chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Excessive redness and swelling and pain at the injection site. Benadryl by mouth and cold compress to arm.
Age: 64.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Induration
Clinical narrative: Very large  redness with induration and blisters.
Age: 1.0
Sex: M
Vaccine: FLUX, MMR, PPV, VARCEL
Symptoms: Cough, Croup infectious, Culture throat, Diarrhoea, Injection site erythema
Clinical narrative: Fever, fussiness, watery stools, one shot side red and swollen, Croup cough, viral syndrome. Fever continues for 5-6 days. Cough is still continuing. First time ER visit: 10/29/2016 10:55 - albuterol (albuterol 0.5% for nebulization) - 2.5 mg, 10/29/2016 11:19 - dexamethasone - 2 mg. Second time ER visit: 10/31/2016 12:03 - dexamethasone - 6 mg.
Age: 1.0
Sex: M
Vaccine: FLUX, MMR, PPV, VARCEL
Symptoms: Injection site swelling, Irritability, Pyrexia, Respiratory syncytial virus test, Viral infection
Clinical narrative: Fever, fussiness, watery stools, one shot side red and swollen, Croup cough, viral syndrome. Fever continues for 5-6 days. Cough is still continuing. First time ER visit: 10/29/2016 10:55 - albuterol (albuterol 0.5% for nebulization) - 2.5 mg, 10/29/2016 11:19 - dexamethasone - 2 mg. Second time ER visit: 10/31/2016 12:03 - dexamethasone - 6 mg.
Age: 28.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives - red and itchy on both arms, stomach and lower back - just a few bumps on each area.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Excessive redness swelling and pain at the injection site measuring over 8 inches across. needing Benadryl, a course of prednisone.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HIBV, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: PENTACEL vaccine was administered with only the DTaP and IPV portion of vial. Contacted Health Department to verify only HIB portion needed to be administered.  HIB portion administered.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Excessive swelling redness and pain at the injection site. Benadryl by mouth and cold compress at site. Reaction was about 3 inches across.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Lip blister
Clinical narrative: Small blisters all around lips and top lip was all one big blister.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: "EXCRUTIATING PAIN" IN THE SPOT WHERE SHE RECEIVED HER FLU SHOT 10/11/2016...
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Decerebrate posture, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Initial unsolicited report received from a pharmacist on 26 Oct 2016. This case involves a 12-year-old male patient who was vaccinated with second dose of FLUZONE QIV (batch number: UI678AE, expiry date: 30 Jun 2017, dose, route of administration were not reported) in left deltoid on 25 Oct 2016 at 5:30 PM. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions no known allergy (NKA), History of syncope in the past. The patient did not receive any concomitant medications. On 25 Oct 2016 at 5:30 PM, immediately following the vaccination, the patient fainted in the chair they laid him flat on a surface after about 8 seconds during this time he was having decerabrate posturing. Same day the patient held in the clinic for about 30 minutes after the incident and then sent him home with his family." The laboratory investigations were not performed. The corrective treatment was not reported. On 25 Oct 2016, the patient was recovered from the event (decerabrate posturing lasted only a few seconds and he returned to consciousness after 1 min). Upon medical review, the case was considered as serious due to important medical event: having decerabrate posturing. List of documents held by sender: none. Sender's Comments: This case concerns a 12 year old male patient who fainted followed by having a decerebrate posture immediately after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Time to onset is compatible with role of vaccine. The subject has a history of syncope in the past. However details such as, previous immunization history and tolerance, concurrent conditions, patient immune status at the time of vaccination and diagnostic work-up to confirm alternative etiology/diagnosis etc. are needed for complete assessment of the case.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Dysarthria, Transient ischaemic attack
Clinical narrative: Initial unsolicited case received from a physician on 26 October 2016. This case involves a 79-year old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose number form, route and site of administration) on an unspecified date. Patient's medical history and concomitant medications were not reported. On 26 October 2016, two hours post vaccination, patient experienced slurred speech and other signs of TIA. Laboratory data and corrective medications were not reported. Outcome of the event were not reported. Upon internal review, the company decided to consider the event serious because of important medical events' TIA and slurred speech. List of documents held by sender: none.; Sender's Comments: Transient ischaemic attack is unlisted with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is compatible with the role of the vaccine. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Excessive redness, swelling and pain at the injection site measuring about 3 inches across. Benadryl by mouth and cold compress.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Hives and itching all over. Went to ED. Fluids, benadryl, solumedrol.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Febrile convulsion
Clinical narrative: FEBRILE SEIZURE.
Age: 47.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Pain in right arm at injection site.  Symptoms have persisted and worsened.  Aches all night and range of motion is limited.  Taking Advil to see if it will help.  Has not gotten better.
Age: 47.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in right arm at injection site.  Symptoms have persisted and worsened.  Aches all night and range of motion is limited.  Taking Advil to see if it will help.  Has not gotten better.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: I had pain in my arm. Did not look at it again until I got home from work the next day. Site were shot was given from raised, red, itchy and painful. There was a large orange shaped circle around the injection site. I felt ill went to bed. The next morning I called doctors office and they advised me to come to urgent care. Seen Doctor he diagnosed as a localized reaction. Gave me prednisone and told me to take antihistamines. Swelling was greatly reduced after a few hours of prednisone. Still a bruise and some itching.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Local reaction, Malaise, Pain in extremity, Pruritus
Clinical narrative: I had pain in my arm. Did not look at it again until I got home from work the next day. Site were shot was given from raised, red, itchy and painful. There was a large orange shaped circle around the injection site. I felt ill went to bed. The next morning I called doctors office and they advised me to come to urgent care. Seen Doctor he diagnosed as a localized reaction. Gave me prednisone and told me to take antihistamines. Swelling was greatly reduced after a few hours of prednisone. Still a bruise and some itching.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: When she went to bed she noticed arm hurt really bad, and she had a big bump at the injection site, that was pink in color and warm to the touch. A hardened area, aprox 2 inches in diameter.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Influenza like illness, Injection site pain, Nausea, Pain
Clinical narrative: APPROXIMATELY 5 HOURS AFTER SECOND SHOT, I STARTED TO HAVE TINGLING, HOT NEEDLE TYPE PAIN, HEADACHE, NAUSEA, FLU LIKE SYMPTOMS. ADVISED DR AT NEXT APPT FOR THE THIRD VACCINE. RECEIVED THIRD VACCINE ON 11/3/2016. THREE DAYS LATER BEGAN HAVING PAIN IN RIGHT DELTOID WHERE I RECEIVED SECOND VACCINE ON 10/30 AS WELL AS TINGLING AND ITCHING  IN ARMS AND FACE.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia, Pruritus
Clinical narrative: APPROXIMATELY 5 HOURS AFTER SECOND SHOT, I STARTED TO HAVE TINGLING, HOT NEEDLE TYPE PAIN, HEADACHE, NAUSEA, FLU LIKE SYMPTOMS. ADVISED DR AT NEXT APPT FOR THE THIRD VACCINE. RECEIVED THIRD VACCINE ON 11/3/2016. THREE DAYS LATER BEGAN HAVING PAIN IN RIGHT DELTOID WHERE I RECEIVED SECOND VACCINE ON 10/30 AS WELL AS TINGLING AND ITCHING  IN ARMS AND FACE.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Feeling hot, Lethargy
Clinical narrative: The day following the influenza vaccine, the patient had a fever up to 104 F with thermodysregulation (chills, then hot).  Scalp pain. Fatigue, lethargy, and weakness.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Pain of skin, Pyrexia, Temperature regulation disorder, Temporal arteritis
Clinical narrative: The day following the influenza vaccine, the patient had a fever up to 104 F with thermodysregulation (chills, then hot).  Scalp pain. Fatigue, lethargy, and weakness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Cardiac stress test, Chest pain, Electrocardiogram, Hypertension
Clinical narrative: Chest pain accompanied by high blood pressure.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX
Symptoms: Dizziness, Presyncope
Clinical narrative: Became dizzy and nearly fainted.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Dizzy x 30 min after HPV.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Lethargy, Secretion discharge
Clinical narrative: DIZZINESS. CHEST TIGHTENING. MUCUS. LETHARGY.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Asthenia, Burning sensation, Fatigue, Pharyngeal oedema
Clinical narrative: Anaphylactic reaction: vomiting, weakness, fatigue, throat swelling, tongue swelling and burning. No known food allergies, including no allergy to eggs.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Vomiting
Clinical narrative: Anaphylactic reaction: vomiting, weakness, fatigue, throat swelling, tongue swelling and burning. No known food allergies, including no allergy to eggs.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pt reports localized rash with mild swelling and itching progressing from injection site halfway to elbow. Began appx 1-2 hours after injection and has continued to contact by phone today. Pt reports a mild cough which she believes is unrelated as she has had for several days previous. No other sequelae noted. Advise pt to use cold compress and perhaps an antihistamine. She is to see her PCP today on an unrelated issue but will ask that provider to also take a look.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Immediate pain in upper arm upon injection. Trouble lifting arm and very painful in shoulder when lifting arm. Next few days were worse pain. Have had severe pain through today and numbness and burning in my shoulder area.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Immediate pain in upper arm upon injection. Trouble lifting arm and very painful in shoulder when lifting arm. Next few days were worse pain. Have had severe pain through today and numbness and burning in my shoulder area.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Aphonia, Arthralgia, Asthenia, Back pain, Discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old  female patient received PREVNAR 13 (Lot# L99262, Exp Date Nov2016), intramuscular at 0.5 ml, single in the left upper arm, on 24Nov2015 for immunisation. Medical history included stage 2 kidney disease from 2014 and ongoing, back surgery in 2001 and in May2015. Concomitant medication included lisinopril since 2006 and ongoing, amlodipine since 2011 and ongoing. On 30Nov2015, the patient experienced slight dull headache, lower back pain, pain in the side around her waist area, joint pain in the knees, muscle aches, fatigue, general feeling of discomfort or illness, couldn't lie down to sleep, pain shooting in her legs, shooting to the back of her arms, 9 on a scale of 0 to 10, severe stiff neck towards her shoulder, general feeling of discomfort or illness, sometimes loses her voice and becomes hoarse, shakiness. In Nov 2016, the patient was hospitalized due to these events and was treated with Dilaudid with outcome of recovered. Also experienced feels weak on 30Nov2015 with outcome of unknown, pain gets much worse when lying down on an unspecified date with outcome of unknown.  Follow-up (03MAR2016): Follow-up attempts completed. No further information expected. Follow-up (31Oct2016):  New information obtained from a contactable consumer includes: Concomitant added, outcome, treatment received, and hospitalization.; Sender's Comments: Linked Report(s) : 2015423784 Legacy paper report number.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Dysphonia, Fatigue, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old  female patient received PREVNAR 13 (Lot# L99262, Exp Date Nov2016), intramuscular at 0.5 ml, single in the left upper arm, on 24Nov2015 for immunisation. Medical history included stage 2 kidney disease from 2014 and ongoing, back surgery in 2001 and in May2015. Concomitant medication included lisinopril since 2006 and ongoing, amlodipine since 2011 and ongoing. On 30Nov2015, the patient experienced slight dull headache, lower back pain, pain in the side around her waist area, joint pain in the knees, muscle aches, fatigue, general feeling of discomfort or illness, couldn't lie down to sleep, pain shooting in her legs, shooting to the back of her arms, 9 on a scale of 0 to 10, severe stiff neck towards her shoulder, general feeling of discomfort or illness, sometimes loses her voice and becomes hoarse, shakiness. In Nov 2016, the patient was hospitalized due to these events and was treated with Dilaudid with outcome of recovered. Also experienced feels weak on 30Nov2015 with outcome of unknown, pain gets much worse when lying down on an unspecified date with outcome of unknown.  Follow-up (03MAR2016): Follow-up attempts completed. No further information expected. Follow-up (31Oct2016):  New information obtained from a contactable consumer includes: Concomitant added, outcome, treatment received, and hospitalization.; Sender's Comments: Linked Report(s) : 2015423784 Legacy paper report number.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pain, Pain in extremity, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old  female patient received PREVNAR 13 (Lot# L99262, Exp Date Nov2016), intramuscular at 0.5 ml, single in the left upper arm, on 24Nov2015 for immunisation. Medical history included stage 2 kidney disease from 2014 and ongoing, back surgery in 2001 and in May2015. Concomitant medication included lisinopril since 2006 and ongoing, amlodipine since 2011 and ongoing. On 30Nov2015, the patient experienced slight dull headache, lower back pain, pain in the side around her waist area, joint pain in the knees, muscle aches, fatigue, general feeling of discomfort or illness, couldn't lie down to sleep, pain shooting in her legs, shooting to the back of her arms, 9 on a scale of 0 to 10, severe stiff neck towards her shoulder, general feeling of discomfort or illness, sometimes loses her voice and becomes hoarse, shakiness. In Nov 2016, the patient was hospitalized due to these events and was treated with Dilaudid with outcome of recovered. Also experienced feels weak on 30Nov2015 with outcome of unknown, pain gets much worse when lying down on an unspecified date with outcome of unknown.  Follow-up (03MAR2016): Follow-up attempts completed. No further information expected. Follow-up (31Oct2016):  New information obtained from a contactable consumer includes: Concomitant added, outcome, treatment received, and hospitalization.; Sender's Comments: Linked Report(s) : 2015423784 Legacy paper report number.
Age: 1.25
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Local swelling, Skin warm
Clinical narrative: This health care professional reported the same event for 2 patients. This is the first of two reports. This is a spontaneous report from a contactable health care professional (HCP). A 15-month-old male patient received PREVNAR) lot number N47827, expiration date Nov2017), via an unspecified route of administration, in the left thigh, on 26Oct2016, as single dose for immunization. The patient's medical history was not reported. Concomitant medication included varicella zoster vaccine (TRADE NAME UNSPECIFED, Lot number N47827, expiration date May2018), in the left arm as single dose for immunization. The patient previously received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein), as first dose, lot number M51192, expiration date May2017, on 05Feb2016 in the right thigh for immunization and experienced no adverse reaction. On 28Oct2016, the patient experienced 5x5 raised hot mark on thigh. The patient visited a physician office due to event. The outcome of 5x5 raised hot mark on thigh was not recovered at the time of reporting on 02Nov2016.; Sender's Comments: Linked Report(s): US-PFIZER INC-2016512480 Same reporter, same drug, same event, different patient.
Age: 1.42
Sex: F
Vaccine: PNC
Symptoms: Local swelling, Skin warm
Clinical narrative: This health care professional reported the same event for 2 patients. This is the second of two reports. This is a spontaneous report from a contactable health care professional (HCP). A 17-month-old female patient received PREVNAR (lot number N47827, expiration date Nov2017), via an unspecified route of administration, in the left thigh, on 31Oct2016, as single dose for immunization. The patient's medical history was reported as none. Concomitant medication included FLU SHOT, as single dose for immunization. The patient previously received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein), as first dose, lot number M27767, expiration date Apr2017, on 16Dec2015 in the right arm for immunization. On 01Nov2016, the patient experienced 5x5 raised hot mark on thigh. The outcome of 5x5 raised hot mark on thigh was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016512345 Same reporter, same drug, same event, different patient.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chest pain, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable physician reported through a Pfizer sales representative. A 18-year-old male patient of an unspecified race received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced pain throughout the shoulder and upper chest area on an unspecified date with outcome of unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient of a unspecified age and race received a single dose of PREVNAR 13 on an unknown date for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced rash on the injection site. The event was resolving at time of report. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 02-AUG-2016, the patient was vaccinated with improperly stored (wistar ra 27-3) M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dysphonia, Dyspnoea, Speech disorder, Throat tightness
Clinical narrative: Started to have trouble breathing, tight chest, throat started to get tight. Had trouble talking, voice going hoarse. Became very hard to breathe. 04:30 pm gave myself a shot of EPI and took Benadryl and my inhaler.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Abasia, Autism spectrum disorder, Injection site mass, Lethargy, Pyrexia
Clinical narrative: Fever 102. Lethargy, unable to walk. large lump in thigh at injection sight.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Right arm, red and swollen and hot to touch- per patient- right wrist to the upper arm.  Patient called into today 11/7/16 to report this reaction, swelling much less and redness only slightly at right elbow now.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Local swelling
Clinical narrative: Swelling of large area on arm, cellulitis.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Tongue disorder
Clinical narrative: Lightheadedness and thick tongue.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Death
Clinical narrative: PT rec'd flu shot at an off site school clinic on 10-26-16, a friend of the pt stated pt had died; pt had been found deceased by her children that morning.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Cold sweat, Decreased appetite, Dizziness
Clinical narrative: Patient was fine all day until 5pm. Shaking, chills, vomiting, chest pains, cold sweats, fever of 101 degrees, chest pain, light headed, tired, no appetite. ER could not find a cause, other than the flu shot received.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pyrexia, Tremor, Vomiting
Clinical narrative: Patient was fine all day until 5pm. Shaking, chills, vomiting, chest pains, cold sweats, fever of 101 degrees, chest pain, light headed, tired, no appetite. ER could not find a cause, other than the flu shot received.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: C-reactive protein increased, Cellulitis, Infection, White blood cell count abnormal
Clinical narrative: Vaccinated 10-24 3PM  with PNEUMOVAX 23 (also receive  FLUZONE HD in other  arm). By 12PM  on 10-25 visited doctor and they gave her BACTRIM DS for suspected cellulitis in left arm (PNEUMOVAX 23). By 4PM  on 10-25 sx worse and went to hospital and received vancomycin around 8PM  on 10-25 and again Thursday am on 10-26. She was allowed to go home and has completely recovered  from cellulitis infection.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Redness, warmth at injection site -> cellulitis.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: STARTED WITH STING SENSATION AND PROGRESS TO REDNESS AND ITCHING WHICH COVERS AREA BELOW THE SITE OF INJECTION FOR TWO DAYS AND THE PRIMARY CARE PHYSICIAN ASSISTANCE PRESCRIBED KEFLEX.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Office visit for Arm Pain: Onset: 2 days ago.  Duration: more than 1 hour. Severity level is moderate.  It occurs constantly and is worsening. Location: left (upper arm). The pain radiates to the  The pain is aching and throbbing. Context: there is no injury.  The pain is aggravated by movement. There are no relieving factors.  Associated symptoms include swelling.  Pertinent negatives include joint tenderness and tingling in the arms. Additional information: pt had two vaccines in upper arm 2 days ago, started having pain, swelling in area and them became red and warm, painful to move arm, has not taken anything for pain. Assessment and Plan:  Cellulitis of the left upper extremity.  Will not give antibiotic shot due to possible cross allergy with PCN (Rx sent to pharm).  Use ice pack or heat on area to help with pain and swelling, if gets worse, redness spreads, start to run a fever please go to the emergency room for treatment. Follow up with us in one week or sooner if needed, if better do not need to follow up. I called patient today (11/7) and he says his L shoulder is still tender to the touch.  He says the redness and swell is down, doesn't feel it.  He is still taking the antibiotic.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain
Clinical narrative: Office visit for Arm Pain: Onset: 2 days ago.  Duration: more than 1 hour. Severity level is moderate.  It occurs constantly and is worsening. Location: left (upper arm). The pain radiates to the  The pain is aching and throbbing. Context: there is no injury.  The pain is aggravated by movement. There are no relieving factors.  Associated symptoms include swelling.  Pertinent negatives include joint tenderness and tingling in the arms. Additional information: pt had two vaccines in upper arm 2 days ago, started having pain, swelling in area and them became red and warm, painful to move arm, has not taken anything for pain. Assessment and Plan:  Cellulitis of the left upper extremity.  Will not give antibiotic shot due to possible cross allergy with PCN (Rx sent to pharm).  Use ice pack or heat on area to help with pain and swelling, if gets worse, redness spreads, start to run a fever please go to the emergency room for treatment. Follow up with us in one week or sooner if needed, if better do not need to follow up. I called patient today (11/7) and he says his L shoulder is still tender to the touch.  He says the redness and swell is down, doesn't feel it.  He is still taking the antibiotic.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Chills and Fever of 101.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Patient reported no signs/symptoms of reaction at time of administration. Patient reports signs of adverse event starting on 11/6 with presentation back to pharmacy on 11/7/16. Left arm sight of injection. Site was red and inflamed, approximately 5 inches in diameter, with a small, hard, raised area at the sight of injection, tender to touch. Possible cellulitis. Recommended patient to urgent care/physician office visit for further evaluation and probable antibiotic therapy.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-11-01.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Right facial droop/bells palsey.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Evening of 11/4/2016 mother noted about a 5cm size redness/itching around the injectin site. On Saturday 11/5/16 the redness became tense to the touch and had increased to 10cm by 12cm in size with the center being purplish in color. Child brought the the emergency room. Vital signs stable, no fever. Provider gave rx for Keflex. On Saturday night the redness had spread to groin area. By Sunday morning redness reduced in color and size. Monday 11/07/2016 redness just pink.
Age: 20.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: C-reactive protein, Electrocardiogram normal, Full blood count, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Started with numbness in left arm the evening of 11/06/2016.  Numbness then went to face and then went down entire left side.  Numbness comes and goes in these areas.  She slept all night and then woke up next day in a.m. with left handed numbness. Received VARIVAX, ADACEL, and FLUZONE on 11/03/2016.  Went to Urgent Care and had EKG done which was normal. Reported that they are suspecting Gullaine Barres.  CBC, CMP, CRP, and ESR done and results are pending.
Age: 20.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Started with numbness in left arm the evening of 11/06/2016.  Numbness then went to face and then went down entire left side.  Numbness comes and goes in these areas.  She slept all night and then woke up next day in a.m. with left handed numbness. Received VARIVAX, ADACEL, and FLUZONE on 11/03/2016.  Went to Urgent Care and had EKG done which was normal. Reported that they are suspecting Gullaine Barres.  CBC, CMP, CRP, and ESR done and results are pending.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: AS soon as the vaccine was given, a hard lump developed under the skin and kept growing. The area bruised and got hot after about 20 minutes. I spoke with the nurse and they may see her if it continues to be bothersome. The patient went home to put ice on the area.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Chest discomfort, Dizziness, Muscular weakness
Clinical narrative: Case number PHEH2016US028448, is an initial spontaneous report from a nurse received on 31 Oct 2016. This report refers to a 51 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185888 and expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 31 Oct 2016. On the same day after vaccination, the patient felt lightheaded, dizzy and weak, her legs felt like jelly and felt tightness in her chest. The discomfort started an hour or less after she received her vaccine. It was reported that, her vitals were monitored at the health center where she worked. The outcome of events was reported as unknown. Seriousness of the events was reported as disability by the nurse. The causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Immediately after the injection my left upper arm hurt very badly and did not subside after several days. Eventually, the pain spread to the shoulder and down my arm into my left thumb which is now partially numb. I have limited range of motion. Some days are not as bad as others, but the pain is constant.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Red, swollen, "hard".
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt's arm became swollen, red, and sore below the site of injection (not on the site).  It is still currently red, swollen and sore. He developed a fever of 103.5 F for 3 days which has resolved as of the time of reporting (11/7/2016 11:50 AM). Has been treating with acetaminophen and ice, and is currently in constant contact with the doctor regarding his condition.  He has not been physically seen by the MD.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Father presented patient for flu vaccination without knowing the patient's mother took the patient for a flu shot the previous day. Flu vaccine administered both days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site is sore, red and swollen to about the size of a quarter.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Injection site rash, Injection site swelling
Clinical narrative: Large injections site swelling/rash; nausea, loss of appetite; loose bowel movements; fatigue.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: Large injections site swelling/rash; nausea, loss of appetite; loose bowel movements; fatigue.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient has a bump at the injection site that has a white head with a dark red ring around the base. The patient also reports arm soreness.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Eye movement disorder, Seizure
Clinical narrative: Per ED physician report, patient left Pediatric office post flu vaccine and began seizing within 30 minutes. Mother took patient to Medical Center Emergency Department. Per ED physician, patient had several seizures and was in the process of transferring to hospital.
Age: 71.0
Sex: M
Vaccine: FLU3, HIBV, MNQ
Symptoms: Acute kidney injury, Chronic kidney disease, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea
Clinical narrative: Patient complained of shortness of breath and respiratory distress secondary to COPD. There was also acute on chronic renal failure and was admitted for evaluation and treatment.
Age: 71.0
Sex: M
Vaccine: FLU3, HIBV, MNQ
Symptoms: Respiratory distress
Clinical narrative: Patient complained of shortness of breath and respiratory distress secondary to COPD. There was also acute on chronic renal failure and was admitted for evaluation and treatment.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site movement impairment, Injection site pain
Clinical narrative: Very sore deltoid muscle for the past 10 days. Patient states soreness is only in the muscle, but it is restricting range of motion.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Influenza virus test negative, Nuclear magnetic resonance imaging normal, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient vomited and had fever that night. Went to doctor's office next day (Thursday) and had swelling/pain on arms and legs. Dr. recommended going to ER. At ER, patient was treated empirically with Vancomycin and Cipro. Patient was found to be septic. MRI and Ultrasound were negative. Treated with steroids and patient sent home Tuesday evening (10/30).
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Sepsis, Ultrasound scan normal, Vomiting
Clinical narrative: Patient vomited and had fever that night. Went to doctor's office next day (Thursday) and had swelling/pain on arms and legs. Dr. recommended going to ER. At ER, patient was treated empirically with Vancomycin and Cipro. Patient was found to be septic. MRI and Ultrasound were negative. Treated with steroids and patient sent home Tuesday evening (10/30).
Age: 17.0
Sex: F
Vaccine: HEP, IPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Swelling/redness of site with fever.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Pain in extremity
Clinical narrative: Extreme arm pain, redness, and inflammation in the injected arm.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Skin exfoliation
Clinical narrative: Skin peels.
Age: 4.0
Sex: M
Vaccine: DTPIPV, FLU4, MMRV
Symptoms: Dermatitis contact
Clinical narrative: Contact dermatitis. Possible contact dermititis - use callowman lotion or benadryl if itching localized adverse reaction to administration of drug. Possible localized reaction to administration of the MMR vaccine.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Headache that latest for 5 days. It was concentrated in my forehead and eye area. My husband and 2 daughters were vaccinated a week later, and one daughter (of 2 children) and my husband both had headaches develop the day after their vaccinations. We have never had this sort of reaction to a flu vaccination before. Their headaches lasted 1 to 2 days.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised, Varicella
Clinical narrative: Patient contacted her doctor after she developed a rash all over her body consistent with chicken pox. Itching.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Malaise, Pyrexia
Clinical narrative: Patient felt "unwell", then seven days later, no appetite, fever, fatigue and chills.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Constipation, Feeling hot, Hypotonia, Incontinence
Clinical narrative: Loss of normal leg function (flopping). Sensation of heat flowing down legs which eventually kept rising to the mid section. Incontinence. Constipation. Tingling of multiple body parts.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Loss of normal leg function (flopping). Sensation of heat flowing down legs which eventually kept rising to the mid section. Incontinence. Constipation. Tingling of multiple body parts.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: Migraine Headache.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling drunk, Impaired work ability, Local reaction, Nausea
Clinical narrative: Had a large local reaction with pain and swelling.  Woke up with shaking all over and nausea without vomiting.  Felt "drunk" and woozy 11/02 and called in sick.  Was "woozy" for 2 days and then that resolved.  Still feels shaky in hands but getting better one week later.  No leg weakness or numbness.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Swelling, Tremor
Clinical narrative: Had a large local reaction with pain and swelling.  Woke up with shaking all over and nausea without vomiting.  Felt "drunk" and woozy 11/02 and called in sick.  Was "woozy" for 2 days and then that resolved.  Still feels shaky in hands but getting better one week later.  No leg weakness or numbness.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Grand mal seizure resulting in 911 call/ambulance to ER.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Erythema, Nausea, Pain in extremity, Rash macular
Clinical narrative: Mom said patient developed erythema after the injection with white splotchy spots from the face and over the body. Her arm was also completely sore. She later on 11/6/16 developed nausea and vomiting with diarrhea.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Mom said patient developed erythema after the injection with white splotchy spots from the face and over the body. Her arm was also completely sore. She later on 11/6/16 developed nausea and vomiting with diarrhea.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth, Limb discomfort
Clinical narrative: SYMPTOMS OF DISCOMFORT FROM DELTOID TO WRIST OF LEFT ARM FOR 2 DAYS, THEN THIS STOPPED.  REDNESS CONTINUED TO DEVELOP TO CIRCUMFERENCE OF BASEBALL AT INJECTION SITE. THAT AREA STILL WARM TO TOUCH AS OF 11-7-16.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site discharge, Injection site infection, Injection site pustule, Injection site swelling, Injection site vesicles
Clinical narrative: PATIENT HAD SWELLING/BLISTERING AND INFECTED LOOKING SKIN AROUND AREA OF ADMINISTRATION. NO PUSS OR SEEPING WAS OBSERVED AT TIME THE PATIENT PRESENTED, HOWEVER, THE PATIENT DID STATE THAT HE HAD OBSERVED SOME PUSS AND SEEPING IN THE PREVIOUS DAYS. UPON EXAMINATION, I RECOMMENDED THAT THE PATIENT SEE HIS PRIMARY CARE DOCTOR, AS THIS DID LOOK LIKE AN INFECTION, BUT BASED ON THE PRESENTATION DATE, WAS NOT UNDER THE IMPRESSION THAT THE ADVERSE EVENT WOULD BE RELATED TO THE IMMUNIZATION.
Age: 85.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: On 11/6 the patient began itching on his right upper arm, upon examination there was a small red spot near the vaccination site, the next morning the patient presented to the pharmacy around 10:30 am and displayed a red spot approximately 6 inches in diameter.  Recommended benadryl for the next two days and monitoring.  Told the patient to call back with any further worsening or questions.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Muscular weakness
Clinical narrative: Left arm/shoulder weakness, difficulty with adduction and forward flexion with arm fully extended.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Loss of consciousness, Muscle spasms
Clinical narrative: Patient states after getting vaccinations she passed out at home and called EMS. Patient states having muscle spasm come/go for past couple weeks .. not severe.. past week they have gotten worse.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Pain in extremity, Syncope
Clinical narrative: Spoke to mother of child via telephone about 6:30pm regarding possible vaccine reaction. I advised to ER and that I would follow up Monday with her. She stated the child said his legs hurt and felt tired. I told her it could be nothing serious but to proceed to the ER regardless, she said she would.
Age: 4.0
Sex: F
Vaccine: DTIPV, FLU4, MMRV
Symptoms: Chest pain, Erythema, Lethargy, Pain in extremity, Pallor
Clinical narrative: Chest hurt, pale, lethergy, body itchy, rash, feet turned red and painful.
Age: 4.0
Sex: F
Vaccine: DTIPV, FLU4, MMRV
Symptoms: Pruritus, Rash
Clinical narrative: Chest hurt, pale, lethergy, body itchy, rash, feet turned red and painful.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site pustule, Injection site swelling
Clinical narrative: Swelling & redness at sight of injection, small pustule visible.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy on upper right side.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site infection, Rash erythematous
Clinical narrative: Pt developed infection in injection arm (right arm) but it's around the bicep and inner arm.  The infection seems to be seperate from the deltoid where the PNEUMOVAX was administered.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Hives, difficulty breathing.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Guillain-Barre syndrome, Nausea, Nerve conduction studies, Vomiting
Clinical narrative: Nausea, vomiting, weakness, came to our office then went to see neurologist and was diagnosed with Guillain Barre syndrome, we have received confirmation from Dr's office of the Guillain Barre syndrome.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue
Clinical narrative: Severe fatigue for 24 hours.
Age: 47.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Insomnia, Pain, Pain in extremity
Clinical narrative: Pain, weakness and loss of movement in the left shoulder.  Symptoms got worse as the days went by and I was having trouble sleeping. I made an appointment and went to an Orthopaedic doctor on October 31, 2016. I was diagnosed with impingement of the shoulder and treated with a cortisone injection.  As of today, November 7, 2016 the symptoms have not gotten any better and the pain is now extended down my left arm into my hand.
Age: 47.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Rotator cuff syndrome, X-ray limb
Clinical narrative: Pain, weakness and loss of movement in the left shoulder.  Symptoms got worse as the days went by and I was having trouble sleeping. I made an appointment and went to an Orthopaedic doctor on October 31, 2016. I was diagnosed with impingement of the shoulder and treated with a cortisone injection.  As of today, November 7, 2016 the symptoms have not gotten any better and the pain is now extended down my left arm into my hand.
Age: 47.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Pain, weakness and loss of movement in the left shoulder.  Symptoms got worse as the days went by and I was having trouble sleeping. I made an appointment and went to an Orthopaedic doctor on October 31, 2016. I was diagnosed with impingement of the shoulder and treated with a cortisone injection.  As of today, November 7, 2016 the symptoms have not gotten any better and the pain is now extended down my left arm into my hand.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Today is 11/7/2016. My Shoulder and arm are still sore. My little finger tingles like it is asleep. The soreness kind of moves up and down from my shoulder to elbow, but hasn't gone away.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Abasia, Cold sweat, Depressed level of consciousness, Dizziness, Head discomfort
Clinical narrative: After 5 minutes of being given the shot, I became clammy, pale, dizzy, heavy headed, and my BP was high.  My BP is never high.  I couldn't walk, and felt like I was passing out. EMT's came to check everything.  My BP went down, and about 15 mins later I felt ok.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Hypertension, Pallor
Clinical narrative: After 5 minutes of being given the shot, I became clammy, pale, dizzy, heavy headed, and my BP was high.  My BP is never high.  I couldn't walk, and felt like I was passing out. EMT's came to check everything.  My BP went down, and about 15 mins later I felt ok.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Chest pain, Pain in extremity, Rash, Swelling
Clinical narrative: Patient developed rash on arm and pain down arm and hand and also armpit/chest area.  Patient said area was somewhat swollen.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site reaction, Insomnia
Clinical narrative: My arm/shoulder muscle hurt immediately from the tetanus (TD)shot. I expected the pain to go away like it always does after an injection. This pain has never gone away and just in the past couple weeks it has gotten to be a real problem. I have limited mobility in my left shoulder and when I go past the limits the pain is severe.  My arm will ache just sitting and watching tv.  It has gotten really difficult to get to sleep.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Patient reports a harden area approximately nickel size to left deltoid. Site painful to touch. Patient is able to have full range of motion, no other problems associated with site.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Injection site pain
Clinical narrative: Chills, headache, injection site soreness.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient described immediate itching at injection site, followed by redness and swelling.