chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Injection site warmth, Myalgia, Night sweats, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient without pertinent medical history or drug reactions/allergies. On 11-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J013344, expiration date 22-JAN-2015), injection, (dose and route not reported). Concomitant medication was not provided. On 12-OCT-2014, the patient experienced soreness, tenderness, and redness at the injection site and a swollen arm from the "injection site down to her elbow" after she received PNEUMOVAX 23. The pharmacist reported the patient stated injection site felt hot and she experienced "a little bit" of fever and was sweaty at night. The patient stated to the physician that the PNEUMOVAX 23 affected her muscles as her balance was "off". No lab diagnostics studies was performed. Unspecified "antibiotics and steroids shot" was given for treated the adverse events. At the time of reporting, the outcome of the events was recovering. The patient went to the doctor to seek medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Neck pain
Clinical narrative: Patient complained that she is unable to lift her arm. Received cortisone injection and oral steroids.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased
Clinical narrative: Patient complained that she is unable to lift her arm. Received cortisone injection and oral steroids.
Age: 77.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Constant pain deep in left shoulder, worsening over time. Limited symptomatic relief with otc and prescribed pain/inflammation meds.
Age: 28.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cough, Induration, Muscular weakness, Myalgia, Pain
Clinical narrative: Extreme swelling and pain. Hard, hot to touch. Muscle impacted by pain. Runny nose, cough, weak muscles. Fever.
Age: 28.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Rhinorrhoea, Skin warm, Swelling
Clinical narrative: Extreme swelling and pain. Hard, hot to touch. Muscle impacted by pain. Runny nose, cough, weak muscles. Fever.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine with aura
Clinical narrative: Migraine headache preceded by visual aura. Took Tylenol at onset of symptoms.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram abnormal, Gait disturbance, Immunoglobulin therapy, Joint range of motion decreased, Movement disorder
Clinical narrative: The patient started feeling bilateral weakness in both arms and hands about 24 hrs after the vaccine injection.  The next day (10/26) he was feeling more severe bilateral weakness of the upper extremities.  He took two aspirin and waited for his wife to come home.  He could barely walk to the car at this point.  She rushed him to the ER where the medical team did a stroke work up.  He received tPA.  He was later found to be negative for stroke.  After more tests, an MRI of the cervical spine revealed transvere myelitis. He received many rounds of IV steroids, IVIG, and is now on an Oral Prednisone taper.   Today 11/6/14, his upper extremity range of motion has improved significantly, however, he still cannot move his left leg and has minimal movement of right leg. He is currently in a rehab center and has a positive attitude about recovery
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging brain normal
Clinical narrative: The patient started feeling bilateral weakness in both arms and hands about 24 hrs after the vaccine injection.  The next day (10/26) he was feeling more severe bilateral weakness of the upper extremities.  He took two aspirin and waited for his wife to come home.  He could barely walk to the car at this point.  She rushed him to the ER where the medical team did a stroke work up.  He received tPA.  He was later found to be negative for stroke.  After more tests, an MRI of the cervical spine revealed transvere myelitis. He received many rounds of IV steroids, IVIG, and is now on an Oral Prednisone taper.   Today 11/6/14, his upper extremity range of motion has improved significantly, however, he still cannot move his left leg and has minimal movement of right leg. He is currently in a rehab center and has a positive attitude about recovery
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Headache, chills, low grade fever, extreme sore throat, fatigue.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Brain injury, Chest X-ray abnormal, Cough, Croup infectious, Cyanosis
Clinical narrative: A consumer report has been received concerning a 5 year old male patient. The patient's concurrent disease included H1N1 virus infection. No concomitant medication was reported. The patient received FLUMIST (intranasal) on an unknown date. During an unspecified year in November he received the flu vaccine and came down with flu on 20-Dec. The patient experienced flu related complications. He was taken to the pediatrician when he developed a barking cough often characterizing croup. He was given doses of steroidal medication, prescribed by his pediatrician to combat the coughing, croup symptoms. His symptoms did not seem to be improving, so he was taken to the emergency room early Christmas morning. Doctors took a soft-tissue X-ray of his upper respiratory system and told it was collapsed a little. After spending the day with the patient, parents felt he needed to go back to the hospital. When his mother was changing his pants patient collapsed right in front of her and turned blue. Paramedics secured an airway. According to the patient's mother, the patient suffered severe brain damage due to a lack of oxygen from a collapsed airway. The patient died from flu related complications, collapsed airway and brain damage on December 29. It was unknown if an autopsy was performed. The reporter considered the events of flu related complications, collapsed airway and brain damage to be serious based on death and hospitalization criteria.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Death, Influenza, Obstructive airways disorder, Syncope
Clinical narrative: A consumer report has been received concerning a 5 year old male patient. The patient's concurrent disease included H1N1 virus infection. No concomitant medication was reported. The patient received FLUMIST (intranasal) on an unknown date. During an unspecified year in November he received the flu vaccine and came down with flu on 20-Dec. The patient experienced flu related complications. He was taken to the pediatrician when he developed a barking cough often characterizing croup. He was given doses of steroidal medication, prescribed by his pediatrician to combat the coughing, croup symptoms. His symptoms did not seem to be improving, so he was taken to the emergency room early Christmas morning. Doctors took a soft-tissue X-ray of his upper respiratory system and told it was collapsed a little. After spending the day with the patient, parents felt he needed to go back to the hospital. When his mother was changing his pants patient collapsed right in front of her and turned blue. Paramedics secured an airway. According to the patient's mother, the patient suffered severe brain damage due to a lack of oxygen from a collapsed airway. The patient died from flu related complications, collapsed airway and brain damage on December 29. It was unknown if an autopsy was performed. The reporter considered the events of flu related complications, collapsed airway and brain damage to be serious based on death and hospitalization criteria.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: A report from a health professional concerns a 33 year old female. No medical history, concurrent disease, or concomitant medication was provided except pregnancy status. On 14-Oct-2014, FLUMIST (intranasal) was administered to the patient who was a few weeks pregnant, and the patient miscarried. According to the company physician the event of patient miscarried was considered to be serious as an important medical event. According to the company physician the event of FLUMIST administered to a woman who is a few weeks pregnant upgraded to serious from non-serious as an important medical event. Follow-up information received by AstraZeneca/MedImmune on 20-Oct-2014 from a health professional upgraded this case to expeditable: New serious event added: patient miscarried. The seriousness of FLUMIST administered to a woman who is a few weeks pregnant changed from non-serious to serious. Pregnancy result updated. Details of the responsible physician added. Narrative update: Corrected Report on 28-Oct-2014. The patient's age at onset added. Start date of the event of FLUMIST administered to a woman who is a few weeks pregnant added. Start date of the suspect drug added. Details of administered by added.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 11/3- redeness at site. 11/4- redness/swelling on entire back of right arm with pain. 11/5 and 11/6- redness moved down patients arm, and pain subsided. All symptoms localized to right arm, no other symptoms reported.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: Fever to 102 F.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature decreased, Chills, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: First a sore throat, then sinus congestions and aches, then lung congestion, aches, fatigue, chills and low body temperature.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Pulmonary congestion, Sinus congestion
Clinical narrative: First a sore throat, then sinus congestions and aches, then lung congestion, aches, fatigue, chills and low body temperature.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site reaction, Urticaria
Clinical narrative: Induration "welt" type reactions on both arms one from each pneumococcal 23 and influenza vaccines.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Convulsion
Clinical narrative: SEIZURE AT RESTAURANT.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patches of vesicular lesions that extend into the dermatomal distribution.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Constant pain in shoulder of the arm the flu vaccine was injected, also sometimes limited range of motion in that shoulder which becomes worse with use.
Age: 44.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Allergy test, Pruritus, Urticaria
Clinical narrative: Large hives about body, especially to legs with itching. Client had symptoms prior to vaccines and she felt it got worst. No difficulty breathing. No wheezing.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site induration, Injection site pruritus, Injection site warmth, Muscular weakness
Clinical narrative: Weakness in legs, headache-both symptoms lasting until the following morning. Area of injection warm, firm and itchy. Itchiness gone today but still warm and firm.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Convulsion, Dizziness, Feeling abnormal, Headache
Clinical narrative: Headache, chills/seizure, body aches, dizziness, over all flu type symptoms but severe. It is now the next day and I feel pretty bad but not like last night.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Pain
Clinical narrative: Headache, chills/seizure, body aches, dizziness, over all flu type symptoms but severe. It is now the next day and I feel pretty bad but not like last night.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Lymph node pain, Pain, Weight bearing difficulty
Clinical narrative: Patient states shot "burned really bad going in" was sore that evening but the next morning had alot of aching in the area, 3 days later lymph nodes in the underarm area of the arm the vaccine was injected were sore and painful, had no swelling. Affected arm hurts with use, especially lifting or putting pressure on the arm, limited range of motion at times.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Eye swelling, Injection site pain, Lacrimation increased, Local swelling
Clinical narrative: I got flu shot yesterday at 1000. I was fine all day until when at the end of the day at around 5:00 pm, I noticed my eyes were itching, teary, and swollen, my hands & feet were swollen and itchy, the injection site was sore, and my throat was also itchy. I took Benadryl right away & fell asleep. When I woke up, my eyes are still swollen & itchy and my hands are swollen. My feet are fine. I was sent by charge nurse to Employee Health.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Throat irritation
Clinical narrative: I got flu shot yesterday at 1000. I was fine all day until when at the end of the day at around 5:00 pm, I noticed my eyes were itching, teary, and swollen, my hands & feet were swollen and itchy, the injection site was sore, and my throat was also itchy. I took Benadryl right away & fell asleep. When I woke up, my eyes are still swollen & itchy and my hands are swollen. My feet are fine. I was sent by charge nurse to Employee Health.
Age: 11.0
Sex: F
Vaccine: FLU3, HEP, IPV, TDAP
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Immediately after vaccines pt experienced blurred vision, nausea, dizziness and a headache. Ice pack applied to nape of neck and pt monitored x 30 mins; Pt was also pale. Pt recovered and was given water and crackers.
Age: 11.0
Sex: F
Vaccine: FLU3, HEP, IPV, TDAP
Symptoms: Vision blurred
Clinical narrative: Immediately after vaccines pt experienced blurred vision, nausea, dizziness and a headache. Ice pack applied to nape of neck and pt monitored x 30 mins; Pt was also pale. Pt recovered and was given water and crackers.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Local swelling
Clinical narrative: Bruising; redness and swelling from deltoid to elbow. Patient was seen by PCP due to side effects, and was instructed to ice and take BENADRYL. No pain. Significant redness and swelling.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Neuralgia, Pain in extremity
Clinical narrative: Pt complained of abnormal soreness in arm day after shot which continued for a week or two after nerve pain extending down arm into hand and a limited range of motion in shoulder also presented.
Age: 13.0
Sex: M
Vaccine: FLUX, MEN
Symptoms: Arthralgia, Headache, Local swelling, Pain in extremity, Pruritus
Clinical narrative: A light reaction, bumps, but got worse since he was scratching. They turned into welts by Sunday. On Saturday they got pretty bad so he took an oatmeal bath and BENADRYL, which calmed it down. There was intense itching, visible hives which were growing and multiplying. Feet were hurting specially thumbs because they were swollen and joints aching; it hurt to walk. No fever. Monday checked in with nurse who mentioned that if problems continued to go to the ER. Pt has not missed school. Today hives were gone, no BENADRYL required, soles of feet swollen and tender and has a headache.
Age: 13.0
Sex: M
Vaccine: FLUX, MEN
Symptoms: Rash, Tenderness, Urticaria
Clinical narrative: A light reaction, bumps, but got worse since he was scratching. They turned into welts by Sunday. On Saturday they got pretty bad so he took an oatmeal bath and BENADRYL, which calmed it down. There was intense itching, visible hives which were growing and multiplying. Feet were hurting specially thumbs because they were swollen and joints aching; it hurt to walk. No fever. Monday checked in with nurse who mentioned that if problems continued to go to the ER. Pt has not missed school. Today hives were gone, no BENADRYL required, soles of feet swollen and tender and has a headache.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Neuralgia
Clinical narrative: Never pain; immobility of arm; physical therapy.
Sex: M
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: This spontaneous report as received from a male patient of unknown age refers to himself. On an unknown date (reported as "over 4 years ago"), the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, frequency were not reported). No concomitant medications were reported. On an unknown date the patient developed cancer (reported as: he now has a cancer). At the time of report, the patient did not recover from cancer. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the patient's cancer was considered to be medically significant. Additional information is not expected due to lack of patient's or physician contact details.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient's arm at injection site became very sore - muscle ws painful when touched - continues to be sore 10 days later and she hsa to restrict arm movement.
Age: 17.0
Sex: F
Vaccine: FLU3, HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: Approx 4.5 cm irregular shapped raised pink patch to left upper arm in fatty area of arm. Nontender but warm to touch and blances easily.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration near injection site on Right upper thigh the size of a 50 cent piece and redness the size of a nickle near injection site.  As reported by patient mother.
Age: 70.0
Sex: F
Vaccine: FLU3, HEPA, PPV
Symptoms: Activities of daily living impaired, Feeling abnormal, Headache, Nausea, Pyrexia
Clinical narrative: PT verbalized, "I had a terrible fever 100'F, I felt terrible with an awful headache and nausea for 3 days. I couldn't do anything." PT denies going to the ED.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient states she "could not sleep on on that arm that night" and could not raise arm the next morning.  This lasted a few days afterward. Still currently has intermittent pain when using arm (shoulder area) especially lifting or with pressure.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Local swelling, Pain in extremity
Clinical narrative: Severe pain in entire arm where vaccine was administered.  Inabillity to lift arm after vaccine for several days.  Swelling that spread down the entire arm associated with heat and redness.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Skin warm
Clinical narrative: Severe pain in entire arm where vaccine was administered.  Inabillity to lift arm after vaccine for several days.  Swelling that spread down the entire arm associated with heat and redness.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eye pain, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Throbbing pain w/in 1 inch of injection site like someone punched arm really hard a few times (no redness, swelling, bump there). Sore to the point pt can only lift arm 45 degrees then it throbs causing a  pain in her eyes. Left arm (Pneumovax).
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dizziness, Dyspnoea, Local swelling, Pain
Clinical narrative: Patient states after receiving the flu shot she has experienced swelling left arm up to upper shoulder above clavicle, pain, dizziness, loss of appetite, shortness of breath.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia, X-ray limb
Clinical narrative: Pain to lateral superior deltoid m. Received flu shot on 10/15/14 and states she is unable to raise Lt arm above shoulder since then.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: Chills, temp max 100.7, achiness.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site vesicles, Lymphadenopathy, Muscle spasms, Neck pain
Clinical narrative: 10/17/14-Red blister about 1 inch to the left of injection site and swollen lymph node (golf ball sized) by L clavicular bone. 10/18/13 and 10/19/14 - severe muscle spasms to R upper back. 10/20/14-sore neck, no back spasms.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Received vax at 11 11 am. Shortly after, felt numbness on left side progressed to random sharp pains in chest with numbness in face/jaw area. No shortness of breath, muscular skeletal pain, lasted throughout day with same intensity. Numbness included in (L) leg, only on (L) side. Resolved on own about 21:00.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site mass, Injection site pain, Insomnia
Clinical narrative: Felt sharp pain during administration. Tenderness and pain at injection site is continuous. Rates 7 on 1-10 scale. Pain 9 in the morning. Difficult to dress and apply deodorant and sleep on that side. Feels as if there is a lump at injection site. No redness/swelling or fever.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Started with rash/welts all over fews days after no receiving vaccine on 10/17/14. Took Benadryl for few days until symptoms resolved.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Rash, Rash pruritic
Clinical narrative: started with a cough few hours after receiving vaccine and 1 wk later started with itchy rash on lower extremities that lasted 1 wk.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pruritus
Clinical narrative: Started with flushed/itchy face after receiving vaccine on 10/14/14 took loratadine 10 mg daily x 2 days until symptoms resolved.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Started with itchy face after receiving vaccine on 10/14/14. Took Benadryl 1 tax and few  hours later symptoms resolved.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: States 48 hours after receiving vaccine developed an itchy rash on lower extremities. Loratidine 10 mg given with  inst to cont daily until resolved. Lasted 1 week.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Headache, Injection site pruritus, Paraesthesia
Clinical narrative: Got shot around 4:30 at 5 pm c/o H.A./dull and took 3 (200 mg) ibuprofen. Relief for H.A. Around 7 pm area around shot became itchy - scratched it. Tingly with radiation down to elbow. Feels hot inside. Tingly with movement down to elbow. Rx: Ice BP 148/68. Nursing supervisor to bring to ER to evaluate.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Throat tightness
Clinical narrative: 5 min after receiving flu vac , pt c/o flushed face, feeling warm and thickness in throat. Pt taken to ER. Alert - oriented. Has never received flu shot.
Age: 20.0
Sex: M
Vaccine: HPVX
Symptoms: Nervous system disorder
Clinical narrative: Neurological problems.
Age: 54.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site rash, Rash
Clinical narrative: RASH NECK 4 INCHES FROM SITE OF FLU SHOT INJECTION.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: Dizziness, Nausea, Vomiting, Vertigo.
Age: 71.0
Sex: U
Vaccine: FLU3
Symptoms: Chills, Lymphadenopathy, Nasal congestion, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore arm, sore throat, chill. Swollen glands, running nose then get congested. A little bit of fever.
Age: 71.0
Sex: U
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Sore arm, sore throat, chill. Swollen glands, running nose then get congested. A little bit of fever.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Noted area at left upper arm measjring 4 1/2 in length 3 1/2 inches width with redness, warmth, swelling.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. Other patient's demographics were not reported. Concurrent conditions, medical history and allergies were not reported. On 17-OCT-2014 the patient was vaccinated with both VARIVAX (Merck) (strength, dose, anatomical location, lot number and expiration date were not reported) and PROQUAD (Merck) (strength, dose, anatomical location, lot number and expiration date were not reported) both subcutaneously. Other suspect and concomitant therapies were not reported. Not adverse events were reported. No further information provided. Additional information has been requested.
Age: 1.71
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Diarrhoea, Frequent bowel movements, Irritability, Pallor
Clinical narrative: By around 7 he was very pale and irritable.  He also wasn't that hungry.  I had him sleep with me so I could keep an eye on him.  I woke up twice between maybe ten and 230. The first time it seemed like his heart was beating very fast, but then it slowed down right away. Then I woke up cause I thought the bed was shaking, and I wondered if he was having one of those seizures, but he was still sleeping. Then he woke up between 230 and 5am. He threw up three times, mostly water.  He didn't have much of an appetite the next day, was very fussy, and seemed to have loose bowels. He's been pooping every single time he eats something. Sometimes its more like diarrhea and sometimes just regular. He's been pooping about 6 times a day since he had the vaccine.  He seems better overall now, but is still fussy (could be teething cause he was fussy before), but he is still pooping whenever he eats, even if he just pooped, hell still poop a little bit. I think the vaccine upset his bowels again. No fever at any point.
Age: 1.71
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: By around 7 he was very pale and irritable.  He also wasn't that hungry.  I had him sleep with me so I could keep an eye on him.  I woke up twice between maybe ten and 230. The first time it seemed like his heart was beating very fast, but then it slowed down right away. Then I woke up cause I thought the bed was shaking, and I wondered if he was having one of those seizures, but he was still sleeping. Then he woke up between 230 and 5am. He threw up three times, mostly water.  He didn't have much of an appetite the next day, was very fussy, and seemed to have loose bowels. He's been pooping every single time he eats something. Sometimes its more like diarrhea and sometimes just regular. He's been pooping about 6 times a day since he had the vaccine.  He seems better overall now, but is still fussy (could be teething cause he was fussy before), but he is still pooping whenever he eats, even if he just pooped, hell still poop a little bit. I think the vaccine upset his bowels again. No fever at any point.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Accidental exposure to product, Circumstance or information capable of leading to medication error, Erythema, Pruritus, Rash
Clinical narrative: Patient listed did not receive the vaccination.  The vaccine was splashed/drizzled onto patient's hand as she was restraining her 2 yr. old to receive it.  The child squirmed and snorted so that the vaccine was drizzled onto the parent's (patient's) hand. Pt. stated she did not wash her hands after but used hand sanitizer about 15 min. afterwards. Pt. stated that redness, swelling, itching noticed the next A.M. She called our dept. 2 days after incident @ about 1:30pm to report her symptoms.  She stated she hadn't used anything to relieve her symptoms. Advised to seek medical care w/own clinic if symptoms were bothersome. Pt. came by on 5th day following the incident to show her hands.  States her own doctor gave her prednisone pills and anti-itch meds.  Both hands showed redness and mild/mod rash on back and palmar surface of hands. Pt. states that her hands are getting better (showed photos of hands from camera phone) from 2-3 days prior. Encouraged to continue meds per her provider's direction.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Swelling
Clinical narrative: Patient listed did not receive the vaccination.  The vaccine was splashed/drizzled onto patient's hand as she was restraining her 2 yr. old to receive it.  The child squirmed and snorted so that the vaccine was drizzled onto the parent's (patient's) hand. Pt. stated she did not wash her hands after but used hand sanitizer about 15 min. afterwards. Pt. stated that redness, swelling, itching noticed the next A.M. She called our dept. 2 days after incident @ about 1:30pm to report her symptoms.  She stated she hadn't used anything to relieve her symptoms. Advised to seek medical care w/own clinic if symptoms were bothersome. Pt. came by on 5th day following the incident to show her hands.  States her own doctor gave her prednisone pills and anti-itch meds.  Both hands showed redness and mild/mod rash on back and palmar surface of hands. Pt. states that her hands are getting better (showed photos of hands from camera phone) from 2-3 days prior. Encouraged to continue meds per her provider's direction.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Pain in extremity, Tenderness
Clinical narrative: After receiving the vaccine the pt's arm became sore, it then developed a small amount of induration and was tender to the touch.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Nasal ulcer, Stomatitis
Clinical narrative: Began with feeling run down, then began with hard chills, developed mouth and nares sores. Saw MD and received Azithromax, Cephalexin for the mouth and nares sores.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Coagulation test abnormal, Compartment syndrome, Deep vein thrombosis, Drug hypersensitivity, Fasciotomy
Clinical narrative: Entire right leg swelled. Iced and elevated. Next day she was diagnosed with a DVT from abdomen to ankle. 6 surgeries within 7 days, including fasciotomies for compartment syndrome of the calf and eventually AK amputation of right leg.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Leg amputation, Local swelling, Surgery
Clinical narrative: Entire right leg swelled. Iced and elevated. Next day she was diagnosed with a DVT from abdomen to ankle. 6 surgeries within 7 days, including fasciotomies for compartment syndrome of the calf and eventually AK amputation of right leg.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial fibrillation, Hypopnoea, Pollakiuria, Pyrexia
Clinical narrative: ATRIAL FIBRILLATION, SHALLOW BREATHING, FEVER, EXCESS URINATION.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Hyperhidrosis, Vomiting
Clinical narrative: Immediately after returning from the flu clinic, she felt faint, flushed, was diaphoretic and vomited twice.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Hypersensitivity, Injection site bruising, Local swelling
Clinical narrative: Next morning, red area on inner thigh. Injection site is bruised.  allergic reaction. Red, raised and patchy spot.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Radiculitis brachial
Clinical narrative: Brachial neuritis in right shoulder. Patient was seen by physician in corporate health and is currently receiving physical therapy.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dyskinesia, Immediate post-injection reaction, Muscle contractions involuntary, Posture abnormal
Clinical narrative: HPV was given in Right deltoid IM. Immediately after administration he slumped over, clenched eyes tight and his fists and left arm jerking for 2 seconds. Drs. came to room. Pulse ox 99 % on Room air, BP 90/58, Heart rate in the 50's.  Patient does not remember incident. Patient sat in room for 10 minutes, alert and able to leave office in stable condition.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Musculoskeletal pain
Clinical narrative: Painful shoulder continuing up to present, difficulty sleeping. Treatment- Prednisone-Meloxicam.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe left shoulder pain. Decreased range of motion.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Discomfort, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe left shoulder pain. Decreased range of motion.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Swelling
Clinical narrative: Severe left shoulder pain. Decreased range of motion.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's palsy.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Chest pain, Herpes zoster, Pruritus, Rash
Clinical narrative: Itchy pain under left breast. Rash under left breast that grew larger over the next few days. Increased pain under left breast and also on left back.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: It has been almost a month an the arm still aches.  There has been no erythema, fevers or any other symptom.  The only symptoms is pain at the injection site with certain ROM. Painful to abduct the arm to the side.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Local swelling, Skin warm
Clinical narrative: Leg is red, warm to the touch and swollen. Not affected walking. Gave ibuprofen but no improvement.
Age: 49.0
Sex: F
Vaccine: FLU3, HEP, PPV, TDAP
Symptoms: Erythema, Injected limb mobility decreased, Pain, Urticaria
Clinical narrative: Either later that night or the next morning she was in major excruciating pain, couldn't move her arm, and had 3 quarter sized hives on her arm that she had both the Fluvirin flu shot and the Pneumovax pneumonia shot in.  Later that day or the next morning her whole upper arm was red and the hives were red raised areas.  She saw a physician who prescribed her a couple pain medications- I do not know the names of them though.  Now she feels fine and have recovered fully.
Age: 31.0
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: Strong ache in the left shoulder around the site of injection (Tdap and flu shot) becoming stronger with time into the next day.  Arm was used in moderate to heavy exercise after being injected. Pain then into the neck and became more generalized throughout the body, though less intense.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Injection site vesicles
Clinical narrative: At 2pm, blisters formed on injection site.  By evening time, the blisters had burst where an infection began.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Urticaria
Clinical narrative: Patient called pharmacy to report 2 inches below injection site a red, hot and very sore area of arm. Had noticed a hive on chin that had gone away.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Convulsion
Clinical narrative: Seizure, seen in the Emergency Department.  Dr requests to be reported as no other indications for seizure.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site scab
Clinical narrative: Patient said that a couple of days after the vaccination his arm started itching at the site of injection. It has not gotten better for almost 1 month. His arm itches at site, he itches it, scratches off the scab and it scabs over again. The process repeats. Patient's doctor told his to use hydrocortisone for the itching but result of this is unknown at this time.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling of body temperature change, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling started almost immediately after injection about 2 inches below the injection site on the thigh. The swelling started slowly spreading up and out towards the injection site increasing in an odd irregular fashion. Within 30 minutes the swelling had reached the injection site and continued to spread outward. The skin became red and was warm to the touch about 2 degrees difference in temperature than other areas of the body. (Temporal temp was 99.2/ Off site thigh temp 96.7/ onsite red and swollen areas of the thigh temp 98.7/) Administered a homeopathic remedy and applied essential oils 2.5 hours later the swelling decreased dramatically. However, swelling resumed the next day upon rise. Patient complained it was sore when touched.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Patient was in school and apparently had a blanking out type episode and was not responsive to teacher.  Patient taken to ER.  ER provider reports that patient had muscle related seizure like activity and was afebrile.  Patient was transferred to another Pediatrician for monitoring.  Patient has never had a episode like one reported and Providers are unsure of cause.  Only known recent change had been vaccination.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye movement disorder, Loss of consciousness, Migraine, Nausea
Clinical narrative: Dizziness such as vertigo. When rolling over in bed, eyes started "rolling" sensation and the whole room felt like a boat on rough seas. Also nausea and blacking out when got up to go to bathroom. Lasted until 130pm then a migraine started.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Dizziness such as vertigo. When rolling over in bed, eyes started "rolling" sensation and the whole room felt like a boat on rough seas. Also nausea and blacking out when got up to go to bathroom. Lasted until 130pm then a migraine started.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Small rash at injection site.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives over entire body.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient called pharmacy on 11/6/14 to report local injection site reaction to Zostavax vaccine. Patient denied any systemic side effects(redness/rash measured about 5 inches in diameter); was slightly warm to the touch, and slightly swollen; patient decided to go to doctor to have the reaction looked at; doctor prescribed patient an antibiotic in case there was any infection; doctor drew around the redness/rash and instructed patient to watch to see if the rash grew.
Age: 81.0
Sex: F
Vaccine: FLUX, PPV, TTOX, VARZOS
Symptoms: Ageusia, Cardiomegaly, Joint swelling, Nausea, Weight decreased
Clinical narrative: This medically confirmed report (initial receipt 08-Oct-2014) concerns an 81 year old female patient who had a medical history of tape allergy (redness), lung cancer diagnosed in Dec-2011. The patient received a right lower lobectomy and pathology revealed a 1.9cm adenocarcinoma that was invading the visceral pleura with a negative margin. The patient had 3/8 peribronchial lymph nodes positive for metastatic adenocarcinoma. Molecular testing revealed ALK translocation. On the 26-Mar-2012, the patient completed 4 cycles of adjuvant carboplatin and ALIMTA. In May-2014, the patient had a PET (Positron emission tomography) and CT (Computerised Tomography) scan that showed extensive mediastina and hilar uptake and additional several bone lesions were identified. On the 04-Jun-2014, a FNA of paratracheal node confirmed metastatic N5CLC-Adeno with ALK mutation. Concomitant medications included risedronate 150mg monthly, zolpidem (5 mg and 6.25 mg extended release) when required for sleep, ondansetron 4mg orally when required for nausea, vomiting. Other documented medications included 'Bone Strength Take Care' 3000mg orally daily, iron 28mg orally daily, krill oil 1 capsule orally daily and levothyroxine 25 mcg orally daily. On the 26-Jun-2014, the patient commenced crizotinib, 200 mg twice daily orally. On the 28-Aug-2014, the patient presented for a regular follow up. The patient reported that for the last four to five days, she was having watery diarrhoea (with no blood or mucus) several times a day. The week prior, she was constipated and was advised to take magnesium citrate, polyethylene glycol and senna. After taking these medications, she developed diarrhoea. Two weeks prior, the patient developed worsening fatigue, LE (left) edema had increased over the past few weeks. The patient denied fever, chills, hemoptysis and headaches. The patient reported poor appetite. On the 09-Sep-2014, the patient received the influenza vaccine (manufacturer and batch number not reported) and concomitantly received Pneumococcal vaccine (manufacturer and batch number not provided), tetanus vaccine (manufacturer and batch number not provided) and zoster vaccine (manufacturer and batch number not provided). On an unspecified date, the patient developed nausea, some weight loss, at times taste loss, heart was somewhat enlarged and ankles were swollen. Outcome was reported as recovering.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dry mouth, Feeling abnormal, Musculoskeletal stiffness, Pain
Clinical narrative: Patient experienced "stiffness" in her left arm and a "weird feeling" about 4:30 pm the afternoon of her administered vaccine. Later at 6:30 pm, Patient reported "chills, fever of 102 degrees F, and body ache." Patient also reported having dry mouth and excess urination.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pollakiuria, Pyrexia, White blood cell count increased
Clinical narrative: Patient experienced "stiffness" in her left arm and a "weird feeling" about 4:30 pm the afternoon of her administered vaccine. Later at 6:30 pm, Patient reported "chills, fever of 102 degrees F, and body ache." Patient also reported having dry mouth and excess urination.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Nausea, Pyrexia
Clinical narrative: Violent headache for 48 hours. Other symptoms such as fever 101, joint pain, nausea persisted for upto 3 days.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Swelling
Clinical narrative: Rash and swelling. Patient taking antibiotics now for ifxn.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Feeling abnormal, Increased bronchial secretion, Ocular hyperaemia, Rash
Clinical narrative: 10/31/14: That evening 6PM client stated she started wheezing and coughing had mucous in lungs and bronchial tube, eyes red, face swollen, rash on face, chest and arms. Husband wanted to go to urgent care but she took Benadryl - not sure of dose and waited it out at home. After 2 hours, coughing subsided but eves were red until Sunday early but swelling present until Sunday night 11/2/14. 11/1/14-Felt lousy all day.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Wheezing
Clinical narrative: 10/31/14: That evening 6PM client stated she started wheezing and coughing had mucous in lungs and bronchial tube, eyes red, face swollen, rash on face, chest and arms. Husband wanted to go to urgent care but she took Benadryl - not sure of dose and waited it out at home. After 2 hours, coughing subsided but eves were red until Sunday early but swelling present until Sunday night 11/2/14. 11/1/14-Felt lousy all day.
Age: 10.0
Sex: M
Vaccine: FLUN4, TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Tdap vaccine given on 11/4/14. Pt. now with redness, swelling and upper arm hot to touch.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Joint injury, Tendonitis
Clinical narrative: Shoulder injury - tendonitis or bursitis - decreased range of motion on left arm - anti-inflammatory tx ibu 800mg tid prn.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: Continued (L) shoulder and upper arm pain 2 weeks post vaccination - flu shot, pain and decreased ROM to (L) shoulder.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling cold, Headache, Pallor
Clinical narrative: Pt got the shot at around 5 PM on 11/2/14. Approached the pharmacy counter about 5 min after complained of dizziness and as time passed she mentioned having headaches. She was very cold and pale looking. Paramedics were called in. She rested, lying down about 15-20 mins - stabilized, left.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Swelling of tongue 30 minutes after vaccination given, urgent care gave short course of steriods and swelling resolved.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Mass, Skin warm
Clinical narrative: Red area, warm t touch, lump hard under skin.  Due to other health issues Dr. prescribed KEFLEX 500 (1tid x 10d).
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain in extremity, Ultrasound scan
Clinical narrative: Arm started swelling and hurt-still swollen and hurts but wearing a sleeve that helps hasn't done any other treatment.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site infection
Clinical narrative: Infection at injection site from ZOSTAVAX.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Flushing, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: L upper arm redness, swelling, tenderness, face flushing, pain in neck, shoulder blades. Diagnosis: Cellulitis.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: L upper arm redness, swelling, tenderness, face flushing, pain in neck, shoulder blades. Diagnosis: Cellulitis.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Rash
Clinical narrative: 7 day after PREVNAR - red and bumpy-no blisters 2 inches, lasted about 4 days =, no other symptoms. Left arm.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Malaise, Oropharyngeal pain, Swelling face
Clinical narrative: Patient's face appeared swollen (especially in cheeks) and red. Complained of feeling ill and throat pain 5 minutes after vaccination. She was evaluated by Dr. Dose of BENADRYL given in office. Vitals taken and monitored, were within normal limits. Patient and mother given teaching on EPIPEN Jr and received Rx for EPIPEN Jr. Patient was in office for 1 hour, left in good condition feeling well. Last set of vitals was BP 97/63, HR 84, RR 20.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Spinal pain
Clinical narrative: Pt called at 5:15 PM reported her arm hurt yesterday at injection site and now pain had settled in her spine.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site reaction, Injection site warmth, Malaise, Pain in extremity
Clinical narrative: Patient complained of a raised red rash that was warm to the touch below the site of the injection. She also said she felt fatique and generally did not feel well. Had a fever of 99.7 on 11/5/14 and arm pain as well.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Patient complained of a raised red rash that was warm to the touch below the site of the injection. She also said she felt fatique and generally did not feel well. Had a fever of 99.7 on 11/5/14 and arm pain as well.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Child developed urticaria 48 hours s/p receiving FLUMIST. Patient gave PO BENADRYL. Hives persisted and child was evaluated by MD who Rx'ed Prednisone.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, chills, diaphoresis, chest pain.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ
Symptoms: Flushing, Injection site erythema, Injection site macule, Injection site warmth
Clinical narrative: Flushing of face. Redness and warmth of injection site and top of opposite shoulder with 5 red macules. Started receding within 20 minutes, almost resolved at 30 minutes.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Acute pain in shoulder. Flu vaccine administered high on shoulder. pain after 1 week in lifting up arm. Pain not subsiding.