chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Epstein-Barr virus antibody positive, Erythema nodosum, Eye swelling, Headache
Clinical narrative: 1 day after GARDASIL developed fever, myalgias, swollen eyes; diagnosed with "mono". Monospot (+) however EBV titers all negative. Never felt completely well -> recurrent myalgias, swollen glands, headache. EBV IgG titers (+) 11/08. Multiple complaints myalgias, knee pain; erythema nodosum diagnosed 4/09.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis, Lymphadenopathy, Malaise, Mononucleosis heterophile test positive, Myalgia
Clinical narrative: 1 day after GARDASIL developed fever, myalgias, swollen eyes; diagnosed with "mono". Monospot (+) however EBV titers all negative. Never felt completely well -> recurrent myalgias, swollen glands, headache. EBV IgG titers (+) 11/08. Multiple complaints myalgias, knee pain; erythema nodosum diagnosed 4/09.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: 1 day after GARDASIL developed fever, myalgias, swollen eyes; diagnosed with "mono". Monospot (+) however EBV titers all negative. Never felt completely well -> recurrent myalgias, swollen glands, headache. EBV IgG titers (+) 11/08. Multiple complaints myalgias, knee pain; erythema nodosum diagnosed 4/09.
Age: 8.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: About 24h after vaccination, child developed 11cm diam red tender indurated lesion on right deltoid centered at varicella injection site. By 48h, increased tenderness. By 72h - almost completely resolved.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site rash
Clinical narrative: 1 cm raised patch ~ 1cm above MMR injection site in right arm, occurred almost immediately after injection. Child observed for ~20min. Rash enlarged to 1.5cm, no spread to other area and no breathing problems. Diphenhydramine 5ml given.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Lacrimation increased, Loss of consciousness, Pallor
Clinical narrative: Pt A and O x3. HPV given L deltoid. Pt passed out 1-2 secs after vaccine given. Pt arousable. A and O x 3. Vital signs stable. Pt tearful and pale. Pt states she had not eaten or drank anything. Pt given 8 oz apple juice.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local redness and swelling 4 days after vaccines R arm- TDAP 5 1/2 - 6cm. L arm- MENACTRA 4x4 5cm.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blister, Oedema peripheral
Clinical narrative: Swelling: blistering of arm.
Age: 1.2
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Erythema, Swelling
Clinical narrative: 1- Vaccine and Anaphylactic reaction reaction 10 minutes after vaccination patient presents, generalized swelling, erythema, cough, shortness of breath, vomiting / Epinephrine 1:1000 @ 15 cc administered with good results.
Age: 1.2
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Vomiting
Clinical narrative: 1- Vaccine and Anaphylactic reaction reaction 10 minutes after vaccination patient presents, generalized swelling, erythema, cough, shortness of breath, vomiting / Epinephrine 1:1000 @ 15 cc administered with good results.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: Pt given PNEUMOVAX in left deltoid. Skin got red, hot, erythematous. Pain in arm started within 2 hrs of getting shot. Using ice prn, otc Benadryl 25mg 1 q 6 hours prn + Cephalexin 500mg 1 TID # 15.
Age: 4.0
Sex: M
Vaccine: HIBV
Symptoms: Wrong technique in drug usage process
Clinical narrative: Vaccine Administration error HIB vaccine mixed with Merck DILUENT for MMR DILUENT Lot # 4060X Exp Dec 2010
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient developed a 3cm erythematous, warm, circular area at site of injection the morning after she received it. Treatment - Benadryl PO prn, Motrin prn, cool compresses.
Age: 85.0
Sex: F
Vaccine: DT
Symptoms: Injection site irritation, Injection site pruritus
Clinical narrative: Pt states started burning itchy area on site area that night and next day Rtc - got more down arm - said took BENADRYL 2 days that helped - so didn't call us. Inside near elbow area wasn't red until Sunday. Denies any SOB or trouble breathing - just itchy and scratchyed.
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Injection site nodule, Pain in extremity, Tenderness
Clinical narrative: Left arm soreness, tenderness, knot @ site, no redness.
Age: 53.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Abdominal discomfort, Confusional state, Headache, Memory impairment, Muscle spasms
Clinical narrative: 30 min- after given, sudden onset head ache stomach pressure and nausea, last 2 hours with sudden relief. Also during this time family noted Pt had some episodes of mild confusion and forgetfulness. During night calf, ankle and foot cramping (bilateral). All resolved in AM.
Age: 53.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Nausea
Clinical narrative: 30 min- after given, sudden onset head ache stomach pressure and nausea, last 2 hours with sudden relief. Also during this time family noted Pt had some episodes of mild confusion and forgetfulness. During night calf, ankle and foot cramping (bilateral). All resolved in AM.
Age: 53.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Headache, Nausea
Clinical narrative: 30 min- after given, sudden onset head ache stomach pressure and nausea, last 2 hours with sudden relief. Also during this time family noted Pt had some episodes of mild confusion and forgetfulness. During night calf, ankle and foot cramping (bilateral). All resolved in AM.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm is red, swollen from deltoid to elbow warm & tender to touch.  Referred to PMD. & this office to follow up with mother on Monday 7-13-09.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness at injection site, left deltoid, measuring approximately 4cm. long, 3cm. wide. Warm to touch, no pain, knot approximately 2cm. round, itching.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Wrong drug administered
Clinical narrative: ANTHRAX WAS GIVEN AS PPD. 0.1 ANTHRAX GIVEN INSTEAD OF TST.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Wrong drug administered
Clinical narrative: SERVICE MEMBER GIVEN ATHRAX 0.1 ML INSTEAD OF TST.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Arm and head have hurt enough to prevent sleep. Some 30 hours after innoculation chills and fever were experienced for about an hour.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Seizure 7:30PM on 7/10/09 and at 8:30am while asleep. 8/5/09 Primary care provider medical records received DOS 6/17/09 to 7/14/09. Includes portion of neurological consultation records previously abstracted and coded. Assessment: Seizures. Parent has informed primary care provider that child has had 3 seizures since vaccine administration.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Dysphagia, Injection site pustule, Lymph node pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Multiple pustules at site of inoculation spreading to Pt's neck, chest and arms. Sore throat with minimal exudate on (R) tonsil, difficulty swallowing, mild fever, rhinorhea. Anterior cervical lymph node TTP. Lung sounds clear bilat.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular, Rhinorrhoea
Clinical narrative: Multiple pustules at site of inoculation spreading to Pt's neck, chest and arms. Sore throat with minimal exudate on (R) tonsil, difficulty swallowing, mild fever, rhinorhea. Anterior cervical lymph node TTP. Lung sounds clear bilat.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Facial palsy
Clinical narrative: FACIAL PALSY(RIGHT SIDE) DAY AFTER ADMINISTRATION NO OTHER COMPLAINT REFERD BY PT. NO FEVER GENERAL MALAISE OR HEADACHE.EVALUATED BY ENT GIVEN MEDROL PO AND ALSO NEUROLOGIST WHO GAVE PT ACICLOVIR PO.SENT TO PHYSIOLOGIST FOR PHYSICAL THERAPY.CAME TO PEDIATRICIAN WHO ADMINISTRATED VACCINES TO INFORM HER OF SYPMTOMS.GIVEN VITAMIN B COMPLEX,REASSURANCE AND REFERD FOR PHYSICAL  THERAPY.
Age: 0.1
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: On  Tues.7th my 5 week old daughter was given a Hepatitis A vaccine by a medical assistant in my doctors office. She was supposed to get the second round of her Hepatitis B vaccine and the person that I was told was a nurse giving her the shot gave the wrong one. I notified the doctors office as soon as I realized their mistake. As I said my daughter is 5weeks old and the Hep. A immunization is not supposed to be given until 12 to 23 months. I was told by my doctor that the vaccination would not harm her and would have no lasting side effects.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swollen (slight), looks reddish (as if hit by tennis ball on left arm.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: after the third vaccine of GARDISIL i stoped getting my period, now if i dont take birth controls i wont get my period.
Age: 24.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Blood pressure, Body temperature, Headache, Heart rate, Respiratory rate
Clinical narrative: Woke up at 0200 with pounding headache, and took excedrine. Came into clinic this morning for follow up after receiving 2 vaccines yesterday. Pulse 78, RR 12, Temp 100.1, and BP 128/84. Sligt tenderness around eyes, possible sinuitis.
Age: 24.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Tenderness
Clinical narrative: Woke up at 0200 with pounding headache, and took excedrine. Came into clinic this morning for follow up after receiving 2 vaccines yesterday. Pulse 78, RR 12, Temp 100.1, and BP 128/84. Sligt tenderness around eyes, possible sinuitis.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Alcohol use, Chills, Headache, Myalgia, Pain
Clinical narrative: CHills, myalgias, headache all started around 11pm last night. Also had a "few drinks" last evening. Chief complaint today: headache, aches. Denies vomiting, nausea and diarrhea. Temp 99.2, BP: 108/92, Pulse: 68
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pyrexia
Clinical narrative: CHills, myalgias, headache all started around 11pm last night. Also had a "few drinks" last evening. Chief complaint today: headache, aches. Denies vomiting, nausea and diarrhea. Temp 99.2, BP: 108/92, Pulse: 68
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Joint range of motion decreased, Malaise, Musculoskeletal pain, Pain in extremity
Clinical narrative: 3 weeks after Tdap vaccine, awakened with painful, hands and feet, malaise, fatigue. Initially would occur as frequent episodes. Pain was symetrical occuring in hands feet, arms. Now have several episodes per week when I am unable to use extremity involved until it runs it's course of hours to days. I am now being treated for palindromic rheumatism with humira and methyltrexate so far without results. I had a previous diptheria/tetanus vaccine  in 1974 with swelling of upper arm and malaise. treated with benedryl and resolved. In 1978 contacted hepatitis B from a needle stick. Had severe arthralgias and myalgias until becoming jaundiced when they dissappeared for a few weeks and then returned lasting episodically for several years (about 6)always assoc with general feeling of being unwell.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella vaccine breakthrough.  Had varivax on 1/14/03.  Diagnosed in our office today with Varicella.  Had over 50 lesions.  No fever.  Had mild case of varicella, physician diagnosed, on 7/5/07 as well.  That case was previously reported to VAERS and the health department.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Lip swelling, Metabolic function test, Mouth ulceration, Rash
Clinical narrative: Information has been received from a physician concerning a 67 year old female with leukopenia, Grave's disease, hypertension and congestive heart failure and no known drugs allergies, who on 07-AUG-2008 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included SYNTHROID, hydrochlorothiazide (manufacturer unknown), aspirin, ALLEGRA and nystatin. On 08-AUG-2008 the patient developed swelling of her lips and tongue, then a rash on her legs, chest and buttocks and periodically mouth ulcers. the patient had a complete blood count and a metabolic profile (results unspecified). The patient sought medical attention at an office visit. As of 09-MAR-2009 the patient had recovered from the rash on legs, chest and buttocks; but lips and tongue swelling and mouth ulcers persisted. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: Information has been received from a physician concerning a 67 year old female with leukopenia, Grave's disease, hypertension and congestive heart failure and no known drugs allergies, who on 07-AUG-2008 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included SYNTHROID, hydrochlorothiazide (manufacturer unknown), aspirin, ALLEGRA and nystatin. On 08-AUG-2008 the patient developed swelling of her lips and tongue, then a rash on her legs, chest and buttocks and periodically mouth ulcers. the patient had a complete blood count and a metabolic profile (results unspecified). The patient sought medical attention at an office visit. As of 09-MAR-2009 the patient had recovered from the rash on legs, chest and buttocks; but lips and tongue swelling and mouth ulcers persisted. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dental discomfort, Myalgia
Clinical narrative: Information has been received from a physician concerning a 71 year old female patient with no pertinent medical history who in May 2007, was vaccinated with ZOSTAVAX (Merck) (lot # not unspecified). Concomitant suspect therapy included alendronate sodium (MSD) (dose, duration, formulation and indication not reported). The physician stated that the patient developed myalgia 2 to 3 weeks after administration of ZOSTAVAX (Merck). She was referred to a rheumatologist who prescribed high dose steroids (unspecified). The patient developed unbearable dental pain. The physician discontinued alendronate sodium and steroids. The patient was examined by a dentist. It was reported that the patient will have her dental implants removed a later date. The patient sought medical attention at the physician's office. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on unspecified date was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) by subcutaneous route. The patient experienced a rash and goose egg at the injection site that was hot and painful. The patient had sought unspecified medical attention. At the time of reporting, the outcome of patient's rashes was unknown. Follow-up information indicated that a 59 years old patient who was vaccinated with ZOSTAVAX (Merck) (lot#663638/1706X). This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on unspecified date was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) by subcutaneous route. The patient experienced a rash and goose egg at the injection site that was hot and painful. The patient had sought unspecified medical attention. At the time of reporting, the outcome of patient's rashes was unknown. Follow-up information indicated that a 59 years old patient who was vaccinated with ZOSTAVAX (Merck) (lot#663638/1706X). This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Rash, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female patient with allergy to HCTZ (WAES # 0903USA01581), simvastatin (WAES # 0903USA01582) and CRESTOR, convulsion, hypertension, carotid artery stenosis, hyperlipidaemia, "bronchistasis" and selected IgG subclass deficiency who on 06-JAN-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 662858/1558X) SQ. Concomitant therapy included DILANTIN, gabapentin, atenolol, lorazepam, aspirin, VERAMYST, charcoal, activated and TUMS. On 01-FEB-2009 the patient had an "itchy painful rash" on her neck and an "itchy sensitive area" on her right scapula and under her right breast. There were "regular red papules" on her neck and no lesions on her trunk. The patient was treated with acyclovir 5X daily for 7 days. The patient had sought medical attention. On 25-FEB-2009 the patient recovered from "itchy painful rash" on her neck, "itchy sensitive area" on her right scapula and under her right breast and "regular red papules" on her neck. This is one of several reports from the same source on the same patient. Follow-up information has been received from the registered nurse reported that the patient had recovered. The registered nurse reported that there was no change since the initial report. No further information is available.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hyperaesthesia, Pain, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female patient with allergy to HCTZ (WAES # 0903USA01581), simvastatin (WAES # 0903USA01582) and CRESTOR, convulsion, hypertension, carotid artery stenosis, hyperlipidaemia, "bronchistasis" and selected IgG subclass deficiency who on 06-JAN-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 662858/1558X) SQ. Concomitant therapy included DILANTIN, gabapentin, atenolol, lorazepam, aspirin, VERAMYST, charcoal, activated and TUMS. On 01-FEB-2009 the patient had an "itchy painful rash" on her neck and an "itchy sensitive area" on her right scapula and under her right breast. There were "regular red papules" on her neck and no lesions on her trunk. The patient was treated with acyclovir 5X daily for 7 days. The patient had sought medical attention. On 25-FEB-2009 the patient recovered from "itchy painful rash" on her neck, "itchy sensitive area" on her right scapula and under her right breast and "regular red papules" on her neck. This is one of several reports from the same source on the same patient. Follow-up information has been received from the registered nurse reported that the patient had recovered. The registered nurse reported that there was no change since the initial report. No further information is available.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Hypotonic-hyporesponsive episode, Pallor
Clinical narrative: Pale and subdued x15-20 min. Responsive to voice and touch. Looked as if "he was going to vomit." No emesis. HR and resp. wnl according to Grandma who is a pediatrician. No seizure activity
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Pallor
Clinical narrative: Pale and subdued x15-20 min. Responsive to voice and touch. Looked as if "he was going to vomit." No emesis. HR and resp. wnl according to Grandma who is a pediatrician. No seizure activity
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stomatitis
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female nurse with a history of cold sores (but never on her eyes or nose before) who on 05-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot #663174/1552X). On 08-FEB-2009, 3 days after vaccination, the patient developed cold sores on her lips. About 8 days after vaccination the patient developed cold sores on her nose and eyes. Subsequently, the patient recovered on unspecified dates. The patient worked in the ER and may have consulted a doctor she worked with. Follow up information was received from the registered nurse concerning the patient with no illness at time of vaccination who on 08-FEB-2009 developed sores on lip approximately 3-4 days after receiving vaccine. She then developed sores on her nose as well as around her eyes on 13-FEB-2009, 8 days after receiving vaccine. The patient recovered on unspecified dates. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes ophthalmic, Oral herpes
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female nurse with a history of cold sores (but never on her eyes or nose before) who on 05-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot #663174/1552X). On 08-FEB-2009, 3 days after vaccination, the patient developed cold sores on her lips. About 8 days after vaccination the patient developed cold sores on her nose and eyes. Subsequently, the patient recovered on unspecified dates. The patient worked in the ER and may have consulted a doctor she worked with. Follow up information was received from the registered nurse concerning the patient with no illness at time of vaccination who on 08-FEB-2009 developed sores on lip approximately 3-4 days after receiving vaccine. She then developed sores on her nose as well as around her eyes on 13-FEB-2009, 8 days after receiving vaccine. The patient recovered on unspecified dates. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 63 year old female patient with penicillin, sulfonamide, codeine, MOTRIN, and compazine allergies and no liver or kidney problems who on approximately 10:00 AM 02-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663893/0128Y) SQ. No immediate reaction was reported. On 03-MAR-2009 the patient noticed itching at 10:00. By 03-MAR-2009 afternoon the patient experienced injection site red, swollen, hard and hot. The patient had applied ice and diphenhydramine cream with minimal results. The patient had been seen by the physician and was diagnosed with cellulitis. Cephalosporins 500 mg QID and ATARAX 25 mg were prescribed for the treatment of cellulitis. The outcome of the cellulitis was not reported. Follow-up information has been received from the registered pharmacist that on approximately 10:00 02-MAR-2009 the 63 year old female patient with no illness and allergies at the time of vaccination was vaccinated with her first dose of ZOSTAVAX (Merck) (lot # 663893/0128Y) SQ. On 03-MAR-2009 the patient noticed itching of her arm. By 03-MAR-2009 afternoon the patient noticed injection area red, swollen, hard and hot. The patient had applied ice and diphenhydramine cream with minimal results. The patient was diagnosed with cellulitis. Cephalosporins 500 mg QID for 10 days was prescribed for the treatment of cellulitis. The outcome of the cellulitis was not reported. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 63 year old female patient with penicillin, sulfonamide, codeine, MOTRIN, and compazine allergies and no liver or kidney problems who on approximately 10:00 AM 02-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663893/0128Y) SQ. No immediate reaction was reported. On 03-MAR-2009 the patient noticed itching at 10:00. By 03-MAR-2009 afternoon the patient experienced injection site red, swollen, hard and hot. The patient had applied ice and diphenhydramine cream with minimal results. The patient had been seen by the physician and was diagnosed with cellulitis. Cephalosporins 500 mg QID and ATARAX 25 mg were prescribed for the treatment of cellulitis. The outcome of the cellulitis was not reported. Follow-up information has been received from the registered pharmacist that on approximately 10:00 02-MAR-2009 the 63 year old female patient with no illness and allergies at the time of vaccination was vaccinated with her first dose of ZOSTAVAX (Merck) (lot # 663893/0128Y) SQ. On 03-MAR-2009 the patient noticed itching of her arm. By 03-MAR-2009 afternoon the patient noticed injection area red, swollen, hard and hot. The patient had applied ice and diphenhydramine cream with minimal results. The patient was diagnosed with cellulitis. Cephalosporins 500 mg QID for 10 days was prescribed for the treatment of cellulitis. The outcome of the cellulitis was not reported. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 63 year old female patient with penicillin, sulfonamide, codeine, MOTRIN, and compazine allergies and no liver or kidney problems who on approximately 10:00 AM 02-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663893/0128Y) SQ. No immediate reaction was reported. On 03-MAR-2009 the patient noticed itching at 10:00. By 03-MAR-2009 afternoon the patient experienced injection site red, swollen, hard and hot. The patient had applied ice and diphenhydramine cream with minimal results. The patient had been seen by the physician and was diagnosed with cellulitis. Cephalosporins 500 mg QID and ATARAX 25 mg were prescribed for the treatment of cellulitis. The outcome of the cellulitis was not reported. Follow-up information has been received from the registered pharmacist that on approximately 10:00 02-MAR-2009 the 63 year old female patient with no illness and allergies at the time of vaccination was vaccinated with her first dose of ZOSTAVAX (Merck) (lot # 663893/0128Y) SQ. On 03-MAR-2009 the patient noticed itching of her arm. By 03-MAR-2009 afternoon the patient noticed injection area red, swollen, hard and hot. The patient had applied ice and diphenhydramine cream with minimal results. The patient was diagnosed with cellulitis. Cephalosporins 500 mg QID for 10 days was prescribed for the treatment of cellulitis. The outcome of the cellulitis was not reported. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a registered pharmacist concerning a 63 year old female patient with penicillin, sulfonamide, codeine, MOTRIN, and compazine allergies and no liver or kidney problems who on approximately 10:00 AM 02-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663893/0128Y) SQ. No immediate reaction was reported. On 03-MAR-2009 the patient noticed itching at 10:00. By 03-MAR-2009 afternoon the patient experienced injection site red, swollen, hard and hot. The patient had applied ice and diphenhydramine cream with minimal results. The patient had been seen by the physician and was diagnosed with cellulitis. Cephalosporins 500 mg QID and ATARAX 25 mg were prescribed for the treatment of cellulitis. The outcome of the cellulitis was not reported. Follow-up information has been received from the registered pharmacist that on approximately 10:00 02-MAR-2009 the 63 year old female patient with no illness and allergies at the time of vaccination was vaccinated with her first dose of ZOSTAVAX (Merck) (lot # 663893/0128Y) SQ. On 03-MAR-2009 the patient noticed itching of her arm. By 03-MAR-2009 afternoon the patient noticed injection area red, swollen, hard and hot. The patient had applied ice and diphenhydramine cream with minimal results. The patient was diagnosed with cellulitis. Cephalosporins 500 mg QID for 10 days was prescribed for the treatment of cellulitis. The outcome of the cellulitis was not reported. No further information is available.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia facial, Nervousness, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 74 female patient with hypertension and severe osteoarthritis who on 12-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663672/1709X) SQ in the left arm. Concomitant therapy included metoprolol, lisinopril, EVISTA, lactulose and simvastatin. 15 minutes after the dose the patient developed tingling and numbness from her jaw to the base of the left eye. Over the next minute or two the tingling crossed to the mid line of the upper lip. The patient's blood pressure was elevated, but the patient had not taken her medication. She was instructed to take her antihypertensive medication and was observed in the office for an hour. At the office her blood pressure improved and she was discharged to home. The symptoms of tingling and numbness resolved in 3-4 hours. The office called the patient today to follow up with her and stated that she was "doing fine". Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 74 female patient with hypertension and severe osteoarthritis who on 12-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663672/1709X) SQ in the left arm. Concomitant therapy included metoprolol, lisinopril, EVISTA, lactulose and simvastatin. 15 minutes after the dose the patient developed tingling and numbness from her jaw to the base of the left eye. Over the next minute or two the tingling crossed to the mid line of the upper lip. The patient's blood pressure was elevated, but the patient had not taken her medication. She was instructed to take her antihypertensive medication and was observed in the office for an hour. At the office her blood pressure improved and she was discharged to home. The symptoms of tingling and numbness resolved in 3-4 hours. The office called the patient today to follow up with her and stated that she was "doing fine". Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on an unspecified date, was vaccinated with ZOSTAVAX (Merck). On "late December", the patient developed a red streak on her arm when the injection was given. Lot number was not available. The patient's status was unknown. The patient sought medical attention through the pharmacist. Follow-up information was received from the pharmacist indicating that the patient was a 71 year old female patient, with penicillin allergy and hypertension, who on 30-DEC-2008 at 9:30 AM, was vaccinated subcutaneously in the left arm with ZOSTAVAX (Merck) (Lot # 663638/1706X) (Lot valid for VARIVAX (Merck)). There was no illness at the time of vaccination. The pharmacist reported that the patient called him in March to report that she had had a red mark on arm that never went away. The patient went to the pharmacy on 20-MAR-2009 and showed the pharmacist the mark, which was red, not uniform and looked like a birth mark. The site did not bother the patient but the patient stated that she wanted to report the incident and that she was going to the dermatologist. It was also reported that the patient experienced a raised red area around shot site which was still red, not swollen just red. The patient was not in pain, just did not like the mark on her arm. The patient went to see the dermatologist, who said that she had gotten status post "tiangematic M and T", body immune system left mark. The dermatologist also stated it was the bodies' natural response to live virus and that there was no problem. At the time of the report, the patient's outcome was unknown (the dermatologist said that it should have go away). Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on an unspecified date, was vaccinated with ZOSTAVAX (Merck). On "late December", the patient developed a red streak on her arm when the injection was given. Lot number was not available. The patient's status was unknown. The patient sought medical attention through the pharmacist. Follow-up information was received from the pharmacist indicating that the patient was a 71 year old female patient, with penicillin allergy and hypertension, who on 30-DEC-2008 at 9:30 AM, was vaccinated subcutaneously in the left arm with ZOSTAVAX (Merck) (Lot # 663638/1706X) (Lot valid for VARIVAX (Merck)). There was no illness at the time of vaccination. The pharmacist reported that the patient called him in March to report that she had had a red mark on arm that never went away. The patient went to the pharmacy on 20-MAR-2009 and showed the pharmacist the mark, which was red, not uniform and looked like a birth mark. The site did not bother the patient but the patient stated that she wanted to report the incident and that she was going to the dermatologist. It was also reported that the patient experienced a raised red area around shot site which was still red, not swollen just red. The patient was not in pain, just did not like the mark on her arm. The patient went to see the dermatologist, who said that she had gotten status post "tiangematic M and T", body immune system left mark. The dermatologist also stated it was the bodies' natural response to live virus and that there was no problem. At the time of the report, the patient's outcome was unknown (the dermatologist said that it should have go away). Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old female with no medical history or drug allergy who on 27-MAR-2009 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot #663637/1705X). Concomitant therapy included lovastatin (manufacturer unspecified) and FOSAMAX. On 27-MAR-2009, soon after the vaccination, the patient experienced dizziness, nausea and was sweaty. She felt better 10-15 minutes after the adverse event and by the evening when pharmacist spoke to the patient at 19:30-20:00 she had recovered. The patient was with the pharmacist for medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot No: 663639/1707X). Secondary suspect vaccine included a dose of PNEUMOVAX 23 (Lot No: 661740/1408X). The registered pharmacist reported that the patient received ZOSTAVAX (Merck) that was reconstituted with PNEUMOVAX 23. The registered pharmacist reported that on an unknown date, the patient experienced injection site reaction. On an unknown date, the patient recovered. The patient sought medical attention in a physician's visit. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site reaction, Wrong technique in drug usage process
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot No: 663639/1707X). Secondary suspect vaccine included a dose of PNEUMOVAX 23 (Lot No: 661740/1408X). The registered pharmacist reported that the patient received ZOSTAVAX (Merck) that was reconstituted with PNEUMOVAX 23. The registered pharmacist reported that on an unknown date, the patient experienced injection site reaction. On an unknown date, the patient recovered. The patient sought medical attention in a physician's visit. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (Lot No: 663639/1707X). Secondary suspect vaccine included a dose of PNEUMOVAX 23 (Lot No: 661740/1408X). The registered pharmacist reported that the patient received ZOSTAVAX (Merck) that was reconstituted with PNEUMOVAX 23. The registered pharmacist reported that on an unknown date, the patient experienced injection site reaction. On an unknown date, the patient recovered. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site reaction, Wrong technique in drug usage process
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (Lot No: 663639/1707X). Secondary suspect vaccine included a dose of PNEUMOVAX 23 (Lot No: 661740/1408X). The registered pharmacist reported that the patient received ZOSTAVAX (Merck) that was reconstituted with PNEUMOVAX 23. The registered pharmacist reported that on an unknown date, the patient experienced injection site reaction. On an unknown date, the patient recovered. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Periorbital oedema
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female patient with penicillin allergy who on 24-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663893/0128Y) SQ in the left arm. Concomitant therapy included multivitamins and estrogen patch. The patient developed some reactions. The patient had a painful rash and swelling at the injection site. The patient also had bilateral periorbital edema. On 30-Mar-2009 the patient was seen for the swelling of the eyes and was given BENADRYL, TYLENOL and cold compresses. It was noted that she still has slight swelling in the eyes and the injection site was still tender to the touch. The registered also reported that the painful rash was a common reaction seen in many patients (unspecified number of patients, WAES# 0904USA00353). At the time of reporting the patient was recovering from the adverse events. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Periorbital oedema
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female patient with penicillin allergy who on 24-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663893/0128Y) SQ in the left arm. Concomitant therapy included multivitamins and estrogen patch. The patient developed some reactions. The patient had a painful rash and swelling at the injection site. The patient also had bilateral periorbital edema. On 30-Mar-2009 the patient was seen for the swelling of the eyes and was given BENADRYL, TYLENOL and cold compresses. It was noted that she still has slight swelling in the eyes and the injection site was still tender to the touch. The registered also reported that the painful rash was a common reaction seen in many patients (unspecified number of patients, WAES# 0904USA00353). At the time of reporting the patient was recovering from the adverse events. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARZOS, VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old patient who was inadvertently vaccinated with ZOSTAVAX (Merck) due to nursing error. No adverse effect was reported. Follow-up information has been received from the registered nurse that the patient was inadvertently vaccinated with 0.5 mL of ZOSTAVAX (Merck) instead of VARIVAX (Merck) (MSD). The patient was doing fine. The registered nurse grabbed the wrong vial when she administered ZOSTAVAX (Merck). Follow-up information has been received from the registered nurse who reported that the 6 year old female patient with no pertinent medical history reported and no illness at time of vaccination was vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck) (MSD) (lot. 662756/1624X), 0.5 mL, subcutaneously, in the right arm, at 16:00 pm. It was reported that the patient had received previously a dose of VARIVAX (Merck) (MSD) on an unspecified date. At time of reporting no adverse events had been reported. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARZOS, VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old patient who was inadvertently vaccinated with ZOSTAVAX (Merck) due to nursing error. No adverse effect was reported. Follow-up information has been received from the registered nurse that the patient was inadvertently vaccinated with 0.5 mL of ZOSTAVAX (Merck) instead of VARIVAX (Merck) (MSD). The patient was doing fine. The registered nurse grabbed the wrong vial when she administered ZOSTAVAX (Merck). Follow-up information has been received from the registered nurse who reported that the 6 year old female patient with no pertinent medical history reported and no illness at time of vaccination was vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck) (MSD) (lot. 662756/1624X), 0.5 mL, subcutaneously, in the right arm, at 16:00 pm. It was reported that the patient had received previously a dose of VARIVAX (Merck) (MSD) on an unspecified date. At time of reporting no adverse events had been reported. Additional information is not expected.
Age: 68.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Influenza like illness, Pyrexia, Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on unspecified date was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) by subcutaneous route. The patient had shingles in the evening after the injection. The patient had sought unspecified medical attention and was put on antivirals. At the time of reporting, the outcome of patient's shingles was unknown. Follow-up information indicated that the patient was 68 years old and vaccinated with ZOSTAVAX (Merck) (lot#663638/1706X). This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on unspecified date was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) by subcutaneous route. The patient had shingles in the evening after the injection. The patient had sought unspecified medical attention and was put on antivirals. At the time of reporting, the outcome of patient's shingles was unknown. Follow-up information indicated that the patient was 68 years old and vaccinated with ZOSTAVAX (Merck) (lot#663638/1706X). This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Haemorrhage, Injection site erythema, Injection site pruritus, Pain, Pruritus
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 69 year old female who on 03-NOV-2008 was vaccinated subcutaneously with one 0.65 ml dose of ZOSTAVAX (Merck) (lot # 663195/1416X). The patient experienced a rash at the site of vaccine administration in February 2009. At the time of reporting (04-MAR-2009) the patient was recovering. It was noted that the patient also experienced a rash at the injection site shortly after receiving the vaccination. Follow up information was received from a registered Pharmacist concerning the 69 year old patient who was vaccinated with a dose of ZOSTAVAX (Merck) on 03-NOV-2008. The vaccine was given at a pharmacy. It was reported that the patient had pain, swelling and itching which lasted 2 weeks after injection. She didn't do anything then and about a week ago (on approximately 18-FEB-2009) on the injection site was red and itching. She scratched and bled and she was worried. Her doctor told her to put on VASELINE. It healed after a week (approximately 25-FEB-2009). At the time of reporting (11-APR-2009) the patient was fine. The patient sought medical attention and was seen by the physician. No further information is available.
Age: 69.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Scratch, Swelling
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 69 year old female who on 03-NOV-2008 was vaccinated subcutaneously with one 0.65 ml dose of ZOSTAVAX (Merck) (lot # 663195/1416X). The patient experienced a rash at the site of vaccine administration in February 2009. At the time of reporting (04-MAR-2009) the patient was recovering. It was noted that the patient also experienced a rash at the injection site shortly after receiving the vaccination. Follow up information was received from a registered Pharmacist concerning the 69 year old patient who was vaccinated with a dose of ZOSTAVAX (Merck) on 03-NOV-2008. The vaccine was given at a pharmacy. It was reported that the patient had pain, swelling and itching which lasted 2 weeks after injection. She didn't do anything then and about a week ago (on approximately 18-FEB-2009) on the injection site was red and itching. She scratched and bled and she was worried. Her doctor told her to put on VASELINE. It healed after a week (approximately 25-FEB-2009). At the time of reporting (11-APR-2009) the patient was fine. The patient sought medical attention and was seen by the physician. No further information is available.
Age: 69.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 69 year old female who on 03-NOV-2008 was vaccinated subcutaneously with one 0.65 ml dose of ZOSTAVAX (Merck) (lot # 663195/1416X). The patient experienced a rash at the site of vaccine administration in February 2009. At the time of reporting (04-MAR-2009) the patient was recovering. It was noted that the patient also experienced a rash at the injection site shortly after receiving the vaccination. Follow up information was received from a registered Pharmacist concerning the 69 year old patient who was vaccinated with a dose of ZOSTAVAX (Merck) on 03-NOV-2008. The vaccine was given at a pharmacy. It was reported that the patient had pain, swelling and itching which lasted 2 weeks after injection. She didn't do anything then and about a week ago (on approximately 18-FEB-2009) on the injection site was red and itching. She scratched and bled and she was worried. Her doctor told her to put on VASELINE. It healed after a week (approximately 25-FEB-2009). At the time of reporting (11-APR-2009) the patient was fine. The patient sought medical attention and was seen by the physician. No further information is available.