chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, Fall, Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a healthcare worker who refers to a 18 years old female patient (who was not in pregnant) with hypothyroid and no drug allergies/reactions. On 03-OCT-2012, the patient was vaccinated intramuscularly with a first dose of GARDASIL lot # (672233/1561AA, expiry date 26-AUG-2012) (dose and anatomical location not reported). Concomitant medications included: ARMOUR THYROID TABLETS. On 03-OCT-2012, a few minutes after vaccination the patient fainted, after she stood up in the exam room. It was reported that the patient hit her head "very hard" on the floor and E.M.S. was called to transport the patient to the emergency room for unspecified treatment. The patient was "not very responsive" and fainted a second time after "smelling salts" were used after she fainted the first time. The patient did not receive any treatment for adverse events. No lab diagnostic tests were performed. At the time of the report patient's status was reported as not recovered. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 31 years old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated IM. with first dose of, 0.5 ml GARDASIL (lot number reported as "0518AE", expired date 21-NOV-2014) on 25-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnancy before getting the vaccine. Initial exposure to GARDASIL was at 28 week(s) gestation. The patient's LMP was on approximately 13-MAR-2012 and EDD was on approximately 18-DEC-2012. The patient was exposed to GARDASIL during trimester 3. No treatment information was performed. The outcome of the patient was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number not reported) on 13-JUL-2012. The primary reporter was reporting that a patient received the GARDASIL doses on the following dates: 13-JUL-2012, 20-SEP-2012 and 29-SEP-2012. NO adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on 02-AUG-2007 (route, dose and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. ON 05-OCT-2012, the patient was in the office to get the second dose of GARDASIL (route, dose and lot # not reported). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information was received from a registered nurse regarding males who were vaccinated with GARDASIL. She stated that males feel GARDASIL is a painful vaccination. No further information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age. The nurse reported that first and second doses of GARDASIL were almost 2 years apart. The patient was vaccinated with dose 1 GARDASIL (route, dose and lot # not reported) on 19-AUG-2010. On 09-AUG-2012, the patient was vaccinated with dose 2 GARDASIL (route, dose and lot # not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a registered nurse concerning a patient who was vaccinated with GARDASIL. The patient was vaccinated with the first dose of GARDASIL on 05JUN2012, vaccinated with the second dose of GARDASIL on 02AUG2012 and was vaccinated with the third dose of GARDASIL. No adverse event reported. Additional information not expected.
Sex: U
Vaccine: HPV2
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from an office manager who reported a patient (age, sex not reported) was administered CERVARIX for the second dose, instead of GARDASIL. Office manager reported she would have the physician call back and ended the call. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a female patient of unknown age who in August 2011 was vaccinated with a 0.5 ml dose of GARDASIL, IM (Lot # not reported) and on 05-OCT-2012 was vaccinated with a second 0.5 ml dose of GARDASIL, IM (Lot # not reported). No adverse effect was reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Abdominal distension, Culture urine negative, Diarrhoea, Differential white blood cell count normal, Full blood count normal
Clinical narrative: Information has been received from a physician, author of the article, regarding a healthy 2-month-old boy (patient 4) who presented with 3 days of nonbloody diarrhea and 2 days of fever and irritability (also reported as diarrhea none and 4 days of vomiting with a maximum of 3 episodes in 24 hours). On physical exam, he was fussy but consolable with a slightly distended abdomen and hyperactive bowels sounds. Negative laboratory examinations included complete blood count with differential, urinalysis, and urine culture (catheterized). The patient was orally rehydrated and discharged. He received his first dose of Live, Oral, ROTATEQ 2 days before illness onset (also reported as 1 day). Four distinct VP7 genotypes were detected in a specimen obtained 3 days after illness onset: the G1 gene of Live, Oral, ROTATEQ component strain W179-9 (G1P[5]) (100% identity in 116 bases); the G2 gene of strain SC2-9 (G2P[5]) (100% identity in 202 bases); the G4 gene of strain BrB-9 (G4P[5]) (100% identity in 363 bases); and the G6 gene of strain W179-4 (G6P[8]) (99.8% identity in 421 bases). The VP4 P[8] gene (99.9% identity in 835 bases) and VP6 12 (100% identity in 342 bases) genes from Live, Oral ROTATEQ strain W179-4 (G6P[8]) were detected. The VP3 M2 gene matched the sequence of strains W179-4 (G6P [8]), W178-8 (G3P{5]), and BrB-9 (G4P[5]) (100% identity in 500 bases). This specimen appears to contain 4 strains, the W179-4 (G6P[8]) component strain itself and 3 potential reassortant strains each composed of strain W179-4 (G6P[8]) but expressing G1, G2, and G4 individually. Rotaviruses were observed by EM, and real-time Rt-PCR was positive for norovirus genogroup II. All other tests were negative. This patient illustrate a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences include detection of an Live, Oral, ROTATEQ in a recently vaccinated child (patient 4). Patient 4 had diarrhea without respiratory symptoms, the presence of norovirus genogroup II in his fecal specimen along with the potential vaccine-reassortant strains makes it impossible to discern the cause of his illness. The presence of multiple reassortant Live, Oral ROTATEQ strains in patient 4 stool is very unusual, and these findings will be confirmed using an advanced genetic characterization method such as microarray analysis and/or deep sequencing. This is one of the several reports of the same source. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Gastrointestinal sounds abnormal, Irritability, Microscopy, Norovirus test positive, Polymerase chain reaction
Clinical narrative: Information has been received from a physician, author of the article, regarding a healthy 2-month-old boy (patient 4) who presented with 3 days of nonbloody diarrhea and 2 days of fever and irritability (also reported as diarrhea none and 4 days of vomiting with a maximum of 3 episodes in 24 hours). On physical exam, he was fussy but consolable with a slightly distended abdomen and hyperactive bowels sounds. Negative laboratory examinations included complete blood count with differential, urinalysis, and urine culture (catheterized). The patient was orally rehydrated and discharged. He received his first dose of Live, Oral, ROTATEQ 2 days before illness onset (also reported as 1 day). Four distinct VP7 genotypes were detected in a specimen obtained 3 days after illness onset: the G1 gene of Live, Oral, ROTATEQ component strain W179-9 (G1P[5]) (100% identity in 116 bases); the G2 gene of strain SC2-9 (G2P[5]) (100% identity in 202 bases); the G4 gene of strain BrB-9 (G4P[5]) (100% identity in 363 bases); and the G6 gene of strain W179-4 (G6P[8]) (99.8% identity in 421 bases). The VP4 P[8] gene (99.9% identity in 835 bases) and VP6 12 (100% identity in 342 bases) genes from Live, Oral ROTATEQ strain W179-4 (G6P[8]) were detected. The VP3 M2 gene matched the sequence of strains W179-4 (G6P [8]), W178-8 (G3P{5]), and BrB-9 (G4P[5]) (100% identity in 500 bases). This specimen appears to contain 4 strains, the W179-4 (G6P[8]) component strain itself and 3 potential reassortant strains each composed of strain W179-4 (G6P[8]) but expressing G1, G2, and G4 individually. Rotaviruses were observed by EM, and real-time Rt-PCR was positive for norovirus genogroup II. All other tests were negative. This patient illustrate a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences include detection of an Live, Oral, ROTATEQ in a recently vaccinated child (patient 4). Patient 4 had diarrhea without respiratory symptoms, the presence of norovirus genogroup II in his fecal specimen along with the potential vaccine-reassortant strains makes it impossible to discern the cause of his illness. The presence of multiple reassortant Live, Oral ROTATEQ strains in patient 4 stool is very unusual, and these findings will be confirmed using an advanced genetic characterization method such as microarray analysis and/or deep sequencing. This is one of the several reports of the same source. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Pyrexia, Rotavirus test positive, Urine analysis normal, Vomiting
Clinical narrative: Information has been received from a physician, author of the article, regarding a healthy 2-month-old boy (patient 4) who presented with 3 days of nonbloody diarrhea and 2 days of fever and irritability (also reported as diarrhea none and 4 days of vomiting with a maximum of 3 episodes in 24 hours). On physical exam, he was fussy but consolable with a slightly distended abdomen and hyperactive bowels sounds. Negative laboratory examinations included complete blood count with differential, urinalysis, and urine culture (catheterized). The patient was orally rehydrated and discharged. He received his first dose of Live, Oral, ROTATEQ 2 days before illness onset (also reported as 1 day). Four distinct VP7 genotypes were detected in a specimen obtained 3 days after illness onset: the G1 gene of Live, Oral, ROTATEQ component strain W179-9 (G1P[5]) (100% identity in 116 bases); the G2 gene of strain SC2-9 (G2P[5]) (100% identity in 202 bases); the G4 gene of strain BrB-9 (G4P[5]) (100% identity in 363 bases); and the G6 gene of strain W179-4 (G6P[8]) (99.8% identity in 421 bases). The VP4 P[8] gene (99.9% identity in 835 bases) and VP6 12 (100% identity in 342 bases) genes from Live, Oral ROTATEQ strain W179-4 (G6P[8]) were detected. The VP3 M2 gene matched the sequence of strains W179-4 (G6P [8]), W178-8 (G3P{5]), and BrB-9 (G4P[5]) (100% identity in 500 bases). This specimen appears to contain 4 strains, the W179-4 (G6P[8]) component strain itself and 3 potential reassortant strains each composed of strain W179-4 (G6P[8]) but expressing G1, G2, and G4 individually. Rotaviruses were observed by EM, and real-time Rt-PCR was positive for norovirus genogroup II. All other tests were negative. This patient illustrate a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences include detection of an Live, Oral, ROTATEQ in a recently vaccinated child (patient 4). Patient 4 had diarrhea without respiratory symptoms, the presence of norovirus genogroup II in his fecal specimen along with the potential vaccine-reassortant strains makes it impossible to discern the cause of his illness. The presence of multiple reassortant Live, Oral ROTATEQ strains in patient 4 stool is very unusual, and these findings will be confirmed using an advanced genetic characterization method such as microarray analysis and/or deep sequencing. This is one of the several reports of the same source. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Bandaemia, Conjunctivitis, Cough, Culture urine negative, Diarrhoea
Clinical narrative: Information has been received from a physician, author of a article, regarding a previously healthy 2-month-old girl (patient 3) who presented with 4 days of vomiting and 2 days of fever, cough, and conjunctivitis without diarrhea (also reported as 3 days of diarrhea with a maximum of 18 episodes in 24 hours, vomiting none and 1 day of fever). On physical exam, she was fussy but consolable with mild conjunctival injection and nasal discharge. Laboratory evaluation revealed an elevated white blood cell count (10 700 1/2 L) with 12% bandemia. Urinalysis and urine culture were negative. The patient was treated with intravenous ceftriaxone and discharged. She received her first dose of ROTATEQ 1 day before illness onset (also reported as 2 days). A fecal specimen was obtained 5 days after illness onset and appeared to contain nonreassortant ROTATEQ component strain BrB-9 (G4P[5]) alone. The VP7 G4 gene of BrB-9 (G4P[5]) was detected (100% identity in 363 bases) along with VP4 P [5] (100% identity in 416 bases), VP6 I2 (100% identity in 342 bases), and VP3 M2 genes (100% identity in 500 bases) consistent with BrB-9 (G4P[5]). By EM. a few unidentified 30-nm particles were observed; all other tests were negative. This patient illustrated a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences included detection of a nonreassortant ROTATEQ vaccine strain in a recently vaccinated child (patient 3). Patient 3 had upper respiratory symptoms accompanied by vomiting or diarrhea, and her illness was less typical of rotavirus disease alone. This is one of the several reports of the same source. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Irritability, Microscopy, Pyrexia, Rhinorrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician, author of a article, regarding a previously healthy 2-month-old girl (patient 3) who presented with 4 days of vomiting and 2 days of fever, cough, and conjunctivitis without diarrhea (also reported as 3 days of diarrhea with a maximum of 18 episodes in 24 hours, vomiting none and 1 day of fever). On physical exam, she was fussy but consolable with mild conjunctival injection and nasal discharge. Laboratory evaluation revealed an elevated white blood cell count (10 700 1/2 L) with 12% bandemia. Urinalysis and urine culture were negative. The patient was treated with intravenous ceftriaxone and discharged. She received her first dose of ROTATEQ 1 day before illness onset (also reported as 2 days). A fecal specimen was obtained 5 days after illness onset and appeared to contain nonreassortant ROTATEQ component strain BrB-9 (G4P[5]) alone. The VP7 G4 gene of BrB-9 (G4P[5]) was detected (100% identity in 363 bases) along with VP4 P [5] (100% identity in 416 bases), VP6 I2 (100% identity in 342 bases), and VP3 M2 genes (100% identity in 500 bases) consistent with BrB-9 (G4P[5]). By EM. a few unidentified 30-nm particles were observed; all other tests were negative. This patient illustrated a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences included detection of a nonreassortant ROTATEQ vaccine strain in a recently vaccinated child (patient 3). Patient 3 had upper respiratory symptoms accompanied by vomiting or diarrhea, and her illness was less typical of rotavirus disease alone. This is one of the several reports of the same source. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Upper respiratory tract infection, Urine analysis normal, Vomiting, White blood cell count increased
Clinical narrative: Information has been received from a physician, author of a article, regarding a previously healthy 2-month-old girl (patient 3) who presented with 4 days of vomiting and 2 days of fever, cough, and conjunctivitis without diarrhea (also reported as 3 days of diarrhea with a maximum of 18 episodes in 24 hours, vomiting none and 1 day of fever). On physical exam, she was fussy but consolable with mild conjunctival injection and nasal discharge. Laboratory evaluation revealed an elevated white blood cell count (10 700 1/2 L) with 12% bandemia. Urinalysis and urine culture were negative. The patient was treated with intravenous ceftriaxone and discharged. She received her first dose of ROTATEQ 1 day before illness onset (also reported as 2 days). A fecal specimen was obtained 5 days after illness onset and appeared to contain nonreassortant ROTATEQ component strain BrB-9 (G4P[5]) alone. The VP7 G4 gene of BrB-9 (G4P[5]) was detected (100% identity in 363 bases) along with VP4 P [5] (100% identity in 416 bases), VP6 I2 (100% identity in 342 bases), and VP3 M2 genes (100% identity in 500 bases) consistent with BrB-9 (G4P[5]). By EM. a few unidentified 30-nm particles were observed; all other tests were negative. This patient illustrated a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences included detection of a nonreassortant ROTATEQ vaccine strain in a recently vaccinated child (patient 3). Patient 3 had upper respiratory symptoms accompanied by vomiting or diarrhea, and her illness was less typical of rotavirus disease alone. This is one of the several reports of the same source. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site rash, Rash, Urticaria
Clinical narrative: Rash/hives developed on both twins; location included front chest & back; there was also a group of red bumps surrounding near the injection site on thigh.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Generalised erythema, Malaise, Oropharyngeal pain, Rash vesicular
Clinical narrative: Information has been received from a 58 year old female consumer (62 inches, 184 pounds) with allergies to monosodium glutamate and glycerin, high blood pressure, arthritis, low potassium level, asthma, gastroesophageal reflux disease, migraines, gout and a history of urinary tract infections, anxiety, muscle spasms and shingles (2010). On 21-SEP-2012, the female was vaccinated with ZOSTAVAX (lot number reported as 0006-4963-41 "possibly") under the skin in the left arm. Concomitant medications included: triamterene + hydrochlorothiazide (manufacturer unknown), potassium, glucosimine, multivitamins over the counter (OTC), vitamin D OTC, mometasone furoate (MSD), FLEXAMIN, ZANTAC, PROVENTIL, allopurinol, trimethoprin and diazepam. On 23-SEP-2012, a few days after she received the ZOSTAVAX, she began not feeling very well and them noticed she had a sore and scratchy throat. The next day she began breaking out all over her body with red, fluid like blisters. She reported some of them have begun crusting over and as 27-SEP-2012 she was still noticing new "bumps". The female describes this as looking just like the chickenpox. She did not seek medical attention. She reported having an MRI and EEG in the summer of 2012 (reason and results not reported). At the time of this report, the events were ongoing. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Throat irritation
Clinical narrative: Information has been received from a 58 year old female consumer (62 inches, 184 pounds) with allergies to monosodium glutamate and glycerin, high blood pressure, arthritis, low potassium level, asthma, gastroesophageal reflux disease, migraines, gout and a history of urinary tract infections, anxiety, muscle spasms and shingles (2010). On 21-SEP-2012, the female was vaccinated with ZOSTAVAX (lot number reported as 0006-4963-41 "possibly") under the skin in the left arm. Concomitant medications included: triamterene + hydrochlorothiazide (manufacturer unknown), potassium, glucosimine, multivitamins over the counter (OTC), vitamin D OTC, mometasone furoate (MSD), FLEXAMIN, ZANTAC, PROVENTIL, allopurinol, trimethoprin and diazepam. On 23-SEP-2012, a few days after she received the ZOSTAVAX, she began not feeling very well and them noticed she had a sore and scratchy throat. The next day she began breaking out all over her body with red, fluid like blisters. She reported some of them have begun crusting over and as 27-SEP-2012 she was still noticing new "bumps". The female describes this as looking just like the chickenpox. She did not seek medical attention. She reported having an MRI and EEG in the summer of 2012 (reason and results not reported). At the time of this report, the events were ongoing. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender, who on 19-SEP-2012 was vaccinated with a dose of PNEUMOVAX 23 (dose and route not reported) (lot # 667912/0933Z, Exp: 25-FEB-2012). No symptoms reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a 62 years old male patient concerning himself with arthritis and no drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX on 11-SEP-2012 (lot #, dose and site of administration were not provided). No other co-suspects were reported. Concomitant medications included: diclofenac sodium. The patient mentioned that he had the ZOSTAVAX twice. He mentioned he felt the nurse injection the first vaccine deep the muscle causing pain. The nurse noticed he complained about pain and quickly administered another dose. This time he mentioned it was under the skin because he did not even feel it. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
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 lot # (670978/0750AA) ZOSTAVAX on 15-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 15-SEP-2012 the patient received expired ZOSTAVAX (expiry date 18-AUG-2012). No known adverse effects were reported. This case is linked to case 1209USA011717 by same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning two patients of unknown age and gender. On an unknown date, patients were vaccinated with 0.65 millimeter (ml) ZOSTAVAX (route and lot number unspecified), once. No concomitant medications were reported. On an unknown date, after the vaccination, both the patients experienced a very mild case of shingles. Patients sought unspecified medical attention. Both the patients were given VALTREX as a treatment. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient was vaccinated with single dose 0.65 ml ZOSTAVAX. Route of administration, vaccination date, and lot number were not provided. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles two weeks post vaccine. It was reported that the patient sought medical attention by an office visit. No additional treatment information was reported. The outcome of patient developed shingles two weeks post vaccine is unknown. The relatedness for patient developed shingles two weeks post vaccine was not reported for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old patient. The patient was vaccinated with lot # (669373/0130AA, expiration date 12-AUG-2012) PNEUMOVAX 23 on 25-SEP-2012, 0.5 ml single dose, by intramuscular injection. No other co-suspected were reported. No concomitant medications were reported. On 25-SEP-2012 the patient was administered an expired dose of PNEUMOVAX 23 (expiry date 12-AUG-2012). No treatment information was reported. No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Lymph node pain
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 65 years old female patient with high cholesterol, osteopenia, gastrooesophageal reflux disease (GERD), arthritis, asthma, anemia, postherpetic neuralgia and allergy to codeine. On 24-AUG-2012 the patient was vaccinated IM with a dose of PNEUMOVAX23 (lot # reported as 0653AE, exp. date: 10-FEB-2014). Concomitant medications included aspirin, vitamin D (unspecified), ALLEGRA, NITROSTAT, PRILOSEC, NEURONTIN, omega-3 marine triglycerides, PRAVACHOL and EFFEXOR. On 25-AUG-2012 the patient developed redness, swelling and rash at the site of injection. Also, she developed lymph node pain in the underarm area of the arm that received the injection. No treatment was given for the adverse event. No lab diagnostics studies performed. The patient did not seek medical attention. The patient recovered completely on 28-AUG-2012. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from an approximately 60 years old male physician refers to himself. On approximately 18-SEP-2012 (reported as "about a week ago") the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # not reported) for prevention shingles. On approximately 18-SEP-2012 (reported as "about a week ago") after the patient got the ZOSTAVAX shot, the shot hurt and his arm was sore for a couple of days then he was fine. No treatment was given for the adverse event. The patient did not seek medical attention. The outcome of the events was reported as recovered. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a pediatric male patient. The patient was vaccinated with the first dose of VARIVAX (Merck) (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced chickenpox like rash after receiving the first dose of VARIVAX (Merck). No laboratory diagnostics studies were performed. The outcome of adverse event was reported as recovered on an unspecified date. The patient was seen by the physician for medical attention. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 05-OCT-2012 the patient was vaccinated with an expired dose of ZOSTAVAX (Lot# 670382/0218AA, expired on 16-MAY-2012, dose and route not reported. No adverse experience had been observed or reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus generalised, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 58 year old male was vaccinated with ZOSTAVAX on 21Sep2012. The pharmacist reported that the patient developed a rash on his chest and generalized itching following the vaccination. The exact time frame of the development of the rash and generalized itching was not specified. The patient had contacted his physician (date, outcome not specified). It was reported the patient was not recovered. No further information was reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a 58 year old male was vaccinated with ZOSTAVAX on 21Sep2012. The pharmacist reported that the patient developed a rash on his chest and generalized itching following the vaccination. The exact time frame of the development of the rash and generalized itching was not specified. The patient had contacted his physician (date, outcome not specified). It was reported the patient was not recovered. No further information was reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a Registered Pharmacist (R.Rh.), concerning a 72 year old female patient. The patient had no known drug allergies. On 17-SEP-2012, the patient was vaccinated subcutaneously in the left arm with a 0.65 ml dose of ZOSTAVAX (lot #: 0565AE; expiration date 23-SEP-2013) There were no concomitant medications. On 19-SEP-2012, the patient experienced a mild fever, swelling, warm to touch, and redness at the injection site. Patient sought medical attention by calling the pharmacy and on 20-SEP-2012, patient went to the pharmacy and the swelling of left arm had gotten bigger and was still red, but the fever had subsided. Pharmacist stated it was normal for the patient to react like that after getting a vaccination. At the time of the report, the patient had not recovered from swelling at the injection site, warm to touch and redness at the injection site and was recovering from mild fever. The relatedness for mild fever, the swelling at the injection site, redness at the injection site and warm to touch at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Local reaction
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 63 years old male patient who on 20-AUG-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number 0562AE, Exp. Date: 20-MAR-2013) on his left arm. No other co-suspects were reported. No other vaccines, unspecified if other concomitant medications. The pharmacist reported that on an unknown date, in approximately August 2012, the patient developed an unspecified localized reaction with rash, approximately 6 inches in diameter around the injection site of his left arm. Treatment was over the counter oral BENADRYL. No lab diagnostics studies were performed. The reaction lasted 5 to 7 days and resolved completely on an unspecified date in 2012. The patient sought medical attention by contacted the pharmacist. The relatedness for patient developed an unspecified localized reaction with rash, approximately 6 inches in diameter around the injection site of left arm was unknown for ZOSTAVAX. Additional information is not expected.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Malaise, Poor quality sleep, Pyrexia
Clinical narrative: This spontaneous report was received from a 61 years old physician reporting on himself who on 03-OCT-2012, was vaccinated with a dose ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that "last night" on 03-OCT-2012, he slept poorly, and then "today" on 04-OCT-2012, noted low grade fever, malaise and erythema at the injection site with four vesicles. Not thinking clearly, he took an took an aspirin 325 mg tablet. At the time of the report, the patient's outcome was unknown. The physician was wondering to know of he was at risk for Reye's syndrome. It was unspecified if the patient sought medical attention. The relatedness for I sleep poorly last night, not thinking clearly, injection site with four vesicles, erythema at the injection site, malaise and low grade fever was unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Thinking abnormal
Clinical narrative: This spontaneous report was received from a 61 years old physician reporting on himself who on 03-OCT-2012, was vaccinated with a dose ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that "last night" on 03-OCT-2012, he slept poorly, and then "today" on 04-OCT-2012, noted low grade fever, malaise and erythema at the injection site with four vesicles. Not thinking clearly, he took an took an aspirin 325 mg tablet. At the time of the report, the patient's outcome was unknown. The physician was wondering to know of he was at risk for Reye's syndrome. It was unspecified if the patient sought medical attention. The relatedness for I sleep poorly last night, not thinking clearly, injection site with four vesicles, erythema at the injection site, malaise and low grade fever was unknown for ZOSTAVAX. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a physician refers to a 20 years old male patient. Patient's medical history included pneumonia. On 10-SEP-2012, the patient was vaccinated intramuscularly with lot # (672041/1477AA) (expiry-14-MAY-2013) PNEUMOVAX23. Concomitant medications included Z-PAK and TAMIFLU. On 11-SEP-2012, the patient experienced a pretty nasty, marked, warm and red eight-inch-by-five-inch cellulitis where the vaccine was administered. Patient was seen in an urgi-care center. Treatment included prednisone, BENADRYL and REFLEX. The outcome of a pretty nasty, marked, warm and red eight-inch-by-five-inch cellulitis where the vaccine was administered was reported as not recovered. The relatedness for a pretty nasty, marked, warm and red eight-inch-by-five-inch cellulitis where the vaccine was administered was unknown for PNEUMOVAX23. Additional information is not available.
Age: 41.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain
Clinical narrative: This study was received from the investigator on 27 September 2012. A 41-year-old male subject with a past medical history of dizziness/fainting spells had received ACAM2000 (lot number, route, and site not reported) on 18 January 2012 and 12 days later was diagnosed with Unspecified disease of pericardium. No laboratory tests and diagnostic testing were reported. No further information was available at the time of the report. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (date mining, non-interventional) study. Documents held by sender: none.
Age: 41.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pericardial disease
Clinical narrative: This study was received from the investigator on 27 September 2012. A 41-year-old male subject with a past medical history of dizziness/fainting spells had received ACAM2000 (lot number, route, and site not reported) on 18 January 2012 and 12 days later was diagnosed with Unspecified disease of pericardium. No laboratory tests and diagnostic testing were reported. No further information was available at the time of the report. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (date mining, non-interventional) study. Documents held by sender: none.
Age: 1.26
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Dyskinesia, Electroencephalogram
Clinical narrative: 20 min. Started with screaming and stiffness. Then limper body and convulsions with head cocked to the right in stiff position. Child's body was convulsing and quit breathing. When awoke, he was out of his senses. He could not regain his balance and kept falling down every time he tried to walk for 15 min. after the episode.
Age: 1.26
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Balance disorder, Convulsion, Electroencephalogram normal, Fall, Hypotonia
Clinical narrative: 20 min. Started with screaming and stiffness. Then limper body and convulsions with head cocked to the right in stiff position. Child's body was convulsing and quit breathing. When awoke, he was out of his senses. He could not regain his balance and kept falling down every time he tried to walk for 15 min. after the episode.
Age: 1.26
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Musculoskeletal stiffness, Posture abnormal, Respiratory arrest, Screaming
Clinical narrative: 20 min. Started with screaming and stiffness. Then limper body and convulsions with head cocked to the right in stiff position. Child's body was convulsing and quit breathing. When awoke, he was out of his senses. He could not regain his balance and kept falling down every time he tried to walk for 15 min. after the episode.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Back pain, Dyspnoea
Clinical narrative: Immediately after receiving shots, patient started having severe pain. 911 called and patient taken to ED with elevated BP and slight SOB but it went away.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Blood pressure increased, Dyspnoea, Immediate post-injection reaction, Pain
Clinical narrative: Immediately after receiving shots, patient started having severe pain. 911 called and patient taken to ED with elevated BP and slight SOB but it went away.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Asthenia, Blood pressure abnormal, Blood test normal, Chest X-ray abnormal, Chills
Clinical narrative: This case was reported by a physician, who was also the subject, and described the occurrence of pneumonia in a 55-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), BOOSTRIX. Medical history included the subject receiving a flu vaccine (unspecified manufacturer) many years ago, but only reaction was local effects. Concurrent medical conditions included dry mouth and thirst. Concurrent medications included multivitamins (daily multivitamin). On 02 October 2012, the subject had a general wellness check-up and wellness lab tests and both were within normal limits. She had no cardiovascular or respiratory problems. On 2 October 2012 at 11:00 the subject received dose of FLUARIX (details unknown, left deltoid) and dose of BOOSTRIX (details unknown, left deltoid). The vaccines were administered as one vaccine under the other. On 2 October 2012, hours after vaccination with BOOSTRIX and FLUARIX, the subject experienced malaise, nausea, vomiting, insomnia, pleurisy, couldn't sleep on one side due to pain and dyspnea, headache, weakness, chills, and dizziness. On the same day as the vaccinations (2 October 2012), she experienced pneumonia. On 3 October 2012, less than 24 hours after vaccination with BOOSTRIX and FLUARIX, she experienced fever, difficulty breathing, hypotension and coughing blood. The subject was hospitalised. Relevant test results included chest x-ray which showed right-sided pneumonia. No cultures were obtained. The subject was treated with intravenous fluid(s) (IV fluids), anti-nausea drugs (nausea medication (unknown)), antibiotics (IV antibiotics) and azithromycin. At the time of reporting the events were gradually resolving. The vaccination courses with FLUARIX and BOOSTRIX were discontinued. It was reported that on 02 October 2012, the subject received the FLUARIX and BOOSTRIX and then immediately went downstairs to the clinic lab and had wellness lab tests and results were within normal limits. She left the clinic by 12:00 to go home over 45 minutes. By afternoon, she felt malaise. Then by evening, she developed nausea, vomiting, insomnia, pleuresy, and couldn't sleep on one side due to pain and dyspnea. Then, the nausea worsened, with severe headache, weakness, chills, and dizziness. On the morning of 03 October 2012, less than 24 hours after wellness check-up, she went to the emergency room and was hospitalized for pneumonia with 102.4 degrees Fahrenheit fever, difficulty breathing, hypotension, blood pressure 79/50, and coughing blood. There was no other cough. In hospital, treatment included IV fluids, anti-nausea medications, iv antibiotics, and she went home with oral azithromycin. She was discharged on 04 October 2012 and "now gradually resolving". The discharge diagnosis was pneumonia.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Dizziness, Haemoptysis, Headache, Laboratory test normal, Lymphocyte count normal
Clinical narrative: This case was reported by a physician, who was also the subject, and described the occurrence of pneumonia in a 55-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), BOOSTRIX. Medical history included the subject receiving a flu vaccine (unspecified manufacturer) many years ago, but only reaction was local effects. Concurrent medical conditions included dry mouth and thirst. Concurrent medications included multivitamins (daily multivitamin). On 02 October 2012, the subject had a general wellness check-up and wellness lab tests and both were within normal limits. She had no cardiovascular or respiratory problems. On 2 October 2012 at 11:00 the subject received dose of FLUARIX (details unknown, left deltoid) and dose of BOOSTRIX (details unknown, left deltoid). The vaccines were administered as one vaccine under the other. On 2 October 2012, hours after vaccination with BOOSTRIX and FLUARIX, the subject experienced malaise, nausea, vomiting, insomnia, pleurisy, couldn't sleep on one side due to pain and dyspnea, headache, weakness, chills, and dizziness. On the same day as the vaccinations (2 October 2012), she experienced pneumonia. On 3 October 2012, less than 24 hours after vaccination with BOOSTRIX and FLUARIX, she experienced fever, difficulty breathing, hypotension and coughing blood. The subject was hospitalised. Relevant test results included chest x-ray which showed right-sided pneumonia. No cultures were obtained. The subject was treated with intravenous fluid(s) (IV fluids), anti-nausea drugs (nausea medication (unknown)), antibiotics (IV antibiotics) and azithromycin. At the time of reporting the events were gradually resolving. The vaccination courses with FLUARIX and BOOSTRIX were discontinued. It was reported that on 02 October 2012, the subject received the FLUARIX and BOOSTRIX and then immediately went downstairs to the clinic lab and had wellness lab tests and results were within normal limits. She left the clinic by 12:00 to go home over 45 minutes. By afternoon, she felt malaise. Then by evening, she developed nausea, vomiting, insomnia, pleuresy, and couldn't sleep on one side due to pain and dyspnea. Then, the nausea worsened, with severe headache, weakness, chills, and dizziness. On the morning of 03 October 2012, less than 24 hours after wellness check-up, she went to the emergency room and was hospitalized for pneumonia with 102.4 degrees Fahrenheit fever, difficulty breathing, hypotension, blood pressure 79/50, and coughing blood. There was no other cough. In hospital, treatment included IV fluids, anti-nausea medications, iv antibiotics, and she went home with oral azithromycin. She was discharged on 04 October 2012 and "now gradually resolving". The discharge diagnosis was pneumonia.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Nausea, Pain, Pneumonia, Pulse abnormal, Pyrexia
Clinical narrative: This case was reported by a physician, who was also the subject, and described the occurrence of pneumonia in a 55-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), BOOSTRIX. Medical history included the subject receiving a flu vaccine (unspecified manufacturer) many years ago, but only reaction was local effects. Concurrent medical conditions included dry mouth and thirst. Concurrent medications included multivitamins (daily multivitamin). On 02 October 2012, the subject had a general wellness check-up and wellness lab tests and both were within normal limits. She had no cardiovascular or respiratory problems. On 2 October 2012 at 11:00 the subject received dose of FLUARIX (details unknown, left deltoid) and dose of BOOSTRIX (details unknown, left deltoid). The vaccines were administered as one vaccine under the other. On 2 October 2012, hours after vaccination with BOOSTRIX and FLUARIX, the subject experienced malaise, nausea, vomiting, insomnia, pleurisy, couldn't sleep on one side due to pain and dyspnea, headache, weakness, chills, and dizziness. On the same day as the vaccinations (2 October 2012), she experienced pneumonia. On 3 October 2012, less than 24 hours after vaccination with BOOSTRIX and FLUARIX, she experienced fever, difficulty breathing, hypotension and coughing blood. The subject was hospitalised. Relevant test results included chest x-ray which showed right-sided pneumonia. No cultures were obtained. The subject was treated with intravenous fluid(s) (IV fluids), anti-nausea drugs (nausea medication (unknown)), antibiotics (IV antibiotics) and azithromycin. At the time of reporting the events were gradually resolving. The vaccination courses with FLUARIX and BOOSTRIX were discontinued. It was reported that on 02 October 2012, the subject received the FLUARIX and BOOSTRIX and then immediately went downstairs to the clinic lab and had wellness lab tests and results were within normal limits. She left the clinic by 12:00 to go home over 45 minutes. By afternoon, she felt malaise. Then by evening, she developed nausea, vomiting, insomnia, pleuresy, and couldn't sleep on one side due to pain and dyspnea. Then, the nausea worsened, with severe headache, weakness, chills, and dizziness. On the morning of 03 October 2012, less than 24 hours after wellness check-up, she went to the emergency room and was hospitalized for pneumonia with 102.4 degrees Fahrenheit fever, difficulty breathing, hypotension, blood pressure 79/50, and coughing blood. There was no other cough. In hospital, treatment included IV fluids, anti-nausea medications, iv antibiotics, and she went home with oral azithromycin. She was discharged on 04 October 2012 and "now gradually resolving". The discharge diagnosis was pneumonia.