chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.05
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to a 13 month old male patient, her son. On 11-APR-2013 the patient was vaccinated with MMR II (LOT H012572, exp. date reported as 16-JUN-2014, verified as 29-JUN-2014) and VARIVAX (Merck). It was reported that patient had none medical history and drug reactions/allergies. Concomitant therapies included PREVNAR (manufacturer was reported as unknown) (also vaccinated at 11-APR-2013). In April patient had blood work done and platelets were at 5000 (units not provided), so he was admitted to hospital on 25-APR-2013. Patient was treated with (Intravenous immunoglobulin) IVIG (manufacturer unknown) for 2 nights and platelet count went back up to 91000. Patient was given BENADRYL and TYLENOL, before treatment with IVIG to lessen some of side effect that could occur. It was reported that patient experienced vomiting and fever from IVIG treatment. Consumer stated that patient was diagnosed with "ITP, idiopathic thrombocytopenia". The outcome of all events was reported as recovered/resolved. Upon internal review the idiopathic thrombocytopenia was considered to be medically significant. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to 54 years old female with rheumatoid arthritis and not pregnant at the time of reporting. On 15-DEC-2010, at age of 53, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, lot number and expiration date were not reported). Concomitant therapies included XANAX, ZANTAC, HCTZ, nadolol and FLONASE. In August 2011 the patient developed shingles, information on location or severity was not reported. On 19-JUL-2012 the patient experienced another outbreak of shingles on her buttocks and down her right leg. On 16-OCT-2012 physician prescribed to the patient VALTREX, daily for unspecified period of time. Healthcare worker reported that the second case of shingles was incapacitating to the patient as the patient was a bus driver and shingles were on the buttocks making it impossible to sit. Patient sought unspecified medical attention. The relatedness between shingles and ZOSTAVAX was not provided. The outcome of shingles was unknown. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Atopy, Dry skin, Immediate post-injection reaction, Injection site nodule, Injection site scab
Clinical narrative: Case number PHEH2013US009254 is an initial spontaneous report received from a pharmacist on 23 Apr 2013. This case refers to a 73-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not available) intramuscularly in his left arm on 29 Aug 2012. Immediately after vaccination, he developed knot, scab and rash. The knot and scab are at the left arm injection site. The rash started at the left wrist area. It was like dry patch of skin type rash with little bumps, and the patient stated that it was very itchy and painful. Rash was predominantly on the left side of the body and an area at the spine. He had a physician visit due to these events. The patient's physician stated to patient that the rash was an atopic rash and it was allergy related; the physician also ruled out shingles. He received a cream (not specified) with steroid in it and he had been using it all over his body. The patient stated to the pharmacist that he still has knot and rash (all over his body) at the time of this report. The patient also stated to the pharmacist the rash, knot, and scab come and go. The seriousness and causality were not reported.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Rash generalised, Rash pruritic
Clinical narrative: Case number PHEH2013US009254 is an initial spontaneous report received from a pharmacist on 23 Apr 2013. This case refers to a 73-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not available) intramuscularly in his left arm on 29 Aug 2012. Immediately after vaccination, he developed knot, scab and rash. The knot and scab are at the left arm injection site. The rash started at the left wrist area. It was like dry patch of skin type rash with little bumps, and the patient stated that it was very itchy and painful. Rash was predominantly on the left side of the body and an area at the spine. He had a physician visit due to these events. The patient's physician stated to patient that the rash was an atopic rash and it was allergy related; the physician also ruled out shingles. He received a cream (not specified) with steroid in it and he had been using it all over his body. The patient stated to the pharmacist that he still has knot and rash (all over his body) at the time of this report. The patient also stated to the pharmacist the rash, knot, and scab come and go. The seriousness and causality were not reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction, Lipodystrophy acquired
Clinical narrative: Patient received MENACTRA 2/2013 and returned today 5/2/13 with what appears to be lipodystrophy at the site.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Local swelling
Clinical narrative: 12 1/2 cm x 14 cm raised confluence erythema.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Feeding disorder of infancy or early childhood, Haematochezia, Intussusception, Irritability
Clinical narrative: Pt. received rotavirus vaccine (and PEDIARIX, PREVNAR 13, HIB) on 4/8/13. On 4/15 he developed vomiting and fussiness diagnosed in office as prob. vomiting and pharyngitis. Following day he continued to feed poorly and had bloody stool. Presented to ED where he was dx'd with RUQ intussusception reduced with air enema. Required enema 2 more times.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pharyngitis, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Pt. received rotavirus vaccine (and PEDIARIX, PREVNAR 13, HIB) on 4/8/13. On 4/15 he developed vomiting and fussiness diagnosed in office as prob. vomiting and pharyngitis. Following day he continued to feed poorly and had bloody stool. Presented to ED where he was dx'd with RUQ intussusception reduced with air enema. Required enema 2 more times.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a healthcare student refers to a female patient of unknown age. Five years ago, in approximately April 2008 the patient was vaccinated with first dose of GARDASIL. The reporter questioned if patient could test positive for HPV (Human Papillomavirus virus) after GARDASIL vaccination. A recent (Low Grade Squamous Intraepithelial Lesion) LGSIL test performed in April 2013, showed the patient was positive for HPV. The reporter confirmed that the patient only got one dose of GARDASIL 5 years ago, and never completed the GARDASIL series. The outcome of the patient was unknown. The patient had sought unspecified medical attention. Causality was not reported. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Rash on lt thigh.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Dyspnoea, Lymphadenopathy, Rash
Clinical narrative: Swollen glands, rash, joint pain, shortness of breath.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a other health professional (Immunization Coordinator) refers to a three unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX23 (route, lot number, expiration date were not reported, dose 0.5 ml). Concomitant therapies included ADACEL. On an unknown date the patients received PNEUMOVAX23 and ADACEL in different arms during the same office visit. On an unknown date the patients experienced severe pain, swelling and tenderness at the injection site. It was unspecified by reporter if the severe pain, swelling and tenderness at the injection site occurred in the arm where the PNEUMOVAX 23 was administered. The patients did not seek medical attention. The outcome of the events were not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Pt. received MENVEO on (L) deltoid as well as TDAP after 24 hrs MENVEO site had slight cellulitis. Told to do cold compresses to site and BENADRYL. marked area with pen; no fever; told if site got bigger to be seen in office. Mom understood plan.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Application site cellulitis
Clinical narrative: Pt. received MENVEO on (L) deltoid as well as TDAP after 24 hrs MENVEO site had slight cellulitis. Told to do cold compresses to site and BENADRYL. marked area with pen; no fever; told if site got bigger to be seen in office. Mom understood plan.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reported that her arm hurts red hot and sore at the site of injection. She feels nauseous and dizzy and also reported numbness in the arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Patient reported that her arm hurts red hot and sore at the site of injection. She feels nauseous and dizzy and also reported numbness in the arm.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Approximately on an unknown date in 2003, the patient was vaccinated with doses 1 and 2, RECOMBIVAX HB (lot #, expiration date and route not reported). The patient was in the office on approximately 29-APR-2013 (reported as now) to receive dose 3, RECOMBIVAX HB (lot#, expiration date and route not reported) which would be late. No symptoms reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 1 day after vaccine started with redness (L) thigh --> spread despite ice, BENADRYL - warm to touch 9 x11 cm.
Age: 0.35
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Client's mother called to report patient stated she felt some dizziness and passed out "later in the evening" on day she received rabies vaccination. Stated mother did not witness this and that could have been from "low blood sugar" as she experienced this one other time in past. Mother stated she saw MD this am (prior appointment) and "he wasn't too concerned."
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood culture negative, Chest X-ray normal, Full blood count, Pyrexia, Rash generalised
Clinical narrative: 4/25/13 fever > 101 could not bend (R) knee started on Azithromycin took 1 dose. Developed a full body rash 4/28 started clindamycin after rash.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: X-ray limb
Clinical narrative: 4/25/13 fever > 101 could not bend (R) knee started on Azithromycin took 1 dose. Developed a full body rash 4/28 started clindamycin after rash.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Culture, Myositis, Scan
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 2 year old male patient. The patient had no pertinent medical history. On 12-APR-2013 the patient was vaccinated with PNEUMOVAX 23, .5 ml, intramuscular. Lot number, expiry date and dose number were not reported. Concomitant therapies included AUGMENTIN for an unknown indication which was given two weeks prior to the date of vaccination. On 13-APR-2013, reported as 24 hours after onset of therapy the patient experienced cellulitis (hospitalization) and inflammation of the muscles (hospitalization). The dates of hospitalization were not reported. Unspecified cultures and scans were taken at the hospital, the results were not reported. The patient present status was reported as recovering, the event(s) from which the patient was recovering was not specified. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PNC13
Symptoms: Laryngitis, Vomiting
Clinical narrative: Patient received PREVNAR 13 on 4-16-13. TC from patient this pm (5-2-13) reporting he has had vomiting since 4-17-13. He is able to keep water down. Also now reports laryngitis.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Back pain, Blood test, Injection site pain, Lumbar puncture, Muscular weakness
Clinical narrative: Developed soreness at the site of vaccine (Rt delt). After 7 days Lt shoulder pain, then low back pain and in legs, (rubbery and weak). Pain bilateral upper extremities.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Developed soreness at the site of vaccine (Rt delt). After 7 days Lt shoulder pain, then low back pain and in legs, (rubbery and weak). Pain bilateral upper extremities.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. Approximately on an unknown date in April 2012, the patient was vaccinated with a dose of (Merck) VARIVAX (lot#, expiration date and route not reported) instead of ZOSTAVAX due to a human error. No adverse effect reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt came in next day to show us her (L) deltoid was red and warm to touch and swollen.
Age: 62.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 62 year old patient(gender unknown). No medical history was reported. On 29-APR-2013, the patient was vaccinated with a dose of (merck) VARIVAX (lot number, expiry not reported) instead of (merck) ZOSTAVAX due to human error. No concomitant medications were reported. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth, redness of entire left upper arm, onset 24 hours after vaccination.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Somnolence
Clinical narrative: 15 min after receiving vaccine became drowsy. VS stable. Observed x 30 min - seen in ER later in the day due to excessive drowsiness, symptoms continue.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Gaze palsy, Pallor, Somnolence
Clinical narrative: Mother states pt turned pale and eyes rolled back in his head and fell asleep. This reaction was not observed by Dr or nurse.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Rash developed on upper (R) arm from elbow to shoulder. Red and itchy. Slightly warm to touch. Developed day after vaccine.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever developed 4-6 hrs after vaccine and continued to next morning. Loose stool with intermittent vomiting. No rash.
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Mumps, Parotid gland enlargement
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 30 year old male patient (not from this country otherwise healthy) with an unknown immunization status, no pertinent medical history and no drug reaction/allergies. On 10-APR-2013 the patient was vaccinated with a dose of M-M-R II (lot # H012572, exp. 29-JUN-2014) 0.5 ml, subcutaneously. There was no concomitant medication. On 19-APR-2013, the patient developed swollen glands, specifically parotid and postauricular, and lymphadenopathy. Nurse stated the patient presently felt well and his vitals were fine, no rash, no fever but concerned about mumps. The outcome of the events was unknown. The patient contacted nurse practitioner and visited office for medical attention. No treatment was given for the event and no lab diagnostics studies were performed. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Feeling abnormal, Headache, Pain in extremity, Pyrexia
Clinical narrative: At 01:30 AM, patient woke up crying and had a low-grade fever, she vomited, and then went back to sleep for approximately 30 minutes. She awoke again with a general sense of feeling bad, fever (100 degrees), headache, and arm pain. She continues these symptoms now and it is 06:15am. I will call the doctor when their office opens, but I wanted to report this adverse reaction.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: At 01:30 AM, patient woke up crying and had a low-grade fever, she vomited, and then went back to sleep for approximately 30 minutes. She awoke again with a general sense of feeling bad, fever (100 degrees), headache, and arm pain. She continues these symptoms now and it is 06:15am. I will call the doctor when their office opens, but I wanted to report this adverse reaction.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Chief complaint of increased redness, warmth, and pain with palpation at the site of a shingles vaccine on the left upper arm (at the triceps area).  Patient received the shingles vaccine two days ago.
Age: 54.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Oedema peripheral, Pyrexia
Clinical narrative: Returns to hospital for 2nd vaccine in series. C/o of fever, myalgias, arm with some swelling but lessened.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Induration, Oedema peripheral
Clinical narrative: Pronounced left arm edema and induration.
Age: 48.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Vertigo-like dizziness with nausea upon waking up in the morning.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Chills, Crying, Decreased activity, Decreased appetite, Headache
Clinical narrative: Fever of 102, chills (indicated by goosebumps), headache (assumed by child not wanting to lift head at times & crying), loss of appetite, fussy/crying, listless/cranky/not as active as usual.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Irritability, Listless, Piloerection, Pyrexia
Clinical narrative: Fever of 102, chills (indicated by goosebumps), headache (assumed by child not wanting to lift head at times & crying), loss of appetite, fussy/crying, listless/cranky/not as active as usual.
Age: 36.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Rash
Clinical narrative: Rash around mouth, spread toward left eye. Primary physican rx prednisone.
Age: 46.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: CLIENT EXPERIENCED REDNESS AND SWELLING AT INJECTION SITE IN LEFT ARM 8 CM TIMES 12 CM IN CIRCUMFERENCE.  ALSO EXPERIENCE HEADACHE, LOW GRADE FEVER, AND BODY ACHES.  CLIENT TO TAKE IBUPROFEN FOR PAIN AND FEVER AND APPLY HYDROCORTISONE CREAM TO AREA.  MAY TAKE BENADRYL AS TOLERATED.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash generalised
Clinical narrative: RASH ALL OVER BODY 3 DAYS AFTER VACCINATION- STARTED ON FACE AS 3 DOTS THEN INCREASED DAILY TO ALL OVER THE BODY. BENADRYL 2.5ML  EVERY 6 HOURS, GO TO ER IF CONDITION WORSENS.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema
Clinical narrative: Left arm was red in a large area from the upper arm into the lower arm.  Actual injection site was not red, no swelling etc. It appeared to be more of a cellulitis and was treated by the MD as such.
Age: 1.91
Sex: F
Vaccine: RVX
Symptoms: Irritability, Pruritus, Somnolence, Urticaria
Clinical narrative: Hives, itching, irritability and sleepiness.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Induration, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: 4/10/13 - Pain at site of injection, difficulty lifting arm, up all night with pain. Seen by MD. Possible local myositis. 4/11/13 - Woke up with rash on arm above her elbow, hot to touch and feels like a hard lump under skin. See by MD. Cellulitis of arm treated with KEFLEX.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mass, Pain, Rash, Skin warm
Clinical narrative: 4/10/13 - Pain at site of injection, difficulty lifting arm, up all night with pain. Seen by MD. Possible local myositis. 4/11/13 - Woke up with rash on arm above her elbow, hot to touch and feels like a hard lump under skin. See by MD. Cellulitis of arm treated with KEFLEX.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Facial pain, Fatigue, Headache
Clinical narrative: Left cheek and jaw pain, followed by erythematous macular rash on trunk (primarily on left side), headache, fatigue, diarrhea, chills.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Rash macular
Clinical narrative: Left cheek and jaw pain, followed by erythematous macular rash on trunk (primarily on left side), headache, fatigue, diarrhea, chills.
Age: 1.11
Sex: F
Vaccine: MMRV, PNC13, VARCEL
Symptoms: Incorrect storage of drug, No adverse event, Wrong drug administered
Clinical narrative: This spontaneos report as received from a licensed practical nurse refers to a 13 month old female patient. On 11-APR-2013, the patient was vaccinated with improperly stored (Merck) PROQUAD (lot # H020137, expiry date, route and dose were not reported) tht was exposed to refrigerator temperatures not greater than 46F for 30 days (720 hours). The reporter stated that the patient was mistaenly administered (Merck) PROQUAD instead of M-M-R II. The patient also received a first dose of (Merck) VARIVAX (Lot number, expiry date, route and dose were not reported) on this same day. No adverse symptoms reported. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 week old male patient. On approximately 04-APR-2013 the patient was vaccinated with the first dose of ROTATEQ (lot# unspecified) at age 16 weeks. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# unspecified). On an unknown date the patient developed a shingles rash in her mouth 2-3 years after receiving the vaccine. The outcome of shingles rash in her mouth was unknown. The patient was treated with VALTREX. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient without drug reactions/allergies. On 16-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H019999, Exp. 02-FEB-2014) subcutaneously for shingles prevention. On 16-APR-2013, shortly after the vaccine was administered the patient experienced redness around the injection site. Redness around the injection site was still present on 23-APR-2013. The pharmacist mentioned the redness was about the size of a quarter initially and had now progressed to be about 2 inches down from the injection site. The outcome of redness around the injection site was reported as recovering/resolving. The patient contacted pharmacist. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a physician refers to a 14 month old female patient. The patient had no pertinent medical history or drug allergies. On 14-FEB-2013, the patient was vaccinated with a dose of VARIVAX (Merck), (lot number reported as H015137, expiry date 09-AUG-2014, route was subcutaneous). Concomitant medications were not reported. On 24-APR-2013, the patient developed shingles after receiving a dose of VARIVAX (Merck). The patient developed dermatomal rash on the legs. The rash was not painful. The physician sent the lesions for the analysis and confirmed that the rash was shingles. The patient was treated with Acyclovir. The outcome of the reported events were unknown. The patient sought medical attention (saw physician). Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test, Asthma, Blood immunoglobulin G, Blood immunoglobulin M, Bronchitis
Clinical narrative: This spontaneous report was received from a licensed vocational nurse on behalf of the physician refers to a 37 year old male patient. The patient has asthma, recurrent bronchitis, chronic sinusitis and shingles. On an unknown date, the patient may have been vaccinated with a dos eof VARIVAX (Merck) (lot number, expiry date and route was not reported) as a child (at unspecified age and nurse unsure if administration occurred). Concomitant medications were not reported. On an unknown date, the patient is suffering from asthma, recurrent bronchitis and chronic sinusitis. The patient stated that he had experienced multiple and frequent episodes of shingles as an adult (unspecified age of onset). Herpes zoster titer was performed results were IGG (Blood immunoglobulin G) was lesser than 0.91 and IGM (Blood immunoglobulin M) which was also lesser than 0.91. Treatment for shingles was unspecified. The patient also stated that he visited the emergency room on 14-MAR-2013. Chest x ray resulted in diagnosis of bronchitis. Treatment rendered for the events included ROCEPHIN, AZITHROMYCIN, DECADRON, CEFTAN, MEDROL, promethezine with codeine. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest X-ray abnormal, Chronic sinusitis, Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received from a licensed vocational nurse on behalf of the physician refers to a 37 year old male patient. The patient has asthma, recurrent bronchitis, chronic sinusitis and shingles. On an unknown date, the patient may have been vaccinated with a dos eof VARIVAX (Merck) (lot number, expiry date and route was not reported) as a child (at unspecified age and nurse unsure if administration occurred). Concomitant medications were not reported. On an unknown date, the patient is suffering from asthma, recurrent bronchitis and chronic sinusitis. The patient stated that he had experienced multiple and frequent episodes of shingles as an adult (unspecified age of onset). Herpes zoster titer was performed results were IGG (Blood immunoglobulin G) was lesser than 0.91 and IGM (Blood immunoglobulin M) which was also lesser than 0.91. Treatment for shingles was unspecified. The patient also stated that he visited the emergency room on 14-MAR-2013. Chest x ray resulted in diagnosis of bronchitis. Treatment rendered for the events included ROCEPHIN, AZITHROMYCIN, DECADRON, CEFTAN, MEDROL, promethezine with codeine. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Gave expired vaccine RotaTeq. Vaccine expired on 4/26/2013, date vaccinated was 4/30/2013.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: Large swelling area, red skin color, very sore to touch or move the arm.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site induration, "Swelling in the Deltoid Area where shot was given 2.5"x2.75"; Redness, itching, hot and hard to the touch. The redness and hardness spreading.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Gave expired RotaTeq on 4/30/13. RotaTeq expired on 4/26/13.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Expired RotaTeq given to patient. RotaTeq expired on 4/26/2013.
Age: 0.74
Sex: F
Vaccine: HIBV, IPV
Symptoms: Crying, Eye disorder, Irritability, Muscle spasms, Pyrexia
Clinical narrative: Atypical fussiness, crying, restlessness, pink sick-looking eyes, 101F fever started around 10:00 PM (May 1) and has continued on until 03:00 PM on 05/02/2013 (ongoing at date/time of this notification). Muscle spasms last night.
Age: 0.74
Sex: F
Vaccine: HIBV, IPV
Symptoms: Restlessness
Clinical narrative: Atypical fussiness, crying, restlessness, pink sick-looking eyes, 101F fever started around 10:00 PM (May 1) and has continued on until 03:00 PM on 05/02/2013 (ongoing at date/time of this notification). Muscle spasms last night.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Headache, Neck pain, Pain, Pharyngeal oedema
Clinical narrative: Body aches, headache, sore neck, throat feels swollen, 99.5 temp.
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Unevaluable event
Clinical narrative: No
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood electrolytes normal, Blood pressure increased, Computerised tomogram head normal, Dizziness, Feeling abnormal
Clinical narrative: Patient became dizzy, spacey and tremulous and c/o stabbing headache.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Headache, Tremor
Clinical narrative: Patient became dizzy, spacey and tremulous and c/o stabbing headache.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, IPV, PNC13
Symptoms: Agitation, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Fever, agitated, arm red and swollen, baseball size.
Age: 0.23
Sex: F
Vaccine: HIBV, MNQ
Symptoms: Convulsion, Diet refusal, Dyskinesia, Mobility decreased
Clinical narrative: Baby couldn't move her leg. She was shrieking for close to an hour. She refuses to nurse until approx 9pm. She has fitful sleep accompanied by "what can best be described as "jerking" until approx 4am.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: L deltoid with erythema, warmth, induration, mimimally tender to palpation. Recommended cold compressed, ibuprofen PRN for pain.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Chills, Haematuria, Heart rate increased, IgA nephropathy, Laboratory test
Clinical narrative: I had the chills, fever of 103, high pulse. On 27-JUL-2012, I started gross hematuria. It was a lot of blood that lasted for five days, slowly dwindling. The doctors tested me for everything but this virus, i.e. cysts, kidney stones, etc.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Pyrexia
Clinical narrative: I had the chills, fever of 103, high pulse. On 27-JUL-2012, I started gross hematuria. It was a lot of blood that lasted for five days, slowly dwindling. The doctors tested me for everything but this virus, i.e. cysts, kidney stones, etc.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Here for 4 y/o physical on 4/29/13. Given izs and (L) upper arm swollen, hot, red, 10 cm x 10 cm area when seen on 5/1/13 at 5pm.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (R) arm, red and swollen, painful from injection on 4-29-13.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: On 4/18/13 patient called the Pharmacy and complained of redness and itching at the site. He said it started frontal then moved to the back of the arm up to the top of the shoulder. The patient called the doctor and the doctor suggested ZYRTEC.
Age: 29.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Vomiting
Clinical narrative: PNEUMOVAX inj. subQ given in (L) arm at 3:30 pm 04/23/13. Patient assistant 1 episode of vomiting in evening on 04/23. assistant erythema at site, increasing in size. Patient advised to go to ER/Urgent Care. Patient went to clinic on 04/24/13. Put on antibiotics, cold compress, anti-inflammatories.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Rt arm swollen.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Lt arm was swollen and red.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Movement disorder, Neck pain, Rash
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 65 year old female patient. The patient has osteopenia, dyslipidemia and sulfa gives patient a rash. On 30-APR-2013, the patient was vaccinated with a dose of 0.5 ML (milliliter) PNEUMOVAX23 (lot # reported as H01775, expiry date 04-JUL-2014). Concomitant therapies included TYELNOL, WELLBUTRIN, VALPARIN, estradiol, gabapentin, glucosamine sulfate, BONIVA, ATIVAN, METAMUCIL and Vitamins (unspecified). Approximately on 30-APR-2013 (reported as within last 24 hours at the time of this report), the patient experienced neck pain (disability) and could barely move her left arm (disability). The nurse believed that PNEUMOVAX23 was given in the shoulder joint instead of the deltoid muscle. At an unspecified time patient used NEOSPORIN (manufacturer unknown) and it caused rash. There was no treatment rendered for the events. There were no lab diagnostics performed. At the time of this report the patient had not recovered from the reported events. The patient sought medical attention (saw the physician). Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 10 year old female patient. No medical history was reported. On an unknown date approximately in 2004 at the age of 1 year, the patient was vaccinated with (merck) VARIVAX (lot #, expiry not reported)dose 1, subcutaneously. On an unknown date approximately in 2007 at the age of 4 years, the patient was vaccinated with (merck) VARIVAX (lot #, expiry not reported) dose 2, subcutaneously. No concomitant medications were reported. On 29-APR-2013(two days ago), the patient experienced zoster like rash on the trunk. The rash was red, vesicular, with no exudates, and no report of pain at rash site. No treatment was received. Patient sought medical attention (unspecified). The company representative expressed his concern that it might be an Merck strain zoster virus. Therapy with (merck) VARIVAX was discontinued 4 years ago (approximately April 2009). The outcome of zoster like rash was reported as not recovered. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients (no demographic details were provided). No medical history was provided. The pharmacist mentioned that sometimes, ZOSTAVAX stings for a moment when administered to a patient. ZOSTAVAX was administered subcutaneous. No further dosing information and no administration dates were provided. Furthermore, no co-suspected or concomitant medications were reported. It was reported that medical attention was sought in the pharmacy, due to the adverse event. The onset date of the adverse event stings for a moment was not specified. The outcome of stings for a moment was reported as recovered/resolved. The reporter did not provide a causality assessment for ZOSTAVAX and the adverse event. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager who was working in physician's office. Office manager reported that the office improperly stored GARDASIL (dose, lot number and expiration date not reported). Reporter also stated that she didn't know if any dose were administered to any patients. No adverse events were reported. Additional information has been requested.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Injection site haemorrhage, Vaccination site oedema
Clinical narrative: Ecchymosis and edema presented at vaccination site 4 days after vaccine. Dr consulted with allergist on 3/17/13. Referred to allergist. Mother has not returned calls for follow-up.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (LPN) concerning a female patient of unknown age. The patient received GARDASIL (dose, route and lot number was not reported) on 17-OCT-2012, 18-DEC-2012 and 04-MAR-2013. No adverse effect reported. No PQC involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age who on an unknown date, was vaccinated with 0.65 ml dose of ZOSTAVAX (dose, route and lot number not reported). It was reported that approximately three weeks after receiving ZOSTAVAX on an unknown date, the patient experienced shingles. At the time of the report, the patient's outcome was unknown. The relatedness for shingles and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown ages. On an unknown date, the patients were vaccinated with 0.5 ml doses of VARIVAX (Merck) (lot # not reported) subcutaneously. The nurse reported that on an unknown date, the patients were given VARIVAX (Merck) and then got chickenpox. There were no Lab diagnosis or studies performed. The outcome of chickenpox was unknown. Additional information has been requested.
Age: 1.13
Sex: M
Vaccine: MMR, MMRV
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 month old patient. On 25-APR-2013 the patient was vaccinated with MMR II (dose 1, subcutaneous, concentration and lot number unknown). On the same day the patient was also vaccinated with PROQUAD (dose 1, subcutaneous, concentration and lot number unknown). No adverse effect was reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 06-AUG-2007, the patient received the first dose of GARDASIL (lot number, dose and route not reported). On 08-OCT-2007 the patient was vaccinated with the second dose of GARDASIL (lot number, route and dose not reported). It was reported that the patient was concerned because the she wasn't sure if she had the third dose of GARDASIL or not. No adverse effect reported. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Dizziness, Erythema, Eye colour change, Hyperhidrosis
Clinical narrative: Case number PHHY2013US000482, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 469164) web site on 02 Jan 2013 with the follow-up received from Quality Assurance Department (reference number: 209127) on 02 May 2013. This report refers to a 23-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with MENVEO (batch number: A11077) intramuscularly into the left arm on 08 Oct 2012. On the same day, the patient experienced sweating, lightheadedness, nausea, vomiting, diarrhea, fever and numbness throughout his body. Patient also noticed his eyes were white without the normal coloring. Patient also had a site-reaction of swelling, and redness to his left arm. The outcome of the events was condition unchanged. The seriousness and causality assessment was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: A11077 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality Assurance Department on 02 May 2013: Updated batch review report.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Case number PHHY2013US000482, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 469164) web site on 02 Jan 2013 with the follow-up received from Quality Assurance Department (reference number: 209127) on 02 May 2013. This report refers to a 23-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with MENVEO (batch number: A11077) intramuscularly into the left arm on 08 Oct 2012. On the same day, the patient experienced sweating, lightheadedness, nausea, vomiting, diarrhea, fever and numbness throughout his body. Patient also noticed his eyes were white without the normal coloring. Patient also had a site-reaction of swelling, and redness to his left arm. The outcome of the events was condition unchanged. The seriousness and causality assessment was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: A11077 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality Assurance Department on 02 May 2013: Updated batch review report.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Case number PHHY2013US000482, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 469164) web site on 02 Jan 2013 with the follow-up received from Quality Assurance Department (reference number: 209127) on 02 May 2013. This report refers to a 23-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with MENVEO (batch number: A11077) intramuscularly into the left arm on 08 Oct 2012. On the same day, the patient experienced sweating, lightheadedness, nausea, vomiting, diarrhea, fever and numbness throughout his body. Patient also noticed his eyes were white without the normal coloring. Patient also had a site-reaction of swelling, and redness to his left arm. The outcome of the events was condition unchanged. The seriousness and causality assessment was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: A11077 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality Assurance Department on 02 May 2013: Updated batch review report.
Age: 17.0
Sex: M
Vaccine: FLU3, HEPA, IPV, MNQ
Symptoms: Asthenia, Dyskinesia, Pallor, Posture abnormal, Seizure like phenomena
Clinical narrative: Case number PHHY2013US000608, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 472288) web site on 02 Jan 2013 with the follow-up received from Quality Assurance Department (reference number: 209115) on 30 Apr 2013. This report refers to a 17-year-old male patient. His current condition included cough. The patient did not have any other illness, afebrile with body temperature 97.8 degree Fahrenheit. Concomitant medication was not reported. On 22 Oct 2012, he was vaccinated with MENVEO (batch number: M11051), intramuscularly into left arm; FLUZONE (batch number: UH716AD) IM into left arm; HAVRIX (batch number: AHAVB515BA) IM into right arm and IPOL (batch number: H1330) IM into right arm. On the same day around 2:25 PM, the patient's head dropped and appeared to slump forward after last shot was given. 2 jerks and seizure-like activity was observed in right arm and chest. The patient "came to" and on inquiry verbalized "feeling weak". Complexion was pale. The patient was sitting in chair with legs raised and was then transferred to stretcher. Vitals on stretcher at 2:33 PM, reported blood pressure 113/75, pulse 58, oxygen 97%. He was transferred to EMS squad after vitals. Complexion improved. The final outcome of the events was recovered. The seriousness and causality assessment was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO vaccine (batch number: M11051) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality Assurance Department on 30 Apr 2013: Updated batch review report.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Deafness bilateral, Ear, nose and throat examination normal, Fatigue, Rhinorrhoea
Clinical narrative: Same day of shot...experienced flu/allergy like symptoms runny nose, fatigue, watery eyes & muffled/plugged ears. Flu/allergy symptoms went away in a few days. Muffled/plugged ears did not. Diagnosis: Eustachian tube dysfunction.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Eustachian tube dysfunction, Fatigue, Hypersensitivity, Hypoacusis, Influenza
Clinical narrative: Same day of shot...experienced flu/allergy like symptoms runny nose, fatigue, watery eyes & muffled/plugged ears. Flu/allergy symptoms went away in a few days. Muffled/plugged ears did not. Diagnosis: Eustachian tube dysfunction.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lacrimation increased, Rhinorrhoea
Clinical narrative: Same day of shot...experienced flu/allergy like symptoms runny nose, fatigue, watery eyes & muffled/plugged ears. Flu/allergy symptoms went away in a few days. Muffled/plugged ears did not. Diagnosis: Eustachian tube dysfunction.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Periarthritis, X-ray normal
Clinical narrative: Pain, stiffness, and limited range of movement in left shoulder.  Difficulty sleeping at night.  Frozen shoulder.  Completed 6 weeks of physical therapy.  Helped somewhat but still having symptoms.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Insomnia, Joint range of motion decreased, Musculoskeletal stiffness, Pain, Periarthritis
Clinical narrative: Pain, stiffness, and limited range of movement in left shoulder.  Difficulty sleeping at night.  Frozen shoulder.  Completed 6 weeks of physical therapy.  Helped somewhat but still having symptoms.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray limb normal
Clinical narrative: Pain, stiffness, and limited range of movement in left shoulder.  Difficulty sleeping at night.  Frozen shoulder.  Completed 6 weeks of physical therapy.  Helped somewhat but still having symptoms.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Injection site redness and rash, treated on 5/2/13 with Zyrtec and ultravate.  Patient to start falters only if blistering occurs.