chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 05-DEC-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 14-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 86-year-old female patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on 17May2017, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced redness and swelling at the injection site on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration, on unspecified date, single dose, for immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, after the use of meningococcal group B rlp2086, the patient experienced flu like symptoms, body aches, stiff neck and fever. Patient was admitted to emergency room. The outcome of the events was unknown.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site rash, Nausea, Oropharyngeal pain
Clinical narrative: Achy, nauseous, headache, sore throat, rash (solid red area) at site of injection that appears to be spreading.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Achy, nauseous, headache, sore throat, rash (solid red area) at site of injection that appears to be spreading.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Areflexia, Electromyogram abnormal, Pain in extremity, Peripheral sensory neuropathy
Clinical narrative: Patient describes two days post vaccine had pain on left foot, then both feet. Reports primary care doctor noted loss of reflexes in legs. Pain progressed to involve both calves.  EMG on 10/26/2016 and on 5/25/2017 both show axonal polyneuropathy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: PT GOT 2 IMMUNIZATIONS ON RIGHT THIGH 2 DAYS AGO.  LAST NIGHT PT STARTED GETTING SWELLING AND PRURITUS IN THE AREA.
Age: 1.5
Sex: F
Vaccine: HEP
Symptoms: Blood culture, Body temperature increased, Chest X-ray, Culture, Culture urine
Clinical narrative: Foster mom reports child had a seizure that started around 1pm at a department store where 911 was called and patient transported to  Hospital where she treated with a second dose of anti seizure medication then transported to another hospital where she continued seizure activity for over an hour. Foster mom report twitching all over body, eyes rolling and left side of body becoming limp toward the end of seizure. Child was drooling and nonresponsive to verbal stimuli.
Age: 1.5
Sex: F
Vaccine: HEP
Symptoms: Drooling, Electrocardiogram, Electroencephalogram, Eye movement disorder, Hypotonia
Clinical narrative: Foster mom reports child had a seizure that started around 1pm at a department store where 911 was called and patient transported to  Hospital where she treated with a second dose of anti seizure medication then transported to another hospital where she continued seizure activity for over an hour. Foster mom report twitching all over body, eyes rolling and left side of body becoming limp toward the end of seizure. Child was drooling and nonresponsive to verbal stimuli.
Age: 1.5
Sex: F
Vaccine: HEP
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging, Seizure, Unresponsive to stimuli
Clinical narrative: Foster mom reports child had a seizure that started around 1pm at a department store where 911 was called and patient transported to  Hospital where she treated with a second dose of anti seizure medication then transported to another hospital where she continued seizure activity for over an hour. Foster mom report twitching all over body, eyes rolling and left side of body becoming limp toward the end of seizure. Child was drooling and nonresponsive to verbal stimuli.
Sex: F
Vaccine: FLU3
Symptoms: Exposure via eye contact, Eye irrigation, Eye pain, No adverse event
Clinical narrative: This spontaneous case, initially received on 31-Oct-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received ALFURIA for indication not reported from 31-OCT-2016 to 31-OCT-2016. Dose regimen: Not reported, Route of administration: Unknown. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 31-Oct-2016, as the nurse was taking the syringe needle out of the vial, the vaccine splashed upwards and got in her eye. No reaction reported. Nurse will flush her eyes with water, she flushed it with 10 ml of water. The nurse stated her eye is a little sore (outcome: unknown). The nurse does not report any trouble with vision, burning or other eye discomfort. Special circumstances: accidental exposure to product. The healthcare professional classified the event as a medication error. The nurse states that her eye is a little sore, but she believes that is because of all the fluid that has been in it.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, initially received on 05-Oct-2016, was reported by a health professional and concerns a 64-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received ALFURIA from 26-SEP-2016 to 26-SEP-2016. Dose: 0.5ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 26-Sep-2016, the patient experienced a local red raise warm reaction size of half dollar and rash from injection area down to elbow from deltoid (outcome: recovered / resolved). Lasted a week, reaction did subside. The healthcare professional considered all events non-serious.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Odynophagia, Thyroid disorder, Thyroid pain
Clinical narrative: This spontaneous case, initially received on 12-Oct-2016, was reported by a health professional and concerns a 42-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 08-OCT-2016 to 08-OCT-2016. Dose regimen: 0.5 ml single dose, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Oct-2016 48 hours after AFLURIA vaccination, the patient experienced thyroid discomfort (outcome: not reported). Reporter comments: The healthcare professional considered the event non-serious. Additional information was received on 25-Jan-2017: Patient details added (weight and height). On 08-Oct-2016, the patient received AFLURIA (batch number: 13149221A). On 10-Oct-2016, the patient experienced right thyroid pain and odynophagia which improved. The outcome was reported as recovered on 28-Oct-2016. Reporter's comments: The reporter assessed the events as non-serious and considered the causality as certain/highly probable.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a 42-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous care, initially received on 26-Oct-2016, was reported by a health professional and concerns 60-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received ALFURIA from 26-OCT-2016 to 26-OCT-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54607. No additional suspect drugs. Adverse event description: On 26-Oct-2016, the patient received a dose of AFLURIA that had experienced a temperature excursion (outcome: unknown, special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). The PFS (pre-filled syringe) reached 68-72 Fahrenheit for a maximum of 40 hours. Reporter's comments: The healthcare professional considered the event non-serious and classified the report as misuse.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain, Chest pain, Lethargy, Mobility decreased
Clinical narrative: This spontaneous case, initially received on 27-Oct-2016, was reported by a health professional and concerns a male patient. Weight: not provided; Height: not provided. Drug history included influenza vaccine (non-Seqirus brand, previous year) (reaction: aching in left shoulder/aching left shoulder blade, aching neck, pain radiated from upper chest, left arm could not be raised above shoulder, low grade fever of 99, lethargy, aching clavicle, pain shoulder joint). Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date four days after injection, the patient started aching in left shoulder, left shoulder blade, neck and clavicle (outcome: not reported). Pain radiated from upper chest, shoulder joint, shoulder blade and neck (outcome: not reported). Left arm could not be raised above shoulder (outcome: not reported). Pain scale was 5-6 of 10. Low grade fever of 99 and lethargy was present for 3 days (outcome: not reported). Ibuprofen was used to lessen symptoms. Reporter comments: The healthcare professional considered all events non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pyrexia
Clinical narrative: This spontaneous case, initially received on 27-Oct-2016, was reported by a health professional and concerns a male patient. Weight: not provided; Height: not provided. Drug history included influenza vaccine (non-Seqirus brand, previous year) (reaction: aching in left shoulder/aching left shoulder blade, aching neck, pain radiated from upper chest, left arm could not be raised above shoulder, low grade fever of 99, lethargy, aching clavicle, pain shoulder joint). Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date four days after injection, the patient started aching in left shoulder, left shoulder blade, neck and clavicle (outcome: not reported). Pain radiated from upper chest, shoulder joint, shoulder blade and neck (outcome: not reported). Left arm could not be raised above shoulder (outcome: not reported). Pain scale was 5-6 of 10. Low grade fever of 99 and lethargy was present for 3 days (outcome: not reported). Ibuprofen was used to lessen symptoms. Reporter comments: The healthcare professional considered all events non-serious.
Sex: U
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: This spontaneous case, initially received on 27-Sep-2016, was reported by a health professional and concerns a(n) unk patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA for Influenza vaccination from 27-SEP-2016 to 27-SEP-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: 14049222A. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Black spot at the injection site (outcome: Unknown). Special circumstances: Poor quality drug administered. The reporter used the multidose vial and after drawing up the vaccine, the needle seemed to have some sort of residue and after administrating the vaccine, the patient had a black spot at the injection site.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Immediate post-injection reaction, Nausea
Clinical narrative: This spontaneous case, initially received on 28-Sep-2016, was reported by a health professional and concerns a 52-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA for influenza vaccination from 27-SEP-2016 to 27-SEP-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WAT55407. No additional suspect drugs. Adverse reactions/events and outcomes: On 27-Sep-2016 immediately after injection with AFLURIA, the patient was nauseated and experienced a metallic taste in mouth (outcome: unknown). Reporter comments: The healthcare professional considered all events non-serious.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: 4 yo patient coming into clinic for routine well-child check, needing scheduled immunizations. Resident physician, myself, checked off the incorrect vaccination to be given (HPV was checked instead of IPV). Patient was given the incorrect vaccination. Mom was called and notified. Attending was informed of mistake as well. Mom was instructed to monitor for any adverse symptoms; otherwise, to bring patient at next scheduled visit and receive correct vaccination.
Age: 8.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Arm swelling at the site then getting worse-- hot, red and swelling spreading to encompass a large area of upper arm. Then developed a hive below the swelling.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Periarthritis
Clinical narrative: Sore shoulder, limited shoulder mobility.
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: This spontaneous case, initially received on 20-Oct-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA for influenza vaccination from 20-OCT-2016 to 20-OCT-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54707. No additional suspect drugs. Adverse event description: On 20-Oct-2016, a partial dose was administered to the patient as the needle was not fully attached to the syringe (special circumstances: underdose without adverse event, wrong technique in drug usage process without adverse event). No product complaint, they did not attach the needle fully. Reporter comments: The healthcare professional classified the event as a medication error. Additional information received on 24-Jan-2017: QA investigations results: WT54707 Final assessment: Risk has been excluded. The review and investigation of the manufacturing, dispensing, shipping and product testing of Influenza Vaccine lot: WT54707 found no evidence of a product quality issue to prompt the potential 'vaccine reaction'.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 20-Oct-2016, was reported by a health professional and concerns a 27-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 20-OCT-2016 to 20-OCT-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT52406. No additional suspect drugs. Adverse event description: On 20-Oct-2016, the patient received an AFLURIA dose after a temperature excursion (Outcome: unknown, special circumstances: drug administration error without adverse event). The PFS (pre-filled syringe) was stored at 72 degrees Fahrenheit (22.22 degrees C) for 4 hours before being administered. The reporter is not aware of any adverse events that were experienced. Reporter comments: The healthcare professional considered the event non-serious and classified the report as misuse.
Sex: M
Vaccine: FLU3
Symptoms: Drug administration error, No adverse event
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a non health professional and concerns a(n) male patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 17-OCT-2016 to 17-OCT-2016. Dose regimen: 0.5 ml single dose, Route of administration: Intramuscular. Batch number: WT57208. No additional suspect drugs. Special circumstances: Drug administration error without adverse event. The patient reported that when the doctor injected him, the doctor noticed there was no vaccine in the syringe. The doctor injected the patient again in the other arm because he could not inject him in the same arm again. The patient was worried whether or not the first needle was an already used needle or did it come that way. The patient stated that the doctor took the vaccine out of the fridge where the other vaccines were stored. The pharmacist who administered the vaccine reported that the PFS plunger resisted plunging. No vaccine was administered, but the needle was attached to the PFS and inserted in the patient's arm. The patient was then administered vaccine in the other arm with new PFS with no difficulties. Reporter's comments: The reporter assessed the event as non-serious.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 20-Oct-2016, was reported by a health professional and concerns a 27-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 17-OCT-2016 to 17-OCT-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT51905. No additional suspect drugs. Adverse event description: On 17-Oct-2016, temperature excursion, syringe was administered to a patient (outcome: not reported, special circumstances: drug administration error without adverse event). The PFS (pre-filled syringe) was out of range for 72 hours. Maximum 51 degrees Fahrenheit (10.56 degrees Celsius). The facility has since discarded all other PFS affected. Reporter comments: The healthcare professional considered the event non-serious.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Vomiting
Clinical narrative: This spontaneous case, initially received on 25-Oct-2016, was reported by a health professional and concerns a 68-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for Indication not reported on 17-OCT-2016. Dose regiment: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On 17-Oct-2016, the patient also received PNEUMOVAX 23 injection (batch number M005287), Route: intramuscular. Adverse reactions/events and outcomes: On 17-Oct-2016, the patient experienced Pain in her arm (outcome: Unknown) that lasted for an unspecified amount of time and Vomited after she got out of the shower on the same day after administration (outcome: Unknown). No additional information provided. No treatment was given. Follow-up information received 01-Nov-2016: The outcome for the events 'pain in the arm' and 'vomiting' were reported as recovered / resolved on 17-Oct-2016. Reporter comments: The healthcare professional considers the event non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous case, initially received on 27-Oct-2016, was reported by a health professional and concerns a 24-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 21-OCT-2016 to 21-OCT-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: WT54406. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date within 24 hours of injection, the patient experienced tiny red bumps resembling a rash that itched on both arms (outcome: recovering / resolving). Adverse event is resolving. Reporter comments: The healthcare professional considered all events non-serious.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 28-Oct-2016, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): ON an unknown date, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse event description: On an unknown date, someone inadvertently gave a dose of expired AFLURIA from last season (outcome: not reported, special circumstances: expired drug administered without adverse event).
Sex: M
Vaccine: FLUX
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous case, initially received on 19-Aug-2016, was reported by a non health professional and concerns a male patient. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported (unknown strength/dosage/manufacturer). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced a bad reaction with a flu vaccine (outcome: not reported).
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old female patient. The patient's other medications, current illnesses, medical history and prior vaccinations were not reported. On 07-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm (dose, frequency, lot number and lot expiration date unknown) for prophylaxis and same day, the patient experienced dizziness for 30 minutes after GARDASIL 9 administration. The outcome of dizziness was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to twelve patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (19400 plaque-forming units) (dose, route of administration, lot # and expiry date were not reported) for prevention of shingles. Other suspect therapies included sterile diluent. On unknown dates, the patients experienced shingles. The physician reported that these were "wild-type shingles, not vaccine-type shingles". The physician did not believe that ZOSTAVAX was effective in preventing wild-type shingles. Action taken with the suspect therapies, the outcome of the events and the relatedness between the events and suspect therapies were not reported. Additional information is not expected as there was no consent to contact the physician.
Sex: U
Vaccine: MMR
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. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 19-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, albumin status: recombinant human albumin (rHA)). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Sex: F
Vaccine: FLUX
Symptoms: Vitreous floaters
Clinical narrative: This spontaneous case, initially received on 18-Oct-2016, was reported by a non health professional and concerns a female patient. Weight: not provided; Height: not provided. Drug history includes AFLURIA received in 2014 (reaction: no side effects) and Shingles vaccine (reaction: arm blew up, went to urgent care, outcome: resolved within 48 hours, start date: occurred 2 years ago). Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date at least 4 years ago, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drug. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient had vision floaters in her eyes (outcome: recovered / resolved). The patient saw the eye doctor.
Sex: U
Vaccine: MMR
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. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 16-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, albumin status: recombinant human albumin (rHA)). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Sex: U
Vaccine: MMR
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. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 14-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, albumin status: recombinant human albumin (rHA)). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. ; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 02-NOV-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-DEC-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 01-DEC-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 17-JAN-2017, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 11-JAN-2017, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 18-JAN-2017, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of an unknown age and gender. The patient's medical history, drug and allergy history and current conditions were not reported. It was reported that on an unknown date, a patient was vaccinated with an improperly stored dose of PROQUAD lot # M031567 and expiration date of 24-DEC-2017. The patient's concomitant therapies were not provided. The vaccine was stored at a temperature of 6° Fahrenheit (F) during a time frame of 14 hours and 55 minutes with no previous temperature excursions. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: This spontaneous case, initially received on 27-Sep-2016, was reported by a health professional and concerns a 66-year-old female patient. Weight: not provided; Height: not provided. Drug history included thiomersal (reaction: allergy). Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient has a reaction to the AFLURIA she received at her doctor's office 5 days ago. The patient experienced some swelling (outcome: not reported). Reporter's assessment: The LPN (Licensed Practical Nurse) considered the event swelling as non-serious and related (possible) to the administration of AFLURIA. The LPN does not know specifically if the patient received the PFS (prefilled syringe) or the MDV (multi-dose vial) but thinks the patient is reacting to the thiomersal in the MDV.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous case, initially received on 18-Oct-2016, was reported by a health professional and concerns a 60-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received AFLURIA from 18-OCT-2016 to 18-OCT-2016. Dose regimen: 0.5 ml single dose, Route of administration: Subcutaneous. Batch number: WT53306. No additional suspect drugs. Adverse event description: On 18-Oct-2016, a 5/8 inch needle was used to administer vaccine and may have been given subcutaneously (outcome: not reported, special circumstances: incorrect route of drug administration without adverse event). Reporter comments: The healthcare professional considered the event non-serious and classified it as a medication error.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 18-Oct-2016, was reported by a non health professional and concerns a 78-year-old male patient. Weight: not provided; Height: not provided. Drug history included Flu vaccine (reaction: dizziness / lightheadedness, allergic reaction) and Terazosin (reaction: allergies). Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received AFLURIA from 09-SEP-2016 to 09-SEP-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date a week after vaccination, the patient started to have pain in the shoulder. The pain level is 1-5 on a scale of 1-10. The pain appears and disappears sporadically. The pain is present without touching. The patient states he has not gone to a doctor about the arm pain. Outcome for all events: not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous case, initially received on 29-Sep-2016, was reported by a health professional and concerns a 28-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 29-SEP-2016 to 29-SEP-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT52005. No additional suspect drugs. Adverse event description: On 29-Sep-2016, the patient received a partial dose of AFLURIA because the plunger got stuck during the administration (special circumstances: medication error, underdose without adverse event).
Age: 83.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 83 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 14-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 14-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: This spontaneous case, initially received on 24-Oct-2016, was reported by a non health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On 14-Oct-2016, the patient received AFLURIA with Pharmajet Stratis needle-free injection system. Dose regimen: Not reported. Batch number: not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient experienced bruising at the site of injection (outcome: not recovered / not resolved). It was reported that no death occurred, no serious injury occurred. Reporter's assessment: It was reported that it appeared to be bruising from local site reaction to the vaccination and should dissipate on its own in several days. It was not device-related. Follow-up information received 28-Oct-2016: The patient was 61 years of age at the time of vaccination. AFLURIA was administered via the intramuscular route. Site: Right arm. The patient states that the PharmaJet did not work in her left arm, then her right arm was used. On 17-Oct-2016, the patient's arm showed bruising at the site of injection after PharmaJet used and she experienced a bad bruise on her right arm / bruise on arms (outcome: recovering resolving). Reactions are getting better now. The injection was given at work place. The patient has not gone to doctor.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous case, initially received on 23-Sep-2016, was reported by a Non-Health Professional and concerns a 35-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 23-SEP-2016 to 23-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT52406. No additional suspect drugs. Adverse event description: On 23-Sep-2016, less than full dose of AFLURIA administered (to the patient) as a small amount was expelled when air bubble removed (outcome: unknown, special circumstances: underdose without adverse event). The reporter classified the event as a medication error.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous case, initially received on 25-Oct-2016, was reported by a health professional and concerns a 55-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 25-OCT-2016 to 25-OCT-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT55207A. No additional suspect drugs. Adverse event description: On 25-Oct-2016, an AFLURIA dose was partially given to the patient (outcome: unknown, special circumstances: underdose without adverse event).
Age: 79.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 79 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.