chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Goitre, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US048886, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 568828) website on 21 Apr 2015. This report refers to a 28-year old male patient. Past medical history included Helicobacter Pylori infection (one year ago). Concurrent condition included ADD (attention deficit/hyperactivity disorder) since the age of five years. The patient's gall bladder was removed and the patient had no birth defects and allergies. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 15 Feb 2015. On 17 Feb 2015, the patient experienced trouble in swallowing, chest pain and shortness of breath. Further, the patient's thyroid feels swollen to touch and it was causing difficulty swallowing. On 06 Mar 2015, the patient was seen in emergency room due to paralysis of face, burning in scalp and extreme fatigue.  The symptoms were getting worse. The patient went to a doctor and was treated with prednisone and tetracycline for the described symptoms. The final outcome of the events was condition unchanged. The events were reported as non-serious. Causality was not reported. The event 'paralysis of face' was internally upgraded as medically significant based on the information available in the source document. Following an internal review on 28 Apr 2015 for the information received on 21 Apr 2015, following correction was done: the event burning in scalp was linked to facial paralysis and difficulty swallowing was linked to thyroid feels swollen (previously burning sensation and swallowing difficult were standalone events).
Age: 28.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chest pain, Dysphagia, Dyspnoea, Fatigue, Goitre
Clinical narrative: Case number PHHY2015US048886, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 568828) website on 21 Apr 2015. This report refers to a 28-year old male patient. Past medical history included Helicobacter Pylori infection (one year ago). Concurrent condition included ADD (attention deficit/hyperactivity disorder) since the age of five years. The patient's gall bladder was removed and the patient had no birth defects and allergies. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 15 Feb 2015. On 17 Feb 2015, the patient experienced trouble in swallowing, chest pain and shortness of breath. Further, the patient's thyroid feels swollen to touch and it was causing difficulty swallowing. On 06 Mar 2015, the patient was seen in emergency room due to paralysis of face, burning in scalp and extreme fatigue.  The symptoms were getting worse. The patient went to a doctor and was treated with prednisone and tetracycline for the described symptoms. The final outcome of the events was condition unchanged. The events were reported as non-serious. Causality was not reported. The event 'paralysis of face' was internally upgraded as medically significant based on the information available in the source document. Following an internal review on 28 Apr 2015 for the information received on 21 Apr 2015, following correction was done: the event burning in scalp was linked to facial paralysis and difficulty swallowing was linked to thyroid feels swollen (previously burning sensation and swallowing difficult were standalone events).
Age: 28.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Skin burning sensation, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US048886, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 568828) website on 21 Apr 2015. This report refers to a 28-year old male patient. Past medical history included Helicobacter Pylori infection (one year ago). Concurrent condition included ADD (attention deficit/hyperactivity disorder) since the age of five years. The patient's gall bladder was removed and the patient had no birth defects and allergies. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 15 Feb 2015. On 17 Feb 2015, the patient experienced trouble in swallowing, chest pain and shortness of breath. Further, the patient's thyroid feels swollen to touch and it was causing difficulty swallowing. On 06 Mar 2015, the patient was seen in emergency room due to paralysis of face, burning in scalp and extreme fatigue.  The symptoms were getting worse. The patient went to a doctor and was treated with prednisone and tetracycline for the described symptoms. The final outcome of the events was condition unchanged. The events were reported as non-serious. Causality was not reported. The event 'paralysis of face' was internally upgraded as medically significant based on the information available in the source document. Following an internal review on 28 Apr 2015 for the information received on 21 Apr 2015, following correction was done: the event burning in scalp was linked to facial paralysis and difficulty swallowing was linked to thyroid feels swollen (previously burning sensation and swallowing difficult were standalone events).
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from physician assistant refers to a female patient of unknown age. No medical history and concurrent conditions reported. On an unknown date of April-2011 the patient was vaccinated with ZOSTAVAX (dose, route, lot#, frequency not reported). There was no concomitant medication reported. On 20-JAN-2015, (also reported as 2 weeks ago) the patient was diagnosed with rash on the trunk. On 26-JAN-2015 the patient was diagnosed with shingles. On 09-FEB-2015 the patient reported having back pain. On each of these reported dates the patient was seen in the office by the physician assistant. The patient not sought medical attention. At the time of the report the patient's status was unknown. Follow up information has been received from the physician assistant on 01-MAY-2015 referring to the 63 (also reported as 64) years old female patient. The patient's concurrent condition included: SEPTRA allergy, hepatitis, depression, diabetes, hypertension, hyperlipidaemia, knee osteoarthritis and gastrooesophageal reflux disease (GERD). The patient had chickenpox at 8 years old and did not have herpes zoster in the past. The patient didn't exposure to chickenpox and herpes zoster recently. No illness at the time of vaccination. On 20-APR-2011 14:50, the patient was vaccinated with ZOSTAVAX (lot# reported as 14162) dose 1, subcutaneously in the right arm. There was no rash at the site of injection or elsewhere within 42 days of vaccination. The patient began with left flank pain on 20-JAN-2015 and seen doctor on 26-JAN-2015 for rash along dermatomes of left trunk. 10 out of 10 pain score. Multiple lesions of herpes zoster. Thoracic region dermatomes were on T6 and T7. Patient visit the office for post herpetic neuralgia (it was reported as back pain in previous version). No polymerase chain reaction (PCR) and no other test performed. Maximum temperature of the patient was 97.6. The outcome of the herpes zoster was reported as recovered/resolved but had occasional itching to site on approximately 09-FEB-2015 which was 2 weeks after rash started. The outcome of post herpetic neuralgia was resolved on unknown date in 2015. The reporter considered the events to be medically significant. Additional information has been requested. Patient information, concurrent condition, product information, seriousness criteria, event and narrative were updated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Flank pain, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report as received from physician assistant refers to a female patient of unknown age. No medical history and concurrent conditions reported. On an unknown date of April-2011 the patient was vaccinated with ZOSTAVAX (dose, route, lot#, frequency not reported). There was no concomitant medication reported. On 20-JAN-2015, (also reported as 2 weeks ago) the patient was diagnosed with rash on the trunk. On 26-JAN-2015 the patient was diagnosed with shingles. On 09-FEB-2015 the patient reported having back pain. On each of these reported dates the patient was seen in the office by the physician assistant. The patient not sought medical attention. At the time of the report the patient's status was unknown. Follow up information has been received from the physician assistant on 01-MAY-2015 referring to the 63 (also reported as 64) years old female patient. The patient's concurrent condition included: SEPTRA allergy, hepatitis, depression, diabetes, hypertension, hyperlipidaemia, knee osteoarthritis and gastrooesophageal reflux disease (GERD). The patient had chickenpox at 8 years old and did not have herpes zoster in the past. The patient didn't exposure to chickenpox and herpes zoster recently. No illness at the time of vaccination. On 20-APR-2011 14:50, the patient was vaccinated with ZOSTAVAX (lot# reported as 14162) dose 1, subcutaneously in the right arm. There was no rash at the site of injection or elsewhere within 42 days of vaccination. The patient began with left flank pain on 20-JAN-2015 and seen doctor on 26-JAN-2015 for rash along dermatomes of left trunk. 10 out of 10 pain score. Multiple lesions of herpes zoster. Thoracic region dermatomes were on T6 and T7. Patient visit the office for post herpetic neuralgia (it was reported as back pain in previous version). No polymerase chain reaction (PCR) and no other test performed. Maximum temperature of the patient was 97.6. The outcome of the herpes zoster was reported as recovered/resolved but had occasional itching to site on approximately 09-FEB-2015 which was 2 weeks after rash started. The outcome of post herpetic neuralgia was resolved on unknown date in 2015. The reporter considered the events to be medically significant. Additional information has been requested. Patient information, concurrent condition, product information, seriousness criteria, event and narrative were updated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from physician assistant refers to a female patient of unknown age. No medical history and concurrent conditions reported. On an unknown date of April-2011 the patient was vaccinated with ZOSTAVAX (dose, route, lot#, frequency not reported). There was no concomitant medication reported. On 20-JAN-2015, (also reported as 2 weeks ago) the patient was diagnosed with rash on the trunk. On 26-JAN-2015 the patient was diagnosed with shingles. On 09-FEB-2015 the patient reported having back pain. On each of these reported dates the patient was seen in the office by the physician assistant. The patient not sought medical attention. At the time of the report the patient's status was unknown. Follow up information has been received from the physician assistant on 01-MAY-2015 referring to the 63 (also reported as 64) years old female patient. The patient's concurrent condition included: SEPTRA allergy, hepatitis, depression, diabetes, hypertension, hyperlipidaemia, knee osteoarthritis and gastrooesophageal reflux disease (GERD). The patient had chickenpox at 8 years old and did not have herpes zoster in the past. The patient didn't exposure to chickenpox and herpes zoster recently. No illness at the time of vaccination. On 20-APR-2011 14:50, the patient was vaccinated with ZOSTAVAX (lot# reported as 14162) dose 1, subcutaneously in the right arm. There was no rash at the site of injection or elsewhere within 42 days of vaccination. The patient began with left flank pain on 20-JAN-2015 and seen doctor on 26-JAN-2015 for rash along dermatomes of left trunk. 10 out of 10 pain score. Multiple lesions of herpes zoster. Thoracic region dermatomes were on T6 and T7. Patient visit the office for post herpetic neuralgia (it was reported as back pain in previous version). No polymerase chain reaction (PCR) and no other test performed. Maximum temperature of the patient was 97.6. The outcome of the herpes zoster was reported as recovered/resolved but had occasional itching to site on approximately 09-FEB-2015 which was 2 weeks after rash started. The outcome of post herpetic neuralgia was resolved on unknown date in 2015. The reporter considered the events to be medically significant. Additional information has been requested. Patient information, concurrent condition, product information, seriousness criteria, event and narrative were updated.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Dyspnoea, Injection site hypoaesthesia, Injection site pain
Clinical narrative: This spontaneous report as received from a 72 year old female consumer refers to herself. Patient medical history was not reported and current condition include allergy to penicillin and unspecified antibiotics. On 07-APR-2015 the patient was vaccinated with ZOSTAVAX. The patient experienced lips tingling, shortness of breath and an upset stomach after being injected with zoster vaccine live. Also on 9-APR-2015 the patient arm was sore at the injection site and he noticed a red area that was about two inches in diameter. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Dyspnoea, Injection site erythema, Injection site pain, Paraesthesia oral
Clinical narrative: This spontaneous report as received from a 72 year old female consumer refers to herself. Patient medical history was not reported and current condition include allergy to penicillin and unspecified antibiotics. On 07-APR-2015 the patient was vaccinated with ZOSTAVAX. The patient experienced lips tingling, shortness of breath and an upset stomach after being injected with zoster vaccine live. Also on 9-APR-2015 the patient arm was sore at the injection site and he noticed a red area that was about two inches in diameter. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Neuralgia, Nuclear magnetic resonance imaging, Swelling, Tenderness
Clinical narrative: Nerve pain throughout neck, shoulder, shoulder blade down into fingers and breast on left side with swelling throughout area, painful to touch, unable to raise arm - (neuroforaminal stenosis).
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Neuralgia, Nuclear magnetic resonance imaging, Pain, Swelling
Clinical narrative: Nerve pain throughout neck, shoulder, shoulder blade down into fingers and breast on left side with swelling throughout area, painful to touch, unable to raise arm - (neuroforaminal stenosis).
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vertebral foraminal stenosis
Clinical narrative: Nerve pain throughout neck, shoulder, shoulder blade down into fingers and breast on left side with swelling throughout area, painful to touch, unable to raise arm - (neuroforaminal stenosis).
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Severe swelling at injection site and extending down arm to elbow.  Fever 102-103 for three days.  Headache, severe fatigue, muscle aches.  Given prednisone, clindamycin & lidex to counteract problems.
Age: 0.11
Sex: F
Vaccine: HEP
Symptoms: Death
Clinical narrative: No known adverse event.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Measles, Pyrexia, Rash
Clinical narrative: Patient received MMR vaccine 4/22/15. Developed fever x 3 days (101-104 degrees), Koplik spots and rash on body 7 days after vaccine.
Age: 1.51
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13, DTAPIPVHIB, FLUX, PNC13
Symptoms: Eye movement disorder, Foaming at mouth, Pyrexia, Seizure
Clinical narrative: Per Hx and reviewed from ER records. Pt had fever and per gma she was told she had seizure rolling up her eyes, foaming of the mouth 24 hrs after shots per ER records immunization was not mentioned.
Sex: U
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose, route, frequency, lot # unspecified). No concomitant medications were reported. The physician reported to the field representative that 2 hours after receiving the M-M-R II , the unspecified baby (age unspecified) patient experienced an episode of vomiting. The field representatie stated, the baby's mother said she won't be vaccinating her child with any more vaccines because her baby always has a reaction after receiving a vaccine. The field representative could not provide any further information regarding the unspecified baby patient reactions to other unspecified vaccines. The unspecified patient's mother called the physician. Action taken was not applicable (also reported as therapy stopped). The outcome of vomiting was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions were not reported. On 24-APR-2015, the patients were vaccinated with improperly stored doses of GARDASIL (120 Y, dose, frequency, route of administration, lot# and expiration date were not reported). Concomitant medications were not reported. No adverse effects were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected due to lack of contact details.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions were not reported. On 24-APR-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency, route of administration, lot# and expiration date were not reported). Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected due to lack of contact details.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions were not reported. On 24-APR-2015, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, frequency, route of administration, lot# and expiration date were not reported). Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected due to lack of contact details.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician (who is also the patient's mother) refers to a male patient of unknown age. No concurrent conditions or medical history were provided. The physician report that her son was administered the 3 doses in the GARDASIL series (strength, dose, route and site of administration, lot# and expiry date unspecified for all) on 26-JUN-2014, 10-OCT-2014, and 08-JAN-2015. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Myalgia, Swollen tongue
Clinical narrative: Information has been received from a physician referring to a 38 year old female patient with asthma, rhinitis, allergic to penicillin, cefdinir, azithromycin and clarithromycin. On 14-APR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, lot# K020215, expiration date 15-MAR-2016, due to "having low protective strept pneumo titers". Concomitant therapies included FLOVENT, azelastine hydrochloride, DYMISTA and ZYRTEC. On 16-APR-2015, the patient experienced "diffused" myalgia. On 17-APR-2015, the patient experienced shortness of breath. On 18-APR-2015 the patient experienced "possible" tongue swelling. No lab diagnostics studies were performed. The patient was seen by the physician on 20-APR-2015. The physician prescribed the patient a "5 day course" of prednisone and increased the patient's FLOVENT to an unspecified amount due to the shortness of breath. The outcome of the events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from pharmacy technician refers to 2 patients of unknown age and unknown gender. The 2 patients pertinent medical history was not reported. On an unknown date (reported as within the past few days), the 2 patients were vaccinated with improperly stored ZOSTAVAX. No symptoms reported. No product quality complaint (PQC) was reported for zoster vaccine live. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager regarding several unspecified patients of unknown age and demographics. The patients concurrent condition and medical history was not provided. On or after 12-FEB-2015 at unspecified times, the patients were vaccinated with improperly stored PEDVAX HIB lot# J016187; expiry date: 21-OCT-2016; lot: K002747; expiry date: 09-FEB-2016 (also reported as 09-DEC-2016) and H021853; expiry date: 11-OCT-2015. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager regarding several unspecified patients of unknown age and demographics. The patients concurrent condition and medial history was not provided. On or after 12-FEB-2015 at unspecified times, the patients were vaccinated with improperly stored ROTATEQ, lot # K001716; expiration date: 24-NOV-2015. No adverse effects reported. This is one of several report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager regarding several unspecified patients of unknown age and demographics. The patients concurrent condition and medical history was not provided. On or after 12-FEB-2015 at unspecified times, the patients were vaccinated with improperly stored COMVAX, lot/batch # J013884; expiry date: 19-AUG-2016. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager regarding several unspecified patients of unknown age and demographics. The patients concurrent condition and medical history was not provided. On or after 12-FEB-2015 at unspecified times, the patients were vaccinated with improperly stored PNEUMOVAX 23, lot # J011045; expiration date: 15-MAY-2015 (also reported as 15-MAY-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager regarding several unspecified patients of unknown age and demographics. The patients concurrent condition and medical history was not provided. On or after 12-FEB-2015 at unspecified times, the patients were vaccinated with 4 doses of M-M-R II, lot # J007930; expiry date: 28-JUN-2015 and J014873; expiry date: 21-NOV-2015 not supported by stability data were administered. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 53 year old female patient. The patient had no medical history or concurrent conditions. On 12-SEP-1990, the patient was vaccinated with one dose of M-M-R II albumin status HSA (human serum albumin) route default to subcutaneous (dose, lot# and expiration date were not provided). There was no concomitant medication. On 21-JAN-2015, the patient had performed studies for titers of measles - negative, mumps - negative, varicella - positive, rubella - positive. The patient has negative mumps and measles titers after receiving one dose of M-M-R II. The patient did not seek medical attention, and no specific treatment was given for reported events. Action taken with M-M-R II and the outcome of negative mumps and measles titers were not reported. The causality between M-M-R II and negative mumps and measles titers was not provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Swelling
Clinical narrative: PATIENT STATES SHE HAD PAIN AT TIME OF INJECTION THAT NEVER WENT AWAY AND NOTICED SWELLING AND MORE SEVERE PAIN AFTER WORK. NO OTHER S/S NOTED.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports that se awoke on 5/1 & area on left arm where she received varicella vaccine was red, swollen, & warm to touch with some itching.  Applied cool compresses & took anti-inflammatory OTC med & Benadryl.  Continued on Sat. 5/2/15, then improved.  No hives or difficulty breathing.  Discovered also that she had chickenpox disease in 1990.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from the patient's daughter via Pfizer (manufacturer control # 2015130287) concerning to her mother a currently 68 years old female patient with asthma and chronic obstructive pulmonary disease (COPD). Medical history and allergies were not reported. In April 2013, the patient was vaccinated with a dose of PNEUMOVAX 23, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported0. Other suspect and concomitant therapies were not reported. On an unspecified date in September 2013, 5 months after the vaccination with PNEUMOVAX 23, the patient experienced pneumonia. The reporter was wondering if the patient should receive PREVNAR 13 and what would be the time interval required between both vaccines. The outcome of pneumonia was unknown. The relatedness between pneumonia and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Headache, Injection site pain
Clinical narrative: This spontaneous report was received from a nurse via a company representative refers to a female patient of unknown age without pertinent medical history. Concurrent conditions and allergies were not reported. On 19-FEB-2015, the patient was vaccinated with the first dose of GARDASIL, dose and frequency reported as "per the prescribing information", intramuscularly, (strength and anatomical location were not reported) (reported as "as indicated"). On 21-APR-2015, the patient was vaccinated with the second dose of GARDASIL, dose and frequency reported as "per the prescribing information" intramuscularly, (strength and anatomical location were not reported), (lot # K005083, expiration date: 04-NOV-2016) (reported as "as indicated"). Other suspect and concomitant therapies were not reported. On 21-APR-2015, the patient experienced injection site pain, flushing of the skin and headache. The patient sought medical attention the same day while in the office and was given chewable ibuprofen for the headache. None lab diagnostics studies were performed. Additionally was reported that the patient's mother called the following day and reported that the patient still had not recovered. The outcome of flushing of the skin, headache and injection site pain was reported as not recovered/not resolved. The relatedness between flushing of the skin, headache and injection site pain and therapy with GARDASIL was not reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Aphasia, Clumsiness, Pyrexia, Social avoidant behaviour
Clinical narrative: Symptoms appeared within 24 hrs. tactile fever regressed -> decrease in speech, decrease in recognition, withdrawn, clumsy, lasted 4 weeks then slowly resolved.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Bacterial test positive, Blood testosterone decreased, Fatigue, Gastrointestinal bacterial infection, Gastrointestinal inflammation
Clinical narrative: Case number PHEH2015US007728, is an initial spontaneous report from a consumer (also patient) received on 20 Apr 2015. This report refers to a 42-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. Prior to vaccination the patient was healthy. The patient was vaccinated with FLUVIRIN (batch number: 1103001) intramuscularly in his shoulder in Oct 2011. The patient does not remember needle breaking skin and no band aid was needed after vaccination. In Oct 2011 after vaccination, the patient went to the emergency room with aching pain all over the body. The patient reported that after the vaccination he had weakened immune system. Further, the patient had experienced fatigue problems, memory problems, tinnitus, weight gain and gray hair. In Jun 2013, the patient was admitted to the hospital for 10 days due to rectal bleeding, swollen colon and inflamed small intestine. The patient's lab results revealed bacteria in intestine. The patient was treated with cefadroxil and minocycline. The patient was also treated for low testosterone. The final outcome of the events was unknown. Causality was not reported.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Hair colour changes, Immune system disorder, Local swelling, Memory impairment, Pain
Clinical narrative: Case number PHEH2015US007728, is an initial spontaneous report from a consumer (also patient) received on 20 Apr 2015. This report refers to a 42-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. Prior to vaccination the patient was healthy. The patient was vaccinated with FLUVIRIN (batch number: 1103001) intramuscularly in his shoulder in Oct 2011. The patient does not remember needle breaking skin and no band aid was needed after vaccination. In Oct 2011 after vaccination, the patient went to the emergency room with aching pain all over the body. The patient reported that after the vaccination he had weakened immune system. Further, the patient had experienced fatigue problems, memory problems, tinnitus, weight gain and gray hair. In Jun 2013, the patient was admitted to the hospital for 10 days due to rectal bleeding, swollen colon and inflamed small intestine. The patient's lab results revealed bacteria in intestine. The patient was treated with cefadroxil and minocycline. The patient was also treated for low testosterone. The final outcome of the events was unknown. Causality was not reported.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Rectal haemorrhage, Tinnitus, Weight increased
Clinical narrative: Case number PHEH2015US007728, is an initial spontaneous report from a consumer (also patient) received on 20 Apr 2015. This report refers to a 42-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. Prior to vaccination the patient was healthy. The patient was vaccinated with FLUVIRIN (batch number: 1103001) intramuscularly in his shoulder in Oct 2011. The patient does not remember needle breaking skin and no band aid was needed after vaccination. In Oct 2011 after vaccination, the patient went to the emergency room with aching pain all over the body. The patient reported that after the vaccination he had weakened immune system. Further, the patient had experienced fatigue problems, memory problems, tinnitus, weight gain and gray hair. In Jun 2013, the patient was admitted to the hospital for 10 days due to rectal bleeding, swollen colon and inflamed small intestine. The patient's lab results revealed bacteria in intestine. The patient was treated with cefadroxil and minocycline. The patient was also treated for low testosterone. The final outcome of the events was unknown. Causality was not reported.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Ear discomfort, Musculoskeletal discomfort, Musculoskeletal stiffness, Neck pain
Clinical narrative: Information has been received from a pharmacist concerning a 42 year old male patient. The patient had no pertinent medical history. The patient had no drug allergies and reaction. On 07-APR-2015 the patient was vaccinated with a dose of M-M-R II (0.5 ml, lot # reported as K007743, expiration date: 28-MAY-2015, subcutaneous). The patient had no concomitant therapies. It was reported that the patient developed pain, stiffness, and discomfort in his ear and neck (side unspecified) within 3 hours on 28-MAY-2015 after receiving the M-M-R II. Naproxen was given as treatment for the events. The patient had visited the pharmacy for medical attention. There was no lab diagnostics performed. The outcome of the events were reported as recovering. Lot # K007743 was not valid for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients that were vaccinated with RECOMBIVAX HB. The physician reported on unspecified dates an unspecified number of patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB. No adverse events were reported. No further information was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug dose omission, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a registered nurse who is also the patient refers to herself. Patient medical history and current condition was reported. On an unknown date the patient was vaccinated with ZOSTAVAX via subcutaneous route. Other co-suspects and concomitant medication was not reported. On an unknown date the syringe plunger blew out due to pressure issue after reconstitution, while withdrawing solution to receive ZOSTAVAX, causing her to miss the dose. No adverse effects reported. Product quality complaint has been filed. The outcome of the events was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Expanding redness/swelling at site of injection, about 6" in diameter, tx for cellulitis.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Dizziness, Dysstasia, Pallor, Presyncope
Clinical narrative: Dizziness, pale face and lips, unable to stand up by himself, almost fainted. Pt recovered after 20 minutes and did not need further assistance or medical care.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Erythema
Clinical narrative: 8 x 8" area of erythema no induration NSAID/BENADRYL.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: 11 cm x 9 cm reddened area Lt upper arm around site of injections.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Respiratory distress, Speech disorder, Urticaria
Clinical narrative: Hives, difficulty speaking, mild respiratory distress. Patient given O2, diphenhydramine, epinephrine and SOLU-MEDROL. Patient stabilized. Diphenhydramine-50mg IV, SOLU-MEDROL 125mg IV, Epinephrine 0.5mg IM.
Age: 26.0
Sex: M
Vaccine: YF
Symptoms: Influenza like illness, Rash
Clinical narrative: Rash extremities, trunk x 3 days flu-like symptom x 2 days both 8-10 days post vaccine.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity vasculitis, Injection site swelling, Myalgia, Pruritus, Rash
Clinical narrative: 4/25/15 Developed rash on legs and back areas itching. 4/25 and 4/26 myalgia 4/27/15 seen in office, rash on legs and back continue. Myalgia improved. Swell noted at injection site. Plan: CLARITIN/ZYRTEC 10 mg daily follow up as needed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm red, swollen and red to elbow, warm to touch hard area approx 2" diameter total area 13cm x 13 cm.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site pain, Skin lesion, Skin warm, Swelling
Clinical narrative: Pain and burning to (L) deltoid. Severe swelling and discoloration in surrounding 4 in of vaccination site. Swollen, red lesions and several welts at periphery. Warm to the touch. Naproxen 500 mg bid, ATARAX 25mg , rest, fluids.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria, Vaccination site discolouration, Vaccination site swelling
Clinical narrative: Pain and burning to (L) deltoid. Severe swelling and discoloration in surrounding 4 in of vaccination site. Swollen, red lesions and several welts at periphery. Warm to the touch. Naproxen 500 mg bid, ATARAX 25mg , rest, fluids.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site inflammation, Injection site rash
Clinical narrative: Inflammatory rash at injection site. Treatment: Neosporin/HCBID.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash macular, Vaccination site erythema
Clinical narrative: Macular patchy rash on the face only. No wheezing. Mild erythema at vaccine administration site on right thigh. Treated with BENADRYL po. Varicella given on (R) thigh.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, CSF test normal, Chills, Injection site pain, Injection site swelling
Clinical narrative: Swelling, and pain at injection site. Fever, chills, diffuse joint pain.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test normal, Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Swelling, and pain at injection site. Fever, chills, diffuse joint pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Local reaction, Rash macular
Clinical narrative: Large localized reaction on her right thigh where administered. One red blotch on forearm and one red splotch on each hand/fingers.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Local swelling
Clinical narrative: Large area local swelling to left thigh.
Age: 26.0
Sex: F
Vaccine: VARCEL, SMALL
Symptoms: Ear pain, Eye discharge, Eye irritation, Eye pain, Eye swelling
Clinical narrative: 26yo female pt arrived with left ear and left eye pain. Pt has swelling in her left eye. Pt complains that pain level is 8/10. Pt received smallpox vaccine 21APR2015 and complained of throbbing eye discomfort over the weekend. Pt complains of inability to sleep at night. Pt has sensitivity to light and discharge from left eye. Pt explained that discomfort escalated to pain 30APR2015, when she woke up her eye was red, burning, and had pain 5/10. Pt has no radiating pain. Pt complains of left ear pain beginning 30APR2015 4/10 and today 7/10. Pt taking Advil for pain. Pt complains of constant pain and has not been able to alleviate pain.
Age: 26.0
Sex: F
Vaccine: VARCEL, SMALL
Symptoms: Insomnia, Laboratory test, Ocular hyperaemia, Photophobia
Clinical narrative: 26yo female pt arrived with left ear and left eye pain. Pt has swelling in her left eye. Pt complains that pain level is 8/10. Pt received smallpox vaccine 21APR2015 and complained of throbbing eye discomfort over the weekend. Pt complains of inability to sleep at night. Pt has sensitivity to light and discharge from left eye. Pt explained that discomfort escalated to pain 30APR2015, when she woke up her eye was red, burning, and had pain 5/10. Pt has no radiating pain. Pt complains of left ear pain beginning 30APR2015 4/10 and today 7/10. Pt taking Advil for pain. Pt complains of constant pain and has not been able to alleviate pain.
Age: 26.0
Sex: F
Vaccine: VARCEL, SMALL
Symptoms: Conjunctival hyperaemia, Conjunctivitis, Ear pain, Eye discharge, Eyelid margin crusting
Clinical narrative: 26yo female pt arrived with left ear and left eye pain. Pt has swelling in her left eye. Pt complains that pain level is 8/10. Pt received smallpox vaccine 21APR2015 and complained of throbbing eye discomfort over the weekend. Pt complains of inability to sleep at night. Pt has sensitivity to light and discharge from left eye. Pt explained that discomfort escalated to pain 30APR2015, when she woke up her eye was red, burning, and had pain 5/10. Pt has no radiating pain. Pt complains of left ear pain beginning 30APR2015 4/10 and today 7/10. Pt taking Advil for pain. Pt complains of constant pain and has not been able to alleviate pain.
Age: 26.0
Sex: F
Vaccine: VARCEL, SMALL
Symptoms: Eyelid oedema, Headache, Lymphadenopathy, Ocular discomfort, Orthopoxvirus test positive
Clinical narrative: 26yo female pt arrived with left ear and left eye pain. Pt has swelling in her left eye. Pt complains that pain level is 8/10. Pt received smallpox vaccine 21APR2015 and complained of throbbing eye discomfort over the weekend. Pt complains of inability to sleep at night. Pt has sensitivity to light and discharge from left eye. Pt explained that discomfort escalated to pain 30APR2015, when she woke up her eye was red, burning, and had pain 5/10. Pt has no radiating pain. Pt complains of left ear pain beginning 30APR2015 4/10 and today 7/10. Pt taking Advil for pain. Pt complains of constant pain and has not been able to alleviate pain.
Age: 26.0
Sex: F
Vaccine: VARCEL, SMALL
Symptoms: Otitis media, Polymerase chain reaction positive, Rash vesicular, Vaccinia virus infection, Vision blurred
Clinical narrative: 26yo female pt arrived with left ear and left eye pain. Pt has swelling in her left eye. Pt complains that pain level is 8/10. Pt received smallpox vaccine 21APR2015 and complained of throbbing eye discomfort over the weekend. Pt complains of inability to sleep at night. Pt has sensitivity to light and discharge from left eye. Pt explained that discomfort escalated to pain 30APR2015, when she woke up her eye was red, burning, and had pain 5/10. Pt has no radiating pain. Pt complains of left ear pain beginning 30APR2015 4/10 and today 7/10. Pt taking Advil for pain. Pt complains of constant pain and has not been able to alleviate pain.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt received Prevnar 13 in the office on 4/29. Pt came to clinic today with left upper arm red, swollen and warm to the touch just below injection site. Lot #J31687.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient report that her arm is swollen and red.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reporte that the arm she received the vaccine in was swollen, sore, red and warm to touch.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient report that the arm she received the vaccine was red, swollen, warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper leg swelling, redness, warm and tender to the touch per Mother. Redness in approx 1.5 inches across per Mother. Child was never evaluated by nurse or physician in our office. Was seen at an Urgent Care facility.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Secretion discharge, Sinusitis
Clinical narrative: Sinus infection that lasted 3 weeks; extreme fatigue, heavy yellow mucous discharge.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Disturbance in attention, Dizziness, Injected limb mobility decreased, Injection site swelling
Clinical narrative: 5/2/15 @ 10:00 PM Severe pain in deep muscle of right arm. Swelling noted at injection site. Could not lift hand due to pain in upper arm at vaccine administation site.  Onset of high fever 102.0 F.  Inablility to concentrate, body weakness and fever continued into 5/3/15.  Unable to sleep through the night.  5/4/15 fever 100.oF.  Less pain in arm.  5/5/15 Fever on and off, body weakness and "woozy" feeling.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Insomnia, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: 5/2/15 @ 10:00 PM Severe pain in deep muscle of right arm. Swelling noted at injection site. Could not lift hand due to pain in upper arm at vaccine administation site.  Onset of high fever 102.0 F.  Inablility to concentrate, body weakness and fever continued into 5/3/15.  Unable to sleep through the night.  5/4/15 fever 100.oF.  Less pain in arm.  5/5/15 Fever on and off, body weakness and "woozy" feeling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reports that 24 hours after vaccine she broke out in a rash that required no treatment and went away after 2 days.
Age: 46.0
Sex: F
Vaccine: PNC, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Warmth and redness.
Age: 46.0
Sex: F
Vaccine: PNC, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warmth and redness.
Age: 52.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Rotator cuff syndrome
Clinical narrative: Flu shot given in upper left arm.  After the shot left arm has been very sore and now has an impingement that has caused limited range of motion and severe stabbing pains.  Went to my doctor who diagnosed the impingement and referred to Physical Therapy.  Have been going to Physical Therapy for 13 weeks and my arm has not gotten better.
Age: 52.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Pain in extremity, Rotator cuff syndrome
Clinical narrative: Flu shot given in upper left arm.  After the shot left arm has been very sore and now has an impingement that has caused limited range of motion and severe stabbing pains.  Went to my doctor who diagnosed the impingement and referred to Physical Therapy.  Have been going to Physical Therapy for 13 weeks and my arm has not gotten better.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Pain of skin, Rash erythematous, Rash papular
Clinical narrative: I have very tender sensitive skin around the left side of my midsection [front to back].  It feels like a sunburn.  There is no redness, but a few days ago I had 3-4 small red bumps, like bug bites.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chest X-ray normal, Echocardiogram normal, Electroencephalogram normal, Hypotonic-hyporesponsive episode, Laboratory test normal
Clinical narrative: Suspected hypotonic hyporesponsive event; infant hospitalized same day as vaccination.
Age: 1.27
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Irritability, Rash erythematous
Clinical narrative: Red rash-trunk, back, legs, arm spreading, no fever increased irritable.