chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Injection site erythema, Injection site nodule, Local reaction
Clinical narrative: Parent reports redness and "knot" rt thigh where vaccine given. Parent contacted priv MD and was told was "local reaction" and to call health dept.
Age: 1.23
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Urticaria
Clinical narrative: WOKE UP WITH FEVER AND LARGE RED WELTS ON LEFT THIGH AND SPREADING TO BUTTOCKS AND RIGHT THIGH.
Age: 21.0
Sex: M
Vaccine: RAB, TYP
Symptoms: Flushing, Rash
Clinical narrative: Patient was given Oral Typhoid started his first dose on April 23rd, second dose on April 25th, and third dose on April 27th. Shortly after taking his third dose of ORAL TYPHOID he developed a raise rash on his extremities and chest. His face was slightly flushed. Treated with 3 days of Prednisone.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness, Nausea
Clinical narrative: PATIENT REPORTED SICKNESS TO STOMACH SHORTLY AFTER ADMINISTRATION.  I STAYED WITH PATIENT IN IMMUNIZATION AREA TO ENSURE SHE WAS OK.  WITHIN 3-4 MINUTES POST ADMINISTRATION, THE PATIENT PASSED OUT.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Activated partial thromboplastin time normal, Dizziness, Epistaxis, Full blood count normal, Mental status changes
Clinical narrative: Patient becoming dizzy and state mental changes after leaving clinic and after stopping at pharmacy, hitting gas instead of brake and had profuse bloody nose, patient taken to ER and needed packing to stop. CBC, PT/PTT, CMP normal.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Metabolic function test normal, Prothrombin time normal
Clinical narrative: Patient becoming dizzy and state mental changes after leaving clinic and after stopping at pharmacy, hitting gas instead of brake and had profuse bloody nose, patient taken to ER and needed packing to stop. CBC, PT/PTT, CMP normal.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: ITCHING RASH ON ARMS AND BELLY, AND AT VISIT WITH PCP 5/7/15 PT STATES HER NECK AND FACE ARE STARTING TO ITCH AS WELL. RASH APPEARED LIKE PAPULAR RED PRURITIC SCATTERED TYPE OF RASH.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Chest pain, Herpes zoster, Musculoskeletal pain, Neck pain
Clinical narrative: Blisters initially on my chest and my neck and shoulder had pain. I went to a walk in clinic where I was staying at the time.  I received an antiviral medication.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin
Clinical narrative: Blisters initially on my chest and my neck and shoulder had pain. I went to a walk in clinic where I was staying at the time.  I received an antiviral medication.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Musculoskeletal pain, Neck pain, Rash
Clinical narrative: Blisters initially on my chest and my neck and shoulder had pain. I went to a walk in clinic where I was staying at the time.  I received an antiviral medication.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella virus test
Clinical narrative: A spontaneous report has been received from a physician regarding a 28 year old male patient who completed (Merck) VARIVAX immunization series at age 12. He had a titer drawn for varicella zoster virus (VZV) in 2014 (specific date unspecified) and the results came back as "equivocal" with level of 1.09. Medical history included allergic rhinitis. Concomitant medication included proton pump inhibitor (not further specified) and generic FLONASE. Patient's present status was reported as "not recovered". No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, reported as: "2 to 3 years ago", the patient was vaccinated with a dose of GARDASIL (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. Following vaccination the patient experienced and unspecified anaphylactic reaction to the vaccine. The reporting physician stated that the event was reported to VAERS on an unspecified date. The outcome of anaphylactic reaction was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date the patients were vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). No co-suspect or concomitant medications were reported. On an unknown date, after receiving the zoster vaccine live, the patients subsequently had contracted "Shingles". It was not specified if the patients sought any medical attention. The outcome of shingles was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Area around injection site, swollen, red, tender advised to try heat/ice and TYLENOL/Ibuprofen Pt notified office on 4-16-15.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swelling, redness, pain, itching/burning. Treatment TYLENOL PRN, NSAIDS PRN BENADRYL 35mg QHS PRN 3-5 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Shot given 5/1/15. Mom noticed night of 5/2/15 a small reddened area on right thigh. Area continued to get larger over next couple days. Brought into clinic on 5/7/15 w/5x6 cm circular reddened area to right thigh. Reddened, raised, hard to touch, warm to touch, tender. Given oral antihistamine and oral steroid rx. Will call if not better.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site swelling, Local reaction, Screaming
Clinical narrative: 2 month vaccines given 5/7/15 1P at 3:20 pm woke from nap screaming inconsolably calmed down at 4P, seen in our office 4:10 pm, noted 3cm swelling on (L) thigh at PENTACEL site. Per dr consistent with local reaction will observe for increased swelling.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness
Clinical narrative: Patient recv'd vaccines, waited in room with mom for 10-15 minutes. After checking out and leaving office she became dizzy and almost fell backward. Mom caught her, no injury noted. She was brought back into office and monitored until symptoms resolved.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Head injury, Laceration, Loss of consciousness, Paraesthesia
Clinical narrative: Patient was checking out and fell backwards, hitting her head on the door; loss of consciousness 30 seconds. 4-5 cm laceration right head and c/o bilateral hand and lip paresthesias. Patient transported to ER via ambulance.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to 9 patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ, oral (lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse event. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash and swelling to pt (right) upper arm. BENADRYL 50 mg every 8 hrs. Ice.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 68 yo on COUMADIN for who presents after being seen for left arm swelling that started Friday night. He had gotten the PNEUMOVAX in the left arm and began having some pain in the arm later that night. He noted redness and swelling Saturday morning. He denied any pruritus at that time but began developing this morning. He was seen in the ER on Saturday and was given a short supply of cephalexin. He notes improvement in the symptoms with taking it. ADR is described as significant local erythema, pain, edema at injection site following day-diagnosed by ER MD as cellulitis.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: 68 yo on COUMADIN for who presents after being seen for left arm swelling that started Friday night. He had gotten the PNEUMOVAX in the left arm and began having some pain in the arm later that night. He noted redness and swelling Saturday morning. He denied any pruritus at that time but began developing this morning. He was seen in the ER on Saturday and was given a short supply of cephalexin. He notes improvement in the symptoms with taking it. ADR is described as significant local erythema, pain, edema at injection site following day-diagnosed by ER MD as cellulitis.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling around injection site on day 7 after shot.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen at injection site.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site nodule
Clinical narrative: Large erythema to the left arm/hard knot from inj site. Diphenhydramine 50 mg BID.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling at vaccine site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Autism, Condition aggravated
Clinical narrative: Received KINRIX and MMRV 5/1. Mom stated 2 days later patient developed worsening behavioral problems, acting out at school and home. Patient w/autism. Taking TENEX.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.67
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives started next day - lasting 5-6 days - ORAPRED, ZYRTEC - referred to allergist.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pt presents to clinic with c/o left arm pain. Pt states on 3/9/10 I had a pneumonia shot and since I've had terrible pain in my arm. Pt seen at clinic with PNEUMOVAX to left deltoid with onset of 10/10 pain upon awakening the following morning. Since has applied ice without any relief. Pain sharp increasing with over head arm movement, denies radiation, numbness, bruising. Upon admission to triage. Pt received TORADOL 60mg IM now to buttocks which pt reports pain decreased to 6/10. Pt discharged with ibuprofen 600mg tab take one tablet by mouth every 8 hours as needed for pain/inflammation and to continue ice to area. Neuropathic pain-arm.
Age: 37.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: 37 year old needed Tdap given Dtap. Per public health nurse no need to revaccinate with Tdap.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: Employee felt nauseated and lightheaded 15 min after immunization. She also had a headache and SOB. She stated that she felt like she had a fever. Her preimmunization temp was 99.2 and post was 97.7, SOB and lightheadedness resolved after 20 mins. Instructed her to call or receive medical attention if symptoms worsen. Employee still has some nausea and a headache.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Brief febrile seizures 24 hrs after vaccination. Temp 102.5. Will offer antipyretics TYLENOL +/- MOTRIN for fever management.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Rash, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old female patient. The patient's medical history included supraventricular tachycardia and hives reaction to AUGMENTIN. On 31-MAR-2015, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular (Lot # K010215 expiration date was not reported). There was not concomitant therapy reported. On an unknown date in approximately in March 2015, reported as "shortly after received GARDASIL" the patient experienced rash and burning sensation in both legs, and urticaria reported as "hives in her stomach". The patient sought medical attention by calling to the physician's office. The physician stated that the patient's mother queried if the patient mother or not her daughter should receive the complete GARDASIL doses. The outcome of rash, urticaria and burning sensation was unknown. This is a linked report from the same reporter. 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 a physician refers to a patient of unknown age and gender. On 17-MAR-2015, the patient was vaccinated with the first dose of VAQTA (dose and lot # not reported) intramuscularly and on 24-MAR-2015, the patient received the second dose of VAQTA (dose and lot # not reported) intramuscularly. No adverse experience was reported. Additional information is not expected. There is no permission to contact the physician.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Exposure during pregnancy
Clinical narrative: Information has been received from a 24 year old female patient via a company representative concerning herself who became pregnant (which was captured as Maternal exposure timing unspecified) with Last Menstrual Period (LMP) of 26-MAR-2015 and expected date of delivery (EDD) of 31-DEC-2015. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, route, lot# and expiration date unknown). No concomitant therapy was reported. On 13-APR-2015 the patient experienced adverse event while on GARDASIL. No treatment was given for this event. The patient did not seek medical attention. The outcome of adverse event was unknown. The pregnant outcome was pending. Additional information is not expected since there is no contact information.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB, (dose, route, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. 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 nurse practitioner refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ, oral (dose, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (route, anatomical location, lot# and expiration date were not reported). There was not concomitant therapy reported. On an unknown date the patients experienced urticaria "hives". The outcome of urticaria and was unknown. This is a linked report from  the same reporter 1504USA020634. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Injection site erythema, Injection site reaction, Myalgia
Clinical narrative: Muscle pain and redness over injection site, which has. Diphenhydramine 25 mg TID.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Feeling cold
Clinical narrative: 63 yo who presented to the ZOSTAVAX clinic and had a vaccination today. Approximately 10 minutes after the injection, he felt cold/clammy and dizzy. He had no associated headache, vision change, chest pain, dyspnea, nausea/vomiting, or abdominal pain. He had eaten this morning without problems. He exercises regularly without any recent change in exercise tolerance He felt back to normal within a few minutes of being in the Walk-in center. He had had similar symptoms once before after getting blood work dose. Dizziness.
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The nurse reported GARDASIL which expired on 11APR2015 was inadvertently administered to a patient on 28APR2015. No adverse effects reported. No additional information was provided. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with no pertinent medical history/drug allergies or drug reactions reported. On 09-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX, (route, anatomical location, lot# and expiration date were not reported). On 10-APR-2015, the patient was vaccinated with another dose of ZOSTAVAX, subcutaneous (lot# reported as L003216 expiration date 30-APR-2016). There was no concomitant therapy reported. On 12-APR-2015, the patient experienced injection site swelling and injection site warmth reported by the pharmacist as large, swollen, warm area at the site injection. No laboratory tests were performed. The patient sought a medical attention by called the pharmacist. The outcome of injection site swelling and injection site warmth was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient had not pertinent medical history and there were no drug allergies/drug reactions reported. On an unknown date, the patient was vaccinated with (Merck) VARIVAX, (Lot number, expiration date, dose and strength were not reported), route default as subcutaneous. No concomitant medication was reported. The reporter stated, that the patient was vaccinated with the (Merck) VARIVAX, which had been subject to defrost cycling. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA, (dose, route, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 73.0
Sex: M
Vaccine: TD
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: 73 y/o male with c/o developing fever after receiving Td shot. States he has had Td in the past with no ill effects. This patient received Tetanus Toxoid at 11:27am. At around 14:10, patient went back to clinic c/o uncontrollable chills and vomit x2. Prochlorperazine 5 mg once, ranitidine 50 mg once, acetaminophen 1300 mg once.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 26-year-old female patient who received FLUARIX (batch number 3744Y, expiry date 30th June 2015). On 26th January 2015 10:50, the patient received FLUARIX (intramuscular). On 28th January 2015, 2 days after receiving FLUARIX, the patient experienced myalgia (serious criteria disability and other: Serious as per reporter), injected limb mobility decreased (serious criteria disability and other: Serious as per reporter), heaviness in limbs, tingling of extremity, numbness of upper extremities and injection site pain. The patient was treated with Anti-Inflammatory. On an unknown date, the outcome of the myalgia, injected limb mobility decreased, heaviness in limbs, tingling of extremity, numbness of upper extremities and injection site pain were recovering/resolving. The reporter considered the myalgia, injected limb mobility decreased, heaviness in limbs, tingling of extremity, numbness of upper extremities and injection site pain to be possibly related to FLUARIX. Additional details were provided as follows: The patient is experiencing persistent post injection myalgia at the injection site. She began experiencing this pain in her left shoulder approximately two days after receiving the vaccination and could hardly move her arm. She also experienced some numbness, tingling, heaviness with this pain and tests were performed to rule out other causes. She was given anti-inflammatory medications and the events were reported to be about 90% better. However, today she was reevaluated and the improvement has regressed to about 50% better.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Injection site reaction, Laboratory test
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 26-year-old female patient who received FLUARIX (batch number 3744Y, expiry date 30th June 2015). On 26th January 2015 10:50, the patient received FLUARIX (intramuscular). On 28th January 2015, 2 days after receiving FLUARIX, the patient experienced myalgia (serious criteria disability and other: Serious as per reporter), injected limb mobility decreased (serious criteria disability and other: Serious as per reporter), heaviness in limbs, tingling of extremity, numbness of upper extremities and injection site pain. The patient was treated with Anti-Inflammatory. On an unknown date, the outcome of the myalgia, injected limb mobility decreased, heaviness in limbs, tingling of extremity, numbness of upper extremities and injection site pain were recovering/resolving. The reporter considered the myalgia, injected limb mobility decreased, heaviness in limbs, tingling of extremity, numbness of upper extremities and injection site pain to be possibly related to FLUARIX. Additional details were provided as follows: The patient is experiencing persistent post injection myalgia at the injection site. She began experiencing this pain in her left shoulder approximately two days after receiving the vaccination and could hardly move her arm. She also experienced some numbness, tingling, heaviness with this pain and tests were performed to rule out other causes. She was given anti-inflammatory medications and the events were reported to be about 90% better. However, today she was reevaluated and the improvement has regressed to about 50% better.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Limb discomfort, Musculoskeletal pain, Myalgia, Paraesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 26-year-old female patient who received FLUARIX (batch number 3744Y, expiry date 30th June 2015). On 26th January 2015 10:50, the patient received FLUARIX (intramuscular). On 28th January 2015, 2 days after receiving FLUARIX, the patient experienced myalgia (serious criteria disability and other: Serious as per reporter), injected limb mobility decreased (serious criteria disability and other: Serious as per reporter), heaviness in limbs, tingling of extremity, numbness of upper extremities and injection site pain. The patient was treated with Anti-Inflammatory. On an unknown date, the outcome of the myalgia, injected limb mobility decreased, heaviness in limbs, tingling of extremity, numbness of upper extremities and injection site pain were recovering/resolving. The reporter considered the myalgia, injected limb mobility decreased, heaviness in limbs, tingling of extremity, numbness of upper extremities and injection site pain to be possibly related to FLUARIX. Additional details were provided as follows: The patient is experiencing persistent post injection myalgia at the injection site. She began experiencing this pain in her left shoulder approximately two days after receiving the vaccination and could hardly move her arm. She also experienced some numbness, tingling, heaviness with this pain and tests were performed to rule out other causes. She was given anti-inflammatory medications and the events were reported to be about 90% better. However, today she was reevaluated and the improvement has regressed to about 50% better.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: On Saturday, May 2, patient began to have a fever.  On Sunday, fever continued and arm began to have redness, heat, and swelling.  Patient applied ice, Vick's Vapor Rub, and Voltaren cream which provided some relief.  When patient arrived at clinic on Tuesday, May 5, left arm remained reddened, swollen, and warm.  Symptomatic area measured 70 mm by 70 mm.  When patient was seen by physician on Wednesday, May 6, symptoms were still present but slightly improved.
Age: 0.65
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Decreased appetite, Irritability, Lethargy, Pyrexia
Clinical narrative: Fussiness and lack of appetite for 3 days culminating in fever (102*) and lethargy on the 3rd day. No other symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Peripheral swelling
Clinical narrative: Severe swelling in the arm.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Depressed level of consciousness, Immediate post-injection reaction, Lethargy
Clinical narrative: After his 2 month shots, patient became lethargic and unarousable for 24 hours.  Self-resolved.  After the exact same vaccinations at 4 months, patient again became significantly lethargic immediately following vaccines.  No fevers.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient reported significant burning of arm during injection of Prevnar 13 vaccine.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL. 35 doses were administered. No adverse effects were reported. This is one of several reports 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 was received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored PNEUMOVAX 23. 4 doses were administered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 29-APR-2015 the patient was vaccinated with improperly stored VAQTA (lot # K010579 and expiry date: 12-FEB-2017) (dose, frequency and route were not reported). The patient did nott experience any adverse events. No product quality complaint (PQC) was reported for hepatitis a vaccine, inactivated. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 01-APR-2015 the patient was vaccinated with improperly stored VAQTA (lot # K010579 and expiry date: 12-FEB-2017) (dose, frequency and route were not reported). The patient did not experience any adverse events. No product quality complaint (PQC) was reported for hepatitis a vaccine, inactivated. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician referring to a male patient of unknown age who participated in a market research that was conducted by agency. The patient's medical history or concurrent condition were not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, lot#, dose, route and duration were unspecified). No concomitant therapy was provided. On an unknown date the patient experienced unspecified adverse event. The physician considered the adverse event to be non-serious and not related to ZOSTAVAX. The outcome of the adverse event was unknown. Additional information is not expected as the doctor was not willing to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a patient of unknown age and gender. On 25-MAR-2015, the patient was vaccinated with a 0.5 ml dose of improperly stored MMR II (Lot # J014873, expiry: 21-NOV-2015) subcutaneously which was exposed to 48F for 13 hours. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a male patient between 50-55 years. No medical history and concomitant medications were reported. On an unknown date approximately in April 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot#K014853, expiry: 14-DEC-2015) to prevent shingles. On an unspecified date in April 2015, within a few days, but less than a week after the administration of the vaccine the patient developed swelling, redness, a hard lump and warmth around the injection site. The patient sought medical attention by contacting the pharmacist. Treatment received included ice and ibuprofen. On an unknown date in April 2015, the patient recovered from the events. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a clinical medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with MMR II (lot# reported as K011188, expiry date 12-AUG-2015; dose and route were not reported), which were involved in a storage issue. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a clinical medical assistant referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with VAQTA (lot # K004856, expiry date 07-DEC-2016; dose and route were not reported), which were involved in a storage issue. This is one of several reports 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 as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with doses of improperly stored GARDASIL (dose and frequency not reported). No adverse experiences reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 23-APR-2015 the patient was vaccinated with improperly stored VAQTA (lot # K010579 and expiry date: 12-FEB-2017) (dose, frequency and route were not reported). The patient did not experience any adverse events. No product quality complaint (PQC) was reported for a hepatitis a vaccine, inactivated. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 13-APR-2015 the patient was vaccinated with a dose of expired ZOSTAVAX (lot # not reported, expired on 26-FEB-2015), 0.65 ml, once, subcutaneously. No adverse events were reported. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Fever, fussy, severe rash on the neck, chest, back.  Treated with oral corticosteroid, hydrocortisone topical cream, Benadryl PO.  Referral to dermatology.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 04-MAY-2015 the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD (lot # K019102, expiration date 15-APR-2015, 0.5 ml/once), subcutaneously. No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information has been received from a nurse practitioner via a company representative referring to a 14 year old patient of unknown gender. On 04-MAY-2015 the patient was inadvertently vaccinated with a dose of GARDASIL (0.5 ml, once, lot# was not reported) in the left hip subcutaneously or intramuscularly (Vaccine administered at inappropriate site). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. The physician reported that a patient who may or may not received ZOSTAVAX developed a dramatic case of shingles on an unknown date. The patient sought medical attention- visited the office. Unspecified antiviral medication were given to the patient as treatment. The physician mentioned that medical records got mixed up in the office and the physician was not sure if the patient was one of the patients who received ZOSTAVAX. The outcome and causality for herpes zoster was unknown. Additional information is not expected as the reporter does not want to be contacted.
Age: 89.0
Sex: M
Vaccine: PNC13
Symptoms: Anaemia, Blood glucose normal, Blood triglycerides normal, Dry skin, Fluid retention
Clinical narrative: This is a spontaneous report from a contactable consumer and from a contactable physician. A 89-year-old male patient received PREVNAR 13 (Lot/Batch H86212), on 20Nov2014 between 8 and 9 in the morning in the right arm at single dose. Patient had anaemia from Jan2015 and ongoing, ongoing hypertension for 40 or 50 years. Concomitant medication included amlodipine for blood pressure decreased from 2013 at 10 mg daily and from Nov2014 at 5 mg daily and ongoing, Vitamin D3 orally for low Vitamin D and lack of sun at 1000 units once a day from 2015 and ongoing, lisinopril for heart orally at 40 mg, 1x/day (at night) from 2010 and ongoing and atenolol for heart at 50 mg twice a day from 1990 and ongoing, garlic 1000mg and vitamin B2 50 mg. Patient specified he was taking amlodipine in the morning and that 7 days prior to the injection, he was told to cut the amlodipine down from 10 mg daily to 5 mg daily. 50-60 years before, the patient received cholera vaccine and had poisoning and body reaction as he got a big bubble. On 10Jan2015 lab tests were done with the following results: triglycerides and glucose were good and high density lipoprotein level was a little low. On 18Jan2015 patient got rash on his legs, internal itching effect on whole body, rough skin and was retaining fluid in ankle and calves. Events "rash" and "itching" were treated with Prednisone and he took BENADRYL which helped to hold down the itch a little bit. The patient visited a physician, who told him about the possibility that the retaining fluid could be caused by his blood pressure medication. Amlodipine decreased from 10 mg to 5 mg helped to decreased the fluid level a little bit. "Fluid retention" as considered serious as it led to hospitalization. Outcome for "rough skin" and "Fluid retention" was not recovered; patient recovered from the other events. The reporting physician stated that the patient mentioned he got the vaccine about 2 months before the report and then had the rash 1 month later. However the physician was not sure if it was related to the vaccine and was not aware of the reported adverse events. Follow-up (30Mar2015): New information from a contactable physician includes: causality assessment detail. Follow-up(01May2015): New information from a contactable consumer includes: concomitant, vaccine and details, seriousness. Follow-up attempts completed. No further information expected.
Age: 89.0
Sex: M
Vaccine: PNC13
Symptoms: High density lipoprotein decreased, Pruritus generalised, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer and from a contactable physician. A 89-year-old male patient received PREVNAR 13 (Lot/Batch H86212), on 20Nov2014 between 8 and 9 in the morning in the right arm at single dose. Patient had anaemia from Jan2015 and ongoing, ongoing hypertension for 40 or 50 years. Concomitant medication included amlodipine for blood pressure decreased from 2013 at 10 mg daily and from Nov2014 at 5 mg daily and ongoing, Vitamin D3 orally for low Vitamin D and lack of sun at 1000 units once a day from 2015 and ongoing, lisinopril for heart orally at 40 mg, 1x/day (at night) from 2010 and ongoing and atenolol for heart at 50 mg twice a day from 1990 and ongoing, garlic 1000mg and vitamin B2 50 mg. Patient specified he was taking amlodipine in the morning and that 7 days prior to the injection, he was told to cut the amlodipine down from 10 mg daily to 5 mg daily. 50-60 years before, the patient received cholera vaccine and had poisoning and body reaction as he got a big bubble. On 10Jan2015 lab tests were done with the following results: triglycerides and glucose were good and high density lipoprotein level was a little low. On 18Jan2015 patient got rash on his legs, internal itching effect on whole body, rough skin and was retaining fluid in ankle and calves. Events "rash" and "itching" were treated with Prednisone and he took BENADRYL which helped to hold down the itch a little bit. The patient visited a physician, who told him about the possibility that the retaining fluid could be caused by his blood pressure medication. Amlodipine decreased from 10 mg to 5 mg helped to decreased the fluid level a little bit. "Fluid retention" as considered serious as it led to hospitalization. Outcome for "rough skin" and "Fluid retention" was not recovered; patient recovered from the other events. The reporting physician stated that the patient mentioned he got the vaccine about 2 months before the report and then had the rash 1 month later. However the physician was not sure if it was related to the vaccine and was not aware of the reported adverse events. Follow-up (30Mar2015): New information from a contactable physician includes: causality assessment detail. Follow-up(01May2015): New information from a contactable consumer includes: concomitant, vaccine and details, seriousness. Follow-up attempts completed. No further information expected.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient had a fever and seizure episode seen at hospital. Dxed febrile seizure 5/6/15 d/c home. Had f/u on 57/15 pt still have a fever 102 but no episode of seizure. Pt playful and physical exam normal.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a consumer refers on behalf of herself as a 63 year old female patient. No pertinent medical history was reported. On 24-MAR-2015, the patient was vaccinated with ZOSTAVAX VIAL (dose and lot# were not reported) in the upper right arm for prevention of Shingles. Concomitant medications includes blood pressure medications (brand, manufacturer & dose unspecified). On 27-MAR-2015, the patient experienced red itchy rash that began on her hands and legs and now progressed upward throughout her body from inner thighs, stomach and shoulder area. The patient contacted her physician and set an appointment on 10-APR-2015. The patient attempted to treat the itchiness with an over the counter ointment cream (brand, dose & manufacturer unspecified). The cream works for short period of time and then the itchiness returns. Action taken was not applicable. The outcome of events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Rash
Clinical narrative: Rash.
Age: 0.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Erythema, Injection site erythema, Injection site papule, Papule
Clinical narrative: 24 hours after 2 m vaccines administered in bilateral thigh, she developed erythematous papules at injection sites which spread diffusely over her body. Seen in ER, Tx with BENADRYL, 40sec. resp. symptom no fever.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema, Pain, Skin warm, Swelling
Clinical narrative: Vaccine administered approx. 2 inches (back of arm) below deltoid in adipose tissues. Edema-swelling, heat, pain - 3 inch x 6 inch size - extended to elbow. Lasted 5-6 days. Took ALLEGRA antihistamine 1 tab ea day.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Received PREVNAR 13 on Wednesday, April 29, 2015. She said arm was sore that night and a little red the next day at injection site. She said by Sunday or Monday (May 3d or 4th) she had a rash at injection site about size of thumb print and it was warm when touching rash. She came to our pharmacy on 5/7/2015 at 9:55 and the rash is significantly larger (about 4 inches round), red and feels warm. She is going to dr today to see what to do. I tried calling at 6:00p, on 5/7/2015 and left message for her to call back.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: Erythema 1.5 in x 3 in at site of injection; warm to the touch. No edema. Started this am (5/7/15) Seen 5/7/15 at 4 pm. Rash did not spread since AM. BENADRYL PO. OTC topical hydrocortisone cream.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 14 year old male patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route number, route, lot number and expiration date were unspecified). No concomitant therapies were reported. Since an unspecified date the patient developed nausea and dizziness so the patient's mother called the physician's office. The treatment given for the adverse events was not reported. The outcome of the nausea and dizziness was reported as not recovered. The relatedness between the events and GARDASIL was not reported. 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 healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with doses of improperly stored ROTATEQ (dose and frequency not reported). No adverse experiences reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria, Vomiting
Clinical narrative: Onset of hives within 15 minutes, parents gave antihistamine, which pt. vomited. Family then directed to ED, given epinephrine IM with rapid resolution of symptoms, prescribed 5 day course oral steroids.
Age: 87.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Redness, swelling and itching on left arm. Urticaria.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ. 19 doses were administered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Pain, Swelling
Clinical narrative: Pt received an pneumonia inj on 8/5/09, and came into the non-urgent care clinic on 8/7/09 claiming that and as soon as he received it he stated it hurt and then progressed to swell up by the evening. He did take an ALEVE x 1- did not use any ice or any antihistamines. Patient was discharged from non-urgent care clinic with BENADRYL 50mg q8pm the next 2-3, day and a prednisone taper.