chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Visual impairment
Clinical narrative: Cataract; Nerve Damage; Post Herpetic Neuralgia; Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After injection, pt suffered a painful blistering rash, issues with her vision and nerve pain. As a result of her symptoms, pt presented to a medical provider and was diagnosed with Shingles, Post Herpetic Neuralgia, Cataract and Nerve Damage. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX),pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Cataract, herpes zoster, post herpetic neuralgia and nerve injury were considered to be disability. Upon internal review, cataract was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 month old patient received a dose of GARDASIL 9; no adverse effect; This spontaneous report was received from a physician refers to a 5 month old patient of unknown gender.     The patient's medical history, concurrent conditions and concomitant medications were unknown. On 18-NOV-2019, the 5 months old patient  was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age) via intramuscular route (lot # 1614897 exp.date : 20-SEP-2021) for prophylaxis.        No adverse events were reported. No product quality compliant was received. The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product quality issue, Syringe issue, Wrong technique in product usage process
Clinical narrative: no adverse event; a finger flange that is broken into 2 pieces and has broken off of the gardasil 9 syringe; vaccine administered from a syringe with a broken finger flange; This spontaneous report was received from a Registered Nurse referring to a 11 year old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were unknown.      On 13-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027576 and expiry date 23-JUN-2021 reported, for prophylaxis (strength, dose, route not reported). On 13-NOV-2019, the nurse reported a finger flange that was broken into 2 pieces and had broken off (product quality issue, wrong technique in product usage process) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe. The nurse reported that the vaccine was administered to a patient. No adverse event reported. The outcome of the events was unknown.
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, Pneumonia
Clinical narrative: pneumonia; bronchitis; This spontaneous report has been received from a lawyer referring to a female elderly patient of unknown age. The patient's historical vaccines included measles vaccine and mumps vaccine. The patient was a non-smoker. The patient's medical history and concomitant medication were not reported.  In 2011 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, strength, batch/lot# and expiration date were unknown) for prophylaxis. In the same year, the patient also received flu vaccine.   On an unknown date the patient experienced pneumonia and bad bronchitis. The outcome of both events was unknown. The reporter considered pneumonia and bronchitis to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  Upon internal review, pneumonia was determined to be medically significant.  The case is linked to case# US-009507513-1806USA003153 due to the same patient.; Sender's Comments:  US-009507513-1806USA003153:
Sex: U
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: swelling at injection site around 4 inches; redness at injection site of about 4 inches; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient had swelling and redness at the injection site of the old shingles shot.  The redness and swelling was around 4 inches. The patient asked did that mean I will with this one?
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Muscular weakness, Pain
Clinical narrative: chills; body aches; muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received Shingrix. In November 2019, 12 hrs after receiving Shingrix, the patient experienced chills, general body pain and muscle weakness. On an unknown date, the outcome of the chills, general body pain and muscle weakness were unknown.   It was unknown if the reporter considered the chills, general body pain and muscle weakness to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine on day before reporting. The patient experiencing chills, body aches, and muscle weakness. The patient enquired whether to take 2nd shot and what is the time. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Pyrexia
Clinical narrative: large joints were quite painful-shoulders; fever; knees hurt like crazy / joints were quite painful / hip pain; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Shingrix. On 24th July 2019, 1 days after receiving Shingrix, the patient experienced fever (serious criteria other: serious per reporter) and knee pain (serious criteria other: serious per reporter). In August 2019, the patient experienced shoulder pain (serious criteria other: serious per reporter). The patient was treated with naproxen (Aleve) and meloxicam. On 26th July 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the knee pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, knee pain and shoulder pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a serious reaction to the first injection and asked to advise him or her. The patient enquired about getting the second injection or the timing of that second injection. A day later both knees hurt like crazy when going upstairs. The patient also had a fever of 101. These symptoms were faded over a couple of days, but several weeks later (mid-August) all large joints were quite painful including knees, hips and shoulders. Treating with Aleve was only partially effective in relieving the pain, so patient visited to Internist. The Internist prescribed Meloxicam 25 mg for 2 weeks and patient then refilled that for an additional 10 days. That round of medication was just completed and patient's joints were much improved, but not back to normal. The Internist had suggested pushing out the second injection as late as possible, and had also referred patient to a rheumatologist. Rheumatologists were apparently in hot demand as the first available appointment would not until February. The patient would like to see the rheumatologist prior to getting the second injection, but wondered how long between doses was acceptable, and whether had any additional advice. The patient never had any reaction to a vaccine other than at the site. Unless the rheumatologist felt it was not recommended based on the reaction to the first one. This had been quite scary as patient felt like it added about 15 years of age. The patient was sure hope it continued to improve and that did not regret getting the Shingrix for the rest of life. The reporter requesting consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: muscle aches; fever; foggy brain; TIRED; flu like; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, muscle pain, fever, foggy feeling in head, tiredness and influenza like illness. On an unknown date, the outcome of the injection site pain and influenza like illness were recovered/resolved and the outcome of the muscle pain, fever, foggy feeling in head and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, fever, foggy feeling in head, tiredness and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient reported pain at the injection site that lasted 2 days and had resolved.  The other symptoms were still present.   The patient described it as feeling like she had the flu with a foggy brain. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: muscle aches; fever; foggy brain; TIRED; flu like; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, muscle pain, fever, foggy feeling in head, tiredness and influenza like illness. On an unknown date, the outcome of the injection site pain and influenza like illness were recovered/resolved and the outcome of the muscle pain, fever, foggy feeling in head and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, fever, foggy feeling in head, tiredness and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient reported pain at the injection site that lasted 2 days and had resolved.  The other symptoms were still present.   The patient described it as feeling like she had the flu with a foggy brain. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Breast swelling, Peripheral swelling
Clinical narrative: Swelling in the arms; Swelling in the breast; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a adult female patient who received HAV (Havrix) (batch number E9G4E, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number ZMM22C ?, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Havrix and Shingrix. On an unknown date, unknown after receiving Havrix and Shingrix, the patient experienced swelling arm and breast swelling. On an unknown date, the outcome of the swelling arm and breast swelling were unknown.   It was unknown if the reporter considered the swelling arm and breast swelling to be related to Havrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received both Havrix and Shingrix and developed swelling in the arms and breast after that.  The reporter provided all patient identifiers and batch number but no expiration date, as it was not available.  The reported batch number for Shingrix ZMM22C was not available in sales data base, however it was captured as ZMM22C ?
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Aches, Chills, Fever, nausea, no energy
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix (DTAP-IPV) age range is 4-6 yrs old. Pt received vaccine at 2 yrs old. No adverse reaction was reported.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Wrong product administered
Clinical narrative: Physician ordered a Hepatitis B vaccine to be given and the nurse gave a Hepatitis A instead.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Sedation, Vomiting
Clinical narrative: Sedation, Fever & NauseaVomiting
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Malaise, Suicidal ideation
Clinical narrative: 4 days post vaccine continue with icepick headache, general malaise with severe fatigue, experienced suicidal thoughts day 2, unable to carry out routine activities through day 4 post vaccine.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash and itch on left shoulder with many bumps about 2-3mm each. Itch persisted until bedtime on that evening. Bumps were still there the next morning. Did not want to take any antihistamine.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Blister, Cellulitis, Erythema, Skin disorder, Skin weeping
Clinical narrative: erythema and skin breakdown, vesiculation, weeping within 24-48h of vaccine admin; presumed cellulitis vs erysipelas  treated with oral Keflex  outcome pending as pt actively being treated
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: swelling, redness, and blisters at the injection site.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hyporesponsive to stimuli, Hypotonia, Respiration abnormal
Clinical narrative: PT RECEIVED ROUTINE 6MO VACCINES IN OFFICE AROUND 2:20PM ON 11/25/19. MOM AND DAD PRESENTED TO ER AROUND 8PM REPORTING THAT PT WAS HAVING POOR RESPOSIVENESS, HYPOTONIA, AND ALTERED BREATHING PATTERN THAT STARTED AROUND 630PM. PT WAS TRANSFERRED FROM LOCAL ER TO ANOTHER HOSPITAL. PT IS STILL THERE AT THIS TIME.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug hypersensitivity, Nausea, Vomiting
Clinical narrative: Nausea Vomiting MECLIZINE
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray normal, Cough
Clinical narrative: PT HAD FLU SHOT LAST WEEKAND HAS BEEN COUGHING SINCE SHE GOT IT; This case was reported by a consumer via other manufacturer and described the occurrence of cough in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included treprostinil (Tyvaso) (batch number 2101701, expiry date 30th September 2020) for pulmonary arterial hypertension, macitentan (Opsumit) for an unknown indication and sildenafil citrate (Revatio) for an unknown indication.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 21st January 2015, the patient started Tyvaso 1 dosage form(s) 4 times daily (4 dosage form(s) daily). On an unknown date, the patient started Opsumit at an unknown dose and frequency and Revatio at an unknown dose and frequency. In November 2019, less than 2 weeks after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced cough. The action taken with Tyvaso was unknown. The action taken with Opsumit was unknown. The action taken with Revatio was unknown. On an unknown date, the outcome of the cough was unknown.   It was unknown if the reporter considered the cough to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient had flu shot in last week and had been coughing since she got it. The patient went to primary care physician and had chest x-ray and it was negative. No further details were provided. It was unknown if the reporter considered the cough to be related to Tyvaso, Opsumit and Revatio. The reporter consented to follow up.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased
Clinical narrative: 3 days post vaccination patient says she could not move her arm. She reported to her MD. Called the pharmacy 11/25/19
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: 3 days post vaccination patient says she could not move her arm. She reported to her MD. Called the pharmacy 11/25/19
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Pallor, Presyncope, Tremor, Vomiting
Clinical narrative: Right after the 4th vaccine was administered he became pale and appeared to have passed out . No reported eye rolling, but he appeared to shake before the episode. he swiftly jumped up after the incident and ran to the sink reporting he would vomit. He was sat down and given a drink of water. After 15-20 minutes of rest, he was re-evaluated.  Pallor improved and he reported he felt better.  Presentation appears to be consistent with a vasovagal response to the pain, and he was already anxious and nervous about vaccines."
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Impaired work ability, Injection site erythema, Pain, Pruritus, Pyrexia
Clinical narrative: 1st message from pt:  Patient called and said she had a reaction to the shingles shot and pnemonia shot. Whole shoulder turned bright red, fever of 102, sore all over, itchy, left work early on Friday because of the reaction. Is scheduled to come back in on Jan 29 for her second shingles shot. Did not go to the er, urgent care. Should patient move this apt because of the reaction or is there something patient can take before hand. Patient is afraid this may happen again at 2nd shot. Arm is still red.  2nd message from pt:  Patient called and said she had a reaction to the shingles shot and pnemonia shot. Whole shoulder turned bright red, fever of 102, sore all over, itchy, left work early on Friday because of the reaction. Is scheduled to come back in on Jan 29 for her second shingles shot. Did not go to the er, urgent care. Should patient move this apt because of the reaction or is there something patient can take before hand. Patient is afraid this may happen again at 2nd shot. Arm is still red.   Nurses note:  Checked with Dr, she said that the pt should not get the 2nd shingles shot.  She can take tylenol, ibuprofen, and/or benadryl as needed.  Called pt, relayed this info.  She confirmed what was in the 2 messages.  She said that she wasn't short of breath but felt like she didn't have enough room for air.  That is gone now.  Told her not to take benadryl while working, driving, or if needing to be awake since it causes drowsiness.  She verbalizes understanding. She said that it's been getting a little better each day.  Told her to call us back in a couple of days if she doesn't continue getting better each day.  She verbalizes understanding.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Vaccination complication
Clinical narrative: 1st message from pt:  Patient called and said she had a reaction to the shingles shot and pnemonia shot. Whole shoulder turned bright red, fever of 102, sore all over, itchy, left work early on Friday because of the reaction. Is scheduled to come back in on Jan 29 for her second shingles shot. Did not go to the er, urgent care. Should patient move this apt because of the reaction or is there something patient can take before hand. Patient is afraid this may happen again at 2nd shot. Arm is still red.  2nd message from pt:  Patient called and said she had a reaction to the shingles shot and pnemonia shot. Whole shoulder turned bright red, fever of 102, sore all over, itchy, left work early on Friday because of the reaction. Is scheduled to come back in on Jan 29 for her second shingles shot. Did not go to the er, urgent care. Should patient move this apt because of the reaction or is there something patient can take before hand. Patient is afraid this may happen again at 2nd shot. Arm is still red.   Nurses note:  Checked with Dr, she said that the pt should not get the 2nd shingles shot.  She can take tylenol, ibuprofen, and/or benadryl as needed.  Called pt, relayed this info.  She confirmed what was in the 2 messages.  She said that she wasn't short of breath but felt like she didn't have enough room for air.  That is gone now.  Told her not to take benadryl while working, driving, or if needing to be awake since it causes drowsiness.  She verbalizes understanding. She said that it's been getting a little better each day.  Told her to call us back in a couple of days if she doesn't continue getting better each day.  She verbalizes understanding.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER AND VOMITING
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt with large amount of redness from site down to his knee that then wrapped around the back of his leg, along with mild swelling and itchiness
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Hypoaesthesia, Muscle fatigue, Peripheral coldness, Sensory disturbance
Clinical narrative: Employee had Fluzone vaccine on 10/01/2019 in Employee Health office. Employee states she began to have "vague symptoms" involving bilateral feet and lower legs on 10/17/2019. On 10/21/2019 sypmtons became worse. On 10/22/2019 employee reported sypmtoms to her direct supervisor and was referred to Employee Health. Sypmtons included numb, cold, wet sensation in both feet, muscle fatigue and difficulty walking. Employee was referred to her PCP for evaluation. PCP referred employee to Neurology for evaluation on 10/23/2019. Per employee, at neurologist follow-up on 11/05/2019, neurologist stated "probable adverse reaction to flu vaccine".
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Employee had Fluzone vaccine on 10/01/2019 in Employee Health office. Employee states she began to have "vague symptoms" involving bilateral feet and lower legs on 10/17/2019. On 10/21/2019 sypmtons became worse. On 10/22/2019 employee reported sypmtoms to her direct supervisor and was referred to Employee Health. Sypmtons included numb, cold, wet sensation in both feet, muscle fatigue and difficulty walking. Employee was referred to her PCP for evaluation. PCP referred employee to Neurology for evaluation on 10/23/2019. Per employee, at neurologist follow-up on 11/05/2019, neurologist stated "probable adverse reaction to flu vaccine".
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site ulcer, Injection site vesicles, Rash, Skin ulcer, Wound secretion
Clinical narrative: Woke up about 2 days after the flu shot (and 9 days after 2nd Shingles shot) and noticed blisters by injection site and a sore on the injection site.  She then developed sores all over including on the thighs and back.  These spots were oozing slightly.  She now has rash all over forearms, knees, fingers.  She has tried Claritin, Benadryl and various lotions, which have not been helping.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Back pain, Eye pain, Feeling abnormal
Clinical narrative: Muscle aches all over (including eye  muscles), left lower back pain, headaches, scalp aches including skin on temples, lack of energy brain fog, sleepy, joint pain, lethargic, difficult sleeping. Adverse events all gone by 11/25/2019. The last to go were the scalp pain, sore eye muscles, and brain fog.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Insomnia, Lethargy, Myalgia, Pain
Clinical narrative: Muscle aches all over (including eye  muscles), left lower back pain, headaches, scalp aches including skin on temples, lack of energy brain fog, sleepy, joint pain, lethargic, difficult sleeping. Adverse events all gone by 11/25/2019. The last to go were the scalp pain, sore eye muscles, and brain fog.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Pain of skin, Somnolence
Clinical narrative: Muscle aches all over (including eye  muscles), left lower back pain, headaches, scalp aches including skin on temples, lack of energy brain fog, sleepy, joint pain, lethargic, difficult sleeping. Adverse events all gone by 11/25/2019. The last to go were the scalp pain, sore eye muscles, and brain fog.
Age: 16.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Abdominal pain, Anal fissure, Basophil count decreased, Blood culture negative, C-reactive protein increased
Clinical narrative: Patient presented to office on 10/24/19, 3 days after immunization.  Reported 2 days of fever with TMax 104, erythema and swelling of injection site at right arm, warm and tender to touch, continuing to spread.  At home tried Tylenol with improvement in fever reduction, Benadryl had no change.  He had also been taking Bactrim for finger cellulitis during that time and reported improvement.   Patient appeared acutely ill but stable, was afebrile in office T 100.1F, HR 105.  Injection site erythema measured 3x4inches, was warm, tender to palpation.    Reviewed case reports that showed 5 adult patients had similar reactions from receiving both influenza and PPSV 23.  Discussed with patient and guardian, did initial labwork as below.  Monitored and saw patient back the following day with decreasing fever curve and reduction in injection site swelling.  Did complain of abdominal pain and rectal bleeding at that time, but was found to have a superficial anal fissure on exam.
Age: 16.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Eosinophil count decreased, Haematocrit decreased, Haemoglobin decreased, Injection site erythema
Clinical narrative: Patient presented to office on 10/24/19, 3 days after immunization.  Reported 2 days of fever with TMax 104, erythema and swelling of injection site at right arm, warm and tender to touch, continuing to spread.  At home tried Tylenol with improvement in fever reduction, Benadryl had no change.  He had also been taking Bactrim for finger cellulitis during that time and reported improvement.   Patient appeared acutely ill but stable, was afebrile in office T 100.1F, HR 105.  Injection site erythema measured 3x4inches, was warm, tender to palpation.    Reviewed case reports that showed 5 adult patients had similar reactions from receiving both influenza and PPSV 23.  Discussed with patient and guardian, did initial labwork as below.  Monitored and saw patient back the following day with decreasing fever curve and reduction in injection site swelling.  Did complain of abdominal pain and rectal bleeding at that time, but was found to have a superficial anal fissure on exam.
Age: 16.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Lymphocyte count normal, Mean cell haemoglobin concentration normal
Clinical narrative: Patient presented to office on 10/24/19, 3 days after immunization.  Reported 2 days of fever with TMax 104, erythema and swelling of injection site at right arm, warm and tender to touch, continuing to spread.  At home tried Tylenol with improvement in fever reduction, Benadryl had no change.  He had also been taking Bactrim for finger cellulitis during that time and reported improvement.   Patient appeared acutely ill but stable, was afebrile in office T 100.1F, HR 105.  Injection site erythema measured 3x4inches, was warm, tender to palpation.    Reviewed case reports that showed 5 adult patients had similar reactions from receiving both influenza and PPSV 23.  Discussed with patient and guardian, did initial labwork as below.  Monitored and saw patient back the following day with decreasing fever curve and reduction in injection site swelling.  Did complain of abdominal pain and rectal bleeding at that time, but was found to have a superficial anal fissure on exam.
Age: 16.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Mean cell haemoglobin decreased, Mean cell volume normal, Mean platelet volume normal, Monocyte count increased, Neutrophil count increased
Clinical narrative: Patient presented to office on 10/24/19, 3 days after immunization.  Reported 2 days of fever with TMax 104, erythema and swelling of injection site at right arm, warm and tender to touch, continuing to spread.  At home tried Tylenol with improvement in fever reduction, Benadryl had no change.  He had also been taking Bactrim for finger cellulitis during that time and reported improvement.   Patient appeared acutely ill but stable, was afebrile in office T 100.1F, HR 105.  Injection site erythema measured 3x4inches, was warm, tender to palpation.    Reviewed case reports that showed 5 adult patients had similar reactions from receiving both influenza and PPSV 23.  Discussed with patient and guardian, did initial labwork as below.  Monitored and saw patient back the following day with decreasing fever curve and reduction in injection site swelling.  Did complain of abdominal pain and rectal bleeding at that time, but was found to have a superficial anal fissure on exam.
Age: 16.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Platelet count normal, Platelet morphology normal, Pyrexia, Rectal haemorrhage, Red blood cell anisocytes present
Clinical narrative: Patient presented to office on 10/24/19, 3 days after immunization.  Reported 2 days of fever with TMax 104, erythema and swelling of injection site at right arm, warm and tender to touch, continuing to spread.  At home tried Tylenol with improvement in fever reduction, Benadryl had no change.  He had also been taking Bactrim for finger cellulitis during that time and reported improvement.   Patient appeared acutely ill but stable, was afebrile in office T 100.1F, HR 105.  Injection site erythema measured 3x4inches, was warm, tender to palpation.    Reviewed case reports that showed 5 adult patients had similar reactions from receiving both influenza and PPSV 23.  Discussed with patient and guardian, did initial labwork as below.  Monitored and saw patient back the following day with decreasing fever curve and reduction in injection site swelling.  Did complain of abdominal pain and rectal bleeding at that time, but was found to have a superficial anal fissure on exam.
Age: 16.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Red blood cell count normal, Red blood cell morphology abnormal, Red blood cell sedimentation rate increased, Red cell distribution width normal, White blood cell count increased
Clinical narrative: Patient presented to office on 10/24/19, 3 days after immunization.  Reported 2 days of fever with TMax 104, erythema and swelling of injection site at right arm, warm and tender to touch, continuing to spread.  At home tried Tylenol with improvement in fever reduction, Benadryl had no change.  He had also been taking Bactrim for finger cellulitis during that time and reported improvement.   Patient appeared acutely ill but stable, was afebrile in office T 100.1F, HR 105.  Injection site erythema measured 3x4inches, was warm, tender to palpation.    Reviewed case reports that showed 5 adult patients had similar reactions from receiving both influenza and PPSV 23.  Discussed with patient and guardian, did initial labwork as below.  Monitored and saw patient back the following day with decreasing fever curve and reduction in injection site swelling.  Did complain of abdominal pain and rectal bleeding at that time, but was found to have a superficial anal fissure on exam.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: C/o pain at injection site immediately, reported cont. pain and decreased strength in arm. Pain increases with movement of are.  Currently being seen by Work Comp MD for filed work comp claim due to this at our facility where employee works.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Injected limb mobility decreased, Injection site pain
Clinical narrative: Excruciating pain at injection site, inability to move arm.  Flu-like symptoms for about 8 hours: shivering, sweating, muscle aches.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Myalgia
Clinical narrative: Excruciating pain at injection site, inability to move arm.  Flu-like symptoms for about 8 hours: shivering, sweating, muscle aches.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Bradyphrenia, Chills, Discomfort, Dizziness, Feeling abnormal
Clinical narrative: Drove home at 12:30pm.  Brain was slow moving, made bad decisions, was zoned out.  Felt woozy & out of it the rest of the day.  Around dinner time felt hot but no fever.  Sleep: felt moderately hot, mod. to severe chills, nausea.  Nov. 13:  Woke up with frontal HA, mild nausea, congested, felt unsafe to drive, 101.1F oral temp.  Went out into 28F weather & felt better.  All symptoms aliviated except for mild HA.  2pm I felt woozy, congested & uncomfortable.  After dinner all symptoms gone.  Wife's hand on head temp felt a little warm but not nearly as hot as in early morning.  Tx.:  Alleve bid, rest. Nov. 14:  slept 7+hs. despite 1 h. nap at 10am.  (usually sleep 5 1/2 hs).  Asymptomatic.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Impaired driving ability, Nausea, Respiratory tract congestion
Clinical narrative: Drove home at 12:30pm.  Brain was slow moving, made bad decisions, was zoned out.  Felt woozy & out of it the rest of the day.  Around dinner time felt hot but no fever.  Sleep: felt moderately hot, mod. to severe chills, nausea.  Nov. 13:  Woke up with frontal HA, mild nausea, congested, felt unsafe to drive, 101.1F oral temp.  Went out into 28F weather & felt better.  All symptoms aliviated except for mild HA.  2pm I felt woozy, congested & uncomfortable.  After dinner all symptoms gone.  Wife's hand on head temp felt a little warm but not nearly as hot as in early morning.  Tx.:  Alleve bid, rest. Nov. 14:  slept 7+hs. despite 1 h. nap at 10am.  (usually sleep 5 1/2 hs).  Asymptomatic.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms for 24 hours.  Same effect from first shot on May 31, 2019.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased
Clinical narrative: Pain at injection site immediately, c/o decreased ROM, being seen by OHS MD at place of work.  Treatment with Acupuncture has provided decrease in pain.
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain, Disturbance in attention, Fatigue, Feeling hot, Flatulence
Clinical narrative: FLATULENCE; INSOMNIA; HALLUCINATION, VISUAL; FEELING HOT; HYPERSALIVATION; SKIN BURNING SENSATION; PALPITATIONS; HYPERHIDROSIS; VISUAL IMPAIRMENT; PAPULE; DISTURBANCE IN ATTENTION; NECK PAIN; IRRITABILITY; INCREASED APPETITE; ABDOMINAL PAIN; JOINT CLICKING; FATIGUE; A spontaneous report has been received from a pharmacist and a consumer via the regulatory authority concerning a 6 year old male patient.    No medical history was reported. No concomitant products were reported.    During Nov-2018, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal) (batch number(s) KJ21501B) one dosage form ,x1, nasal.     During Mar-2019, the patient experienced flatulence (preferred term: Flatulence), insomnia (preferred term: Insomnia), hallucination, visual (preferred term: Hallucination, visual), feeling hot (preferred term: Feeling hot), hypersalivation (preferred term: Salivary hypersecretion), skin burning sensation (preferred term: Skin burning sensation), palpitations (preferred term: Palpitations), hyperhidrosis (preferred term: Hyperhidrosis), visual impairment (preferred term: Visual impairment), papule (preferred term: Papule), disturbance in attention (preferred term: Disturbance in attention), neck pain (preferred term: Neck pain), irritability (preferred term: Irritability), increased appetite (preferred term: Increased appetite), abdominal pain (preferred term: Abdominal pain), joint clicking (preferred term: Joint noise) and fatigue (preferred term: Fatigue).     The patient recovered with sequelae from the events of flatulence, insomnia, hallucination, visual, feeling hot, hypersalivation, skin burning sensation, palpitations, hyperhidrosis, visual impairment, papule, disturbance in attention, neck pain, irritability, increased appetite, abdominal pain, joint clicking and fatigue on an unspecified date.     The events were considered serious (disability) by the reporter.; Sender's Comments: This case concerns a 6-year old male patient with 16 serious events that are not listed in the company core data sheet of quadrivalent live attenuated influenza vaccine. Visual hallucination, irritability, disturbance in attention, insomnia could be in connection. However due to limited information on the exact event details, patient's relevant medical history, concurrent medical conditions, circumstances leading to the occurrence of the events, clinical course of the events, suspect drug indication and action taken with the suspect drug and clinical workup, concomitant medications, complete diagnostic workup, it is not possible to make a conclusive assessment of the causal relationship between events and suspect drug.
Sex: M
Vaccine: FLUN4
Symptoms: Hallucination, visual, Hyperhidrosis, Increased appetite, Insomnia, Irritability
Clinical narrative: FLATULENCE; INSOMNIA; HALLUCINATION, VISUAL; FEELING HOT; HYPERSALIVATION; SKIN BURNING SENSATION; PALPITATIONS; HYPERHIDROSIS; VISUAL IMPAIRMENT; PAPULE; DISTURBANCE IN ATTENTION; NECK PAIN; IRRITABILITY; INCREASED APPETITE; ABDOMINAL PAIN; JOINT CLICKING; FATIGUE; A spontaneous report has been received from a pharmacist and a consumer via the regulatory authority concerning a 6 year old male patient.    No medical history was reported. No concomitant products were reported.    During Nov-2018, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal) (batch number(s) KJ21501B) one dosage form ,x1, nasal.     During Mar-2019, the patient experienced flatulence (preferred term: Flatulence), insomnia (preferred term: Insomnia), hallucination, visual (preferred term: Hallucination, visual), feeling hot (preferred term: Feeling hot), hypersalivation (preferred term: Salivary hypersecretion), skin burning sensation (preferred term: Skin burning sensation), palpitations (preferred term: Palpitations), hyperhidrosis (preferred term: Hyperhidrosis), visual impairment (preferred term: Visual impairment), papule (preferred term: Papule), disturbance in attention (preferred term: Disturbance in attention), neck pain (preferred term: Neck pain), irritability (preferred term: Irritability), increased appetite (preferred term: Increased appetite), abdominal pain (preferred term: Abdominal pain), joint clicking (preferred term: Joint noise) and fatigue (preferred term: Fatigue).     The patient recovered with sequelae from the events of flatulence, insomnia, hallucination, visual, feeling hot, hypersalivation, skin burning sensation, palpitations, hyperhidrosis, visual impairment, papule, disturbance in attention, neck pain, irritability, increased appetite, abdominal pain, joint clicking and fatigue on an unspecified date.     The events were considered serious (disability) by the reporter.; Sender's Comments: This case concerns a 6-year old male patient with 16 serious events that are not listed in the company core data sheet of quadrivalent live attenuated influenza vaccine. Visual hallucination, irritability, disturbance in attention, insomnia could be in connection. However due to limited information on the exact event details, patient's relevant medical history, concurrent medical conditions, circumstances leading to the occurrence of the events, clinical course of the events, suspect drug indication and action taken with the suspect drug and clinical workup, concomitant medications, complete diagnostic workup, it is not possible to make a conclusive assessment of the causal relationship between events and suspect drug.
Sex: M
Vaccine: FLUN4
Symptoms: Joint noise, Neck pain, Palpitations, Papule, Salivary hypersecretion
Clinical narrative: FLATULENCE; INSOMNIA; HALLUCINATION, VISUAL; FEELING HOT; HYPERSALIVATION; SKIN BURNING SENSATION; PALPITATIONS; HYPERHIDROSIS; VISUAL IMPAIRMENT; PAPULE; DISTURBANCE IN ATTENTION; NECK PAIN; IRRITABILITY; INCREASED APPETITE; ABDOMINAL PAIN; JOINT CLICKING; FATIGUE; A spontaneous report has been received from a pharmacist and a consumer via the regulatory authority concerning a 6 year old male patient.    No medical history was reported. No concomitant products were reported.    During Nov-2018, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal) (batch number(s) KJ21501B) one dosage form ,x1, nasal.     During Mar-2019, the patient experienced flatulence (preferred term: Flatulence), insomnia (preferred term: Insomnia), hallucination, visual (preferred term: Hallucination, visual), feeling hot (preferred term: Feeling hot), hypersalivation (preferred term: Salivary hypersecretion), skin burning sensation (preferred term: Skin burning sensation), palpitations (preferred term: Palpitations), hyperhidrosis (preferred term: Hyperhidrosis), visual impairment (preferred term: Visual impairment), papule (preferred term: Papule), disturbance in attention (preferred term: Disturbance in attention), neck pain (preferred term: Neck pain), irritability (preferred term: Irritability), increased appetite (preferred term: Increased appetite), abdominal pain (preferred term: Abdominal pain), joint clicking (preferred term: Joint noise) and fatigue (preferred term: Fatigue).     The patient recovered with sequelae from the events of flatulence, insomnia, hallucination, visual, feeling hot, hypersalivation, skin burning sensation, palpitations, hyperhidrosis, visual impairment, papule, disturbance in attention, neck pain, irritability, increased appetite, abdominal pain, joint clicking and fatigue on an unspecified date.     The events were considered serious (disability) by the reporter.; Sender's Comments: This case concerns a 6-year old male patient with 16 serious events that are not listed in the company core data sheet of quadrivalent live attenuated influenza vaccine. Visual hallucination, irritability, disturbance in attention, insomnia could be in connection. However due to limited information on the exact event details, patient's relevant medical history, concurrent medical conditions, circumstances leading to the occurrence of the events, clinical course of the events, suspect drug indication and action taken with the suspect drug and clinical workup, concomitant medications, complete diagnostic workup, it is not possible to make a conclusive assessment of the causal relationship between events and suspect drug.
Sex: M
Vaccine: FLUN4
Symptoms: Skin burning sensation, Visual impairment
Clinical narrative: FLATULENCE; INSOMNIA; HALLUCINATION, VISUAL; FEELING HOT; HYPERSALIVATION; SKIN BURNING SENSATION; PALPITATIONS; HYPERHIDROSIS; VISUAL IMPAIRMENT; PAPULE; DISTURBANCE IN ATTENTION; NECK PAIN; IRRITABILITY; INCREASED APPETITE; ABDOMINAL PAIN; JOINT CLICKING; FATIGUE; A spontaneous report has been received from a pharmacist and a consumer via the regulatory authority concerning a 6 year old male patient.    No medical history was reported. No concomitant products were reported.    During Nov-2018, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal) (batch number(s) KJ21501B) one dosage form ,x1, nasal.     During Mar-2019, the patient experienced flatulence (preferred term: Flatulence), insomnia (preferred term: Insomnia), hallucination, visual (preferred term: Hallucination, visual), feeling hot (preferred term: Feeling hot), hypersalivation (preferred term: Salivary hypersecretion), skin burning sensation (preferred term: Skin burning sensation), palpitations (preferred term: Palpitations), hyperhidrosis (preferred term: Hyperhidrosis), visual impairment (preferred term: Visual impairment), papule (preferred term: Papule), disturbance in attention (preferred term: Disturbance in attention), neck pain (preferred term: Neck pain), irritability (preferred term: Irritability), increased appetite (preferred term: Increased appetite), abdominal pain (preferred term: Abdominal pain), joint clicking (preferred term: Joint noise) and fatigue (preferred term: Fatigue).     The patient recovered with sequelae from the events of flatulence, insomnia, hallucination, visual, feeling hot, hypersalivation, skin burning sensation, palpitations, hyperhidrosis, visual impairment, papule, disturbance in attention, neck pain, irritability, increased appetite, abdominal pain, joint clicking and fatigue on an unspecified date.     The events were considered serious (disability) by the reporter.; Sender's Comments: This case concerns a 6-year old male patient with 16 serious events that are not listed in the company core data sheet of quadrivalent live attenuated influenza vaccine. Visual hallucination, irritability, disturbance in attention, insomnia could be in connection. However due to limited information on the exact event details, patient's relevant medical history, concurrent medical conditions, circumstances leading to the occurrence of the events, clinical course of the events, suspect drug indication and action taken with the suspect drug and clinical workup, concomitant medications, complete diagnostic workup, it is not possible to make a conclusive assessment of the causal relationship between events and suspect drug.