chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old female patient with opiates allergy. The patient was vaccinated SC. with a dose of ZOSTAVAX (lot number was 0364AE, expired date 16-MAR-2013) on 29-AUG-2012. No other co-suspects were reported. Concomitant medications included clonazepam, ESTRACE, hyoscyamine and VIVELLE-DOT. On 30-AUG-2012 the patient developed a cold sore in her left nostril, headache in her left temple and a left ear pain. No treatment information was reported. No lab diagnostic performed. The patient had called the pharmacy for medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. On 10-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) subcutaneously. On the same day the patient had a sensation at the injection site like a biting. The patient stated itching, and burning at the site. The patient sought for medical attention by seeing her physician who advised her to take BENADRYL. The outcome was unknown. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) on 12-SEP-2012. The patient was not experiencing any known symptoms. It was unspecified whether the patient had sought medical attention or not. The outcome was unknown. This is one of several reports received from same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was intramuscularly vaccinated with a dose of 0. 5ml PNEUMOVAX23 (lot # 669579/0595AA) on 12-SEP-2012. The patient was not experiencing any known symptoms. It was unspecified whether the patient had sought medical attention or not. The outcome was unknown. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to multiple patients of unknown age. The patients were vaccinated with a dose of ZOSTAVAX, (lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit is -5C. At the time of the call, he does not know which lot numbers were involved, how long the storage unit was set at -5C, nor how many patients have received the improperly stored doses of ZOSTAVAX. He did not know if any patients had experienced any adverse effects. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old female patient. The patient was vaccinated with a dose of VARIVAX (Merck) (Lot # not reported) on an unspecified date when patient was 4 years old. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on an unknown date, the patient experienced shingles-like rash on her right arm. The sought medical attention by an office visit. The outcome of shingles like rash on her right arm was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with PNEUMOVAX23 (lot # 669579/0595AA, expiration date 30-AUG-2012) that expired (reporter stated that expired on 31-AUG-2012) on 06-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age with a history of previous cancer who on an unspecified date was vaccinated a dose of ZOSTAVAX (lot #, dose and site of administration were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced shingles. No treatment was given for the adverse event. It was reported that the patient advised to his doctor. At the time of the report, the outcome of shingles was unknown. Additional information has been requested.
Age: 29.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old patient of unknown gender, who on 27-AUG-2012 was vaccinated with a dose of M-M-R II 0.5 ml, SQ, rHA, lot # (667246/0907Z) that had expired on 09-JUL-2012. No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 65 years old female patient with codeine allergy and no pertinent medical history. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (Lot # not reported) IM on 05-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 10-SEP-2012, the patient experienced redness, swelling and warmth at the injection site, and was having difficulty moving her arm. The patient was recommended to take ADVIL and TYLENOL. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (lot number, dose and route not reported) on 21-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-JUN-2012 the patient experienced cellulitis. The patient sought medical attention by visiting emergency room and was treated with CIPRO. The outcome of cellulitis was reported as recovered/resolved. The relatedness for cellulitis was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with the first 0.5 ml dose of VAQTA (lot # not reported) on 23-MAR-2012. The medical assistant reported that the patient was vaccinated intramuscularly with the second 0.5 ml dose of VAQTA (lot # not reported) on 04-SEP-2012, which was a little earlier than the recommended interval of 6 months. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient with unspecified age, with no pertinent medical history or drug reactions / allergies. The pharmacist stated that the patient was vaccinated subcutaneously in the triceps with 0.65 ml dose ZOSTAVAX on 20-AUG-2012. No other co-suspects were reported. Concomitant therapies included "a lot" (therapies unspecified). On 21-AUG-2012 the patient experienced at injection site a knot that was the size of a fist, hot to the touch, redness and heat spreading to the elbow. The reaction was worse at the time of report. The patient would saw the primary care physician in 2 days. At the time of report, the patient had not recovered. The patient call the pharmacist for medical attention. The patient would be put ice on affected area. There were not diagnostic test performed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a pediatric patient of unknown age who on 13-SEP-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot number 0363AE, Exp. Date: 16-MAR-2013) instead of intended VARIVAX (Merck). This would have been the patient's second dose of VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This spontaneous report was received from a female registered nurse reporting on herself who on an unknown date, was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that at an unspecified time in the past, she experienced sore muscle at her left deltoid. She believed that vaccine was administered intramuscularly (also reported as subcutaneously). No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. The relatedness for the patient developed a sore muscle on her left deltoid was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed injection site redness an a small rash 5 days after she received the vaccination. The patient sought medical attention by contacting the pharmacist. No treatment was given for the events. The outcome of injection site redness and small rash was unknown. The relatedness for injection site redness and small rash was not provided for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age who a year ago, in approximately September 2011, was vaccinated with a 0.65 ml dose ZOSTAVAX (route and lot number not reported) at unspecified pharmacy. No other co-suspects were reported. No concomitant medications were reported. The physician reported that a year ago, in approximately September 2011, the patient developed cellulitis. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient developed cellulitis was unknown for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer refers to his daughter a female patient of unknown age allergic to neomycin. The patient was vaccinated with PEDVAXHIB (manufacturer unknown) on an unspecified date. Other suspect therapies included DTaP (manufacturer unknown). No concomitant medications were reported. The consumer reported that the patient had the vaccine and had a skin rash and blew up on an unknown date. The patient was given BENDARYL as treatment. The reporter was not completely sure if his daughter received PEDVAXHIB (manufacturer unknown). The consumer mentioned that his daughter may have received DTaP (manufacturer unknown) also. The outcome of skin rash and blew up was unknown. The relatedness of skin rash and blew up was not provided for PEDVAXHIB (manufacturer unknown). Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report was received from a 79 years old female consumer reporting on herself with no pertinent medical history and allergy to anything with antihistamines, who on 20-JUN-2012, was vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. Concomitant medications included: CLARITIN. The consumer reported that on 21-JUN-2012, she had severe swelling and redness for two days, after receiving ZOSTAVAX. No treatment was given for the experience. No lab diagnostics studies were performed. It was stated that the event started to clear on the third day and the consumer recovered after a week on 30-JUN-2012. The consumer believed that it was an allergic reaction. The patient did not seek medical attention. The relatedness for patient had severe swelling, redness and an allergic reaction was unknown for ZOSTAVAX. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Burning sensation, Herpes zoster
Clinical narrative: This spontaneous report as received from a 75 years old female consumer refers to herself. The patient had none pertinent medical history. The patient had drug allergies to cortisone/prednisone. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported) subcutaneously on 14-AUG-2012. Concomitant medications included: blood pressure, thyroid, cholesterol pills and vitamin D. It was reported that after having the vaccine the patient developed a burning sensation around her shoulders and back of her neck on 15-AUG-2012. The patient sought for medical attention via an ER visit. And the sensation was diagnosed as shingles. BENADRYL was given as treatment. Unspecified blood work tests were performed, no results provided. It was reported that the adverse event came and went. The outcome was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. The patients were vaccinated with doses of M-M-R II (doses, routes, lot numbers not reported) which were reconstituted with expired sterile water diluent (expiration date May 2012). The nurse noted that 1 or 2 doses were administered on 01-AUG-2012 and approximately 9 other doses were administered on unspecified days. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.09
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 1 month old patient who on 15-AUG-2012, was vaccinated with a 0.5 ml dose of RECOMBIVAX HB (lot number 666026/1455Y) (route not reported) that was expired. The vaccine expired on 03-AUG-2012. No adverse effects had been demonstrated by the patient. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 60 years old patient with no pertinent medical history and no drug reactions or allergies, who on 05-SEP-2012, was vaccinated "possibly intramuscularly" with one 0.65 ml dose of ZOSTAVAX (lot number 0422AE, Exp. Date: 27-MAR-2013). No other co-suspects were reported. No concomitant medications were reported. On 06-SEP-2012, the patient developed bruising and redness at injection site area after possible intramuscular administration of ZOSTAVAX. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. The relatedness for patient developed bruising and redness at injection was unknown for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Oral pain, Swelling
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) last Wednesday (on 05-SEP-2012). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that a couple of days after she had gotten the vaccine she felt that the left side of her mouth inside and out was hurting. The patient also felt that her jaw was swollen. No rash was reported. The patient sought medical attention by talking to the pharmacist. No treatment information was reported. The outcome of left side of her mouth inside and out was hurting and felt that her jaw was swollen was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated IM. into deltoid instead of subcutaneous with a dose of ZOSTAVAX on approximately 17-AUG-2012 (reported as "1 to 2 weeks ago"). No other co-suspects were reported. No concomitant medications were reported. In August 2012 (reported as "couple days after injection") the patient experienced redness and swelling at injection site. No treatment information was reported. The relatedness for redness and swelling at injection site was unknown for ZOSTAVAX. No lab diagnostics were performed. The patient had contacted pharmacist. At the time of report, the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient who was vaccinated with a dose of M-M-R II (lot # 668070/1059Z; Exp Date 11-AUG-2012) on 29-AUG-2012 which was expired. No known adverse effects. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Age: 1.23
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash pustular, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 years old male patient with no known allergies. The patient was vaccinated with VARIVAX (lot # (666872/0473Z), expiration date: 31-MAR-2012, dose unknown) on 12-OCT-2011. No other co-suspects were reported. No concomitant medications were reported. On 29-AUG-2012 the patient developed chicken pox. The nurse reported that the patient had about 40 pustules on the trunk and legs that were itchy, without fever. Treatment of over the counter AVEENO was given for the adverse event. The outcome of chicken pox was reported as not recovered/not resolved. The relatedness for chicken pox is unknown for VARIVAX. No lab diagnosis studies performed. The patient sought medical attention via office visiting. Additional information is not expected.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous report as received from a registered nurse via Sanofi Pasteur refers to a 39 years old male patient with no known allergies and none illness at time of vaccination. The patient's medical history included coarctation of aortal repair in 1977. The patient was vaccinated with the third dose of PNEUMOVAX 23 (lot # 672962/0025AE) intramuscularly on his left deltoid at 04-SEP-2012 11:00 am. No other co-suspects were reported. There were no concomitant medications. At 05-SEP-2012 6:00 am the patient noticed area of redness measuring 8cm x 3cm and area warm to touch with skin intact, afebrile. It was unspecified if the patient had sought medical attention. There were no relevant diagnostics tests or laboratory data. The outcome of area of redness and area warm to touch was unknown at time of this report. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Polymerase chain reaction, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male patient with attention deficit disorder and no drug allergy who on 08-JUL-2003 was vaccinated with the first dose of VARIVAX (Merck) and on 04-JAN-2009 was SC vaccinated the second 0.5 ml dose of VARIVAX (Merck). Concomitant therapy included FOCALIN. On 25-JUN-2012 the patient had been diagnosed with shingles. The vesicular lesions were distributed on the left arm. The patient sought medical attention by office visit. No treatment was given at the time of the report. No lab diagnostics study was performed. At the time of report, the patient was not recovered. Follow up information has been received from the physician concerning a 9 year old male patient with attention deficit disorder and drug allergies to penicillin and steroid, with no history of chickenpox, who on 04-JAN-2009, was SC vaccinated the second 0.5 ml dose of VARIVAX (Merck) on the right arm (lot# 658182/1559U; Exp Date 27-SEP-2009). Vesicle/lesion sample was obtained on 25-JUN-2012. There were many cluster of tiny red vesicular distributed to the left arm and hand of the patient. The patient had not recent exposure to chickenpox or shingles. Follow-information has been received on 19-JUL-2012. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. It was reported that on 25-JUN-2012, a lesion specimen was obtained from a vesicular lesion on left forearm. It was reported that varicella zoster virus (VZV) DNA was amplified. It was also stated that beta-globin DNA was amplified. The PCR result from the vesicular specimen identified vaccine type varicella zoster virus (VZV) strain. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cystitis, Diarrhoea, Headache, Injection site erythema, Injection site reaction
Clinical narrative: This spontaneous report as received from a 50 years old female healthcare worker with no pertinent medical history or drug reactions refers to herself. The patient was vaccinated SC into left arm with 0.65 ml ZOSTAVAX (lot number not reported) on 21-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 22-AUG-2012 the patient developed a red, raised, hot area the size of a half dollar, on her left arm, at the injection site. She also stated that her left arm became swollen from her shoulder to her elbow. The healthcare worker stated that she also experienced a headache, tingling in her mouth, face and tongue, diarrhea, a bladder infection and hives (the caller stated that this was not a rash, per her physician, but hives) after receiving ZOSTAVAX. The patient had taken phone call and office visit to physician and was treated with MEDROL, CIPRO and PYRIDIUM. The outcome of the patient was reported as recovering/resolving. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Paraesthesia, Urticaria
Clinical narrative: This spontaneous report as received from a 50 years old female healthcare worker with no pertinent medical history or drug reactions refers to herself. The patient was vaccinated SC into left arm with 0.65 ml ZOSTAVAX (lot number not reported) on 21-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 22-AUG-2012 the patient developed a red, raised, hot area the size of a half dollar, on her left arm, at the injection site. She also stated that her left arm became swollen from her shoulder to her elbow. The healthcare worker stated that she also experienced a headache, tingling in her mouth, face and tongue, diarrhea, a bladder infection and hives (the caller stated that this was not a rash, per her physician, but hives) after receiving ZOSTAVAX. The patient had taken phone call and office visit to physician and was treated with MEDROL, CIPRO and PYRIDIUM. The outcome of the patient was reported as recovering/resolving. Additional information has been requested.
Age: 0.05
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 17 days old patient. The patient was vaccinated with the first, second, third and fourth dose of RECOMBIVAX HB (dose, route and lot number not provided) respectively on 28-JUL-1997, 11-AUG-1997, 24-SEP-1997 and 09-FEB-1998. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from medical assistant (also reported as doctor's nurse) refers to a 7 years old male patient. On unknown date, the patient was vaccinated with the first dose of Hep A (manufacturer unknown) (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient had injection site reaction with a sunburn appearance, redness and swelling at the injection site. The patient sought unspecified medical attention. Patient was treated with ice and BENADRYL. At the time of report, the second dose of Hep A (manufacturer unknown) was not given (also reported as not reintroduced). It was reported that the patient's events resolved (date unspecified). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. The patients were vaccinated with doses of VARIVAX (Merck) (doses, routes, lot numbers not reported) which were reconstituted with expired sterile water diluent (expiration date May 2012). The nurse noted that 1 or 2 doses were administered on 01-AUG-2012 and approximately 9 other doses were administered on unspecified days. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient was given ZOSTAVAX and had a reaction with "redness, swelling, pain and warmth at the injection site and the reaction was about 3" in diameter". It took about 2-3 weeks for the reactions to go away. The patient was recovered at the time of report. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 months old male patient. The patient's medical history was reported as ventricular septal defect (VSD). The patient was vaccinated with the first dose of VARIVAX (lot# was reported as 0079AE) subcutaneous on right thigh on 07-AUG-2012 2:49pm. The patient had no illness at time of vaccination. On 07-AUG-2012 the patient developed redness and swelling at immunization site. On 20-AUG-2012 the patient was seen with several vesicles at immunization site. Spoke with mom on 24-AUG-2012, rash had resolved for the most part. The outcome of patient was reported as recovered on 24-AUG-2012. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac disorder, Cardiac monitoring, Heart rate increased, Hyperhidrosis
Clinical narrative: This spontaneous report as received from a 66 year old male consumer refers to himself with no drug reactions or allergies. The patient's concurrent condition included diabetes and sleep apnea. The patient's medical history included heart ablation. On 14-JUL-2012, the patient was vaccinated with dose 1, 0.65 ml ZOSTAVAX (lot# unspecified) subcutaneously. Other co-suspects included BYDUREON. Concomitant medications included ALTACE, JANUMET, SINGULAIR, warfarin, SPIRIVA, metoprolol, CRESTOR, pantoprazole, hydrocodone and LOVAZA. After getting the ZOSTAVAX vaccine, the patient mentioned his heart had been acting funny. He was perspiring more and his pulse rate was up. He did not think it was the vaccine because he had heart problems prior to getting the vaccine and this did not start until a couple weeks ago. He thought it was an experimental drug, BYDUREON (manufacturer unknown), he was currently on. The patient called to HCP and his cardiologist put him on a heart monitor for 48 hours and has not yet heard the results. The patient was going to his cardiologist to discuss it. Unspecified treatment for the adverse events was given. At the time of reporting, the patient had not recovered from all reported adverse events. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 19 patients. The patients received M-M-R II (lot# reported as 0679AE; expired date: 02-APR-2014) that was reconstituted with expired sterile diluent (lot# reported as 6103Y; expired date: February 2012). The patients received M-M-R II sometime between 27-AUG-2012-31 to 31-AUG-2012. No concomitant medications were reported. Pharmacist stated their wholesaler sent them expired diluent. The patients were not experiencing known symptoms. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a adult patient of unknown age. The patient was vaccinated with the first dose of M-M-R II (dose and lot # unknown) on 19-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. The adult patient's titer for Mumps was low after receiving a first dose of M-M-R II. The titer was drawn on 05-SEP-2012. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal sensation in eye, Eye swelling, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report was received from a 68 years old female patient. The patient was vaccinated with ZOSTAVAX one dose injection on 28-AUG-2012. Lot# and route were unspecified. Concomitant medication included lisinopril (manufacturer unknown). On 02-SEP-2012 the patient experienced shingles. On 04-SEP-2012, the patient developed a rash all over the left side of her face. On 05-SEP-2012, the reactions became much worse. The patient said it felt like "there are millions of needles in her eye" and her left eye was almost completely swollen. In addition, her "left ear feels like there is stinging in it". On 06-SEP-2012, the patient went to her physician and was prescribed medications. They were: acyclovir, gabapentin, and hydrocodone acetaminophen 7.5-325m. The patient still had shingles and was not recovered yet. No lab diagnostic study was performed. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with, .5 ml VARIVAX injection by subcutaneously on 03-SEP-2012 (lot: 0966Z, pending lot validation, expired date: 21-JUL-2012). On 03-SEP-2012, the patient received VARIVAX that was expired. The patient was not experiencing any known symptoms. The outcome for the event was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Dizziness, Dyspnoea, Hypersensitivity, Swollen tongue
Clinical narrative: All of our patients are advised to stay with us for 10 to 15 minutes after vaccination administration. Within 10 minutes of recieving the vaccine, patient reported a headache. Within 20 minutes, the patient report difficulty breathing. EMT was call and patient sent to Emergency Room.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Headache
Clinical narrative: All of our patients are advised to stay with us for 10 to 15 minutes after vaccination administration. Within 10 minutes of recieving the vaccine, patient reported a headache. Within 20 minutes, the patient report difficulty breathing. EMT was call and patient sent to Emergency Room.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Confusional state, Influenza virus test, Neurological examination, Pyrexia, Seizure like phenomena
Clinical narrative: Pt. received GARDASIL #3 at 4pm 9-10-12. At 10 pm high tactile fever, chills, rigor. Given TYLENOL at 3 AM pt began sleep walking, speaking deliriously and shaking arms in rhythmical movement no F at this time 5:30 AM pt began having fever of 103 again. In office no fingers except fever & chills.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Somnambulism
Clinical narrative: Pt. received GARDASIL #3 at 4pm 9-10-12. At 10 pm high tactile fever, chills, rigor. Given TYLENOL at 3 AM pt began sleep walking, speaking deliriously and shaking arms in rhythmical movement no F at this time 5:30 AM pt began having fever of 103 again. In office no fingers except fever & chills.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chills, Delirium, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Pt. received GARDASIL #3 at 4pm 9-10-12. At 10 pm high tactile fever, chills, rigor. Given TYLENOL at 3 AM pt began sleep walking, speaking deliriously and shaking arms in rhythmical movement no F at this time 5:30 AM pt began having fever of 103 again. In office no fingers except fever & chills.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pyrexia, Somnambulism, Tremor
Clinical narrative: Pt. received GARDASIL #3 at 4pm 9-10-12. At 10 pm high tactile fever, chills, rigor. Given TYLENOL at 3 AM pt began sleep walking, speaking deliriously and shaking arms in rhythmical movement no F at this time 5:30 AM pt began having fever of 103 again. In office no fingers except fever & chills.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chills, Delirium, Dyskinesia, Pyrexia, Somnambulism
Clinical narrative: Pt. received GARDASIL #3 at 4pm 9-10-12. At 10 pm high tactile fever, chills, rigor. Given TYLENOL at 3 AM pt began sleep walking, speaking deliriously and shaking arms in rhythmical movement no F at this time 5:30 AM pt began having fever of 103 again. In office no fingers except fever & chills.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, raised bump at site of injection (right deltoid) about 1 inch in diameter.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain and stiffness to right arm.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to his/her 78 years old mother. The patient was vaccinated with 0.5 ml PNEUMOVAX 23 (lot number was not reported) by subcutaneous or intramuscular injection in her left arm on an unknown date in 2011. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in 2011 the patient experienced an injection site reaction. Her left arm swelled up with a huge red "knot." The patient was hospitalized, and had recovered on an unknown date. The patient had sought unspecified medical attention. Additional information is not expected.
Sex: M
Vaccine: MNQ
Symptoms: Bacterial test positive, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24-year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and one month after vaccination developed meningococcal sepsis, year reported as 2008 (Q 4). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MNQ
Symptoms: Bacterial test positive, Death, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19-year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and three months after vaccination developed meningococcal sepsis, year reported as 2007 (Q 3). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. The patient's outcome was fatal. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Pt calls to report red area, approx size of baseball, to left arm where he received TDAP. TDAP administered 9/15/12 & pt first noticed today, 9/17/12. Advised ice & anti-inflammatories, come in to office if no better.
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Unevaluable event
Clinical narrative: Initial report received from scientific literature on 04 September 2012. This case is not valid as no identified patient (subjects). The following is verbatim: "Background: The global spread of a novel influenza A (H1N1) virus in 2009 led the Health Organization (HO) to declare a pandemic. Vaccine manufacturers worldwide dramatically increased efforts for pandemic H1N1 vaccine production, to make it available to a sizable proportion of the world's population. Objectives: To investigate the feasibility of globally concerted vaccine safety assessment according to the same protocol as a proof of concept. To test the association between H1N1 vaccination and Guillain Barre Syndrome (GBS) first detected in 1976 with the introduction of the swine flu vaccine. Methods: The primary outcome of interest was the relative incidence of GBS in the 42 days following vaccination with monovalent adjuvanted and non-adjuvanted pandemic H1N1 vaccine. Cases were identified using hospital or population based health care databases. This included sentinel hospitals and databases of countries choosing to participate. All patients with GBS hospitalized in the selected institutions during the study period were classified according to the Brighton Collaboration case definition of GBS. Data analysis using the self-controlled case series method is being performed with both a pooled data set and a meta-analytic approach. Results: In total, 546 cases of GBS from 15 countries were included in the study. One hundred and forty-seven subjects with Brighton Collaboration levels 1, 2 or 3 were exposed to pandemic H1N1 vaccine, 78 of which were adjuvanted, 61 of which were non-adjuvanted vaccines, and 8 of which had missing adjuvant data. The self-controlled case series analysis is ongoing. Conclusions: This study demonstrates that a global collaboration with a common protocol is feasible and should allow for estimation of relative incidence of adverse events following exposure to different formulations of the same vaccine." The patients' outcomes were not reported. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial report was received on 04 September 2012 via a search of the scientific literature. The following is verbatim per the report: "Background: Annually, over 2 million are administered influenza vaccinations. As of the 2010-2011 influenza season, the safety of the influenza vaccine was actively monitored nationally. Possible associations between potential adverse events of interest and influenza vaccination were evaluated at the end of the influenza season. Objectives: The goal of this study was to determine the safety of the 2010-2011 influenza vaccinations in the population treated. Methods: Integrated automated databases were used to identify patients who were diagnosed with Guillain-Barre Syndrome (GBS), idiopathic thrombocytopenic purpura (ITP), and Bell's palsy from 10/1/10 to 3/31/11 as identified by ICD-9 code. The influenza vaccination status for these patients was determined using the Immunization Package database in addition to the integrated automated and prescription databases. Adverse event rates in the risk period (within 1-42 days) were compared to rates in the non-risk period (43 days or after) in terms of incidence rate ratios (IRR) using the self controlled case series method. Only vaccinated cases were included. Seasonality was included to account for possible fluctuation of disease occurrence over the calendar time. Results: Approximately 2.1 million received the influenza vaccines (including 42,375 high-dose vaccines) from 10/1/10 to 3/31/11. A total of 38 GBS, 81 ITP, and 575 Bell's palsy post-vaccinated cases were identified. No significant risks for GBS (IRR = 2.07 and 95% CIs =0.59-7.24), ITP (IRR = 0.71, 95% CIs = 0.32-1.59), and Bell's palsy (IRR = 0.90, 95% CIs = 0.67-1.22) were observed for patients who received the regular dose influenza vaccines. Similarly, no significant increased risk for Bell's palsy (IRR = 1.13, 95% CIs = 0.21-6.02) was observed for patients who received high-dose influenza vaccines. There were no GBS and ITP cases after high dose vaccines. Conclusions: There was no evidence of increased risks of GBS, ITP, and Bell's palsy following 2010-2011 influenza vaccinations in the population treated in the health care system." The reporter for this case is the same as for case number 2012-08441. Documents held by sender: None.
Sex: M
Vaccine: MNQ
Symptoms: Bacterial test positive, Meningitis meningococcal, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24 year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and 4 months after vaccination developed meningococcal meningitis and sepsis, year reported as 2009 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.