chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 739225), concerns a 35-year-old, adult female patient. On 01-Feb-2018, the patient was administered FLUVIRIN (dose: 0.5 ml, frequency: 1, route of administration: intramuscular, batch number: 179901P, anatomical location: unknown and expiry date: not reported). On 09-Feb-2018, 8 days after vaccination, the patient experienced rash and hives that covered most of her body. On the same day, these adverse reactions were reported. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Urticaria
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 739293), concerns a 08-year-old child male patient. The patient's historical conditions included stomach virus and gastroenteritis (about one month prior). On 20-Feb-2018, the patient was administered influenza vaccine (dose: unknown, route of administration: injection [SYR as reported], anatomical location: left arm, trade name and batch number: not reported, expiry date, manufacturer: unknown). On 24-Feb-2018, 4 days after vaccination, the patient experienced hives all over legs, top to bottom, top of hands, arms and leg and knee joint pain. The patient was treated with BENADRYL but the symptoms would come back as wore off with BENADRYL. It was reported that, the symptoms lasted for 3-4 days. On an unspecified date, patient had recovered from the events (arthralgia and urticaria). The reporter assessed the case as non-serious. Update 31-Jul-2018: Significant case correction was performed with IRD 02-Jul-2018: The patient's conditions (stomach virus and gastroenteritis) were changed from current conditions to historical conditions in patient tab. The narrative was amended accordingly.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Nervousness, Presyncope
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 739294), concerns a 32-year-old, adult, male patient. In the past, the patient experienced altered state of consciousness, dizziness, abnormal feeling and nervousness when TDAP was administered. The patient was allergic to nickel. The patient had no current illness. The patient was not taking any concomitant medications at the time of vaccination. On 28-Feb-2018, the patient was administered FLUVIRIN (dose: 0.5 ml, frequency: unknown, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day shortly after vaccination, the patient experienced light-headedness and felt like he might pass-out. For several minutes, the events got gradually worse for about 5 to 10 minutes when it started to subside. The patient was told that the events were likely a nervous reaction, however the patient did not feel like that. The patient felt like he was high on something for a few minutes after injection. The patient stated that those events re-occurred every time, after injections how much ever the patient tried to calm himself beforehand. The reaction was not immediate, and they would take a minute or two to begin. Hence, the patient felt like it was a physical response vs nervous response. At the time of this report, the patient had recovered from the event. The reporter assessed this case as non-serious. Update received on 20-Sep-2018: Significant case correction (IRD: 06-Aug-2018): The event nervousness was changed from symptom to diagnosis in the event tab.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 739344), concerns a 11-year-old, female child. The patient had no relevant medical history and allergies and did not receive any concomitant medications. On 13-Feb-2018, the patient was administered FLUVIRIN Thiomersal [explicitly reported as FLUVIRN TIV] (dose: 0.5 ml [frequency reported as unknown], route of administration: intramuscular, anatomical location: left arm, batch number: 1721201 and expiry date: not reported) and non-company suspect vaccine MENVEO (route of administration: intramuscular, anatomical location: left arm, batch number: M16099, [frequency reported as unknown], dose and expiry date: not reported) (explicitly coded as drug administration error). On the same day (13-Feb-2018), 8 hours after vaccination, the patient experienced reactions like extensive swelling, redness, itching at the injection site and had limited elevation of the left arm (decreased mobility) which peaked on 15-Feb-2018. The symptoms had improved with cold compresses. On an unspecified date, the patient experienced mild erythema in the external aspect of left arm with no tenderness or swelling. On an unspecified date, the patient made an office visit. On an unspecified date, the patient was recovering from the events (swelling, redness and itching at the injection site and decreased mobility of the left arm). The outcome of the event erythema was not reported. The reporter assessed the case as non-serious.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Laboratory test normal, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 739453), concerning a 45-year-old, adult, female patient. On 04-Oct-2017, the patient was administered FLUVIRIN Thiomersal [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location left arm, batch number: 1720701, expiry date: not reported). On the same day, after vaccination, the patient experienced numbness and pain in arm. The patient had made an emergency room and physician office visit. Lab investigation to rule Guillain-Barre syndrome was done and found to be negative (normal). At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update 26-Aug-2018: Non-significant case correction was performed with IRD 06-Aug-2018: Added events instead of event in case comment.
Sex: F
Vaccine: FLUX, MMRV
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 739703), concerning a 1-year-old, female infant. The patient's current conditions included bacterial sinus infection, conjunctivitis, upper respiratory infection, hand-foot-and-mouth disease (HFMD as reported). The patient was allergic to honeydew, SEPTRA and occasionally peanut butter (since an unspecified date). The concomitant medications included Vitamin D, FLORASTOR and AMOXCLAV for an unknown indication. On 19-Feb-2018, the patient was administered influenza vaccine (route of administration: injection [syr as reported], dose: 2 [as reported], batch number, expiry date, trade name and manufacturer: not reported and anatomical location: unknown) and non-company product PROQUAD (route of administration: injection [syr as reported], dose: 1, batch number, expiry date, trade name and manufacturer: not reported and anatomical location: unknown). On 05-Mar-2018, 14 days after vaccination, the patient experienced fever and measles like rash. The patient had an office visit. At the time of this report, the outcome of the events (fever and measles like rash) was unknown. The reporter assessed the case as non-serious. Update 31-Jul-2018: Non-significant case correction was performed with IRD 02-Jul-2018: Added generic name of the co-suspect PROQUAD in the case comment. Case comment was amended accordingly. No changes were made in the narrative.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 739789), concerns a 79-year-old, elderly female patient. The patient was allergic to latex. On 14-Feb-2018, the patient was administered FLUVIRIN Thiomersal [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 1720701 and expiry date: not reported]. The reported batch number (1720701), does not match FLUVIRIN batch numbers, however, the batch number was mapped to FLUVIRIN Thiomersal. Hence, the suspect vaccine was explicitly coded as FLUVIRIN Thiomersal. On the same day, the patient was also administered PREVNAR 13 [batch number: S74425, dose and expiry date: not reported]. On the same day after vaccination, the patient experienced pain at the injection site which had radiated to neck, shoulder, arm and hand. The patient had also developed a silver dollar size pink discoloration at the site of injection. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious. Update 29-Aug-2018: Significant case correction was performed 06-Aug-2018: The determined causality for all the events was changed from 'related' to 'unassessable' and the case comment was amended accordingly.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Exercise tolerance decreased, Injected limb mobility decreased, Injection site discomfort, Limb discomfort, Pain in extremity
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 739896), concerning a 56-year-old, adult, female patient. The patient's current condition included arthritis (reported as medical history) and the patient was allergic to codeine (since an unspecified date). The patient had no concomitant medications. On 17-Oct-2017, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On 24-Oct-2017, 7 days after vaccination, the patient's arm was sore which became hard to hold any weight up and doing planks. The patient felt like a 'bunch' in the arm at the injection site. At the time of this report, the patient had not recovered from the events (mobility decreased, injection site discomfort, pain in extremity). The reporter assessed the case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Weight bearing difficulty
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 739896), concerning a 56-year-old, adult, female patient. The patient's current condition included arthritis (reported as medical history) and the patient was allergic to codeine (since an unspecified date). The patient had no concomitant medications. On 17-Oct-2017, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On 24-Oct-2017, 7 days after vaccination, the patient's arm was sore which became hard to hold any weight up and doing planks. The patient felt like a 'bunch' in the arm at the injection site. At the time of this report, the patient had not recovered from the events (mobility decreased, injection site discomfort, pain in extremity). The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 739920), concerns a female infant of an unspecified age. The patient's medical history and allergies were unknown. On 01-Mar-2018, the patient was administered (route of administration: injection [reported as SYR], dose, anatomical location, batch number, expiry date, manufacturer and trade name: not reported) instead of Hepatitis B vaccine (wrong vaccine administered). It was reported that, there was delay in treatment with Hepatitis B vaccine. No adverse event was reported after the influenza vaccine. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Flatulence, Headache, Nausea
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 740045), concerns a 22-year-old, adult female patient. The patient historical condition, current condition, concomitant medication, allergies were reported as none. On 06-Mar-2018, the patient was administered FLUVIRIN (dose: 0.5 ml, frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: 179905P, expiry date: not reported). On the same day after vaccination, the patient experienced headache, nausea, vomiting, general weakness, severe body ache, gas and pain in abdomen. The patient had made an office visit. The lab data was reported as none. On the same day, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Vomiting
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 740045), concerns a 22-year-old, adult female patient. The patient historical condition, current condition, concomitant medication, allergies were reported as none. On 06-Mar-2018, the patient was administered FLUVIRIN (dose: 0.5 ml, frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: 179905P, expiry date: not reported). On the same day after vaccination, the patient experienced headache, nausea, vomiting, general weakness, severe body ache, gas and pain in abdomen. The patient had made an office visit. The lab data was reported as none. On the same day, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 0.5
Sex: M
Vaccine: DTOX, FLUX, HEP, HIBV, PNC13, RVX
Symptoms: Vomiting
Clinical narrative: This is spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 740088), concerns a 06-month-old (reported as 0.50), male child patient. The patient had no medical history and did not receive any concomitant medications. On 27-Feb-2018, the patient was administered influenza vaccine, (dose: unknown, route of administration: injection [SYR], anatomical location: unknown, trade name, batch number and expiry date were not reported). On the same day (27-Feb-2018), the patient also received non-company suspect PREVNAR 13 (dose: unknown, route of administration: injection [SYR], anatomical location: unknown, manufacturer: Pfizer/Wyeth, batch number was not reported). On the same day, the patient also received non-company suspect rotavirus vaccine (dose: unknown, route of administration: per oral [also reported as mouth under anatomical location], batch number was not reported). On the same day, the patient also received non-company suspect Diphtheria vaccine w/Haemophilus influenza type B vaccine/Hepatitis B vaccine/Pe (dose: unknown, route of administration: injection [reported as SYR], anatomical location: unknown, batch number was not reported). On 28-Feb-2018, one day after vaccination, the patient vomited after he woke up from a nap at day care. The patient was given 5 oz. of breast milk after he threw up and drank the entire bottle. It was reported that, the patient had not thrown up since he drank milk. This was reported because the patient has never thrown up before. At the time of this report, patient recovered from the event vomiting. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 740137), concerns a 65-year-old, elderly, female patient. The patient's current condition included high blood pressure (since an unspecified date) [reported as medical history], controlled by unspecified medications. The patient had no allergies. On 03-Nov-2017, the patient administered influenza vaccine (dose, route of administration, anatomical location: unknown, batch number, expiry date, trade name, manufacturer: not reported). On 07-Nov-2017, 4 days after vaccination, the patient developed shingles. The only infected area was the side/back of head and back of neck. The patient also experienced very bad pain. The patient visited the office on an unspecified date. The patient was prescribed with unspecified medications. It was reported that, pain lasted approximately for 4 weeks. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Update 31-Jul-2018: Non-significant case correction performed with IRD 02-Jul-2018: In the narrative 'the only infected area was the side/back of head and back of neck' was mentioned.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 740162), concerns a 42-year-old, adult, female patient. On 08-Feb-2018, the patient was administered FLUVIRIN (dose: 0.5 ml [frequency reported as 1], route of administration: intramuscular, anatomical location: left arm, batch number: 1720701 [reported as 1720781], expiry date: not reported). On the same day, after vaccination, the patient experienced pain and pain spread to elbow and hand. The patient went to a doctor office and received an unspecified steroid shot. At the time of report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This is spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 740211), concerns a 57-year-old, adult, female patient. The patient's medical history was not reported. The patient's concomitant medication included PRALUENT injection (150 mg). On 01-Jul-2016, the patient was administered influenza vaccine (dose, route of administration, anatomical location, manufacturer and batch number: unknown, trade name was not reported). On an unspecified date, following vaccination, the patient had an allergic reaction to flu vaccine. The patient had an emergency room [ER] visit and office visit. The patient's lab tests were not reported. The patient was treated with steroids. The outcome of the event (hypersensitivity) was unknown. Update 31-Jul-2018: Non-significant case correction was performed with IRD 02-Jul-2018: Corrected spelling [no to not] in the case comment. Case comment was amended. No changes were made in the narrative.
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 741038), concerns a 39-year-old adult female patient. On 06-Feb-2018, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On 08-Feb-2018, after 02 days of vaccination, the patient developed rash. On an unspecified date, the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Rales
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 741869), concerns a 42-year-old, adult, female patient. On an unspecified date, the patient was administered influenza vaccine (dose, route of administration, anatomical location: unknown, batch number, expiry date, trade name, manufacturer: not reported). On 02-Nov-2017, the patient experienced lip swelling and respiratory crackles (considered as allergic reaction). At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Update 31-Jul-2018: Significant case correction received with IRD 02-Jul-2018: The company causality for all the events was changed from 'related' to 'unassessable'. The narrative was corrected.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Computerised tomogram, Headache, Myalgia, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 742053), concerns a 61-year-old, adult male patient. The patient's historical conditions were not reported. The patient had no allergies. The patient's concomitant medications included Loperamide and WELCHOL for unknown indications. On 15-Oct-2016, the patient was administered influenza vaccine (anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name and manufacturer: not reported) and non-company suspect product pneumococcal vaccine (anatomical location: left arm, dose, route of administration, batch number and expiry date: not reported). On 21-Mar-2017, patient received a non-company suspect product testosterone cypionate (dose, route of administration, batch number and expiry date: not reported) for an unknown indication. On an unspecified date in 2017 (reported as between 21-Mar-2017 and Oct/Nov 2017), after vaccination, the patient experienced 2 episodes of soreness, hives and muscle pain in left arm while bending or lifting. The patient went to the clinic and was seen by various doctors over the time. The patient was prescribed with an unspecified over the counter medication for soreness. On an unspecified date (reported as last month), the patient again went to the doctor with headache, skin ulcer and persisted pain in arm and neck and prescribed ibuprofen 800 mg. On an unknown date, patient's nuclear magnetic resonance imaging (MRI), computerised tomogram (CT) scan and X ray were performed for which results were not reported. The patient referred to the neurologist and his appointment was scheduled on 05th of April (unspecified year). It was reported that, patient received TYLENOL-Extra Strength 1-2 times a day and up to 4 times a day. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update 31-Jul-2018: Significant case correction received with IRD 02-Jul-2018: The company causality for the events (headaches, skin ulcer, pain in arm and neck pain) was changed to not related. The case comment was corrected.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain, Pain in extremity, Skin ulcer, Skull X-ray, Urticaria
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 742053), concerns a 61-year-old, adult male patient. The patient's historical conditions were not reported. The patient had no allergies. The patient's concomitant medications included Loperamide and WELCHOL for unknown indications. On 15-Oct-2016, the patient was administered influenza vaccine (anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name and manufacturer: not reported) and non-company suspect product pneumococcal vaccine (anatomical location: left arm, dose, route of administration, batch number and expiry date: not reported). On 21-Mar-2017, patient received a non-company suspect product testosterone cypionate (dose, route of administration, batch number and expiry date: not reported) for an unknown indication. On an unspecified date in 2017 (reported as between 21-Mar-2017 and Oct/Nov 2017), after vaccination, the patient experienced 2 episodes of soreness, hives and muscle pain in left arm while bending or lifting. The patient went to the clinic and was seen by various doctors over the time. The patient was prescribed with an unspecified over the counter medication for soreness. On an unspecified date (reported as last month), the patient again went to the doctor with headache, skin ulcer and persisted pain in arm and neck and prescribed ibuprofen 800 mg. On an unknown date, patient's nuclear magnetic resonance imaging (MRI), computerised tomogram (CT) scan and X ray were performed for which results were not reported. The patient referred to the neurologist and his appointment was scheduled on 05th of April (unspecified year). It was reported that, patient received TYLENOL-Extra Strength 1-2 times a day and up to 4 times a day. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update 31-Jul-2018: Significant case correction received with IRD 02-Jul-2018: The company causality for the events (headaches, skin ulcer, pain in arm and neck pain) was changed to not related. The case comment was corrected.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal X-ray, Abdominal pain upper, Back pain, Blood test normal, Chest X-ray normal
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 742101), concerns a 10-year-old, male child patient. The patient's current condition included moderate eczema since a baby (reported as medical history). On 22-Feb-2018, the patient was administered FLUVIRIN [dose: 0.5 ml, frequency reported as unknown, route of administration: injection (reported as SYR), anatomical location: right arm, batch number and expiry date: not reported]. On the same day after vaccination, the patient experienced constant severe chest pain. The patient also experienced dizziness, fatigue, lack of appetite and intermittent pain in his stomach, side and back. Since 26-Feb-2018 (reported as Monday), the patient was sick. The patient was seen by four different doctors (two primary care physicians (PCPs), one paediatrician and one paediatric gastrointestinal (GI) specialist). At the time of this report, the patient was not diagnosed. On unspecified dates, the patient had two blood tests and stool test done which were found to be normal. On unspecified dates, chest and abdominal X-rays, an electrocardiogram (EKG) was performed which showed normal results. It was reported that, the patient had made an office visit. At the time of reporting, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Decreased appetite, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 742101), concerns a 10-year-old, male child patient. The patient's current condition included moderate eczema since a baby (reported as medical history). On 22-Feb-2018, the patient was administered FLUVIRIN [dose: 0.5 ml, frequency reported as unknown, route of administration: injection (reported as SYR), anatomical location: right arm, batch number and expiry date: not reported]. On the same day after vaccination, the patient experienced constant severe chest pain. The patient also experienced dizziness, fatigue, lack of appetite and intermittent pain in his stomach, side and back. Since 26-Feb-2018 (reported as Monday), the patient was sick. The patient was seen by four different doctors (two primary care physicians (PCPs), one paediatrician and one paediatric gastrointestinal (GI) specialist). At the time of this report, the patient was not diagnosed. On unspecified dates, the patient had two blood tests and stool test done which were found to be normal. On unspecified dates, chest and abdominal X-rays, an electrocardiogram (EKG) was performed which showed normal results. It was reported that, the patient had made an office visit. At the time of reporting, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Flank pain, Malaise, Stool analysis normal, X-ray normal
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 742101), concerns a 10-year-old, male child patient. The patient's current condition included moderate eczema since a baby (reported as medical history). On 22-Feb-2018, the patient was administered FLUVIRIN [dose: 0.5 ml, frequency reported as unknown, route of administration: injection (reported as SYR), anatomical location: right arm, batch number and expiry date: not reported]. On the same day after vaccination, the patient experienced constant severe chest pain. The patient also experienced dizziness, fatigue, lack of appetite and intermittent pain in his stomach, side and back. Since 26-Feb-2018 (reported as Monday), the patient was sick. The patient was seen by four different doctors (two primary care physicians (PCPs), one paediatrician and one paediatric gastrointestinal (GI) specialist). At the time of this report, the patient was not diagnosed. On unspecified dates, the patient had two blood tests and stool test done which were found to be normal. On unspecified dates, chest and abdominal X-rays, an electrocardiogram (EKG) was performed which showed normal results. It was reported that, the patient had made an office visit. At the time of reporting, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Chills, Headache, Injection site pruritus, Nausea
Clinical narrative: This is a spontaneous case, reported by physician to VAERS and initially retrieved on 02-Jul-2018 by Seqirus from VAERS (VAERS ID: 742135), concerns a 74-year-old, elderly female patient. The patient's medical history and concomitant medication were not reported. On 08-Jan-2018, the patient was administered influenza vaccine (anatomical location: right vastus, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On 12-Jun-2018, 4 days after vaccination, the patient experienced severe headache, burning sensation, itching at the site, teeth chattering, chills and nausea but had no vomiting. Laboratory investigation and treatment were not reported. The outcome of the events was unknown. The reporter assessed this case as non-serious.
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 742380), concerns a 04-year-old, female child patient. On 26-Mar-2018, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left leg, batch number: 1721501, expiry date: not reported) and non-company suspect vaccine KINRIX (dose: 0.5 ml [frequency reported as 1], route of administration: intramuscular, anatomical location: right leg, batch number; 2439H, expiry date: not reported). On 27-Mar-2018, 1 day after vaccination, the patient developed erythema, oedema, tenderness and warmth on her left thigh at injection site. The patient's mom noticed the next day that, the reaction was of 2 inches and 24 hours later, it was doubled in size. It was mentioned, that they had iced the area prior to the events being noticed. The patient had made a physician office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This spontaneous case, was reported by other health professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (743286) and concerns an adult male patient of unspecified age. On an unspecified date in 2010, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date in 2010, after vaccination, the patient became sick. Other laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was not reported. The reporter assessed this case as non-serious. This case (201803101) was linked to the original case (201803100) due to same patient. Update 26-Aug-2018: Significant case correction was performed 02-Aug-2018: The as determined causality of the event (malaise) was changed from 'related' to 'unassessable' and the case comment amended accordingly.
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 743504), concerns a 60-year-old, adult, female patient. The patient's current condition included diabetes type 1 (reported as medical history) (since an unspecified date). The patient's concomitant medications included insulin, estrogen (estradiol), magnesium, vitamin B complex, Vitamin C and Vitamin D. On 25-Oct-2017, the patient was administered INN Flu vaccine seasonal (dose, route of administration, anatomical location: unknown, batch number, expiry date, trade name, and manufacturer: not reported). On 27-Oct-2017, 2 days after vaccination, the patient developed pain and limited movement of left shoulder and arm. The patient experienced disrupt sleep and chronic pain exacerbated by moving arm back which persisted for 5 months and was not subsided. It was reported that, the patient had made a visit to office. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 744595), concerns a 40-year-old, adult female patient. The patient's historical condition included overweight. The patient's current illness, allergies and concomitant medications were not reported. On 16-Mar-2018, the patient was administered FLUVIRIN (dose: 0.5 ml [frequency reported as 7+], route of administration: intramuscular, anatomical location: left arm, batch number: 179804P, expiry date: not reported) and Dtap (dose: [frequency reported as 1], route of administration: intramuscular, anatomical location: left arm, batch number: 22X79, expiry date: not reported). On the same day after vaccination, the patient experienced headache, chills and fever. The patient had made an office visit. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 744876), concerning a 57-year-old, adult, female patient. On 19-Oct-2017, the patient was administered FLUVIRIN (TIV) (dose: 0.5 ml, batch number: 179903P, route of administration: unknown, anatomical location: left arm, expiry date: not reported). On the same day (19-Oct-2017) after vaccination, the patient developed a knot on her arm. Over six months after vaccination, the knot had not yet receded. At the time of the report, the patient had not recovered from the event. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy test, Cough, Lower respiratory tract congestion, Pain, Pulmonary function test
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 25-year-old, adult, female patient. On unspecified dates in 2009, 2010, 2011, 2013 and 2014, the patient administered the influenza vaccine and 2 weeks after vaccination developed reproducible likely non-immunoglobulin E [IgE] mediated reactions with same severity which included fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient's current conditions included allergic rhinitis (reported as medical history) and patient was allergic to sulpha drugs (since an unspecified date). On 01-Sep-2015, the patient was administered influenza vaccine, (dose: unknown, route of administration, anatomical site, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date in Sep-2015, 2 weeks after vaccination [as reported], the patient experienced fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient had made an emergency room and physician office visit. On an unspecified date in 2015, the patient underwent pulmonary evaluation for reaction and was sent for allergy evaluation to identify the potential etiology (findings not reported). It was reported that, the patient did not decline yearly vaccinations as she worked as a registered nurse in a hospital. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious and the causality of the events as related to the suspect vaccine.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Upper respiratory tract congestion
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 25-year-old, adult, female patient. On unspecified dates in 2009, 2010, 2011, 2013 and 2014, the patient administered the influenza vaccine and 2 weeks after vaccination developed reproducible likely non-immunoglobulin E [IgE] mediated reactions with same severity which included fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient's current conditions included allergic rhinitis (reported as medical history) and patient was allergic to sulpha drugs (since an unspecified date). On 01-Sep-2015, the patient was administered influenza vaccine, (dose: unknown, route of administration, anatomical site, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date in Sep-2015, 2 weeks after vaccination [as reported], the patient experienced fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient had made an emergency room and physician office visit. On an unspecified date in 2015, the patient underwent pulmonary evaluation for reaction and was sent for allergy evaluation to identify the potential etiology (findings not reported). It was reported that, the patient did not decline yearly vaccinations as she worked as a registered nurse in a hospital. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious and the causality of the events as related to the suspect vaccine.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cough, Lower respiratory tract congestion, Pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 25-year-old, adult, female patient. On unspecified dates in 2009, 2010, 2011, 2013 and 2014, the patient administered the influenza vaccine and 2 weeks after vaccination developed reproducible likely non-immunoglobulin E [IgE] mediated reactions with same severity which included fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient's current conditions included allergic rhinitis (reported as medical history) and patient was allergic to sulpha drugs (since an unspecified date). On 01-Sep-2015, the patient was administered influenza vaccine, (dose: unknown, route of administration, anatomical site, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date in Sep-2015, 2 weeks after vaccination [as reported], the patient experienced fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient had made an emergency room and physician office visit. On an unspecified date in 2015, the patient underwent pulmonary evaluation for reaction and was sent for allergy evaluation to identify the potential etiology (findings not reported). It was reported that, the patient did not decline yearly vaccinations as she worked as a registered nurse in a hospital. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious and the causality of the events as related to the suspect vaccine.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: This spontaneous case, reported by other non-health professional (consumer) to VAERS and initially retrieved on 06-Aug-2018 by Seqirus from VAERS (VAERS ID: 745656), concerns a 46-year-old, adult female patient. The patient had been receiving the flu shot for over 25 years but never had an issue. The patient had no medical history, current illnesses and allergies. The patient's concomitant medication included probiotic. On 01-Jan-2018, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day, after vaccination, the patient experienced pain in left arm at the injection site. It was reported that, the pain was so severe for 02 months that woke up her in night. At the time of this report, the patient still had pain but was manageable (almost 4 months as of now). At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update 26-Aug-2018: Significant case correction was performed with IRD 06-Aug-2018: The as determined causality of the event (sleep disturbance) was corrected from related to not related in event assessment tab. The case comment was corrected accordingly.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Sep-2018 by Seqirus from VAERS (VAERS ID: 750204), concerns a 72-year-old, elderly male patient. The patient had no relevant history and current condition. The patient had no known drug allergies (NKDA). The concomitant medications included ASA and CELEBREX for unknown indications. On 09-Feb-2018, the patient was administered FLUVIRIN Thiomersal [dose: 0.5 ml, (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 1721401 and expiry date: not reported]. On 10-Feb-2018, one day after vaccination, the patient experienced pain in his right shoulder. On an unspecified date, the patient made a physician office visit. The patient was prescribed two steroid dose packs and eventually underwent nuclear magnetic resonance imaging (MRI) (result was not reported). The patient was also given cortisone shot that had worn off. At the time of this report, the patient was then being treated with CELEBREX. At the time of this report, the patient still had pain (not recovered). The reported assessed this case as non-serious. Update received on 27-Sep-2018: Significant case correction (IRD: 03-Sep-2018): The CELEBREX was added as concomitant medication in the product tab. The narrative was amended accordingly.
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 766681), concerns an adult female patient of unspecified age. On an unspecified date, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date and trade name: not reported). On an unspecified date in 2017 (reported as last year), after vaccination, the patient developed swelling in arm. The outcome of the event swelling in arm was not reported. This case: 201805043 was linked to the source case: 201804977 due to the same reporter/patient. The reporter assessed this case as non-serious.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphasia, Gait inability, Pulmonary thrombosis
Clinical narrative: This case was reported by a consumer via other and described the occurrence of stomach pain in a female patient who received SHINGRIX for prophylaxis. On 29th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced stomach pain (serious criteria hospitalization), nausea (serious criteria hospitalization) and diarrhea (serious criteria hospitalization). On an unknown date, the outcome of the stomach pain, nausea and diarrhea were unknown. The reporter considered the stomach pain, nausea and diarrhea to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient ended up being hospitalized for severe stomach pain, nausea and diarrhea. The patient believed that, all her medical treatment and recent health problems were related to this vaccine. For tolerance to next dose, refer case US2019GSK004751.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: This case was reported by a consumer via other and described the occurrence of stomach pain in a female patient who received SHINGRIX for prophylaxis. On 29th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced stomach pain (serious criteria hospitalization), nausea (serious criteria hospitalization) and diarrhea (serious criteria hospitalization). On an unknown date, the outcome of the stomach pain, nausea and diarrhea were unknown. The reporter considered the stomach pain, nausea and diarrhea to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient ended up being hospitalized for severe stomach pain, nausea and diarrhea. The patient believed that, all her medical treatment and recent health problems were related to this vaccine. For tolerance to next dose, refer case US2019GSK004751.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Myalgia, Pain, Pain in extremity
Clinical narrative: Muscle in left arm is still tender at injection site. I can press on arm and know exactly where shot was given. Sleeping on left arm had caused pain but gradually is residing. Lifting arm above ahead and trying to circle still causes a bit of discomfort.