chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Dizziness, Headache, Nausea
Clinical narrative: Severe headache - after 2 PM, 10/11/15 - to present off and on. Severe faint feeling, severe dizziness - after 2 PM, 10/11/15 - to present - off and on daily. Severe nausea - after 2 PM, 10/11/15 - to present - off and on. Severe weakness - after 2 PM, 10/11/15. Palpitation - on and off, started 10/12/15 AM to present - slow to very slow off and on daily. Severe pains and tingling - feet, toes, limbs, ankle, legs, arms, hands, fingers, back, torso, lower bodice - to present - off and on, daily. Shaking and tremors - 2 days after - to present, off and on.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain, Palpitations, Paraesthesia, Tremor
Clinical narrative: Severe headache - after 2 PM, 10/11/15 - to present off and on. Severe faint feeling, severe dizziness - after 2 PM, 10/11/15 - to present - off and on daily. Severe nausea - after 2 PM, 10/11/15 - to present - off and on. Severe weakness - after 2 PM, 10/11/15. Palpitation - on and off, started 10/12/15 AM to present - slow to very slow off and on daily. Severe pains and tingling - feet, toes, limbs, ankle, legs, arms, hands, fingers, back, torso, lower bodice - to present - off and on, daily. Shaking and tremors - 2 days after - to present, off and on.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis
Clinical narrative: Severe headache - after 2 PM, 10/11/15 - to present off and on. Severe faint feeling, severe dizziness - after 2 PM, 10/11/15 - to present - off and on daily. Severe nausea - after 2 PM, 10/11/15 - to present - off and on. Severe weakness - after 2 PM, 10/11/15. Palpitation - on and off, started 10/12/15 AM to present - slow to very slow off and on daily. Severe pains and tingling - feet, toes, limbs, ankle, legs, arms, hands, fingers, back, torso, lower bodice - to present - off and on, daily. Shaking and tremors - 2 days after - to present, off and on.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, FLUN4, HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave FluMist to a client that expired the day before- no adverse events, it was just an error.
Age: 38.0
Sex: F
Vaccine: FLUR3
Symptoms: Influenza
Clinical narrative: This is an initial report of an AE, received on 10Feb2016, with additional information received on 12Feb2016 for Protein Sciences FLUBLOK. Subject, a 38 year-old female teacher, received FLUBLOK Intramuscular on 10Oct2015. The subject reported that, on or around 31Jan2016, she contacted a strain of Influenza and FLUBLOK is a possible relationship in light of the safety profile information that individuals with immunocompromised may not respond to the vaccine. In summary, this case report does not change the known safety profile of FLUBLOK.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Cough, Decreased appetite, Pruritus, Rash, Rhinorrhoea
Clinical narrative: The patient is a 4 year, 11 month old female who presents with a complaint of Rash. The patient is accompanied to the office visit today by their mother, The rash has been occurring for 1 day(s). The rash is present at the abdomen, back and elbow. Symptoms of the rash have included itching. Note for "Rash" Note: Patient comes for a rash since last night. The rash was discovered because of itches. She has no fever and her appetite is decreased. There has been no vomiting or diarrhea. She has a runny nose and a cough.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Blood urine absent, CSF culture negative, Computerised tomogram head, Culture urine negative
Clinical narrative: Pt was irritable/inconsolable starting 1.5 hrs after vaccinations. 3 hrs later, he developed a bulging anterior fontanelle. Irritability waxed and waned, but fontanelle continued and bulge. The next day he was admitted via ER at hospital. Workup was negative. His fontanelle remained bulging until 48 hrs after the shots...resolved and back to his baseline. D/C'd home after 1 day.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Emotional distress, Fontanelle bulging, Full blood count normal, Irritability, Lumbar puncture normal
Clinical narrative: Pt was irritable/inconsolable starting 1.5 hrs after vaccinations. 3 hrs later, he developed a bulging anterior fontanelle. Irritability waxed and waned, but fontanelle continued and bulge. The next day he was admitted via ER at hospital. Workup was negative. His fontanelle remained bulging until 48 hrs after the shots...resolved and back to his baseline. D/C'd home after 1 day.
Age: 1.34
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever up to 105.7 and febrile seizure 9 days after MMR, VARIVAX, and Hib administered.
Age: 0.21
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Diarrhoea, Infantile spitting up, Respiratory tract congestion, Vomiting
Clinical narrative: Patient had vomiting, diarrhea, spitting up and congestion.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No medical history and concurrent conditions were reported. On an unknown date (also reported as several years ago) the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced shingles after the vaccine which caused her to be hospitalized. The outcome of herpes zoster was unknown. The relatedness of the event to the therapy with ZOSTAVAX was unknown. This case is related to case number 1602USA008968 via same reporter link. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: 7cm x 7cm area of erythema, warmth treated with KEFLEX BID for 10 days.
Age: 1.02
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site rash, Injection site urticaria, Nasal congestion, Papule
Clinical narrative: Low grade fever, generalized rash 1/26/16 some hives/some papules (started with facial rash approximately 1/25/16). Patient presents with skin rash x2 days. Fever slight, low grade up to 100. Nasal congestion started yesterday. Temperature 98.6 degrees F (37 degrees C), temperature source Temporal Artery, weight 20 lb 12 oz (9.412 kg). Low fever started Tuesday, last pm again low. Some congestion x 1 days. No cough. Eats fair. Had photo from yesterday and rash was more intense, cheeks bright red (was in the bath). Seemed tender to touch earlier. Rash (slightly raised hive-like rash on upper thighs, sides and back, calves with similar rash but also some more raised red papules. Back of upper arms with faint hive like rash also noted.
Age: 1.02
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rash generalised, Tenderness, Urticaria
Clinical narrative: Low grade fever, generalized rash 1/26/16 some hives/some papules (started with facial rash approximately 1/25/16). Patient presents with skin rash x2 days. Fever slight, low grade up to 100. Nasal congestion started yesterday. Temperature 98.6 degrees F (37 degrees C), temperature source Temporal Artery, weight 20 lb 12 oz (9.412 kg). Low fever started Tuesday, last pm again low. Some congestion x 1 days. No cough. Eats fair. Had photo from yesterday and rash was more intense, cheeks bright red (was in the bath). Seemed tender to touch earlier. Rash (slightly raised hive-like rash on upper thighs, sides and back, calves with similar rash but also some more raised red papules. Back of upper arms with faint hive like rash also noted.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Patient developed a raised red itchy rash in the a.m. of 2-9-16 from the shoulder to the elbow of the (R) arm. Parent also reported the upper arm was reddened et tender. The child was taken to their HCP and the practitioner dx an allergic reaction et prescribed BENADRYL. The rash was resolved on 2-12-16 with no further f/u required.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Patient developed a raised red itchy rash in the a.m. of 2-9-16 from the shoulder to the elbow of the (R) arm. Parent also reported the upper arm was reddened et tender. The child was taken to their HCP and the practitioner dx an allergic reaction et prescribed BENADRYL. The rash was resolved on 2-12-16 with no further f/u required.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Constipation, Laboratory test normal, Listless, Vomiting, X-ray normal
Clinical narrative: Persistent vomiting, listlessness one hour post vaccines x 12 hours. Seen in ED, given ZOFRAN. Resolved.
Age: 19.0
Sex: F
Vaccine: FLUN4
Symptoms: Borrelia test negative, Lacrimation increased, Swelling face, VIIth nerve paralysis
Clinical narrative: Left sided facial swelling. Increased tearing of left eye. Prednisone. Bells Palsy.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site reaction
Clinical narrative: Pt had a mild injection site reaction and suffered flu-like symptoms for 48 hours post injection. Symptoms had fairly rapid onset. Pt informed me on 2/16/16.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest pain, Musculoskeletal disorder, Pain in extremity, Sleep disorder
Clinical narrative: Approximately 1 month after receiving a high-dose flu shot in my left arm a tremendous pain hit my left am and chest area that nearly took my breath away. The pain continued through the night, and from that time forward I was not able to sleep on my left side, nor use my arm for hardly anything because of pain and weakness for the next 22 months, when it finally abated and gradually became normal.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: Pt went to ER day after vaccination with (L) arm pain and swelling. Dx in ER with cellulitis with BACTRIM.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Herpes zoster, Injection site pain, Injection site swelling, Rash
Clinical narrative: Swelling/pain size of softball at injection site also got shingles at injection site and between shoulder and neck - swelling has gone down, but rash is still present.
Age: 70.0
Sex: M
Vaccine: FLU3, HEPAB, PPV
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: Pt was given influenza vaccine PF on 2/16/16. Pt reports on the morning of 2/18 he discovered a red area on left bicep that wrapped around both sides. Pt reported pain in bicep that extended to left chest muscles, axilla and shoulder. Pt also given TWINRIX to left deltoid on 2/16/16. Also reported fever, body aches x 2-3 days.
Age: 70.0
Sex: M
Vaccine: FLU3, HEPAB, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Pt was given influenza vaccine PF on 2/16/16. Pt reports on the morning of 2/18 he discovered a red area on left bicep that wrapped around both sides. Pt reported pain in bicep that extended to left chest muscles, axilla and shoulder. Pt also given TWINRIX to left deltoid on 2/16/16. Also reported fever, body aches x 2-3 days.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV, VARCEL
Symptoms: Chest discomfort, Dyspnoea, Erythema, Nausea
Clinical narrative: Member was immunized by 3 vaccines. FLUARIX. PNUps. VAR (varicella).
Age: 84.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: One shot in right arm for flu and pneumonia pain in right when lying on left arm - need to change to right side to relieve pain - pain continues as of 03-11-15.
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Erythema, Lethargy, Muscular weakness, Myalgia
Clinical narrative: Arm weakness, back ache, lethargy, myalgias, arm redness and swelling.
Sex: M
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Arm weakness, back ache, lethargy, myalgias, arm redness and swelling.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Patient came in today stating she has arm pain from her flu shot given 3 months ago. It has not gotten better and is affecting movement and sleep.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Headache, Local swelling, Musculoskeletal pain
Clinical narrative: Day of injection -exhaustion - spent 8hr in bed, HA day 3 an on from elbow to shoulder extreme pain, pain radiates to neck, movement increases pain, same area is swollen dr gave doxycycline. No redness not hot.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Day of injection -exhaustion - spent 8hr in bed, HA day 3 an on from elbow to shoulder extreme pain, pain radiates to neck, movement increases pain, same area is swollen dr gave doxycycline. No redness not hot.
Age: 55.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Arthralgia, Diarrhoea, Eyelid oedema, Nausea, Swollen tongue
Clinical narrative: Reports 24 hours after vaccine administered onset (2/19/16) eyelid swelling, tongue swelling, joint pain, nausea, vomiting and diarrhea. Asymptomatic 2-22-16.
Age: 55.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Vomiting
Clinical narrative: Reports 24 hours after vaccine administered onset (2/19/16) eyelid swelling, tongue swelling, joint pain, nausea, vomiting and diarrhea. Asymptomatic 2-22-16.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt states that she has had excruciating pain in the left arm that the flu shot was given since the shot and nothing her Dr has done for her has helped. She also stated that she knows it wasn't staff's fault.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient received vaccine on 9/29/15. She returned to the pharmacy on the second week of January stating that since the injection, she has had arm pain when moving or bending her arm. She consulted a physician who speculated that the needle hit a muscle fiber. She is currently undergoing physical therapy. (Right arm).
Age: 0.34
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Barium enema, Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: Intussusception.
Age: 0.34
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Intussusception.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Fatigue, Loss of consciousness, Paraesthesia, Vision blurred
Clinical narrative: Moments after leaving the doctors office, I felt very tired and low of energy. I then noticed something was wrong, and as my body started to tingle all over, my vision became blurry. I released my foot from the gas pedal and that was when I blacked out while driving.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Computerised tomogram head, Contusion, Culture urine, Differential white blood cell count, Dizziness
Clinical narrative: Moments after leaving the doctors office, I felt very tired and low of energy. I then noticed something was wrong, and as my body started to tingle all over, my vision became blurry. I released my foot from the gas pedal and that was when I blacked out while driving.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Electrocardiogram, Feeling of body temperature change, Full blood count, Lipase, Liver function test
Clinical narrative: Moments after leaving the doctors office, I felt very tired and low of energy. I then noticed something was wrong, and as my body started to tingle all over, my vision became blurry. I released my foot from the gas pedal and that was when I blacked out while driving.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Metabolic function test, Paraesthesia, Pregnancy test urine, Road traffic accident
Clinical narrative: Moments after leaving the doctors office, I felt very tired and low of energy. I then noticed something was wrong, and as my body started to tingle all over, my vision became blurry. I released my foot from the gas pedal and that was when I blacked out while driving.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope, Urine analysis
Clinical narrative: Moments after leaving the doctors office, I felt very tired and low of energy. I then noticed something was wrong, and as my body started to tingle all over, my vision became blurry. I released my foot from the gas pedal and that was when I blacked out while driving.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Incorrect route of drug administration, Product packaging confusion
Clinical narrative: Pt was administer medication (Pediarix) via incorrect route (orally) due to confusion with packaging similarities to Rotavirus.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in the mouth. Denies SOB, no treatment given except to continue monitor.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: BLISTERS DEVELOPED ON FOREHEAD, MD DIAGNOSED SHINGLES.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in her mouth. No treatment given except to continue to monitor. No SOB or difficulty breathing at present.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: PLEASE SEE ATTACHED
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at site of injection. Advised to continue monitoring area, take Benadryl and use cold compress.
Age: 66.0
Sex: F
Vaccine: FLUC3, PNC13
Symptoms: Cellulitis, Leukocytosis, Peripheral swelling, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Bilateral arm swelling after admin of influenza vaccine and PCV 13, left arm w/ s/s cellulitis.
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Back pain, Facial paresis, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness
Clinical narrative: Fascial weakness, back pain, leg weakness.
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Nerve conduction studies
Clinical narrative: Fascial weakness, back pain, leg weakness.
Age: 1.03
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Seizure
Clinical narrative: Mother reported that her son started to have convulsions and she brought him to Hospital where her was admitted for 3 days. Diagnosis per mother was febrile seizures. No medications were prescribed upon discharge.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness in arm, headache for 2 days, diffuse swelling and redness to left upper extremity affecting a greater area than where the shot was given.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Allergy to vaccine, Injection site swelling
Clinical narrative: Allergic to TRUMENBA (L)/arm swollen at the site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Local reaction
Clinical narrative: Pt had relatively immediate localized reaction to PROQUAD vaccine in office was given BENADRYL and recommended ice by MD. Pt received DTaP-IPV and MMRV.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and pain in hand. Went to ER and was treated with steroids. Swelling and pain subsided after treatment.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: -Patient had vaccine Feb 15. -Had home care nurse look at arm Feb 16 - Red, warm, arm hurt. -Called Pharmacy Feb 20 to complain arm - Red, warm, painful - area larger.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Apparent life threatening event, Retching, Vomiting
Clinical narrative: Intractable vomiting with gagging and concern for ALTE.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Disorientation, Eye movement disorder, Immediate post-injection reaction, Muscle rigidity, Tremor
Clinical narrative: Client was given Tdap and HPV9 vaccines in R deltoid, followed by MCV4 IM in L deltoid. Immediately following third vaccine, client's eyes rolled back in head and she became unresponsive. This was followed by extremity rigidity, both arms and some visible tremors. Within 2-3 minutes, client relaxed and eyes began to focus. She appeared disoriented and did not respond verbally, but looked at provider when her name was called. She gradually became more alert and oriented, able to give her name and age. She was evaluated by physician on site. BP 123/79, P78, R18. Client was given juice and crackers, as she had not eaten since breakfast. At the onset of the event, 911 was called. The EMT squad arrived and also evaluated vital signs and level of consciousness. No visible injuries were sustained. The mother declined transport to the hospital. On further questioning with the mother, it was determined that the client had fainted previously when she had gone long periods without eating. The client continued to be observed for 20 -30 minutes and then left ambulatory with mother.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Client was given Tdap and HPV9 vaccines in R deltoid, followed by MCV4 IM in L deltoid. Immediately following third vaccine, client's eyes rolled back in head and she became unresponsive. This was followed by extremity rigidity, both arms and some visible tremors. Within 2-3 minutes, client relaxed and eyes began to focus. She appeared disoriented and did not respond verbally, but looked at provider when her name was called. She gradually became more alert and oriented, able to give her name and age. She was evaluated by physician on site. BP 123/79, P78, R18. Client was given juice and crackers, as she had not eaten since breakfast. At the onset of the event, 911 was called. The EMT squad arrived and also evaluated vital signs and level of consciousness. No visible injuries were sustained. The mother declined transport to the hospital. On further questioning with the mother, it was determined that the client had fainted previously when she had gone long periods without eating. The client continued to be observed for 20 -30 minutes and then left ambulatory with mother.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient called the pharmacy today (2/22/2016) stating that the injection site was swollen, had a bump and warm to the touch.  The patient went to her primacy care doctor.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Mobility decreased
Clinical narrative: LEGS BEGIN TO FEEL HEAVY AND HAD TROUBLE GETTING INTO CAR AND WHEN GOT HOME COULD BARELY GETTING INTO HOUSE WITHOUT HELP.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient states painful and sore arm with a knot at site of injection; limited range of motion. Patient states occurred shortly after injection.  Went to doctor on 11/20/15, at which time doctor told patient to take ibuprofen and use hot compress to alleviate pain.  Patient called me on 12/3/15 stating the above and that it does not seem to be getting better; she will call with update.  I called doctor on 2/15/16 to see if any follow-up had been done by patient.  Spoke to person who states patient called still complaining of pain and limited range of motion due to vaccination.  Dr. has referred patient to Physical Medicine Specialist at this time.  Dr's office will inform us of any outcome.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: My daughter developed a high fever that I couldn't reduce for about 5 to 6 days.  She maintained a 103 to 104 to 105 temperature.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain swelling to site, following that, redness, pain swelling and heat. Dr prescribed RX for Keflex for infection.
Age: 1.02
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Crying, Culture urine negative, Dyspnoea, Extremity contracture, Grunting
Clinical narrative: Around 11pm, parents noted a grunting noise and crying. Went into room, pt laying on L side in fetal position, eyes open, making quick gasping noises and contracting BUE at same time. Did not turn blue. Lasted b/w 1-5 minutes (parents have different recollections on duration), then pt started crying.
Age: 1.02
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Urine analysis
Clinical narrative: Around 11pm, parents noted a grunting noise and crying. Went into room, pt laying on L side in fetal position, eyes open, making quick gasping noises and contracting BUE at same time. Did not turn blue. Lasted b/w 1-5 minutes (parents have different recollections on duration), then pt started crying.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin discolouration
Clinical narrative: Later that day large red rash larger than 50cent piece appeared then bubbly yellow bumps appeared bigger than pimple on her arm. Now there is rash under both arms.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, itchy injection site.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Contusion, Erythema, Pruritus, Skin exfoliation
Clinical narrative: Large red, burning itching, scaly lesion on right thigh. Lasted 5 weeks and took many forms which included large bruise above it. Treated with topical steroid cream (Clobetasol Propionate) which did not help at all.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Skin lesion
Clinical narrative: Large red, burning itching, scaly lesion on right thigh. Lasted 5 weeks and took many forms which included large bruise above it. Treated with topical steroid cream (Clobetasol Propionate) which did not help at all.
Age: 1.9
Sex: M
Vaccine: DTAP, PNC13, VARCEL
Symptoms: Fatigue, Injection site rash, Pyrexia
Clinical narrative: Large rash around injection sight about 2" diameter.  101.9 fever.  Tired.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Diarrhoea, Pyrexia, Vomiting projectile
Clinical narrative: Started with fever, then projectile vomiting after every feeding. Continued to get worse, keeping very little milk down, then diarrhea started. Seemed to get slightly better on Sunday, then worse again Sunday night and Monday (today). Still projectile vomiting as of right now.
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: literature case report received on 18 Feb 2016. The author in the article discussed about membranous nephropathy (MN) and severe acute kidney injury (AKI) following influenza vaccination. This report refers to a male patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after receiving vaccination, the patient died from GB syndrome. It was unknown if an autopsy was performed. The author presented an interesting case of MN and severe AKI following the 2009 H1N1 vaccination (see case: PHHY2016US023093). Optimal therapy of influenza vaccine associated glomerular diseases including MN was unknown. The author concluded that based on the experience one can consider corticosteroid therapy in patients with MN and AIN following influenza vaccination. However, further studies are required to investigate the exact pathogenesis of influenza vaccine-induced MN.
Age: 10.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient rec'd Tdap and Flu later that night (L) deltoid became red, swollen. No fever and deltoid cleaned with multiple alcohol wipes before vaccine given.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 17-FEB-2016, the patient was vaccinated with expired (Oka/Merck) VARIVAX lot #K001364, expiration date 12-FEB-2016 (strength, dose, frequency and route not reported). The vaccine was 4 days passed the expiration date. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to unspecified amount of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L004014, expiration date March 2017 and lot # L016428, expiration date July 2017) (dosage, strength and route unknown) (temperature fridge 0.1 degree centigrade, time frame 2 hours and 59 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to unspecified amount of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # L039659, expiration date March 2017) (dosage, strength and route unknown) (temperature fridge 0.1 degree Centigrade, time frame 2 hours and 59 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to unspecified amount of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L029631, expiration date 14-AUG-2017) (dosage, strength and route unknown) (temperature fridge 0.1 degree Centigrade, time frame: 2 hours and 59 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache
Clinical narrative: Information has been received via a company representative from a 52 year old female patient, who was a nurse, referring to herself. There was no medical history or drug reaction/allergies reported. On 03-FEB-2016 the patient was vaccinated with a dose of VARIVAX (Merck) (subcutaneous injection, dose and lot# were unknown) required for employment. No concomitant therapy was reported. On the same day, after the vaccination, the patient experienced headache. The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a consumer referring to unknown female patients of unknown age, There was no concurrent condition or medical history reported. The reporter stated that GARDASIL or GARDASIL 9 was killing and injuring girls. Lives were being irreversibly altered after vaccination. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to unspecified amount of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored oral ROTATEQ (lot # L022447, expiration date February 2017) (dosage and strength unknown) (temperature fridge 0.1 degree centigrade, time frame 2 hours and 59 minutes) orally. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Those patients' medical histories, concomitant medications and drug histories were unknown. On unknown dates, patients received GARDASIL (lot number reported as L004741 and expiration date 04-MAR-2017, dose and route of administration were unknown), that was not stored in proper storage conditions and not supported by stability data. The reporter stated that no patients reported any unwanted affects to her. Those patients' laboratory data were unknown. At the time of the report it was unknown if any of those patients still received GARDASIL. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 6 month old male patient who was born a preemie at 23 weeks gestation. On 18-FEB-2016, the patient was inadvertently vaccinated with the first dose of ROTATEQ, oral. No adverse effects reported. Additional information is not expected as the reporters do not want to be contacted regarding this report.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Patients' medical histories, concomitant medications and drug histories were unknown. On unknown dates, patients received oral ROTATEQ as a single dose, given one time for immunization (lot # K020182 and expiration date 25-JUN-2016, route of administration was unknown). The (oral) ROTATEQ was not stored in proper storage conditions and not supported by stability date. The reporter stated that no patients reported any unwanted effects to her. Those patients' laboratory data were unknown. At the time of the report if was unknown if any of those patients still received oral ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified amounts of children of unknown age and gender. On an unknown dates, the children received doses of improperly stored PROQUAD (Merck) (lot # L030586 with expire date 10-FEB-2017) (dose and route unspecified). The vaccines were stored in refrigerator temperature of 36 to 46F for 48 hours. Then they were stored at 48.7F for 18 minutes. There was no previous temperature excursion. No adverse effect was reported at this time. This was one of several reports received from same reporter. Additional information is not expected because the reporter refused additional contact.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a 60 year old patient of unknown gender. On 18-FEB-2016 the patient was vaccinated with an expired dose of ZOSTAVAX vial 19400 PFU (plaque-forming units) (lot # K021953; expiry: 10-FEB-2016). No adverse experience has been reported. No additional information was provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red swollen area at vaccine site. Warm.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. The patient was administered the first dose of GARDASIL 9 on 12-OCT-2015, the second dose of GARDASIL 9 on 16-DEC-2015 (lot number and expiration date, dose, route and vaccination site were unspecified for both doses) and the third dose of GARDASIL 9 (lot# L045711, expiration date 08-MAY-2017) on 16-FEB-2016 (inappropriate schedule of drug administration). This was outside the recommendations per the GARDASIL 9 prescribing information. No adverse effects were reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: On Tuesday 1/12/16 developed itchiness and redness at site, redness spread and became swollen half of upper arm involved tried OTC hydrocortisone.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Two days after vaccination, patient returned to the pharmacy displaying a large, raised, red area, encircling the injection site. I instructed her to take diphenhydramine to counteract what appeared to be an allergic reaction. Pt returned again on 1/18/16 with a prescription for LEVAQUIN and Prednisone. The reacting area had increased and spread to her elbow.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Gave expired Hep B - expired 2-4-16 and administered 2-12-16. It was a booster. D/T titer being non-reactive. Pt was informed and rescheduled for a booster.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: Round circle around injection site 1 week post injection. No pain, warmth, swelling, or fever.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 02-10-16 area of injection pink, reddened, swollen and raised; warm to touch. Suggested Ibuprofen taken with food; and intermittent cool pack to area. Will phone 2/11/16 with condition update. Patient did not call back - presumed to be OK.
Age: 1.19
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site bruising, Injection site discolouration, Injection site induration, Injection site nodule
Clinical narrative: Small firm area of discoloration on right and left lateral thigh. (2/21/16). 1 cm firm subcutaneous nodule lateral thighs w/o tenderness (+) mild bruising (2/22/16).
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. The nurse reported that the 10 doses of PNEUMOVAX 23 (lot # L003188, expiry date 06-JUL-2016) which were exposed to 18 degree centigrade for 36 hours, had been administered to unspecified patients on unspecified dates since 30-NOV-2015 (dose and route unspecified). She was not aware of any adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 19-FEB-2016 the patient was inadvertently vaccinated with an expired dose of (Oka/Merck) PROQUAD (lot # K010211, expiration 17-JAN-2016, dose and route were not reported) (expired product administered). No adverse effects were reported. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Eye swelling, Rash, Urticaria
Clinical narrative: Started with urticarial rash on 2/13/16 in the arm, progressing to face and swollen eyes later in the day. No fevers, no vomiting. Still with minimal rash on 2/18.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Electrocardiogram normal, Fatigue, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: Vasovagal, fainting, patient pale, diaphoretic and tired. O2 2L NC, EKG (sinus rhythm), transferred to hospital via EMS.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Vasovagal, fainting, patient pale, diaphoretic and tired. O2 2L NC, EKG (sinus rhythm), transferred to hospital via EMS.
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to ENGERIX. Additional details were provided as follows: The other healthcare professional reported that the patient might have had an allergic reaction after vaccination with ENGERIX B. No further information or clarification was obtained.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, PNC, RV1
Symptoms: Rash generalised
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 4-month-old patient who received PEDIARIX. Co-suspect products included ROTARIX. Previously administered products included ROTARIX, PEDIARIX and PREVNAR (all the vaccines received at 2 months of age without experiencing any adverse reaction). Concomitant products included PREVNAR. On an unknown date, the patient received PEDIARIX and ROTARIX. On an unknown date, 2 days after receiving PEDIARIX and ROTARIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to PEDIARIX and ROTARIX. Additional details were provided as follows: A GlaxoSmithKline's sales representative reported on behalf of other healthcare professional that the patient received several vaccines, which included PEDIARIX, ROTARIX and PREVNAR and after 48 hours experienced general rash. No further information reported regarding the event.
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Ear congestion, Hearing impaired
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a male patient who received RABAVERT. On an unknown date, the patient received the 1st dose of RABAVERT. On an unknown date, 1 days after receiving RABAVERT, the patient experienced dizziness, ear congestion and auditory disorder. On an unknown date, the outcome of the dizziness, ear congestion and auditory disorder were unknown. It was unknown if the reporter considered the dizziness, ear congestion and auditory disorder were unknown. It was unknown if the reporter considered the dizziness, ear congestion and auditory disorder to be related to RABAVERT. Additional details were provided as follows. This case was reported by the patient himself. The reporter said that he had two doses of the RABAVERT. The reporter said on the 2nd day of his 1st dose (1 day after vaccination), he experienced a little dizziness which was very subtle and he believed that it may have been congestion. He also said that his hearing was different.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of unspecified patients. Patients' medical history and concurrent conditions were not reported. Starting on 11-JAN-2016 and after, the patients were vaccinated with an unspecified umber of improperly stored doses of M-M-R II lot # L024265 and expiry date on 01-JUL-2017, (strength, route, dose and frequency were not reported). Concomitant medications were not reported. No adverse effect was reported and no product quality complaint was involved. The stored temperature reported was 48.6 F degrees for 40 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of unspecified patients. Patient's medical history and concurrent conditions were not reported. Starting on 11-JAN-2016 and after, the patients were vaccinated with an unspecified number of improperly stored PEDVAXHIB lot # K011077 and expiry date on 30-MAR-2017, (strength, route, dose and frequency were not reported). Concomitant medications were not reported. No adverse effect was reported and no product quality complaint was involved. The stored temperature reported was 48.6 F degrees for 40 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Left deltoid area. Local reaction around injection - redness - not confluent - gave 25 mg BENADRYL -> and resolving in 15 min - down to 2 inches.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not provided. In February 2014, reported as 2 years ago, the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration, lot number and expiration date were not provided). The patient's concomitant medications were not reported. Approximately in 2014, after being vaccinated with ZOSTAVAX the patient experienced a rash down her right arm (rash). The patient seek medical attention and the pharmacist instructed the patient to go to an unspecified Emergency Department at that time, however it was not known if patient went. No product quality issue was involved. At the time of the report, the outcome of rash was unknown and the relatedness between rash and vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 12 year old male patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medication were not provided. Nurse reported that the patient received a dose of GARDASIL on 20-AUG-2015 and he received a dose of GARDASIL 9 on 17-OCT-2015. Nurse stated that the patient came to the practice on 17-FEB-2016 to received his third dose of human papillomavirus (HPV) vaccine, but the practice only had GARDASIL in stock. She didn't specified whether or not the patient will receive a dose of GARDASIL as third dose in his HPV vaccination series. The patient did not reported or exhibited any adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies reported. On an unknown dates in 2016, the patients were vaccinated with an improperly stored doses of M-M-R II (lot# L011528, expiration date 03-APR-2017; lot# L024266, expiration date 01-JUL-2017, dose, anatomical location and route of administration were not reported). No adverse events were reported. The reporting nurse suspected, that some doses were administered as excursion, which occurred on 29-JAN-2016. Time frame 2 hours and 4 minutes, temperature 10.3 Celsius degree. This is one of several reports received from the same reporter. Additional information has been requested.