chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Electrocardiogram normal, Myopericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 15 October 2013. A male subject (age and date of birth not reported) with no reported past medical history received an injection of ACAM2000 (lot number, route and site not reported) and an injection of Anthrax vaccine (manufacturer, lot number, route and site not reported) on 20 July 2010. On 29 July 2010, the subject experienced elevated troponin. Troponin I on 27 July 2010 was 0.11 ng/mL and troponin I on 11 August 2010 was <0.10 ng/mL. ECG on 11 August 2010 was normal. The subject had no cardiac symptoms. The subject recovered on 11 August 2010. According to the investigator, the event of elevated troponin was definitely related to the administration of ACAM2000. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Blister, Erythema, Headache, Injection site erythema
Clinical narrative: This spontaneous report was received from a 60 year old female patient with no pertinent medical history and tramadol allergy (dosage, frequency and manufacturer unknown) reporting on herself. On 28-JUN-2013, the patient was vaccinated with a single dose injection of ZOSTAVAX (dose, route, lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The patient reported that on 30-JUN-2013, she experienced extreme hair loss; two rashes on different unspecified parts of the body, and headache after receiving ZOSTAVAX. The patient stated that she had been treated by numerous unspecified physicians and was prescribed fluocinonide cream (0.01%/at bed time/Amneal Pharma) as well as another unspecified medication that did not work for her. The patient also reported that a dermatologist had prescribed spironolactone (also reported as the patient did not receive any treatment for the AE by the reporter). She was also having sciatic and back pain (on 30-JUN-2013). She was getting steroid shots to treat back pain. Because of this, the patient was upset that she was not aware of the prescribing information before she received ZOSTAVAX, since the medication she was on could have been immunosuppressive. Blood work was performed to the patient (data not showed). At the time of the report, patient's outcome was recovering. The patient sought medical by seeing the doctor. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site vesicles, Pruritus
Clinical narrative: This spontaneous report was received from a 60 year old female patient with no pertinent medical history and tramadol allergy (dosage, frequency and manufacturer unknown) reporting on herself. On 28-JUN-2013, the patient was vaccinated with a single dose injection of ZOSTAVAX (dose, route, lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The patient reported that on 30-JUN-2013, she experienced extreme hair loss; two rashes on different unspecified parts of the body, and headache after receiving ZOSTAVAX. The patient stated that she had been treated by numerous unspecified physicians and was prescribed fluocinonide cream (0.01%/at bed time/Amneal Pharma) as well as another unspecified medication that did not work for her. The patient also reported that a dermatologist had prescribed spironolactone (also reported as the patient did not receive any treatment for the AE by the reporter). She was also having sciatic and back pain (on 30-JUN-2013). She was getting steroid shots to treat back pain. Because of this, the patient was upset that she was not aware of the prescribing information before she received ZOSTAVAX, since the medication she was on could have been immunosuppressive. Blood work was performed to the patient (data not showed). At the time of the report, patient's outcome was recovering. The patient sought medical by seeing the doctor. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Blister, Erythema, Headache, Pruritus
Clinical narrative: This spontaneous report was received from a 60 year old female patient with no pertinent medical history and tramadol allergy (dosage, frequency and manufacturer unknown) reporting on herself. On 28-JUN-2013, the patient was vaccinated with a single dose injection of ZOSTAVAX (dose, route, lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The patient reported that on 30-JUN-2013, she experienced extreme hair loss; two rashes on different unspecified parts of the body, and headache after receiving ZOSTAVAX. The patient stated that she had been treated by numerous unspecified physicians and was prescribed fluocinonide cream (0.01%/at bed time/Amneal Pharma) as well as another unspecified medication that did not work for her. The patient also reported that a dermatologist had prescribed spironolactone (also reported as the patient did not receive any treatment for the AE by the reporter). She was also having sciatic and back pain (on 30-JUN-2013). She was getting steroid shots to treat back pain. Because of this, the patient was upset that she was not aware of the prescribing information before she received ZOSTAVAX, since the medication she was on could have been immunosuppressive. Blood work was performed to the patient (data not showed). At the time of the report, patient's outcome was recovering. The patient sought medical by seeing the doctor. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Back pain, Blood test, Emotional distress, Headache
Clinical narrative: This spontaneous report was received from a 60 year old female patient with no pertinent medical history and tramadol allergy (dosage, frequency and manufacturer unknown) reporting on herself. On 28-JUN-2013, the patient was vaccinated with a single dose injection of ZOSTAVAX (dose, route, lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The patient reported that on 30-JUN-2013, she experienced extreme hair loss; two rashes on different unspecified parts of the body, and headache after receiving ZOSTAVAX. The patient stated that she had been treated by numerous unspecified physicians and was prescribed fluocinonide cream (0.01%/at bed time/Amneal Pharma) as well as another unspecified medication that did not work for her. The patient also reported that a dermatologist had prescribed spironolactone (also reported as the patient did not receive any treatment for the AE by the reporter). She was also having sciatic and back pain (on 30-JUN-2013). She was getting steroid shots to treat back pain. Because of this, the patient was upset that she was not aware of the prescribing information before she received ZOSTAVAX, since the medication she was on could have been immunosuppressive. Blood work was performed to the patient (data not showed). At the time of the report, patient's outcome was recovering. The patient sought medical by seeing the doctor. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Sciatica
Clinical narrative: This spontaneous report was received from a 60 year old female patient with no pertinent medical history and tramadol allergy (dosage, frequency and manufacturer unknown) reporting on herself. On 28-JUN-2013, the patient was vaccinated with a single dose injection of ZOSTAVAX (dose, route, lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The patient reported that on 30-JUN-2013, she experienced extreme hair loss; two rashes on different unspecified parts of the body, and headache after receiving ZOSTAVAX. The patient stated that she had been treated by numerous unspecified physicians and was prescribed fluocinonide cream (0.01%/at bed time/Amneal Pharma) as well as another unspecified medication that did not work for her. The patient also reported that a dermatologist had prescribed spironolactone (also reported as the patient did not receive any treatment for the AE by the reporter). She was also having sciatic and back pain (on 30-JUN-2013). She was getting steroid shots to treat back pain. Because of this, the patient was upset that she was not aware of the prescribing information before she received ZOSTAVAX, since the medication she was on could have been immunosuppressive. Blood work was performed to the patient (data not showed). At the time of the report, patient's outcome was recovering. The patient sought medical by seeing the doctor. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous and follow up report as received from a pharmacist and a field employee respectively refers to a 77 year old female patient with allergy to FLAGYL, penicillin and ciprofloxacin. On 11-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J004267, expiration date 12-JUL-2014, 0.65 ml, subcutaneous. Concomitant medications were not reported. On 12-OCT-2013, 2 days after onset of therapy the patient experienced headaches, body aches and symptoms at the injection site such as warm to touch, swelling, redness "about silver dollar size" and itchiness. On 15-OCT-2013, the patient went into the pharmacy and informed the pharmacist. No lab diagnostics studies were performed. No treatment was given for the events. The outcome of the events was reported as recovering. This is one of several reports received from same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous and follow up report as received from a pharmacist and a field employee respectively refers to a 77 year old female patient with allergy to FLAGYL, penicillin and ciprofloxacin. On 11-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J004267, expiration date 12-JUL-2014, 0.65 ml, subcutaneous. Concomitant medications were not reported. On 12-OCT-2013, 2 days after onset of therapy the patient experienced headaches, body aches and symptoms at the injection site such as warm to touch, swelling, redness "about silver dollar size" and itchiness. On 15-OCT-2013, the patient went into the pharmacy and informed the pharmacist. No lab diagnostics studies were performed. No treatment was given for the events. The outcome of the events was reported as recovering. This is one of several reports received from same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Hypersensitivity, Pruritus, Skin warm
Clinical narrative: Headache, treated with acyclovir and Advil.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache
Clinical narrative: Headache, treated with acyclovir and Advil.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Injection site pain, Injection site swelling, Listless
Clinical narrative: Extreme headache, overall listlissness, numbness in appendages, slight fever, neck and shoulder pain, swelling at injection site, pain at injection site, heaviness in arm of injection site.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Neck pain, Pyrexia, Sensation of heaviness
Clinical narrative: Extreme headache, overall listlissness, numbness in appendages, slight fever, neck and shoulder pain, swelling at injection site, pain at injection site, heaviness in arm of injection site.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Blister, Herpes ophthalmic, Herpes zoster, Pruritus
Clinical narrative: Onset of blisters and itching in face that progressed over a period of one week into a full blown case of shingles. Patient never had shingles in past.
Sex: M
Vaccine: HEP
Symptoms: Brain injury, Cerebrovascular accident, Convulsion, Electrocardiogram, Nuclear magnetic resonance imaging
Clinical narrative: My newborn son experience a large stroke that destroyed 1/4 of his brain and a smaller stroke.  The first indication something was wrong was that he began having seizures after the immunization.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Chest discomfort, Chest pain, Chills, Confusional state
Clinical narrative: Disorientation and confusion for several hours, headache, joint pain, loss of appetitite, occasional chest pain and heaviness, severe chills, shortness of breath, continues until 19 Oct.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Decreased appetite, Disorientation, Dyspnoea, Headache
Clinical narrative: Disorientation and confusion for several hours, headache, joint pain, loss of appetitite, occasional chest pain and heaviness, severe chills, shortness of breath, continues until 19 Oct.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Headache, Hypoacusis, Tinnitus
Clinical narrative: Vertigo, tinnitus, dizziness, mental confusion, severe headache, hearing difficulties.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Vertigo, tinnitus, dizziness, mental confusion, severe headache, hearing difficulties.
Sex: F
Vaccine: FLUX
Symptoms: Dehydration, Swelling face, Urticaria
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-Oct-2013) concerns a female patient with a history of allergy to VALTREX. The patient had no pertinent medical history or concomitant medication. On an unreported date (2 years ago), the patient received influenza (batch and manufacturer not reported). On an unreported date (2 years ago) the patient broke out in hives and her face was swollen. She became dehydrated. She visited a healthcare centre but was not admitted to hospital. She was treated with BENADRYL and IV fluids. Outcome was reported as recovered.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Hot flush, Injection site erythema, Injection site pruritus, Local swelling
Clinical narrative: This spontaneous report as received from a 61 years old female consumer with rheumatoid illness and no drug reactions/allergies refers to herself. On 02-OCT-2013 (3 weeks ago) the patient was vaccinated with a "standard" dose of ZOSTAVAX (lot #, expiration date unspecified), subcutaneously. No Concomitant Medication was reported. She stated during the first week after vaccination she developed an injection site reaction where she had swelling in her arm and around the injection site was red and itchy. She stated that the injection site reaction lasted for 1 full week. She then stated that 3 days after her injection site reaction had ceased she developed intense warming and flushing in her face that then spread to her arms and upper chest. She then stated that she began experiencing discomfort from her right earlobe to her jawbone. She had been to an oral surgeon to assess the discomfort in her jaw area and an (ear, nose, and throat) ENT as well, both providers had ruled out the discomfort due to some type of infection. She would continue to seek medical attention for these events. She also explained that she was seen at her local emergency room (ER) facility who prescribed a 4mg daily of MEDROL which she had taken for 3 days at this time and, she explained, had helped to treat the flushing and warmth symptoms. No Lab Diagnostics Studies Performed. The events outcome except for injection site reaction was reported as not recovered. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw
Clinical narrative: This spontaneous report as received from a 61 years old female consumer with rheumatoid illness and no drug reactions/allergies refers to herself. On 02-OCT-2013 (3 weeks ago) the patient was vaccinated with a "standard" dose of ZOSTAVAX (lot #, expiration date unspecified), subcutaneously. No Concomitant Medication was reported. She stated during the first week after vaccination she developed an injection site reaction where she had swelling in her arm and around the injection site was red and itchy. She stated that the injection site reaction lasted for 1 full week. She then stated that 3 days after her injection site reaction had ceased she developed intense warming and flushing in her face that then spread to her arms and upper chest. She then stated that she began experiencing discomfort from her right earlobe to her jawbone. She had been to an oral surgeon to assess the discomfort in her jaw area and an (ear, nose, and throat) ENT as well, both providers had ruled out the discomfort due to some type of infection. She would continue to seek medical attention for these events. She also explained that she was seen at her local emergency room (ER) facility who prescribed a 4mg daily of MEDROL which she had taken for 3 days at this time and, she explained, had helped to treat the flushing and warmth symptoms. No Lab Diagnostics Studies Performed. The events outcome except for injection site reaction was reported as not recovered. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 21-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 12-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager at the physician's office via company representative refers to a patient of unknown age and gender. The reporter stated that an expired dose of ZOSTAVAX (lot# unspecified) (route, dose and location unspecified) was administered to an unspecified patient, possibly on 21-OCT-2013. No adverse effect reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Breast pain, Burning sensation, Herpes zoster
Clinical narrative: This spontaneous report was received from an approximately a 65 year old female patient regarding herself. There were no pertinent medical history and no drug reactions or allergies. Approximately on an unknown date in June 2013 (reported as about four months ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapy included levothyroxine sodium. On 05-OCT-2013, the patient experienced shingles. The patient explained that on 05-OCT-2013, she began experiencing pain and a burning sensation on her back and breast. On 06-OCT-2013, she noticed that she was experiencing more pain and that she had developed a blister on her back. On 07-OCT-2013, the patient reported that she had developed a rash on her back and breast and the pain in those areas had increased. The patient sought medical attention (office visit on 08-OCT-2013). The physician prescribed VALTREX (reported as generic VALTREX (manufacturer unknown, 1 tablet three times daily) to treat the symptoms of the patient. No lab tests were performed. Of her present condition, the patient stated that the blisters were drying but she still had a significant amount of pain. The outcome of shingles, burning sensation, rash on her back and breast was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from an approximately a 65 year old female patient regarding herself. There were no pertinent medical history and no drug reactions or allergies. Approximately on an unknown date in June 2013 (reported as about four months ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapy included levothyroxine sodium. On 05-OCT-2013, the patient experienced shingles. The patient explained that on 05-OCT-2013, she began experiencing pain and a burning sensation on her back and breast. On 06-OCT-2013, she noticed that she was experiencing more pain and that she had developed a blister on her back. On 07-OCT-2013, the patient reported that she had developed a rash on her back and breast and the pain in those areas had increased. The patient sought medical attention (office visit on 08-OCT-2013). The physician prescribed VALTREX (reported as generic VALTREX (manufacturer unknown, 1 tablet three times daily) to treat the symptoms of the patient. No lab tests were performed. Of her present condition, the patient stated that the blisters were drying but she still had a significant amount of pain. The outcome of shingles, burning sensation, rash on her back and breast was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old female patient with asthma, peanut allergy, shrimp allergy, dog, cat allergy and dust mites allergy. On 27-AUG-2013, the patient was vaccinated with a first dose of GARDASIL lot # J006850 exp. date 31-MAR-2016, 0.5 ml, intramuscular. Concomitant therapies included EPIPEN. On 30-AUG-2013, after receiving her first dose of GARDASIL, the patient experienced severe swelling that was 8x10 cm and bumpy rash. Physician also reported that the patient was seen in her office on 30-AUG-2013 and she instructed to use cool towel (as a treatment for the events). There was no lab diagnostics studies performed. The outcome of severe swelling that was 8x10cm and bumpy rash was unknown. Causality was not reported. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia, Tremor
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a male patient in his late 20's. On 12-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 due to Sinusitis (dose, frequency, lot# and expiration date unknown, therapy route injection as reported). Within an unspecified period of time following administration, the patient began to experience vomiting, chills, shaking and fever. Additionally, an injection site reaction was experienced, presenting as redness and tenderness. The patient sought medical attention and the physician noted that, while most adverse symptoms subsided by time of follow-up office visit, "several weeks later," the injection site remained sore, tender and red. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a male patient in his late 20's. On 12-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 due to Sinusitis (dose, frequency, lot# and expiration date unknown, therapy route injection as reported). Within an unspecified period of time following administration, the patient began to experience vomiting, chills, shaking and fever. Additionally, an injection site reaction was experienced, presenting as redness and tenderness. The patient sought medical attention and the physician noted that, while most adverse symptoms subsided by time of follow-up office visit, "several weeks later," the injection site remained sore, tender and red. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 82 year old male patient with diabetes and high blood pressure. The patient's relevant past drug history was unknown. The patient was started on PNEUMOVAX 23 0.5 ml every 5 years for prevention of pneumonia 5 years ago. On 17-OCT-2013, the patient was vaccinated subcutaneously with PNEUMOVAX 23 lot # 671401/1158AA expiry date 10-APR-2013, dose 2, .5 ml, subcutaneous. Concomitant therapies included PLAVIX, FUROSEMIDE and METOPROLOL for high blood pressure and GLYBURIDE for diabetes. On 17-OCT-2013, the pharmacist discovered that the PNEUMOVAX 23 the patient received on 17-OCT-2013 had expired on 10-APR-2013. The outcome of the PNEUMOVAX 23 the patient received on 17-oct-2013 had expired on 10-apr-2013 was unknown. There was no relevant lab data. As of 26-OCT-2013, the patient was continuing PNEUMOVAX 23 every 5 years and has not reported any problems after receiving an expired vaccine. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site joint pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. There was no pertinent medical history. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date and route was unknown). On an unknown date, the patient was vaccinated with a dose of influenza virus vaccine (manufacturer unknown). Concomitant therapies included allergenic injections (allergenic extract). On an unknown date, a few hours after vaccination the patient experienced injection site redness and a hot, red, raised area and pain in joints above and below the injection site. The patient took over the counter ADVIL and the symptoms dissipated. The patient also experienced mild injection site symptoms after receiving a dose of influenza virus vaccine(manufacturer unknown). There was no lab tests performed. At the time of the report the patient recovered from all the reported events. The patient did not seek medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Muscular weakness, Nausea, Sensation of heaviness
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 year old female patient with amoxicillin allergy. Patient had no pertinent medical history. On 24-OCT-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J009243; expiry date: 23-APR-2016). There was no concomitant medication. On 24-OCT-2013, the patient experienced nausea and weakness in her legs after vaccination. The patient remained seated for 15 minutes following the administration of GARDASIL and then felt nauseous and stated her legs felt heavy and weak. These symptoms persisted for an additional 20 minutes and the patient was taken to her mother's car in a wheelchair and sent home. The patient had difficulty walking. No treatment was given for events. No lab tests were performed. The patient had sought medical attention. The outcome of the events was unknown. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 12-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Pt called today stating her arm has been swelling, itching, red (size of softball) and warm to touch. No temp taken. Since receiving shot. Dr advised BENADRYL as nothing tried at this point. Sores on lips but gone now.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redden/swelling to touch, RA, area approx 3" x 2" where the Flu vac. was given. Raised area approx 1 1/4" where the Tdap was given.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from medical assistant via company representative refers to a 53 year old female patient with no pertinent medical history and no drug reactions or allergies. On 11-OCT-2013, the patient was vaccinated with first dose of ZOSTAVAX lot # J002692 exp. date 30-APR-2014 (dose and route not reported). There was no concomitant medication. On an approximately 11-OCT-2013, within 24 hours (exact time to onset unspecified), the patient noted pain, swelling, and hardness at the injection site. The area was also warm to the touch and had a bright erythema the size of an egg surrounding it. Today (14-OCT-2013) the erythema was larger and there was a blistering rash. However, the pain, swelling, hardness, warmth have all lessened. It was also reported that the patient's outcome was not recovered. There was no treatment given for the patient's events. No lab diagnostics studies were performed. It was reported that the patient called the office in regards to events. Causality was not provided. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from medical assistant via company representative refers to a 53 year old female patient with no pertinent medical history and no drug reactions or allergies. On 11-OCT-2013, the patient was vaccinated with first dose of ZOSTAVAX lot # J002692 exp. date 30-APR-2014 (dose and route not reported). There was no concomitant medication. On an approximately 11-OCT-2013, within 24 hours (exact time to onset unspecified), the patient noted pain, swelling, and hardness at the injection site. The area was also warm to the touch and had a bright erythema the size of an egg surrounding it. Today (14-OCT-2013) the erythema was larger and there was a blistering rash. However, the pain, swelling, hardness, warmth have all lessened. It was also reported that the patient's outcome was not recovered. There was no treatment given for the patient's events. No lab diagnostics studies were performed. It was reported that the patient called the office in regards to events. Causality was not provided. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via company representative concerning a 2 month old patient of unknown gender who on an unknown date was might have been vaccinated with a dose of MMR II lot # H017433, exp date 20-SEP-2014 (dose not provided). No adverse effects were reported. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called on 10/29/13 and verbalized that her arm was red and hot and swollen near her injection site. She denied other sx. She was instructed to take BENADRYL and to report to the ER for worsening symptoms.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Upper extremity mass
Clinical narrative: Arm is reddened and bruised with a "lump" no other s/s.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity, Pruritus, Rash
Clinical narrative: Night of and day after shot - Red, swollen pain from neck down to elbow. 2 days post inj. red rash up and down arm, itching, hot.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Night of and day after shot - Red, swollen pain from neck down to elbow. 2 days post inj. red rash up and down arm, itching, hot.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 64 year old male patient with asthma and hypertension. None drug reactions nor allergies were reported. On 12-OCT-2013, the patient was vaccinated with ZOSTAVAX vial, 0.65 ml/once, subcutaneous (lot number was not reported). Concomitant therapies included FLONASE, FLOMAX, hydrochlorothiazide (manufacturer unknown), albuterol (manufacturer unknown) and lisinopril (manufacturer unknown). Approximately in October 2013 (information received on 14-OCT-2013), the patient developed redness, soreness and itchiness at injection site after receiving ZOSTAVAX. The patient reported to the pharmacist that the reaction "looked like hives" and was "2 inches by 4 inches" in size. None treatment was given. None laboratories were performed. It was reported that the patient sought medical attention by calling the pharmacy. The outcome of the events was reported as not recovered. Causality was not assessed by reporter. 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 another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 05-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown indication. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 62 year old patient. The physician reported that she had intended to administer ZOSTAVAX to a 62 year old patient, however, a dose of VARIVAX (Merck), (lot #, expiration date, dose and route unspecified) was inadvertently administered to the patient on 15-OCT-2013. No adverse effects 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 another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 10-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown). Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. 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 another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 09-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown indication. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. 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 another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 12-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown indication. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PNC
Symptoms: Death
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age, ethnicity, and gender received PREVNAR, via an unspecified route of administration on an unspecified date at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unknown, the patient passed away from an unknown cause. Therapeutic measures taken in response to the event were unknown.The clinical outcome was fatal and it was unknown if an autopsy was performed.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 15 October 2013. A 19-year-old male subject with no reported past medical history had received on 19 July 2010 the following vaccines: ACAM2000 (lot number, route and site not reported) and anthrax (manufacturer, lot number, route and site of administration not reported) and seven days later on 26 July 2010 was found to have an elevated Troponin I level of 0.11 ng/ml. On 02 August 2010 was subject was found to have a Troponin I level of 0.13 ng/ml and a normal ECG. The subject had no cardiac symptoms. The subject had no concomitant medications. According to the investigator, the subject was unable to be reached for further follow-up but was referred appropriately. No further information was available at the time of the report. The subject's outcome was not recovered. According to the investigator, the event of elevated Troponin was considered an other important event and definitely related to vaccination. Per the investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Initial report received from a healthcare professional on 16 October 2013. A male patient (age was not reported), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE INTRADERMAL (batch number not reported, route of administration: Intradermal and anatomical site of administration was not reported) on an unspecified date. On unspecified date, the patient had "serious reaction" after the intradermal shot of vaccine. Complementary investigations and laboratory data were not reported. As of 16 October 2013, the outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On the same day, the patient was administered with this improperly stored GARDASIL (route of administration unknown). Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Antibody test negative, Blister, Injection site urticaria, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female patient with no pertinent medical history and no known drug allergies who on 16-NOV-2011 was vaccinated SC with a dose of VARIVAX (Merck) (lot number: 669230/1682Z, exp. Date: 09-DEC-2012), 0.5 ml. There was no concomitant medication. On approximately 04-DEC-2011, about 2.5 weeks after administration of VARIVAX (Merck), the patient developed 5 to 6 varicella like lesions on head and body after administration of VARIVAX (Merck). The patient also developed urticaria at injection site. Unspecified antihistamine was given for the treatment of the adverse event. The patient sought medical by an office visit. No lab test was performed. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the registered nurse concerning the student with no illness at the time of vaccination, no adverse events following prior vaccinations and not immune to varicella zoster (on 19-OCT-2011) who on 16-NOV-2011 at 10:41am, was vaccinated subcutaneously in the left arm with the first 0.5 ml dose of VARIVAX (Merck) (lot number: 669230/1682Z, exp. Date 09-DEC-2012). Secondary suspect vaccines included the first dose of MMR II (lot number 669517/0037AA, exp. date 01-FEB-2013), subcutaneously in the right arm on 16-NOV-2011, at 10:41am. Concomitant vaccines included the first dose of ENGERIX-B (lot number: AHBV009AA) intramuscularly in the left deltoid on 16-NOV-2011, at 10:41am. The registered nurse reported that on 05-DEC-2011 the patient developed itchy rash, 2 lesions on scalp, 2 lesions on chest, several vesicles on forehead, 3 cm urticarial type lesion on left arm and all spots were itchy and painful. The patient was given ZYRTEC for 10 days and advised to avoid contact with high risk people. On 17-JAN-2012 lab diagnostic tests were performed and the results were varicella zoster equivocal. The patient did not seek medical attention (previously reported by the registered nurse as sought medical attention by an office visit). At the time of the report the patient recovered from the event. Follow up information has been received from another registered nurse reported that "in 2011" the patient received the second dose of VARIVAX (merck) (lot number, expiry date and route was not reported) and on an unknown date developed "a varicella like syndrome with rash". She stated that it was like chicken pox. She stated it might have been reported at that time. An unspecified treatment was given for the event. The outcome of the event was recovered on an unknown date. The patient sought medical attention. It has been determined that case # {1309USA013858} is a duplicate of case # {1112USA01189} therefore, case # {1309USA013858} is being deleted from our files and the cases consolidated into case# {1112USA01189}. Additional information is not expected.