chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient stopped by the pharmacy today (12-7-17) to report on-going arm pain after receiving her seasonal flu shot. She stated that her arm was "very sore" at the site of injection, and that she had "shooting pains" that ran down her arm into her fingers as well. Based on the information she provided, it was implied the symptoms evolved into the shooting arm pain (not sure of the time frame) but the injection site soreness was from time of vaccination (as explained and expected) through today. I immediately suggested a visit to her physician for an examination of the affected arm, as it had been 3 weeks since her vaccination. I also explained that the vaccination does go into the muscle tissue and there is no way of knowing if a vessel or nerve will be hit during vaccination. I again suggested a visit to her physician to ensure there was not something else going on, and informed her I would document the reaction in her profile as well as submit a VAERS report of the incident.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Skin reaction, Skin warm
Clinical narrative: Patient reported her arm swelling the night after receiving her PNEUMOVAX shot. She came to the pharmacy the next day mid-afternoon. Her left arm was swollen, red, and mildly warm to the touch. She said she was experiencing no pain. The majority of the swelling was well below where she received the vaccine, but located mostly above the elbow. She was instructed to go to her PCP's office and show them the reaction.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever started later that afternoon after vaccines. Tm=102.
Age: 73.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt experienced a strong aching pain with pressure upon injection. Currently, the pain is a constant throbbing pain that runs down her entire right arm.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Left arm was sore at injection spot immediately following the flu shot and never recovered. Shooting pain in arm (from elbow to shoulder with emphasis on injection spot) during spontaneous motion or when lifting arm above shoulder level or twisting across by body to the right (basically when the muscle/ tendon is flexed in a specific way). Health Center recommended six physical therapy sessions and then review the injury to determine whether more physical therapy is needed.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram, Antiacetylcholine receptor antibody, Antinuclear antibody, Blood creatine phosphokinase, Borrelia test
Clinical narrative: Patient felt tired and not well beginning on 10/29/2017. Experienced sharp pain behind right eye on 10-31-17. She couldn't open her eye and severe headache. 2 to 3 weeks of extreme fatigue. Has seen 5 doctors. DX: microvascular incident, paralysis of 3rd craninal nerve. Has double vision.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Diplopia, Eye pain, Eyelid function disorder, Fatigue, Headache
Clinical narrative: Patient felt tired and not well beginning on 10/29/2017. Experienced sharp pain behind right eye on 10-31-17. She couldn't open her eye and severe headache. 2 to 3 weeks of extreme fatigue. Has seen 5 doctors. DX: microvascular incident, paralysis of 3rd craninal nerve. Has double vision.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: IIIrd nerve paralysis, Immunology test, Laboratory test, Malaise, Nuclear magnetic resonance imaging
Clinical narrative: Patient felt tired and not well beginning on 10/29/2017. Experienced sharp pain behind right eye on 10-31-17. She couldn't open her eye and severe headache. 2 to 3 weeks of extreme fatigue. Has seen 5 doctors. DX: microvascular incident, paralysis of 3rd craninal nerve. Has double vision.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Smooth muscle antibody
Clinical narrative: Patient felt tired and not well beginning on 10/29/2017. Experienced sharp pain behind right eye on 10-31-17. She couldn't open her eye and severe headache. 2 to 3 weeks of extreme fatigue. Has seen 5 doctors. DX: microvascular incident, paralysis of 3rd craninal nerve. Has double vision.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Mobility decreased, Skin warm, Swelling
Clinical narrative: Warmth, erythema, swelling, localized to left arm. Patient states he had decreased mobility the night following the injection but had regained mobility at the time of viewing the reaction.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Injection site erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm swelled up as big as a bar of soap he said it felt hot and was hard to touch. The redness spread from site around arm to the inside of the elbow, (but was not as swollen on second day). He discussed with doctor, whom said he had never seen that type of reaction before. As far as I know it resolved on its own because he has not called or returned since reporting.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Hives all over body, swelling in arms, hands, legs and feet. Itchiness on arms and legs. BENADRYL resolved symptoms. Doctor prescribed a 72 hour medicine to help calm symptoms until vaccine works through her body.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Lymphadenopathy, Tenderness
Clinical narrative: Spoke with Pt. she states she had her flu shot Monday when she saw staff, Pt. states the next morning she woke up with tenderness in her neck, Pt. states she feels that her lymph node is swollen, Pt. has been fatigued for several days. Discussed with Pt. common side effects of the flu vaccine such as soreness, redness at injection site, headache, fever, nausea, muscle aches. Pt. denies having any of these, she states her tenderness starts about 4 inches above the injection site near her clavicle. Pt. is advised to come to UC for an evaluation if she concerned about her symptoms.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Areflexia, Back pain, Computerised tomogram head abnormal, Corneal reflex decreased, Dysphonia
Clinical narrative: 11/30/17: Patient presented to the hospital ER with tingling and numbness in both hands and legs, pain in lower back and down back of legs, stiff hands, ankles, and hips. BP was 200/100's, nausea/vomiting, CT brain showed area of hypoattenuation within the right parietal lobe that extends to the cortex, was started on nicardipine drip. 12/1/17: Lumbar puncture and intubation - patient unable to lift legs/arms, using accessory muscles, voice barely audible. IVIG therapy started. 12/3/17: Awake, attempting to talk; flaccid 0/5, able to move head, tracks examiner. IVIG continued 12/4/7: Pupils fixed and dilated, no corneal reflexes, weak gag, unresponsive on no sedation.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Endotracheal intubation, Hypoaesthesia, Hypotonia, Immunoglobulin therapy, Injected limb mobility decreased
Clinical narrative: 11/30/17: Patient presented to the hospital ER with tingling and numbness in both hands and legs, pain in lower back and down back of legs, stiff hands, ankles, and hips. BP was 200/100's, nausea/vomiting, CT brain showed area of hypoattenuation within the right parietal lobe that extends to the cortex, was started on nicardipine drip. 12/1/17: Lumbar puncture and intubation - patient unable to lift legs/arms, using accessory muscles, voice barely audible. IVIG therapy started. 12/3/17: Awake, attempting to talk; flaccid 0/5, able to move head, tracks examiner. IVIG continued 12/4/7: Pupils fixed and dilated, no corneal reflexes, weak gag, unresponsive on no sedation.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Joint stiffness, Lumbar puncture, Mobility decreased, Musculoskeletal stiffness, Mydriasis
Clinical narrative: 11/30/17: Patient presented to the hospital ER with tingling and numbness in both hands and legs, pain in lower back and down back of legs, stiff hands, ankles, and hips. BP was 200/100's, nausea/vomiting, CT brain showed area of hypoattenuation within the right parietal lobe that extends to the cortex, was started on nicardipine drip. 12/1/17: Lumbar puncture and intubation - patient unable to lift legs/arms, using accessory muscles, voice barely audible. IVIG therapy started. 12/3/17: Awake, attempting to talk; flaccid 0/5, able to move head, tracks examiner. IVIG continued 12/4/7: Pupils fixed and dilated, no corneal reflexes, weak gag, unresponsive on no sedation.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain in extremity, Paraesthesia, Pupil fixed, Unresponsive to stimuli
Clinical narrative: 11/30/17: Patient presented to the hospital ER with tingling and numbness in both hands and legs, pain in lower back and down back of legs, stiff hands, ankles, and hips. BP was 200/100's, nausea/vomiting, CT brain showed area of hypoattenuation within the right parietal lobe that extends to the cortex, was started on nicardipine drip. 12/1/17: Lumbar puncture and intubation - patient unable to lift legs/arms, using accessory muscles, voice barely audible. IVIG therapy started. 12/3/17: Awake, attempting to talk; flaccid 0/5, able to move head, tracks examiner. IVIG continued 12/4/7: Pupils fixed and dilated, no corneal reflexes, weak gag, unresponsive on no sedation.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Use of accessory respiratory muscles, Vomiting
Clinical narrative: 11/30/17: Patient presented to the hospital ER with tingling and numbness in both hands and legs, pain in lower back and down back of legs, stiff hands, ankles, and hips. BP was 200/100's, nausea/vomiting, CT brain showed area of hypoattenuation within the right parietal lobe that extends to the cortex, was started on nicardipine drip. 12/1/17: Lumbar puncture and intubation - patient unable to lift legs/arms, using accessory muscles, voice barely audible. IVIG therapy started. 12/3/17: Awake, attempting to talk; flaccid 0/5, able to move head, tracks examiner. IVIG continued 12/4/7: Pupils fixed and dilated, no corneal reflexes, weak gag, unresponsive on no sedation.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Chest X-ray, Chills, Choking
Clinical narrative: Symptoms started approximately 1 hour after the vaccine was given, starting with weakness, chills, instability, needing help to restroom, poor appetite, vomiting, facial paralysis, tongue enlargement. Seizure occurred approximately 3 days later. These symptoms also went on for about 3 days before taking him to outpatient, and after 11 hours they discharged him with no clear answers. Then called PCP and was seen there, then ear, nose and throat doctor, then neurologist, then doctor, and PCP again. All of the doctors associated the symptoms and paralysis as an adverse event from the flu shot. Patient is still choking on medications and food due to tongue swelling and facial paralysis. Instability, weakness, and poor appetite are continued adverse events that have not resolved.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Facial paralysis, Gait disturbance, Laboratory test, Seizure
Clinical narrative: Symptoms started approximately 1 hour after the vaccine was given, starting with weakness, chills, instability, needing help to restroom, poor appetite, vomiting, facial paralysis, tongue enlargement. Seizure occurred approximately 3 days later. These symptoms also went on for about 3 days before taking him to outpatient, and after 11 hours they discharged him with no clear answers. Then called PCP and was seen there, then ear, nose and throat doctor, then neurologist, then doctor, and PCP again. All of the doctors associated the symptoms and paralysis as an adverse event from the flu shot. Patient is still choking on medications and food due to tongue swelling and facial paralysis. Instability, weakness, and poor appetite are continued adverse events that have not resolved.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Swollen tongue, Vomiting
Clinical narrative: Symptoms started approximately 1 hour after the vaccine was given, starting with weakness, chills, instability, needing help to restroom, poor appetite, vomiting, facial paralysis, tongue enlargement. Seizure occurred approximately 3 days later. These symptoms also went on for about 3 days before taking him to outpatient, and after 11 hours they discharged him with no clear answers. Then called PCP and was seen there, then ear, nose and throat doctor, then neurologist, then doctor, and PCP again. All of the doctors associated the symptoms and paralysis as an adverse event from the flu shot. Patient is still choking on medications and food due to tongue swelling and facial paralysis. Instability, weakness, and poor appetite are continued adverse events that have not resolved.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Hyperhidrosis, Pruritus, Urticaria
Clinical narrative: Dizziness, sweating, itching from hives, occurred within 30 minutes. ER overnight stay. Was given epinephrine, ZOFRAN.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches began around 10 PM. Reached peak at 2:30 AM at 101.6. No treatment. Around 8:30 AM fever was 99.6 with body aches. Treated with Ibuprofen 600mg and symptoms cleared up around 10:00. No further reaction.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Pt states they had a hard painful lump at injection area and went to urgent care. Pt was diagnosed with an infection and prescribed doxycycline 100 bid.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine given to patient under 19, staff did not know about this limitation.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine given to person under 19 years of age.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Rash, Rash erythematous, Rash pruritic, Scab
Clinical narrative: I BEGAN GETTING A PRICKLY ACHY, SLIGHTLY ITCHY RASH WITHIN A FEW HRS OF RECEIVING THE INFLUENZA VACCINE. THE RASH WAS DEVELOPED ON UPPER ABDOMEN, THEN FELT PRICKLY AND ACHY AROUND MY RIGHT SIDE TO BACK WHERE IT WAS LIGHT RED IN COLOR. THE RASH ON MY UPPER ABDOMEN IS MORE PRONOUNCED WITH LITTLE HIVES IN ONE AREA THAT HAVE SCABBED. I HAVE NOT NOTICED IT ELSEWHERE YET. I HAD A NURSE AND DR LOOK AT THE RASH AND THEY BELIEVED IT TO BE THE ONSET OF SHINGLES.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: I BEGAN GETTING A PRICKLY ACHY, SLIGHTLY ITCHY RASH WITHIN A FEW HRS OF RECEIVING THE INFLUENZA VACCINE. THE RASH WAS DEVELOPED ON UPPER ABDOMEN, THEN FELT PRICKLY AND ACHY AROUND MY RIGHT SIDE TO BACK WHERE IT WAS LIGHT RED IN COLOR. THE RASH ON MY UPPER ABDOMEN IS MORE PRONOUNCED WITH LITTLE HIVES IN ONE AREA THAT HAVE SCABBED. I HAVE NOT NOTICED IT ELSEWHERE YET. I HAD A NURSE AND DR LOOK AT THE RASH AND THEY BELIEVED IT TO BE THE ONSET OF SHINGLES.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Electrocardiogram, Gastroenteritis, Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Within several hours shoulder became extremely painful and difficult to move and I began to experience PACs/PVCs at frequent intervals. Within 48 hours developed gastroenteritis which persisted for about 10 days. PACs continued during this time and began to abate slowly following end of digestive problems. I submitted several EKG readings from implanted loop recorder to cardiologist. Results showed PACs/PVCs but no AFib. Was advised to increase atenolol dosage from 25mg X 2 to 25 mg AM and 50mg PM as symptoms were worse at night. PACs have continued to decrease over time. Shoulder soreness at injection site is virtually gone as of this date.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: Within several hours shoulder became extremely painful and difficult to move and I began to experience PACs/PVCs at frequent intervals. Within 48 hours developed gastroenteritis which persisted for about 10 days. PACs continued during this time and began to abate slowly following end of digestive problems. I submitted several EKG readings from implanted loop recorder to cardiologist. Results showed PACs/PVCs but no AFib. Was advised to increase atenolol dosage from 25mg X 2 to 25 mg AM and 50mg PM as symptoms were worse at night. PACs have continued to decrease over time. Shoulder soreness at injection site is virtually gone as of this date.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Foetal heart rate abnormal, Ultrasound antenatal screen abnormal
Clinical narrative: Flu vaccine given in clinic at 8 weeks pregnant, ultrasound done that day showing viable pregnancy.  Patient returned for follow up 12wk OB appointment and 11w4d and ultrasound showed no cardiac activity with pregnancy measuring 8w6d.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Blood sodium decreased, Chest X-ray normal, Cyanosis, Febrile convulsion, Full blood count normal
Clinical narrative: About 4 hours following the immunizations the patient was seen having a seizure lasting about a minute. No fever noted prior to the seizure, though he did have a fever following the seizure. Some cyanosis during the seizure so was taken to the ED where he was diagnosed with febrile seizure, though it is uncertain if fever was the cause of the seizure. Was seen again in clinic the following day for follow up and did have a little fever, but was otherwise doing very well.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Metabolic acidosis, Pyrexia, Seizure
Clinical narrative: About 4 hours following the immunizations the patient was seen having a seizure lasting about a minute. No fever noted prior to the seizure, though he did have a fever following the seizure. Some cyanosis during the seizure so was taken to the ED where he was diagnosed with febrile seizure, though it is uncertain if fever was the cause of the seizure. Was seen again in clinic the following day for follow up and did have a little fever, but was otherwise doing very well.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion
Clinical narrative: She got a big bruise in the arm after about 5 days.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient called pharmacy to inform that he has had soreness and pain of the arm in which he received the immunization. The pain started 2 days after immunization. He says the pain has gotten worse since it began. He said that it is difficult to raise his arm unless he massages the arm first. He has treated with TYLENOL and massage. Still has pain today. Pain has persisted about 6 -7 days now.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Big (baseball size), red, round, sore area on left arm where vaccinated (deltoid). Lasted 2-3 days, then went away.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Pt stated she has had pain radiating down left arm to hand since vaccine. She also stated having pain radiating from shoulder up through neck. Pt stated movement has improved but cannot sleep on left side due to pain. The pain does not radiate down to hand any longer but does go to elbow. Pt stated heat makes pain worse and has taken ALEVE some to help with pain. Pt stated certain movements are very painful but has full range of motion.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Vertigo
Clinical narrative: Pt reports feeling "not so good" for a day or so after receiving vaccination, then 2 days after she had a bad episode of dizziness/vertigo. Husband called ambulance. Pt reports she was feeling better by the time EMT's arrived and was checked out, but they were unable to find anything wrong. They did not take her to the hospital. Pt reports feeling fine now (7 days later). When asked about other symptoms, pt reports no headache, fever, muscle aches, or nausea during time of feeling "not so good" or during the episode.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Swelling and severe soreness at the site of injection. Some itching developed. Onset was within 24 hours of receiving vaccination. Patient was seen by primary care provider and reaction was said to be allergic. Type not specified. No signs of infection or trauma at site of injection. Complete resolution of symptoms within 1 week.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: I continue to have pain in my arm that radiates from my shoulder down. I also feel sharp pain in my left scapula area.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, White blood cell count increased
Clinical narrative: Patient got red swollen arm with streaks, went to ER 12/4/2017 got ROCEPHIN shot and now on KEFLEX.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Erythema, Swelling face
Clinical narrative: Facial swelling, redness, minimal trouble breathing. In ER, given steroids, PEPCID and inhaler.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient with 2 weeks of redness and swelling at site of injection. Patient was already on antibiotics for a different condition.
Age: 12.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Pain
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender with sinus infection as concurrent condition. No information was provided regarding the patient's medical history, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced vomiting, arthralgia and fever overnight. The reporter stated that the patient was in the emergency room at an unspecified hospital getting unspecified test for "flu". The outcome of vomiting, pyrexia, and arthralgia was reported as not recovered. The causality between the aforementioned events and PNEUMOVAX 23 was not reported. Follow-up information was received from the physician on 30-NOV-2017. The patient was identified to be a 12 year old male. His concurrent conditions included asthma, allergic rhinitis, recurrent sinusitis and allergies. On 13-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N011867 and expiration on 08-NOV-2018) at left deltoid via intramuscular route. The patient's concomitant therapies included ADVAIR, PROAIR HFA, FLONASE and XYZAL. The patient was vaccinated at the private doctor's office/hospital. The vaccine was purchased with the private funds. It was reported that his illness at the time of vaccination was sinusitis. On 13-NOV-2017, the patient also received AUGMENTIN for sinusitis. The patient did not receive any other vaccinations within 4 weeks prior to PNEUMOVAX 23 received on 13-NOV-2017. On 13-NOV-2017, the patient developed elevated temperature, redness and warmth at injection site at left deltoid. The patient was vomiting in the evening and morning following the vaccination. On 14-NOV-2017, the white blood cells (WBC) was found to be 30020 (units not reported) (also reported as greater than 30,000). Over 15-NOV-2017, the patient developed elevated temperature, dizziness, weakness, body aches and vomiting. The patient was directed to the emergency room (ER). On an unknown date in November 2017, the patient was admitted, where the initial diagnosis was cellulitis, however was eventually diagnosed with sepsis. It was reported that the patient received treatment at a different facility, however more details were not aware. On an unknown date in 2017, the patient had low pneumococcal titers. The outcome of low pneumococcal titers was unknown. On an unknown date in 2017, the patient had recovered from sepsis, injection site erythema, and injection site warmth. The causality for the events was unknown.
Age: 12.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Retching, Vomiting
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender with sinus infection as concurrent condition. No information was provided regarding the patient's medical history, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced vomiting, arthralgia and fever overnight. The reporter stated that the patient was in the emergency room at an unspecified hospital getting unspecified test for "flu". The outcome of vomiting, pyrexia, and arthralgia was reported as not recovered. The causality between the aforementioned events and PNEUMOVAX 23 was not reported. Follow-up information was received from the physician on 30-NOV-2017. The patient was identified to be a 12 year old male. His concurrent conditions included asthma, allergic rhinitis, recurrent sinusitis and allergies. On 13-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N011867 and expiration on 08-NOV-2018) at left deltoid via intramuscular route. The patient's concomitant therapies included ADVAIR, PROAIR HFA, FLONASE and XYZAL. The patient was vaccinated at the private doctor's office/hospital. The vaccine was purchased with the private funds. It was reported that his illness at the time of vaccination was sinusitis. On 13-NOV-2017, the patient also received AUGMENTIN for sinusitis. The patient did not receive any other vaccinations within 4 weeks prior to PNEUMOVAX 23 received on 13-NOV-2017. On 13-NOV-2017, the patient developed elevated temperature, redness and warmth at injection site at left deltoid. The patient was vomiting in the evening and morning following the vaccination. On 14-NOV-2017, the white blood cells (WBC) was found to be 30020 (units not reported) (also reported as greater than 30,000). Over 15-NOV-2017, the patient developed elevated temperature, dizziness, weakness, body aches and vomiting. The patient was directed to the emergency room (ER). On an unknown date in November 2017, the patient was admitted, where the initial diagnosis was cellulitis, however was eventually diagnosed with sepsis. It was reported that the patient received treatment at a different facility, however more details were not aware. On an unknown date in 2017, the patient had low pneumococcal titers. The outcome of low pneumococcal titers was unknown. On an unknown date in 2017, the patient had recovered from sepsis, injection site erythema, and injection site warmth. The causality for the events was unknown.
Age: 12.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Antibody test negative, Arthralgia, Asthenia, Dizziness, Influenza virus test
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender with sinus infection as concurrent condition. No information was provided regarding the patient's medical history, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced vomiting, arthralgia and fever overnight. The reporter stated that the patient was in the emergency room at an unspecified hospital getting unspecified test for "flu". The outcome of vomiting, pyrexia, and arthralgia was reported as not recovered. The causality between the aforementioned events and PNEUMOVAX 23 was not reported. Follow-up information was received from the physician on 30-NOV-2017. The patient was identified to be a 12 year old male. His concurrent conditions included asthma, allergic rhinitis, recurrent sinusitis and allergies. On 13-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N011867 and expiration on 08-NOV-2018) at left deltoid via intramuscular route. The patient's concomitant therapies included ADVAIR, PROAIR HFA, FLONASE and XYZAL. The patient was vaccinated at the private doctor's office/hospital. The vaccine was purchased with the private funds. It was reported that his illness at the time of vaccination was sinusitis. On 13-NOV-2017, the patient also received AUGMENTIN for sinusitis. The patient did not receive any other vaccinations within 4 weeks prior to PNEUMOVAX 23 received on 13-NOV-2017. On 13-NOV-2017, the patient developed elevated temperature, redness and warmth at injection site at left deltoid. The patient was vomiting in the evening and morning following the vaccination. On 14-NOV-2017, the white blood cells (WBC) was found to be 30020 (units not reported) (also reported as greater than 30,000). Over 15-NOV-2017, the patient developed elevated temperature, dizziness, weakness, body aches and vomiting. The patient was directed to the emergency room (ER). On an unknown date in November 2017, the patient was admitted, where the initial diagnosis was cellulitis, however was eventually diagnosed with sepsis. It was reported that the patient received treatment at a different facility, however more details were not aware. On an unknown date in 2017, the patient had low pneumococcal titers. The outcome of low pneumococcal titers was unknown. On an unknown date in 2017, the patient had recovered from sepsis, injection site erythema, and injection site warmth. The causality for the events was unknown.
Age: 12.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site warmth, Pain, Pyrexia, Sepsis
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender with sinus infection as concurrent condition. No information was provided regarding the patient's medical history, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced vomiting, arthralgia and fever overnight. The reporter stated that the patient was in the emergency room at an unspecified hospital getting unspecified test for "flu". The outcome of vomiting, pyrexia, and arthralgia was reported as not recovered. The causality between the aforementioned events and PNEUMOVAX 23 was not reported. Follow-up information was received from the physician on 30-NOV-2017. The patient was identified to be a 12 year old male. His concurrent conditions included asthma, allergic rhinitis, recurrent sinusitis and allergies. On 13-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N011867 and expiration on 08-NOV-2018) at left deltoid via intramuscular route. The patient's concomitant therapies included ADVAIR, PROAIR HFA, FLONASE and XYZAL. The patient was vaccinated at the private doctor's office/hospital. The vaccine was purchased with the private funds. It was reported that his illness at the time of vaccination was sinusitis. On 13-NOV-2017, the patient also received AUGMENTIN for sinusitis. The patient did not receive any other vaccinations within 4 weeks prior to PNEUMOVAX 23 received on 13-NOV-2017. On 13-NOV-2017, the patient developed elevated temperature, redness and warmth at injection site at left deltoid. The patient was vomiting in the evening and morning following the vaccination. On 14-NOV-2017, the white blood cells (WBC) was found to be 30020 (units not reported) (also reported as greater than 30,000). Over 15-NOV-2017, the patient developed elevated temperature, dizziness, weakness, body aches and vomiting. The patient was directed to the emergency room (ER). On an unknown date in November 2017, the patient was admitted, where the initial diagnosis was cellulitis, however was eventually diagnosed with sepsis. It was reported that the patient received treatment at a different facility, however more details were not aware. On an unknown date in 2017, the patient had low pneumococcal titers. The outcome of low pneumococcal titers was unknown. On an unknown date in 2017, the patient had recovered from sepsis, injection site erythema, and injection site warmth. The causality for the events was unknown.
Age: 12.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender with sinus infection as concurrent condition. No information was provided regarding the patient's medical history, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced vomiting, arthralgia and fever overnight. The reporter stated that the patient was in the emergency room at an unspecified hospital getting unspecified test for "flu". The outcome of vomiting, pyrexia, and arthralgia was reported as not recovered. The causality between the aforementioned events and PNEUMOVAX 23 was not reported. Follow-up information was received from the physician on 30-NOV-2017. The patient was identified to be a 12 year old male. His concurrent conditions included asthma, allergic rhinitis, recurrent sinusitis and allergies. On 13-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N011867 and expiration on 08-NOV-2018) at left deltoid via intramuscular route. The patient's concomitant therapies included ADVAIR, PROAIR HFA, FLONASE and XYZAL. The patient was vaccinated at the private doctor's office/hospital. The vaccine was purchased with the private funds. It was reported that his illness at the time of vaccination was sinusitis. On 13-NOV-2017, the patient also received AUGMENTIN for sinusitis. The patient did not receive any other vaccinations within 4 weeks prior to PNEUMOVAX 23 received on 13-NOV-2017. On 13-NOV-2017, the patient developed elevated temperature, redness and warmth at injection site at left deltoid. The patient was vomiting in the evening and morning following the vaccination. On 14-NOV-2017, the white blood cells (WBC) was found to be 30020 (units not reported) (also reported as greater than 30,000). Over 15-NOV-2017, the patient developed elevated temperature, dizziness, weakness, body aches and vomiting. The patient was directed to the emergency room (ER). On an unknown date in November 2017, the patient was admitted, where the initial diagnosis was cellulitis, however was eventually diagnosed with sepsis. It was reported that the patient received treatment at a different facility, however more details were not aware. On an unknown date in 2017, the patient had low pneumococcal titers. The outcome of low pneumococcal titers was unknown. On an unknown date in 2017, the patient had recovered from sepsis, injection site erythema, and injection site warmth. The causality for the events was unknown.
Age: 51.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Breast tenderness, Burning sensation, Herpes zoster, Pruritus, Rash
Clinical narrative: Diagnosed with Shingles(Herpes Zoster) 12/2/17 by Urgent Care. Received a TWINRIX HepA/HepB stick on 11/15/17 at Primary Care. On or about 11/22/17 noticed itching/burning in one specific location on my right side upper back. A few days later noticed pain/tenderness in right breast. A rash appeared on or about 11/28/17.
Age: 51.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Breast pain, Breast tenderness, Burning sensation, Herpes zoster, Pruritus
Clinical narrative: Diagnosed with Shingles(Herpes Zoster) 12/2/17 by Urgent Care. Received a TWINRIX HepA/HepB stick on 11/15/17 at Primary Care. On or about 11/22/17 noticed itching/burning in one specific location on my right side upper back. A few days later noticed pain/tenderness in right breast. A rash appeared on or about 11/28/17.
Age: 51.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Rash
Clinical narrative: Diagnosed with Shingles(Herpes Zoster) 12/2/17 by Urgent Care. Received a TWINRIX HepA/HepB stick on 11/15/17 at Primary Care. On or about 11/22/17 noticed itching/burning in one specific location on my right side upper back. A few days later noticed pain/tenderness in right breast. A rash appeared on or about 11/28/17.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe pain in shoulder and limited a movement.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 17-year-old male patient with attention deficit disorder with hyperactivity (ADHD). On 11-OCT-2012, the patient received first dose of GARDASIL (dose, route of administration, lot# and expiration dates were not reported). On 30-NOV-2012, and subsequently 01-APR-2013, the patient was vaccinated with a second and third dose of GARDASIL (dose, route of administration, lot# and expiration dates were not reported). On an unknown date, the patient was vaccinated with GARDASIL 9, for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On 08-NOV-2017, the patient was vaccinated with of GARDASIL 9, 1 dose, intramuscularly in right deltoid, lot# reported as N021733 for prophylaxis (expiration date was not reported) and first dose of BEXSERO 1 dose, intramuscularly in left deltoid batch# 16Btd at private doctor's office/ hospital. The vaccines was purchased with private funds. Concomitant therapies included propranolol and atomoxetine hydrochloride (STRATTERA). On 11-OCT-2017, the patient developed a fever of unknown temperature. The patient did not have prescribe any treatment for the event. The patient recovered form the event on an unknown date in approximately November 2017. The relatedness between th events and suspect vaccines was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to pa atient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (STERILE DILUENT). The nurse reported that on an unspecified date the patient received an improperly stored dose of ZOSTAVAX lot number: N025387 (expiration date: 12-DEC-2018) for prophylaxis (strength, route, dose or units were not provided), which was reconstituted with a properly stored sterile diluent (STERILE DILUENT). The storage characteristics were the following: - Temperature: 15 °F to 46°F - Time frame: 40 minutes - Previous temperature excursion: 15 °F to 46°F for 40 minutes No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner concerning a 16 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date, before patient's 15th birthday, she was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 20-NOV-2017 (reported as today) the patient went to the office to receive GARDASIL 9 second dose for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Nodule, Swelling
Clinical narrative: This spontaneous report was received from a physician and a medical assistant, via a company representative, referring to a 67 year old female patient. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. 20-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 one injection of 0.5 ml intramuscularly in the arm, lot # N020501, expiration date on 03-MAR-2019, previously reported as lot # NO23651, expiration date on an unknown date in May 2019, for vaccination per CDC guidelines (strength was not reported). On 21-NOV-2017, reported as a day later, the patient experienced red ringed rash with heat at the injection site. On the same day, the patient also experienced large knot, redness, swelling and tenderness that lasted 4 days. The patient sought medical attention and called the physician who advised the patient to take an unspecified dose of the over-the-counter antihistamine cetirizine hydrochloride (ZYRTEC) as treatment, also reported by the medical assistant as no medication was prescript as treatment for the adverse event; conflicting information. At the time of reporting, the outcome of the injections site warmth and injection site rash was unknown. The outcome of large knot, redness, swelling and tenderness was reported as resolved on 25-NOV-2017. Additionally, the causality assessment between events and PNEUMOVAX 23 was not provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010085:
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: This spontaneous report was received from a physician and a medical assistant, via a company representative, referring to a 67 year old female patient. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. 20-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 one injection of 0.5 ml intramuscularly in the arm, lot # N020501, expiration date on 03-MAR-2019, previously reported as lot # NO23651, expiration date on an unknown date in May 2019, for vaccination per CDC guidelines (strength was not reported). On 21-NOV-2017, reported as a day later, the patient experienced red ringed rash with heat at the injection site. On the same day, the patient also experienced large knot, redness, swelling and tenderness that lasted 4 days. The patient sought medical attention and called the physician who advised the patient to take an unspecified dose of the over-the-counter antihistamine cetirizine hydrochloride (ZYRTEC) as treatment, also reported by the medical assistant as no medication was prescript as treatment for the adverse event; conflicting information. At the time of reporting, the outcome of the injections site warmth and injection site rash was unknown. The outcome of large knot, redness, swelling and tenderness was reported as resolved on 25-NOV-2017. Additionally, the causality assessment between events and PNEUMOVAX 23 was not provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010085:
Sex: U
Vaccine: HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On unspecified dates, the patients received an improperly stored dose of ROTATEQ (lot #N003392, expiration date 11-OCT-2018, lot N011648 expiration date 01-DEC-2018), or M-M-R II (lot N004433, expiration date 07-FEB-2019, lot M011667, expiration date 08-MAR-2018), or LIQUID PEDVAXHIB (lot N012920, expiration date 07-FEB-2020, lot M034188, expiration date 20-MAY-2019) . The sterile diluent (manufacturer unknown) (lot N006804, expiration date 11-MAR-2018) to reconstitute measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was properly stored. The time frame was 1 hour 14 minutes with temperature of 9 degree Celsius (C) to 25 degree C (10 degree C). Digital Data Logger was involved. There was previous temperature excursion (9 degree C to 25 degree C (10 degree C) for 2 hours 15 minutes). No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a single dose of PNEUMOVAX 23 one dose, 0.5 ml, intramuscularly, lot # N012840 and expiration date: 20-JAN-2019. The medical assistant reported a leaking PNEUMOVAX 23 Luer-Lok syringe during administration of the vaccine. No adverse effect was reported. No causality assessment was provided by the reporter.
Age: 0.83
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report as received from a physician via company representative concerning to a 10 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with ROTATEQ by oral route of administration for prevention of rotavirus (dose, lot number and expiration date were not reported). On an unknown date, the patient was hospitalized "for an unknown number of days" and was diagnosed with intussusception. The patient received an unspecified treatment and eventually recovered from the event. The causal relationship between the event and therapy with ROTATEQ was not reported and no product quality complaint was involved. Upon internal review the event intussusception was considered to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of properly stored M-M-R II therapy type rHA, lot # N013868, expiration date 04-MAY-2019 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with improperly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse events were reported. The sterile diluent had been improperly stored at a temperature of -1 degree Celsius or colder (-10 degrees Celsius) for 6 days, through unknown number of cycles. There had been no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA003734:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of properly stored M-M-R II therapy type rHA, lot # N009800, expiration date 24-MAR-2019 (also reported as 24-FEB-2019) (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with improperly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse events were reported. The sterile diluent had been improperly stored at a temperature of -1 degree Celsius or colder (-10 degrees Celsius) for 6 days, through unknown number of cycles. There had been no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA003734: