chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse (LVN) refers to unspecified patients of an unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with a dose of oral, ROTATEQ, (lot # K024700, expiration date 30-JUL-2016 and Lot No: L008051, expiration date 17-NOV-2016) (dose was not provided). The licensed vocational nurse (LVN) reported that on multiple unspecified dates, multiple unspecified patients were administered improperly stored oral, ROTATEQ. No adverse effects were 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 was received from a licensed vocational nurse (LVN) refers to unspecified patients of an unknown age and gender. The patient's concurrent conditions and medical history were not provided. on an unknown date, the patients were vaccinated with a dose of oral, ROTATEQ, (lot # K024700, expiration date 30-JUL-2016 and Lot No: L008051, expiration date 17-NOV-2016)(dose was not provided). The licensed vocational nurse (LVN) reported that on multiple unspecified dates, multiple unspecified patients were administered improperly stored oral, ROTATEQ. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients, of unknown ages and gender. No medical history or concurrent conditions were reported. Since 02-NOV-2015, an unspecified number of improperly stored doses of PEDVAXHIB (Lot # L002867, expiry date on 11-NOV-2017) were inadvertently administration to an unspecified number of patients. No adverse events were reported. This is one of 4 reports received from the same source. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Altered state of consciousness, Cold sweat, Hyperhidrosis, Nausea
Clinical narrative: Shortly after administration (within 3 minutes) patient said he felt nauseous. Started sweating, felt clammy and said he felt like he may black out. Called 911. Got ice pack. Placed on back of neck. Ice water to drink. Talked with him to ER.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 69 year old female patient's pertinent medical history and concurrent conditions were not reported. On 03-DEC-2015, the patient was vaccinated with expired dose of ZOSTAVAX (lot # J012679; expiry date: 21-JAN-2015) dose, route unknown. No adverse effects were reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) referring to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unknown dates after 29-OCT-2015 the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L030591, expiration date 10-FEB-2017, dose and route were not reported). Concomitant drug was not reported. No adverse events were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 07-AUG-2009, the patient was vaccinated with a dose of GARDASIL (dose, route and site of administration, lot#, expiry date were not reported). On 20-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose, route and site of administration, lot#, expiry date were not reported) and another dose of GARDASIL 9 was administered on 08-DEC-2015 (dose, route and site of administration, lot#, expiry date were not reported). The reporter confirmed that the series was continued and completed with GARDASIL 9. No adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site extravasation
Clinical narrative: This spontaneous report was received from pharmacist and refers to a 69 year old female patient with asthma and hypertension. The patient had no drug reactions or allergies. On 09-DEC-2015, the patient was vaccinated with ZOSTAVX injection (lot# L024997, expiration date 06-OCT-2016) 0.65 ml, subcutaneously in the left arm. There was no information about patient's concomitant medications reported. Within 24 hours after vaccination, the patient experienced white, sticky, gooey substance at the injection site. She also stated that some of the vaccine leaked from the injection site and that she slept on the arm where the vaccine was administered. The pharmacist stated no rash, no papules, no other complaints at the patient's injection site. No treatment was given. The outcome of the events was reported as not recovered. The patient sought medical attention and called pharmacist. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 month old male patient. The patient's medical history includes a pneumonia which he had recovered from. On 01-DEC-2015, the patient was vaccinated with a dose of VARIVAX (Merck), lot # L023592 expiration date 26-JUN-2017 (frequency and route of administration were not specified), and he was also vaccinated with a dose of MMRV (Merck) (manufacturer unknown) lot number reported as L016393, expiration date 08-NOV-2015. The reporter stated that the patient was administered VARIVAX (Merck) normally and then accidentally given MMR and V (Merck), also reported as "MMR/Varicella Combo" which then makes a double dose of VARIVAX (Merck). Concomitant medications were not reported. The outcome of accidental overdose was unknown. Additional information is not expected, as the reporter did not give consent to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patient, of unknown ages and genders. No medical history or concurrent conditions were reported. Since 02-NOV-2015, an unspecified number of improperly stored doses of ROTATEQ (Lot # reported as L00568, expiry date on 10-JUL-2016) were inadvertently administered to an unspecified number of patients. No adverse events were reported. This is one of 4 reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nervousness
Clinical narrative: After Tdap was given patient was asked to wait in office. After 5-7 minutes of receiving the shot patient felt very shaky and dizzy. BP 140/90, HR 94. Monitored in the office for 30 min then sent to ER.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR
Symptoms: Papule, Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: Scattered popular-vesicular eruptions on face, upper extremities. Faded appearing papules on lower extremities; Solitary erythematous popular lesion on left palm.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional and refers to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 23-FEB-2015 the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # J005071 expiration date 19-ENE-2015, (strength, route, dose and frequency were not provided). There was no concomitant medication described. No adverse effect was reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Asthenia, Dehydration, Malaise, Oedema peripheral, Pyrexia
Clinical narrative: Patient was vaccinated on 12/10/15 with the vaccines Tdap, Pneumonia, and Influenza. That same day patient started to feel malaise on the arms but the next day after 12:00pm felt high fever and the right arm started to show an edema - there was an abscess under the right arm. On the third day after vaccination patient felt weak and started to vomit and got dehydrated. Patient went to the hospital and was given BENADRYL for the arm swelling and got fluids intravenously.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Subcutaneous abscess, Vomiting
Clinical narrative: Patient was vaccinated on 12/10/15 with the vaccines Tdap, Pneumonia, and Influenza. That same day patient started to feel malaise on the arms but the next day after 12:00pm felt high fever and the right arm started to show an edema - there was an abscess under the right arm. On the third day after vaccination patient felt weak and started to vomit and got dehydrated. Patient went to the hospital and was given BENADRYL for the arm swelling and got fluids intravenously.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: Left deltoid (injection) site became red, warm covering complete deltoid with induration on upper half of deltoid.  Hurt to raise left arm more than parallel to floor.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Red itchy rash, some burning, first on arms, then progressed everywhere, head, back, legs, scalp.
Age: 22.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Laboratory test normal, Nausea, Vomiting
Clinical narrative: Nausea/vomiting requiring ER visit. Sent home after ER visit.
Age: 1.04
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Hypersomnia, Hyporesponsive to stimuli, Lethargy, Miosis
Clinical narrative: Prolonged sleepiness, Lethargy, confusion, pupil constriction, abnormal response to stimulus.
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Flucelvax flu vaccine given to 17y.o. patient.  Approved age for Flucelvax is 18 and older.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Patient described a red knot the size of a baseball at the injection site that started itching approximately 2 hours after the administration and noticed the knot the next morning while taking a shower. Patient was referred to primary care provider for treatment if needed.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site pruritus, Injection site rash, Injection site scab
Clinical narrative: Rash from elbow to shoulder on vaccinated arm -- occasionally itchy --"scabbed up" according to mom -- not swollen or warm to touch.  Diarrhea x 2 days no fever or other symptoms.  ADLs WNL. We have a photo if you tell us how to send it to you.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal distension, Back pain, Erythema
Clinical narrative: Redness chest and back, tightness abdomen, pinch in back feeling. Discussed increase cetirizine to one tab po bid.  Started topical fluocinonide.  Injection was given at 2nd floor injection center. Came for Allergy office appt. 12/14/15.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient had redness and tenderness on left arm where injection was given. Also had 100.8 fever at that time. Patient did received MMR on the 11/04/2015.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: First noticed tenderness & redness on left upper arm.  Condition worsen through the day to: area hot & hard to touch, redness increased and pain. Spoke with M.D. office. Advised to monitor & go to E.R. if condition worsens.  No treatment received.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood test normal, Chapped lips, Culture negative, Feeding disorder, Headache
Clinical narrative: The symptoms started next day was 101 fever and rash on back of legs. These symptoms progressed over the next few days with congestion and chapped lips that bled. On Friday, 27th the rash consumed his whole body and face and his temp hit 102.5. His congestion was impeding his ability to nurse. I took him to urgent care, they sent me to ER. ER Dr took blood sample and insisted of a Spinal tap. We were sent to hospital where they took a urine sample and mouth swab for more testing. By this time his rash was subsiding and his fever gone. They put him on two different antibiotics until tests came back. At 34 hours, all test came back negative and we were sent home. He is still suffering from trauma and painful headaches. His fingers and toes are peeling.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lip haemorrhage, Lumbar puncture normal, Pyrexia, Rash, Rash generalised
Clinical narrative: The symptoms started next day was 101 fever and rash on back of legs. These symptoms progressed over the next few days with congestion and chapped lips that bled. On Friday, 27th the rash consumed his whole body and face and his temp hit 102.5. His congestion was impeding his ability to nurse. I took him to urgent care, they sent me to ER. ER Dr took blood sample and insisted of a Spinal tap. We were sent to hospital where they took a urine sample and mouth swab for more testing. By this time his rash was subsiding and his fever gone. They put him on two different antibiotics until tests came back. At 34 hours, all test came back negative and we were sent home. He is still suffering from trauma and painful headaches. His fingers and toes are peeling.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Respiratory tract congestion, Skin exfoliation, Urine analysis normal
Clinical narrative: The symptoms started next day was 101 fever and rash on back of legs. These symptoms progressed over the next few days with congestion and chapped lips that bled. On Friday, 27th the rash consumed his whole body and face and his temp hit 102.5. His congestion was impeding his ability to nurse. I took him to urgent care, they sent me to ER. ER Dr took blood sample and insisted of a Spinal tap. We were sent to hospital where they took a urine sample and mouth swab for more testing. By this time his rash was subsiding and his fever gone. They put him on two different antibiotics until tests came back. At 34 hours, all test came back negative and we were sent home. He is still suffering from trauma and painful headaches. His fingers and toes are peeling.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Malaise, Pain, Peripheral swelling
Clinical narrative: Achy, tender, swelling, redness (around arm down to elbow), chills, malaise.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Achy, tender, swelling, redness (around arm down to elbow), chills, malaise.
Age: 13.0
Sex: F
Vaccine: FLU4, TYP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: MMRV administered to a 13 yr. old female.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood thyroid stimulating hormone, Coagulation test, Computerised tomogram head, Electrocardiogram, Electroencephalogram
Clinical narrative: Syncope after event while standing at check-out desk.  3 weeks later, had an episode at home concerning for first time seizure that necessitated ER visit and further workup (ongoing).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Full blood count, Metabolic function test, Seizure, Syncope
Clinical narrative: Syncope after event while standing at check-out desk.  3 weeks later, had an episode at home concerning for first time seizure that necessitated ER visit and further workup (ongoing).
Age: 1.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Anaemia, Cyanosis, Cytomegalovirus test negative, Epstein-Barr virus test negative, Loss of consciousness
Clinical narrative: Blue lips, Loss of Consciousness on 05/16/2013; taken to doctor's office, diagnosed with Severe Anemia and sent to another Hospital for further tests.
Age: 1.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Parvovirus B19 test negative, Reticulocyte count increased
Clinical narrative: Blue lips, Loss of Consciousness on 05/16/2013; taken to doctor's office, diagnosed with Severe Anemia and sent to another Hospital for further tests.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm swollen at deltoid, circular red, warm area 7 cm, circum. 32 cm left arm, 29 cm right arm circum. Also had Tdap in right arm, flu shot in left arm.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fver 101.2, vomiting.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Diarrhoea, Fall, Guillain-Barre syndrome, Loss of consciousness
Clinical narrative: Patient started having a couple of symptoms on this date--diarrhea, falling, blackouts, leg weakness and was unable to walk.  He did not go to the hospital until 11/29.  They sent him home and he went back on 11/30 when they called in a neurologist.  He was then diagonsed with Guillain Barre syndrome at that time.  This was not reported to the pharmacy until today, 12/15/15.  The patient is now recovering in a rehabilitation facility.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Patient started having a couple of symptoms on this date--diarrhea, falling, blackouts, leg weakness and was unable to walk.  He did not go to the hospital until 11/29.  They sent him home and he went back on 11/30 when they called in a neurologist.  He was then diagonsed with Guillain Barre syndrome at that time.  This was not reported to the pharmacy until today, 12/15/15.  The patient is now recovering in a rehabilitation facility.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: It has been 17 days since being immunized and patient states she is still experiencing soreness and limited range in mobility in her left arm. She states she is unable to raise her left arm above her head and unable to move her arm too far backwards.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient Denies any Symptoms, Signs such as nausea, vomiting, headache, fever or allergic reaction.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chills, Erythema, Feeling hot, Local swelling
Clinical narrative: Fevers, chills, weakness; localized swelling/ erythema/ warmth.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fevers, chills, weakness; localized swelling/ erythema/ warmth.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Unevaluable event
Clinical narrative: Patient's parents deny patient to have any signs and symptoms like nausea, vomiting, fever, or allergic reaction to vaccine.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Quarter size raised skin area at sight of injection with small amount of redness.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Rash.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient awoke with injection site severly swollen, red, hot, and firm to the touch.  Also made her arm hurt.
Age: 97.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: LARGE SOFTBALL SIZE AREA OF REDNESS AND SOME SWELLING.
Age: 88.0
Sex: F
Vaccine: FLUR3
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Redness, swelling and itching from elbow to shoulder.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Numbness and tingling at injection site since the date of administration.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Red spot about 1 inch wide starting 2 days after the vaccination.
Sex: U
Vaccine: RV5
Symptoms: Dehydration, Viral infection, Vomiting, Weight decreased
Clinical narrative: This spontaneous report as received from an executive via a company representative refers to a baby (infant) of unknown age and gender. Medical history and concurrent condition was unspecified. On an unknown date, the patient was vaccinated with a dose of ROTATEQ, orally (lot# not reported). Concomitant medication was unspecified. On an unknown date, after the vaccination, the patient subsequently contracted the virus. Further, the patient had to be hospitalized due to dehydration and vomiting, and also, lost three pounds of body weight (hospitalization details unspecified). The executive could not confirm or deny that the vaccine was ROTATEQ. The outcome of dehydration, vomiting, viral infection and weight decreased was unknown. Causality was not provided by the reporter. Product quality complaint was not filed. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. Since 01-APR-2015, the patients were vaccinated with doses of PEDVAXHIB (lot # reported as K05462, expiration date: 07-AUG-2017; lot # L014426, expiration date: 08-MAR-2018; dose and route were not provided). which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 25-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 24-NOV-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (Lot # K024036, expiration date 26-NOV-2016) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Inconsolable crying 4 hours.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: In 4 hrs - fever, aching. 12 hrs later - fever, arm swollen, upper joints ached, chills. 3 days later - fever, chills, fatigue, nauseous, both arms and elbows ache, dizzy. Starting to improve.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: In 4 hrs - fever, aching. 12 hrs later - fever, arm swollen, upper joints ached, chills. 3 days later - fever, chills, fatigue, nauseous, both arms and elbows ache, dizzy. Starting to improve.
Age: 0.84
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Fever 103.8.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Initial tinnitus followed by loss of hearing in ear on one side.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None noted. Vaccine given at too early of an age. (Hepatitis A vaccine). Hepatitis A HAVRIX given 12/10/15.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Injection site pain
Clinical narrative: After vaccine experienced, next day, site ((L) deltoid) soreness, aching pains all body joints (especially shoulder jts and scapula, and both hips, B/L knees, ankles, calves and feet and anterior shins) with associated extreme fatigue - all over last 4 weeks. ADVIL helps a little.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal, Injection site erythema, Injection site irritation, Musculoskeletal pain
Clinical narrative: Patient has been experiencing severe muscle and joint pain from his ankles to his shoulders since three days after his vaccination. Patient's worse pain is in his legs, arms, and shoulders. Physicians have not been able to come up with a diagnosis. Patient has been taking Ibuprofen 800mg TID. Where the vaccine was given pt. had a large red/irritated area.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Vascular test normal
Clinical narrative: Patient has been experiencing severe muscle and joint pain from his ankles to his shoulders since three days after his vaccination. Patient's worse pain is in his legs, arms, and shoulders. Physicians have not been able to come up with a diagnosis. Patient has been taking Ibuprofen 800mg TID. Where the vaccine was given pt. had a large red/irritated area.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site reaction, Pruritus, Pyrexia, Rash macular, Urticaria
Clinical narrative: Urticarial rash-itchy blotchy raised lesions noted same night as he received Dtap #3 and Hep A#1 (within several hours of immunization, (12 hrs); stated by parent report on left thigh where received Dtap, spread to trunk and buttocks. Started 11/10/15l seen office on 11/19, diagnosed with hives; no anaphylaxis. Treated with BENADRYL, low grade fever day 1 and 2 only.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient states he had swelling, warm to the touch on his arm after getting the PNEUMOVAX shot. The swelling didn't go away until 3 days later. He's ok now. He was taking ALEVE to help swelling. No temperature. No systemic anaphylactic effects.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 19-NOV-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (Lot # K024036, expiration date 26-NOV-2016) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Rhinorrhoea
Clinical narrative: Patient stated that 24 hours after he received his flu vaccine he began having a severe runny nose.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 58 patients of an unknown ages and genders. The concurrent conditions and medical histories were not provided. Between 01-NOV-2015 through 10-DEC-2015, the patients were vaccinated with improperly stored dose of VARIVAX (Merck) (route and dose were not provided) lot # L025205, expiration date: 07-JUL-2017 and lot # L016127, expiration date: 10-DEC-2015. Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, who was a certified medical assistant referring to multiple unspecified patients. The information of concurrent conditions, medical history and concomitant medications was not provided. On multiple unspecified dates, the patients were administered improperly stored VARIVAX (Merck) injection (lot number K020758 and expired date 31-OCT-2016, lot number K002048 and expired date 10-FEB-2016, lot number L001325 and expired date 13-JAN-2017, dose, frequency and route were not provided). No known adverse effect was reported. This is one of two reports received from the same source (linked report MARRS#1512USA008017). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot #, dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist referring to a 62 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 01-DEC-2015 the patient was vaccinated with ZOSTAVAX vial, (L032399 expired date 26-NOV-2016) 0.65 ml, subcutaneously. Then on 02-DEC-2015 the same unspecified patient received dose of ZOSTAVAX vial, (L032399 expired date 26-NOV-2016) 0.65 ml, subcutaneously. Concomitant therapies included LEXAPRO. On 03-DEC-205, the patient called to report itching and redness at injection site that began on an unspecified date in December 2015. No lab diagnostics studies were performed. No treatment was given for the events. The outcome of the events was reported as not recovered. Causality was not provided. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: This spontaneous report was received from a 71 year old female patient who had animal allergies as concurrent condition. The patient had none pertinent medical history. On 02-DEC-2015, the patient was vaccinated with ZOSTAVAX (route of administration, lot# and expiration date were unspecified) 1 DF once in the arm. Concomitant therapies included ZYRTEC. On 02-DEC-2015, the patient experienced headache and stated that she had tenderness at the injection site. It was stated that none laboratory diagnostics were performed and that she did not seek for medical attention. No product quality complaint as involved. At the time of the report, the outcome of headache and injection site pain was reported as not recovered since she stated that she still has a headache and her arm was still tender. The relatedness of ZOSTAVAX with the adverse events was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Injection site rash
Clinical narrative: This spontaneous report was received from a 71 year old female patient who had animal allergies as concurrent condition. The patient had none pertinent medical history. On 02-DEC-2015, the patient was vaccinated with ZOSTAVAX (route of administration, lot# and expiration date were unspecified) 1 DF once in the arm. Concomitant therapies included ZYRTEC. On 02-DEC-2015, the patient experienced headache and stated that she had tenderness at the injection site. It was stated that none laboratory diagnostics were performed and that she did not seek for medical attention. No product quality complaint as involved. At the time of the report, the outcome of headache and injection site pain was reported as not recovered since she stated that she still has a headache and her arm was still tender. The relatedness of ZOSTAVAX with the adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients, of unknown ages and genders. No medical history or concurrent conditions were reported. Since 02-NOV-2015, an unspecified number of improperly stored doses of PROQUAD (Merck) (Lot # L016395 expiry date on 08-NOV-2016; lot numbers reported as L011082 expiry date on 01-APR-2017, K020758 expiry date on 03-JUL-2016, L011082 expiry date on 01-APR-2017, K020758 expiry date on 30-OCT-201) were inadvertently administered to an unspecified number of patients. No adverse events were reported. This is one of 4 reports received from the same source. Additional information has been requested.
Age: 43.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 43 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 23-NOV-2015, the 43 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 23-NOV-2015, the 42 year old patient was vaccinated with a dose of ZOSTAVAX lot # L015417, expiration date o1-AUG-2016 (strength, dose and route of administration were not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with unspecified number of doses of improperly stored GARDASIL (dose and route not reported; lot # K009482, expiration date 06-MAR-2017; lot # K011325, expiration date 08-APR-2017; lot #K011562, expiration date 08-APR-2017). No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 11-DEC-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # reported as L028277, expiration date 28-JUL-2017). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in approximately June 2015 (reported as "this summer"), the patients were vaccinated with the second dose (of two) of VARIVAX (Merck) (dose and route of administration were not reported). On an unknown date in approximately 2015, the patients experienced injection site reaction, the injection site was red and swelling. The patients sought medical attention, they were in the physician's office. No treatment was given to them for the event. The outcomes of the events were reported as recovered on an unspecified date in approximately 2-15. The relatedness between the events and VARIVAX (Merck) was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L006384, expiry date: 25-FEB-2017; dose and route 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 medical assistant and refers to an unspecified number of patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. Since 01-APR-2015, the patients were vaccinated with doses of ROTATEQ orally (lot # K009901, expiration date: 08-MAY-2016; lot # K023534, expiration date: 22-MAY-2016; lot # K020181, expiration date: 24-JUN-2016; dose was not provided), which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 19-NOV-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (Lot # 1003855, expiration date 05-FEB-2017) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 01-DEC-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient were vaccinated with two doses of ROTATEQ (strength, dose, frequency and route were not reported) lot # K023535 with an expiry date of 22-MAY-2016. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certificated medical assistant (C.M.A.) referring to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unknown dates after 29-OCT-2015 the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L021215, expiration date 10-JUN-2017, dose and route were not reported). Concomitant drug was not reported. No adverse events were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact, Incorrect product storage, No adverse event, Product physical issue
Clinical narrative: This spontaneous report was received from a female pharmacist of unknown age, reporting on herself. Medical history, concurrent conditions, concomitant medications were not reported. On an unknown date, the pharmacist suffered an accidental topical to exposure to the powder from a vial of ZOSTAVAX, 19400 unit 1 standard package vial of 1, lot # K018175 and expiration date in January 2016, that may have been leaking. The pharmacist reported also that ZOSTAVAX was stored at room temperature, as it had already been pulled from the freezer some time ago, and was slated for return to the distributor (incorrect product storage). No adverse events were reported and Product Quality Control (PQC) was filled on 18-NOV-2015. This is one of two reports received from the same source (MARRS# 1512USA006659). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: Raised red welt about 7 inches long and 3 inches wide. Pt taking BENADRYL, ice on arm, and ibuprofen. Started 1-2 days after immunization, still present 5th day after.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This literature marketed report as received from the authors of a public article abstract, refers to an unspecified number of young female patients of unknown age. Abstract information as below: Using the Faces Pain Scale - Revised, the reporters assessed injection site pain 10 minutes after vaccination in the patients randomized to receive either HPV4 before of after concomitantly administered vaccines. Although pain was modestly more after HPV4 injection than after other vaccines, the pain intensity after HPV4 injection was significantly less in those who received HPV4 before receiving other concomitant vaccines. On unknown date, the patients were vaccinated with GARDASIL (reported as "HPV4") (dose, lot #, route and injection site not reported). The patients also received other unspecified vaccines concomitantly before or after HPV4. Within 10 minutes after vaccination with HPV4, the patients experienced injection site pain. The outcome of injection site pain was unknown. The intensity of injection site pain was assessed by the reporters, and the result was stated as above. 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 healthcare worker refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with two doses of ROTATEQ (strength, dose, frequency and route were not reported) lot # K023535 with an expiry date of 22-MAY-2016. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report as received from a physician refers to a 69 year old male patient. The patient was enrolled in a post marketing active surveillance. The patient's medical history and current conditions were not provided. On an unknown date in approximately 2015, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown day in October 2015 (six weeks after injection), the patient experienced new herpetic lesions in buttock area - developed shingles event after vaccination with ZOSTAVAX. The physician felt that ZOSTAVAX was not effective. The outcome of new herpetic lesions in buttock area- shingles after vaccination was reported as recovered on an unknown date approximately in 2015. The outcome of vaccination failure was unknown. The relatedness between adverse events and ZOSTAVAX was unknown (also reported as "not sure"). Additional information is not expected due to no consent to contact Health Care Professional was given.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to an unspecified patient of unknown age and gender. On an unspecified date, the patient was vaccinated with an unsupported dose of M-M-R II, lot # L012480, expiry date 10-AUG-2017, (dose and route not reported) at an unspecified location (incorrect product storage). The outcome of the event was unknown. The case was elevated for further stability evaluation. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to an unspecified number of patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9 lot # L017407; expiry: 15-AUG-2017. M-M-R II, K021152/ expiry. 02-NOV-2016, lot # L011528/ expiry: 03-APR-2017 was within recommended storage range at 32F. No adverse effects were reported. No further information was provided. This is one of several reports received 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 was received from a register nurse referring to an unspecified number of patients of unknown age and gender, whom concurrent condition and medical history were not provided. On an unknown dates in 2015, reported as since 02-NOV-2015, an unspecified number of patients were vaccinated with ROTATEQ lot # L008057, expiration date 01-DEC-2016, oral (dose, concentration and dose number were not provided) exposed to temperatures outside of the recommended range, concomitant therapies were reported. No adverse experience was reported. This is one of two reports received from the same source. Additional information has been requested.