chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Abdominal pain upper, Agitation, Eye pain, Eye swelling, Ocular hyperaemia
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 11 August 2016. This case involves a 2 month old male patient who was vaccinated with a dose of DAPTACEL (batch number- C5101AA, expiry date- 26 November 2018, route of administration was not reported) in left deltoid and dose of POLIOMYELITIS VACCINE INACTIVATED (IPV) (other manufacturer, batch number, expiry date, route of administration was not reported) in left deltoid on 10 August 2016. The patient had medical history of eosinophilic esophagitis, and reactive airway diseases and multiple allergies with milk, wheat, egg, tree nuts, soy, fish, shellfish, corn, and oats. The patient receives "allergy shots" twice a week. Concomitant medications were not reported. On 10 August 2016, about 5-10 minutes following the vaccination, the patient began to scream in pain and he was bending over holding his stomach, his eyes and stomach were hurting him. On the same date, screaming increased and he was acting very agitated, vomited once and developed hives on chest and back, had bright red rash and hives erupted all over and eyes were beginning to swell. The office nurse assessed the patient. The patient required ER/doctor visit. Lab was not performed. The patient received corrective treatment with Benadryl  Diphenhydramine hydrochloride) (given by physician), EPI pen (epinephrine), Zyrtec (Cetirizine hydrochloride) and steroids (prednisolone). The patient would be on Prednisolone for few more days. The event eye swelling was (subsided) recovered on unknown date and hives were decreased. The outcome of the event stomach pain, agitation, screaming, vomiting once and painful red eyes were reported as unknown.No respiratory involvement reported. Follow up information received from a consumer on 16 September 2016. Patient's demographic detail was updated. This case involves four-year-old patient who was vaccinated with a dose of POLIOMYELITIS VACCINE (INACTIVATED) (Ipv) (batch number: M/205, manufacturer: Merck, route of administration were not reported). Patient vomited twice and red hives increased in number post vaccination. Patient's corrective treatment included epipen and medications and benadryl was given by nurse. On an unspecified date patient recovered from the events after treatment. List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Pain, Rash erythematous, Screaming, Swelling, Urticaria
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 11 August 2016. This case involves a 2 month old male patient who was vaccinated with a dose of DAPTACEL (batch number- C5101AA, expiry date- 26 November 2018, route of administration was not reported) in left deltoid and dose of POLIOMYELITIS VACCINE INACTIVATED (IPV) (other manufacturer, batch number, expiry date, route of administration was not reported) in left deltoid on 10 August 2016. The patient had medical history of eosinophilic esophagitis, and reactive airway diseases and multiple allergies with milk, wheat, egg, tree nuts, soy, fish, shellfish, corn, and oats. The patient receives "allergy shots" twice a week. Concomitant medications were not reported. On 10 August 2016, about 5-10 minutes following the vaccination, the patient began to scream in pain and he was bending over holding his stomach, his eyes and stomach were hurting him. On the same date, screaming increased and he was acting very agitated, vomited once and developed hives on chest and back, had bright red rash and hives erupted all over and eyes were beginning to swell. The office nurse assessed the patient. The patient required ER/doctor visit. Lab was not performed. The patient received corrective treatment with Benadryl  Diphenhydramine hydrochloride) (given by physician), EPI pen (epinephrine), Zyrtec (Cetirizine hydrochloride) and steroids (prednisolone). The patient would be on Prednisolone for few more days. The event eye swelling was (subsided) recovered on unknown date and hives were decreased. The outcome of the event stomach pain, agitation, screaming, vomiting once and painful red eyes were reported as unknown.No respiratory involvement reported. Follow up information received from a consumer on 16 September 2016. Patient's demographic detail was updated. This case involves four-year-old patient who was vaccinated with a dose of POLIOMYELITIS VACCINE (INACTIVATED) (Ipv) (batch number: M/205, manufacturer: Merck, route of administration were not reported). Patient vomited twice and red hives increased in number post vaccination. Patient's corrective treatment included epipen and medications and benadryl was given by nurse. On an unspecified date patient recovered from the events after treatment. List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Vomiting
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 11 August 2016. This case involves a 2 month old male patient who was vaccinated with a dose of DAPTACEL (batch number- C5101AA, expiry date- 26 November 2018, route of administration was not reported) in left deltoid and dose of POLIOMYELITIS VACCINE INACTIVATED (IPV) (other manufacturer, batch number, expiry date, route of administration was not reported) in left deltoid on 10 August 2016. The patient had medical history of eosinophilic esophagitis, and reactive airway diseases and multiple allergies with milk, wheat, egg, tree nuts, soy, fish, shellfish, corn, and oats. The patient receives "allergy shots" twice a week. Concomitant medications were not reported. On 10 August 2016, about 5-10 minutes following the vaccination, the patient began to scream in pain and he was bending over holding his stomach, his eyes and stomach were hurting him. On the same date, screaming increased and he was acting very agitated, vomited once and developed hives on chest and back, had bright red rash and hives erupted all over and eyes were beginning to swell. The office nurse assessed the patient. The patient required ER/doctor visit. Lab was not performed. The patient received corrective treatment with Benadryl  Diphenhydramine hydrochloride) (given by physician), EPI pen (epinephrine), Zyrtec (Cetirizine hydrochloride) and steroids (prednisolone). The patient would be on Prednisolone for few more days. The event eye swelling was (subsided) recovered on unknown date and hives were decreased. The outcome of the event stomach pain, agitation, screaming, vomiting once and painful red eyes were reported as unknown.No respiratory involvement reported. Follow up information received from a consumer on 16 September 2016. Patient's demographic detail was updated. This case involves four-year-old patient who was vaccinated with a dose of POLIOMYELITIS VACCINE (INACTIVATED) (Ipv) (batch number: M/205, manufacturer: Merck, route of administration were not reported). Patient vomited twice and red hives increased in number post vaccination. Patient's corrective treatment included epipen and medications and benadryl was given by nurse. On an unspecified date patient recovered from the events after treatment. List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Diet refusal, Haematochezia, Hypersomnia, Intussusception
Clinical narrative: Presented 5 days after 2 month vaccines were given with lethargy and decreased appetite. HR 162, concern for abdominal tenderness. GASTROGRAFIN enema showed intussusception which was reduced without complication.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: Presented 5 days after 2 month vaccines were given with lethargy and decreased appetite. HR 162, concern for abdominal tenderness. GASTROGRAFIN enema showed intussusception which was reduced without complication.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal tenderness, Decreased appetite, Enema administration, Intussusception, Lethargy
Clinical narrative: Presented 5 days after 2 month vaccines were given with lethargy and decreased appetite. HR 162, concern for abdominal tenderness. GASTROGRAFIN enema showed intussusception which was reduced without complication.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Therapeutic procedure
Clinical narrative: Presented 5 days after 2 month vaccines were given with lethargy and decreased appetite. HR 162, concern for abdominal tenderness. GASTROGRAFIN enema showed intussusception which was reduced without complication.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Pt. developed a coin size, cellulitis a few days after the injection (at site of injection). Pt. had to get an antibiotic to treat the infection. The cellulitis went away after the course of antibiotic.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Pt. developed a coin size, cellulitis a few days after the injection (at site of injection). Pt. had to get an antibiotic to treat the infection. The cellulitis went away after the course of antibiotic.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Computerised tomogram normal, Dyskinesia, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Sustained tremors of all limbs which improved over 24 hours. Brief speech difficulty and left sided mild weakness which resolved.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Computerised tomogram head normal, Full blood count normal, Hemiparesis, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Sustained tremors of all limbs which improved over 24 hours. Brief speech difficulty and left sided mild weakness which resolved.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Speech disorder, Tremor, Urine analysis normal
Clinical narrative: Sustained tremors of all limbs which improved over 24 hours. Brief speech difficulty and left sided mild weakness which resolved.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Balance disorder, Blood test, Claustrophobia, Computerised tomogram normal, Dyskinesia
Clinical narrative: Sustained tremors of all limbs which improved over 24 hours. Brief speech difficulty and left sided mild weakness which resolved.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Electrocardiogram normal, Fatigue, Flushing, Headache, Hyperaesthesia
Clinical narrative: Sustained tremors of all limbs which improved over 24 hours. Brief speech difficulty and left sided mild weakness which resolved.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sustained tremors of all limbs which improved over 24 hours. Brief speech difficulty and left sided mild weakness which resolved.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Renal pain, Skin warm, Speech disorder, Tremor, Urinary tract infection
Clinical narrative: Sustained tremors of all limbs which improved over 24 hours. Brief speech difficulty and left sided mild weakness which resolved.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Urine analysis abnormal
Clinical narrative: Sustained tremors of all limbs which improved over 24 hours. Brief speech difficulty and left sided mild weakness which resolved.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling. MD prescribed cephalexin.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Slight pain at injection site, with pain in hand.
Age: 67.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme pain in right shoulder. Loss of mobility in right arm. Could not lift the arm.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT STATED THAT THE INJECTION SITE ON THE RIGHT ARM WAS SORE, SWOLLEN, AND WARM TO TOUCH.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Merck) (service request number: 00171545) on 20-SEP-2016. This case involves 27 year old female patient who was vaccinated with a dose Fluzone Quadrivalent (batch number, expiry date, route and site of administration: not reported), and a dose of Pneumovax 23 (manufacturer: other, batch number: M020521, expiry date: 17-NOV-2017, route and site of administration: not reported) on 25-AUG-2016. Patient had Drug reaction/ allergies to latex and other pertinent medical history was reported as none. Concomitant medications included Metadate and Jolessa. On 25-AUG-2016, same day following vaccination with Fluzone and 12 hours post Pneumovax 23 vaccination, patient developed pain at the injection site. The reporter reported that pain had continued to worsen and on an unspecified date post vaccination, the patient now had pain, swelling and a rash that extended to the elbow, was unable to use her arm due to the pain and that her arm was in a sling. It was reported that the patient required doctor visit (sought medical attention from her physician). Laboratory data was reported as none. The patient received corrective treatment (not specified). The outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Initial unsolicited report received from a pharmaciston 23 September 2016. This case involves a 69-year-old female patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI663AB, expiration date, dose, dose in series were not reported) intramuscularly in the right deltoid on 22 September 2016. Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were hypertension (HTN), arthritis, and hypothyroidism. Illness at the time of vaccination was also reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 22-Sep-2016, same day following the vaccination, the patient developed itchy palms which were red and swollen due to her scratching them. The patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood urine absent, Protein urine absent, Pyrexia, Rash, Rash macular
Clinical narrative: Patient developed fever of 101 on the evening of vaccine administration. Fever abated by morning and was followed by a red, macular lesions on the legs that had a vasculitic appearance on exam. These became confluent on the legs and lower abdomen by morning and then generalized to the trunk, arms and face. No purpura. No petechiae. No edema. No observed hematuria. Baby remained active and in good spirits.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vasculitic rash
Clinical narrative: Patient developed fever of 101 on the evening of vaccine administration. Fever abated by morning and was followed by a red, macular lesions on the legs that had a vasculitic appearance on exam. These became confluent on the legs and lower abdomen by morning and then generalized to the trunk, arms and face. No purpura. No petechiae. No edema. No observed hematuria. Baby remained active and in good spirits.
Age: 1.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV, PNC13
Symptoms: Laboratory test, Seizure
Clinical narrative: Seizure.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Muscular weakness
Clinical narrative: Patient describes a weakness in the arm the vaccine was administered in.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Extreme pain in shoulder. Unable to move shoulder or lift arm. 10 days later pain still present. Will see doctor today.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Information has been received from a physician via Pfizer (MFN# 2016440514) referring to a patient of unknown age and gender reported in the newspaper. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose and route were unknown). The patient also received PREVNAR 13 on an unspecified date. On an unknown date, the patient developed pneumonia symptoms. The doctor stated that the patient's pneumonia symptoms were consistent with pneumococcal pneumonia. The outcome of pneumococcal pneumonia was unknown. The causality assessment between the pneumococcal pneumonia and PNEUMOVAX 23 was not reported. The article also noted that neither vaccine was 100% effective. Upon internal review, pneumococcal pneumonia was determined to be a medically significant event. Additional information is not expected as no contact information was provided.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Diarrhoea, Headache
Clinical narrative: Initial unsolicited report received from a consumer (Patient's parent) on 21-SEP-2016. This case involves nine year old male patient who was vaccinated with a dose of Fluzone QIV (batch number and expiry date were not reported) via intramuscular route in left deltoid on 20-SEP-2016. Patient had no illness at time of vaccination and the pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Other vaccinations within 4 weeks of vaccination and other concomitant medications were not reported. On 20-SEP-2016, same day post vaccination by the evening, patient had developed symptoms of pain at injection site, stomachache, loose stools, vomiting, headache, shivering, and a temp of 100F. The patient's laboratory data was reported as none. Corrective treatment was not reported. The events were still present and the outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer (Patient's parent) on 21-SEP-2016. This case involves nine year old male patient who was vaccinated with a dose of Fluzone QIV (batch number and expiry date were not reported) via intramuscular route in left deltoid on 20-SEP-2016. Patient had no illness at time of vaccination and the pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Other vaccinations within 4 weeks of vaccination and other concomitant medications were not reported. On 20-SEP-2016, same day post vaccination by the evening, patient had developed symptoms of pain at injection site, stomachache, loose stools, vomiting, headache, shivering, and a temp of 100F. The patient's laboratory data was reported as none. Corrective treatment was not reported. The events were still present and the outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a registered nurse on 22 September 2016. This case involves a 40 years old female who was vaccinated with a dose of Fluzone Quadrivalent (batch number: UI158AB, expiry date, dose, route of administration was not reported) intramuscularly at left deltoid on 19 September 2016. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination, patient experienced burning, redness, heat and swelling from the elbow to the shoulder on the left side. Lab data and corrective treatment were not reported. On an unspecified date, 5 days after the onset the patient recovered from events. List of documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patients medical history, concomitant therapy and concurrent condition were not provided. On 01-SEP-2016, the patient was vaccinated with (Oka/Merck) VARIVAX (strength, dose and frequency were unknown; lot number M010482 with expiration date 01-MAR-2018). (Oka/Merck) VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml, single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 31-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml, single dose vial of sterile water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 02-SEP-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 06-SEP-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml, single dose vial of sterile water for injection, for drug diluent use, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 23-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 12 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 16-AUG-2016 the patient was vaccinated with an adult dose of VAQTA (lot # L048222, expiration date 19-DEC-2016, intramuscular, dose unknown). It was the first dose in the patient's series. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 26-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 06-SEP-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number M010482 with expiration date 01-MAR-2018). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a multiple unspecified patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored PNEUMOVAX 23 lot # was not provided). No adverse effect was reported. Temperature 48.79 Fahrenheit, time frame was 13 hours for 30 minutes. Previous temperature excursion was 46.5 Fahrenheit for 10 hours 48 minutes. There was no data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports that she developed redness, swelling and warmth in the area of the injections about 2 days after receiving it.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, IPV, RVX
Symptoms: Crying, Emotional distress, Pyrexia, Screaming
Clinical narrative: Child started crying around 5:30 PM. Checked for fever. Fever was 101.5. Tylenol was administered. Child continued to scream/cry for the next four hours. Tylenol was repeated administered every four hours, but child was still crying and was inconsolable. A warm bath was given to try to help calm child, but was unsuccessful. Child stopped crying after 4-5 hours, but remained upset until the following morning.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Electromyogram abnormal, Joint range of motion decreased, Limb discomfort, Muscular weakness
Clinical narrative: Initial onset of Parsonage Turner Syndrome began with weakness/heaviness of right arm, followed by pain, restricted ROM, scapular winging and dyskinesis.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve conduction studies abnormal, Nerve injury, Neuralgic amyotrophy, Pain in extremity, Winged scapula
Clinical narrative: Initial onset of Parsonage Turner Syndrome began with weakness/heaviness of right arm, followed by pain, restricted ROM, scapular winging and dyskinesis.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Injected limb mobility decreased
Clinical narrative: Severe upper arm pain and extreme limited range of motion both in right arm.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe upper arm pain and extreme limited range of motion both in right arm.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5in x 10in oval red area to upper left arm. Warm to the touch. Made Dr apt with her pcp for further eval today.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 26-SEP-2016, unspecified patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL 9 lot # L036301 (expiry date: 20-DEC-2016), lot # L043213 (expiry date: 28-AUG-2018) and lot # M007764 (expiry date: 30-JAN-2018). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified doses of ZOSTAVAX (lot# reported as M032651 with expiration date: 15-JUN-2017) that were improperly stored (freezer: temperature of 31F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Route of administration was not reported. Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received an adult dose of VAQTA (lot # L042039, expiration date 14-JAN-2017; dose and route and were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 24-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as M006733 with expiration date 09-FEB-2018). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 26-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as M006733 with expiration date 09-FEB-2018). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml, single dose vial of Sterile water for injection, lot # 54-152-DK with expiration date 01-JUN-2018" instead of Merck supplied diluent. No adverse effect reported. This is one of the twelve reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 31-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Dizziness, Headache, Influenza virus test negative, Multi-organ disorder, Pain
Clinical narrative: Dizziness, HA, body aches, vomiting - on exam 9/30/16 organ megaly.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Vomiting
Clinical narrative: Dizziness, HA, body aches, vomiting - on exam 9/30/16 organ megaly.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified doses of PEDVAXHIB (lot # M010439 with expiration date: 08-DEC-2018, lot# M014927 with expiration date: 18-FEB-2019, lot# M025193 with expiration date: 21-MAR-2019 and lot# M001813 with expiration date: 14-OCT-2018) that were improperly stored (freezer: temperature of 31F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Route of administration was not reported. Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Employee reports that she experienced redness, swelling and warmth at the injection site within 30 minutes. Instructed her to take a Benadryl and apply ice. She experienced continued symptoms that required her to continue to take Benadryl. On 9/20 a rash and itching developed on her RUE/ injection site. 9/24 symptoms into her shoulders and LUE. 9/28 She reported that she woke up and felt that her lip was swollen. She was seen at her physician's office and treated with steroids and Keflex PO.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: Employee reports that she experienced redness, swelling and warmth at the injection site within 30 minutes. Instructed her to take a Benadryl and apply ice. She experienced continued symptoms that required her to continue to take Benadryl. On 9/20 a rash and itching developed on her RUE/ injection site. 9/24 symptoms into her shoulders and LUE. 9/28 She reported that she woke up and felt that her lip was swollen. She was seen at her physician's office and treated with steroids and Keflex PO.
Age: 24.0
Sex: F
Vaccine: HPVX
Symptoms: Facial paralysis, Hypoaesthesia, Paraesthesia, Swelling face
Clinical narrative: Facial swelling, droop, numbness, tingling in left side of face. Then on 8/07/16 @ 11AM - Same thing but on right side of face.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL injection, lot # K007828, expiration date: 02-MAR-2017 (exact dose, dose number and route of administration were not provided). Administered doses of vaccines experienced the temperature excursion of 33.2 degrees Celsius for 11 hours and 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Redness and swelling at site of injection started 9/28/16. Seen in office on 9/29/16 and at that time left arm with erythema above deltoid down to elbow, warm, taut on lateral surface, soft on medial surface. Patient given Cephalexin 250/5 for treatment of cellulitis.
Age: 6.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site warmth, Skin tightness
Clinical narrative: Redness and swelling at site of injection started 9/28/16. Seen in office on 9/29/16 and at that time left arm with erythema above deltoid down to elbow, warm, taut on lateral surface, soft on medial surface. Patient given Cephalexin 250/5 for treatment of cellulitis.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Injection site bruising
Clinical narrative: Bleeding, large bruise at injection site followed several hours later by headache.  2 days later, diarrhea, headache, dizziness, fever, chills,
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site haemorrhage, Pyrexia
Clinical narrative: Bleeding, large bruise at injection site followed several hours later by headache.  2 days later, diarrhea, headache, dizziness, fever, chills,
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: CSF test, Rash, Varicella, Varicella virus test positive
Clinical narrative: Information has been received from a physician referring to a 13 years old male patient. There were none pertinent medical history, concomitant therapy and drug reactions/allergies. On 08-OCt-2008 and 04-OCT-2004, the patient was vaccinated with doses of VARIVAX (strength, dose, frequency, lot number and expiration date were unknown). On an unknown date in September 2016, the patient developed a facial rash that resembles varicella and meningoencephalitis "within the past two weeks."  The patient was admitted to hospital on 22-SEP-2016, reported as "6 days ago."  The patient was treated with acyclovir since admission since he tested positive for varicella by unspecified laboratory tests, and the patient was recovering. The patient would be discharged from the hospital tomorrow, 29-SEP-2016. The causal relationship between VARIVAX and the event was unknown. The physician states  that her facility has retained a specimen of cerebrospinal fluid (CSF) for the patient, and she is interested in sending the specimen for analysis. VZVIP faxed to the physician to the nurses' station. She states that microbiology lab director, has the CSF sample, and she can be called. Left voice mails with the physician's cell phone number and case number.  This  AE will be e-mailed and  employees  and  VZVID mailbox. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients unknown age and gender. No medical history and concurrent conditions were reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of PEDVAXHIB (Lot number L038501, expiry date 16-APR-2018; Lot number L051122, expiry date 12-OCT-2018; Lot number M001813, expiry date 14-OCT-2018) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken and the outcome of the events was unknown. There was no product quality complaint reported. This case is linked to case number 1609USA014777 and 1609USA014778 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown dates the patients were vaccinated with an improperly stored dose of M-M-R II (Lot number L034731, expiry date 09-SEP-2017, Lot number L035674, expiry date 17-SEP-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. The action taken and the outcome of the events was unknown. There was no product quality complaint reported. This case is linked to case number 1609USA014778 and 1609USA013289 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown day in 2016, the patients were vaccinated with an improperly stored doses of PROQUAD (lot # L032761, expiry date 24-FEB-2017) dosage regiment and route unknown. Concomitant medications were not reported. No adverse events were reported. The vaccine was subjected to temperature excursion of 45.9 degrees Fahrenheit for 4.5 hours on 11-JUL-2016. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This reports is one of several reports received from the same reporter. 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 medical assistant regarding unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date in 2016, the patients were vaccinated with an improperly stored doses of VARIVAX (lot # M000756, expiry date 06-JAN-2018) dosage regimen and route unknown. Concomitant medications were not reported. No adverse events were reported. The vaccine was subjected to temperature excursion of 45.9 degrees Fahrenheit for 4.5 hours on 11-JUL-2016. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This report is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a healthcare professional via company representative (Merck Replacement) regarding a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was administered the 1st dose in the series with GARDASIL 0.5 ml (lot# and expiry date unknown). On an unknown date, the patient was administered the 2nd dose in the series as GARDASIL 9 (dosing details, lot# and expiry date not known) and then the 3rd dose in the series as GARDASIL 9 (dosing details, lot# and expiry date not known) (unknown date). Wrong vaccine administration was considered. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, lot # L008996 with expiration date: 01-DEC-2016 or lot # L033545 with expiration date: 30-MAY-2017 (exact dose was not provided). There were no symptoms reported. Administered doses of vaccines experienced the temperature excursion of 33.2 degrees Celsius for 11 hours and 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Inflammation, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient had no pertinent medical history and no drug reactions/allergies. There were no concomitant medications. On 22-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M027552 with an expiration date: 04-February-2018 (dose, route of vaccination and anatomical location were not reported). On 23-SEP-2016, reported as about one day after receiving the vaccine, the patient experienced cellulitis, swelling and inflammation about 2 inches below the injection site. The patient sought medical attention and visited pharmacist. The patient was directed to take unspecified antihistamine medication and put ice on his arm. No lab diagnostics studies were performed. The outcome of cellulitis, inflammation and swelling was unknown. The relatedness between the events and vaccination with PNEUMOVAX 23 was not reported. Upon internal review cellulitis was determined to be medically significant. This is one of two reports from the same source. Additional information has been requested.