chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Mobility decreased
Clinical narrative: Case number PHHY2017US016179, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 665991) on 23 Jan 2017. This report refers to a 42 years old male patient. Historical condition was not reported. Current conditions included felt a little sick, possibly had the flu a little and allergy to morphine. Concomitant medication was reported as none. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 12 Nov 2016. On same day after vaccination, the patient's lower back started hurting extremely bad. Next day on 13 Nov 2016, the patient could not get out of bed and back was still hurting throughout weekend, it was really bad. It was reported that, the patient's back was still hurts pretty bad, but it was getting slowly better. The patient went to emergency room on an unknown date. The outcome of the event lower back started hurting was reported as condition improving and for other event it was reported as unknown. The seriousness of the event was reported as non serious and causality was not reported.
Age: 11.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Incontinence, Neurological examination, Syncope
Clinical narrative: Case number PHHY2017US013547, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 666375) on 23 Jan 2017. This report refers to an 11 years old male patient. Medical history was reported as none. Concomitant medications included Probiotic, Vitamin D and fish oil. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) intramuscularly into right arm on GARDASIL (other manufacturer), batch number: not reported), both on 15 Nov 2016. On same day after vaccination, the patient experienced fainting spell with incontinence. It was reported that neurological examination was completed by doctor (result unspecified). The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Erythema, Influenza like illness, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2017US012268 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 666582) website on 23 Jan 2017. This report refers to 41 year old female patient. Historical condition included IBS (irritable bowel syndrome) and current condition included inflammatory arthritis and undiagnosed autoimmune disorder. Concomitant medication were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on an unknown date. The patient was also vaccinated with diphtheria vaccine, pertussis vaccine, polio vaccine, tetanus vaccine, (manufacturer unknown, batch number: not reported) on an unknown date. After vaccination, on an unspecified date, the patient experienced painful red arm swelling and flu like symptoms. The final outcome, seriousness and causality of the events were not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Chest X-ray normal, Culture throat negative, Laboratory test normal, Myalgia, Pyrexia
Clinical narrative: Case number PHHY2017US017822, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 666930) on 23 Jan 2017. This report refers to a 57 years old female patient. Medical history was reported as none. Concomitant medications included melatonin and UNISOM. The patient was vaccinated with sixth dose of seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) intramuscularly into left arm on 31 Oct 2016. On 01 Nov 2016 after vaccination, the patient experienced fever, muscle aches and some congestion lasting 18 days. On an unknown date, the patient was seen in the clinic and ruled out the other causes, as they performed the laboratory tests such as urinalysis, chest x-ray, throat culture and street test and all were found to be negative. The final outcome of the events was reported as unknown. The  seriousness of the events was reported as non serious and causality not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion, Urine analysis normal
Clinical narrative: Case number PHHY2017US017822, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 666930) on 23 Jan 2017. This report refers to a 57 years old female patient. Medical history was reported as none. Concomitant medications included melatonin and UNISOM. The patient was vaccinated with sixth dose of seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) intramuscularly into left arm on 31 Oct 2016. On 01 Nov 2016 after vaccination, the patient experienced fever, muscle aches and some congestion lasting 18 days. On an unknown date, the patient was seen in the clinic and ruled out the other causes, as they performed the laboratory tests such as urinalysis, chest x-ray, throat culture and street test and all were found to be negative. The final outcome of the events was reported as unknown. The  seriousness of the events was reported as non serious and causality not reported.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Musculoskeletal chest pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2017US017122, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 667013) on 23 Jan 2017. This report refers to a 50 years old female patient. Historical condition was reported as unknown. Current condition included sickness. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) and pneumococcal vaccine polyvalent (other manufacturer, batch number: not reported) both into arm on 14 Nov 2016. On same day after vaccination, the patient experienced red, swollen area of upper arm, triceps area sore into breast area and lower arm. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Dysgraphia, Injection site pain, Joint range of motion decreased, Periarthritis, Tendonitis
Clinical narrative: Case number PHHY2017US016497, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667052) website on 23 Jan 2017. This report refers to a 49 years old female patient. Past medical history was not reported. The patient's vaccination  history included influenza vaccine in the shoulder. Concomitant medication included CENTRUM. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 23 Sep 2015. On 24 Sep 2015, the patient experienced that injection site very painful and developed from shoulder she lost range of motion in right arm constant pain. The patient also experienced tendinitis and capsulitis of shoulder and had limited ability to write clearly and without pain. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 62.0
Sex: U
Vaccine: FLUX
Symptoms: Chest discomfort, Erythema, Malaise, Muscle spasms, Pruritus
Clinical narrative: Case number PHHY2017US017912 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667090) website on 23 Jan 2017. This report refers to a 62 year old patient of unspecified gender. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on 27 Oct 2016 (Thursday) around 7:30 AM. On the same day after vaccination, about 15 to 20 minutes later, the patient started to feel tight in chest and the face of the patient was warm, red and itching. It was reported that itching was all over when the patient got home and 30 minutes later the face of the patient was broken out and started having muscle spasms in heart and both sides of chest. It was reported that patient was treated with BENADRYL and TYLENOL. It was reported that patient visited clinic on 28 Oct 2016 (Friday) and the physician of the patient gave methylprednisolone for treatment. It was reported that the patient felt better not completely well on an unknown date. It was reported that patient was still having minor muscle spasms and face was still broken out, not as bad. On 14 Nov 2016, the patient felt better. It was reported that for two weeks after the flu vaccination the patient was very sick. The outcome of the event malaise was reported as condition unchanged and for the other events was reported as condition improving. The seriousness of the events was reported as non serious and causality was not reported.
Age: 62.0
Sex: U
Vaccine: FLUX
Symptoms: Pruritus generalised, Rash, Skin warm
Clinical narrative: Case number PHHY2017US017912 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667090) website on 23 Jan 2017. This report refers to a 62 year old patient of unspecified gender. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on 27 Oct 2016 (Thursday) around 7:30 AM. On the same day after vaccination, about 15 to 20 minutes later, the patient started to feel tight in chest and the face of the patient was warm, red and itching. It was reported that itching was all over when the patient got home and 30 minutes later the face of the patient was broken out and started having muscle spasms in heart and both sides of chest. It was reported that patient was treated with BENADRYL and TYLENOL. It was reported that patient visited clinic on 28 Oct 2016 (Friday) and the physician of the patient gave methylprednisolone for treatment. It was reported that the patient felt better not completely well on an unknown date. It was reported that patient was still having minor muscle spasms and face was still broken out, not as bad. On 14 Nov 2016, the patient felt better. It was reported that for two weeks after the flu vaccination the patient was very sick. The outcome of the event malaise was reported as condition unchanged and for the other events was reported as condition improving. The seriousness of the events was reported as non serious and causality was not reported.
Age: 78.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Adverse drug reaction, Asthenia, Ear infection, Urinary tract infection, Urticaria
Clinical narrative: Case number PHHY2017US012029 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668334) website on 23 Jan 2016. This report refers to 78 year old female patient. Medical history and concomitant medication were not reported. Concomitant medications included metformin, glipizide, levothyroxine, liothyronine, Baby Aspirin, Vitamin C and Vitamin D. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on 04 Oct 2016. The patient was also vaccinated with PREVNAR 13 (manufacturer unknown, batch number: not reported) on 04 Oct 2016. It was reported that the patient received both the vaccines at same time. After vaccination on 04 Nov 2016, patient experienced urinary tract infection and infection in right ear. It was reported that the patient received treatment with antibiotics for urinary infection and antibiotic oil for ear infection. It was reported that the patient developed hives from the antibiotics and had to go to the emergency room 23 Nov 2016 for a possible ITA (involuntary treatment act) and for overall weakness in body. The patient was on treatment with pain pills for overall distress in body. It was reported that before the shots (flu and pneumonia at the same time) the patient was swimming laps every day and was in excellent health. The final outcome of the events was reported as condition unchanged. The events were assessed as non serious and causality were not reported.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Eyelid oedema, Pyrexia
Clinical narrative: Case number PHHY2017US016093, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 668787) on 23 Jan 2017. This report refers to a 06 years old female patient. Historical condition included slight stomach upset that resolved the following day. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) into left arm on 26 Nov 2016. On 28 Nov 2016 after vaccination, the patient experienced swelling around eyes and fever with body temperature 101 to 102 Fahrenheit. The outcome of the event swelling around eyes was reported as resolved in 12 hours (complete recovery) and for other event it was not reported. The seriousness of the event was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Food allergy, Hypersensitivity
Clinical narrative: Case number PHHY2017US015624, is an initial spontaneous report received from consumer via other pharmaceutical company (Merck) and Vaccine Adverse Event Reporting System (VAERS reference number: 668807) website on 23 Jan 2017. This report refers to a female patient of unspecified age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unspecified date. On an unknown date after receiving the vaccine the patient experienced an unspecified allergic reaction to the egg content. The patient laboratory tests and corrective treatment were not reported. The outcome, seriousness and causality of the event were not reported.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2017US016220, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 669567) website on 23 Jan 2017. This report refers to a 53 years old female patient. Past medical history was not reported. Current conditions included as Type 1 diabetes, psoriatic arthritis, Hashimotos thyroiditis, fibromyalgia and Chronic Fatigue Syndrome (CFS), no acute illness (had some chronic health issues). Concomitant medications included as HUMALOG, liothyronine, hydrocortisone, magnesium and malic acid, vitamin NOS, Omega 3 Fish oil, curcumin and Coenzyme Q10. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 04 Nov 2016. On 06 Nov 2016, the patient experienced shoulder was hurting and could barely lift her arm. Patient did not have bad site pain initially so she did not connect it at first to the vaccine. Patient saw the physician who was skeptical but she had done research and was pretty sure this was a vaccine injury. Patient sent her physician the information on frozen shoulder and vaccines. The physician she saw said if it did not go away in a couple of weeks it might be an injury but he was very dismissing. Patient doubt they were going to report it but it had been a month - she still can barely lift that arm and it was painful when she get to a certain point. Patient think vaccines were worthwhile but she was not going get a flu shot again. From what she read this was going to take a year to get better and she was frustrated that her physician were not paying any attention to it. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Bone pain, Chills, Fatigue, Feeling of body temperature change
Clinical narrative: Case number PHHY2017US012432 is an initial spontaneous report received from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 669594) website on 23 Jan 2017. This report refers to a 74 year old female patient. Prior vaccination history included vaccination with tetanus toxoid (manufacturer unknown, batch number: not reported) and patient experienced severe muscle aches and pain. Historical condition not reported. Current condition included allergy to pollen, seasonal allergy, allergy to pet dander, sleep disorder, shortness of breath and wheezing during night when asleep. Concomitant medication included Dicyclomine, loperamide, AREDS2, Multivitamin, Calcium vitamin D3, PROZAC, gabapentin, ATIVAN, Chelated Magnesium, ZYRTEC, Albuterol, TYLENOL, FLONASE. The patient was vaccinated with eighth dose of seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) intramuscularly into left arm on 27 Nov 2016. After vaccination on 28 Nov 2016 (reported as on Monday and Tuesday) patient experienced fatigue, felt hot then cold, chills, muscle and bone aches. On 01 Dec 2016 patient began to notice that she was off balance when walking, and several near falls. The outcome of the events fatigue was reported as continued (condition unchanged), for the events chills and muscle aches reported as stopped after the first 2 days (complete recovery on 30 Nov 2016) and for the other events was not reported. Seriousness and causality of the events were not reported.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Case number PHHY2017US012432 is an initial spontaneous report received from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 669594) website on 23 Jan 2017. This report refers to a 74 year old female patient. Prior vaccination history included vaccination with tetanus toxoid (manufacturer unknown, batch number: not reported) and patient experienced severe muscle aches and pain. Historical condition not reported. Current condition included allergy to pollen, seasonal allergy, allergy to pet dander, sleep disorder, shortness of breath and wheezing during night when asleep. Concomitant medication included Dicyclomine, loperamide, AREDS2, Multivitamin, Calcium vitamin D3, PROZAC, gabapentin, ATIVAN, Chelated Magnesium, ZYRTEC, Albuterol, TYLENOL, FLONASE. The patient was vaccinated with eighth dose of seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) intramuscularly into left arm on 27 Nov 2016. After vaccination on 28 Nov 2016 (reported as on Monday and Tuesday) patient experienced fatigue, felt hot then cold, chills, muscle and bone aches. On 01 Dec 2016 patient began to notice that she was off balance when walking, and several near falls. The outcome of the events fatigue was reported as continued (condition unchanged), for the events chills and muscle aches reported as stopped after the first 2 days (complete recovery on 30 Nov 2016) and for the other events was not reported. Seriousness and causality of the events were not reported.
Age: 62.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Cough, Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative. This  physician reported for three patients. This is the first of three patients. A 62-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot R19477, Expiration Date Jan2018, NDC number 100009260230), via an unspecified route of administration on 08Mar2017 at 0.5 ml, single in the arm, for immunisation. The patient medical history was not reported. Concomitant medication included Aspirin, PRILOSEC and penicillin. On 08Mar2017 the patient experienced swelling and redness left upper arm immediately after receiving pneumococcal 13-val conj vac (dipht crm197 protein), myalgia, fever, drowsiness, weakness, neck discomfort posteriorly, minimal cough. The outcome for all the events was recovering. All the events were considered non serious and related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 62.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Musculoskeletal discomfort, Myalgia, Pyrexia, Somnolence
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative. This  physician reported for three patients. This is the first of three patients. A 62-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot R19477, Expiration Date Jan2018, NDC number 100009260230), via an unspecified route of administration on 08Mar2017 at 0.5 ml, single in the arm, for immunisation. The patient medical history was not reported. Concomitant medication included Aspirin, PRILOSEC and penicillin. On 08Mar2017 the patient experienced swelling and redness left upper arm immediately after receiving pneumococcal 13-val conj vac (dipht crm197 protein), myalgia, fever, drowsiness, weakness, neck discomfort posteriorly, minimal cough. The outcome for all the events was recovering. All the events were considered non serious and related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 69.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Skin irritation
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative. This  physician reported for three patients. This is the second of three patients. A 69-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot R19477, Exp. Date Jan2018, NDC number 100009260230), via an unspecified route of administration on 20Feb2017 at 0.5 ml, single in the arm for immunisation. The patient medical history was not reported. Concomitant medication included fish oil, and CENTRUM. The patient experienced irritation same night of injection, redness and swelling at injection site, all on 20Feb2017. The outcome for all the events was recovered. All the events were considered non serious and related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 69.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative. This  physician reported for three patients. This is the second of three patients. A 69-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot R19477, Exp. Date Jan2018, NDC number 100009260230), via an unspecified route of administration on 20Feb2017 at 0.5 ml, single in the arm for immunisation. The patient medical history was not reported. Concomitant medication included fish oil, and CENTRUM. The patient experienced irritation same night of injection, redness and swelling at injection site, all on 20Feb2017. The outcome for all the events was recovered. All the events were considered non serious and related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen red and hot to touch. (+) Indurated and C/O pain at injection site. Tx: Ibuprofen, BENADRYL, clindamycin, and mupirocin ointment.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site induration, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen red and hot to touch. (+) Indurated and C/O pain at injection site. Tx: Ibuprofen, BENADRYL, clindamycin, and mupirocin ointment.
Age: 66.0
Sex: F
Vaccine: DTAP, FLUX, HEPAB, TD, FLU3, HEPAB, TDAP, DTAP, FLUX, HEPAB, TD
Symptoms: Blood test, Erythema, Peripheral swelling, Pruritus, Skin burning sensation
Clinical narrative: Pt. c/o of muscle aches after vaccination especially in thigh area. 3 days after vaccinations were given and Tuberculin test were placed, he developed what looks like cellulitis (L) calf.
Age: 66.0
Sex: F
Vaccine: DTAP, FLUX, HEPAB, TD, FLU3, HEPAB, TDAP, DTAP, FLUX, HEPAB, TD
Symptoms: Ultrasound scan, Urticaria
Clinical narrative: Pt. c/o of muscle aches after vaccination especially in thigh area. 3 days after vaccinations were given and Tuberculin test were placed, he developed what looks like cellulitis (L) calf.
Age: 66.0
Sex: F
Vaccine: DTAP, FLUX, HEPAB, TD, FLU3, HEPAB, TDAP, DTAP, FLUX, HEPAB, TD
Symptoms: Blood test, Cellulitis, Myalgia, Ultrasound scan
Clinical narrative: Pt. c/o of muscle aches after vaccination especially in thigh area. 3 days after vaccinations were given and Tuberculin test were placed, he developed what looks like cellulitis (L) calf.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Bone pain, Chills, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable nurse. A 65-year-old female patient received PREVNAR 13 lot number: N97935, intramuscular in left deltoid on 20Mar2017 15:21 at 0.5 ml, single for immunisation, ADACEL lot U5521BA, intramuscular in left deltoid on 20Mar2017 at 0.5 ml, single for immunisation. Medical history included invasive ductal breast carcinoma from 15Sep2016 and ongoing (Right breast), ongoing hyperlipidaemia, fatigue from 20Mar2017 prior to vaccination, arthralgia from 20Mar2017 prior to vaccination, dyspnoea from an unknown date and unknown if ongoing. The following allergies to medications were reported: Cephalexin, reported 11Oct2016  experienced difficulty breathing; Penicillin, reported 11Oct2016 experienced difficulty breathing (this documented when new patient at this facility); Sulfa on 28Jun2016 experienced bronchospasms. Concomitant medication included anastrozole from 21Dec 2016 1mg tablet by mouth daily and ongoing, VITAMIN K+D 1000units/100mcg tablet once daily, and calcium carbonate 2 tablets twice daily. The patient previously took tetanus vaccine and did not report any event. The patient stated that since 22Mar2017 had swollen arm/injection arm, swollen shoulder to elbow, fever/101 degree fever, bone pain, chills, headache, injection hot, bright red, hard and itchy, some hardness to arm, achiness on an unspecified date with outcome of recovered.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 65-year-old female patient received PREVNAR 13 lot number: N97935, intramuscular in left deltoid on 20Mar2017 15:21 at 0.5 ml, single for immunisation, ADACEL lot U5521BA, intramuscular in left deltoid on 20Mar2017 at 0.5 ml, single for immunisation. Medical history included invasive ductal breast carcinoma from 15Sep2016 and ongoing (Right breast), ongoing hyperlipidaemia, fatigue from 20Mar2017 prior to vaccination, arthralgia from 20Mar2017 prior to vaccination, dyspnoea from an unknown date and unknown if ongoing. The following allergies to medications were reported: Cephalexin, reported 11Oct2016  experienced difficulty breathing; Penicillin, reported 11Oct2016 experienced difficulty breathing (this documented when new patient at this facility); Sulfa on 28Jun2016 experienced bronchospasms. Concomitant medication included anastrozole from 21Dec 2016 1mg tablet by mouth daily and ongoing, VITAMIN K+D 1000units/100mcg tablet once daily, and calcium carbonate 2 tablets twice daily. The patient previously took tetanus vaccine and did not report any event. The patient stated that since 22Mar2017 had swollen arm/injection arm, swollen shoulder to elbow, fever/101 degree fever, bone pain, chills, headache, injection hot, bright red, hard and itchy, some hardness to arm, achiness on an unspecified date with outcome of recovered.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Bone pain, Chills, Dyspnoea, Headache, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable nurse. A 65-year-old female patient received PREVNAR 13 lot number: N97935, intramuscular in left deltoid on 20Mar2017 15:21 at 0.5 ml, single for immunisation, ADACEL lot U5521BA, intramuscular in left deltoid on 20Mar2017 at 0.5 ml, single for immunisation. Medical history included invasive ductal breast carcinoma from 15Sep2016 and ongoing (Right breast), ongoing hyperlipidaemia, fatigue from 20Mar2017 prior to vaccination, arthralgia from 20Mar2017 prior to vaccination, dyspnoea from an unknown date and unknown if ongoing. The following allergies to medications were reported: Cephalexin, reported 11Oct2016  experienced difficulty breathing; Penicillin, reported 11Oct2016 experienced difficulty breathing (this documented when new patient at this facility); Sulfa on 28Jun2016 experienced bronchospasms. Concomitant medication included anastrozole from 21Dec 2016 1mg tablet by mouth daily and ongoing, VITAMIN K+D 1000units/100mcg tablet once daily, and calcium carbonate 2 tablets twice daily. The patient previously took tetanus vaccine and did not report any event. The patient stated that since 22Mar2017 had swollen arm/injection arm, swollen shoulder to elbow, fever/101 degree fever, bone pain, chills, headache, injection hot, bright red, hard and itchy, some hardness to arm, achiness on an unspecified date with outcome of recovered.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Injection site induration, Injection site pruritus, Injection site warmth, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 65-year-old female patient received PREVNAR 13 lot number: N97935, intramuscular in left deltoid on 20Mar2017 15:21 at 0.5 ml, single for immunisation, ADACEL lot U5521BA, intramuscular in left deltoid on 20Mar2017 at 0.5 ml, single for immunisation. Medical history included invasive ductal breast carcinoma from 15Sep2016 and ongoing (Right breast), ongoing hyperlipidaemia, fatigue from 20Mar2017 prior to vaccination, arthralgia from 20Mar2017 prior to vaccination, dyspnoea from an unknown date and unknown if ongoing. The following allergies to medications were reported: Cephalexin, reported 11Oct2016  experienced difficulty breathing; Penicillin, reported 11Oct2016 experienced difficulty breathing (this documented when new patient at this facility); Sulfa on 28Jun2016 experienced bronchospasms. Concomitant medication included anastrozole from 21Dec 2016 1mg tablet by mouth daily and ongoing, VITAMIN K+D 1000units/100mcg tablet once daily, and calcium carbonate 2 tablets twice daily. The patient previously took tetanus vaccine and did not report any event. The patient stated that since 22Mar2017 had swollen arm/injection arm, swollen shoulder to elbow, fever/101 degree fever, bone pain, chills, headache, injection hot, bright red, hard and itchy, some hardness to arm, achiness on an unspecified date with outcome of recovered.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Pain, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning to a female patient (age not reported), with no concomitant medication, pertinent medical history nor allergies. On 19-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX (Lot No. M036296, exp. 14-NOV-2017) subcutaneous for prophylaxis. Other suspect therapies included sterile diluent (Lot No. L026395, exp. 16-MAR-2018). On an unknown date in 2017, "a few days after" the vaccination with ZOSTAVAX, the patient developed a rash at the injection site (unspecified arm), which was the "size of a coffee mug". On an unknown date the patient visited her physician, who felt the rash was indicative of a skin infection, and prescribed unspecified antibiotic and an unspecified topical cream. On an unspecified date, " the rash cleared up within another couple of days". There was no intervention to prevent serious criteria, no disability, hospitalization, life threatening, overdose, cancer nor death. The relationship between injection site rash and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site reaction, Skin infection
Clinical narrative: Information has been received from a pharmacist concerning to a female patient (age not reported), with no concomitant medication, pertinent medical history nor allergies. On 19-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX (Lot No. M036296, exp. 14-NOV-2017) subcutaneous for prophylaxis. Other suspect therapies included sterile diluent (Lot No. L026395, exp. 16-MAR-2018). On an unknown date in 2017, "a few days after" the vaccination with ZOSTAVAX, the patient developed a rash at the injection site (unspecified arm), which was the "size of a coffee mug". On an unknown date the patient visited her physician, who felt the rash was indicative of a skin infection, and prescribed unspecified antibiotic and an unspecified topical cream. On an unspecified date, " the rash cleared up within another couple of days". There was no intervention to prevent serious criteria, no disability, hospitalization, life threatening, overdose, cancer nor death. The relationship between injection site rash and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Allergy to vaccine, Cellulitis, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: The day after injection patient developed big red spot that continued to grow.  Nurse practitioner diagnosed and treated as cellulitis with steroids and antibiotics. Medicine cleared it up and patient is fine now.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: The day after injection patient developed big red spot that continued to grow.  Nurse practitioner diagnosed and treated as cellulitis with steroids and antibiotics. Medicine cleared it up and patient is fine now.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: The day after injection patient developed big red spot that continued to grow.  Nurse practitioner diagnosed and treated as cellulitis with steroids and antibiotics. Medicine cleared it up and patient is fine now.
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, MMRV, PNC13
Symptoms: Induration, Irritability, Lymphadenopathy, Rhinorrhoea, Viral upper respiratory tract infection
Clinical narrative: Patient became very fussy, got a runny nose and what appeared to be cold-like symptoms. I checked her neck and her lymph nodes, with the one on her left being larger, were swollen to the size of grapes. The node on the right has since decreased a good bit: however, the node on the left is still quite hard and much larger than it should be over 2 months later.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Tenderness
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 65 year old female patient. Concomitant medication, medical history, drug reactions or allergies were unknown by the reporter. The patient was vaccinated with unspecified pneumococcal 13v conj vaccine (also reported as PCB13) one year ago (approximately March 2016). On 07-MAR-2017 (also reported as "within the last 2 weeks"), the patient was vaccinated with the suspect drug, PNEUMOVAX 23 (dose, frequency and route of administration were not reported, lot N003997, expiration date: 20-OCT-2018) as prevention of pneumococcal disease. Within one day of receiving the vaccine, the patient contacted her physician and stated that her arms were red, painful to touch and feverish (reaction started in approximately March 2017, exact onset dates were not provided). The patient received unspecified treatment for the adverse events. The outcome of the adverse events was reported as recovered in approximately March 2017. The relatedness between the adverse events and the vaccine was related. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant student regarding an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On 21-MAR-2017, the patient was inadvertently vaccinated with a second dose of RECOMBIVAX HB injection 5/0.5 microgram/ml, pediatric formulation (dose and route were not reported) (lot number: M044032; expiration date: 03-JUL-2019) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blood test, Cough, Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from the patient's daughter referring to a 69 year old female patient. The patient's concurrent conditions included epilepsy. The patient's medical history was not provided. Additionally, it was reported that the patient was not taken any concomitant medications, and did not have drug reaction or allergies. On an unspecified day in 2011, the patient was vaccinated with ZOSTAVAX 0.65 ml, as single dose, in the right arm (route of administration, lot number and expiration date were not reported) as shingles prevention. On 19-MAR-2017 (past Sunday), the patient started to develop coughing and wheezing episodes and she went to see her primary care physician who prescribed her azithromycin (Z-PAK) antibiotics because the doctor thought the patient had a respiratory infection. On 21-MAR-2017, at the overnight, the patient experienced extreme pain inside her back around to her lower back and when the patient woke up on 22-MAR-2017 (Wednesday), at the morning, she noticed that she had developed a rash all over the right side of her waist; it was covering a large area approximately 9 inches by 9 inches. The reporter mentioned that the patient's rash also consisted of darker red patches and welts. The reporter said that she took the patient to a nearby Emergency Room (ER) on the same date, due to the adverse event (AE). The reporter stated that in the hospital, a nurse and a physician that was working at the ER evaluated the patient's rash and both felt that the patient's rash had the characteristics of a shingles rash. As treatment the patient was placed on prednisone (manufacturer unknown), oxycodone (+) acetaminophen (PERCOCET) and an unknown antiviral. On an unspecified date a blood test was performed but the results were not provided.  The reporter confirmed that the patient was not hospitalized because she was released from the ER on the same day after receiving some treatment. At the time of reporting the patient had not recovered from the respiratory tract infection, the back pain and the shingles.  Upon internal review, the respiratory tract infection was considered to be a medically significant event. The causal relationship between the events and the ZOSTAVAX was not provided.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Respiratory tract infection, Urticaria, Wheezing
Clinical narrative: This spontaneous report was received from the patient's daughter referring to a 69 year old female patient. The patient's concurrent conditions included epilepsy. The patient's medical history was not provided. Additionally, it was reported that the patient was not taken any concomitant medications, and did not have drug reaction or allergies. On an unspecified day in 2011, the patient was vaccinated with ZOSTAVAX 0.65 ml, as single dose, in the right arm (route of administration, lot number and expiration date were not reported) as shingles prevention. On 19-MAR-2017 (past Sunday), the patient started to develop coughing and wheezing episodes and she went to see her primary care physician who prescribed her azithromycin (Z-PAK) antibiotics because the doctor thought the patient had a respiratory infection. On 21-MAR-2017, at the overnight, the patient experienced extreme pain inside her back around to her lower back and when the patient woke up on 22-MAR-2017 (Wednesday), at the morning, she noticed that she had developed a rash all over the right side of her waist; it was covering a large area approximately 9 inches by 9 inches. The reporter mentioned that the patient's rash also consisted of darker red patches and welts. The reporter said that she took the patient to a nearby Emergency Room (ER) on the same date, due to the adverse event (AE). The reporter stated that in the hospital, a nurse and a physician that was working at the ER evaluated the patient's rash and both felt that the patient's rash had the characteristics of a shingles rash. As treatment the patient was placed on prednisone (manufacturer unknown), oxycodone (+) acetaminophen (PERCOCET) and an unknown antiviral. On an unspecified date a blood test was performed but the results were not provided.  The reporter confirmed that the patient was not hospitalized because she was released from the ER on the same day after receiving some treatment. At the time of reporting the patient had not recovered from the respiratory tract infection, the back pain and the shingles.  Upon internal review, the respiratory tract infection was considered to be a medically significant event. The causal relationship between the events and the ZOSTAVAX was not provided.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 64 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On 28-MAR-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (strength and dose were not reported) administered intramuscularly (lot number: L019836; expiration date: 24-MAR-2017) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a female patient of an unknown age. The patient's medical history and concomitant drugs were not reported. The patient had an allergic reaction to BENADRYL. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 intramuscular (dose, lot number and expiration date were not reported) for prevent pneumonia (prophylaxis). On an unknown date after receiving PNEUMOVAX 23, the patient experienced "swelling in the entire arm". It was reported that an unspecified treatment was given for the event. On an unknown date, the patient contacted with her physician. At the time of reporting, the outcome of the event was recovered on an unknown date. The causal relationship between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent conditions were not reported. Since 01-MAR-2017, the patients were vaccinated with PROQUAD (which had the lot # reported as M040141, lot # M043308 and M03886, the vaccines and sterile diluent expiration dates were unknown) (dosage information and route of vaccination were not informed) for prophylaxis. Information regarding concomitant medication was not provided. There was no product quality complaint involved. It was also reported that the vaccines experienced temperatures from 6 F degrees to 14 F degrees for 22 days. There was no previous temperature excursion. The call was not because of a "data logger". This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent conditions were not reported. Since 01-MAR-2017, the patients were vaccinated with VARIVAX (which had the lot # of M039317, M039318 and M041079, the vaccines and sterile diluent expiration dates were unknown) (dosage information and route of vaccination were not informed) for prophylaxis. Information regarding concomitant medication was not provided. No adverse effects were reported. There was no product quality complaint involved. It was also reported that the vaccines experienced temperatures from 6 F degrees to 14 F degrees for 22 days. There was no previous temperature excursion. The call was not because of a "data logger". This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA014463.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, between January, 2016 and March, 2017, these patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis (strength, dosing details, anatomical location, lot# and expiration date were unknown). No adverse effects were reported. Time frame of temperature excursion was from January, 2016 until March, 2017 (exact hours not provided). There were no previous temperature excursions. A data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1704USA000110: US-009507513-1704USA000112: US-009507513-1704USA000111.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, between January, 2016 and March, 2017, these patients were vaccinated with improperly stored doses of M-M-R II for prophylaxis (strength, dosing details, anatomical location, lot# and expiration date were unknown). The nurse could not provide the lot and expiration date for the properly stored STERILE WATER DILUENT used to reconstitute the doses of M-M-R II. No adverse effects were reported. Time frame of temperature excursion was from January, 2016 until March, 2017 (exact hours not provided). There were no previous temperature excursions. A data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1704USA000068: US-009507513-1704USA000111: US-009507513-1704USA000112.