chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates (reported as since 18-NOV-2016), the patients might have been administered with PNEUMOVAX 23 (lot # M036161, expiry date: 06-MAY-2018). The vaccine was stored at a temperature of 9C for 176 hours (a maximum temperature reading of 9C in the morning for 11 days, from 18-NOV-2016 to 28-NOV-2016 evaluated for 16 hours each day). There was no previous temperature excursion. Data logger was not involved. No adverse effects have been reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA001425: US-009507513-1612USA001916: US-009507513-1612USA001924.
Sex: U
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a medical assistance and refers to a multiple patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a GARDASIL (dose, route of administration, frequency, lot # and expiration date were not reported). Immediately, after receving a GARDASIL, while the patients were still in the office, they developed episodes of syncope, which usually lasted for about 45 minutes. No treatment was given to the patients for the event. There was no product quality complaint involved. Subsequently, the patients were fully recovered and went home. The causality between event of syncope and GARDASIL was not provided. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA007023.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M007124, expiration date 05-OCT-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 33.4 degrees Fahrenheit for 60 hours and 35 minutes. There were no previous excursions. It was unsure if data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA008871.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer. This consumer reported similar events for herself and a friend. This is 2nd of 2 reports. A female patient of an unspecified age and race received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date (3 or 4 years ago) for immunisation. The patient medical history and concomitant medications were not reported. The patient just got pneumonia recently on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016449610 Same reporter/vaccine/event, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his mother.  A female patient of an unspecified age and race received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced some redness and swelling. Some days later, the swelling started to worsen compared to before and the redness increased to where it is covering almost the entire arm. Also, she began experiencing itching at the injection site. The outcome of the events was not recovered.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Presyncope, Syncope
Clinical narrative: This is a spontaneous report from a contactable medical assistant communicated to a Pfizer sales representative. A 16 or 17 years old male patient of an unspecified age and race received TRUMENBA, intramuscular at 0.5 ml single and MENACTRA MCV4, via an unspecified route of administration at 1 DF single, both on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the patient receiving the vaccines, he fainted, had a vassal vagal response to them with outcome of unknown.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. The pharmacist reported same event for 2 patients. This is the first of two reports. A 65 years old age or older female patient of an unspecified race received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen arm in Jul2016 with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016561791 Same product/event/reporter, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. The pharmacist reported same event for 2 patients. This is the second of two reports. A patient of unspecified age, race and gender received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen arm in Jul2016 with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016561730 Same product/event/reporter, different patient.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dyspnoea
Clinical narrative: Shortness of Breath began 4 hours after being administered PREVNAR 13 and FLUZONEHD. Patient used oxygen that her husband had at home and felt better after 2 hours.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature fluctuation, Chills, Hyperhidrosis, Injection site erythema, Injection site pruritus
Clinical narrative: Began with feeling chilled and whole body shaking; muscles in legs tightened; at 9:30 pm fever of 100.5 F; by 10:00 pm was 103.8 F (Grad 3).  Took 1 Aleve at 9:45 and a second at 10:00.  Began cold compresses to reduce fever.  By 11:30 pm had reduced to 102.2 F.  Had sweats most of the night with fever of 98.0 F when awoke.  During 12/05 temperature fluctuated between 98.4 F and 99.4 F. Note:  I had had itching and redness at the injection site; minimal/expected of Grade 1.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle tightness, Pyrexia, Tremor
Clinical narrative: Began with feeling chilled and whole body shaking; muscles in legs tightened; at 9:30 pm fever of 100.5 F; by 10:00 pm was 103.8 F (Grad 3).  Took 1 Aleve at 9:45 and a second at 10:00.  Began cold compresses to reduce fever.  By 11:30 pm had reduced to 102.2 F.  Had sweats most of the night with fever of 98.0 F when awoke.  During 12/05 temperature fluctuated between 98.4 F and 99.4 F. Note:  I had had itching and redness at the injection site; minimal/expected of Grade 1.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: Had her first seizure on Sunday morning while attending church. No history of seizures, and no family history of seizures.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope after vaccine administration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Allergic reaction and hypersensitivity after the vaccine was administrated. The mother of the patient stated that the kid had hives all over his body, a rash and a lot of itching the day after the vaccine was administrated.
Age: 15.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Cold sweat, Electrocardiogram normal, Heart rate increased, Pallor, Syncope
Clinical narrative: Patient received hep A and hep B vaccines at 10:40 am. 10 minutes post administration patient became pale/grey in color with cool clammy skin and had an episode of syncope. Patient also with heart rate of 45 beats per minute. Syncopal episode lasted about 10 seconds, oxygen was applied and within 2-3 minutes patients heart rate increased and patient's color returned to pink. 911 called, EMS arrived to scene and patient escorted to emergency department for further evaluation.
Age: 15.0
Sex: F
Vaccine: IPV, MNQ, TD, VARCEL
Symptoms: Syncope
Clinical narrative: During vaccine administration patient had an episode of syncope. Patient remained conscious but was out of if for a few seconds, was pale but vital signs stable throughout. Patient recovered after 5-10 minutes of resting, drinking water and ice being applied to head.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: PATIENT SAID HIS ARM HAS BEEN SORE SINCE FOR A COUPLE OF WEEKS SINCE RECEIVING THE INFLUENZA VACCINE. DO NOT KNOW WHEN OR WHAT TIME IT BEGAN HURTING.  HAS NOT SEEN MD YET, BUT IS PLANNING ON MAKING AN APPOINTMENT.
Age: 65.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Pain in extremity, Pneumonia pneumococcal
Clinical narrative: This is a spontaneous report from a contactable physician, reporting for himself. This report was received via a sales representative.  An approximately 65-year-old male patient received PREVNAR 13 on an unspecified date at 0.5ml single dose intramuscularly in arm for preventive care.  The patient medical history was not reported.  Concomitant vaccine included influenza vaccine administered at the same time in the same arm.  The patient received the vaccines in a pharmacy. The patient developed Pneumococcal Pneumonia and was hospitalized on an unspecified date with outcome of unknown. The patient also experienced prolonged arm pain for 4 months, with outcome not recovered. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: 11/21/16 early evening with soreness in arm and limited use. Developed chills & fever later that evening. Tuesday 11/22/16 - Early morning - felt better - no chills - felt very tired and slept most of the day Early evening - fever (101) returned with chills - slept most of the night. Wednesday 11/23/16 Fever and chills gone. Redness on arm.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Somnolence
Clinical narrative: 11/21/16 early evening with soreness in arm and limited use. Developed chills & fever later that evening. Tuesday 11/22/16 - Early morning - felt better - no chills - felt very tired and slept most of the day Early evening - fever (101) returned with chills - slept most of the night. Wednesday 11/23/16 Fever and chills gone. Redness on arm.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose of Hep B was given to child.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose of Hep B given to child.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Neck pain, Pain, Pyrexia
Clinical narrative: Fever of 100.5, body aches and tiredness, pain in joints and neck on side where shot was given.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Itching and rash left shoulder and across torso.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pt was given the FLULAVAL QIV in left deltoid on 10/04/16. On 10/11/2016, Pt began having severe left shoulder pain and has been experiencing continued pain and decreased range of motion. The week of 11/21/16, Pt took a Medrol dose pak which did not provide relief. Pt is still undergoing diagnostics and treatment. On approx. 12/2/16, Pt had a shingles outbreak on her left torso/left arm. History of prior shingles breakouts but none in this location.
Age: 0.08
Sex: F
Vaccine: PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: It was found that when the pt received vaccines on 11/25/16 the PENTACEL powder was mixed with sterile diluent not the liquid component of the PENTACEL vaccine.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site erythema, Pruritus generalised
Clinical narrative: 3x2 inch red patch at injection site that became black and blue, Itching all over her body.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Multiple unspecified patients were administered improperly stored doses of GARDASIL 9; exposed to 29.3 F for 16 hours; No adverse effect; This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient's were vaccinated with improperly stored doses of GARDASIL 9 lot # M016193 with expiry date of 24-APR-2018 (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature of 29.3 Fahrenheit for 16 hours and this was logged on a digital data logger. No adverse effects were reported. Product quality complaint was not involved. As of 21-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA000952: MERCK 1610USA003023:Mfr number.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, after receiving the vaccine, the patient experienced severe swelling all the way down to elbow of the arm where injection was administered. The outcome of the event was unknown. Causality was not provided. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA004452.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender, who had an artificial limb. The patient's medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot# and expiration date were unknown) for prophylaxis. The vaccine was not actually administered into the artificial limb. On an unknown date, after receiving the vaccine, the patient experienced severe swelling and possible infection around injection site. The outcome of the events was unknown. Causality was not provided. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA004402.
Age: 19.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a 19 year old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 11-NOV-2016, a dose of ZOSTAVAX 19400 PFU (dose was unknown; lot number was M035147 with expiration date 25-OCT-2017) was administered subcutaneously to the patient in error today for prophylaxis. The patient was indicated to receive a dose of yellow fever vaccine, manufactured by Sanofi Pasteur. She states that the error was made because she reached in the freezer to get the vaccine, rather than the refrigerator. The patient did receive the dose of yellow fever vaccine in the other arm. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, FLUX, IPV, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report received from a medical assistant referred to a 5 year old female patient. The patient had no medical history or concomitant medications. In past on an unknown date, she had taken VARICELLA vaccine. The patient was prescribed 1 dose of M-M-R II but received 1 dose of PROQUAD 0.5 ml subcutaneously (Lot number: M029595, expiry date: 10-DEC-2017) for prophylaxis instead on 21-OCT-2016. The medical assistant reports to her knowledge the patient has not had any adverse effects to the PROQUAD vaccine. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case received from a medical assistant referred to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. From 18-NOV-2016 to 30-NOV-2016, the patients were administered improperly stored VARIVAX (lot number: L042266, expiry date: 27-OCT-2017). No adverse events were reported by the patients. The vaccine was stored at 0.1C for 1 hour and 16 minutes. There was no previous temperature excursions and call was because of data logger. This is one of the two reported received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case received from a pharmacist via a field representative referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received a ZOSTAVAX (dose, frequency, lot number and expiry date not reported) and the patient later had developed shingles (severity, duration, and lesion locations unknown). The current status of the patient is unknown. Causality for shingles is not reported. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperglycaemia
Clinical narrative: Hyperglycemia requiring increase use of insulin.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Acne, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: She received her seasonal influenza vaccine on 18 November and approximately 10 days later noted onset of localized redness and swelling associated with mild itching at the site. Over the past week she notes the redness has progressed and now notes a "pimple" at the injection site. She denies pain, swollen nodes, fever/chills, and systemic symptoms. She denies drainage from the injection site. She has received the seasonal influenza vaccine in past years and denies adverse reaction to this vaccine or other vaccines. She denies frequent infections to include skin infections.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Staphylococcus test positive
Clinical narrative: She received her seasonal influenza vaccine on 18 November and approximately 10 days later noted onset of localized redness and swelling associated with mild itching at the site. Over the past week she notes the redness has progressed and now notes a "pimple" at the injection site. She denies pain, swollen nodes, fever/chills, and systemic symptoms. She denies drainage from the injection site. She has received the seasonal influenza vaccine in past years and denies adverse reaction to this vaccine or other vaccines. She denies frequent infections to include skin infections.
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: Discomfort, Injection site urticaria, Urticaria
Clinical narrative: Hives appeared on back and shoulders the day following vaccine administration.  He reports that hydrocortisone cream helped some with the discomfort.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphonia, Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: I administered the Tdap vaccine to patient at 2:43 pm today. I told her to stay around in the area for at least 20 minutes so that we can monitor for allergic reactions. She came back to the pharmacy counter at 3:00 pm because she was having an allergic reaction, and she  needed Epipen administration. I administered the Epipen at 3:02 pm because she was having shortness of breath, she was hoarse, and she felt like her throat was closing. I asked the Technician to call 911. I observed patient closely until EMS arrived; she remained calm, alert, and sat in an upright position. EMS arrived at 3:08 pm and took her to the hospital.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt complained of extreme pain at the time of the injection and her arm was very sore for a couple of days. She is still experiencing pain in her arm when moving up and down. Pain is relieved by myoflex rub.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Patient presented with a raised red rash on the back of her upper arm that migrated down to the outer elbow.
Age: 12.0
Sex: F
Vaccine: FLU4, HEPA, MNQ
Symptoms: Allergy to animal, Condition aggravated, Eye pruritus, Musculoskeletal pain, Neck pain
Clinical narrative: Tingling in fingers on 12/1 that lasted two hours. 12/2: Neck/shoulder pain, with Sore throat, itchy eyes following a visit to her aunts.  Aunt has pets, which she is allergic.  Also, Patient was caring for mother who had viral URI that developed the day of vaccine administration.  Symptoms progressed on 12/3-4, worse on Sunday, given motrin 600mg which helped.  Seen on Monday morning.
Age: 12.0
Sex: F
Vaccine: FLU4, HEPA, MNQ
Symptoms: Oropharyngeal pain, Paraesthesia
Clinical narrative: Tingling in fingers on 12/1 that lasted two hours. 12/2: Neck/shoulder pain, with Sore throat, itchy eyes following a visit to her aunts.  Aunt has pets, which she is allergic.  Also, Patient was caring for mother who had viral URI that developed the day of vaccine administration.  Symptoms progressed on 12/3-4, worse on Sunday, given motrin 600mg which helped.  Seen on Monday morning.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Infection, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient describes swollen, warm, red injection site.  Physician husband suspects infection, and they will see PCP tomorrow.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Asthenia, Blood immunoglobulin A increased, Burning sensation, Costochondritis
Clinical narrative: Costal chondritis began the morning after the first injection in the series. 2nd shot resulted in lactose intolerance, loss of appetite and serious bleeding and lethargy with period. 3rd shot resulted in petechial rashes and HSP and IGA in her system. Multiple hospital stays. And pancreatitis due to meds administered for pain.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Decreased appetite, Dysmenorrhoea, Fatigue, Haemorrhage, Henoch-Schonlein purpura
Clinical narrative: Costal chondritis began the morning after the first injection in the series. 2nd shot resulted in lactose intolerance, loss of appetite and serious bleeding and lethargy with period. 3rd shot resulted in petechial rashes and HSP and IGA in her system. Multiple hospital stays. And pancreatitis due to meds administered for pain.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Lactose intolerance, Lethargy, Menorrhagia, Pancreatitis, Petechiae
Clinical narrative: Costal chondritis began the morning after the first injection in the series. 2nd shot resulted in lactose intolerance, loss of appetite and serious bleeding and lethargy with period. 3rd shot resulted in petechial rashes and HSP and IGA in her system. Multiple hospital stays. And pancreatitis due to meds administered for pain.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash pustular
Clinical narrative: Costal chondritis began the morning after the first injection in the series. 2nd shot resulted in lactose intolerance, loss of appetite and serious bleeding and lethargy with period. 3rd shot resulted in petechial rashes and HSP and IGA in her system. Multiple hospital stays. And pancreatitis due to meds administered for pain.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Influenza virus test positive, Pyrexia, Rhinorrhoea
Clinical narrative: Started getting a runny nose.  Condition worsened for the next three days with acute runny nose, cough and fever coming on.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient describes that after receiving the influenza immunization, he had a dull achy pain that occasionally radiates to his elbow. He has pain daily and it has been present ever since the immunization. He sought medical treatment by his primary doctor on 12/1/16. The doctor is not certain of the cause but attributes his pain to either muscle damage caused by the injection or a torn rotator cuff due to lifting weights several times weekly. He will follow up with physical therapy and X-ray if symptoms do not improve.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Nodule, Pruritus
Clinical narrative: KNOT IN ARM, ITCHING, REDNESS AT SITE.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Pyrexia
Clinical narrative: PATIENT HAD ITCHING, REDNESS IN A LARGE PATCH, POSSIBLE SLIGHT FEVER.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Herpes zoster, Malaise, Rash
Clinical narrative: Lower back pain, feeling sick, followed by rash on lower back.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Electroencephalogram, Febrile convulsion, Pyrexia, Seizure
Clinical narrative: Mother called provider on call was informed child fever increased 101.7 (A) and a prolonged febrile seizure. Was taken to ER and then transferred to another hospital.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Cold sweat, Fall, Injection site haemorrhage, Pallor
Clinical narrative: Pt received a flu vaccine at a school clinic on 11/16/16. Pt tol vaccine well, walked back to his classroom. Approx 15 min later, pt was sitting at his desk, removed the bandaid saw a sm dot of blood at injection site and had syncopal episode falling onto floor. Pt's teacher said when she noticed pt he was unresponsive but breathing, laying on floor supine. Teacher summoned for assistance. School nurse and this public health nurse responded at 10:50 AM to find pt very drowsy but responsive laying on floor pale and clammy. P-99. R-20. Pt denies pain, no seizure act, no incontinence. 1058 B/P 90/60. P-71. R-16. O2 98%.  Pt A & O, answering appropriately to current events. Denies neck or back pain. Moves all extremities, passively and denies discomfort. No PMH. Verbalized he ate a donut for breakfast. PEARL. Grasp - strong and =. Mother notified 11A. Pt sat up and vomited approx 75 cc emesis. HR-170. R-24. O2 sat 99%. B/P 82/50. No obvious head trauma. No bleeding. No hematoma. Mom present and said pt has been dealing w/anxiety. Pt normally gets vaccines in a health care setting instead of school clinic. 1110A B/P 112/78. P-100. R-16. O2 sat 94%. Color pale and warm. Family Dr, contacted and mother to take for an evaluation. Pt sitting up again quiet but feeling better. 1117 AM - B/P 100/60. P-92. R-20. PEARL. A & ). to care in W/C. This nurse then spoke w/Dr staff. No lab, no x-rays ordered. No seizure act. DX - Syncopal episode R/t anxiety.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Somnolence, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Pt received a flu vaccine at a school clinic on 11/16/16. Pt tol vaccine well, walked back to his classroom. Approx 15 min later, pt was sitting at his desk, removed the bandaid saw a sm dot of blood at injection site and had syncopal episode falling onto floor. Pt's teacher said when she noticed pt he was unresponsive but breathing, laying on floor supine. Teacher summoned for assistance. School nurse and this public health nurse responded at 10:50 AM to find pt very drowsy but responsive laying on floor pale and clammy. P-99. R-20. Pt denies pain, no seizure act, no incontinence. 1058 B/P 90/60. P-71. R-16. O2 98%.  Pt A & O, answering appropriately to current events. Denies neck or back pain. Moves all extremities, passively and denies discomfort. No PMH. Verbalized he ate a donut for breakfast. PEARL. Grasp - strong and =. Mother notified 11A. Pt sat up and vomited approx 75 cc emesis. HR-170. R-24. O2 sat 99%. B/P 82/50. No obvious head trauma. No bleeding. No hematoma. Mom present and said pt has been dealing w/anxiety. Pt normally gets vaccines in a health care setting instead of school clinic. 1110A B/P 112/78. P-100. R-16. O2 sat 94%. Color pale and warm. Family Dr, contacted and mother to take for an evaluation. Pt sitting up again quiet but feeling better. 1117 AM - B/P 100/60. P-92. R-20. PEARL. A & ). to care in W/C. This nurse then spoke w/Dr staff. No lab, no x-rays ordered. No seizure act. DX - Syncopal episode R/t anxiety.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Bedridden, Discomfort, Influenza like illness, Muscular weakness
Clinical narrative: Patient reports she could not walk for 3 days. All of her muscles were very weak and heavy. She had to use a walker or cane over the last week and a half. Patient reports that 5 years ago she had more mild flu-like symptoms and was bed ridden for 4 days. Patient denies any respiratory component.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Walking aid user
Clinical narrative: Patient reports she could not walk for 3 days. All of her muscles were very weak and heavy. She had to use a walker or cane over the last week and a half. Patient reports that 5 years ago she had more mild flu-like symptoms and was bed ridden for 4 days. Patient denies any respiratory component.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Discomfort, Drug administered to patient of inappropriate age, Muscular weakness, Walking aid user
Clinical narrative: Patient reports she could not walk for 3 days. All of her muscles were very weak and heavy. She had to use a walker or cane over the last week and a half. Patient reports that 5 years ago she had more mild flu-like symptoms and was bed ridden for 4 days. Patient denies any respiratory component.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on upper torso and arms.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Nausea, Pain in extremity, Retching
Clinical narrative: Patient reports arm pain, chills, cough, nausea, and gagging ever since receiving vaccine on 11/9/2016.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Induration, Inflammation, Peripheral swelling, Skin warm
Clinical narrative: Arm swelling and hard, inflamed and hot immediately following vaccination and continued for 4 plus weeks.
Age: 72.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Induration, Peripheral swelling
Clinical narrative: Patient described left arm was swollen and "hard as a rock"; sx began afternoon of 12/6/16. Advised patient to call his MD.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: FLUX
Symptoms: Abdominal pain, Diarrhoea, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, hard (L) upper arm - hot to touch, took 4 days to go away. Severe diarrhea that night. Sore abdomen for 3 weeks. (Hx of leaky gut).
Age: 10.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Erythema, Hypoaesthesia, Pain, Peripheral swelling, Pruritus
Clinical narrative: 12/1/16 -child presented to clinic with concern for redness and swelling to (L) arm. At home, the evening after vaccines given, redness and swelling began. Patient told mom there was pain and some numbness. The following morning parents noticed swelling from shoulder to elbow and was red. Pain also with movement. Pain improved, but some itchiness, redness also improved. No fever. No treatment needed.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt received PCV13 on 9/15/16 and states to have persistent left shoulder pain at the sight of injection. Pain has been subsiding slowly.
Age: 64.0
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives allergist is following up.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Pain, Rash erythematous, Skin warm
Clinical narrative: Pain, redness, warmth, hardness, erythematous and patch rash.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: The patient has been having pain in her arm for 3 weeks since the shot. Referred the patient to her doctor.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Red erythema on lower (L) arm below injection site. Occurred night of Flu shot. Currently has erythema (Red/Purple color) w/Heat, no pain, about 5 inches x 3 inches in size.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Inflammation, cellulitis at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site inflammation
Clinical narrative: Inflammation, cellulitis at injection site.
Age: 62.0
Sex: M
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: And swelling
Age: 60.0
Sex: M
Vaccine: DTP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: And warmth, redness, tenderness 2 inch duration around injection site.
Age: 59.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: The patient called the pharmacy 12-5-16. He stated he is having numbness and tingling in his right arm after receiving a vaccine on 11/29/16. I left a message with his primary care MD and spoke with staff at the ordering physician's office. Staff recommended pt go to ER. I let pt know that.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Limb discomfort, Mobility decreased, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received BEXSERO (batch number 151401A, expiry date December 2016). On 27th July 2016 14:00, the patient received the 1st dose of BEXSERO (intramuscular). On 27th July 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain (serious criteria disability) and injected limb mobility decreased (serious criteria disability). BEXSERO was discontinued. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. The reporter considered the injection site pain and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional details were received as follows: The concomitant medications were unknown. The patient received a dose of BEXSERO in her left deltoid. It was reported that the patient experienced severe pain. The arm where the patient received the vaccine got hurt like she had broken her arm. For 3 weeks the patient could hardly move her arm and had difficulty moving or raising her arm. The reporter came to know about the event when the patient came in for her 2nd dose on 14th September 2016. It was decided not to administer the 2nd dose. The reporter stated that she had told this information to the field representative and the field representative told her to call GlaxoSmithKline. It was unknown if the field representative had called for this event.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received BEXSERO (batch number 151401A, expiry date December 2016). On 27th July 2016 14:00, the patient received the 1st dose of BEXSERO (intramuscular). On 27th July 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain (serious criteria disability) and injected limb mobility decreased (serious criteria disability). BEXSERO was discontinued. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. The reporter considered the injection site pain and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional details were received as follows: The concomitant medications were unknown. The patient received a dose of BEXSERO in her left deltoid. It was reported that the patient experienced severe pain. The arm where the patient received the vaccine got hurt like she had broken her arm. For 3 weeks the patient could hardly move her arm and had difficulty moving or raising her arm. The reporter came to know about the event when the patient came in for her 2nd dose on 14th September 2016. It was decided not to administer the 2nd dose. The reporter stated that she had told this information to the field representative and the field representative told her to call GlaxoSmithKline. It was unknown if the field representative had called for this event.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Influenza like illness, Injection site inflammation, Injection site swelling, Paraesthesia
Clinical narrative: Marked swelling, redness and pain of entire right arm and hand (injection in right arm). Dizziness, loss of balance and lightheadedness. Swelling and redness reduced after 5-6 days. Other symptoms persist to some degree more than a week post injection.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Balance disorder, Dizziness, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Marked swelling, redness and pain of entire right arm and hand (injection in right arm). Dizziness, loss of balance and lightheadedness. Swelling and redness reduced after 5-6 days. Other symptoms persist to some degree more than a week post injection.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Tremor
Clinical narrative: C/O dizziness and Shakiness after influenza vaccines was administered.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician 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 14-SEP-2016, the patient was vaccinated with an expired dose of ROTATEQ, orally, lot # L008034, expiration date: 05-AUG-2016 (dose was not provided) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Follow up information was received from the physician on 21-NOV-2016. The patient was vaccinated at the private reporter's office/hospital. The reporter did not have any additional information to provide for the patient. Additional information is not expected, as no further information is available. Sender's Comments: MERCK 1609USA007571:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse (RN) concerning an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. Since 22-SEP-2016, the patients were vaccinated with an unspecified number of improperly stored doses of VARIVAX for prophylaxis (lot number M025867 with an expiration date of 24-MAY-2018, lot number M024683 with an expiration date of 18-MAY-2018, lot number reported as M024675 with an expiration date of 18-MAY-2018 and lot number L050956 with an expiration date of 17-DEC-2017) (strength, dosage, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. Lot number M024675 has been verified to be a valid lot number for VARIVAX. Follow up information was received on 21-NOV-2016 from the registered nurse via a telephone call. The nurse stated that she would research and fax the patient identifiers and any dates of vaccinations. Additional information has been requested. Sender's Comments: MERCK 1610USA001176:Mfr number.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ Vial, lot # M019707 with expiry date 25-OCT-2017 (dosing details unknown) for prophylaxis. Administered doses of ROTATEQ experienced a temperature excursion of 60.1 degrees Fahrenheit (F) for 14 hours and 15 minutes, 47.5 degrees Fahrenheit (F) for 30 minutes, 47.3 degrees Fahrenheit (F) for 30 minutes, 50.7 degrees Fahrenheit(F) for 30 minutes and 32.7 degrees Fahrenheit (F) for 2 hours and 15 minutes. There was no previous temperature excursion. The call was because of a data logger. No symptoms were reported. Product quality complain was not reported. Follow up information has been received on 01-DEC-2016 from a nurse, who stated that administered doses of ROTATEQ experienced also a temperature excursion of 33.1 degrees Fahrenheit (F) for 4 hours. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA005809: MERCK 1611USA005196:Mfr number.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in 2016, reported as "both were given within the year 2016", the patient inadvertently received 2 doses of PNEUMOVAX 23 (route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported. There was not product quality complaint involved. Additional information is not expected since there was no consent to contact the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a office manager and refers to multiple patient of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9, lot number L036301, expiration date 20-DEC-2017, lot number L037554, expiration date 25-DEC-2017, and lot number reported as M026306, expiration date 30-APR-2018, (dose, frequency, route, anatomical location were not reported), for prophylaxis. No other suspect or concomitant therapies were reported. The vaccines were exposed to 34.1 Fahrenheit degrees for 8 hours. A digital data logger was involved and there were no prior excursions. No adverse events were reported. No product quality complain was involved. Lot number M026306 is an invalid lot number for GARDASIL 9. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1611USA007153: MERCK 1611USA007209: Mfr number.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: Information has been received from a 43 years old "MR" moderator concerning unspecified patients (the patients' age and gender were not provided). On an unknown date, the patient was vaccinated with unidentified Merck hpv vaccine (name, lot #, expiration date, dosage and therapy route were not provided), for prophylaxis. Concomitant therapies were not informed. On an unspecified date, a negative published articles regarding unidentified Merck hpv vaccine were sent to the researcher moderator's social media. The outcome of the adverse event was unknown at the time of the report. The causal relationship between the adverse event and the suspect therapies was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and 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 an improperly stored dose of VARIVAX lot # M027342, expiration date 01-JUN-2018 (dose and route of administration was not reported). There was no adverse effects reported. Administered dose of vaccine was exposed to the temperature excursion of -14 degrees Celsius for 10 minutes. Data logger was involved. There were no previous excursions reported. No product compliant (PQC) was involved. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist referring to an 81 year old male patient. There was no information about the patient's  pertinent medical history, concomitant medications and drug reactions or allergies provided. On 16-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (dose, site of administration , lot# and expiration date were not reported) for prevention of shingles. On 17-NOV-2016 (reported as the following day), the patient returned to the pharmacist and was experiencing swelling from the shoulder to the elbow and it was tender, itchy and red (onset date on 17-NOV-2016). An unspecified treatment was given for the events. Product quality complaint was not involved. The outcome of swelling from the shoulder to the elbow, tender and itchy was considered to be recovering/resolving, while the outcome of redness was considered to be not recovered/not resolved, as  the patient returned on 21-NOV-2016 (reported as today) and stated that the symptoms "had gotten better but still a little red". The relatedness between the events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Rash pruritic, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist referring to an 81 year old male patient. There was no information about the patient's  pertinent medical history, concomitant medications and drug reactions or allergies provided. On 16-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (dose, site of administration , lot# and expiration date were not reported) for prevention of shingles. On 17-NOV-2016 (reported as the following day), the patient returned to the pharmacist and was experiencing swelling from the shoulder to the elbow and it was tender, itchy and red (onset date on 17-NOV-2016). An unspecified treatment was given for the events. Product quality complaint was not involved. The outcome of swelling from the shoulder to the elbow, tender and itchy was considered to be recovering/resolving, while the outcome of redness was considered to be not recovered/not resolved, as  the patient returned on 21-NOV-2016 (reported as today) and stated that the symptoms "had gotten better but still a little red". The relatedness between the events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.