chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a consumer on 10-Oct-2016. THIS CASE IS LINKED WITH 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with INFLUENZA VACCINE (lot number, Expiration date, route of administration, site of administration and dose details were not reported) on an unknown date. The medical history and concomitant medications were not reported. On an unspecified date, following vaccination, the patient was very ill. The lab test and the corrective treatment was not reported. The outcome of the events was reported as unknown. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851, 2016SA191730, 2016SA191735, 2016SA191741, 2016SA191743, 2016SA191744. (Same reporter source, same vaccine). This case involves a female patient (age not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced Guillain Barre Syndrome (which nearly killed her). The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. Upon medical review, the case was considered as serious due to important medical event: Guillain Barre Syndrome. List of documents held by sender: none. Sender's Comments: This is very poorly documented case where patient experienced Guillain Barre syndrome after influenza vaccination. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Ultrasound scan
Clinical narrative: Blood in stool. did go to the ER.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash macular
Clinical narrative: Vaccination site started to itch. By Thursday, the area surrounding the site was red and splotchy. Still itchy today (Friday following vaccination).
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Tenderness, warmth and redness at site of immunization. Becoming more red and painful. Began as the size of a quarter and today it's the size of an orange. Hard and painful.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Tenderness, warmth and redness at site of immunization. Becoming more red and painful. Began as the size of a quarter and today it's the size of an orange. Hard and painful.
Age: 3.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Crying, Cyanosis, Eye movement disorder, Injection site erythema
Clinical narrative: Seizure. Was fussy during the day yesterday. Woke up crying at night. Eyes rolling back, nose and lips turned blue, stiff, no shaking, lasted 2 min, groggy afterwards. Also has some redness/ warmth to left thigh. No fever, but temp 99.9 tymp at 230 am- got some TYLENOL. In ambulance temp was 100.7 rectal. Left leg is a little red and does not want it touched. Tolerating feeds well today. No emesis. Is a good mood. No fever today.
Age: 3.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site warmth, Irritability, Musculoskeletal stiffness, Seizure
Clinical narrative: Seizure. Was fussy during the day yesterday. Woke up crying at night. Eyes rolling back, nose and lips turned blue, stiff, no shaking, lasted 2 min, groggy afterwards. Also has some redness/ warmth to left thigh. No fever, but temp 99.9 tymp at 230 am- got some TYLENOL. In ambulance temp was 100.7 rectal. Left leg is a little red and does not want it touched. Tolerating feeds well today. No emesis. Is a good mood. No fever today.
Age: 3.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Somnolence
Clinical narrative: Seizure. Was fussy during the day yesterday. Woke up crying at night. Eyes rolling back, nose and lips turned blue, stiff, no shaking, lasted 2 min, groggy afterwards. Also has some redness/ warmth to left thigh. No fever, but temp 99.9 tymp at 230 am- got some TYLENOL. In ambulance temp was 100.7 rectal. Left leg is a little red and does not want it touched. Tolerating feeds well today. No emesis. Is a good mood. No fever today.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted for less than a minute while sitting.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Injected limb mobility decreased, Injection site warmth, Pain in extremity
Clinical narrative: At approximately 9:40 AM on Thursday, October 20th, I received a call from patient that she had experienced pain after the injection. She said she had pain since the injection. She had stated she could not move her arm because it was sore and she could not lift anything with the arm that received the injection. She also complained of stomach upset she felt was associated from her arm pain. The patient had been taking her pain medicine as prescribed from her pain doctor. I asked if she had a fever and she said no. I asked if her arm was swollen or felt warm to the touch at the injection site. She stated it was warm at the injection site. I instructed her to place ice on the arm for 20 minutes each hour and to continue her pain medicine (oxycodone/acetaminophen 5-325 mg). She had an appointment with Dr. at 12:15PM on 10/21/16 for her pain medication and the patient inquired about her arm pain. The patient stated her arm was observed and Dr. did not see the necessity for further treatment. At 2:30PM, patient contacted me and she seemed to have improved from the morning. She explained the interaction with Dr. and that their office had recommended to alternate heat and ice therapy. She could move her arm but it was still sore. I explained that the soreness is a common effect from the vaccination and I will continue to contact her until the issue is resolved fully.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Headache, Immediate post-injection reaction, Injection site pruritus, Injection site rash
Clinical narrative: Burning of left arm and itching at time of vaccine administration. Severe HA developed on 10/16/16. Widespread rash on bilateral upper arms with warmth and itching. No MD or ED visit required. Employee planned on taking BENADRYL.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth, Pruritus, Rash, Skin warm
Clinical narrative: Burning of left arm and itching at time of vaccine administration. Severe HA developed on 10/16/16. Widespread rash on bilateral upper arms with warmth and itching. No MD or ED visit required. Employee planned on taking BENADRYL.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site is swollen, itchy, and numb to touch.
Age: 65.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site pain, Rash
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck (Manufacturer control number 00211732). A contactable female consumer reported for herself. This female patient of unknown age and race received PREVNAR 13 for immunization on unknown date in Sep2016 at single dose. The patient experienced injection site pain and a rash on her arm. The patient was being treated with unspecified antibiotics. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Blood test normal, Culture, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck (Manufacturer control number 00211732). A contactable female consumer reported for herself. This female patient of unknown age and race received PREVNAR 13 for immunization on unknown date in Sep2016 at single dose. The patient experienced injection site pain and a rash on her arm. The patient was being treated with unspecified antibiotics. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck (Manufacturer control number 00211732). A contactable female consumer reported for herself. This female patient of unknown age and race received PREVNAR 13 for immunization on unknown date in Sep2016 at single dose. The patient experienced injection site pain and a rash on her arm. The patient was being treated with unspecified antibiotics. The outcome of the events was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case was linked with cases 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851, 2016SA191730, 2016SA191735, 2016SA191739, 2016SA191741, 2016SA191743 (Same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Flu shot (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified day of 1965. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient got sick. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoacusis, Musculoskeletal pain, Neck pain, Pain in jaw
Clinical narrative: Vaccine administration site was left deltoid.  Patient states that later that day she experienced pain radiating up left side of neck and to left TMJ. Also felt that her hearing in her left ear was temporarily muffled.  These symptoms resolved completely by the time she returned to the Employee Health clinic on 10/21/16. Now states the only lingering effect is some pain under left shoulder blade.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Gastrointestinal motility disorder, Nerve injury
Clinical narrative: Nerve damage to colon.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Lip pruritus, Lip swelling, Nasal pruritus
Clinical narrative: Swelling and itching in upper lip and inside nose. Still swelled on each side of nose at 8:00 AM on 10/21/2016.
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Axillary pain, Blood culture, Cough, Diarrhoea
Clinical narrative: Patient is a 23 year old female presents complaining of right arm pain, fever. Patient states 6 days ago had Pneumovax shot right arm. States 5 days ago started to have pain right arm and difficulty moving arm because of pain. States now able to move the arm but pain has spread to right axilla. + fever 101.8 last night. Denies headache, cough, rhinorrhea, sore throat, vomiting, diarrhea, numbness, weakness + nausea. Denies abdominal pain. No dysuria. No rash.
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Full blood count, Headache, Hypoaesthesia, Laboratory test, Liver function test
Clinical narrative: Patient is a 23 year old female presents complaining of right arm pain, fever. Patient states 6 days ago had Pneumovax shot right arm. States 5 days ago started to have pain right arm and difficulty moving arm because of pain. States now able to move the arm but pain has spread to right axilla. + fever 101.8 last night. Denies headache, cough, rhinorrhea, sore throat, vomiting, diarrhea, numbness, weakness + nausea. Denies abdominal pain. No dysuria. No rash.
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Patient is a 23 year old female presents complaining of right arm pain, fever. Patient states 6 days ago had Pneumovax shot right arm. States 5 days ago started to have pain right arm and difficulty moving arm because of pain. States now able to move the arm but pain has spread to right axilla. + fever 101.8 last night. Denies headache, cough, rhinorrhea, sore throat, vomiting, diarrhea, numbness, weakness + nausea. Denies abdominal pain. No dysuria. No rash.
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: Patient is a 23 year old female presents complaining of right arm pain, fever. Patient states 6 days ago had Pneumovax shot right arm. States 5 days ago started to have pain right arm and difficulty moving arm because of pain. States now able to move the arm but pain has spread to right axilla. + fever 101.8 last night. Denies headache, cough, rhinorrhea, sore throat, vomiting, diarrhea, numbness, weakness + nausea. Denies abdominal pain. No dysuria. No rash.
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood culture negative, Body temperature increased, Full blood count, Laboratory test, Lumbar puncture
Clinical narrative: Patient is a 23 year old female presents complaining of right arm pain, fever. Patient states 6 days ago had Pneumovax shot right arm. States 5 days ago started to have pain right arm and difficulty moving arm because of pain. States now able to move the arm but pain has spread to right axilla. + fever 101.8 last night. Denies headache, cough, rhinorrhea, sore throat, vomiting, diarrhea, numbness, weakness + nausea. Denies abdominal pain. No dysuria. No rash.
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient is a 23 year old female presents complaining of right arm pain, fever. Patient states 6 days ago had Pneumovax shot right arm. States 5 days ago started to have pain right arm and difficulty moving arm because of pain. States now able to move the arm but pain has spread to right axilla. + fever 101.8 last night. Denies headache, cough, rhinorrhea, sore throat, vomiting, diarrhea, numbness, weakness + nausea. Denies abdominal pain. No dysuria. No rash.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Lip swelling, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: This was a free flu shot from work... I have had them before at least 3 times. Never had a reaction that I am aware of. I have a cough but no fever or other issues. I am taking MUCINEX DM 1200mg every 12 hours for few days. I have used it before many times and never saw hives or anything from it. Also the hives etc come on almost at the 12 hour mark of using the MUCINEX but I didn't take it during the events just to be sure it wasn't associated. The only thing I can attribute these oddities to was the flu shot I received. I have no explanation otherwise. Hives across entire back very itchy felt like mosquito bites. 12 hours after the shot. Took BENADRYL and they went away. (Almost never get hives ever). 10/20/2016 7:pm 36 hours after shot Upper lip swelled up for no reason and had two hives on lower external eyelids. Went away in an hour or so. 10/21/2016 40 some hours after shot. 230am woke up restless and arms were itching and hands tingling arms and hands felt puffy. Web between fingers was red and itchy subsided on its own. I am not a hypochondriac I almost never go to Dr. I just thought maybe I should report this in case anyone else had these types of side effects. I feel ok just odd things happening nothing that I would consider worrisome or prolonged. The lot for my shot is below if it has anything to do with these oddities: Lot# 9N2x7 EXP. 2017 APR GlaxoSmithKline VIS 8/7/2015.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Restlessness, Urticaria
Clinical narrative: This was a free flu shot from work... I have had them before at least 3 times. Never had a reaction that I am aware of. I have a cough but no fever or other issues. I am taking MUCINEX DM 1200mg every 12 hours for few days. I have used it before many times and never saw hives or anything from it. Also the hives etc come on almost at the 12 hour mark of using the MUCINEX but I didn't take it during the events just to be sure it wasn't associated. The only thing I can attribute these oddities to was the flu shot I received. I have no explanation otherwise. Hives across entire back very itchy felt like mosquito bites. 12 hours after the shot. Took BENADRYL and they went away. (Almost never get hives ever). 10/20/2016 7:pm 36 hours after shot Upper lip swelled up for no reason and had two hives on lower external eyelids. Went away in an hour or so. 10/21/2016 40 some hours after shot. 230am woke up restless and arms were itching and hands tingling arms and hands felt puffy. Web between fingers was red and itchy subsided on its own. I am not a hypochondriac I almost never go to Dr. I just thought maybe I should report this in case anyone else had these types of side effects. I feel ok just odd things happening nothing that I would consider worrisome or prolonged. The lot for my shot is below if it has anything to do with these oddities: Lot# 9N2x7 EXP. 2017 APR GlaxoSmithKline VIS 8/7/2015.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site rash, Pain, Tenderness, Urticaria
Clinical narrative: Hive like rash on upper extremity where injection was received, severe soreness and tenderness.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Mobility decreased, Muscular weakness, Musculoskeletal pain, Neck pain
Clinical narrative: Thursday evening 10/06/206 complaints of feeling weakness in arm and shoulder followed by extreme pain in arm shoulder and neck. Upper left arm was extremely Red swollen and hot to the touch under injection site about 6 to 7 inch diameter. 10/07/2016 Unable to move his arm on his own. 2 1/2 wks before complete complaints ended and regular none pained movement returned.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Thursday evening 10/06/206 complaints of feeling weakness in arm and shoulder followed by extreme pain in arm shoulder and neck. Upper left arm was extremely Red swollen and hot to the touch under injection site about 6 to 7 inch diameter. 10/07/2016 Unable to move his arm on his own. 2 1/2 wks before complete complaints ended and regular none pained movement returned.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Neck pain, Pain, Tongue discomfort
Clinical narrative: Headache/ neck ache, dizziness, achiness, burning feeling on her tongue as if she burned it with a hot liquid.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Areflexia, Axonal neuropathy, CSF test normal, Death, Electromyogram abnormal
Clinical narrative: This is a 92 y.o., male a 92 year  old male with past medical history of hypothyroidism, HTN, HLD, IBC, vitamin D deficiency, and anemia who presented with a complaint of progressive weakness in all four extremities x 2 days prior to presentation. Given concurrent absence of reflexes and progressive extremity weakness S/P recent immunization (flu shot), a 5 day course of IVIG was started and completed for a presumptive diagnosis of AIDP. As part of his evaluation, EMG/NC was remarkable for sensorimotor peripheral neuropathy with axonal an demyelinating features. No temporal dispersion or conduction block at this time, per report. A Lumbar puncture was obtained. CSF studies was not consistent with an infection so far, his HSV was also negative. The lumbar puncture was a difficult and traumatic tap with limited CSF fluid collected. We monitored his respiratory parameters with PVC/NIF Q2hrs. On 8/18/16, his respiratory status declined requiring HFNC 100% FIO2. Given that the family had requested he be intubated if needed on a temporary basis on admission despite a Postform stating otherwise, he was transferred to the ICU. However family eventually decided that the patient would not want to be intubated/trached or PEG placed. Supportive Care was consulted to facilitate the family discussion. Following a family meeting, "they agree with the option of weaning from HFNC while keeping pt comfortable with morphine." Early morning, on 10/20/16, the on call neurology resident was paged that the "patient does not have any spontaneous respirations." He was subsequently pronounced dead at 0250 on 10/20/2016.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Herpes simplex test negative, Immunoglobulin therapy, Intensive care, Muscular weakness
Clinical narrative: This is a 92 y.o., male a 92 year  old male with past medical history of hypothyroidism, HTN, HLD, IBC, vitamin D deficiency, and anemia who presented with a complaint of progressive weakness in all four extremities x 2 days prior to presentation. Given concurrent absence of reflexes and progressive extremity weakness S/P recent immunization (flu shot), a 5 day course of IVIG was started and completed for a presumptive diagnosis of AIDP. As part of his evaluation, EMG/NC was remarkable for sensorimotor peripheral neuropathy with axonal an demyelinating features. No temporal dispersion or conduction block at this time, per report. A Lumbar puncture was obtained. CSF studies was not consistent with an infection so far, his HSV was also negative. The lumbar puncture was a difficult and traumatic tap with limited CSF fluid collected. We monitored his respiratory parameters with PVC/NIF Q2hrs. On 8/18/16, his respiratory status declined requiring HFNC 100% FIO2. Given that the family had requested he be intubated if needed on a temporary basis on admission despite a Postform stating otherwise, he was transferred to the ICU. However family eventually decided that the patient would not want to be intubated/trached or PEG placed. Supportive Care was consulted to facilitate the family discussion. Following a family meeting, "they agree with the option of weaning from HFNC while keeping pt comfortable with morphine." Early morning, on 10/20/16, the on call neurology resident was paged that the "patient does not have any spontaneous respirations." He was subsequently pronounced dead at 0250 on 10/20/2016.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve conduction studies abnormal, Peripheral sensorimotor neuropathy, Respiratory rate decreased
Clinical narrative: This is a 92 y.o., male a 92 year  old male with past medical history of hypothyroidism, HTN, HLD, IBC, vitamin D deficiency, and anemia who presented with a complaint of progressive weakness in all four extremities x 2 days prior to presentation. Given concurrent absence of reflexes and progressive extremity weakness S/P recent immunization (flu shot), a 5 day course of IVIG was started and completed for a presumptive diagnosis of AIDP. As part of his evaluation, EMG/NC was remarkable for sensorimotor peripheral neuropathy with axonal an demyelinating features. No temporal dispersion or conduction block at this time, per report. A Lumbar puncture was obtained. CSF studies was not consistent with an infection so far, his HSV was also negative. The lumbar puncture was a difficult and traumatic tap with limited CSF fluid collected. We monitored his respiratory parameters with PVC/NIF Q2hrs. On 8/18/16, his respiratory status declined requiring HFNC 100% FIO2. Given that the family had requested he be intubated if needed on a temporary basis on admission despite a Postform stating otherwise, he was transferred to the ICU. However family eventually decided that the patient would not want to be intubated/trached or PEG placed. Supportive Care was consulted to facilitate the family discussion. Following a family meeting, "they agree with the option of weaning from HFNC while keeping pt comfortable with morphine." Early morning, on 10/20/16, the on call neurology resident was paged that the "patient does not have any spontaneous respirations." He was subsequently pronounced dead at 0250 on 10/20/2016.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states she has had severe arm pain and loss of mobility for a week after receiving FLUZONE HD and PREVNAR 13. She called on 10/21/16 stating she still had arm pain. She has not seen a doctor as of 10/21/16, I encouraged her to do so.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: She had needle prick pain then on 10/19 then it was better the next day until she did an intense yoga class and felt the pain in her arm. She it may be workout related but it not sure.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pyrexia, Sensory loss
Clinical narrative: High Fever 101; loss of feeling in left hand, pounding headache.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Autism, Pyrexia, Rash
Clinical narrative: Rashes on his body, fever we visit the doctor every week after.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Patient said that her arm was black and blue. Also red and swollen. Said that swelling is going down, but it hurts when she touches her arm.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a female patient who received FLUARIX QUADRIVALENT. In October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and hives. On an unknown date, the outcome of the anaphylactic reaction and hives were unknown. The reporter considered the anaphylactic reaction and hives to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not provided. The sales representative had limited details to share. The nurse stated that one of the patients received FLUARIX QUADRIVALENT on 7th October 2016 and the other patient received FLUARIX QUADRIVALENT vaccine the week before reporting date. One of the patient experienced the events two days after vaccination, but unknown which of the two patients. Also, one patient went to the emergency room, but it was unknown which of the two patients. No further information was provided. This case was linked to case US2016150173, reported by the same reporter.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Peripheral swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a female patient who received FLUARIX QUADRIVALENT. In October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and hand swelling. In October 2016, the outcome of the anaphylactic reaction and hand swelling were recovered/resolved. The reporter considered the anaphylactic reaction and hand swelling to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not provided. The sales representative had limited details to share. The nurse stated that one of the patients received FLUARIX QUADRIVALENT on 7th October 2016 and the other patient received FLUARIX QUADRIVALENT the week before reporting date. One of the patient experienced the events two days after vaccination, but unknown which of the two patients. Also, one patient went to the emergency room, but it was unknown which of the two patients. No further information was provided. This case was linked to case US2016150175, reported by the same reporter.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a female patient who received FLUARIX QUADRIVALENT. In October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and hand swelling. In October 2016, the outcome of the anaphylactic reaction and hand swelling were recovered/resolved. The reporter considered the anaphylactic reaction and hand swelling to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not provided. The sales representative had limited details to share. The nurse stated that one of the patients received FLUARIX QUADRIVALENT on 7th October 2016 and the other patient received FLUARIX QUADRIVALENT the week before reporting date. One of the patient experienced the events two days after vaccination, but unknown which of the two patients. Also, one patient went to the emergency room, but it was unknown which of the two patients. No further information was provided. This case was linked to case US2016150175, reported by the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: A nurse administered a hepatitis b vaccine to a newborn and charted it in the EMR. The next day, another nurse was told that the baby still needed the vaccine. She pulled the medication from the automated dispensing machine and went to the bedside to administer the dose. She scanned the medication into the EMR. The EMR did not alert her that it has already been given the previous day and allowed her to continue with the administration. The newborn was given the vaccine 2 days in a row. **Upon further investigation, an appropriate box in the EMR was not given a value which would have made the med fall off the administration record once the med was given.** Age of patient at the time of event: 2 days.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Band neutrophil count increased, Blood culture negative, Discomfort, Emotional distress
Clinical narrative: Information has been received from a physician referring to a 35 year old female patient. The patient had a history of smoking and no drug reactions/allergies. The patient's concurrent conditions included overweight, attention deficit/hyperactivity disorder, genital herpes, acne and mild eczema. Concomitant therapies included ADDERALL, valacyclovir hydrochloride, spironolactone, piroxicam and hydrocortisone (manufacturer unknown). On 12-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (intramuscular, lot # was reported as M033080; dose and expiration date were unknown) (patient requested the vaccine). The physician stated later in the day on 13-OCT-2016, the patient developed a large, red, warm, tender spot at the injection site that was 3 by 4 inches and a 101.3 Fahrenheit degree fever. She had achy joints in her hip and rib cage and was in mild to moderate distress and she just wasn't comfortable. The physician stated the patient took ibuprofen at home on 13-OCT-2016 as treatment however it didn't really help. The physician stated the patient was seen on 14-OCT-2016 and had a full blood count (CBC) and Comprehensive Metabolic Panel (CMP) performed which showed her white count was 29700 (unit unknown), neutrophils were 21000 (unit unknown), bands were 3861 (unit unknown), metamyelocytes were 891 (unit unknown) and her monocytes were 2376 (unit unknown). The physician stated they gave the patient TYLENOL and intravenous (IV) fluids as treatment on 14-OCT-2016. The physician stated the patient was seen in the office on 15-OCT-2016 for re-evaluation and had another CBC and CMP performed which showed her white count was 27000 (unit unknown) and her neutrophils were 24000 (unit unknown). The patient also had blood cultures grown on 14-OCT-2016 and 15-OCT-2016 which showed no growth. The physician stated the patient was admitted to the hospital on 15-OCT-2016 due to her symptoms. The physician stated "the hospital gave her a preliminary diagnosis of cellulitis but she did not have cellulitis, she had a reaction to the PNEUMOVAX 23". The physician stated the patient was still in the hospital. The outcome of the events was unknown. The physician considered the events to be significant disability as the patient could not do routine work. Upon internal review, cellulitis was considered to be medically significant. Lot number M033080 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Metabolic function test, Metamyelocyte count
Clinical narrative: Information has been received from a physician referring to a 35 year old female patient. The patient had a history of smoking and no drug reactions/allergies. The patient's concurrent conditions included overweight, attention deficit/hyperactivity disorder, genital herpes, acne and mild eczema. Concomitant therapies included ADDERALL, valacyclovir hydrochloride, spironolactone, piroxicam and hydrocortisone (manufacturer unknown). On 12-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (intramuscular, lot # was reported as M033080; dose and expiration date were unknown) (patient requested the vaccine). The physician stated later in the day on 13-OCT-2016, the patient developed a large, red, warm, tender spot at the injection site that was 3 by 4 inches and a 101.3 Fahrenheit degree fever. She had achy joints in her hip and rib cage and was in mild to moderate distress and she just wasn't comfortable. The physician stated the patient took ibuprofen at home on 13-OCT-2016 as treatment however it didn't really help. The physician stated the patient was seen on 14-OCT-2016 and had a full blood count (CBC) and Comprehensive Metabolic Panel (CMP) performed which showed her white count was 29700 (unit unknown), neutrophils were 21000 (unit unknown), bands were 3861 (unit unknown), metamyelocytes were 891 (unit unknown) and her monocytes were 2376 (unit unknown). The physician stated they gave the patient TYLENOL and intravenous (IV) fluids as treatment on 14-OCT-2016. The physician stated the patient was seen in the office on 15-OCT-2016 for re-evaluation and had another CBC and CMP performed which showed her white count was 27000 (unit unknown) and her neutrophils were 24000 (unit unknown). The patient also had blood cultures grown on 14-OCT-2016 and 15-OCT-2016 which showed no growth. The physician stated the patient was admitted to the hospital on 15-OCT-2016 due to her symptoms. The physician stated "the hospital gave her a preliminary diagnosis of cellulitis but she did not have cellulitis, she had a reaction to the PNEUMOVAX 23". The physician stated the patient was still in the hospital. The outcome of the events was unknown. The physician considered the events to be significant disability as the patient could not do routine work. Upon internal review, cellulitis was considered to be medically significant. Lot number M033080 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Monocyte count increased, Musculoskeletal chest pain, Neutrophil count increased, Pyrexia, Vaccination complication
Clinical narrative: Information has been received from a physician referring to a 35 year old female patient. The patient had a history of smoking and no drug reactions/allergies. The patient's concurrent conditions included overweight, attention deficit/hyperactivity disorder, genital herpes, acne and mild eczema. Concomitant therapies included ADDERALL, valacyclovir hydrochloride, spironolactone, piroxicam and hydrocortisone (manufacturer unknown). On 12-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (intramuscular, lot # was reported as M033080; dose and expiration date were unknown) (patient requested the vaccine). The physician stated later in the day on 13-OCT-2016, the patient developed a large, red, warm, tender spot at the injection site that was 3 by 4 inches and a 101.3 Fahrenheit degree fever. She had achy joints in her hip and rib cage and was in mild to moderate distress and she just wasn't comfortable. The physician stated the patient took ibuprofen at home on 13-OCT-2016 as treatment however it didn't really help. The physician stated the patient was seen on 14-OCT-2016 and had a full blood count (CBC) and Comprehensive Metabolic Panel (CMP) performed which showed her white count was 29700 (unit unknown), neutrophils were 21000 (unit unknown), bands were 3861 (unit unknown), metamyelocytes were 891 (unit unknown) and her monocytes were 2376 (unit unknown). The physician stated they gave the patient TYLENOL and intravenous (IV) fluids as treatment on 14-OCT-2016. The physician stated the patient was seen in the office on 15-OCT-2016 for re-evaluation and had another CBC and CMP performed which showed her white count was 27000 (unit unknown) and her neutrophils were 24000 (unit unknown). The patient also had blood cultures grown on 14-OCT-2016 and 15-OCT-2016 which showed no growth. The physician stated the patient was admitted to the hospital on 15-OCT-2016 due to her symptoms. The physician stated "the hospital gave her a preliminary diagnosis of cellulitis but she did not have cellulitis, she had a reaction to the PNEUMOVAX 23". The physician stated the patient was still in the hospital. The outcome of the events was unknown. The physician considered the events to be significant disability as the patient could not do routine work. Upon internal review, cellulitis was considered to be medically significant. Lot number M033080 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician referring to a 35 year old female patient. The patient had a history of smoking and no drug reactions/allergies. The patient's concurrent conditions included overweight, attention deficit/hyperactivity disorder, genital herpes, acne and mild eczema. Concomitant therapies included ADDERALL, valacyclovir hydrochloride, spironolactone, piroxicam and hydrocortisone (manufacturer unknown). On 12-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (intramuscular, lot # was reported as M033080; dose and expiration date were unknown) (patient requested the vaccine). The physician stated later in the day on 13-OCT-2016, the patient developed a large, red, warm, tender spot at the injection site that was 3 by 4 inches and a 101.3 Fahrenheit degree fever. She had achy joints in her hip and rib cage and was in mild to moderate distress and she just wasn't comfortable. The physician stated the patient took ibuprofen at home on 13-OCT-2016 as treatment however it didn't really help. The physician stated the patient was seen on 14-OCT-2016 and had a full blood count (CBC) and Comprehensive Metabolic Panel (CMP) performed which showed her white count was 29700 (unit unknown), neutrophils were 21000 (unit unknown), bands were 3861 (unit unknown), metamyelocytes were 891 (unit unknown) and her monocytes were 2376 (unit unknown). The physician stated they gave the patient TYLENOL and intravenous (IV) fluids as treatment on 14-OCT-2016. The physician stated the patient was seen in the office on 15-OCT-2016 for re-evaluation and had another CBC and CMP performed which showed her white count was 27000 (unit unknown) and her neutrophils were 24000 (unit unknown). The patient also had blood cultures grown on 14-OCT-2016 and 15-OCT-2016 which showed no growth. The physician stated the patient was admitted to the hospital on 15-OCT-2016 due to her symptoms. The physician stated "the hospital gave her a preliminary diagnosis of cellulitis but she did not have cellulitis, she had a reaction to the PNEUMOVAX 23". The physician stated the patient was still in the hospital. The outcome of the events was unknown. The physician considered the events to be significant disability as the patient could not do routine work. Upon internal review, cellulitis was considered to be medically significant. Lot number M033080 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Autoimmune disorder, Measles antibody negative
Clinical narrative: Information has been received from a physician referring to a 47 years old female patient. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date as a child, the patient was vaccinated with M-M-R II series (strength, dose, frequency, route, lot # and expiration date were unspecified). On an unknown date, the patient had unspecified titers drawn for school and the results for measles came back as low. The patient had an unspecified autoimmune disease that was diagnosed on an unspecified date. The causal relationship between M-M-R II and the events was unknown. Upon internal review, autoimmune disease was determined to be medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Injection site erythema, Oedema peripheral, Vaccination site induration
Clinical narrative: Large amount of armpit swelling, redness and induration at site of vaccine.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt states that about an hour after vaccine their arm was in pain. Pain has not gotten worse, but has remained the same today. Pain is minimal when still, but more painful when moving. Pt is traveling and cannot come back in, told to put ice and take an antiinflammatory, and will seek medical attention if it gets worse.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt was given the PREVNAR vaccine on Oct 14th, and she developed a patch of redness on her arm below the area where the PREVNAR vaccine was given. She has had the patch of redness for the last 3 days (18th, 19th, and 20th). She also said that she has red itchy bumps on the trunk of her body. Pt said she was not sure if the itchy bumps were from the vaccine or if they were from working out in the yard & being around bugs. I recommended she call her physician and let them know about the reaction and also suggested she try hydrocortisone cream for the itchy bumps.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Joint stiffness, Pain
Clinical narrative: Severe pain in left elbow joing about 6 inches below injection sight, elbow became sore and very painful to move. Administered naproxen sodium which did little to aleviate pain and stiffness which lasted approx. 24 hours.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Dyspnoea, Exposure during pregnancy, Malaise, Tonic clonic movements
Clinical narrative: Approximately 15 mins after administration of Tdap patient placed on  monitor for NST. Within minutes of reclining on NST chair pt became unresponsive after stating that she did not feel well, pulse noted to 140. Tonic movements of arms noted.  Oxygen mask, Pulse oximeter 100%, smelling salt given.  FHR initially 140 with accels to 160 then down to 90 - 100 X 2 mins during episode. EMS called. Episode lasted total @ 10 mins. Pt noted that she felt Chest pain and difficulty breathing immediately prior to episode and some residual chest after syncopal episode. BP 111/71   P 80    Prior to being transported by EMS to ED.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Approximately 15 mins after administration of Tdap patient placed on  monitor for NST. Within minutes of reclining on NST chair pt became unresponsive after stating that she did not feel well, pulse noted to 140. Tonic movements of arms noted.  Oxygen mask, Pulse oximeter 100%, smelling salt given.  FHR initially 140 with accels to 160 then down to 90 - 100 X 2 mins during episode. EMS called. Episode lasted total @ 10 mins. Pt noted that she felt Chest pain and difficulty breathing immediately prior to episode and some residual chest after syncopal episode. BP 111/71   P 80    Prior to being transported by EMS to ED.
Age: 16.0
Sex: M
Vaccine: HPVX
Symptoms: Abdominal pain, Complement factor C3 decreased, Haematuria, Henoch-Schonlein purpura, Hypersensitivity vasculitis
Clinical narrative: Onset of rash consistent w leukoclastic vasculitis followed by belly pain, hematuria and diagnosis of HSP.
Age: 16.0
Sex: M
Vaccine: HPVX
Symptoms: Purpura, Rash
Clinical narrative: Onset of rash consistent w leukoclastic vasculitis followed by belly pain, hematuria and diagnosis of HSP.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient has raised red area at site of administration, states it hurts and itches, not sure of exactly what time it started, but sometime today 10/21/16.
Age: 48.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site pain
Clinical narrative: Patient called in 10/17/2016 reporting concerns with pain at injection site. Offered Office Visit.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure, Systemic lupus erythematosus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus in a 69-year-old female patient who received Flu Seasonal TIV Dresden. In October 2016, the patient received Influenza. In October 2016, less than a month after receiving influenza vaccine  unspecified, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant) and seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the systemic lupus erythematosus and seizure were unknown. It was unknown if the reporter considered the systemic lupus erythematosus and seizure to be related to influenza vaccine unspecified. Additional details were provided as follows: This case was reported by the patient's friend. the age at vaccination was not reported. the reporter contacted GlaxoSmithKline's (GSK) lupus line to discuss what was lupus and while in conversation, he reported that his friend had an influenza shot recently (unknown date) and experienced seizures and was diagnosed as having lupus. The reporter provided limited information.