chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Paraesthesia
Clinical narrative: Patient experienced pain, redness, and swelling to left upper arm and area was warm to the touch after vaccine administration on 6/01/16. Area was red and swollen on back side of upper arm approximately 2 inches above elbow and coming around inner arm under axilla. Patient had taken BENADRYL, applied compresses and taken TYLENOL for pain. Onset of symptoms were reported to have occurred within a few hours after administration. No changes occurred over night to next morning (6/2/16). As day progressed to later in the evening, redness, pain, and swelling continued down arm making arm numb and tingly. Client preceded to ER for treatment as instructed by local health department if symptoms worsened. At ER patient was given bolus IV 0.9% 1000ml, BENADRYL 25 mg IVP, TORADOL 30 mg IVP, SOLU-MEDROL 40 mg IVP, and CLARITIN 10 mg Oral. Patient was sent home with prescriptions for PERCOCET 5-325 1 tablet by Oral route every 6 hours as needed and Prednisone 20 mg 2 tablets by Oral route once daily for 2 days. Patient to continue as needed for symptoms, BENADRYL, CLARITIN, and may use ibuprofen 800 mg every eight hours as needed for pain. Patient to follow-up with Primary Care Physician in 5-6 days. 6/6/16 Patient reports symptoms are resolved as of Sunday 6/5/16.
Age: 32.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Asthenia, Dizziness, Eye pain, Headache, Myalgia
Clinical narrative: Severe pain "mialgia" severa weakness sensation, diziness, throat inflamed, fever, headache, pain in eyes these have lasted already 3 days and ongoing now.
Age: 32.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Pain, Pharyngeal inflammation, Pyrexia
Clinical narrative: Severe pain "mialgia" severa weakness sensation, diziness, throat inflamed, fever, headache, pain in eyes these have lasted already 3 days and ongoing now.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Diarrhoea, Headache, Injection site induration
Clinical narrative: Hard, swollen, fevered area at the site of the injection; diarrhea, area is sore to the touch, headache, decreased appetite, chills.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Hard, swollen, fevered area at the site of the injection; diarrhea, area is sore to the touch, headache, decreased appetite, chills.
Age: 1.33
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Balance disorder, Crying, Pyrexia, Rash generalised, Vomiting
Clinical narrative: Mom states that patient vomited 5-6 times over 2 days. She did not have a fever. She was crying quite a bit and seemed off balance. She did end up with a rash over her body on Friday evening.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin reaction, Skin warm
Clinical narrative: Skin reaction, redness, pain, warmth.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a physician refers to 1 year old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 26-APR-2016, the patient was vaccinated with VARIVAX (lot # L049536 expiry date 08-DEC-2017, dosage information not provided). Concomitant medication was not provided. On an unknown date in 2016, the patient experienced local cellulitis. On 07-MAY-2016, the patient was seen by the physician and the patient was treated with KEFLEX for local cellulitis. Since then patient's symptoms were resolved, on an unknown date. Causality assessment was not provided. Upon internal review "cellulitis" was determined to be medically significant. This is one of several cases received from the same source. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: RVX, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception; received Rotavirus vaccine on 6/3/2016.
Age: 0.25
Sex: F
Vaccine: RVX, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cough, Emotional distress, Faeces discoloured, Haematochezia, Intussusception
Clinical narrative: Intussusception; received Rotavirus vaccine on 6/3/2016.
Age: 0.25
Sex: F
Vaccine: RVX, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Mucous stools, Respiratory tract congestion, Vomiting
Clinical narrative: Intussusception; received Rotavirus vaccine on 6/3/2016.
Age: 0.25
Sex: F
Vaccine: RVX, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Cough congestion fussiness started 6/12/16 - Pt worsened and developed irritability and difficulty consoling. Vomiting x 2 episodes with dark stool with blood and mucus - pt sent to ER and diagnosed with intussusception. Pt admitted to hospital 6/13/16.
Age: 0.25
Sex: F
Vaccine: RVX, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cough, Emotional distress, Faeces discoloured, Haematochezia, Intussusception
Clinical narrative: Cough congestion fussiness started 6/12/16 - Pt worsened and developed irritability and difficulty consoling. Vomiting x 2 episodes with dark stool with blood and mucus - pt sent to ER and diagnosed with intussusception. Pt admitted to hospital 6/13/16.
Age: 0.25
Sex: F
Vaccine: RVX, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Mucous stools, Respiratory tract congestion, Vomiting
Clinical narrative: Cough congestion fussiness started 6/12/16 - Pt worsened and developed irritability and difficulty consoling. Vomiting x 2 episodes with dark stool with blood and mucus - pt sent to ER and diagnosed with intussusception. Pt admitted to hospital 6/13/16.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Cough
Clinical narrative: COUGH,BLATTER LEAKAGE.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: PATIENT NOTICED REACTION THAT NIGHT. RASH ON ARM AT INJECTION SITE, WARM TO TOUCH, SWOLLEN AND PAINFUL TO LIFT.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Condition aggravated, Seizure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of seizure in a 16-year-old female patient who received BEXSERO. The patient's past medical history included seizure. On an unknown date, the patient received BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to BEXSERO. Additional details were provided as follows: The other healthcare professional reported that the patient experienced seizure on the same day after receiving BEXSERO. Prior to receiving BEXSERO, the patient did not have seizure for a long period of time. The sales representative had limited information, but the other healthcare professional had additional information which could be obtained by follow up.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Bell's Palsy in a 13-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced Bell's Palsy (serious criteria GSK medically significant and other: As per reporter). On an unknown date, the outcome of the Bell's Palsy was not recovered/not resolved. It was unknown if the reporter considered the Bell's Palsy to be related to BEXSERO. Additional details were received as follows: BEXSERO was the only vaccine administered to the patient. The patient was seen in the emergency department for the symptoms. The sales rep had limited information but other health professional had additional information which could be obtained by follow up.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable health care professional via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose. The patient's medical history and concomitant medications were not reported. On 23May2016 the patient experienced injection site soreness and came in to the doctor and the injection site was red, swollen, itchy and warm to touch and at the point of time, the doctor diagnosed the patient with a soft tissue infection. Outcome was unknown. The doctor stated that the events occurred because of PREVNAR 13.
Sex: U
Vaccine: PNC13
Symptoms: Soft tissue infection
Clinical narrative: This is a spontaneous report from a contactable health care professional via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose. The patient's medical history and concomitant medications were not reported. On 23May2016 the patient experienced injection site soreness and came in to the doctor and the injection site was red, swollen, itchy and warm to touch and at the point of time, the doctor diagnosed the patient with a soft tissue infection. Outcome was unknown. The doctor stated that the events occurred because of PREVNAR 13.
Age: 74.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Audiogram abnormal, Deafness neurosensory, Deafness unilateral, Expired product administered, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Information has been received from a physician assistant via a company representative referring to a 74 year old male patient. The patient had no drug reactions or allergies. No concurrent condition, medical history or concomitant therapy was reported. On an unknown date of September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # 0467AE with expiration date of April 2013, 0.65 ml, once, subcutaneous). On the same day, an unspecified seasonal influenza vaccine was administered. On an unknown date in October 2013, the patient was sent for an audiogram for an unspecified reason. The audiogram showed sudden sensory neural hearing loss on the left and subsequent brain magnetic resonance imaging (MRI) (date unspecified) was negative for any abnormalities of the brain. No treatment was given to the patient. At reporting time, the patient had not recovered from sudden sensory neural hearing loss on the left. Upon internal review, the event sudden sensory neural hearing loss on the left was considered to be medically significant. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Sudden hearing loss
Clinical narrative: Information has been received from a physician assistant via a company representative referring to a 74 year old male patient. The patient had no drug reactions or allergies. No concurrent condition, medical history or concomitant therapy was reported. On an unknown date of September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # 0467AE with expiration date of April 2013, 0.65 ml, once, subcutaneous). On the same day, an unspecified seasonal influenza vaccine was administered. On an unknown date in October 2013, the patient was sent for an audiogram for an unspecified reason. The audiogram showed sudden sensory neural hearing loss on the left and subsequent brain magnetic resonance imaging (MRI) (date unspecified) was negative for any abnormalities of the brain. No treatment was given to the patient. At reporting time, the patient had not recovered from sudden sensory neural hearing loss on the left. Upon internal review, the event sudden sensory neural hearing loss on the left was considered to be medically significant. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Cyst removal, Muscular weakness, Nausea, Neck pain
Clinical narrative: This spontaneous report has been received from a physician referring to a 15 year old female patient. The patient did not have any pertinent medical history, drug reaction or allergies. On 28-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9, (route, anatomical location and dose were not provided) lot # L044475, and expiration date 12-MAY-2017. The patient did not had any concomitant therapy. On 03-APR-2016, the patient experienced abdominal pain, vomiting and nausea. Subsequently to the mentioned events, on 06-APR-2016, the patient went to the physician who prescribed omeprazole for abdominal symptoms. However on 10-APR-2016, the patient went to the emergency room for persisted with the abdominal pain, vomiting and nausea, but she was not admitted to the hospital on this time. Then on 20-APR-2016, she went for second time to the physician, she complained for neck pain and weakness in left leg in addition to her abdominal pain, nausea and vomiting. On 25-APR-2016 (reported as sometime after this time, the physician could not provide the exact date), the patient went back to the hospital and an this time she was diagnosed with a cervical spine cyst, for this reason an Magnetic resonance imaging (MRI) was ordered and the result of the study confirmed the diagnosis; the physician stated that the patient persisted with abdominal pain, nausea and vomiting. Later, on an unknown date, the patient was hospitalized and had the surgery to remove the cyst. The physician could not provide the exact date of procedure or the length of the hospitalization, also reported that the patient was doing better after surgery. But she continued complaining of weakness in left leg. At the time of reporting the outcome of cervical cyst, nausea, vomiting, neck pain and abdominal pain were recovering and the outcome of weakness in left leg was reported as not recovered. The relatedness between the aforementioned events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Spinal meningeal cyst, Vomiting
Clinical narrative: This spontaneous report has been received from a physician referring to a 15 year old female patient. The patient did not have any pertinent medical history, drug reaction or allergies. On 28-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9, (route, anatomical location and dose were not provided) lot # L044475, and expiration date 12-MAY-2017. The patient did not had any concomitant therapy. On 03-APR-2016, the patient experienced abdominal pain, vomiting and nausea. Subsequently to the mentioned events, on 06-APR-2016, the patient went to the physician who prescribed omeprazole for abdominal symptoms. However on 10-APR-2016, the patient went to the emergency room for persisted with the abdominal pain, vomiting and nausea, but she was not admitted to the hospital on this time. Then on 20-APR-2016, she went for second time to the physician, she complained for neck pain and weakness in left leg in addition to her abdominal pain, nausea and vomiting. On 25-APR-2016 (reported as sometime after this time, the physician could not provide the exact date), the patient went back to the hospital and an this time she was diagnosed with a cervical spine cyst, for this reason an Magnetic resonance imaging (MRI) was ordered and the result of the study confirmed the diagnosis; the physician stated that the patient persisted with abdominal pain, nausea and vomiting. Later, on an unknown date, the patient was hospitalized and had the surgery to remove the cyst. The physician could not provide the exact date of procedure or the length of the hospitalization, also reported that the patient was doing better after surgery. But she continued complaining of weakness in left leg. At the time of reporting the outcome of cervical cyst, nausea, vomiting, neck pain and abdominal pain were recovering and the outcome of weakness in left leg was reported as not recovered. The relatedness between the aforementioned events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from an unknown reporter via company representative regarding a 53 years old female patient. The patient's pertinent medical history and concomitant medications were not reported. On 31-MAY-2016, the patient was vaccinated with ZOSTAVAX (strength: 19400 PFU) lot # L046893, 19400 PFU, subcutaneously. On an unknown date the patient experienced suspected cellulitis. The patient visited to doctor's office for seeking medical attention and was being treated with steroids and antibiotics (brands and manufacturers unspecified). The outcome of cellulitis was unknown. The reporter did not provide the relatedness of the event with ZOSTAVAX. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness,swelling, and itching in and around the injection site got worse around 72 hours after injection and has started to subside.  Family dr was contacted and he was unconcerned said it was a normal reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: I noticed an inflamed with an area about 2" surrounding the injection site.  It was firm, very warm and reddened.  By Saturday morning around 7 AM this area had doubled in size, the area now reaches from my elbow to my armpit and has also started to feel itchy.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Arthritis bacterial, Hypotonia, Inflammatory marker increased, Joint swelling, Nuclear magnetic resonance imaging abnormal
Clinical narrative: R knee swelling, pain, limp, fever.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pain, Pyrexia
Clinical narrative: R knee swelling, pain, limp, fever.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from an external source (reported as an executive) via a company representative, and refers to a 54 year old female patient. No information regarding patient's medical history, concurrent conditions and drug reactions/allergies was not reported. On 02-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, 19400 PFU, lot # reported as L046893 (expiration date was not reported). No concomitant medications were reported. It was reported that, on an unspecified date in June 2016 (reported as within 24 hours of vaccination), the patient went to an unspecified hospital emergency room for a possible localized cellulitis, where she was "treated with steroids and amoxicillin". However, no intervention to prevent serious criteria was performed. No product quality complaint was involved. At the time of reporting, the outcome of cellulitis was unknown. Additionally, the relatedness between the event and the ZOSTAVAX was not provided by the reporter. Upon internal review, cellulitis was determined to be medically significant event. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Eye movement disorder, Hiccups, Pyrexia, Seizure like phenomena, Viral infection
Clinical narrative: Seizure type symptoms.  Appeared as if he was having hiccups and his eyes were rolled back.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Viral test positive
Clinical narrative: Seizure type symptoms.  Appeared as if he was having hiccups and his eyes were rolled back.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal tenderness, Blood culture, C-reactive protein, Cellulitis, Full blood count
Clinical narrative: On Monday (6/6/16), patient was given her 6 month vaccines, soon after mother noticed that the site of vaccine, right lateral thigh area, became a bit hard. The next day the patient had an axillary fever of approximately 101 and the site became red and swollen. She called her PCP who recommended warm compression but that provided no relief. The patients mother then gave Tylenol for pain relief. The redness and pain persisted at the night of admission (6/12/16) the patient had a fever of 101.9 as said by mother, so the mother bought her to the emergency room. Patient has tachycardia and redness and tenderness of the right lateral thigh extending to her right lower abdomen. Cellulitis was suspected so and IV was inserted and labs were ordered (CBC, CMP, BMP, CRP, blood culture). She was started of cefazolin 100 mg/kg/day divided Q8H and she was admitted for IV antibiotics.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Metabolic function test
Clinical narrative: On Monday (6/6/16), patient was given her 6 month vaccines, soon after mother noticed that the site of vaccine, right lateral thigh area, became a bit hard. The next day the patient had an axillary fever of approximately 101 and the site became red and swollen. She called her PCP who recommended warm compression but that provided no relief. The patients mother then gave Tylenol for pain relief. The redness and pain persisted at the night of admission (6/12/16) the patient had a fever of 101.9 as said by mother, so the mother bought her to the emergency room. Patient has tachycardia and redness and tenderness of the right lateral thigh extending to her right lower abdomen. Cellulitis was suspected so and IV was inserted and labs were ordered (CBC, CMP, BMP, CRP, blood culture). She was started of cefazolin 100 mg/kg/day divided Q8H and she was admitted for IV antibiotics.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pain, Pyrexia, Tachycardia
Clinical narrative: On Monday (6/6/16), patient was given her 6 month vaccines, soon after mother noticed that the site of vaccine, right lateral thigh area, became a bit hard. The next day the patient had an axillary fever of approximately 101 and the site became red and swollen. She called her PCP who recommended warm compression but that provided no relief. The patients mother then gave Tylenol for pain relief. The redness and pain persisted at the night of admission (6/12/16) the patient had a fever of 101.9 as said by mother, so the mother bought her to the emergency room. Patient has tachycardia and redness and tenderness of the right lateral thigh extending to her right lower abdomen. Cellulitis was suspected so and IV was inserted and labs were ordered (CBC, CMP, BMP, CRP, blood culture). She was started of cefazolin 100 mg/kg/day divided Q8H and she was admitted for IV antibiotics.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dyskinesia, Haemorrhage, Myalgia, New daily persistent headache
Clinical narrative: Received HPV vaccine 9/22/10, 10/27/10, 3/22/11. 6/2015 - started having involuntary movements in sleep. Dx with seizures. Patient is a 17 y.o. female. Is also scratching her face during her sleep so wearing gloves now she is unaware of what happens during her sleep but says since stopping her ADHD medication 3 months ago has new daily headaches all over AM to PM no vomiting or nausea but whole body is achy and muscles are sore and has started uncontrolled tic like shiver of her shoulders several random times a day is eating well has gained a little weight no H/O trauma no h/o seizures and has had some headaches in the past but nothing like these mom just happened to noticed the first one 3 months ago while patient was sleeping in the recliner but getting more frequent and lasting longer latest one was night before last and mom was "scared" seemed longer patient unaware the next day but notes that her sheets are bloody where she is scratching the lower left side of her face while she sleeps.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Pain, Scratch, Seizure, Tic
Clinical narrative: Received HPV vaccine 9/22/10, 10/27/10, 3/22/11. 6/2015 - started having involuntary movements in sleep. Dx with seizures. Patient is a 17 y.o. female. Is also scratching her face during her sleep so wearing gloves now she is unaware of what happens during her sleep but says since stopping her ADHD medication 3 months ago has new daily headaches all over AM to PM no vomiting or nausea but whole body is achy and muscles are sore and has started uncontrolled tic like shiver of her shoulders several random times a day is eating well has gained a little weight no H/O trauma no h/o seizures and has had some headaches in the past but nothing like these mom just happened to noticed the first one 3 months ago while patient was sleeping in the recliner but getting more frequent and lasting longer latest one was night before last and mom was "scared" seemed longer patient unaware the next day but notes that her sheets are bloody where she is scratching the lower left side of her face while she sleeps.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: Received HPV vaccine 9/22/10, 10/27/10, 3/22/11. 6/2015 - started having involuntary movements in sleep. Dx with seizures. Patient is a 17 y.o. female. Is also scratching her face during her sleep so wearing gloves now she is unaware of what happens during her sleep but says since stopping her ADHD medication 3 months ago has new daily headaches all over AM to PM no vomiting or nausea but whole body is achy and muscles are sore and has started uncontrolled tic like shiver of her shoulders several random times a day is eating well has gained a little weight no H/O trauma no h/o seizures and has had some headaches in the past but nothing like these mom just happened to noticed the first one 3 months ago while patient was sleeping in the recliner but getting more frequent and lasting longer latest one was night before last and mom was "scared" seemed longer patient unaware the next day but notes that her sheets are bloody where she is scratching the lower left side of her face while she sleeps.
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a physician refers to a 1 year old patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 22-APR-2016, the patient was vaccinated with VARIVAX (lot # L049536 expiry date 08-DEC-2017, dosage information not provided). Concomitant medication was not provided. On an unknown date in 2016, the patient experienced local cellulitis. On 06-MAY-2016 and 07-MAY-2016, the patient was seen by the physician and the patient was treated with KEFLEX for local cellulitis. Since then patient's symptoms were resolved, on an unknown date. Causality assessment was not provided. Upon internal review "cellulitis" was determined to be medically significant. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a physician refers to 1 year old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 20-JAN-2016, the patient was vaccinated with VARIVAX (lot # L049536 expiry date 06-DEC-2017, dosage information not provided). Concomitant medication was not provided. On an unknown date in 2016, the patient experienced local cellulitis. On 06-MAY-2016, the patient was seen by the physician and the patient was treated with KEFLEX for local cellulitis. Since then patient's symptoms were resolved, on an unknown date. Causality assessment was not provided. Upon internal review "cellulitis" was determined to be medically significant. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Chest X-ray, Eye movement disorder, Feeling hot, Full blood count, Tremor
Clinical narrative: Per mom patient felt very hot, was shaking, eyes rolled back, not responding appropriately for 10 minutes and vomited.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Unresponsive to stimuli, Urine analysis, Vomiting
Clinical narrative: Per mom patient felt very hot, was shaking, eyes rolled back, not responding appropriately for 10 minutes and vomited.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain, Pruritus
Clinical narrative: Large area of erythema (6x6cm), with small area of induration, pruritis, pain, pain with range of motion with shoulder and elbow. Improved over 48 hours with Tylenol, Naproxen, and Benadryl.
Age: 17.0
Sex: F
Vaccine: ADEN_4_7, FLU3, HEP, MNQ, TDAP
Symptoms: Chest discomfort, Dizziness, Throat tightness
Clinical narrative: Dizziness, tightness in chest and feeling of throat closing.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Headache, Injection site swelling, Malaise
Clinical narrative: Patient reports event to Pharmacist 6-13-16 at 2:30 PM.  Reports swelling at injection site at first.  Now swelling "spreading to right side of arm."  Reports a fever high temp of 101.5 degrees.  Headaches, weak, general fatgiue (malaise).
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Patient reports event to Pharmacist 6-13-16 at 2:30 PM.  Reports swelling at injection site at first.  Now swelling "spreading to right side of arm."  Reports a fever high temp of 101.5 degrees.  Headaches, weak, general fatgiue (malaise).
Age: 1.03
Sex: M
Vaccine: HEP, HEPA, MMR, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh redness, swelling, warmth, tender to touch.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Dizziness, Dysphonia, Fatigue, Feeling abnormal
Clinical narrative: Patient reports that about an hour after the vaccine was given she developed headache, fatigue and cough. The next day she continued to feel poorly and was seen by myself in our walk in clinic.  In addition she had dizziness, felt cold, had increased thirst, had hoarseness, and felt like her legs were heavy. No rashes.  I treated her with epinephrine and her respiratory symptoms improved.  She was sent home after being observed in clinic, and when I called her at home the next day she said she felt better although not completely well.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling cold, Headache, Limb discomfort, Respiratory symptom, Thirst
Clinical narrative: Patient reports that about an hour after the vaccine was given she developed headache, fatigue and cough. The next day she continued to feel poorly and was seen by myself in our walk in clinic.  In addition she had dizziness, felt cold, had increased thirst, had hoarseness, and felt like her legs were heavy. No rashes.  I treated her with epinephrine and her respiratory symptoms improved.  She was sent home after being observed in clinic, and when I called her at home the next day she said she felt better although not completely well.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin mass, Skin warm
Clinical narrative: Patien't had small red spot, area warm to the touch, and small knot under the skin.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Barium enema abnormal, Clostridium test positive, Crying, Diarrhoea haemorrhagic, Enema administration
Clinical narrative: Patient presented to the ER on 6/8 with less than 12 hours of vomiting and bloody diarrhea and had been well prior to this. Mom reported intermittent currant jelly stools since the morning on the 8th.  Ultrasound was obtained and consistent with intussusception.  He was taken to the OR emergently due to failure with the barium enema.  Of note, film array was + for C.diff and rotavirus, however the C.diff was not treated due to the patient's age and likely colonization.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Intussusception, Large intestinal obstruction reduction, Presyncope, Rotavirus test positive
Clinical narrative: Patient presented to the ER on 6/8 with less than 12 hours of vomiting and bloody diarrhea and had been well prior to this. Mom reported intermittent currant jelly stools since the morning on the 8th.  Ultrasound was obtained and consistent with intussusception.  He was taken to the OR emergently due to failure with the barium enema.  Of note, film array was + for C.diff and rotavirus, however the C.diff was not treated due to the patient's age and likely colonization.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Surgery, Ultrasound abdomen abnormal, Vomiting, X-ray, X-ray gastrointestinal tract abnormal
Clinical narrative: Patient presented to the ER on 6/8 with less than 12 hours of vomiting and bloody diarrhea and had been well prior to this. Mom reported intermittent currant jelly stools since the morning on the 8th.  Ultrasound was obtained and consistent with intussusception.  He was taken to the OR emergently due to failure with the barium enema.  Of note, film array was + for C.diff and rotavirus, however the C.diff was not treated due to the patient's age and likely colonization.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Administration site induration, Administration site pain, Administration site reaction, Administration site swelling, Erythema
Clinical narrative: Severe pain upon administration. Then redness and hard lump in the administration area (2 in across by 1 inch height) and swelling from shoulder to elbow the next day. Treatment consisted of ice and Aleve. Redness, pain and swelling went away after a week but was itchy and still hard. After three weeks, there is still occasional itching and a hard lump by administration sight the size of a pea.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Severe pain upon administration. Then redness and hard lump in the administration area (2 in across by 1 inch height) and swelling from shoulder to elbow the next day. Treatment consisted of ice and Aleve. Redness, pain and swelling went away after a week but was itchy and still hard. After three weeks, there is still occasional itching and a hard lump by administration sight the size of a pea.
Age: 35.0
Sex: F
Vaccine: FLU3, HEP, MMR, TDAP, VARCEL
Symptoms: Condition aggravated, Facial paralysis, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Pain on the upper left arm, and redness on injection site. Later that day patient c/o minor numbness on the lower left arm and weakness on the left arm with soreness. Patient states that injection site swelled approximately the size of an egg. Patient states had a history of Bell's Palsy in the past, patient experienced Bell's Palsy again and decided to go to the hospital, was given an allergy cocktail in the ER.
Age: 35.0
Sex: F
Vaccine: FLU3, HEP, MMR, TDAP, VARCEL
Symptoms: Injection site swelling, Muscular weakness
Clinical narrative: Pain on the upper left arm, and redness on injection site. Later that day patient c/o minor numbness on the lower left arm and weakness on the left arm with soreness. Patient states that injection site swelled approximately the size of an egg. Patient states had a history of Bell's Palsy in the past, patient experienced Bell's Palsy again and decided to go to the hospital, was given an allergy cocktail in the ER.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Death, Feeling hot, Hyperhidrosis, Impaired work ability, Malaise
Clinical narrative: Patient started feeling ill after his night shift started.  He worked as an overnight stocker at the location where he received the vaccination.  As the night went on, patient started feeling sick and after his lunch break around 2 am he got hot, feverish and was sweating profusely.  He went and sat down in the meat cooler to try and cool down for a few minutes.  After awhile he told his supervisor and a co-worker that he was leaving to go home sick.  He asked his co-worker to get the chair for him he left in the cooler and left his jacket there overnight.  It is not like patient to leave work early, much less ask someone to get a chair for him that he left behind.  The next night he called in sick again from work which was Sunday, Sept. 20, 2015.  He died later that evening according to paramedics whom did not find him until a good friend and next door neighbor found him laying on the floor in his home dead on Monday, Sept. 21 around 6:39 PM.  The paramedics and sheriff said he had been gone for possibly 18-24 hours.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient started feeling ill after his night shift started.  He worked as an overnight stocker at the location where he received the vaccination.  As the night went on, patient started feeling sick and after his lunch break around 2 am he got hot, feverish and was sweating profusely.  He went and sat down in the meat cooler to try and cool down for a few minutes.  After awhile he told his supervisor and a co-worker that he was leaving to go home sick.  He asked his co-worker to get the chair for him he left in the cooler and left his jacket there overnight.  It is not like patient to leave work early, much less ask someone to get a chair for him that he left behind.  The next night he called in sick again from work which was Sunday, Sept. 20, 2015.  He died later that evening according to paramedics whom did not find him until a good friend and next door neighbor found him laying on the floor in his home dead on Monday, Sept. 21 around 6:39 PM.  The paramedics and sheriff said he had been gone for possibly 18-24 hours.
Age: 73.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: Area around vaccine became red inflamed, swollen and very itching according to patient.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Injection site erythema, Injection site reaction, Pyrexia, Rash pustular, Urticaria
Clinical narrative: Fever, raised red welt at injection site. Pox on stomach, back, diaper area.
Age: 1.49
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Facial paralysis, Facial paresis, Pyrexia
Clinical narrative: Night of 6/1 patient had left sided facial weekness, fever 101F. Patient was referred to ER 6/3 where Bell's Palsy Diagnosis was given.  Augmentin 3.5ml BID was started by PCP 6/3, Prednisolone 15mg/5ml - 4ml QD X10 days then taper was started on 6/3 in ER, Acyclovir 200mg/5ml - 5ml 4Xa day X12 days - started 6/6.
Age: 72.0
Sex: F
Vaccine: PNC
Symptoms: Atypical pneumonia, Bronchitis, Chest X-ray, Chills, Cytomegalovirus test
Clinical narrative: Chills, muscle aches, fever, fatigue x 11 days. Neuropathy hands, fingers, thighs x 5 weeks. Atypical pneumonia vs. bronchitis. Rx Augmentin, Azithromycin, Oxycodon, Naproxen.
Age: 72.0
Sex: F
Vaccine: PNC
Symptoms: Fatigue, Full blood count, Hepatitis B virus test, Hepatitis C virus test, Liver function test
Clinical narrative: Chills, muscle aches, fever, fatigue x 11 days. Neuropathy hands, fingers, thighs x 5 weeks. Atypical pneumonia vs. bronchitis. Rx Augmentin, Azithromycin, Oxycodon, Naproxen.
Age: 72.0
Sex: F
Vaccine: PNC
Symptoms: Mononucleosis heterophile test, Myalgia, Neuropathy peripheral, Pyrexia
Clinical narrative: Chills, muscle aches, fever, fatigue x 11 days. Neuropathy hands, fingers, thighs x 5 weeks. Atypical pneumonia vs. bronchitis. Rx Augmentin, Azithromycin, Oxycodon, Naproxen.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Gait disturbance, Pain
Clinical narrative: This spontaneous report was received from a 51 year old female patient with asthma and migraines (since she was five) who was reporting on herself. The patient did not have any drug reactions or allergies. On an unknown date in approximately 2010 at 3 PM (reported as "about 5-6 years ago"), the patient was vaccinated with a dose of PNEUMOVAX 23 1 shot, once (strength, lot # and expiration date not reported). The patient's concomitant therapies included ZYRTEC and unspecified vitamins. On an unknown date in approximately 2010 (reported as "by morning of the following day, a Thursday" after vaccination), the patient could barely walk. She was also debilitated by pain which she described as "worse than excruciating back labor, on a scale of 1-10 the pain was one hundred, it went through her body like wildfire". By Friday the pain reduced to "50 on a scale of 1-10." It went down again on Saturday to about 10 on a scale of 1-10. The pain continued to lessen and by Monday, the pain was completely gone. That was the day she was scheduled to see her physician. There was nothing more to be done at that point but they did give her some pain pills. It was reported that no treatment was given to the patient and no laboratory studies were performed. The patient recovered from the events on an unspecified date. The patient did not get any pneumococcal vaccines since that time. She stated that she had all of her normal vaccinations without any issues. The patient considered the events to be related to PNEUMOVAX 23 and life threatening, she stated that PNEUMOVAX 23 "nearly killed her". Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: HIV infection, HIV test positive, Pneumocystis jirovecii pneumonia, Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 65 year old male patient. The patient's concurrent conditions were not provided and his medical history included thrush. The patient did not have any drug reactions or allergies. In November 2015, the patient was vaccinated with ZOSTAVAX injection, (lot number, dose, route and anatomical site of injection were not reported). Concomitant therapies were not provided. On an unspecified date in 2015, after vaccination, the patient experienced a rash across his back, that was treated with valacyclovir hydrochloride (reported as "valcyclovir") for 7 days, starting on 08-DEC-2015. Later, he was treated with acyclovir for 10 days, starting on 27-DEC-2015. On an unknown date, the patient experienced pneumocystis jirovecii pneumonia that required him to be admitted in the hospital on 30-MAY-2016, where it was stated that he received treatment with LEVAQUIN and BACTRIM for this condition. On the same date, the patient was diagnosed to be human immunodeficiency virus (HIV) positive. No product quality complain (PQC) was involved. It was stated that no intervention to prevent serious criteria was necessary and that the adverse events were not significant disability or incapacity or life threatening. At the time of reporting, the outcome of rash was not recovered as the patient still had lesions on his back. It was also reported that the patient was still receiving BACTRIM for pneumocystis jirovecii pneumonia, however, it was unknown the outcome for this condition. The outcome of HIV test positive was unknown. The reporter did not provide a causality assessment between the events and the ZOSTAVAX. Upon internal review, it was determined that Pneumocystis jirovecii pneumonia was considered as other medically significant adverse event. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant regarding a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUN-2016, the patient inadvertently received additional dose of VAQTA (lot # M009377, expiry date 17-JUN-2017) dosing details unknown, intramuscularly. The patient received first dose of VAQTA on 05-DEC-2013 and second dose of VAQTA on 02-FEB-2015. No adverse effects have been reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Allergy test positive, Drug hypersensitivity, Food allergy, Immediate post-injection reaction, Injection site rash
Clinical narrative: MMR vaccine given in (R) thigh at routine physical. Rash, ? hive developed at site immediately. 4 ml of BENADRYL given and observed.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (therapy type: Digital data logger; lot # L031196, expiry date: 05-FEB-2017; lot # L017757, expiry date: 08-APR-2018). Healthcare worker stated that the vaccine underwent a temperature excursion at 49.5 degree Fahrenheit for 186 hours. There were no previous temperature excursions. Healthcare worker confirmed that the vaccine was administered on unspecified dates before their expiration date. No adverse effects were reported. This is one of the six reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Steven Johnson's Syndrome within a few days of 12 mo vaccines, VARICELLA, Hep A, PREVNAR. Currently being treated with PREDNISOLONE and ROCEPHIN.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (thepay type: Digital data logger; lot # K018183, expiry date: 04-MAY-2016; lot # L024132, expiry date: 21-JAN-2017. Healthcare worker stated that the vaccine underwent a temperature excursion at 49.5 degree Fahrenheit for 186 hours. There were no previous temperature excursions. Healthcare worker confirmed that the vaccine was administered on unspecified dates before their expiration date. No adverse effects were reported. This is one of the six reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large area of swelling, redness, warmth and pain around injection site; about 6" diameter; started 1-2 d after resolving some by 72 hrs.