chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Headache, Influenza like illness, Injection site oedema, Nausea
Clinical narrative: Localized erythema, edema at injection site. Flu-like symptoms developed approximately 24 hrs later. Headache, body aches, fever, nausea.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Localized erythema, edema at injection site. Flu-like symptoms developed approximately 24 hrs later. Headache, body aches, fever, nausea.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of unspecified patients. On unknown dates the unspecified number of unspecified patients were vaccinated with RECOMBIVAX HB INJ 10. There were unspecified extensions of the intervals between doses. These unspecified patients had negative titers for hepatitis B after completion of the RECOMBIVAX HB series. Outcome of the event was unknown. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Neck pain, Pruritus
Clinical narrative: Received Tdap (deltoid) on 1/14/13. Presented to me on 1/30/13 with complaint of pain on right neck after the injection on 01/14/13 with some associated facial itches. Pain progressively worse 42 cm x 3 cm area of cellulitis at angle of jaw and adjust (R) neck on 1/30/13 c/w cellulitis.
Age: 54.0
Sex: F
Vaccine: HEPA, MNQ, TYP
Symptoms: Erythema, Full blood count normal, Local swelling, Nausea, Pyrexia
Clinical narrative: Fever. Severe redness and swelling (L) arm. Nausea.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Posture abnormal, Syncope
Clinical narrative: Pt had already had vaccine 10 mins prior to fainting spell. Pt was told to sit for 15 mins, nurse talking to pt to make sure pt was ok. Nurse turned away from pt and pat slumped in the chair. No history of previous reaction as per father; pt had a light breakfast. Pt did not suffer injury from a fall.
Age: 0.77
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician and nurse refers to a currently 18 year old male patient. No medical history provided. On 19-SEP-1994 the patient received on the 1st dose in a series of  Hepatitis B vaccinations (indication routine vaccinations). The nurse was unsure who the manufacturer of each Hepatitis B does was but initials were provided for each dose. First dose was RECOMBIVAX HB with initials MSD (lot # 1788W; exp date: 27-OCT-1996). No concomitant medications were reported. On 22-NOV-1994 the second dose was Hepatitis B virus vaccine (unspecified) (manufacturer unknown) with initials ENG (lot # 1392A2). On 23-MAY-1995 third dose RECOMBIVAX HB with initials MSD (lot # 1285A, exp date: 11-JUL-1997). The physician reports that he had titers drawn for the patient, on an unspecified date the Hepatitis B and the titers resulted negative. The physician reports that the reason for having the titer drawn for the patient was due to the patient having tattoos done on an unspecified date and the physician wanted to ensure that the patient was not exposed to Hepatitis B. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site reaction, Pallor
Clinical narrative: Erythemic flat blanchable redness developed 24 hours after KINRIX vaccine given to right upper thigh. 24 hours later (48 hrs after vaccine) area doubled in size. Ice was applied and erythema improved. Some pain noted to area, mild ecchymosis noted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unknown number of patients, who, on unspecified dates, may have received M-M-R II (dose, route and lot # not reported) exposed to unknown temperatures for 2 months, which subsequently were found to be unsupported by in-house stability data. No adverse symptoms reported. This is one of several reports from the same source. Attempts are being made to obtain identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a currently 29 year old female patient with allergy to DEMEROL and DARVOCET. The patient received RECOMBIVAX HB on 08-JUL-1996, 20-AUG-1996, and on 14-JAN-1997, respectively (doses, routes and lot numbers not specified). On 21-JUN-2013, the patient was found to have a low hepatitis B antibody titer (blood titer test was performed). As a result, the patient was restarted on the RECOMBIVAX HB vaccination series. However, on 08-JUL-2013, this adult patient was given a pediatric dose of RECOMBIVAX HB in error. The patient's present status was unspecified. The outcome of adverse events was not reported. The relatedness for RECOMBIVAX HB and adverse event was not reported. Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On 05-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # 0172AE) with an expiration date of 18-APR-2013. No adverse effect reported. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 1 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were  reported. On 29-JUN-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB (Lot #, dose, route and frequency not reported). On 30-JUL-2013, the patient was inadvertently administered on "adult dose of RECOMBIVAX HB (Lot #,  dose, route and frequency not reported)", instead of the pediatric dose. No adverse effect reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody negative, Biopsy skin abnormal, C-reactive protein increased, Full blood count normal, Granuloma skin
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a 64 year old female patient with breast cancer, sulfa allergy-skin reaction and MSG allergy-does not tolerate foods with MSG. On approximately 09-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included ADVAIR, ZYRTEC, vitamin D (unspecified), CYMBALTA and ARIMIDEX. The physician's assistant reported that in approximately July 2013, the patient experienced a generalized rash, that began on legs and spread to include the face, trunk and arms, after she received ZOSTAVAX. The patient also experienced a fever, above 101 degrees, for first two weeks, and felt ill. The patient saw primary care physician one week later and was treated with acyclovir 800 mg TID and doxycycline. The patient was referred to physician assistant and was seen on 22-JUL-2013. The patient had lab studies: urinalysis was negative, complete blood count was negative, complete metabolic panel was negative, antinuclear antibody was negative, sedimentation rate was 55 and C-reactive protein was 4.21. Biopsy of skin was also performed. Biopsy results indicated a non specific granulomatous dermatitis. After biopsy results were obtained on 30-JUL-2013, "2 days ago", the patient was started on prednisone 40 mg to taper down to 5 mg, over the next 14 days. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Metabolic function test normal, Pyrexia, Rash generalised, Red blood cell sedimentation rate increased
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a 64 year old female patient with breast cancer, sulfa allergy-skin reaction and MSG allergy-does not tolerate foods with MSG. On approximately 09-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included ADVAIR, ZYRTEC, vitamin D (unspecified), CYMBALTA and ARIMIDEX. The physician's assistant reported that in approximately July 2013, the patient experienced a generalized rash, that began on legs and spread to include the face, trunk and arms, after she received ZOSTAVAX. The patient also experienced a fever, above 101 degrees, for first two weeks, and felt ill. The patient saw primary care physician one week later and was treated with acyclovir 800 mg TID and doxycycline. The patient was referred to physician assistant and was seen on 22-JUL-2013. The patient had lab studies: urinalysis was negative, complete blood count was negative, complete metabolic panel was negative, antinuclear antibody was negative, sedimentation rate was 55 and C-reactive protein was 4.21. Biopsy of skin was also performed. Biopsy results indicated a non specific granulomatous dermatitis. After biopsy results were obtained on 30-JUL-2013, "2 days ago", the patient was started on prednisone 40 mg to taper down to 5 mg, over the next 14 days. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis normal
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a 64 year old female patient with breast cancer, sulfa allergy-skin reaction and MSG allergy-does not tolerate foods with MSG. On approximately 09-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included ADVAIR, ZYRTEC, vitamin D (unspecified), CYMBALTA and ARIMIDEX. The physician's assistant reported that in approximately July 2013, the patient experienced a generalized rash, that began on legs and spread to include the face, trunk and arms, after she received ZOSTAVAX. The patient also experienced a fever, above 101 degrees, for first two weeks, and felt ill. The patient saw primary care physician one week later and was treated with acyclovir 800 mg TID and doxycycline. The patient was referred to physician assistant and was seen on 22-JUL-2013. The patient had lab studies: urinalysis was negative, complete blood count was negative, complete metabolic panel was negative, antinuclear antibody was negative, sedimentation rate was 55 and C-reactive protein was 4.21. Biopsy of skin was also performed. Biopsy results indicated a non specific granulomatous dermatitis. After biopsy results were obtained on 30-JUL-2013, "2 days ago", the patient was started on prednisone 40 mg to taper down to 5 mg, over the next 14 days. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to two college age female patients. As children these two patients were vaccinated with the primary dose of RECOMBIVAX HB could not be ruled out. Lot #, dose and route not reported). Recently (this month) the two patients had negative titer tests for hepatitis B. No adverse event was reported. The patients contacted office for medical attention. Outcome was not reported. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Borrelia test negative, Endoscopy upper gastrointestinal tract normal, Fatigue
Clinical narrative: This spontaneous report was received from a physician assistant who is also the patient's sister refers to a 27 year old female patient. No medical history or drug allergies were reported. On 01-MAY-2013, the patient was vaccinated with a dose of GARDASIL (lot#, expiry not reported), intramuscularly. No concomitant medications were reported. Since an unknown date in May 2013, after receiving GARDASIL, the patient experienced viral symptoms such as: nausea, fatigue, weakness, muscle aches, weakness and spasms of the legs. Patient has also experienced tingling of the hands and migraines. The reporter also stated that in the last three months since May 2013, the patient has missed a lot of work due to exhaustion. Patient sought medical attention. On an unknown date in 2013, the patient visited her primary care physician in which laboratory work was conducted, such as complete blood count (CBC), Lymes, lupus, thyroid and other autoimmune diseases, but all results were negative. The patient then saw a gastrointestinal doctor and had an upper endoscopy completed, results were normal. The patient then saw a neurologist who stated these symptoms may be from the GARDASIL, but did not treat it. Reporter stated that two weeks ago, patient felt 50 percent better for four days, then relapsed. The outcome of nausea, fatigue, weakness, muscle aches, weakness and spasms of the legs, migraines, tingling of the hands, muscle and missed a lot of work due to exhaustion was reported as not recovered. Causality was not reported. The reporter considered the event missed a lot of work due to exhaustion as disabling. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Laboratory test normal, Migraine, Muscle spasms, Myalgia
Clinical narrative: This spontaneous report was received from a physician assistant who is also the patient's sister refers to a 27 year old female patient. No medical history or drug allergies were reported. On 01-MAY-2013, the patient was vaccinated with a dose of GARDASIL (lot#, expiry not reported), intramuscularly. No concomitant medications were reported. Since an unknown date in May 2013, after receiving GARDASIL, the patient experienced viral symptoms such as: nausea, fatigue, weakness, muscle aches, weakness and spasms of the legs. Patient has also experienced tingling of the hands and migraines. The reporter also stated that in the last three months since May 2013, the patient has missed a lot of work due to exhaustion. Patient sought medical attention. On an unknown date in 2013, the patient visited her primary care physician in which laboratory work was conducted, such as complete blood count (CBC), Lymes, lupus, thyroid and other autoimmune diseases, but all results were negative. The patient then saw a gastrointestinal doctor and had an upper endoscopy completed, results were normal. The patient then saw a neurologist who stated these symptoms may be from the GARDASIL, but did not treat it. Reporter stated that two weeks ago, patient felt 50 percent better for four days, then relapsed. The outcome of nausea, fatigue, weakness, muscle aches, weakness and spasms of the legs, migraines, tingling of the hands, muscle and missed a lot of work due to exhaustion was reported as not recovered. Causality was not reported. The reporter considered the event missed a lot of work due to exhaustion as disabling. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Paraesthesia, Thyroid function test normal, Viral infection
Clinical narrative: This spontaneous report was received from a physician assistant who is also the patient's sister refers to a 27 year old female patient. No medical history or drug allergies were reported. On 01-MAY-2013, the patient was vaccinated with a dose of GARDASIL (lot#, expiry not reported), intramuscularly. No concomitant medications were reported. Since an unknown date in May 2013, after receiving GARDASIL, the patient experienced viral symptoms such as: nausea, fatigue, weakness, muscle aches, weakness and spasms of the legs. Patient has also experienced tingling of the hands and migraines. The reporter also stated that in the last three months since May 2013, the patient has missed a lot of work due to exhaustion. Patient sought medical attention. On an unknown date in 2013, the patient visited her primary care physician in which laboratory work was conducted, such as complete blood count (CBC), Lymes, lupus, thyroid and other autoimmune diseases, but all results were negative. The patient then saw a gastrointestinal doctor and had an upper endoscopy completed, results were normal. The patient then saw a neurologist who stated these symptoms may be from the GARDASIL, but did not treat it. Reporter stated that two weeks ago, patient felt 50 percent better for four days, then relapsed. The outcome of nausea, fatigue, weakness, muscle aches, weakness and spasms of the legs, migraines, tingling of the hands, muscle and missed a lot of work due to exhaustion was reported as not recovered. Causality was not reported. The reporter considered the event missed a lot of work due to exhaustion as disabling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 25-AUG-2009 the patient was vaccinated with the first dose of VARIVAX (Merck) (0.5 mg, lot number and expiration date not reported) subcutaneous. On 22-AUG-2012 the patient was vaccinated with the second dose of VARIVAX (Merck) (0.5 mg, lot number and expiration date not reported) subcutaneous. On 29-JUL-2013 the patient was vaccinated with a third dose of VARIVAX (Merck) (0.5 mg, lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. No adverse effect reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 70 year old male patient with allergic to oxycodone. On 01-AUG-2013 the patient was vaccinated with PNEUMOVAX23 (lot number, route and injection site were not reported) (0.5 ml). Concomitant therapies included EXFORGE, ZYRTEC. The patient experienced ad adverse reaction after receiving PNEUMOVAX23 on 01-AUG-2013. This patient reported that on 01-AUG-2013 a short unspecified amount of time after receiving PNEUMOVAX23 he began to feel fatigue, experienced a headache and noticed that the unspecified injection site was tender to touch, red and warm, had some swelling and was painful. The patient called his unspecified physician on an unspecified date for medical attention to report these symptoms and his physician recommended the use of ice to the injection site and to administer an unspecified amount of TYLENOL to manage the symptoms. There was no treatment given for adverse events and no lab diagnostics studies performed at the time of report. The outcome was reported as not recovered/resolved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 70 year old male patient with allergic to oxycodone. On 01-AUG-2013 the patient was vaccinated with PNEUMOVAX23 (lot number, route and injection site were not reported) (0.5 ml). Concomitant therapies included EXFORGE, ZYRTEC. The patient experienced ad adverse reaction after receiving PNEUMOVAX23 on 01-AUG-2013. This patient reported that on 01-AUG-2013 a short unspecified amount of time after receiving PNEUMOVAX23 he began to feel fatigue, experienced a headache and noticed that the unspecified injection site was tender to touch, red and warm, had some swelling and was painful. The patient called his unspecified physician on an unspecified date for medical attention to report these symptoms and his physician recommended the use of ice to the injection site and to administer an unspecified amount of TYLENOL to manage the symptoms. There was no treatment given for adverse events and no lab diagnostics studies performed at the time of report. The outcome was reported as not recovered/resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site rash
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. On 18-JUL-2013 the patient was vaccinated with a single dose of ZOSTAVAX, subcutaneous, lot # not provided. On 19-JUL-2013, the patient experienced an enlarged redness with bumps at the injection site for ZOSTAVAX. Caller stated the area was like a hard-knot. The patient did not seek medical attention. There was no treatment given for the patient's events. The outcome of adverse events was unknown. The relatedness between ZOSTAVAX and adverse events was unknown. Additional information is not expected.
Age: 0.77
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 month old male patient. On 01-OCT-2008 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot #, route and dose not reported) when he was under 12 months of age. On 12-MAR-2009, the patient was subsequently administered the second dose of VARIVAX (Merck) (lot # route and dose not reported). No adverse effect reported. It was unknown if the patient sought medical attention or not. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid function disorder, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a pharmacist via company representative, refers to a 52 year old male patient. On 27-DEC-2012 the patient was vaccinated with ZOSTAVAX (strength, dose and lot number were not reported). On 31-DEC-2012, the patient developed Bell's Palsy, droopiness in face and problems blinking after receiving ZOSTAVAX. The patient sought medical attention, he spoke with his wife who was a pharmacist. The patient was treated with acupuncture for the adverse events. The outcome of Bell's Palsy, droopiness in face and problems blinking was reported as not recovered/not resolved. The relatedness between Bell's Palsy, droopiness in face, problems blinking and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to two patients of unknown age and gender. On an unknown dates both patients were vaccinated with ZOSTAVAX (dose, strength and route of administration not reported). On an unknown date both patients got shingles. The outcome of shingles for both patients was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Chest pain, Heart rate increased, Hypotension, Pain, Pyrexia
Clinical narrative: Weak, chest pains, low blood pressure, fast heart rate, shakes, low grade fever, body aches.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Tremor
Clinical narrative: Weak, chest pains, low blood pressure, fast heart rate, shakes, low grade fever, body aches.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: 2 hours after receiving vaccine, child experienced swelling at injection site.  Next morning injection site/upper arm swollen, rock hard to touch, hot to touch, painful to move.  Child taken to ER.  Given Benadryl and Prednisone dose pack.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Dysarthria
Clinical narrative: Child's speech became slurred and not understandable. This lasted 48 hours.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Dyspnoea, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Swollen, red, hot arm.  Stomach pain and trouble breathing.
Age: 23.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 10 cm in diameter, red, swollen, warm.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Constipation, Erythema, Mass, Oedema peripheral
Clinical narrative: Fever, chills, body pain, swollen arm, lump, big red spot on the arm, tenderness, constipation.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Fever, chills, body pain, swollen arm, lump, big red spot on the arm, tenderness, constipation.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 14-AUG-2012 the patient was vaccinated with GARDASIL dose 1 (route and lot number not provided) and would receive her second dose on 02-AUG-2013. There were no adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Excessive eye blinking, Eyelid function disorder, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient with medical history of allergic rhinitis, asthma, type 2 diabetes, GERD, HTN, insomnia and overweight and with drug reactions/allergies to DEMEROL (unknown reaction). ON 12-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001692, Exp date as 08-MAY-2014, 0.65 ml, subcutaneous. On 29-JUL-2013, the patient developed Bell's Palsy after being administered ZOSTAVAX. It was reported that the patient began to experience symptoms on 29-JUL-2013 which included difficulty in closing her left eye, excessive blinking of her right eye and drooping on the left side of her face. This patient called the physician's office on an unspecified d ate, but the patient was seen in the office for evaluation on 31-JUL-2013. The unspecified physician prescribed an unspecified dose of prednisone (manufacturer unknown) and valacyclovir, along with over the counter artificial tears to manage the patient's symptoms. The nurse reported that the  patient was instructed to follow up with the physician in 10 days for re-evaluation. The outcome of bell's palsy was reported as recovering/resolving. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 88 year old female patient regarding herself. On an unknown date in 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported), subcutaneously. Concomitant therapies included GRALISE and CYMBALTA. On an unknown date in November 2012, the patient was diagnosed with the shingles after receiving the vaccine in 2008. She said it was on her left arm and elbow and left breast and shoulder. Patient received treatment with prescribed antivirals-the name not given. Patient sought medical attention. She stated she was following up with her physician. The outcome of shingles was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from a physician refers to 2 female patients of unknown age. On an unknown date the 2 patients were vaccinated with GARDASIL (dose, route and lot# unknown) in the arm. No other co-suspects were reported. No concomitant medications were reported. The physician reported the 2 patients (anonymous) missed the third dose GARDASIL because they experienced dizziness that lasted a few weeks after they received the second dose of GARDASIL (onset date not reported). It was unknown if they had sought medical attention. The outcome was reported as recovered/resolved on an unknown date. Action taken was not provided. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 year old patient. The nurse reported the patient received PROQUAD (Merck) (dose and lot # not reported) and VARIVAX (Merck) (dose and lot # not reported) on 31-JUL-2013. No adverse symptoms were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 2.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 year old patient. The nurse reported the patient received PROQUAD (dose and lot # not reported) and VARIVAX (dose and lot # not reported) on 31-JUL-2013. No adverse symptoms were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Incorrect route of drug administration, Injection site streaking, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On 01-AUG-2013 the patient was vaccinated with PNEUMOVAX23 (lot number was not reported) (0.1 ml intradermal dose) in her right forearm instead of MANTOUX. On 01-AUG-2013 the patient sought medical attention in the physician's office due to redness and swelling of her right forearm. Treatment prescribed was KEFLEX 500 mg twice daily for 10 days. The patient returned to the physician's office for medical attention on 02-AUG-2013 for redness on her right forearm which had spread. The nurse also reported that the patient's right forearm was painful and there was "a little bit of streaking" at the site of administration. There was no lab diagnostics studies performed. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On 01-AUG-2013 the patient was vaccinated with PNEUMOVAX23 (lot number was not reported) (0.1 ml intradermal dose) in her right forearm instead of MANTOUX. On 01-AUG-2013 the patient sought medical attention in the physician's office due to redness and swelling of her right forearm. Treatment prescribed was KEFLEX 500 mg twice daily for 10 days. The patient returned to the physician's office for medical attention on 02-AUG-2013 for redness on her right forearm which had spread. The nurse also reported that the patient's right forearm was painful and there was "a little bit of streaking" at the site of administration. There was no lab diagnostics studies performed. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 18 year old patient (gender unknown). On 30-JAN-2013, the patient was vaccinated with dose 1 and on 14-MAY-2013, patient received dose 2 of GARDASIL (lot#, expiry not reported) 0.5 milliliter (ml), intramuscularly. On 01-AUG-2013, the patient received dose 3 GARDASIL (lot#, expiry not reported), 0.5 ml, intramuscularly. No adverse effects reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a female consumer referring to her 18 year old. The mother of the patient called to question the probability of any adverse effect for her son, who had received a fourth dose of GARDASIL, after already having the third and final dose. A misuse was also reported within this same case, for the same patient, due to the fact that this patient received the first two doses at the recommended times and the third dose two months after the second. No adverse effect was reported with the misuse. The third dose of GARDASIL was received in November 2012 and the fourth dose was received in August 2013. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unknown number of patients, who, on unspecified dates, may have received VARIVAX (Merck) (dose, route and lot # not reported) exposed to unknown temperatures for 2 months, which subsequently were found to be unsupported by in-house stability data. No adverse symptoms reported. This is one of several reports from the same source.. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abdominal X-ray, Diarrhoea, Diarrhoea haemorrhagic, Ultrasound abdomen normal, X-ray normal
Clinical narrative: Development of diarrhea in <24 hours which progressed to bloody diarrhea. Abdo XR (-), abdo U/S (-).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unknown number of patients, who, on unspecified dates, may have received GARDASIL (dose, route and lot # not reported) exposed to unknown temperatures for 2 months, which subsequently were found to be unsupported by in-house stability data. No adverse symptoms reported. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with hypertension and drug reaction/allergies to "iodides" (no further specified). On 29-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot # J000494, expiry date 14-APR-2014) (number of dose, dose, route, frequency not reported) to prevent shingles. Concomitant therapies included PROPRANOL and LIPITOR. On 30-JUL-2013 the patient experienced redness that was spreading down the patient's arm from the injection site and a bulge at the injection site and bulge at the injection site. The patient was treated with BENADRYL. The outcome of redness that was spreading down the patient's arm from the injection site and a bulge at the injection was reported as not recovered/not resolved. No laboratory diagnosis was performed. The patient sought medical attention by contacting pharmacist. The reporter did not assess the relationship between the therapy with ZOSTAVAX and redness that was spreading down the patient's arm from the injection site and a bulge. This is one of several reports received from the same source. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 82 year old female patient with allergy to ampicillin. The patient's medical history included infections of the bladder. On 08-JUL-2013 the patient was vaccinated with ZOSTAVAX (dose, strength, site of administration not reported) (lot #J001700, exp: 08-MAY-2014). On an unknown date the patient developed a rash. The rash was itchy, hurt and felt like sunburn when touched. No treatment was given. No lab diagnostic studies were performed. The outcome of events was reported as unknown. The relatedness between ZOSTAVAX and the events was not reported. The patient sought medical attention via contacting with pharmacist. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Red pruritic spots at injection site on right thigh red patchy spots on chin chest back very itchy. Have sent pt for a varicella titer.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Antibody test, Injection site erythema, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: Red pruritic spots at injection site on right thigh red patchy spots on chin chest back very itchy. Have sent pt for a varicella titer.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Rash erythematous, Varicella virus test
Clinical narrative: Red pruritic spots at injection site on right thigh red patchy spots on chin chest back very itchy. Have sent pt for a varicella titer.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Injection site pain, Mobility decreased, Myalgia
Clinical narrative: Sx started evening after vaccine given. Temp 99.2. Severe headaches, muscular pain - generalized. Unable to lift affected arm with pain. Inj. site - tender to touch. Rx - Ibuprofen as needed, rest, fluids. F/U PM in 2 days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Local swelling
Clinical narrative: 12 to 24 hours post vaccination patient had rash around injection site and the arm was swollen. No treatment was necessary.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Headache, Hyperhidrosis, Nausea, Skin oedema
Clinical narrative: At 11:45, MCV and Hep A vaccine were administered to pt. At 11:50, pt had severe headache, dizziness, nausea, sweating, and skin edema in bilateral hands. Blood pressure was 78/39 P 60 O2 97% or RA. Pt placed supine. EMS called and arrived to treat pt. Pt was discharged to ER with mom and EMS at 12:15. At discharge, BP 107/62, symptoms improving.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Presents to ER complaining of arm pain after injection.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Feeling hot, Headache, Pain
Clinical narrative: C/O feeling achy, weak, headache and warm, no fever, temp 97.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Crying, Fall, Syncope
Clinical narrative: Patient alert oriented with no signs of distress noted. Dad had child sitting on lap during administration of multi vaccines. Child responsive, pleasant after immunization. Dad and child sill in room observing sibling getting immunization when child fainted, fell backward, hit floor. Dad carries child, child immediately began to cry. No signs/symptoms of shortness of breath noted. EMS assessed patient vital signs normal. Father took child to ER for observation due to fall.
Age: 1.87
Sex: M
Vaccine: DTAP, HEP, HEPA, PPV
Symptoms: Febrile convulsion, Postictal state
Clinical narrative: Febrile seizure lasting < 2 minutes.  Post ictal for several hours w/o lateralizing features.
Age: 45.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus
Clinical narrative: Itchiness on scalp and neck and ears.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Syncope, Vomiting
Clinical narrative: Pt had emesis x1 with a syncopal episode. Pt returned on 8/7/2013 with persistant nausea, vomiting and headaches.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large warm red hard area on right deltoid.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Chest discomfort, Heart rate increased, Hyperhidrosis, Paraesthesia
Clinical narrative: Chest tightness, increased heart rate from 66 at time of initial assessment to 106 after Tdap injection, feeling of doom, sweat, tingling down spine.
Age: 2.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Given HPV injection.
Age: 19.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Hives, one large raised itchy patch (11/2 inches x 4 inches) and multiple smaller raised hives over inner/front thigh and around lower trunk. He took two Benadryl. We got medical advice. There was no problem with chest tightness or breathing nor any other symptoms.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Cough, Dyspnoea, Erythema, Urticaria
Clinical narrative: Redness from chest up, hives, dyspnea, cough. Took Benadryl and used inhaler.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed redness, swelling, pain, and fever the day after his vaccines, on left deltoid area where had Kinrix shot. Went to ED, diagnosed with cellulitis, started trim-sulfa.
Age: 1.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 1.05
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Leg was swollen, red and hot to the touch around injection site. The area was 4" in diameter . He was irritable and tired the day and day after (today) the shot. His leg is also swollen. I gave him ibuprofen before bed to help with the soreness. I have yet to see if this will worsen or improve as we are still in the early stages.
Age: 1.05
Sex: M
Vaccine: DTAP
Symptoms: Pain
Clinical narrative: Leg was swollen, red and hot to the touch around injection site. The area was 4" in diameter . He was irritable and tired the day and day after (today) the shot. His leg is also swollen. I gave him ibuprofen before bed to help with the soreness. I have yet to see if this will worsen or improve as we are still in the early stages.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Decreased appetite, Irritability, Lethargy, Pyrexia, Urticaria
Clinical narrative: Hives on legs 7 days, fever 102-103F 3 days, lack of appetite 4 days, lethargic 3 days, irritability for 5 days.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling at injection site. Treatment: Cephalexin and sma/tmp.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Received Tdap, MENACTRA and varicella vaccines. Mother states at site of varicella pt. c/o pain, burining immed. after shot. Then had swelling at site - was seen in ER - 8-3-13. Was told to take BENADRYL and it has hepled obut cont. to have swelling at site.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness, Muscle twitching, Posture abnormal, Unresponsive to stimuli
Clinical narrative: 1550 - shortly after receiving the HPV after Hep A IM, the patient slump over on the exam table after passing out. Patient had a 5 second upper body twitching and was not responding to name. Within 5 seconds later, patient came to.
Age: 15.0
Sex: F
Vaccine: HEPA, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, mild tenderness/itching at the site (L deltoid/SQ tissue lateral arm), was noted within 6 hours of vaccination.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pt reports shortly after " a few hours later" L deltoid became very swollen, tender, 1 day later developed headache, chills, shakes, joint pain, body ache. Treated - Tylenol/Aleve/Motrin, Ice pack.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Tremor
Clinical narrative: Pt reports shortly after " a few hours later" L deltoid became very swollen, tender, 1 day later developed headache, chills, shakes, joint pain, body ache. Treated - Tylenol/Aleve/Motrin, Ice pack.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dysphemia
Clinical narrative: 4 1/2 hrs after vaccine pt. had stuttering speech. Slow reaction.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Computerised tomogram head, Dysphemia, Full blood count, Laboratory test, Mobility decreased
Clinical narrative: 4 1/2 hrs after vaccine pt. had stuttering speech. Slow reaction.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Blood glucose, Blood test, Computerised tomogram, Dysphemia
Clinical narrative: 4 1/2 hrs after vaccine pt. had stuttering speech. Slow reaction.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Fatigue, Pain in extremity, Psychomotor skills impaired, Speech disorder
Clinical narrative: 4 1/2 hrs after vaccine pt. had stuttering speech. Slow reaction.
Age: 18.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Incorrect dose administered
Clinical narrative: None. Client 18y 9m 11 d was given adult dose of Hep A. Should have been pediatric.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Red, hard, swollen rash on (L) deltoid. Chills, fever and tonsil swelling.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Tonsillar hypertrophy
Clinical narrative: Red, hard, swollen rash on (L) deltoid. Chills, fever and tonsil swelling.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 29-JUL-2012 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, lot# and route not reported). On 22-AUG-2012, the patient experienced Guillain Barre syndrome. The outcome of Guillain Barre syndrome was unknown. Base internal review, Guillain Barre syndrome was considered to be medically significant. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Productive cough, Pyrexia, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: 4 hour after receiving vaccines, had nasal discharge, on and off production cough and recurrent low grade fever. Office visit next day 8-7-13 - diagnosis URI. Father with same symptoms. Tx: supportive mgt. and acetaminophen for fever.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 12 year old male patient. On 31-JUL-2012, the patient received the first dose of GARDASIL (lot #, expiry not reported) and the second dose was administered on 05-AUG-2013. No adverse effects reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 59 year old female patient. No medical history or drug allergies were reported. On 01-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H022152, expiry: 18-MAR-2014). Concomitant therapies included RESTASIS. On 03-AUG-2013, the patient experienced redness around the injection site after receiving ZOSTAVAX. Patient sought medical attention contacted pharmacist. No treatment was given. No laboratory diagnostics studies were performed. The outcome of redness around the injection site was reported as recovering. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (route, lot number and expiration date not reported). There was no concomitant medication reported. The nurse reported that the patient received the second dose of GARDASIL (route, lot number and expiration date not reported) one year after the first dose in series of an unspecified date. No adverse were reported. Additional information has been requested.