chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, X-ray limb
Clinical narrative: Left arm and shoulder pain, unable to raise arm - symptoms progressed/worsened over the next 1-2 weeks.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Administered vaccine, patient had syncopic episode 2 minutes after. Patient was given orange juice and observed upon awakening. Vitals were checked, patient allowed to leave 30 min later.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Choking, Cough, Decreased appetite, Irritability, Pyrexia
Clinical narrative: Vaccines administered at 9:00AM. Pt awoke from nap at 11:30 a.m. with runny nose, cough, poor appetite and fussy. Mother gave TYLENOL every 4-6 hrs during the day as well as Hyland Cough Syrup and Hyland Teething Tablets. Baby was choking on mucous at 8:30pm and quit breathing with color change. Went to ER at 9:00pm. Fever 99.8 -> 100.5.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Respiratory arrest, Rhinorrhoea, Skin discolouration
Clinical narrative: Vaccines administered at 9:00AM. Pt awoke from nap at 11:30 a.m. with runny nose, cough, poor appetite and fussy. Mother gave TYLENOL every 4-6 hrs during the day as well as Hyland Cough Syrup and Hyland Teething Tablets. Baby was choking on mucous at 8:30pm and quit breathing with color change. Went to ER at 9:00pm. Fever 99.8 -> 100.5.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Computerised tomogram head normal, Headache, Hypoaesthesia, Musculoskeletal pain, Neck pain
Clinical narrative: Frontal headache, neck and shoulder pain, visual field disturbence x 5 minutes, numbness/tingling left hand, occipital headache.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Paraesthesia, Visual field defect
Clinical narrative: Frontal headache, neck and shoulder pain, visual field disturbence x 5 minutes, numbness/tingling left hand, occipital headache.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Idiopathic thrombocytopenia purpura.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a from pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot #J007955; expiration date:27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with (Oka/Merck) VARIVAX that was exposed to 43.1 degrees F for 29 hours on. 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema abnormal, Haematochezia, Intestinal malrotation, Intussusception, Surgery
Clinical narrative: 7 days after receiving 4 month vaccines, including ROTATEQ, he began with vomiting, bloody stools. (+) Intussusception/Malrotation, required surgery to correct.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: 7 days after receiving 4 month vaccines, including ROTATEQ, he began with vomiting, bloody stools. (+) Intussusception/Malrotation, required surgery to correct.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age. On an unknown date, improperly stored VAQTA 25/0.5 U/ml (dose, lot# and expiration date unspecified) that was exposed to 49F and 28F over a period of 5 days, was administered to an unknown number of patients on unknown dates. No adverse symptoms were reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and tenderness at left thigh. Possible cellulitis being treated with antibiotics.
Age: 39.0
Sex: F
Vaccine: TYP, YF
Symptoms: Blood test, Electrocardiogram, Presyncope
Clinical narrative: Near syncope sensation, continues for 2 weeks.
Age: 56.0
Sex: F
Vaccine: HEPA, VARZOS, HEPA, VARZOS
Symptoms: Back pain, Breast pain, Headache, Herpes zoster, Influenza like illness
Clinical narrative: Headache, malaise that progressed to flu-like symptoms and left shoulder blade and back ache. Breasts were achy. Noticed rash on top and below left breast. Diagnosed with Shingles on 6/12/14. Prescribed Acyclovir.
Age: 56.0
Sex: F
Vaccine: HEPA, VARZOS, HEPA, VARZOS
Symptoms: Malaise, Musculoskeletal pain, Rash
Clinical narrative: Headache, malaise that progressed to flu-like symptoms and left shoulder blade and back ache. Breasts were achy. Noticed rash on top and below left breast. Diagnosed with Shingles on 6/12/14. Prescribed Acyclovir.
Age: 56.0
Sex: F
Vaccine: HEPA, VARZOS, HEPA, VARZOS
Symptoms: Back pain, Chills, Herpes zoster, Influenza like illness, Insomnia
Clinical narrative: Headache, malaise that progressed to flu-like symptoms and left shoulder blade and back ache. Breasts were achy. Noticed rash on top and below left breast. Diagnosed with Shingles on 6/12/14. Prescribed Acyclovir.
Age: 56.0
Sex: F
Vaccine: HEPA, VARZOS, HEPA, VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Headache, malaise that progressed to flu-like symptoms and left shoulder blade and back ache. Breasts were achy. Noticed rash on top and below left breast. Diagnosed with Shingles on 6/12/14. Prescribed Acyclovir.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Fever and Flu-like symptoms for 2 days.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Autoimmune disorder, Blindness, Constipation, Dermatitis acneiform
Clinical narrative: Swollen/arthritic joints, headache/complete vision loss caused by encephalitis, exhaustion, tremors, rash covering face and head, severe stomach aches, weight loss, eczema on hands, hot flashes, constipation followed by diarrhea, random fevers, chronic autoimmune disease.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Eczema, Encephalitis, Fatigue, Headache
Clinical narrative: Swollen/arthritic joints, headache/complete vision loss caused by encephalitis, exhaustion, tremors, rash covering face and head, severe stomach aches, weight loss, eczema on hands, hot flashes, constipation followed by diarrhea, random fevers, chronic autoimmune disease.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Hot flush, Joint swelling, Polyarthritis, Pyrexia, Rash
Clinical narrative: Swollen/arthritic joints, headache/complete vision loss caused by encephalitis, exhaustion, tremors, rash covering face and head, severe stomach aches, weight loss, eczema on hands, hot flashes, constipation followed by diarrhea, random fevers, chronic autoimmune disease.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor, Weight decreased
Clinical narrative: Swollen/arthritic joints, headache/complete vision loss caused by encephalitis, exhaustion, tremors, rash covering face and head, severe stomach aches, weight loss, eczema on hands, hot flashes, constipation followed by diarrhea, random fevers, chronic autoimmune disease.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Mother reports "welt" @ injection site in back of Left arm which progressed in size from the evening of 06/10/14 to morning of 06/12/14 at the time mother phoned with reaction.  Size reached 3 inches in diameter, is raised, and is also warm to touch, therefore has an appt. with family doctor to examine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a health care worker refers to a 60 year old female patient with no drug allergies. The patient's current conditions included benign hypertension, insomnia and sinusitis. On 28-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot# J012658, expiry date: 10-JAN-2015), subcutaneously to prevent shingles. Concomitant medications were none. On 10-JUN-2014, the patient developed a shingles outbreak on the lower back and the right hip. The patient sought medical attention by contacting the physician. The patient was treated with hydrocodone (manufacturer unknown) and VALTREX on 10-JUN-2015. The outcome of shingles on her lower back and the right hip was reported as not recovered. The causality was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Rubella antibody negative
Clinical narrative: This spontaneous retrospective pregnancy report as received from a pharmacist refers to a female patients of unknown age (about 120-150 patients) with unknown demographics. The patients pertinent medical history, concurrent conditions and drug reactions and allergies were reported as unspecified by the reporter. On an unknown date the patient was vaccinated with M-M-R II, HSA therapy type 0.5 ml, subcutaneous (dose number, lot#, anatomical location not reported). No concomitant medications reported. The patient became pregnant. The LMP and EDD were not known. The patient had live birth and delivered baby (unspecified) The pharmacist reported that about 120-150 unspecified patients had titers drawn after having a baby on unspecified dates and he stated that a majority of the results of the titers are equivocal for rubella. The pharmacist also stated that he was pretty sure that all of those patients had been vaccinated with the M-M-R II previously on unspecified dates. It was unspecified whether the patient sought medical attention. The outcome of the adverse event was unknown at the time of the report. The patient was not hospitalized due to experience was not life threatening. There was no persistent or significant incapacity. No death Intervention to prevent serious criteria was not required. Product quality compliant was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Tenderness
Clinical narrative: This spontaneous report as received from a consumer via Market research agency, refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. No other concomitant medications were reported. On 04-SEP-2013 the patient experienced tender rash on back. The outcome of tender rash on back is unknown. The causality of tender rash on back is not reported. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Chlamydial infection, Exposure during pregnancy, Gestational diabetes
Clinical narrative: Information has been reported in a government agency slide in the Vaccine Adverse Reporting System (VAERS):This spontaneous retrospective pregnancy report as received from a registered nurse (RN) in Center for Disease control and Prevention (CDC) concerning a female patient of unknown age who experienced gestational diabetes and chlamydia. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced gestational diabetes and chlamydia. The outcome of gestational diabetes and chlamydia was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient reported as "over the age of 65". Patient's concurrent conditions, medical history, information regarding drug reactions or allergies were not reported. In approximately April 2014 (reported as: "2 months ago") the patient was vaccinated with a 1 shot of ZOSTAVAX, (injection, lot#, expiration date, route of administration and anatomical location not reported). Concomitant medications were not reported. ZOSTAVAX had been administered by an unspecified pharmacist about two weeks prior to the patient presenting the symptoms to physician. About 2 weeks after ZOSTAVAX administration, in approximately 2014 (exact date not reported), the patient developed a shingles-like rash around ZOSTAVAX administration, in approximately 2014 (exact date not reported), the patient developed a shingles-like rash around ZOSTAVAX injection site. There was no treatment given for the event. Patient sought medical attention by calling physician's office. The relatedness between the event of shingles-like around the ZOSTAVAX injection site and ZOSTAVAX  was not reported. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23) in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 5 of the four patients who experienced no adverse event. On an unknown date, the patient became pregnant. The last menstrual period (LPM) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. No adverse event reported. The outcome of pregnancy was unknown. This is one of the 18 reports PNEUMOVAX 23 administered during pregnancy) that received from the same source. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-MAY-2014 the patient was vaccinated with VARIVAX (lot# and expiration date not provided) of dose 0.5 ml (milliliters) subcutaneously. It was reported that VARIVAX was exposed to an improper temperature for the third time on 29-MAY-2014 in which it reached a high temperature of 25 Farenheit (F) for 20.5 hours. No adverse effect was reported. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA015420, MARRS#1405USA015421, MARRS#1405USA015422, MARRS#1405USA015423, MARRS#1406USA005107, MARRS#1406USA005109, MARRS#1405USA014687). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to about 6 patients of unknown age (gender unknown). On an unknown date about 6 patient was vaccinated with VARIVAX, subcutaneous (strength, dose, frequency unknown) which was improperly exposed to 10F for 3 days and to 5-9.6F for 360 hours. No known adverse effects. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported. On 28-MAY-2014 the patient was vaccinated with ZOSTAVAX (second dose, dose, units, route of administration, anatomical location, lot number was not reported). Concomitant medications were not reported. The reporter stated that the patient was inadvertently administered a second dose of ZOSTAVAX, on 28-MAY-2104 (reported as yesterday), in May 2012, about 2 years after administration of the first dose ZOSTAVAX (dose, units, route of administration, anatomical location, lot number was not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-MAY-2014 the patient was vaccinated with VARIVAX (Merck) (lot# and expiration date not provided) of dose 0.5 ml (milliliters) subcutaneously. It was reported that VARIVAX (Merck) was exposed to an improper temperature for the third time on 29-MAY-2014 in which it reached a high temperature of 25 Farenheit (F) for 20.5 hours. There was no product quality complaint involved. No adverse effect was reported. Outcome of the medication error was unknown. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA015420, MARRS#1405USA015421, MARRS#1405USA015422, MARRS#1405USA015423, MARRS#1406USA005108,MARRS#1406USA005109, MARRS#1405USA014687). Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Watery diarrhea and emesis.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient is a 18 year old female who presents for evaluation of rash she has had for 1 day(s). Describes localized involvement on upper arm  and inner bilateral upper legs that are raised, maculopapular, scattered, red, well demarcated and itchy.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Injected limb mobility decreased, Injection site pain, Injection site reaction, Mass
Clinical narrative: Hot to the touch, swollen, painful, couldn't lift left arm.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Skin warm, Swelling, Ultrasound scan
Clinical narrative: Hot to the touch, swollen, painful, couldn't lift left arm.
Age: 55.0
Sex: M
Vaccine: MMR
Symptoms: Contusion, Cough, Cyanosis, Epistaxis, Headache
Clinical narrative: Got measles shot last week in April (28th). About a week later broke out in a rash chest and head. A few on top of head were itchy, otherwise non itchy/not painful. Denies fever or URI symptoms. Seemed better after couple of weeks, but noticed rash right chest again about 1 week ago. When blowing nose in the morning will blow out bloody scabs x  2 weeks. Pain right temple/forehead when coughing x 1 week. "Was a little bluish initially" No pain this morning. Bruise easily since getting shot. Exam noted petechial/vascular rash right chest area and several bruises as well as irritated/bloody nose. Labwork revealed platelet count of 1. Sent to ER for treatment. Was hospitalized.
Age: 55.0
Sex: M
Vaccine: MMR
Symptoms: Increased tendency to bruise, Nasal discomfort, Petechiae, Platelet count decreased, Rash
Clinical narrative: Got measles shot last week in April (28th). About a week later broke out in a rash chest and head. A few on top of head were itchy, otherwise non itchy/not painful. Denies fever or URI symptoms. Seemed better after couple of weeks, but noticed rash right chest again about 1 week ago. When blowing nose in the morning will blow out bloody scabs x  2 weeks. Pain right temple/forehead when coughing x 1 week. "Was a little bluish initially" No pain this morning. Bruise easily since getting shot. Exam noted petechial/vascular rash right chest area and several bruises as well as irritated/bloody nose. Labwork revealed platelet count of 1. Sent to ER for treatment. Was hospitalized.
Age: 55.0
Sex: M
Vaccine: MMR
Symptoms: Rash pruritic, Scab
Clinical narrative: Got measles shot last week in April (28th). About a week later broke out in a rash chest and head. A few on top of head were itchy, otherwise non itchy/not painful. Denies fever or URI symptoms. Seemed better after couple of weeks, but noticed rash right chest again about 1 week ago. When blowing nose in the morning will blow out bloody scabs x  2 weeks. Pain right temple/forehead when coughing x 1 week. "Was a little bluish initially" No pain this morning. Bruise easily since getting shot. Exam noted petechial/vascular rash right chest area and several bruises as well as irritated/bloody nose. Labwork revealed platelet count of 1. Sent to ER for treatment. Was hospitalized.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, HEPA, IPV, MMR, MNQ, PPV, TD
Symptoms: Chills, Erythema, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Right arm bicep (anterior and medial part of upper arm): sore, red, warm to the touch. Flu like syptoms: chills, aches.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, HEPA, IPV, MMR, MNQ, PPV, TD
Symptoms: Skin warm
Clinical narrative: Right arm bicep (anterior and medial part of upper arm): sore, red, warm to the touch. Flu like syptoms: chills, aches.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: Eythema, slight edema, and warm to touch - applied ice and gave Benadryl, advised to continue with ice and Benadryl PRN. Resolved by next day.
Age: 0.32
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Ear swelling, Erythema, Pruritus
Clinical narrative: Swelling, redness and itching noted to left ears. 10:40 Benadryl 5mg given IM.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PPV, VARCEL
Symptoms: Abasia, Decreased appetite, Toe walking, Vomiting
Clinical narrative: Started walking pigeon toed, woke up the next morning unable to walk. Was able to walk later in the day still pigeon toed. Loss of appetite the following day and vomiting.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Approx. 7cm area around injection site, slightly red, warm to touch and raised. Inside circle area of reaction was a 1x3cm rectangular shape lighter area. Applied ice to area, administered oral Benadryl per pt weight. Sent home with ice packs and advised to get Benadryl for home. Mom verbalized understanding as well as stated she did not "hear" the instructions regarding ice after IZ admin r/t sibling in room having tantrum. Advised mom to return to office for recheck.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache, Nausea, Pyrexia
Clinical narrative: She began to get generalized headache and felt feverish, some nausea.  No photophobia.   Temp 37.7  Headache 7 on 1-10 scale.   Has had headache off and on since then though gradually getting better and do not think major problem.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site inflammation, Injection site warmth
Clinical narrative: Area around injection site appeared slightly inflamed and warm to touch - an area approx. 4cm diameter.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling abnormal
Clinical narrative: Pt left clinic and shopped in the store, she returned to the clinic approx 10 minutes and reported that her face felt "weird" like when she has allergic rx to coconut in the past. I had pt come to clinic and lay down, took vital signs, I called my medical director and followed his recommendation to give pt 50 mg of oral Benadryl. I called 911 and they came to examine pt. Pt declined transportation by EMS to ER but stated she was going to the ER and waited in the clinic until her friend could drive her to the ER which was approx 20 minutes after EMS left clinic.
Age: 13.0
Sex: M
Vaccine: MEN
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia, Sleep talking
Clinical narrative: The site of the injection became red and slightly swollen within the first 5 minutes. Later that day at around 3pm, the site became itchy. Patient was running a slight fever. He woke up from sleep at 4:00 AM sleep walking and talking. Something that he has never done before and didn't remember doing when he woke up. The site of the vaccine was still itchy on day two and still slightly red and swollen--but itchy was mainly what he experienced.
Age: 13.0
Sex: M
Vaccine: MEN
Symptoms: Somnambulism
Clinical narrative: The site of the injection became red and slightly swollen within the first 5 minutes. Later that day at around 3pm, the site became itchy. Patient was running a slight fever. He woke up from sleep at 4:00 AM sleep walking and talking. Something that he has never done before and didn't remember doing when he woke up. The site of the vaccine was still itchy on day two and still slightly red and swollen--but itchy was mainly what he experienced.
Sex: F
Vaccine: MEN, PPV
Symptoms: Headache, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US068695 is an initial literature report received on 31 May 2014. In this article, the authors presented a case of a five year old female who developed limb swelling after receiving pneumococcal vaccine and meningococcal vaccine conjugate. Her past medical history included sickle cell disease. Her vaccination history included one dose of pneumococcal vaccine (other manufacturer, batch number: not reported) two and a half years earlier and one dose of meningococcal vaccine conjugate (manufacturer: not reported, batch number: not reported) six months earlier. She developed low grade fever after receiving the vaccinations (please see the case PHHY2014US069273). She was vaccinated with pneumococcal vaccine (other manufacturer, batch number: not reported) into her right arm and meningococcal vaccine conjugate (manufacturer: not reported, batch number: not reported) into her left arm on an unspecified date. One day after the vaccination, she developed pain in her head, neck and arm with a fever of 102.9 degrees F. She was treated by her mother with ibuprofen at an unspecified dose. Ten hours later, she developed right arm swelling with oedema which made it difficult to put a shirt sleeve over her arm and at presentation, she also reported nausea. On examination, her right arm was tender with redness and was swollen down to her elbow. She was treated with KETOROLAC at an unspecified dose, ondansetron at an unspecified dose and prophylactic ceftriaxone at an unspecified dose. She was discharged with morphine and ibuprofen at unspecified doses for breakthrough pain. The right arm swelling completely resolved after 24 hours of treatment and the outcome of pain in her head, neck and arm, right arm oedema and tenderness with redness was not reported. The case report scored a three on Naranjo algorithm for determining the adverse events and the authors concluded that it was likely that pneumococcal vaccine caused the adverse event. Additionally, the immune reaction might have been amplified by the conjugated meningococcal vaccine administered concurrently in the other arm.
Sex: F
Vaccine: MEN, PPV
Symptoms: Nausea, Neck pain, Pyrexia
Clinical narrative: Case number PHHY2014US068695 is an initial literature report received on 31 May 2014. In this article, the authors presented a case of a five year old female who developed limb swelling after receiving pneumococcal vaccine and meningococcal vaccine conjugate. Her past medical history included sickle cell disease. Her vaccination history included one dose of pneumococcal vaccine (other manufacturer, batch number: not reported) two and a half years earlier and one dose of meningococcal vaccine conjugate (manufacturer: not reported, batch number: not reported) six months earlier. She developed low grade fever after receiving the vaccinations (please see the case PHHY2014US069273). She was vaccinated with pneumococcal vaccine (other manufacturer, batch number: not reported) into her right arm and meningococcal vaccine conjugate (manufacturer: not reported, batch number: not reported) into her left arm on an unspecified date. One day after the vaccination, she developed pain in her head, neck and arm with a fever of 102.9 degrees F. She was treated by her mother with ibuprofen at an unspecified dose. Ten hours later, she developed right arm swelling with oedema which made it difficult to put a shirt sleeve over her arm and at presentation, she also reported nausea. On examination, her right arm was tender with redness and was swollen down to her elbow. She was treated with KETOROLAC at an unspecified dose, ondansetron at an unspecified dose and prophylactic ceftriaxone at an unspecified dose. She was discharged with morphine and ibuprofen at unspecified doses for breakthrough pain. The right arm swelling completely resolved after 24 hours of treatment and the outcome of pain in her head, neck and arm, right arm oedema and tenderness with redness was not reported. The case report scored a three on Naranjo algorithm for determining the adverse events and the authors concluded that it was likely that pneumococcal vaccine caused the adverse event. Additionally, the immune reaction might have been amplified by the conjugated meningococcal vaccine administered concurrently in the other arm.
Age: 1.65
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Rash
Clinical narrative: 1 wk after vaccination mother noticed bruise at injection site, then red bump, then rash started spreading out over thigh. By May 29th rash had spread, and by June 10th rash spread to face. No fever, no illness no other symptoms. MD made Dermatology referral mom declined days it was from vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report received from a healthcare worker refers to a unknown number of patients of unknown age and gender. Since 23-MAY-2014 the suspect vaccines were improperly stored and on unknown date (in approximately May 2014) the patients were vaccinated with VARIVAX Lot #, dosage, anatomical localization and route of administration were not reported. Vaccines has been administered up to 8 patients. No adverse effects reported. This is one of the several reports of the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-MAY-2014 the patient was vaccinated with VARIVAX (lot# and expiration date not provided) of dose 0.5 ml (milliliters) subcutaneously. It was reported that VARIVAX was exposed to an improper temperature for the third time on 29-MAY-2014 in which it reached a high temperature of 25 Farenheit (F) for 20.5 hours. No adverse effect was reported. No product Quality complaint involved. Outcome of medication error was not reported. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA015420, MARRS#1405USA015421, MARRS#1405USA015422, MARRS#1405USA015423, MARRS#1406USA005107, MARRS#1406USA005108, MARRS#1405USA014687). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Bladder catheterisation, Constipation, Myelitis transverse
Clinical narrative: This female received a flu vaccine at pharmacy on 12/28/13. She developed back pain, weakness, foot drop and presented herself to the emergency room on 12/31/13. She was evaluated and on 1/2/14, she was felt to have a transverse myelitis and was transferred to another hospital. There she underwent exhausted workup and was felt to have an acute transverse myelitis secondary to the flu vaccine, which is a very rare complication. She was subsequently transferred to my care at Nursing and Rehabilitation Center for subacute therapies and at that time, she was admitted with transverse myelitis, neurogenic bladder, paraplegia, urinary retention with Foley catheter and obstipation. She underwent physical therapies and has not improved. I am trying to get her into the transverse myelitis clinic at another facility as an outpatient. Patient is diagnosed with acute transverse myelitis secondary to flu vaccine with other diagnoses as noted above. She is unfortunately going to be completely and totally disabled starting 12/31/13, through the rest of her life due to this unfortunate illness. I am going to enclose records that I have from the other facilities.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Neurogenic bladder, Paraplegia, Peroneal nerve palsy, Urinary retention
Clinical narrative: This female received a flu vaccine at pharmacy on 12/28/13. She developed back pain, weakness, foot drop and presented herself to the emergency room on 12/31/13. She was evaluated and on 1/2/14, she was felt to have a transverse myelitis and was transferred to another hospital. There she underwent exhausted workup and was felt to have an acute transverse myelitis secondary to the flu vaccine, which is a very rare complication. She was subsequently transferred to my care at Nursing and Rehabilitation Center for subacute therapies and at that time, she was admitted with transverse myelitis, neurogenic bladder, paraplegia, urinary retention with Foley catheter and obstipation. She underwent physical therapies and has not improved. I am trying to get her into the transverse myelitis clinic at another facility as an outpatient. Patient is diagnosed with acute transverse myelitis secondary to flu vaccine with other diagnoses as noted above. She is unfortunately going to be completely and totally disabled starting 12/31/13, through the rest of her life due to this unfortunate illness. I am going to enclose records that I have from the other facilities.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 3 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care student refers to an unspecified patient of unknown age and gender. On 06-JUN-2014 the patient was vaccinated with expired dose of MMR II (subcutaneous, lot # 0683AE, Expiry date: 02-APR-2014). Pertinent medical history and concomitant medications were not reported. No adverse effect reported by the reporter. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a 47 year old female patient with asthma, spinal stenosis, environmental allergies, allergy to sulfa drugs, codeine, acetaminophen, VICODIN, Tramadol and history of anxiety. On 13-MAY-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscularly injection in the right deltoid (lot#, expiry date unspecified). Concomitant therapies included CELEXA 20 mg, XYZAL 5 mg, albuterol (manufacturer unknown) as needed, ranitidine 150 mg twice daily and FLOVENT two puffs twice daily. On 14-MAY-2014, the patient developed swelling, warmness, pain at the injection site of right deltoid. The patient sought medical attention, came into office and was treated with DEXAMETHASONE injection in the deltoid area, ALEVE, and cold compress as needed. No diagnostic test were provided. The outcome of events was unknown. The relatedness between events and PNEUMOVAX 23 was not reported. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a from pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a from pharmacy technician concerning a currently 16 years old adolescent. Gender was not reported. Medical history and concurrent conditions were not reported. On 05-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test normal, Fatigue, Full blood count normal, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Pt received Tdap 5/22 - then returned to clinic 5/27 c/o sore throat and swollen lymph nodes with fever and fatigue pt. returned 5/29 same symptoms - referred to ID.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Pt received Tdap 5/22 - then returned to clinic 5/27 c/o sore throat and swollen lymph nodes with fever and fatigue pt. returned 5/29 same symptoms - referred to ID.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old female patient. On 05-JUN-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous, lot # J008436, expiration date 11-OCT-2014. Concomitant therapies included atorvastatin and tramadol hydrochloride. None pertinent medical history, drug reactions and allergies were reported. On 07-JUN-2014 (reported as 48 hours later), the patient developed a red area on an unspecified arm that was the size of a "tennis ball" after receiving ZOSTAVAX. At them time of the report the outcome of the event was reported as not recovered. The patient sought medical attention, she called the pharmacist on 07-JUN-2014. No treatment was given for the event. The pharmacist also reported that she had see other unspecified patients that developed redness after receiving ZOSTAVAX but never as big as a tennis ball. This is one of two reports from the same reporter (1406USA005593). Additional information has been requested.
Age: 1.49
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 17 month old male patient. There was no pertinent medical history and no drug reactions or allergies. On 25-FEB-2014, the patient was vaccinated with VARIVAX (Merck) lot# H015136, exp 09-AUG-2014, 0.5 ml, subcutaneous for M-M-R II, lot # J002502, exp 28-FEB-2015 (dose and route not reported). On 28-MAY-2014, the patient was inadvertently vaccinated with VARIVAX (Merck) lot # H022156, exp 18-DEC-2014 (dose and route not reported) and M-M-R II lot # J002502, exp 28-FEB-2015 (dose and route not reported). Concomitant therapies included SINGULAIR. On 28-MAY-2014, the patient experienced rash on his face and torso. The patient's mother seek for medical attention (called the office). No lab diagnostics performed. No treatment given for the events. The outcome of rash on his face and torso was reported as not recovered. This is one of two reports from the same patient (1406USA006616). Additional information has been requested.
Age: 1.49
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 17 month old male patient. There was no pertinent medical history and no drug reactions or allergies. On 25-FEB-2014, the patient was vaccinated with VARIVAX (Merck) lot# H015136, exp 09-AUG-2014, 0.5 ml, subcutaneous for M-M-R II, lot # J002502, exp 28-FEB-2015 (dose and route not reported). On 28-MAY-2014, the patient was inadvertently vaccinated with VARIVAX (Merck) lot # H022156, exp 18-DEC-2014 (dose and route not reported) and M-M-R II lot # J002502, exp 28-FEB-2015 (dose and route not reported). Concomitant therapies included SINGULAIR. On 28-MAY-2014, the patient experienced rash on his face and torso. The patient's mother seek for medical attention (called the office). No lab diagnostics performed. No treatment given for the events. The outcome of rash on his face and torso was reported as not recovered. This is one of two reports from the same patient (1406USA006616). Additional information has been requested.
Age: 1.49
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 17 month old patient. There was no pertinent medical history and no drug reactions or allergies. On 25-FEB-2014, the patient was vaccinated with MMR II, lot# J002502, exp 28-FEB-2015 (dose and route not reported). On 28-MAY-2014, the patient was inadvertently vaccinated with MMR II lot# J002502, exp 28-FEB-2015 (dose and route not reported). Patient received extra dose. Concomitant therapies included SINGULAIR. This is one of two reports from the same patient (1405USA015663). Additional information has been requested.
Age: 1.49
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 17 month old patient. There was no pertinent medical history and no drug reactions or allergies. On 25-FEB-2014, the patient was vaccinated with MMR II, lot# J002502, exp 28-FEB-2015 (dose and route not reported). On 28-MAY-2014, the patient was inadvertently vaccinated with MMR II lot# J002502, exp 28-FEB-2015 (dose and route not reported). Patient received extra dose. Concomitant therapies included SINGULAIR. This is one of two reports from the same patient (1405USA015663). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with PROQUAD (Merck) (lot, dose and route not reported), exposed to temperatures outside of the proper range. Concomitant medication was not reported. No adverse effect reported. This is one of two reports from the same source (1406USA006620). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with VARIVAX (Merck) (lot, dose and route not reported), exposed to temperatures outside of the proper range. Concomitant medication was not reported. No adverse effect reported. This is one of two reports from the same source (1406USA005491). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from other (administration) via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with MMR II (strength, dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The administrator reported that "the patient fainted a few minutes after receiving the MMR II vaccine" on an unknown date. The patient sought for medical attention and was seen in office visit on an unspecified date. The outcome of the event was reported as recovered on an unknown date. Additional information has been requested.
Sex: U
Vaccine: MMR
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 10-JUN-2014 the patient was vaccinate with an expired dose of M-M-R II (lot # 0649AE, expiration date 27-MAR-2014) (rHA status not provided) 0.5 ml subcutaneous. Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with a history of anemia and an unspecified reaction to COMPAZINE. On 04-JUN-2014, the patient was vaccinated with ZOSTAVAX via 19400 PFU, 0.65 ml subcutaneous injection on the left arm (lot number and expiration date not reported). On an unspecified date in June 2014, the patient contacted the pharmacist to report that her injection site where she received of ZOSTAVAX was red, swollen, and warm to the touch. The pharmacist does not know when the adverse effect was first experienced by the patient. The patient reported that she contacted her physician who prescribed Cephalexin, unspecified dose, for treatment of her injection site adverse effect. At the time of this report, the pharmacist reported that the patient's injection site was improving, and the patient stated that she was recovering. The pharmacist reported that the patient did not experience a rash at her injection site or anywhere else on her body. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting in herself. Two or three years ago the patient received her first dose of hepatitis b vaccine (manufacturer unknown) (dose and dosage schedule were not reported). "Six months ago", in approximately NOV-2013 the patient was vaccinated with the second dose of hepatitis b vaccine (manufacturer unknown) (dose and dosage schedule were not reported) (it was other than indicated in the prescribing information). Additional information has been requested.
Age: 1.11
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 13 months old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 07-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.56
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Patient had a fever x 2 days. Rash appeared this morning. Rash on torso and face.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Somnolence
Clinical narrative: Mom unable to get baby awake. Baby had been asleep 2 1/2 hours - Mom states she was unable to wake him to eat - she came to the MD office about 2 pm - baby still asleep upon arrival - but woke up shortly thoughtful and was able to nurse while at the office - MD examined and told mom he was fine.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Anal pruritus, Papule, Proctalgia, Skin lesion
Clinical narrative: On 25 Feb she received the Tdap, HPV, MCV4P Immunizations. A week later she developed 3-4 pruritic, mildly painful, papules around anus. They were small, the size of the opening of a retractable pin. Her mother questioned her closely about sexual abuse and there seemed to be none. She was treated with warm compresses and Vaseline topical with relief after 3 days or so. She had HPV Dose #2 on 25 April 2014 and on 6 May developed one similar lesion.