chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L007225, expiration date 03-MAR-2017; lot # L026407, expiration date 15-JUL-2017; lot # reported as M000433 (invalid), expiration date 26-JAN-2018; dose and route were not reported). It was reported that the vaccine was improperly stored at -13.5 Celsius degree (C) for 2 hours 9 minutes and at -14.7 C for 56 minutes and then was back in range. There was no previous temperature excursion. Data logger was involved. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This solicited report as received from a pharmacist, as part of a marketing research program, refers to a 65 years old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2013 (when the patient was approximately 62 years old), the patient was vaccinated with 1 dose of ZOSTAVAX, one time injection (route of administration, lot# and expiry date were not reported). On an unknown date in 2016, the patient experienced mild case of shingles. The patient recovered/resolved with sequelae from the event on an unknown date, in 2016. Causality assessment was not provided. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent for further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning 8 unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On 26-AUG-2016, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M006726, expiration date 08-FEB-2018; strength, dose and frequency were unknown), subcutaneously, which was exposed to temperature excursion of 11.5 degrees Fahrenheit for 1 hour and 52 minutes. Previous temperature excursion was 13.1 degrees Fahrenheit for 48 hours. Data logger was involved. No adverse effects were 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On 16-AUG-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M006726, expiration date 08-FEB-2018; strength, dose and frequency were unknown), subcutaneously, which was exposed to temperature excursion of 11.5 degrees Fahrenheit for 1 hour and 52 minutes. Previous temperature excursion was 13.1 degrees Fahrenheit for 48 hours. Data logger was involved. No adverse effects were 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: F
Vaccine: VARZOS
Symptoms: Shock
Clinical narrative: This spontaneous report as received from a consumer (the patient's friend) via a certified medical assistant refers to a female patient of unknown age. The patient's concurrent conditions included allergy to penicillin. No information regarding the patient's medical history was provided. On an unknown date, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX injection (exact dose, lot# and expiry date were not reported) at another pharmacy. There were no concomitant therapies reported. On an unknown date, the patient went into shock. The outcome of the event was not reported. The relatedness between ZOSTAVAX and the event was not provided. Upon internal review, the event of shock was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to an unknown number of unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. In approximately 2016, reported as on unknown dates starting on or after 11-JUL-2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L033545, expiration date: 30-MAY-2017 and lot# M004885, expiration date: 23-OCT-2017 (dose was not reported). Administered doses of vaccine experienced temperature excursion of 48 degree Fahrenheit for 30 minutes, on unknown date. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 05-JUL-2016, the patient was vaccinated with a third dose of VARIVAX (dose and route of administration were not reported, lot# reported as 1048467, expiry date on 02-DEC-2017). No adverse reactions were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Itching, warmth, hardness around injection site.
Age: 50.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Induration, Injection site reaction, Nodule, Swelling
Clinical narrative: REDNESS, HARD NODULE AND SEVERE SWELLING,  PATIENT WAS AT URGENT CARE FOR ANOTHER ISSUE AND HAD THE PHYSICIAN LOOK AT HER INJECTION SITE.  THEY TOLD HER IT COULD BE FROM A SKIN INFECTION. THEY DISPENSED ANTIBIOTICS TO HER.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient woke with swelling and redness surrounding injection site.  She consulted her pharmacist and used Benadryl and Ibuprofen with resolution of symptoms.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site reaction, Pain, Urticaria
Clinical narrative: 3 welts on left upper arm below the injection site. welt #1 3.5cmx 4cm, welt #2 2cm x2cm, welt 3 3cm x 4 cm. Small amount of soreness.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Disturbance in social behaviour, Fatigue, Injection site pain, Injection site rash, Social avoidant behaviour
Clinical narrative: Pain at injection site, rash around injection site, fatigue, behavioral disturbances, distant, with-drawn behavior.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia, Tremor
Clinical narrative: Extreme chills, fever, trembling, muscle ache for 3 hours, followed by 2 days of less severe symptoms.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, White blood cell count increased
Clinical narrative: Family of three received vaccines.  Husband and wife received HD and flu and PNEUMOVAX and daughter received quad flu vaccines on Saturday.  Daughter had pain at site and no other reaction while both parents state they had red swollen arms (like welt) but no rash.  They went to urgent care clinic and blood tests showed elevated white cell counts for both of them and the urgent care doctor states they had received a "bad batch" of vaccine.  The husband was given antibiotics (keflex and bactrim) per patient's wife because he is a heart patient, but she is just on benadryl.  Both are doing okay now and state they did not want to call but doctor was very concerned and told them they needed to call us about the "bad batch".  I thanked patient for notifying us and told her to not worry about, as she put it "being a bother/drama queen", and that she did the right thing notifying us.   I told her swelling and pain can occur and elevated white count is part of intended/expected immune response to vaccine, but if she felt it was severe enough to go to the urgent care that she did the right thing and we would report all details to VAERS.   Patient voiced concern that she she travels alot and is educated and thought maybe she received the cholera shot accidentally since it was near closing.  Assured patient 1 we do not stock the cholera vaccine and 2 she did in fact receive the intended vaccines PNEUMOVAX and HD flu 3. being near closing would not change our procedures.    All patients were counseled before administration, given a VIS, and have received flu vaccines with us previously.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, White blood cell count increased
Clinical narrative: Family of three received vaccines.  Husband and wife received HD and flu and PNEUMOVAX and daughter received quad flu vaccines on Saturday.  Daughter had pain at site and no other reaction while both parents state they had red swollen arms (like welt) but no rash.  They went to urgent care clinic and blood tests showed elevated white cell counts for both of them and the urgent care doctor states they had received a "bad batch" of vaccine.  The husband was given antibiotics (keflex and bactrim) per patient's wife because he is a heart patient, but she is just on benadryl.  Both are doing okay now and state they did not want to call but doctor was very concerned and told them they needed to call us about the "bad batch".  I thanked patient for notifying us and told her to not worry about, as she put it "being a bother/drama queen", and that she did the right thing notifying us.   I told her swelling and pain can occur and elevated white count is part of intended/expected immune response to vaccine, but if she felt it was severe enough to go to the urgent care that she did the right thing and we would report all details to VAERS.   Patient voiced concern that she she travels alot and is educated and thought maybe she received the cholera shot accidentally since it was near closing.  Assured patient 1 we do not stock the cholera vaccine and 2 she did in fact receive the intended vaccines PNEUMOVAX and HD flu 3. being near closing would not change our procedures.    All patients were counseled before administration, given a VIS, and have received flu vaccines with us previously.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Local reaction, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient had been to the doctors office and came to us.  Seemed to be a typical localized reaction to the immunization with heat, pain, some swelling, and slight discomfort from the shoulder to the elbow.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Swelling face, Urticaria
Clinical narrative: 1200 Injection site red, hot and raised at 1630 hives to truck and right arm; had mild facial swelling on 9/2 and 9/3/2016; took Benadryl and loratadine on 9/2. Vaccine-FLUARIX 2016/2017 Formula lot 79PE5 exp 6/15/2017.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Confusional state, Diet refusal, Dyskinesia, Emotional distress, Fatigue
Clinical narrative: Around 5:00 pm he became very tired and irritable and refused to eat.  I thought he was just upset from the day's events so I put him to bed. Around 9 the next morning he woke up & seemed confused & was very irritable. By 9:30 am he started throwing up & complaining of a headache. He would not eat or drink and his fever was 101. Over the course of the next 4 hours he threw up 6x. He was extremely upset and screaming in pain. His body was occasionally jerking almost like mild seizures.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Headache, Irritability, Pain, Pyrexia, Screaming
Clinical narrative: Around 5:00 pm he became very tired and irritable and refused to eat.  I thought he was just upset from the day's events so I put him to bed. Around 9 the next morning he woke up & seemed confused & was very irritable. By 9:30 am he started throwing up & complaining of a headache. He would not eat or drink and his fever was 101. Over the course of the next 4 hours he threw up 6x. He was extremely upset and screaming in pain. His body was occasionally jerking almost like mild seizures.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Vomiting
Clinical narrative: Around 5:00 pm he became very tired and irritable and refused to eat.  I thought he was just upset from the day's events so I put him to bed. Around 9 the next morning he woke up & seemed confused & was very irritable. By 9:30 am he started throwing up & complaining of a headache. He would not eat or drink and his fever was 101. Over the course of the next 4 hours he threw up 6x. He was extremely upset and screaming in pain. His body was occasionally jerking almost like mild seizures.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Developmental regression, Inability to crawl, Irritability, Rash, Tongue movement disturbance
Clinical narrative: Patient started with rash, then was very fussy. This progressed into some sort of delopmental regression.  He was crawling before the vaccine, but stopped crawling and started tongue thrusting again.  These problems have slowly improved per parental report.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Child started breaking out with welts (hives) on trunk, arms and face. No difficulty breathing speaking or swallowing.  Dr gave patient Benadryl.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Angina pectoris, Arthralgia, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: Persistent heart stabbing pain that lasted for four days, short of breath, numbness, headaches, skin rush that persisted for about 2 weeks; prolonged joint pain (hip, knees, ankles) that continue for over a year now.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Rash
Clinical narrative: Persistent heart stabbing pain that lasted for four days, short of breath, numbness, headaches, skin rush that persisted for about 2 weeks; prolonged joint pain (hip, knees, ankles) that continue for over a year now.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Stiff arm and painful.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Ear pain, Posture abnormal, Screaming
Clinical narrative: Patient administered vaccine. With in 2 minutes patient slumped forward and was caught by mother and laid back on table. Child grabbed ears and started screaming.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient called us and stated that her arm was swelled up to her elbow.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Emotional distress, No adverse event
Clinical narrative: Patient did not understand until after administration of Tdap that it included pertussis vaccine. No adverse effect observed, but Patient VERY upset about additional components.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Rash pruritic, Vaccination site reaction
Clinical narrative: Itchy rash on left deltoid (where vaccination was administered).
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache
Clinical narrative: Headaches beginning 9/2/16 and increasing intensity/severity as of 9/6/16.
Age: 52.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Raised, red, painful area at Sq injection site (ZOSTAVAX). Hot to touch, about 2 square inches in area.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: C-reactive protein, Electrocardiogram, Full blood count, Hypophagia, Laboratory test
Clinical narrative: Lethargy, poor PO intake the day after vaccines given. He had URI and had been on BENADRYL x 1 d before vaccine. Propranolol since late July 2016.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lethargy
Clinical narrative: Lethargy, poor PO intake the day after vaccines given. He had URI and had been on BENADRYL x 1 d before vaccine. Propranolol since late July 2016.
Age: 1.0
Sex: M
Vaccine: HEPA, HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. The reporter stated that, on 02-SEP-2016, the patient was vaccinated with an expired dose of M-M-R II once via subcutaneous route (# lot M001200, expiry date 28-AUG-2016, dose, strength, vaccination site unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and 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. Since 04-AUG-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L044056, expiration date 02-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 16.7 degrees Fahrenheit for 4 hours and 20 minutes. The previous excursion was of 26.2 degrees Fahrenheit during 14 hours. The cumulative excursion was of 26.2 degrees Fahrenheit for 18 hours and 20 minutes. Data logger was involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 98.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a pharmacist via a Center (case # US16-038842) refers to a 98 year old female patient. There was no information about the patient's concurrent conditions or medical history provided. Her historical medications included PROAIR and albuterol. On an unknown date in 2014, the patient was vaccinated with the first dose of ZOSTAVAX injection, once, lot # M003487 with expiration date: 21-APR-2017 (exact dose and route of administration were not provided). On 17-AUG-2016, the patient was vaccinated with the second dose of ZOSTAVAX injection (exact dose, route of administration, lot #, expiration date and anatomical location were not provided). Concomitant therapies included iron and unspecified blood pressure medications. It was reported, that the pharmacist was not aware that the patient had received one previously until the daughter called to say that her mother had one in 2014 already. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and 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. Since 04-AUG-2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L029466, expiration date 06-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 16.7 degrees Fahrenheit for 4 hours and 20 minutes. The previous excursion was of 26.2 degrees Fahrenheit during 14 hours/ The cumulative excursion was of 26.2 degrees Fahrenheit for 18 hours and 20 minutes. Data logger was involved. This is one two reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a physician via company representative to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient received one dose of GARDASIL 9 injection (strength, dose, lot number, expiration date, route of administration were not reported). On an unknown date the patient received one dose of GARDASIL 9 injection (strength, dose, lot number, expiration date, route of administration were not reported. On unknown dates, after vaccination the patient developed a skin wart on his hand. The outcome of the event was unknown and no product quality complaint was involved. The relationship between the event and the GARDASIL 9 was unknown. Additional information is not expected as the reporter did not consent a new follow up attempts.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 27 years old female patient with rubber sensitivity. On 25-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 injection lot # M020521 (strength,dose,expiration date were not provided). Concomitant therapies included METADATE, ethinyl estradiol, JOLESSA and FLUZONE. On 25-AUG-2016, 12 hours after receiving PNEUMOVAX 23,she developed pain at the injection site. The primary reporter stated that the patient's pain continued to worsen and the patient now had pain,swelling, and a rash that extends to the elbow. The pharmacist also reported that the patient now was unable to use her arm, due to the pain, and that her arm was  in a sling. The Pharmacist stated that the patient had not recovered and would seek medical attention form her physician. No laboratory tests were performed. The outcome of the events was not resolved. The relationship between the events and the PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist via company employee referring to an approximately 64 years old patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was administered one dose of PREVNAR 13 (dose, lot #, expiration date unknown). Eleven months later, on an unknown date, the patient was inadvertently administered a dose of PNEUMOVAX 23 (strength, dose, frequency, route, lot number and expiration date were unknown) (Inappropriate schedule of drug administration). No adverse effects reported. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Arm very sore. All my body ached, front of head hurt. Felt very sick to stomach, nausea. This was for four days. I never got sick from a flu shot before.
Age: 65.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Anxiety, Arthritis, Asthenia, Condition aggravated, Dizziness
Clinical narrative: By afternoon, hoarseness, itchy eyes, headache, fatigue, weakness, dizziness, fast heart beat, warts, panic attacks. Weeks later still had itchy eyes, anxiety, weakness, dizziness, rapid heart beats and trouble focusing. Called doctor but did not go to the office. Told to take lots of liquids and go to ER if worsen. Lately had also blurry eyes, pain in eyes for a while. Noise/pain in ears. Arthritis has been worse since vaccination. There was swelling in the area in the beginning.
Age: 65.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Dysphonia, Ear pain, Eye pain, Eye pruritus, Fatigue
Clinical narrative: By afternoon, hoarseness, itchy eyes, headache, fatigue, weakness, dizziness, fast heart beat, warts, panic attacks. Weeks later still had itchy eyes, anxiety, weakness, dizziness, rapid heart beats and trouble focusing. Called doctor but did not go to the office. Told to take lots of liquids and go to ER if worsen. Lately had also blurry eyes, pain in eyes for a while. Noise/pain in ears. Arthritis has been worse since vaccination. There was swelling in the area in the beginning.
Age: 65.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Headache, Heart rate increased, Panic attack, Skin papilloma, Swelling
Clinical narrative: By afternoon, hoarseness, itchy eyes, headache, fatigue, weakness, dizziness, fast heart beat, warts, panic attacks. Weeks later still had itchy eyes, anxiety, weakness, dizziness, rapid heart beats and trouble focusing. Called doctor but did not go to the office. Told to take lots of liquids and go to ER if worsen. Lately had also blurry eyes, pain in eyes for a while. Noise/pain in ears. Arthritis has been worse since vaccination. There was swelling in the area in the beginning.
Age: 65.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Tinnitus, Vision blurred
Clinical narrative: By afternoon, hoarseness, itchy eyes, headache, fatigue, weakness, dizziness, fast heart beat, warts, panic attacks. Weeks later still had itchy eyes, anxiety, weakness, dizziness, rapid heart beats and trouble focusing. Called doctor but did not go to the office. Told to take lots of liquids and go to ER if worsen. Lately had also blurry eyes, pain in eyes for a while. Noise/pain in ears. Arthritis has been worse since vaccination. There was swelling in the area in the beginning.
Age: 65.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Anxiety, Arthritis, Asthenia, Condition aggravated, Disturbance in attention
Clinical narrative: By afternoon, hoarseness, itchy eyes, headache, fatigue, weakness, dizziness, fast heart beat, warts, panic attacks. Weeks later still had itchy eyes, anxiety, weakness, dizziness, rapid heart beats and trouble focusing. Called doctor but did not go to the office. Told to take lots of liquids and go to ER if worsen. Lately had also blurry eyes, pain in eyes for a while. Noise/pain in ears. Arthritis has been worse since vaccination. There was swelling in the area in the beginning.
Age: 65.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Dizziness, Dysphonia, Ear pain, Eye pain, Eye pruritus
Clinical narrative: By afternoon, hoarseness, itchy eyes, headache, fatigue, weakness, dizziness, fast heart beat, warts, panic attacks. Weeks later still had itchy eyes, anxiety, weakness, dizziness, rapid heart beats and trouble focusing. Called doctor but did not go to the office. Told to take lots of liquids and go to ER if worsen. Lately had also blurry eyes, pain in eyes for a while. Noise/pain in ears. Arthritis has been worse since vaccination. There was swelling in the area in the beginning.
Age: 65.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Fatigue, Headache, Heart rate increased, Panic attack, Rhinalgia
Clinical narrative: By afternoon, hoarseness, itchy eyes, headache, fatigue, weakness, dizziness, fast heart beat, warts, panic attacks. Weeks later still had itchy eyes, anxiety, weakness, dizziness, rapid heart beats and trouble focusing. Called doctor but did not go to the office. Told to take lots of liquids and go to ER if worsen. Lately had also blurry eyes, pain in eyes for a while. Noise/pain in ears. Arthritis has been worse since vaccination. There was swelling in the area in the beginning.
Age: 65.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Skin papilloma, Swelling, Vision blurred
Clinical narrative: By afternoon, hoarseness, itchy eyes, headache, fatigue, weakness, dizziness, fast heart beat, warts, panic attacks. Weeks later still had itchy eyes, anxiety, weakness, dizziness, rapid heart beats and trouble focusing. Called doctor but did not go to the office. Told to take lots of liquids and go to ER if worsen. Lately had also blurry eyes, pain in eyes for a while. Noise/pain in ears. Arthritis has been worse since vaccination. There was swelling in the area in the beginning.
Sex: U
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, Scratch
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 1 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 29-AUG-2016, while attempting to administer VARIVAX (lot # M000761 and expiration date 06-JAN-2018, dose and route of administration were not reported) to the patient, they received an invalid dose because they kicked, the needle came out of their leg and some of the vaccine leaked out. It was also reported that when the patient kicked and the needle came out, they received a scratch on the leg from the needle. The patient received treatment (unspecified) for the event. The outcome of the event was not reported. The relatedness between the event and VARIVAX was not reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 2 year old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, at one year of age, the patient was vaccinated with VARIVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date, an unspecified amount of time after the dose was administered, the patient developed shingles. The outcome of the event was not reported. The relatedness between the event and VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant mediations were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of PROQUAD (lot #, expiration date, dose and route were not reported). No adverse effects were reported. PROQUAD was supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blister, Dyspnoea, Erythema, Hypoaesthesia, Pain
Clinical narrative: 9/3 - Received ZOSTAVAX. 9/4 - Rash; trouble breathing; burning pain; itchy; Bright Red and swollen. 9/4 - 8pm went to Pt first and they gave BENADRYL and Abx; hands numb/face numb/tight throat. 9/5 - Not worse but rash still there; blisters worse.
Age: 53.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Rash, Swelling, Throat tightness
Clinical narrative: 9/3 - Received ZOSTAVAX. 9/4 - Rash; trouble breathing; burning pain; itchy; Bright Red and swollen. 9/4 - 8pm went to Pt first and they gave BENADRYL and Abx; hands numb/face numb/tight throat. 9/5 - Not worse but rash still there; blisters worse.
Age: 35.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache
Clinical narrative: Hepatitis B and ADACEL given at 1130 AM. Patient c/o chest fullness, headache, lightheadedness and shortness of breath at 1356. She was sent to Emergency Dept where she was treated and released. She felt much better following ED visit.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Eye movement disorder, Hyperhidrosis, Hypotonia, Irritability
Clinical narrative: Came in on 8/29/16 for vaccine update-PEDIARIX, HIB, PREVNAR, ROTATEQ-pt. was slightly fussy prior to vaccines and had been up the night before; temp check at office. Rectal temp 99.1 prior to vaccines. At 6pm; mom reported pt was "sweaty"; pt's head flopped forward and eyes appeared to roll back for a few seconds per dad. Pt very "floppy" vomited and seemed out of it for 3 minutes then seemed fine.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Posture abnormal, Vomiting
Clinical narrative: Came in on 8/29/16 for vaccine update-PEDIARIX, HIB, PREVNAR, ROTATEQ-pt. was slightly fussy prior to vaccines and had been up the night before; temp check at office. Rectal temp 99.1 prior to vaccines. At 6pm; mom reported pt was "sweaty"; pt's head flopped forward and eyes appeared to roll back for a few seconds per dad. Pt very "floppy" vomited and seemed out of it for 3 minutes then seemed fine.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient returned to pharmacy stating arm was still sore 10 days after shot.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody, Arthralgia, Autoimmune disorder, Inflammation, Systemic lupus erythematosus
Clinical narrative: Auto-immune inflammatory disorder brought on by the influenza vaccine. Severe joint pain, lupus-like s/s etc. Steroids - PLAQUENIL.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Local reaction, Pruritus
Clinical narrative: Local skin reaction still visible after 48 hours softball sized red spot, slightly inflamed and itchy no visible swelling, no arm pain per patient.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Rash maculo-papular, Skin lesion
Clinical narrative: Began with pain 2 days after injection, one red, round, maculopapular lesion 5 days after injection. Achy pain increasing, radiculopathy going down to fingers of left side. Lesions have increased in number and severity; no sensory or motor loss.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Throat closed up approximately 4-5 hours later then subsided.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: Patients arm was very painful and he could not lift it after a dose of PNEUMOVAX23. He went to ER and M.D. said Inj. site was correct and he must be having a non-specific reaction to Inj/Serum. Prescribed Diazepam 5mg Q 8H.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: 2cm rash on right hand. (Hand of injection site arm), noticed about 20min or 1/2 hour after administration-(20-30 mins).
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Myalgia, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: Rash (full body) extremely itchy, muscle aches, fever, swelling of neck muscles, scratchy throat. Not yet treated. Patient has never had reaction in past.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Rash (full body) extremely itchy, muscle aches, fever, swelling of neck muscles, scratchy throat. Not yet treated. Patient has never had reaction in past.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site, warm to touch, sore, achy, within 12 hours, sore to the touch, no fever. Apply icepack to area swelling reduced. Ibuprofen reduced pain by 24 hours.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Pruritus generalised, Sleep disorder
Clinical narrative: Patient woke up during night after receiving vaccine feeling itchy all over and unable to sleep. Gradually subsided over 3 days til gone.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site warmth, Local reaction, Nausea
Clinical narrative: Local reaction around injection site, warm to touch: also has been nauseated.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Patient came in for her second Hep B shot when patient was in the room she showed me pictures of a rash that had developed the day after the shot. I has a doctor examine the pictures. Patient was not given another dose. Patient stated that she had not come in for the reaction on the day of because she was unsure.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: About 3 hours after receiving vaccine, patient experienced redness, warm to touch ,rash, approximately 5 inches around the site of vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: The vaccines were given on 8/17/2016. To left arm is MCV4. To rt arm is HPV. Mom called on 8/19/2016. the (L) arm is hot, red and induration to about 3-4 inches. Pt has no cardioresp. compromise.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling below neck-began around 8/1/16. Especially when outdoors and sweating. Tingling in shoulder area.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Diarrhoea, Erythema, Malaise
Clinical narrative: Chills, diarrhea, malaise, joint (knee) pain over next 48 hrs. Arm swollen, red, hot, painful.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Chills, diarrhea, malaise, joint (knee) pain over next 48 hrs. Arm swollen, red, hot, painful.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Paraesthesia
Clinical narrative: Left hand and right lower leg paresthesia lasting 3 days after vaccination.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Left arm soreness, fatigue, headache, joint and muscle pain, nausea, fever and chills. Treated with ibuprofen.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Left arm soreness, fatigue, headache, joint and muscle pain, nausea, fever and chills. Treated with ibuprofen.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Product preparation error
Clinical narrative: PENTACEL vaccine mixed incorrectly. HIB was mixed with saline diluent. PENTACEL will need to be given again.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and hot to touch at injection site.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever developed 24-48 hours after vaccine was received. Increased to 103-104 degrees.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Headache, Malaise, Pruritus, Pyrexia, Rash pruritic
Clinical narrative: Pt had onset of vesicle type pruritic rash with low grade fever, general malaise and headache 5 days ago. The rash/vesicles scattered to upper torso, face, nose and legs. C/O itching and now vesicles scabbed over. Treatment was supportive therapy.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Rash vesicular, Scab
Clinical narrative: Pt had onset of vesicle type pruritic rash with low grade fever, general malaise and headache 5 days ago. The rash/vesicles scattered to upper torso, face, nose and legs. C/O itching and now vesicles scabbed over. Treatment was supportive therapy.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness upon injection site.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, and swelling around injection site. Given BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Pt was checking out with mother. Fell backwards fainting. Place feet up. Came too approx 1-2 minutes.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Cough, Diarrhoea, Fatigue, Headache, Peripheral swelling
Clinical narrative: Swelling of arm, coughing, diarrhea, headache, tiredness, change in personality.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Personality change
Clinical narrative: Swelling of arm, coughing, diarrhea, headache, tiredness, change in personality.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Patient had four vaccine administered and passed out for a few seconds, laid her down and gave a snack after a few minutes. She hadn't ate lunch yet at appt time.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Blood glucose normal, Disorientation, Hyperhidrosis, Mental status changes, Neutrophil percentage increased
Clinical narrative: Change in mental health, possible seizure (unresponsive, then diaphoretic and disoriented).
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Toxicologic test normal, Unresponsive to stimuli, White blood cell count increased
Clinical narrative: Change in mental health, possible seizure (unresponsive, then diaphoretic and disoriented).
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for 3 days.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Arthritis, Chills, Pyrexia
Clinical narrative: Six hours later I had violent chills, fever. The next day I had all joint pain that lasted a week. It triggered arthritis.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV, PPV
Symptoms: Body temperature increased, Fatigue, Headache, Pain, Vomiting
Clinical narrative: Date given 8-12-16. Symptom onset: 8-22-16 Severe headache, Temp 103.2, vomiting, body aches, fatigue lasted 3 days. Physician  called 8-23-16 Monitored pt treated with TYLENOL and ibuprofen, rest.
Age: 75.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Cough, Vomiting
Clinical narrative: Coughing extremely, vomiting. Awake at night, coughing uncontrollably.
Age: 75.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Blood glucose increased, Chest X-ray normal, Cough, Influenza virus test negative, Product quality issue
Clinical narrative: Coughing extremely, vomiting. Awake at night, coughing uncontrollably.
Age: 75.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Vomiting
Clinical narrative: Coughing extremely, vomiting. Awake at night, coughing uncontrollably.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis of right and left upper limb pt treated with cephalexin, BENADRYL and Ibuprofen. ROCEPHIN inj. also given.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Bursitis, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Significant (L) shoulder pain, fever and nausea the pm after a rabies vaccine (L) upper arm - (L) shoulder pain has persisted - increased with use of (L) arm.
Age: 19.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Achy, red, warm to touch, itchy, no fever.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None reported to health dept.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Product use issue
Clinical narrative: None reported to Health Department.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None reported to Health Dept.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None reported to health dept.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Dysphagia, Erythema, Hypertension, Hypoaesthesia
Clinical narrative: Local reaction (swelling and erythema) dizziness, initially she had trouble swallowing but this passes in a few minutes. Her right hand cannot feel heat starting about 6 hours after the injection on the opposite arm. She felt light-headed and bp was high the next day. Still cannot feel heat right hand.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Spinal X-ray abnormal, Spinal osteoarthritis, Testicular swelling
Clinical narrative: Local reaction (swelling and erythema) dizziness, initially she had trouble swallowing but this passes in a few minutes. Her right hand cannot feel heat starting about 6 hours after the injection on the opposite arm. She felt light-headed and bp was high the next day. Still cannot feel heat right hand.
Sex: U
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Accidentally grabbed an MMRV instead of MMR and gave it to the client.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Day of vac. upper left arm got rash - red, pruritus - now spread toward elbow, some warmth. Took BENADRYL and used calamine lotion. To continue antihistamines and cool compresses.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash
Clinical narrative: Rash around injection site.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt had redness and swelling at site of injection, it was also warm to the touch. The spot grew over 2 days before she came in to about 2 inches in diameter. She took BENADRYL, Ibuprofen and applied ice; it went down but she stated she had a 101 degree fever and it still burned. We sent her to a clinic on day 3.
Age: 84.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness around site with little swelling, cold compress.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 17-JUL-2016, the patient was vaccinated with improperly stored M-M-R II lot # L029266, therapy type (albumin status) rHA, (dose, strength, route of administration and expiry date were not reported). This 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 as received from a physician refers to an unspecified number of patients. The patients concurrent conditions and medical history were not reported. On an unspecified dates, an unspecified number of patients received an improperly stored dose of VARIVAX (dose, route of administration, lot number and expiration date were not reported). No concomitant medications were reported. No adverse effect was reported. No further details were provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 27-JUL-2016, the patient was vaccinated with improperly stored MMR II lot # L029266, therapy type, (dose, strength, route of administration and expiry date were not reported). This 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 as received from a medical assistant refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 02-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, (Concentration, dose and route were not reported), lot # M005972, expiration date: 02-FEB-2018. The administered dose of VARIVAX underwent temperature excursion at 26 Fahrenheit degrees, for 6 hours. No previous temperature excursions were reported. The temperature excursions were detected by a data logger. Patient's concomitant medication was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to about 8 unspecified patients of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (concentration, dose and route of administration were not reported), lot # L007228, expiration date 03-SEP-2016. Patient's concomitant medication was not reported. No adverse effects were reported. A product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.