chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site induration, Injection site pain
Clinical narrative: Developed hard, painful knot at site of injection. Recommended to ice intermittently, pain improved some. Next day developed extensive bruising without pain on upper arm and knot became less painful and smaller.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Localized redness and soreness around injection site. No signs of anaphylaxis, joint soreness or cellulitis.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Feeling cold, Pain, Pyrexia
Clinical narrative: Chills fever aches and pain in joints. Took Tylenol and cold compresses.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site - left arm, that became progressively worse to the point where I was not able to move my left arm. Today, 4 days after injection I am still not able to move it, even to drive my car. Excruciating pain, especially at night that keeps me from sleeping. I cannot raise my arm even to put on deodorant.  When I called my doctor on 10/06 to report this, only the receptionist gave me advice - that this is normal, hurts like a tetanus shot, etc.  This does not hurt like a tetanus shot, this hurts like there is something wrong.  I have a good size hard red bump at my shoulder, not the injection site, that hurts the most.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Sleep disorder
Clinical narrative: Pain at injection site - left arm, that became progressively worse to the point where I was not able to move my left arm. Today, 4 days after injection I am still not able to move it, even to drive my car. Excruciating pain, especially at night that keeps me from sleeping. I cannot raise my arm even to put on deodorant.  When I called my doctor on 10/06 to report this, only the receptionist gave me advice - that this is normal, hurts like a tetanus shot, etc.  This does not hurt like a tetanus shot, this hurts like there is something wrong.  I have a good size hard red bump at my shoulder, not the injection site, that hurts the most.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Peripheral swelling, Skin warm
Clinical narrative: Swollen arm, redness, warm to touch, pain radiating up to shoulder; getting worse each day instead of better.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Laboratory test normal, Seizure
Clinical narrative: Had seizure at restaurant that lasted 30 seconds; no prior hx of seizures; no family hx of seizures.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Peripheral swelling
Clinical narrative: My hand began to swell, then began throbbing. Continued throughout the night. Pain was so unbearable my daughter took me to Emergency Room 10/08/16 at 9:00 am. Was checked by ER doctor adverse effect to flu shot. Given wrist splint for left arm, prescribed hydrocodone 5-325 mg, ibuprofen 800 mg oral tablets for pain.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Feeling cold, Pain, Pyrexia
Clinical narrative: Pain, fever, chills, cough.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Severe shoulder pain, continuing to get worse 11 days after vaccine.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Pain at injection site.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Pt experienced inj site rxn:" Entire upper R Arm was red, hard and swollen for 2 days." She took Aleve and feels much better this AM 10/09/2016. She didn't think it was the technique but some type of allergic rxn to the content. She also had some mild itch at the site.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Limb mass
Clinical narrative: Lump on arm.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired healing, Squamous cell carcinoma
Clinical narrative: Patient received Zostavax and developed a wound that would not heal. He eventually went to doctor and it was diagnosed as squamous cell carcinoma.
Age: 57.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Chills, Cough, Dizziness, Headache, Nausea
Clinical narrative: Pt stated she felt extremely nauseous, was dizzy, had a headache, started shivering, was shaeky and was coughin and hacking.  It lasted 45 minutes.  She said she had a headache with a black dot in her sight.  She said she felt nauseous for longer than the 45 minutes.
Age: 57.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Tremor
Clinical narrative: Pt stated she felt extremely nauseous, was dizzy, had a headache, started shivering, was shaeky and was coughin and hacking.  It lasted 45 minutes.  She said she had a headache with a black dot in her sight.  She said she felt nauseous for longer than the 45 minutes.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity, Rash macular
Clinical narrative: Patient received the flu HD in right arm and pneumo 23 in left arm. She reports feeling very under the weather the night the received the shots and in the arm that received the pneumo 23 she reports red blotches (measuring 1-2 inches in diameter). The left arm was very very painful and difficult to move due to the pain; it lasted 2 days. She said that she stayed in bed the day following the shots because she felt so badly. One red blotch was still on her arm today (today is Day 3), but she is up and feeling much better. I asked her to report the reaction to her doctor and I explained that I would report this reaction to VAERS.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Induration, Lymphadenopathy, Pain, Swelling
Clinical narrative: Softball size swelling, harding, red. Very painful. Swollen lymph node in groin on that side.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Swollen tongue
Clinical narrative: After 2-2.5 hrs vaccine was given, pt developed swollen tongue and bloodshot eyes. Pt went to urgent care afterward and admitted to ER for 2 nights.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Severe soreness on right arm, under arm and through to shoulder very painful to lift arm. Taking TYLENOL 1000 mg Q 4 hours. Severe headache, no fever.
Age: 28.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Fluctuance, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Induration at site with erythema, tenderness, mild fluctuance Tx with warm and cold compresses. (L) medial deltoid.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Diarrhoea, Eye contusion, Fall, Nausea
Clinical narrative: Pt had vaccines admin at 12:30pm at pharmacy. Around 2 am, pt experienced vomiting, diarrhea, nausea, weakness. Pt fell and suffered black eye while trying to get out of bed to get to bathroom.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vomiting
Clinical narrative: Pt had vaccines admin at 12:30pm at pharmacy. Around 2 am, pt experienced vomiting, diarrhea, nausea, weakness. Pt fell and suffered black eye while trying to get out of bed to get to bathroom.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pruritus, Pyrexia
Clinical narrative: Patient states that the day after vaccination she had fever and her right arm was red and itchy. Couldn't go to work for two days. Did not seek medical attention and took TYLENOL and cold compress. On 10/7/2016 a phone call was placed and she stated that she felt better, only the itching remained and a little bit of redness on the right arm.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M007764 with expiration date 30-JAN-2018 or lot# reported as K010215 with expiration date 05-MAY-2017, dose and route were unknown). The vaccine had been stored under the temperature of -0.6 Celsius degree for 361 hours and 35 minutes. Digital data logger was involved. It was unknown if there was previous temperature excursion. No adverse effects were reported. Lot number K010215 is an invalid lot number for GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen, red, hot, painful. Used cool compress, ibuprofen to relieve. Contact PCP if continues to worsen. Received cephalexin 500 QID on 10-5-16.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patients complained that the site of injection (ZOSTAVAX) left arm has been itching and swelling.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist, concerning a 72 years old male patient. The patient had no medical history, drug reactions or allergies. On unspecified date in 2011, the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # reported as 0365AA, expiration date 09-JUN-2012, 0.65 ml once, administered per subcutaneous route. The patient was not with concomitant medications. The pharmacist reported that in October of 2016, reported as "this week", the patient had a bad case of shingles. The pharmacist stated that the patient sought medical attention with an unspecified provider on unspecified date and he was diagnosed with shingles. The patient received an unknown treatment. The pharmacist was offered the VZVID packet fax and declined to receive this because it had been over 5 years since the vaccine was given and did not feel there was a need for isolate testing. The outcome of shingles was reported as not recovered. The causal relationship between ZOSTAVAX and shingles was not reported. No overdose or product quality complaint (PQC) was involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site inflammation, Vaccination site nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The patient was allergic to unspecified "SULFA" drugs and nonsteroidal anti-inflammatory drugs (NSAIDS). He had no pertinent medical history. On 20-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX, subcutaneously, lot # L046897, expiry date 23-FEB-2017 (dose and site of administration were not reported). The patient did not take any concomitant medications. In approximately 2016, the patient came back to the pharmacy because he noted that the injection site was red and swollen to the size of a baseball. There was no treatment given for the events. The outcome of injection site redness and swelling was unknown. The relatedness between the injection site redness and swelling was not provided. Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 4 minutes. Data logger was not involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect product storage, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The patient was allergic to unspecified "SULFA" drugs and nonsteroidal anti-inflammatory drugs (NSAIDS). He had no pertinent medical history. On 20-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX, subcutaneously, lot # L046897, expiry date 23-FEB-2017 (dose and site of administration were not reported). The patient did not take any concomitant medications. In approximately 2016, the patient came back to the pharmacy because he noted that the injection site was red and swollen to the size of a baseball. There was no treatment given for the events. The outcome of injection site redness and swelling was unknown. The relatedness between the injection site redness and swelling was not provided. Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 4 minutes. Data logger was not involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. Patient's medical history and concurrent conditions were not provided. The patient did not have drug reactions or allergies. On 26-AUG-2016 the patient was subcutaneously vaccinated with ZOSTAVAX (dose, frequency and indication were not reported, lot # M019645 with expiration date: 18-JUL-2017). Concomitant medications were not reported. On 26-SEP-2016, the patient noticed red mark about the size of a fist around the injection site. The patient mentioned that the red mark used to be bigger. The affected area did not hurt but it itches. The pharmacist recommended the patient to see her physician. Lab diagnostic studies were not performed. No treatment was given for adverse event. The outcome of the events was reported as not recovered. Causality assessment was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. Patient's medical history and concurrent conditions were not provided. The patient did not have drug reactions or allergies. On 26-AUG-2016 the patient was subcutaneously vaccinated with ZOSTAVAX (dose, frequency and indication were not reported, lot # M019645 with expiration date: 18-JUL-2017). Concomitant medications were not reported. On 26-SEP-2016, the patient noticed red mark about the size of a fist around the injection site. The patient mentioned that the red mark used to be bigger. The affected area did not hurt but it itches. The pharmacist recommended the patient to see her physician. Lab diagnostic studies were not performed. No treatment was given for adverse event. The outcome of the events was reported as not recovered. Causality assessment was not reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursitis
Clinical narrative: Upon injection I felt intense pain, I yelled out to the nurse she continued with vaccination.  Within 4 hours I had intense pain in shoulder which worsened throughout that evening and persisted throughout the following days. I saw Dr on 9/21/2016 who suggested improper technique used during administration of the vaccine. Injection site too high up on shoulder and referred me to Orthopedist Dr. I was in terrible pain and had limited to no mobility. She prescribed 15 mg. Mobic to control pain and suggested I give it a few days and if not improved to see Dr. After continued suffering I saw Dr. on 9/30/16 who took 3 x-rays of shoulder and told me the needle had  permeated my bursa fluid sac and hit my bone (bone tissue was inflamed on x-ray) resulting in impingement syndrome and tendonitis. He had me stay on pain meds and return one week later if not better (which I was not.) I saw Dr. again on 10/7/16 at which time he performed a subseqent exam and diagnosed me with subacromial bursitis and impingement syndrome. My symptoms have been much worse in the evenings and mornings, with overnights sleepless and painful. The Mobic I was taking was not helping. Decreased mobility and chronic pain was persisting. He administered a cortisone injection into the left shoulder with instruction to return in two weeks for follow up.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursitis, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Upon injection I felt intense pain, I yelled out to the nurse she continued with vaccination.  Within 4 hours I had intense pain in shoulder which worsened throughout that evening and persisted throughout the following days. I saw Dr on 9/21/2016 who suggested improper technique used during administration of the vaccine. Injection site too high up on shoulder and referred me to Orthopedist Dr. I was in terrible pain and had limited to no mobility. She prescribed 15 mg. Mobic to control pain and suggested I give it a few days and if not improved to see Dr. After continued suffering I saw Dr. on 9/30/16 who took 3 x-rays of shoulder and told me the needle had  permeated my bursa fluid sac and hit my bone (bone tissue was inflamed on x-ray) resulting in impingement syndrome and tendonitis. He had me stay on pain meds and return one week later if not better (which I was not.) I saw Dr. again on 10/7/16 at which time he performed a subseqent exam and diagnosed me with subacromial bursitis and impingement syndrome. My symptoms have been much worse in the evenings and mornings, with overnights sleepless and painful. The Mobic I was taking was not helping. Decreased mobility and chronic pain was persisting. He administered a cortisone injection into the left shoulder with instruction to return in two weeks for follow up.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Osteitis, Pain, Rotator cuff syndrome, Sleep disorder, Tendonitis
Clinical narrative: Upon injection I felt intense pain, I yelled out to the nurse she continued with vaccination.  Within 4 hours I had intense pain in shoulder which worsened throughout that evening and persisted throughout the following days. I saw Dr on 9/21/2016 who suggested improper technique used during administration of the vaccine. Injection site too high up on shoulder and referred me to Orthopedist Dr. I was in terrible pain and had limited to no mobility. She prescribed 15 mg. Mobic to control pain and suggested I give it a few days and if not improved to see Dr. After continued suffering I saw Dr. on 9/30/16 who took 3 x-rays of shoulder and told me the needle had  permeated my bursa fluid sac and hit my bone (bone tissue was inflamed on x-ray) resulting in impingement syndrome and tendonitis. He had me stay on pain meds and return one week later if not better (which I was not.) I saw Dr. again on 10/7/16 at which time he performed a subseqent exam and diagnosed me with subacromial bursitis and impingement syndrome. My symptoms have been much worse in the evenings and mornings, with overnights sleepless and painful. The Mobic I was taking was not helping. Decreased mobility and chronic pain was persisting. He administered a cortisone injection into the left shoulder with instruction to return in two weeks for follow up.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: X-ray limb abnormal
Clinical narrative: Upon injection I felt intense pain, I yelled out to the nurse she continued with vaccination.  Within 4 hours I had intense pain in shoulder which worsened throughout that evening and persisted throughout the following days. I saw Dr on 9/21/2016 who suggested improper technique used during administration of the vaccine. Injection site too high up on shoulder and referred me to Orthopedist Dr. I was in terrible pain and had limited to no mobility. She prescribed 15 mg. Mobic to control pain and suggested I give it a few days and if not improved to see Dr. After continued suffering I saw Dr. on 9/30/16 who took 3 x-rays of shoulder and told me the needle had  permeated my bursa fluid sac and hit my bone (bone tissue was inflamed on x-ray) resulting in impingement syndrome and tendonitis. He had me stay on pain meds and return one week later if not better (which I was not.) I saw Dr. again on 10/7/16 at which time he performed a subseqent exam and diagnosed me with subacromial bursitis and impingement syndrome. My symptoms have been much worse in the evenings and mornings, with overnights sleepless and painful. The Mobic I was taking was not helping. Decreased mobility and chronic pain was persisting. He administered a cortisone injection into the left shoulder with instruction to return in two weeks for follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Emotional distress, Fear, Screaming
Clinical narrative: Grandmother contacted this RN by telephone on 10/5/2016 at 8:15am, and reported that patient had "Bizarre" behavior, which grandmother described as not being able to sleep, screaming and looking like someone was coming after him; and, she stated he has never acted like this before. stated had a "low grade fever" and "felt warm."
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Insomnia, Pyrexia, Screaming, Skin warm
Clinical narrative: Grandmother contacted this RN by telephone on 10/5/2016 at 8:15am, and reported that patient had "Bizarre" behavior, which grandmother described as not being able to sleep, screaming and looking like someone was coming after him; and, she stated he has never acted like this before. stated had a "low grade fever" and "felt warm."
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Anxiety, Crying, Hypervigilance, Insomnia
Clinical narrative: Grandmother contacted this RN by telephone on 10/5/2016 at 8:15am, and reported that patient had "Bizarre" behavior, which grandmother described as not being able to sleep, screaming and looking like someone was coming after him; and, she stated he has never acted like this before. stated had a "low grade fever" and "felt warm."
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Gait disturbance, Musculoskeletal stiffness, Nausea
Clinical narrative: Dizziness, fever, chills, leg stiffness and pain, difficulty walking, nausea.  Symptoms lasted from 11 PM October 7 through 3 PM October 8.  I rested at home and was unable to travel by train for an appointment.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Dizziness, fever, chills, leg stiffness and pain, difficulty walking, nausea.  Symptoms lasted from 11 PM October 7 through 3 PM October 8.  I rested at home and was unable to travel by train for an appointment.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: MUSCLE/JOINTS PAIN AND SORE; FEEL CHILLED; FEVER 100.0; TOOK ADVIL 200 MG IN THE MORNING AND NIGHT.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy on Left Cervical Node.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain upper, Condition aggravated, Diarrhoea, Diet refusal, Faeces discoloured
Clinical narrative: Fever (102 - for 30 hours), diarrhea (for 72 hours), stomach cramping/screaming (about 36 hours after vaccine lasting 8 hours), refusal to eat (for 16 hours - about 12 hours after vaccine), rancid dark green poo for 4 weeks, gas and increased reflux symptoms for 4 weeks. ER visit for potential dehydration do to refusal to eat.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Flatulence, Gastrooesophageal reflux disease, Pyrexia, Screaming
Clinical narrative: Fever (102 - for 30 hours), diarrhea (for 72 hours), stomach cramping/screaming (about 36 hours after vaccine lasting 8 hours), refusal to eat (for 16 hours - about 12 hours after vaccine), rancid dark green poo for 4 weeks, gas and increased reflux symptoms for 4 weeks. ER visit for potential dehydration do to refusal to eat.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Malaise, Oropharyngeal pain, Productive cough
Clinical narrative: Began with post-nasal drip, then a  cough, sore throat, hoarseness, malaise, slight fever, more severe productive cough Treatment was OTC Acetaminophen, Equate Nyquil to allow for sleep, warm fluids, rest, saline gargle, anesthetic throat lozenges ; Course in progress It is October 10, 2016 and symptoms have not yet cleared.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Upper-airway cough syndrome
Clinical narrative: Began with post-nasal drip, then a  cough, sore throat, hoarseness, malaise, slight fever, more severe productive cough Treatment was OTC Acetaminophen, Equate Nyquil to allow for sleep, warm fluids, rest, saline gargle, anesthetic throat lozenges ; Course in progress It is October 10, 2016 and symptoms have not yet cleared.
Sex: F
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Pulmonary function test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband). A female patient of unknown age and ethnicity received a single dose PREVNAR 13 in 2015 (Oct or Nov) for immunization.  The patient medical history included asthma and a form of Parkinson's/dystonia. Concomitant medications included fluticasone propionate, ADVAIR and corticosteroid for asthma. On an unspecified date the patient experienced coughing; she was not coughing prior to receiving the vaccine. The outcome of coughing was not recovered. She also developed short of breath on an unspecified date with outcome of unknown. Follow-up (03Oct2016): New information obtained from a contactable consumer (patient's husband) includes: new event short of breath.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 71-years-old female patient received PREVNAR 13; (lot number M79319, expiration date Aug2017), via an unspecified route of administration, on 03Oct2016 11:00 as single dose for immunisation.  Medical history included egg allergy. Other No other medical conditions were reported. There were no concomitant medications. The patient previously took influenza vaccine for immunisation and was allergic.  The patient experienced hives on 03Oct2016. The details were described as follows: Pharmacist gave the patient the vaccine today and the patient stated that she had hives around where the shot is given. No lab tests were reported. The action taken with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. Therapeutic measures were taken as a result of hives; patient took BENADRYL. The outcome of hives was unknown. The reporting pharmacist reported yes for causality.
Age: 27.0
Sex: F
Vaccine: HPVX
Symptoms: Drooling, Exposure during pregnancy, Foetal disorder, Malaise, Vomiting
Clinical narrative: This spontaneous retrospective pregnancy report was received from an approximately 27 year old female patient. The patient's current conditions included allergy to morphine and CLEREGIL (reported as "Regil"). The patient had no pertinent medical history. In October 2012, the patient was vaccinated with an unidentified HPV vaccine, intramuscularly (name, strength, dose, lot number and expiration date were not provided). The patient had no concomitant medications. The patient reported, that at time of vaccination she was on her 2nd week of pregnancy. She also stated, that during her pregnancy, she felt sick the entire time. Furthermore, she had "liquid" coming from her mouth constantly. On an unspecified date, the patient sought for medical attention and she was admitted to hospital, as she was vomiting constantly. Information regarding the patient's last menstrual period (LMP) and estimated date of delivery (EDD) was not provided). On an unknown date, the patient delivered a male infant. She reported that her son, had not been able to function in a "normal child setting". Sometimes her son banged his head against the wall and had several behavioral issues since he was 1 year old (MARRS # 1610USA002863). At the time of the report, the outcome of vomiting, malaise and drooling was unknown. The outcome of exposure during pregnancy was reported as recovered. Additionally, the reporter did not provide for causality between the adverse events and vaccination with the unidentified HPV vaccine. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives started on legs and spread up the abdomen.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Peripheral swelling, Skin warm
Clinical narrative: Patient's entire arm swelled from shoulder to elbow. Arm was warm to touch. No pain. Mom describes as puffy. Injection site hard. No fever. Urgent Care prescribed antibiotics x 3 days.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Pain and stiffness in right upper arm from injection site to elbow. Started the night of the injection on 9/15/16 and has been consist since then. Using anti-inflammatory drugs and ice packs. Went to Dr on 10/6/16 but he cant do nothing different. Has gotten a little better but still painful at night.
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Injection site reaction, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Employee rec'd influenza vaccine in (L) Deltoid, that evening developed stiff shoulder and couldn't move arm. Three weeks later and still having pain and stiffness in shoulder at injection site.
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Employee rec'd influenza vaccine in (L) Deltoid, that evening developed stiff shoulder and couldn't move arm. Three weeks later and still having pain and stiffness in shoulder at injection site.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Diarrhoea, Haematocrit decreased, Haemoglobin decreased, Mean cell volume decreased
Clinical narrative: Rash, upper extremity, itching, joint pain, migraine, diarrhea.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Migraine, Pruritus, Rash, Red cell distribution width increased, White blood cell count normal
Clinical narrative: Rash, upper extremity, itching, joint pain, migraine, diarrhea.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Laboratory test normal, Polymerase chain reaction, Rash vesicular, Varicella post vaccine
Clinical narrative: Vesicular lesions appear on scalp and spread to rest of body in the next several days. Saw doctor on 8/31/2016 and determined symptoms were clinically compatible with chicken pox.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Swelling, redness, quickly turning into blisters then into one giant massive blister, massive swelling all in arm of shot site, headache, shoulder pain, fever, severe pain. Continued swelling, pain, itching and redness going down arm past elbow.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Swelling, redness, quickly turning into blisters then into one giant massive blister, massive swelling all in arm of shot site, headache, shoulder pain, fever, severe pain. Continued swelling, pain, itching and redness going down arm past elbow.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Swelling, redness, quickly turning into blisters then into one giant massive blister, massive swelling all in arm of shot site, headache, shoulder pain, fever, severe pain. Continued swelling, pain, itching and redness going down arm past elbow.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Dysarthria, Dyskinesia, Headache, Hypokalaemia
Clinical narrative: Symptoms started at 12:00am, which included slurred speech, feeling of the tongue curling, and weakness in the bilateral upper extremities that progressed to weakness in the bilateral lower extremities, upon arrival to the emergency department within that same hour. Patient was not able to perform commands given in the emergency department, but she remained alert and oriented, respirations within normal limits. She was not able to open her mouth and had a persistent headache throughout the visit. Patient was treated with Benadryl, administration of fluids and IV potassium, in which her symptoms progressively diminished. Discharge noted to have been anywhere between the time of 1:00am to 3:00am. Later that day, symptoms had lessened.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test abnormal, Muscular weakness, Thyroid function test normal, Tongue movement disturbance
Clinical narrative: Symptoms started at 12:00am, which included slurred speech, feeling of the tongue curling, and weakness in the bilateral upper extremities that progressed to weakness in the bilateral lower extremities, upon arrival to the emergency department within that same hour. Patient was not able to perform commands given in the emergency department, but she remained alert and oriented, respirations within normal limits. She was not able to open her mouth and had a persistent headache throughout the visit. Patient was treated with Benadryl, administration of fluids and IV potassium, in which her symptoms progressively diminished. Discharge noted to have been anywhere between the time of 1:00am to 3:00am. Later that day, symptoms had lessened.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Cold sweat, Heart rate increased, Loss of consciousness
Clinical narrative: PATIENT BEGAN TO LEAN AGAINST DOOR WITH LEFT SHOULDER AND SAT DOWN ON NURSING STUDENT'S KNEE - WAS CLAMMY AND HAD POUNDING RAPID PULSE - SHE THEN PASSED OUT BUT QUICKLY CAME TO AFTER BEING LAID ON EXAM TABLE AND FEET ELEVATED.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Erythema, itching, rash, red skin, allergic reaction at the injection site of the flu vaccine given in the left thigh region given yesterday. Treatment - BENADRYL and cold compresses.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, warm to touch, swollen, pain 3/10, headache.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Injection site reaction, Pain, Pyrexia, Vomiting
Clinical narrative: Fever 100.2, Generalized body aches, vomiting pain and weakness (R) shoulder/arm. Recommended TYLENOL and Bed Rest. Patient experience fever, localized body aches with pain/weakness in her right deltoid. Was seen at urgent care; Now Care; Dr. 10/7/16, who is documenting further. 10/7/16 RN.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO REACTIONS AT THIS MOMENT. SUBMITING AS A RECORD.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Muscle tightness
Clinical narrative: Patient states that the night he received the vaccination he had tightness throughout his body, especially in his back and chest to the point that he felt like he needed to go to the ER. The tightness eventually subsided enough that they felt comfortable enough not being seen. Patient states that he has had reaction like this before when receiving tetanus shot and possibly the diptheria shot but never with a flu shot.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Lip swelling, Swollen tongue
Clinical narrative: Swollen lips and tongue with numbness on left side of the face.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Discomfort, Dizziness, Headache
Clinical narrative: Shot was administered 10/1/16. On 10/07 pt had stomach pain, runny nose; 10/08 pt had headache, dizziness and chills; 10/09 pt said body felt heavy and had slight body aches (no fever). On 10/8 took Echinacea tea and TYLENOL, felt a little better, prev. used charcoal tabs for stomach?
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Shot was administered 10/1/16. On 10/07 pt had stomach pain, runny nose; 10/08 pt had headache, dizziness and chills; 10/09 pt said body felt heavy and had slight body aches (no fever). On 10/8 took Echinacea tea and TYLENOL, felt a little better, prev. used charcoal tabs for stomach?
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. It was stated that on an unknown date in 2012, the patient might have received ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). On 07-OCT-2016, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # M024700 and expiration date 18-JUL-2017) and with influenza virus vaccine (unspecified). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Flat, red, very tender area approximately 4.5-5 inches by 3-3.5 inches extending from injection site to inner arm.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Significant shoulder pain immediately upon receiving vaccination in left shoulder.  I could feel the liquid going into my shoulder area as it was given.  Then I had fairly significant should soreness for several days, including under my arm near the armpit area.  It is now 2 weeks and I have shoulder pain at night while sleeping and limited range of motion in lifting my left arm, it gets worse at night and when lying down.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypoaesthesia, Induration, Paraesthesia, Peripheral swelling
Clinical narrative: Right arm reddened, with 20 mm area of swelling and induration, numbness and tingling.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Decreased appetite, Erythema, Headache
Clinical narrative: Suddenly felt weak, needed to sit at once. Was told I was very red in the face. While sitting, felt like chest had a heavy book on it and inside my body, it felt as if there were sharp needles or pins flashing away from neck to top of my legs, especially in the stomach and bottom areas. These gradually dissipated starting from the neck area on down. All of this lasted perhaps 5 minutes. I did not sleep that night. The next day (6th) I had a headache, muscle pain, no appetite, slept. The following day (7th) I felt back to normal and have continued to feel that way since.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Myalgia, Paraesthesia
Clinical narrative: Suddenly felt weak, needed to sit at once. Was told I was very red in the face. While sitting, felt like chest had a heavy book on it and inside my body, it felt as if there were sharp needles or pins flashing away from neck to top of my legs, especially in the stomach and bottom areas. These gradually dissipated starting from the neck area on down. All of this lasted perhaps 5 minutes. I did not sleep that night. The next day (6th) I had a headache, muscle pain, no appetite, slept. The following day (7th) I felt back to normal and have continued to feel that way since.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at and around injection site.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Anger, Attention deficit/hyperactivity disorder, Autism, Developmental delay, Injection site pain
Clinical narrative: REGRESSION...STOPPED SAYING ONE/TWO SYLLABLE WORDS, IDENTIFYING THINGS HE WANTED, POTTY-TRAINING, HITTING HIMSELF, UNCONTROLLABLE OUTBURSTS, STARING OFF AS IF IN A TRANCE.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Intentional self-injury, Neuropsychological test abnormal, Pyrexia, Regressive behaviour, Speech disorder developmental
Clinical narrative: REGRESSION...STOPPED SAYING ONE/TWO SYLLABLE WORDS, IDENTIFYING THINGS HE WANTED, POTTY-TRAINING, HITTING HIMSELF, UNCONTROLLABLE OUTBURSTS, STARING OFF AS IF IN A TRANCE.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Staring
Clinical narrative: REGRESSION...STOPPED SAYING ONE/TWO SYLLABLE WORDS, IDENTIFYING THINGS HE WANTED, POTTY-TRAINING, HITTING HIMSELF, UNCONTROLLABLE OUTBURSTS, STARING OFF AS IF IN A TRANCE.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: 102.5F Fever, chills and shivering.  Fever increased t0 104.3 at 2:30AM.  Fever reduced to 101.1 by 6AM and remained there until 3PM.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Left arm and shoulder pain radiating to left hand with weakness , throbbing sharp  radiating pain  to left hand.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Chills, Fever, Pain around injection site, red swollen upper arm with raised welts.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Chills, Fever, Pain around injection site, red swollen upper arm with raised welts.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Got shots Monday 10/03/2016 and her arm got swollen and complains that it itches.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased
Clinical narrative: Patient went through a drive through food restaurant and could not lift her arm to hand payment to attendant.
Age: 48.0
Sex: M
Vaccine: TD, TDAP
Symptoms: Balance disorder, Communication disorder, Disturbance in attention, Dizziness, Executive dysfunction
Clinical narrative: Dizziness within 10 minutes of Tetanus shot.  Lack of concentration within 45 minutes.  Inability to communicate within 60 minutes.  Lack of balance.  Executive functions almost non-existent.  Recovery duration was 2 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cough, Dyspnoea, Nausea
Clinical narrative: Trouble breathing, continuous coughing, facial swelling, itchy, chills, weakness, nausea. Took triple doses of Albuterol inhaler and BENADRYL (1 dose). Took over 8-12 hours for symptoms to start going away.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling face
Clinical narrative: Trouble breathing, continuous coughing, facial swelling, itchy, chills, weakness, nausea. Took triple doses of Albuterol inhaler and BENADRYL (1 dose). Took over 8-12 hours for symptoms to start going away.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Arthropathy, Injection site bruising, Injection site erythema, Injection site pruritus, Skin warm
Clinical narrative: 10 day bruise at site. Red and itching 2 in below site for 7 days. General unwell feeling in joints. Arm was feverish.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Dizziness
Clinical narrative: Chills, no appetite, dizziness lasting 2 days and then resolved.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: The patient presented to the pharmacy several days after administration and informed us that she had severe inflammation and redness at the injection site, along with extreme soreness. She had already visited a physician and been given a steroid shot and steroid tablets (exact drug unknown to pharmacy). As of 10/10/2016, the patient has improved significantly and no longer complains of soreness, redness, or inflammation at the site of injection.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Incorrect route of drug administration, Mobility decreased, Pain in extremity
Clinical narrative: I foolishly had flu shot and pneumonia booster injected into same arm. Five hours later, excruciating pain and for days could not move my arm. Pain was controlled with OTC meds but took many days to abate. I do not think the clinic should innoculate 2 shots in the same arm. It's also possible that the shot was given too deeply and went into the bursa in the shoulder (per the orthopedic doctor that I went to to be checked over 1 1/2 weeks later). I don't want to get anyone in trouble but I would hate to see anyone go through what I went through. I would never recommend an older person have both shots in the same arm, and maybe not even on the same day.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red and warm to the touch 1 1/2" x 2" vertical oval at injection site. Painful to touch. Pt denies any other s/s.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Eyelid oedema, Hypoaesthesia, Pyrexia, Visual impairment
Clinical narrative: I wakened this morning with massive diarrhea. I waited a couple of hours and got a banana and yogurt. The diarrhea continued and numbness in the face. Then, developed a fever (100.5). I still could not read from my left eye and have puffiness.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Loss of consciousness, Pallor, Vomiting
Clinical narrative: PATIENT PASSED OUT AND FELL TO THE FLOOR, SHE HIT HER HEAD ON SIGNAGE ON THE WAY TO THE FLOOR, WHEN SHE CAME TO, WAS PALE AND COMMENCED VOMITING, EMT DISPATCHED AND ASSESSED, ALL VITAL WNL.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Received a Flu shot on 10/3 and apparently had a reaction to it at the injection site. My arm was sore which was to be expected but then I noticed swelling/puffiness and redness at the injection site.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash on arms, legs, chest, back. Mildly itchy. No lip swelling, mouth itchiness, tongue swelling or wheezing.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Reaction started w bumps on the upper part of both arms. By bedtime the bumps were red. By morning the bumps were a solid bright red mass that was extended below the elbow. I took one Benadryl on 10/08/2016 at 8:30 AM and headed to urgent care. I was given a shot of MethylPREDNISolone Sodium Succ 125MG.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient presented on 10/4 with large red itchy spot at area of injection. On 10/5 patient presented again and spot was slightly larger. Patient applied Bactine to spot. By 10/10/2106 spot was no longer red, and itchiness was almost gone.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Anticonvulsant drug level abnormal, Atelectasis, Blood culture, Blood thyroid stimulating hormone, Body temperature increased
Clinical narrative: Temp 101 on 9/30/16 evening; on 10/1/16 temperature ran from 99 to  100 throughout the day; on 10/2/16 Temp 101-102 increased lethargy, altered mental status, decreased respiration with SATs 75% then atelectasis requiring emergency intubation.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Culture, Endotracheal intubation, Full blood count, Lethargy
Clinical narrative: Temp 101 on 9/30/16 evening; on 10/1/16 temperature ran from 99 to  100 throughout the day; on 10/2/16 Temp 101-102 increased lethargy, altered mental status, decreased respiration with SATs 75% then atelectasis requiring emergency intubation.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Mental status changes, Metabolic function test, Nuclear magnetic resonance imaging brain, Oxygen saturation decreased, Respiratory rate decreased
Clinical narrative: Temp 101 on 9/30/16 evening; on 10/1/16 temperature ran from 99 to  100 throughout the day; on 10/2/16 Temp 101-102 increased lethargy, altered mental status, decreased respiration with SATs 75% then atelectasis requiring emergency intubation.