chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lumbar puncture normal, Musculoskeletal disorder, Myelitis transverse, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: This spontaneous report as received from a 52 year old female registered nurse reporting on herself with asthma and allergy to sulfa drugs who on 19-SEP-2014 was vaccinated with one dose of ZOSTAVAX (lot #, expiration date and route were not reported). Concomitant therapy included SYNTHROID. Since unspecified date in 2014, the nurse experienced severe constipation for two months after receiving ZOSTAVAX, which she did not related to ZOSTAVAX. Then on 20-NOV-2014 the patient experienced numbness which started in her right shoulder and then progressed down through her arm and hand. An nuclear magnetic resonance imaging (MRI) of her cervical spine was performed and showed a herniated disc, so the patient was treated with DECADRON 3 mg daily but she did not feel better and considered that it did not work (MARRS # 1501USA012450) and the numbness in her hand and progressed to the point she was unable to use her hand. As a result, the patient was hospitalized on 13-JAN-2015, here, another nuclear magnetic resonance imaging (MRI) was performed and showed swelling of the spine below the location of the herniated disc. Also lumbar puncture, unspecified "ocular studies", an (MRI) of brain and unspecified bloodwork were performed, all of which ruled out an infection. Ultimately the patient was diagnosed with myelitis transverse. The patient was treated with SOLU-MEDROL 1000mg, intravenous for 5 days and prednisone (manufacturer unknown), 100mg, oral, which had since been tapered down to 80 mg. On 18-JAN-2015 the patient was discharged from the hospital. At this moment her right hand was still "100 percent" numb and she was unable to feel anything in that hand. Also the numbness had progressed down to her right side and leg, and was occasionally causing her to lose her balance. At the time of the report the patient had not recovered from the intervertebral disc protrusion, spinal cord oedema, myelitis transverse and balance disorder. On an unknown date the patient recovered from constipation. The registered nurse considered intervertebral disc protrusion, spinal cord oedema, myelitis transverse and balance disorder to be disabling and life threatening. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Spinal cord oedema
Clinical narrative: This spontaneous report as received from a 52 year old female registered nurse reporting on herself with asthma and allergy to sulfa drugs who on 19-SEP-2014 was vaccinated with one dose of ZOSTAVAX (lot #, expiration date and route were not reported). Concomitant therapy included SYNTHROID. Since unspecified date in 2014, the nurse experienced severe constipation for two months after receiving ZOSTAVAX, which she did not related to ZOSTAVAX. Then on 20-NOV-2014 the patient experienced numbness which started in her right shoulder and then progressed down through her arm and hand. An nuclear magnetic resonance imaging (MRI) of her cervical spine was performed and showed a herniated disc, so the patient was treated with DECADRON 3 mg daily but she did not feel better and considered that it did not work (MARRS # 1501USA012450) and the numbness in her hand and progressed to the point she was unable to use her hand. As a result, the patient was hospitalized on 13-JAN-2015, here, another nuclear magnetic resonance imaging (MRI) was performed and showed swelling of the spine below the location of the herniated disc. Also lumbar puncture, unspecified "ocular studies", an (MRI) of brain and unspecified bloodwork were performed, all of which ruled out an infection. Ultimately the patient was diagnosed with myelitis transverse. The patient was treated with SOLU-MEDROL 1000mg, intravenous for 5 days and prednisone (manufacturer unknown), 100mg, oral, which had since been tapered down to 80 mg. On 18-JAN-2015 the patient was discharged from the hospital. At this moment her right hand was still "100 percent" numb and she was unable to feel anything in that hand. Also the numbness had progressed down to her right side and leg, and was occasionally causing her to lose her balance. At the time of the report the patient had not recovered from the intervertebral disc protrusion, spinal cord oedema, myelitis transverse and balance disorder. On an unknown date the patient recovered from constipation. The registered nurse considered intervertebral disc protrusion, spinal cord oedema, myelitis transverse and balance disorder to be disabling and life threatening. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Woke up from sleep Kw/ pain and severe redness along left arm. Site was hot to touch. Called MD following day and was instructed to go to ER. Given KEFLEX.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Hypersensitivity, Injection site warmth, Pain in extremity
Clinical narrative: Woke up from sleep Kw/ pain and severe redness along left arm. Site was hot to touch. Called MD following day and was instructed to go to ER. Given KEFLEX.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Asthma, Croup infectious, Diagnostic procedure, Laboratory test, Surgery
Clinical narrative: Shortly after the 6 month vaccines, patient had his first asthma attack. It was diagnosed as croup and we were sent to a pulmonologist. Patient was completely healthy until this set of vaccines. He has had consistent asthma attacks now for the past three years. Upon further research, this is a common theme with this vaccine. This is the reason for just now reporting it.
Age: 23.0
Sex: M
Vaccine: TTOX
Symptoms: Colitis ulcerative, Colonoscopy, Diarrhoea
Clinical narrative: Horrible diarrhea a few days after vaccine. Diagnosed with Ulcerative Colitis weeks later.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLU4, IPV, MEN, TDAP
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Pt presented with ADEM approximately 1 month after vaccinations.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient of unknown age. On unspecified dates the patient received three doses of GARDASIL (dose, strength, lot# not reported). On unspecified date the patient had a "pap smear" and was diagnosed with cervical cancer. The patient had sought unspecified medical attention. Outcome of cervical cancer was reported as not recovered. Upon internal review, cervical cancer was considered to be medical significant. Additional information has been requested.
Age: 1.23
Sex: F
Vaccine: MMRV, PPV
Symptoms: Diarrhoea, Infection, Lymphadenopathy, Pyrexia, Weight decreased
Clinical narrative: Swollen Lymph nodes in neck and groin area, diarrhea for 10 consecutive days, weigh loss due to that. Low grade fever for 5 days.  Lymph nodes remain in those places, smaller.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Tender red indurated area 8 by 16 cm surrounding injection site on right anterior thigh.
Age: 0.46
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Choking, Cough, Crepitations, Dyspnoea, Glassy eyes
Clinical narrative: Pt. gasping for air, not moving air in lung fields, glassy eyes, stimulated pt and gave O2, pt able to take a deeper breath and then gasping again, lasting several minutes, pulse ox 77%, 911 called, continued 100 % O2 and stimulating baby to keep awake, baby would take bottle which helped regulate breathing while recieving blow by O2, pulse ox improved to 93%, breath sounds with crackles and wheezing which were not present during exam prior to vaccines, after coughing a few times (loose cough), Bs much improved as far as lung volume and no crackles and wheeze, pulse ox improved to 99%, taken to ER by ambulance, HR remained between 160 and 140 during episode, of note were some abnormal findings in musculature during exam and that mother stated she fed pt cereal once and had choking episode.
Age: 0.46
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Wheezing
Clinical narrative: Pt. gasping for air, not moving air in lung fields, glassy eyes, stimulated pt and gave O2, pt able to take a deeper breath and then gasping again, lasting several minutes, pulse ox 77%, 911 called, continued 100 % O2 and stimulating baby to keep awake, baby would take bottle which helped regulate breathing while recieving blow by O2, pulse ox improved to 93%, breath sounds with crackles and wheezing which were not present during exam prior to vaccines, after coughing a few times (loose cough), Bs much improved as far as lung volume and no crackles and wheeze, pulse ox improved to 99%, taken to ER by ambulance, HR remained between 160 and 140 during episode, of note were some abnormal findings in musculature during exam and that mother stated she fed pt cereal once and had choking episode.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Intensive care, Laboratory test, Lumbar puncture abnormal
Clinical narrative: Lost use of legs and hands.  Went to ER at3:00 AM  11/7/14.  Verified GBS on 11/8 via spinal tap. Remained in Intensive Care Unit for 4 weeks - had 20 treatments of Plasmapheresis; from there went to rehab.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Plasmapheresis
Clinical narrative: Lost use of legs and hands.  Went to ER at3:00 AM  11/7/14.  Verified GBS on 11/8 via spinal tap. Remained in Intensive Care Unit for 4 weeks - had 20 treatments of Plasmapheresis; from there went to rehab.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Genital hypoaesthesia, Hypoaesthesia, Myelitis transverse
Clinical narrative: Vaginal area went numb initially.  Over the course of a few weeks also lost feeling in buttocks and feet.
Age: 59.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pain in extremity
Clinical narrative: States entire arm reddened down to fingers, soreness. Resolved over next 48 hrs.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Body temperature increased, Gait disturbance, Headache, Nausea
Clinical narrative: PATIENT REPORTED FEELING WEAK, "WALKED FUNNY," TEMPERATURE 100 DEGREES FAHRENHEIT, NAUSEA, HEADACHE.  PATIENT HAD A DERMATOLOGIST APPT AFTER VACCINE APPT AT PUBLIC HEALTH FOR CRYOTHERAPY FOR PLANTARS WART ON LEG.  PATIENT DENIED HAVING ANY BREAKFAST PRIOR TO IMMUNIZATIONS. MOTHER TOOK PATIENT TO LOCAL ER FOR THESE SYMPTOMS.  CALLED PUBLIC HEALTH THE NEXT MORNING AND REPORTED US OF THESE SYMPTOMS POST VACCINATION.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral
Clinical narrative: Swollen left armpit area, lymph node?
Age: 50.0
Sex: M
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Herpes zoster, Varicella virus test positive
Clinical narrative: 51 y/o male seen in Infectious Disease Clinic on 30Jan2015 with hx of RA and on methotrexate. Received Zostavax on 09 Jan 2015 and developed pretty classic, mild disseminated VZV rash 6-10 days later. On 30 Jan 2015 patient seen in IM clinic first, then derm (masked), followed by Infectious Disease Clinic and was isolated at that time in a negative pressure room in ID Clinic. Patient had 50 lesions total. The rash is non-pruritic and not painful. Over the past 12-15 days he has continued to develop new lesions. He denies having any other symptoms including fevers, chills, cough, shortness of breath and headache. Per MD if VZV grows in culture may try to send for strain typing to determine whether this was Oka-strain or WT varicella. Treated with Valtrex dosed 1gm PO TID for 10-days to expedite resolution of infection.
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Upon follow-up information received on 20 January 2015, the unsolicited case became valid as patient was identified (initials provided). Initial case received from a healthcare professional on 13 January 2014. The physician reported that he has had several unidentified patients get confirmed with influenza after being immunized with FLUZONE vaccine this season. The patient's sex, age, date of birth, lot number, route, dates and site of administration were not reported. The patients' medical histories, relevant lab tests and concomitant medications were not reported. This case is invalid due to patient information details were not reported. No further details available at the time of this report. Patient outcomes are unknown. Follow-up information regarding unsolicited case received from a healthcare professional on 20 January 2015. The case became valid as patient's initials were provided. The suspect vaccine is FLUZONE. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Benign intracranial hypertension, CSF pressure increased, Exposure during pregnancy, Headache, Lumboperitoneal shunt
Clinical narrative: Pt. reports severe headache 1 hour following flu vaccine. This resulted in several ER visits and a hospitalization resulting in being diagnosed w/ pseudotumor cerebri, having LP shunt placed 1/24/15.
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Ultrasound scan
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. No information about medical history, concurrent conditions were reported. The physician reported that patient completed ROTATEQ suspension 2, (route dose strength not reported) series on 23-DEC-2014. No concomitant therapy was reported. Approximately on 27-DEC-3014 (reported as within 4 days after vaccination), the patient developed colicky abdominal pains (hospitalization). Ultrasound(unknown date) revealed possible intussusception (hospitalization). The reporter stated that patient was admitted to unspecified hospital of one day on an unknown date and released to home on an unknown date. The patient was treated for the event in acute care for 24 hours. The outcome of patient developed colicky abdominal pains and possible intussusception was reported as recovering. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Cough, Fatigue, Headache, Influenza A virus test negative
Clinical narrative: 1/23/15 1430 R. deltoid - "cellulitis" red, hot to touch, swelling, blotchy and pain tender to touch firmness. 1/24/15 0024 Systemic Inflammatory Response Syndrome. 1/23/15 1910 fever max recorded on IP chart 101.4, fatigue, occasional cough, lethargy, tachycardia, chills, sore throat, generalized headache.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza B virus test, Influenza virus test negative, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: 1/23/15 1430 R. deltoid - "cellulitis" red, hot to touch, swelling, blotchy and pain tender to touch firmness. 1/24/15 0024 Systemic Inflammatory Response Syndrome. 1/23/15 1910 fever max recorded on IP chart 101.4, fatigue, occasional cough, lethargy, tachycardia, chills, sore throat, generalized headache.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: 1/23/15 1430 R. deltoid - "cellulitis" red, hot to touch, swelling, blotchy and pain tender to touch firmness. 1/24/15 0024 Systemic Inflammatory Response Syndrome. 1/23/15 1910 fever max recorded on IP chart 101.4, fatigue, occasional cough, lethargy, tachycardia, chills, sore throat, generalized headache.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lymphocyte percentage decreased, Neutrophil percentage increased, Nuclear magnetic resonance imaging abnormal, Oropharyngeal pain, Pyrexia
Clinical narrative: 1/23/15 1430 R. deltoid - "cellulitis" red, hot to touch, swelling, blotchy and pain tender to touch firmness. 1/24/15 0024 Systemic Inflammatory Response Syndrome. 1/23/15 1910 fever max recorded on IP chart 101.4, fatigue, occasional cough, lethargy, tachycardia, chills, sore throat, generalized headache.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash macular, Systemic inflammatory response syndrome, Tachycardia, Urine analysis normal, White blood cell count increased
Clinical narrative: 1/23/15 1430 R. deltoid - "cellulitis" red, hot to touch, swelling, blotchy and pain tender to touch firmness. 1/24/15 0024 Systemic Inflammatory Response Syndrome. 1/23/15 1910 fever max recorded on IP chart 101.4, fatigue, occasional cough, lethargy, tachycardia, chills, sore throat, generalized headache.
Age: 1.67
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Abasia, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Developed bilat LE weakness, inability to walk 2 weeks after vaccine. Dx: Guillain-Barre Synd.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain lower, Angiomyolipoma, Asthenia, Atelectasis, Blood bicarbonate increased
Clinical narrative: Initial report received from a healthcare professional on 29 October 2014. Based upon follow-up information received on 20 January 2015, the event has been upgraded to serious. A 71-year-old female patient had received an intramuscular first dose of FLUZONE HD, (batch number U5042AA, expiry date 14 May 2015) in left deltoid on 08 October 2014. The patient's illness at the time of vaccination was not reported and had no history of allergies. It was stated that the patient had not previously ever received FLUZONE HD, but has had several standard Flu vaccines. On 08 October 2014, "a couple of hours" after vaccination, the patient experienced fever, pulse of 110, and chest pain. The patient was sent to emergency room and evaluated by physician which showed no diagnosis, no findings at ER, and was discharged home. Complementary investigations and treatments were not reported. On an unspecified date, the patient had recovered. Follow-up information for this unsolicited case was received from a physician on 20 January 2015. Based upon this new information, which contains emergency room records, the case has been upgraded to serious. The patient's medical history included COPD, hypertension, type 2 diabetes, nausea, hyperlipidemia, rheumatoid arthritis, fibromyalgia, GERD, hypothyroidism, gout, and irritable bowel syndrome. She was a former smoker, and was allergic to DILAUDID and chocolate. Concomitant medications included lisinopril, gabapentin, hydralazine, COREG, allopurinol, colchicine, ocular lubricant, latanoprost, ADVAIR, multivitamin, mometasone, vitamin D, omeprazole, atorvastatin, zolpidem, SYNTHROID, metformin and TYLENOL. The patient denied symptoms prior to vaccination. Shortly after vaccination, she experienced fever with chills, rigors, shortness of breath, chest tightness, right lower quadrant pain, nausea, and severe headache. She presented to the emergency room, where diagnostic testing, including white blood count, lactic acid level, urinalysis, CT of the abdomen, and Influenza testing, were all negative. A chest x-ray showed some atelectasis, but was otherwise negative. Temperature in the emergency department was 39.3 degrees C. Review of symptoms revealed weakness and tiredness, chest tightness, right lower quadrant abdominal pain, nausea, and generalized soreness. Physical exam was essentially normal. The assessment was that the patient had "possible vitals fever", likely an episode of fever following Influenza vaccination with no evidence of active infection. The plan was to observe the patient and offer supportive care, and then discharge once her fever improved. According to the reporter, the event recovered on 10 October 2014. Documents held by sender: ER record.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood lactic acid normal, Blood potassium normal
Clinical narrative: Initial report received from a healthcare professional on 29 October 2014. Based upon follow-up information received on 20 January 2015, the event has been upgraded to serious. A 71-year-old female patient had received an intramuscular first dose of FLUZONE HD, (batch number U5042AA, expiry date 14 May 2015) in left deltoid on 08 October 2014. The patient's illness at the time of vaccination was not reported and had no history of allergies. It was stated that the patient had not previously ever received FLUZONE HD, but has had several standard Flu vaccines. On 08 October 2014, "a couple of hours" after vaccination, the patient experienced fever, pulse of 110, and chest pain. The patient was sent to emergency room and evaluated by physician which showed no diagnosis, no findings at ER, and was discharged home. Complementary investigations and treatments were not reported. On an unspecified date, the patient had recovered. Follow-up information for this unsolicited case was received from a physician on 20 January 2015. Based upon this new information, which contains emergency room records, the case has been upgraded to serious. The patient's medical history included COPD, hypertension, type 2 diabetes, nausea, hyperlipidemia, rheumatoid arthritis, fibromyalgia, GERD, hypothyroidism, gout, and irritable bowel syndrome. She was a former smoker, and was allergic to DILAUDID and chocolate. Concomitant medications included lisinopril, gabapentin, hydralazine, COREG, allopurinol, colchicine, ocular lubricant, latanoprost, ADVAIR, multivitamin, mometasone, vitamin D, omeprazole, atorvastatin, zolpidem, SYNTHROID, metformin and TYLENOL. The patient denied symptoms prior to vaccination. Shortly after vaccination, she experienced fever with chills, rigors, shortness of breath, chest tightness, right lower quadrant pain, nausea, and severe headache. She presented to the emergency room, where diagnostic testing, including white blood count, lactic acid level, urinalysis, CT of the abdomen, and Influenza testing, were all negative. A chest x-ray showed some atelectasis, but was otherwise negative. Temperature in the emergency department was 39.3 degrees C. Review of symptoms revealed weakness and tiredness, chest tightness, right lower quadrant abdominal pain, nausea, and generalized soreness. Physical exam was essentially normal. The assessment was that the patient had "possible vitals fever", likely an episode of fever following Influenza vaccination with no evidence of active infection. The plan was to observe the patient and offer supportive care, and then discharge once her fever improved. According to the reporter, the event recovered on 10 October 2014. Documents held by sender: ER record.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood sodium normal, Blood urea normal, Chest X-ray abnormal, Chest discomfort, Chest pain
Clinical narrative: Initial report received from a healthcare professional on 29 October 2014. Based upon follow-up information received on 20 January 2015, the event has been upgraded to serious. A 71-year-old female patient had received an intramuscular first dose of FLUZONE HD, (batch number U5042AA, expiry date 14 May 2015) in left deltoid on 08 October 2014. The patient's illness at the time of vaccination was not reported and had no history of allergies. It was stated that the patient had not previously ever received FLUZONE HD, but has had several standard Flu vaccines. On 08 October 2014, "a couple of hours" after vaccination, the patient experienced fever, pulse of 110, and chest pain. The patient was sent to emergency room and evaluated by physician which showed no diagnosis, no findings at ER, and was discharged home. Complementary investigations and treatments were not reported. On an unspecified date, the patient had recovered. Follow-up information for this unsolicited case was received from a physician on 20 January 2015. Based upon this new information, which contains emergency room records, the case has been upgraded to serious. The patient's medical history included COPD, hypertension, type 2 diabetes, nausea, hyperlipidemia, rheumatoid arthritis, fibromyalgia, GERD, hypothyroidism, gout, and irritable bowel syndrome. She was a former smoker, and was allergic to DILAUDID and chocolate. Concomitant medications included lisinopril, gabapentin, hydralazine, COREG, allopurinol, colchicine, ocular lubricant, latanoprost, ADVAIR, multivitamin, mometasone, vitamin D, omeprazole, atorvastatin, zolpidem, SYNTHROID, metformin and TYLENOL. The patient denied symptoms prior to vaccination. Shortly after vaccination, she experienced fever with chills, rigors, shortness of breath, chest tightness, right lower quadrant pain, nausea, and severe headache. She presented to the emergency room, where diagnostic testing, including white blood count, lactic acid level, urinalysis, CT of the abdomen, and Influenza testing, were all negative. A chest x-ray showed some atelectasis, but was otherwise negative. Temperature in the emergency department was 39.3 degrees C. Review of symptoms revealed weakness and tiredness, chest tightness, right lower quadrant abdominal pain, nausea, and generalized soreness. Physical exam was essentially normal. The assessment was that the patient had "possible vitals fever", likely an episode of fever following Influenza vaccination with no evidence of active infection. The plan was to observe the patient and offer supportive care, and then discharge once her fever improved. According to the reporter, the event recovered on 10 October 2014. Documents held by sender: ER record.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Computerised tomogram kidney abnormal, Diverticulum, Dyspnoea, Fatigue
Clinical narrative: Initial report received from a healthcare professional on 29 October 2014. Based upon follow-up information received on 20 January 2015, the event has been upgraded to serious. A 71-year-old female patient had received an intramuscular first dose of FLUZONE HD, (batch number U5042AA, expiry date 14 May 2015) in left deltoid on 08 October 2014. The patient's illness at the time of vaccination was not reported and had no history of allergies. It was stated that the patient had not previously ever received FLUZONE HD, but has had several standard Flu vaccines. On 08 October 2014, "a couple of hours" after vaccination, the patient experienced fever, pulse of 110, and chest pain. The patient was sent to emergency room and evaluated by physician which showed no diagnosis, no findings at ER, and was discharged home. Complementary investigations and treatments were not reported. On an unspecified date, the patient had recovered. Follow-up information for this unsolicited case was received from a physician on 20 January 2015. Based upon this new information, which contains emergency room records, the case has been upgraded to serious. The patient's medical history included COPD, hypertension, type 2 diabetes, nausea, hyperlipidemia, rheumatoid arthritis, fibromyalgia, GERD, hypothyroidism, gout, and irritable bowel syndrome. She was a former smoker, and was allergic to DILAUDID and chocolate. Concomitant medications included lisinopril, gabapentin, hydralazine, COREG, allopurinol, colchicine, ocular lubricant, latanoprost, ADVAIR, multivitamin, mometasone, vitamin D, omeprazole, atorvastatin, zolpidem, SYNTHROID, metformin and TYLENOL. The patient denied symptoms prior to vaccination. Shortly after vaccination, she experienced fever with chills, rigors, shortness of breath, chest tightness, right lower quadrant pain, nausea, and severe headache. She presented to the emergency room, where diagnostic testing, including white blood count, lactic acid level, urinalysis, CT of the abdomen, and Influenza testing, were all negative. A chest x-ray showed some atelectasis, but was otherwise negative. Temperature in the emergency department was 39.3 degrees C. Review of symptoms revealed weakness and tiredness, chest tightness, right lower quadrant abdominal pain, nausea, and generalized soreness. Physical exam was essentially normal. The assessment was that the patient had "possible vitals fever", likely an episode of fever following Influenza vaccination with no evidence of active infection. The plan was to observe the patient and offer supportive care, and then discharge once her fever improved. According to the reporter, the event recovered on 10 October 2014. Documents held by sender: ER record.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Haematocrit decreased, Haemoglobin normal, Headache, Influenza virus test negative, Nausea
Clinical narrative: Initial report received from a healthcare professional on 29 October 2014. Based upon follow-up information received on 20 January 2015, the event has been upgraded to serious. A 71-year-old female patient had received an intramuscular first dose of FLUZONE HD, (batch number U5042AA, expiry date 14 May 2015) in left deltoid on 08 October 2014. The patient's illness at the time of vaccination was not reported and had no history of allergies. It was stated that the patient had not previously ever received FLUZONE HD, but has had several standard Flu vaccines. On 08 October 2014, "a couple of hours" after vaccination, the patient experienced fever, pulse of 110, and chest pain. The patient was sent to emergency room and evaluated by physician which showed no diagnosis, no findings at ER, and was discharged home. Complementary investigations and treatments were not reported. On an unspecified date, the patient had recovered. Follow-up information for this unsolicited case was received from a physician on 20 January 2015. Based upon this new information, which contains emergency room records, the case has been upgraded to serious. The patient's medical history included COPD, hypertension, type 2 diabetes, nausea, hyperlipidemia, rheumatoid arthritis, fibromyalgia, GERD, hypothyroidism, gout, and irritable bowel syndrome. She was a former smoker, and was allergic to DILAUDID and chocolate. Concomitant medications included lisinopril, gabapentin, hydralazine, COREG, allopurinol, colchicine, ocular lubricant, latanoprost, ADVAIR, multivitamin, mometasone, vitamin D, omeprazole, atorvastatin, zolpidem, SYNTHROID, metformin and TYLENOL. The patient denied symptoms prior to vaccination. Shortly after vaccination, she experienced fever with chills, rigors, shortness of breath, chest tightness, right lower quadrant pain, nausea, and severe headache. She presented to the emergency room, where diagnostic testing, including white blood count, lactic acid level, urinalysis, CT of the abdomen, and Influenza testing, were all negative. A chest x-ray showed some atelectasis, but was otherwise negative. Temperature in the emergency department was 39.3 degrees C. Review of symptoms revealed weakness and tiredness, chest tightness, right lower quadrant abdominal pain, nausea, and generalized soreness. Physical exam was essentially normal. The assessment was that the patient had "possible vitals fever", likely an episode of fever following Influenza vaccination with no evidence of active infection. The plan was to observe the patient and offer supportive care, and then discharge once her fever improved. According to the reporter, the event recovered on 10 October 2014. Documents held by sender: ER record.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Nephrolithiasis, Pain, Platelet count normal, Pyrexia, Urine analysis normal
Clinical narrative: Initial report received from a healthcare professional on 29 October 2014. Based upon follow-up information received on 20 January 2015, the event has been upgraded to serious. A 71-year-old female patient had received an intramuscular first dose of FLUZONE HD, (batch number U5042AA, expiry date 14 May 2015) in left deltoid on 08 October 2014. The patient's illness at the time of vaccination was not reported and had no history of allergies. It was stated that the patient had not previously ever received FLUZONE HD, but has had several standard Flu vaccines. On 08 October 2014, "a couple of hours" after vaccination, the patient experienced fever, pulse of 110, and chest pain. The patient was sent to emergency room and evaluated by physician which showed no diagnosis, no findings at ER, and was discharged home. Complementary investigations and treatments were not reported. On an unspecified date, the patient had recovered. Follow-up information for this unsolicited case was received from a physician on 20 January 2015. Based upon this new information, which contains emergency room records, the case has been upgraded to serious. The patient's medical history included COPD, hypertension, type 2 diabetes, nausea, hyperlipidemia, rheumatoid arthritis, fibromyalgia, GERD, hypothyroidism, gout, and irritable bowel syndrome. She was a former smoker, and was allergic to DILAUDID and chocolate. Concomitant medications included lisinopril, gabapentin, hydralazine, COREG, allopurinol, colchicine, ocular lubricant, latanoprost, ADVAIR, multivitamin, mometasone, vitamin D, omeprazole, atorvastatin, zolpidem, SYNTHROID, metformin and TYLENOL. The patient denied symptoms prior to vaccination. Shortly after vaccination, she experienced fever with chills, rigors, shortness of breath, chest tightness, right lower quadrant pain, nausea, and severe headache. She presented to the emergency room, where diagnostic testing, including white blood count, lactic acid level, urinalysis, CT of the abdomen, and Influenza testing, were all negative. A chest x-ray showed some atelectasis, but was otherwise negative. Temperature in the emergency department was 39.3 degrees C. Review of symptoms revealed weakness and tiredness, chest tightness, right lower quadrant abdominal pain, nausea, and generalized soreness. Physical exam was essentially normal. The assessment was that the patient had "possible vitals fever", likely an episode of fever following Influenza vaccination with no evidence of active infection. The plan was to observe the patient and offer supportive care, and then discharge once her fever improved. According to the reporter, the event recovered on 10 October 2014. Documents held by sender: ER record.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count normal
Clinical narrative: Initial report received from a healthcare professional on 29 October 2014. Based upon follow-up information received on 20 January 2015, the event has been upgraded to serious. A 71-year-old female patient had received an intramuscular first dose of FLUZONE HD, (batch number U5042AA, expiry date 14 May 2015) in left deltoid on 08 October 2014. The patient's illness at the time of vaccination was not reported and had no history of allergies. It was stated that the patient had not previously ever received FLUZONE HD, but has had several standard Flu vaccines. On 08 October 2014, "a couple of hours" after vaccination, the patient experienced fever, pulse of 110, and chest pain. The patient was sent to emergency room and evaluated by physician which showed no diagnosis, no findings at ER, and was discharged home. Complementary investigations and treatments were not reported. On an unspecified date, the patient had recovered. Follow-up information for this unsolicited case was received from a physician on 20 January 2015. Based upon this new information, which contains emergency room records, the case has been upgraded to serious. The patient's medical history included COPD, hypertension, type 2 diabetes, nausea, hyperlipidemia, rheumatoid arthritis, fibromyalgia, GERD, hypothyroidism, gout, and irritable bowel syndrome. She was a former smoker, and was allergic to DILAUDID and chocolate. Concomitant medications included lisinopril, gabapentin, hydralazine, COREG, allopurinol, colchicine, ocular lubricant, latanoprost, ADVAIR, multivitamin, mometasone, vitamin D, omeprazole, atorvastatin, zolpidem, SYNTHROID, metformin and TYLENOL. The patient denied symptoms prior to vaccination. Shortly after vaccination, she experienced fever with chills, rigors, shortness of breath, chest tightness, right lower quadrant pain, nausea, and severe headache. She presented to the emergency room, where diagnostic testing, including white blood count, lactic acid level, urinalysis, CT of the abdomen, and Influenza testing, were all negative. A chest x-ray showed some atelectasis, but was otherwise negative. Temperature in the emergency department was 39.3 degrees C. Review of symptoms revealed weakness and tiredness, chest tightness, right lower quadrant abdominal pain, nausea, and generalized soreness. Physical exam was essentially normal. The assessment was that the patient had "possible vitals fever", likely an episode of fever following Influenza vaccination with no evidence of active infection. The plan was to observe the patient and offer supportive care, and then discharge once her fever improved. According to the reporter, the event recovered on 10 October 2014. Documents held by sender: ER record.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Feeding disorder, Hypersensitivity, Nausea, Vomiting
Clinical narrative: Woke up in AM w/nausea and vomiting. Unable to eat or drink w/o vomiting.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Body temperature increased, Heart rate increased, Pain
Clinical narrative: Temp 102, increased blood pressure, increased heart rate, body aches.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Seven days after receiving Varivax vaccine, Red scattered spot appear over entire body. Seen and evaluated on 02/02/2015 by PCP prescribed Acyclovir 800mg and advised to stay home for the remaining part of the week. Afebrile and stabe at time of visit.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Eyelid oedema, Nausea, Pain in extremity
Clinical narrative: I woke up with a swollen eye (right), nausea, and a sharp twinge in my left pinky toe.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Lethargy, Listless
Clinical narrative: 01/30/2015 Started with runny nose, 1/31 cough, congestion, no fever.  2/1 listless, lethargic, gasping for breath. Went to ER., dx with pneumonia. Pt. mother read on VIS Varicella it could cause pneumonia.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Pneumonia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: 01/30/2015 Started with runny nose, 1/31 cough, congestion, no fever.  2/1 listless, lethargic, gasping for breath. Went to ER., dx with pneumonia. Pt. mother read on VIS Varicella it could cause pneumonia.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: Chest pains/ accelerated heart rate/ shortness of breath.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: CSF oligoclonal band absent, CSF white blood cell count increased, Demyelination, Hypoaesthesia, Nerve conduction studies normal
Clinical narrative: On 12/11/14 @ approx 9pm, her left toes became numb. By 10pm both feet were numb (sensory-very cold, like ice). On 12/13/14, she had complete parasthesis from waist down with very numb perineum. She vomited twice late in the evening and was admitted to Emerg Dept that night around 8pm. After initial work up, she was admitted to hospital overnight. She was discharged on 12/14/14 under the care of neurologist. Nerve conduction studies of legs and feet were negative. The first MRI was done on 12/19/14 of thoracic and lumbar spine. The results were demyelination of posterior spinal cord at T3 to T5. The second MRI was performed on 12/31/14 of brain and cervical spine. The results were negative. A lumbar puncture was performed on Jan 7th. The results showed an elevated WBC count but negative for oligoclonal bands. She received Methylprednisolone 1000mg daily via IV infusion x 3 days. To date, the condition has improved but has not resolved.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia, Peripheral coldness, Vomiting
Clinical narrative: On 12/11/14 @ approx 9pm, her left toes became numb. By 10pm both feet were numb (sensory-very cold, like ice). On 12/13/14, she had complete parasthesis from waist down with very numb perineum. She vomited twice late in the evening and was admitted to Emerg Dept that night around 8pm. After initial work up, she was admitted to hospital overnight. She was discharged on 12/14/14 under the care of neurologist. Nerve conduction studies of legs and feet were negative. The first MRI was done on 12/19/14 of thoracic and lumbar spine. The results were demyelination of posterior spinal cord at T3 to T5. The second MRI was performed on 12/31/14 of brain and cervical spine. The results were negative. A lumbar puncture was performed on Jan 7th. The results showed an elevated WBC count but negative for oligoclonal bands. She received Methylprednisolone 1000mg daily via IV infusion x 3 days. To date, the condition has improved but has not resolved.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site swelling
Clinical narrative: Swelling on left upper arm that gradually got bigger.  Pt was seen in ER and was treated with antibiotics.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received Hepatitis A vaccine at 8 wks of age. No adverse reaction noted. Follow-up visit occurred 1-29-2015.
Age: 0.45
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Diet refusal, Hypersomnia, Irritability
Clinical narrative: He had no fever but was very grumpy. Wouldn't eat. Sleeping a lot.
Age: 1.61
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site urticaria, Irritability, Urticaria
Clinical narrative: The day after receiving vaccines, mom noticed hives on legs, arms, back, and bottom. Mom called back later in the day stating the hives were spreading and seemed much worse. Baby was also irritable throughout the day.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling hot, Hypoaesthesia, Muscular weakness, Paraesthesia, Restless legs syndrome
Clinical narrative: Restless feet, tingling sensation and warmth, muscle weakness or numbness.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Fall, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: Restless feet, tingling sensation and warmth, muscle weakness or numbness.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging spinal, Restlessness, VIIth nerve paralysis
Clinical narrative: Restless feet, tingling sensation and warmth, muscle weakness or numbness.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Client fainted after receiving the vaccine. Client was only out for less than 20 seconds. Vitals checked and were fine. Ice packs applied and client given juice to drink.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain
Clinical narrative: The day after the shot, I developed severe shoulder pain in my right shoulder and down the outside of my right arm, and limited movement in arm that received the Pneumovax 23 vaccine. More than 3 months later pain has lessened but still significant and somewhat limiting.  Doing physical therapy and anti inflammatories.  Orthopedic doctor said there is a recognized link between this shot and shoulder joint pain. He has another current patient and previous patients with similar condition.  Also patient has 2 friends that experienced a similar problem, one lasting for 6 months and has heard other examples of problems following the shot.  The Physical therapist also mentioned a link and previous experience with this type of injury.  There should be a warning in the literature before the shot is given.  One could at least have the shot in their non-dominant arm.  Literature provided with shot mentions only that you may get a redness and soreness at injection site for a short time.    Patients should be warned of the more severe risks which appear to be more common than reported. This is unacceptable and it appears that the injury is more widespread than is known by the general public.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching and redness at site.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Painful lymph node swelling in armpit and painful lymph node swelling under chin. Injection of Td was in right shoulder.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, X-ray
Clinical narrative: Pain in left shoulder (same arm as vaccine administered).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular Rash.
Age: 1.5
Sex: F
Vaccine: FLUX
Symptoms: Convulsion
Clinical narrative: Short seizure while playing.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of unknown cause of death in a 15-month-old patient who received PEDIARIX. Co-suspect products included PREVNAR 13 (batch number J11488, expiry date November 2016) and HIB vaccine. On 18th November 2014, the patient received PEDIARIX, PREVNAR 13 and HIB VACCINE. On 19th November 2014, 1 days after receiving PEDIARIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 19th November 2014. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the unknown cause of death to be related to PEDIARIX. Additional information was provided: No other medications and medical conditions. The patient was healthy without a lot of clinic visits. The patient passed away on 19 November 2014 at 9:50. An autopsy is currently being done. An investigation was performed on PREVNAR 13. The results showed no issues impacting the identity, strength, safety, purity or quality of the product.
Age: 9.0
Sex: U
Vaccine: FLU3
Symptoms: Body temperature increased, Cellulitis, Injection site erythema
Clinical narrative: Rec'd flu vaccine 1/29 seen in our office 1/31 immun site on (L) arm 3x4cm area of erythema just inferior to injection site. Temp 102 - no streaking. Dx cellulitis prescribed clindamycin x 10 days.
Age: 35.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Erythema, Pain in extremity, Pruritus, Tenderness
Clinical narrative: Client came in for TST reading and c/o (R) arm hurting it very  itchy. PHN observed arm to have big red area measuring 40mm by 35mm in size. Client also c/o that clothing touching arm hurt as well.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to unspecified number of patient (age and gender were not reported), that on an unknown date were vaccinated with ROTATEQ oral (dose, strength and not number were not reported), which on an unknown date experience an incorrect product storage. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEP, MMRV, TDAP
Symptoms: Erythema, Hypersensitivity, Nodule, Pain, Pain in extremity
Clinical narrative: One day after vaccine, arm was sore and had bump. 3 days after, went to MD, told it was a knot and an allergic reaction, given 2 antibiotics. A week after vaccine, it was getting worse (huge "knot", red and painful) went back to MD and was sent to the ER. At ER, was told it was a staph infection - had I and D, given BACTRIM and clindamycin.
Age: 26.0
Sex: F
Vaccine: HEP, MMRV, TDAP
Symptoms: Staphylococcal infection
Clinical narrative: One day after vaccine, arm was sore and had bump. 3 days after, went to MD, told it was a knot and an allergic reaction, given 2 antibiotics. A week after vaccine, it was getting worse (huge "knot", red and painful) went back to MD and was sent to the ER. At ER, was told it was a staph infection - had I and D, given BACTRIM and clindamycin.