chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Swelling, Urticaria
Clinical narrative: Allergic reaction after vaccination approximately 1 hour after receiving-developed difficulty swallowing, rash, itching. This 13 yrs old male presents to ER via walk-in with complaints of Allergic Reaction. The patient presents with difficulty swallowing, itching, rash, redness of skin. Onset: The symptoms/episode began/occurred suddenly, 1 hour(s) ago, after getting 4 injections at Dr's office: HPV, Tdap, meningococcal, Hep A vaccines. Associated signs and symptoms: Pertinent positives: hives, swelling, Pertinent negatives: chest pain, dysphagia, shortness of breath. Possible causes: At home the patient or guardian has treated the symptoms with nothing. Severity of symptoms: At their worst the symptoms were moderate in the emergency department the symptoms are unchanged. The EMS care prior to arrival includes: none. The patient has not experienced similar symptoms in the past. The patient has been recently seen by a physician. Dr., earlier today.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # reported as 1004743 with expiration date 01-JUN-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Neuralgic amyotrophy
Clinical narrative: This spontaneous report was received from a physician and refers to a 71-year-old radiologist. No information about patient's concurrent conditions, concomitant medication and medical history was provided. On an unspecified date in 2009, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date not reported). The patient did not experience any adverse reaction following vaccination. On an unknown date, the patient was administer a booster dose of PNEUMOVAX 23. On an unknown date, 10 day after receiving the booster dose, the patient had an acute onset of pain with neuropathy (also reported as brachial plexus neuritis). The outcome of the event was not reported. The relatedness between PNEUMOVAX 23 and an acute onset of pain with neuropathy was not reported. Additional information has been requested.
Age: 1.41
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 16 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 07-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Extra dose administered, Headache, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse and refers to a 19 year old female patient with asthma, hyperthyroidism and Hashimoto's thyroiditis. There was no drug reactions and allergies reported. On unknown dates, the patient was vaccinated with the first, second, third doses of GARDASIL (lot#, expiration date, dose, site of administration were not reported) and subsequently, had no adverse effects reported regarding these vaccinations. On 08-JUL-2015, the patient was inadvertently vaccinated with the fourth dose of GARDASIL (lot# L012190, expiration date 13-APR-2017, dose, site of administration were not reported) administered intramuscularly. Concomitant therapies included VOLTAREN and CLARITIN. On 09-JUL-2015, the patient called the unspecified physician's office and reported that she experienced fever, headache and shivering. There were no lab diagnostics studies performed and no treatment was given. The outcome of the events was unknown. The patient sought medical attention. The relatedness between the fever, headache, shivering and GARDASIL was not reported. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 05-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml., subcutaneously) (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. No medical history and concurrent conditions were reported. Since 09-JUN-2015 (exact dates unspecified), the patients received doses of improperly stored LIQUID PEDVAXHIB (lot number, dose frequency, route and site of administration was not reported). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 24-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # reported as 1004743 with expiration date 01-JUN-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received form a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 23-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # reported as 1004743 with expiration date 01-JUN-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. ON 21-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot number K021487 (dose and route were not reported) and a dose of improperly stored M-M-R II lot number reported as 014833 (dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports from the same reporter source.  Lot number 014833 is not valid lot number for the M-M-R II. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 26-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot number K021487 (dose and route were not reported) and dose of improperly stored M-M-R lot number reported as 014833 (dose and route not reported). Concomitant medications were not reported. No adverse effects were reported. Lot number 014833 is not valid lot number for M-M-R II.This is one of several reports from the same reporter source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 05-MAY-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 29-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 years old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 years old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 12-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is note expected, as all required information has been received.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers tot a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 18-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored dose of LIQUID PEDVAXHIB (lot#, expiration date, route of administration, dose and indication were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored doses of RECOMBIVAX HB (lot#, expiration date, dose, route of administration and indication were not reported). No adverse effect was reported. 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 certified medical assistant refers to unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K007264 with expiry date 02-MAR-2017 and lot # K011562 with expiry date 08-APR-2017, dose and route of administration not reported). No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to some patients of unknown age and gender. The patients' pertinent medical history and drug reactions were not reported. The nurse stated that in 2001 COMVAX had the 4-dose schedule, then the vaccine was on backorder and on unknown dates, some patients did not receive the 4th dose of COMVAX (also reported as "Hepatitis B"; dose, route of administration, lot# and expiry date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 years old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 27-MAY-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative regarding an 11 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (lot #, dose and route were not provided). On an unknown date, two days after administration of the vaccine the patient experienced full body rash. The outcome of full body rash was unknown. The reporter did not provide the relatedness of the event with GARDASIL 9. Additional information is not expected as the reporter did not wish to be contacted.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old female patient with no known allergies. Patient's medical history and concurrent conditions were not reported. On 10-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L000461, Expiry date: 08-MAR-2016), (dose was not reported), subcutaneous for prevention of shingles. Concomitant therapies included XALATAN, XANAX and MOBIC. Subsequently on an unknown date in July 2015, the patient experienced recurring calf pain. The patient sought medical attention by visiting the physician. On 15-JUL-2015 the patient started therapy with prednisone (formulation not reported) 40 mg daily for five days as a treatment for the calf pain. The outcome of the event 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: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored doses of VAQTA (lot#, expiration date, dose, route of administration and indication were not reported). No adverse effects was reported. 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 was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored doses of GARDASIL (lot#, expiration date, dose, route of administration and indication were not reported). No adverse effect 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 certified medical assistant refers to unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant therapies were not provided. On unknown dates, the patients were administered improperly stored doses of oral ROTATEQ (lot # K023534, expiry date 22-MAY-2016, orally, dose not reported). No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored doses of GARDASIL 9 (lot #, expiration date, dose, route of administration and indication were not reported). No adverse effect was reported. This is one of several 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: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history was not reported. On 23-APR-2014, the patient was vaccinated with the first dose of GARDASIL (lot #, dose, route and site of administration were not reported). On 21-MAY-2015 the patient was vaccinated with the second dose of GARDASIL (lot #, dose, route and site of administration were not reported). Patient just didn't show when they should be vaccinated. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored doses of ROTATEQ, orally, (lot#, expiration date, dose and indication were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. 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 registered nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 20-JUL-2015, the patient was inadvertently vaccinated with an expired dose of MMR II (dose, route, site of administration, lot #, expiration date and therapy type were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a licensed practical nurse refers to a multiple patients of unknown ages and genders. Concurrent conditions and medical histories were not provided. On unspecified dates since 27-MAY-2015, the patients were vaccinated with improperly stored GARDASIL Lot# K007264, Expiration date: 03/02/2017 and Lot# K006117, Expiration date: 01/14/2017 (dose, strength and route not provided). There was no concomitant medication. No adverse events reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # K011801 with expiry date 21-AUG-2016 and lot # reported as L005301 with expiry date 17-FEB-2017, dose and route of administration not reported). No adverse experiences were reported. This is one of several reports 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 medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of ROTATEQ (orally, lot # K014826 with expiration date 28-MAY-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored doses of PNEUMOVAX 23 (dose, lot#, expiration date, route of administration and indication were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a male patient of unknown age with schizophrenia. No medical history and concomitant therapies were reported. On an unknown date, the patient was vaccinated with M-M-R II (lot #, expiration date, dose, route of administration and anatomical location were not reported). On an unknown date, the patient had negative measles titer, but mumps and rubella titers were positive. No treatment for the event was given. The patient did not seek medical attention. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 20 years old male patient. Concurrent conditions included familial risk condition as the patient's mother was diagnosed with shingles on 18-JUN-2015. The medical history was not provided. On 22-JUN-2015 the patient was vaccinated with (Oka/Merck) VARIVAX "vial 1350U", injection, lot # L001327 and expiration date 13-JAN-2017 (route of administration was not provided). There was not concomitant medication reported. On 02-JUL-2015, the patient experienced a rash that appears to be chickenpox (rash vesicular) and was examined by the physician on 07-JUL-2015. The nurse was inquiring, since she did not know which strain of Varicella was causing the patient's rash, whether wild type or Oka-Merck strain, how to cleanse and decontaminate the room in which the patient was examined. At the time of the report the outcome of rash vesicular was reported as not recovered. The reporter did not assess the relatedness of rash vesicular with (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of VAQTA (lot # K019560 with expiration date 02-JUN-2017; dose and route of administration were not reported). 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 healthcare worker refers to a two unspecified patients of unknown age and gender. No information on patients medical history, concurrent conditions or concomitant medications was provided. On 14-JUL-2015, one patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX injection, lot # K011801, expiration date 21-AUG-2016 (strength, route of administration and dose were not reported) that had been improperly stored. On 17-JUL-2015, one additional patient was inadvertently administered with a dose of (Oka/Merck) VARIVAX injection, lot # K011801, expiration date 21-AUG-2016 (strength, route of administration and dose were not reported) that had been improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old male patient. The patient has concurrent condition of hypercholesterolaemia and hypertension. On 13-JUL-2015, the patient was vaccinated with ZOSTAVAX lot # L012475, expiry date 10-JUL-2016, subcutaneous. Concomitant therapies included pravastatin (manufacturer unknown) and unspecified hypertension medication. On 13-JUL-2015, the patient developed a red, warm welt at the injection site a few hours after administration of ZOSTAVAX. No Lab diagnostics were performed. On 16-JUL-2015, the outcome of warm welt at the injection site was reported as recovered/resolved. The patient sought medical attention (came to pharmacy). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: I stated to the nurse after the vaccine was administered that I felt very dizzy; after a couple minutes the dizzy spell went away and I ask if it was okay to leave to which she replied yes. As I was walking out of the office I had to sit down in the waiting room because I had another dizzy spell. Once I sat down the dizziness was overwhelming and my last thought was to get a nurse, (although I don't remember exactly) when I got up to walk to the nurses door I passed out then had a seizure. The nurses and Dr. came out and took me back to put me under observation... I felt better after about 30 minutes. Once I left the Dr.'s office I read the take home care instructions given and it stated that if a patient advises to the nurse she/he is feeling dizzy to have the patient wait 15 minutes which my nurse did not; just thought that could have been related to why I had the reaction I did. Seek Advice Details: I have a primary care physician appt. tomorrow to follow up about side effects from the vaccine. The patient was taking HPV vaccine for: Per nurse request and based on age range.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Full blood count normal, Petechiae, Platelet count decreased
Clinical narrative: Petechial rash on cheeks and left ear.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity, Tenderness
Clinical narrative: Upper arm and shoulder extremely painful, radiating up to the neck; unable to move arm at all without debilitating pain; after 3 days, still extremely tender, not able to lift arm very well.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Body ache, fever, chills, lasting three days and nights, unable to be out of bed or drive to doctor. Injection site sore, red, itchy and swollen for nine inches around site, and this lasted seven days.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: Body ache, fever, chills, lasting three days and nights, unable to be out of bed or drive to doctor. Injection site sore, red, itchy and swollen for nine inches around site, and this lasted seven days.
Age: 39.0
Sex: F
Vaccine: YF
Symptoms: Asthenia, Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness, nausea, vomiting, weakness.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient experiened redness and itching especially on both arms.  Patient called and we recommended for her to take some Benadryl right away.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient experienced redness and itching especially on both arms.  Patient called and we recommeded for her to take some Benadryl right away.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Raised red bumps on back of both arms near elbows and on forearms. Area near right elbow presented with itching. No bumps/itching or irritation near injection site. Employee washed area that itched and stated itching resolved. Nothing warm to the touch. No temperature - current temp was 98.6. No other signs or symptoms. Box 9 marked as no due to bumps remained but itching did resolve.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site joint swelling, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth at shot site, mild headache, now redness has moved down from shot site to elbow, and swelling is around elbow.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Upper arm extremely red with extreme swelling around injection site.   Pt also had headache.  Per pt redness & swelling has diminished but still bothersome.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling, Psoriasis, Skin fissures
Clinical narrative: Painful, swollen hands, splitting, cracking on fingers and palms with deep fissures forming near joints, pain on bending joints of thumbs. Initially used bacitracin ointment and bandages. Showed cardiologist who said it could be dishpan hands. Self treated with minor success, then went to primary Dr., 6/24/15. diagnosed as psoriasis on hands and knees. Prescribed mometsone cream. Since then have applied cream daily and now have pain and cracking in area of heels on both feet.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Pyrexia
Clinical narrative: PATIENT REPORTS CHILLS, LOSS OF APPETITE, FEVER, NAUSEA, AND FATIGUE, WHICH LASTED FOR APPROXIMATELY TWO WEEKS.
Age: 0.49
Sex: F
Vaccine: PNC13
Symptoms: Croup infectious, Crying, Ear discomfort, Irritability, Lacrimation increased
Clinical narrative: Tugging at ears; cold symptoms; increased crying and irritability; teary left eye.  Office visits on 12/18 and 12/21.  Emergency Department visit while traveling on 12/24/14:  given oral steroids for croup.  Seen again in office on 12/28/14.
Age: 0.49
Sex: F
Vaccine: PNC13
Symptoms: Nasopharyngitis
Clinical narrative: Tugging at ears; cold symptoms; increased crying and irritability; teary left eye.  Office visits on 12/18 and 12/21.  Emergency Department visit while traveling on 12/24/14:  given oral steroids for croup.  Seen again in office on 12/28/14.
Age: 1.82
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for five days.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Blood culture, Cellulitis, Full blood count, Hypersensitivity, Injection site erythema
Clinical narrative: Red hot welt, swelling at injection site, fever, vomiting. Antibiotics (Augmentin) given x3 doses, follow up at ER 07/26/2016 given Benadryl, oral steroid, and vancomycin IV. Diagnosis cellulitis and allergic reaction.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Red hot welt, swelling at injection site, fever, vomiting. Antibiotics (Augmentin) given x3 doses, follow up at ER 07/26/2016 given Benadryl, oral steroid, and vancomycin IV. Diagnosis cellulitis and allergic reaction.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Vomiting
Clinical narrative: Red hot welt, swelling at injection site, fever, vomiting. Antibiotics (Augmentin) given x3 doses, follow up at ER 07/26/2016 given Benadryl, oral steroid, and vancomycin IV. Diagnosis cellulitis and allergic reaction.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant concerning a patient of unknown age and gender. On 14-APR-2015 the patient was vaccinated with GARDASIL lot # K006960 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range for 12 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all follow ups requested to complete the case was received.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella post vaccine
Clinical narrative: 6 days after ZOSTAVAX administration, patient called to report symptoms of chickenpox; her doctor agreed and prescribed acyclovir to treat.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant referring to a patient of unknown age and gender. On 30-APR-2015, the patient was vaccinated for prophylaxis with a dose of ROTATEQ oral, lot # K011663, (expiration date, dose and site of administrations were not reported) that was exposed to temperatures outside of the recommended range during 40 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all the follow ups requested to complete the case were received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant concerning a patient of unknown age and gender. On 14-APR-2015 the patient was vaccinated with GARDASIL lot # K006960 (expiration date, dose, route and site of administration were not reported) that was exposed to temperature outside of the recommended range for 12 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected at follow ups requested to complete the case were received
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of age and gender unknown. No concurrent or historical condition was reported. On 01-JUL-2015 the patient was vaccinated with an improperly stored dose of VAQTA, dose, route, frequency, lot number and anatomical location were unknown, and on the same date the patient was also vaccinated with an improperly stored dose of GARDASIL dose, route, frequency, lot number and anatomical location were unknown. No adverse event was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant referring to a patient of unknown age and gender. On 01-MAY-2015, the patient was vaccinated with a dose of ROTATEQ oral, lot # K011663 (expiration date, dose and site of administrations were not reported) that was exposed to temperatures outside of the recommended range during 46 hours. No adverse effects shad been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all the follow ups requested to complete the case were received.
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. No information on concurrent conditions and medical history were not reported. Approximately in July 2015 (one of the date of 13-JUL-2015, 14-JUL-2015 and 15-JUL-2015), the patients were vaccinated with improperly stored GARDASIL (unknown strength and dose) Lot # K006690 with expiry date of 19-FEB-2017 and lot # K004205 with expiry date of 12-JAN-2017. Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from SPMSD (case report # DE-1577272925-E2015-07393) on 23-JUL-2015. Case of medication error was received from a physician on 23-Jun-2015. Case is medically confirmed. A 6-year-old female patient received two doses of GARDASIL (lot-nos. not reported) on unspecified dates in 2001. The patient was vaccinated. The vaccinations were only documented handwritten (no batch label in vaccination documentation). No information regarding an adverse event was given at the time of this report.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant concerning a patient of unknown age and gender. On 17-APR-2015 the patient was vaccinated with GARDASIL lot # K006960 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all follow ups requested to complete the case were received.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse referring to an unspecified number of patients of unknown ages and genders. Concurrent conditions and medical history were not provided. The nurse stated that on an unspecified dates, "about 250" patients received doses of improperly stored vaccines, within them VAQTA injection (dose, route, lot number and expiration date not provided). There was no concomitant medication described. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse referring to an unspecified number of patients of unknown ages and genders. Concurrent conditions and medical history were not provided. The nurse stated that on an unspecified dates, "about 250" patients received doses of improperly stored vaccines, within them RECOMBIVAX HB injection (dose, route, lot number, expiration date and thimerosal content not provided). There was no concomitant medication described. No adverse effect reported. 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 initial spontaneous report was received from a nurse referring to an unspecified number of patients of unknown ages and genders. Concurrent conditions and medical history were not provided. The nurse stated that on an unspecified dates, "about 250" patients received doses of improperly stored vaccines, within them GARDASIL injection (dose, route, lot number and expiration date not provided). There was no concomitant medication described. No adverse effect reported. This is one of several reports received from the same reporter. Additional information ha been requested,
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and genders. Concurrent conditions and medical history were not provided. The nurse stated that on an unspecified dates, "about 250" patients received doses of improperly stored vaccines, within them GARDASIL 9 injection (dose, route, lot number and expiration date not provided). There was no concomitant medication described. No adverse effect reported. 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 Medical Assistant refers to an adult patient of unknown gender who on 22-APR-2015, was vaccinated with a dose of GARDASIL (lot # K006960, expiration date: not reported) which was exposed to 47 degrees C for 15 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an adult patient of unknown gender who on 22-APR-2015, was vaccinated with a dose of GARDASIL (lot # K006960, expiration date: not reported) which was exposed to 47 degree C for 15 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse referring to an unspecified number of patients of unknown ages and genders. Concurrent conditions and medical history were not provided. The nurse stated that on an unspecified dates, "about 250" patients received doses of improperly stored vaccine, within them ROTATEQ oral liquid (dose, lot number and expiration date not provided). There was no concomitant medication described. No adverse effect 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 has been received from a physician referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 30-JUN-2015 the patient was vaccinated the patient was vaccinated with an improperly stored dose of ROTATEQ, oral; dose, route, Lot number and frequency unknown. No adverse event was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients (demographics unknown). On unspecified dates since 29-JUN-2015, the patients were vaccinated with doses of improperly stored, oral ROTATEQ (dose and lot# not provided). No adverse effects were reported. This is one of several reports received from the same source. 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 medical assistant concerning an unspecified number of patients (demographics unknown). On unspecified dates since 29-JUN-2015, the patients were vaccinated with doses of improperly stored GARDASIL (dose, route and lot# not provided). No adverse effects were reported. This is one of several reports received from the same source. 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 medical assistant concerning an unspecified number of patients (demographics unknown). On unspecified dates since 29-JUN-2015, the patients were vaccinated with doses of improperly stored VAQTA (dose, route and lot# not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old patient of unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 05-JUN-2015 the patient was vaccinated with an improperly stored dose of MMR II lot # K014833, expiration date 14-SEP-2016, (dose, dose number, route, albumin status and anatomical location were unspecified). No adverse effects reported. Concomitant therapies were not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old patient of unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 18-MAY-2015 the patient was vaccinated with an improperly stored dose of MMR II lot # K014833, expiration date 14-SEP-2016 (dose, dose number, route, albumin status and anatomical location were unspecified). Concomitant therapies were not reported. On 25-JUN-2015, the patient was revaccinated with an unspecified lot of MMR II (dose, dose number, albumin status, lot number, route and anatomical location were unspecified). No adverse effects reported. Additional information has been requested.