chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Abdominal discomfort, Altered state of consciousness, Anxiety, Chills, Dizziness
Clinical narrative: This spontaneous report as received from a consumer refers to her 18 year old son with drug allergies to CEFZIL, ELAVIL, REGLAN. The patient's medical history included acid reflux and IBS (Irritable Bowel Syndrome). In 2013 the patient was vaccinated with his three doses of GARDASIL (dose, strength, route, lot number were unkonwn) separately. Concomitant therapies included CELEXA 25mg, omeprazole (manufacturer unknown) 40mg and hyoscyamine sulfate 125 mg. In the "latter part of the 2013 school year" the patient had been experiencing tiredness, shortness of breath and continued stomach problems since receiving the GARDASIL vaccines. The mother also repeated the same AE symptoms and provided additional details such as that her son's blood work at an unspecific date showed his "white blood cell count was high" and he was given an ultrasound of his thyroid, and showed swollen lymph nodes. She indicated that was after the second shot that her son had "unusual tiredness" and that 2-3 weeks after the final dose he developed stomach problems. He had also had dizziness, chills, and "almost passed out" in HCP's office. He was diagnosed with anxiety, but the anxiety medication "didn't help." He was taking unspecified "supplements" and "immune boosters." After the unspecified naturopath exposed the patient "HPV serum," physician believed this verified that GARDASIL caused the AE. Patient sought unspecified medical attention. At the time of the report, the outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Fatigue, Lymphadenopathy, Ultrasound thyroid abnormal, White blood cell count increased
Clinical narrative: This spontaneous report as received from a consumer refers to her 18 year old son with drug allergies to CEFZIL, ELAVIL, REGLAN. The patient's medical history included acid reflux and IBS (Irritable Bowel Syndrome). In 2013 the patient was vaccinated with his three doses of GARDASIL (dose, strength, route, lot number were unkonwn) separately. Concomitant therapies included CELEXA 25mg, omeprazole (manufacturer unknown) 40mg and hyoscyamine sulfate 125 mg. In the "latter part of the 2013 school year" the patient had been experiencing tiredness, shortness of breath and continued stomach problems since receiving the GARDASIL vaccines. The mother also repeated the same AE symptoms and provided additional details such as that her son's blood work at an unspecific date showed his "white blood cell count was high" and he was given an ultrasound of his thyroid, and showed swollen lymph nodes. She indicated that was after the second shot that her son had "unusual tiredness" and that 2-3 weeks after the final dose he developed stomach problems. He had also had dizziness, chills, and "almost passed out" in HCP's office. He was diagnosed with anxiety, but the anxiety medication "didn't help." He was taking unspecified "supplements" and "immune boosters." After the unspecified naturopath exposed the patient "HPV serum," physician believed this verified that GARDASIL caused the AE. Patient sought unspecified medical attention. At the time of the report, the outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Chills, Condition aggravated, Dizziness, Dyspnoea
Clinical narrative: This spontaneous report as received from a consumer refers to her 18 year old son with drug allergies to CEFZIL, ELAVIL, REGLAN. The patient's medical history included acid reflux and IBS (Irritable Bowel Syndrome). In 2013 the patient was vaccinated with his three doses of GARDASIL (dose, strength, route, lot number were unkonwn) separately. Concomitant therapies included CELEXA 25mg, omeprazole (manufacturer unknown) 40mg and hyoscyamine sulfate 125 mg. In the "latter part of the 2013 school year" the patient had been experiencing tiredness, shortness of breath and continued stomach problems since receiving the GARDASIL vaccines. The mother also repeated the same AE symptoms and provided additional details such as that her son's blood work at an unspecific date showed his "white blood cell count was high" and he was given an ultrasound of his thyroid, and showed swollen lymph nodes. She indicated that was after the second shot that her son had "unusual tiredness" and that 2-3 weeks after the final dose he developed stomach problems. He had also had dizziness, chills, and "almost passed out" in HCP's office. He was diagnosed with anxiety, but the anxiety medication "didn't help." He was taking unspecified "supplements" and "immune boosters." After the unspecified naturopath exposed the patient "HPV serum," physician believed this verified that GARDASIL caused the AE. Patient sought unspecified medical attention. At the time of the report, the outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Gastric disorder, Gastrooesophageal reflux disease, Lymphadenopathy, Nausea
Clinical narrative: This spontaneous report as received from a consumer refers to her 18 year old son with drug allergies to CEFZIL, ELAVIL, REGLAN. The patient's medical history included acid reflux and IBS (Irritable Bowel Syndrome). In 2013 the patient was vaccinated with his three doses of GARDASIL (dose, strength, route, lot number were unkonwn) separately. Concomitant therapies included CELEXA 25mg, omeprazole (manufacturer unknown) 40mg and hyoscyamine sulfate 125 mg. In the "latter part of the 2013 school year" the patient had been experiencing tiredness, shortness of breath and continued stomach problems since receiving the GARDASIL vaccines. The mother also repeated the same AE symptoms and provided additional details such as that her son's blood work at an unspecific date showed his "white blood cell count was high" and he was given an ultrasound of his thyroid, and showed swollen lymph nodes. She indicated that was after the second shot that her son had "unusual tiredness" and that 2-3 weeks after the final dose he developed stomach problems. He had also had dizziness, chills, and "almost passed out" in HCP's office. He was diagnosed with anxiety, but the anxiety medication "didn't help." He was taking unspecified "supplements" and "immune boosters." After the unspecified naturopath exposed the patient "HPV serum," physician believed this verified that GARDASIL caused the AE. Patient sought unspecified medical attention. At the time of the report, the outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Night sweats, Presyncope, Pyrexia, Rash, Syncope
Clinical narrative: This spontaneous report as received from a consumer refers to her 18 year old son with drug allergies to CEFZIL, ELAVIL, REGLAN. The patient's medical history included acid reflux and IBS (Irritable Bowel Syndrome). In 2013 the patient was vaccinated with his three doses of GARDASIL (dose, strength, route, lot number were unkonwn) separately. Concomitant therapies included CELEXA 25mg, omeprazole (manufacturer unknown) 40mg and hyoscyamine sulfate 125 mg. In the "latter part of the 2013 school year" the patient had been experiencing tiredness, shortness of breath and continued stomach problems since receiving the GARDASIL vaccines. The mother also repeated the same AE symptoms and provided additional details such as that her son's blood work at an unspecific date showed his "white blood cell count was high" and he was given an ultrasound of his thyroid, and showed swollen lymph nodes. She indicated that was after the second shot that her son had "unusual tiredness" and that 2-3 weeks after the final dose he developed stomach problems. He had also had dizziness, chills, and "almost passed out" in HCP's office. He was diagnosed with anxiety, but the anxiety medication "didn't help." He was taking unspecified "supplements" and "immune boosters." After the unspecified naturopath exposed the patient "HPV serum," physician believed this verified that GARDASIL caused the AE. Patient sought unspecified medical attention. At the time of the report, the outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Ultrasound thyroid abnormal, White blood cell count increased
Clinical narrative: This spontaneous report as received from a consumer refers to her 18 year old son with drug allergies to CEFZIL, ELAVIL, REGLAN. The patient's medical history included acid reflux and IBS (Irritable Bowel Syndrome). In 2013 the patient was vaccinated with his three doses of GARDASIL (dose, strength, route, lot number were unkonwn) separately. Concomitant therapies included CELEXA 25mg, omeprazole (manufacturer unknown) 40mg and hyoscyamine sulfate 125 mg. In the "latter part of the 2013 school year" the patient had been experiencing tiredness, shortness of breath and continued stomach problems since receiving the GARDASIL vaccines. The mother also repeated the same AE symptoms and provided additional details such as that her son's blood work at an unspecific date showed his "white blood cell count was high" and he was given an ultrasound of his thyroid, and showed swollen lymph nodes. She indicated that was after the second shot that her son had "unusual tiredness" and that 2-3 weeks after the final dose he developed stomach problems. He had also had dizziness, chills, and "almost passed out" in HCP's office. He was diagnosed with anxiety, but the anxiety medication "didn't help." He was taking unspecified "supplements" and "immune boosters." After the unspecified naturopath exposed the patient "HPV serum," physician believed this verified that GARDASIL caused the AE. Patient sought unspecified medical attention. At the time of the report, the outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 2 year old patient. On 08-JUL-2014 the patient was vaccinated with a dose of M-M-R II (lot # J015503, expiration date: 05-DEC-2015, dose and route not reported) and a does of (Oka/Merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported), both vaccine were stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Laboratory test, Oropharyngeal pain, Pharyngeal oedema, Sensation of foreign body
Clinical narrative: Throat tightness/swelling, itching, starting a few minutes after administration. Went to ER. Has had elevated tryptase and intermittent throat tightness and SOB.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swollen tongue, Tongue disorder
Clinical narrative: Throat tightness/swelling, itching, starting a few minutes after administration. Went to ER. Has had elevated tryptase and intermittent throat tightness and SOB.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Pharyngeal oedema, Pruritus, Throat tightness, Tryptase increased
Clinical narrative: Throat tightness/swelling, itching, starting a few minutes after administration. Went to ER. Has had elevated tryptase and intermittent throat tightness and SOB.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 4 year old patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 26-AUG-2014 the patient was vaccinated with PROQUAD. 0.5 ml, subcutaneous in the left thigh, lot number K007158, expiration date 12-NOV-2015, (dose number were unspecified). On an unknown date in August 2014, the patient experienced injection site reactions and swelling after an injection of PROQUAD. The patient did not seek medical attention. The outcome of the events was unknown. The relatedness between PROQUAD and the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Injection site reaction, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 4 year old patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 26-AUG-2014 the patient was vaccinated with PROQUAD. 0.5 ml, subcutaneous in the left thigh, lot number K007158, expiration date 12-NOV-2015, (dose number were unspecified). On an unknown date in August 2014, the patient experienced injection site reactions and swelling after an injection of PROQUAD. The patient did not seek medical attention. The outcome of the events was unknown. The relatedness between PROQUAD and the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large amnt of swelling, redness and pain in right deltoid area where shot was administered.
Age: 11.0
Sex: M
Vaccine: FLUX, MNQ, TDAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Heat, redness and swelling at injection site, low-grade fever, nausea, fatigue, headache.
Age: 11.0
Sex: M
Vaccine: FLUX, MNQ, TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Heat, redness and swelling at injection site, low-grade fever, nausea, fatigue, headache.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Pyrexia
Clinical narrative: Started out being drained of energy and then fever and severe joint aches.  This lasted for 2 days.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Eye pruritus, Throat irritation, Wheezing
Clinical narrative: EE comes to OHS after having received flu vaccination this morning at approximately 10:30am, stating she began having shortness of breath, wheezing, itching throat, cough, itchy eyes onset approximately 2:00-2:30pm.  EE has hx of asthma and uses inhaler; has used inhaler with minimal improvement.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Drug administered at inappropriate site, Injected limb mobility decreased, Muscular weakness
Clinical narrative: Excruciating pain, inability to raise arm, chills, weakness in arm, dizziness. It has been one week since the shot, and I still have radiating pain from my shoulder down my arm and weakness. The shot appeared to be given too high on my arm and was poked harder into my bone. I cannot raise my arm.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Excruciating pain, inability to raise arm, chills, weakness in arm, dizziness. It has been one week since the shot, and I still have radiating pain from my shoulder down my arm and weakness. The shot appeared to be given too high on my arm and was poked harder into my bone. I cannot raise my arm.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Rash macular, Rash papular
Clinical narrative: Densely spaced erythematous pinpoint papules and macules ant, L lat, and R lat neck and upper chest. Otherwise well.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On approximately 11-AUG-2014 (reported as since 11-AUG-2014) the patients were vaccinated with an improperly storage (Oka/Merck) VARIVAX, subcutaneous. No adverse effects reported.   Follow up information has been received on 03-SEP-2014 from licensed practical nurse. She stated that 7 doses of (Oka/Merck) VARIVAX with lot number K002046 expiration date 10-FEB-2016 has been given to unspecified number of patients (patient's identifiers or dates of vaccination were not available at the time of report). It was also reported that 10 doses of (Oka/Merck) VARIVAX (with lot # J011125, expiration date 05-SEP-2015) and 10 doses of (Oka/Merck) VARIVAX (with lot # J006358, expiration date 23-MAY-2015) were improperly stored (not given to date). This is one of several reports received from the same reporter. 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 Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. The reporter stated that dosesof VAQTA (dose, route and lot# not reported) that were exposed to a supported temperature excursion that occurred on 29-JUL-2014 had been administered to unspecified patients on unspecified dates. The reporter reported that she had not been informed of any adverse effects. It ws unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Injection site discolouration, Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Status post immunization right arm became warm to touch, itchy, swollen, with skin discoloration, and blister like formations at the site of injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: AREA THE SIZE OF SOFTBALL ON INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE. DEVELOPED A BLISTER LIKE RASH ABOUT THE SIZE OF A QUARTER IN THE MIDDLE OF THE INJECTION SITE. ALSO GOT SMALL ITCHY RASH IN A LINE LIKE PATTERN ON THE CHEST BELOW BREASTS.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: AREA THE SIZE OF SOFTBALL ON INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE. DEVELOPED A BLISTER LIKE RASH ABOUT THE SIZE OF A QUARTER IN THE MIDDLE OF THE INJECTION SITE. ALSO GOT SMALL ITCHY RASH IN A LINE LIKE PATTERN ON THE CHEST BELOW BREASTS.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Anxiety, Depression, Dizziness, Ear canal injury, Headache
Clinical narrative: Dizziness and headache occurred. Chronic migraines developed -- never had headaches before thought to have caused trauma to both inner ear canals. Ongoing migraines being treated by neurologist resulting in depression and anxiety.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Migraine
Clinical narrative: Dizziness and headache occurred. Chronic migraines developed -- never had headaches before thought to have caused trauma to both inner ear canals. Ongoing migraines being treated by neurologist resulting in depression and anxiety.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Encephalitis, Encephalomyelitis, Myelitis
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 02 September 2014. A 26 year-old male subject with no past medical history reported was found with Encephalitis, myelitis and encephalomyelitis 9 days after he had received an injection of ACAM2000 (lot number and site of administration not reported) on 25 February 2014. He had previously received the following vaccines on 18 February 2014: Anthrax vaccine and Typhoid, ViCPs vaccine (manufacturers, lot numbers, routes and sites of administration not reported). On 06 March 2014, he was diagnosed with Encephalitis, myelitis and encephalomyelitis. No laboratory test results were provided. It was not reported whether the patient had received any corrective treatment. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Additional information will be requested from the investigator.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Angina pectoris, Electrocardiogram abnormal
Clinical narrative: This study was received from the investigator in a trial on 02 September 2014. A 27 year-old male subject with past medical history of above normal ECG and dizziness/Fainting spells was found to have angina pectoris 12 days after the subject had received an injection of ACAM2000 (lot number and site of administration not reported) on 23 January 2014. The subject had previously received Anthrax vaccine (manufacturer, lot number, route and site of administration not reported) and Typhoid, ViCPs vaccine (manufacturer, lot number, route and site of administration not reported) on 13 January 2014. On 29 January 2014, the subject presented with an abnormal ECG. He was diagnosed with other and unspecified angina pectoris on 04 February 2014. No other laboratory test results were provided. Troponin I level was not performed. It was not reported whether the patient had received any corrective treatment. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Additional information will be requested from the investigator.
Age: 42.0
Sex: M
Vaccine: ANTH, JEVX, MEN, SMALL, TYP
Symptoms: Cardiomyopathy, Electrocardiogram normal
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 02 September 2014. A 42 year-old male subject with a past medical history of high blood pressure, chest pain and psychiatric illness was found with cardiomyopathy 22 days after the subject had received an injection of ACAM2000 (lot number and site of administration not reported) on 26 February 2014, concomitantly with the administration of the following vaccines: Anthrax vaccine, Japanese encephalitis vaccine, Typhoid, ViCPs vaccine, "Meningococcal/Diphtheria" vaccine (manufacturers, lot numbers, routes and sites of administration not reported) on the same date. On 20 March 2014, he was diagnosed with cardiomyopathy ("other primary cardiomyopathies"). ECG was performed on 21 March 2014 and results were normal. Troponin I levels were not performed. No other laboratory test results were provided. It was not reported whether the patient had received any corrective treatment. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Additional information will be requested from the investigator.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram, Pericarditis, Troponin I normal
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 02 September 2014. A 27 year-old male subject whose past medical history included elevated cholesterol and eczema was found to have acute pericarditis unspecified 19 days after the subject had received on 12 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and on 05 March 2014 received the following vaccines, Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory date included: a normal Troponin I and a normal Echocardiogram on 01 April 2014. Results of an ECG were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. 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: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 unspecified children patients of unknown age. On 28-AUG-2014, 2 unspecified patients were administered expired M-M-R II, lot # H015826, expiration date 24-AUG-2014, (dose, frequency and route not reported). No adverse effects reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a healthcare student (pharmacy intern) and a 50 year old female pharmacy technician who is the patient refers to herself. On 19-AUG-2014 the patient was vaccinated with ZOSTAVAX (strength and lot # not reported), 0.65 ml, subcutaneous in the right deltoid. The patient report that on day 1, on 19-AUG-2014, within the first 15 minutes therapy she experienced injection site redness, injection site became like a mosquito bite: it itched, got red and swollen. On the second date, on 20-AUG-2014, the redness went down, and the injection site had no discomfort or redness or itching; there was nothing at the site. On day 3, on 21-AUG-2014 the patient experienced the red circle came back, and it became a little hard and warm. The healthcare student also described the injection site, as it appeared on 22-AUG-2014, as 1.5" inch in diameter, warm to touch, and slightly firm. The patient explained on 22-AUG-2014, the injection site was still not resolved and she had not sought medical attention. The patient offered no other complaints. VZVIP faxed to the patient. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 23-JUL-2014, the patient was vaccinated with a first dose of VAQTA strength reported as 25/0.5 (units not provided) (lot number not reported). The patient received the first dose of VAQTA subcutaneously rather than intramuscularly. No adverse symptoms were reported. Concomitant medications were not reported. Follow up information has been received from a pharmacist refers to the 69 years old female patient with no pre-existing allergies, birth defects or medical conditions. On 23-JUL-2014 PM, the patient was vaccinated with a first dose of VAQTA (subcutaneously, lot# reported as K006604). There was no illness at time of vaccination. Numerous checks had been done for the patient who demonstrated no adverse reactions except some soreness at injection site. Patient returned to record 1 m as appropriate. At the time of report, the status of patient was unknown. Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Cough, Dental implantation, Measles antibody, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a consumer via company representative refers to a male patient (reporter's nephew) of unknown age. Information regarding patient's medical history and drug reactions or allergies was not reported. On an unknown date (also reported as: "administered to him as a kid") the patient was vaccinated with MMR II (dose, route of administration, anatomical location, lot#, expiration date not reported). Concomitant medications were not reported. It was reported that the patient earlier this month (in approximately August 2014) visited a foreign country for about 10 days, returning on 16-AUG-2014. About a day after getting back (approximately on 17-AUG-2014), he began suffering from running nose which lasted for a couple days and was accompanied with a slight fever and cough. There was treatment given with D-COLD, aspirin, and acetaminophen for the events. The patient was also in the last stages of getting a tooth implant and had ibuprofen for the pain. On 18-AUG-2014 the patient submitted a blood sample for measles (rubeola) immunity test with the results of 155 U/ml of antibody, IgG serum. The outcome of the events was unknown. The relatedness between the therapy with MMR II and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number patients of unknown age and gender. The reporter stated that doses of vaccines (hemophilus B conjugate (meningococcal protein conjugate) and COMVAX (dose, route and lot # not reported) that were exposed to  supported temperature excursion that occurred on 29-JUL-2014 had been administered to unspecified patients on unspecified dates. The reporter reported that she had not been informed of any adverse effects. It was unknown if the patients sought medical attention or not. At the time of report the status of patients was unknown.This is one of the several reports received 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 a registered nurse. The nurse stated doses of GARDASIL (doses unspecified in series, 0.5 ml, once, intramuscular) were administered between 24-JUL-2014 and 01-AUG-2014, doses were exposed to -1.5 C for 5 hours. No adverse effects reported. Nurse stated she had no patient specific information. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Erythema, Fatigue, Malaise, Pruritus
Clinical narrative: This spontaneous report as received from healthcare worker refers to a 41 year old male patient. On 05-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J006572, exp. date 07-JUN-2015, 0.5 ml, subcutaneous in the right arm. The patient had no concomitant medication, no medical history and no drug reaction. On 16-AUG-2014, the patient developed 15-20 red, raised, itchy lesions on his scalp, torso and extremities after receiving (Oka/Merck) VARIVAX. The lesions were described as having a "head". The patient also experienced malaise, fatigue, joint pain and possibly a low grade fever. The treatment was not given for events. No lab diagnostics. The patient called office for medical attention. The outcome of events was reported as not recovered/not resolved. Action taken and causality were not reported. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Swelling
Clinical narrative: This spontaneous report as received from healthcare worker refers to a 41 year old male patient. On 05-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J006572, exp. date 07-JUN-2015, 0.5 ml, subcutaneous in the right arm. The patient had no concomitant medication, no medical history and no drug reaction. On 16-AUG-2014, the patient developed 15-20 red, raised, itchy lesions on his scalp, torso and extremities after receiving (Oka/Merck) VARIVAX. The lesions were described as having a "head". The patient also experienced malaise, fatigue, joint pain and possibly a low grade fever. The treatment was not given for events. No lab diagnostics. The patient called office for medical attention. The outcome of events was reported as not recovered/not resolved. Action taken and causality were not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a seven unspecified patients of unknown gender and age. In September 2014 (reported as since the temperature event), the patients were vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported. No product quality complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Petechiae, Rash
Clinical narrative: Patient received their first dose of the Gardasil vaccine on Friday, 8/1/2014 and developed an unusual rash on 8/2/2014. The rash was petechial, periorbital, but only around the left eye, asymptomatic: non-painful, non-pruritic, no associated swelling, and not present anywhere also on the patient's body. The rash had mostly resolved 2-3 days later. No treatment was given.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Not reported until 09/10/2014.  *I do not feel this is the result of the vaccine.   *Patient has pain at injection site and pain with abduction.  She has a history of nerve impingement syndrome.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a three unspecified patients of unknown gender and age. In September 2014 (reported as since the temperature event), the patients were vaccinated with a doses of GARDASIL (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported. No product quality complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 60 year old female patient. Information regarding medical history and drug reactions or allergies was not reported. On 03-SEP-2014 the patient was vaccinated with ZOSTAVAX (1 injection, subcutaneous, lot# reported as: K003604, expiration date reported as: March 2015, dose, route of administration, anatomical location not reported). Concomitant medications were not reported. On 05-SEP-2014, the patient experienced "red streak down her arm" after being administered ZOSTAVAX and returning home. The company representative was not told how far down the streak appeared. No additional side effects such as pain or rash were associated with the "red streak". The outcome of the event was unknown. The patient sought medical attention by calling the pharmacist. The relatedness between the therapy with ZOSTAVAX and the event was not reported. 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. The nurse stated doses of VAQTA (doses unspecified in series) were administered between 24-JUL-2014 and 01-AUG-2014, doses were exposed to -1.5 C for 5 hours. No adverse effects reported. Nurse stated she had no patient specific information. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot# not reported). It was reported that on an unknown date a female patient fainted after receiving GARDASIL (MARRS# 1408USA015205). The male patient experienced the same reaction after receiving GARDASIL. The outcome of the event was unknown. It was unknown if the patient sought medical attention. This is one of the reports from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 59 years old female patient of unknown age. No drug reactions or allergies was reported. On 05-SEP-2014 the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dosing regimen unspecified) (Lot # K003602, expiry: March 2015) for to prevent shingles. Concomitant therapies included methotrexate, omeprazole, folic acid and vitamin D (unspecified). Approximately on an unknown date in September 2014 (also reported as after vaccination) the patient experienced itchy rash after receiving ZOSTAVAX. No treatment was given. No lab tests performed. Patient sought medical attention and contacted pharmacist. There was no product quality complaint (PQC) involved. The outcome of itchy rash is unknown. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number patients of unknown age and gender. The reporter stated that doses of vaccines LIQUID PEDVAXHIB (dose, route and lot# not reported) that were exposed to a supported temperature excursion that occurred on 29-JUL-2014 had been administered to unspecified patients on unspecified dates. The reporter reported that she had not been informed of any adverse effects. It was unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number patients of unknown age and gender. The reporter stated that doses of vaccines PNEUMOVAX 23 (dose, route and lot# not reported) that were exposed to a supported temperature excursion that occurred on 29-JUL-2014 had been administered to unspecified patients on unspecified dates. The reporter reported that she had been informed of any adverse effects. It was unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the unspecified number of patients were vaccinated with unspecified number of doses of improperly stored LIQUID PEDVAXHIB, Dose/Frequency: 0.5 ml (dose number, route, lot# not reported). No adverse effects reported. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On 05-SEP-2014 0.5 ml (Oka/Merck) VARIVAX (lot# unspecified) that underwent a temperature excursion was administered to the patient via subcutaneous. No adverse effect was reported. This is one of two reports from the same reporter. The other report is 1409USA004711. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old female patient with no pertinent medical history or drug reactions/allergies. On 28-AUG-2014 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (lot#, expiration date, dose, route not reported) for prevention of chicken pox. There was no concomitant medication. On 30-AUG-2014, The patient developed a chicken pox like rash. The patient's mother called the physician and also sent pictures of the rash to the physician, the physician described the rash as "a few vesicles on the patient's arm and three on the patient's face". The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unkonwn age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2004, the patient was vaccinated with the first dose of VARIVAX (Merck) 0.5 ml, subcutaneous (lot number was not reported). On an unknown date in 2007, the patient was vaccinated with the second dose of VARIVAX (Merck) (dose, strength frequency, route and lot number were not reported). On 22-AUG-2014, the patient was vaccinated with the third dose of VARIVAX (Merck) lot # J013905, expiration date 30-OCT-2015 in the arm (dose, strength and route were not reported). The nurse reported that the patient received a third dose of VARIVAX (Merck) due to lack of documentation of the second dose of VARIVAX (Merck) at the time of the office visit. No adverse effect was reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Dyspnoea, Erythema, Injection site pain, Pruritus
Clinical narrative: Pain at injection site, itchy, redness, swelling, radiated into joint pain, acute SOB.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: Pain at injection site, itchy, redness, swelling, radiated into joint pain, acute SOB.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At the injection site the arm was red, swollen, hot to the touch, along with extreme pain, add a fever of 101 degrees.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: At the injection site the arm was red, swollen, hot to the touch, along with extreme pain, add a fever of 101 degrees.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Pharyngeal hypoaesthesia, Urticaria
Clinical narrative: PATIENT STARTED COMPLAINING OF HER THROAT FEELING NUMB AND HAVING A HARD TIME SWALLOWING. SHE ALSO STATED THAT THE NEXT MORNING WHEN SHE AWOKE SHE HAD 2 HIVES ON THE BACK OF HER NECK.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a now 17 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On 16-JUL-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, GARDASIL, DTaP (unspecified), TDAP (manufacturer unknown) and MENACTRA (lot#, expiration date, dose, frequency were unknown). Concomitant medication included prenatal vitamins. The patient had a pregnancy test on 20-AUG-2014 that confirmed the patient was now pregnant. Patient became pregnant with last menstrual period (LMP) of 07-JUL-2014 and expected delivery of date (EDD) on 13-APR-2015. The pregnancy outcome was pending. Patient did not seek Medical Attention. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Asthenia, Balance disorder, Irritability, Poor quality sleep, Pyrexia
Clinical narrative: Irritability started around 11:30 PM.  Slept fitfully off and on for 15 minutes at a time for the rest of the night.  Developed low grade fever around 2:00 AM that continued through the 26th.  He was then weak, unsteady on his feet, and just wanted to lay on mom all morning.  Last substantial PO intake was at bedtime on the 24th. Did not resolve until the 26th at bedtime.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Dizziness, Headache, Increased upper airway secretion
Clinical narrative: SEVERE SINUS DRAINAGE/COUGHING UP PHLEGM, FEVER, CHILLS, DIZZINESS, VOMITING, WATERING EYES, HEADACHE LASTING FOR 12 HOURS.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Lacrimation increased, Paranasal sinus hypersecretion, Productive cough, Pyrexia, Vomiting
Clinical narrative: SEVERE SINUS DRAINAGE/COUGHING UP PHLEGM, FEVER, CHILLS, DIZZINESS, VOMITING, WATERING EYES, HEADACHE LASTING FOR 12 HOURS.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number patients of unknown age and gender. The reporter stated that doses of vaccines ROTATEQ (dose, route and lot# not reported) that were exposed to a supported temperature excursion that occurred 29-JUL-2014 had been administered to unspecified patients on unspecified dates. The reporter reported that she had not been informed of any adverse effects. It was unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 6 year old patient. On 03-JUL-2014 the patient was vaccinated with VARIVAX (Merck) (lot # J009728, expiration date: 07-AUG-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and clinical coordinator refers to an approximately 8 week old patient of unknown age. On 08-SEP-2014, the patient was inadvertently vaccinated with expired initial dose of ROTATEQ, lot # H015682, expiry 18-MAR-2014, 2.0 milliliter (ml) once, oral. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On 08-SEP-2014 0.5 ml VARIVAX (Merck) (lot# unspecified) that underwent a temperature excursion was administered to the patient via subcutaneous. No adverse effect was reported. This is one of two reports from the same reporter. The other report is 1409USA004711. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient with no drug reaction/allergies. The patient's medical history included shingles "about two years ago". On 03-SEP-2014, the patient was vaccinated with ZOSTAVAX, 0.5 ml, subcutaneous. Lot number and expiration date were not reported. There was no concomitant medications. On 04-SEP-2014, the patient experienced injection site hard, swollen, red and warm. The outcome of injection site hard, swollen, red and warm was reported as not recovered. The patient sought medical attention; called to pharmacy. No treatment was given for adverse events. No lab diagnostic studies were performed. Additional information has been requested.