chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Skin warm
Clinical narrative: Case number PHHY2015US018594, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551544) website on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 352397) on 17 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 352397) on 17 Mar 2015. This report refers to a 11-year-old male patient. It was reported that as per his mother the patient had no medical history and did not receive any concomitant medications. On 07 Oct 2014, he was vaccinated with MENVEO (batch number: M14021 and expiry date: Jul 2015) intramuscularly in the left arm along with FLUMIST QUADRIVALENT (other manufacturer, batch number: CH2063) intranasally and GARDASIL (other manufacturer, batch number: J010668) intramuscularly in the left arm. On the same date, after vaccination he experienced redness, rash, warm area which was hard to touch. His mother applied ice pack and gave BENADRYL prior to bed. On 08 Oct 2014, his mother noticed 3 inches of left arm swelling, above elbow to shoulder at site of injections. On 09 Oct 2014, his redness, hard to touch and warmth remained same, but his rash was spreading. The patient was taken to emergency care on the same date and he was diagnosed with cellulitis. He received KEFLEX and stated that if he did not recover in 2 days, he was recommended to be taken to the emergency room for intravenous antibiotics. The final outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported. Seriousness assessment of the events (cellulitis and its symptoms) was upgraded based on the available information in the source document. Based on the investigation performed, the QA department stated that, MENVEO (batch number: M14021) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 352397) on 17 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 352397) on 17 Mar 2015: Updated MENVEO batch review report.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Swelling face
Clinical narrative: Case number PHHY2015US032681, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555265) website on 16 Mar 2015. This report refers to a 57 year old female patient. Historical drugs included sulfa, fluoroquinolone antibiotics, LORTAB, morphine and zithromycin. Concomitant medications included VESICARE, VAGIFEM and PRILOSEC. On 21 Nov 2014, she was vaccinated with FLUVIRIN (batch number: 145304) into left arm via intramuscular route. On same day, after vaccination she felt her face was tingly and a bit numb. Further the patient's face felt puffy, but it was not visually puffy. The outcome of the events reported as complete recovery. The reporter assessed the seriousness as non-serious. The causality was not reported. Seriousness assessment of events facial swelling, numbness facial and tingling was upgraded based on information available in the source document.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: Severe "Open Wound" like feeling on full right side of body above knees with very strong "sore" like feeling near collar bone. Severe Chills and shaking with that, fever that reached 102.  General unable to work or do much without multiple med routine of Advil Tylenol.   I had just started a pill of 2.5 mg of Crestor same day, take 112 mg of Synthroid, Zyrtec, and two baby aspirin daily.  Generally healthy professional.   Not overweight.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Intervertebral disc protrusion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old male patient. The patient's medical history included depression and on an unknown date in February 2015 the patient had a foot injury due to fall. No drug allergies were reported. On 11-MAR-2015, the patient was vaccinated with ZOSTAVAX subcutaneously (lot number and expiry date was unknown) (dosing regimen and frequency was unknown). It was reported that the patient was taking concomitant medications (details unspecified). On 13-MAR-2015, the patient visited an unspecified spinal specialist due to fall he had in February 2015 and the spinal specialist diagnosed the patient as having bulging discs (disability) in his back due to the fall the patient had in February 2015. It was reported that the even tcaused the patient significant disability or incapacity and the patient had been out of wrok since February 2015. It was reported that the patient sought medical attention and visited a spinal specialist. The spinal specialist prescribed the patient an unspecified dose of an unspecified corticosteroid. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the event was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Electroencephalogram, Laboratory test, Seizure
Clinical narrative: This spontaneous report was received from a nurse refers to a 13 year old female patient (daughter of the reporter). The patient's pertinent medical history included overweight, the nurse stated that her daughter has always been overweight so the patient did not develop it after M-M-R II. There was no drug reaction or allergies reported. On an unknown date approximately in 1994 (also reported as, when the patient was 13 years old), the patient was vaccinated with M-M-R II (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant therapy was reported. On an unknown date approximately in 1994 the patient developed seizures (medically significant). On an unknown the patient underwent an Electroencephalogram (EEG) and unspecified lab test the results of which was unknown. It was reported that the patient sought medical attention. The patient was seen by an unspecified physician and she was placed on therapy with DEPAKOTE due to her seizures. The nurse stated that the DEPAKOTE controlled seizures until the patient went away to college and then the seizures went out of control. The nurse reported that the patient discontinued use of the DEPAKOTE and on an unknown date, she was placed on unspecified seizure medications but it did not help. On an unknown date in 2007, the patient was seen by an unspecified physician and was placed on therapy with DEPAKOTE and LAMICTAL. The nurse reported that the patient has not had any seizures since 2007. The action taken with the therapy with M-M-R II was unknown. The outcome of the event was reported as recovered. The relatedness of the event to the therapy with M-M-R II was unknown. There was no product quality issue reported. Upon internal review the event seizures was considered as medically significant. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Two large red, hot, achy, itchy areas where on RT arm where varicella and Menveo were given. Instructed to use ice or warm compress, Motrin, and Benadryl for itching.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Blindness, Ocular discomfort, Vision blurred
Clinical narrative: Blurring vision loss in both eyes began 24 hours after injectin.  Also c/o pressure in both eyes after several days.  Vision returned and pressure resolved.  Has an occasional "pressure in eyes".
Age: 1.32
Sex: F
Vaccine: DTAP, FLUX, HEPA, MMR
Symptoms: Cytogenetic analysis normal, Electroencephalogram abnormal, Regressive behaviour, Seizure
Clinical narrative: Regression, seizures.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Nurse gave me vaccine too high on arm. Medical facility refuses to tell me the nurses name. Extreme left shoulder pain and loss of range of motion. Scheduled to see orthopedic specialist next week.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Continuous positive airway pressure, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia, Peripheral coldness
Clinical narrative: Immediate tingling in injection site arm. Following day experiences coldness and tingling in lower extremities.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Sleep study abnormal
Clinical narrative: Immediate tingling in injection site arm. Following day experiences coldness and tingling in lower extremities.
Age: 0.54
Sex: F
Vaccine: PPV, RVX, PNC13, RV5
Symptoms: Aspiration, Computerised tomogram head abnormal, Cyanosis, Extra dose administered, Respiratory syncytial virus infection
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of seizure in a 6-month-old female patient who received Rotavirus vaccine. Co-suspect products included pneumococcal vaccine (batch number unknown, expiry date 31st December 2016). The patient's past medical history included pneumonia (A week and a half prior vaccination, the patient had pneumonia but she was fine on 10 Feb 2015). On 10th February 2015, the patient received the 3rd dose of Rotavirus vaccine and the 2nd dose of pneumococcal vaccine. On 10th February 2015, 3 hrs after receiving Rotavirus vaccine, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced aspiration (serious criteria GSK medically significant), respiratory syncytial virus infection, cyanosis and extra dose administered. On an unknown date, the outcome of the seizure, aspiration, cyanosis and extra dose administered were unknown and the outcome of the respiratory syncytial virus infection was not recovered/not resolved. On an unknown date, a CT scan showed something in skull bone but the brain matter looked fine. It was unknown if the reporter considered the seizure, aspiration, respiratory syncytial virus infection and cyanosis to be related to Rotavirus vaccine. Additional information: Three hours following administration of vaccines, the patient had a seizure. At that time, the patient's mother called 911. The patient had another seizure prior to her admission at hospital. While admitted at hospital, the patient had another two seizures. Patient was then transferred to another hospital, where she had another seizure. The patient had a total of 5 seizures over three days and also turned purple. The patient was discharged Friday evening (on 13 February 2015). On 10 March 2015, another pneumococcal vaccine was administered to the patient.
Age: 0.54
Sex: F
Vaccine: PPV, RVX, PNC13, RV5
Symptoms: Seizure, Skin discolouration
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of seizure in a 6-month-old female patient who received Rotavirus vaccine. Co-suspect products included pneumococcal vaccine (batch number unknown, expiry date 31st December 2016). The patient's past medical history included pneumonia (A week and a half prior vaccination, the patient had pneumonia but she was fine on 10 Feb 2015). On 10th February 2015, the patient received the 3rd dose of Rotavirus vaccine and the 2nd dose of pneumococcal vaccine. On 10th February 2015, 3 hrs after receiving Rotavirus vaccine, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced aspiration (serious criteria GSK medically significant), respiratory syncytial virus infection, cyanosis and extra dose administered. On an unknown date, the outcome of the seizure, aspiration, cyanosis and extra dose administered were unknown and the outcome of the respiratory syncytial virus infection was not recovered/not resolved. On an unknown date, a CT scan showed something in skull bone but the brain matter looked fine. It was unknown if the reporter considered the seizure, aspiration, respiratory syncytial virus infection and cyanosis to be related to Rotavirus vaccine. Additional information: Three hours following administration of vaccines, the patient had a seizure. At that time, the patient's mother called 911. The patient had another seizure prior to her admission at hospital. While admitted at hospital, the patient had another two seizures. Patient was then transferred to another hospital, where she had another seizure. The patient had a total of 5 seizures over three days and also turned purple. The patient was discharged Friday evening (on 13 February 2015). On 10 March 2015, another pneumococcal vaccine was administered to the patient.
Age: 0.54
Sex: F
Vaccine: PPV, RVX, PNC13, RV5
Symptoms: Aspiration, Computerised tomogram abnormal, Cyanosis, Electroencephalogram abnormal, Malaise
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of seizure in a 6-month-old female patient who received Rotavirus vaccine. Co-suspect products included pneumococcal vaccine (batch number unknown, expiry date 31st December 2016). The patient's past medical history included pneumonia (A week and a half prior vaccination, the patient had pneumonia but she was fine on 10 Feb 2015). On 10th February 2015, the patient received the 3rd dose of Rotavirus vaccine and the 2nd dose of pneumococcal vaccine. On 10th February 2015, 3 hrs after receiving Rotavirus vaccine, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced aspiration (serious criteria GSK medically significant), respiratory syncytial virus infection, cyanosis and extra dose administered. On an unknown date, the outcome of the seizure, aspiration, cyanosis and extra dose administered were unknown and the outcome of the respiratory syncytial virus infection was not recovered/not resolved. On an unknown date, a CT scan showed something in skull bone but the brain matter looked fine. It was unknown if the reporter considered the seizure, aspiration, respiratory syncytial virus infection and cyanosis to be related to Rotavirus vaccine. Additional information: Three hours following administration of vaccines, the patient had a seizure. At that time, the patient's mother called 911. The patient had another seizure prior to her admission at hospital. While admitted at hospital, the patient had another two seizures. Patient was then transferred to another hospital, where she had another seizure. The patient had a total of 5 seizures over three days and also turned purple. The patient was discharged Friday evening (on 13 February 2015). On 10 March 2015, another pneumococcal vaccine was administered to the patient.
Age: 0.54
Sex: F
Vaccine: PPV, RVX, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging, Petit mal epilepsy, Respiratory syncytial virus infection, Seizure, Ultrasound scan
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of seizure in a 6-month-old female patient who received Rotavirus vaccine. Co-suspect products included pneumococcal vaccine (batch number unknown, expiry date 31st December 2016). The patient's past medical history included pneumonia (A week and a half prior vaccination, the patient had pneumonia but she was fine on 10 Feb 2015). On 10th February 2015, the patient received the 3rd dose of Rotavirus vaccine and the 2nd dose of pneumococcal vaccine. On 10th February 2015, 3 hrs after receiving Rotavirus vaccine, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced aspiration (serious criteria GSK medically significant), respiratory syncytial virus infection, cyanosis and extra dose administered. On an unknown date, the outcome of the seizure, aspiration, cyanosis and extra dose administered were unknown and the outcome of the respiratory syncytial virus infection was not recovered/not resolved. On an unknown date, a CT scan showed something in skull bone but the brain matter looked fine. It was unknown if the reporter considered the seizure, aspiration, respiratory syncytial virus infection and cyanosis to be related to Rotavirus vaccine. Additional information: Three hours following administration of vaccines, the patient had a seizure. At that time, the patient's mother called 911. The patient had another seizure prior to her admission at hospital. While admitted at hospital, the patient had another two seizures. Patient was then transferred to another hospital, where she had another seizure. The patient had a total of 5 seizures over three days and also turned purple. The patient was discharged Friday evening (on 13 February 2015). On 10 March 2015, another pneumococcal vaccine was administered to the patient.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Chest pain, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Case number PHEH2014US026207, is an initial spontaneous report received from a medical assistant on 19 Dec 2014 and with a follow up information received from medical assistant on 05 Feb 2015 and with another follow up received from the medical assistant on 05 Mar 2015. This report refers to 51 years old female patient. Her medical history was not unknown. Her concomitant medications was reported as NASONEX nasal route of administration daily per allergic rhinitis, fish oil at a dose of 1000 units orally and multivitamins orally daily for health. Her vaccination history included administration of ADACEL (other manufacturer, batch number: not reported) on 31 Oct 2006, FLUZONE (other manufacturer, batch number: not reported) on 12 Sep 2011 and FLUMIST (other manufacturer, batch number: not reported) on 27 Nov 2012. She was vaccinated with FLUVIRIN (batch number: 1412901, expiry date: Jun 2015) intramuscularly at a dose of 0.5 ml in left deltoid on 08 Dec 2014. On 09 Dec 2014, she started experienced pain at injection site, pain in neck and chest which was further described as pain ranks at 7 to 8 in scale of 10. She also experienced severe pain in her arm which started the day after her vaccination on 09 Dec 2014. She was treated with NAPROSYN, ALEVE and ibuprofen for pain. She underwent chest X-ray and results showed that there was no problem. Events lasted for 5 weeks. The outcome of the events was reported as complete recovery. The event pain in arm caused persistent or significant disability or incapacity and seriousness of other events was not reported. The causality of the events was not reported. Follow up information received from the medical assistant on 05 Feb 2015: Updated concomitant medications (NASONEX, Fish oil, multivitamins), vaccination history, route, dose and site of vaccination, event onset date, duration and outcome of the events (complete recovery). Follow up information received from the medical assistant on 05 Mar 2015: Updated indication of NASONEX (allergic rhinitis), date of vaccination of ADACEL, new event (pain in arm) and seriousness of the event (disability).
Age: 30.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Feeling hot, Rash generalised
Clinical narrative: Patient was administered HPV vaccine in clinic. Waited an hour for additional examination in clinic. Patient went home and mother reported later that evening approximately > 2 hours since administration, patient broke out in a full body rash and patient felt "hot all over." Mother denied respiratory distress. Rash subsided without medication.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received the influenza vaccine, but had already had the vaccine on 11-5-14.
Age: 14.0
Sex: M
Vaccine: IPV, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction - left deltoid was swollen, red, itchy and warm to the touch. No other symptoms.
Age: 12.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Eye swelling, Gingival swelling
Clinical narrative: Aunt gave patient Advil 400mg at 9am. Eye and gum swelling started around 12:30pm, around 1:30pm aunt gave Benadryl 40mg capsule and eye drops. Swelling on eyes reduced 6pm gum swelling cleared by next day.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint injury, Mobility decreased
Clinical narrative: Initial unsolicited report was received on 09 March 2015 from a consumer from a media report on the Internet. The reporter also reported another event which is captured in case number 2015SA031442. A female patient, age and date of birth not reported was vaccinated on an unreported date with Influenza vaccine, manufacturer, batch, site and route not reported.  On an unreported date she suffered a shoulder injury and "really can't move her arm". The patient reported that she needed surgery to fix the damage to her shoulder. The patient's medical history, concomitant medications and laboratory tests were not reported. The patient outcome is not recovered. No further details were available at the time of this report. Documents held by sender: None.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Joint injury
Clinical narrative: Initial unsolicited report was received on 09 March 2015 from a consumer from a media report on the Internet. The reporter also reported another event which is captured in case number 2015SA031442. A female patient, age and date of birth not reported was vaccinated on an unreported date with Influenza vaccine, manufacturer, batch, site and route not reported.  On an unreported date she suffered a shoulder injury and "really can't move her arm". The patient reported that she needed surgery to fix the damage to her shoulder. The patient's medical history, concomitant medications and laboratory tests were not reported. The patient outcome is not recovered. No further details were available at the time of this report. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Balance disorder, Blood test, Chest pain, Computerised tomogram, Dizziness
Clinical narrative: After we left the Doctor office from getting a physical, took patient to school recieved a call from the school saying she was really shaking, patient also was dizzy, complained at ER that her chest was hurting, and she had a bad headache.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Electroencephalogram, Headache, Muscular weakness, Tremor, Urine analysis
Clinical narrative: After we left the Doctor office from getting a physical, took patient to school recieved a call from the school saying she was really shaking, patient also was dizzy, complained at ER that her chest was hurting, and she had a bad headache.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Blood test, Chest discomfort, Chills, Computerised tomogram, Drug screen
Clinical narrative: After we left the Doctor office from getting a physical, took patient to school recieved a call from the school saying she was really shaking, patient also was dizzy, complained at ER that her chest was hurting, and she had a bad headache.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Dysphemia, Feeling hot, Gait disturbance, Headache, Memory impairment
Clinical narrative: After we left the Doctor office from getting a physical, took patient to school recieved a call from the school saying she was really shaking, patient also was dizzy, complained at ER that her chest was hurting, and she had a bad headache.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Repetitive speech, Tremor, Urine analysis
Clinical narrative: After we left the Doctor office from getting a physical, took patient to school recieved a call from the school saying she was really shaking, patient also was dizzy, complained at ER that her chest was hurting, and she had a bad headache.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Blood test, Chest discomfort, Computerised tomogram, Drug screen, Feeling hot
Clinical narrative: After we left the Doctor office from getting a physical, took patient to school recieved a call from the school saying she was really shaking, patient also was dizzy, complained at ER that her chest was hurting, and she had a bad headache.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash macular
Clinical narrative: Onset of raised blotchy body rash with itching x 30 min.- then disappeared. Asymptomatic since that time.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vaccinated with Tdap in left deltoid. Allergic reaction: swelling of left deltoid (where the vaccination was administered); redness; heat; itchiness. Next day, all adverse reactions spread down to include tricep and bicep. Treatment: ibuprofen and ice packs.
Age: 29.0
Sex: M
Vaccine: HEPA, HEPAB
Symptoms: Bacterial test, Gram stain, Hepatitis B virus test, Hepatitis C virus test, No adverse event
Clinical narrative: No adverse effects were noted or reported.  The client received the prescribed medications and vaccinations, as ordered (Rocephin IM, Zithromax PO, Twinrix IM), with the exception of Menactra.  Instead of the Menactra, the patient received a Hepatitis A vaccine.
Age: 29.0
Sex: M
Vaccine: HEPA, HEPAB
Symptoms: Treponema test, Wrong drug administered
Clinical narrative: No adverse effects were noted or reported.  The client received the prescribed medications and vaccinations, as ordered (Rocephin IM, Zithromax PO, Twinrix IM), with the exception of Menactra.  Instead of the Menactra, the patient received a Hepatitis A vaccine.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Anxiety, Injection site swelling, Injection site warmth, Pruritus, Pyrexia
Clinical narrative: Patient complained of itching; experienced fever of 102 degrees F; left arm swollen and hot; anxiousness.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: Chills, sweats, headache, lightheaded, lethargic.  Given OTC Tylenol and cortisone topical cream.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza virus test negative, Lethargy, Urine analysis normal
Clinical narrative: Chills, sweats, headache, lightheaded, lethargic.  Given OTC Tylenol and cortisone topical cream.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody increased, Biopsy bone, Bone marrow oedema, Culture, Musculoskeletal stiffness
Clinical narrative: C/o arm stiffness since vaccination. Had PT, MRI and bone bx/ culture due to severe bone marrow edema in proximal humerus. Referred to an Arthritis center due to elevated ANA/Homogeneous pattern.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Red blood cell sedimentation rate increased
Clinical narrative: C/o arm stiffness since vaccination. Had PT, MRI and bone bx/ culture due to severe bone marrow edema in proximal humerus. Referred to an Arthritis center due to elevated ANA/Homogeneous pattern.
Age: 33.0
Sex: F
Vaccine: TTOX
Symptoms: Circadian rhythm sleep disorder, Condition aggravated, Gastrointestinal disorder, Hypothyroidism, Impaired gastric emptying
Clinical narrative: All of the symptoms I have for Myalgic Encephelomyelitis got worse right away and never improved from that point, I also got a fever, and within the next couple of years, I developed multiple chemical sensitivities, hypothyroidism, circadian rhythm disorder, various GI issues including gastroparesis, and orthostatic intolerance.
Age: 33.0
Sex: F
Vaccine: TTOX
Symptoms: Multiple chemical sensitivity, Orthostatic intolerance, Post viral fatigue syndrome, Pyrexia
Clinical narrative: All of the symptoms I have for Myalgic Encephelomyelitis got worse right away and never improved from that point, I also got a fever, and within the next couple of years, I developed multiple chemical sensitivities, hypothyroidism, circadian rhythm disorder, various GI issues including gastroparesis, and orthostatic intolerance.
Age: 1.7
Sex: M
Vaccine: DTAP, MMR
Symptoms: Abasia, Aphasia, Asterixis, Crying, Head banging
Clinical narrative: By the evening of having his shots, the child's arm was hugely swollen, bruised at the shot site, hot to the touch. He couldn't stop crying. By evening, had a high fever. Next day, extremely lethargic and afternoon (about 24 hours) after shot developed rash over trunk that spread to rest of body. Called health department to be told that it was probably a viral rash, that it happened sometimes, nothing to worry about and to take him to ER if he started seizing. Otherwise, alternate Motrin and Tylenol.   Took almost a week before child was feeling well again, eating and drinking. He's never been the same though. He stopped walking in favor of scooting, started habits like verbal tics, hand flapping, head banging. Lost ability to verbally communicate (went from being ahead with short sentences to grunts). Now is speech delayed still at almost 7 years old. Seems to have problems processing things, esp language. Basically, got the second MMR and went backwards for a long while. Parents were told "he's working on other skills."   I don't trust them - no one bothered to log in that I had him naturally and the health department was asking how I was recovering from a c-section at his six month check. GA keeps AWFUL records. Now, I'm feeling extreme guilt over what happened and utter terror at the thought of it again.
Age: 1.7
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth, Lethargy, Pyrexia
Clinical narrative: By the evening of having his shots, the child's arm was hugely swollen, bruised at the shot site, hot to the touch. He couldn't stop crying. By evening, had a high fever. Next day, extremely lethargic and afternoon (about 24 hours) after shot developed rash over trunk that spread to rest of body. Called health department to be told that it was probably a viral rash, that it happened sometimes, nothing to worry about and to take him to ER if he started seizing. Otherwise, alternate Motrin and Tylenol.   Took almost a week before child was feeling well again, eating and drinking. He's never been the same though. He stopped walking in favor of scooting, started habits like verbal tics, hand flapping, head banging. Lost ability to verbally communicate (went from being ahead with short sentences to grunts). Now is speech delayed still at almost 7 years old. Seems to have problems processing things, esp language. Basically, got the second MMR and went backwards for a long while. Parents were told "he's working on other skills."   I don't trust them - no one bothered to log in that I had him naturally and the health department was asking how I was recovering from a c-section at his six month check. GA keeps AWFUL records. Now, I'm feeling extreme guilt over what happened and utter terror at the thought of it again.
Age: 1.7
Sex: M
Vaccine: DTAP, MMR
Symptoms: Rash generalised, Speech disorder developmental, Tic, Viral rash
Clinical narrative: By the evening of having his shots, the child's arm was hugely swollen, bruised at the shot site, hot to the touch. He couldn't stop crying. By evening, had a high fever. Next day, extremely lethargic and afternoon (about 24 hours) after shot developed rash over trunk that spread to rest of body. Called health department to be told that it was probably a viral rash, that it happened sometimes, nothing to worry about and to take him to ER if he started seizing. Otherwise, alternate Motrin and Tylenol.   Took almost a week before child was feeling well again, eating and drinking. He's never been the same though. He stopped walking in favor of scooting, started habits like verbal tics, hand flapping, head banging. Lost ability to verbally communicate (went from being ahead with short sentences to grunts). Now is speech delayed still at almost 7 years old. Seems to have problems processing things, esp language. Basically, got the second MMR and went backwards for a long while. Parents were told "he's working on other skills."   I don't trust them - no one bothered to log in that I had him naturally and the health department was asking how I was recovering from a c-section at his six month check. GA keeps AWFUL records. Now, I'm feeling extreme guilt over what happened and utter terror at the thought of it again.
Age: 1.34
Sex: F
Vaccine: FLU4, HIBV, MMR, VARCEL
Symptoms: Injection site rash, Local reaction, Rash generalised, Urticaria, Vaccination complication
Clinical narrative: 3/9/15 developed local reaction (2 small bumps on L thigh). 3/10/15 developed urticarial rash over much of body, lasting 3-4d. No other clear source for urticarial (pt otherwise well, no new foods/meds). She was seen by her allergist who felt this was c/w rxn to vaccines (vaccines given included VZV, Flu, MMR, HIB) & requested a report be made.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Agitation, Decreased appetite, Fatigue, Pain
Clinical narrative: Patient stated that after the vacination, he experienced tireness, body aches and pain, lost of appetite and agitation.  As of 3-19-2015, patient still experiences these symptoms.
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site within 5 minutes of getting vaccines.  After noticing the redness, mother of patient stated that he gets irritated with some types of band aides. We removed the band aides from the sites and had the provider evaluate the swelling.  The patient had no redness or swelling on other parts of the body.  Patient was reevaluated at 2:45 PM after observation and the redness and swelling was improving.  When reevaluated at 3:15 PM the patient did not have any swelling or redness at the site.  Mother was advised of signs of allergic reaction and what actions to take if the patient started having a reaction again.
Age: 0.34
Sex: F
Vaccine: DTPIHI, RVX
Symptoms: Abnormal behaviour, Crying, Lethargy, Musculoskeletal stiffness, Skin discolouration
Clinical narrative: Strange blank staring. We are watching her closely.
Age: 0.34
Sex: F
Vaccine: DTPIHI, RVX
Symptoms: Somnolence, Staring, Syncope
Clinical narrative: Strange blank staring. We are watching her closely.
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Anxiety, Dizziness, Skin discolouration, Tremor
Clinical narrative: At 5:30PM, PHN was called to check on client at place of employment. Client was found in an office with on site paramedics checking her vital signs. Client was shaky and seemed anxious. Her forearms and hands were mottled, and there was no visible swelling. VS 205/127mmHg, 116 BPM, O2 sats >92%. Client denied difficulty to breathe and stated she felt lightheaded. PHN encouraged client to go to the hospital to control her BP. Client was taken by ambulance to nearest hospital at 6PM.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Weight bearing difficulty
Clinical narrative: I have began to have severe pain at the injection site in my left arm. The pain is extended into my elbow. I have tried muscle creams and hot and cold packs. Nothing is working. I can't lift anything more than a few pounds. And I can't extend my arm out completely without severe arm and elbow pain.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: ITCHY RASH IN NECK AND ABDOMEN AND TRUNK, IMPROVED OVER NEXT 2-3 DAYS, ON 3/19/14, FINE PAPULAR RASH ON NECK PRESENT.
Age: 1.03
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Leg swollen, red, bruised, painful.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Paraesthesia
Clinical narrative: Injection site is red, swollen, itching tingling sensation down arm when arm is raised above head. Site has been red and swollen since the afternoon of 03/17/2015 tingling sensation began in evening of 03/18/2015.
Age: 16.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Severe muscle pain and spasms.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Chest X-ray normal, Crying, Emotional distress, Full blood count abnormal, Influenza virus test negative
Clinical narrative: Patient became very fussy during the evening and then continued to cry every 30-45 mins in his sleep every night for the next 5 nights.  During the day, he was fussy and didn't smile, I couldn't put him down.  He was clinging to me, when I did put him down. He just cried and fussed until I picked him back up. He is typically a very good natured baby, he had a double ear infection and never ran a fever a couple months back.... he even ruptured the ear drum and never acted sick. I just happened to notice stuff in his ear and immediately took him to doctors and he was sick.  No clue how long he was that way.  He never cries and always sleeps 12 hrs a night without waking up.  I know something was not right.... took him back to docs on Saturday and CBC showed viral infection.  I asked about this being related to the vaccine. I was told that they had never seen this kind of reaction so not likely. On 3/17/2015, he was still not feeling well, them woke up from his nap at 6:30pm with 102.5 fever and I immediately took him to ER.  He was tested for flu, strep, rsv..  urine sample taken and chest Xray.  All negative.  He had small red dots on chest and doc at ER said just viral and follow up with regular doc.  Finally, patient slept that night from 2am til 11:30am.  He was asleep on me, so I called his doc after we woke up.  No appts available, which was yesterday.  He was finally seen by them again today.  CBC and strep and mono test.  CBC still shows viral infection and strep and mono are negative. Most red dots are gone now.  Low grade fever intermittent since it spiked on 3/17/15. He is not as fussy, but still not his unusually good natured happy self.  He still won't let me put him down most times.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Irritability, Malaise, Mononucleosis heterophile test negative, Pyrexia, Rash
Clinical narrative: Patient became very fussy during the evening and then continued to cry every 30-45 mins in his sleep every night for the next 5 nights.  During the day, he was fussy and didn't smile, I couldn't put him down.  He was clinging to me, when I did put him down. He just cried and fussed until I picked him back up. He is typically a very good natured baby, he had a double ear infection and never ran a fever a couple months back.... he even ruptured the ear drum and never acted sick. I just happened to notice stuff in his ear and immediately took him to doctors and he was sick.  No clue how long he was that way.  He never cries and always sleeps 12 hrs a night without waking up.  I know something was not right.... took him back to docs on Saturday and CBC showed viral infection.  I asked about this being related to the vaccine. I was told that they had never seen this kind of reaction so not likely. On 3/17/2015, he was still not feeling well, them woke up from his nap at 6:30pm with 102.5 fever and I immediately took him to ER.  He was tested for flu, strep, rsv..  urine sample taken and chest Xray.  All negative.  He had small red dots on chest and doc at ER said just viral and follow up with regular doc.  Finally, patient slept that night from 2am til 11:30am.  He was asleep on me, so I called his doc after we woke up.  No appts available, which was yesterday.  He was finally seen by them again today.  CBC and strep and mono test.  CBC still shows viral infection and strep and mono are negative. Most red dots are gone now.  Low grade fever intermittent since it spiked on 3/17/15. He is not as fussy, but still not his unusually good natured happy self.  He still won't let me put him down most times.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous, Respiratory syncytial virus test negative, Streptococcus test negative, Urine analysis normal, Viral infection
Clinical narrative: Patient became very fussy during the evening and then continued to cry every 30-45 mins in his sleep every night for the next 5 nights.  During the day, he was fussy and didn't smile, I couldn't put him down.  He was clinging to me, when I did put him down. He just cried and fussed until I picked him back up. He is typically a very good natured baby, he had a double ear infection and never ran a fever a couple months back.... he even ruptured the ear drum and never acted sick. I just happened to notice stuff in his ear and immediately took him to doctors and he was sick.  No clue how long he was that way.  He never cries and always sleeps 12 hrs a night without waking up.  I know something was not right.... took him back to docs on Saturday and CBC showed viral infection.  I asked about this being related to the vaccine. I was told that they had never seen this kind of reaction so not likely. On 3/17/2015, he was still not feeling well, them woke up from his nap at 6:30pm with 102.5 fever and I immediately took him to ER.  He was tested for flu, strep, rsv..  urine sample taken and chest Xray.  All negative.  He had small red dots on chest and doc at ER said just viral and follow up with regular doc.  Finally, patient slept that night from 2am til 11:30am.  He was asleep on me, so I called his doc after we woke up.  No appts available, which was yesterday.  He was finally seen by them again today.  CBC and strep and mono test.  CBC still shows viral infection and strep and mono are negative. Most red dots are gone now.  Low grade fever intermittent since it spiked on 3/17/15. He is not as fussy, but still not his unusually good natured happy self.  He still won't let me put him down most times.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Swelling and itching- Right deltoid (swelling). (Itching)- chest. Right arm, head.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache, Nausea, Pallor, Swelling face
Clinical narrative: Received vaccines 3/9, began feeling tired that evening, the developed headache, nausea, dizziness. Upon exam 3/11, facial puffiness, pale, otherwise WNL.
Age: 79.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Arthralgia, Body temperature increased, Headache, Influenza like illness, Nausea
Clinical narrative: Pt reports 3/13/15 that the day of shots she began running a 101 degrees-body aches, HA, nausea et joint pain. Reports she started feeling better 3/12/15 but still feels "like I have the flu."
Age: 79.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Pain
Clinical narrative: Pt reports 3/13/15 that the day of shots she began running a 101 degrees-body aches, HA, nausea et joint pain. Reports she started feeling better 3/12/15 but still feels "like I have the flu."
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 3 unspecified patients of unknown age and gender. On an unspecified dates since 21-FEB-2015, the patients were vaccinated with a dose of an improperly stored ROTATEQ (route oral, lot # K011663, expiration date 24-APR-2016, dose not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: ANTH, TYP
Symptoms: Abasia, Multiple sclerosis
Clinical narrative: Initial unsolicited case received from a consumer on 12 March 2015. A male patient received Typhoid vaccine (lot number and manufacturer not reported) and Anthrax vaccine (lot number not reported, other manufacturer) on an unspecified date. He subsequently developed an aggressive, catastrophic form of multiple sclerosis, and had been hospitalized due to an inability to walk. Outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Cough, Gait disturbance, Myalgia
Clinical narrative: Initial unsolicited report received from a physician, who is also the patient, on 12 March 2015.  A male patient self-administered FLUZONE QIV on an unspecified date "this past season". He subsequently experienced an adverse reaction, consisting of coughing, sneezing, post-nasal issues, wheezing, fever, chills, muscle pain, and joint pain. His kidneys shut down and he lost renal function, and had difficulty walking. He was hospitalized for these events. The patient's medical history was not reported. The reporter did not have the lot number. Outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: FLU4
Symptoms: Nasal disorder, Pyrexia, Renal failure, Renal impairment, Sneezing
Clinical narrative: Initial unsolicited report received from a physician, who is also the patient, on 12 March 2015.  A male patient self-administered FLUZONE QIV on an unspecified date "this past season". He subsequently experienced an adverse reaction, consisting of coughing, sneezing, post-nasal issues, wheezing, fever, chills, muscle pain, and joint pain. His kidneys shut down and he lost renal function, and had difficulty walking. He was hospitalized for these events. The patient's medical history was not reported. The reporter did not have the lot number. Outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: FLU4
Symptoms: Upper-airway cough syndrome, Wheezing
Clinical narrative: Initial unsolicited report received from a physician, who is also the patient, on 12 March 2015.  A male patient self-administered FLUZONE QIV on an unspecified date "this past season". He subsequently experienced an adverse reaction, consisting of coughing, sneezing, post-nasal issues, wheezing, fever, chills, muscle pain, and joint pain. His kidneys shut down and he lost renal function, and had difficulty walking. He was hospitalized for these events. The patient's medical history was not reported. The reporter did not have the lot number. Outcome was not reported. Documents held by sender: None.