chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Injection site papule
Clinical narrative: This is a spontaneous report from a non-contactable nurse who reported on behalf of the daughter. A female patient of an unspecified age and race received the first dose of TRUMENBA on an unspecified date at single dose for immunisation. The patient was going to a University where there was an outbreak of meningococcal disease. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed a papule at the site of injection 1 week after vaccination with unknown outcome. The reporter wanted to know if this is a contraindication to administering the next dose. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for his/her mother. This female patient of an unspecified age, race and ethnicity received PREVNAR 13 via an unspecified route of administration in the arm on 22Nov2016 at 0.5 ml single for immunisation.  The patient medical history and concomitant medications were not reported. On an unspecified day in Nov2016 after the vaccination she had fever and swelling in the injection site that were recovered in 2-3 days but since 27Nov2016 in the morning the site of vaccination started getting swelling again, red and itchy, the size of redness was 50/70 millimeters and it covered most of the upper arm, she was having fever. Outcome was unknown. The reporter asked if it was normal to have recurrence of the problem after fever went down. No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Large itchy rash on arm surrounding injection site. Antihistamines and anti-itch cream applied. Lasted about 4-5 days before clearing.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Acute kidney injury, Blood urine present, Haematuria, Injection site reaction, Local reaction
Clinical narrative: Fever, rash, acute renal failure with hematuria, localized site reaction. 10 days. ER on 11/05/14 then my Doctor on 11/07/2014. SMZ-TMP DS/FLUCONAZOLE/ETC.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash, acute renal failure with hematuria, localized site reaction. 10 days. ER on 11/05/14 then my Doctor on 11/07/2014. SMZ-TMP DS/FLUCONAZOLE/ETC.
Age: 19.0
Sex: M
Vaccine: FLU3, HEP, MNQ, TDAP
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Pt c/o difficulty breathing, swollen eyes. Benadryl, solumedrol and epi auto inject given.
Age: 42.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Discomfort, Eyelid ptosis, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Droopy right eye, numbness/tingling of right arm and fingers, slight headache, heaviness feeling on right side of face, swollen right foot.
Age: 42.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Peripheral swelling
Clinical narrative: Droopy right eye, numbness/tingling of right arm and fingers, slight headache, heaviness feeling on right side of face, swollen right foot.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, C-reactive protein normal, Dizziness, Full blood count normal, Injection site erythema
Clinical narrative: L arm swelling and redness at site of injection. This moved into deltoids with swelling and pain on day 2-3. On day 4-5, became L tricep swelling and pain. Seen in MD office day 10, still having significant L paraspinal muscle and tricep swelling and pain. Also dizziness with standing without orthostatic hypotension starting day 4-5. Also new elevated HTN (from 120-130s systolic to 160 to 170s systolic) despite no change in medication.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Red blood cell sedimentation rate normal
Clinical narrative: L arm swelling and redness at site of injection. This moved into deltoids with swelling and pain on day 2-3. On day 4-5, became L tricep swelling and pain. Seen in MD office day 10, still having significant L paraspinal muscle and tricep swelling and pain. Also dizziness with standing without orthostatic hypotension starting day 4-5. Also new elevated HTN (from 120-130s systolic to 160 to 170s systolic) despite no change in medication.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Chills, Fatigue, Headache, Malaise
Clinical narrative: Body aches, chills, headache, fatigue, neck and back pain.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain
Clinical narrative: Body aches, chills, headache, fatigue, neck and back pain.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer based on information received by Pfizer from agency (manufacturer control number US-AMGEN-USASP2016159593), license party for etanercept (ENBREL). This non-serious spontaneous report (USASP2016159593) was reported to agency on 10Nov2016 by a consumer and involves a 85 year old female patient who experienced her arm was red at the injection site of the PREVNAR 13 injection, arm was burning at the injection site of the PREVNAR 13 injection, and itching at the injection site of the PREVNAR 13 injection while receiving etanercept (ENBREL, Lot # 1071265, exp date 30Apr2018)). No historical medical condition was reported. The patient's current medical condition included Psoriatic arthritis. No relevant concomitant medications were provided. Co-suspect medication included PREVNAR 13 for immunization. The patient began Enbrel on an unknown date. On 02Nov2016, the patient reportedly received a PREVNAR 13 vaccination single dose in her right arm. On 07Nov2016, she administered her ENBREL injection in her right thigh. The patient went to the physician for an examination. On 08Nov2016 Tuesday, the patient's arm was red, with burning and itching at the injection site of the PREVNAR 13 Pneumococcal injection. The patient placed ice on the injection site and it helped a bit. Treatment for the events injection site erythema, injection site pain, and injection site pruritus included placed ice. The outcome of the events injection site erythema, injection site pain, and injection site pruritus were reported as unknown. Action taken with ENBREL was reported as unknown. The causal relationship between the events and the product Enbrel was not provided by the consumer.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales Representative. A 17-year-old male patient of an unspecified race received TRUMENBA via an unspecified route at single dose, in the right arm, on 14Nov2016. Relevant medical history included muscular dystrophy. On an unknown date the patient experienced soreness fever and fatigue. The outcome of the events was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Chemotherapy, Human papilloma virus test positive, Inappropriate schedule of drug administration, Lymphocytic leukaemia
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 24 years old female patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. Approximately in 2007, 2008 and 2013, reported as "at age 15 years, 16 years and 21 years", the patient received a complete series of GARDASIL (strength, dose, route, lot # and expiration date were not provided). In approximately May 2014, reported as "2 and 1/2 years ago", the patient experienced myeloblastic lymphocytic leukemia. On an unknown date, the patient developed two genital warts and had a pap test that showed human papillomavirus (HPV); the reported stated that HPV was not the type of high risk for neoplasm. It was reported that the patient was treated with chemotherapy for myeloid leukaemia and lymphocytic leukaemia and that the patient sought medical attention. At the reporting time, the patient events of myeloid leukaemia and lymphocytic leukaemia were in remission since an unknown date. In addition, the outcome of the event of papilloma viral infection was unknown. The causality between GARDASIL and the events of myeloid leukaemia, lymphocytic leukaemia and papilloma viral infection was not assessed. Upon internal review, the events of myeloid leukaemia and lymphocytic leukaemia were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myeloid leukaemia, Papilloma viral infection
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 24 years old female patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. Approximately in 2007, 2008 and 2013, reported as "at age 15 years, 16 years and 21 years", the patient received a complete series of GARDASIL (strength, dose, route, lot # and expiration date were not provided). In approximately May 2014, reported as "2 and 1/2 years ago", the patient experienced myeloblastic lymphocytic leukemia. On an unknown date, the patient developed two genital warts and had a pap test that showed human papillomavirus (HPV); the reported stated that HPV was not the type of high risk for neoplasm. It was reported that the patient was treated with chemotherapy for myeloid leukaemia and lymphocytic leukaemia and that the patient sought medical attention. At the reporting time, the patient events of myeloid leukaemia and lymphocytic leukaemia were in remission since an unknown date. In addition, the outcome of the event of papilloma viral infection was unknown. The causality between GARDASIL and the events of myeloid leukaemia, lymphocytic leukaemia and papilloma viral infection was not assessed. Upon internal review, the events of myeloid leukaemia and lymphocytic leukaemia were considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Mass
Clinical narrative: Student reports to school nurse on 11/30/16 with visible swelling/tenderness noted on right deltoid around site of flu shot (given yesterday), peas sized tender mass also noted above distal end of clavicle, no fever or other syjmptoms noted.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-OCT-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, intramuscularly, lot # M029680, expiration date: 17-JAN-2018 (exact dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 72 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: This spontaneous report was received from a 77 year old male patient regarding himself. The patient's concurrent conditions included chronic pain due to herniated disc and medical history included chronic lymphocytic leukaemia (CLL). The patient had previously experienced drug allergy while on LYRICA. On 31-OCT-2016, the patient was vaccinated with ZOSTAVAX, one shot/once, parenteral (reported as injection), (lot # unknown, expiry date: 31-OCT-2017). Concomitant therapies included bolus dose intravenous morphine, gabapentin, omeprazole and other unspecified medications. On an unknown date in 2016 (reported as with in 24 hours of administration) the patient experienced headache and pain in his feet. The pain started first and was followed by a headache. The patient reported that the pain in his feet felt like "walking on gravel" and pain lessened while he laid down which he stated was "normal when he get that type of pain". The pain was "3x more intense than it was today". The patient did not sought any medical attention and treated the pain by giving himself "a little more morphine but the morphine did not help" and he suspected that this was due to a "reaction with morphine he takes for his chronic pain". No laboratory tests were performed. The patient felt better today and described himself as fully recovered (event stop date: unknown date in November 2016). Causality was not provided by the reporter. No product quality complaint was involved. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: Body aches, weakness, fatigue, fever of 100.2, chills, and headache.  Symptoms lasted until 11/09/16 at approximately 4:00pm.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Body aches, weakness, fatigue, fever of 100.2, chills, and headache.  Symptoms lasted until 11/09/16 at approximately 4:00pm.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Blindness, Chest pain, Cold sweat, Fatigue, Orthostatic hypotension
Clinical narrative: Heart tachycardia, chest pains,orthostatic hypotention broke out in cold sweat, loss vision, fatigue Did not emergency seek medical treatment.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Tachycardia
Clinical narrative: Heart tachycardia, chest pains,orthostatic hypotention broke out in cold sweat, loss vision, fatigue Did not emergency seek medical treatment.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Severe swelling, redness, painful to move.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: Patient requested Tdap vaccine, was inadvertly given Flu vaccine instead.
Sex: M
Vaccine: FLU4
Symptoms: Apgar score normal, Cleft lip and palate, Congenital anomaly, Foetal exposure during pregnancy
Clinical narrative: This prospective pregnancy case described the occurrence of cleft lip and palate in a male patient. The 17-year-old mother was a subject enrolled in an open label study. The subject received Flu Seasonal QIV Dresden .5 ml on 23rd March 2016. The mother's last menstrual period was on 27th November 2015 and estimated date of delivery was 2nd September 2016. The patient was exposed to Flu Seasonal QIV Dresden at week 16 of gestation and during the second trimester of pregnancy. The pregnancy resulted in a live neonate with a congenital anomaly. At 39 weeks and 4 days, the patient was born via vaginal delivery and weighed 3177 grams (7lbs 0oz) at birth. APGAR scores were 8 and 9. The patient was diagnosed with cleft lip and palate. Serious criteria included GSK medically significant and congenital anomaly. Additional event(s) included maternal exposure during pregnancy. The outcome of cleft lip and palate was recovering/resolving. The outcome(s) of the additional event(s) included maternal exposure during pregnancy (unknown). It was unknown if the investigator considered the cleft lip and palate to be related to Flu Seasonal QIV Dresden. See case US2016GSK046433 for details regarding the mother case. Additional details were reported as follows: The patient did not have any maternal medical history and diagnostic details. The patient had left cleft palate including 20 to 30 percent incomplete cleft of the lip and a complete cleft of the posterior hard and entire soft palate. On 11th January 2017, the left cleft palate operation (repair) was schedule. The birth defect was not evident from prenatal test. No medications were given to the neonate directly in utero or post-delivery.
Age: 66.0
Sex: F
Vaccine: FLUR3
Symptoms: Erythema, Hypersensitivity, Multiple allergies, Peripheral swelling, Pharyngeal oedema
Clinical narrative: This is an initial report of an AE, received on 30Sep2016, for Protein Sciences FLUBLOK. Subject, a female, received FLUBLOK intramuscular on 29Sep2016. On 29Sep2016, within 15 to 20 minutes after receiving FLUBLOK, she experienced redness and swelling of her arms, face and throat that was accompanied by generalized itching. She was treated with diphenhydramine 25 mg, hydroxyzine 50 mg and diazepam 5 mg. At the time of the report, her symptoms had largely resolved. Medical history included a clinical, but not pathologic diagnosis of systemic mastocytosis and allergies to everything.
Age: 66.0
Sex: F
Vaccine: FLUR3
Symptoms: Pruritus generalised, Swelling face, Systemic mastocytosis
Clinical narrative: This is an initial report of an AE, received on 30Sep2016, for Protein Sciences FLUBLOK. Subject, a female, received FLUBLOK intramuscular on 29Sep2016. On 29Sep2016, within 15 to 20 minutes after receiving FLUBLOK, she experienced redness and swelling of her arms, face and throat that was accompanied by generalized itching. She was treated with diphenhydramine 25 mg, hydroxyzine 50 mg and diazepam 5 mg. At the time of the report, her symptoms had largely resolved. Medical history included a clinical, but not pathologic diagnosis of systemic mastocytosis and allergies to everything.
Age: 66.0
Sex: M
Vaccine: MENB
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Pyrexia, Somnolence
Clinical narrative: Mild fever, chronic sleepiness, complete loss of appetite, light headedness, dizziness, blurred vision,diarrhea began second day. Took antibiotic PM of day 3. Diarrhea ended, fever subsided, I was able to be up part of the day.  Recovered slowly over following 2 weeks.
Age: 66.0
Sex: M
Vaccine: MENB
Symptoms: Vision blurred
Clinical narrative: Mild fever, chronic sleepiness, complete loss of appetite, light headedness, dizziness, blurred vision,diarrhea began second day. Took antibiotic PM of day 3. Diarrhea ended, fever subsided, I was able to be up part of the day.  Recovered slowly over following 2 weeks.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Borrelia test, C-reactive protein, Cough, Full blood count, Lumbar puncture
Clinical narrative: C/O fever cough, stridor.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Red blood cell sedimentation rate, Stridor
Clinical narrative: C/O fever cough, stridor.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: Patient reports right are pain. Seen by her PCP and referred for physical therapy. PCP comments exam is consistent with adhesive capsulitis.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Vaccination site swelling
Clinical narrative: Pt received 2nd mening B vaccine on 11/21. The next day pt had a 1inch in diameter round raised area below the vaccine site on her left upper arm. It was a small lump and painful to touch. It was red and hot to touch. It's now been a week and pt complains that the arm is still tender but has returned to university. The lump is gone.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Anticoagulant therapy, Immune tolerance induction, Injection site haematoma, Laboratory test
Clinical narrative: Patient has hemophilia with inhibitor. Vaccine administered IM as per CDC guidelines for vaccination administration in patients with bleeding disorders. Patient experienced hematoma at site of injection that required administration of bypassing factor NovoSeven x 6 to treat bleed. It should be noted that patient is also currently receiving immune tolerance induction therapy with Alphanate. His prophylactic factor is novoseven daily and he also uses Novoseven for on demand treatment of bleeds as his bypassing agent.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Feeling hot, Flushing, Injection site pain, Musculoskeletal pain
Clinical narrative: Extreme shoulder pain in shoulder where vax was given that radiated across collar bones and to other shoulder. Felt flushed/hot all over. First episode was the night of administration and then 2 more times post administration.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: About 1 hour after getting the meningitis vaccine, his right shoulder became swollen, red, hot, and he has pain when trying to move his arm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Electroencephalogram, Febrile convulsion
Clinical narrative: COMPLEX FEBRILE SEIZURE/ADMITTED TO HOSPITAL.
Age: 28.0
Sex: F
Vaccine: YF
Symptoms: Rash, Throat tightness, Wheezing
Clinical narrative: Rash, wheezing, throat narrowing 60 min post vaccine.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Periarthritis
Clinical narrative: Frozen Shoulder,  Extreme pain ,  it hurts mainly at night and early morning hours the pain is listed as a 10.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Mobility decreased, Pain in extremity
Clinical narrative: Diffuse and severe pain of entire arm preventing range of motion and causing weakness.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Soreness and swelling in armpit of injection arm(L);  Same symptoms with vaccine in 2015, (R) arm.
Age: 1.75
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Ct given 0.5 ml dose FLUARIX flu vaccine, ct should of received 0.25 ml based on age.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Intractable rash; self medication with Benadryl; PCP prescribed Atarax 11-30-16.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Dyskinesia, Eye movement disorder, Moaning, Pyrexia, Seizure
Clinical narrative: Fever induced seizure during her sleep time, moaning eyes rolling back strange still arm & leg movements, i am not sure of time course as it was scary for me to witness, I called the nurse careline to ask what to do & what may have caused it.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Erythema, Hypersensitivity, Pruritus, Rash
Clinical narrative: Redness, rash, itchiness, 11/10/16 Primary care Doctor visit. 11/21/10 Second Pri Care Doc visit. Reffered to dermatoglogist. 11/23 first visit. Given cortisone shot and sample cut from back for testing. 11/30 second visit with dermatologist. I was told internal allergic reaction. Given 2nd cortisone shot plus antibiotics.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Diarrhoea, Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Diarrhea, abdominal pain, vomiting, intussusception noted on abdominal ultrasound.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Diarrhea, abdominal pain, vomiting, intussusception noted on abdominal ultrasound.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large golf ball size lump to injection site with the whole area of my bicep hot and swollen. Pain rsdiating down to elbow.
Age: 16.0
Sex: F
Vaccine: BCG, FLU4, MENB
Symptoms: Seizure, Syncope
Clinical narrative: Patient had collapsed, seized, 20 seconds. Was observed in clinic for 30 mins then released to go home.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: (Rash Lt.deltoid, warm, tender) Treatment: Start sulfamethoxazole  Rx: Suspension (200mg- 40 mg/5mL, 15mL orally every 12 hours x 10 days.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Hypoaesthesia, Migraine, Paraesthesia, Photophobia
Clinical narrative: Visual disturbance, numbness/tingling of arm, headache, photophobia - symptoms of migraine however no personal or FH of migraines.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Visual impairment
Clinical narrative: Visual disturbance, numbness/tingling of arm, headache, photophobia - symptoms of migraine however no personal or FH of migraines.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Stiff neck on the right side, same side as shot was given. An ongoing headache, even to the current day.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Large area of swelling and redness.
Age: 78.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Dizziness, Hypotension
Clinical narrative: Patient got weak and dizzy- sent to hospital by ambulance but caregiver called back in the afternoon and said patient was ok. His blood pressure was low but is now ok.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Cytogenetic analysis, Disturbance in social behaviour, Electroencephalogram, Laboratory test, Language disorder
Clinical narrative: Within weeks of vaccinations, she became rowsy/lethargic/"drugged" briefly- then lost facial expression, language/social skills previously acquired.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Nuclear magnetic resonance imaging, Reduced facial expression, Somnolence, Specialist consultation
Clinical narrative: Within weeks of vaccinations, she became rowsy/lethargic/"drugged" briefly- then lost facial expression, language/social skills previously acquired.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pain and swelling at entire back of upper arm and back of shoulder on side of injection, gradually decreasing over three days.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Appendicitis perforated, Dizziness, Dyspnoea, Injection site vesicles
Clinical narrative: Bubble where needle punctured arm, labored breathing, lightheaded. Appendicitis with perforation occurred approximately on 11/11/2016.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling, Pruritus, Skin reaction
Clinical narrative: A "few" hours after the IMZ the patient said her arm got swollen, red, sore, and itchy.  On 11/30/2016 she went to her PCP and he said he'd seen this rxn before-and she appeared to be allergic to the Pneumovax-23.  Dr put her on a course of prednisone and Benadryl.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity, Sensory disturbance
Clinical narrative: Pt describes that her arm is painful and hard to move. Not a lit feeling in hand. Her provider is checking for nerve damager and pt has been prescribed gabapentin. Nurse at Dr office states pt received PNEUMOVAX 23 on  6/10/11. Not reported to alert.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Shot in L. shoulder higher than usual and hurt more than other flu shots. Pain kept getting worse from L. shoulder to elbow and slight numbness in finger tips. Went online to see if it was normal to hurt this much and weeks after. Can't lift arm up all the way or side ways. No pain before shot.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: Shot in L. shoulder higher than usual and hurt more than other flu shots. Pain kept getting worse from L. shoulder to elbow and slight numbness in finger tips. Went online to see if it was normal to hurt this much and weeks after. Can't lift arm up all the way or side ways. No pain before shot.
Age: 85.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Culture wound positive, Injection site erythema, Injection site vesicles, Vaccination site swelling
Clinical narrative: Redness and swelling at vaccine site, vesicular cluster of lesions. Prednisone 20 mg Q AM x one week. Valacyclovir 1 gram tab TID x 1 week.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Rash
Clinical narrative: MA gave vaccines to pt; ask mother to stay for about 20 minutes for any reaction. After 10 minutes came back to room to check on pt. Mother told me he had developed some rash on face I called Dr to evaluate.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dyspnoea, Nausea, Vomiting
Clinical narrative: Vaccine exp 5/25/2017. Patient experienced shortness of breath, shivering, nausea, vomiting.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pt developed pain in L deltoid immediately after injection of influenza vaccine that resulted in pain lasting 6 weeks following injection. Injection was given correctly in L deltoid IM at appropriate location. Pain completely resolved by 11/22/16. No subsequent pain or limitation in range of motion. Pt's examination was WNL.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Myotonia, Syncope
Clinical narrative: Vasovagal syncope with Myotonic activity.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Chills, Myalgia, Tremor
Clinical narrative: "Shaking". Pt reports having meningococcal vaccination at 10am this morning, says he was "not feeling well at the time" due to "going out last night and developing a headache". Pt says while driving home at 2pm he developed "uncontrollable shaking". Pt currently has rigors, c/o back pain and muscle pain. He is fully alert and oriented. Provider was notified.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: 1 1/2 hours after shot - red, hot, swollen area that grew to 4 inches diameter, 1 inch in height. Fever and chills for 24 hours. Entire arm with swelling and tenderness next day, extending to shoulder/neck. Slowly subsided over 6 days with use of cool compresses, BENADRYL and ibuprofen.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: 1 1/2 hours after shot - red, hot, swollen area that grew to 4 inches diameter, 1 inch in height. Fever and chills for 24 hours. Entire arm with swelling and tenderness next day, extending to shoulder/neck. Slowly subsided over 6 days with use of cool compresses, BENADRYL and ibuprofen.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm was very store couldn't lift then went to physician on 11/14/16 and was given Ibuprofen 800. She also followed up with her regular physician. He is seeing her for physical therapy.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Patient came down with flu like symptom which was resolved in 2 days.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Broke out with hives. Patient used BENADRYL and topical steroid.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia, Skin tightness
Clinical narrative: Redness, swelling, tightness at injection site (left arm) and low grade fever.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Injection site extravasation, Injection site rash, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Fever 102 after Imms, then rash and swelling with a little clear fld leaking from MMRV imm site. She's using her arm like normal, still itchy at times, looking better now. Cool compress for comfort.
Age: 68.0
Sex: U
Vaccine: FLU4, PNC13
Symptoms: Drug administered at inappropriate site, Injection site pain, X-ray
Clinical narrative: Appears vaccines in both arms may have been administered too high on the upper arm. Pt not complaining/reports bilateral upper arm and shoulder pain.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Sore and red arm for 5 days.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased activity, Pyrexia, Vomiting
Clinical narrative: Patient developed fever and vomiting within 1-2 hours of receiving Influenza vaccine. Decreased activity level and all appearing within the hour of receiving vaccine. No rash, shortness of breath/wheezing associated. Symptoms resolving within 24 hours.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle tightness, Pain, Pain in extremity
Clinical narrative: A couple hours after shot developed pain in (R) arm. Describes as hot and throbbing. Then became hot, throbbing went away. Now complaining of pain (muscle tightness) when moves arm. States she has limited range of motion + pain from injection site. Across arm to inner elbow. Constantly aches at #5 when moves it is a 10.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: A couple hours after shot developed pain in (R) arm. Describes as hot and throbbing. Then became hot, throbbing went away. Now complaining of pain (muscle tightness) when moves arm. States she has limited range of motion + pain from injection site. Across arm to inner elbow. Constantly aches at #5 when moves it is a 10.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Rash
Clinical narrative: Developed a rash a week after immunizations. Went away after 5 days.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Deafness unilateral, Hypoacusis
Clinical narrative: Pt reported hearing loss in left ear (10/22/16)-I reported to Seqirus next day. There data says nobody ever had hearing loss. I filled out adverse event form and faxed to seqirus 11-7-16. Talked with pt 10 days later says hearing coming back. 11-7-`6-pt says muffled hearing came back 2x but today 11-7-16 hearing back to normal. 11-21-16 follow-up-pt hearing normal. Follow-up 11-30-16-pt says hearing normal. Hearing normal checked with Dr. Pt says dr. said hearing of I reported to Dr office 2x about hearing.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called four weeks after administration date and stated her arm still hurt. Also stated she could not lift arm above her head.
Age: 80.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Dizziness, Hyperhidrosis, Pneumonia
Clinical narrative: Patient received PREVNAR 13 on 10/31/16 at other facility. Three days later patient was hospitalized with acute joint pain, dizziness, sweating and being treated for pneumonia.
Age: 80.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Malaise, Pneumonia
Clinical narrative: Patient received PREVNAR 13 on 10/31/16 at other facility. Three days later patient was hospitalized with acute joint pain, dizziness, sweating and being treated for pneumonia.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hypoaesthesia, Mobility decreased, Muscular weakness, Paraesthesia, Sensation of foreign body
Clinical narrative: Information has been received from an office manager concerning a 15 year old female patient. The patient's pertinent medical history was not informed. Concurrent conditions included asthma and attention deficit/hyperactivity disorder (ADHD). The patient had not had drug reactions or allergies. On 16-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # M028323, expiration date 26-SEP-2018, (dosage was not provided), administered per intramuscular route. Concomitant therapies included methylphenidate and ADVAIR DISKUS. On the same date, immediately after vaccination the patient had "numbness and tingling from the neck going down into upper arm". The reporter informed that "she had weakness in her arm and it was difficult for her to lift and she felt as if she had a lump in her throat". The reporter also stated that "a few hours after vaccination, the patient developed soreness at the injection site". Since the patient was still in the office at that time, she was given BENADRYL (lot # and expiration date unknown) and ibuprofen (lot # and expiration date unknown). None laboratory diagnostics studies were performed. The outcome of numbness, tingling, weakness, difficult to lift the arm and lump in her throat feeling was reported as recovered within 24 hours. The outcome of soreness at the injection site was unknown at the time of the report. The causal relationship between GARDASIL 9 and the adverse events was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Mobility decreased, Muscular weakness
Clinical narrative: Information has been received from an office manager concerning a 15 year old female patient. The patient's pertinent medical history was not informed. Concurrent conditions included asthma and attention deficit/hyperactivity disorder (ADHD). The patient had not had drug reactions or allergies. On 16-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # M028323, expiration date 26-SEP-2018, (dosage was not provided), administered per intramuscular route. Concomitant therapies included methylphenidate and ADVAIR DISKUS. On the same date, immediately after vaccination the patient had "numbness and tingling from the neck going down into upper arm". The reporter informed that "she had weakness in her arm and it was difficult for her to lift and she felt as if she had a lump in her throat". The reporter also stated that "a few hours after vaccination, the patient developed soreness at the injection site". Since the patient was still in the office at that time, she was given BENADRYL (lot # and expiration date unknown) and ibuprofen (lot # and expiration date unknown). None laboratory diagnostics studies were performed. The outcome of numbness, tingling, weakness, difficult to lift the arm and lump in her throat feeling was reported as recovered within 24 hours. The outcome of soreness at the injection site was unknown at the time of the report. The causal relationship between GARDASIL 9 and the adverse events was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Paraesthesia, Sensation of foreign body
Clinical narrative: Information has been received from an office manager concerning a 15 year old female patient. The patient's pertinent medical history was not informed. Concurrent conditions included asthma and attention deficit/hyperactivity disorder (ADHD). The patient had not had drug reactions or allergies. On 16-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # M028323, expiration date 26-SEP-2018, (dosage was not provided), administered per intramuscular route. Concomitant therapies included methylphenidate and ADVAIR DISKUS. On the same date, immediately after vaccination the patient had "numbness and tingling from the neck going down into upper arm". The reporter informed that "she had weakness in her arm and it was difficult for her to lift and she felt as if she had a lump in her throat". The reporter also stated that "a few hours after vaccination, the patient developed soreness at the injection site". Since the patient was still in the office at that time, she was given BENADRYL (lot # and expiration date unknown) and ibuprofen (lot # and expiration date unknown). None laboratory diagnostics studies were performed. The outcome of numbness, tingling, weakness, difficult to lift the arm and lump in her throat feeling was reported as recovered within 24 hours. The outcome of soreness at the injection site was unknown at the time of the report. The causal relationship between GARDASIL 9 and the adverse events was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients. On unspecified dates the patients were vaccinated with PNEUMOVAX 23 (lot # L011531, 07-JAN-2017), which was improperly stored at -0.7 centigrade degree for 5 hours (1 cycle). Previous excursion included 0.7 centigrade degree for 15 hours and -0.7 centigrade degree for 15 hours (cycling unknown). Data logger was involved. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates in November 2016 (reported as since 05-NOV-2016) the patients were vaccinated with doses of improperly stored ROTATEQ orally, lot # M004542, expiration date 18-OCT-2017, lot # L046320, expiration date 29-SEP-2017 (dose was not reported). No adverse experience was reported. Product quality complaint was not involved. The administered doses of ROTATEQ were stored in the temperature of 14.6 degrees Celsius for 62 hours. There was no previous temperature excursion. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (lot number M025867, expiry date 24-MAY-2018) (lot number M025870, expiry date 24-MAY-2018) (lot number M028551, expiry date 07-JUN-2018) (lot number M033906, expiry date 28-JUL-2018) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the VARIVAX experienced a temperature of -5.0 degrees Celsius (C) for 7 hours 55 minutes, -6.4 C for 4 hours 57 minutes and -9.8 C for 4 hours. It was reported that the lots underwent previous temperature excursion of -5.1 C for 3 hours 24 minutes except lot number M033906, expiry date 28-JUL-2018 which was not exposed to previous excursion as it was a newer batch. No adverse effects were reported. There was no product quality complaint was reported. The action taken with the therapy with VARIVAX and the outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates in November 2016 (reported as since 05-NOV-2016), the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 injection, lot # M041394, expiration date 23-MAY-2018 (dose, route and site of administration were not reported). No adverse experience was reported. Product quality complaint was not involved. The administered doses of PNEUMOVAX 23 were stored in the temperature of 14.6 degrees Celsius for 62 hours. There was no previous temperature excursion. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On multiple unspecified dates, the patients were administered improperly stored doses of PNEUMOVAX 23 lot # M038216 with expiration date 09-MAY-2018 (dose and route of administration were not reported. The doses were exposed to 59 degrees Fahrenheit for 12 hours. The temperatures were not recorded with a data logger and there were no previous excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information had been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: This spontaneous report as received from a nurse via Pfizer sales representative refers to a female patient of unknown age. No concurrent conditions, medical history and concomitant medications were reported On an unknown date, the patient was vaccinated PREVNAR 13 (dosing details, lot# and expiry date were not reported) and then 8 weeks later the patient was vaccinated with PNEUMOVAX 23 (dosing details, lot# and expiry date were not reported). Post vaccination with PNEUMOVAX 23, the patient experienced rash and swelling of the arm. The outcome of rash and swelling of the arm was unknown. The reporter did not provide the causality between rash and swelling of the arm and the suspect therapies. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L048854, expiration date 31-AUG-2017 (dose was not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of ROTATEQ were stored in the temperature of 13.98 degrees Celsius for 10 minutes and in the temperature of 10.58 degrees Celsius for 10 minutes. Data logger was involved. There were no previous temperature excursions reported. At the time of reporting, there was no further information to provide. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. On 15-NOV-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX injection (lot# M028798, expiry date 18-AUG-2018; dose and route of administration were not reported). There were no concomitant therapies reported. Administered dose of ZOSTAVAX was exposed to a temperature excursion of 5.2 degrees Fahrenheit for 22 hours on 03-NOV-2016, 19.8 degrees Fahrenheit for 4 hours and 16 minutes on 04-NOV-2016, 16.6 degrees Fahrenheit for 4 hours and 5 minutes on 08-NOV-2016, 16.2 degrees Fahrenheit for 1 hours and 36 minutes on 09-NOV-2016, 7.7 degrees Fahrenheit for 21 hours and 24 minutes on 10-NOV-2016, 9.4 degrees Fahrenheit for 23 hours and 30 min on 13-NOV-2016,  11.9 degrees Fahrenheit for 30 minutes 14-NOV-2016 and 7.7 degrees Fahrenheit for 4 hours and 48 minutes on 15-NOV-2016. It was unknown if any previous temperature excursions took place or if there was a digital data logger involved. No adverse symptoms were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure via eye contact, Eye irrigation, Eye pruritus
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 28 year old female patient. There were not pertinent medical history, drug reactions or allergies. The licensed practical nurse reported that on 23-NOV-2016, the patient who is also a nurse was drawing up M-M-R II lot # L020188, expiration date on 03-JUN-2017, (strength, dosage and frequency were not provided) and upon taken the needle out of vial a "few drops" of the vaccine got into the nurse's left eye. Followed, the nurse flushed her eye for a few minutes and had intermittent itching. The patient sought medical attention in physician's office. There was no laboratories diagnostics performed or treatment given for the adverse event. There were not concomitant therapies. Additional information has been requested.