chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Complication of delivery, Congenital anomaly, Maternal exposure before pregnancy, Pregnancy test positive, Pyrexia
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 09-DEC-2015, the patient was vaccinated with VARIVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On 29-DEC-2015, the patient became pregnant; the reporter stated that it was the patient's conception day. The date of last menstrual period was 15-DEC-2015 and the estimated delivery date was 20-SEP-2016. The pregnancy outcome was pending. No adverse symptoms were reported. Follow up information has been received from nurse practitioner on 11-OCT-2016. This case refers to a 27 year old female patient with seasonal allergy and penicillin allergy. She does not smoke or consume alcohol. The patient's medical history included appendectomy, ruptured ectopic pregnancy and left laparoscopic salpingectomy. On 09-NOV-2015, her varicella antibody test was negative. On 09-DEC-2015, she was vaccinated with VARIVAX from lot # L015048 with expiry date of 29-APR-2017. On 18-JAN-2016, pregnancy test showed gestation age of 5 weeks. On 16-FEB-2016 (at 9 weeks of pregnancy), ABO/Rh and toxoplasmosis was negative, and glucose level was at 77 (units not specified). On 09-MAR-2016, ultrasound scan at 12 weeks of pregnancy was normal. On 19-APR-2016 (at 19 weeks of pregnancy), maternal serum alpha-fetoprotein screening (MSAFP) was negative. On 27-APR-2016, ultrasound scan at 19 weeks and on 03-JUN-2016, ultrasound scan at 24 weeks of pregnancy were normal. On 15-AUG-2016 (at 34 weeks of pregnancy), B-streptococcal test was positive. At 39 weeks gestation, the patient delivered a male infant weighing 4167.37 grams with a length of 21 inches via cesarean delivery and her complications during delivery included fever. The infant's APGAR scores were 8 at one minute and 9 at five minutes. It was conflictingly reported that infant was born normal and infant had congenital anomalies (not specified) (captured in 1610USA011613). On an unknown date in September 2016, she was hospitalized due to chorioamnionitis after delivery. The outcome of fever and chorioamnionitis was unknown. Causality was not provided by the reporter. Upon internal review, "caesarean section and chorioamnionitis" were determined to be medically significant. Additional information has been requested. Patient demographics, pregnancy details, suspect therapy, events and narrative were updated.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Streptococcus test positive, Toxoplasma serology negative, Ultrasound antenatal screen normal, Varicella virus test negative
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 09-DEC-2015, the patient was vaccinated with VARIVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On 29-DEC-2015, the patient became pregnant; the reporter stated that it was the patient's conception day. The date of last menstrual period was 15-DEC-2015 and the estimated delivery date was 20-SEP-2016. The pregnancy outcome was pending. No adverse symptoms were reported. Follow up information has been received from nurse practitioner on 11-OCT-2016. This case refers to a 27 year old female patient with seasonal allergy and penicillin allergy. She does not smoke or consume alcohol. The patient's medical history included appendectomy, ruptured ectopic pregnancy and left laparoscopic salpingectomy. On 09-NOV-2015, her varicella antibody test was negative. On 09-DEC-2015, she was vaccinated with VARIVAX from lot # L015048 with expiry date of 29-APR-2017. On 18-JAN-2016, pregnancy test showed gestation age of 5 weeks. On 16-FEB-2016 (at 9 weeks of pregnancy), ABO/Rh and toxoplasmosis was negative, and glucose level was at 77 (units not specified). On 09-MAR-2016, ultrasound scan at 12 weeks of pregnancy was normal. On 19-APR-2016 (at 19 weeks of pregnancy), maternal serum alpha-fetoprotein screening (MSAFP) was negative. On 27-APR-2016, ultrasound scan at 19 weeks and on 03-JUN-2016, ultrasound scan at 24 weeks of pregnancy were normal. On 15-AUG-2016 (at 34 weeks of pregnancy), B-streptococcal test was positive. At 39 weeks gestation, the patient delivered a male infant weighing 4167.37 grams with a length of 21 inches via cesarean delivery and her complications during delivery included fever. The infant's APGAR scores were 8 at one minute and 9 at five minutes. It was conflictingly reported that infant was born normal and infant had congenital anomalies (not specified) (captured in 1610USA011613). On an unknown date in September 2016, she was hospitalized due to chorioamnionitis after delivery. The outcome of fever and chorioamnionitis was unknown. Causality was not provided by the reporter. Upon internal review, "caesarean section and chorioamnionitis" were determined to be medically significant. Additional information has been requested. Patient demographics, pregnancy details, suspect therapy, events and narrative were updated.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old male patient. Weight: not provided; Height: not provided  Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated he couldn't move the arm (disability, outcome: not recovered / not resolved).  The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed.; Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity).; Sender's Comments: Company comments: Listedness: Brand of vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, injected limb mobility decreased is unlisted. Myalgia is listed. Causality: Not related. The events were reported in the PNEUMOVAX injected arm, hence not related to Influenza vaccination.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old male patient. Weight: not provided; Height: not provided  Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated he couldn't move the arm (disability, outcome: not recovered / not resolved).  The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed.; Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity).; Sender's Comments: Company comments: Listedness: Brand of vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, injected limb mobility decreased is unlisted. Myalgia is listed. Causality: Not related. The events were reported in the PNEUMOVAX injected arm, hence not related to Influenza vaccination.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old male patient. Weight: not provided; Height: not provided  Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated he couldn't move the arm (disability, outcome: not recovered / not resolved).  The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed.; Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity).; Sender's Comments: Company comments: Listedness: Brand of vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, injected limb mobility decreased is unlisted. Myalgia is listed. Causality: Not related. The events were reported in the PNEUMOVAX injected arm, hence not related to Influenza vaccination.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old male patient. Weight: not provided; Height: not provided  Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated he couldn't move the arm (disability, outcome: not recovered / not resolved).  The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed.; Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity).; Sender's Comments: Company comments: Listedness: Brand of vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, injected limb mobility decreased is unlisted. Myalgia is listed. Causality: Not related. The events were reported in the PNEUMOVAX injected arm, hence not related to Influenza vaccination.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old male patient. Weight: not provided; Height: not provided  Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated he couldn't move the arm (disability, outcome: not recovered / not resolved).  The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed.; Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity).; Sender's Comments: Company comments: Listedness: Brand of vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, injected limb mobility decreased is unlisted. Myalgia is listed. Causality: Not related. The events were reported in the PNEUMOVAX injected arm, hence not related to Influenza vaccination.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old male patient. Weight: not provided; Height: not provided  Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated he couldn't move the arm (disability, outcome: not recovered / not resolved).  The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed.; Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity).; Sender's Comments: Company comments: Listedness: Brand of vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, injected limb mobility decreased is unlisted. Myalgia is listed. Causality: Not related. The events were reported in the PNEUMOVAX injected arm, hence not related to Influenza vaccination.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Disability, Mobility decreased
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old male patient. Weight: not provided; Height: not provided  Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated he couldn't move the arm (disability, outcome: not recovered / not resolved).  The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed.; Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity).; Sender's Comments: Company comments: Listedness: Brand of vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, injected limb mobility decreased is unlisted. Myalgia is listed. Causality: Not related. The events were reported in the PNEUMOVAX injected arm, hence not related to Influenza vaccination.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Pruritus, Rash generalised
Clinical narrative: This spontaneous report as received from a 74 year old female patient refers to herself. The patient's concurrent conditions and pertinent medical history included bipolar and blood pressure. Drug reactions/allergies were none. On 27-SEP-2016 the patient was vaccinated with ZOSTAVAX once, intravenously,  (lot/batch# and expiry date were not reported). Concomitant medications included donepezil, flozone, unspecified cough medication and unspecified acid reflux medication. The patient stated that within 24 hours of having ZOSTAVAX administered (event onset  date: 28-SEP-2016)  she experienced an intense rash with properties of hives. She also stated that, they resemble "small measles" and run from her torso down to her thighs. The patient sought medical attention and treatment was given for the events. Lab diagnostic studies included lung examination on an unknown date (results unknown). Outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was involved. Upon internal review, the event "measles" was determined to be medically significant. Additional information is not expected since the reporter  did not give consent to follow-up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, FLU3, VARZOS
Symptoms: Incorrect route of drug administration, Pulmonary physical examination, Rash, Rash morbilliform, Urticaria
Clinical narrative: This spontaneous report as received from a 74 year old female patient refers to herself. The patient's concurrent conditions and pertinent medical history included bipolar and blood pressure. Drug reactions/allergies were none. On 27-SEP-2016 the patient was vaccinated with ZOSTAVAX once, intravenously,  (lot/batch# and expiry date were not reported). Concomitant medications included donepezil, flozone, unspecified cough medication and unspecified acid reflux medication. The patient stated that within 24 hours of having ZOSTAVAX administered (event onset  date: 28-SEP-2016)  she experienced an intense rash with properties of hives. She also stated that, they resemble "small measles" and run from her torso down to her thighs. The patient sought medical attention and treatment was given for the events. Lab diagnostic studies included lung examination on an unknown date (results unknown). Outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was involved. Upon internal review, the event "measles" was determined to be medically significant. Additional information is not expected since the reporter  did not give consent to follow-up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, FLU3, VARZOS
Symptoms: Rash morbilliform, Urticaria
Clinical narrative: This spontaneous report as received from a 74 year old female patient refers to herself. The patient's concurrent conditions and pertinent medical history included bipolar and blood pressure. Drug reactions/allergies were none. On 27-SEP-2016 the patient was vaccinated with ZOSTAVAX once, intravenously,  (lot/batch# and expiry date were not reported). Concomitant medications included donepezil, flozone, unspecified cough medication and unspecified acid reflux medication. The patient stated that within 24 hours of having ZOSTAVAX administered (event onset  date: 28-SEP-2016)  she experienced an intense rash with properties of hives. She also stated that, they resemble "small measles" and run from her torso down to her thighs. The patient sought medical attention and treatment was given for the events. Lab diagnostic studies included lung examination on an unknown date (results unknown). Outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was involved. Upon internal review, the event "measles" was determined to be medically significant. Additional information is not expected since the reporter  did not give consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Hypoaesthesia, Injection site erythema, Injection site pain, Lip swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69 year old female patient. The patient had no history of allergies or history of a neomycin allergy. She did not had any relevant drug history. She had high blood pressure and an unspecified cholesterol condition, for which she was taking unknown high blood pressure medication and an unknown cholesterol medication, respectively. On 13-OCT-2016, the patient was vaccinated with subcutaneous ZOSTAVAX (lot # M030139, expiry date: 18-AUG-2017) in the right arm. On an unknown date in October 2016, she developed an injection site reaction characterized by slight swelling and inflammation and a little bit of redness on her right arm. She stated the injection site reaction was mild, it was only slightly pink, inflamed and swollen and was only local and did not involve her whole arm. In the morning of 16-OCT-2016 at about 10:30 EST, she began to experience facial swelling and soreness on the left side of her face. The patient did not had any redness, but her lips and the corner/crease of her mouth were swollen as if she was going to get a cold sore. She also experienced a burning sensation and numbness on the left side of her face. No relevant tests were done. As of 16-OCT-2016, she was no longer getting ZOSTAVAX. The patient continued to experience the injection site reaction characterized by slight swelling and inflammation as well as a little bit of redness on her right arm and facial swelling and soreness on the left side of her face that included a burning sensation and numbness. Relatedness between the events and suspect therapy was not reported. Reporter considered all the events to be potentially serious. Additional information is  expected.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Facial pain, Hypoaesthesia, Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69 year old female patient. The patient had no history of allergies or history of a neomycin allergy. She did not had any relevant drug history. She had high blood pressure and an unspecified cholesterol condition, for which she was taking unknown high blood pressure medication and an unknown cholesterol medication, respectively. On 13-OCT-2016, the patient was vaccinated with subcutaneous ZOSTAVAX (lot # M030139, expiry date: 18-AUG-2017) in the right arm. On an unknown date in October 2016, she developed an injection site reaction characterized by slight swelling and inflammation and a little bit of redness on her right arm. She stated the injection site reaction was mild, it was only slightly pink, inflamed and swollen and was only local and did not involve her whole arm. In the morning of 16-OCT-2016 at about 10:30 EST, she began to experience facial swelling and soreness on the left side of her face. The patient did not had any redness, but her lips and the corner/crease of her mouth were swollen as if she was going to get a cold sore. She also experienced a burning sensation and numbness on the left side of her face. No relevant tests were done. As of 16-OCT-2016, she was no longer getting ZOSTAVAX. The patient continued to experience the injection site reaction characterized by slight swelling and inflammation as well as a little bit of redness on her right arm and facial swelling and soreness on the left side of her face that included a burning sensation and numbness. Relatedness between the events and suspect therapy was not reported. Reporter considered all the events to be potentially serious. Additional information is  expected.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Lip swelling, Swelling face
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69 year old female patient. The patient had no history of allergies or history of a neomycin allergy. She did not had any relevant drug history. She had high blood pressure and an unspecified cholesterol condition, for which she was taking unknown high blood pressure medication and an unknown cholesterol medication, respectively. On 13-OCT-2016, the patient was vaccinated with subcutaneous ZOSTAVAX (lot # M030139, expiry date: 18-AUG-2017) in the right arm. On an unknown date in October 2016, she developed an injection site reaction characterized by slight swelling and inflammation and a little bit of redness on her right arm. She stated the injection site reaction was mild, it was only slightly pink, inflamed and swollen and was only local and did not involve her whole arm. In the morning of 16-OCT-2016 at about 10:30 EST, she began to experience facial swelling and soreness on the left side of her face. The patient did not had any redness, but her lips and the corner/crease of her mouth were swollen as if she was going to get a cold sore. She also experienced a burning sensation and numbness on the left side of her face. No relevant tests were done. As of 16-OCT-2016, she was no longer getting ZOSTAVAX. The patient continued to experience the injection site reaction characterized by slight swelling and inflammation as well as a little bit of redness on her right arm and facial swelling and soreness on the left side of her face that included a burning sensation and numbness. Relatedness between the events and suspect therapy was not reported. Reporter considered all the events to be potentially serious. Additional information is  expected.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Lip swelling, Mouth swelling, Swelling face
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69 year old female patient. The patient had no history of allergies or history of a neomycin allergy. She did not had any relevant drug history. She had high blood pressure and an unspecified cholesterol condition, for which she was taking unknown high blood pressure medication and an unknown cholesterol medication, respectively. On 13-OCT-2016, the patient was vaccinated with subcutaneous ZOSTAVAX (lot # M030139, expiry date: 18-AUG-2017) in the right arm. On an unknown date in October 2016, she developed an injection site reaction characterized by slight swelling and inflammation and a little bit of redness on her right arm. She stated the injection site reaction was mild, it was only slightly pink, inflamed and swollen and was only local and did not involve her whole arm. In the morning of 16-OCT-2016 at about 10:30 EST, she began to experience facial swelling and soreness on the left side of her face. The patient did not had any redness, but her lips and the corner/crease of her mouth were swollen as if she was going to get a cold sore. She also experienced a burning sensation and numbness on the left side of her face. No relevant tests were done. As of 16-OCT-2016, she was no longer getting ZOSTAVAX. The patient continued to experience the injection site reaction characterized by slight swelling and inflammation as well as a little bit of redness on her right arm and facial swelling and soreness on the left side of her face that included a burning sensation and numbness. Relatedness between the events and suspect therapy was not reported. Reporter considered all the events to be potentially serious. Additional information is  expected.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Induration, Pruritus, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received FLULAVAL QUADRIVALENT. The patient's past medical history included lung transplant. Concomitant products included IMURAN, NASOCORT, amoxicillin, clarithromycin, NEXIUM, sulphamethoxazole, SEPTRA DS, tacrolimus, prednisone, sertraline, clonazepam and ALLEGRA. On 7th October 2016, the patent received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 8th October 2016, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema and injection site warmth. On 9th October 2016, the patient experienced injection site itching. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were not recovered/not resolved. The reporter considered the injection site erythema, injection site warmth and injection site itching to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: On Friday, the patient received FLULAVAL QUADRIVALENT on Left arm. The next morning, the patient noted some redness and warmth at the injection site. On Sunday, 2 days after receiving FLULAVAL QUADRIVLENT, the patient experienced the redness and warmth were spreading further down the arm and that it was began to itch. The patient noted that the pharmacist submitted an adverse event report. The patient was pretty upset about the pharmacy and pharmacist did not provide site.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received FLULAVAL QUADRIVALENT. The patient's past medical history included lung transplant. Concomitant products included IMURAN, NASOCORT, amoxicillin, clarithromycin, NEXIUM, sulphamethoxazole, SEPTRA DS, tacrolimus, prednisone, sertraline, clonazepam and ALLEGRA. On 7th October 2016, the patent received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 8th October 2016, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema and injection site warmth. On 9th October 2016, the patient experienced injection site itching. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were not recovered/not resolved. The reporter considered the injection site erythema, injection site warmth and injection site itching to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: On Friday, the patient received FLULAVAL QUADRIVALENT on Left arm. The next morning, the patient noted some redness and warmth at the injection site. On Sunday, 2 days after receiving FLULAVAL QUADRIVLENT, the patient experienced the redness and warmth were spreading further down the arm and that it was began to itch. The patient noted that the pharmacist submitted an adverse event report. The patient was pretty upset about the pharmacy and pharmacist did not provide site.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient of unknown race received PREVNAR 13) lot N16515, NDC number 00005197101, exp.date Oct2017) for immunization at single dose via intramuscular route in the left deltoid on 04Oct2016. Medical history included post menopause, high cholesterol, insomnia, menopausal symptoms, likely for dry eye syndrome, arthritis and pain. Concomitant medicines included meloxicam since 01Aug2016 and ongoing  for suspected pain or arthritis, 15 mg, daily; ciclosporin (RESTASIS) since 30Sep2016  and ongoing for dry eye 1 DF in each eye, 2x/day; estradiol (MINIVELLE) since Aug2016 and ongoing for menopausal symptoms. The patient had received first dose of FLUZONE high- dose (Sanofi Pastuer, Lot: UI642AC, Expiry: 03Apr2017, NDC: 49281039988), intramuscularly in the left deltoid on 10Sep2016. On 13Oct2016 the patient  experienced rash and hives around area that she received injection and on unknown date an allergic reaction. The outcome of the event injection site rash was reported as not recovered while the outcome for the other events was reported as unknown. She took as treatment Benadryl and Prednisone 20 mg two tablets in am for two days.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypersensitivity, Injection site rash, Injection site urticaria
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient of unknown race received PREVNAR 13) lot N16515, NDC number 00005197101, exp.date Oct2017) for immunization at single dose via intramuscular route in the left deltoid on 04Oct2016. Medical history included post menopause, high cholesterol, insomnia, menopausal symptoms, likely for dry eye syndrome, arthritis and pain. Concomitant medicines included meloxicam since 01Aug2016 and ongoing  for suspected pain or arthritis, 15 mg, daily; ciclosporin (RESTASIS) since 30Sep2016  and ongoing for dry eye 1 DF in each eye, 2x/day; estradiol (MINIVELLE) since Aug2016 and ongoing for menopausal symptoms. The patient had received first dose of FLUZONE high- dose (Sanofi Pastuer, Lot: UI642AC, Expiry: 03Apr2017, NDC: 49281039988), intramuscularly in the left deltoid on 10Sep2016. On 13Oct2016 the patient  experienced rash and hives around area that she received injection and on unknown date an allergic reaction. The outcome of the event injection site rash was reported as not recovered while the outcome for the other events was reported as unknown. She took as treatment Benadryl and Prednisone 20 mg two tablets in am for two days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Medication error, No adverse event
Clinical narrative: Per LPN -Twins receiving injections (DTaP/IPV and MMRV - both sets of injections were administered to pt. Monitored for 15 minutes after vaccinations.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Per LPN -Twins receiving injections (DTaP/IPV and MMRV - both sets of injections were administered to pt. Monitored for 15 minutes after vaccinations.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Rash generalised, Seizure
Clinical narrative: Rash over entire body. Fever over 105 degrees F. Convulsions.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site pain
Clinical narrative: Arm pain around injection site. Worsened over time.  Given shot of NASID. Arm pain still persistent after 3 days. Respiratory difficulty. Cough suppressant and inhaler prescribed.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Sleep disorder
Clinical narrative: Lost complete shoulder mobility and not just sore, but pain level a 10, out of I to 10. On day two zero improvement.  Can't sleep pain is so severe. Called dr and she said the same thing happened her and to give it a few days to see if improvement. Don't think I can wait a third day the pain is so great.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, White blood cell count increased
Clinical narrative: Pt presented to ER with arm swelling WBC 15.2 Heart rate of 150.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Sneezing, runny nose, achy, headache, extreme soreness and stiffness of arm. Took 50 mg Benadryl.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Sneezing
Clinical narrative: Sneezing, runny nose, achy, headache, extreme soreness and stiffness of arm. Took 50 mg Benadryl.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Anger, Depression, Mood swings
Clinical narrative: Mood Swings, Depression, rage.
Sex: U
Vaccine: FLUX, MENB
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a non-contactable Health Care Professional. A child of an unspecified age, gender and race, received, on an unknown date, the second dose of TRUMENBA single dose for immunization. Relevant medical history was unknown. Concomitant medication included influenza vaccine, for immunization. On an unspecified date, the patient experienced extreme fatigue (the child was sleeping and barely waking up). Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 73-year-old female patient received PREVENAR 13) Lot Number: N16560, Expiration Date: Sep2017), intramuscular as a single dose in the left arm on 10Oct2016 for immunization. The patient's medical history and concomitant medications were not provided. In Oct2016, a couple of day after the patient received pneumococcal 13-valent conjugate vaccine, her arm became really red and swollen around the injection area. It was elaborated that the swelling and redness was the size of her hand on the left arm. There was no laboratory data provided. The clinical outcome of the events, red and swollen around the injection area, was not recovered.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A male patient in his late 60s of an unspecified ethnicity received either PREVNAR 13 or PNEUMOVAX 23, via an unspecified route of administration in the arm on an unknown date in 2015 at a single dose for immunization. The patient's medical history and concomitant medications were not reported.  On an unknown date in 2015, the patient experienced some swelling around the injection site in the arm that the vaccine was given. The outcome was unknown.
Age: 1.0
Sex: U
Vaccine: PNC13
Symptoms: Nodule
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative.  A 12-month-old patient of an unspecified ethnicity and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration, in the right thigh, on an unspecified date in 2016, as single dose for routine vaccination.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced dime sized knot that occurred post injection.  The action taken with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable.  Therapeutic measures were taken as a result of dime sized knot that occurred post injection and included warm packs and the administrating office monitored the event; office also told the parent that if it persists to call back and the parent made no call back to the office.  The outcome of dime sized knot that occurred post injection was unknown.
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Initial unsolicited report received from nurse on 11 October 2016. This case involves female patient (age not reported) who was vaccinated with dose of Fluzone (Batch number, expiration date, dose, site and route of administration were not reported) on an unspecified date. Patient medical history and concomitant medication were not reported. It was reported that on an unspecified date the patient was hospitalized for cellulitis (date unspecified) following getting a flu vaccine about 5 years ago. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none. Sender's Comments: Patient had cellulitis following INFLUENZA QUADRIVAL A-B VACCINE 5 years ago. Time to onset is unknown, detail medical history, allergic history, site of cellulitis, past vaccination history are needed to further assess the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced flu. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10-Oct-2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu shot (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient got sick and almost died. The patient's laboratory data and corrective treatment was not reported. The outcome of events were not reported. Case was considered as serious due to life threatening events: almost died and sick. List of documents held by sender: none. Sender's Comments: This poorly document case as patient got sick and almost after flu shot, detail medical history, any comorbidity, past vaccination history and its tolerance are needed to further assess the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date (reported as early one year). The patient's previous medications included vaccination with Prevnar 13, five year pneumonia shot and shingles vaccine. Other medical history and concomitant medications were not reported. On an unspecified date (reported as Jan), following the vaccination, patient experienced flu. The patient's laboratory data and corrective treatment was not reported. The outcome of events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is liked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851.. (same source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a first dose of flu shot (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient was sick for a month and patient though that she would pass. Patient's lab data and corrective treatment was not reported. On an unspecified date, patient recovered from the event sick and outcome of the event though I would pass was not reported. List of documents held by sender: none.