chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria, Wheezing
Clinical narrative: Systemic Allergic Reaction: mom called, symptoms began with swelling of lips, ears, hands, fingers, wheezing. Mom was advised to bring patient to ER, mom declined , came to office. By the time the patient arrived at the office at 11:40 am, he had welts, grunting while breathing, very swollen bottom lip, ears, rash on extremities, poor peripheral perfusion, unable to speak, not moving air well. Pt was immediately brought back to exam room, vitals taken, provider entered room to assess, was given Epi 1:1000  0.2cc IM Left lateral thigh at 11:44am. Started Albuterol neb 0.083% at 11:47 am. Vitals reassessed every 5 minutes, were stable throughout other than the normal side effects of EPI (shaky, Tachycardia) and Albuterol (Tachy and shaky). Pt was kept in office for 2 hrs to ensure reaction did not reoccur once medications wore off. RX for Epi pen JR called into pharmacy, educated mom on the seriousness of allergic reaction. Allergist contacted to ensure patient gets appointment.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Spiking hot fevers, only controlled with alternating fever reducer every three hours. Rash on forehead and legs.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Mother states when the child woke up the next day 8/19/2017 there were hives over her body and she had a fever. Took the child to the Hospital ER. Was told child had a reaction. Given something for fever and med for rash. Mother did not know the name of medications. Stated she was on her way to work. States she was told to call the clinic and report the reaction.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Induration, Pain in extremity
Clinical narrative: Patient returned to the pharmacy this morning after getting her vaccination yesterday afternoon, her arm is swollen, red, hard, and painful; it looks like the patient may be having an allergic reaction.  I suggested she see her primary care provider to be sure there is no possibility of cellulitis as she is going on vacation in a couple of days. She stated that she started feeling an 'itchy, burning sensation' in her arm immediately after the vaccination. She also stated she had had a problem in the past with a tetanus (she believes) vaccine about 10 years ago.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Patient returned to the pharmacy this morning after getting her vaccination yesterday afternoon, her arm is swollen, red, hard, and painful; it looks like the patient may be having an allergic reaction.  I suggested she see her primary care provider to be sure there is no possibility of cellulitis as she is going on vacation in a couple of days. She stated that she started feeling an 'itchy, burning sensation' in her arm immediately after the vaccination. She also stated she had had a problem in the past with a tetanus (she believes) vaccine about 10 years ago.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia
Clinical narrative: Per mom, on the evening after vaccine administration, pt ran a fever with TMAX of 104 degrees rectal, pt was given TYLENOL and MOTRIN alternating, mom reports that next two days temp reached a max of 102 degrees rectal. No fever day 3 or after.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Hyperhidrosis, Pallor, Wheezing
Clinical narrative: The FLUZONE was given first. The second shot was GARDASIL and was given a few minutes later.  Within 5 minutes patient felt faint. Mom and I sat her down on a chair and had her put her head between her knees. I didn't see her lose consciousness but her back was to me when we lowered her in the chair. She was sweating, white and had a slight wheeze. She was able to follow directions and communicate with us. It took about 5 minutes before she started feeling better. She sat for about 30 min and had some food and soda.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Muscle rigidity, Syncope
Clinical narrative: Vasovagal syncope. Within a few minutes of receiving the three vaccines the patient fell lightheaded and fell slowly to the floor. Was witnessed by mother who said he was out for a few seconds and body went rigid in that time. He came to within a minute and was back to normal self a few minutes later.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 62 year old female patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On an unspecified date, 2 or three years before report's date, the patient was vaccinated with ZOSTAVAX, 0.65 ml subcutaneously for prophylaxis (lot number and expiration date were not provided). On an unknown date (reported as recently), the patient was seen in physician's office with shingles. The outcome of the event was reported as recovering/resolving. The causality assessment between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. On 18-JUL-2017, the patient was vaccinated with an improperly storage dose of PNEUMOVAX 23 lot number m042324 with expiration date on 10-JUN-2018; lot number reported as "m044564" with expiration date on 22-OCT-2018 or lot number n001007 with expiration date on 09-SEP-2018 for prophylaxis. No adverse effects were reported. The doses of PNEUMOVAX 23 were exposed to a temperature of 47 Fahrenheit degrees (F) to 77 F for time frame of 1 hour 20 minutes. There were no previous temperature excursions. Digital data logger was involved. No symptoms reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA002800.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. On 14-JUL-2017, the patient was vaccinated with an improperly storage dose of PNEUMOVAX 23 lot number m042324 with expiration date on 10-JUN-2018; lot number reported as "m044564" with expiration date on 22-OCT-2018 or lot number n001007 with expiration date on 09-SEP-2018 for prophylaxis. No adverse effects were reported. The doses of PNEUMOVAX 23 were exposed to a temperature of 47 Fahrenheit degrees (F) to 77 F for time frame of 1 hour 20 minutes. There were no previous temperature excursions. Digital data logger was involved. No symptoms reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA002800.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Nurse reported that an expired dose of MMR II was inadvertently administered to patient; This spontaneous report was received from a other health professional refers to a patient of unknown age and gender. On 15-AUG-2017 the patient was vaccinated with an expired dose of M-M-R II (HSA) lot # L027432 and expiration date of  22-JUL-2017, 0.5 ml subcutaneous for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT).  No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of an unknown age. On 18-AUG-2017, the patient was vaccinated with GARDASIL 9 lot # L018351, intramuscular for prophylaxis. On 18-AUG-2017, the patient experienced expired product administered. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot#, expiry date, dosing details, anatomical location, route were unknown) for prophylaxis. Previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010102: US-009507513-1708USA010099: US-009507513-1708USA010100: US-009507513-1708USA010102: US-009507513-1708USA010103: US-009507513-1708USA010101:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot# N009768 with expiry date: 24-MAR-2019, lot# N008827 with expiry date: 16-MAR-2019 and lot# M046004 with expiry date: 18-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis.  The vaccines were reconstituted with properly stored diluent (details not reported). It was reported that the vaccines were exposed to a temperature range of 15 F to 46 F for a duration of 3 hours and 33 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # M023169 with expiry date: 13-JUN-2018 (dosing details, anatomical location and route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 9C to 25C (9.9C) for a duration of 13 hours and 15 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 9C to 25C (11.5C) for 7 hours and 45 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009985: US-009507513-1708USA009988: US-009507513-1708USA009987: US-009507513-1708USA009986:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot#N000237 with expiry date:25-OCT-2019,lot#N003698 with expiry date:31-OCT-2019 (dosing details, anatomical location and route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 9C to 25C (9.9C) for a duration of 13 hours and 15 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 9C to 25C (11.5C) for 7 hours and 45 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA009615:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011867 with expiry date: 08-NOV-2018 (dosing details, anatomical location and route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 9C to 25C (9.9C) for a duration of 13 hours and 15 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 9C to 25C (11.5C) for 7 hours and 45 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009615:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # M041765 with expiry date: 05-MAY-2018 and lot#M045546 with expiry date: 12-JUN-2018 (dosing details, anatomical location were unknown) orally for prophylaxis.  It was reported that the vaccines were exposed to a temperature range of 9C to 25C (9.9C) for a duration of 13 hours and 15 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 9C to 25C (11.5C) for 7 hours and 45 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved.  This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009615:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot#N005274 with expiry date: 03-APR-2018  (dosing details, anatomical location and route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 9C to 25C (9.9C) for a duration of 13 hours and 15 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 9C to 25C (11.5C) for 7 hours and 45 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009615:
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Breath holding, Chest X-ray normal, Febrile convulsion, Haematocrit normal, Haemoglobin normal
Clinical narrative: Per parent report, fever 101-102 started the evening of 6 mo vaccines and continued every day until incident 8/22/17 with no other symptoms. Evening of 8/22/17 pt felt normal then had a <1 min. episode of staring/arm shaking/breath holding followed by a period of sleepiness/lethargy. Event is consistent with a simple febrile seizure followed by a post-ictal period. On arrival to ED, temp 103, normal CXR, O2 sak 100%, normal exam. Discharged to home. Examined by myself (Dr.) the following morning (8/23/17). Normal temperature and exam in clinic. CBC normal except mildly low platelets (105).
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Lymphocyte percentage, Neutrophil percentage decreased, Platelet count decreased, Postictal state
Clinical narrative: Per parent report, fever 101-102 started the evening of 6 mo vaccines and continued every day until incident 8/22/17 with no other symptoms. Evening of 8/22/17 pt felt normal then had a <1 min. episode of staring/arm shaking/breath holding followed by a period of sleepiness/lethargy. Event is consistent with a simple febrile seizure followed by a post-ictal period. On arrival to ED, temp 103, normal CXR, O2 sak 100%, normal exam. Discharged to home. Examined by myself (Dr.) the following morning (8/23/17). Normal temperature and exam in clinic. CBC normal except mildly low platelets (105).
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Somnolence, Staring, Tremor, White blood cell count normal
Clinical narrative: Per parent report, fever 101-102 started the evening of 6 mo vaccines and continued every day until incident 8/22/17 with no other symptoms. Evening of 8/22/17 pt felt normal then had a <1 min. episode of staring/arm shaking/breath holding followed by a period of sleepiness/lethargy. Event is consistent with a simple febrile seizure followed by a post-ictal period. On arrival to ED, temp 103, normal CXR, O2 sak 100%, normal exam. Discharged to home. Examined by myself (Dr.) the following morning (8/23/17). Normal temperature and exam in clinic. CBC normal except mildly low platelets (105).
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, UNK
Symptoms: Irritability, Pyrexia
Clinical narrative: At 9:00 am, my daughter got extremely fussy and crabby and showed a 100.1 degree low grade fever. At that time, she was given 2.5 ml of Tylenol, which didn't help the fever at all. The doctor recommended increasing the Tylenol dosage and to give between 2.75 and 3.75 ml.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Induration, Lacrimation increased, Musculoskeletal pain
Clinical narrative: Extreme swelling in upper arm, hard, hot and some redness. Severe pain radiating into back shoulder blade when moving or not; Some itchiness, watery eyes and fuzzy throat. Nausea, unusual drowsiness,  chills.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Peripheral swelling, Pruritus, Skin warm, Somnolence
Clinical narrative: Extreme swelling in upper arm, hard, hot and some redness. Severe pain radiating into back shoulder blade when moving or not; Some itchiness, watery eyes and fuzzy throat. Nausea, unusual drowsiness,  chills.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Throat irritation
Clinical narrative: Extreme swelling in upper arm, hard, hot and some redness. Severe pain radiating into back shoulder blade when moving or not; Some itchiness, watery eyes and fuzzy throat. Nausea, unusual drowsiness,  chills.
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Anger, Back pain, Headache, Hyperventilation, Peripheral swelling
Clinical narrative: 8/21/2107 back pain and headache; 8/22/2017 shaking, abnormal breathing, deep breaths, anger and sweating. Pain and swelling in arm. I took him to the emergency room and was told it is a normal reaction to immunizations.
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Respiration abnormal, Tremor
Clinical narrative: 8/21/2107 back pain and headache; 8/22/2017 shaking, abnormal breathing, deep breaths, anger and sweating. Pain and swelling in arm. I took him to the emergency room and was told it is a normal reaction to immunizations.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Headache, Peripheral swelling
Clinical narrative: Two days after the shot was given arm swelled and large red area from shoulder to elbow. Followed by days of a headache. Weekend On call doctor was paged. Instructed to give TYLENOL and BENADRYL. Followed up with administering pediatrician regarding my concern over the shot given at age 10 well visit versus the CDC recommended age of 11-12. I am awaiting a follow up email regarding the medical center protocol.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Skin burning sensation, Syncope
Clinical narrative: Patient returned to the pharmacy and complained her arm was burning. She then sat down and started to faint. I was able to hold her up but she remained unconscious for a few mins and was in and out. 911 was called and she was taken to the hospital where she was kept overnight for observation.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dizziness, Presyncope, Syncope
Clinical narrative: Patient experienced feeling lightheaded and then fainted. Provider came to assess and confirmed patient experienced a vasovagal attack. Patient given apple juice and two sets of vital signs taken. Patient verbalized feeling better and walked out of clinic accompanied by mother.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. On 13-JUL-2017, the patient was vaccinated with an improperly storage dose of PNEUMOVAX 23 lot number m042324 with expiration date on 10-JUN-2018; lot number reported as "m044564" with expiration date on 22-OCT-2018 or lot number n001007 with expiration date on 09-SEP-2018 for prophylaxis. No adverse effects were reported. The doses of PNEUMOVAX 23 were exposed to a temperature of 47 Fahrenheit degrees (F) to 77 F for time frame of 1 hour 20 minutes. There were no previous temperature excursions. Digital data logger was involved. No symptoms reported. This is one of several reports received from the same source.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. On 03-JUL-2017, the patient was vaccinated with an improperly storage dose of PNEUMOVAX 23 lot number m042324 with expiration date on 10-JUN-2018; lot number reported as "m044564" with expiration date on 22-OCT-2018 or lot number n001007 with expiration date on 09-SEP-2018 for prophylaxis. No adverse effects were reported. The doses of PNEUMOVAX 23 were exposed to a temperature of 47 Fahrenheit degrees (F) to 77 F for time frame of 1 hour 20 minutes. There were no previous temperature excursions. Digital data logger was involved. No symptoms reported. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1708USA002800:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX (Strength, anatomical location and route) of lot # M020071 with an expiry date of 18-JUL-2017 (Expired product administered), at a dose of 0.65 ml, once for prophylaxis. Co-suspect therapy included sterile diluent of lot # L034399 with an expiry date of 16-APR-2018. No adverse effects were reported. There was no product quality complaint involved. Lot number, M020071 has been verified to be a valid lot number for ZOSTAVAX.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) refers to unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent. On an unknown date, in 2017 (reported as "20-JUL-2017 to 18-AUG-2017") improperly stored doses of PROQUAD (lot # N004629, expiration date # 07-AUG-2017) (route, dose number, dose, frequency) were administered to unspecified patients for prophylaxis. No adverse effects were reported. The vaccines were exposed to a temperature 15 degrees F to 46 degrees F for a time period of 3 hours. There was no previous temperature excursions. Digital data logger was not involved. No additional information was provided. Product quality complaint (PQC) was not reported.
Age: 24.0
Sex: M
Vaccine: HIBV, MNQ, PPV
Symptoms: Activated partial thromboplastin time normal, Blood culture negative, Cellulitis, Chest X-ray normal, Chills
Clinical narrative: Support Call Center: Have 24 year old patient who was completing pre-vaccination requirements for upcoming splenectomy on 9/28/2017 (patient has a cyst on the spleen the MD will be removing). Approximately 24 hours later, patient c/o pain and tenderness to left deltoid then redness. Over next 24 hours this reaction worsened and he complained of chills, fever, lethargy and presented to ER on Monday. They reported his rectal temp was 102.4F and his WBC was 24. Dr. admitted him for cellulitis and began treatment with vancomycin. As of 8/22/2017 is WBC count was down to 15 and fever resolved with left deltoid swelling almost gone. He will keep him in the hospital for another 2-3 days on antibiotics tx.
Age: 24.0
Sex: M
Vaccine: HIBV, MNQ, PPV
Symptoms: Computerised tomogram abdomen abnormal, Culture urine negative, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Support Call Center: Have 24 year old patient who was completing pre-vaccination requirements for upcoming splenectomy on 9/28/2017 (patient has a cyst on the spleen the MD will be removing). Approximately 24 hours later, patient c/o pain and tenderness to left deltoid then redness. Over next 24 hours this reaction worsened and he complained of chills, fever, lethargy and presented to ER on Monday. They reported his rectal temp was 102.4F and his WBC was 24. Dr. admitted him for cellulitis and began treatment with vancomycin. As of 8/22/2017 is WBC count was down to 15 and fever resolved with left deltoid swelling almost gone. He will keep him in the hospital for another 2-3 days on antibiotics tx.
Age: 24.0
Sex: M
Vaccine: HIBV, MNQ, PPV
Symptoms: Lethargy, Liver function test normal, Lymphocytosis, Metabolic function test normal, Monocyte percentage increased
Clinical narrative: Support Call Center: Have 24 year old patient who was completing pre-vaccination requirements for upcoming splenectomy on 9/28/2017 (patient has a cyst on the spleen the MD will be removing). Approximately 24 hours later, patient c/o pain and tenderness to left deltoid then redness. Over next 24 hours this reaction worsened and he complained of chills, fever, lethargy and presented to ER on Monday. They reported his rectal temp was 102.4F and his WBC was 24. Dr. admitted him for cellulitis and began treatment with vancomycin. As of 8/22/2017 is WBC count was down to 15 and fever resolved with left deltoid swelling almost gone. He will keep him in the hospital for another 2-3 days on antibiotics tx.
Age: 24.0
Sex: M
Vaccine: HIBV, MNQ, PPV
Symptoms: Neutrophil percentage increased, Prothrombin time normal, Pyrexia, Smear site unspecified abnormal, Ultrasound abdomen abnormal
Clinical narrative: Support Call Center: Have 24 year old patient who was completing pre-vaccination requirements for upcoming splenectomy on 9/28/2017 (patient has a cyst on the spleen the MD will be removing). Approximately 24 hours later, patient c/o pain and tenderness to left deltoid then redness. Over next 24 hours this reaction worsened and he complained of chills, fever, lethargy and presented to ER on Monday. They reported his rectal temp was 102.4F and his WBC was 24. Dr. admitted him for cellulitis and began treatment with vancomycin. As of 8/22/2017 is WBC count was down to 15 and fever resolved with left deltoid swelling almost gone. He will keep him in the hospital for another 2-3 days on antibiotics tx.
Age: 24.0
Sex: M
Vaccine: HIBV, MNQ, PPV
Symptoms: White blood cell count increased
Clinical narrative: Support Call Center: Have 24 year old patient who was completing pre-vaccination requirements for upcoming splenectomy on 9/28/2017 (patient has a cyst on the spleen the MD will be removing). Approximately 24 hours later, patient c/o pain and tenderness to left deltoid then redness. Over next 24 hours this reaction worsened and he complained of chills, fever, lethargy and presented to ER on Monday. They reported his rectal temp was 102.4F and his WBC was 24. Dr. admitted him for cellulitis and began treatment with vancomycin. As of 8/22/2017 is WBC count was down to 15 and fever resolved with left deltoid swelling almost gone. He will keep him in the hospital for another 2-3 days on antibiotics tx.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The patient suffered NO adverse reaction to the vaccination. She should have been given a booster for the meningococcal B vaccine (TRUMENBA), but was given MENACTRA by mistake.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt first called on 08/22/17 stating she now had swelling and a fever after the vaccine that was given to her. The RN called pt back and pt stated she has a fever of 99.0 that last night and this morning the injection site was itchy, red, and swollen to the height of a mosquito bite and circumference of a baseball. Pt denied rash, hives, swelling of face or throat, difficulty breathing, tachycardia, dizziness, weakness. RN advised Pt that if she experiences any of those sx she should seek immediate medical attention at the ED; for difficulty breathing or throat swelling she should call 911. RN advised Pt to use a cool compress on the area and oatmeal bath to reduce itching and swelling. Pt voiced understanding and had no further questions at that time. The following day, the patient called regarding the reaction. She stated that she had to go to the urgent care because it became more swolen, hard and painful. The reaction covered her arm up to her tricep area. The RN returned call to Pt, the Pt stated that she had a reaction to the varicella vaccine, as documented on 8/22. Initially the affected area was the size of a baseball, redness and itching were mild to moderate. As the evening progressed the affected area became increasingly reddened, painful/burning, hard, and extended to the axillary area; Pt also had a fever of 100. Pt went to UC and was prescribed an antibiotic and steroid. Pt reported that swelling and pain have decreased slightly. Pt denied rash, hives, swelling of face or throat, difficulty breathing, tachycardia, dizziness, weakness. Pt drew a line around affected area to monitor for increase in size. RN advised Pt to seek immediate care at the ED for these sx or for increase in severity of current sx. Pt voiced understanding and had no further questions at that time.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Swelling
Clinical narrative: Pt first called on 08/22/17 stating she now had swelling and a fever after the vaccine that was given to her. The RN called pt back and pt stated she has a fever of 99.0 that last night and this morning the injection site was itchy, red, and swollen to the height of a mosquito bite and circumference of a baseball. Pt denied rash, hives, swelling of face or throat, difficulty breathing, tachycardia, dizziness, weakness. RN advised Pt that if she experiences any of those sx she should seek immediate medical attention at the ED; for difficulty breathing or throat swelling she should call 911. RN advised Pt to use a cool compress on the area and oatmeal bath to reduce itching and swelling. Pt voiced understanding and had no further questions at that time. The following day, the patient called regarding the reaction. She stated that she had to go to the urgent care because it became more swolen, hard and painful. The reaction covered her arm up to her tricep area. The RN returned call to Pt, the Pt stated that she had a reaction to the varicella vaccine, as documented on 8/22. Initially the affected area was the size of a baseball, redness and itching were mild to moderate. As the evening progressed the affected area became increasingly reddened, painful/burning, hard, and extended to the axillary area; Pt also had a fever of 100. Pt went to UC and was prescribed an antibiotic and steroid. Pt reported that swelling and pain have decreased slightly. Pt denied rash, hives, swelling of face or throat, difficulty breathing, tachycardia, dizziness, weakness. Pt drew a line around affected area to monitor for increase in size. RN advised Pt to seek immediate care at the ED for these sx or for increase in severity of current sx. Pt voiced understanding and had no further questions at that time.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Blood glucose normal, Dizziness, Flushing
Clinical narrative: VIS sheet reviewed with patient who verbalized understanding of side effects. Patient reports never having a previous reaction to any vaccine. Hepatitis B vaccine given IM to left deltoid. Patient administered vaccine at 9:05 am. VS taken at 9:10 am BP 110/60, temp 97.0 pulse 75 respirations 14 patient feels well. 9:12 am patient felt faint, dizzy, flushed. Patient was put in 45 degree angle position with feet up, given cold compress, blood, water, blood glucose taken 118. VS BP 110/60, pulse 50, 97% O2, resps 16 provider notified and evaluated patient, juice given with improvement in symptoms. 9:20 VS BP 110/60, pulse 65, O2 99%, resps 14 patient reported improvement in symptoms. 9:32 BP 90/50, resps 14, O2 97%, pulse 78. 9:36 O2 100%, pulse 69 98/60. Patient monitored for nine minutes. 9:45 patient was cleared by physician to leave office. In reviewing the package insert for ENERGIX: low pulse is a listed reaction. He did not lose consciousness and has never had a vasovagal reaction before. He did have breakfast this am. We monitored him as above and will report the reactions to VAERS. He had not blood sugar issues either. I let him know I would not advise further Hep B vaccines given this reaction. I will let his PCP Dr know what happened.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Dyspnoea, Sensation of foreign body, Wheezing
Clinical narrative: The patient reported a lump in her throat to a nurse approximately 5 minutes after receiving VARIVAX. The nurse walked the student to Dr. where she was assessed and diagnosed with an anaphylactic allergic reaction. Dr. stated she heard a possible wheeze in the right upper lung to accompany the difficulty breathing. The patient was given epinephrine 0.3 mg intramuscularly and hydroxyzine hydrochloride 50 mg orally. Paramedics were contacted and arrived to transport the patient to the local hospital for follow-up care. The patient was conscious and alert at the time of transport.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: CHILD RECEIVED VARICELLA VACCINE AND WITHIN 10 MINUTES 2 INCH CIRCUMFERANCE, PINK, RAISED WELT DEVELOPED AT SITE OF INJECTION. Child WAS NOT IN DISTRESS AND SHE SAID IT DID NOT HURT. SKIN AT SITE WAS NOT WARM TO TOUCH. CALLED MOM ON 8/22/2017 AND MOM STATES THAT CHILDS RIGHT ARM WELT WENT AWAY AND WAS NO LONGER PINK AND THAT CHILD WAS NOT IN ANY DISTRESS AND HAD NO FEVER AND SHE WAS PLAYING .
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Dizziness, Swollen tongue
Clinical narrative: Swollen tongue, confusion, dizziness.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient began to feel pain in his arm the day after receiving the vaccine. He still feels pain in the arm and has trouble lifting it.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Numbing sensation in face, neck and chest beging within 24hrs of vax and continuing presently.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Death
Clinical narrative: Death reported by physician 8/23/17.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Death, Rash erythematous, Rash generalised
Clinical narrative: Death reported by physician 8/23/17.
Age: 83.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Haematoma, Haemorrhage
Clinical narrative: Pt. described some additional bleeding and what seems to be a hematoma. Bleeding stopped by the time he contacted me. Advised patient to use cold compress for 15 minutes. Will check back with pt. later tonight to assess situation.
Age: 83.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Malaise, Tremor, Vomiting
Clinical narrative: Pt. described some additional bleeding and what seems to be a hematoma. Bleeding stopped by the time he contacted me. Advised patient to use cold compress for 15 minutes. Will check back with pt. later tonight to assess situation.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Crying, Loss of consciousness, Nervousness
Clinical narrative: Patient was very nervous before getting the vaccines. About 2 minutes after receiving the vaccines, the patient worked himself up and was crying and asking for water. He passed out for around 10 seconds but regained consciousness very quickly. He was sitting down so he did not have any injuries.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site warmth, Night sweats
Clinical narrative: Patient states injection site, is red, bruised, lump at injection, warm to touch, wakes up with night sweats, more phlegm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Productive cough
Clinical narrative: Patient states injection site, is red, bruised, lump at injection, warm to touch, wakes up with night sweats, more phlegm.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abdominal pain upper, Back pain, Dyskinesia, Feeling abnormal, Headache
Clinical narrative: Immediately after administration the patient expressed that she did not feel quite right. Her eyes were bloodshot. She expressed that she experienced tingling in her lips and "pins and needles" in her face. Minutes after she jerked her back and expressed sharp pain down her back and in her stomach. We offered the patient water and waited around 20 minutes for her symptoms to subside. I followed up with a phone call two hours later and the patient said that she was still feeling miserable and had a headache and was laying down on the couch. I told her if anything changes to go to the emergency room and she is going to follow up with her PCP.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Immediate post-injection reaction, Ocular hyperaemia, Paraesthesia, Paraesthesia oral
Clinical narrative: Immediately after administration the patient expressed that she did not feel quite right. Her eyes were bloodshot. She expressed that she experienced tingling in her lips and "pins and needles" in her face. Minutes after she jerked her back and expressed sharp pain down her back and in her stomach. We offered the patient water and waited around 20 minutes for her symptoms to subside. I followed up with a phone call two hours later and the patient said that she was still feeling miserable and had a headache and was laying down on the couch. I told her if anything changes to go to the emergency room and she is going to follow up with her PCP.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abasia, Back pain, Paralysis, Spinal pain
Clinical narrative: Immediately after administration the patient expressed that she did not feel quite right. Her eyes were bloodshot. She expressed that she experienced tingling in her lips and "pins and needles" in her face. Minutes after she jerked her back and expressed sharp pain down her back and in her stomach. We offered the patient water and waited around 20 minutes for her symptoms to subside. I followed up with a phone call two hours later and the patient said that she was still feeling miserable and had a headache and was laying down on the couch. I told her if anything changes to go to the emergency room and she is going to follow up with her PCP.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The right arm turned bright red from below the shoulder to just above the arm the day after getting the vaccination. It was sore and tender to touch and also swollen. The patient iced the area for 3 days before going to the Dr. The patient reported it to the pharmacy after 9 days, at which point the redness had subsided (though still present).
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, hot arm, painful, swollen.
Age: 95.0
Sex: F
Vaccine: PPV
Symptoms: Pulse absent, Respiratory arrest, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient got PNEUMOVAX in store on 8/23/17. 1 minute later patient was unresponsive, no breathing, and pulseless. Administered epinephrine and 1 round of compressions with 2 breaths and patient had pulse and breathing again.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Severe outbreak of shingles on right side of forehead and eye (lid and all of eye area). Also scalp.
Age: 44.0
Sex: F
Vaccine: ANTH, MMR, SMALL, TYP
Symptoms: Areflexia, Babinski reflex test, Dysstasia, Guillain-Barre syndrome, Hyporeflexia
Clinical narrative: 43 yo female patient on temporary assignment abroad presented with Ascending Paralysis on 8/17/2017 to the ED via 911. No significant PMH, No recent illnesses reported and no trauma. On arrival she reported feeling some weakness in her lower extremities on 8/15 which progressed to inability to stand on 8/17. She had 5/5 dorsi and plantar flexion but 1/5 hip flexion and extension. No Achilles of patellar reflexes could be elicited. Toes did not fan with Babinski. Exam was benign otherwise.
Age: 44.0
Sex: F
Vaccine: ANTH, MMR, SMALL, TYP
Symptoms: Laboratory test, Lumbar puncture, Mobility decreased, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: 43 yo female patient on temporary assignment abroad presented with Ascending Paralysis on 8/17/2017 to the ED via 911. No significant PMH, No recent illnesses reported and no trauma. On arrival she reported feeling some weakness in her lower extremities on 8/15 which progressed to inability to stand on 8/17. She had 5/5 dorsi and plantar flexion but 1/5 hip flexion and extension. No Achilles of patellar reflexes could be elicited. Toes did not fan with Babinski. Exam was benign otherwise.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: After administration of FLUZONE vaccine, patient developed a hard lump. Patient was concerned so I gave her an ice pack to apply to arm where shot was administered. Lump did not go down so I gave her BENADRYL by mouth. Lump decreased in size a little. After 20-25 minutes, the patient said she felt fine except site of injection was still a little swollen and sore. Patient left store with her mom.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Rt thigh swollen, red area- 8x8 cm- with blistering.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Local reaction
Clinical narrative: Localized reaction to the left deltoid region. Redness, pain, pruritis at the injection site.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Muscle twitching
Clinical narrative: Tenderness, redness, soreness at site of injection and below site of injection; pt reported muscle twitch at time of injection.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC13, RV1
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This patient received both PENTACEL and PEDIARIX today in clinic. Instead of ordering hepatitis B I ordered PEDIARIX and both were given. No adverse reaction. Mother of child informed of this by ordering physician.
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a male patient who received BEXSERO. On 1st July 2017, the patient received BEXSERO. On 1st July 2017, less than a day after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be almost certainly related to BEXSERO. Additional details were provided as follows: The age at the time of vaccination was not reported. The patient received a dose of BEXSERO into an unknown arm.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth, Phlebitis
Clinical narrative: Patient received 2 shots on 8/21/17, PNEUMOVAX and FLUARIX. Presented today, 8/23, with red area, palm size around injxn site and hot to touch, suspect phlebitis.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site urticaria, Swelling, Urticaria
Clinical narrative: Hives left deltoid which started at injection site an hour after given- spread to entire leg arm, swelling- Mom gave BENADRYL 50mg at onset and for 24hrs after - Self resolved.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Paraesthesia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 17-year-old female patient who received BEXSERO. On 28th July 2017, the patient received BEXSERO. In July 2017, less than a week after receiving BEXSERO, the pateint experienced injection site erythema, injection site swelling, injection site warmth, tingling of extremity and general body pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, tingling of extremity and general body pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, tingling of extremity and general body pain to be related to BEXSERO. Additional details were provided as follows: The sales representative received the information from the pharmacist as well. On 31st July 2017, the patient returned the office with tingling in arms down to hand and up to her neck. The patient was also having body aches and the injection site was red with a large bump and warm to touch. The adverse events had been reported through VAERS.
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Nausea, Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a adolescent female patient who received BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown, less than a week after receiving BEXSERO, the patient experienced injection site swelling, vomting and nausea. On an unknown date, the outcome of the injection site swelling, vomiting and nausea were unknown. It was unknown if the reporter considered the injection site swelling, vomiting and nausea to be related to BEXSERO. Additional details were provided as follows: The age at the time of vaccination was not reported. The physician reported that one of the her teenage patient had all of the possible side effects of BEXSERO after receiving a second dose and then specifically commented that the patient had swelling at the injection site, nausea and vomiting within 2 days of vaccination. No further related information was provided by the physician excepting that the field representative said that she had asked the doctor if the patient had had any anaphylactic reactions to the second dose of BEXSERO. The physician had responded that the patient had not had any anaphylactic reactions to the BEXSERO dose. It was unknown if the health care professional gave permission for being contacted. The doctor told that she didn't want to report, and then the field representative told the physician that she would be reporting to GSK. The health care professional said that, she did not know at which practice site of the doctor the patient was administered the BEXSERO.
Age: 9.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: Drug dispensed to wrong patient
Clinical narrative: Child received vaccines for his sibling. Provider input vaccines to wrong patient chart and gave verbal order to give vaccines to wrong patient.