chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no pertinent medical history and no drug reactions or allergies. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose: 0.65 ml, subcutaneous, anatomical location not provided, lot # K009199, expiration date 27-SEP-2015). Concomitant therapies included simvastatin (manufacturer unknown), omeprazole (manufacturer unknown), VICODIN and sertraline hydrochloride. On unspecified date in October 2014, the patient experienced injection site reaction and came to the pharmacy. Injection site was red and itching and there was bruising around it. The reporter stated that reddened area was 4-5 inches in diameter. The patient sought medical attention via a pharmacy visit. No lab diagnostics were performed. There was no treatment given for the adverse events. The outcome of the events: injection site reaction, injection site red and itching and bruising around it was reported as not recovered/not resolved (at the time of the report). The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of VAQTA (dose and site not reported) which were improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received on 28-OCT-2014 from Registered Nurse reported that 1 patient of 25-44 years old adult with unknown gender were vaccinated with VAQTA (lot # J005010 and expiration date was 23-OCT-2015) (dose and route were not reported) which were improperly stored. This is one of the several reports from the same source. 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 a other health professional (Registered nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date in 2014 (reported as since September 2014) the patients were vaccinated with PROQUAD (Merck) for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Since September 2014, the patients were administered improperly stored PROQUAD (Merck). No adverse effects were noted. Outcome and causality assessment was not reported. Product quality complaint was not reported. No additional information was 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 as received from a healthcare worker refers to unspecified patients of unknown age and gender. Since 22-SEP-2014, the patients were vaccinated with improperly stored oral, ROTATEQ (lot#, expiration date and dose were unknown). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (Registered nurse) refers unspecified number of patients of unknown age. Current conditions and medical history was not provided. On an unknown date in 2014 (reported as since September 2014) the patients were vaccinated with (Merck) VARIVAX (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Since September 2014, the patients were administered improperly stored (Merck) VARIVAX. No adverse effects were noted. Outcome and causality assessment was not reported. Product quality complaint was not reported. No additional information was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (Registered nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date in 2014 (reported as since September 2014) the patients were vaccinated with ZOSTAVAX for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Since September 2014, the patients were administered improperly stored ZOSTAVAX. No adverse effects were noted. Outcome and causality assessment was not reported. Product quality complaint was not reported. No additional information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse, refers to a 12 month old patient (gender was not reported). On 22-OCT-2014, the patient was vaccinated with the dose of MMR II (dose, lot number and albumin status were not reported), subsequently a little to right of the vastus lateralis (almost on the backside). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with a dose of VARIVAX (Merck) (lot numb, expiration date, dose, route were not reported) that underwent a supported temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Current conditions and medical history was not reported. On 31-OCT-2014, the patient was vaccinated with first dose of ZOSTAVAX vial 19400 PFU (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 05-NOV-2014, second dose of ZOSTAVAX was inadvertently administered. No adverse effects reported. Product quality complaint was not reported. No additional information to report. 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 other health professional (registered nurse) refers to a patient of unknown age. Current conditions and medical history was not reproted. On 22-OCT-2014, the patient was vaccinated with M-M-R II injection, lot number K002036, expiry date 10-FEB-2016 for an unknown indication (dose, route and frequency were not reported). Concomitant medications were not reported. On 22-OCT-2014, the patient was administered a dose of improperly stored M-M-R II. No adverse events were reported. The outcome and causality assessment was not reported. Product quality complaint was not reported. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Allergy test, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient in mid fifties. On 28-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous. On an unknown date in 2014, after vaccination, the patient developed fluid filled vesicles around injection site. On an unknown date the patient was "screened for allergies like gelatin and neomycin" so no allergies related to ZOSTAVAX ingredients. No treatment was given for the adverse event. The patient sought medical attention and contacted with the physician. The outcome of fluid filled vesicles was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a office manager (healthcare worker) via a company representative on 04-NOV-2014 and refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient were vaccinated with late doses of GARDASIL (dose, lot #, expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported an expired M-M-R II (dose, route and lot# were not reported, exp 09-AUG-2014) was given on 28-OCT-2014. No adverse effect reported. The pharmacist would like to know if this should be counted as an administration or should the patient receive 2 additional doses. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of VAQTA (dose and site not reported) which were improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received on 28-OCT-2014 from Registered Nurse reported that 1 patient of 45-64 years old adult with unknown gender were vaccinated with VAQTA (lot # J005010 and expiration date was 23-OCT-2015) (dose and route were not reported) since 30-AUG-2014 to 30-SEP-2014 which were improperly stored. This is one of the several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient. None pertinent medical history, drug reactions or allergies were reported. On an unknown date in October 2012 (also reported as "2 years ago"), the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). None concomitant therapies were reported. On an unknown date in 2012, after receiving ZOSTAVAX, the patient experienced a rash around the injection site. No treatment was given for the adverse event. The patient did not seek medical attention. None laboratory diagnostic studies were performed. The outcome of rash around the injection site was reported as recovered on an unknown date in 2012, "2 days after injection". The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of VAQTA (dose and site not reported) which were improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received on 28-OCT-2014 from Registered Nurse reported that 2 patients of 10-14 years old with unknown gender were vaccinated with VAQTA (2 doses) (lot # J005010 and expiration date was 23-OCT-2015) (dose and route were not reported) which were improperly stored. This is one of several reports from the same source. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Corneal transplant, Eye pain
Clinical narrative: This spontaneous report as received from a nurse on 06-NOV-2014 refers to a 78 year old male patient with chronic obstructive pulmonary disease (COPD). On an unknown date of 2009 (also reported as 5 years ago) the patient was vaccinated with ZOSTAVAX (strength, dose and lot# were unknown). Concomitant therapies included prednisone (manufacturer unknown) and LEVAQUIN. On an unknown date of 2014 (also reported as recently) the patient had a corneal transplant and had been experiencing a lot of pain in his eye. The patient had an office visit for seeking medical attention. The patient was told by his physician on 06-NOV-2014 (also reported as today) that he could possibly has ophthalmic zoster. The physician prescribed valacyclovir, but the patient stated he had not gotten the prescription filled, and may not take that medication. The outcome of events was reported as not recovered/ not resolved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of VAQTA (dose and site not reported) which were improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received on 28-OCT-2014 from Registered Nurse reported that 1 patient of 3-4 years old with unknown gender was vaccinated with VAQTA (2 doses) (lot # J005010 and expiration date was 23-OCT-2015) (dose and route were not reported) which were improperly stored. This is one of the several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of VAQTA (dose and site not reported) which were improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received on 28-OCT-2014 from Registered Nurse reported that 3 patients of 2 years old with unknown gender were vaccinated with VAQTA (2 doses) (lot # J005010 and expiration date was 23-OCT-2015) (dose and route were not reported) which were improperly stored. This is one of the several reports from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling face, Throat tightness
Clinical narrative: Pt had some facial swelling and throat closing for a few hrs. but pt. recovered.
Age: 1.19
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Lymphadenopathy, Pyrexia, Rash generalised, Vaccination complication
Clinical narrative: Patient received MMR, VZV, HIB, PCV and developed fever one day after; then rash; rash worsened and covered child's entire body as well as swelling of lymph nodes in neck. Child was examined by MD and dx with reaction from MMR vaccine.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site of injection swelling to size of egg by morning after (Tues), doubled by Tuesday evening and trippled by Wednesday: Tuesday experienced full body aches and headache. Injection site ached, itched, was red, warm and swollen. Sought medical attention and was given an antibiotic. Called pharmacy 11/7/14.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain
Clinical narrative: Site of injection swelling to size of egg by morning after (Tues), doubled by Tuesday evening and trippled by Wednesday: Tuesday experienced full body aches and headache. Injection site ached, itched, was red, warm and swollen. Sought medical attention and was given an antibiotic. Called pharmacy 11/7/14.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Received rotavirus Monday 11-3-2014 began having quite mucousey stools Thurs 11-6-14 and hemocult (+) stools in office Friday 11-7-14.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. In approximately November 2012 the patient was vaccinated with first dose of GARDASIL (dose and route of administration were not reported). On an unknown date the patient who received her first dose of GARDASIL two years ago came into the office on 07-NOV-2014 (reported as "today") to receive second dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Lump, red, hot to touch.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to two patients of unknown age and gender. On 23-OCT-2014, patients were vaccinated with GARDASIL lot number K009811, expiration date 19-JUN-2014 (dose, strength and frequency were not reported), that were improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Day of vaccination - red around site. Next day - swelling from above injection site down to elbow. Swollen, warm, red, itchy, hard. Has used warm and cool compresses. As of 11/10/14 - improving but still red and swollen.
Age: 82.0
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 82 year old patient with penicillin allergy. On 20-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J014809, expiration date: 20-FEB-2015) 0.65 ml, once, subcutaneous. No concomitant medications were reported. The patient stated that on an unknown date in October 2014, after vaccination, he had a stiff neck and it hurt to hold his neck up or move the neck in any way. On an unknown date in October 2014 the patient sought medical attention and contacted unspecified pharmacist. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. On an unknown date the patient experienced a mild case of shingles. It was reported that the patient sought medical attention (details unspecified). The patient was treated with unspecified antivirals.  The outcome of a mild case of shingles was reported as not recovered. The action taken with the therapy with ZOSTAVAX was unknown. The relatedness of the events to the therpay with ZOSTAVAX was unknown. No product quality issue was reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Big red spot (redness) around the area. 10/27/14 shot was given. 10/28/14 about 2 inches "area". 10/29/14 about 5 inches "area".
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: (L) arm became swollen shoulder to elbow - 2 days fter - not reported till a week later.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a clinical medical assistant refers to a patient of unknown age. On 30-OCT-2014, the patient was vaccinated with the fourth dose of GARDASIL, 0.5 ml once, intramuscular (lot number not provided). No adverse effect was reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: C/O fever, headache, mucle pain evening after receiving vaccine - still slight headache and muscle pain the next day.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patient of unknown age and gender. The nurse reported an unspecified number of patients received improperly stored M-M-R II (lot#, strength, dosage, frequency and route unknown) on an unspecified date. No adverse effects reported. The outcome of the events was unknown. This is one of two reports from the same reporter. The other report is MARRS# 1411USA002360. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 30-OCT-2014 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot# and dose not reported) which was expired on 19-OCT-2014. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site induration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, route, anatomical location were unspecified). Concomitant therapies were unspecified. On an unknown date the patient experienced bruising and hardness at the injection site. Treatment given for the adverse event was unspecified. The outcome of bruising and hardness at the injection site was reported as recovered on an unspecified date. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, hot area on arm where she got shot. Told to take BENADRYL.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 63 year old patient of age gender. On 23-OCT-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous (Lot # reported as K00884, expiration date reported as 13-MAR-2015). The reporter stated that patient received ZOSTAVAX that was improperly exposed to 29F for 19 hours 40 minutes. No known adverse effects was reported. No product quality complaint was involved. This is one of several reports from the same reporter source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Extrme pain in LUE at injetion area/site.
Age: 35.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain in extremity
Clinical narrative: Pt. states continuous arm pain post receiving injections in arm. Claims has needed physical therapy due to pain.
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Listless
Clinical narrative: Elevate temp - 102.6. Listless.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Scar
Clinical narrative: Patient currently has mild outbreak "pock marks" on left arm. Area of injection swollen and red area. Facial "pock" on left cheek.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity
Clinical narrative: Rt arm painful to lift.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Diarrhea starting 8/15/14 lasting 4 weeks, contact dr. said possible side effect. At 5 weeks massive hive break out 3 trips to ER. 3 trips to allergist, felt internal hive break out from stress on her body. No one thinks its related to shot, but we do.
Age: 23.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Local swelling, Pain in extremity
Clinical narrative: Allergic type reaction, arm swelling shoulder to elbow, painful, patient went to ER received IV and PO antibiotics and BENADRYL.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Two days after shingles 10/29/14 patient had a red rash at injection site a few inches that was hot to the touch. Told her to go to doctor in case of infection. Was given steroid and antibiotic 10/30/14. At 7:00PM 10/30/14 patient stated she feels better.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Next day injection sight red, itchy, bumpy, hot to touch. Used cortizone then went to PA. Antibiotic given, using BENADRYL.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: Los of ROM in left arm very painful at injection and about an inch down. Can't reach back without causing extreme pain can't even raise my arm all the way up to put deodarant on.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin lesion
Clinical narrative: Erythema and induration 13 x 16 cm left lateral thigh, upper leg slightly swollen; induration within border of redness. BENADRYL and TYLENOL as needed started at 48 hr post vaccination. The patient is a 4 year old female who is brought to the office today by her mother for evaluation of a skin lesion that began 2 days ago. The skin lesion involves the left lower extremity and is characterized by redness. The rash developed suddenly and has been progressively worsening. She has had a recent history of having received a PROQUAD vaccine at the affected area. She does not attend daycare. There are no aggravating factors. The symptoms have improved with no know factors. The patient/caregiver reports no additional symptoms. The patient denies: fever, itching, night waking with the pain, and vomiting. The patient reports no ill contacts.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site swollen, warm to the touch, and itches 1 day post administration. Prescribed AUGMENTIN. Rechecked on 11/1/14 - mild erythema, however no heat, non tender, remains indurated.
Age: 15.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Culture wound negative, Ear pain, Herpes simplex serology negative
Clinical narrative: CC: Rash second MMR and Varicella received 9/26/14. Patient OV 10/10/14 with acute (L) ear pain. Dx'd bulbous myringitis and rx'd amoxicillin for infection triamcinolone for eczema. Returned 10/15/14 with itchy vesicular/ulcerative rash x 2 days.
Age: 15.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Myringitis bullous, Polymerase chain reaction, Rash, Rash pruritic, Rash vesicular
Clinical narrative: CC: Rash second MMR and Varicella received 9/26/14. Patient OV 10/10/14 with acute (L) ear pain. Dx'd bulbous myringitis and rx'd amoxicillin for infection triamcinolone for eczema. Returned 10/15/14 with itchy vesicular/ulcerative rash x 2 days.
Age: 15.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin ulcer
Clinical narrative: CC: Rash second MMR and Varicella received 9/26/14. Patient OV 10/10/14 with acute (L) ear pain. Dx'd bulbous myringitis and rx'd amoxicillin for infection triamcinolone for eczema. Returned 10/15/14 with itchy vesicular/ulcerative rash x 2 days.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Rednesss in injection site on 10/30. Went to ER on 11/1 /on antibiotics.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female consumer of unknown age referring to herself. The patient's medical history included prior case of shingles. None drug reactions or allergies were reported. On an unknown date in 2006 the patient was vaccinated with ZOSTAVAX, subcutaneous injection, 1 single shot, (dose, dose number, anatomical location, expiration date and lot number were unspecified). Concomitant therapies included an unspecified heart medication. On an unknown date the patient experienced that she has had 3 shingles outbreaks since ZOSTAVX vaccination. None laboratory diagnostic studies were performed. The patient sought medical attention (unspecified). The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 24 year old female patient. Pertinent medical history, drug reactions or allergies were unspecified. On 13-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 "1 shot", lot # K004542, expiration date 19-AUG-2015, (dose, dose number, route, anatomical location were unspecified). Concomitant therapies were not reported. On 15-OCT-2014 the patient experienced cellulitis. The patient sought medical attention (unspecified). The patient received an unspecified antibiotic for the treatment of the cellulitis. The outcome of cellulitis was reported as recovering. The relatedness between cellulitis and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 21 year old female patient. Pertinent medical history, drug reactions or allergies were unspecified. On 10-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 "1 shot", lot # K004542, expiration date 19-AUG-2015, (dose, dose number, route, anatomical location were unspecified). Concomitant therapies were not reported. On 12-OCT-2014 the patient experienced cellulitis. The patient sought medical attention (unspecified). The patient received an unspecified antibiotic for the treatment of the cellulitis. The outcome of cellulitis was reported as recovering. The relatedness between cellulitis and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 42 year old male patient. Pertinent medical history, drug reactions or allergies were unspecified. On 16-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 "1 shot", lot # K004542, expiration date 19-AUG-2015, (dose, dose number, route, anatomical location were unspecified). The patient also received a Flu vaccine (unspecified) on 16-OCT-2014. Concomitant therapies included PERAZONE. On 17-OCT-2014 the patient experienced cellulitis. The patient sought medical attention (unspecified). The patient received an unspecified antibiotic for the treatment of the cellulitis. The outcome of cellulitis was reported as recovering. The relatedness between cellulitis and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Erythema, Injection site urticaria, Musculoskeletal chest pain
Clinical narrative: Patient called 11/10/14: 10/31/14 developed muscle aches, arthralgias and pain in rib cage: now improving slowly v. slightly red non-painful. 11/5/14 noticed pea sized "welt" upper left arm - "pea sized". Went to health care provider and given KEFLEX. 11/7/14 developed 100.7 degrees fever, chills, muscle aches -> went back to PCP who advised further evaluation -> went to ER and ultrasound done-> not fluid-filled, no lymph node involvement and given BACTRIM and KEFLEX x 10 days.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Myalgia, Pyrexia, Ultrasound scan normal
Clinical narrative: Patient called 11/10/14: 10/31/14 developed muscle aches, arthralgias and pain in rib cage: now improving slowly v. slightly red non-painful. 11/5/14 noticed pea sized "welt" upper left arm - "pea sized". Went to health care provider and given KEFLEX. 11/7/14 developed 100.7 degrees fever, chills, muscle aches -> went back to PCP who advised further evaluation -> went to ER and ultrasound done-> not fluid-filled, no lymph node involvement and given BACTRIM and KEFLEX x 10 days.
Age: 97.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site pruritus, Pollakiuria, Pyrexia, Urinary tract infection
Clinical narrative: 97-year-old female accompanied by her daughter. Received PCV-13 vaccination in the left upper arm on 11/03/14 which was 7 days ago. Since then she has felt feverish with a documented temperature of 100.5 three days ago. Afebrile in office today. Used TYLENOL on Friday and Saturday but none since then. This has been accompanied by fatigue and soreness at the vaccination site. Over the past 2 days she's developed a 15 cm x 8 cm area of erythema without swelling around the vaccination site in the left upper arm. She states it is very itchy but there has been no scaling, drainage, bleeding. Patient thinks she may have a urinary tract infection as well with urinary frequency but no dysuria or gross hematuria identified. No flank or back pain, suprapubic pain, vomiting.
Age: 97.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: 97-year-old female accompanied by her daughter. Received PCV-13 vaccination in the left upper arm on 11/03/14 which was 7 days ago. Since then she has felt feverish with a documented temperature of 100.5 three days ago. Afebrile in office today. Used TYLENOL on Friday and Saturday but none since then. This has been accompanied by fatigue and soreness at the vaccination site. Over the past 2 days she's developed a 15 cm x 8 cm area of erythema without swelling around the vaccination site in the left upper arm. She states it is very itchy but there has been no scaling, drainage, bleeding. Patient thinks she may have a urinary tract infection as well with urinary frequency but no dysuria or gross hematuria identified. No flank or back pain, suprapubic pain, vomiting.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Localized allergic reaction, not systemic.
Sex: M
Vaccine: RVX
Symptoms: Intussusception, Surgery
Clinical narrative: Information was received from Freedom of Information Act (FOI) concerning a male patient of unknown age. On 21-NOV-2013, the patient was vaccinated with ROTAVIRUS VACCINE. As a result of ROTAVIRUS VACCINE, the patient experienced intussusception (date not reported). It was reported that the patient was hospitalized for intussusception and had to have surgery to correct it. The outcome of intussusception is unknown. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTPPHIB, PPV, RVX
Symptoms: Blood culture, Full blood count, Injection site erythema, Injection site rash, Injection site reaction
Clinical narrative: Cellulitis on thigh at site of injection.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTPPHIB, PPV, RVX
Symptoms: Injection site warmth, Irritability, Pyrexia, Skin lesion
Clinical narrative: Cellulitis on thigh at site of injection.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTPPHIB, PPV, RVX
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis on thigh at site of injection.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Cough
Clinical narrative: Case number PHEH2014US021804, is a combined initial and follow up spontaneous report received from a consumer (patient) on 27 Oct 2014, 31 Oct 2014 and from a healthcare professional (HCP) on behalf of an optometrist on 03 Nov 2014. This report refers to a 54 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412201) via intramuscular route on 23 Oct 2014. On the same day following vaccination, she experienced continuous body ache, chills, pricking pain in her left ear, pain in left side of her leg as well as itchy eyes. She visited emergency room 03 to 04 times of a hospital but that did not help her. She visited emergency room of another hospital where she was given TORADOL at a dose of 60 mg which helped her pain. On 28 Oct 2014, she went to a doctor where diagnosis of neuropathy was made. She was given NEURONTIN for the treatment of neuropathy. Patient complained that her body was not the same since she received the vaccine. She was also having tears in her left eye. She had consulted an optometrist and would also visit a specialist in the coming month. It was reported that the patient was tired all the time and had no quality of life. She was feeling miserable and depressed. Final outcome for pain (body pain) was condition improving (better). Outcome for chills, pain in her left ear, pain in left side of leg, itchy eyes, neuropathy, tired all the time, feeling miserable and depressed was ongoing (condition unchanged). Seriousness assessment of neuropathy was upgraded based on information available in source documents. The HCP reported that the events were unrelated (not suspected) to FLUVIRIN. The optometrist also explained that the events were not related to FLUVIRIN.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Discomfort, Ear pain, Eye pain, Feeling abnormal, Headache
Clinical narrative: Case number PHEH2014US021804, is a combined initial and follow up spontaneous report received from a consumer (patient) on 27 Oct 2014, 31 Oct 2014 and from a healthcare professional (HCP) on behalf of an optometrist on 03 Nov 2014. This report refers to a 54 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412201) via intramuscular route on 23 Oct 2014. On the same day following vaccination, she experienced continuous body ache, chills, pricking pain in her left ear, pain in left side of her leg as well as itchy eyes. She visited emergency room 03 to 04 times of a hospital but that did not help her. She visited emergency room of another hospital where she was given TORADOL at a dose of 60 mg which helped her pain. On 28 Oct 2014, she went to a doctor where diagnosis of neuropathy was made. She was given NEURONTIN for the treatment of neuropathy. Patient complained that her body was not the same since she received the vaccine. She was also having tears in her left eye. She had consulted an optometrist and would also visit a specialist in the coming month. It was reported that the patient was tired all the time and had no quality of life. She was feeling miserable and depressed. Final outcome for pain (body pain) was condition improving (better). Outcome for chills, pain in her left ear, pain in left side of leg, itchy eyes, neuropathy, tired all the time, feeling miserable and depressed was ongoing (condition unchanged). Seriousness assessment of neuropathy was upgraded based on information available in source documents. The HCP reported that the events were unrelated (not suspected) to FLUVIRIN. The optometrist also explained that the events were not related to FLUVIRIN.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hyperhidrosis, Influenza virus test negative, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Case number PHEH2014US021804, is a combined initial and follow up spontaneous report received from a consumer (patient) on 27 Oct 2014, 31 Oct 2014 and from a healthcare professional (HCP) on behalf of an optometrist on 03 Nov 2014. This report refers to a 54 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412201) via intramuscular route on 23 Oct 2014. On the same day following vaccination, she experienced continuous body ache, chills, pricking pain in her left ear, pain in left side of her leg as well as itchy eyes. She visited emergency room 03 to 04 times of a hospital but that did not help her. She visited emergency room of another hospital where she was given TORADOL at a dose of 60 mg which helped her pain. On 28 Oct 2014, she went to a doctor where diagnosis of neuropathy was made. She was given NEURONTIN for the treatment of neuropathy. Patient complained that her body was not the same since she received the vaccine. She was also having tears in her left eye. She had consulted an optometrist and would also visit a specialist in the coming month. It was reported that the patient was tired all the time and had no quality of life. She was feeling miserable and depressed. Final outcome for pain (body pain) was condition improving (better). Outcome for chills, pain in her left ear, pain in left side of leg, itchy eyes, neuropathy, tired all the time, feeling miserable and depressed was ongoing (condition unchanged). Seriousness assessment of neuropathy was upgraded based on information available in source documents. The HCP reported that the events were unrelated (not suspected) to FLUVIRIN. The optometrist also explained that the events were not related to FLUVIRIN.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: Case number PHEH2014US021804, is a combined initial and follow up spontaneous report received from a consumer (patient) on 27 Oct 2014, 31 Oct 2014 and from a healthcare professional (HCP) on behalf of an optometrist on 03 Nov 2014. This report refers to a 54 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412201) via intramuscular route on 23 Oct 2014. On the same day following vaccination, she experienced continuous body ache, chills, pricking pain in her left ear, pain in left side of her leg as well as itchy eyes. She visited emergency room 03 to 04 times of a hospital but that did not help her. She visited emergency room of another hospital where she was given TORADOL at a dose of 60 mg which helped her pain. On 28 Oct 2014, she went to a doctor where diagnosis of neuropathy was made. She was given NEURONTIN for the treatment of neuropathy. Patient complained that her body was not the same since she received the vaccine. She was also having tears in her left eye. She had consulted an optometrist and would also visit a specialist in the coming month. It was reported that the patient was tired all the time and had no quality of life. She was feeling miserable and depressed. Final outcome for pain (body pain) was condition improving (better). Outcome for chills, pain in her left ear, pain in left side of leg, itchy eyes, neuropathy, tired all the time, feeling miserable and depressed was ongoing (condition unchanged). Seriousness assessment of neuropathy was upgraded based on information available in source documents. The HCP reported that the events were unrelated (not suspected) to FLUVIRIN. The optometrist also explained that the events were not related to FLUVIRIN.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Depressed mood, Ear pain, Eye pruritus, Fatigue
Clinical narrative: Case number PHEH2014US021804, is a combined initial and follow up spontaneous report received from a consumer (patient) on 27 Oct 2014, 31 Oct 2014 and from a healthcare professional (HCP) on behalf of an optometrist on 03 Nov 2014. This report refers to a 54 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412201) via intramuscular route on 23 Oct 2014. On the same day following vaccination, she experienced continuous body ache, chills, pricking pain in her left ear, pain in left side of her leg as well as itchy eyes. She visited emergency room 03 to 04 times of a hospital but that did not help her. She visited emergency room of another hospital where she was given TORADOL at a dose of 60 mg which helped her pain. On 28 Oct 2014, she went to a doctor where diagnosis of neuropathy was made. She was given NEURONTIN for the treatment of neuropathy. Patient complained that her body was not the same since she received the vaccine. She was also having tears in her left eye. She had consulted an optometrist and would also visit a specialist in the coming month. It was reported that the patient was tired all the time and had no quality of life. She was feeling miserable and depressed. Final outcome for pain (body pain) was condition improving (better). Outcome for chills, pain in her left ear, pain in left side of leg, itchy eyes, neuropathy, tired all the time, feeling miserable and depressed was ongoing (condition unchanged). Seriousness assessment of neuropathy was upgraded based on information available in source documents. The HCP reported that the events were unrelated (not suspected) to FLUVIRIN. The optometrist also explained that the events were not related to FLUVIRIN.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling abnormal, Lacrimation increased, Neuropathy peripheral, Pain, Pain in extremity
Clinical narrative: Case number PHEH2014US021804, is a combined initial and follow up spontaneous report received from a consumer (patient) on 27 Oct 2014, 31 Oct 2014 and from a healthcare professional (HCP) on behalf of an optometrist on 03 Nov 2014. This report refers to a 54 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412201) via intramuscular route on 23 Oct 2014. On the same day following vaccination, she experienced continuous body ache, chills, pricking pain in her left ear, pain in left side of her leg as well as itchy eyes. She visited emergency room 03 to 04 times of a hospital but that did not help her. She visited emergency room of another hospital where she was given TORADOL at a dose of 60 mg which helped her pain. On 28 Oct 2014, she went to a doctor where diagnosis of neuropathy was made. She was given NEURONTIN for the treatment of neuropathy. Patient complained that her body was not the same since she received the vaccine. She was also having tears in her left eye. She had consulted an optometrist and would also visit a specialist in the coming month. It was reported that the patient was tired all the time and had no quality of life. She was feeling miserable and depressed. Final outcome for pain (body pain) was condition improving (better). Outcome for chills, pain in her left ear, pain in left side of leg, itchy eyes, neuropathy, tired all the time, feeling miserable and depressed was ongoing (condition unchanged). Seriousness assessment of neuropathy was upgraded based on information available in source documents. The HCP reported that the events were unrelated (not suspected) to FLUVIRIN. The optometrist also explained that the events were not related to FLUVIRIN.