chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Cough, Dyspnoea, Feeling abnormal
Clinical narrative: 10/31 First day felt a little sweaty. Next three days short of breath and cold sweats. Didn't feel good all of November. Had a slight cough that really got bad by Jan. Had to call Dr. and was prescribed ZITHROMAX and cough meds. Saw Dr. on Jan. 30 was told not to get another flu shot.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Oropharyngeal pain, Pollakiuria, Tinnitus
Clinical narrative: Sore throat 3 days 12/17/2016 - 4 days. Excessive frequent urination 3 weeks! (R) knee joint pain 2 weeks, ADVIL. Tinnitus moderate to very annoying 2 weeks.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: I received vaccine early after evening my arm started to swell. Then, fever and chills. Next day-fever and arm was red and swollen. Next day-red and swollen from upper arm to elbow. Lasted 4 days.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site induration, Injection site swelling
Clinical narrative: Received vaccine on 1-26-17. Two days later noticed left arm was beginning to get red with some swelling at site. Today, five days later, site is red with approx 5mm induration at site, but swelling and redness go down arm approx 2/3 of the way to the elbow.
Age: 0.17
Sex: F
Vaccine: DTAP, IPV, PPV, RV5
Symptoms: Wrong drug administered
Clinical narrative: Patient was given PPSV-23 instead of PCV-13 in error.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin discolouration
Clinical narrative: Purple-Redness-Streaks about 8am.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt states she woke up day after getting vaccine and noted it was very tender and reddened. Pt states it just seemed to get bigger and down around arm. Reddened area noted a site that measures 50mm x 65mm. Instructed to use ice a couple times a day and to take Ibuprofen for discomfort.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Headache
Clinical narrative: Headache, difficulty breathing.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: FLUVIRIN multidose vaccine was administered to patient on 2/6/17. Pt developed facial paralysis and symptoms of Bells Palsy on 2/10/17.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Dizziness, Hypoaesthesia, Nausea, Pain in extremity
Clinical narrative: Pt C/O feeling nauseated, lightheaded after vaccines and later day pain his (R) arm. Felt numb all day. Subsided on its own. Spoke to pt's mother no further problems the following day.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Diarrhoea, Rash
Clinical narrative: Rash and diarrhea
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal distension, Erythema, Headache, Nausea, Pain in extremity
Clinical narrative: Pain in arm, swollen, redness, headache, nausea.  I took Advil so I could sleep.  It was painful to even have clothes on arm or have arm touch mattress or sheet to sleep.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Pain in arm, swollen, redness, headache, nausea.  I took Advil so I could sleep.  It was painful to even have clothes on arm or have arm touch mattress or sheet to sleep.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Headache, Nausea
Clinical narrative: Headache, joint pain, queasy stomach.  Continues into next day time of report is 9:02 am, 2.11.17.
Age: 28.0
Sex: F
Vaccine: ANTH, JEV1
Symptoms: Burning sensation, Diarrhoea, Erythema, Feeling hot, Flushing
Clinical narrative: On 08 Feb, patient reported burning sensation in RT arm immediately following immunization and a generalized feeling of flushing or "hotness." Patient reported diarrhea approximately 3 hours later. On the morning of 09 Feb, patient reported swelling and tenderness across chest and into the Right Armpit. The patient went to see a physician on the morning of 10 Feb. Redness appeared on the morning of 11 Feb across face and chest area. Patient was given cetirizine to be taken 10 and 11 Feb.
Age: 28.0
Sex: F
Vaccine: ANTH, JEV1
Symptoms: Immediate post-injection reaction, Swelling, Tenderness
Clinical narrative: On 08 Feb, patient reported burning sensation in RT arm immediately following immunization and a generalized feeling of flushing or "hotness." Patient reported diarrhea approximately 3 hours later. On the morning of 09 Feb, patient reported swelling and tenderness across chest and into the Right Armpit. The patient went to see a physician on the morning of 10 Feb. Redness appeared on the morning of 11 Feb across face and chest area. Patient was given cetirizine to be taken 10 and 11 Feb.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain. Lack of mobility. It has been 1 month since injection which was very high on shoulder and I believe caused significant injury.  Condition has not improved since injection date. E.R. visits twice and returned to PCP on Feb 2/1/2017.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Had redness and itching at reaction site.
Age: 93.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Pt states they have pain at injection site when they lift their arm.  No swelling, or other symptoms.  Pain is the same, and hasn't increased since shot was given,  no fever, no pain unless arm is lifted.  Pt advised to take an OTC pain killer but states they would prefer not to.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Blood culture negative, CSF culture negative, Circumoral oedema, Computerised tomogram head abnormal, Drug hypersensitivity
Clinical narrative: Patient was seen on 2/3/17 for lumbar strain, received 2nd dose of HPV vaccine. Patient and family flew on 2/4, patient awoke in morning with fever, malaise, headache. Then after landing, headache returned vomiting x2, with altered mental status and petechial rash. Admitted to Medical Center from 2/4-2/7. Had lumbar puncture, started on CFTX/Vancomycin for presumed meningitis, then had drug allergy- hives and perioral edema. Switched to Meropenem and Linezolid, acyclovir. Mild leukocytosis- cultures, RPR, strep cultures negative Blood cultures negative CT showed subtle hypodensities in supratentorial white matter, MRI recommend MRI.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Headache, Leukocytosis, Malaise, Meningitis, Mental status changes
Clinical narrative: Patient was seen on 2/3/17 for lumbar strain, received 2nd dose of HPV vaccine. Patient and family flew on 2/4, patient awoke in morning with fever, malaise, headache. Then after landing, headache returned vomiting x2, with altered mental status and petechial rash. Admitted to Medical Center from 2/4-2/7. Had lumbar puncture, started on CFTX/Vancomycin for presumed meningitis, then had drug allergy- hives and perioral edema. Switched to Meropenem and Linezolid, acyclovir. Mild leukocytosis- cultures, RPR, strep cultures negative Blood cultures negative CT showed subtle hypodensities in supratentorial white matter, MRI recommend MRI.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Petechiae, Pyrexia, Streptococcus test negative, Treponema test negative, Urticaria
Clinical narrative: Patient was seen on 2/3/17 for lumbar strain, received 2nd dose of HPV vaccine. Patient and family flew on 2/4, patient awoke in morning with fever, malaise, headache. Then after landing, headache returned vomiting x2, with altered mental status and petechial rash. Admitted to Medical Center from 2/4-2/7. Had lumbar puncture, started on CFTX/Vancomycin for presumed meningitis, then had drug allergy- hives and perioral edema. Switched to Meropenem and Linezolid, acyclovir. Mild leukocytosis- cultures, RPR, strep cultures negative Blood cultures negative CT showed subtle hypodensities in supratentorial white matter, MRI recommend MRI.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Vomiting
Clinical narrative: Patient was seen on 2/3/17 for lumbar strain, received 2nd dose of HPV vaccine. Patient and family flew on 2/4, patient awoke in morning with fever, malaise, headache. Then after landing, headache returned vomiting x2, with altered mental status and petechial rash. Admitted to Medical Center from 2/4-2/7. Had lumbar puncture, started on CFTX/Vancomycin for presumed meningitis, then had drug allergy- hives and perioral edema. Switched to Meropenem and Linezolid, acyclovir. Mild leukocytosis- cultures, RPR, strep cultures negative Blood cultures negative CT showed subtle hypodensities in supratentorial white matter, MRI recommend MRI.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Blood culture negative, CSF culture negative, Circumoral oedema, Computerised tomogram head abnormal, Culture negative
Clinical narrative: Patient was seen on 2/3/17 for lumbar strain, received 2nd dose of HPV vaccine. Patient and family flew on 2/4, patient awoke in morning with fever, malaise, headache. Then after landing, headache returned vomiting x2, with altered mental status and petechial rash. Admitted to Medical Center from 2/4-2/7. Had lumbar puncture, started on CFTX/Vancomycin for presumed meningitis, then had drug allergy- hives and perioral edema. Switched to Meropenem and Linezolid, acyclovir. Mild leukocytosis- cultures, RPR, strep cultures negative Blood cultures negative CT showed subtle hypodensities in supratentorial white matter, MRI recommend MRI.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Drug hypersensitivity, Headache, Leukocytosis, Lumbar puncture, Malaise
Clinical narrative: Patient was seen on 2/3/17 for lumbar strain, received 2nd dose of HPV vaccine. Patient and family flew on 2/4, patient awoke in morning with fever, malaise, headache. Then after landing, headache returned vomiting x2, with altered mental status and petechial rash. Admitted to Medical Center from 2/4-2/7. Had lumbar puncture, started on CFTX/Vancomycin for presumed meningitis, then had drug allergy- hives and perioral edema. Switched to Meropenem and Linezolid, acyclovir. Mild leukocytosis- cultures, RPR, strep cultures negative Blood cultures negative CT showed subtle hypodensities in supratentorial white matter, MRI recommend MRI.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Meningitis, Mental status changes, Petechiae, Pyrexia, Streptococcus test negative
Clinical narrative: Patient was seen on 2/3/17 for lumbar strain, received 2nd dose of HPV vaccine. Patient and family flew on 2/4, patient awoke in morning with fever, malaise, headache. Then after landing, headache returned vomiting x2, with altered mental status and petechial rash. Admitted to Medical Center from 2/4-2/7. Had lumbar puncture, started on CFTX/Vancomycin for presumed meningitis, then had drug allergy- hives and perioral edema. Switched to Meropenem and Linezolid, acyclovir. Mild leukocytosis- cultures, RPR, strep cultures negative Blood cultures negative CT showed subtle hypodensities in supratentorial white matter, MRI recommend MRI.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Treponema test negative, Urticaria, Vomiting, White matter lesion
Clinical narrative: Patient was seen on 2/3/17 for lumbar strain, received 2nd dose of HPV vaccine. Patient and family flew on 2/4, patient awoke in morning with fever, malaise, headache. Then after landing, headache returned vomiting x2, with altered mental status and petechial rash. Admitted to Medical Center from 2/4-2/7. Had lumbar puncture, started on CFTX/Vancomycin for presumed meningitis, then had drug allergy- hives and perioral edema. Switched to Meropenem and Linezolid, acyclovir. Mild leukocytosis- cultures, RPR, strep cultures negative Blood cultures negative CT showed subtle hypodensities in supratentorial white matter, MRI recommend MRI.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Chills, Headache, Influenza like illness
Clinical narrative: I began to have chills, fever, headache, joint aches and feeling weak.  These symptoms persisted for 5 days with fever up to 102.6.  These symptoms completely mimicked a bad case of the flu. Also by day 3 I had a stuffy nose. Today, one week later, I am not 100% strong, but better. My husband who is supposed to also receive Prevnar 23, is probably not going to get it after watching what happened to me.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: I began to have chills, fever, headache, joint aches and feeling weak.  These symptoms persisted for 5 days with fever up to 102.6.  These symptoms completely mimicked a bad case of the flu. Also by day 3 I had a stuffy nose. Today, one week later, I am not 100% strong, but better. My husband who is supposed to also receive Prevnar 23, is probably not going to get it after watching what happened to me.
Age: 23.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chest discomfort, Dyspnoea, Pain in extremity, Pyrexia
Clinical narrative: FEVER, CHEST TIGHTNESS, LABORED BREATHING, ARM PAIN.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Precise day of onset not recalled (b/c I thought it would go away). Subacute onset of severe pain in arm within days/week of vaccination; first noted as inability to reach into a sleeve (to dress) because of shooting pain down left arm. Pain developed quickly in multiple areas:  anterior shoulder, deltoid, down lateral side of arm, exacerbated  with any attempt at external rotation or abduction, getting bumped or sudden startle. Significantly restricted range of motion (initially due to pain, then weeks of restricted motion, developed frozen shoulder syndrome). Only pain-free motion in directly anterior arm raise, to 90 degrees. Pain elicited by any attempt to raise arm laterally, rotate arm or forearm externally, reach across(anteriorly across chest (e.g. toward right shoulder), unable to reach behind body, push or pull laterally (even lightly); pain waking (me) from sleep 5-10 times/night despite splinting/propping with pillows, etc. Pain increased and persisted and disrupted sleep for months. Evaluated by orthopedist 2/19; Provisional dx is adhesive capsulitis (on MRI), however there is much local pain in arm that is not explained by this diagnosis. Treated with steroid injection and physical therapy, ongoing for 8 weeks. Pain and treatment are ongoing. Final outcome is not yet known.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Periarthritis, Sleep disorder, X-ray limb normal
Clinical narrative: Precise day of onset not recalled (b/c I thought it would go away). Subacute onset of severe pain in arm within days/week of vaccination; first noted as inability to reach into a sleeve (to dress) because of shooting pain down left arm. Pain developed quickly in multiple areas:  anterior shoulder, deltoid, down lateral side of arm, exacerbated  with any attempt at external rotation or abduction, getting bumped or sudden startle. Significantly restricted range of motion (initially due to pain, then weeks of restricted motion, developed frozen shoulder syndrome). Only pain-free motion in directly anterior arm raise, to 90 degrees. Pain elicited by any attempt to raise arm laterally, rotate arm or forearm externally, reach across(anteriorly across chest (e.g. toward right shoulder), unable to reach behind body, push or pull laterally (even lightly); pain waking (me) from sleep 5-10 times/night despite splinting/propping with pillows, etc. Pain increased and persisted and disrupted sleep for months. Evaluated by orthopedist 2/19; Provisional dx is adhesive capsulitis (on MRI), however there is much local pain in arm that is not explained by this diagnosis. Treated with steroid injection and physical therapy, ongoing for 8 weeks. Pain and treatment are ongoing. Final outcome is not yet known.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Body temperature increased, Heart rate increased, Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Our son had a large red spot on his leg surrounding injection site.  It grew to 5-6 inches circular.  Very hot, very red, very hard.  We went to urgent care and he had a temperature which rose to 101.4 and pulse which increased to 200.  He was very lethargic, wouldn't cry or respond when they were touching the sore.  They sent us to the Emergency Room and we started antibiotics and Tylenol.  The next day our PCP saw him.  He had had 2 doses of cephelexin (5 ml).  He's 15 months old and 26 lbs.  We saw his Dr at 11:15 am and the leg was less hard, less red, and less hot.  Dr gave us the choice to be admitted to the hospital or wait and see if things got better.  We had drawn on his leg the night before outlining the red area and the area had grown by approximately one inch.  Dr drew a new circle around the area it had grown to.  I saw my son shaking while sleeping-his hand.  His thighs were trembling while he was awake. Throughout the rest of the day the area improved.  Today the area is slightly hard and not hot at all.  It is bruised.  The entire 5-6 inch circle area is becoming a dark bruise from how swollen and hard the tissues had been.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Tremor
Clinical narrative: Our son had a large red spot on his leg surrounding injection site.  It grew to 5-6 inches circular.  Very hot, very red, very hard.  We went to urgent care and he had a temperature which rose to 101.4 and pulse which increased to 200.  He was very lethargic, wouldn't cry or respond when they were touching the sore.  They sent us to the Emergency Room and we started antibiotics and Tylenol.  The next day our PCP saw him.  He had had 2 doses of cephelexin (5 ml).  He's 15 months old and 26 lbs.  We saw his Dr at 11:15 am and the leg was less hard, less red, and less hot.  Dr gave us the choice to be admitted to the hospital or wait and see if things got better.  We had drawn on his leg the night before outlining the red area and the area had grown by approximately one inch.  Dr drew a new circle around the area it had grown to.  I saw my son shaking while sleeping-his hand.  His thighs were trembling while he was awake. Throughout the rest of the day the area improved.  Today the area is slightly hard and not hot at all.  It is bruised.  The entire 5-6 inch circle area is becoming a dark bruise from how swollen and hard the tissues had been.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Very stiff and sore neck on left back side; SEVERE stabbing/shooting pains through left shoulder and down left upper arm.  Vaccination injection was on upper left arm. 5 days later and pain continues.  Rate 10 on pain scale of 1 to 10.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Very stiff and sore neck on left back side; SEVERE stabbing/shooting pains through left shoulder and down left upper arm.  Vaccination injection was on upper left arm. 5 days later and pain continues.  Rate 10 on pain scale of 1 to 10.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: I administered vaccine and applied a band-aid to patient's arm, she stood up and immediately sat back down, stating she was light- headed and that she does not like needles. She became pale and passed-out. She was unresponsive for approx. 20 seconds during which time my co-worker called 911. Pt was attended to by rescue workers and eventually walked out on her own, driven home by her father. Patient stated she thinks this happened to her a while ago when she got a vaccine because she is nervous about needles.
Age: 78.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Pain in extremity
Clinical narrative: Patient reporting pain in left arm that she attributes to her flu shot. She experienced pain 1-4 hours after vaccination that resolved in 3-4 days, but she says the pain has returned now. Pain is "almost 6" on 1-10 scale and she is going to see MD about it. Does have arthritis in other shoulder per patient.
Age: 0.5
Sex: F
Vaccine: 6VAX-F
Symptoms: Cough, Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: She had a fever and runny nose with a cough the next morning and then the following Saturday 02/11/2017 she developed a rash over her entire body.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Adrenocortical steroid therapy, Anaemia, Biopsy bone marrow, Cytogenetic analysis, Flow cytometry
Clinical narrative: Initial symptoms were bleeding gums. Labs revealed thrombocytopenia (plt < 10), refractory to inpatient treatment with glucocorticoids and IVIg. Hematology consult most highly suspected ITP, as of 2/12/17, she remains on plt drip and has initiated rituximab.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Gastrointestinal haemorrhage, Gingival bleeding, Immune thrombocytopenic purpura, Immunoglobulin therapy, Mucosal haemorrhage
Clinical narrative: Initial symptoms were bleeding gums. Labs revealed thrombocytopenia (plt < 10), refractory to inpatient treatment with glucocorticoids and IVIg. Hematology consult most highly suspected ITP, as of 2/12/17, she remains on plt drip and has initiated rituximab.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Platelet count decreased, Platelet transfusion, Thrombocytopenia, Transfusion
Clinical narrative: Initial symptoms were bleeding gums. Labs revealed thrombocytopenia (plt < 10), refractory to inpatient treatment with glucocorticoids and IVIg. Hematology consult most highly suspected ITP, as of 2/12/17, she remains on plt drip and has initiated rituximab.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Injection site swelling
Clinical narrative: Headache combined with large rash and swelling at injection site (rash 3x2" and lighter red swelling of entire tricep vicinity- elbow to lower deltoid). Returned to Pharmacy where they stated reaction was severe and not normal. Arm swelling has increased each day (3 days since injection). Will visit doctor this week.
Age: 76.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Limb mass
Clinical narrative: Patient came several months after the vaccination has a lump in his arm. He did not say when it came up, but was still there. He said there was no pain, redness, swelling or discomfort.
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Contusion, Head injury, Immune thrombocytopenic purpura, Immunoglobulin therapy, Increased tendency to bruise
Clinical narrative: Patient ran a fever that reached over 104 for 4 days, the fever began within 48 hours of vaccination. He was taken to the pediatrician who found no cause and said if the fever didn't go away after 5 days he would need a full work up. On October 10 he hit his head and it bruised immediately. Over the next 2 weeks he developed unexplained bruises over his body. He was taken to the pediatrician, then the ER on October 27 and was diagnosed with ITP with platelets under 10,000. Treatment is still ongoing as his condition has not improved. He still has platelets under 10,000 even after going through steroid and IVIG treatment.
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Platelet count decreased, Pyrexia
Clinical narrative: Patient ran a fever that reached over 104 for 4 days, the fever began within 48 hours of vaccination. He was taken to the pediatrician who found no cause and said if the fever didn't go away after 5 days he would need a full work up. On October 10 he hit his head and it bruised immediately. Over the next 2 weeks he developed unexplained bruises over his body. He was taken to the pediatrician, then the ER on October 27 and was diagnosed with ITP with platelets under 10,000. Treatment is still ongoing as his condition has not improved. He still has platelets under 10,000 even after going through steroid and IVIG treatment.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient stated at night she felt an aching "like a hammer hitting" on her arm, soreness, and stiffness in the injected arm.
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: INFLAMMATION. PAIN. SWELLING AT INJECTION SITE.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain
Clinical narrative: Swelling about 5 inches away from injection site area on under side of arm.  Pain and redness.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large area of redness, warmth, and pain surrounding injection (about 4 inches).
Age: 64.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Rash
Clinical narrative: Patient had rash on chest and all over back. The rash did not hurt or itch. As of 2/11/2017 the rash was almost gone.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Headache, Injection site discomfort, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching and discomfort at site, weakness in arm and body, headache.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Muscular weakness
Clinical narrative: Swelling, itching and discomfort at site, weakness in arm and body, headache.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Chest X-ray normal, Cough, Rash, Respiratory symptom, Rhinorrhoea
Clinical narrative: Rash to face, chest and back, also upper respiratory symptoms (cough, runny nose.)
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Streptococcus test negative
Clinical narrative: Rash to face, chest and back, also upper respiratory symptoms (cough, runny nose.)
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash macular
Clinical narrative: The pt. developed a splotchy rash on calf and arm. The pt. applied benadryl cream to affected areas and redness decreased.  She also was going to take benadryl capsule orally, apply an ice pack, and take famotidine tablets as well.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at site of injection.
Age: 25.0
Sex: M
Vaccine: IPV, JEV1, RAB, YF
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Insomnia, Myalgia
Clinical narrative: Myalgia, fever, nausea, vomiting, diarrhoea, extreme fatigue, insomnia, loss of appetite. Duration: 7 days Odanestron prescribed for nausea, paracetamol recommended for pain,
Age: 25.0
Sex: M
Vaccine: IPV, JEV1, RAB, YF
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Myalgia, fever, nausea, vomiting, diarrhoea, extreme fatigue, insomnia, loss of appetite. Duration: 7 days Odanestron prescribed for nausea, paracetamol recommended for pain,
Age: 45.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Asthenia, Dizziness, Pallor
Clinical narrative: Patient experienced paleness, weakness, and dizziness.
Sex: U
Vaccine: MMR, MMR
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-JAN-2017, the patient inadvertently received the third dose of M-M-R II lot # L040960, expiration date: 16-OCT-2017, subcutaneously (exact dose, therapy type and anatomical location were not provided). There were no adverse effects provided. Additional information has been requested.
Sex: U
Vaccine: MMR, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-JAN-2017, the patient inadvertently received the third dose of M-M-R II lot # L040960, expiration date: 16-OCT-2017, subcutaneously (exact dose, therapy type and anatomical location were not provided). There were no adverse effects provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old non-pregnant female patient. The patient's pertinent medical history included seasonal allergies. The patient did not take any concomitant medications and had no drug reactions or allergies. On 22-JAN-2017, reported as 17 days ago, the patient was vaccinated with GARDASIL 9 (dose, route and site of administration were not reported), lot # M023169, expiry date 13-JUN-2018 for prophylaxis. On 06-FEB-2017, the patient presented at the physician's office with redness, swelling and pain and a hard raised area at the injection site and reported that symptoms began on 04-FEB-2017. The physician diagnosed the patient with cellulitis and prescribed AUGMENTIN 500 mg twice a day for 10 days, ibuprofen and warm compresses. The outcome of cellulitis was unknown. The relatedness between the event and the suspect therapy was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old non-pregnant female patient. The patient's pertinent medical history included seasonal allergies. The patient did not take any concomitant medications and had no drug reactions or allergies. On 22-JAN-2017, reported as 17 days ago, the patient was vaccinated with GARDASIL 9 (dose, route and site of administration were not reported), lot # M023169, expiry date 13-JUN-2018 for prophylaxis. On 06-FEB-2017, the patient presented at the physician's office with redness, swelling and pain and a hard raised area at the injection site and reported that symptoms began on 04-FEB-2017. The physician diagnosed the patient with cellulitis and prescribed AUGMENTIN 500 mg twice a day for 10 days, ibuprofen and warm compresses. The outcome of cellulitis was unknown. The relatedness between the event and the suspect therapy was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: Hypoaesthesia, Injection site rash, Pruritus
Clinical narrative: Pt had rash around inj site and numbness in fingers for the weekend. Pt if feeling well now but still has itchy sensation.
Age: 46.0
Sex: M
Vaccine: MMR, YF
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 28-DEC-2016, the patient was vaccinated with a dose of yellow fever virus vaccine (dose and route of administration were not reported). On 18-JAN-2017 (21 days after prior vaccination with the live vaccine), the patient was vaccinated subcutaneously with a dose of M-M-R II (dose and albumin status therapy type were not provided, lot # L019989, expiration date 01-JUN-2017). No adverse event was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. In an unspecified date in 2011, the patient was vaccinated with the first dose of GARDASIL (route, lot # and expiration date were not reported) for prophylaxis. In November 2016, the patient was vaccinated with the second dose of GARDASIL lot # K008931 with expiration date: 04-MAR-2017 (route was not reported) also for prophylaxis. Furthermore, there was no adverse effects reported. At the reporting time, the third dose of GARDASIL had not been administered. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a 13 month old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On 19-JAN-2017, the patient was vaccinated with a dose of PROQUAD (dose, route, lot# and expiration date unknown) not VARIVAX (dose and route unknown, lot# reported as L005461, expiration date: 28-OCT-2017) in the mist of confusion for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013134: US-009507513-1701USA013135: US-009507513-1701USA013137: US-009507513-1701USA013138: US-009507513-1701USA013139: US-009507513-1701USA013132: US-009507513-1701USA013136: US-009507513-1701USA013133:
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a male patient in his twenties. Medical history and concomitant medications were not reported. On an unspecified date, the pharmacist accidentally administered VARIVAX subcutaneously (lot # not reported) to the patient instead of ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a multiple patients of unknown age and gender. There was no information about the patients' concomitant therapies, concurrent conditions or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot # M022924 with an expiration date 24-JAN-2018, 0.5 ml, intramuscularly for prophylaxis (anatomical location was not reported). There was no adverse effect reported. Administered doses of VAQTA experienced the temperature excursion between 0 and 2 degrees Celsius for 37 hours. A digital data logger was involved. There was no previous temperature excursion. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005226:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA010177: US-009507513-1701USA013134: US-009507513-1701USA013139: US-009507513-1701USA013136: US-009507513-1701USA013137: US-009507513-1701USA013138: US-009507513-1701USA013132: US-009507513-1701USA013135.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 27-JAN-2017, the health care worker administrated to the patient a dose of VARIVAX (lot # M033211, expiration date 13-SEP-2018) (Dose, route and anatomic location were not provided) for prophylaxis. The same date the patient was vaccinated with a dose of PROQUAD (Lot number, expiration date, dose, route and anatomic location were not provided) for prophylaxis (Accidental Overdose). The healthcare worker administered the two vaccines vaccines because did not realize that the PROQUAD vaccine was contained the VARIVAX. No adverse effects were reported.  Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from the director of quality at a facility via a company representative refers to a 18 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot number and expiration date were not provided) intramuscularly for prophylaxis. Concomitant medication was nor reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Wrong drug administered
Clinical narrative: This spontaneous report was received from a 66 years old female patient reporting on herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unspecified date in June 2011, the patient was vaccinated with the first dose of ZOSTAVAX (strength, route, anatomical location, lot number and expiration date were not reported) for prophylaxis, subsequently on an unspecified date in February 2015, the patient received a second dose of ZOSTAVAX by accident instead of a PREVNAR 13 (manufactured by Pfizer) (Interchange of vaccine products). The reporter did not specify if she had ever received the PREVNAR 13 vaccination. On an unknown date, following the second administration of ZOSTAVAX, the patient developed a case of shingles (herpes zoster). No product quality complaint was involved. The outcome of herpes zoster was reported as recovering. The outcome of product use issue is unknown.  The reporter did not assess the relatedness between the event and ZOSTAVAX. Additional information is not expected, since no consent to contact the reporter was provided.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 14 year old male patient. It was no reported any patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications. On 15-JUL-2004, the patient received the first dose of VARIVAX (dose, route of administration, Lot # and expiration date were not reported). Then, on 19-MAY-2008, he received the second dose of VARIVAX (dose, route of administration, Lot # and expiration date were not reported), both for prophylaxis. On 28-JAN-2017, the patient developed "lesions all over his body". On 31-JAN-2017, the patient was seen by the physician and was diagnosed with chickenpox (varicella). There was no treatment given for the condition and it was unknown if laboratory studies were performed. The patient was not hospitalized. At the time of the report, the patient's present status was not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Product name confusion, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 2 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 31-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # M017983, expiration date on 31-JAN-2017 (strength, dose number, route and anatomical location were not reported) for prophylaxis in error instead of LIQUID PEDVAXHIB. It was reported that the healthcare facility that made the error reported that "HPV was confused with HIB." The pharmacist didn't have any other details about how the error occurred. 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 nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JAN-2017, the patient was vaccinated with the improperly stored dose of PROQUAD subcutaneously (dose was not reported) (lot # M031568, expiration date 24-DEC-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA004127: US-009507513-1702USA004124: US-009507513-1702USA004125: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA004123: US-009507513-1702USA004176:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported. On 26-JAN-2017, the patient was vaccinated with a properly-stored but expired dose of VAQTA injection 25/0.5 (dose, frequency and route were not reported) (Lot number: K004856; expiration date: 07-DEC-2016) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as reporter refused additional contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On unknown dates between 20-DEC-2016 and 02-FEB-2017, the patients were vaccinated with improperly stored PNEUMOVAX23 (0.5 ml, once) via intramuscular route for prophylaxis. Nurse reported that the vaccines were exposed to 50.9F temperature for 6 hours on 20-DEC-2016. There were no previous temperature excursions. Data Logger was involved. Nurse also mentioned that the refrigerator was small and did not stored many products, so the lots may have varied and were specific to patients. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ orally (lot number M004508, expiration date 29-JUN-2017, dose was not reported) for prophylaxis. The temperature exposure was between 46° F and 77° F for 2 hours and 54 minutes and between 32° F and 36° F for 17 hours and 42 minutes. It was reported that there was additional excursions but the reporter did not have details. There was no previous excursions involved and a data logger was related. A product quality complaint was not involved. Additional information has been requested. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1702USA004114:Original Case : 1702USA002297.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events reported. No product quality complaint was involved. The vaccines were improperly stored with a temperature of excursion of: 32-36°F (Fahrenheit degrees) for 8 hours and 12 hours respectively. There were no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005002: US-009507513-1702USA005003: US-009507513-1702USA005001.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 22-OCT-2016 to 31-JAN-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M024261 with expiration date: 30-JUL-2018 (route and dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered vaccines experienced temperature of (48 grades Fahrenheit), more than 46 grades Fahrenheit but less than 77 grades Fahrenheit for 24 hours and on 02-DEC-2016 (33 grades Fahrenheit), between 32 grades Fahrenheit and 36 grades Fahrenheit for 60 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004995: US-009507513-1702USA004996: US-009507513-1702USA004997:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 01-FEB-2017 and on 02-FEB-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX (lot number M032649 and expiration date 11-NOV-2018, dose and route were not reported) for prophylaxis. The temperature exposure was more than 8 Celsius degrees but less than 25 Celsius degrees for 2 hours and 23 minutes. There was not previous excursions or data logger involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1702USA001003:Original Case : 1702USA001003; US-009507513-1702USA003522:Original Case : 1702USA001003; US-009507513-1702USA003520:Original Case : 1702USA001003; US-009507513-1702USA003521:Original Case : 1702USA001003.