chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Respiratory syncytial virus test negative, Respirovirus test, Rhinorrhoea, Vaccination failure, Viral test negative
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 765665), concerns an adult, female pregnant patient of unspecified age (equal or more than 18 years as reported). It was reported that the patient was the part of study which aims the study of acute respiratory illness due to respiratory viruses and associated clinical outcomes during pregnancy. The patient was enrolled Patients were enrolled at an outpatient obstetric (for routine and high-risk obstetric care) and gynaecologic clinic, between 1 October and 10 May to coincide with the 2015-2016 respiratory virus season. The patient's family history, medical history and the concomitant medications were not reported. On an unspecified date, the patient was administered influenza vaccine [dose, route of administration and anatomical location: unknown, batch number, expiry date, manufacturer and trade name: not reported]. It was unknown whether the vaccination was given during pregnancy or not (as reported). On an unspecified date (between 01-Oct-2015 to 10-May-2016, 2015-2016, 7-month season of respiratory virus season) after vaccination, in her second or third trimester period, during the regular prenatal and sick visits at an outpatient center and gynaecologic clinic the patient reported symptoms of acute respiratory infection which included rhinorrhea, sore throat, cough, shortness of breath, wheezing. On an unspecified date (less than or equal to 7 days of symptom onset) the visited the clinic and diagnosed with acute lower respiratory tract illness (ALRTI). The patient's nasopharyngeal secretions were collected by a combined throat and nasal swab and evaluated for respiratory viruses by real-time reverse transcription-polymerase chain reaction (RT-PCR). The respiratory syncytial virus (RSV) A and B tests, human rhinovirus (HRV) virus tests, influenza virus types A and B tests; human coronaviruses (HCoVs) NL-63, HKU1, OC43, and 229E tests, parainfluenza virus (PIV) types 1, 2, and 3 tests, human metapneumovirus (HMPV) tests, adenovirus, bocavirus, mycoplasma pneumoniae and Bordetella pertussis virus tests were performed. The virus tests, RSV tests and Bordetella pertussis tests showed negative. Influenza virus test and polymerase chain reaction was found to be positive. The normal laboratory results were not reported. On an unspecified date, the patient was diagnosed with unspecified type of influenza (considered as vaccination failure). The patient's treatment was unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Wheezing
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 765665), concerns an adult, female pregnant patient of unspecified age (equal or more than 18 years as reported). It was reported that the patient was the part of study which aims the study of acute respiratory illness due to respiratory viruses and associated clinical outcomes during pregnancy. The patient was enrolled Patients were enrolled at an outpatient obstetric (for routine and high-risk obstetric care) and gynaecologic clinic, between 1 October and 10 May to coincide with the 2015-2016 respiratory virus season. The patient's family history, medical history and the concomitant medications were not reported. On an unspecified date, the patient was administered influenza vaccine [dose, route of administration and anatomical location: unknown, batch number, expiry date, manufacturer and trade name: not reported]. It was unknown whether the vaccination was given during pregnancy or not (as reported). On an unspecified date (between 01-Oct-2015 to 10-May-2016, 2015-2016, 7-month season of respiratory virus season) after vaccination, in her second or third trimester period, during the regular prenatal and sick visits at an outpatient center and gynaecologic clinic the patient reported symptoms of acute respiratory infection which included rhinorrhea, sore throat, cough, shortness of breath, wheezing. On an unspecified date (less than or equal to 7 days of symptom onset) the visited the clinic and diagnosed with acute lower respiratory tract illness (ALRTI). The patient's nasopharyngeal secretions were collected by a combined throat and nasal swab and evaluated for respiratory viruses by real-time reverse transcription-polymerase chain reaction (RT-PCR). The respiratory syncytial virus (RSV) A and B tests, human rhinovirus (HRV) virus tests, influenza virus types A and B tests; human coronaviruses (HCoVs) NL-63, HKU1, OC43, and 229E tests, parainfluenza virus (PIV) types 1, 2, and 3 tests, human metapneumovirus (HMPV) tests, adenovirus, bocavirus, mycoplasma pneumoniae and Bordetella pertussis virus tests were performed. The virus tests, RSV tests and Bordetella pertussis tests showed negative. Influenza virus test and polymerase chain reaction was found to be positive. The normal laboratory results were not reported. On an unspecified date, the patient was diagnosed with unspecified type of influenza (considered as vaccination failure). The patient's treatment was unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Respiratory syncytial virus test negative, Respiratory tract infection, Rhinorrhoea, Vaccination failure, Viral test negative
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 765665), concerns an adult, female pregnant patient of unspecified age (equal or more than 18 years as reported). It was reported that the patient was the part of study which aims the study of acute respiratory illness due to respiratory viruses and associated clinical outcomes during pregnancy. The patient was enrolled Patients were enrolled at an outpatient obstetric (for routine and high-risk obstetric care) and gynaecologic clinic, between 1 October and 10 May to coincide with the 2015-2016 respiratory virus season. The patient's family history, medical history and the concomitant medications were not reported. On an unspecified date, the patient was administered influenza vaccine [dose, route of administration and anatomical location: unknown, batch number, expiry date, manufacturer and trade name: not reported]. It was unknown whether the vaccination was given during pregnancy or not (as reported). On an unspecified date (between 01-Oct-2015 to 10-May-2016, 2015-2016, 7-month season of respiratory virus season) after vaccination, in her second or third trimester period, during the regular prenatal and sick visits at an outpatient center and gynaecologic clinic the patient reported symptoms of acute respiratory infection which included rhinorrhea, sore throat, cough, shortness of breath, wheezing. On an unspecified date (less than or equal to 7 days of symptom onset) the visited the clinic and diagnosed with acute lower respiratory tract illness (ALRTI). The patient's nasopharyngeal secretions were collected by a combined throat and nasal swab and evaluated for respiratory viruses by real-time reverse transcription-polymerase chain reaction (RT-PCR). The respiratory syncytial virus (RSV) A and B tests, human rhinovirus (HRV) virus tests, influenza virus types A and B tests; human coronaviruses (HCoVs) NL-63, HKU1, OC43, and 229E tests, parainfluenza virus (PIV) types 1, 2, and 3 tests, human metapneumovirus (HMPV) tests, adenovirus, bocavirus, mycoplasma pneumoniae and Bordetella pertussis virus tests were performed. The virus tests, RSV tests and Bordetella pertussis tests showed negative. Influenza virus test and polymerase chain reaction was found to be positive. The normal laboratory results were not reported. On an unspecified date, the patient was diagnosed with unspecified type of influenza (considered as vaccination failure). The patient's treatment was unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 43.0
Sex: M
Vaccine: FLUX, PPV, TTOX, FLUX, PPV, TTOX
Symptoms: Electromyogram abnormal, Foreign travel, Gait inability, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 766810), concerns a 43-year-old, adult male patient. The patient's historical condition included chronic diarrhoea after bowel resection (procedure). In past, the patient experienced rash after taking vancomycin. The concomitant medication included pantoprazole for an unknown indication. On 01-Apr-2018, the patient was administered INN flu vaccine seasonal (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported), on the same day the patient was also administered non-company suspect vaccines, pneumococcal vaccine (dose, route of administration, anatomical location, batch number and expiry date: not reported) and tetanus vaccine (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, after vaccination, the patient went on a trip. On 26-May-2018, approximately 3 to 4 weeks later, upon return from the trip, the patient developed pins and needle sensation which progressed to thighs, weakness of legs and was unable to ambulate. The patient went to an emergency room. Subsequently, the patient was hospitalized. On 28-May-2018, the patient underwent plasmapheresis. On the same day, lumbar puncture was performed, and the results were consistent with acute inflammatory demyelinating polyneuropathy. On an unspecified date, electromyogram (EMG) and nerve conduction studies were performed, and the reports of both the studies were abnormal consistent with severe length dependent demyelinating sensorimotor peripheral neuropathy with very little denervation but secondary axonal degeneration in the lower extremity. It was reported that the patient was hospitalized for 32 days. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as serious (hospitalization). Adjudication Data Entry
Age: 43.0
Sex: M
Vaccine: FLUX, PPV, TTOX, FLUX, PPV, TTOX
Symptoms: Muscular weakness, Nerve conduction studies abnormal, Paraesthesia, Peripheral sensorimotor neuropathy, Plasmapheresis
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 766810), concerns a 43-year-old, adult male patient. The patient's historical condition included chronic diarrhoea after bowel resection (procedure). In past, the patient experienced rash after taking vancomycin. The concomitant medication included pantoprazole for an unknown indication. On 01-Apr-2018, the patient was administered INN flu vaccine seasonal (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported), on the same day the patient was also administered non-company suspect vaccines, pneumococcal vaccine (dose, route of administration, anatomical location, batch number and expiry date: not reported) and tetanus vaccine (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, after vaccination, the patient went on a trip. On 26-May-2018, approximately 3 to 4 weeks later, upon return from the trip, the patient developed pins and needle sensation which progressed to thighs, weakness of legs and was unable to ambulate. The patient went to an emergency room. Subsequently, the patient was hospitalized. On 28-May-2018, the patient underwent plasmapheresis. On the same day, lumbar puncture was performed, and the results were consistent with acute inflammatory demyelinating polyneuropathy. On an unspecified date, electromyogram (EMG) and nerve conduction studies were performed, and the reports of both the studies were abnormal consistent with severe length dependent demyelinating sensorimotor peripheral neuropathy with very little denervation but secondary axonal degeneration in the lower extremity. It was reported that the patient was hospitalized for 32 days. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as serious (hospitalization). Adjudication Data Entry
Age: 43.0
Sex: M
Vaccine: FLUX, PPV, TTOX, FLUX, PPV, TTOX
Symptoms: Demyelination, Electromyogram abnormal, Gait inability, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 766810), concerns a 43-year-old, adult male patient. The patient's historical condition included chronic diarrhoea after bowel resection (procedure). In past, the patient experienced rash after taking vancomycin. The concomitant medication included pantoprazole for an unknown indication. On 01-Apr-2018, the patient was administered INN flu vaccine seasonal (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported), on the same day the patient was also administered non-company suspect vaccines, pneumococcal vaccine (dose, route of administration, anatomical location, batch number and expiry date: not reported) and tetanus vaccine (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, after vaccination, the patient went on a trip. On 26-May-2018, approximately 3 to 4 weeks later, upon return from the trip, the patient developed pins and needle sensation which progressed to thighs, weakness of legs and was unable to ambulate. The patient went to an emergency room. Subsequently, the patient was hospitalized. On 28-May-2018, the patient underwent plasmapheresis. On the same day, lumbar puncture was performed, and the results were consistent with acute inflammatory demyelinating polyneuropathy. On an unspecified date, electromyogram (EMG) and nerve conduction studies were performed, and the reports of both the studies were abnormal consistent with severe length dependent demyelinating sensorimotor peripheral neuropathy with very little denervation but secondary axonal degeneration in the lower extremity. It was reported that the patient was hospitalized for 32 days. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as serious (hospitalization). Adjudication Data Entry
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous case, reported by pharmacist to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 766904), concerns a female patient of unspecified age. On an unspecified date in 2017, the patient was administered influenza vaccine [anatomical location: arm, dose, route of administration, batch number, expiry date, manufacturer and trade name: not reported] and non-company suspect product PNEUMOVAX 23 [route of administration: intramuscular, anatomical location: arm, batch number: N013541, expiry date: 23-Jan-2019, dose: not reported]. It was reported that, both the vaccines were administered to the same arm. On an unspecified date in 2017, after vaccination, the patient developed cellulitis at the injection site. On an unspecified date, the patient went to emergency room and received BACTRIM DS for cellulitis. It was unknown whether lab diagnostic tests or studies were performed. At the time of this report, the outcome of the event injection site cellulitis was unknown. The reporter assessed the case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dyspnoea, Ocular hyperaemia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 767205), concerns a 52-year-old, adult, female patient. On 22-Aug-2018, the patient was administered influenza vaccine, (dose, route of administration, anatomical location: unknown, batch number, trade name, manufacturer and expiry date: not reported). On the same day, after vaccination, the patient experienced shortness of breath (SOB) and developed red eyes. On an unspecified date, the patient had made an emergency room and physician office visit. The patient was treated with SOLU-MEDROL injection (125 mg) and BENADRYL injection (50 mg). At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 67.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 767471), concerns a 67-year-old, elderly female patient. The patient was allergic to macrolide antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs). The patient's concomitant medications included loratadine, NORCO, omeprazole, telmisartan, duloxetine, gabapentin and fluticasone for unknown indications. On 24-Aug-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 250790 and expiry date: not reported). On the next day (25-Aug-2018) after vaccination, the patient experienced soreness in arm, redness around the injection site and itching. 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, FLUX, FLUX
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous case, reported by a pharmacist to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 767541), concerns a patient of an unspecified age and gender. On an unspecified date, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date after the vaccination, the patient experienced allergic reaction. At the time of report, the outcome of the event was not reported. The reporter assessed the case as non-serious. This case: 201805326 was cross-linked to the case: 201804932 (same patient).
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous case, reported by pharmacist to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 767541), concerns an adult patient of an unspecified age and gender. The patient experienced allergic reaction to flu shot in the past. On an unspecified date, 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 after the vaccination, the patient experienced allergic reaction. At the time of report, the outcome of the event was unknown. The reporter assessed the case as non-serious. This case: 201804932 was cross-linked to the case: 201805326 (same patient).
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 767965), concerning a 74-year-old, elderly female patient. The patient's current condition included high blood pressure (reported as medical history). The patient was allergic to sulfa drugs and bee sting. The concomitant medications included amlodipine w/olmesartan, EVISTA, calcium plus D plus K and ibuprofen for unknown indications. On 27-Aug-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, frequency: unknown, route of administration, anatomical location, batch number and expiry date: not reported]. The patient was also administered a non-company suspect vaccine PNEUMOVAX (frequency: unknown, dose, route of administration, anatomical location, batch number and expiry date: not reported]. On the same day after vaccination, the patient experienced severe pain in her left arm and she was unable to move it. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 65.0
Sex: M
Vaccine: FLUA3, PPV, TDAP, FLUA3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 767966), concerns a 65-year-old, elderly, male patient. On 22-Aug-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 251234 (as reported) and expiry date: not reported). The co-suspects included PNEUMOVAX (dose: frequency reported as 2, route of administration: intramuscular, anatomical location: left arm, batch number: R009163 and expiry date: not reported) and BOOSTRIX (route of administration: intramuscular, anatomical location: right arm, batch number: X55LD, dose and expiry date: not reported). On an unspecified date after vaccination, the patient experienced redness and tenderness at site of injection. The patient's blood pressure was 136/88. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS (VAERS ID: 768265) and initially retrieved  on 30-Oct-2018, concerning a 49-year-old, adult female patient. The patient's medical history, current conditions and drug interaction or allergies were unknown. On 28-Aug-2018, the patient (under age of 65 years) was administered 0.5 ml (frequency: 1), intramuscular, FLUAD (TIV) [egg-derived, MF59, batch number: 250790, expiry date: not reported] in left arm (coded as inappropriate age at vaccination administration). The pharmacist without proper knowledge, thought the patient was vaccinated against flu but did not realize that she was vaccinating the patient using an age specific product. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS (VAERS ID: 768265) and initially retrieved  on 30-Oct-2018, concerning a 49-year-old, adult female patient. The patient's medical history, current conditions and drug interaction or allergies were unknown. On 28-Aug-2018, the patient (under age of 65 years) was administered 0.5 ml (frequency: 1), intramuscular, FLUAD (TIV) [egg-derived, MF59, batch number: 250790, expiry date: not reported] in left arm (coded as inappropriate age at vaccination administration). The pharmacist without proper knowledge, thought the patient was vaccinated against flu but did not realize that she was vaccinating the patient using an age specific product. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Dyspnoea, Erythema, Pruritus, Skin warm
Clinical narrative: This non-serious spontaneous case reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 768370), concerns an adolescent female patient of an unspecified age. On an unspecified date in 2017, the patient was administered influenza vaccine, (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date, after vaccination, the patient developed redness at the injection site which was hard. At the time of this report, the outcome of the event was not reported. This case 201805119 was linked to original case 201805028 due to same reporter.
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This non-serious spontaneous case reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 768370), concerns an adolescent female patient of an unspecified age. On an unspecified date in 2017, the patient was administered influenza vaccine, (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date, after vaccination, the patient developed redness at the injection site which was hard. At the time of this report, the outcome of the event was not reported. This case 201805119 was linked to original case 201805028 due to same reporter.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Nausea, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 768559), concerns a 66-year-old, elderly female patient. The patient's current condition included headache (reported as prior to vaccination). The patient had been allergic to cephalexin, azithromycin and tobramycin. On 28-Aug-2018, the patient was administered FLUAD [TIV] (does: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 25134 and expiry date: not reported) and non-company suspect product PNEUMOVAX (route of administration: intramuscular, anatomical location: left arm, batch number: R006466, dose and expiry date: not reported). On the same day, after vaccination, in the evening, the patient experienced fever, body aches and nausea. Additionally, the patient experienced redness, hardness and soreness at injection site. On an unspecified date in Aug-2018 (reported as after two days), the patient had recovered from the events fever, body aches and nausea. The events redness, hardness and soreness at injection site had gotten better, but not yet completely recovered. The reporter assessed this case as non-serious.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 768559), concerns a 66-year-old, elderly female patient. The patient's current condition included headache (reported as prior to vaccination). The patient had been allergic to cephalexin, azithromycin and tobramycin. On 28-Aug-2018, the patient was administered FLUAD [TIV] (does: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 25134 and expiry date: not reported) and non-company suspect product PNEUMOVAX (route of administration: intramuscular, anatomical location: left arm, batch number: R006466, dose and expiry date: not reported). On the same day, after vaccination, in the evening, the patient experienced fever, body aches and nausea. Additionally, the patient experienced redness, hardness and soreness at injection site. On an unspecified date in Aug-2018 (reported as after two days), the patient had recovered from the events fever, body aches and nausea. The events redness, hardness and soreness at injection site had gotten better, but not yet completely recovered. The reporter assessed this case as non-serious.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administration error
Clinical narrative: This spontaneous case, initially received on 17-Sep-2018, from a pharmacist, concerning a 73-year-old, elderly, female patient of weight 165 pounds. The patient's historical conditions and concomitant medications were unknown. On 17-Sep-2018, at 4pm, the patient was administered FLUAD TIV [dose: 0.5 ml, batch number: 250792, expiry date: 30-Apr-2019, route of administration and anatomical location: not reported] with a 5/8-inch needle instead of 1-inch needle (which was usually used for intramuscular injections) (explicitly coded as drug administration error). The pharmacist was not sure if the needle penetrated the muscle. The patient did not experience any adverse events, after administration of the vaccine. The reporter assessed this case as non-serious. The case was considered as lost to follow-up as the reporter had not provided the consent to follow-up.
Sex: M
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous case, initially received from pharmacist on 16-Oct-2018, concerning an elderly, male patient of unspecified age. On an unspecified date, the patient was administered FLUAD (TIV) (dose, route of administration, batch number and expiry date: not reported). The patient was also administered PNEUMOVAX 23 (dose: reported as 1, frequency: once as reported, batch number: N032092, expiry date: 09-Dec-2019 and anatomical location: arm). On an unspecified day after vaccination, the patient experienced redness and swelling at injection site that went from shoulder to elbow, the skin at the injection site was painful to touch and the patient had trouble lifting the injected arm. It was reported that, the patient under the weather felt flu like symptoms that persisted for 3 to 4 days. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious. Follow-up received on 02-Nov-2018 (combinedly processed with follow-up received on 14-Nov-2018): The suspect vaccine coding was changed to FLUAD (TIV) to Non Seqirus Product in the product tab. The narrative was amended accordingly. Significant case amendment (02-Nov-2018): The suspect vaccine coding was changed from Non Seqirus Product to FLUAD (TIV) in the product tab. The narrative was amended accordingly.
Age: 83.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Musculoskeletal disorder, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 10-Oct-2018, concerns an 83-year-old, elderly, female patient. The patient did not have any medical history. The patient's concomitant medication included unspecified eye drops for unknown indication. On 01-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250793 and expiry date: 30-Apr-2019]. On 02-Oct-2018, one day after vaccination, the patient experienced swelling and soreness at the injection site and then it went to her arm, wrist and finger tips. It was reported that it was still sore (reported as of yesterday). At the time of this report, the patient had not recovered from the events injection site pain and radiating pain and the outcome of the events injection site swelling, swelling arm and swelling wrist was not reported. The reporter assessed the case as non-serious. Non-significant follow up received from the reporter on 02-Nov-2018: No new information was received. Hence, no changes were made in narrative.
Age: 83.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Joint swelling, Pain in extremity
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 10-Oct-2018, concerns an 83-year-old, elderly, female patient. The patient did not have any medical history. The patient's concomitant medication included unspecified eye drops for unknown indication. On 01-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250793 and expiry date: 30-Apr-2019]. On 02-Oct-2018, one day after vaccination, the patient experienced swelling and soreness at the injection site and then it went to her arm, wrist and finger tips. It was reported that it was still sore (reported as of yesterday). At the time of this report, the patient had not recovered from the events injection site pain and radiating pain and the outcome of the events injection site swelling, swelling arm and swelling wrist was not reported. The reporter assessed the case as non-serious. Non-significant follow up received from the reporter on 02-Nov-2018: No new information was received. Hence, no changes were made in narrative.
Age: 83.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 10-Oct-2018, concerns an 83-year-old, elderly, female patient. The patient did not have any medical history. The patient's concomitant medication included unspecified eye drops for unknown indication. On 01-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250793 and expiry date: 30-Apr-2019]. On 02-Oct-2018, one day after vaccination, the patient experienced swelling and soreness at the injection site and then it went to her arm, wrist and finger tips. It was reported that it was still sore (reported as of yesterday). At the time of this report, the patient had not recovered from the events injection site pain and radiating pain and the outcome of the events injection site swelling, swelling arm and swelling wrist was not reported. The reporter assessed the case as non-serious. Non-significant follow up received from the reporter on 02-Nov-2018: No new information was received. Hence, no changes were made in narrative.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Pain of skin, Pruritus, Rash
Clinical narrative: Arm painful greater than 7 days.  8/17 (10 days after vaccination) skin on back became painful and itchy. Rash erupted 8/20. Saw MD 8/21 - diagnosed with shingles.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient states that as soon as the needle went in her shoulder she felt a pain at the injection site. She was sore for about a week. After that week, she experienced pain up and down her arm when  she stretched up or put a jacket on.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient states that as soon as the needle went in her shoulder she felt a pain at the injection site. She was sore for about a week. After that week, she experienced pain up and down her arm when  she stretched up or put a jacket on.
Age: 75.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from an approximately 75 years old patient, reporting on herself with drug reactions or allergies sulfa, penicillin, "some metals", atorvastatin calcium (LIPITOR), cephalexin (KEFLEX ) and codeine. Historical drug include: sulfa, ,atorvastatin calcium (LIPITOR), cephalexin (KEFLEX),codeine. Concomitant therapies include: a lot of medications unspecified. On 05-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 lot # N000463, expiration date 19-OCT-2018, intramuscularly, for prophylaxis (strength and dose were not provided). A few days after vaccination the patient experienced severe pain in her arm approximately in October 2018.The patient sought medical attention by calling  her physician , who stated that the pain should only last 3-5 days, but the pain had persisted . It was reported that " some days she can barely lift her arm (injected limb mobility decreased), on an unspecified date in 2018.No treatment was given for the adverse event and  none laboratory test was  performed. No laboratory test was performed. The outcome of the events was reported as not recovered/not resolved. At the time of the report the causality assessment between PNEUMOVAX 23 and the adverse events was not provided.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 68-year-old male patient who received Shingrix for prophylaxis. On 8th December 2018, the patient received the 1st dose of Shingrix. On 8th December 2018, less than a day after receiving Shingrix, the patient experienced pain localized and muscle pain. The patient was treated with paracetamol (Tylenol) and hydrocodone. On an unknown date, the outcome of the pain localized and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the pain localized and muscle pain to be related to Shingrix. Additional information was provided as follows: The patient received Shingrix in the left arm. The patient received Shingrix and on the same day, he has experienced pain that is two inches lower than the injection site on his left arm and his arm is killing him. The patient reported that it was a sore muscular pain that fades and then comes back. When he hunches down with his head down, it relaxes more but the pain still was unresolved. The patient has tried ice, Tylenol, Hydrocodone and heat and nothing would resolve the pain. Consent to follow up was given.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 68-year-old male patient who received Shingrix for prophylaxis. On 8th December 2018, the patient received the 1st dose of Shingrix. On 8th December 2018, less than a day after receiving Shingrix, the patient experienced pain localized and muscle pain. The patient was treated with paracetamol (Tylenol) and hydrocodone. On an unknown date, the outcome of the pain localized and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the pain localized and muscle pain to be related to Shingrix. Additional information was provided as follows: The patient received Shingrix in the left arm. The patient received Shingrix and on the same day, he has experienced pain that is two inches lower than the injection site on his left arm and his arm is killing him. The patient reported that it was a sore muscular pain that fades and then comes back. When he hunches down with his head down, it relaxes more but the pain still was unresolved. The patient has tried ice, Tylenol, Hydrocodone and heat and nothing would resolve the pain. Consent to follow up was given.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 68-year-old male patient who received Shingrix for prophylaxis. On 8th December 2018, the patient received the 1st dose of Shingrix. On 8th December 2018, less than a day after receiving Shingrix, the patient experienced pain localized and muscle pain. The patient was treated with paracetamol (Tylenol) and hydrocodone. On an unknown date, the outcome of the pain localized and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the pain localized and muscle pain to be related to Shingrix. Additional information was provided as follows: The patient received Shingrix in the left arm. The patient received Shingrix and on the same day, he has experienced pain that is two inches lower than the injection site on his left arm and his arm is killing him. The patient reported that it was a sore muscular pain that fades and then comes back. When he hunches down with his head down, it relaxes more but the pain still was unresolved. The patient has tried ice, Tylenol, Hydrocodone and heat and nothing would resolve the pain. Consent to follow up was given.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Swelling on left arm began quickly. By evening, it was the size of a baseball. The next morning it began creeping down my arm and was much larger. Skin was hot, itchy, hard and sensitive. Very difficult to sleep. Next day, severe muscle aches, severe aching in joints, throbbing in joints, all over feeling of lethargy. Unable to participate in daily routine. Following day, felt better but arm still hurting very much. Called pharmacist to inquire if this is normal, to which he said it is not. Tried OTC cortisone cream, lavender oil, calamine and BENADRYL. Sleeping was very difficult for 3-4 nights. Did not see a physician as it was gradually getting better. Today is one week and one day later and my arm is still red and very itchy. Swelling has reduced.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Insomnia, Lethargy, Loss of personal independence in daily activities
Clinical narrative: Swelling on left arm began quickly. By evening, it was the size of a baseball. The next morning it began creeping down my arm and was much larger. Skin was hot, itchy, hard and sensitive. Very difficult to sleep. Next day, severe muscle aches, severe aching in joints, throbbing in joints, all over feeling of lethargy. Unable to participate in daily routine. Following day, felt better but arm still hurting very much. Called pharmacist to inquire if this is normal, to which he said it is not. Tried OTC cortisone cream, lavender oil, calamine and BENADRYL. Sleeping was very difficult for 3-4 nights. Did not see a physician as it was gradually getting better. Today is one week and one day later and my arm is still red and very itchy. Swelling has reduced.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Pruritus, Sensitive skin
Clinical narrative: Swelling on left arm began quickly. By evening, it was the size of a baseball. The next morning it began creeping down my arm and was much larger. Skin was hot, itchy, hard and sensitive. Very difficult to sleep. Next day, severe muscle aches, severe aching in joints, throbbing in joints, all over feeling of lethargy. Unable to participate in daily routine. Following day, felt better but arm still hurting very much. Called pharmacist to inquire if this is normal, to which he said it is not. Tried OTC cortisone cream, lavender oil, calamine and BENADRYL. Sleeping was very difficult for 3-4 nights. Did not see a physician as it was gradually getting better. Today is one week and one day later and my arm is still red and very itchy. Swelling has reduced.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin induration, Skin warm
Clinical narrative: Swelling on left arm began quickly. By evening, it was the size of a baseball. The next morning it began creeping down my arm and was much larger. Skin was hot, itchy, hard and sensitive. Very difficult to sleep. Next day, severe muscle aches, severe aching in joints, throbbing in joints, all over feeling of lethargy. Unable to participate in daily routine. Following day, felt better but arm still hurting very much. Called pharmacist to inquire if this is normal, to which he said it is not. Tried OTC cortisone cream, lavender oil, calamine and BENADRYL. Sleeping was very difficult for 3-4 nights. Did not see a physician as it was gradually getting better. Today is one week and one day later and my arm is still red and very itchy. Swelling has reduced.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine. On an unknown date, 7 days after receiving Flu vaccine, the patient experienced influenza and pain. On an unknown date, the outcome of the influenza and pain were recovered/resolved. It was unknown if the reporter considered the influenza and pain to be related to Flu vaccine. Additional information was provided as follows: The age at vaccination was not reported. The patient states that in the past she has received the flu vaccine (unknown manufacturer) and each time she would get the flu 1 week later. The patient states that she would experience achiness along with other flu symptoms. Did not consent to follow up.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine. On an unknown date, 7 days after receiving Flu vaccine, the patient experienced influenza and pain. On an unknown date, the outcome of the influenza and pain were recovered/resolved. It was unknown if the reporter considered the influenza and pain to be related to Flu vaccine. Additional information was provided as follows: The age at vaccination was not reported. The patient states that in the past she has received the flu vaccine (unknown manufacturer) and each time she would get the flu 1 week later. The patient states that she would experience achiness along with other flu symptoms. Did not consent to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Patient came shopping in store on 12/26/18 stating she had an allergic reaction from SHINGRIX vaccination received on 12/15/18 - itchy red rash all over the body (not painful). Advised patient to call and see PCP immediately, but stated she has an appointment on 01/11/19.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Severe general muscle pain of the shoulder muscle that lasted 2 days. Continued sharp pain only at the immediate area where the shot was administered, especially when raising the arm.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to patient of unknown age and gender. Information about concomitant medication, pertinent medical history, drug reactions/allergies was not provided. On 30-NOV-2018, the patient was inadvertently vaccinated with VAQTA (lot #:N026997, expiration date: 10-NOV-2018, 25/0.5 unspecified dose in series, frequency were not reported) intramuscular for prophylaxis (expired product administered). No adverse effects reported. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided.
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Information has been received from an unknown age male patient referring to himself. Information about concurrent condition, concomitant medication and medical history was unknown. In approximately December 2018 (reported as about 1 year ago), the patient received the VARIVAX (strength, dose, frequency, route, lot#, expiration date were not reported) for prophylaxis. In approximately 2018, the patient was unsure if he had received the second dose (inappropriate schedule of product administration).
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-DEC-2018, the patient was vaccinated with an expired date dose of VARIVAX, lot # M039317 expiration date 20-SEP-2018 and also with an expired dose of VAQTA, lot # N028743 expiration date 23-NOV-2018, for prophylaxis (Expired product administered). No adverse effects were reported.