chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.29
Sex: M
Vaccine: DTAP, FLU3, HEPA, VARCEL
Symptoms: Body temperature increased, Irritability, Laboratory test normal, Lymphocyte percentage, Neutrophil percentage decreased
Clinical narrative: Oral temperature recorded at 103.5 at home on repeated measures.  Irritability.
Age: 1.29
Sex: M
Vaccine: DTAP, FLU3, HEPA, VARCEL
Symptoms: White blood cell count decreased
Clinical narrative: Oral temperature recorded at 103.5 at home on repeated measures.  Irritability.
Age: 38.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Fever, muscle pain, erythema in area of injection.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Headache, Influenza virus test negative, Oropharyngeal pain, Sneezing
Clinical narrative: Sore throat, headache, sneezing, severe upper respiratory that worsened over the next 24-30 hours; patient is 30 weeks pregnant.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Streptococcus test negative, Upper respiratory tract infection
Clinical narrative: Sore throat, headache, sneezing, severe upper respiratory that worsened over the next 24-30 hours; patient is 30 weeks pregnant.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Swelling at injection site, hives that began spreading and eventually covered full body, took antihistamines and went to urgent care where they prescribed a steroid pack to get rid of hives.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Dental caries, Gingival bleeding, Tooth discolouration, Tooth fracture, Toothache
Clinical narrative: Teeth started hurting, a few months later teeth started graying and gums started to bleed. The facility fixed what they could and the teeth still decay around the repairs.  I now have 8 teeth thats gray or black and some chipped or broken. It is spreading from tooth to tooth even though I brush and rinse with mouth was regularly.  The decay is progressing faster than normal and painful.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Flushing, Local swelling
Clinical narrative: I had a little arm swelling and turned bright red for a couple of hours,Trunk, arms, and head were bright red. Only turned red, for two to three hours. Took half a Benadryl when I got home. No itching/no hives, just red.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Intense pain when moving arm for 18 days after immunization that continues today. Hurts to lift arm in any direction.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Influenza A virus test negative, Influenza B virus test, Laboratory test normal, Pain
Clinical narrative: PATIENT NOTICED BODY ACHES THEN PROGRESSED TO CHILLS AND FEVER OF 101, TESTED NEGATIVE FOR FLU 11/11/2013, TREATED WITH TYLENOL AND IBU AS NEEDED.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: PATIENT NOTICED BODY ACHES THEN PROGRESSED TO CHILLS AND FEVER OF 101, TESTED NEGATIVE FOR FLU 11/11/2013, TREATED WITH TYLENOL AND IBU AS NEEDED.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Alopecia, Anaemia, Anxiety, Back pain, Depression
Clinical narrative: Anemia, IBD, anxiety attacks, depression, back pain, hair loss, insomnia, racing heart, sore throat, sweats, fatigue, swollen nodes, yeast infection in breasts, headaches.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Fatigue, Fungal infection, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Anemia, IBD, anxiety attacks, depression, back pain, hair loss, insomnia, racing heart, sore throat, sweats, fatigue, swollen nodes, yeast infection in breasts, headaches.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Irritable bowel syndrome, Lymphadenopathy, Oropharyngeal pain, Palpitations
Clinical narrative: Anemia, IBD, anxiety attacks, depression, back pain, hair loss, insomnia, racing heart, sore throat, sweats, fatigue, swollen nodes, yeast infection in breasts, headaches.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Injection site inflammation, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Severe tingling and shooting pain when the injection was given.  Continued shoulder pain increasing in severity over the next few days. On 11/11/2013 went to my personal physician.  Shoulder was x-rayed.  It was determined that the shot was given high and into the shoulder joint. Am now on a course of steroids to attempt to relieve the inflammation.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray limb abnormal
Clinical narrative: Severe tingling and shooting pain when the injection was given.  Continued shoulder pain increasing in severity over the next few days. On 11/11/2013 went to my personal physician.  Shoulder was x-rayed.  It was determined that the shot was given high and into the shoulder joint. Am now on a course of steroids to attempt to relieve the inflammation.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe tingling and shooting pain when the injection was given.  Continued shoulder pain increasing in severity over the next few days. On 11/11/2013 went to my personal physician.  Shoulder was x-rayed.  It was determined that the shot was given high and into the shoulder joint. Am now on a course of steroids to attempt to relieve the inflammation.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Paraesthesia, X-ray
Clinical narrative: Pt reported weskness and tingling in Right arm and leg--stated 1 week after vaccine and continued for 2 weeks. MD to rule out pinched nerve.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic shock, Cough, Dysphonia, Respiratory failure
Clinical narrative: Started coughing and horse voice 30 minutes after vaccination, taken to emergency room in severe respiratory failure due to anaphylactic shock from flu vaccine.
Age: 0.34
Sex: F
Vaccine: DTP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Diarrhoea, Vomiting projectile
Clinical narrative: Projectile vomiting and diarrhea until 10/30/13 at 12:00 PM.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Severe shoulder pain whenever I lift arm. Pain at site of flu shot and around shoulder joint.  Pain shoots down arms to elbow at time and in hand.
Age: 1.01
Sex: M
Vaccine: DTAP, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Allergy test positive, Aphasia, Asthma, Autism, Blood test
Clinical narrative: My son was a healthy happy twin who met all his milestones early or on time. After receiving the HEP A, DTaP, Influenza, MMR, Varicella, and Pneumococcal vaccines at his 12 month well baby visit my son soon became ill with a fever and rash all over his body. With in the next few weeks he lost all of his speech, lost eye contact and my happy and outgoing baby became reverted and wanted to be by himself. By 18 months my son was diagnosed with autism, speech delay, and sensory processing disorder. With in months after this adverse reaction he also started getting food allergies. He is allergic to wheat, peanuts, has asthma, eczema and has gastric intestional problems along with sleeping disorders.  My son has received ABA, ST, and OT therapies.
Age: 1.01
Sex: M
Vaccine: DTAP, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Coeliac disease, Decreased eye contact, Eczema, Food allergy, Gastrointestinal disorder
Clinical narrative: My son was a healthy happy twin who met all his milestones early or on time. After receiving the HEP A, DTaP, Influenza, MMR, Varicella, and Pneumococcal vaccines at his 12 month well baby visit my son soon became ill with a fever and rash all over his body. With in the next few weeks he lost all of his speech, lost eye contact and my happy and outgoing baby became reverted and wanted to be by himself. By 18 months my son was diagnosed with autism, speech delay, and sensory processing disorder. With in months after this adverse reaction he also started getting food allergies. He is allergic to wheat, peanuts, has asthma, eczema and has gastric intestional problems along with sleeping disorders.  My son has received ABA, ST, and OT therapies.
Age: 1.01
Sex: M
Vaccine: DTAP, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Regressive behaviour, Sensory disturbance, Skin test
Clinical narrative: My son was a healthy happy twin who met all his milestones early or on time. After receiving the HEP A, DTaP, Influenza, MMR, Varicella, and Pneumococcal vaccines at his 12 month well baby visit my son soon became ill with a fever and rash all over his body. With in the next few weeks he lost all of his speech, lost eye contact and my happy and outgoing baby became reverted and wanted to be by himself. By 18 months my son was diagnosed with autism, speech delay, and sensory processing disorder. With in months after this adverse reaction he also started getting food allergies. He is allergic to wheat, peanuts, has asthma, eczema and has gastric intestional problems along with sleeping disorders.  My son has received ABA, ST, and OT therapies.
Age: 1.01
Sex: M
Vaccine: DTAP, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Sleep disorder, Social avoidant behaviour, Speech disorder developmental
Clinical narrative: My son was a healthy happy twin who met all his milestones early or on time. After receiving the HEP A, DTaP, Influenza, MMR, Varicella, and Pneumococcal vaccines at his 12 month well baby visit my son soon became ill with a fever and rash all over his body. With in the next few weeks he lost all of his speech, lost eye contact and my happy and outgoing baby became reverted and wanted to be by himself. By 18 months my son was diagnosed with autism, speech delay, and sensory processing disorder. With in months after this adverse reaction he also started getting food allergies. He is allergic to wheat, peanuts, has asthma, eczema and has gastric intestional problems along with sleeping disorders.  My son has received ABA, ST, and OT therapies.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Dyspnoea, Fatigue
Clinical narrative: Case number PHEH2013US022847 is a combined initial and follow-up spontaneous report received from a consumer on 28 Oct 2013 and 04 Nov 2013 respectively. This report refers to a 36-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly on 15 Oct 2013. It was reported that on 15 Oct 2013, beginning night after vaccination, she experienced achy joints, muscle stiffness, chills, sweats, weakness, fatigue, shortness of breath and nausea. The outcome of the event was reported as condition unchanged. The seriousness and causality were not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Musculoskeletal stiffness, Nausea
Clinical narrative: Case number PHEH2013US022847 is a combined initial and follow-up spontaneous report received from a consumer on 28 Oct 2013 and 04 Nov 2013 respectively. This report refers to a 36-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly on 15 Oct 2013. It was reported that on 15 Oct 2013, beginning night after vaccination, she experienced achy joints, muscle stiffness, chills, sweats, weakness, fatigue, shortness of breath and nausea. The outcome of the event was reported as condition unchanged. The seriousness and causality were not reported.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHEH2013US022764 is an initial spontaneous report from the consumer received on 28 Oct 2013. This report refers to a 69-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 17 Oct 2013. Three days after vaccination she developed a severe form of hives behind her ears, both hands and scalp. The patient was unsure whether the events related to FLUVIRIN vaccine or not. She received methylprednisolone, but it did not do anything with the events. She visited the urgent care center on 27 Oct 2013 and received 8 mg shot of dexamethasone. The patient felt better. Later that night hives reappeared and the severity was unchanged. It was reported that the patient could not even make a fist. The seriousness and causality were not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Neuritis, Pain in extremity
Clinical narrative: Case number PHEH2013US022842 is an initial spontaneous report received from a nurse on 29 Oct 2013: This report refers to a 48-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) 0.5 ml intramuscularly on an undetermined date in the first week of Oct 2012. On an unknown date after vaccination, she experienced pain (arm) that lasted several months. She ended up seeking medical treatment because of the pain and difficulty in range of motion. Her physician said it was inflammation of the nerves and put her on anti-inflammatory. The reporter stated that even now, there were times when she had a quick reaction (like if something was falling and she went to reach for it) her arm hurt. She would not get an injection in the deltoid because of this. Final outcome of the events was unknown. No further information about causality and seriousness was reported.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac monitoring normal, Chest X-ray normal, Fatigue, Hypotension, Muscular weakness
Clinical narrative: Patient with fever, (R) lower extremity weakness, fatigue - hypotension, tachycardia, in ER received aggressive IV fluid hydration IV abx and change in dose of blood pressure meds.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Tachycardia, White blood cell count increased
Clinical narrative: Patient with fever, (R) lower extremity weakness, fatigue - hypotension, tachycardia, in ER received aggressive IV fluid hydration IV abx and change in dose of blood pressure meds.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Epstein-Barr virus antigen positive, Eyelid oedema, Flank pain, Liver function test abnormal, Lymphocyte count increased
Clinical narrative: This medically-confirmed spontaneous report (initial receipt 11-Oct-2013) involves a female patient. On an unreported date, the patient received an influenza virus vaccine (batch and manufacturer not reported). On the same day the patient received GARDASIL. 24 hours after receiving the vaccines, the patient experienced elevated temperature, fever, flank pain and eyelid swelling (eyelids bilaterally swollen). The fever resolved within 72 hours, however the eyelid swelling was still present when patient was last reviewed, but there was no redness/itching. Laboratory work showed mono-like syndrome (EBV+), no proteinuria, renal function normal, elevated LFTs (liver function tests) and other lymphocytes. Outcome was not reported.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Mononucleosis syndrome, Protein urine absent, Pyrexia, Renal function test normal
Clinical narrative: This medically-confirmed spontaneous report (initial receipt 11-Oct-2013) involves a female patient. On an unreported date, the patient received an influenza virus vaccine (batch and manufacturer not reported). On the same day the patient received GARDASIL. 24 hours after receiving the vaccines, the patient experienced elevated temperature, fever, flank pain and eyelid swelling (eyelids bilaterally swollen). The fever resolved within 72 hours, however the eyelid swelling was still present when patient was last reviewed, but there was no redness/itching. Laboratory work showed mono-like syndrome (EBV+), no proteinuria, renal function normal, elevated LFTs (liver function tests) and other lymphocytes. Outcome was not reported.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Redness, soreness, inflammed area 2-3 inches in diameter at site of injection, warm to the touch.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: C/O muscle pain started after 5 days below injection site - started with (+) swelling subsided localized pain 10/30/13 (+) fatigue.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Fever started 4 hrs after vaccine administration and pain followed 30 min. later at 7pm. Mother took pt to ER at 8:30pm with arm and neck pain. Back pain started while in ER. ER gave Ibuprofen. Left ER with only mild arm pain at injection site. Next morning only mild arm pain persisted.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever started 4 hrs after vaccine administration and pain followed 30 min. later at 7pm. Mother took pt to ER at 8:30pm with arm and neck pain. Back pain started while in ER. ER gave Ibuprofen. Left ER with only mild arm pain at injection site. Next morning only mild arm pain persisted.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye pain, Eye swelling, Ophthalmic herpes zoster, Rash
Clinical narrative: Developed shingles in and around left eye, went to Primary Doctor; then went to eye doctor. Shingles is in the left eye; no signs of shingles prior to flu shot; Taking Acyclovir tablets and Prednisolone acetate ophthalmic suspension; terrible eye pain; terrible eye swelling; extreme redness and shingles rash; No symptoms of illness prior to flu shot; shingles appeared in less than 12 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative concerning a female patient of unknown age. On an unknown date in 2007, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose unspecified), subcutaneously. No concomitant therapy was reported. Approximately on an unknown date in October 2013 (reproted as within the last month), the patient developed shingles on their face. The patient sought medical attention (doctor's visit). It was unspecified if any treatment was provided of if any lab tests were performed. The outcome of shingles on their face was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness around the area the day after the vaccine was administered.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. Over approximately the last 2 months, approximately since August 2013, on unspecified dates the patients were received improperly stored VARIVAX (Merck) injection subcutaneously (dose, frequency unknown, lot # H021799 was not valid for VARIVAX (Merck), expiration date 07-DEC-2013 that was exposed to "23 Fahrenheit since it was received in the facility about 2 months ago". No know adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Pt didn't seem to have reaction until next morning. Starting with light red slightly itchy rash. Saturday night applied Caladryl clear. Itching cleared up. Sunday 11/10/13 morning rash now raised, very itchy, warm to touch. "Lump" is approximately 3 1/2" x 2". Monday 11/11/13 pt woke up at 5:30 AM rash appeared better. By 3:30 AM itching is worse. Dr. applied Caladryl clear. AM, itching much worse. Caladryl clear effects aren't seeming last as long. Pt reported reaction to Dr.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient with percocet allergy and hypertension. On 25-OCT-2013, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, (lot number, expiry date and route was unknown), subcutaneous in the left arm. Concomitant medications included unspecified blood pressure medication. On 29-OCT-2013, (reported as today) the patient experienced bump underneath her left arm where her bra line comes across almost like a mosquito bite. The pharmacist stated that she does not think it was a lesion nor a beginning of a rash. The outcome of the event was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Arm swollen, red, warm to touch.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer of unknown age and gender. Patient's current conditions and medical history were not reported. On an unknown date in 2011, the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (Lot number, expiry date, route and dose were not reported). Concomitant medications were not reported. On an unknown date in 2013, the patient had shingles. The outcome of shingles was unknown. The causality was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Swelling, redness, local hot feeling.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 23 year old female patient with no pertinent medical history and no drug reactions or allergies. On 25-SEP-2013, the patient was vaccinated with 0.5 milliliter (ml) of MMR II (lot number and expiry date were reported as J004201 and 12-APR-2015 respectively), subcutaneously. Concomitant therapy included desogestrel, MARVELON. Approximately on an unknown date in September 2013, the patient experienced a 2 inch X 1.5 inch diameter of red area on left dorsal of the arm at the injection site and the area was warm to the touch. The patient sought medical attention. The patient came back 2 days after vaccination to see the nurse. No lab tests were performed. The nurse recommended ibuprofen and icing the area 30 minutes twice a day and if it got worse to seek medical attention especially if there was a fever or rash. The patient came back to see the nurse on 30-SEP-2013 and the area was better and it took 2 weeks after vaccination for the reaction to resolve. Approximately on an unknown date in October 2013, the patient recovered from the events. The relatedness for the events was unknown for MMR II. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Mobility decreased, Skin warm, Swelling
Clinical narrative: Swelling, redness, hot, loss of mobility in arm.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a nurse refers to a 20 years old female patient. The patient concurrent conditions included Crohn's disease and drug reactions/allergies to aspirin, KEFLEX, ZITHROMAX. On 20-SEP-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # J006082, exp. date 12-APR-2014, 0.5 ml, intramuscular, site of administration not reported) for prevention of pneumonia. On an unknown date in 2013, after injection of PNEUMOVAX 23, the patient experienced injection site cellulitis. The patient saw physician. The patient was treated with AUGMENTIN and CHLORTRIMETRON. The outcome of injection site cellulitis was reported as recovered/resolved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Erythema
Clinical narrative: Localized redness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Rash, Staphylococcal infection
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient. The patient had no drug allergies, no known health conditions. On 18-OCT-2013, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, (lot number J004268, expiry date 12-JUL-2014), subcutaneous. No concomitant medications were reported. On an unknown date in OCT-2013, the patient developed rash at the injection site and a rash on one thigh. The patient visited her physician who thought that the rashes were staph infections. The patient was prescribed an unspecified antibiotic as a treatment. The physician told the patient that the rash on thigh (which looked like 4 to 5 pimples) was shingles and was a residual effect from ZOSTAVAX. The physician decided not to treat the shingles on the thigh. The outcome of the events were unknown. The patient sought medical attention. The pharmacist mentioned that approximately 50 percent of her patients who receive ZOSTAVAX develops rash at the injection site. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker who placed the nurse on the phone refers to an unknown number of unspecified gender patients of unknown age. The unknown number of patients might had received a dose of improperly stored PEDVAX HIB, (lot #, dose, route and strength not reported) for vaccination since 01-OCT-2013 to present (22-OCT-2013). No adverse event reported. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue, Product reconstitution issue
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient missed a dose of ZOSTAVAX (lot #, expiry not reported) because the diluent was under filled. No adverse event was reported. PQC reported because of the under fill. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report refers to a 10 year old patient. On 08-APR-2013 patient received MMR II. On 20-APR-2013 the patient was vaccinated with VARIVAX (Merck) (Inappropriate schedule of vaccine). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a community nursing service refers to a patient of unknown age and gender. No information regarding the patient's medical history was provided. On an unknown date the patient was vaccinated with PROQUAD with valid lot # J004322 (expiry date 17-OCT-214). Total dosage was not reported. No concomitant medication was reported. It was reported that the vaccine had been stored improperly. No outcome was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No medical history provided. On 23-OCT-2013 the patient was inadvertently vaccinated with VARIVAX (Merck) (0.65 ml, subcutaneous) instead of ZOSTAVAX. No concomitant medications were provided. No adverse effects were reported. No outcome provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site reaction, Underdose
Clinical narrative: This spontaneous report as received from a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, route and site of administration were not reported). When he received a ZOSTAVAX, the vaccine had sprayed out of his arm and had gotten onto his skin. The patient felt dizzy after receiving ZOSTAVAX and had some unspecified injection-site reaction (date unknown). The outcome of adverse events was not reported. The relatedness between vaccination with ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 04-NOV-2013, the patient was vaccinated with an expired dose of oral ROTATEQ (lot number and expiry date were reported as H010063 and 02-NOV-2013 respectively, dose and route unspecified). The nurse did not specify which dose in the series this was for the patient. No concomitant therapy was reported. No adverse symptoms were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Sensation of heaviness
Clinical narrative: Heaviness and numbness and pain on left arm mediating down.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 09-JUL-2013 the patient was vaccinated with the first dose of oral ROTATEQ, 2 ml, orally. On 30-OCT-2013, the patient was vaccinated with a dose of expired oral ROTATEQ, 2 ml, orally. The oral ROTATEQ with lot number 0577AE had expired on 26-OCT-2013. No adverse effects were reported. This is one of two reports received from the same source (other case ID: 1311USA000165). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient experienced redness at the injection site after the vaccination. The patient sought medical attention (called pharmacy). It was unspecified if any treatment was given or if any lab tests were performed. The outcome of redness at the injection site was unknown. The relatedness for redness at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dry skin, Rash pruritic
Clinical narrative: Patient reported dry, itchy rash around ankles - started 2 days after vaccination; worsening for 8 days.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administration error, Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a female consumer who is employed at a physician's office. It was reported that a ZOSTAVAX was reconstituted in preparation for a patient who changed their mind and the vial was placed in the refrigerator for an unspecified amount of time. The unused vaccine was "later in the day" offered to the medical staff and was administered to the patient. It was noted that no adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to 4 patients of unknown age and gender. Pharmacist stated that the ZOSTAVAX has been a very well tolerated vaccination. On an unknown date 4 patients were vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and dose were not reported), subcutaneously. On an unknown date, the 4 patients either experienced tingling sensation, sore arm or an itchy sensation. The pharmacist also stated that in about 300 patients who had been administered ZOSTAVAX at his pharmacy, he has had only about 4 patients who have experienced either a sore arm, a tingling sensation, or an itchy sensation. The patients sought medical attention (saw the pharmacist). No treatment was given. On an unknown date, the events of tingling sensation, sore arm and itchy sensation were recovered/resolved. Additional information has been requested.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Laboratory test normal, Tremor, Wheezing
Clinical narrative: On 11/1/13 pt felt tremulous, wheezing, SOB presented at ER approximately 30 min after vaccination. Pt had hx of wheezing for previous 2 wks. Labs normal; no fever; no chills. Pt asymptomatic on release.
Age: 13.0
Sex: F
Vaccine: FLUN4, HPV2
Symptoms: Papule, Pruritus
Clinical narrative: Fine, pruritic papules started 24h after vaccines nearly resolved 48 hours after vaccine.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker who placed the nurse on the phone refers to an unknown number of unspecified gender patients of unknown age. The unknown number of patients might have received a dose of improperly stored GARDASIL, (lot#, dose, route and strength not reported) since 01-OCT-2013 to present (22-OCT-2013). No adverse event reported. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a patient of unknown age. The patient's current condition included shingles. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) while having an active case of shingles. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as CMA - certified medical assistant) refers to a patient of unknown age and gender. On 01-AUG-2012 the patient was vaccinated with first dose of RECOMBIVAX HB 10 mcg/ml, 1 ml, intramuscular, site of administration not reported). On 30-OCT-2013 the patient was vaccinated with second dose of RECOMBIVAX HB. No adverse events reported. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Infection, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt. received FLUZONE on 11-6-2013. Left arm was rash, hot, swelling at site of injection.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Local swelling, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 57 year old female patient with latex allergy. No medical history or drug reactions were reported. On 28-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported). Concomitant medication included SPORANOX. On 29-OCT-2013, the patient arm was arm was swollen, sore and warm to touch after receiving ZOSTAVAX. The patient stated she had a swollen area about the size of a golf ball at the injection site. No treatment was given. Patient sought medical attention-contacted physician. No laboratory tests were performed. The outcome of swollen area about the size of a golf ball at the injection site, arm was swollen, sore and warm to touch was reported as recovering. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer (who is also company representative) refers to his 55 year old female wife. The patient has erythromycin allergy, betadine allergy and sulfa allergy. On 25-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was unknown). Concomitant therapies included HYZAAR and estrogens, conjugated, PREMPRO. On 27-OCT-2013, the patient experienced a significant raised, painful and red area surrounding the injection site after receiving ZOSTAVAX that measured about two inches in diameter. The patient also used BENADRYL cream on the area but has not noticed any improvement yet. The outcome of the events were reported as not recovered. The patient did not seek medical attention. 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 other refers to a patient of unknown age. On 11-FEB-2013 the patient was vaccinated with a first dose of GARDASIL 120 Y, dose, indication, site and route of administration not reported). It was reported that (on 01-NOV-2013) the patient would now like to receive the second dose of GARDASIL. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 21-OCt-2013 the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU (lot # H012519, expiration date 09-OCT-2013) (dose and route were not reported). Concomitant medications were not reported. No adverse symptoms reported. This case is linked to case 1310USA009900 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a female patient. On 14-OCT-2013 the patient was vaccinated with ZOSTAVAX (Lot # J002865, expiration 07-JUN-2014), 0.65 ml subcutaneous. The patient came back to the facility "a couple of days later" to report she had experienced a rash at the injection site. The pharmacist reported "a few days after that" patient returned again to the facility and she stated the rash was "getting better." No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Information was received from a female consumer. On 24-OCT-2013 the patient was vaccinated with ZOSTAVAX in her right arm. The patient stated that after she was given the ZOSTAVAX vaccine, she has been experiencing "three red bumps in her upper left joint." The patient felt it may be shingles. The patient reported she had shingles previously in OCT2012. No further information was reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Information was received from a pharmacist concerning a patient of unknown age. On an unknown date in the past, the patient was vaccinated with PNEUMOVAX 23. It was reported that the patient had an unspecified anaphylactic reaction after receiving PNEUMOVAX 23 in the past. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-JUN-2013 the patient was vaccinated with the first dose of oral ROTATEQ, 2 ml, orally. On 29-OCT-2013, the patient was vaccinated with a dose of expired oral ROTATEQ, 2 ml, orally. The oral ROTATEQ with lot number 0577AE had expired on 26-OCT-2013. No adverse effects were reported. This is one of two reports received from the same source (other case ID: 1311USA003798). Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a third party claims administrator regarding a case in litigation concerning a female consumer. On 23OCT13, the patient had a flu vaccine (non MSD) and a PNEUMOVAX vaccine lot # J004332 expiration date 26SEP14 and had an adverse reaction (unspecified). The reporter reported it was unclear which vaccine the patient had the adverse reaction to. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a pediatric 6 weeks old patient of unknown gender. On 22-OCT-2013 the patient received a dose of RECOMBIVAX HB (lot number, route and dose were not reported), and a dose of PEDIARIX (lot number, route and dose were not reported, during the same office visit. Concomitant medication were not reported. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient, who on 21OCT2013 was vaccinated with the PNEUMOVAX and a flu vaccine (Manufacturer not specified). The lot # for PNEUMOVAX was H016283 with an expiration date of 21FEB2014. The patient experienced an adverse reaction (not further specified). It is unknown at this time which vaccine the patient had the reaction to. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that on 23-JAN-2013 the patient received the first dose of PNEUMOVAX 23 (lot number, dose, indication and route were not reported), and another dose of PNEUMOVAX 23 (lot number, dose, indication and route were not reported), on 22-OCT-2013. Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from pharmacist (also reported as a physician) regarding a patient (demographics unknown), who on 15-OCT-2013, was vaccinated with ZOSTAVAX lot # J006155. It was reported that the patient received ZOSTAVAX which had been exposed to 26 C for 24 hours. No adverse symptoms reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 year old male patient with amoxicillin allergy. The patient has no pertinent medical history. On 22-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot # h016238, expiration date 11-APR-2015) 0.5 ml, intramuscular for immunization. There were no concomitant medications. Nurse reported that a patient came in her office for his second dose of GARDASIL, but she decided not to administer it. The patient stated that in 2013, after receiving his first dose, the injections site swelled to "the size of a soft ball" and was painful. The patient stated that he took over the counter Benadryl and the swelling resolved in an unspecified amount of time. The outcome of injection site swelled and injection site painful was reported as recovered/resolved on an unspecified date in 2013. No lab diagnostic studies were performed. The relationship between GARDASIL and the events was not reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 36 year old female patient. On an unknown date, (also reported as "in her twenties") the patient was vaccinated with VARIVAX (Merck) both doses for chicken pox prevention. The physician stated that the on unspecified date, patient had her blood drawn recently and "titer for varicella came back negative". The physician stated that the patient was seeking to be pregnant and was advised to have titer drawn. The outcome of titer for varicella come back negative was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 0.09
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccines given too soon, at only 5 ws of age. Mother was notified.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Pruritus
Clinical narrative: Vaccine was administered at approximately 12:20 PM on 11/10/13. Patient complained of itching at 12:22 PM. An approximately 2"x2" red, irritated area was at the injection site. Patient was observed for 30 minutes, area of redness lessened to a 1"x1" area. Per patient itching went away. Patient was referred to a doctor immediately.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Hives and rash for 6 weeks. Saw PCP - steroid shot and Dose pak, had to stop taking BENADRYL PRN.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Insomnia, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Patient called pharmacy stated his arm was swollen and sore. He was unable to sleep on it and he stated it was warm to the touch he was going to call his primary physician.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Patient received Flu vaccine injection on 11/8/13. She call drug store to let us know she was sick all weekend and Monday. Feeling achy, feverish, tired, slept most of 2 days. As of Monday 11/11/13 her doctor has not seen her!
Age: 0.54
Sex: F
Vaccine: DTAP, FLU3, HIBV, IPV, PNC13
Symptoms: Drug administered to patient of inappropriate age, Pyrexia, Somnolence
Clinical narrative: Vaccine influenza given to child that is intended for ages 3 years and up. Child had a 102 degree fever and drowsy, reduced on its own. No treatment.
Age: 1.42
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Decreased appetite, Drug administered to patient of inappropriate age, Somnolence
Clinical narrative: Influenza vaccine given to child that is intended for ages 3 years and up. Child had a decreased appetite and drowsy, resolved on its own. No treatment.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site rash
Clinical narrative: Pt's skin formed a bump at injection site immediately. After injection on 8/4/13 about 1 week ago 11/2/13 that bump which is still there started to hurt. In the last few days pain has subsided some what.
Age: 13.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Axillary pain, Oedema
Clinical narrative: Developed (B) axillary pain, (L) SS > (R) ; and (L) axillary edema that started within 24 hours of vaccine.
Age: 90.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: 90 yr old female developed redness from DTAP injection site 12" x 12" down (L) arm from deltoid - appeared like scalded skin, non tender with some swelling - placed on KEFLEX for cellulitis with f/u on 11/15/13.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red - puffy 5 to 6 inch diameter hot to touch, tender, as of yet still getting bigger (spreading).
Age: 0.27
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Baby got vaccine 3 days ago and has been screaming for 3 days at the top of her lungs. The screaming has gotten worse and worse.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Inflammation, Pain in extremity
Clinical narrative: Inflamed and red area below the vaccination site. Patient complained of pain in her limbs and a headache.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Feeling hot, Flushing, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient reported feeling hot/flushed, numbness and tingling in the thighs and face and numbness in the arm. No trouble breathing, injection site looked completely normal. Patient took a clonazepam tablet to calm down.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Eyelid function disorder, Lacrimation increased, Nuclear magnetic resonance imaging brain normal, Pain, VIIth nerve paralysis
Clinical narrative: Right side of mouth drooping, unable to close right eye completely. Right eye is watery. Symptoms began 10-31-13. Saw office physician 11-6-13 when e c/o mild pain behind right ear. He was unable to wrinkle his forehead on the right side. Pt c/o dropping things.