chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Eye discharge, Headache, Myalgia
Clinical narrative: Racing heart, tingling around my mouth after about one hour of receiving the vaccination. Then felt light-headed. I actually prepared myself to advise a co-worker that I may need 911. About 4:00 PM, a hard, white, large mucous developed in the corners of my eyes and that continued for 24 hours. Achy muscles developed in the evening. Woke up in the middle of the night with pain in my head, pain in my mouth area/jaw and was very weak. I felt I may have had a fever but did not look for a thermometer to take my temperature. I stayed awake for several hours and during that time, the pain reduced tremendously. Fell back asleep and woke up at 6:30 AM feeling great except had the hard white large mucous in the corner of my eyes. The eye mucous reduced and disappeared about lunch time. I took no pain medication during that time. I hadn't received a flu vaccination in about 10 years previous to this vaccination. I'm thinking I will not get another vaccination. Thank you.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Oral pain, Palpitations, Paraesthesia oral, Pyrexia
Clinical narrative: Racing heart, tingling around my mouth after about one hour of receiving the vaccination. Then felt light-headed. I actually prepared myself to advise a co-worker that I may need 911. About 4:00 PM, a hard, white, large mucous developed in the corners of my eyes and that continued for 24 hours. Achy muscles developed in the evening. Woke up in the middle of the night with pain in my head, pain in my mouth area/jaw and was very weak. I felt I may have had a fever but did not look for a thermometer to take my temperature. I stayed awake for several hours and during that time, the pain reduced tremendously. Fell back asleep and woke up at 6:30 AM feeling great except had the hard white large mucous in the corner of my eyes. The eye mucous reduced and disappeared about lunch time. I took no pain medication during that time. I hadn't received a flu vaccination in about 10 years previous to this vaccination. I'm thinking I will not get another vaccination. Thank you.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4, MEN
Symptoms: Cold sweat, Feeling cold, Loss of consciousness, Pallor, Syncope
Clinical narrative: Fainted/lost consciousness while still at doctors office, remained pale, clammy, shaky and cold for a while.  Remained at doctors office until he felt better.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4, MEN
Symptoms: Tremor
Clinical narrative: Fainted/lost consciousness while still at doctors office, remained pale, clammy, shaky and cold for a while.  Remained at doctors office until he felt better.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Rash, Urticaria
Clinical narrative: Sore throat, aches, hive rash on upper back and neck and chest area.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eye movement disorder, Injection site rash, Petit mal epilepsy, Pyrexia, Rash
Clinical narrative: On 9/22/2015, a red bump rash appeared on patient's sides of his torso, with several bumps on his legs, and face. This rash continued for 5 days. On 9/24/2015, patient had an event where his eyes were focused completely to the left and was completely unresponsive for 7 seconds. He was seen that afternoon by Dr. and it was determined that patient suffered an Absence Seizure. Beginning on 9/27/2015 and lasting until 9/30/2015, patient has been suffering from high fevers fluctuating from 102.5 and is continuing to have fever.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Unresponsive to stimuli
Clinical narrative: On 9/22/2015, a red bump rash appeared on patient's sides of his torso, with several bumps on his legs, and face. This rash continued for 5 days. On 9/24/2015, patient had an event where his eyes were focused completely to the left and was completely unresponsive for 7 seconds. He was seen that afternoon by Dr. and it was determined that patient suffered an Absence Seizure. Beginning on 9/27/2015 and lasting until 9/30/2015, patient has been suffering from high fevers fluctuating from 102.5 and is continuing to have fever.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: Right arm pain/weakness, radiating into the neck.  No bruising or swelling noted by patient.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Hypersomnia, Nausea, Pharyngeal oedema
Clinical narrative: I am still having symptoms. It started with severe fatigue and sleeping 16 hours or more. As of 09/25/2015 I have had a headache, nausea and a terrible itch in my throat. Today I took allergy medicine because my throat was swollen. I can barely stay awake. Last year I broke out in hives for 10 days and my throat was swollen. I received a high dose of prednisone about 3 weeks after the flu shot. Was not 100% sure it was from the flu shot, but now I know it was.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: I am still having symptoms. It started with severe fatigue and sleeping 16 hours or more. As of 09/25/2015 I have had a headache, nausea and a terrible itch in my throat. Today I took allergy medicine because my throat was swollen. I can barely stay awake. Last year I broke out in hives for 10 days and my throat was swollen. I received a high dose of prednisone about 3 weeks after the flu shot. Was not 100% sure it was from the flu shot, but now I know it was.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema, Peripheral swelling
Clinical narrative: Bruising and redness and swelling of arm down to elbow.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Approximately 2 hours after receiving influenza vaccine, patient returns to clinic with hives to face and neck. Denies SOB/difficulty breathing. Patient assessed by provider and released home with BENADRYL.
Age: 4.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: (L) anterior thigh with 3 cm erythematous inflammed pain.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Oral herpes
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever blister in a 54-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2T3JZ, expiry date 21st June 2016). The patient's past medical history included fever blister (had fever blisters occasionally). On 16th September 2015, the patient received FLUARIX QUADRIVALENT. On 18th September 2015, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was recovering/resolving. It was unknown if the reporter considered the fever blister to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The patient had had outbreak of fever blisters on her upper and lower lips, which progressed to blisters on both upper and lower gums. The patient had self treated with salt water rinses and the blisters were resolving.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 47-year-old female patient who received BOOSTRIX (batch number 9N74F, expiry date 19th August 2017). Concomitant products included ESTRACE, FLEXERIL, PROTONIX, PROZAC, XANAX and ZANTAC. On 28th August 2015, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 28th August 2015, less than a day after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX vaccine in left arm. The patient experienced soreness at injection site (left arm). In 2015, less than a month after receiving the vaccine, the patient could not lift her injected arm (injected limb mobility decreased). The patient came back to visit the doctor and the physician assessed the arm and noticed that there was no injury. The patient might had taken some medicine for the pain. The day before the time of reporting, the patient was feeling much better but still a little sore. The reported batch number (9N74S) of BOOSTRIX did not exist and was updated to 9N74F as per the sales database.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 43-year-old female patient who received FLULAVAL QUADRIVALENT (batch number H33J2, expiry date 31st May 2016). Concomitant medications included levofloxacin, nitrofurantoin, omeprazole and pantoprazole. On 21st September 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On 22nd September 2015, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling, injection site warmth, injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema and injection site tenderness to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was reported by a medical assistant. On 21st September 2015, at 8.30 am, the patient received FLULAVAL QIV. On the day of reporting, the patient returned to the medical assistant's office and reported redness, tenderness, warm to the touch arm with a raised bump and swelling at the injection site. No other vaccines were administered on the same day or within 4 weeks of injection with FLULAVAL. No additional details were available at the time of reporting.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Localized redness, measuring 10'x5 1/2" irregular shaped surrounding the injection site.  Warm to the touch and patient report pain 5 out of 10 to the area.  Patient encouraged to apply ice pack throughout the day.  This nurse outlined the redness with ink pen.  Appointment scheduled with doctor 10/1/15.  Encouraged patient to seek help at Urgent Care clinic if the redness continues.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing
Clinical narrative: Generalized flushing onset 45 min to 1 hour post vaccination. Took Benadryl 25mg at onset, symptoms improved after 20-30 minutes. Denies difficulty breathing, throat or lip swelling, or chest tightness.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: 24 hours after injection  swelling. 48 hours after injection  continued swelling, redness, heat, persistent itching. Took Zyrtec and applied ice pack.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: 4 INCH RASH SURROUNDING INJECTION SITE.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Pruritus, Urticaria
Clinical narrative: Pt. stated she noted itching at injection site approx. 15 minutes after injection.  She called @ 10:03 AM to report itching and hives.  Told her to come by to let infection control nurses check it.  HR arranged for appt to see Occupational Health.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Headache, Injection site warmth, Malaise
Clinical narrative: Chills, Fatigue, Muscle Aches, Sore Arm, Hot at site of injection, Mild Headache, Malaise.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Chills, Fatigue, Muscle Aches, Sore Arm, Hot at site of injection, Mild Headache, Malaise.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: After receiving the shingles and flu shots I felt very flu like aches. Developed a fever of 100.3 sore, red, hot, hard bump at injection site and a very bad headache. Fever lasted until mid morning, still have mild headache and arm is still red, hot, sore, and hard bump 24 hrs after injection.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: After receiving the shingles and flu shots I felt very flu like aches. Developed a fever of 100.3 sore, red, hot, hard bump at injection site and a very bad headache. Fever lasted until mid morning, still have mild headache and arm is still red, hot, sore, and hard bump 24 hrs after injection.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Chest discomfort, Dysstasia, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Leg numbness. In able to walk or stand and later upper body numbness and chest tightness.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Arthralgia of elbow of injection site arm, pain in great toe metatarsophalangeal joint, pain in ankle.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Flushing, Musculoskeletal discomfort, Respiratory tract congestion, Vomiting
Clinical narrative: Approximately five minutes after the patient received his vaccines, he began vomiting, his face became flushed, he became congested and mom reported patient started pulling at his neck. Patient taken to Emergency Room by his mother.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Allergy test, Haematochezia, Laboratory test, Occult blood positive
Clinical narrative: Blood in stool starting 2 days after vaccines were given. No improvement after milk was eliminated by breastfeeding mother. Blood in stool persists as of 09/28/2015.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat, fever, joint aches, productive cough, nasal congestion, stomach cramps, diarrhea.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough, Pyrexia
Clinical narrative: Sore throat, fever, joint aches, productive cough, nasal congestion, stomach cramps, diarrhea.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthropathy, Back pain, Dysstasia, Gait disturbance, Injected limb mobility decreased
Clinical narrative: The night of her vaccination, the patient had trouble lifting her left arm.  The next day she also had trouble lifting her right arm, then her back hurt and she had problems with her knees and joints.  She reported trouble standing and walking.  She improved 2 days after the vaccine, and the symptoms had resolved after 3 days.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: The night of her vaccination, the patient had trouble lifting her left arm.  The next day she also had trouble lifting her right arm, then her back hurt and she had problems with her knees and joints.  She reported trouble standing and walking.  She improved 2 days after the vaccine, and the symptoms had resolved after 3 days.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient fainted and fell with head injury resulting.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Computerised tomogram, Laboratory test, Pain
Clinical narrative: Patient started to feel achy from head to toes and had severe stomach upset. It was severe enough that patient reported to ER.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Balance disorder, Fatigue, Feeling hot, Headache
Clinical narrative: At 7:00PM (8/6/15) she started feeling off balance when walking only. She c/o pain in her right temple area and felt warmer than usual. She felt very tired on 8/7/15. Denies rash/hives/SOB.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Over night it felt sore, as day progressed the reaction has spread to a rash around the site of injection with mild swelling and mild warmth to touch.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Injection site atrophy
Clinical narrative: Dimple @ site of injection. Left thigh.   Dimple increased in size over the next 6 months.   Dimple is now the size of a dime.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration, Injection site swelling
Clinical narrative: Patient states site of injection swelled within hours of receiving vaccine. Large bruise at site 4-5 inches round. No blistering or peeling. Bruise now yellow and purple in color.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: CSF protein increased, Electromyogram normal, Guillain-Barre syndrome, Muscular weakness, Nuclear magnetic resonance imaging spinal
Clinical narrative: EHS unaware of adverse reaction until 9/22/15 when patient requested flu vaccine exemption. History: Rec'd flu vaccine 10/17/14. Awakened 11/3/14 with (L) arm tingling; 11/4/14 (R) arm tingling also; 11/5/14 feet and legs tingling, progressive to weakness at extremities on 11/7/14. Seen in ES 11/7/14 and hospitalized 1 day. Multiple studies then and since to confirm Dx.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: EHS unaware of adverse reaction until 9/22/15 when patient requested flu vaccine exemption. History: Rec'd flu vaccine 10/17/14. Awakened 11/3/14 with (L) arm tingling; 11/4/14 (R) arm tingling also; 11/5/14 feet and legs tingling, progressive to weakness at extremities on 11/7/14. Seen in ES 11/7/14 and hospitalized 1 day. Multiple studies then and since to confirm Dx.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Headache, Lethargy
Clinical narrative: Patient awoke after going to bed with a debilitating headache, severe lower back pain. She felt lethargic. Symptoms continued for 24 hours.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed warmth, redness and swelling of left upper arm after receiving flu vaccine.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia
Clinical narrative: Patient had a fever of 101 overnight. She took aspirin. She had a headache this morning.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Red, swollen, hot to touch, localized reaction to right arm around injection site. Size about 6 inches in diameter. No fever.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extreme constant pain at injection site and top half of arm.  From elbow to shoulder, arm feels extremely hot; this has led to an elevated body temperature for me.  The injection site is raised and red and is barely 1 fingers width from the top of my shoulder.  Cannot sleep, as the pain is excruciating to the touch.  Shoulder hurts constantly.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Musculoskeletal pain
Clinical narrative: Extreme constant pain at injection site and top half of arm.  From elbow to shoulder, arm feels extremely hot; this has led to an elevated body temperature for me.  The injection site is raised and red and is barely 1 fingers width from the top of my shoulder.  Cannot sleep, as the pain is excruciating to the touch.  Shoulder hurts constantly.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Started out as red circle around shot. By third day it had spread to entire upper arm, very swollen, very hot, ached horribly, and it ran into the inside of the arm and down to elbow area.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Autoimmune dermatitis, Culture throat, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Developed a rash and fever. Started on 9/9/15. Was seen in a urgent care on 9/12/15. Tested for strep which was negative. Put on Amoxicillin. Rash continued so went to doctor on 9/16/15. No other symptoms noted. Diagnosed with auto immune dermatitis and physician stated in notes it could have been a reaction/side effect from the meningococcal vaccine.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Mobility decreased, Nausea, Pain, Palpitations
Clinical narrative: PATIENT DESCRIBED INITIALLY HAD COLD FEET, THEN PROGRESSIVELY WORSENED INCLUDING HER SKIN FEELING IT WAS BURNING, EXTREMELY NAUSEOUS, PALPITATIONS AND SORE THROUGHOUT BODY. SHE REPORTED SHE HAD A TEMPERATURE OF 100.4F. COULD NOT MOVE FOR HOURS AND SLOWLY THE SYMPTOMS LESSENED, BUT STILL REMAINS SORE.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral coldness, Skin burning sensation
Clinical narrative: PATIENT DESCRIBED INITIALLY HAD COLD FEET, THEN PROGRESSIVELY WORSENED INCLUDING HER SKIN FEELING IT WAS BURNING, EXTREMELY NAUSEOUS, PALPITATIONS AND SORE THROUGHOUT BODY. SHE REPORTED SHE HAD A TEMPERATURE OF 100.4F. COULD NOT MOVE FOR HOURS AND SLOWLY THE SYMPTOMS LESSENED, BUT STILL REMAINS SORE.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: The patient received both the Pneumovax and Fluzone HD in the left shoulder. That patient now has redness and warmth in the left bicep. The doctor diagnosed it as cellulitis.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess, Injection site swelling
Clinical narrative: EXTREME SWELLING AND HEAT AT INJECTION SITE AND SURROUNDING AREA. RESOLVED WITHIN 4 DAYS.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Pain
Clinical narrative: Patient reported pain upon injection.  Patient returned on 9/29/15 showing a bruise of approx. 4 mm and said the area was very sore.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Administration site pain, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient reported very painful around site of administration to the point where it hurt to move her arm. Swelling, redness. Area was warm. Patient stated arm continued to hurt more as time progressed.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: 102 fever lasted 4 days, could not lift arm, vomiting, redness, and swelling that was moving down to her arms. Went to doctor 2 times was given antibiotic. She reported to us on 9/25 after her Dr visit and by then fever was down and redness was outside a line where her Dr. made a line around the area. 9/28 no fever, swelling is down and still some redness. Dr added more days to be on antibiotic.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Vomiting
Clinical narrative: 102 fever lasted 4 days, could not lift arm, vomiting, redness, and swelling that was moving down to her arms. Went to doctor 2 times was given antibiotic. She reported to us on 9/25 after her Dr visit and by then fever was down and redness was outside a line where her Dr. made a line around the area. 9/28 no fever, swelling is down and still some redness. Dr added more days to be on antibiotic.
Age: 91.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus, Rash generalised
Clinical narrative: Patient states after receiving Prevnar at MD office, then an hour later receiving Fluzone HD at Pharmacy, developed rash on most of body with itching.  Lasting a couple days.
Age: 50.0
Sex: F
Vaccine: FLUR3
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen red, itching and pain at injection site, Slight Shortness of Breath, within 3 hrs mild skin redness in abdominal area and arms. Raised red lesions (hives) within 6 hrs.
Age: 50.0
Sex: F
Vaccine: FLUR3
Symptoms: Skin lesion, Urticaria
Clinical narrative: Swollen red, itching and pain at injection site, Slight Shortness of Breath, within 3 hrs mild skin redness in abdominal area and arms. Raised red lesions (hives) within 6 hrs.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Lymphadenopathy, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Sore shoulder and neck, continued to get worse each day and travel from shoulder to neck upper back and down arm of side vaccination was on, it is 7 days later and I had to intermittently lay on ice or heating pad all night last night to get any sleep, my lymph nodes feel swollen on that side under my arm and in my neck  I am trying to reach my Dr about it.
Age: 8.0
Sex: M
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Child had two sm. hive like bumps on face. Occurred w/in 1/2 hr. of receiving vaccine. Encouraged parent to take child to PCP or Emergent care center.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Exposure during pregnancy, Joint range of motion decreased
Clinical narrative: Increasing pain in shoulder joint.  Pain is sharp and limits range of motion.  Due to pregnancy, treatment has been icing and Tylenol.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Per father pt. woke up with the left arm area red and swollen/hard.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling jittery, Heart rate increased, Hypopnoea
Clinical narrative: Fast heartbeat, shallow breathing, jittery feeling for about 45 minutes.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Influenza like illness, Musculoskeletal pain, Neck pain, Somnolence
Clinical narrative: Flu like symptoms of weakness, aches near shoulders and neck area. Patient claims she could not stay awake and felt like she wouldn't be able to go into work the next day. When waking up at 5 in the morning the day after the vaccine was given she felt completly normal again and was able to attend work.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV9, MNQ
Symptoms: Blood pressure increased, Dizziness, Headache
Clinical narrative: Patient reported to nurse who checked him that he was feeling lightheaded and had a headache after receiving the HPV, Menactra, and Influenza vaccines.  Headache was 10/10.  Vital signs were checked and initially normal.  Patient was assessed by physician and no focal deficits were noted.  He was advised to lie down after drinking water and given Tylenol for headache.  Upon reassessment patient reported decreased lightheadedness and headache now 9/10.  Vital signs rechecked and blood pressure was elevated, other vital signs stable.  Due to symptoms still being present advised further evaluation and assessment in ED.  Patient was subsequently seen there and given IV fluids and Reglan and Nephrology was consulted due to his blood pressure.  Examination remained unchanged from initial exam when first assessed after vaccination.
Age: 5.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Injection site hypoaesthesia
Clinical narrative: Numbness in the lateral right leg.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chest pain, Erythema, Peripheral swelling, Sensation of foreign body
Clinical narrative: Patient received flu vaccine at clinic. Within 10 minutes came back to injection room and her left arm was swollen, red and hot to touch. While examing patient she was clearing her throat several times. When questioned further she also stated that her throat felt "like it was closing up." Patient was immediately taken to our observation room and given epinephrine in LLT. She was also given 50 mg Benadryl. She was monitored in clinic for an hour with some improvement of symptoms however at around 12:45 pm she said she was having a burning sensation in her chest and she was having abdominal cramping. Patient also was continuously clearing her throat and said "it felt like something is caught in my throat." PA came back down to observation area to see patient. Patient was given another 0.3 mg dose of epi. She was transported to ED by medics.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Throat irritation, Throat tightness
Clinical narrative: Patient received flu vaccine at clinic. Within 10 minutes came back to injection room and her left arm was swollen, red and hot to touch. While examing patient she was clearing her throat several times. When questioned further she also stated that her throat felt "like it was closing up." Patient was immediately taken to our observation room and given epinephrine in LLT. She was also given 50 mg Benadryl. She was monitored in clinic for an hour with some improvement of symptoms however at around 12:45 pm she said she was having a burning sensation in her chest and she was having abdominal cramping. Patient also was continuously clearing her throat and said "it felt like something is caught in my throat." PA came back down to observation area to see patient. Patient was given another 0.3 mg dose of epi. She was transported to ED by medics.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Bruxism, Ear pain, Erythema, Heart rate increased
Clinical narrative: PT COMPLAINED OF INCREASED HEART RATE, THROBBING IN THE EARS, CLINCHING PAIN IN HER TEETH, AND BACK PAIN/STIFFNESS. PT SHOWED REDDENING OF THE CHEST AND NECK AREAS. PT WAS GIVEN 2 TEASPOONFULS OF DIPHENHYDRAMINE. TOOK BLOOD PRESSURE AND IT WAS 165/99 (SITTING POSITION) WITH A HEART RATE OF 100 BPM. PT DID NOT WANT TO CALL AN AMBULANCE. SHE SAT FOR APPROXIMATELY 10 MINUTES. SHE STOOD UP AND REDDENING SUBSIDED.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: PT COMPLAINED OF INCREASED HEART RATE, THROBBING IN THE EARS, CLINCHING PAIN IN HER TEETH, AND BACK PAIN/STIFFNESS. PT SHOWED REDDENING OF THE CHEST AND NECK AREAS. PT WAS GIVEN 2 TEASPOONFULS OF DIPHENHYDRAMINE. TOOK BLOOD PRESSURE AND IT WAS 165/99 (SITTING POSITION) WITH A HEART RATE OF 100 BPM. PT DID NOT WANT TO CALL AN AMBULANCE. SHE SAT FOR APPROXIMATELY 10 MINUTES. SHE STOOD UP AND REDDENING SUBSIDED.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Pain in shoulder joint of arm where vaccine was administered immediately and decreased flexion, abduction, internal rotation.
Age: 59.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: INJECTION SITE (LEFT DELTOID) PAINFUL KNOT THE SIZE OF A HALF DOLLAR. WAS WARM TO TOUCH. STAYED SAME FOR 1 WEEK, THEN GOT SMALLER. PRESENTLY CAN FEEL KNOT TO BE 1 INCH BY 1/2INCH WIDE.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia, Nausea, Pain
Clinical narrative: I woke up extremely nauseous, whole body ached, severe head ache, vomiting, later progressed into fever at 1200. I had chills and muscle pain. Friend who received flu shot with me also experienced the same symptoms. I called the health clinic and talked to the NP, she told me that there was nothing she could do and I just had to wait it out.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: I woke up extremely nauseous, whole body ached, severe head ache, vomiting, later progressed into fever at 1200. I had chills and muscle pain. Friend who received flu shot with me also experienced the same symptoms. I called the health clinic and talked to the NP, she told me that there was nothing she could do and I just had to wait it out.
Age: 40.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Limb discomfort, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm was swollen, painful, feverish, rash like in a 5 inch radius circle.  Patient put ice on red area, and took ibuprofen, Benadryl and hydroxyzine.  As of 9/30/15, red, painful, swollen area is decreasing in size and discomfort.
Age: 40.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash
Clinical narrative: Arm was swollen, painful, feverish, rash like in a 5 inch radius circle.  Patient put ice on red area, and took ibuprofen, Benadryl and hydroxyzine.  As of 9/30/15, red, painful, swollen area is decreasing in size and discomfort.
Age: 33.0
Sex: M
Vaccine: FLUX, MMR, TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever (101F), headache, and body aches for about 36 hours.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Swelling face
Clinical narrative: Swelling of lips and face.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, IPV, MMR, VARCEL
Symptoms: Vaccination site rash
Clinical narrative: Rash surrounding vaccine sites. No swelling.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Immunization: FLUZONE and PNEUMOVAX at 4:31 pm 9/24/15 at 10 pm (9/24/15) pt start had sore then fever. Fever increased 102.4 on Sat 9/26. Patient took ADVIL 3 Q 6 hours, and APAP fever down to 98.2 on Sunday 9/27.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site upper left deltoid area excess of 24 hours pain on touch.
Age: 96.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills
Clinical narrative: Pt received flu shot on 9/18/15 with no side effects. On 9/28 he complained of weakness and chills. Says he has never experienced this before. No fever, no sweats. Called pharmacy 9/30 4:20 PM.
Age: 0.67
Sex: M
Vaccine: FLU3
Symptoms: Blood immunoglobulin E increased, C-reactive protein increased, Differential white blood cell count, Erythema multiforme, Full blood count
Clinical narrative: Fever, feet swelling, and rash (erythema multiforme-like). Flu shot given 9/22/15, symptoms started 9/23/15.
Age: 0.67
Sex: M
Vaccine: FLU3
Symptoms: Haemoglobin decreased, Peripheral swelling, Pyrexia, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Fever, feet swelling, and rash (erythema multiforme-like). Flu shot given 9/22/15, symptoms started 9/23/15.
Age: 0.67
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis
Clinical narrative: Fever, feet swelling, and rash (erythema multiforme-like). Flu shot given 9/22/15, symptoms started 9/23/15.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Gave vaccine at 10 AM. By 3 PM symptoms (muscle weakness and tingling in hands) started. Pt. wife called me, I referred to ER to r/o Guillain Barre. ER physician didn't think it was G-B.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Laboratory test, Muscular weakness, Paraesthesia
Clinical narrative: Gave vaccine at 10 AM. By 3 PM symptoms (muscle weakness and tingling in hands) started. Pt. wife called me, I referred to ER to r/o Guillain Barre. ER physician didn't think it was G-B.
Age: 57.0
Sex: F
Vaccine: FLU4, HEP, PNC13, FLU4, HEP, PNC13
Symptoms: Cellulitis, Chills, Pyrexia
Clinical narrative: Cellulitis with fever (R) deltoid.
Age: 57.0
Sex: F
Vaccine: FLU4, HEP, PNC13, FLU4, HEP, PNC13
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Cellulitis with fever (R) deltoid.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 29-SEP-2015, the patient was vaccinated with a dose of improperly stored VAQTA 25/0.5 (unit not provided), (lot#, expiry date, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN) referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patients were vaccinated with doses of improperly stored PROQAUD (Merck) (lot # L011080, expiry date: 01-OCT-2016, dose, route and frequency unspecified). Other suspect and concomitant therapies were not reported. No adverse effects reported. No product quality complaint (PQC) reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. The pharmacist reported that on 21-SEP-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L006382, expiration date 25-MAY-2016) (Dose and route were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected because the pharmacist declined to provided patient's or physician's information at this time.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN) referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # L011085, expiry date: 01-APR-2017; lot# L012036, expiry date: 07-APR-2017; lot# L016126, expiry date: 06-MAY-2017, dose, route and frequency unspecified). Other suspect and concomitant therapies were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN) referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # L012475, expiry date: 10-JUL-2016, route, dose and frequency unspecified). Other suspect and concomitant therapies were not reported. No adverse effects reported. No product quality complaint (PQC) reported. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin reaction, Swelling
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 61 years old female patient. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route unknown). Concomitant therapy was not reported. On an unknown date after vaccination, the patient developed a red, swollen, "severe" unspecified skin reaction (unspecified as to where on the body the reaction occurred). The patient then visited her primary care physician and was prescribed prednisone (dose and frequency unspecified). The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a female patient of unknown age. Information regarding concurrent conditions and medical history was not provided. The patient was vaccinated with her first dose of GARDASIL on 31-AUG-2011 and second dose of GARDASIL on 14-SEP-2015, (dose, lot #, route and application site were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients was received improperly stored RECOMBIVAX HB (lot# K018180 and expiry date: 17-SEP-2016; lot# K022265 and expiry date: 22-DEC-2016; lot# 1004754 and expiry date: 10-NOV-2016). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a male consumer, referring to her 226 days old (reported also as 32 weeks + 2 days old) son. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first and second dose of ROTATEQ (strength, dose, lot # and expiration date were not reported). It was reported that the patient completed 32 weeks + 2 days and he still did not take the third dose of ROTATEQ and asked if he/she could give it to him and if it was effective or not. No concomitant therapies were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients was received improperly stored VAQTA (lot# K012457 and expiry date: 04-JUN-2017; lot# L004743 and expiry date: 01-JUN-2017; lot# L023232 and expiry date: 25-FEB-2017. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients was received improperly stored ROTATEQ (lot# K022990 and expiry date: 26-JUN-2016; lot# K023537 and expiry date: 22-JUN-2016; lot# L004466 and expiry date: 02-AUG-2016). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored VAQTA lot # L0122249, expiry date 05-NOV-2016. No adverse effects reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pruritus, Injection site reaction, Peripheral swelling, Pruritus
Clinical narrative: Night after injection. Palms were red and itchy bilaterally. Palms were swollen for three days. Fever 48 hrs after, injection site was red in two areas lasted for three days. Area was itchy.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Night after injection. Palms were red and itchy bilaterally. Palms were swollen for three days. Fever 48 hrs after, injection site was red in two areas lasted for three days. Area was itchy.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored Oral, ROTATEQ lot # K019370, expiry date 16-JUL-2016 and K009900, expiry date 04-MAY-2016. No adverse effects reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: After admin of HPV pt. felt dizzy. I had her lay down and she fainted on the way down. Came back soon after. Looked  at by RN normal pulse. Stayed for 15 min before leaving.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 67 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On an unspecified date, the patient was vaccinated intramuscularly (instead of subcutaneously) with a dose of ZOSTAVAX injection (dose, lot# and expiry date were not reported). There were no concomitant therapies reported. On an unknown date, the patient had an unspecified "terrible reaction" to ZOSTAVAX. The reporter could not describe the reaction other than that it lasted a few days. The outcome of the event was not reported. The relatedness between ZOSTAVAX and the event was not provided. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Local reaction
Clinical narrative: Localized reaction in the right upper extremity from immunization. KINRIX (Dtap and IPV), moderate erythema; induration, blisters.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding to an unspecified patient of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot #L016428, expiration date 30-JUL-2017, dose was not provided). No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received fro ma 66 year old female retired medical assistant reporting on herself. The patient's allergies included allergy or reaction to penicillin. On 23-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). Concomitant medication was not provided. On 24-SEP-2015, the patient experienced redness, warmth and tenderness at the injection site. The patient did not received treatment for the adverse events and did not seek medical attention. Laboratories studies were not performed. Subsequently, within a few days, the patient recovered from these symptoms. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # K021030, expiration date: 22-JUN-2016. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Local reaction
Clinical narrative: It was a local rxn no fever.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. The patient's medical history and current conditions were not provided. On 23-JUL-2015, the patient was vaccinated with a first dose of VAQTA (lot #, expiration date, dose and route were not reported). On 21-SEP-2015, the patient was vaccinated with a second dose of VAQTA (lot #, expiration date, dose and route were not reported) which was outside of the recommendations in the VAQTA prescribing information. No adverse effect has been reported. This is one of two reports received from the same reporter. Additional information is not expected due to no consent to contact Health Care Professional was given.