chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Syncope
Clinical narrative: At about 11:54 am the patient fainted after receiving vaccines. The patient was transferred to the bed and legs were elevated. Vital signs were done and the MD was called. The patient was monitored or about 20 minutes and given reassurance. After about 30 min. the patient was ambulating without any signs of distress.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Dehydration, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: Fever over 101 degrees, severe chills, multiple incidents of vomiting, dehydration, muscle aches/pain, nasal congestion, newly acquired sinus infection diagnosed at doctor visit 12/15/2014. Initial symptoms treated with ibuprofen, attempts to replenish fluids. Sinus infection treated with prescription nasal spray and 10-day course of antibiotics.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Sinusitis, Vomiting
Clinical narrative: Fever over 101 degrees, severe chills, multiple incidents of vomiting, dehydration, muscle aches/pain, nasal congestion, newly acquired sinus infection diagnosed at doctor visit 12/15/2014. Initial symptoms treated with ibuprofen, attempts to replenish fluids. Sinus infection treated with prescription nasal spray and 10-day course of antibiotics.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Tenderness
Clinical narrative: Shoulder pain and pain radiating down arm.  Tender to touch.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder pain, pain radiating down arm lasting for 3+ wks, not resolving; difficult to lift arm.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ, PPV
Symptoms: Cellulitis, Chills, Culture tissue specimen, Incisional drainage, Injection site pain
Clinical narrative: Patient was hospitalized from 12/10/14-12/13/14 for thyrotoxicosis. Upon discharge on 12/13 she received three vaccinations: MCV4 in the right deltoid, PPSV23 in the left arm sq, and influenza quadrivalent in the right deltoid. Her mother brought her to the ED on 12/15/14 as the patient developed a fever to 102, chills, pain and swelling in the left shoulder. The patient was admitted to the hospital with a diagnosis of cellulitis. She was subsequently taken to the OR to I&D the site. Necrotic tissue was excised and is being cultured. She was initially admitted to the med/surg floor but transferred to ICU post-surgery due to her previous medical condition, where she currently remains. During her previous hospitalization she was initiated on methimazole and propranolol to treat the hyperthyroidism.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ, PPV
Symptoms: Injection site swelling, Intensive care, Pyrexia, Soft tissue necrosis, Thyroxine free increased
Clinical narrative: Patient was hospitalized from 12/10/14-12/13/14 for thyrotoxicosis. Upon discharge on 12/13 she received three vaccinations: MCV4 in the right deltoid, PPSV23 in the left arm sq, and influenza quadrivalent in the right deltoid. Her mother brought her to the ED on 12/15/14 as the patient developed a fever to 102, chills, pain and swelling in the left shoulder. The patient was admitted to the hospital with a diagnosis of cellulitis. She was subsequently taken to the OR to I&D the site. Necrotic tissue was excised and is being cultured. She was initially admitted to the med/surg floor but transferred to ICU post-surgery due to her previous medical condition, where she currently remains. During her previous hospitalization she was initiated on methimazole and propranolol to treat the hyperthyroidism.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ, PPV
Symptoms: Thyroxine increased, White blood cell count increased
Clinical narrative: Patient was hospitalized from 12/10/14-12/13/14 for thyrotoxicosis. Upon discharge on 12/13 she received three vaccinations: MCV4 in the right deltoid, PPSV23 in the left arm sq, and influenza quadrivalent in the right deltoid. Her mother brought her to the ED on 12/15/14 as the patient developed a fever to 102, chills, pain and swelling in the left shoulder. The patient was admitted to the hospital with a diagnosis of cellulitis. She was subsequently taken to the OR to I&D the site. Necrotic tissue was excised and is being cultured. She was initially admitted to the med/surg floor but transferred to ICU post-surgery due to her previous medical condition, where she currently remains. During her previous hospitalization she was initiated on methimazole and propranolol to treat the hyperthyroidism.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder pain, difficult to lift arm, pain radiating down arm to hand.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Incorrect dose administered, Swelling, Wrong drug administered
Clinical narrative: INADVERTENT ADMINISTRATION OF AFLURIA (FLU VACCINE) WHEN PT REQUESTED ZOSTAVAX. PT HAD PREVIOUSLY RECEIVED FLU SHOT APPROX 4 WEEKS PRIOR, NOT GIVE AT PHARMACY. APPROX 20 HOURS LATER, PT NOTED "SWELLING".
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Ache and pain in muscles of right arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site rash, Injection site warmth
Clinical narrative: PATIENT HAD 3 EVENINGS OF CHILLS. AREA WHERE SHE GOT THE SHOT FELT HOT TO TOUCH. THERE WAS ALSO A RASH IN THE AREA THAT RESOLVED SLOWLY OVER A 3 WEEK PERIOD.
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, RV1
Symptoms: Constipation
Clinical narrative: Constipation.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Peripheral swelling, Pruritus
Clinical narrative: Left arm swelled up to twice the size it should have been. Horrid itching, major headache and acute severe pain.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo positional
Clinical narrative: Diagnosed Benign Positional Paroxysmal Vertigo.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Periarthritis
Clinical narrative: I am currently being treated for a frozen shoulder that occurred immediately following what I believe was an incorrectly administered flu shot.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: I did not put shot and pain together, so unsure of date and time of onset. Just know that within a couple of weeks of flu shot, which was administered really really high--almost at top of left shoulder---started having much pain and limited range of motion in high shoulder area. I can't cross arms as if to take a shirt off---raising left arm over head, etc. quite painful.
Age: 1.26
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Lymphadenopathy, Rash, Rash erythematous
Clinical narrative: I (mother of patient) noticed a widespread rash on the back and trunk of patient. The spots are about 1/2" apart and 1/16th" in diameter. They are a light pink/red in color. I also noticed swollen lymph nodes on the left side of her neck.
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHEH2014US024787, is an initial spontaneous report received from a nurse received on 09 Dec 2014. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1411401) intramuscularly on 04 Dec 2014. On the same day, after vaccination, the patient experienced cellulitis around the injection site. The patient consulted physician and was taking antibiotics. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of cellulitis around the injection site was upgraded based on the NVS-IMS list.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug ineffective, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to his/her friend who was a 75 year old female patient who enrolled in ZOSTAVAX Testing program (the reporter was also reported as the patient herself). On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency and route unknown). On unknown dates the patient developed shingles twice after receiving shingles vaccination. The outcome of the event was reported as recovered/resolved with sequelae. The reporter considered the event to be serious due to hospitalization/prolonged. Additional information is not expected as the reporter is not willing of follow up contact.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a certified nurse assistance regarding a 12 year old male (as reported) patient who was administered GARDASIL (lot # J008423) injection intramuscular 0.5ml in right thigh on 23JUN2014. The GARDASIL was involved in a temperature excursion. No adverse event was reported. Please see additional information for other cases reported by same provider. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Gait disturbance, Injection site pain, Insomnia, Musculoskeletal disorder
Clinical narrative: Pain on site of injection that radiate to shoulder and lower arm, sleeplessness, hardly can walk, can't dress, can't hold anything with the arm. Went to MD, only APAP prescribed. Hard to take shower.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain on site of injection that radiate to shoulder and lower arm, sleeplessness, hardly can walk, can't dress, can't hold anything with the arm. Went to MD, only APAP prescribed. Hard to take shower.
Sex: F
Vaccine: HEP
Symptoms: Respiratory rate decreased
Clinical narrative: Parent report decreased respiration following HBV in hospital.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion
Clinical narrative: Contusion.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt still has significant arm pain at injection site. Pt was in for follow-up and mentioned her concern.
Age: 81.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Decreased appetite, Dehydration, Diarrhoea, Fatigue
Clinical narrative: 4 hours after injection - began to have severe vomiting and diarrhea lasting 1-2 hrs. Very painful injection site. Body aches (no headache) intense fatigue, no appetite. In PM T. of 101.4 degrees, chills - no respiratory symptoms. Dehydration. Next day - BRAT diet, low grade fever. Felt "wiped out" x 4 days.
Age: 81.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Pain, Pyrexia, Vomiting
Clinical narrative: 4 hours after injection - began to have severe vomiting and diarrhea lasting 1-2 hrs. Very painful injection site. Body aches (no headache) intense fatigue, no appetite. In PM T. of 101.4 degrees, chills - no respiratory symptoms. Dehydration. Next day - BRAT diet, low grade fever. Felt "wiped out" x 4 days.
Age: 31.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
Clinical narrative: You can observe in the arms that is edematous red and warm to touch.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt describe soreness and pain at injection site. No redness or open sore noted. It has been 1 month since injection.
Age: 1.03
Sex: F
Vaccine: FLU3, HEPA, MMR
Symptoms: Basophil percentage, C-reactive protein normal, Eosinophil percentage, Haematocrit normal, Haemoglobin normal
Clinical narrative: MMR given (R) leg- developed toxic synovitis on same side.
Age: 1.03
Sex: F
Vaccine: FLU3, HEPA, MMR
Symptoms: Monocyte percentage increased, Platelet count normal, Red blood cell sedimentation rate normal, Synovitis, White blood cell count normal
Clinical narrative: MMR given (R) leg- developed toxic synovitis on same side.
Age: 1.03
Sex: F
Vaccine: FLU3, HEPA, MMR
Symptoms: X-ray normal
Clinical narrative: MMR given (R) leg- developed toxic synovitis on same side.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Tdap vaccine given. Pt states left arm swollen, bright red, painful, and felt large knot. States fever x 4 days.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Blood electrolytes normal, Convulsion, Syncope
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 13-year-old male subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline). The subject had none concomitant medication, medical history or past drug therapy. On 3 September 2014, the subject received 1st dose of HAVRIX pediatric (.5 ml, unknown route, right arm). On 3 September 2014, 5 minutes after vaccination with HAVRIX pediatric, the subject experienced episode of syncope followed by seizure. This case was assessed as medically serious by GSK. The subject was kept in the physician's office and his blood pressure was monitored. On 3 September 2014, the events were resolved. Follow-up information received on 08 December 2014 from a nurse: Some VAERS details were updated. The patient's events were witnessed. The events were not preceded by aura or headache and the patient did not lose consciousness, he remembered the event, he did not experienced urine/faecal incontinence. There was no evidence the symptoms may have resulted from withdrawal of alcohol or other psychotropic substances. In the past, the patient did not receive any medication which was known to reduce the seizure threshold. The patient's medical history did not included seizure (febrile seizures and epilepsy), movement disorder, head injury, cerebral palsy, neurological handicap or congenital abnormality, diabetes, renal failure, alcohol or drug abuse or other CNS conditions. The vaccination with HAVRIX pediatric was discontinued.
Age: 1.07
Sex: M
Vaccine: MMR, VARCEL
Symptoms: C-reactive protein, Culture, Red blood cell sedimentation rate, Weight bearing difficulty, X-ray
Clinical narrative: 12/3/14 was seen for difficulty bearing wt. Treated with antibiotics.
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Convulsion, Dyskinesia, Muscle rigidity
Clinical narrative: This spontaneous report was received from a health care worker refers to a male patient of unknown age. On approximately 05-DEC-2014 (reported as last week) the patient was vaccinated with PNEUMOVAX 23 lot # K004483, expiration date: 16-AUG-2015 (strength, route of administration and dose were not reported) simultaneously with a dose of FLUZONE and ADACEL. On approximately 05-DEC-2014 (reported as last week) the patient experienced convulsion, uncontrollable movements and muscle rigidity for about an hour and a half, following the administration of the vaccines. The reporter requested lot check. The outcome of the events was reported as recovered/resolved on unknown date in December 2014. Upon internal review, convulsion was determined to be medically significant. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Anaphylactic reaction
Clinical narrative: is spontaneous report as received from a pharmacist refers to a 58 year old male patient. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown) (route, lot number and expiration date were not reported). On an unknown date, the patient experienced anaphylactic reaction to the unspecified hepatitis B vaccine, reporter stated RECOMBIVAX HB could not be ruled out. The outcome of anaphylactic reaction to an unspecified hepatitis B vaccine was reported as recovered (on an unknown date). Upon internal review the event of anaphylactic reaction to an unspecified hepatitis B vaccine was considered medically significant. Additional information is not expected, because the reporter did not want to be contacted.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm, starting day after flu shot. Continuing.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Throat tightness
Clinical narrative: Vaccine admin at pharmacy appx. 10:40 AM on 12/10/14. Pt went home at appx 10:50 AM, and reports that at appx 1 PM she felt her throat "thickening" and difficulty breathing/swallowing. She went to ER, at approx. 5 PM that evening she came back to the pharmacy and told us what happened, she was treated and feeling better.
Age: 1.44
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles, Injection site warmth
Clinical narrative: Child had redness, edema, heat, and blistering of the skin to right thigh, redness, edema, and heat to the left thigh. Did not report fever, disfigurement or disability.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Dyspnoea, Erythema, Rash, Rash macular, Urticaria
Clinical narrative: Hives, rash, trouble breath, blotchy skin, red circles on face.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse effects reported.
Age: 14.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on abdomen, neck, back, both arms, legs, hands and feet 30 minutes after receiving FLUMIST. At time of visit no hives, back was itchy.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Patient was given PNEUMOVAX vaccination on 8/12/2014 but the vaccination expiration was on 8/10/2014. No adverse event occurred.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Herpes zoster, Liver function test normal
Clinical narrative: Patient states she started to develop shingles on her right side on her back post vaccination. Also, had pain in the liver area.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of ROTATEQ, oral (strength, dose and lot # were not reported). It was reported that the vaccine was not monitored for unspecified period of time and there were no temperature logs available. The reporter was not aware of any adverse experiences at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Rash, Swelling
Clinical narrative: Headache, rash, erythema, swelling, warmth
Age: 49.0
Sex: F
Vaccine: YF
Symptoms: Blister, Induration, Peripheral swelling, Skin warm
Clinical narrative: Arm swelled to size of watermelon. Bubbles and blisters. Hard and hot.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site warmth
Clinical narrative: Left deltoid area red, inflamed, edematous and warm to touch. Started on AUGMENTIN for 10 days.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Asthma, Erythema, Pain in extremity, Skin warm
Clinical narrative: Pain in left arm. Red - hot to touch size of racketball, all beginning of symptoms started within 12 hours - symptoms increased for first three days - triggered asthma - reaction started to decrease after 5 days.
Age: 7.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Crying, Decorticate posture, Loss of consciousness, Tooth injury
Clinical narrative: Pt received DAPTACEL (L) delt and varicella (R) delt cried a little but then calmed walking out with mom and had LOC with ? decorticate posture 10-15 sec. Hit tooth jaw alert/consolable with difficulty.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site urticaria
Clinical narrative: Welts on arm at injection site 100 degree temperature for 24 hrs.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Chest discomfort, Dyspnoea, Erythema, Pruritus, Throat tightness
Clinical narrative: 15:43 Dec 03 2014 Admitted to medical center emergency room with redness, itching, tightness in his throat and heaviness in his chest, with difficulty breathing.
Age: 1.66
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Activities of daily living impaired, Pyrexia
Clinical narrative: Intermittent fever since vaccination; highest 104.5; at times unable to be controlled by tandem ibuprofen/acetaminophen; 2 ER visits, 3 doctor office visits; Secondary infections (11/17) (conjunctivitis/ear infections); 3 weeks of missed daycare; This was the 1st time these vaccines were given together to child. The vaccine schedule for 18 mo is too aggressive; break up the shots!
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error
Clinical narrative: Patient received a BOOSTRIX 12/5/14. Had received an ADACEL 10/12/2010.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Cellulitis
Clinical narrative: Pt was dx with cellulitis on 12/15/14. Pt put on KEFLEX.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Medication error
Clinical narrative: MMR given 8/1/14. Varicella given 8/21/14.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: Pain at site of injection to shoulder (left). 5 red raised bumps.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Ear swelling, Erythema, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Red face with round, splotchy spots, were itchy: red itchy bumps all over back, neck. Ears bright red and swollen. Symptoms began within 2 hours of shots. Mom reports similar reaction with DTaP as baby. BENADRYL 25mgs every 6 hours for 24 hours.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a non-pregnant patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 10-DEC-2014 the patient was vaccinated with a dose of RECOMBIVAX HB (injection, lot # J014855, expiry date 16-APR-2016, 0.5 ml, intramuscular) post not supported temperature excursion. Patient didn't report any adverse effect. This is one of several reports received from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Pt developed significant swelling at injection site on right upper arm. Pt was seen by PCP and cephalexin was prescribed on 12/8/14. (500 mg 1 qid x 10 days)
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a non-pregnant patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 10-DEC-2014 the patient was vaccinated with a dose of RECOMBIVAX HB (injection, lot #J014855, expiry date 16-APR-2016, 0.5 ml, intramuscular) post not supported temperature excursion. Patient didn't report any adverse effect. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Redness, swelling and itching at site of vaccination started 2 days after. Seen by MD 12/8/14 and swelling measured 3 inches in diameter. 12/9/14 patient reports much improvement. Treatment: BENADRYL, Hydroxyzine, CLARITIN.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a adult female patient who received ENGERIX B adult (batch number 3744L, expiry date 17th May 2016. Concomitant products included ENGERIX B adult. On an unknown date, the patient received the 2nd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the drug dose administration interval too short to be related to ENGERIX B adult. Additional information received: A patient inadvertently given her second dose of ENGERIX B 3 weeks after the 1st dose.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema
Clinical narrative: Patient came to pharmacy day after ZOSTAVAX immunization complained of redness around injection site. Counseled patient that sometimes irritation occurs at injection site and to see MD if not better. Patient comes back 11/28/14 four days after immunization and presents two prescriptions for antibiotics and states she was diagnosed with an infection. Asked patient if she had any pain or discomfort she responded that she was concerned with the redness. Patient understanding of situation and seemed in good spirits. Counseled her on antibiotics and told her if she had any questions to call or come in.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a pharmacist and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 17 September 2014, the subject received a dose of BOOSTRIX (administration site and route unknown). The last menstrual period and estimated date of delivery were not provided. The subject was exposed to the vaccine during the 3rd trimester, at 36 weeks of gestation. At the time of reporting, the pregnancy was ongoing. Please see case A1089876B for details regarding previous vaccination with DTaP during pregnancy. Follow-up information received on 08 October 2014 from the physician: The VAERS details were provided. Some of the patient's details were provided. On 17th September 2014, the patient received DTaP vaccine (intramuscular) .5 ml in pharmacy.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 29 April 2014 and 2 weeks after on 13 May 2014, the subject received 1st dose and 2nd dose of BOOSTRIX (unknown route and injection site) which led to an drug dose administration interval too short as repeat vaccination against DTP should be performed at intervals as per official recommendations (generally 10 years) and extra dose administered. Her last menstrual period was on 18 September 2013 and estimated date of delivery was on 14 July 2014. The subject was exposed to the vaccines during the last trimester. No adverse events were reported. At the time of reporting the pregnancy was ongoing. Follow-up information received on 28 October 2014: The VAERS details were provided. Patient's details were updated. This was a normal conception and any complications occurred until the time of reporting.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 22-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014 for vaccination. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of (Oka/Merck) VARIVAX (from lot # K005182, expiration date 10-APR-201 only) that were improperly. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 19-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VAIRVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of M-M-R II (strength, route of administration, dose and lot # were not reported). It was reported that the vaccine was not monitored for unspecified period of time and there were no temperature logs available. The reporter was not aware of any adverse experiences at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: None stated
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-201 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 22-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports form the same reporter. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 32 year old patient of unknown gender. On 11-DEC-2014 the patient was vaccinated with a pediatric dose of VAQTA (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reproted the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional concerning to a patient (age and gender not reported) who in 2006 was vaccinated with a dose of ZOSTAVAX (dose, site and lot number not reported). The healthcare professional reported that the patient "may" have received a second dose of ZOSTAVAX on an unspecified date "recently". No adverse effect was reported. Additional information is not expected as no follow up was authorized by reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 21-NOV-2014, a dose of VARIVAX (Merck) (subcutaneous, dose and lot# was unknown), which underwent a supported temperature excursion, was administered to the patient. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was provided. 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 ender. On 15-DEC-2014 the patient was  vaccinated an expired dose of M-M-R II, lot # H009781, expiry date: 15-MAY-2014, 0.5 ml, subcutaneous, anatomical location was not reported). No adverse experienced reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (route of administration and lot number were not reported). The patient experienced swelling and redness on her arm after receiving PNEUMOVAX 23 (date unspecified). The patient did not seek a medical attention. The outcomes of the events were unknown. The causality between PNEUMOVAX 23 and the events was not reported. Additional information is not expected because the physician did not give a consent for further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (strength, route of administration, dose and lot # were not reported). It was reported that the vaccine was not monitored for unspecified period of time and there were no temperature logs available. The reporter was not aware of any adverse experiences at the time of the report. This is one of several reports receivd from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified nurse assistant regarding a 13 year old male patient who was administered GARDASIL (lot # J008423) injection intramuscular 0.5ml in left deltoid on 21MAR2014. The GARDASIL was involved in a temperature excursion. No adverse event was reported. Please see additional information for other cases reported by same provider. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS
Symptoms: Rash, Rash pruritic, Varicella
Clinical narrative: This medically confirmed spontaneous report (initial receipt 06-Oct-2014) concerns an 81 year old female patient who had a drug reaction/allergy to codeine. The patient had never experienced chicken pox. Concomitant medications included unspecified proton pump inhibitors. On 06-Sep-2014, the patient received an unspecified high dose Influenza virus vaccine (manufacturer and batch number not provided) and subcutaneous ZOSTAVAX vaccine (batch number K003596, expiry Mar-2015). On an unknown date within a few days after the vaccination, the patient experienced itchy bumps on her leg, upper thighs, arms, knees and her waistline which was one sided. She was instructed to treat it with BENADRYL and to follow up with her primary care physician. Outcome was reported as not recovered. Reporter comments: The regulator reported the case as non-serious. The regulator reported the terms 'varicella' and 'rash'. Follow up (02-Dec-2014) Upgrade to serious, medical history, concomitant medications, overall listedness, reporter comments and new events.
Age: 80.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS
Symptoms: Rash pruritic
Clinical narrative: This medically confirmed spontaneous report (initial receipt 06-Oct-2014) concerns an 81 year old female patient who had a drug reaction/allergy to codeine. The patient had never experienced chicken pox. Concomitant medications included unspecified proton pump inhibitors. On 06-Sep-2014, the patient received an unspecified high dose Influenza virus vaccine (manufacturer and batch number not provided) and subcutaneous ZOSTAVAX vaccine (batch number K003596, expiry Mar-2015). On an unknown date within a few days after the vaccination, the patient experienced itchy bumps on her leg, upper thighs, arms, knees and her waistline which was one sided. She was instructed to treat it with BENADRYL and to follow up with her primary care physician. Outcome was reported as not recovered. Reporter comments: The regulator reported the case as non-serious. The regulator reported the terms 'varicella' and 'rash'. Follow up (02-Dec-2014) Upgrade to serious, medical history, concomitant medications, overall listedness, reporter comments and new events.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HEP, PPV, RVX
Symptoms: Angiogram, Blood test, Bone scan, Culture, Decreased appetite
Clinical narrative: High fever loss of mobility of left arm, loss of appitite, very irritable.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HEP, PPV, RVX
Symptoms: Echocardiogram, HIV test, Injected limb mobility decreased, Irritability, Lumbar puncture
Clinical narrative: High fever loss of mobility of left arm, loss of appitite, very irritable.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HEP, PPV, RVX
Symptoms: Moaning, Nuclear magnetic resonance imaging, Pain, Pyrexia
Clinical narrative: High fever loss of mobility of left arm, loss of appitite, very irritable.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HEP, PPV, RVX
Symptoms: Decreased appetite, Injected limb mobility decreased, Irritability, Meningitis bacterial, Osteomyelitis
Clinical narrative: High fever loss of mobility of left arm, loss of appitite, very irritable.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HEP, PPV, RVX
Symptoms: Pyrexia
Clinical narrative: High fever loss of mobility of left arm, loss of appitite, very irritable.
Age: 74.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Bone pain, Fatigue, Headache, Muscular weakness
Clinical narrative: Migratory polyarthritis with myalgias. Migratory polyneuralgias and muscle weakness till today.
Age: 74.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Migratory polyarthritis with myalgias. Migratory polyneuralgias and muscle weakness till today.
Age: 74.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Exercise electrocardiogram, Laboratory test
Clinical narrative: Migratory polyarthritis with myalgias. Migratory polyneuralgias and muscle weakness till today.
Age: 74.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Myalgia, Polyarthritis, Polyneuropathy
Clinical narrative: Migratory polyarthritis with myalgias. Migratory polyneuralgias and muscle weakness till today.
Age: 58.0
Sex: M
Vaccine: FLUC3, FLU4
Symptoms: Ageusia
Clinical narrative: Felt ill. Patient said he couldn't smell food and bad taste in mouth, had weight loss 50 lbs as a result.
Age: 58.0
Sex: M
Vaccine: FLUC3, FLU4
Symptoms: Anosmia, Computerised tomogram, Dysgeusia, Malaise, Nuclear magnetic resonance imaging
Clinical narrative: Felt ill. Patient said he couldn't smell food and bad taste in mouth, had weight loss 50 lbs as a result.
Age: 58.0
Sex: M
Vaccine: FLUC3, FLU4
Symptoms: Weight decreased
Clinical narrative: Felt ill. Patient said he couldn't smell food and bad taste in mouth, had weight loss 50 lbs as a result.
Age: 1.58
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cough, Decreased appetite, Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: Immunizations given on 11-18-14 and mom stated that on 11-25-14 he developed a fever 103.7 but was giving him TYLENOL to keep fever down.
Age: 1.58
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Pyrexia
Clinical narrative: Immunizations given on 11-18-14 and mom stated that on 11-25-14 he developed a fever 103.7 but was giving him TYLENOL to keep fever down.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 57 year old female patient who had unspecified reaction to penicillin. Medical history was reported as none. On 23-NOV-2014, the patient was vaccinated with ZOSTAVAX vial 19400 PFU for routine administration (dose, route and frequency were not reported). Lot number was reported as K014835 and expiry date as 14-DEC-2015. Concomitant therapies included losartan potassium (manufacturer unknown), ATIVAN, valacyclovir, lisinopril (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown). On an unknown date approximately in 2014, the patient experienced small diffuse maculopapular rash down her arm. No lab diagnostics studies performed. No treatment was given for the event. Patient sought medical attention and saw physician. The outcome of small diffuse maculopapular rash down her arm was reported as recovering. Causality assessment was not reported. Product quality complaint was not reported. Varicella zoster virus (VZV) packet accepted. No additional information to report. Additional information has been requested.