and into clavicle area   Can't sleep at night due to severe pain.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Insomnia, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient experienced pain in the upper arm and shoulder that began immediately at the time of immunization. She is currently still experiencing pain in the shoulder that radiates to the upper chest and down the arm. She is experiencing limited range of motion and difficulty sleeping due to the pain. She was seen at an urgent care facility on 10/18/19 and it was determined that swelling was present in her shoulder causing nerve impingement and was prescribed a prednisone taper and meloxicam.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient experienced pain in the upper arm and shoulder that began immediately at the time of immunization. She is currently still experiencing pain in the shoulder that radiates to the upper chest and down the arm. She is experiencing limited range of motion and difficulty sleeping due to the pain. She was seen at an urgent care facility on 10/18/19 and it was determined that swelling was present in her shoulder causing nerve impingement and was prescribed a prednisone taper and meloxicam.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chest pain, Immediate post-injection reaction, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient experienced pain in the upper arm and shoulder that began immediately at the time of immunization. She is currently still experiencing pain in the shoulder that radiates to the upper chest and down the arm. She is experiencing limited range of motion and difficulty sleeping due to the pain. She was seen at an urgent care facility on 10/18/19 and it was determined that swelling was present in her shoulder causing nerve impingement and was prescribed a prednisone taper and meloxicam.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Insomnia, Joint range of motion decreased, Pain, Pain in extremity, Radiculopathy
Clinical narrative: Patient experienced pain in the upper arm and shoulder that began immediately at the time of immunization. She is currently still experiencing pain in the shoulder that radiates to the upper chest and down the arm. She is experiencing limited range of motion and difficulty sleeping due to the pain. She was seen at an urgent care facility on 10/18/19 and it was determined that swelling was present in her shoulder causing nerve impingement and was prescribed a prednisone taper and meloxicam.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: fever 100.2 chills fatigue nasusea
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Myalgia
Clinical narrative: Patient stated about 4 to 5 days after getting flu shot- she woke up to shoulder pain. Up until that point, she stated she experienced the usual muscle soreness associated with a shot.  Over the last couple of days, the pain has worsened. She also states it's hard to move her arm from the elbow up to the shoulder, with limited range of motion
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient's left upper arm (lower deltoid to elbow region) was all red and inflamed.  Patient brought to pharmacy's attention on 10/19/19 and was advised to visit urgent care.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Joint range of motion decreased, Musculoskeletal pain, Product administered at inappropriate site, Tendonitis
Clinical narrative: (Vaccine was not injected in the correct area of the deltoid of left arm)Shoulder pain and limited range of motion within one hour of vaccine and continues today.  I have been to the doctor three times and was told bursitis and tendinitis. I have been prescribed Celebrex, Voltaren Gel,  received a steroid injection, and physical therapy at home. It has been 20 days since vaccine and have had very little improvement in shoulder pain and range of motion.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion
Clinical narrative: Patient received immunization on 10/10. Returned to pharmacy with bruising on upper left arm about 6-8 inches. Complained about administration. Patient addressed with MD who told her vessel hit creating pooling downward due to gravity. Patient came in on 10/18 and area should major improvement.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: PATIENT STATES THAT HE FEELS THAT HIS BLOOD PRESSURE IS UP AND HE IS DIZZY SINCE GETTING THIS
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 62 years of age and received fluzone HD dose (65+)
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Patient states she had muscle spasms in her right arm, at flu vaccine injection site,  on 10-20 and 10-21-19, and was unsure if related to getting the flu vaccine on 10-17-19.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Pain in extremity
Clinical narrative: Pt reports unusual pain in arm and bruising.
Age: 83.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Fatigue, Injection site swelling, Skin warm
Clinical narrative: Patient states day of vaccination she had severe swelling (like a knot) form at the site of injection shortly after receiving the flublok in her left arm.  Over the course of the next few days she had severe swelling (the size of a lemon) on her arm with severe redness and it was very hot to the touch. She denied running a fever, but did state she was very tired overall.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Mom came in to speak  about the situation. Mom thinks the shot was given to high. Pt has been using ice and ibuprofen.  Pt is have some soreness in the arm.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Blood immunoglobulin A increased, Clostridium test, Dysarthria, Dysphagia
Clinical narrative: Seen in ER on 10/14/2019 for two days of weakness, slurred speech,  difficulty swallowing, and numbness and tingling to extremities bilaterally. Back in ER on 10/19/2019 progressive weakness, trouble swallowing, arm weakness and feels as though it is progressing to legs, and SOB. Client was intubated. 20G of IVIG was administered 10/19/2019. Client was transferred from Regional to  Hospital. Currently in-patient. Client was weaned off ventilator on 10/20/2019.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyspnoea, Endotracheal intubation, Hypoaesthesia, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: Seen in ER on 10/14/2019 for two days of weakness, slurred speech,  difficulty swallowing, and numbness and tingling to extremities bilaterally. Back in ER on 10/19/2019 progressive weakness, trouble swallowing, arm weakness and feels as though it is progressing to legs, and SOB. Client was intubated. 20G of IVIG was administered 10/19/2019. Client was transferred from Regional to  Hospital. Currently in-patient. Client was weaned off ventilator on 10/20/2019.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Seen in ER on 10/14/2019 for two days of weakness, slurred speech,  difficulty swallowing, and numbness and tingling to extremities bilaterally. Back in ER on 10/19/2019 progressive weakness, trouble swallowing, arm weakness and feels as though it is progressing to legs, and SOB. Client was intubated. 20G of IVIG was administered 10/19/2019. Client was transferred from Regional to  Hospital. Currently in-patient. Client was weaned off ventilator on 10/20/2019.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills, myalgia, low grade fever
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, CSF protein increased, CSF white blood cell count negative, Dysphagia, Guillain-Barre syndrome
Clinical narrative: The patient presented on 10/10/19 with generalized weakness, dysphagia, worsening numbness and tingling in her fingertips, feet, and tongue. Symptoms were much ore severe in her legs compared to her upper extremities. In the ED she was found to have a BP of 208/92 and a pulse of  56 bpm. She was admitted to the ICU and started on a Cardene infusion. Neurology was consulted and saw the patient on 10/11. Gullain-Barre Syndrome was suspected. A lumbar puncture was performed and IVIG 25g every 18 hours (2grams/kg over 5 doses) was initiated.  The lumbar puncture was consistent with Guillain-Barre syndrome with albumino cytologic dissociation. The patients symptoms persisted through 10/13. On 10/14 the patient's numbness and tingling began to improve. By 10/17 the patient symptomatically improved and ready to be discharged, though still very weak and required rehabilitation after discharge.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy, Intensive care, Paraesthesia
Clinical narrative: The patient presented on 10/10/19 with generalized weakness, dysphagia, worsening numbness and tingling in her fingertips, feet, and tongue. Symptoms were much ore severe in her legs compared to her upper extremities. In the ED she was found to have a BP of 208/92 and a pulse of  56 bpm. She was admitted to the ICU and started on a Cardene infusion. Neurology was consulted and saw the patient on 10/11. Gullain-Barre Syndrome was suspected. A lumbar puncture was performed and IVIG 25g every 18 hours (2grams/kg over 5 doses) was initiated.  The lumbar puncture was consistent with Guillain-Barre syndrome with albumino cytologic dissociation. The patients symptoms persisted through 10/13. On 10/14 the patient's numbness and tingling began to improve. By 10/17 the patient symptomatically improved and ready to be discharged, though still very weak and required rehabilitation after discharge.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Paraesthesia oral
Clinical narrative: The patient presented on 10/10/19 with generalized weakness, dysphagia, worsening numbness and tingling in her fingertips, feet, and tongue. Symptoms were much ore severe in her legs compared to her upper extremities. In the ED she was found to have a BP of 208/92 and a pulse of  56 bpm. She was admitted to the ICU and started on a Cardene infusion. Neurology was consulted and saw the patient on 10/11. Gullain-Barre Syndrome was suspected. A lumbar puncture was performed and IVIG 25g every 18 hours (2grams/kg over 5 doses) was initiated.  The lumbar puncture was consistent with Guillain-Barre syndrome with albumino cytologic dissociation. The patients symptoms persisted through 10/13. On 10/14 the patient's numbness and tingling began to improve. By 10/17 the patient symptomatically improved and ready to be discharged, though still very weak and required rehabilitation after discharge.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient stated that swelling (localized to the upper arm) and redness (localized to the upper arm) occurred starting the day after the administration of the vaccine and continued lasted 2 days. She took otc ibuprofen to help with the pain.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives all over body for two weeks. Treatment: still treating with benadryl, patient will see doctor soon.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Diarrhoea
Clinical narrative: Patient came in on 10/21 and claims she has been having repeated occurrences of diarrhea since she got her flu shot.  No dark, tarry or bloody stools reported.  Counseled patient on taking imodium and eating high fiber food and if not resolved to discuss with doctor.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever, achy, headache, chills
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Muscle spasms, Vomiting
Clinical narrative: Stomach cramps. On last day of oral pill, severe cramping and vomiting.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance
Clinical narrative: Parents report child was limping after vaccine was given and continued to limp at today's visit 10/21/2019.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: patient got swelling in left arm 2 days after getting immunizations, went to urgent care and doctor diagnosed cellulitis
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Blood test normal, Brain scan normal, Exposure during pregnancy, Gait disturbance, Imaging procedure
Clinical narrative: Dtap vac durring pregnancy.  Baby due nov. 22. Arm was sore at injection location in arm.  Full body aches and pain by dinner. Impossible to sleep in pain at night.  Difficult to walk next day.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: Dtap vac durring pregnancy.  Baby due nov. 22. Arm was sore at injection location in arm.  Full body aches and pain by dinner. Impossible to sleep in pain at night.  Difficult to walk next day.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Headache, Neck pain
Clinical narrative: Arm swollen, arm pain, all joints hurt, fever, chills, back pain, neck pain, headache.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm swollen, arm pain, all joints hurt, fever, chills, back pain, neck pain, headache.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Rash
Clinical narrative: pt. stated that she starts to experience swelling of feet ,knee, arms and fingers. by Friday she could not bend her knees. she experienced a little rash on and off in fingers and chest areas. she stated joints and ankles hurts. but no swelling at injection site or areas around it. patient came in to report on 10-21-2019 . At this time, her fingers has decreased in swelling.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in arm that started right after vaccine was given. Today is 7 days post vaccination and patient still reports numbness in her arm.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pain, Tremor
Clinical narrative: Body aches, severe headache, chills, uncontrollable shaking, sweating, nausea, vomiting. Phoned for advice, no fever, so no intervention. No prior reactions to annual flu shots, incl high dose type. Symptoms gradually resolved in about 12 hours.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Body aches, severe headache, chills, uncontrollable shaking, sweating, nausea, vomiting. Phoned for advice, no fever, so no intervention. No prior reactions to annual flu shots, incl high dose type. Symptoms gradually resolved in about 12 hours.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Loss of consciousness, Pallor, Syncope
Clinical narrative: Vasovagal syncope.  A few moments after vaccine patients mother brought her to counter and stated she was wobbly and blacking out.  We took her to waiting area and raised her legs and called 911.  By time paramedics arrived her color was returning and she was much better. Paramedics observed her for a bit and advised mom to take her to urgent care to have her checked over.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Starting on day after receiving vaccine, patient began experiencing headache, body aches, fever, chills. This continued all of Friday, 10/17, and into Saturday, 10/18.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot, red raised area on vaccinated arm  4 inches x 6 inches patch that remained for 10 days.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Cough, Injection site bruising, Pruritus, Pyrexia
Clinical narrative: 10/17/19 evening, pt reported hives approx 6.5x4.5 inches wide, bruising at injection site, exacerbation of asthma symptoms: sneezing, coughing, itching, fever of 100.6 max, severe drainage;  pt contacted dr. and dr recommended pt receive qvar, benadryl, and hydrocortisone to treat and to contact pharmacy to fill a vaers.  pt states is feeling better and would like to report that she suspects eggs used in birds that may have been fed tree nuts.