chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 17-MAY-2016, the patient was vaccinated with first dose of RECOMBIVAX HB f(lot #, expiry date, dose, strength, vaccination site, route not provided). On 01-JUN-2016, the patient was inadvertently vaccinated with a second dose of RECOMBIVAX HB earlier than recommended (lot #, expiry date, dose, strength, vaccination site, route not provided). No adverse effects were reported. Product quality complaint (PCQ) was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical reported. On an unknown date, the patients were vaccinated with improperly stored (in the temperature: - 9.1 degree Celsius) (Oka/Merck) VARICELLA lot# L045955 with expiry date: 17-NOV-2017 and lot # reported as M000762 with expiry date: 06-NOV-2018 (dose and frequency were not reported). The time frame that the (Oka/Merck) VARIVAX out of range was 1 hour and 21 minutes. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There we no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JUN-2016, the patient was vaccinated with an expired dose of ROTATEQ lot# K015816, expiration date: 29-MAY-2016, orally (exact dose was not reported). There were no adverse effects noted. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. on  07-JUN-2016, the patient was inadvertently administered an expired dose of ZOATAVAX injection, lot # L006382, expiration date: 26-MAY-2016 (exact dose, dose number, route of administration and anatomical location were not reported). There were no adverse effects reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site lymphadenopathy, Injection site nodule, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 41-year-old female patient who received BOOSTRIX (batch number FB942, expiry date 3rd December 2017). On 11th April 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On 11th April 2016, less than a day after receiving BOOSTRIX, the patient experienced injection site pain. On 13th April 2016, the patient experienced injection site nodule, injection site lymphadenopathy, injection site inflammation, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site nodule, injection site lymphadenopathy, injection site inflammation, injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the injection site pain, injection site nodule, injection site lymphadenopathy, injection site inflammation, injection site erythema and injection site swelling to be possibly related to BOOSTRIX. Additional details provided were as follows: The case was not previously reported to anyone. On 11th April 2016 at 19:00, the patient received BOOSTRIX in left deltoid and on the same day, the patient's arm became painful, which had continued since that day. On 14th April 2016, 2 days after vaccination, the patient had redness and swelling at injection site. She also noticed that the lymph node under her left arm was swollen, there was a raised nodule, a red circle and very red inflammation (approximately 2.5 inches in diameter) at the injection site. The injection site was painful to touch, but was not interfering with normal daily activities. The reporter inquired about having any recommendations. The call was transferred to Medical Information System. This case was identified as duplicate of US2016054163. Case US2016054163 was deleted and all the future correspondence will be added in the present case which stands as case record for this patient.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lymphadenopathy, Nodule, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 41-year-old female patient who received BOOSTRIX (batch number FB942, expiry date 3rd December 2017). On 11th April 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On 11th April 2016, less than a day after receiving BOOSTRIX, the patient experienced injection site pain. On 13th April 2016, the patient experienced injection site nodule, injection site lymphadenopathy, injection site inflammation, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site nodule, injection site lymphadenopathy, injection site inflammation, injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the injection site pain, injection site nodule, injection site lymphadenopathy, injection site inflammation, injection site erythema and injection site swelling to be possibly related to BOOSTRIX. Additional details provided were as follows: The case was not previously reported to anyone. On 11th April 2016 at 19:00, the patient received BOOSTRIX in left deltoid and on the same day, the patient's arm became painful, which had continued since that day. On 14th April 2016, 2 days after vaccination, the patient had redness and swelling at injection site. She also noticed that the lymph node under her left arm was swollen, there was a raised nodule, a red circle and very red inflammation (approximately 2.5 inches in diameter) at the injection site. The injection site was painful to touch, but was not interfering with normal daily activities. The reporter inquired about having any recommendations. The call was transferred to Medical Information System. This case was identified as duplicate of US2016054163. Case US2016054163 was deleted and all the future correspondence will be added in the present case which stands as case record for this patient.
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Contusion, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Bruising, petechial started approximately 2-3 wks after vaccination. Evaluated in office 6/6/16 and found to have low platelets (thrombocytopenia).
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-APR-2016, the patient was vaccinated with an improperly stored dose of MMR II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursion reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site pain, Injection site swelling
Clinical narrative: Patient had several red indurated rings across her deltoid and bicep with swelling and pain down to her elbow (in (R) deltoid area).
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. The nurse reported that the patient received two doses of GARDASIL, each dose on separate dates (unknown). On an unknown date in 2014, the patient received her second dose of GARDASIL. The nurse stated that the patient was seen in the office on 16-MAY-2016 to receive her third dose of GARDASIL but the nurse thinks that the patient may have received a different vaccine instead (the nurse was unsure of what vaccine the patient received) of the GARDASIL accidentally but she was not sure. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from healthcare professional refers to a pediatric patient of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2009, the patient was vaccinated with first dose of VAQTA. On 10-MAY-2016, the patient was vaccinated with second dose of VAQTA (inappropriate schedule of drug administration). No adverse event reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple, unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL (lot # K008931, exp. date: 04-MAR-2017) (dose number and route were not reported). The doses of GARDASIL were stored in 11.4 Celsius degree for 1 hour and 14 minutes. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX injection, lot # M001578, expiry date 21-NOV-2018, lot # M010212, expiry date 21-JAN-2019, lot # reported as M022077, expiry date 10-MAR-2019, lot # L045117, expiry date 06-OCT-2018, lot # M001578, expiry date 21-NOV-2018 and lot # L030608, expiry date 15-APR-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of RECOMBIVAX HB underwent temperature excursion at 1 Celsius degrees for 2 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 07-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, subcutaneous injection, (lot # M003435, expiry date 19-JUL-2017), with a temperature excursion of 40 degrees F for 25 hours. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent condition, concomitant therapies or medical history provided. On 09-May-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Patient with fever of 104 degrees. Parents brought child to ER no rash or redness at the sight of injection. Just fever.
Age: 37.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 37 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in left deltoid, lot # reported as 042946, expiration date 15-SEP-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # M003011, expiry date 15-NOV-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of VAQTA underwent temperature excursion at 1 Celsius degrees for 2 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PWC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral solution, lot # reported as L046318, expiry date 20-SEP-2017, lot # L037574, expiry date 01-JUL-2017, lot # L035637, expiry date 09-JUN-2017, lot # reported as L039640, expiry date 24-AUG-2017, lot # L037924, expiry date 22-JUN-2017 and lot # L037547, expiry date 01-JUL-2017 (dose was not specified). On an unknown date, the administered doses of ROTATEQ underwent temperature excursion at 1 Celsius degrees for 2 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L038917, expiry date 20-FEB-2018, lot # L048459, expiry date 20-FEB-2018, lot # L044475, expiry date 12-MAY-2017 and lot # L043213, expiry date 28-AUG-2017 (dose, route of administration and anatomical location were not specified). On an unknown date the administered doses of GARDASIL 9 underwent temperature excursion of 1 Celsius degrees for 2 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection, lot # L021367, expiry date 05-NOV-2016 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of PNEUMOVAX 23 underwent temperature excursion at 1 Celsius degrees for 2 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not 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: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with VARIVAX was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (reported lot # L008990, exp. date: 01-DEC-2016) and RECOMBIVAX HB (lot # L018501, exp. date: 22-JUN-2017) (for both: dose number and route were not reported). The dose of ROTATEQ and RECOMBIVAX HB were stored in 1.4 Celsius degree for 2 hours and 41 minutes. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple, unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (lot # L018501, exp. date: 22-JUN-2017 and lot# M000442, expiration date: 31-MAR-2018) (doses number and route were not reported). The doses of RECOMBIVAX HB were stored in 11.4 Celsius degree for 1 hour and 14 minutes. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an adult patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 18-MAY-2016, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (lot # L048848, expiration date 09-AUG-2018; dose and route not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 04-MAR-2016, the patient received the first dose of GARDASIL. The patient would like to receive the second dose of GARDASIL on 25-MAY-2016 (inappropriate schedule of drug administration). No adverse symptoms were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with VARIVAX (dosing details, lot#, expiry were not reported). On an unknown date, the patient developed chicken pox all over his body after his mother developed a rash (case#1605USA012999) after receiving VARIVAX (dosing details, lot#, expiry were not reported). The patient was up-to date with his varicella vaccinations. The outcome of chicken pox was unknown. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: Eczema
Clinical narrative: Eczema outbreak lasting 6 weeks, date of onset is approximate, as early as 3 days earlier or 7 days later.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Rash erythematous, Skin discolouration
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 78 year old female patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Stent, Stroke and ASA desensitized. The patient had no illness at the time of vaccination. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA not reported on 23-Sep-2015 - unknown stop date, Batch no: not provided, Route of administration: Unknown, Site: Unknown. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 26-Sep-2015, 4 days after starting / treatment with AFLURIA the patient experienced [Red from rash/] discoloration approximately 2 inches from injection site (non serious, outcome: Unknown), Red [from rash/discoloration] approximately 2 inches from injection site (non serious, outcome: Unknown), [Red from] rash [/discoloration] approximately 2 inches from injection site / Resembles rash or subdermal infiltration (non serious, outcome: Unknown), Injection site bruising (non serious, outcome: Unknown). VAERS ID: 598601. Reporter's assessment: Non-serious. The health authority reported the symptom injection site bruising.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 50 year old male patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Hypertension, High cholesterol, Gout, GERD, Sleep apnea, Type 2 diabetes and 'kidney diseases'. For concomitant medication and therapy dates refer to the appropriate report sections. Concomitant medication also includes metformin and JANUMET and TRILIPIX. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA (thiomersal containing) not reported on 01-Oct-2015 - unknown stop date, Batch no: 11149211A, Route of administration: Intramuscular, Site: Right arm (RA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 01-Oct-2015, 1 day after starting / treatment with AFLURIA the patient experienced Difficult moving arm in which injection was given (non serious, outcome: Not Recovered / Not Resolved). Reporter's assessment: Non serious. VAERS ID: 604258.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site pain, Pain in extremity
Clinical narrative: Very sore arm, from site of injection to below elbow lasting more than 24 hours.  Extreme fatigue for 24 hours.
Age: 44.0
Sex: M
Vaccine: VARCEL
Symptoms: Biopsy skin, Blood test, Computerised tomogram liver, Hepatitis, Malaise
Clinical narrative: This spontaneous report was received from a physician and refers to a 44 year old male patient. The patient had no pertinent medical history, no drug reactions or allergies and no concomitant medications. On an unknown date, the patient's child was vaccinated with VARIVAX (Merck) (dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date in November 2015, about a month later, the patient sought medical attention and was seen in the emergency room (ER) at the hospital because he was not feeling well. The patient was diagnosed at that time with an unspecified rash on an unspecified area of the body and varicella hepatitis. The physician stated that the patient had unspecified skin biopsy, unspecified blood work, a computerized tomogram (CT) scan of the liver and an ultrasound of the liver while he was in the ER (no result was provided). The patient was admitted to the hospital for about a week and received treatment for the events (unspecified). The patient has been recovered from the events since an unknown date approximately in 2016, since about 3 months after being discharged from the hospital on an unknown date approximately in 2015. The relatedness between the events and VARIVAX (Merck) was not reported. The physician considered the event of varicella hepatitis as life threatening. Upon internal review the event of varicella hepatitis was considered to be medically significant. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Ultrasound liver
Clinical narrative: This spontaneous report was received from a physician and refers to a 44 year old male patient. The patient had no pertinent medical history, no drug reactions or allergies and no concomitant medications. On an unknown date, the patient's child was vaccinated with VARIVAX (Merck) (dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date in November 2015, about a month later, the patient sought medical attention and was seen in the emergency room (ER) at the hospital because he was not feeling well. The patient was diagnosed at that time with an unspecified rash on an unspecified area of the body and varicella hepatitis. The physician stated that the patient had unspecified skin biopsy, unspecified blood work, a computerized tomogram (CT) scan of the liver and an ultrasound of the liver while he was in the ER (no result was provided). The patient was admitted to the hospital for about a week and received treatment for the events (unspecified). The patient has been recovered from the events since an unknown date approximately in 2016, since about 3 months after being discharged from the hospital on an unknown date approximately in 2015. The relatedness between the events and VARIVAX (Merck) was not reported. The physician considered the event of varicella hepatitis as life threatening. Upon internal review the event of varicella hepatitis was considered to be medically significant. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site bruising, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Severe Headache, muscle aches and cramping, muscle stiffness, assistance needed to walk because of muscles weakness and soreness. Unable to move arm where vaccine was administered.  Swelling, bruising at vaccine injection site. One week later still having pain in left arm and mobility issues. Muscle weakness and inability to have full range of motion in arm where vaccine was administered. Also experiencing pain that is radiating down left arm into hand. Awakening at night because of severity of pain in arm where vaccine was given.  General pain throughout the day.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Middle insomnia, Muscle spasms, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Severe Headache, muscle aches and cramping, muscle stiffness, assistance needed to walk because of muscles weakness and soreness. Unable to move arm where vaccine was administered.  Swelling, bruising at vaccine injection site. One week later still having pain in left arm and mobility issues. Muscle weakness and inability to have full range of motion in arm where vaccine was administered. Also experiencing pain that is radiating down left arm into hand. Awakening at night because of severity of pain in arm where vaccine was given.  General pain throughout the day.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity, Walking aid user
Clinical narrative: Severe Headache, muscle aches and cramping, muscle stiffness, assistance needed to walk because of muscles weakness and soreness. Unable to move arm where vaccine was administered.  Swelling, bruising at vaccine injection site. One week later still having pain in left arm and mobility issues. Muscle weakness and inability to have full range of motion in arm where vaccine was administered. Also experiencing pain that is radiating down left arm into hand. Awakening at night because of severity of pain in arm where vaccine was given.  General pain throughout the day.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Right arm pain increasing since vaccine was given 10/10 pain on 6/2, seen in office 6/3/16 pain was 7/10, then worsened now with tingling to arm.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Paralysis, Polymyalgia rheumatica
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 63-year-old male patient. The patient had no pertinent medical history, drug reactions, allergies or concomitant medications. On 31-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # L036823, expiry date December 2016, (dose, frequency, site and route of administration were not reported). On an unknown date in April 2016 (reported as within two weeks of the administration of the ZOSTAVAX), the patient experienced muscle pain in the shoulders which radiated to his thighs, hips and back. The reporter noted that the patient was basically "paralyzed" due to such severe pain. The patient has been seen by several different physicians for this condition as well as hospitalized (at an unknown hospital on an unknown date in 2016 for an unknown length of time). The reporter noted that the patient walked into the pharmacy on 07-JUN-2016 and stated that he was recently diagnosed with "PMR"-polymyalgia rheumatica by a physician at a hospital. He stated that the diagnosing physician associated the polymyalgia rheumatica with the ZOSTAVAX. The reporter was unaware of the treatment for the polymyalgia rheumatica, although the patient just had a prescription filled for 10 mg prednisone (manufacturer unknown) on 03-JUN-2016. No further information was provided. The outcome of polymyalgia rheumatica was reported as ongoing. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the event of polymyalgia rheumatica was considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: -swollen; hot to touch; hard; inflamed; redness; local reaction at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: -swollen; hot to touch; hard; inflamed; redness; local reaction at injection site.
Age: 32.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Brachial plexopathy, Electromyogram abnormal, Insomnia, Mononeuropathy
Clinical narrative: The patient received H1N1 IIV on APR 17 2010. He states 4-5 days later he experienced (L) shoulder blade pain, sharp, of such severity he could not sleep. He self-treated with ibuprofen which did not help. He started to experience left arm paralysis and muscle atrophy. He could not move his fingers. He saw an orthopedist on 23 July 2010 who documented onset report as 8 days after receipt. POC was conservative. Pt saw ortho again on 17 SEP 2010 due to worsening weakness and atrophy. The ortho ordered nerve conduction studies which demonstrated damage to his brachial nerve plexus. He was diagnosed with Parsonage Turner syndrome. 22 Nov 2013 neurology eval did not detect residual deficits, although patient states continued mild sensory deficits and currently states shoulder pain he thinks may be due to secondary injury (doing PT pushups with weakness).
Age: 32.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Monoplegia, Muscle atrophy, Musculoskeletal pain, Musculoskeletal stiffness, Nerve conduction studies abnormal
Clinical narrative: The patient received H1N1 IIV on APR 17 2010. He states 4-5 days later he experienced (L) shoulder blade pain, sharp, of such severity he could not sleep. He self-treated with ibuprofen which did not help. He started to experience left arm paralysis and muscle atrophy. He could not move his fingers. He saw an orthopedist on 23 July 2010 who documented onset report as 8 days after receipt. POC was conservative. Pt saw ortho again on 17 SEP 2010 due to worsening weakness and atrophy. The ortho ordered nerve conduction studies which demonstrated damage to his brachial nerve plexus. He was diagnosed with Parsonage Turner syndrome. 22 Nov 2013 neurology eval did not detect residual deficits, although patient states continued mild sensory deficits and currently states shoulder pain he thinks may be due to secondary injury (doing PT pushups with weakness).
Age: 32.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging spinal normal, Radiculopathy, Sensory loss, Ulnar nerve injury
Clinical narrative: The patient received H1N1 IIV on APR 17 2010. He states 4-5 days later he experienced (L) shoulder blade pain, sharp, of such severity he could not sleep. He self-treated with ibuprofen which did not help. He started to experience left arm paralysis and muscle atrophy. He could not move his fingers. He saw an orthopedist on 23 July 2010 who documented onset report as 8 days after receipt. POC was conservative. Pt saw ortho again on 17 SEP 2010 due to worsening weakness and atrophy. The ortho ordered nerve conduction studies which demonstrated damage to his brachial nerve plexus. He was diagnosed with Parsonage Turner syndrome. 22 Nov 2013 neurology eval did not detect residual deficits, although patient states continued mild sensory deficits and currently states shoulder pain he thinks may be due to secondary injury (doing PT pushups with weakness).
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Intense (L) shoulder pain at time of vac. - cont to this day. TX P.T. and over counter med.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Soreness at injection site, increased pain at injection site and shoulder (right). 4 days later swelling appeared, loss of motion, excruciating pain. Today no redness or swelling noted. Some improvement noted.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Left thigh is tender to palpation without erythema/induration.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Crying, Gait disturbance, Hyperaesthesia, Inability to crawl, Irritability
Clinical narrative: Would not walk or crawl or stop crying per mom, No redness, no bump but terrible sore. Child terrible fussy. Per mom would not even let her touch area at all.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Whole upper arm was swollen, painful and red.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Unresponsive to stimuli
Clinical narrative: After vaccines were given, client watched her brothers receive their vaccines. Client was sitting on the floor and started to pass out. Nurse in room at time and helped lower client to floor. Client was unresponsive with eyes open for less than 1 minute. She verbally responded to mother. She was able to sit up and drink water and eat crackers. Mother and brothers at her side. Client states she was fine and left with mother and brothers
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Gait disturbance, Injection site pain
Clinical narrative: Leg terrible sore, very painful, refuses to walk on it. No redness noted at site.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Malaise, Narcolepsy
Clinical narrative: General malaise. Weakness. 2 narcolepsy events.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: HPI Rash The problem is new.  The current episode started  3 days.  Since onset, the problem has been gradually worsening (spreading).  Affected locations include left arm.  Symptom characteristics include warmth and redness.  Exposed to: Had herpes zoster vaccine 4 days ago.  Associated symptoms include fatigue (slight).  Negative for non-blanching rash, headache, sore throat, stiff neck, joint pain, anorexia, congestion, malaise, swollen glands, vomiting, myalgias, cough, diarrhea, nail changes, facial edema, painful lesions, fever, shortness of breath and rhinorrhea.  Treatments tried: Ice and motrin.  Tetanus  status is unknown.  PMH includes Negative for diabetes, immunocompromised, MRSA, psoriasis, strep, asthma, allergies, eczema, varicella series (had disease) and mmr series (had mumps). Pt had herpes zoster vaccine administered by a pharmacist 6/4/16 and 6/5/16 developed redness, warmth, itching +  swelling to site on posterior left arm that has been increasing in size. has been applying ice and taking ibuprofen w/ effect.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: HPI Rash The problem is new.  The current episode started  3 days.  Since onset, the problem has been gradually worsening (spreading).  Affected locations include left arm.  Symptom characteristics include warmth and redness.  Exposed to: Had herpes zoster vaccine 4 days ago.  Associated symptoms include fatigue (slight).  Negative for non-blanching rash, headache, sore throat, stiff neck, joint pain, anorexia, congestion, malaise, swollen glands, vomiting, myalgias, cough, diarrhea, nail changes, facial edema, painful lesions, fever, shortness of breath and rhinorrhea.  Treatments tried: Ice and motrin.  Tetanus  status is unknown.  PMH includes Negative for diabetes, immunocompromised, MRSA, psoriasis, strep, asthma, allergies, eczema, varicella series (had disease) and mmr series (had mumps). Pt had herpes zoster vaccine administered by a pharmacist 6/4/16 and 6/5/16 developed redness, warmth, itching +  swelling to site on posterior left arm that has been increasing in size. has been applying ice and taking ibuprofen w/ effect.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Urticaria
Clinical narrative: The patient received GARDASIL and within 10-15 minutes developed hives on her back and started to have erythema in a discrete patch on her face. She was given 50 mg PO of BENADRYL, monitored for > 30 minutes, no hypoxia, no wheezing, and hives improved.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram head, Dizziness, Electrocardiogram, Eye movement disorder, Fall
Clinical narrative: Pt was checking out and speaking when she stated she felt light headed. She stiffened, eyes rolled up and she fell backwards. Pt was out for several seconds.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Pt was checking out and speaking when she stated she felt light headed. She stiffened, eyes rolled up and she fell backwards. Pt was out for several seconds.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medial assistant regarding a patient of unknown age and gender. information on the concurrent conditions and medical history of the patient was not reported. On 29-MAR-2016, the patients was vaccinated with unspecified doses of improperly stored GARDASIL immunization series lot # K011562, expiry date 08-APR-2017, dose #, units, frequency, route and anatomical location were not specified. Concomitant medication were not reported. There were no adverse effects reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the product the product was exposed was 33 degree Fahrenheit for 72 hours. Temperature and time frame at which the product was exposed previously: 34 degree Fahrenheit for 72 hours and 47 degree Fahrenheit for 12 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding a patient of unknown age and gender. Information on the concurrent conditions and medical history of the patient was not reported. On 29-MAR-2016, the patient was vaccinated with unspecified doses of improperly stored GARDASIL lot # K011562, expiry date 08-APR-2017 (dose, units, frequency, route and anatomical location were not specified). Concomitant medication were not reported. There were no adverse effects reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the product was exposed was 33 degree Fahrenheit for 72 hours. Temperature and time frame at which the product was exposed previously: 34 degree Fahrenheit for 72 hours and 47 degree Fahrenheit for 12 hours. This is one of several reports received from same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Patient states she had vaccination on Thursday, February 25, 2016 and states that side effects consisted of headache, nausea, chills, fever redness/swelling at the injection site. Patient states she had taken ibuprofen, TYLENOL, and BENADRYL prophylactically or the side effects would've been worse. Patient states she's back to normal now (3/1/16).
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient states she had vaccination on Thursday, February 25, 2016 and states that side effects consisted of headache, nausea, chills, fever redness/swelling at the injection site. Patient states she had taken ibuprofen, TYLENOL, and BENADRYL prophylactically or the side effects would've been worse. Patient states she's back to normal now (3/1/16).