chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist's student and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 03-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (dose, and route of administration were not reported) (lot # L028280 and expiration date 28-OCT-2016) for prophylaxis. The sterile water diluent that was used to reconstituted the ZOSTAVAX was not expired (lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified multiple patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, lot # M002254 expiration date: 15-NOV-2017, lot# M004508, expiration date: 29-JUN-2017, lot# M012495, expiration date: 09-OCT-2017, lot# M025568, expiration date: 07-NOV-2017 (dose was not reported). The temperature excursion ranged from 32 to 35 degrees Fahrenheit for 24 hours. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013069: US-009507513-1703USA013068.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Drug administered to patient of inappropriate age, Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from the administrator and refers to a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-JAN-2017, the patient received a dose of expired adult formulation (instead of pediatric) VAQTA lot # L027735 which had expired on 12-JAN-2017 (dose and route were not reported) for prophylaxis. In addition, on 16-MAR-2017, the patient received the second dose too early of VAQTA lot #M030598, expiration date 13-OCT-2017 (dose and route were not reported) for prophylaxis. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 23-MAR-2017, the patient was inadvertently vaccinated with a dose of PROQUAD (rHA) lot# M043308, expiration date 24-APR-2018, along with VARIVAX lot# L034369, expiration date 08-SEP-2017 (dose and route of administration were not provided for both). The patient was scheduled to receive M-M-R II and inadvertently received PROQUAD because of human error. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 50 year old female patient. The patient's medical history, concurrent conditions, drug allergies or concomitant medications were not reported. On an unspecified date in February 2017, the patient might have been vaccinated with a dose of RECOMBIVAX HB 10/1.0 microgram/ml injection, pediatric formulation (dose, lot number and expiration date were not provided) for prophylaxis. In March 2017, (reported as "approximately one month later"),  the patient received an adult dose of RECOMBIVAX HB 10/1.0 microgram/ml injection, (dose was not reported) (lot number: M039201; expiration date: 04-NOV-2018) for prophylaxis. No adverse effects were reported. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, since January 2017, the patients were vaccinated with PROQUAD (route of administrations, lot numbers and expiry dates were not reported). No adverse effect was reported. Data logger was involved. At the time of the report, temperature excursion and time frame of temperature excursion were not known. There was no previous temperature excursion. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013078.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a 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 date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M033583 with an expiration date 14-APR-2019 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of GARDASIL 9 experienced the temperature excursion of 1 degrees Celsius for 93 hours. A digital data logger was involved. There was no previous temperature excursion.  Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013107: US-009507513-1703USA013108: US-009507513-1703USA013106:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD subcutaneous injection as a single dose (strength was not reported) (lot # M041507, expiration date 09-APR-2018; lot #: M037652, expiration date: 28-FEB-2018) for prophylaxis. The patients were also administered sterile diluent (strength, lot number and expiration date were not reported). According to the reporter, PROQUAD doses were exposed to the following temperatures excursions: 22 degrees Fahrenheit (F) for 1 hour daily during defrost cycle. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information is not expected as the reported refused additional contact. Sender's Comments: US-009507513-1703USA006881.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified multiple patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB injection, lot# M007762, expiration date: 07-DEC-2018, lot# M036612, expiration date: 19-MAY-2019 (dose and route of administration were not reported). The temperature excursion ranged from 32 to 35 degrees Fahrenheit for 24 hours. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013069: US-009507513-1703USA009342.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified multiple patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX23 injection, lot# M018624, expiration date: 28-MAY-2017, lot# M036728, expiration date: 20-MAY-2018 (dose and route of administration were not reported). The temperature excursion ranged from 32 to 35 degrees Fahrenheit for 24 hours. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009342: US-009507513-1703USA013068:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, since January 2017, the patients were vaccinated with VARIVAX  (route of administration, lot number and expiry dates were not reported). No adverse effect was reported. Data logger was involved. At the time of the report, temperature excursion and time frame of temperature excursion were not known. There was no previous temperature excursion. Thi is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA011830:
Age: 66.0
Sex: F
Vaccine: TDAP, UNK, VARZOS
Symptoms: Injected limb mobility decreased, Injection site movement impairment, Musculoskeletal stiffness, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old female patient with hypertension. On 13-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX, (lot # M035147, expiry date 25-OCT-2017) in the left arm for prevention of shingles. On the same day the patient was also vaccinated with a dose of BOOSTRIX also in the left arm and with a dose of a 3rd unspecified vaccine at unspecified location of her body. At the time of the vaccination the patient was taken losartan (manufacturer unknown) 50 mg daily. On an unknown date, in December 2016, shortly after received the vaccines, the patient began to experience muscle pain, and stiffness that started from her left shoulder down to her lower arm. The pharmacist reported that after a month the patient had reported that she was still experiencing the same symptoms and then on 27-MAR-2017 the patient went into the pharmacy and reported that she had not gotten better, even after taking medication with cyclobenzaprine and tramadol (unspecified dose and frequency for both products), going to physician therapy and unspecified referrals. The patient stated that she had not experienced anything like that before. The outcome of musculoskeletal stiffness, myalgia and injected limb mobility decreased was reported as not recovered/not resolved. The pharmacist stated that this did affect the patient's ability to perform daily tasks and was very bothersome for her. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, redness and now tenderness that has been getting progressively worse. No treatment yet - just prescribed naproxen twice daily.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Bladder dysfunction, Injected limb mobility decreased, Lumbar puncture, Mobility decreased, Muscular weakness
Clinical narrative: Impaired mobility of arms and legs, impaired function of bladder, weakness in hands, pain.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Impaired mobility of arms and legs, impaired function of bladder, weakness in hands, pain.
Age: 81.0
Sex: M
Vaccine: HEP
Symptoms: Balance disorder, Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 81-year-old male patient who received ENGERIX B Adult. On 15th March 2017, the patient received the 2nd dose of ENGERIX B Adult. On 15th March 2017, 1 hr 30 min after receiving ENGERIX B Adult, the patient experienced nausea (serious criteria hospitalization), sweating (serious criteria hospitalization), felt faint (serious criteria hospitalization), balance difficulty (serious criteria hospitalization) and vomiting (serious criteria hospitalization). On an unknown date, the outcome of the nausea, sweating, felt faint, balance difficulty and vomiting were recovered/resolved. It was unknown if the reporter considered the nausea, sweating, felt faint, balance difficulty and vomiting to be related to ENGERIX B Adult. Additional details were provided as follows: The event was previously reported to a doctor. The patient received vaccine at about 1:30 PM. The patient also reported that this injection was 2 days later than normal. It had been 32 days after his 1st injection. In the early evening, the patient felt nauseous, vomited, felt like fainting and sweated profusely. Also, the patient noted he had difficulty balancing. The patient called the rescue squad at about 8 PM and was taken to the hospital. He spent one night and was discharged. The patient provided limited physician information about address and contact information.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Ammonia, Blood creatine phosphokinase, Blood lactic acid, Blood pyruvic acid, Electroencephalogram
Clinical narrative: Complex febrile seizure, rapid eye movement, flexed and stiff, shaking.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Eye movement disorder, Febrile convulsion, Full blood count, Metabolic function test, Musculoskeletal stiffness
Clinical narrative: Complex febrile seizure, rapid eye movement, flexed and stiff, shaking.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Posture abnormal, Tremor, Urine analysis
Clinical narrative: Complex febrile seizure, rapid eye movement, flexed and stiff, shaking.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site mass
Clinical narrative: A lump developed 1 - 2 inches away from actual vaccine site.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assiostant referring to unspecified patients of unknown genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ Lot number reported as "M039434" with expiration date on 24-MAY-2018 (strength and route of administration were not reported) for prophylaxis, however no adverse effects reported.  It was reported that the vaccines were exposed to temperature of 22 grades F (Fahrenheit) for a time frame of 12 hours. There were no previous temperature excursions for vaccines.  The temperature excursion was recorded by a data logger. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006986: US-009507513-1703USA006985: US-009507513-1703USA006936: US-009507513-1703USA006983:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assistant referring to unspecified patients of unknown genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of M-M-R II Lot number reported as "M039202" with expiration date on 05-JUL-2018 (strength and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 22 grades F (Fahrenheit) for a time frame of 12 hours. There were no previous temperature excursions for vaccines. The temperature excursion was recorded by a data logger. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006986: US-009507513-1703USA006936: US-009507513-1703USA006983: US-009507513-1703USA006984.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assiostant referring to unspecified patients of unknown genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VAQTA Lot number "M039202" with expiration date on 11-MAR-2018 (strength and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 22 grades F (Fahrenheit) for a time frame of 12 hours. There were no previous temperature excursions for vaccines.  The temperature excursion was recorded by a data logger. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009836: US-009507513-1703USA006985: US-009507513-1703USA006983: US-009507513-1703USA006984:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 23-MAR-2017, the patient was vaccinated with an improperly stored VAQTA lot # M022924 and expiration date 24-JAN-2018 (strength, dose, frequency, route of administration and anatomical location were not provided) for prophylaxis. The reported storage temperature was 32 to 35 degrees Fahrenheit (F) for a time frame of 4 hours 2 minutes. There was no previous temperature excursion. No adverse effects were reported. There was no further information to report. No product quality complain (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown demographics. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unspecified dates since 15-FEB-2017, the patients received an improperly stored doses of PROQUAD injection (lot # M043308 with expiration date at 24-APR-2018, lot # M007961with expiration date at 15-AUG-2017, lot # M007964 with expiration date at 15-AUG-2017, lot # M002056 with expiration date at 11-JUL-2017, lot # L050909 with expiration date at 14-JUN-2017 and lot # reported as M042498 with expiration date at 17-APR-2018; albumin status, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of -0.2 (unit not provided) for 3 hours and 9 minutes (189 min). Data logger was used to track the temperature. No previous temperature excursion was reported. 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.; Sender's Comments: US-009507513-1703USA013140:
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 28-MAR-2017, the patient was vaccinated with GARDASIL 9, intramuscularly (lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and MENACTRA. On the same date, while the patient was waiting in the physician office, she felt dizzy and faint. The patient continued to wait in the office, sipping water, until she was recovered. Furthermore, product quality issue was not involved. At the time of the report, the outcome of dizziness and syncope was reported as recovered. Additionally, the reporter did not provide for a causality between the adverse events and vaccination with GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M036292 with expiration date 17-AUG-2018, (dose, route and anatomical location were not reported) for prophylaxis. Other suspect therapy included sterile diluent(STERILE DILUENT), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The vaccine was exposed to temperature of 24.4F (Fahrenheit) during 3 hours and 21 minutes. There was no previous temperature excursion. Data logger was filled. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown demographics. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unspecified dates since 15-FEB-2017, the patients received an improperly stored doses of VARIVAX injection (lot # M039316 with expiration date at 20-SEP-2018, lot # L045956 with expiration date at 17-NOV-2017 and lot # reported as M040138 with expiration date at 28-SEP-2018; dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of -0.2 (unit not provided) for 3 hours and 9 minutes (189 min). Data logger was used to track the temperature. No previous temperature excursion was reported. 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.; Sender's Comments: US-009507513-1703USA013034:
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Basal cell carcinoma, Biopsy skin abnormal, Injection site erythema, Injection site haemorrhage, Pain
Clinical narrative: 01/12/14 Sun 4:11 PM, where the flu needle went into my left arm and come out left arm. At the place on my left arm, came on as a red dot it would bleed and getting bigger I went on like this for the dermatology. P.A. did a biopsy on 3-21-16 1:40P biopsy came back as basal cell carcinoma cancer. Well it scared me to hear cancer and the way it look. And the way my arm felt and looked, waiting to see if it would get heal on it on time, but instead the spot got bigger. Report two years it gave me, 1 1/2 year problems and pain, and sore. The Dermatology said he could not say or not that the shot gave me the cancer. But I know the shot went in my arm and came out at the spot that would not go away. So something took place. Well I did not think the doctor would say the shot did it. But I know it was not his arm that it went into. It was my arm, it was the same little spot the needle came out. I had to use bandage on it to keep it from bleeding everywhere. Well I wanted to let the pharmacist to know about this first. Before I talk with my lawyer. Hope you know the right thing to do for my suffering that I went through. I take a flu shot each year because I work with children. But this is the first time one has done this to me and I'm 80 year old. The Dr. gave me mupirocin ointment USP 22 grams 2% to keep on the spot it did not do much good I have never been through something like this before with hope I hope I'm doing  the right thing.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: By night arm sore and movement was limited. Pain extends from fingerprints to neck/chin. Was in agony at night from the pain; took ADVIL/TYLENOL. Called in doctor in the doctor who recommended to continue ADVIL/TYLENOL, hot packs and give it 48 hours for AES to resolve. Went to doctor on 3/24 who prescribed antibiotics, ALEVE and to continue applying heat. Shoulder is leaning in because pt in so much pain. Doctor will schedule MRI if symptoms don't resolve in next couple of days.
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Malaise, Vaccination failure
Clinical narrative: Case number PHEH2017US008800, is an initial spontaneous report received from a nurse (who is a patient) on 21 Mar 2017. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (lot number: 187276, expiry date: Jun 2017) at a dose of 0.5 ml intramuscularly on 30 Nov 2016. On 16 Mar 2017, the patient got infected with influenza and she became ill on 20 Mar 2017. Outcome of the events was unknown and seriousness of the events was reported as non serious. Causality was not reported. Seriousness assessment of the events influenza and vaccination failure were upgraded to serious (medically significant) based on the information available in the source document.
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Malaise, Vaccination failure
Clinical narrative: Case number PHEH2017US008821, is an initial spontaneous report received from a nurse on 21 Mar 2017. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (lot number: 187276, expiry date: Jun 2017) at a dose of 0.5 ml intramuscularly on 30 Nov 2016. On 16 Mar 2017, the patient got infected with influenza and she became ill. Outcome of the events was unknown and seriousness of the events was reported as non serious. Causality was not reported. Seriousness assessment of the events influenza and vaccination failure were upgraded to serious (medically significant) based on the information available in the source document.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: And erythema. Treatment: Methylprednisolone
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema Multiform and erythema, swelling, pain at injection site. Treatment: Diphenhydramine.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Blister, Erythema, Pyrexia
Clinical narrative: Fever and erythema, blister. Treatment: Loratadine, cephalexin.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema
Clinical narrative: Angioedema.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Dermatitis atopic
Clinical narrative: And Atopic dermatitis. Treatment: Prednisone 20 mg BID, diphenhydramine 25 mg QID.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: And erythema. Treatment: Prednisone, diphenhydramine.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Limited mobility of shoulder joint. Initially had pain at site of injection. Experienced shoulder pain for approximately 2 months, then consulted PCP regarding continuous shoulder pain.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site joint pain, Laboratory test, Neck pain, Pain in extremity
Clinical narrative: Acute onset of joint pain starting in my right shoulder on Friday night, then Saturday moving to my knees, right great toe, then Sunday moving to my neck.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Acute onset of joint pain starting in my right shoulder on Friday night, then Saturday moving to my knees, right great toe, then Sunday moving to my neck.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 3 by 4 inch red rash, itching.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; "tired-like headache"; no associated nausea, vomiting or fever. Unresolved with Motrin or Tylenol.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received vaccine 2 days ago; localized redness, mild swelling around site of injection started yesterday.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Redness and swelling at injection site; redness progressed down arm below injection site; warm to touch.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain
Clinical narrative: Extreme pain and soreness for approx 2 week after vaccine. Extreme pain reoccurred several times later after moderate exercise cortisone injection on 30NOV2017 helped some but continued pain and restricted movement.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reporter stated that, since 09-MAR-2017, the patients received an improperly stored dose of VARIVAX lot number M040137, expiration date 28-SEP-2018, and lot number M037643 with an expiration date 01-SEP-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided) for prophylaxis. The nurse did not have access to the lot numbers and expiration dates for the diluent that was used. The vaccine was exposed to a temperature between 15 and 46 Fahrenheit (F) for 15 hours. The call was not because of a data logger, and there was no previous temperature excursion. No adverse effects had been reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA013127.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring a patient of unknown age and gender. Information about concurrent conditions, medical history, concomitant medications and drug reactions or allergies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # N003993, expiration date 20-OCT-2018, dose and route of administration were not reported), for prophylaxis. Subsequently, the nurse noted that, at the time of reporting, the patient was experiencing injection site reaction with red, hot and hard lump at the injection site, which was most likely cellulitis. The nurse also noted that the patient was experiencing pain (reported as aches and pains). No further information was provided. The outcome of administration site cellulitis, injection site erythema, injection site induration, injection site warmth and pain was unknown. The causal relationship between the events and the therapy with PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012535: US-009507513-1703USA011244.
Sex: U
Vaccine: PPV
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring a patient of unknown age and gender. Information about concurrent conditions, medical history, concomitant medications and drug reactions or allergies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # N003993, expiration date 20-OCT-2018, dose and route of administration were not reported), for prophylaxis. Subsequently, the nurse noted that, at the time of reporting, the patient was experiencing injection site reaction with red, hot and hard lump at the injection site, which was most likely cellulitis. The nurse also noted that the patient was experiencing pain (reported as aches and pains). No further information was provided. The outcome of administration site cellulitis, injection site erythema, injection site induration, injection site warmth and pain was unknown. The causal relationship between the events and the therapy with PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012535: US-009507513-1703USA011244.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist and a physician refers to a 72 year old female patient. While her medical history was unknown, her historical drug usage included XOLAIR and her concurrent conditions included hypertension, a possibility of a rheumatic issue and hypercholesterolaemia. Meanwhile, her concomitant therapies included hydroxychloroquine sulfate, simvastatin (manufacturer unknown), BYSTOLIC and doxazosin. On 23-MAR-2017, the patient was vaccinated with ZOSTAVAX (which had a lot # of M035693 with an expiration date of 07-NOV-2017), subcutaneously, in the right arm, for prophylaxis. The reporter described the anatomical site to be the fatty area 2 cm above the elbow on the dorsal side. Aside from this, the patient was also administered a sterile diluent (manufacturer unknown) on an unknown date (the strength, dose, frequency, route of administration, and indication were unknown). Subsequently, on 27-MAR-2017, the patient paid her physician a visit regarding some unspecified complaints. She was diagnosed with cellulitis at the site of injection. The site was described to be warm with redness. It was unknown whether any treatment had been administered although, the physician had provided a prescription for an EPIPEN. The injection site cellulitis was inferred to be resolving since the  physician stated that the site was smaller than it what it had been before. No causal relationship was provided between the event and the two suspect therapies. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JAN-2017, 15-MAR-2017 and 28-MAR-2017, the patient was vaccinated with ROTATEQ, orally, for prophylaxis (dose number, lot # and expiration date were unknown) (product use issue). No adverse symptoms were reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Influenza virus test negative, Tremor
Clinical narrative: Patient had febrile seizure shaking movement whole body lasting around 10 min - took to ER.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: DTaP number 4 was given on 3/20/17 - vaccine had expired on 3/5/17 - (15 days prior). No adverse events noted or reported by parent.
Age: 1.08
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: Dtap was given on 3/7/17 - vaccine was expired on 3/5/17 (2 days prior to administration) - no AE reported by parent.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Expired product administered, Local swelling
Clinical narrative: DTaP #4 was administered on 3/16/17 on left thigh. Vaccine was expired on 3/5/17 (11 days prior to administration) local swelling reported by parent.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Rash
Clinical narrative: Skin Rash, Rash and redness; rash.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: VARIVAX and Flu vaccine given (R) thigh 3/9/17. Mom noticed firm lump Rt. thigh 3/18 and 3/19/17. Redness developed 3/21/17. No fevers. Acting well.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Body temperature decreased, Dizziness, Headache, Nausea, Skin warm
Clinical narrative: Dizzy, headache, warm head, low body temp. nausea.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin lesion, Urticaria
Clinical narrative: Increasing erythema, raised lesion consistent with a hive and extreme pruritus.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen injection site, warm and red, tender. Was given BENADRYL by mother; mother reports swelling is "going down".
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site reaction, Rash macular
Clinical narrative: Beginning day after vaccine, she noticed itching at the site. She mentioned an adhesive allergy on 3/28/17, and did not remove bandage for several hours. On 3/28/17, area became blotchy and red. She came in to show me. Her MD on 3/27/17 told her to try using Hydrocortisone cream. No other symptoms.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: 74 year old male patient who received Zoster vaccine immunization on 11/01/16. Reports generalized rash and hives. MD contacted with symptom report. Additionally, patient stated that he had received a prednisone prescription from MD to treat symptoms. Rash and Urticaria. Pruritus. Zoster vaccine 0.65 ml once.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Pt reports red, hot, swollen arm at site of injection with general malaise and fever. Went to local ED 2 days after for IV to PO Antibx.
Age: 61.0
Sex: F
Vaccine: YF
Symptoms: Injection site urticaria
Clinical narrative: Patient developed localized hives, on 3/24/17, around site of injection. Returned to office 3/28/17 and discussed antihistamines and going to E.D. if symptoms worsen.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Pain, Pruritus, Rash erythematous
Clinical narrative: Red rash at injection site, itchy, sore, no blisters, no fever - Pt visited local Dr who prescribed SEPTRA DS one tab every day for 7 days and BACTROBAN ointment - for a possible bacterial infection at injection site - rash resolved in 48 hours or less.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site reaction, Skin infection
Clinical narrative: Red rash at injection site, itchy, sore, no blisters, no fever - Pt visited local Dr who prescribed SEPTRA DS one tab every day for 7 days and BACTROBAN ointment - for a possible bacterial infection at injection site - rash resolved in 48 hours or less.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Right upper arm (shoulder to elbow) (surrounding vaccine site) with swelling/urticarial rxn in 24 hours after influenza vaccine. Tx=sx care (diphenhydramine, cool compresses).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Heart rate decreased, Pallor, Syncope
Clinical narrative: Patient fainted after injection of PROQUAD (MMRV) and KINRIX (IPV-DTaP). HR dropped to 67. Pt. was pale, dusky. Required stimulation. Sats 97% - 100% RA. Returned to nl activity within 10 minutes.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: 6 cm erythema left deltoid. Triamcinolone topical 0.1% TID to left deltoid area.
Age: 38.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythema induration and TIP at (R) deltoid. Noted 3/9/2017. Advised pt. warm compresses, NSAIDs, ED precautions. Sx began approximately 24hrs. after immun.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Swelling
Clinical narrative: Redness at injection site. Swelling, tiny blisters.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt described a quarter size swelling and a little sore at the site of injection.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Entire arm (past elbow) was red, swollen, and warm. Painful to patient, but improving.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Pain
Clinical narrative: Patient called and claims after receiving the ZOSTAVAX vaccine on 10/18/12, she has bouts of shingles symptoms every year since. Per protocol and CDC recommendations, we needed a prescription from her PCP as she was not of age for a standing order from the pharmacy. Claims fatigue, pain persisting for 12 months every year.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Redness noted on upper arm on 3/28/2017 that gradually spread towards elbow. Redness and warmth noted. Doxycycline 100mg bid and hydroxyzine prescribed for itch.
Age: 1.25
Sex: M
Vaccine: HIBV, MMRV, PPV
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Patient broke out in a high fever and developed a rash within hours of receiving the PROQUAD (MMR,varicella), pneumococcal, and hib vaccines. He also had swollen lymph nodes in his neck.
Age: 1.08
Sex: M
Vaccine: HBHEPB, IPV
Symptoms: Crying, Decreased appetite, Irritability, Pyrexia
Clinical narrative: Patient had a high fever, loss of appetite, very irritable and crying.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at injection site, erythema, swelling from injection site dow to elbow, very warm to the touch.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Electroencephalogram normal, Excessive eye blinking, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Eye blinking, unresponsive x 1-2 min. Episode occurred on 3/12/17, 4-8 after admin (approx). Pt presented to ED. Admitted overnight for monitoring.  EEG negative.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Vomiting projectile
Clinical narrative: Vomiting projectile with diarrhea started 3-26-17 at midnight. Went to ED 3-26-17 at noon.
Age: 34.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Erythema, Parotid gland enlargement, Tenderness
Clinical narrative: 1st MMR date 06-08-84. New hire MMR 03-15-17 SQ RUA. Sat 03-18-17 staff report to ER excuse from work x 5 days. (R) parotid swelling, tenderness. Denies temp. Reports afebrile . + red. 03-23-17 Thurs report to office bilateral R and L parotid swelling, tenderness. Report afebrile.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 102.8 F rectally at 1906 on 3-27-17, took to local ER for evaluation. Fever down to 100 F 3-28-17 at 16:16.
Age: 1.58
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Patient started with small dots on evening after shots were given. They got worse overnight and was covered this next morning. The spots are itchy and raised red bumps. Patient also has a large raised red area at site of where Hep A vaccine was administered.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash L torso.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Body temperature decreased, Epistaxis, Headache, Malaise, Pain in extremity
Clinical narrative: Patient presented to the office on 3/20/17 and reported feeling a sore left arm on 3/18/17 (one day after receiving the vaccination) that resolved in that one day. He presented to the office on 3/20/17 reporting a nosebleed, headache, and a feeling of malaise the morning of 3/20/17. The office checked his BP which was 124/66 and his temperature which was 96.8. He was instructed to rest and increase fluids and follow up with the office the following day. The office called him on 3/21/17 and he reported that all of his symptoms were resolved and he was actively able and well enough to play football the night before on 3/20/17. No further reactions have been reported from the patient since.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Case number PHHY2016US166590, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 638099) website on 21 Nov 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on an unknown date in 2013. On an unknown date in 2013, the patient experienced joint pain, fever, chills and headache. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Headache, Impaired work ability, Malaise
Clinical narrative: Case number PHHY2016US166200, is an initial spontaneous report received from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 638126) website on 21 Nov 2016. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date. On an unspecified date after vaccination, the patient missed work for 02 days, headache and was sick. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.