chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV4, FLUN4, HPVX, HPV4
Symptoms: Convulsion, Seizure like phenomena
Clinical narrative: Information was received from a registered nurse regarding a 13 year old male patient. On 10-JUN-2013, the patient was vaccinated with GARDASIL. On 16-OCT-2013, the patient was vaccinated with dose 2 of GARDASIL lot # J006236 (exp. 25-FEB-2016). Concomitant therapies includes: LEXAPRO and VYNASE. On 16-OCT-2013, the patient became pale and did not look good right after GARDASIL was administered and he stated having seizure like activity which lasted about 45 seconds. After the seizure-like activity ended, the patient was still not completely coherent and was a little agitated. The patient was observed in the office and within 30 minutes of administration, the patient came back to normal and was sent home. The patient's brother experienced exactly the same reaction (see case # 1310USA008525). Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV4, FLUN4, HPVX, HPV4
Symptoms: Agitation, Convulsion
Clinical narrative: Information was received from a registered nurse regarding a 13 year old male patient. On 10-JUN-2013, the patient was vaccinated with GARDASIL. On 16-OCT-2013, the patient was vaccinated with dose 2 of GARDASIL lot # J006236 (exp. 25-FEB-2016). Concomitant therapies includes: LEXAPRO and VYNASE. On 16-OCT-2013, the patient became pale and did not look good right after GARDASIL was administered and he stated having seizure like activity which lasted about 45 seconds. After the seizure-like activity ended, the patient was still not completely coherent and was a little agitated. The patient was observed in the office and within 30 minutes of administration, the patient came back to normal and was sent home. The patient's brother experienced exactly the same reaction (see case # 1310USA008525). Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV4, FLUN4, HPVX, HPV4
Symptoms: Agitation, Incoherent, Pallor, Seizure like phenomena
Clinical narrative: Information was received from a registered nurse regarding a 13 year old male patient. On 10-JUN-2013, the patient was vaccinated with GARDASIL. On 16-OCT-2013, the patient was vaccinated with dose 2 of GARDASIL lot # J006236 (exp. 25-FEB-2016). Concomitant therapies includes: LEXAPRO and VYNASE. On 16-OCT-2013, the patient became pale and did not look good right after GARDASIL was administered and he stated having seizure like activity which lasted about 45 seconds. After the seizure-like activity ended, the patient was still not completely coherent and was a little agitated. The patient was observed in the office and within 30 minutes of administration, the patient came back to normal and was sent home. The patient's brother experienced exactly the same reaction (see case # 1310USA008525). Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a 72 year old female patient with no pertinent medical history or drug reactions/allergies. On 14-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J001180; expiration date 18-AUG-2013), 0.5 ml, intramuscular. No other co-suspect therapy was reported. Concomitant therapies include "multiple medications". It was reported that the patient received PNEUMOVAX23 developed cellulitis in the arm that the PNEUMOVAX23 was administered two days later, on 16-OCT-2013. The patient was prescribed an unspecified antibiotic on 16-OCT-2013 as treatment. No laboratory tests were performed. The outcome of cellulitis in the arm was unknown. It was reported that the patient sought medical attention seeing the physician (on 16-OCT-2013). This is one of two reports from the same source (MARRS # 1310USA010333). Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Time is approximate, pt reported that the soreness started the evening of the vaccine. He also noticed some dizziness when he woke up in the middle of the night a few times. He said that he has more recently noticed a knot at the injection site (noticed in the last week or so, but not sure how long it has been there). He said that it does seem to be getting smaller. He is still having soreness over a month later, so he reported it to us on 11-13-13 and he also filled out his own report online (our office asked me to do one as well). He said now it mostly bothers him at night and when he reaches back.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Injection site nodule, Pain
Clinical narrative: Time is approximate, pt reported that the soreness started the evening of the vaccine. He also noticed some dizziness when he woke up in the middle of the night a few times. He said that he has more recently noticed a knot at the injection site (noticed in the last week or so, but not sure how long it has been there). He said that it does seem to be getting smaller. He is still having soreness over a month later, so he reported it to us on 11-13-13 and he also filled out his own report online (our office asked me to do one as well). He said now it mostly bothers him at night and when he reaches back.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt reported prickly heat, redness over most of body resembling sunburn. She became very itchy also. She tried to contact her MD via on call doc but never recd call back. She took otc Sudafed and Tussin Cough/cold med along with Ketoconazole topical cream. Said this combination relieved the itching and redness reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Generalised erythema, Miliaria, Pruritus
Clinical narrative: Pt reported prickly heat, redness over most of body resembling sunburn. She became very itchy also. She tried to contact her MD via on call doc but never recd call back. She took otc Sudafed and Tussin Cough/cold med along with Ketoconazole topical cream. Said this combination relieved the itching and redness reaction.
Age: 27.0
Sex: F
Vaccine: ANTH, FLU3, SMALL
Symptoms: Contraindication to vaccination, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Member recieved smallpox vaccine 10Aug2013 and confirmed pregnancy 15Nov2013.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Clostridium difficile infection, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to a 75 year old female patient with breast cancer. No drug reaction/allergies were reported. On 30-OCT-2013, the patient was vaccinated with her first dose of PNEUMOVAX23, (lot # H022280, Exp date 16-JUL-2014), intramuscular in the left arm, (dose and indication not reported). Concomitant therapies included ARIMIDEX. On 31-OCT-2013, the patient experienced pain and a nodule at the injection site. On 01-NOV-2013 the injection site became red, warm and swelling extended up to her shoulder from her elbow. She was diagnosed with cellulitis. She was given AUGMENTIN and consequently developed a clostridium difficile infection which required hospitalization at an unspecified hospital. The outcome of the events was unknown. The patient sought medical attention by saw in office. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician refers to a 75 year old female patient with breast cancer. No drug reaction/allergies were reported. On 30-OCT-2013, the patient was vaccinated with her first dose of PNEUMOVAX23, (lot # H022280, Exp date 16-JUL-2014), intramuscular in the left arm, (dose and indication not reported). Concomitant therapies included ARIMIDEX. On 31-OCT-2013, the patient experienced pain and a nodule at the injection site. On 01-NOV-2013 the injection site became red, warm and swelling extended up to her shoulder from her elbow. She was diagnosed with cellulitis. She was given AUGMENTIN and consequently developed a clostridium difficile infection which required hospitalization at an unspecified hospital. The outcome of the events was unknown. The patient sought medical attention by saw in office. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to 3 or 4 patients of unknown demographics. On unknown date in October 2013, 3 or 4 patients were vaccinated with PNEUMOVAX23 vial (dosage, lot and expiry date were not reported) for vaccine. The reporter's partner had seen 3 or 4 patients with injections site reactions (onset date approximately October 2013). Some patients sought medical attention-called the pharmacist. The outcome of event was not reported. This is 3 of 3 reports received from the same reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 50 year old female patient with none of drug reactions/allergies. On 07-NOV-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous in the right arm (dose was not provided, lot #J006831 14-SEP-2014). Concomitant therapies included Lisinopril (manufacturer unknown), Tramadol Hydrochloride, Lorazepam, Seroquel, acetaminophen, Percocet and Omeprazole. The patient received ZOSTAVAX and then developed a low grade fever, pain, heat and swelling at the injections site and a "splotchy rash on her chest". The patient contacted pharmacist for seek medical attention. The patient was treated with ibuprofen. She also felt achy. The outcome of events was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 50 year old female patient with none of drug reactions/allergies. On 07-NOV-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous in the right arm (dose was not provided, lot #J006831 14-SEP-2014). Concomitant therapies included Lisinopril (manufacturer unknown), Tramadol Hydrochloride, Lorazepam, Seroquel, acetaminophen, Percocet and Omeprazole. The patient received ZOSTAVAX and then developed a low grade fever, pain, heat and swelling at the injections site and a "splotchy rash on her chest". The patient contacted pharmacist for seek medical attention. The patient was treated with ibuprofen. She also felt achy. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown a date the patient was vaccinated with ZOSTAVAX (lot number and expiry date not reported) (dosing regimen, route and frequency unknown). On an unknown date the patient experienced rash post vaccination. It was reported that the pharmacist was unsure if the rash was shingles or not. The outcome of rash post vaccination was unknown. The relatedness of the events to the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 06-NOV-2013 the patient was vaccinated with ZOSTAVAX lot # J006827, expiry date 14-SEP-2014 subcutaneously. No concomitant medications were reported. The pharmacist reported that reconstituted product was difficult to withdraw from ZOSTAVAX vial because of resistance from the vial. Product quality complaint (PQC) was filed. Despite this PQC, she was able to fully withdraw the reconstituted product from the ZOSTAVAX vial, but some reconstituted product was lost when cap of the syringe needle was removed and therefore only 0.5ml of reconstituted ZOSTAVAX product remained which was administered to the patient. No adverse effect was reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Biopsy skin abnormal, Dehydration, Pruritus generalised, Renal failure
Clinical narrative: After receiving flu vaccine on 10/4/13 began "breaking out" with generalized wheals and itching the night of 10/08/13, "all over except palms of hands and soles of feet". Taken to local ED by husband. Received steroid inj, BENADRYL while in ED, stayed for 4 hours. Discharged home with steroid dose pk/BENADRYL. Wheals/itching lessened but not go away. Went to PCP 10/10/13; sent to dermatologist same day. Biopsy of wheal in arm performed. On 10/24/13 was informed by dermatologist "allergic to flu vaccine". The pt. also reported, "on 10/16/13 and 10/17/13 started vomiting repeatedly". Pt. presented to her PCP, on 10/18/13, subsequently hospitalized with diagnoses of "dehydration and kidney failure". Was transferred by ambulance on 10/20/13 to another hospital, remained hospitalized there until 10/22/13, where upon she was discharged home. While talking via telephone to pt today, 11/14/13, day the pt. reported adverse event to Health Dept., pt reports she is continuing to experience "itching" on her back. Continues to take BENADRYL daily.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, Vomiting
Clinical narrative: After receiving flu vaccine on 10/4/13 began "breaking out" with generalized wheals and itching the night of 10/08/13, "all over except palms of hands and soles of feet". Taken to local ED by husband. Received steroid inj, BENADRYL while in ED, stayed for 4 hours. Discharged home with steroid dose pk/BENADRYL. Wheals/itching lessened but not go away. Went to PCP 10/10/13; sent to dermatologist same day. Biopsy of wheal in arm performed. On 10/24/13 was informed by dermatologist "allergic to flu vaccine". The pt. also reported, "on 10/16/13 and 10/17/13 started vomiting repeatedly". Pt. presented to her PCP, on 10/18/13, subsequently hospitalized with diagnoses of "dehydration and kidney failure". Was transferred by ambulance on 10/20/13 to another hospital, remained hospitalized there until 10/22/13, where upon she was discharged home. While talking via telephone to pt today, 11/14/13, day the pt. reported adverse event to Health Dept., pt reports she is continuing to experience "itching" on her back. Continues to take BENADRYL daily.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Muscular weakness, Nuclear magnetic resonance imaging, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a male, 70 years old patient without drug reactions/allergies, refers to himself. The patient's medical history included asthma. In 2011 (reported as two years ago) the patient was vaccinated with a dose of ZOSTAVAX (dose, lot number and expiration date were not reported) once, for preventions of shingles. Two years after receiving ZOSTAVAX (in September 2013) the patient experienced outbreak of shingles and post herpetic neuralgia (PHN). The patient was seeing a pain specialist. Location: top of the leg, knew and muscle weakness (right leg). Lab diagnostic studies included: MRI of leg, results not provided. The patient was treated with gabapentin 1200 mg 3 x daily (also reported as concomitant therapy) and ibuprofen. The outcome of events was not reported. The patient sought medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. Concurrent conditions included unspecified plasma and neurological disorder. On 15-JUL-2013 the patient was vaccinated with ZOSTAVAX (19, 400 PFU 10 of 1), .65 ml, subcutaneously. Concomitant therapies included Lipitor. On 25-JUL-2013, 10 days after onset of therapy, the patient experienced nerve pain and shingles. The outcome of nerve pain and shingles was reported as recovered/resolved on an unknown date in August 2013 (reported as end of August 2013). There were no lab diagnostics studies performed. The patient sought medical attention (reported as contacted physician). The causality for the events was not reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 46 year old female patient with high blood pressure and latex allergy. On 04-NOV-2013 the patient was vaccinated with PNEUMOVAX23 (lot number J004387, expiry date 04-JAN-2015) intramuscular in the left arm. On 04-NOV-2013, the patient experienced fever and erythema around the injection site. There were no lab diagnostic studies performed. It was reported that the patient sought medical attention and called a pharmacy. The outcome of fever was unknown (also reported as fever broke yesterday). It was reported that the erythema around injection site spread from half inch to 3 inches in diameter. The outcome of erythema around the injection site was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients were vaccinated with VAQTA (dose, lot and expiry date was unknown). The vaccine was exposed to 28 Fahrenheit for 15 days, an excursion that was found to be unsupported by in-house stability data. No adverse symptoms were reported. The nurse was unable to provide administration dates and well as lot and expiration dates for the vaccine involved. This is 2 of 3 reports by same reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients were vaccinated with GARDASIL (dose, lot and expiry date was unknown). The vaccine was exposed to 28 Fahrenheit for 15 days, an excursion that was found to be unsupported by in-house stability data. No adverse symptoms were reported. The nurse was unable to provide administration dates and well as lot and expiration dates for the vaccine involved. This is 3 of 3 reports by same reporter. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old patient. On 01-NOV-2013, the patient was vaccinated with an expired dose of 0.5 ml PNEUMOVAX23 (lot # 0556AE, expiry date 27-OCT-2013), intramuscular. No adverse effect was reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient with lupus and no known drug allergies. On 05-NOV-2013 the patient was vaccinated with a dose of PNEUMOVAX23, lot# J004332, expiration date 09/26/2014 (dose and route not reported) for pneumonia prevention. Concomitant therapies included Plaquenil. The pharmacist stated that patient did experience tenderness at injection site on 5-NOV-213. However patient returned to the pharmacy "today" (on 06-NOV-2013), and stated that the injections site was red, tender and swollen from the injections site down to the elbow. No treatment was advised. The outcome of the events was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a pharmacist via field representative regarding a patient of unknown age with beef allergy. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, expiry date, dose and route were not reported). No concomitant medications were reported. The pharmacist was reported that the patient was experienced an unspecified reaction after administration of ZOSTAVAX. The patient was sought the medical attention but type was unknown. On an unspecified date, the patient recovered from the event. The causality for the event with the ZOSTAVAX was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: FLUN4, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 06 November 2013. A 23-year-old female subject received the following vaccinations: On 06 September 2013 an injection of ACAM2000 (lot number not reported) and Influenza, live, intranasal quadrivalent (manufacturer and lot number not reported) and on 22 August 2013 an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported) and Anthrax (manufacturer and lot number not reported). On 16 September 2013, the subject was diagnosed with acute pericarditis, unspecified. The subject had a past medical history of chest pain, abnormal ECG (electrocardiogram), shortness of breath and asthma. On 18 September 2013, the subject had an abnormal electrocardiogram (ECG) and on 19 September 2013, the subject had a normal echocardiogram. Troponin I results were not available. The 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 (data mining, non-interventional study). Documents held by sender: None.
Age: 1.13
Sex: M
Vaccine: FLU4
Symptoms: Autopsy, Culture, Cyanosis, Death, Resuscitation
Clinical narrative: Initial report was received on 23 October 2013 with additional information received on 03 November from a health care professional. A 13 month-old male patient who had no illness at the time of vaccination and no reported past medical history had received on 18 October 2013 at 1045 AM an intramuscular right thigh injection of FLUZONE QIV, lot number U4779AA and an unspecified amount of time later was found with no chest movement and blue. The patient was put to bed at 9 PM and at 1145 PM or 1245 AM the mother checked on the child who was found with no chest movement and the child was blue. Cardiopulmonary resuscitation (CPR) was performed with no response. An "autopsy done: gross examination unrevealing; no obvious cause of death identified; results of cultures, toxicology pending (will take up to ~6 weeks for results to come back)." No further information was available at the time of the report. The patient's outcome was fatal. Documents held by sender: none.
Age: 1.13
Sex: M
Vaccine: FLU4
Symptoms: Toxicologic test
Clinical narrative: Initial report was received on 23 October 2013 with additional information received on 03 November from a health care professional. A 13 month-old male patient who had no illness at the time of vaccination and no reported past medical history had received on 18 October 2013 at 1045 AM an intramuscular right thigh injection of FLUZONE QIV, lot number U4779AA and an unspecified amount of time later was found with no chest movement and blue. The patient was put to bed at 9 PM and at 1145 PM or 1245 AM the mother checked on the child who was found with no chest movement and the child was blue. Cardiopulmonary resuscitation (CPR) was performed with no response. An "autopsy done: gross examination unrevealing; no obvious cause of death identified; results of cultures, toxicology pending (will take up to ~6 weeks for results to come back)." No further information was available at the time of the report. The patient's outcome was fatal. Documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Discomfort, Drug eruption, Inner ear disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 year old male patient. The patient's pertinent medical history and drug allergies or drug reactions were not reported. On 09-OCT-2013, the patient was vaccinated with a first dose of MMR II (lot number, expiry date and route not reported.\). On 17-OCT-2013, the patient was vaccinated with a second dose of MMR II, (lot number, expiry date and route not reported). On 17-OCT-2013, the patient experienced inner ear discomfort. The physician determined that the patient was probably developing a ear infection and prescribed amoxicillin. On 25-OCT-2013, the patient developed a rubella rash all over his body. The unspecified physician determined that the patient was not developing an ear infection on 17-OCT-2013 but the ear discomfort was from the rubella rash developing inside of his ears. The pharmacist stated that the patient was taken to an unspecified emergency room on an unknown date but was not admitted to the hospital. The patient was treated with unspecified steroids and unspecified antihistamines. However these treatments did not make the patients conditions improved. There was no lab tests performed. The outcome of the events were reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Encephalitis post immunisation, Lumbar puncture normal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 06 November 2013. A 19-year-old male subject, with no reported past medical history, received the following vaccination: an injection of ACAM2000 (lot number not reported) on 17 July 2013 and anthrax (manufacturer and lot number not reported) on 28 June 2013. On 05 August 2013, the subject was diagnosed with encephalitis following immunization procedures. On 30 July 2013, the subject had an abnormal Troponin I of 00.11, a normal echocardiogram and a normal lumbar puncture (spinal tap). The 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 (data mining, non-interventional) study. Documents held by sender: None.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: This spontaneous report as received from a patient of unknown age and gender refers to herself/himself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot #, dose, route and strength not reported). The patient reported that she/he had been suffering from shingles on and off for 39 years. Even after the vaccine she/he was still getting shingles on an unknown date. The outcome of event was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician refers to a 47 year old patient with no history of chicken pox. On 05-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). It was reported that it was medically necessary for zoster vaccine and requesting vaccination due to family have had zoster attacked. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator a trial on 06 November 2013. A 19-year-old male subject, with no significant past medical history, received on injection of ACAM2000 (lot number not reported) on 15 August 2013. On 09 September 2013, the subject was diagnosed with non-specific myocarditis. The subject had an abnormal ECG on 26 August 2013. On 27 August 2013, the subject had abnormal troponin I of 10.49 and an abnormal echocardiogram. The 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 (data mining, non-interventional) study. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female pregnant patient with no pertinent medical history and no drug reactions or allergies, who on 31-AUG-2010 was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly (lot number not reported). Then on 09-NOV-2010 and 19-MAY-2011 she received her second and third 0.5 ml doses (lot numbers not reported), respectively. There was no concomitant medication. It was stated that on 13-JUN-2011, the patient reported that she was pregnant. A monoclonal pregnancy test was performed on an unspecified date. Follow-up information has been received for GARDASIL, a Pregnancy Registry product, in which the estimated due date was reported as approximately March 2012. Last menstrual period (LMP) was approximated to an unknown date in 2011. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Area around the vaccination turned beet red, ached and itched for approximately three days.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 80 years old male patient. On 07-NOV-2013 the patient was vaccinated with PNEUMOVAX23 lot # H016295, Expiry date: 02-NOV-2013, 0.5 ml, intramuscular. The pharmacist reported that the patient received an expired dose of PNEUMOVAX23. No adverse effects were reported. Additional information is not expected.
Age: 46.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiomyopathy, Condition aggravated, Echocardiogram abnormal, Electrocardiogram abnormal, Troponin I
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 06 November 2013. A 46-year-old male subject received the an injection of ACAM2000 (lot number not reported) on 17 July 2013. On 19 July 2013 the subject had an abnormal ECG and an abnormal echocardiogram. The subject was diagnosed with cardiomyopathy in other diseases classified on 23 July 2013 and other primary cardiomyopathies on 01 August 2013. Troponin I results were not available. The subject had a past medical history of high blood pressure, elevated cholesterol, cardiomyopathy and abnormal ECG. The 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 (data mining, non-interventional) study. Documents held by sender: None.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of age in 80s (years) with drug reactions/allergies to sulfite. On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown). On an unknown date (report as at an unspecified time in the past), the patient immediately began to feel bad after receiving a pneumococcal vaccine (manufacturer unspecified). Benadryl was given as treatment for the event. The patient reported to the nurse that it took her a week to recover. Reporter's causality assessment was not provided. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age. On an unknown date in August 2013 the patient was vaccinated with the first dose of RECOMBIVAX HB 1 ml, intramuscular. The physician reported the patient was inadvertently administered the third dose of RECOMBIVAX HB on 08-NOV-2013, 2 months after (approximately in September 2013) the second dose of RECOMBIVAX HB. No adverse effects reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Blood count, Culture, Differential white blood cell count
Clinical narrative: After the 1st vaccine, he began to complain of fatigue, after the 2nd vaccine he became ill quickly. He was hospitalized 8/23/2013 - 8/25/2013 at hospital. He has strep a few times Mono. He has major weakness in joints and muscles. He is not getting better with joint and fatigue and weakness!. So worried.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Malaise, Mononucleosis heterophile test, Muscular weakness, Streptococcus test
Clinical narrative: After the 1st vaccine, he began to complain of fatigue, after the 2nd vaccine he became ill quickly. He was hospitalized 8/23/2013 - 8/25/2013 at hospital. He has strep a few times Mono. He has major weakness in joints and muscles. He is not getting better with joint and fatigue and weakness!. So worried.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product reconstitution issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a patient of unknown age and gender. On an unknown date, at least one patient was vaccinated with ZOSTAVAX (vial), 0.63 ml only (lot, expiry date was not reported). The reporter (representative) called about a pharmacy, which was getting a volume less than 0.65 ml when withdrawing reconstituted ZOSTAVAX when reconstituted, the total volume was 0.63ml only. The entire content of the diluents was withdrawn into a syringe and the entire content of reconstituted vaccine volume was 0.63 ml. Pharmacist informed at least one patient was vaccinated. No adverse effects reproted at this time. No other information provided. The information was  forwarded for review as product quality complaint (PQC) was involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Upper respiratory tract infection
Clinical narrative: This spontaneous report was received from a physician refers to a 12 year old male patient. The patient received GARDASIL (lot #, expiry not reported) dose 1, dose 2 and dose 3 on 24-OCT-2012, 27-SEP-2013 and 25-OCT-2013 respectively and was now in the physician's office with an upper respiratory infection (onset date approximately 2013). Patient sought medical attention-office visit. The outcome of upper respiratory infection was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. On an unknown date the patients were vaccinated with unsupported PROQUAD (Merck) (lot # J002931, expired date: 12-SEP-2013, dose not reported) which reached a temperature of 39F for 101 hours. No adverse effects. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On an unknown date on unspecified number of patients were vaccinated with RECOMBIVAX HB (dose, lot and expiry date was unknown). The vaccine was exposed to 28 Fahrenheit for 15 days, an excursion that was found to be unsupported by in-house stability data. No adverse symptoms were reported. The nurse was unable to provide administration dates and well as lot and expiration dates for the vaccine involved. This is 1 of 3 reports by the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site nodule, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse refers to 2 patients of unknown demographics. On 04-NOV-2013, the patients were vaccinated with a dose of PNEUMOVAX23 (lot# J004080, expiry date 22-AUG-2014). On 04-NOV-2013 the patients developed a rash, warmth and knot at the injection site. No treatment was provided for the events, however, the patients sought medical attention (spoke with the nurse). The events were reported to be recovered on 05-NOV-2013. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose unknown). No concomitant medications were reported. The pharmacist reproted that the GARDASIL was exposed to a temperature of 27F for 216 hours. The pharmacist stated that he would call back once he knew for sure if GARDASIL was administered or not. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 11-NOV-2013 the patient was vaccinated with partial dose of ZOSTAVAX due to syringe or needle leakage (leaked at the syringe hub where the needle was connected during administration). No adverse event was reported. This is 1 of 2 reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with partial dose of ZOSTAVAX due to syringe or needle leakage. No adverse event was reported. This is 2 of 2 reports from same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Rash generalised
Clinical narrative: Intense generalized rash went to urgent care was treated there, evening after shot were given.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Approximately 6 hrs after FLUZONE, patient developed redness, swelling in lower (R) arm extremity, no pain at injection site in upper (R) deltoid and no swelling in upper (R) deltoid.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot and expiry date). ON an unknown date the patient developed hives at injection site 2 days post vaccination. The pharmacist had suggested the patient to take an unspecified over the counter agent as treatment and the patient was referred to follow up with her doctor. The outcome of event hives at injection site was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient with tetracycline allergy. ON 08-NOV-2013 the patient was vaccinated with ZOSTAVAX (0.6ml) (lot number J006158, expiry date 30-AUG-2014) subcutaneous in the right arm. The concomitant medications were reported as none. On 08-NOV-2013, the patient experienced rash at injection site. On 13-NOV-2013 the patient experienced bumps at injection site and 2 bumps with itching on an unspecified wrist. There were no lab diagnostic studies performed. The patient sought medical attention and had visited a pharmacist. The patient was treated with ALEVE and col compresses at the injection site. The outcome of rash at injection site and bumps at injection site and 2 bumps with itching on an unspecified wrist was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Rash, Rash erythematous, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient (reported as wife of pharmacist) of unknown age. The patients concurrent condition included similar reaction (as reported) to Yellow fever vaccine and IGA issues (details unspecified). On an unknown date the patient was vaccinated with ZOSTAVAX. On an unknown date the patient experienced red rash over the entire arm (same arm as injection) and the rash was described as being "hot to the touch". The time between administration and development of rash was unspecified. It was reported that the pharmacy does not require follow up VZP mailing. No treatment was given for the events. The patient had not sought medical attention. The outcome of the events was reported as recovered/resolved (reported as after approximately three weeks). The causality for the events was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized, erythematous swelling of left arm approximately 5 cm, posteriorly. Pt. returned 11/13/13 for follow-up.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: On 10/12/13 patient noticed a rash on her stomach. It was red, blotchy and itchy. Patient took BENADRYL and a topical anti-itch cream. The rash persisted for 4 days and spread to the arms.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pain, Rash erythematous, Skin warm, Tenderness
Clinical narrative: Bright red and warm, sore rash surrounded by red spots all around, making it a 6 x 6 area tender.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Breast pain, Chest pain, Dyspnoea, Lymphadenopathy
Clinical narrative: Soreness and tenderness, swollen lymph nodes, pain from armpit across breast to the sternum. Trouble breathing. Patient did see her personal physician and the symptoms are improving.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Tenderness
Clinical narrative: Soreness and tenderness, swollen lymph nodes, pain from armpit across breast to the sternum. Trouble breathing. Patient did see her personal physician and the symptoms are improving.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Dizziness, Injection site reaction, Malaise, Myalgia
Clinical narrative: Bruising - Muscle throbbing deep in injection site into neck area. All over body aches and throbbing muscle aches. Lightheaded. All over malaise.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Bruising - Muscle throbbing deep in injection site into neck area. All over body aches and throbbing muscle aches. Lightheaded. All over malaise.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. The nurse lives with the family. The patient used no concomitant medication and had no known drug reactions or allergies. On 29-OCT-2013 the pati3ent was vaccinated with GARDASIL lot # 0636AE, expiry date 09-JAN-2015, dose 3, intramuscularly in the right deltoid. No information was provided with regards to the first and second dose of GARDASIL. On 30-OCT-2013 within 24 hours after vaccination the patient experienced fever of 102F. The fever of 102F persisted through the evening but resolved in the morning of 31-OCT-2013. No treatment was provided. The outcome of fever of 102F was reported as recovered/resolved. No action taken with GARDASIL was reported. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Numbness from neck down.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to unspecified patients of unknown age. On an unknown date the unspecified patients were vaccinated with VARIVAX (Merck) (doses, routes, lot numbers not reported) that had been shipped between clinics on dry ice and possibly exposed to temperatures below -58F. No adverse effects reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: PATIENT'S MOTHER REFERS THAT AFTER VACCINATION THE WENT BACK HOME AND THE CHILD BEGAN EXPERIENCING EDEMA AND ITCH IN THE ARM THAT RECEIVED THE VACCINES. DR. SAW HER AND WROTE A PRESCRIPTION.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Movement disorder
Clinical narrative: Unable to raise arm above parallel.  Swelling of hand.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral
Clinical narrative: NUMBNESS OF LIPS AND TONGUE AFTER RECEIVING THE FLU SHOT.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Generalized rash and pruritis. Recommend Benadryl.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red, warm and itchy to injection area.  Taking Claritin and can take OTC Benadryl and apply ice.  Given Ibuprofen.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Swelling, very hot and hard and red.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT REFERS NUMBNESS, REDNESS, SWOLLEN AND HOT AREA IN THE LEFT ARM WHERE THE VACCINE WAS ADMINISTERED. SHE WENT TO THE DOCTOR AND WAS PRESCRIBED WITH NAPROXEN.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral
Clinical narrative: Complained of numbness and tingling and swelling of lips 1.5 hours after flu shot. Started Benadryl ever 6 hours.  Lips still "puffy" next day, but feeling was back.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Vaccine administered on 11/12/13 on 11/14/13 my arm began to ache, the site swelled to the size of a lemon and itches a lot. If it gets bumped, it causes pain for a few minutes. It's also very red. It did not cause my breathing to be affected.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Swelling face, Swollen tongue, Urticaria
Clinical narrative: Approx. 8 hours after receiving influenza injection at school clinic developed hives from head to toes and swelling of face, lips and tongue per mother's report.  Was given 2 Benadryl (not sure of dosage), slept all night and was completely recovered 24 hours after the shot.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Type III immune complex mediated reaction, Varicella virus test negative
Clinical narrative: Arthus reaction with onset of symptoms a few hours after administration.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Keloid scar, Vaccination site reaction
Clinical narrative: After Fluzone Intradermal admin. site itched intensly but not scratched. Subsequently, a keloid scar of about 12 cm formed at the vaccine site.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Painful arm, redness that extended to elbow, red area "hot" and onset of fever later in the evening; went to walk-in clinic and received antibiotics the evening of 11/14/2013.