chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Arthritis, Asthenia, Blood test, Bone pain
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Convulsion, Injection site pain, Loss of consciousness, Mobility decreased, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Negative thoughts, Pain, Pain in extremity, Poor quality sleep, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Suicidal ideation
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Convulsion, Dermatitis contact, Injection site pain, Loss of consciousness, Middle insomnia
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Negative thoughts, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Suicidal ideation
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX23 and reported adverse events was unknown. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Muscular weakness, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Pain at injection site that was attributed to shot and lasted for 10 days.  Shoulder pain and muscle weakness has progressively gotten worse since that time.  Pain when sleeping and using shoulder or arm.  Muscles in upper arm sore all of the time.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: Pain at injection site that was attributed to shot and lasted for 10 days.  Shoulder pain and muscle weakness has progressively gotten worse since that time.  Pain when sleeping and using shoulder or arm.  Muscles in upper arm sore all of the time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Large area of swelling and redness around injection site.  Fatigue and light-headedness.
Sex: U
Vaccine: PPV
Symptoms: Burning sensation, Injected limb mobility decreased, Neuralgia
Clinical narrative: This spontaneous report as received from a pharmacist via representative refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, route, dose and lot number (unknown). On an unknown date, the patient experienced burning, and nerve pain, in the vaccinated arm, post vaccination with the PNEUMOVAX 23. In addition to the burning sensation and nerve pain the patient had limited limb mobility for about one week after getting vaccinated. Unspecified treatment was given for adverse event. The patient was reported as recovered/resolved. Upon internal review, the event limited limb mobility for about one week after getting vaccinated was considered to be disabling. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient in her 50's with no relevant medical history and no drug reactions and allergies. The nurse reported that about 10 years ago, approximately in 2004, the patient received Hepatitis B vaccine series (manufacturer unknown, RECOMBIVAX HB could not have be ruled out). On an unknown date, the patient had titers drawn which showed negative immunity. In approximately 2009, reported as "about 5 years ago", the patient had a booster dose of Hepatitis B vaccine (manufacturer unknown) RECOMBIVAX HB could not have been ruled out). On an unknown date, the patient had titers drawn which again showed negative immunity. On 31-MAR-2014, the patient was seen in the office and titers drawn performed again showed negative immunity. No treatment was given. Relatedness between event of Anti-HBs Antibody Negative and RECOMBIVAX HB was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On unspecified dates, the patient was vaccinated with the first and second doses of GARDASIL injection (lot#, expiration date, route, dose and strength not reported), respectively. The reporter stated that the patient was late getting the third dose. No adverse symptoms reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 46 year old male patient who living with HIV received ZOSTAVAX (lot # not reported). The healthcare worker stated that the physician told her that "the patient was immunocompromised at the time when he received the dose, but he has had shingles in the past and we wanted to prevent recurrence." No adverse effects reported. Additional information is not expected.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site vesicles, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to her 18 month old granddaughter. On approximately 13-FEB-2014, about 6 weeks ago, the patient was vaccinated with a dose of unspecified varicella containing vaccine (manufacturer unknown) and another unspecified vaccine (manufacturer unknown). In February 2014, the patient developed a local injection site eruption of small vesicles on an unspecified date within 4 days of being vaccinated. In February 2014, shortly thereafter, the patient developed a similar outbreak spot on her stomach around the umbilicus and the outbreak had since spread around the patient's entire right side near her diaper band. The nurse practitioner stated that the vesicular rash was extremely itchy. The patient was taken to see an unspecified pediatrician on an unspecified date who prescribed the patient with unspecified oral steroids (manufacturer unknown), an unspecified antihistamine (manufacturer unknown) and an topical cream. The outcome of the events were not reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: MNQ, PNC13
Symptoms: Headache, Pyrexia
Clinical narrative: Fever 101 degrees F. Mild Headache.
Age: 43.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug administration error
Clinical narrative: None. Misadministration.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Asthenia, Blood test, Cellulitis, Chills, Dizziness
Clinical narrative: Fever symptoms (heavy chills, burning up) body ache, exhaustion, dizziness intense muscle aches, weakness, paleness. Fever ended on 4th day; rash started on 4th day -- diagnosed as cellulitis by M.D. [Rash is 4" by 7" but no red streaks or pus yet; painful & tender.]
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Fatigue, Feeling hot, Myalgia, Pain, Pallor
Clinical narrative: Fever symptoms (heavy chills, burning up) body ache, exhaustion, dizziness intense muscle aches, weakness, paleness. Fever ended on 4th day; rash started on 4th day -- diagnosed as cellulitis by M.D. [Rash is 4" by 7" but no red streaks or pus yet; painful & tender.]
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Rash, Streptococcus test negative, Tenderness, Urine analysis normal
Clinical narrative: Fever symptoms (heavy chills, burning up) body ache, exhaustion, dizziness intense muscle aches, weakness, paleness. Fever ended on 4th day; rash started on 4th day -- diagnosed as cellulitis by M.D. [Rash is 4" by 7" but no red streaks or pus yet; painful & tender.]
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Blood test normal, Febrile convulsion, Pyrexia, Urine analysis normal
Clinical narrative: Febrile seizure after having fever from a few hours after vaccines.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old patient with unknown gender. No information regarding the patient's medical history was provided. On 26-MAR-2014 the patient was vaccinated with PROQUAD, lot # H015631, which had been expired on 23-FEB-2014. No concurrent medication was reported. No adverse effect was reported. No outcome was reported. The case was linked to case # 1404USA006599 (same reporter, different patient). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a consumer (patient father) refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and frequency were no reported). On an unknown date, the patient underwent a Pap smear test and tested positive for HPV. It was reported that it was unknown whether the patient completed all three shots of GARDASIL. The patient sought medical attention and saw the doctor. It was reported that currently the patient was tested positive for HPV and presently no active symptoms. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information regarding the patient's medical history was provided. On 08-APR-2014 the patient was vaccinated with VAQTA dose 2, 0.5 ml, intramuscularly, less than six months after the patient received the first dose (on 18-MAR-2014). No concomitant medication was reported. No adverse effect was reported. No outcome was reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Viral titre
Clinical narrative: This spontaneous report was received from a registered nurse refers to a male patient of unknown age. On 13-JUN-2008 the patient was vaccinated with VARIVAX (dose strength was not reported) dose 2, subcutaneous. And on 27-AUG-1999 patient received dose 1 of VARIVAX. No concomitant medication was reported. Nurse reported that patient has negative titers after receiving 2 doses of VARIVAX. It was reported that patient sought medical attention and visited the office. There was no product quality complaint involved. The outcome of patient has negative titers after receiving 2 doses of VARIVAX was reported as not resolved. The relatedness between the VARIVAX and event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age. On 14-APR-2014, the patient was vaccinated with expired dose of RECOMBIVAX HB Lot # 1157AA (Expiry: 06-APR-2014) (dose, route and frequency were not reported). No adverse effects reported. No further information was provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema
Clinical narrative: LA 4X5CM. POSITIVE REDNESS.
Age: 12.0
Sex: U
Vaccine: HEP
Symptoms: Cold sweat, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 12 year old patient. On an unknown date the patient was vaccinated with the first dose of RECOMBIVAX HB (lot# unknown) 5 Microgram via an unknown route. On an unknown date the patient experienced injection site "it was very painful" and was "cold and clammy" all over. It was unknown if the patient had sought medical attention. The outcome and action taken were unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse. The nurse stated that on 01-APR-2014 (reported as yesterday) that a few patients was vaccinated with PROQUAD, subcutaneously and VARIVAX, subcutaneously which were improperly stored. No adverse events were reported. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 15 year old male patient with penicillin allergy, acne, asthma and attention deficit hyperactivity disorder (ADHD). The patient's medical history included possibly had a "malignancy" on his ankle at age 3 years. On 02-OCT-2013, the patient was vaccinated with the first dose of GARDASIL (lot# and expiry not reported), 0.5 ml, intramuscular (IM). Concomitant therapies included CLEOCIN, loratadine (manufacturer unknown), albuterol sulfate, DUONEB, amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL, PUMICORT, SINGULAIR and albuterol sulfate (manufacturer unknown). During that same visit, on 02-OCT-2013, he was given a prescription for minocycline (unspecified manufacturer) to treat his acne. The patient then developed a rash on his body. At that time, the nurse practitioner thought the rash was caused by the minocycline so she had him discontinue the minocycline. The patient was prescribed prednisone and the rash resolved (unspecified date). The patient received the second dose of GARDASIL (lot# and expiry not reported), 0.5 ml, intramuscular (IM) on 02-DEC-2013. He then developed another rash on his body and was seen at the office on 11-DEC-2013. He was treated with prednisone and the rash resolved (unspecified date). On 01-APR-2014, the patient received the third dose of GARDASIL (lot# and expiry not reported), 0.5 ml, intramuscular (IM) and he again developed a rash on his body. The nurse practitioner thought that the rashes started each time within 24 hours of receiving a dose of GARDASIL. She now thought the rashes were probably caused by GARDASIL. The minocycline was never restarted after it was discontinued. The patient had been prescribed oral prednisone again to treat the rash and he was currently recovering. No lab diagnostics were performed. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a health care worker via physician refers to 2 patients of unknown demographics. Approximately on 27-MAR-2014 (also reported as about 2 weeks ago) the patient was vaccinated with VARIVAX, (dose strength and dose number was not reported). No concomitant medication was reported. Approximately on 27-MAR-2014 (also reported as about 2 weeks ago) the patient experienced cellulitis. Patient sought medical attention and contacted physician. There was no product quality complaint involved. The outcome of cellulitis was reported as recovered approximately on an unknown date in 2014. Causality assessment was not provided. This case is linked to 1404USA007558 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a registered nurse concerning a female (age unknown) who was vaccinated with GARDASIL on the following dates: first dose 21-OCT-2013, second dose 11-NOV-2013 and third dose 12-JAN-2014. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unknown number of patients with unknown demography. On an unknown date, the unknown number of patients was vaccinated with improperly stored MMR II (dose, route and frequency were not reported). No adverse effect reported. No further information was provided. This case is linked to the case 1404USA010658 and 1404USA010659 (same reporter link). Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Influenza like illness, Local swelling, Pruritus, Rash generalised, Skin exfoliation
Clinical narrative: This spontaneous report as received from the mother of a 17 year old male patient. Pertinent medical history was not reported. On MAR-2013 the patient was vaccinated with his third dose of GARDASIL. He received his first dose in 2012 (month and date unspecified) without symptoms. It was not specified when he received his second dose. Concomitant therapies included amoxicillin (reason taking not identified). Within days of receiving the third dose, the patient experienced full body rash, intermittent swelling in arms from hand to shoulders, "alligator and chicken like scales", itchiness and flu like symptoms. Upon visiting a physician (date unspecified), the patient was referred to a pulmonary allergist. No diagnosis to date had been made. The outcome of the events were reported as not recovered/not resolved. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Aphthous stomatitis, Blood test, Diarrhoea, Ear infection
Clinical narrative: This spontaneous report as received from the mother of a 17 year old male patient. Pertinent medical history was not reported. On MAR-2013 the patient was vaccinated with his third dose of GARDASIL. He received his first dose in 2012 (month and date unspecified) without symptoms. It was not specified when he received his second dose. Concomitant therapies included amoxicillin (reason taking not identified). Within days of receiving the third dose, the patient experienced full body rash, intermittent swelling in arms from hand to shoulders, "alligator and chicken like scales", itchiness and flu like symptoms. Upon visiting a physician (date unspecified), the patient was referred to a pulmonary allergist. No diagnosis to date had been made. The outcome of the events were reported as not recovered/not resolved. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Influenza like illness, Injection site swelling, Local swelling, Pharyngeal oedema, Pruritus
Clinical narrative: This spontaneous report as received from the mother of a 17 year old male patient. Pertinent medical history was not reported. On MAR-2013 the patient was vaccinated with his third dose of GARDASIL. He received his first dose in 2012 (month and date unspecified) without symptoms. It was not specified when he received his second dose. Concomitant therapies included amoxicillin (reason taking not identified). Within days of receiving the third dose, the patient experienced full body rash, intermittent swelling in arms from hand to shoulders, "alligator and chicken like scales", itchiness and flu like symptoms. Upon visiting a physician (date unspecified), the patient was referred to a pulmonary allergist. No diagnosis to date had been made. The outcome of the events were reported as not recovered/not resolved. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Skin discolouration, Skin exfoliation, Skin irritation
Clinical narrative: This spontaneous report as received from the mother of a 17 year old male patient. Pertinent medical history was not reported. On MAR-2013 the patient was vaccinated with his third dose of GARDASIL. He received his first dose in 2012 (month and date unspecified) without symptoms. It was not specified when he received his second dose. Concomitant therapies included amoxicillin (reason taking not identified). Within days of receiving the third dose, the patient experienced full body rash, intermittent swelling in arms from hand to shoulders, "alligator and chicken like scales", itchiness and flu like symptoms. Upon visiting a physician (date unspecified), the patient was referred to a pulmonary allergist. No diagnosis to date had been made. The outcome of the events were reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a medical assistant who stated that approximately a total of 20 patients (demographics unknown) were administered either GARDASIL (case #1403USA013058) or ROTATEQ (dates of administration, dosage and route of administration not provided) that was improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unknown number of patients with unknown demography. On an unknown date, the unknown number of patients was vaccinated with improperly stored PNEUMOVAX 23 (dose, route and frequency were not reported). No adverse effect reported. No further information was provided. The case is linked to the case 1404USA0102442 and 1404USA010658 (same reporter link). Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Immediate post-injection reaction, Injection site oedema, Paraesthesia oral
Clinical narrative: HPV #2 given in (L) deltoid. (HPV #1 given 2/2/2012). Immediately upon removal of the needle from the injection site, there was edema approx 3.0 cm round. Ice applied to site; child c/o tongue "felt funny"; ARNP ordered EPIPEN 0.3mg per 0.3ml and was given SQ (R) thigh; popsicle given; no complications BP immediately following 136/68; 30 mins post BP 124/70.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On 16-APR-2014, the patient was vaccinated with PNEUMOVAX 23 (dose, route and frequency were not reported) which was expired on 12-APR-2014. No adverse effects reported. No further AE information was available. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling abnormal, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: After receiving the vaccination, patient stood up to leave vaccination area. When she reached the waiting area she sat in a chair and passed out. She was dazed and non-responsive for 2 to 3 minutes. When she was able to respond she informed us that she has passed out before unrelated to vaccines.
Age: 3.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: There is no adverse event. Nurse gave client .25 cc dose of flu instead of .5 cc dose per child's age.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unknown number of patients with unknown demography. On an unknown date, the unknown number of patients was vaccinated with improperly stored ROTATEQ (dose, route and frequency were not reported). No adverse effect reported. No further information was provided. This case is linked to the case 1404USA010242 and 1404USA010659 (same reporter link). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling/redness of (L) upper extremity after getting PNEUMOVAX. Poss cellulitis. Treated w/prednisone/antibiotics.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Eye swelling
Clinical narrative: Blisters on left side of face, eye swollen, wouldn't open left eye. Went to see Dr and took acyclovir for 10 days. Also saw ophthalmologist.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Emotional distress, Eye swelling, Impaired work ability, Scab
Clinical narrative: Blisters on left side of face, eye swollen, wouldn't open left eye. Went to see Dr and took acyclovir for 10 days. Also saw ophthalmologist.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Scar
Clinical narrative: Blisters on left side of face, eye swollen, wouldn't open left eye. Went to see Dr and took acyclovir for 10 days. Also saw ophthalmologist.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a medical assistant who stated that approximately a total of 20 patients (demographics unknown) were administered either GARDASIL or ROTATEQ (case #1404USA010671) (dates of administration, dosage and route of administration not provided) that was improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: FLUN4
Symptoms: Nervous system disorder
Clinical narrative: A report from a Pharmacist via medical representative concerning a patient of unknown age and gender. Relevant history and concomitant drugs were not reported. The patient received nasal FLUMIST Quadrivalent on an unknown date. The patient experienced a neurological adverse event. The outcome of the neurological adverse event was unknown. The reporter assessed the event of neurological adverse event to be serious as an important medical event.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Dizziness, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: Between 2-3 p.m., which prob was 3 hrs after vacc. My arm was completely lip, unable to move it. Extreme pain, spasms, tingling from armpit to hand, joint pains. Between 2-3 p.m. which was 3 hours after being vaccinated in my lt. arm, my arm went completely limp no muscle strength. It started to improve by p.m. It was extremely painful with spasms at the injection site. I had tingling from my arm pit to my hand, joint pains in my hands but mostly in my knees. The pain in my hands were severe, pale dizzy, fatigued. The following day was the worst for the pain and spasms. I should have gone to the ER. By bedtime on the day of the injection, my arm limpness started to improve. Every day "it" "the limpness" improved by 50% then gradually improved over days - until I could raise it above my head. I used heat wraps muscle rubs, epsome salt soaks, TYLENOL, percogesic. The pain and spasms in my arm was horrible. I contacted my doctor on Sunday then a second time by email. He had never heard of such a strong reaction and said to continue with the TYLENOL. He did not know what else to do.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Muscle spasms, Muscular weakness, Pallor, Paraesthesia
Clinical narrative: Between 2-3 p.m., which prob was 3 hrs after vacc. My arm was completely lip, unable to move it. Extreme pain, spasms, tingling from armpit to hand, joint pains. Between 2-3 p.m. which was 3 hours after being vaccinated in my lt. arm, my arm went completely limp no muscle strength. It started to improve by p.m. It was extremely painful with spasms at the injection site. I had tingling from my arm pit to my hand, joint pains in my hands but mostly in my knees. The pain in my hands were severe, pale dizzy, fatigued. The following day was the worst for the pain and spasms. I should have gone to the ER. By bedtime on the day of the injection, my arm limpness started to improve. Every day "it" "the limpness" improved by 50% then gradually improved over days - until I could raise it above my head. I used heat wraps muscle rubs, epsome salt soaks, TYLENOL, percogesic. The pain and spasms in my arm was horrible. I contacted my doctor on Sunday then a second time by email. He had never heard of such a strong reaction and said to continue with the TYLENOL. He did not know what else to do.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode following vaccination. Patient assisted to floor and then placed lying down on exam table. No injuries sustained. Vital signs checked twice, and patient allowed to leave under care of parent once symptoms dissipated.
Age: 46.0
Sex: M
Vaccine: MMR
Symptoms: Paraesthesia
Clinical narrative: Tingling on both fingers. NO SOB, In no acute distress. No rashes in body.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Meniscus operation
Clinical narrative: This case was reported by a consumer and described the occurrence of arthralgia in a female subject aged between 30 and 39 years old who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included partial thyroidectomy. Concurrent medical conditions included Graves' disease and high blood pressure. Concurrent medications included Hydrochlorothiazide (HCTZ), SYNTHROID and CELEBREX. On unspecified dates in the 1990s, the subject received two unspecified doses of LYMERIX (unknown). In the 1990s, shortly after vaccination with LYMERIX, the subject experienced pain in knees and joints. In October 2012, she underwent right knee operation (meniscus repair and clean out of arthritis). In April 2014 the subject experienced pain in left knee, ankle and hips. The subject stated she first began to experience pain in her knees and joints shortly after the second dose of LYMERIX sometime in the 1990s (date unknown). She clarified that it was "pain in her joints, including both knees and hips". Limited information was provided because the subject could not remember. At the time of reporting the arthralgia was unresolved; knee repair resolved on an unspecified date. This case was assessed as medically serious by GSK.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypotonic-hyporesponsive episode, Lethargy, Unresponsive to stimuli
Clinical narrative: This case was reported by a physician via a sale representative and described the occurrence of unresponsive to stimuli in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline) and Hib. On 4 April 2014, the subject received unspecified dose of PEDIARIX (unknown route and injection site; lot number not provided). In April 2014, 1 day after vaccination with PEDIARIX, the subject was found to be lethargic and unresponsive to stimuli. This case was assessed as medically serious by GSK due to unresponsive to stimuli. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 11 April 2014 from the physician: Concurrent vaccination included pneumococcal vaccines (non-gsk) ;non-GSK manufacturer; given on 4 April 2014 and rotavirus vaccine (non-gsk) ;non-GSK manufacturer; both given on 4 April 2014. Concomitant medication was not reported. The subject had no known medical history or past drug therapy. The subject's previous vaccinations went uncomplicated. On 4 April 2014, the subject received 3rd dose of PEDIARIX and unspecified dose of Hib (unknown route and injection site; lot number not provided). In April 2014, within 24 hours after vaccination with Hib and PEDIARIX, the subject experienced a hypotonic-hyporesponsive episode. The episode did not last for a long time. The subject visited the emergency room. At the time of reporting the events were resolved.
Age: 1.26
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Erythema, Injection site mass, Injection site swelling, Local swelling
Clinical narrative: 4/10/14 (R) arm  - swollen lump at site of VARIVAX injection. Size of 25 cent piece. Slight rash on back of neck up to ear for past 48 hours. Afebrile til 4/16 evening. T 100.5. 4/11/14 Seen in office. Hands  and feet swollen, red. T98, SpO2 96%. Rash on neck. Recom. BENADRYL.
Age: 1.26
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: 4/10/14 (R) arm  - swollen lump at site of VARIVAX injection. Size of 25 cent piece. Slight rash on back of neck up to ear for past 48 hours. Afebrile til 4/16 evening. T 100.5. 4/11/14 Seen in office. Hands  and feet swollen, red. T98, SpO2 96%. Rash on neck. Recom. BENADRYL.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Local swelling, Pyrexia
Clinical narrative: Local reaction with fever to 102 and local arm swelling/redness 4 days post vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Papule, Pruritus, Rash
Clinical narrative: Localized rash, pruritus (L) thigh, papule. Symptoms developed over the course of 4 days. BENADRYL cream applied to area, 25 mg. BENADRYL PO Q 6-8 hrs.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Crying, Rash erythematous, Rash generalised
Clinical narrative: Sudden onset crying accompanied by red, non-raised rash over entire body. Event occurred 30 minutes after receiving vaccines. Treatment received at hosp.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and severe swelling/pain at injection site. Prescribed prednisone patch and ibuprofen.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Chest discomfort, Diarrhoea, Dizziness, Dyspnoea, Headache
Clinical narrative: 2 hours after office visit and MCV she had chest tightness and difficulty breathing. She was treated for wheezing in the ED with Albuterol x 1. She also reported vomiting and diarrhea x 1 about 4 hours after. Some dizziness; No syncope. Had 2 doses of BENADRYL. Has had headaches on and off too. Sore throat began 4 hours after immun.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Oropharyngeal pain, Vomiting, Wheezing
Clinical narrative: 2 hours after office visit and MCV she had chest tightness and difficulty breathing. She was treated for wheezing in the ED with Albuterol x 1. She also reported vomiting and diarrhea x 1 about 4 hours after. Some dizziness; No syncope. Had 2 doses of BENADRYL. Has had headaches on and off too. Sore throat began 4 hours after immun.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Pyrexia, Rash
Clinical narrative: Localized rash, high fever. Went to see dr and is diagnosed with cellulitis. Currently on antibiotic. Called 4/7 - she is fine and free of infection.