chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 21-JAN-2015, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse experience had been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: Information has been received from an unspecified healthcare worker via a field representative concerning the healthcare worker's niece of unknown age. The patient's medical history and concurrent condition were not reported. In approximately 2013 (reported as around 2 years ago), the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and dose not reported). Co-suspect therapy and concomitant therapy were not reported. The healthcare worker reported that on an unknown date the patient experienced an unspecified "autoimmune disorder" while on therapy with GARDASIL. The outcome of the event was unknown. Additional information is not expected because the field representative did not have contact information including the reporter, the patient and the physician.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 21-JAN-2015, unspecified number of patients were vaccinated with improperly stored GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse experience had been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 21-JAN-2015, unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse experience had been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Fall, Head injury
Clinical narrative: Administered Menveo, Hep. A,  HPV. Was at table side, witnessed patient fall forward & hit his head, he rolled to the left side.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dysgeusia, Headache, Myalgia
Clinical narrative: Headache, mayalgia, weakness; improving; recent onset (6/17/15) metallic taste; similar symptoms with first vaccine, lasting 2 days.
Age: 1.62
Sex: M
Vaccine: TYP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Reporting medical error. PHN administered typhoid-IM instead. Medical error was not discovered until after vaccine had been administered. Mom was notified over the phone. Sanofi Pasteur was called regarding safety in children under 2 years old. Per medical staff, typhimVi is not approved for children under 2 due to poor immunogenic response. Per medical staff, adverse events from clinical trials (including children 1-12 years old) showed no severe or unusual side effects. Mom was given safety information and what the typical side effects are. Primary care provider was also notified of mistake in case family had to call their medical provider regarding the medical error. VERP report was submitted.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to an 82 year old female patient. Patient's pertinent medical history and drug reactions/ allergies were not reported. On 10-JUN-2015 the patient was vaccinated with ZOSTAVAX, 0.65 ml, once, subcutaneous (Lot # L008357, expiry date; 11-JUN-2016). Concomitant medications were unspecified. Following the administration of ZOSTAVAX, the patient developed extreme swelling (an area as big as a baseball), redness and itching at the injection site on 11-JUN-2015. Patient sought medical attention on an unspecified date and was seen in the pharmacy. Lab diagnostic studies were unspecified. Reporting pharmacist stated that the patient was treated with ice application at the injection site along with an unspecified dose of BENADRYL. Action taken with ZOSTAVAX was not reported. Outcome of the events were reported as not recovered. Reporting pharmacist did not provide the causal relationship between the events and the suspect product, ZOSTAVAX. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm, red, swollen warm, tender.
Age: 60.0
Sex: M
Vaccine: HEP, PPV, VARZOS
Symptoms: Eyelid function disorder, Facial paresis, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Diagnosed as: Bells Palsy.  The patient is a 60 year old male who presents with facial weakness. Note for "Facial weakness": Here today for f/u visit from ED. Went to ED 2 days ago for 2-day history of right facial droop and numbness, and could not close his right eye. Did not have weakness of any extremity, dizziness, headache, seizure, nausea, tingling, visual changes, or loss of consciousness.  Treated with acyclovir and prednisone course.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Mobility decreased, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Work up on 12/31/2014 to horrific pain in left shoulder, neck and arm.  Could not straighten head.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray
Clinical narrative: Work up on 12/31/2014 to horrific pain in left shoulder, neck and arm.  Could not straighten head.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pallor, Unresponsive to stimuli, Vomiting
Clinical narrative: Vomiting followed by pale and brief unresponsive episode. Occurred after 2 month shots as well. About 5 hours after both. Both were precipitated by vomiting.
Age: 71.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Abasia, Fall, Lumbar puncture, Mobility decreased, Pain
Clinical narrative: Falling, not able to walk, pain, no use of hands, paralysis from the neck down.
Age: 71.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Paralysis
Clinical narrative: Falling, not able to walk, pain, no use of hands, paralysis from the neck down.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Swelling
Clinical narrative: 4 days after injection, significant swelling, pain to left axilla.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Injection site oedema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient presented to the emergency room 01/24/2014. Pt c/o pain and swelling, at the site, from a vaccination received yesterday here. Right shoulder with localized edema, no redness. Pt also stated he felt chills last night. Pt denies SOB, wheezing. Shoulder pain intense with movement. Minimal pain at rest.  Methylprednisolone 300 mg UD, acetaminophen/hydrocodone 1 to 2 tablets mg PRN, clindamycin mg QID.
Age: 83.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema multiforme, Swelling
Clinical narrative: Erythema Multiforme and swelling. Clindamycin 450 mg QID.
Age: 59.0
Sex: M
Vaccine: DTP, VARZOS
Symptoms: Rash
Clinical narrative: Rash.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling, itching.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injection site infection, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient called with complaints of getting immunization one day prior at clinic (R) deltoid. Stated arm is red and sore and fingers are swollen. States he understand will have some normal side effect, however states site appears to be infected. Denies any drainage. Arm is warm to touch. Appt made with an avail provider this afternoon as requested for further eval. Prednisone 40 mg every day.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Rash and swelling. Diphenhydramine 50 mg TID, naproxen 500 mg BID.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Rash, Swelling, Vomiting
Clinical narrative: Rash, nausea vomiting & swelling.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test, Antinuclear antibody positive, Arthralgia, Bone pain, Double stranded DNA antibody
Clinical narrative: Looking back now I had vague symptoms the summer of 2014; fatigue, muscle weakness, femur pain at night as well as impulses through my body that would wake me up.  3/7/2015 was my first episode of joint pain, swelling and redness. I had blood tests per my pop which stated that I had Lupus. Being treated by a Rheumatologist and presently on Plaquenil.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Laboratory test, Middle insomnia, Muscular weakness
Clinical narrative: Looking back now I had vague symptoms the summer of 2014; fatigue, muscle weakness, femur pain at night as well as impulses through my body that would wake me up.  3/7/2015 was my first episode of joint pain, swelling and redness. I had blood tests per my pop which stated that I had Lupus. Being treated by a Rheumatologist and presently on Plaquenil.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sensory disturbance, Swelling, Systemic lupus erythematosus
Clinical narrative: Looking back now I had vague symptoms the summer of 2014; fatigue, muscle weakness, femur pain at night as well as impulses through my body that would wake me up.  3/7/2015 was my first episode of joint pain, swelling and redness. I had blood tests per my pop which stated that I had Lupus. Being treated by a Rheumatologist and presently on Plaquenil.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: Shot area turned red. Had a rash that was large as an apple. Itching. Pain in arm.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None at this time.
Age: 64.0
Sex: F
Vaccine: DTAP
Symptoms: Blood test, Muscle twitching, Muscular weakness, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Pain and extreme muscle weakness began in right arm and then spread to lower legs, upper legs, left arm, shoulders, hands.  All over body.  Muscles would twitch and still do.
Age: 64.0
Sex: F
Vaccine: DTAP
Symptoms: X-ray limb
Clinical narrative: Pain and extreme muscle weakness began in right arm and then spread to lower legs, upper legs, left arm, shoulders, hands.  All over body.  Muscles would twitch and still do.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: LEFT ARM SORE AT INJECTION SITE. PATIENT COMPLAINING OF SORENESS UNABLE TO LIFT BECAUSE HIS ARM WAS SORE.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin lesion, Skin warm, Swelling
Clinical narrative: LEFT ARM WELT, ITCHY, RED SKIN LESION, HIVES, RAISED, WARM. PATIENT DENIES ANY THROAT SWELLING.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: LEFT ARM WELT, ITCHY, RED SKIN LESION, HIVES, RAISED, WARM. PATIENT DENIES ANY THROAT SWELLING.
Age: 40.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Haemoglobin decreased, Immunoglobulin therapy, Menorrhagia, Platelet count decreased, Platelet transfusion
Clinical narrative: Abnormal heavy menstrual period for 7 hours.  Changing soaked tampon 20 minutes.  In emergency room Platelet count 2K.  Hemoglobin 9.2 dropped from 12.9 in 1.5 hours. Diagnosed with thrombocytopenia.  Given immune globulin and platelet transfusion.
Age: 40.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Thrombocytopenia
Clinical narrative: Abnormal heavy menstrual period for 7 hours.  Changing soaked tampon 20 minutes.  In emergency room Platelet count 2K.  Hemoglobin 9.2 dropped from 12.9 in 1.5 hours. Diagnosed with thrombocytopenia.  Given immune globulin and platelet transfusion.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site induration, Injection site movement impairment, Injection site pain, Injection site swelling
Clinical narrative: Beginning around 2:00 PM, patient complained of pain while walking on his leg. Around 3:00 PM, I checked his leg for swelling and it was significantly swollen from his groin to his knee, including his knee.  Very noticeable to the plain eye, but also the skin was hard when touched.  Patient had difficulty straightening his knee, causing him to walk with a pronounced limp. He also had a mild fever (99-100 F) for about 24 hours. The significant swelling from groin through knee, lasted for approximately 72 hours, as did the difficulty walking and straightening his knee.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Beginning around 2:00 PM, patient complained of pain while walking on his leg. Around 3:00 PM, I checked his leg for swelling and it was significantly swollen from his groin to his knee, including his knee.  Very noticeable to the plain eye, but also the skin was hard when touched.  Patient had difficulty straightening his knee, causing him to walk with a pronounced limp. He also had a mild fever (99-100 F) for about 24 hours. The significant swelling from groin through knee, lasted for approximately 72 hours, as did the difficulty walking and straightening his knee.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pt complained of redness, soreness and a rash at the site of injection.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of drug administration
Clinical narrative: MMRV vaccine was administered IM instead of its proper route of SC.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Dysgeusia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Immediately have injection, pins and needles feeling over most of body with extra intensity in throat - with a metallic taste.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, swollen, warm to touch, very painful.
Age: 70.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Headache, Induration, Local reaction, Peripheral swelling
Clinical narrative: Headache all day; arm red, hard and swollen "larger than baseball size" local reaction lasted one week.
Age: 1.26
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Pt. got splotchy red rash on face approx. 10 days after receiving MMR injection. No treatment.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Pruritus, Pyrexia, Swelling
Clinical narrative: Had low grade fever night of vaccine (midnight) until Monday. Had vaccine on Friday. Sat = started feeling swelling in area, redness, itching until today (Wed 6/17). Felt chills today 6/17.
Sex: F
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of whooping cough in a female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 61 days after receiving dTpa vaccine, the patient experienced whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the whooping cough was unknown. It was unknown if the reporter considered the whooping cough to be related to dTpa vaccine. Additional details were provided as follow: The patient had a whooping cough inoculation many years ago and contracted whooping cough 2 months later.
Age: 63.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Haemoglobin normal, Headache, Injection site erythema, Injection site pain
Clinical narrative: The pt received PNEUMOVAX in L-should and flu shot in the morning (10/3) and experienced headache that evening. He woke the following day with chills, nasal congestion and that evening was febrile to 101.5 and noticed swelling, pain and redness of his left shoulder where he'd received the PNEUMOVAX. Vancomycin 1 gm once.
Age: 63.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Nasal congestion, Neutrophil percentage increased, Platelet count normal, Pyrexia
Clinical narrative: The pt received PNEUMOVAX in L-should and flu shot in the morning (10/3) and experienced headache that evening. He woke the following day with chills, nasal congestion and that evening was febrile to 101.5 and noticed swelling, pain and redness of his left shoulder where he'd received the PNEUMOVAX. Vancomycin 1 gm once.
Age: 63.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: The pt received PNEUMOVAX in L-should and flu shot in the morning (10/3) and experienced headache that evening. He woke the following day with chills, nasal congestion and that evening was febrile to 101.5 and noticed swelling, pain and redness of his left shoulder where he'd received the PNEUMOVAX. Vancomycin 1 gm once.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ, orally (unknown strength and dose). Concomitant medications were not reported. There was no known adverse effect. The outcome of the events was unknown. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient was administered three doses of GARDASIL (intramuscular, lot #, expiration date and dose were unknown) on 08-NOV-2012, 03-MAR-2014 and 24-JUL-2014, respectively. No adverse effect was reported. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 14 day old patient (gender unknown). No concurrent condition, medical history or allergy/drug reactions were reported. On 12-JUN-2015, the patient was vaccinated with VAQTA 25/0.5 (units unknown) once, intramuscular (lot # and expiry date unspecified). No adverse effects were noted. No product quality complaint (PQC) was involved. The outcome of the event was unknown. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old patient. Relevant medical history and drug reactions were not reported. On 26-MAY-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number reported as H021709 with expiration date: 07-DEC-2014, dose, route unspecified). No adverse effects had been observed or reported. Additional information has been requested. Lot number H021709 has been verified to be a valid lot number for VARIVAX (Merck).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL (unknown route, strength, and dose). Concomitant medications were not reported. There was no known adverse effect. The outcome of the events was unknown. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 65 year old female patient. The patient's current conditions and pertinent medical history were none. Drug reactions or allergies were none. On 03-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 prefilled syringes (lot # L001311 and expiry date of 06-JUL-2016), intramuscularly. This was the only dose of PNEUMOVAX 23 the patient had ever received. Concomitant medications were none. On 03-JUN-2015, the same day, the patient experienced redness and cellulitis at the injection site. Lab diagnostics studies were none. The patient sought medical attention and came back to the office on 04-JUN-2015 (next day) and received doxycycline as treatment in response to the events. The outcome of the events was reported as recovering. Causality assessment for the events with suspect therapy was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding unspecified number of patients of unknown demographics. There was information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored GARDASIL lot # K0061241, Expiration Date- 02-FEB-2017, (dose strength and route was unknown). No concomitant medication was reproted. No adverse event reported. No product quality was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist, as part of a marketing research program refers to a female patient in early 60's. The patient did not have any relevant conditions and did not take any concomitant medications. On an unknown date (also reported as "sometime in 2012-2013") the patient was vaccinated with a dose ZOSTAVAX (dose volume, route of administration, lot number were not reported). On an unknown date the patient developed a rash that looked to originate from the injection site and went around three-fourth of her arm. The patient called the pharmacist next day to ask what to do and said it was a little itchy. There was no lab studies performed. The rash resolved in 3-4 days (date unspecified). The outcome of the event was reported as recovered/resolved. The reporter considered the causality between the event and ZOSTAVAX as related. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a physician regarding unspecified number of patients of unknown demographics. There was information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB lot # J013394, Expiration date- 23-AUG-2016, (dose strength and route was unknown). No concomitant medication was reported. No adverse event reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician's business manager referring to a 2 patients of unknown age and gender. The patients drug reactions/allergies and pertinent medical history were not reported. On an unspecified dates, the patients were vaccinated with the dose of VARIVAX (Merck) (dose, frequency, route and lot# were not reported) which were improperly stored. No adverse events were reported. On 18-MAY-2015, a phone call was placed to the reporting physician. A voice mail message was left requesting that the physician return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up have been unsuccessful. Follow-up information has been received from a business manager on 20-MAY-2015. The reporter identified the two patients who received improperly stored VARIVAX (Merck). The second patient received dose on 12-MAR-2015. It was reported that improperly stored dose was lot# K002036, expiration date 26-FEB-2016. This is one of several reports from the same reporter. All scheduled correspondence was sent. Lot number K002036 is an invalid lot number for VARIVAX (Merck). Additional information has been requested. Analysis has been updated.
Sex: M
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a consumer referring to her son, a male patient of unknown age. The information of concurrent conditions, medical history and concomitant medications was not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot number, dose, frequency and route were not provided). On an unknown date, at the sight of the insertion, there was a bump which was not red just at the normal skin problem, but the bump never went away. But then, the patient's mother chose to end the treatment. Additional information is not expected since there is no contact information provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 29-MAY-2015, the patient was vaccinated with an unknown dose of expired M-M-R II, subcutaneously (lot # J006137, and expiry date 24-MAY-2015). No adverse event occurred. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 2 year old male patient. On 19-MAY-2015, the patient was vaccinated inadvertently with PROQUAD (Merck) (L004005, expiry date 05-AUG-2016) who was supposed to receive MMR II. On 07-APR-2014, the patient received VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Myalgia, Pruritus, Skin warm, Swelling
Clinical narrative: Vaccination site was hurting by the evening. There was a sore spot on the muscle which was creeping down the arm and was red and swollen far as the muscle extends to the elbow. Itches badly, put ice, then became warm. Did not have fever at any time. Area still is quite red, still itches. Has used cortisone cream. Problems going away gradually. Will go to the doctor 6/17.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site was hurting by the evening. There was a sore spot on the muscle which was creeping down the arm and was red and swollen far as the muscle extends to the elbow. Itches badly, put ice, then became warm. Did not have fever at any time. Area still is quite red, still itches. Has used cortisone cream. Problems going away gradually. Will go to the doctor 6/17.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 0.08
Sex: M
Vaccine: DTAPIPV, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given KINRIX (DTaP/IPV) combo at 6 wks of age.
Age: 65.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Swelling
Clinical narrative: Per patient arm started out as itching around 1:00 pm and became red/swelling around 2 pm. Patient iced arm and started OTC pain medications at 5 pm. Arm is red, swollen to touch and is a 14 cm width. Patient is afebrile. Patient started on Abx 6/17/15 per MD.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Borrelia test negative, Differential white blood cell count normal, Epstein-Barr virus antibody negative, Headache
Clinical narrative: Pt weak in legs and arms since vaccine on 6/1/15, sleeping a lot, daily frontal headaches and stomach pain occasionally.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersomnia, Metabolic function test normal, Muscular weakness
Clinical narrative: Pt weak in legs and arms since vaccine on 6/1/15, sleeping a lot, daily frontal headaches and stomach pain occasionally.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash & urticaria pruritus. Diphenhydramine 25-50 mg other.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis in the left arm where she had received a PNEUMOVAX 23 vaccine injection, pt. was started on oral antibiotics, OMNICEF and BACTRIM DS on 6-17-15.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pyrexia, White blood cell count normal
Clinical narrative: Pain with rash at injection site (R) deltoid) on Thurs (Oct 4). Pt states redness at site started to show up more than 24 hr after shots was given with fever at this time. Pt had both Pneumococcal and flu shots on same site. Temp was 100.0 (F) at triage. Doxycycline 100 mg BID.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal stiffness, Paraesthesia
Clinical narrative: 5-21-15 pt was bitten by a wild kitten which she caught in her back yard. She went to hospital where she stated she rec'd post exposure rabies Tx and was referred to public health for tetanus vaccine. 5-22-15 pt. stated she received Td at approx 5:00 pm and the following symptoms began at approx. 7:00 pm that same day. Pt c/o "needle poke" sensation in her finger tips and palms of both hands and arms and stiffness in both hands. Also had needle poke sensation in her right side of her face (specifically her right cheek). States that these symptoms come and go, but the stiffness in both hands has been constant. Pt stated the kitten was tested for rabies which showed negative results. Pt rec'd four doses of rabies vaccine at hospital on the following dates: 5-21-15, 5-24-15, 5-28-15, 6-4-15. Pt stated she has received antibiotics and anti-inflammatory medications from either or both the hospital or her PCP. Pt's PCP instructed her to do warm water soaks in the AM, light exercises and to taken an anti-inflammatory of which the pt said she was not taking because she doesn't like to take medications.
Age: 1.65
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA
Symptoms: Injection site rash, Pruritus
Clinical narrative: Pt had rash approximately one hand breadth in size on left thigh, rash occurred one day after vaccines given, parents state pt c/o itching, rash going down 24 hrs after event. Parent advised to use hydrocortisone cream on rash, advised when to call 911/seek medical help.
Age: 27.0
Sex: M
Vaccine: HEPA, TDAP, YF
Symptoms: Eyelid oedema, Pruritus
Clinical narrative: Pt called complaining of itchy hands and puffy eyes. No shortness of breath or temp.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pruritus
Clinical narrative: Local redness (L) upper arm with pruritis.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dyspnoea, Tremor, Urticaria
Clinical narrative: Developed tremors, shortness of breath, and facial urticaria approx. 1 hr after vaccines given. Mother gave PROAIR at home, and symptoms resolved within about 1 hour. He returned to my office 3 hours after vaccines given and had returned to baseline.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: HepB vaccine dated 6/16/16 exp. given to pt on 6/16/15. No adverse reactions reported to supervisor. State DOH contacted. CDC Info contacted. To repeat dose at next visit (3 mths).
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Faeces discoloured, Lymphadenopathy, Pyrexia
Clinical narrative: Hep A 10:45 am on 6/13/15, Tm 102 at 8 pm on 6/13/15 with green stool, fever x3 days, +swollen glands to neck, complains of joint pain.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unspecified patient of unknown age and gender. No concurrent condition or medical history was reported. On 04-JUN-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, route of administration, anatomical location, lot # and expiration date were not reported). No adverse effect were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dysphemia, Enuresis, Tic
Clinical narrative: Facial tic has developed along with stuttering and bed wetting.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: Cellulitis, pain at injection site. Methylprednisolone, diphenhydramine, clindamycin.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) (route, dose anatomical location, lot # and expiration date were not reported). There was no concomitant therapy reported. No adverse effects were reported. The reporter did not have the lot numbers of PROQUAD (Merck) at the time of this report. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 28-MAY-2015, the patient was vaccinated with one dose of M-M-R II, (strength, dose, frequency, route and anatomical location were not reported) (lot # J008153 with expiration date: 08-JUL-2015), which was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a female patient of  unknown age. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL intramuscular injection (lot #, expiration date, dose and route of administration were not reported), then, four months later on an unknown date, a dose (reported as a second dose) of GARDASIL 9 injection (lot #, expiration date, dose and route of administration were not reported) was administered (interchange of vaccine products). No adverse effects were reported. Concomitant therapies were not specified. At the time of the report, the outcome of interchange of vaccine products was unknown. Additional information is not expected since there was not consent from the reporter to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to an unspecified number of patients of unknown age and gender. The reporter state that on 22-DEC-2014, 29-DEC-2014, 13-DEC-2014 and 20-MAR-2015, the unspecified patients received doses of RECOMBIVAX that were improperly stored, (strength, lot number, expiration date, dose # and route of administration were not reported). There was no concomitant medication reported. No adverse experiences were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a 18 month old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. On 11-DEC-2014, the patient was vaccinated with the first dose of VAQTA, (strength, dose, route, anatomical location, lot number and expiration date were not reported), and the second dose of VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not reported) was administered on 29-MAY-2015 which was 13 days early, by error. The patient had not demonstrated any adverse effects. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 01-JUN-2015 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 vial (lot # was not reported, expiration date: 22-MAR-2015) (dose, frequency and route of administration were not reported). No adverse effect was reported. Concomitant therapies were not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 12-JUN-2015 the patient received improperly stored PROQUAD (Merck) (lot # L005293, expiration date: 17-AUG-2016, 0.5 ml, once, subcutaneous) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Follow up information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with VARIVAX (Merck) (lot# was reported as K016161, expiration date 13-SEP-2016, dose and route were unknown) which had been exposed to temperatures outside of the recommended range. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician assistant concerning unspecified number of patients of unknown demographics. Relevant medical history and drug reactions were not reported. On unknown dates, since the stored temperature excursions which occurred in August 2014, the patients were vaccinated with the improperly stored PNEUMOVAX 23 (dose and route unspecified; lot # K004930 with expiration date: 16-MAR-2015). The physician assistant reported that PNEUMOVAX 23 were all administered prior to their expiration date. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Influenza, Pain
Clinical narrative: Information has been received from a female physician referring to herself. Patient's pertinent medical history included: asthma. On an unknown date the patient gave herself vaccinated with PNEUMOVAX 23, 0.5 ml injection for prevent pneumococcus (route and lot# unknown). No concomitant medication was reported. The patient reported that she had "flu symptoms and felt pain all over" from an unknown date. Patient had sought medical attention and self-treated. Therapy was reported as continued. The outcome of the events was unknown. Causality was not provided. No product quality issue (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients. No pertinent medical history or drug reactions/allergies were reported. On unknown dates the patients were vaccinated with doses of 0.65 ml ZOSTAVAX (lot# and expiration date unspecified), subcutaneously. No concomitant medications were reported. On unknown dates the patients experienced redness, swelling, warmth and pain at the injection site. No lab diagnostics studies were performed. The patients sought medical attention via visited to pharmacy and received BENADRYL as treatment. The outcome of events was reported as resolved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding unspecified number of patients of unknown demographics. There was information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored MMR II lot # K014833, Expiration Date-14-SEP-2016 (dose strength and route was unknown). No concomitant medication was reported. No adverse event reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding unspecified number of patients of unknown age. There was information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored VAQTA lot # K019560, Expiration Date- 02-JUN-2017, (dose strength and route was unknown). No concomitant medication was reported. No adverse event reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old female patient. Concurrent condition included, Diabetes mellitus and a "possible neuropathy", drug reactions and allergies were reported as none and no medical history was provided. On approximately 22-MAY-2015 (reported as about a week ago), the patient was vaccinated with ZOSTAVAX (Lot # L006380; Exp date 28-MAY-2016 (also reported as 25-MAY-2016)) in the ar (Dose, route of administration, dose number and concentration were not provided), for prevention of shingles. Concomitant therapies included LYRICA. Since the administration of ZOSTAVAX on approximately 22-MAY-2015, the patient experienced "tingling" in the injection arm. At the time of the report the outcome of injection site paresthesia was reported as not recovered. The patient sought medical attention and called the pharmacy but no treatment was given for the event. It was also reported that there were no laboratory diagnostics studies performed. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding unspecified number of patients of unknown demographics. There was information about concurrent conditions and historical medication. On an unknown date, the patiens were vaccinated with unspecified doses of improperly stored oral, ROTATEQ lot # K008140, Expiration Date- 30-MAR-2016, (dose strength and route was unknown). No concomitant medication was reported. No adverse event reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with M-M-R II (lot#, expiration date, dose, frequency and route were not reported) which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL 9 (unknown strength and route). Concomitant medications were not reported. No adverse effect was reported. The outcome of the events was unknown. There was no product quality complaint involved. 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 nurse refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored ROTATEQ, oral (unknown strength). Concomitant medications were not reported. No adverse effect was reported. The outcome of the events was unknown. There was not product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL (unknown strength and route). Concomitant medications were not reported. No adverse effect was reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.