chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Injection site erythema, Injection site pain
Clinical narrative: Her daughter received a third Prevnar 13 dosage on 27Nov, after that she was notified that the administered vaccine expired on February (10 months ago)/the shot given had expired; Still has redness and soreness at injection site; Still has redness and soreness at injection site; This is a spontaneous report from a contactable nurse. A 16-year-old female patient received the third dose of meningococcal group b rlp2086 (TRUMENBA, Batch/lot number S5887, Expired date Feb2019) intramuscular in the muscle of right upper arm on 27Nov2019 at 3pm at single dose for routine vaccination. The patient medical history was not reported. Concomitant medication included unspecified birth control medication. The patient received first two doses of meningococcal group b rlp2086 on an unspecified date for immunization. The mother reported that her daughter received a third dosage vaccine on 27Nov2019, after that she was notified that the administered vaccine expired on February2019 (10 months ago), which was considered as serious (medically significant) per reporter. She still was very sore and there was some redness at the injection site on 27Nov2019, which she was told to expect. The reporter considered the events "very sore and there was some redness at the injection site" were non-serious. The outcome of events "very sore and there was some redness at the injection site" was not recovered. The reporter considered events were related to vaccination of meningococcal group b rlp2086.     The information on the batch/lot number has been requested.  Follow-up (04Dec2019 and 05Dec2019): New information reported from a contactable Nurse included the case was upgraded to serious, patient data (age), suspect vaccine (updated to meningococcal group b rlp2086, route, anatomical location), concomitant medication, reaction data (new events very sore and there was some redness at the injection site), reporter's assessment (serious, related).; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient stated that she had a fever that began about 2 hours post vaccination, and resolved about 12 hours later
Age: 39.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Tendonitis
Clinical narrative: Left Arm Pain- Deltoid Tendinitis, Since 10/30/19
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Gait disturbance, Injection site pain
Clinical narrative: Woke up next morning could barely walk.. Severe pain in lower back. Very sore at injection site.  Soreness and pain remained  until yesterday 12/8/2019.  Heating pad applied to lower back help for me to sleep. I find this interesting because I have heard the Chicken Pox Virus lives on in your body in the Spinal Column. Is it possible the reaction was caused by a direct attack by the vaccine against the dormant virus. If so That might be a great reaction to the vaccine. All pain has now disappeared.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: patient states he has pain and itching at injection site and a hives type rash of about 4 inch by 7 inch around injection site.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dry skin, Injection site rash, Rash, Rash erythematous
Clinical narrative: Small rash spots started to form on her legs and now are almost completely covering her legs and are spreading to her tummy, arms, and face. It is a very rough and red rash
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness and Swelling was reported to pharmacy that began the evening of vaccination, and last for 3-4 days before resolving.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient reports pain from shoulder to wrist.
Age: 66.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Cold sweat, Injected limb mobility decreased, Musculoskeletal pain, Nausea, Neck pain
Clinical narrative: Unbearable pain in the right arm.  Unable to move arm, felt like a broken arm.  Pain radiating down the arm and up over neck and shoulders. Dr.s  office was called, they called in a muscle relaxer and precscribed a X-ray,   which I refused.
Age: 66.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Unbearable pain in the right arm.  Unable to move arm, felt like a broken arm.  Pain radiating down the arm and up over neck and shoulders. Dr.s  office was called, they called in a muscle relaxer and precscribed a X-ray,   which I refused.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient not experiencing any symptoms; unspecified dose of ROTATEQ that was improperly stored; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number R016792, expiration date: 29-APR-2020) orally for prophylaxis (exact dose was not provided) that was improperly stored on 07-NOV-2019. The patient did not experience any symptoms.  Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion of 8.8 degree Celsius for 1 hour 30 minutes. The previous temperature excursion of 51.6 degree Fahrenheit for 7 hours was reported. The digital data logger was involved.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives & severe itching all over body continuing to present time!! Hives are continuing - He is using Zyrtec which helps only A Little!! (It's been over 4 months! We could us some help & Advice. A reply would be greatly appreciated!! F.Y.I. - I received the same vaccination on the same day & Time & have had NO adverse reaction. I have also had the second shot. ALSO No reaction. OBVIOUSLY The Pharmacist Advised against the second dose for Husband! I do not have internet or access to a fax machine!!
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Immediate stiff arm and pain, never before experienced, lasting for 4 days. Some pain went away and then returned the following week.  Entire left shoulder and upper arm, unable to move, throbbing. It felt like a seperated shoulder when I tried to move my arm, lasting for several weeks. It was difficult for me to even get dressed.  It has now been over two months and while the pain has decreased, a little at a time, but still remains when I try to lift, shovel snow, drive-turning a tight right corner. I am concerned about getting vaccinated next year.  In the past I have been given the increased flu dosage, but it was unavailable at the time I got the flu vaccine this year.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Immediate stiff arm and pain, never before experienced, lasting for 4 days. Some pain went away and then returned the following week.  Entire left shoulder and upper arm, unable to move, throbbing. It felt like a seperated shoulder when I tried to move my arm, lasting for several weeks. It was difficult for me to even get dressed.  It has now been over two months and while the pain has decreased, a little at a time, but still remains when I try to lift, shovel snow, drive-turning a tight right corner. I am concerned about getting vaccinated next year.  In the past I have been given the increased flu dosage, but it was unavailable at the time I got the flu vaccine this year.
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA, HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was given after expiration date, expired 10/22/19. No adverse outcomes have been identified but needs to be re-vaccinated
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Expired product administered
Clinical narrative: vaccine given after expiration date, expired 10/22/19
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Hypoaesthesia, Injection site erythema, Injection site rash
Clinical narrative: Arm very painful after vaccination. Rash developed over injection site/red, not raised, covering proximal 1/3 of upper arm, was resolving on 12/9/19.  Developed dizziness the following day which has been persistent from day 1 after vaccination until seen in the office on 12/9 and it had not resolved yet. No LOC. Also reported numbness and decreased sensation in toes 3-5 on left foot. 5th toe had resumed normal sensation by time of f/u visit on 12/9, but still with decreased sensation on toes 3 and 4. Normal neuro exam otherwise. No s/s GBS. Pt was also concurrently reporting 3 days of low grade fever 99-100, sore throat and headaches, mild congestion following vaccination. Unclear whether this was related to vaccine or viral illness
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Neurological examination normal, Oropharyngeal pain, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: Arm very painful after vaccination. Rash developed over injection site/red, not raised, covering proximal 1/3 of upper arm, was resolving on 12/9/19.  Developed dizziness the following day which has been persistent from day 1 after vaccination until seen in the office on 12/9 and it had not resolved yet. No LOC. Also reported numbness and decreased sensation in toes 3-5 on left foot. 5th toe had resumed normal sensation by time of f/u visit on 12/9, but still with decreased sensation on toes 3 and 4. Normal neuro exam otherwise. No s/s GBS. Pt was also concurrently reporting 3 days of low grade fever 99-100, sore throat and headaches, mild congestion following vaccination. Unclear whether this was related to vaccine or viral illness
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Sensory disturbance, Streptococcus test negative
Clinical narrative: Arm very painful after vaccination. Rash developed over injection site/red, not raised, covering proximal 1/3 of upper arm, was resolving on 12/9/19.  Developed dizziness the following day which has been persistent from day 1 after vaccination until seen in the office on 12/9 and it had not resolved yet. No LOC. Also reported numbness and decreased sensation in toes 3-5 on left foot. 5th toe had resumed normal sensation by time of f/u visit on 12/9, but still with decreased sensation on toes 3 and 4. Normal neuro exam otherwise. No s/s GBS. Pt was also concurrently reporting 3 days of low grade fever 99-100, sore throat and headaches, mild congestion following vaccination. Unclear whether this was related to vaccine or viral illness
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Mother states patient developed Redness to area of vaccine injection site on Left upper thigh Within 24 hrs of the vaccine being given. She applied warm compresses to area and redness has almost completely resolved. No further treatment necessary.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Flushing, Pruritus, Rash, Swelling
Clinical narrative: Rash started 11/30/19over arms. neck & chest worse 12/2 with swelling, rash & itching did have slight heaviness in chest. & face felt flushed  12/3 with less rash & itching, swelling is almost gone - never any wheezing
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Acoustic stimulation tests normal, Ear discomfort, Ear infection, Ear pain, Ear, nose and throat examination normal
Clinical narrative: 1 week later: (1) right arm rash, 3 in wide around arm - looks like arm band (2) developed ear infection, took ZPAK from urgent care (3) right ear feels blocked + pain - ENT wants further testing I haven't had ear infection in probably 60 years. (1) Hearing is normal for age in fact above normal. Checked 12/5/19 otolaryngology. 6 week followup for further testing if symptoms persist. (2) rash is still there faintly new, still itches (3) 11/20/19 woke up with blocked ear & pain. Went to urgent care. I was told ear was infected. I took Z-PAK. No change
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pruritus, Rash
Clinical narrative: 1 week later: (1) right arm rash, 3 in wide around arm - looks like arm band (2) developed ear infection, took ZPAK from urgent care (3) right ear feels blocked + pain - ENT wants further testing I haven't had ear infection in probably 60 years. (1) Hearing is normal for age in fact above normal. Checked 12/5/19 otolaryngology. 6 week followup for further testing if symptoms persist. (2) rash is still there faintly new, still itches (3) 11/20/19 woke up with blocked ear & pain. Went to urgent care. I was told ear was infected. I took Z-PAK. No change
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Acoustic stimulation tests normal, Deafness unilateral, Ear discomfort, Ear infection, Injection site erythema
Clinical narrative: 1 week later: (1) right arm rash, 3 in wide around arm - looks like arm band (2) developed ear infection, took ZPAK from urgent care (3) right ear feels blocked + pain - ENT wants further testing I haven't had ear infection in probably 60 years. (1) Hearing is normal for age in fact above normal. Checked 12/5/19 otolaryngology. 6 week followup for further testing if symptoms persist. (2) rash is still there faintly new, still itches (3) 11/20/19 woke up with blocked ear & pain. Went to urgent care. I was told ear was infected. I took Z-PAK. No change
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity, Rash
Clinical narrative: 1 week later: (1) right arm rash, 3 in wide around arm - looks like arm band (2) developed ear infection, took ZPAK from urgent care (3) right ear feels blocked + pain - ENT wants further testing I haven't had ear infection in probably 60 years. (1) Hearing is normal for age in fact above normal. Checked 12/5/19 otolaryngology. 6 week followup for further testing if symptoms persist. (2) rash is still there faintly new, still itches (3) 11/20/19 woke up with blocked ear & pain. Went to urgent care. I was told ear was infected. I took Z-PAK. No change
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: 1 week later: (1) right arm rash, 3 in wide around arm - looks like arm band (2) developed ear infection, took ZPAK from urgent care (3) right ear feels blocked + pain - ENT wants further testing I haven't had ear infection in probably 60 years. (1) Hearing is normal for age in fact above normal. Checked 12/5/19 otolaryngology. 6 week followup for further testing if symptoms persist. (2) rash is still there faintly new, still itches (3) 11/20/19 woke up with blocked ear & pain. Went to urgent care. I was told ear was infected. I took Z-PAK. No change
Age: 69.0
Sex: M
Vaccine: FLU4, PPV, TD
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient came in on 12/6 with complaints of redness and swelling in right upper arm. Provider saw patient and diagnosed as cellulitis. Patient was also "kicked" by one of their cows on right arm. Patient was given antibiotics.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills, fever and head ache from 12/6/19 AM to Sun. 12/8/19
Age: 8.0
Sex: F
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Cellulitis, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh swelling/induration/warmth 7cm x 10cm developed after vaccines 11/22 seen 12/3 in clinic. Appeared cellulitic started on Keflex
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: 2 weeks after getting Shingrix #1, burning & tingling in legs (right mostly) next 1 1/2 yrs spread to hands & feet
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Flushing, Hyperaesthesia, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Her arm at the site of injection and extending from shoulder to elbow became inflamed, hot to touch, indurated, and the skin was "so sore to touch that it felt like I was burned." She experienced intense sensitivity which lasted for 4 days, and stated it was very painful to move her arm and even touch it. She also developed a band of erythema around her arm above the elbow, that lasted for several days, turned yellow, and eventually disappeared. She increased her fluid intake, applied ice and took Tylenol. She felt flushed, but had no fever. It took 7-10 days to normalize.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Her arm at the site of injection and extending from shoulder to elbow became inflamed, hot to touch, indurated, and the skin was "so sore to touch that it felt like I was burned." She experienced intense sensitivity which lasted for 4 days, and stated it was very painful to move her arm and even touch it. She also developed a band of erythema around her arm above the elbow, that lasted for several days, turned yellow, and eventually disappeared. She increased her fluid intake, applied ice and took Tylenol. She felt flushed, but had no fever. It took 7-10 days to normalize.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Malaise, Myalgia, Pain
Clinical narrative: Feeling achy several hours after immune. 24 hours later chills, hot, states in bed for 24hrs. with malaise, muscle aches States 80% recovered on 12/9/19
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: hives (R) leg evening after vaccines 24 hrs later hives ON trunk, face, (L) & (R) leg
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Peripheral swelling, Urticaria
Clinical narrative: Flu like symptoms, welts on Arm, Swelling of arm, Joint pain.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Imm. givEN 11-13-19 - c/o PAIN, REDNESS, WARMTH TO TOUCH ON 11-14-19 = WORSENING Sx 11-15-10 = SEEN IN OFFICE APPROXIMATELY 7cmx14cm red, warmth, SWelling to INJ. AREA Tx CooL ComPRESSES
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Nausea
Clinical narrative: Patient felt nauseous, lightheaded, and with cold, clammy sweat. Patient was instructed to remain seated with head lowered in between his knees. EMT monitored his BP and it was not elevated per EMS.
Sex: M
Vaccine: FLUR4
Symptoms: Exposure via skin contact, Product quality issue, Syringe issue, Underdose
Clinical narrative: patient may have received a portion or a small bit of the vaccine/no AE; After I squirted it in to him, i checked the needle and it was on tightly/no AE; there was a hole near the hub and that is what caused the leak.The syringe and needle/no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 89 years old male patient who received partial dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Immunodeficiency and Leukaemia.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) for Immunisation.  On 14-Oct-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1912 via unknown route in unknown administration site.  It was of actual medication error due to Vaccine underdose and Exposure via skin contact. It was also a case of Product quality issue. The syringe needle was injected into the patient and then when pharmacist pushed the plunger, the vaccine liquid squirted out from the hub to where it narrows down- the gap between the hub and the syringe- it squirted out there between the glass and the hub of the syringe. The liquid fell out on the chair. The pharmacist stated "it felt like it might not be sterile. There was a hole. The liquid vaccine looked clear and was not cloudy. After pharmacist squirted it in to him, pharmacist checked the needle and it was on tightly. It is not an issue with the needle, but there appears that there was a hole near the hub and that is what caused the leak. The syringe and needle are in the sharps container and are not available for return. The patient may have received a portion or a small bit of the vaccine. The pharmacist gave the patient another dose of the Flublok Quad vaccine of the same lot as the one that leaked. The second syringe was fine. The patient is already immunocompromised. He has leukemia. The pharmacist stated that she is concerned that the vaccine that she gave was not sterile and worries about what could happen as a result to this immunocompromised patient.  It was unknown whether any adverse event was noted or not.  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: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: severe joint soreness some pain and soreness in her right wrist; severe muscle soreness; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 81 years old female patient who experienced severe joint soreness some pain and soreness in her right wrist and severe muscle soreness, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Arthralgia.   On 17-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right deltoid.  On 19-Oct-2019, the patient developed a non-serious severe joint soreness some pain and soreness in her right wrist (arthralgia) and severe muscle soreness (myalgia) 2 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  Final diagnosis was myalgia and arthralgia.  The patient was treated with Ibuprofen 600 mg daily for arthritis, she also used her TENS unit on her right shoulder for her back.  The patient outcome was reported as unknown for myalgia and arthralgia.  Information on batch number is requested.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: not sure how much of the medication the patient got, with no ae; There is a crack in the syringe, with no ae; More of the vaccine got on her arm and her face than she received intramuscularly, with no ae; Initial information received on 21-Nov-2019 regarding an unsolicited valid non-serious case received from an office Staff.   This case involves a 64 years old female patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UJ273AB, expiry date: 30-Jun-2020), via intramuscular route in the Left Deltoid, on 21-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to vaccine underdose and exposure via skin contact. It was also a case of syringe issue as there was a crack in the syringe. When injected the needle in the patient and it felt like it popped and a lot of liquid went out of the syringe. More of the vaccine got on her arm and her face than she received intramuscularly. The crack is not on the area where anyone screw the needle on but it is on that end of the syringe.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Urticaria
Clinical narrative: Patient experienced hives all over body (legs/back/arms/stomach/face) but did not have any reaction around the injection site. Patient did experience tenderness at the injection site.
Age: 0.67
Sex: M
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given outside of approved age range, Flucelvax is not approved until 4 years old
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given an adult dose instead of a pediatrics dose
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Rash, Rash macular, Rash vesicular
Clinical narrative: Rash on upper body, chest, torso, back, arms, looks like shingles but spread out.  Not itchy. Joint pain. Started Saturday morning, used hydrocortisone 1% blotches subsided but still there a little bit.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Acute disseminated encephalomyelitis, Asthenia, CSF culture, CSF electrophoresis normal, CSF oligoclonal band absent
Clinical narrative: ** HAD FLU VACCINE** on 10/18/19  2 yo healthy female sx of altered speech behavior and strength started on 11/28 admitted 12/5 for ADEM (abormal MRI, CSF wnl). High-dose solumedrol, D#5/5 reovering speech walking now said "I want to go home" DIET: reg, IVF--trying to wean to saline lock [ ] CSF cx ntd, -CSF send out to Mayo for multiple sclerosis and encephalitis panel--Pending Ref Range & Units 12/5/19 12:09 PM OLIGOCLONAL BANDS, CSF, ELECTROPHORESIS NO BANDS NO BANDS -to QuestEBV/CMV negative [ ] monitor BP--normal [ ] enterovirus PCR--pending [ ] monitor for clinical improvement Parents asking about tapering steroids at home--tbd by Dr. at discharge(for now he does not feel its necessary)--UTD comments on 4-6 week taper but does not change outcomes. Mother asking if flu vaccine did this--explained that more than a moth after the vaccine where she had symptoms so highly doubtful--Monday team can call VAERs and disc with peds id. Also other vaccines in the future--what to do.  Says some words but not at baseline Stil very irritable throughout the day but motor skills improving. Monday D#5 steroids.  Started NS with kcla bc not great oral intake but only at 20ml/hr and left our glucose given patient on high dose steroids  Abdomen us to r/o teratoma Will be discharging today due to return of speech and motor function improvement
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: CSF test normal, Cytomegalovirus test negative, Enterovirus test, Epstein-Barr virus test negative, Hypophagia
Clinical narrative: ** HAD FLU VACCINE** on 10/18/19  2 yo healthy female sx of altered speech behavior and strength started on 11/28 admitted 12/5 for ADEM (abormal MRI, CSF wnl). High-dose solumedrol, D#5/5 reovering speech walking now said "I want to go home" DIET: reg, IVF--trying to wean to saline lock [ ] CSF cx ntd, -CSF send out to Mayo for multiple sclerosis and encephalitis panel--Pending Ref Range & Units 12/5/19 12:09 PM OLIGOCLONAL BANDS, CSF, ELECTROPHORESIS NO BANDS NO BANDS -to QuestEBV/CMV negative [ ] monitor BP--normal [ ] enterovirus PCR--pending [ ] monitor for clinical improvement Parents asking about tapering steroids at home--tbd by Dr. at discharge(for now he does not feel its necessary)--UTD comments on 4-6 week taper but does not change outcomes. Mother asking if flu vaccine did this--explained that more than a moth after the vaccine where she had symptoms so highly doubtful--Monday team can call VAERs and disc with peds id. Also other vaccines in the future--what to do.  Says some words but not at baseline Stil very irritable throughout the day but motor skills improving. Monday D#5 steroids.  Started NS with kcla bc not great oral intake but only at 20ml/hr and left our glucose given patient on high dose steroids  Abdomen us to r/o teratoma Will be discharging today due to return of speech and motor function improvement
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Irritability, Magnetic resonance imaging abnormal, Motor dysfunction, Polymerase chain reaction, Speech disorder
Clinical narrative: ** HAD FLU VACCINE** on 10/18/19  2 yo healthy female sx of altered speech behavior and strength started on 11/28 admitted 12/5 for ADEM (abormal MRI, CSF wnl). High-dose solumedrol, D#5/5 reovering speech walking now said "I want to go home" DIET: reg, IVF--trying to wean to saline lock [ ] CSF cx ntd, -CSF send out to Mayo for multiple sclerosis and encephalitis panel--Pending Ref Range & Units 12/5/19 12:09 PM OLIGOCLONAL BANDS, CSF, ELECTROPHORESIS NO BANDS NO BANDS -to QuestEBV/CMV negative [ ] monitor BP--normal [ ] enterovirus PCR--pending [ ] monitor for clinical improvement Parents asking about tapering steroids at home--tbd by Dr. at discharge(for now he does not feel its necessary)--UTD comments on 4-6 week taper but does not change outcomes. Mother asking if flu vaccine did this--explained that more than a moth after the vaccine where she had symptoms so highly doubtful--Monday team can call VAERs and disc with peds id. Also other vaccines in the future--what to do.  Says some words but not at baseline Stil very irritable throughout the day but motor skills improving. Monday D#5 steroids.  Started NS with kcla bc not great oral intake but only at 20ml/hr and left our glucose given patient on high dose steroids  Abdomen us to r/o teratoma Will be discharging today due to return of speech and motor function improvement
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound abdomen
Clinical narrative: ** HAD FLU VACCINE** on 10/18/19  2 yo healthy female sx of altered speech behavior and strength started on 11/28 admitted 12/5 for ADEM (abormal MRI, CSF wnl). High-dose solumedrol, D#5/5 reovering speech walking now said "I want to go home" DIET: reg, IVF--trying to wean to saline lock [ ] CSF cx ntd, -CSF send out to Mayo for multiple sclerosis and encephalitis panel--Pending Ref Range & Units 12/5/19 12:09 PM OLIGOCLONAL BANDS, CSF, ELECTROPHORESIS NO BANDS NO BANDS -to QuestEBV/CMV negative [ ] monitor BP--normal [ ] enterovirus PCR--pending [ ] monitor for clinical improvement Parents asking about tapering steroids at home--tbd by Dr. at discharge(for now he does not feel its necessary)--UTD comments on 4-6 week taper but does not change outcomes. Mother asking if flu vaccine did this--explained that more than a moth after the vaccine where she had symptoms so highly doubtful--Monday team can call VAERs and disc with peds id. Also other vaccines in the future--what to do.  Says some words but not at baseline Stil very irritable throughout the day but motor skills improving. Monday D#5 steroids.  Started NS with kcla bc not great oral intake but only at 20ml/hr and left our glucose given patient on high dose steroids  Abdomen us to r/o teratoma Will be discharging today due to return of speech and motor function improvement
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Body aches & tiredness; maybe similar to flu like aches
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Decreased appetite, Fatigue, Muscular weakness, Nausea, Vaccination site erythema
Clinical narrative: Patient reported redness surrounding the area of the pneumococcal vaccination on the right arm. In the same arm she reports weakness that has gotten better over the last 2 days. Additionally she is experiencing fatigue and loss of appetite secondary to nausea. She is taken Tylenol 1-2 tablets per day to control symptoms. She has not checked her temperature but says she does not feel like she is running a fever.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erysipelas, Erythema, Peripheral swelling
Clinical narrative: Pt presented to the ER on 12/6/19 reporting 'a reaction' which was an entirely normal redness and swelling of bilateral deltoids.  Mom claims they went to the ER because school nurse was concerned. Pt was Dx with erysipelas and the vaccines were added to his allergy list by the ER despite notation of 'no evidence of allergic reaction' by the provider.  Today he saw Dr 12/9/19 and there is no sign of redness or warmth or swelling or erysipelas of any type.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, UNK
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chest discomfort, Chills, Condition aggravated
Clinical narrative: Of course arm pain (it was in my left (non-dominant) arm in which I sometimes have discomfort from nerve impingement at my neck & for which I take gabapentin. The pharmacist helpfully instructed me to gently move arm to avoid stiffening. Also I took some Advil before the shot, and that helped, too. The movement and the Advil  helped, and everyone taking this vaccine should be instructed to do so.  The more alarming symptoms were a kind of labored breathing. It's true I have some emphysema and continue to smoke! but this was different. I did feel increased weakness. I have had dizziness sporadically for a year, maybe two  years, and I'm not sure if this vaccine increased or exacerbated that. I felt some general chest  pressure as well as some panic, both of which I sometimes do anyway, and again, I feel the vaccine may have worsened these. I felt a little bit of sweating & chills. My heart beat is usually pretty slow (49, 62 - it varies) but these first several hours after the vaccine it was up to about 72 bpm and not worrisome to me. After about 6 hours or so these symptoms lessened, and I calmed down more as well. I want to mention them because some of my symptoms were on the "Call 911 if this happens" list and I didn't quite know what to do.  (I had an "innocent murmur" at one time in my life and I'm not sure if this is gone, or turned into a calcified aortic vale.)
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Hyperhidrosis, Pain in extremity
Clinical narrative: Of course arm pain (it was in my left (non-dominant) arm in which I sometimes have discomfort from nerve impingement at my neck & for which I take gabapentin. The pharmacist helpfully instructed me to gently move arm to avoid stiffening. Also I took some Advil before the shot, and that helped, too. The movement and the Advil  helped, and everyone taking this vaccine should be instructed to do so.  The more alarming symptoms were a kind of labored breathing. It's true I have some emphysema and continue to smoke! but this was different. I did feel increased weakness. I have had dizziness sporadically for a year, maybe two  years, and I'm not sure if this vaccine increased or exacerbated that. I felt some general chest  pressure as well as some panic, both of which I sometimes do anyway, and again, I feel the vaccine may have worsened these. I felt a little bit of sweating & chills. My heart beat is usually pretty slow (49, 62 - it varies) but these first several hours after the vaccine it was up to about 72 bpm and not worrisome to me. After about 6 hours or so these symptoms lessened, and I calmed down more as well. I want to mention them because some of my symptoms were on the "Call 911 if this happens" list and I didn't quite know what to do.  (I had an "innocent murmur" at one time in my life and I'm not sure if this is gone, or turned into a calcified aortic vale.)
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Panic attack
Clinical narrative: Of course arm pain (it was in my left (non-dominant) arm in which I sometimes have discomfort from nerve impingement at my neck & for which I take gabapentin. The pharmacist helpfully instructed me to gently move arm to avoid stiffening. Also I took some Advil before the shot, and that helped, too. The movement and the Advil  helped, and everyone taking this vaccine should be instructed to do so.  The more alarming symptoms were a kind of labored breathing. It's true I have some emphysema and continue to smoke! but this was different. I did feel increased weakness. I have had dizziness sporadically for a year, maybe two  years, and I'm not sure if this vaccine increased or exacerbated that. I felt some general chest  pressure as well as some panic, both of which I sometimes do anyway, and again, I feel the vaccine may have worsened these. I felt a little bit of sweating & chills. My heart beat is usually pretty slow (49, 62 - it varies) but these first several hours after the vaccine it was up to about 72 bpm and not worrisome to me. After about 6 hours or so these symptoms lessened, and I calmed down more as well. I want to mention them because some of my symptoms were on the "Call 911 if this happens" list and I didn't quite know what to do.  (I had an "innocent murmur" at one time in my life and I'm not sure if this is gone, or turned into a calcified aortic vale.)
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, RV1
Symptoms: Wrong product administered
Clinical narrative: Influenza vaccine given instead of pneumococcal vaccine at 2 months old.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain
Clinical narrative: My arm hurt immediately after getting the flu shot. But I didn't think anything right away as this is typical. The next day it was still bad and didn't go away. It hurt near the shoulder, a sharp pain when I would move  my arm in most directions. Simple things like releasing the parking brake in the car by my knee, pulling a blanket over me in bed. Lifting light things. Opening a door. Everything. I rested it a few days to little but not much improvement. Then things around it started hurting because I wasn't using it and had it glued to my side. My back started freezing up. I was able to treat my back and the things around it with 2 visits to massage therapist specializing in fixing problems. But the shoulder never improved. Still sharp pain from most day to day arm activities with no improvemnt and increasing worry. I finally started in physical therapy after 5 weeks (10/25/19)and I started improving immediately from the strengthening and movement exercises he gave me. These were exercises for shoulder impingement. Bursitis may also describe what I have. I have made consistent progress but it has been a long process. It has been 6 weeks of twice daily physical therapy exercises and icing at home (with 3 PT visits to monitor and increase exercises 10/25, 11/7, 11/22) and now I am able to use my arm more. I still get twinges from most movements and pain (much less than before) from various movements and still have only limited weight-bearing capacity but I continue to do the exercises and go to PT.  Both the doctor and physical therapist asked extensively about other possible causes when I indicated it was due to a flu shot. I said there was no hurt or trauma event and then I've had zero history of shoulder issues and it happens immediately following the flu shot It seems to fit SIRVA shoulder injury related to vaccine administration. My weight and smaller arm muscle mass seem to fit descriptions where the injection can go in too deep and hit the Bursa sack or something else.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray normal
Clinical narrative: My arm hurt immediately after getting the flu shot. But I didn't think anything right away as this is typical. The next day it was still bad and didn't go away. It hurt near the shoulder, a sharp pain when I would move  my arm in most directions. Simple things like releasing the parking brake in the car by my knee, pulling a blanket over me in bed. Lifting light things. Opening a door. Everything. I rested it a few days to little but not much improvement. Then things around it started hurting because I wasn't using it and had it glued to my side. My back started freezing up. I was able to treat my back and the things around it with 2 visits to massage therapist specializing in fixing problems. But the shoulder never improved. Still sharp pain from most day to day arm activities with no improvemnt and increasing worry. I finally started in physical therapy after 5 weeks (10/25/19)and I started improving immediately from the strengthening and movement exercises he gave me. These were exercises for shoulder impingement. Bursitis may also describe what I have. I have made consistent progress but it has been a long process. It has been 6 weeks of twice daily physical therapy exercises and icing at home (with 3 PT visits to monitor and increase exercises 10/25, 11/7, 11/22) and now I am able to use my arm more. I still get twinges from most movements and pain (much less than before) from various movements and still have only limited weight-bearing capacity but I continue to do the exercises and go to PT.  Both the doctor and physical therapist asked extensively about other possible causes when I indicated it was due to a flu shot. I said there was no hurt or trauma event and then I've had zero history of shoulder issues and it happens immediately following the flu shot It seems to fit SIRVA shoulder injury related to vaccine administration. My weight and smaller arm muscle mass seem to fit descriptions where the injection can go in too deep and hit the Bursa sack or something else.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever, fatigue
Age: 1.58
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Edema, erythema, induration from the site of injection on the lateral mid third of the right thigh and progressed the next day to the pubic area involving also her right side vulva, inguinal area.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Extra dose administered
Clinical narrative: Patient was given the Pneumococcal and Influenza vaccine twice over a two month period.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain, Rash, Urticaria
Clinical narrative: Rash/hives over most of the body, sore arm by lymph nodes.  Pt was started on a course of prednisone for 10 days for the rash/hives.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Loss of personal independence in daily activities, Neuropathy peripheral, Paraesthesia
Clinical narrative: Neuropathy of both hands and feet. Burning and pin prick sensations that were significant enough to cause early release from school and one-day absence. The neuropathy continues, one week post vaccine.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count, Rash
Clinical narrative: As per parent patient developed a rash on left arm 1 after flu shot.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: The patient is reporting pain in the area the immunization was given. She reports experiencing pain when raising her arm to brush her hair, for instance. Patient states she believes the shot was given to high up on the arm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Pyrexia
Clinical narrative: Patient received vaccine around 9:25am, and by that evening (~5:00pm) she had fever of 101, chills, headache, and dizziness. By the next morning, she noticed redness around the injection site which started out about dime size, then progressively got larger over the next couple of days to where it was widespread across her upper arm.  Patient visited her MD on 12/5 (the day after the vaccination) and he instructed her to use Benadryl. She then saw the doctor again today (12/9) and she prescribed a course of cephalexin and instructed patient to take Claritin.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient reported right arm swelling at site of injection on 12/09/19.  Patient does state the swelling is improving.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Parent reported to MD that child broke out with a rash and had full-blown chickenpox the night of his vaccine administration. This lasted for 2 weeks.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Wrong product administered
Clinical narrative: Kinrix (Dtap & IPV) was given instead of Pediarix (Dtap, IPV, and Hep B).   Parents were informed.  CDC was called.   There is no harm to the patient.  Event was documented within our facility.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Patient complained of dizziness.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Dizziness, Dyspnoea, Flushing, Heart rate increased
Clinical narrative: Immediate flushing of the face, elevated heart-rate, dizziness, burning of the lungs and throat and shortness of breath. Recovered quickly (<1hr, and I saw no need to tell a doctor)
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Throat irritation
Clinical narrative: Immediate flushing of the face, elevated heart-rate, dizziness, burning of the lungs and throat and shortness of breath. Recovered quickly (<1hr, and I saw no need to tell a doctor)
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: nausea, sore arm (injection site), other sore muscles, headache, no appetite, eyes sensitive to light.  Affect for about 12 hours.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Photophobia
Clinical narrative: nausea, sore arm (injection site), other sore muscles, headache, no appetite, eyes sensitive to light.  Affect for about 12 hours.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Alcoholic hangover, Chills, Exercise tolerance decreased, Fatigue
Clinical narrative: Injection site felt painful right after the injection and the pain  escalated and continued for 2 days and then started falling off.  Cannot sleep on the shoulder as the pain is felt when laying on the side / shoulder.  About 3 hours after the shot started feeling overly tired and achey all over.   During the night developed a head ache and spells of feeling very cold.  The  next morning felt like  I had an alcohol hangover on top of the flu.  Tried to get on with my day.  About noon just couldn't do any more.  Retired to the recliner where I spent the day and evening. Fever went up to 100.3.  Several bouts of chills, upset stomach and constant headache.   60 hours after the shot feel about 70% recovered.  Still cannot go thru a full exercise routine.  Hope to be better tomorrow.                                           QUESTION - is this vaccine 1 size fits all?  I am wondering if it is sized for the largest possible person say at 300 pounds.  I'm 135 pounds.  I'm thinking a smaller but still yet effective dose might not provide as sever a reaction.      Based on this experience I'm not sue if I'll go through with the second shot.