chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: swollen, red, and painful
Age: 1.03
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Dermatitis diaper, Irritability, Limb discomfort, Pyrexia
Clinical narrative: Child had rash in the diaper area of folliculitis at office visit- then last evening rash spread rapidly on to the torso and arms, child very fussy, fever over 101, decreased appetite and child biting at arm.
Age: 1.03
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Child had rash in the diaper area of folliculitis at office visit- then last evening rash spread rapidly on to the torso and arms, child very fussy, fever over 101, decreased appetite and child biting at arm.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness  with swelling at the injection site. painful. pain and swelling resolving on evaluation today.
Age: 0.3
Sex: M
Vaccine: MEN
Symptoms: Meningococcal infection
Clinical narrative: Initial report received from a consumer, who is also the patient's mother, on 14 June 2014. It was retrieved during routine monitoring of the Sanofi Pasteur Facebook page. A three-month-old male, with no reported medical history, was "vaccinated for meningitis" on an unspecified date. Less than one week later, he contracted meningococcal disease. He was hospitalized for nine days. Per the reporter, "though he suffered side effects for years, he is now a healthy, thriving 15 year old". No additional information was reported, and follow-up was not available. Documents held by sender: None.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with 1 dose of CERVARIX and then administered 2 doses of GARDASIL (lot#, dose and route were not provided), in order to complete an HPV series. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site reaction, Injection site urticaria, Pruritus generalised, Urticaria
Clinical narrative: This spontaneous report as received from nurse practitioner on behalf of the physician refers to a 12 year old female patient with Von Willebrand disease. On 18-JUN-2014 the patient was vaccinated with GARDASIL (first dose, 0.5 ml, intramuscular) (lot number J013777 with expiry date of 11-AUG-2016) in her left deltoid region. On the same day of vaccination, the patients mother contacted the physician and stated that her daughter experienced itchy, large welts and hives starting at the left deltoid GARDASIL injection site later in the evening of the same day of vaccination which progressed to further down on her arm and then move throughout her entire body later in the evening to her arms, legs and trunk. Adverse events were further described by the physician to nurse that patient possibly experienced an allergic reaction to GARDASIL. The patient was treated with BENADRYL (orally). The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. There was no patient overdose and product quality issue involved. This case is linked to same patient link# 1406USA010867. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 months old patient (gender was not specified). The reporter stated that on 20-MAY-2014 the patient was vaccinated with M-M-R II ((lot # H009784) subcutaneous, dose/frequency: 0.5 ml, once) that was expired on 15-MAY-2014. Pertinent medical history and concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. No further information was provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Asthenia, Blindness, Disorientation, Flushing, Loss of consciousness
Clinical narrative: Nausea, followed by loss of vision, followed by flushing, followed by fainting/loss of consciousness, followed by roughly 20 minutes of disorientation, then mild weakness.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Nausea, Syncope
Clinical narrative: Nausea, followed by loss of vision, followed by flushing, followed by fainting/loss of consciousness, followed by roughly 20 minutes of disorientation, then mild weakness.
Age: 49.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Incorrect route of drug administration, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a 49 year old male patient. On 10-JUN-2014 the patient was inadvertently, intramuscularly vaccinated in the deltoid with 0.5 ml dose of PROQUAD (lot/batch number as K005196, expiration date 10-OCT-2015) post excursion. It was reported that PROQUAD was stored in refrigerator for 5 days (120 hours), excursion not supported. The patient did not seek medical attention. No adverse effects reported by patient. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: About 5 minutes after receiving MMRV vaccine, child developed a hive lesion proximal to the injection site on (R) upper arm (lesion measured 10mm and was about 15mm from injec. site) - no other sx. Pt sent home to take BENADRYL and parents to monitor.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Convulsion, Dizziness, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Pt stated "I feel dizzy", he turned pale, and loss consciousness. He began to convulse (3 seconds). Laid back onto bed and began snoring. Became conscious about 20 seconds later. He sweat profusely. Stated he was extremely sleepy. No Hx of seizures.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Snoring, Somnolence
Clinical narrative: Pt stated "I feel dizzy", he turned pale, and loss consciousness. He began to convulse (3 seconds). Laid back onto bed and began snoring. Became conscious about 20 seconds later. He sweat profusely. Stated he was extremely sleepy. No Hx of seizures.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Swelling
Clinical narrative: Pt presented with raised, swollen blisters on left arm 5 days after vaccine administered. Rash was from wrist up to mid arm MD was contacted and prescribed halobetasol crm BID x 7d. On the 6th day when came to get prescription the rash had migrated to right arm. No pain or itching reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles (severe) - still suffering.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: C/O fretful, high fever today 101.8 (R), appetite decreased.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Body temperature increased, Chest X-ray, Febrile convulsion, Full blood count, Otitis media acute
Clinical narrative: 6/18 4:36 AM Seen in ER with a temp of 104.3 and febrile seizure. Dx with febrile seizure and acute OM. Given Rx for AMOXIL. 6/18 Seen in ER with temp of 103.5 rectal and febrile seizure. Dx with febrile seizure and OM - given ROCEPHIN and Rx for AMOXIL. Returned to clinic 6/19/14 temp 98.4 - ears clear.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain
Clinical narrative: 6/18/14 Patient received PPSV vaccine 6/17/14 9:29 AM on left arm. Patient felt pain same day. Noticed redness around injection site today. Patient states no SOB, hives, weakness, no palpitations nor dizziness.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Broke out in hives, started in both wrists, then spread to back, BENADRYL prn hives up and down both arms, itch, not painful.
Age: 67.0
Sex: U
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Patient given ENGERIX vaccine 6/13/14 40mcg IM. Stated experienced hives that PM on body. (Lot 3744L exp 5/7/16).
Age: 48.0
Sex: F
Vaccine: TYP
Symptoms: Vertigo
Clinical narrative: Client received vaccines a-c listed in #13 on 5-21-14. Client started oral typhoid pills, d on #13, 5-23-14. Client experienced extreme vertigo beginning 5-25-14. Still has mild vertigo. Seeing MD for it.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, warm, arm at site of injection: very hard area pt received treatment at urgent care received antibiotic, cortisone and ZYRTEC.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at site of APDT and MMR injection upper left arm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Pain in arm, itching. Advised patient to place ice pack over area and take BENADRYL.
Age: 1.32
Sex: F
Vaccine: DTAP, HEP, HEPA
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: Right upper lateral thigh with 5x7 inch erythema, warmth to touch, and discomfort.  Mother reports that child also had itching over site and on chest.  No fever, chills or other symptoms.  Mother had not medicated child.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Rt arm where varicella was given w/ red/edema area of 1 1/2-2. Client stated that area itches. Advise to treat sym. Given BENADRYL out to area and if size increases or blister appears to call office.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial information was received on 12 June 2014 from a health care professional. Two unidentified patients, ages, dates of birth, and genders were not reported, were vaccinated intramuscularly on an unspecified date in June 2014 with ADACEL, Batch number C4519AA. The sites of administration were not reported. On an unspecified date in June 2014, the patients experienced redness, tenderness and swelling at the injection site. Both were seen by a physician and were diagnosed with cellulitis. Concomitant medications were not reported. The patients did not have any illness at the time of vaccination. Their medical histories were not reported. Laboratory tests and treatments were not provided. The patients' outcomes are not recovered. Documents held by sender: None.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Feeling hot, Loss of consciousness
Clinical narrative: Pt was given immunizations, stated she felt fine during the shots and had a conversation with the technician. Pt says she got up and left the immunization clinic and was walking to the waiting area. She says she remembers going to the door and feeling warm and once she got to the door she says she doesn't remember anything else. Pt passed out in the waiting area. Pt was on floor, elevated legs, checked out by provider, vitals completed. Pt laid down for a little bit, sat her up and gave her some water to sip. Got her into chair and gave her something to eat. She hadn't eaten anything prior.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Injection site pain, Myalgia, Somnolence
Clinical narrative: Pt was very sleepy very fatigued w/ any activity was not sweaty. Myalgia and weakness, fatigue, terrible (L) arm ache mid deltoid.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Fatigue, Insomnia, Pain in extremity
Clinical narrative: Parent complains child developed sudden onset of cough/fatigue post vaccination. I am writing to inform you that after receiving the Tdap vaccine on 5th June 2014, patient started a cough. Her cough started on June 6th, the day after the vaccine. Nurse had informed regarding pain or fever but had not mentioned cough as a possible side-effect. The pain in her arm lasted for approx. 3 days but the cough has progressively increased. Last night, she could not sleep due to persistent cough. So at  approx. 1.30 am I called facility phone number to ask what to do. Earlier during the day patient fell asleep in the afternoon while sitting which she has never done before. The doctor on call called back. He said he had not heard of cough after Tdap vaccine. I told the doctor on call that patient did not have a cough prior to the vaccine and that the cough came on suddenly without any symptoms. Patient also did not have a common cold or was not ill prior to the vaccine. So he said to give patient some cough suppressant and warm tea with honey to ease her cough and to watch out for her breathing. We gave patient DELSYM and warm drink. She finally fell asleep. She still has a cough. So I am writing to find out the signs we should be watching over the next few days to ensure she is okay. Also, please report this side-effect to CDC (VAERS). Please let me know what we should be watching out for.
Age: 1.27
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 2 hrs after vaccines - developed hives over body. Responded well to oral BENADRYL.
Age: 30.0
Sex: M
Vaccine: MMR, TDAP, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Dr ordered Varicella vaccine. Nurse administered Zoster vaccine in error.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Petechiae - hematology MD admitted.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unknown age and gender patient. Medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX lot number, route, strength and dosage were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patient was diagnosed with a case of shingles at unspecified amount of time later. The outcome of the event was unknown. Additional information is not expected.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 4 month old patient of unknown demography. On 18-JUN-2014, the patient was vaccinated with expired dose of ROTATEQ (dose and frequency were not reported) orally. No adverse effects reported. No AE/PQC. Additional information is not expected.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Oedema, Pain, Rash
Clinical narrative: Skin rash and local skin redness, soreness, soft tissue edema. Hydrocortisone 125 mg once, diphenhydramine 25 mg once.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 18 year old male patient who on 04-APR-2014 and on 22-MAY-2014, was vaccinated with adult doses of RECOMBIVAX HB (lot #s not reported). No adverse effect had been observed or reported. Additional information has been requested.
Age: 0.37
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Irritability, decreased appetite, red and swollen knot in leg at injection site. Injection site painful at touch.
Age: 0.37
Sex: F
Vaccine: PPV
Symptoms: Irritability
Clinical narrative: Irritability, decreased appetite, red and swollen knot in leg at injection site. Injection site painful at touch.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse refers to an unknown number of patients of an unknown age and gender. Medical history was reported. The reporter informed that on an unknown date the patients were vaccinated with VARIVAX lot number, expiration date, strength, dosage and route were not reported. Also informed that the VARIVAX was exposed to -14C for an unknown number of hours occurring intermittently over a period of 20 months. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No drug reactions or allergies and pertinent medical history were reported. On an unknown date the patient was vaccinated with VARIVAX dose 2, subcutaneous (strength, dose and lot number were unspecified). Concomitant therapies were unspecified. On an unknown date, the patient experienced blood test (blood titer) showed negative anti-varicella antibody titers. No treatment was given for the adverse event. The outcome of blood test titers negative was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and two patients of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot# J008652, exp. date: 10-JUL-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid disorder, Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 45 year old female patient. Patient's medical history and concurrent condition was none. On 16-JUN-2014 the patient was vaccinated with ZOSTER, 65 ml, subcutaneous. Patient's concomitant medication was reported was reported as none. On an unknown date approximately in June 2014 the patient developed a reddened injection site the size of a silver dollar with one lesion at its border the size of the head of a pencil and that her eyelids felt heavy, but she was not tired. The reporter stated that the patient reported that she had seen an unspecified physician who prescribed prednisone and Loratidine. PQC was not filed. The outcome of the event was reported as not recovered/not resolved. Reporter's causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse refers to an unknown number of patients of unknown age and gender. Medical history was reported. The reporter informed that on an unknown date the patients were vaccinated with ZOSTAVAX vial, lot number, expiration date, strength, dosage and route were not reported. Also informed that the ZOSTAVAX was exposed to -14C for an unknown number of hours occurring intermittently over a period of 20 months. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and two patients of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot# J003711, exp. date: 10-JUL-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Pyrexia
Clinical narrative: High fever of 105 after receiving vaccine.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. On an unknown date 10 doses of LIQUID PEDVAXHIB (dose, route of administration, LOT# and expiration date were not provided) all of which reached the temperature outside the product information, have been administered to unspecified patients. The temperature was supported. No adverse effects were reported. This is one of several reports from the same source (MARS# 1406USA008283, 1406USA008284, 1406USA007026) Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot# J009990 exp. Date: 12-AUG-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Skin lesion
Clinical narrative: Information has been received from a registered pharmacist concerning a 60 year old male patient with not pertinent medical history who on 21-SEP was vaccinated with a dose of ZOSTAVAX (Lot# 665531/0698Z, Exp. date 28-APR-2011) (route not reported). The pharmacist reported that on 29-SEP-2010 the patient developed a rash with lesions, shingles. At the time of the report, the outcome of the patient was reported. The patient called the pharmacy for medical attention. It has been determined the case #1405USA006086 is duplicate of case # 1010USA00154. Therefore, case # 1405USA006086 is being deleted from our files and the cases are consolidated into case # 1010USA00154. Additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and two patients of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot# J008652 exp. Date: 10-JUL-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a approximate 67 year old female patient. On 25-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H018798, expiration date 15-JAN-2014 (reported as 10/2013), 0.65 ml, subcutaneous). Concomitant medications were not reported. On an unspecified date in March 2014 the patient developed shingles after receiving ZOSTAVAX. At time of the report, outcome of the event was reported as not improved. The patient sought medical attention by contacting pharmacist. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route not reported). Concomitant medications were not reported. On an unspecified date the patient developed shingles after receiving ZOSTAVAX. Outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 17-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# not reported), subcutaneous. On an unspecified date in June the patient experienced that her left arm was red at injection site. Patient stated that the redness was now dissipating on an unspecified date. The outcome of her arm was red at injection site was red at injection site was reported as recovering/resolving. No treatment was given. It was not specified if the patient sought medical attention. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Client states swelling, warmth, hard to touch, and pain to injection site.
Age: 82.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Swelling at injection site. Three days after injection, severe itching that has not subsided to date.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Patients arm (elbow to shoulder) swelled and turned red.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to patients of unknown demographics. No relevant medical history of the patients was reported. It was reported that on unspecified dates an unspecified number of patients were vaccinated with improperly stored VARIVAX (Merck) (Lot number reported as J013904) (strength, dose and route of administration were not reported). No concomitant medications were reported. It was reported that the stored VARIVAX (Merck) were exposed to temperatures of -11 degrees Celsius for 13 hours. There were no adverse effects reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager (registered nurse, R.N.) refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, the patient received an improperly stored dose of PROQUAD injection (dose, frequency, route and lot number were not reported). Concomitant medications were not specified. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from the physician assistant, refers to a patient of unknown age and gender. On 23-JUN-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot# not reported, expiration date 30-APR-2014), .65 ml, subcutaneous. No adverse effects reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old male patient. On an unknown date that patient was vaccinated with the first dose of VARIVAX (dose, frequency and route were unknown) .  After two weeks, the patient developed a mild case of chickenpox. The outcome of the event was report as recovering. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and two patients of unspecified age and gender who were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J008652, exp date: 10-JUL-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified amount if patients. Concomitant medication and pertinent medical history were not provided. The nurse reported that LIQUID PEDVAXHIB (injection, dose, route, frequency and indication were not provided) that underwent a temperature excursion had been administered. No adverse effect reported. This is one of several reports received from the same source (MARRS# 1406USA009879). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified amount of patients. Concomitant medication and pertinent medical history were not provided. The nurse reported that RECOMBIVAX (injection, dose, route, frequency and indication were not provided) that underwent a temperature excursion had been administered. No adverse effect reported. This is one of several reports received from the same source (MARRS# 1406USA009879). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified amount of patients. Concomitant medication and patient medical history were not provided. The nurse reported that GARDASIL (injection, dose, route, frequency and indication were not provided) that underwent a temperature excursion had been administered. No adverse effect reported. This is one of several reports received from the same reporter. This is one of  several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients (age and gender unknown). On unknown dates the patients were vaccinated with improperly stored GARDASIL dose, route of administration and lot# were not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came into store on 6/23/14 and complained of itching, redness, swelling around injection site. I told customer to check with physician.
Age: 2.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 year old patient of unknown gender. On 19-JUN-2014, the patient was vaccinated with a dose of VAQTA, strength: 50/1.0 U/mL 1.0 ml, intramuscular (lot#, expiration date and indication not reported). The reporter stated that the patient received an adult dose of VAQTA today (19-JUN-2014). No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Fibromyalgia
Clinical narrative: This spontaneous report as received from a Nurse Practitioner via a company representative refers to a female patient of unknown age. The patient's medical history included fibromyalgia symptoms. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot# expiration date, does not reported). On an unknown date the patient experienced fibromyalgia symptoms after receiving GARDASIL. The patient did not seek medical attention. The outcome of the event was unknown. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The nurse reported that unspecified number of improperly stored PROQUAD (Merck) doses have been administered to unspecified number of patients on unspecified dates. The vaccines had been stored at -10 C (Celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. This is one of two reports. The case is linked to (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The nurse reported that unspecified number of improperly stored VARIVAX (merck) 0.5 milliliter (ml) doses have been administered subcutaneously to unspecified number of patients on unspecified dates. The vaccine have been stored at -10 C (celcius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. This is one of two reports. The case is linked to 1406USA010764 (same reporter link). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Ocular hyperaemia, Rash vesicular
Clinical narrative: Rash on her forehead, bumps on her forehead looks like shingles. Her eyes turn red, left eye, nose is red, eyebrow lining is red.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ocular hyperaemia, Rash, Rash pruritic, Skin lesion
Clinical narrative: Rash on her forehead, bumps on her forehead looks like shingles. Her eyes turn red, left eye, nose is red, eyebrow lining is red.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Cough, Nasopharyngitis, Productive cough, Pyrexia
Clinical narrative: Cold symptoms (runny nose, congestion), chills, low grade fever, persistent cough (mainly dry cough although some yellow phlegm produced).
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Cold symptoms (runny nose, congestion), chills, low grade fever, persistent cough (mainly dry cough although some yellow phlegm produced).
Age: 0.48
Sex: F
Vaccine: HEP
Symptoms: Cyanosis, Dyspnoea, Hypotonia, Respiratory arrest
Clinical narrative: Child became blue around her face stopped breathing for a few seconds and then seem to air hunger for additional few minutes then became limp all over body. Then regained composure back to normal.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Nausea, Syncope, Tonic clonic movements
Clinical narrative: Nausea, lightheaded, tonic-clonic movement, syncope x 5 seconds. Treated by placing patient supine after consciousness regained; orthostatic BP & HR: supine 2:38 pm: 96/56 P 77; sitting at 2:48 pm: 89/64 P 91; standing at 2:55pm: 98/68 P 109.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash erythematous, Rash generalised
Clinical narrative: Red raised bumps at injection site that have spread today down legs and feet, up to chest and face.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: CSF test, Computerised tomogram head normal, Convulsion, Decreased appetite, Lumbar puncture
Clinical narrative: 18 y/o male with no previous PMHx who presents with new onset seizure and altered mental status. Symptoms initially began 4 days prior to admission after he had been soldering with lead for 4-5 hours at work with no mask. Headache per mother was localized to the posterior occiput and he tried to take some Aleve with no relief. Two days prior to admission he developed left sided neck pain that was not associated with neck stiffness. His mother also noted that he was having some episodes of chills, but no fever. One day prior to admission he developed lower back pain in addition to the previous symptoms and presented to his PMD who examined him, ordered blood work and felt he had a muscle strain. He was given the HPV vaccine at that time. The morning of admission at 10:30am his mother heard noises coming from the patient's bedroom and went to check on him. She found him having seizure activity with vertical nystagmus, tonic-clonic movements of the upper extremities and was not responsive. There was no cyanosis or incontinence. She denied any facial or limb twitching. The mother reports she may have felt that the left upper extremity started shaking first before the rest of his body but she is not sure. It lasted for 2-3 minutes before stopping spontaneously. ROS: No photophobia, no phonophobia, no URI symptoms, no recent travel, no fever, (+)co-worker who recently traveled to vietnam, (+) decreased appetite.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Mental status changes, Nuclear magnetic resonance imaging brain, Nystagmus, Tonic clonic movements, Tremor
Clinical narrative: 18 y/o male with no previous PMHx who presents with new onset seizure and altered mental status. Symptoms initially began 4 days prior to admission after he had been soldering with lead for 4-5 hours at work with no mask. Headache per mother was localized to the posterior occiput and he tried to take some Aleve with no relief. Two days prior to admission he developed left sided neck pain that was not associated with neck stiffness. His mother also noted that he was having some episodes of chills, but no fever. One day prior to admission he developed lower back pain in addition to the previous symptoms and presented to his PMD who examined him, ordered blood work and felt he had a muscle strain. He was given the HPV vaccine at that time. The morning of admission at 10:30am his mother heard noises coming from the patient's bedroom and went to check on him. She found him having seizure activity with vertical nystagmus, tonic-clonic movements of the upper extremities and was not responsive. There was no cyanosis or incontinence. She denied any facial or limb twitching. The mother reports she may have felt that the left upper extremity started shaking first before the rest of his body but she is not sure. It lasted for 2-3 minutes before stopping spontaneously. ROS: No photophobia, no phonophobia, no URI symptoms, no recent travel, no fever, (+)co-worker who recently traveled to vietnam, (+) decreased appetite.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: 18 y/o male with no previous PMHx who presents with new onset seizure and altered mental status. Symptoms initially began 4 days prior to admission after he had been soldering with lead for 4-5 hours at work with no mask. Headache per mother was localized to the posterior occiput and he tried to take some Aleve with no relief. Two days prior to admission he developed left sided neck pain that was not associated with neck stiffness. His mother also noted that he was having some episodes of chills, but no fever. One day prior to admission he developed lower back pain in addition to the previous symptoms and presented to his PMD who examined him, ordered blood work and felt he had a muscle strain. He was given the HPV vaccine at that time. The morning of admission at 10:30am his mother heard noises coming from the patient's bedroom and went to check on him. She found him having seizure activity with vertical nystagmus, tonic-clonic movements of the upper extremities and was not responsive. There was no cyanosis or incontinence. She denied any facial or limb twitching. The mother reports she may have felt that the left upper extremity started shaking first before the rest of his body but she is not sure. It lasted for 2-3 minutes before stopping spontaneously. ROS: No photophobia, no phonophobia, no URI symptoms, no recent travel, no fever, (+)co-worker who recently traveled to vietnam, (+) decreased appetite.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, PPV, RVX
Symptoms: Crying, Decreased appetite, Pyrexia, Vomiting
Clinical narrative: Non stop crying: 4 hours; low grade fever; loss of appetite; vomiting-----Tylenol infant.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Condition aggravated, Gastrooesophageal reflux disease, Vomiting
Clinical narrative: Vomiting - GERS exacerbated.
Sex: F
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthropathy, Heart rate irregular, Knee arthroplasty
Clinical narrative: This case was reported by a consumer and described the occurrence of double knee replacement in a female subject of unspecified age who was vaccinated with Lyme vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject had no history of joint problems before the vaccinations. On unspecified dates, the subject received 2 of the 3 doses of Lyme vaccine (unknown routes and injection sites, batch numbers not provided). At an unspecified time after vaccination with Lyme vaccine, the subject was forced to restrict her activities. She experienced joint problems and underwent double knee replacement. Her heartbeat was also irregular. This case was assessed as medically serious by GSK. At the time of reporting, the events were unresolved. The vaccination course with Lyme vaccine was discontinued since subject's physician advised her not to get the 3rd dose.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt. received ZOSTAVAX SQ of inner side, lower left arm 2" x 3" rash appeared at injection site 2 days later. Dr. recommended ice and BENADRYL cream and to consult with pharmacy on 6/24/14 due to concern of injection site. Pharmacy consulted with manufacturer who stated CDC does not show any safety or efficiency concerns in SQ locations outside of deltoid.
Sex: F
Vaccine: HPV4
Symptoms: Ovarian failure
Clinical narrative: This spontaneous report was received from a physician assistant via a social media (unspecified new source) concerning two female patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (dose and route were not reported). Concomitant medication, medical history, drug allergies and reactions were not reported. The physician assistant reported that a patient brought in a news article that on unknown date, two sisters developed ovarian failure after receiving GARDASIL. The physician assistant is not the healthcare provider for the sisters and did not have any patients who are experiencing ovarian failure after receiving GARDASIL. The outcome of patients developed ovarian failure after receiving GARDASIL was unkonwn. This is an unconfirmed case and one of two reports received from the same reporter MARRS # 1406USA008485. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising
Clinical narrative: Mother called to report child has "2 big bruises" on both legs where shots were given. Dr recommended massage, ibuprofen, and follow up in 2 days if not improving.
Age: 20.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 20 years old patient of unknown gender. Medical history was not reported. On 11-JUN-2014 the patient was vaccinated with ZOSTAVAX, lot number, expiration date, strength, dosage and route was not reported. Concomitant therapy was not reported. The reported informed the on 11-JUN-2014 the patient was mistakenly administered ZOSTAVAX instead of VARIVAX. No adverse effects were reported. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal inflammation, Rash erythematous, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 62 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (frequency, dose and lot # not reported), "injection". On an unknown date the patient experienced red rash under her yes, her nasal passages were inflamed and she also developed a shingles-like rash on her fingers, after receiving ZOSTAVAX. On an unspecified date, the patient sought medical attention by office visit. The outcome of the adverse events was reported as recovered/resolved on an unspecified. Additional information has been requested.