chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Swelling
Clinical narrative: Patient report pain-redness-swelling which increased 8 hrs. after shot note MD. Upon awakening patients hand was significantly swollen. On call provider was called 11/2/14 and patient was told to elevate, ice and take BENADRYL. Follow up call to patient at 1:03 pm on 11/2/14 patient reports swelling in hand has gone down.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient vaccinated 10/28 2:40 pm noticed rash 2x2" around 6pm 10/25 said rash itching.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a 67 year old female patient refers to herself. The patient had no pertinent medical history, no drug reactions or allergies. On 29-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, injection, 1 single shot (route and lot # unknown). Concomitant therapies included CRESTOR and lorazepam. On 29-SEP-2014, after receiving PNEUMOVAX 23, the patient experienced swelling and redness at the injection site. The patient could barely lift her arm. The patient sought medical attention and was treated with KEFLEX. There were no lab diagnostics studies performed. The outcome of events was reported as recovering/resolving at reporting time. The causality was not reported. Follow up information has been received from a physician on 30-OCT-2014 regarding a 67 year old female patient. There was no illness at time of vaccination, no pre-existing allergies, birth defects nor medical conditions, no adverse events following prior vaccination. On 29-SEP-2014 15:45 (reported as at 3:45 PM), the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K009105, expiration date 21-JAN-2016, intramuscularly in the left deltoid. On an unknown date, the patient was vaccinated  with FLUVIRIN lot # 1412301, intramuscular, site reported as "Rt". On 30-SEP-2014 (previously reported as 29-SEP-2014), the patient experienced redness, pain and swelling of Lt (left) deltoid muscle at site of injection. The patient was treated with KEFLEX PO (per oral). On 10-OCT-2014, the patient recovered from the events. The adverse events were reported as serious, for the patient required medical intervention to prevent one of the outcome listed. Additional information is not expected, as all required information has been received.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased
Clinical narrative: This spontaneous report as received from a 67 year old female patient refers to herself. The patient had no pertinent medical history, no drug reactions or allergies. On 29-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, injection, 1 single shot (route and lot # unknown). Concomitant therapies included CRESTOR and lorazepam. On 29-SEP-2014, after receiving PNEUMOVAX 23, the patient experienced swelling and redness at the injection site. The patient could barely lift her arm. The patient sought medical attention and was treated with KEFLEX. There were no lab diagnostics studies performed. The outcome of events was reported as recovering/resolving at reporting time. The causality was not reported. Follow up information has been received from a physician on 30-OCT-2014 regarding a 67 year old female patient. There was no illness at time of vaccination, no pre-existing allergies, birth defects nor medical conditions, no adverse events following prior vaccination. On 29-SEP-2014 15:45 (reported as at 3:45 PM), the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K009105, expiration date 21-JAN-2016, intramuscularly in the left deltoid. On an unknown date, the patient was vaccinated  with FLUVIRIN lot # 1412301, intramuscular, site reported as "Rt". On 30-SEP-2014 (previously reported as 29-SEP-2014), the patient experienced redness, pain and swelling of Lt (left) deltoid muscle at site of injection. The patient was treated with KEFLEX PO (per oral). On 10-OCT-2014, the patient recovered from the events. The adverse events were reported as serious, for the patient required medical intervention to prevent one of the outcome listed. Additional information is not expected, as all required information has been received.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Infection
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route unspecified). After receiving the shot, in 2014, between 29-JUL-2014 to 01-AUG-2014 the patient developed an allergic reaction. The reaction caused an infection and the patient went to the doctor. The patient stated that they were put on an antibiotic. The events outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLUN4
Symptoms: Pruritus, Rash
Clinical narrative: Facial rash and itching developed and persisted to the next day, was seen in the emergency room and had some improvement after Benadryl and Pepcid given.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: Noticed injection was high.  Experienced progressive immobility of shoulder, weakness, and extreme pain.  Problem persists.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Injection site pain, Migraine, Myalgia
Clinical narrative: Sharp "Nerve pain" on injection, but it went away. Fever rising to 101F, intense muscle aches, weakness, dizziness, nausea.  800mg Ibuprofen taken at 5:00 PM did not help.  Fever went down by next day, but triggered migraine for the next week.  Did not develop muscle pain at injection site until two weeks after, now it is tender. Never EVER have reacted to vaccinations before in my life.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Neuralgia, Pyrexia
Clinical narrative: Sharp "Nerve pain" on injection, but it went away. Fever rising to 101F, intense muscle aches, weakness, dizziness, nausea.  800mg Ibuprofen taken at 5:00 PM did not help.  Fever went down by next day, but triggered migraine for the next week.  Did not develop muscle pain at injection site until two weeks after, now it is tender. Never EVER have reacted to vaccinations before in my life.
Age: 55.0
Sex: M
Vaccine: FLUX, HEP, PPV
Symptoms: Chills, Malaise, Myalgia
Clinical narrative: Extreme chills, muscle aches, general feeling of malaise.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Pain in shoulder joint radiating down arm. Ibuprofen, first doctor visit on 10/13/14, subsequent visits on 10/23/14 and 10/31/14. Pain still in left shoulder joint when raised above arm level and moved across body. Anti-inflammatory shot given on 10/31/14 along with Tramadol. Physical Therapy to start on 11/5/14. No relief after shot given on 10/31/14.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram normal, Balance disorder, Borrelia test negative, Computerised tomogram normal, Dizziness
Clinical narrative: Severe Headache, Dizziness, Unstable on feet, Nausea, Neck Pain, Shoulder Pain.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal pain, Nausea, Neck pain, Nuclear magnetic resonance imaging normal
Clinical narrative: Severe Headache, Dizziness, Unstable on feet, Nausea, Neck Pain, Shoulder Pain.
Age: 27.0
Sex: M
Vaccine: FLUN4, MNQ, TYP, YF
Symptoms: Arthralgia, Rash papular, Rash pruritic
Clinical narrative: On 27 Oct 14, patient received yellow fever and meningococcal vaccines on their right arm. He received typhoid vaccine in left arm and the nasal Flumist. On 29 Oct 14, patient states he noticed some bumps on his right arm (forearm and elbow) that itched. Patient states over the course of the day, they swelled very large.  On 31 Oct 14, patient states he noticed more bumps and rashes on his right arm and right side that also itched.  Patient states that starting on 29 Oct 14, he also had soreness in all of his joints. Patient was seen on 3 Nov 14 by a physician. Patient was told to keep an eye on it. Patient was also told to report to immunization's clinic to file VAERS report.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Impaired work ability, Malaise, Myalgia
Clinical narrative: Chills, fever, malaise, myalgia, weakness X 24 hours. Treated with ibuprofen and acetaminophen. Resulted in loss of 1 work day.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Chills, fever, malaise, myalgia, weakness X 24 hours. Treated with ibuprofen and acetaminophen. Resulted in loss of 1 work day.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Hypotonia, Mobility decreased, Palpitations
Clinical narrative: Shaking, Headaches, Palpitations. Weakness, Flaccid R. arm, Immobility. Was picked up and taken to emergency care.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Shaking, Headaches, Palpitations. Weakness, Flaccid R. arm, Immobility. Was picked up and taken to emergency care.
Age: 68.0
Sex: M
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Patient reported an itchy rash forming around the injection site on his RT arm.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: States she awoke 10/29/2014 with very swollen face. Used Benadryl for the swelling. Face remained swollen until 10/30/2014 afternoon.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysphonia, Fatigue, Headache, Injection site erythema
Clinical narrative: About 4 hours after receiving vaccine, client developed a bad headache and felt tired. Around 7:30pm had pain, swelling, redness, heat @ injection site and developed a stiff neck. Pt. called physician. 10/28/14 symptoms continued with development of dizziness & fatigue. Redness was about 4.5 inches in diameter. Pt went home about 1:30. 10/29/14-no change. 10/30/14 pt woke up with hoarseness. Redness decreased to 4 inches. Injection site tender and warm to touch. 10/31/14 pt stayed home. 11/3/14 pt improving. Continues with hoarseness and tender to touch.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: About 4 hours after receiving vaccine, client developed a bad headache and felt tired. Around 7:30pm had pain, swelling, redness, heat @ injection site and developed a stiff neck. Pt. called physician. 10/28/14 symptoms continued with development of dizziness & fatigue. Redness was about 4.5 inches in diameter. Pt went home about 1:30. 10/29/14-no change. 10/30/14 pt woke up with hoarseness. Redness decreased to 4 inches. Injection site tender and warm to touch. 10/31/14 pt stayed home. 11/3/14 pt improving. Continues with hoarseness and tender to touch.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Convulsion, Eye movement disorder, Full blood count, Metabolic function test
Clinical narrative: Seizure, eyes rolled back and had convulsions for about 3min
Age: 42.0
Sex: F
Vaccine: FLUR3
Symptoms: Dysphonia, Pharyngeal oedema, Throat irritation
Clinical narrative: The pt received an egg-free flu shot, as she has a severe allergy to eggs.  She had never before had a flu shot. She sat, observed, for 20 minutes and denied any s/s reaction. 30 minutes after the shot she was driving back to work when her throat began to feel hot, hoarse, and swollen.
Age: 43.0
Sex: F
Vaccine: FLUC3
Symptoms: Rubber sensitivity
Clinical narrative: Received flu vaccine at clinic.  Vaccine had trace amounts of latex in rubber tip.  Patient has latex allergy.
Sex: F
Vaccine: VARCEL
Symptoms: Gastroenteritis, Incomplete course of vaccination, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician refers to a 20 year (reported as patient currently in her 20s) old female patient. Current conditions and medical history was not reported. On an unknown date (reported as many years ago) the patient (at an unspecified age) was vaccinated with VARIVAX (Merck) injection, dose 1, 0.5 milliliter (ml), subcutaneous. Concomitant medications were not reported. The patient did not receive dose 2 of VARIVAX (Merck). On an unknown date (many years ago) patient developed gastroenteritis (hospitalization) and when the patient was 4 or 5 years old patient had chickenpox (hospitalization). At the time when the patient had developed chickenpox she was in the hospital because she was being treated for gastroenteritis. It was while she was hospitalized for gastroenteritis that she developed chickenpox. It was not known if her hospitalization was prolonged due to her development of chickenpox in the hospital. Unspecified if the gastroenteritis was related to the VARIVAX (Merck) (the gastroenteritis had developed sometime after the patient received Dose 1 of VARIVAX (Merck)). Treatments provided were unspecified. On an unspecified date, outcome of the events were reported as recovered. Patient sought medical attention. No product quality complaint (PQC) has been reported. Causality assessment was not provided. This case is related to case number 1411USA000474 (same reporter). Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Coronary arterial stent insertion, Erythema, Injection site reaction, Local swelling, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to 71 year old female patient with not know drug allergies and unspecified medical history. The reporting pharmacist stated that 2 patients reported injection site reactions to PNEUMOVAX 23. On 28-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K005957, expiration date: 08-MAR-2014; dose: 0.5 ml, intramuscular, anatomical location not reported). Concomitant medications were not reported. The reporting pharmacist stated that, in approximately October 2014 (exact dates not reported), the patient reported a swollen arm, large area of redness "like sunburn", no fever, painful and stinging which has subsided. Pharmacist stated also that the patient received "stents in her heart" at an unspecified time recently (in approximately 2014, exact dates not reported) and was concerned. There was no treatment given for the reported events thus far and the pharmacist suggested ice to the patient which did not help. The outcome of stent in heart, injection site reaction, swollen arm, painful arm and large area of redness like sunburn was unknown. The outcome of stinging was reported as recovered/resolved/subsided (approximately in October 2014, exact dates not reported). The relatedness between the events and the therapy with PNEUMOVAX 23 was not reported. Upon internal review the event of "stent in her heart" was determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to 71 year old female patient with not know drug allergies and unspecified medical history. The reporting pharmacist stated that 2 patients reported injection site reactions to PNEUMOVAX 23. On 28-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K005957, expiration date: 08-MAR-2014; dose: 0.5 ml, intramuscular, anatomical location not reported). Concomitant medications were not reported. The reporting pharmacist stated that, in approximately October 2014 (exact dates not reported), the patient reported a swollen arm, large area of redness "like sunburn", no fever, painful and stinging which has subsided. Pharmacist stated also that the patient received "stents in her heart" at an unspecified time recently (in approximately 2014, exact dates not reported) and was concerned. There was no treatment given for the reported events thus far and the pharmacist suggested ice to the patient which did not help. The outcome of stent in heart, injection site reaction, swollen arm, painful arm and large area of redness like sunburn was unknown. The outcome of stinging was reported as recovered/resolved/subsided (approximately in October 2014, exact dates not reported). The relatedness between the events and the therapy with PNEUMOVAX 23 was not reported. Upon internal review the event of "stent in her heart" was determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.35
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 16 month old female inadvertently given Fluarix Quadrivalent dose of Influenza vaccine.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Discomfort, Injection site swelling, Vaccination complication
Clinical narrative: 10/21/14 @0930 - Assessed L arm parent concern for swelling. L arm swollen, not red. Told to give Tylenol/Motrin for discomfort and warm pack as tol. 10/22/14- Morning Clinic visit. Nurse was contacted of NP diagnosis of cellulitis/ as reaction to vaccine.
Age: 46.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Pt developed a 10mm induration on the back of the left arm at the site of the injection. The area was discolored, painful, and itchy.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Blood sodium decreased, Confusional state, Diarrhoea, Hallucination, Nausea
Clinical narrative: Became very nausea, diarrhea, became confused, haullucinations.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Adverse event, Blood sodium decreased
Clinical narrative: Became very nausea, diarrhea, became confused, haullucinations.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Episode of elbow pain 1 wk prior to vaccine administration. During the night approximately 11 hours after administration, developed a sharp pain in left elbow. Rated 9 on 1-10 scale. Pain subsided in 24 hrs. Follow up with PMD on 10-20-14 and PMD did not feel pain was related to Flu vaccine since she had prior. P.T. recommended. Pain returned and unable to move fingers. EMG 11-7-14.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Swelling, pain, itching same day as administration. It continues to itch on day 5. Patient has used pain pill to control pain and hydrocortosone and alcohol topically to aid itching.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Ear discomfort, Hypoaesthesia oral, Paraesthesia oral, Throat tightness
Clinical narrative: (times above are approximate). Received flu vaccine last year and within 1/2 hour had circumoral numbness and tingling (unreported).  This year, within minutes of receiving vaccine, mouth was flooded with metallic taste, followed by circumoral numbness/ tingling within the next five minutes, followed by fullness in ears and throat (as is typical during allergic reaction). The numbness/tingling lasted for only about 5-10 minutes.  The metallic taste and full sensation in ears and throat lasted throughout the evening.  These symptoms had just about completely resolved by 11 pm.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Balance disorder, Blood test normal, Computerised tomogram normal, Gait disturbance
Clinical narrative: Stiff neck and sore, achy muscles and joints lasting until 10/21/2014. Extreme weakness in legs, feet and arms and numbness and tingling all over.  Also, trouble with walking and balance beginning 10/29/2014 an ongoing.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Stiff neck and sore, achy muscles and joints lasting until 10/21/2014. Extreme weakness in legs, feet and arms and numbness and tingling all over.  Also, trouble with walking and balance beginning 10/29/2014 an ongoing.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Urine analysis normal
Clinical narrative: Stiff neck and sore, achy muscles and joints lasting until 10/21/2014. Extreme weakness in legs, feet and arms and numbness and tingling all over.  Also, trouble with walking and balance beginning 10/29/2014 an ongoing.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Musculoskeletal stiffness, Myalgia, Paraesthesia
Clinical narrative: Stiff neck and sore, achy muscles and joints lasting until 10/21/2014. Extreme weakness in legs, feet and arms and numbness and tingling all over.  Also, trouble with walking and balance beginning 10/29/2014 an ongoing.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urine analysis normal
Clinical narrative: Stiff neck and sore, achy muscles and joints lasting until 10/21/2014. Extreme weakness in legs, feet and arms and numbness and tingling all over.  Also, trouble with walking and balance beginning 10/29/2014 an ongoing.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Local swelling
Clinical narrative: Swelling, numbness of injection limb, extending distally to hand.  Patient was taken to ED.  Treating physician prescribed antibiotics but advised notification of immunizer as possible adverse event.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Extreme sore throat, fever up to 101.5 degrees, body aches.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cyanosis, Dizziness, Fall, Fatigue, Head injury
Clinical narrative: Approx 5:30 pm developed lightheadedness, H/A, nausea. Approx 15 min later states "passed out" - fell to the floor, hit back side of his head. Thinks he may have been out for a few minutes. Rested in bed until 9:30 pm - felt better had toast and milk. Lightheaded, H/A and nausea started to subside. Wen to sleep - awoke 10/31 feeling better but still tired and with rt arm soreness at vaccination site. Noticed pain in rt foot - 1st 3 toes black and blue from the fall. Still tired and slept most of the day on 10/31/14. Denies s/s from back rt side of head - nothing seen on 11-3-14. Advised to phone PMD to discuss above incident and for evaluation. States he will.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Loss of consciousness, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Approx 5:30 pm developed lightheadedness, H/A, nausea. Approx 15 min later states "passed out" - fell to the floor, hit back side of his head. Thinks he may have been out for a few minutes. Rested in bed until 9:30 pm - felt better had toast and milk. Lightheaded, H/A and nausea started to subside. Wen to sleep - awoke 10/31 feeling better but still tired and with rt arm soreness at vaccination site. Noticed pain in rt foot - 1st 3 toes black and blue from the fall. Still tired and slept most of the day on 10/31/14. Denies s/s from back rt side of head - nothing seen on 11-3-14. Advised to phone PMD to discuss above incident and for evaluation. States he will.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Migraine, Swelling face
Clinical narrative: 1:30 AM - woke up with pounding migraine - took migraine medication at 1:30 and 6:00 AM. HA tolerable by 10:00 AM, noticed swelling of total face. Swelling gone by 11-2014 AM. Washed out the next day.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: She have a rash on the site of injection. It's kinda of hot as well. We have advised her to take some Benadryl and put some ice on it and if it does not get better then see Dr.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Mobility decreased, Pain
Clinical narrative: Saturday morning October 25, 2014, started having rigors and chills. At night on Saturday was unable to move or get out of bed due to body aches, and other symptoms lasted until Sunday morning.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Lacrimation increased, Lip swelling, Nasal congestion, Retching
Clinical narrative: Tongue swelling, gagging persistant cough; Eyes watered, all symptoms occurred about 3-4 hours after administration. Lips swelled. Nasal congestion. OTC Benadryl treatment, symptoms subsided over the next day or two. No swelling of throat.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling, gagging persistant cough; Eyes watered, all symptoms occurred about 3-4 hours after administration. Lips swelled. Nasal congestion. OTC Benadryl treatment, symptoms subsided over the next day or two. No swelling of throat.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Lymphadenopathy
Clinical narrative: Flu vaccine given to employee during her shift at work. Employee reported, 1 week later, that she noticed lip swelling and lymph node enlargement in her neck area approx. 16 hours after she received her flu vaccine. She had gone home from work, went to sleep and noticed when she woke up. No breathing difficulties noted. Symptoms resolved within 24 hours with no treatment. Was not evaluated medically. History of anaphylaxis to bees and hair dye.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Limited range of motion left arm, soreness at site.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neuropathy peripheral
Clinical narrative: (L) shoulder pain, neuropathy.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Mobility decreased, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Pain in deltoid muscle that radiates to upper shoulder, upper back and neck. Difficulty lifting arm. Symptoms present for 4 weeks. No signs of infection.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Arthralgia, Back pain, Blood creatine phosphokinase, Chest discomfort
Clinical narrative: Pt is complaining of pain in his head  that moved to abdomen and has now set up in top of hips in back side. He had has this since last Sunday. Feels much better. 5 days ago while at breakfast, he felt a weird feeling in scalp he describes as tightness that moved to chest. No sweating, or SOB or neck pressure or arm pan or nausea or vomiting. Lasted 3-4 days. States next morning 4 days ago, he woke with soreness in the low back muscles. No urinary complaints. Doing some better, but still in pain. Only wit pain with sit to stand and walking. No pain at rest.  Low back pain/probably reaction to influenza vaccine. Fluids, rest, call if worse or no better in 3 days. Hydrocodone/Acetaminophen 5m/g325 mg table. Take 1 to 2 tablet(s) by mouth 6 hr prn #20 (twenty) tablet(s) Refills: 0.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Differential white blood cell count, Full blood count, Haemoglobin, Headache, Musculoskeletal pain
Clinical narrative: Pt is complaining of pain in his head  that moved to abdomen and has now set up in top of hips in back side. He had has this since last Sunday. Feels much better. 5 days ago while at breakfast, he felt a weird feeling in scalp he describes as tightness that moved to chest. No sweating, or SOB or neck pressure or arm pan or nausea or vomiting. Lasted 3-4 days. States next morning 4 days ago, he woke with soreness in the low back muscles. No urinary complaints. Doing some better, but still in pain. Only wit pain with sit to stand and walking. No pain at rest.  Low back pain/probably reaction to influenza vaccine. Fluids, rest, call if worse or no better in 3 days. Hydrocodone/Acetaminophen 5m/g325 mg table. Take 1 to 2 tablet(s) by mouth 6 hr prn #20 (twenty) tablet(s) Refills: 0.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Platelet count, Red blood cell count, Red blood cell sedimentation rate, Skin disorder
Clinical narrative: Pt is complaining of pain in his head  that moved to abdomen and has now set up in top of hips in back side. He had has this since last Sunday. Feels much better. 5 days ago while at breakfast, he felt a weird feeling in scalp he describes as tightness that moved to chest. No sweating, or SOB or neck pressure or arm pan or nausea or vomiting. Lasted 3-4 days. States next morning 4 days ago, he woke with soreness in the low back muscles. No urinary complaints. Doing some better, but still in pain. Only wit pain with sit to stand and walking. No pain at rest.  Low back pain/probably reaction to influenza vaccine. Fluids, rest, call if worse or no better in 3 days. Hydrocodone/Acetaminophen 5m/g325 mg table. Take 1 to 2 tablet(s) by mouth 6 hr prn #20 (twenty) tablet(s) Refills: 0.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication, White blood cell count
Clinical narrative: Pt is complaining of pain in his head  that moved to abdomen and has now set up in top of hips in back side. He had has this since last Sunday. Feels much better. 5 days ago while at breakfast, he felt a weird feeling in scalp he describes as tightness that moved to chest. No sweating, or SOB or neck pressure or arm pan or nausea or vomiting. Lasted 3-4 days. States next morning 4 days ago, he woke with soreness in the low back muscles. No urinary complaints. Doing some better, but still in pain. Only wit pain with sit to stand and walking. No pain at rest.  Low back pain/probably reaction to influenza vaccine. Fluids, rest, call if worse or no better in 3 days. Hydrocodone/Acetaminophen 5m/g325 mg table. Take 1 to 2 tablet(s) by mouth 6 hr prn #20 (twenty) tablet(s) Refills: 0.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Patient experienced right side only tongue swelling, denies difficulty breathing.
Age: 23.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Arm, swelling, redness, tenderness.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Large erythema region (R) thigh 3 inch circular nodule.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Insomnia, Pain in extremity, Sleep disorder, Vision blurred
Clinical narrative: Eye sight - blurred vision; soreness to arm; loss of appetite; insomnia/sleep problems.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchospasm, Dyspnoea, Nausea, Pruritus
Clinical narrative: Addendum on 31 October 2014. Upon internal review it was identified that the suspect product INFLUENZA INTRADERMAL (476) should have been coded as INFLUENZA INTRADERMAL (390). The correction has been made to this case. Initial report received from a healthcare professional on 24 October 2014. A 59-year-old female patient, whose medical history was unknown, received an intradermal injection of FLUZONE ID (lot number not reported) on 03 October 2014. Approximately 15 minutes post-vaccination, the patient experienced bronchospasm, shortness of breath, nausea, and itchiness. She was seen in the emergency department and treated; treatment information was not reported. Outcome was reported as unknown, however at the time of the report the patient still complained of some ongoing shortness of breath. She had not been evaluated by a physician since 03 October 2014 per the reporter. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain continued at injection site. Denies numbness/tingling/paresthesia/loss of grip strength. No erythema or swelling noted.
Age: 29.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site reaction, Neutrophil count increased, Pain in extremity, Pyrexia
Clinical narrative: Fever - temp up to 104.2 degrees per patient. Only able to get down to 102.0 degrees at home with ADVIL 600 mg. Arm red and painful. Advised to ER. Pt was admitted to rule out cellulitis. Infectious disease evaluated patient. Diagnosed with injection site reaction with serum sickness type reaction.
Age: 29.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Serum sickness-like reaction, White blood cell count increased
Clinical narrative: Fever - temp up to 104.2 degrees per patient. Only able to get down to 102.0 degrees at home with ADVIL 600 mg. Arm red and painful. Advised to ER. Pt was admitted to rule out cellulitis. Infectious disease evaluated patient. Diagnosed with injection site reaction with serum sickness type reaction.
Age: 1.65
Sex: M
Vaccine: FLU3
Symptoms: Chills, Grunting, Influenza virus test, Intensive care, Oxygen saturation decreased
Clinical narrative: Pt. was given flu vaccine at 2:30p on Thur. At 12:10a, pt woke with uncontrolled shivering, grunting, and SpO2 levels were in 60's, pt was transported via ambulance to local hosp and was admitted to PICU for monitoring. (Given TYLENOL over course). On Thursday October 23rd 2014 at 2:30 pm, Patient was given the flu vaccine at local Drs. Office. Vaccine was given in Left thigh with no immediate reaction. Patient proceeded as normal throughout the course of the afternoon and evening. Parents give TYLENOL prior to bedtime (6:50 pm) as a preventative for any fever. Patient was put to bed as normal at 7:30 pm with no complications. At 12:10 am, patient woke up grunting, and shivering out of control. Parents called to speak with Dr., however while waiting on the phone attached a Pulse oximeter and called Ambulance transport after Oxygen saturation readings were in the 60's (68) when they are normally in the mid-high 80s. Patient was taken to Hospital ER at approximately 1245am, and later admitted to the PICU under Intermediate Care Status for observation. Over the course of the next 12 hours patient was observed, and tested for flu, RSV, and other viruses or causes for illness. Patient was found to have a fever in between TYLENOL doses, but otherwise was acting normally. Patient was discharged from the hospital at 5pm on Friday October 24th 2014 with a conclusion of Flu Vaccine Reaction. No other adverse symptoms have been witnessed as of October 29th 2014 per parents. Patient has history of Hypoplastic Left Heart Syndrome with 15 surgeries including 2 Open Heart Surgeries has not been hospitalized since Early May of 2014. Patient had slight Upper respiratory complications after having a flu shot in the previous year (2013) however such reactions did not occur until more than 72 hours after the vaccine was given.
Age: 1.65
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory syncytial virus test, Vaccination complication, Viral test
Clinical narrative: Pt. was given flu vaccine at 2:30p on Thur. At 12:10a, pt woke with uncontrolled shivering, grunting, and SpO2 levels were in 60's, pt was transported via ambulance to local hosp and was admitted to PICU for monitoring. (Given TYLENOL over course). On Thursday October 23rd 2014 at 2:30 pm, Patient was given the flu vaccine at local Drs. Office. Vaccine was given in Left thigh with no immediate reaction. Patient proceeded as normal throughout the course of the afternoon and evening. Parents give TYLENOL prior to bedtime (6:50 pm) as a preventative for any fever. Patient was put to bed as normal at 7:30 pm with no complications. At 12:10 am, patient woke up grunting, and shivering out of control. Parents called to speak with Dr., however while waiting on the phone attached a Pulse oximeter and called Ambulance transport after Oxygen saturation readings were in the 60's (68) when they are normally in the mid-high 80s. Patient was taken to Hospital ER at approximately 1245am, and later admitted to the PICU under Intermediate Care Status for observation. Over the course of the next 12 hours patient was observed, and tested for flu, RSV, and other viruses or causes for illness. Patient was found to have a fever in between TYLENOL doses, but otherwise was acting normally. Patient was discharged from the hospital at 5pm on Friday October 24th 2014 with a conclusion of Flu Vaccine Reaction. No other adverse symptoms have been witnessed as of October 29th 2014 per parents. Patient has history of Hypoplastic Left Heart Syndrome with 15 surgeries including 2 Open Heart Surgeries has not been hospitalized since Early May of 2014. Patient had slight Upper respiratory complications after having a flu shot in the previous year (2013) however such reactions did not occur until more than 72 hours after the vaccine was given.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Inflammation, Local swelling
Clinical narrative: Red, swollen, inflammation at injection arm; hospitalized for cellulitis.
Age: 43.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Malaise, Paraesthesia, VIIth nerve paralysis
Clinical narrative: On 9-12-2014 received Tdap and Hep A vaccine. 2 weeks later had progressive numbness/tingling to extremities. Spent 6 days in hospital diagnosed with Guillain Barre. Presents today ambulatory with (L) sided facial paralysis. Under the care of neurologist. Pt was Tx/Dx at medical center.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Injected limb mobility decreased, Injection site pain, Laboratory test abnormal
Clinical narrative: The client reported that since receiving the flu injection that she has had limited mobility in the left arm and pain from her biceps to the left elbow that has not been relieved by OTC medications. Reported that she was seeing her personal physician on 10/15/2014. Called client on 10/17/14 to follow up after her physician visit. She reported that the physician did lab work at the visit that indicated that she had inflammation in the left arm. He prescribed medication that she did not recall the name of but indicated that the pain in the arm was improving.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea
Clinical narrative: Employee states he began having diarrhea 2 hours after the immunization which lasted for 1 day. Condition resolved after 1 day, no other symptoms reported.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Full blood count normal, Local swelling, Ultrasound scan normal
Clinical narrative: Swelling and discomfort in right axilla.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Immediate post-injection reaction, Syncope
Clinical narrative: Abdominal pain, syncope immediately after injection. Client fainted.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Aphagia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: Arm swollen, hot and red at injection site.  Also ran temp, chilling, nausea and dizzy.  Also had headache. Unable to eat anything Friday, Oct 31st, but ate soup and drank liquids Friday.  Felt better Sun PM.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Arm swollen, hot and red at injection site.  Also ran temp, chilling, nausea and dizzy.  Also had headache. Unable to eat anything Friday, Oct 31st, but ate soup and drank liquids Friday.  Felt better Sun PM.
Age: 1.63
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Injection site rash
Clinical narrative: Mother states that rash started at injection site on right thigh which varicella was administered. Mother also said that child had a temperature of 102.00.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Demyelinating polyneuropathy, Diagnostic procedure, Dizziness, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Lower and upper extremity weakness, dizziness.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left upper arm where pneumovax given area red, painful, and warm to palaption.  Diagnosis of cellulitis.  Treated with clindamycin for 7 days.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Almost immediate unbearable pain, a short break from the pain. Then several days later it returned and has not left 3 weeks later. Pain at raising arm, some passive arm movement pain, pain at weight bearing or completing daily required tasks (dressing, washing, driving).  Following a doctor's visit on 11/3/2014 with no x-rays completed the doctor stated that possibly a nerve or other sensitive area was hit by the injection. Muscle weakness was noted. Physical exam and range of motion was explored by my physician.
Age: 48.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient developed severe pain in the arm where vaccine was administered. Difficulty moving arm. Pt was advised to go to an urgent care for evaluation and treatment of pain. Pt given vicodin with minimal relief of symptoms. 5 days later still reporting arm pain.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The area on left deltoid is red (5.5cmX7cm) swollen and itching after receiving influenza vaccination. Child is afebrile.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Vaccine administered in (L) deltoid. Lymph nodes swollen and tender to touch in (L) axilla noted day after administration of vaccine and became very pronounced and exquisitely tender over the course of the next 2-3 days.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Computerised tomogram head, Dysstasia, Fall, Gait disturbance
Clinical narrative: On Saturday afternoon, I began to experience numbness and tingling in my right hand and arm.   Within a couple of days, the numbness and tingling was also experienced in my left hand and arm.   I then noticed I was beginning to have numbness and tingling in both of my legs.   On 10/28/2014, I saw my primary care doctor.    I experienced significant weakness in my legs, and I fell on 10/28/2014 while trying to stand and walk. The weakness in all four extremities continued to get worse, and on 10/30/2014, Dr. sent me to the ER.   I was seen there and eventually hospitalized.   I was released on 11/1/2014, with continued symptoms.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: On Saturday afternoon, I began to experience numbness and tingling in my right hand and arm.   Within a couple of days, the numbness and tingling was also experienced in my left hand and arm.   I then noticed I was beginning to have numbness and tingling in both of my legs.   On 10/28/2014, I saw my primary care doctor.    I experienced significant weakness in my legs, and I fell on 10/28/2014 while trying to stand and walk. The weakness in all four extremities continued to get worse, and on 10/30/2014, Dr. sent me to the ER.   I was seen there and eventually hospitalized.   I was released on 11/1/2014, with continued symptoms.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Paraesthesia, Scan with contrast
Clinical narrative: On Saturday afternoon, I began to experience numbness and tingling in my right hand and arm.   Within a couple of days, the numbness and tingling was also experienced in my left hand and arm.   I then noticed I was beginning to have numbness and tingling in both of my legs.   On 10/28/2014, I saw my primary care doctor.    I experienced significant weakness in my legs, and I fell on 10/28/2014 while trying to stand and walk. The weakness in all four extremities continued to get worse, and on 10/30/2014, Dr. sent me to the ER.   I was seen there and eventually hospitalized.   I was released on 11/1/2014, with continued symptoms.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Musculoskeletal discomfort, Pain
Clinical narrative: Vaccine administered on 10/13/14 and experienced the usual soreness at injection site.  After 3-4 days, discomfort extended to shoulder with pain raising arm overhead and abducting arm, limiting range of motion.  Has not worsened since then but has not improved either.  Occasional twinges of tingling/numbness in hand also reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Vaccine administered on 10/13/14 and experienced the usual soreness at injection site.  After 3-4 days, discomfort extended to shoulder with pain raising arm overhead and abducting arm, limiting range of motion.  Has not worsened since then but has not improved either.  Occasional twinges of tingling/numbness in hand also reported.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: PATIENT RECEIVED A PNEUMONIA SHOT. THE ARM BECAME RED AND A LITTLE SWOLLEN AT THE BACK UP TO THE ELBOW.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Reports rt shoulder pain following injection with subsequent increased pain and reduced mobility to right shoulder/trouble raising arm above head.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain in extremity
Clinical narrative: Burning pain radiating up her arm to head, which was causing a headache.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Musculoskeletal discomfort, Musculoskeletal pain, Pain, Sensation of heaviness
Clinical narrative: I woke up with a sore right shoulder and wondered if I had done something the day before that would make it ache.  As the day went on (hour by hour) my right shoulder and upper back ached really bad, and by the time I went to bed that night, I had to have my husband help me lay down.  The pain was terrible, and it felt like my shoulder and upper back weighed 500 pounds.  It really hurt to have my shoulder touch the bed, and then after I got situated, it was okay until I had any movement.  The pain was almost unbearable!  This lasted for one week, and then slowly subsided.  Four months later, I can still feel some discomfort when I roll over in bed.  I was able to work during this time (office job), but I had to be really careful not to brush my back up to anything.  Please note that I have had shingles before (about 10 years ago).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: I woke up with a sore right shoulder and wondered if I had done something the day before that would make it ache.  As the day went on (hour by hour) my right shoulder and upper back ached really bad, and by the time I went to bed that night, I had to have my husband help me lay down.  The pain was terrible, and it felt like my shoulder and upper back weighed 500 pounds.  It really hurt to have my shoulder touch the bed, and then after I got situated, it was okay until I had any movement.  The pain was almost unbearable!  This lasted for one week, and then slowly subsided.  Four months later, I can still feel some discomfort when I roll over in bed.  I was able to work during this time (office job), but I had to be really careful not to brush my back up to anything.  Please note that I have had shingles before (about 10 years ago).
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Gingival blister, Gingival inflammation, Hypersomnia, Injection site nodule
Clinical narrative: Slept 20 hours straight Friday 10-24 then hives on face, neck, arms on Saturday & Sunday, mild asthma on Saturday & Sunday, large hot knot at injection site and that arm swollen, severe hives in mouth (blisters and sores on tongue and gums, and cheeks and throat.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth, Local swelling, Oropharyngeal blistering, Pharyngeal ulceration, Stomatitis
Clinical narrative: Slept 20 hours straight Friday 10-24 then hives on face, neck, arms on Saturday & Sunday, mild asthma on Saturday & Sunday, large hot knot at injection site and that arm swollen, severe hives in mouth (blisters and sores on tongue and gums, and cheeks and throat.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Tongue blistering, Tongue ulceration, Urticaria
Clinical narrative: Slept 20 hours straight Friday 10-24 then hives on face, neck, arms on Saturday & Sunday, mild asthma on Saturday & Sunday, large hot knot at injection site and that arm swollen, severe hives in mouth (blisters and sores on tongue and gums, and cheeks and throat.