chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In 2016 (report as from starting from 17-JUN-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L007560, expiration date 15-JUN-2017; lot # L037554, expiration date 25-DEC-2017; lot # L048237, expiration date 08-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased, Pain
Clinical narrative: Soreness, can barely move when washes up, started 20 days after vaccine administration.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Pt complains of pain at time of vaccination that progressed by evening. Pt unable to sleep at night due to fever and pain at injection site. Injection site is red, swollen, and hot 24h later, even with use of cold packs and ibuprofen. Pt plans to go to ER for evaluation since pain has not subsided.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt complains of pain at time of vaccination that progressed by evening. Pt unable to sleep at night due to fever and pain at injection site. Injection site is red, swollen, and hot 24h later, even with use of cold packs and ibuprofen. Pt plans to go to ER for evaluation since pain has not subsided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unknown date in March 2016, the patient was inadvertently vaccinated with a dose of RECOMBIVAX HB (intramuscularly, lot# reported as: L02577, expiry date: 15-APR-2017) instead of ordered GARDASIL. No concomitant therapy was reported. No adverse effect was reported. Additional information is not expected, because there is no consent to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician referring to a 81-year-old male patient. The patient's pertinent medical history included unspecified type of cancer. The patient was allergic to penicillin. On an unspecified date in 2011 the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# and expiration date were not reported). On 23-AUG-2016, the patient developed shingles. The patient sought medical attention in the physician's office. No lab diagnostics studies were performed. The patient received unspecified treatment for the event. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was not reported. This is one of two cases 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 medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In 2016 (reported as from starting from 17-JUN-2016), the patients were vaccinated with improperly stored doses of M-M-R II (lot #, expiration date, therapy type, dose and route of administration were not reported). There was no adverse effect reported. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Herpes zoster, Insomnia, Pain
Clinical narrative: This spontaneous report as received from a female patient of unknown age reporting on herself. Patient's medical history included shingles (developed when she was in her 40's). On an unknown date, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, frequency and indication were not reported). On 17-AUG-2016, the patient developed shingles (reported as three weeks ago and again this week). She had a bad breakout which causes pain that kept her awake at night. The rash was at the tip end of her spine and down to the sciatica nerve. This was causing difficulty walking and caused pain that felt like needles stabbing her. The patient received unspecified treatment. The outcome of the events was reported as recovering. Causality assessment was not reported. 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 registered nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was administered an improperly stored dose of RECOMBIVAX HB lot # M001578, expiration date 21-NOV-2018, intramuscularly (dose not provided). The vaccine underwent a temperature excursion of 48.7 degrees Fahrenheit for 48 hours. It was reported that data logger was used. There were no previous excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On unspecified dates the unspecified number of patients were vaccinated with improperly stored doses (incorrect product storage) of VAQTA (lot # M002268 and expiry date 20-SEP-2017) (dosing regimen and route of administration were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unknown patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On multiple unknown dates, the patients were vaccinated with improperly stored dose of PEDVAXHIB lot # L006545 with expiration date 16-NOV-2017 and lot # L014428 with expiration date 12-MAR-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursions below 36 degrees Fahrenheit for unknown time (reported as "more than 25 times"). It was reported that Data logger was used. No adverse effects reported. This is one of several reports received from the same source. 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 a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of PROQUAD (lot # L051101 and expiration date 17-JUL-2017, albumin status therapy type, dose and route of administration were not reported) that was improperly stored. The temperature of excursion was 6 Celsius degrees and the time frame of excursion was 52 hours. There was no previous excursion and the call was not because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. 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 physician refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On unspecified dates the unspecified number of patients were vaccinated with improperly stored doses of M-M-R II (lot # L026553 and expiry date 16-JUL-2017) (dosing regimen and route of administration were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was flied. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-SEP-216, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # K011188, expiration: date 12-AUG-2016 (dose, route of administration, were not reported). The nurse reported that the patient received a properly stored, expired dose of (wistar ra 27-3) M-M-R II. There was no product quality complain (PQC) involved. There was no adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of an unknown age and gender. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# L048848, expiration date: 09-AUG-2018) (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of an unknown age and gender. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot number: M007764, expiration date: 30-JAN-2018, dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. 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 registered nurse refers to an unknown number of patients of an unknown age and gender. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot number: L043703, expiration date: 30-NOV-2017; dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: In vitro fertilisation, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (public health nurse) refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M018810, expiry date 28-MAY-2018, dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of three reports received 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 registered nurse refers to an unknown number of patients of an unknown age and gender. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot number: L027067, expiration date: 06-APR-2017; lot number: M019691, expiration date: 02-NOV-2017; dose was not reported) orally. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with an expired and unsupported dose of ZOSTAVAX (lot # L000450, expiration date 09-MAR-2016; dose and route were not reported). No adverse reactions were reported. 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 certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L039092, expiry date 06-OCT-2017, lot # L043622, expiry date 03-NOV-2017, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). There were no known adverse effects. The vaccines experienced temperature excursion of -5.2 degrees Celsius for 50 hours 17 minutes. This is one of several reports received from the same source. Follow up information has been received from a certified medical assistant on 30-AUG-2016. The nurse reported that the specified lot numbers of improperly stored vaccines administered between 19-MAY-2016 to 01-JUL-2016 were not available. This report refers to a patient of unknown age and gender. On 08-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ orally, Lot#L035511 or K022993 or L029618. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 61 year old female patient with allergic rhinitis. Information regarding relevant medical history and concomitant medications were not reported. On 04-OCT-2012, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported). After receiving the vaccine, on an unknown date, the patient's arm swelled and there was redness. The patient also had a welt the size of a goose egg. The outcome of the events was unknown. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with a doses of ROTATEQ following a temperature excursion (reported lot # A41DB544A, expiration date: 27-FEB-2017) (dose and frequency were not reported) orally. No apparent adverse effects were reported. The outcome of event was not reported. This is one of two reports from the same reporter. 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 nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L042836. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 22-SEP-2016, the patient was vaccinated with expired dose of ZOSTAVAX lot # L017165, expiration date: 13-AUG-2016, intramuscularly which was outside of prescribing information. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date in 2015 (also reported as a year ago) the patient was vaccinated with first dose of PNEUMOVAX 23. On an unknown date 2015 the patient experienced injection site reaction. On an unknown date (also reported as a few days ago) the patient was vaccinated with another dose of PNEUMOVAX 23. The outcome of the event injection site reaction is unknown. The reporter did not provide the causality assessment between the event and the suspect therapy. 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 three patients of an unknown age and gender. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # L016123, expiration date: 06-MAY-2017, dose was not reported) subcutaneously. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L026602. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site rash, Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's concurrent conditions and medical history included diabetes mellitus and drug reaction/allergy to FARXIGA. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (Lot # M027552, expiration date 04-FEB-2018) 0.5 ml, intramuscular, in the right arm. The patient received an unspecified flu vaccine in the left arm concomitantly with the PNEUMOVAX 23. The patient was also on concomitant medications but they were unknown. On an unknown date, within 24 hours after receiving the PNEUMOVAX 23 the patient experienced soreness at the injection site where the vaccine was administered, within the past 24 hours the patient developed an unspecified rash at the injection site that spread to his chest. The patient was scheduled to see his physician on 21-SEP-2016, regarding this adverse events. At the time of the report, the outcome of injection site pain, rash and injection site rash was reported as not recovered/not resolved. The reporter did not assess the causal relationship between the adverse events and the vaccination with PNEUMOVAX 23. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with ZOSTAVAX (lot number, expiration date, dose, route and anatomical location were not provided). There was not concomitant medication reported. On unknown dates, the patients developed nodules at the injection site on an unspecified time after they received ZOSTAVAX. At the time of the report, the outcome of injection site nodule was unknown. The reporter did not assess the causal relationship between the adverse events and the vaccination with ZOSTAVAX. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 13-SEP-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # L025738, expiration date: 14-AUG-2017, intramuscular. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 25.7 degrees Celsius for 57 hours. Data logger was involved. There was no previous excursion reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (public health nurse) refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L043704, expiry date 04-NOV-2017, dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a physician refers to a child of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 21-SEP-2016, the patient received a partial dose of PROQUAD (lot number reported as M026879 and expiration date 27-NOV-2017, albumin status therapy type, dose and route of administration were not reported) due to the fact that the parent, who was holding the patient, moved during the injection procedure. The patient did not experience any adverse effects. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Dermatitis contact, Generalised vaccinia, Lymph node pain, Lymphadenopathy, Miliaria
Clinical narrative: Patient sought medical evaluation on 29 August for a pruritic, papular rash that began on post-vaccine day 15 (8/24/16). Rash began on upper extremities, then noted on lower extremities and neck and face. No rash on trunk. Patient's smallpox vaccination site progressed as expected without significant local reaction. (However, on post-vaccine day 9, patient sought evaluation of left supraclavicular lymph node that was swollen and tender.) Patient denies fever, chills, body aches, chest pain, shortness of breath, headaches, and malaise. He also denied any other potential triggering headaches and malaise. He also denied any other potential triggering exposures, other than travel. No prior history of skin conditions. PMH reported as negative. Patient evaluation included differential diagnoses of nonviral pustulosis, benign acral papulovesicular eruptions, generalized vaccinia, contact dermatitis and heat rash. Patient was treated with antihistamine and instructed on actions to avoid potential contact transmission as a precaution. Also, patient exposure to sun and skin irritation were limited. Patient evaluated on 1 Sep 2016 - Lesions on face consistent with acne. Lesions on arms, neck and ankle are dry.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular, Rash pruritic, Skin lesion, Viral test positive
Clinical narrative: Patient sought medical evaluation on 29 August for a pruritic, papular rash that began on post-vaccine day 15 (8/24/16). Rash began on upper extremities, then noted on lower extremities and neck and face. No rash on trunk. Patient's smallpox vaccination site progressed as expected without significant local reaction. (However, on post-vaccine day 9, patient sought evaluation of left supraclavicular lymph node that was swollen and tender.) Patient denies fever, chills, body aches, chest pain, shortness of breath, headaches, and malaise. He also denied any other potential triggering headaches and malaise. He also denied any other potential triggering exposures, other than travel. No prior history of skin conditions. PMH reported as negative. Patient evaluation included differential diagnoses of nonviral pustulosis, benign acral papulovesicular eruptions, generalized vaccinia, contact dermatitis and heat rash. Patient was treated with antihistamine and instructed on actions to avoid potential contact transmission as a precaution. Also, patient exposure to sun and skin irritation were limited. Patient evaluated on 1 Sep 2016 - Lesions on face consistent with acne. Lesions on arms, neck and ankle are dry.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M002064, expiration date 12-JAN-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product packaging issue
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in September 2016, the patient was vaccinated with a dose of M-M-R II (dose and frequency were not reported) subcutaneously. The reporter stated that a dose of M-M-R II with vial Lot# K014832 and expiration date 14-SEP-2016, was removed from a box of M-M-R II labeled lot# L010488, expiration date: 26-MAR-2017 and was administered to a patient. No apparent adverse effects had been noted at this time. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and conditions and concomitant medications were not reported. On 13-SEP-2016 and 14-SEP-2016, the patients were improperly stored vaccinated with PROQUAD (dosing details were not reported) (lot # M015698, expiry date: 26-SEP-2017) which was at a temperature of 11 degree Fahrenheit for a duration of 12 hours 35 minutes. No adverse effects were reported. There was no product quality complaint reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-AUG-2016, the patient was vaccinated by the physician with the first dose of ZOSTAVAX (reported lot# M027117, expiration date: 26-JUL-2017) 0.65 ml, subcutaneously. On 20-SEP-2016, the patient was vaccinated by the pharmacist with the second dose of ZOSTAVAX (reported lot# M027117, expiration date: 26-JUL-2017) 0.65 ml, subcutaneously. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Gait disturbance, Lip swelling
Clinical narrative: (L) thigh red and swollen, red streaks and pt is limping.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives covering the left armpit.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: Patient had developed a stuffy nose after receiving the vaccine at approximately 1:15 pm.  At approximately 1:pm patient said she still had at stuffy nose and also a runny nose.  At approximately 2:50 pm patient said she still has a stuffy and runny nose.  At 5:00 PM patient said her stuff nose had cleared but she still had a runny nose.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Liver function test increased, Pain in extremity
Clinical narrative: The patients mom came to consultation area and stated that patient is recovering from her immunization at a hospital. She stated that she has arm pain, weakness, and elevated liver function tests. She wanted to know if I ever seen anything like that before. She was not specific in the timeline but stated that her arm started hurting around 5 hours after the immunization. I went over side effects, answered her questions, and told her I would report the adverse event. She stated that patient is starting to get better.
Age: 43.0
Sex: M
Vaccine: DTP
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Pain in shoulder, unable to raise.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Death
Clinical narrative: Death
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dysphonia, Erythema, Injected limb mobility decreased, Musculoskeletal stiffness
Clinical narrative: Weakness dec range of motion left arm pain swelling redness itching stiff neck hoarseness.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Weakness dec range of motion left arm pain swelling redness itching stiff neck hoarseness.
Age: 71.0
Sex: M
Vaccine: HPVX
Symptoms: Swelling face
Clinical narrative: (Vaccinated in left arm): right jaw (inside) appears to have been slightly swollen. It felt like I was biting the inside of my jaw. I rinsed my mouth with warm salt-water. After slightly less than 24 hours, things returned to normal.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: First felt sorenesss and swelling at injection site in morning following injection.  By evening on same day, had chills and fever of 99.7.  By next morning (Sept 24) fluish malaise and fever of 100.7.  Felt sick all day with fever, following day (Sept 25), fever went down to 99.3 in morning, but redness around injection site has spread to approx 5 inches in diameter.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: First felt sorenesss and swelling at injection site in morning following injection.  By evening on same day, had chills and fever of 99.7.  By next morning (Sept 24) fluish malaise and fever of 100.7.  Felt sick all day with fever, following day (Sept 25), fever went down to 99.3 in morning, but redness around injection site has spread to approx 5 inches in diameter.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain, Pain in extremity
Clinical narrative: Patient claims the vaccine was given too high up on her arm and was injected into her joint.  She said she has soreness and thinks she had frozen shoulder.  However, the next day and later on that day she was able to move her arm with some soreness.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Severe headache, pain at injection site, fever from 103.5 to 101.5 (the entire next day), painful body, aches and pains.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site pruritus, Injection site vesicles
Clinical narrative: At the site of administration there was fluid oozing from the site. Patient also had some fluid under the skin and it was bubbling up. She also said the site was itchy.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Movement disorder
Clinical narrative: NOTE: Adverse event onset date has been since the date of administration per patient, but he bought this matter to our attention at the pharmacy on 09/23/2016. Patient states he cannot move his right hand above his shoulder level.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Cough, Dysphagia, Eye swelling, Foreign body sensation in eyes
Clinical narrative: Throat swelling, difficulty swallowing, difficulty coughing, tight chest, red watery eyes, grainy feeling in eyes, eventual major swelling of skin around eyes.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Lacrimation increased, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Throat swelling, difficulty swallowing, difficulty coughing, tight chest, red watery eyes, grainy feeling in eyes, eventual major swelling of skin around eyes.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: Significant swelling in the arm that received two vaccinations, returned to normal after about 36 hours.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Patient stated she had some numbness start in vaccination arm and travel to other arm and legs.  Also, some numbness in chest.  Symptoms started 9/24/16 but reported 9/25/16.  Symptoms have been self resolving.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray normal
Clinical narrative: Limited range of motion in left shoulder. Shoulder pain the same day as the shot. Pain and range of motion got worse as time went on. Saw nurse practitioner two weeks following flu vaccine. Ice three times a day, 2 aleve in morning, 2 aleve at night.  Sent to orthopedic doctor. X-ray was taken Cortisone shot was administered. Some relief in pain two days after shot, four days after shot pain is slowly coming back.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Pt stated that she had a reaction to both the PREVNAR 13 and FLUZONE HD vaccines which were given in different arms. Pt reported redness, warmth, and rash from shoulders to elbows on both arms.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia, Pruritus generalised
Clinical narrative: Pt says that she started itching every where.  She felt little pin pricks like i was sticking her with a pin.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt woke up with localized heat and redness around the injection site that continued to spread.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Swelling
Clinical narrative: Pt reports pain and redness to injection site and several hours after administration. Reports on 9/24/2016 pain worsened. As of 9/25/16 when patient was seen in our clinic pain was improved but swelling and redness and worsened. Erythema noted to wrap around pt left upper arm and was warm to touch. Prednisone was ordered along with OTC Benadryl.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Autism spectrum disorder, Chromaturia, Dizziness, Hepatic failure
Clinical narrative: Although I was completely vaccinated at a young age, I was diagnosed with Hepatitis A. I had severe abdominal pain, nausea, loss of appetite, dizziness, fainting, discolored urine. I went to the doctor to figure out what was wrong and she said my urine showed signs of my liver failing.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A, Hepatitis A virus test, Hepatitis B virus test, Nausea, Syncope
Clinical narrative: Although I was completely vaccinated at a young age, I was diagnosed with Hepatitis A. I had severe abdominal pain, nausea, loss of appetite, dizziness, fainting, discolored urine. I went to the doctor to figure out what was wrong and she said my urine showed signs of my liver failing.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Urine analysis abnormal
Clinical narrative: Although I was completely vaccinated at a young age, I was diagnosed with Hepatitis A. I had severe abdominal pain, nausea, loss of appetite, dizziness, fainting, discolored urine. I went to the doctor to figure out what was wrong and she said my urine showed signs of my liver failing.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT NOTICED THAT AN APPROXIMATELY 4 INCH DIAMETER AREA AT THE PREVNAR 13 INJECTION SITE WAS PAINFUL, RED AND WARM TO THE TOUCH ON 9/21/16. SHE NOTIFIED THE PHARMACY ON 9/25/16. SHE APPLIED ICE.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Injection site erythema, Nausea, Vomiting
Clinical narrative: Patient experienced skin erythema around injection site, nausea, vomiting, and diarrhea after receiving PNEUMOVAX 23 vaccination on 9-20-16 with LOT: M024673.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Injection site erythema, Nausea, Vomiting
Clinical narrative: Patient experienced skin erythema around injection site, nausea, vomiting, and diarrhea after receiving Pneumovax 23 vaccination on 9-20-16 with LOT: M024673.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Cannot lift arm above chest level, still cannot lift arm above chest level 3 days later.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose decreased, Confusional state, Disorientation, Feeling abnormal, Injection site erythema
Clinical narrative: Patient states she started feeling bad approximately 1 to 2 hours post-injection. She complained of increasing confusion and disorientation over the next two days. She awoke each of the next two nights on the floor beside her bed. A family member called for EMS on Sept 9 for transport to Hospital. She was admitted and kept overnight for observation. She states the EMS told her her blood sugar was 53. The hospital also stated she had low blood sugar levels. She was discharged from the hospital on Sept 9 with instructions to monitor blood sugar.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Patient states she started feeling bad approximately 1 to 2 hours post-injection. She complained of increasing confusion and disorientation over the next two days. She awoke each of the next two nights on the floor beside her bed. A family member called for EMS on Sept 9 for transport to Hospital. She was admitted and kept overnight for observation. She states the EMS told her her blood sugar was 53. The hospital also stated she had low blood sugar levels. She was discharged from the hospital on Sept 9 with instructions to monitor blood sugar.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Tinnitus, Vomiting
Clinical narrative: Dizziness, headache, nausea, vomiting, ringing in ears.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: Upon administering it was tough to get the needle in SQ. I don't know if it was a combination of the needle and her skin. I was able to administer at least half of the vaccine when she asked me to stop and I've never experienced this before. I've talked to her since she has been home and she said she is doing fine and not to worry about her. She isn't having any problems, but I'm concerned because I was unable to administer the whole vaccine.
Age: 63.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: PATIENT STATES HER RIGHT ARM IS RED, SWOLLEN AND HOT. HAS GOTTEN PROGRESSIVELY WORSE. SHE IS CONCERNED THAT IT IS ABSCESSED. SHE HAS USED WARM COMPRESSES ON THE SITE.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Migraine. Ongoing migraines ever since HPV VACCINE.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site rash
Clinical narrative: My son showed me his rash on his leg (at site of injection) and said his rash matched mine (I was having an allergic reaction on my hand at the time).  His rash looked pretty bad, covering the entire upper thigh.  I called the phone nurse at the pediatrician's office to ask about both my reaction and his rash.  The phone nurse scheduled an appointment for my son to be seen the next day at the doctor's office.  We went to his appointment the next day and the doctor we saw said that she wasn't sure if it was an adverse event or if it was an infection of some sort. She prescribed antibiotics to be sure to clear it up in case of infection.  The rash was about 18 cm in length and about 6 cm in width on the upper left thigh.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test, Monoplegia
Clinical narrative: Guillain-Barre Syndrome; right leg paralysis, IVIG (4 doses); subsequent 45 day hospital stay.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Electromyogram, Guillain-Barre syndrome, Immunoglobulin therapy, Irritability, Lumbar puncture
Clinical narrative: Fever and fussiness to start, followed by weakness starting in the legs, trunk and upper extremities. Ultimately diagnosed with Guillain Barre syndrome. IVIG over 5 days followed by another course of IVIG given over 5 days five weeks later.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Fever and fussiness to start, followed by weakness starting in the legs, trunk and upper extremities. Ultimately diagnosed with Guillain Barre syndrome. IVIG over 5 days followed by another course of IVIG given over 5 days five weeks later.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Angiogram, Blood test, Computerised tomogram thorax, Eye pain, Eyelid ptosis
Clinical narrative: Cold like symptoms, severe eye pain, behind eye socket, pain on right side, top of head as if someone was pulling my hair. Right eyelid started to droop.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nasopharyngitis, Neuro-ophthalmological test, Nuclear magnetic resonance imaging, Ultrasound Doppler
Clinical narrative: Cold like symptoms, severe eye pain, behind eye socket, pain on right side, top of head as if someone was pulling my hair. Right eyelid started to droop.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Venogram
Clinical narrative: Cold like symptoms, severe eye pain, behind eye socket, pain on right side, top of head as if someone was pulling my hair. Right eyelid started to droop.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Confusional state, Injection site swelling, Muscular weakness, Pain
Clinical narrative: Patient has swollen at injection site, pain, confusion and weakness of legs.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Dermatitis, Pyrexia, Swelling
Clinical narrative: Information has been received from a physician via Pfizer (manufacturer report number# 2016433837), referring to a currently 75 year old female patient. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, dose number, lot# and expiration date were not reported). On an unknown date, the patient experienced allergies to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) with symptoms including swelling, dermatitis and fever. The outcome of the event was not reported. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (the suspect therapy was reported as allergen). This is one of two reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 62 years old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On 02-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date unknown) subcutaneously. On 06-SEP-2016, the patient experienced a red, bumpy rash. No treatment was given for the event. The patient had sought medical attention. The patient did not recover from the event. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On 02-SEP-2016, the patient was inadvertently vaccinated with a dose of M-M-R II which was expired on 28-AUG-2016 (lot # M001200, dose and route were unknown). This dose was supported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant regarding unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (digital logger)(lot # L026602, expiry:19-OCT-2017; lot# L043214, expiry:30-AUG-2017, lot# M005714, expiry:03-OCT-2017. The vaccines were exposed On 10-AUG-2016 at 28.9F for 3.8 hours, on 11-AUG-2016 at 31.8F for 1.7 hours and on 26-AUG-2016 at 31.1F for 3.75 hours. There was no previous temperature excursion.No adverse effects were reported. This is 1 of 3 reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-SEP-2016, the patient was vaccinated with an expired dose of VAQTA (lot # L004439, expiration date 15-FEB-2016, dose and route unknown). In addition, the reporter was certain that the dose was exposed to room temperature for an unspecified period of time. No adverse experience had been observed or reported. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (strength, dose and route unknown, lot # L032184, expiration date: 25-NOV-2016). No adverse effects were reported. Additional information has been requested.