chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Initial case was received from a health care professional on 09 October 2013. A 69 years old male patient had no medical history reported, received a dose of FLUZONE HD vaccine intramuscularly on 06 October 2013 (batch number U4764AA). Patient had not reported concomitant medication. It was reported that on 06 October 2013 patients had dizziness which was worsen in 09 October 2013. No corrective treatment was reported. At the time of report the outcome of event was not recovered.
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Initial case was received from a healthcare professional on 14 November 2013. A male patient whose age, concomitant and medical history was not provided has received a dose of FLUZONE HD vaccine on 16 September 2013 (anatomical site, dose and batch number were not reported). On 16 September 2013, the patient developed pain at the vaccination site. Corrective treatments were not reported and laboratory investigations were unknown. At the time of this report, the patient had not recovered from the event. Documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 14 October 2013. A 77-year-old male patient had received a dose of FLUZONE HD vaccine (lot number, dose number, route and anatomical site of administration were not reported) on 08 October 2013. On 08 October 2013 after 4 hours of vaccination, the patient experienced severe chills, fever 102 F, dizziness, aches and weakness. Laboratory investigation was and corrective treatments were not reported. On 10 October 2013, the patient had recovered from severe chills, dizziness and fever. On 11 October 2013, the patient had recovered from aches and on 14 October 2013, the patient had recovered from weakness. Documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain
Clinical narrative: Initial report received on 16 September 2013 from a vaccine provider. A 74-year-old female patient, whose medical history included yearly flu shot, concomitant medications was not reported, received a dose of FLUZONE HD (lot # U4714AA) at left deltoid intramuscularly on 14 September 2013). It was reported that a patient have received the FLUZONE ID. On 16 September 2013. Patient reported body aches and pulsating veins in her head. The events were resolving. List of documents held by sender: none
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dysphonia, Headache, Hyperhidrosis
Clinical narrative: Initial report received from Consumer on 14 October 2013. An 87-year-old female patient whose medical history and concomitant medication were not reported, had received a dose  of FLUZONE HD (lot number, route and anatomical site of administration were not reported) on an unspecified date on last Wednesday. On an unspecified date Sunday, the patient had begun to perspiring and feeling "woozy". The patient sat down for a few minutes. When the patient went home felt weakness, headache, sore throat, hoarseness and rash on chest. Laboratory investigations and corrective medications were not reported. On an unspecified date, the patient had recovered from events. Documents held by sender: none
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Rash
Clinical narrative: Initial report received from Consumer on 14 October 2013. An 87-year-old female patient whose medical history and concomitant medication were not reported, had received a dose  of FLUZONE HD (lot number, route and anatomical site of administration were not reported) on an unspecified date on last Wednesday. On an unspecified date Sunday, the patient had begun to perspiring and feeling "woozy". The patient sat down for a few minutes. When the patient went home felt weakness, headache, sore throat, hoarseness and rash on chest. Laboratory investigations and corrective medications were not reported. On an unspecified date, the patient had recovered from events. Documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site vesicles
Clinical narrative: Initial report received from a health care professional on 11 October 2013. A female patient (date of birth and age at the time of event was not reported) had received an intramuscular dose of FLUZONE HD (batch number and site of administration was not reported) on an unspecified date of October 2013. The patient illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On an unspecified date of October 2013, the patient developed a bleb under the skin at the injection site and it bleeds a lot. Laboratory tests were not reported and the patient had received Aspirin as corrective treatments. At the time of this report the outcome was unknown. List of documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Initial report received from health care professional on 07 October 2013. A female patient whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date of last Friday. On an unspecified date after vaccination, the patient experienced significant redness and itching. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Initial report received from a health care professional on 09 October 2013. This case is the summary of multiple patients. It is reported that several patients of age over 65 had received FLUZONE HD vaccine from September to October (exact date, batch number, route and site of administration not reported). The medical history of the patients is not reported. The concomitant medication details not reported. Reporter states several patients have reported redness, site swelling, site soreness and malaise after FLUZONE HD, stated office has been giving FLUZONE HD since September 2013, patients seen on return visits in October 2013 have reported having these events. Corrective treatment was not provided. It is reported the patients were recovered from the events reported redness, site swelling, site soreness and malaise (stop date not reported). No more information available. Documents held by the sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: Initial report received from a healthcare professional on 08 October 2013. A female patient whose birthdate and age at the time of event, medical history and concomitant medication were not reported, had received a dose of FLUZONE HD vaccine (lot number: U4764AA, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient developed topical bruising and localized discoloration. Bruise was on the shoulder then traveled to elbow area. At the time of this report, the bruise was only at the elbow. Laboratory investigations and corrective medications were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: None. Follow-up information received on 20 January 2014. The patient received FLUZONE HD vaccine on 13 September 2013. On 08 October 2013, the patient developed topical bruising and localized discoloration.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 16 October 2013. A 70 year old female patient (date of birth not reported) had received FLUZONE HD vaccine on 14 October 2013 of lot number U4530AA expiry date October 2012 at left deltoid by intramuscular route. The patient had no relevant medical history and no known allergies. The subject had no concomitant medications. On 16 October 2013, the patient experienced redness and swelling at injection site. Corrective treatment was not reported. The outcome of the event redness and swelling was unknown. No more information available. Documents held by the sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Eye irritation, Eye swelling, Rhinorrhoea
Clinical narrative: Initial case was received from a health care professional on 08 October 2013. A 67 years old female patient had history of allergies to BENADRYL, received a dose of FLUZONE HD vaccine in left deltoid 08 October 2013 (route not reported and batch number U4717AA). Patient had not reported concomitant medication. It was reported that on 08 October 2013 patient had diarrhea, running nose and burning and swollen eyes. No corrective treatment was reported. At the time of report the outcome of event was not recovered.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Initial case was received from a health care professional on 04 October 2013. A 74 years old female patient had no medical history reported, received a dose FLUZONE HD vaccine intramuscularly in left deltoid 03 October 2013 (batch number U4760AA). Patient had not reported concomitant medication. It was reported that on 04 October 2013 patient experience left arm was purple like the size of a quarter. No corrective treatment was reported. At the time of report the outcome of event was not recovered.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Initial report received from healthcare professional on 09 October 2013. A 41-year-old female patient whose medical history and concomitant medications were not reported received dose of FLUZONE HD (route, dose, frequency and batch number not reported) on an unspecified date. On an unspecified date, the patient had flu like symptoms such as weakness, fatigue, slight fever and weakness. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Chills, Nausea, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 03 October 2013. A female patient, whose age is greater than 65, had received an intramuscular dose of FLUZONE HD, batch number U4764AA, dose number was not reported in left deltoid on 02 October 2013. On 02 October 2013, 8 hours after vaccination, the patient experienced chills, nausea, vomiting, and health anxiety. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient was recovered from chills, nausea, vomiting. And health anxiety was not recovered. Documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Initial report was reported by healthcare professional on 11-Oct-2013: A 74 year old female, medical history included allergy (patient was not sure she had allergy or not) concomitant medication was unknown, received dose of FLUZONE HD lot# U4718AA at left deltoid on 09-Oct-2013. Patient was experiencing swelling, redness about 4 inches below injection site and a "mild fever, less than 100F on 10-Oct-2013). Event was not resolved on the day of reporting (11-Oct-2013). List of documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: Initial case was received from a health care professional on 11 October 2013. A 74 years old male patient had no medical history reported, received a dose FLUZONE HD vaccine intramuscularly in right deltoid on 10 October 2013 (batch number U4717AA). Patient had not reported concomitant medication. It was reported that on 11 October 2013 patients had blisters around injection site which extended to under his arm and down his arm on palm of hand. No corrective treatment was reported. At the time of report the outcome of event was unknown.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Pain
Clinical narrative: Initial case was received from a health care professional on 14 October 2013. A 87 years old patient (gender unknown) had no medical history reported, received a dose of FLUZONE HD (batch number U4783AA). Patient had not reported concomitant medication. It was reported that on 13 October 2013 patient had horrible aches and pains, feels like she is vibrating. Patient took two ES TYLENOL and then took ALEVE (route, site and dose not reported) as a corrective treatment. At the time of report the outcome of event was unknown.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Erythema, Sunburn
Clinical narrative: Initial case was received from a health care professional on 03 October 2013. A 72 year male patient had no medical history reported, received a dose of FLUZONE HD vaccine intramuscularly on 30 September 2013 (batch number not reported). Patient had not reported concomitant medication. It was reported that on 30 September 2013 patient experienced red like sunburn on arms, trunk, groin and back pain. No corrective treatment was reported. At the time of report the outcome was recovered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 15-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K010648, expiry date: 30-OCT-2015, 0.65 ml, subcutaneous, anatomical location was unknown) that underwent an unsupported temperature excursion. Concomitant medications were unspecified by reporter. No adverse event reported. The outcome of the events was unknown. No further information provided. This case# 1501USA008296 is linked to the case# 1501USA008553 via same reporter link. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin rash and rash.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 20-JAN-2015 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX dose: 0.65 ml, subcutaneously (lot # J013133, expiration date: 17-JAN-2015). No adverse effects reported. Additional information is not expected, because there was no consent to contact the reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a health professional refers to an unspecified patient. No concurrent or historical conditions were reported. On 19-JAN-2015 the patient was vaccinated with a dose of expired M-M-R II (lot # J000201, expiration date 09-JAN-2015), subcutaneous which was potency supported. No adverse effects reported. The patient had not sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with VARIVAX (Merck) which were exposed to a supported temperature excursion (lot#, expiration date, dose and route were unknown). No adverse effects have been reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 21-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 7 May 2014, the subject received an unspecified dose of BOOSTRIX (administration site and route unknown). Her last menstrual period was on 22 September 2013 and estimated date of delivery was on 29 June 2014. The subject was exposed to the vaccine during the third trimester. The pregnancy was ongoing. Follow-up received on 04 November 2014: No relevant test performed. At the time of the follow-up report, the pregnancy outcome was unknown.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included 1 delivery of baby and 1 miscarriage at 10 weeks. On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site and batch number). Her last menstrual period was on 15 November 2013 and estimated date of delivery was on 15 August 2014. The subject was exposed to the vaccine during the third trimester. At the time of reporting, the pregnancy was ongoing. Follow-up received on 24 October 2014: The VAERS details were provided. Weight 8 lbs 1 oz and was healthy.
Sex: U
Vaccine: VARZOS
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: This spontaneous report received from a other health care professional (reported as pharmacy manager) refers to a patient of unknown age and gender. No information about medical history, concurrent conditions were reported. The reporter stated that on an unknown date ZOSTAVAX (Lot K016325, expiration date 24-DEC-2015) strength, route subcutaneous) had began to liquefy causing the patient miss vaccination. No concomitant therapy was reported. No adverse effects reported. Product quality complaint has been filled. The outcome of events reported is unknown. The patient had not sought medical attention. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: From 1/14/15 NP resident urgent care note: Pt noticed what he believes to a rxn to yesterday's zoster vaccine the morning in the shower at the site of injection. This morning it was very red, whole arm was painful, and there was a large lump underlying the redness. The lesions were very pruritic and slightly TTP. Hasn't put anything on it or taken any medications for it. Now he thinks it has gotten substantially less red, the underlying lump has dissipated, but it is still pruritic and TTP. No trouble breathing, cough, dysphoria or dysphagia, wheeze, other rashes or lesions, or GI upset or vomiting. No known allergies to gelatin or neomycin. Skin rash, rash and urticaria.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient medical history and concurrent condition was not reported. On 19-JAN-2015 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # J000192, expiry date: 07-JAN-2015) 0.5 ml, subcutaneously. No adverse experience reported. No product quality complaint (PQC) reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to himself. The age of the patient was unknown. Pertinent medical history was unknown. On an unknown date the patient was vaccinated with ZOSTAVAX (1 shot, parenteral (reported as injection). lot# was unknown). Concomitant medications were unspecified by reporter. On an unknown date the patient developed shingles after getting ZOSTAVAX. The outcome of shingles was unknown. The causal relationship between the event and ZOSTAVAX was not reported. No further adverse event information was provided. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 51 year old female patient with codeine allergy. On 20-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration and lot# was unknown). Concomitant medications were unspecified by reporter. On 20-JAN-2015, the patient experienced injection site reaction. The injection site was warm, swelling, itchiness, and there was pain. BENADRYL, unspecified ointment and ZYRTEC was given as treatment for the events. Action taken with ZOSTAVAX was not reported. The patient sought medical attention by making a call to the physician. The outcome of the events was reported as recovering/resolving. The causal relationship between the events and ZOSTAVAX was not reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Blood test, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. Historical drug included unspecified flu shot. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and route unspecified). Concomitant therapies included FLUZONE. The patient was vaccinated with FLUZONE and then administered PNEUMOVAX 23 about 3 weeks later. The next day, the patient experienced vomiting and a fever 101 Fahrenheit. The patient consulted physician who performed unspecified blood work. The outcome of the events was reported as recovering/resolving. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Blood test, Body temperature increased, Extra dose administered, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. Historical drug included unspecified flu shot. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and route unspecified). Concomitant therapies included FLUZONE. The patient was vaccinated with FLUZONE and then administered PNEUMOVAX 23 about 3 weeks later. The next day, the patient experienced vomiting and a fever 101 Fahrenheit. The patient consulted physician who performed unspecified blood work. The outcome of the events was reported as recovering/resolving. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 16-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K010648, expiry date: 30-OCT-2015, 0.65 ml, subcutaneous, anatomical location was unknown) that underwent an unsupported temperature excursion (Incorrect product storage). Concomitant medications were unspecified by reporter. No adverse event reported. The outcome of the events was unknown. No further information provided. This case# 1501USA008553 is linked to the case# 1501USA008296 via same reporter link. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 65-year-old female patient who received INFANRIX (batch number 32PC3, expiry date 14th December 2015). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: INFANRIX was administered to a 65 years old patient instead of Tdap.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included 1 full-term pregnancy. On 13 May 2014, the subject received an unspecified dose of BOOSTRIX (intramuscular, administration site unknown). The last menstrual period was on 17 October 2013 and estimated date of delivery was on 24 July 2014. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 01 October 2014 from nurse: The subject received dtpa vaccine at week 29 of the pregnancy and during the third trimester of pregnancy. The VAERS details were provided. Some of the patient's details were updated. This has a normal conception pregnancy. Follow-up information received on 10 November 2014 from nurse: After 39 weeks, the subject have birth to a female neonate via vaginal delivery. The pregnancy resulted in a live neonate with no apparent congenital anomaly. The neonate weighed (8lbs 18oz) at birth. APGAR scores 9 and 9.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal weight gain, Adrenal disorder, Anxiety, Arthralgia, Asthenia
Clinical narrative: 2011-2014 Diagnosed with Autoimmune disorder (Hypothyroidism) Hashimoto's, extreme fatigue, weakness, depression from the thyroid disease, chronic nausea, headaches, eye pressure/pain (eye changes were diagnosed on exam) digestive issues, kidney and adrenal issues, leaky gut syndrome, enlarged liver (seen on ultrasound). Nervousness, anxiety, unusual weight gain first 2 years after vaccination then weight loss of 30 lbs in 2014 due to vitamin / nutrient deficient. Bone and joint pain began in 2014. Ovarian cysts and hormone imbalances as well. Patient has had numerous unexplained symptoms and Drs/Er visits. Numerous lab work and tests completed. Thermography scan performed in 2014 showed toxicity. Can submit all documentation if needed.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune thyroiditis, Bone pain, Depression, Dyspepsia, Eye disorder
Clinical narrative: 2011-2014 Diagnosed with Autoimmune disorder (Hypothyroidism) Hashimoto's, extreme fatigue, weakness, depression from the thyroid disease, chronic nausea, headaches, eye pressure/pain (eye changes were diagnosed on exam) digestive issues, kidney and adrenal issues, leaky gut syndrome, enlarged liver (seen on ultrasound). Nervousness, anxiety, unusual weight gain first 2 years after vaccination then weight loss of 30 lbs in 2014 due to vitamin / nutrient deficient. Bone and joint pain began in 2014. Ovarian cysts and hormone imbalances as well. Patient has had numerous unexplained symptoms and Drs/Er visits. Numerous lab work and tests completed. Thermography scan performed in 2014 showed toxicity. Can submit all documentation if needed.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pain, Fatigue, Gastric emptying study, Gastrointestinal disorder, Headache
Clinical narrative: 2011-2014 Diagnosed with Autoimmune disorder (Hypothyroidism) Hashimoto's, extreme fatigue, weakness, depression from the thyroid disease, chronic nausea, headaches, eye pressure/pain (eye changes were diagnosed on exam) digestive issues, kidney and adrenal issues, leaky gut syndrome, enlarged liver (seen on ultrasound). Nervousness, anxiety, unusual weight gain first 2 years after vaccination then weight loss of 30 lbs in 2014 due to vitamin / nutrient deficient. Bone and joint pain began in 2014. Ovarian cysts and hormone imbalances as well. Patient has had numerous unexplained symptoms and Drs/Er visits. Numerous lab work and tests completed. Thermography scan performed in 2014 showed toxicity. Can submit all documentation if needed.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatomegaly, Hormone level abnormal, Hypothyroidism, Hypovitaminosis, Malnutrition
Clinical narrative: 2011-2014 Diagnosed with Autoimmune disorder (Hypothyroidism) Hashimoto's, extreme fatigue, weakness, depression from the thyroid disease, chronic nausea, headaches, eye pressure/pain (eye changes were diagnosed on exam) digestive issues, kidney and adrenal issues, leaky gut syndrome, enlarged liver (seen on ultrasound). Nervousness, anxiety, unusual weight gain first 2 years after vaccination then weight loss of 30 lbs in 2014 due to vitamin / nutrient deficient. Bone and joint pain began in 2014. Ovarian cysts and hormone imbalances as well. Patient has had numerous unexplained symptoms and Drs/Er visits. Numerous lab work and tests completed. Thermography scan performed in 2014 showed toxicity. Can submit all documentation if needed.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Nervousness, Ocular discomfort, Ovarian cyst, Renal disorder
Clinical narrative: 2011-2014 Diagnosed with Autoimmune disorder (Hypothyroidism) Hashimoto's, extreme fatigue, weakness, depression from the thyroid disease, chronic nausea, headaches, eye pressure/pain (eye changes were diagnosed on exam) digestive issues, kidney and adrenal issues, leaky gut syndrome, enlarged liver (seen on ultrasound). Nervousness, anxiety, unusual weight gain first 2 years after vaccination then weight loss of 30 lbs in 2014 due to vitamin / nutrient deficient. Bone and joint pain began in 2014. Ovarian cysts and hormone imbalances as well. Patient has had numerous unexplained symptoms and Drs/Er visits. Numerous lab work and tests completed. Thermography scan performed in 2014 showed toxicity. Can submit all documentation if needed.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Thermogram abnormal, Ultrasound liver abnormal, Weight decreased, X-ray
Clinical narrative: 2011-2014 Diagnosed with Autoimmune disorder (Hypothyroidism) Hashimoto's, extreme fatigue, weakness, depression from the thyroid disease, chronic nausea, headaches, eye pressure/pain (eye changes were diagnosed on exam) digestive issues, kidney and adrenal issues, leaky gut syndrome, enlarged liver (seen on ultrasound). Nervousness, anxiety, unusual weight gain first 2 years after vaccination then weight loss of 30 lbs in 2014 due to vitamin / nutrient deficient. Bone and joint pain began in 2014. Ovarian cysts and hormone imbalances as well. Patient has had numerous unexplained symptoms and Drs/Er visits. Numerous lab work and tests completed. Thermography scan performed in 2014 showed toxicity. Can submit all documentation if needed.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse and described the occurrence of drug dose administration interval too short in a 5-month-old male patient who received PEDIARIX. On an unknown date, the patient received the 3rd dose of PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administratoin interval too short was unknown. Additional information: The 3rd dose of PEDIARIX was inadvertently given early at 3 weeks and 4 days after the 2nd dose of PEDIARIX.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAVRIX (batch number AHAVB597AA, expiry date 6th September 2014). On 12th November 2014, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional HAVRIX given to a 19 years old male.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Dermatitis, Pruritus, Rash generalised
Clinical narrative: She reports going camping 1 wk after vaccine admin. and 2 days into camping trip she develops "severe" raised generalized rash all over w/pruritis. She went to MD 1/6/15 and was put on steroid PO and had improvement in 2 days. MD diagnosed with dermatitis. her husband who was vaccinated co same time had similar but very "mild" rash that began 2 days after her's.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients received improperly stored doses of PROQUAD (Merck) (lot # not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients received improperly stored doses of VARIVAX (Merck) (lot # not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain
Clinical narrative: Pt received HPV on 1-20-15 at 6 pm RA. Pt c/o neck pain on (R) side of neck.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site hypersensitivity
Clinical narrative: Large area of erythema covering site (left upper arm). Consistent with allergic reaction. Well demarcated.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever x 5 days up to 102. No other assoc. URI sx.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. On unspecified dates the patients received doses of improperly stored RECOMBIVAX HB (dose, route, lot number and expiry date were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. On unspecified dates the patients received doses of improperly stored VAQTA (dose, route, lot number and expiry date were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender with inflammatory bowel disease. Allergies were not reported. On an unspecified date in December 2014, the patient was vaccinated with a dose of PNEUMOVAX 23, (strength, dose and route were not reported), (lot # K009809, expiration date: 16-MAY-2015) in an unspecified arm. Other suspect and concomitant therapies were not reported. On an unspecified date in December 2014, the patient developed redness, tenderness and pain that radiated down the arm from the injection site. The patient sought medical attention and was seen for the physician the following day (unspecified date) who determined the symptoms to be a cellulitis and prescribed an unspecified antibiotic. Lab diagnostics studies were not performed. A lot check was being requested for this adverse event. The outcome of cellulitis was unkonwn. The relatedness between cellulitis and therpay with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date (exact date was not provided by the reporter), the patient was vaccinated with a dose of ZOSTAVAX subcutaneously injection, intramuscular (dose, series, anatomical location, batch/lot # and expiration date were not reported). This was coded as "incorrect route of drug administration" (reported as "a patient was administered ZOSTAVAX intramuscularly instead of subcutaneously"). Concomitant therapies were not reported. On an unknown date the patient experienced injection site pain. The patient did not seek medical attention, and it was not specified by the reporter if the patient received treatment for the events. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Extreme swelling and redness at injection site. Patient went to ER and received BENADRYL by mouth and topical as treatment.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Arthralgia
Clinical narrative: This spontaneous report as received from a consumer refers to her 13 year old daughter with no pertinent medical history and no drug reactions or allergies. In October 2014, the patient was vaccinated with the first dose of GARDASIL (route, dose and lot # not reported). There was no concomitant medication. The consumer reported that in November 2014, the patient experienced arthralgia and amenorrhea. The patient had pain in her hips. The patient's mother stated that the last record of her daughter having her menstrual period was before she was administered the GARDASIL. The patient had not had her menstrual period since starting the GARDASIL. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. Therapy with GARDASIL was reported as discontinued. The outcome of arthralgia and amenorrhea was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 60 year old female patient with allergy to sulfa drugs, BACTRIM, EFFEXOR. On 14-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported, lot# reported as K010969) in her left triceps. Concomitant medications were not provided. The patient reported that her arm was red and tender at the injection site. The patient stated that the redness and tenderness started on 15-JAN-2015. The patient visited the physician on 16-JAN-2015. The nurse stated that there was erythema and tenderness at injection site. The redness was measured at 8 by 6 centimeters around the injection site. The patient had no fever. The physician treated the patient with cephalexin (500mgs, three times a day for 1 week), BENADRYL and ibuprofen (as needed). Outcome of the events was reported as not recovered. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated
Clinical narrative: This spontaneous report has been received from a 61 year old male patient with asthma and hypothyroidism refers to himself. The patient's medical history included acid reflux, breath arrest at 2 years old after receiving penicillin, irritated nerve in his neck after receiving aminoglycosides and his skin turned red after receiving vancomycin. On 10-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported, lot# was not reported). Concomitant therapies included ADVAIR, PROAIR HFA, PREVACID, domperidone, FLOMAX, PAXIL and levothyroxine sodium. On 11-JAN-2015 the patient experienced exacerbation of his asthma. The patient visited the office to seek medical attention. None lab was performed. The patient received prednisone to treat the events. The outcome of the exacerbation of his asthma was reported as not recovered/not resolved. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Injection site rash, Peripheral swelling
Clinical narrative: Information has been received from a pharmacist referring to a 75 year old male patient. The patient had no pertinent medical history or drug allergies/reactions. On 16-JAN-2015 the patient was vaccinated with 0.65ml dose of ZOSTAVAX (lot# was reported as K010969, expiry date 07-NOV-2015, subcutaneous) in his left arm. The pharmacist also reported that the patient received an unspecified tetanus shot in his right arm on the same day. Other concomitant therapies included generic of CELEXA, SYMBICORT, ZOPITAN, hydrochlorothiazide (manufacture unknown), LOPRESSOR and simvastatin (manufacture unknown). On 17-JAN-2015, the patient developed an unspecified rash at the injection site of his left arm and swelling "like the size of a grapefruit" of his left arm after receiving ZOSTAVAX in his left arm. On 20-JAN-2015, the patient called the pharmacist for medical attention and didn't receive any treatment for the adverse events. No lab diagnostics study was performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a male patient of unknown age regarding himself. Patient's current condition and medical history was unknown. On 16-DEC-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous. On 16-DEC-2014, ever since receiving the therapy with ZOSTAVAX, the patient experienced headache. The outcome of headache is unknown. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The pharmacist reported that on 19-JAN-2015 the patient was administered a second dose of ZOSTAVAX (dose, route not reported, lot# J013134 with expiration date 17-JAN-2015) which was expired. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple different unspecified number of patients of unknown age and gender. The patient's medical history, current conditions, drug reactions and allergies were unknown. On an unknown date, the patients were vaccinated with PROQUAD (Merck) (dose, route of administration, anatomical location, and expiry date were not reported) that were stored improperly. No adverse effects reported. No product quality complaint was reported for PROQUAD (Merck). This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple different unspecified number of patients of unknown age and gender. The patient's medical history, current conditions, drug reactions and allergies were unknown. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (dose, route of administration, anatomical location and exp. date were not reported) that were stored improperly. No adverse effects reported. No product quality complaint was reported for VARIVAX (Merck). This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. From an unspecified date, unspecified patients were vaccinated with 59 doses of improperly stored ROTATEQ (dose and frequency were not reported) (lot # K005396 and expiry date: 28-SEP-2016) since the excursion. No adverse effects reported. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1501USA005041 and 1501USA008492 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding drug reactions or allergies and medical history was not reported. On 20-JAN-2015 the patient was administered with PNEUMOVAX 23 (route, dose, anatomical location, lot# were not reported) that had expired on 18-JAN-2015. Concomitant therapies were not reported. No adverse events were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included pregnancies - gravida 2 para 2. On 13 May 2014 the subject received unspecified dose of BOOSTRIX (0.5 ml, intramuscular). Her last menstruation period was on 19 October 2013 and her estimated date of delivery was on 26 July 2014. The subject was exposed to the vaccine during the 3rd trimester (29 weeks of gestation). At the time of reporting, the pregnancy was ongoing. Follow-up information received on 22 July 2014: Subject details were reported. Vaccine responsible physician details were provided. Follow-up information received on 01 October 2014 from nurse: The subject received Tdap vaccine at week 29 of the pregnancy and during the third trimester of pregnancy. The VAERS details were provided. Some of the patient's details were updated. This has a normal conception pregnancy. Follow-up information received on 6 November 2014 from nurse: At 39 weeks and 4 days, the subject gave birth to a male neonate via vaginal delivery. The pregnancy resulted in a live neonate with no apparent congential anomaly. The neonate weighed (8lbs 5oz) at birth. APGAR scores was 9 and 9.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, lot# and expiration date were not reported) instead of a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported). Information  about concomitant medication was not reported. The reporter stated that the ZOSTAVAX was ordered for the patient but the healthcare worker who administered VARIVAX (Merck) "read the order wrong". No adverse events were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via field representative refers to a 61 year old female patient. No concurrent or historical conditions were reported. On 18-DEC-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K010646, expiration date and route unspecified), 1 injection, in left arm. Concomitant therapies included levothyroxine sodium. On 19-DEC-2014, the patient experienced redness and swelling around the injection site after being administered ZOSTAVAX in left arm. The events outcome was unknown. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.