chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2016). No adverse effects were reported. Follow up information has been received on 14-MAY-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccinations for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 25-APR-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to a three patients of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were inadvertently vaccinated with ZOSTAVAX intramuscular, (dosage, lot # and expiration date were not reported). Concomitant therapy was not reported. There was not adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2016). No adverse effects were reported. Follow up information has been received on 14-MAY-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccination for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 07-APR-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route and lot # not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route and lot # not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to "2 or 3" unspecified patients. Information regarding concurrent conditions and medical history was not provided. The "2 or 3" unspecified patients were vaccinated with doses of improperly stored VARIVAX (Merck) on unspecified dates since 14-APR-2015 (dose, dose #, lot #, route and application site were not reported). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65 ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2015). No adverse effects were reported. Follow up information has been received on 14-MAY-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccination for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 21-APR-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Achlorhydria, Addison's disease, Adrenal disorder, Alopecia, Aphasia
Clinical narrative: Sore arm, flu like symptons, sick to stomach.  Within 6 to 48 hour period body rash, high fever, enlarged to grapefruit at site of injection, chest pain, difficulty breathing, severe piercing migraine center of brain, unable to speak, blacked out 2x, body rash, scalp swollen, kidney/adrenal pain, hair loss, body muscle pain.  Kidney pain increased and within 7 days adrenals slowed down and developed parietal cell damage.  Later developing Addison's Disease.  Patient warned doctor of sensitivity to casein/milk minutes prior to vaccine and vaccine contained casamino acid or milk.  Also, continues to have large hives on body and scalp 7 years post vaccine.  Not recovered and currently in VACCINE COURT with trial in July 2015.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Dyspnoea, Influenza like illness, Injection site swelling, Laboratory test abnormal
Clinical narrative: Sore arm, flu like symptons, sick to stomach.  Within 6 to 48 hour period body rash, high fever, enlarged to grapefruit at site of injection, chest pain, difficulty breathing, severe piercing migraine center of brain, unable to speak, blacked out 2x, body rash, scalp swollen, kidney/adrenal pain, hair loss, body muscle pain.  Kidney pain increased and within 7 days adrenals slowed down and developed parietal cell damage.  Later developing Addison's Disease.  Patient warned doctor of sensitivity to casein/milk minutes prior to vaccine and vaccine contained casamino acid or milk.  Also, continues to have large hives on body and scalp 7 years post vaccine.  Not recovered and currently in VACCINE COURT with trial in July 2015.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Limb discomfort, Loss of consciousness, Migraine, Myalgia, Nausea
Clinical narrative: Sore arm, flu like symptons, sick to stomach.  Within 6 to 48 hour period body rash, high fever, enlarged to grapefruit at site of injection, chest pain, difficulty breathing, severe piercing migraine center of brain, unable to speak, blacked out 2x, body rash, scalp swollen, kidney/adrenal pain, hair loss, body muscle pain.  Kidney pain increased and within 7 days adrenals slowed down and developed parietal cell damage.  Later developing Addison's Disease.  Patient warned doctor of sensitivity to casein/milk minutes prior to vaccine and vaccine contained casamino acid or milk.  Also, continues to have large hives on body and scalp 7 years post vaccine.  Not recovered and currently in VACCINE COURT with trial in July 2015.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia, Rash, Rash generalised, Renal pain
Clinical narrative: Sore arm, flu like symptons, sick to stomach.  Within 6 to 48 hour period body rash, high fever, enlarged to grapefruit at site of injection, chest pain, difficulty breathing, severe piercing migraine center of brain, unable to speak, blacked out 2x, body rash, scalp swollen, kidney/adrenal pain, hair loss, body muscle pain.  Kidney pain increased and within 7 days adrenals slowed down and developed parietal cell damage.  Later developing Addison's Disease.  Patient warned doctor of sensitivity to casein/milk minutes prior to vaccine and vaccine contained casamino acid or milk.  Also, continues to have large hives on body and scalp 7 years post vaccine.  Not recovered and currently in VACCINE COURT with trial in July 2015.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling, Urticaria, Vaccination complication
Clinical narrative: Sore arm, flu like symptons, sick to stomach.  Within 6 to 48 hour period body rash, high fever, enlarged to grapefruit at site of injection, chest pain, difficulty breathing, severe piercing migraine center of brain, unable to speak, blacked out 2x, body rash, scalp swollen, kidney/adrenal pain, hair loss, body muscle pain.  Kidney pain increased and within 7 days adrenals slowed down and developed parietal cell damage.  Later developing Addison's Disease.  Patient warned doctor of sensitivity to casein/milk minutes prior to vaccine and vaccine contained casamino acid or milk.  Also, continues to have large hives on body and scalp 7 years post vaccine.  Not recovered and currently in VACCINE COURT with trial in July 2015.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a currently 72 year old female who was a nurse refers to herself. On an unknown date the patient was vaccinated with the 3 dose series of RECOMBIVAX HB (lot#, strength, frequency and route were not reported). The patient reported that she was serologically tested for Hepatitis B antibodies some time after the vaccination series and was determined to be seronegative for Hepatitis B antibodies. The patient sent information to nurse. The outcome of the patient's event was not reported. The relatedness between vaccination with RECOMBIVAX HB and the patient's event was not reported. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Body temperature decreased, Cyanosis, Dyspnoea, Intensive care
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns an 85 year old male patient. The patient had medical history of morphine intolerance. On 22-OCt-2014, the patient received AFLURIA injection (batch number: T50707) in the right arm (route SYR, Dose 1). On 26-Oct-2014, four days after vaccination, the patient was transferred from the living centre to the emergency department and then to ICU (intensive care unit) as the patient experienced lethargy, his nail bed and lips were blue, respiration was labored, blood sugar was 321, blood pressure was 98/58, pulse was 82, temperature was 96.8 and respiration was 22. The next day, he was transferred to general medicine floor and then two days later, back to living centre. The living centre physician reported that the flu shot had caused the patient to be admitted to the hospital the last three years d/t hypotension etc, nausea, vomiting and hypotension. (Sodium hydrochloride). The outcome was reported as recovered. Reporter's comments: The authority assessed the case as serious as it led to hospitalisation of the patient, and reported the symptom 'Intensive care'.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lethargy
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns an 85 year old male patient. The patient had medical history of morphine intolerance. On 22-OCt-2014, the patient received AFLURIA injection (batch number: T50707) in the right arm (route SYR, Dose 1). On 26-Oct-2014, four days after vaccination, the patient was transferred from the living centre to the emergency department and then to ICU (intensive care unit) as the patient experienced lethargy, his nail bed and lips were blue, respiration was labored, blood sugar was 321, blood pressure was 98/58, pulse was 82, temperature was 96.8 and respiration was 22. The next day, he was transferred to general medicine floor and then two days later, back to living centre. The living centre physician reported that the flu shot had caused the patient to be admitted to the hospital the last three years d/t hypotension etc, nausea, vomiting and hypotension. (Sodium hydrochloride). The outcome was reported as recovered. Reporter's comments: The authority assessed the case as serious as it led to hospitalisation of the patient, and reported the symptom 'Intensive care'.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Cyanosis, Dyspnoea, Intensive care, Lethargy
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns an 85 year old male patient. The patient had medical history of morphine intolerance. On 22-OCt-2014, the patient received AFLURIA injection (batch number: T50707) in the right arm (route SYR, Dose 1). On 26-Oct-2014, four days after vaccination, the patient was transferred from the living centre to the emergency department and then to ICU (intensive care unit) as the patient experienced lethargy, his nail bed and lips were blue, respiration was labored, blood sugar was 321, blood pressure was 98/58, pulse was 82, temperature was 96.8 and respiration was 22. The next day, he was transferred to general medicine floor and then two days later, back to living centre. The living centre physician reported that the flu shot had caused the patient to be admitted to the hospital the last three years d/t hypotension etc, nausea, vomiting and hypotension. (Sodium hydrochloride). The outcome was reported as recovered. Reporter's comments: The authority assessed the case as serious as it led to hospitalisation of the patient, and reported the symptom 'Intensive care'.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nail discolouration
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns an 85 year old male patient. The patient had medical history of morphine intolerance. On 22-OCt-2014, the patient received AFLURIA injection (batch number: T50707) in the right arm (route SYR, Dose 1). On 26-Oct-2014, four days after vaccination, the patient was transferred from the living centre to the emergency department and then to ICU (intensive care unit) as the patient experienced lethargy, his nail bed and lips were blue, respiration was labored, blood sugar was 321, blood pressure was 98/58, pulse was 82, temperature was 96.8 and respiration was 22. The next day, he was transferred to general medicine floor and then two days later, back to living centre. The living centre physician reported that the flu shot had caused the patient to be admitted to the hospital the last three years d/t hypotension etc, nausea, vomiting and hypotension. (Sodium hydrochloride). The outcome was reported as recovered. Reporter's comments: The authority assessed the case as serious as it led to hospitalisation of the patient, and reported the symptom 'Intensive care'.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 67 year old female patient. The patient had history of 'sulfa drugs '. She had no current illness. Her concomitant medications included acetaminophen/hydrocodone, colesevelam hydrochloride, lisinopril, amlodipine, CENTRUM SILVER, calcium and vitamin D, fish oil, oxybutynin and omeprazole. On 23-OCT-2014, the patient received intramuscular AFLURIA injection (batch number T57505) in the left arm (given in top left shoulder-pointing down). On 24-Oct-2014, the day right after flu shot, the patient had sharp pain in the shoulder. She could not raise the left arm to change her clothes by herself nor could she sleep except sitting up. She underwent an MRI which showed tear in the rotator cuff. The patient was sent to orthopaedic surgeon and then to physical therapist after the pain medicine could not stop the pain. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious, reported that the patient presented at the 'Emergency Room, and reported the symptom 'Injection site pain'.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Insomnia, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 67 year old female patient. The patient had history of 'sulfa drugs '. She had no current illness. Her concomitant medications included acetaminophen/hydrocodone, colesevelam hydrochloride, lisinopril, amlodipine, CENTRUM SILVER, calcium and vitamin D, fish oil, oxybutynin and omeprazole. On 23-OCT-2014, the patient received intramuscular AFLURIA injection (batch number T57505) in the left arm (given in top left shoulder-pointing down). On 24-Oct-2014, the day right after flu shot, the patient had sharp pain in the shoulder. She could not raise the left arm to change her clothes by herself nor could she sleep except sitting up. She underwent an MRI which showed tear in the rotator cuff. The patient was sent to orthopaedic surgeon and then to physical therapist after the pain medicine could not stop the pain. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious, reported that the patient presented at the 'Emergency Room, and reported the symptom 'Injection site pain'.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Lymphadenopathy, Neck pain, Tongue disorder
Clinical narrative: Information has been received from the patient's mother referring to her 18 year old daughter with allergy to yeast who on 17-MAR-2015, was vaccinated with a dose of GARDASIL or GARDASIL 9 (dose, lot number, expiration date and route of administration were not reported) (reported as "does not know if the daughter received GARDASIL or GARDASIL 9"). Concomitant medication included an "unspecified birth control" medication. On 18-MAR-2015, the patient experienced swollen glands, swollen lymph nodes and neck pain. On 24-MAR-2015, most recently, the patient developed red bumps on the back of her tongue. The patient was a student away at college and went to seek medical attention from school nurse practitioner. On an unknown date, unspecified blood work was performed (no result provided). At the time of the report, the patient had not recovered from neck pain, lymphadenopathy and tongue disorder. It was reported that the patient was not hospitalized. The relatedness between the adverse events and GARDASIL or GARDASIL 9 was not reported. Follow up information has been received from a health professional on 22-MAY-2015 concerning the patient who was a student. The patient had been allergic to egg yolk, dairy and bananas. It was unknown if there were adverse events following prior vaccination. On 17-MAR-2015 at 10:15 AM, the patient was vaccinated with the first dose of GARDASIL, lot # K003520, expiration date 20-NOV-2016, intramuscularly (IM) at the right deltoid. On 19-MAR-2015, the patient experienced neck swelling and neck pain (onset date previously reported as 18-MAR-2015). BENADRYL was given for the events. Relevant diagnostic tests and laboratory data were not performed or ordered here and lab work was done outside of office. The patient required emergency room and doctor visit, but there was no information concerning where the patient received medical care. The outcome of neck pain and neck swelling was unknown. The reporter considered neck swelling and neck pain to be serious due to the event required medical/surgical intervention to prevention of the outcome listed. The therapy of GARDASIL 9 was deleted from the case. Additional information is not expected as all follow-ups requested to complete the case were received. Reporter, patient, product, event and narrative were updated.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Local swelling, Lymphadenopathy, Neck pain, Tongue discolouration
Clinical narrative: Information has been received from the patient's mother referring to her 18 year old daughter with allergy to yeast who on 17-MAR-2015, was vaccinated with a dose of GARDASIL or GARDASIL 9 (dose, lot number, expiration date and route of administration were not reported) (reported as "does not know if the daughter received GARDASIL or GARDASIL 9"). Concomitant medication included an "unspecified birth control" medication. On 18-MAR-2015, the patient experienced swollen glands, swollen lymph nodes and neck pain. On 24-MAR-2015, most recently, the patient developed red bumps on the back of her tongue. The patient was a student away at college and went to seek medical attention from school nurse practitioner. On an unknown date, unspecified blood work was performed (no result provided). At the time of the report, the patient had not recovered from neck pain, lymphadenopathy and tongue disorder. It was reported that the patient was not hospitalized. The relatedness between the adverse events and GARDASIL or GARDASIL 9 was not reported. Follow up information has been received from a health professional on 22-MAY-2015 concerning the patient who was a student. The patient had been allergic to egg yolk, dairy and bananas. It was unknown if there were adverse events following prior vaccination. On 17-MAR-2015 at 10:15 AM, the patient was vaccinated with the first dose of GARDASIL, lot # K003520, expiration date 20-NOV-2016, intramuscularly (IM) at the right deltoid. On 19-MAR-2015, the patient experienced neck swelling and neck pain (onset date previously reported as 18-MAR-2015). BENADRYL was given for the events. Relevant diagnostic tests and laboratory data were not performed or ordered here and lab work was done outside of office. The patient required emergency room and doctor visit, but there was no information concerning where the patient received medical care. The outcome of neck pain and neck swelling was unknown. The reporter considered neck swelling and neck pain to be serious due to the event required medical/surgical intervention to prevention of the outcome listed. The therapy of GARDASIL 9 was deleted from the case. Additional information is not expected as all follow-ups requested to complete the case were received. Reporter, patient, product, event and narrative were updated.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tongue disorder
Clinical narrative: Information has been received from the patient's mother referring to her 18 year old daughter with allergy to yeast who on 17-MAR-2015, was vaccinated with a dose of GARDASIL or GARDASIL 9 (dose, lot number, expiration date and route of administration were not reported) (reported as "does not know if the daughter received GARDASIL or GARDASIL 9"). Concomitant medication included an "unspecified birth control" medication. On 18-MAR-2015, the patient experienced swollen glands, swollen lymph nodes and neck pain. On 24-MAR-2015, most recently, the patient developed red bumps on the back of her tongue. The patient was a student away at college and went to seek medical attention from school nurse practitioner. On an unknown date, unspecified blood work was performed (no result provided). At the time of the report, the patient had not recovered from neck pain, lymphadenopathy and tongue disorder. It was reported that the patient was not hospitalized. The relatedness between the adverse events and GARDASIL or GARDASIL 9 was not reported. Follow up information has been received from a health professional on 22-MAY-2015 concerning the patient who was a student. The patient had been allergic to egg yolk, dairy and bananas. It was unknown if there were adverse events following prior vaccination. On 17-MAR-2015 at 10:15 AM, the patient was vaccinated with the first dose of GARDASIL, lot # K003520, expiration date 20-NOV-2016, intramuscularly (IM) at the right deltoid. On 19-MAR-2015, the patient experienced neck swelling and neck pain (onset date previously reported as 18-MAR-2015). BENADRYL was given for the events. Relevant diagnostic tests and laboratory data were not performed or ordered here and lab work was done outside of office. The patient required emergency room and doctor visit, but there was no information concerning where the patient received medical care. The outcome of neck pain and neck swelling was unknown. The reporter considered neck swelling and neck pain to be serious due to the event required medical/surgical intervention to prevention of the outcome listed. The therapy of GARDASIL 9 was deleted from the case. Additional information is not expected as all follow-ups requested to complete the case were received. Reporter, patient, product, event and narrative were updated.
Age: 25.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain, X-ray
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 25 year-old female patient who had no known current illness, no concomitant medications, and no medical history. On 07-Oct-2014, the patient received AFLURIA injection (batch number T58706) via the intramuscular route in the left arm. On an unspecified date, immediately after the immunization, the patient had a loss of motion in arm and experienced pain. The patient visited the physician once in Nov-2014 and Dec-2014. Due to the pain and lack of motion, the patient received physical therapy two to three times a week. The patient also had an x-ray. The outcome was reported as unknown. Reporter's comments: The regulatory authority assessed the case as non-serious, reported the symptom of 'X-ray', and reported the patient presented at the Emergency Room.
Age: 25.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity, X-ray
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 25 year-old female patient who had no known current illness, no concomitant medications, and no medical history. On 07-Oct-2014, the patient received AFLURIA injection (batch number T58706) via the intramuscular route in the left arm. On an unspecified date, immediately after the immunization, the patient had a loss of motion in arm and experienced pain. The patient visited the physician once in Nov-2014 and Dec-2014. Due to the pain and lack of motion, the patient received physical therapy two to three times a week. The patient also had an x-ray. The outcome was reported as unknown. Reporter's comments: The regulatory authority assessed the case as non-serious, reported the symptom of 'X-ray', and reported the patient presented at the Emergency Room.
Age: 44.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This spontaneous report was received from a subject, via a company representative, and concerns a 44 year old female: local case ID 2015-12. Additional reporters include: 1 Physician. The subject's height was 67 inches and weight was 128 pounds. The subject's medical history and concurrent conditions included: eczema, immunodeficiency, peanut allergy, penicillin allergy, and sulfa drugs (Bactrim) allergy. The subject had a drug history of typhoid vaccine for which the subject had unspecified problems following the last injection. On unspecified dates, the subject received 4 doses of typhoid vaccine oral ty21a (capsule, hard, oral, batch 3000948) administered every other day for prophylactic vaccination. On 27-APR-2015, the subject received the first dose, the second dose on 29-APR-2015, the third dose on 01-MAY-2015 and the fourth dose on 03-MAY-2015. Concomitant medications included prednisone for eczema. The subject had completed a 3 day course of systemic steroid treatment for eczema on 13-APR-2015. Around 2 weeks later, on 04-MAY-2015, a day after receiving the last dose of typhoid vaccine oral ty21a, the subject experienced fever, grade 3 fatigue, headache, abdominal pain and muscle aches. The subject was treated with Tylenol (acetaminophen) and the events resolved spontaneously and abruptly. Action taken with typhoid vaccine oral ty21a was not applicable. The subject had recovered from fever, grade 3 fatigue, headache, abdominal pain and muscle ache on 07-MAY-2015. This report was serious (medically significant).
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Hives all over body. Redness. Swelling. Hospital gave steroids and Benadryl.
Age: 1.26
Sex: F
Vaccine: DTAP, HEP, HEPA, HIBV, HPVX, IPV, MMR, VARCEL
Symptoms: Lip swelling, Pharyngeal oedema, Swollen tongue, Urticaria
Clinical narrative: Lips swollen, tongue and airway swollen. Hives. Hospital prescribed steroids and Benadryl.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Seizure
Clinical narrative: This spontaneous report was received from a certified registered nurse practitioner via a company representative regarding a 26 year old female patient. No concurrent condition or medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL 1 vial, intramuscularly. On an unknown date, the patient was at unspecified OBGYN's office and after the patient received her second dose of GARDASIL, she had a seizure (for unspecified time). The patient did not get the third dose of GARDASIL. On an unknown date, the patient recovered from the event (reported as after stopping the therapy). Reporter causality was not provided. No product quality complaint was reported. No further information was given. Upon internal review the event of seizure was considered to be medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient complains of significant burning at injection site during injection.  Similar reports received recently from other patients receiving Prevnar 13 vaccine.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Young lady reported to the Pharmacist with in 10 min of receiving the vaccine. She felt fatigue, headache, nausea and muscle pain in her legs.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Blood test normal, Inflammation, Ultrasound scan normal
Clinical narrative: Patient with flight abroad.  Acute Abdominal pain.  Treated-inflammation-all blood tests and US normal. Released-abdominal pain improved.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Fall
Clinical narrative: Intermittent falling since vaccines given no swelling, redness or tenderness or fever. Sx had improved before appt on 5-17-15.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Insomnia, Pain, X-ray abnormal
Clinical narrative: I received a shingles vaccine in my left shoulder in January. For two weeks, I couldn't even sleep on my left side; it hurt so much. It seemed to get better, but now is worse and I would like to restrict my motion, but don't want to lose ability. Doc recommended x-rays, which showed arthritis, which doctor brother says it only means that I had arthritis before the shot. Wasn't aware of it there before. Now I have an appt. with the orthopedic specialist in two weeks.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Asthenia, Cough, Decreased appetite, Dyspnoea
Clinical narrative: On April 9, 2015, dad saw Dr, a pulmonary specialist for a routine visit. He said dad was doing fine and suggested he get the new pneumonia shot, PREVNAR 13. He received that vaccine the same day at the pharmacy. He started coughing that evening. By Friday, April 10th, he was unusually weak and tired, irritable, had loss of appetite and still had a terrible cough. By Saturday, April 11th, he continued to have the above mentioned symptoms which had worsen and hadn't ate anything that whole day, plus he was now experiencing wheezing, had a fever and had developed shortness of breath. He was so weak that he could hardly walk or get undressed for bed. We took him to the ER that evening and he was admitted to the hospital at once. We were told he had developed pneumonia. He was in the hospital and rehab for almost three weeks. He's now home, but is still receiving therapy to get his strength back.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Gait disturbance, Irritability, Laboratory test, Pneumonia
Clinical narrative: On April 9, 2015, dad saw Dr, a pulmonary specialist for a routine visit. He said dad was doing fine and suggested he get the new pneumonia shot, PREVNAR 13. He received that vaccine the same day at the pharmacy. He started coughing that evening. By Friday, April 10th, he was unusually weak and tired, irritable, had loss of appetite and still had a terrible cough. By Saturday, April 11th, he continued to have the above mentioned symptoms which had worsen and hadn't ate anything that whole day, plus he was now experiencing wheezing, had a fever and had developed shortness of breath. He was so weak that he could hardly walk or get undressed for bed. We took him to the ER that evening and he was admitted to the hospital at once. We were told he had developed pneumonia. He was in the hospital and rehab for almost three weeks. He's now home, but is still receiving therapy to get his strength back.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Wheezing
Clinical narrative: On April 9, 2015, dad saw Dr, a pulmonary specialist for a routine visit. He said dad was doing fine and suggested he get the new pneumonia shot, PREVNAR 13. He received that vaccine the same day at the pharmacy. He started coughing that evening. By Friday, April 10th, he was unusually weak and tired, irritable, had loss of appetite and still had a terrible cough. By Saturday, April 11th, he continued to have the above mentioned symptoms which had worsen and hadn't ate anything that whole day, plus he was now experiencing wheezing, had a fever and had developed shortness of breath. He was so weak that he could hardly walk or get undressed for bed. We took him to the ER that evening and he was admitted to the hospital at once. We were told he had developed pneumonia. He was in the hospital and rehab for almost three weeks. He's now home, but is still receiving therapy to get his strength back.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Asthenia, CSF glucose normal, CSF protein normal, CSF white blood cell count increased, Dehydration
Clinical narrative: Child seen in office on 5/11/15 with c/o fever and lethargy x1 week. Attempted TYLENOL/MOTRIN for fever. Went to ER on 5/8/15. Received IVF for dehydration. In office found patient to be hypotonic, (+) weakness noted, (+) tongue protrusion repeatedly. Patient sent to hosp for admit. Nerve conduction study done-abnormal. Treated for Guillain Barre syndrome over 5 days with IVIG.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Guillain-Barre syndrome, Hypotonia, Immunoglobulin therapy, Lethargy, Mastoid effusion
Clinical narrative: Child seen in office on 5/11/15 with c/o fever and lethargy x1 week. Attempted TYLENOL/MOTRIN for fever. Went to ER on 5/8/15. Received IVF for dehydration. In office found patient to be hypotonic, (+) weakness noted, (+) tongue protrusion repeatedly. Patient sent to hosp for admit. Nerve conduction study done-abnormal. Treated for Guillain Barre syndrome over 5 days with IVIG.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Parainfluenzae virus infection, Protrusion tongue
Clinical narrative: Child seen in office on 5/11/15 with c/o fever and lethargy x1 week. Attempted TYLENOL/MOTRIN for fever. Went to ER on 5/8/15. Received IVF for dehydration. In office found patient to be hypotonic, (+) weakness noted, (+) tongue protrusion repeatedly. Patient sent to hosp for admit. Nerve conduction study done-abnormal. Treated for Guillain Barre syndrome over 5 days with IVIG.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Respirovirus test positive, Viral test positive
Clinical narrative: Child seen in office on 5/11/15 with c/o fever and lethargy x1 week. Attempted TYLENOL/MOTRIN for fever. Went to ER on 5/8/15. Received IVF for dehydration. In office found patient to be hypotonic, (+) weakness noted, (+) tongue protrusion repeatedly. Patient sent to hosp for admit. Nerve conduction study done-abnormal. Treated for Guillain Barre syndrome over 5 days with IVIG.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash
Clinical narrative: Elevated bumps around injection site approx 3" x 3". Cellulitis approximately 10 cm L x 5 cm W. Redness immediately surrounding injection site remainder within 48 hours. 5 pm to hosp. Prescription for KEFLEX.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Musculoskeletal pain, Nausea, Neck pain
Clinical narrative: (L) arm, neck and shoulder pain, nausea, chills, fatigue. 5/22/15-Advised to go to ER if worsened did not comply. 5/22/15-Seen in office Ibuprofen 800 mg. 5/26/15 Seen in office. Cephalexin 500 mg, methylprednisolone 4 mg. Still complains of arm pain 5/26/15.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: (L) arm, neck and shoulder pain, nausea, chills, fatigue. 5/22/15-Advised to go to ER if worsened did not comply. 5/22/15-Seen in office Ibuprofen 800 mg. 5/26/15 Seen in office. Cephalexin 500 mg, methylprednisolone 4 mg. Still complains of arm pain 5/26/15.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient reported significant pain during administration of Prevnar 13 vaccine.  Similar complaints from other patients have been received recently at this clinic.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Atrial fibrillation, Electrocardiogram abnormal
Clinical narrative: I am set to have pacemaker installed 5-28-15.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever > 102.6.
Age: 1.05
Sex: U
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site reaction, Urticaria
Clinical narrative: Urticarial rash immediately after vaccines administered localized to injection sites on both thighs.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site nodule, Nodule, Pain, Pruritus generalised
Clinical narrative: Itching all over, knots on shoulders, painful; sx began 1 day after injection and have lasted 6 days.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Dizziness, Pain in extremity, Sinus congestion
Clinical narrative: Tdap vaccine given on 5/12/15, sore arm evening 5/12/15. 5/13/15 AM-dizziness, joint pain, continued arm soreness. 5/15/15-diarrhea, sinus congestion. Seen in office on 5/19/15-still having sinus congestion. Going to his personal MD. Arm with decreased soreness.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Four days after injection, patient noticed redness - about 3 to 4 inches around injection site, was itchy and she thought her temp was elevated (8=98.9). I recommended Benadryl. She saw doctor next day - no temp. Dr told her take Benadryl and watch for any signs of infection - outlined circumference of red area.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dry mouth, Urticaria
Clinical narrative: After vaccination employee left and returned to her department. There is no prior history of vaccine sensitivity. She began to feel dizzy then developed a dry mouth and hives on her neck and chest. She was seen in the ED where she received 0.3 mg epinephrine IM and 10 mg ZYRTEC by mouth. She improved after the meds and returned to her department in stable condition.
Age: 0.12
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Erythema, Irritability, Swelling
Clinical narrative: Facial redness/swelling/fussy. Pt went to ED; given TYLENOL and discharged.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt received PREVNAR on 5/11/15 on (L) arm. On 5/12 patient experienced swelling and redness down to elbow and back of arm. Area was warm to touch. On 5/18 seen Dr. Was prescribed antibiotic and Naproxen.
Age: 0.96
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash 2-3 days after 2nd flu shot.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash macular, Rash maculo-papular
Clinical narrative: Blotchy red rash starting shortly after vaccine given and worsened over next 2-3 days. Maculopapular rash on face, neck and trunk.  Less on the extremities. Benadryl.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Red, warm, swollen L deltoid, area painful 11 cm x 7 cm low grade temp 99.1 F. Treated with Bactrim DS twice daily x 10 days.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: May 12, 2015 4 y/o received PROQUAD 5/12/2015. Returned 5/15/2015 swollen, redden at vaccine site.
Age: 93.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Hypersomnia, Pruritus, Rash
Clinical narrative: Patient presented to pharmacy Sunday 5/10/15 after receiving ADACEL vaccine on 5/7/15. Patient's arm was covered in a dark real purple rash from her  shoulder to the crook of her elbow. She reported her whole arm was very itchy. She also reported beginning to feel extremely fatigued the Friday evening after her vaccine. Reports that she slept 20 hours straight through Saturday 5/9.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: 5/13/15 - evening of imms, pain, given ADVIL. 5/14/15 - AM - given ADVIL for pain. 5/14/15 - noon - given ADVIL and ice for pain, redness, swelling, warm to touch, itchiness.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Px had 3.5 inches erythematous, edematous, induration in the injection site, it is alsohot and painful to touch.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives following 3rd GARDASIL injection, resolving with BENADRYL and MEDROL Pak. Not reported until 1 month following injection.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Electroencephalogram normal, Laboratory test normal, Somnolence, Upper respiratory tract infection
Clinical narrative: Child had a well child exam on 4/13/15 and received vaccines. 48 hours later parents had a hard time waking child up. Was taken to ER and alert at that time. Child had a URI so I saw later in day. Lab normal. EEG normal. Child doing well.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling, itching, redness, blisters at injection site.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt received the Prevnar13 and Adacel on 5/21/15 got a local reaction to the Prevnar vacc within one hr. Was seen at our office on 5/22/15 not treatment necessary. Spoke to patient on 5/26/15 pt is dong fine. The swelling and redness she had on L arm from Prevnar13 is all gone.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Pt reports redness at (L) deltoid within 24 hours which progressed to 70 x 120 mm red, hot area with induration and itching.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Local reaction, Local swelling, Skin warm
Clinical narrative: Large local reaction on rt. arm after injection - warm, swollen, given top. mupirocin, BENADRYL and ZANTAC.
Age: 69.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus, Rash, Skin discolouration, Skin warm
Clinical narrative: Rash about the size of a Kiwi. Patient reported itching and heat around area---no fever and no joint or muscle pain was reported when I asked her.  Rash was red and white in color.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Headache, Liver function test normal, Muscular weakness, Myalgia
Clinical narrative: Pain in my neck was first. Then severe headache. Middle back pain. Took ibuprofen and that helped some but not fully. Returned more severe at about 8:00 PM that night. Total body aches with headache. Same thing has continued for a week. Monday the 25th 2015 symptoms have decreased to mainly less severe muscle pain/weakness. Slight headache. Tuesday morning woke up with severe pain in the lower legs (knee and below) ibuprofen was taken. I dont know if it is related but my white blood cell count was low when I returned to the doctor on 05/19/2015. Was rechecked 05/26/2015, results still pending so far appears to be recovering from the reaction.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain, Pain in extremity, Renal function test normal, White blood cell count decreased
Clinical narrative: Pain in my neck was first. Then severe headache. Middle back pain. Took ibuprofen and that helped some but not fully. Returned more severe at about 8:00 PM that night. Total body aches with headache. Same thing has continued for a week. Monday the 25th 2015 symptoms have decreased to mainly less severe muscle pain/weakness. Slight headache. Tuesday morning woke up with severe pain in the lower legs (knee and below) ibuprofen was taken. I dont know if it is related but my white blood cell count was low when I returned to the doctor on 05/19/2015. Was rechecked 05/26/2015, results still pending so far appears to be recovering from the reaction.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Reported initially experiencing right deltoid soreness and shoulder stiffness beginning Sunday, May 17 which progressively became worse and radiated to: neck stiffness, elbow and hand joint pain and swelling, and to pain radiating to the ankle joints. "I counted 17 joints that have been affected. My right shoulder hurt so much; it was as if I had a major shoulder injury I didn't have any arm involvement that appeared resemble an infection, but I think I have developed vaccine syndrome. Each year I have a worse reaction to the flu shot. I am a proponent of vaccinations, but if a patient came to me like this, I would not recommend vaccinations."
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: Redness at site, swelling of entire arm, itching at site.
Age: 1.03
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Pt. rec'd 12 mo imm. on 05-11-15. Redness and knot appeared on Lt arm at site on 05-21-15. Pt. seen in office on 5/22/15. (+) Lt upper posterior arm with linear redness; afebrile; non-tender; no other rashes present. Area = 2.5 cm x 0.5 cm. TX = ibuprofen, ice pack; to return prn.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: R leg swollen, reddened, warm to touch. Pt stated hurt to walk on. No fever. Too to urgent care, given Abx >10cm aea.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Cerebrovascular accident, Muscular weakness, Nuclear magnetic resonance imaging brain
Clinical narrative: C/O leg weakness hours after vac was administered patient was advised to go to the ER and was admitted in a CVA dx.