chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction
Clinical narrative: This is a spontaneous report obtained from a contactable physician. A patient of unknown age, gender, and ethnicity received, on an unspecified date, PREVAR13 single dose. Relevant history and concomitant medications were unknown. Vaccines given on the same day and vaccines taken within the last four weeks were unknown. On an unspecified date, in SEP2013 or OCT2013, the patient had some sort of reaction. Relevant laboratory data was unknown. At time of this report, clinical outcome of the event was unknown. Causality between the event and PREVNAR13 was unknown. Follow-up (14NOV2014): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer via a sales representative and a contactable physician. A 71-year-old male patient received on 23OCT2014 the first dose of PREVNAR13; Lot Number: J23867; Expiration Date: 31JAN2016) intramuscular in the arm at 0.5 ml, single dose. Medical history included celiac disease, cholesterol, and hypertension. Concomitant medications included ZOCOR (table at 40 mg, for cholesterol), TOPROL at unknown dose for unspecified indication., BENICAR (tablet) at 20mg for hypertension, and ASPIRIN, all of which were ongoing. Within 2 to 4 hours of the injection, the patient's arm was totally swollen, red, hot and very painful. The swelling lasted for 4 days from 23OCT2014 to 26OCT2014. He was very tired from 23OCT2014 to 29OCT2014. The patient did not go to the hospital for any of the events. The clinical outcome of the events, patient's arm was red, hot and very painful, was recovered on unknown dates in 2014. The physician denied occurrence of the events. Follow-up (10NOV2014): New information obtained from a contactable physician includes: not medically confirmed. No follow-up attempts possible. No further information expected. Follow-Up (15DEC2014): New information received from the same contactable consumer includes: patient age, suspect product data, concomitant medications, reaction data, treatment, and outcome (recovered). Follow-up attempts completed. No further information expected.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose increased
Clinical narrative: This is a spontaneous report from a contactable nurse, who reported for her mother. An 88-year-old female patient of an unspecified ethnicity received PREVNAR13, via an unspecified route of administration on 06OCT2014 in an arm at a single dose. Medical history included ongoing type 2 diabetes mellitus for the past 10 years. Concomitant medications included JANUVIA, glipizide, and SYNTHROID. During the night of 07OCT2014, the patient experienced blood sugar was elevated at 160. This did not settle for 3 days. The clinical outcome of the event, blood sugar was elevated at 160 was recovered on 09OCT2014. The nurse also mentioned that she received her regular flu shot in the other arm;  however, the day of this vaccination was not mentioned. Follow-up (09JAN2015): Follow up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. It was reported that a dose (0.5 ml single) of PREVNAR13 was given intramuscularly to an adult female patient at an adult clinic. They observed bad local reaction with redness and swelling in the upper arm (unknown which side). The physician stated that it was not complete cellulitis, the reporting company representative thought that the physician gave the patient antibiotics as treatment for the events. The outcome of the events was unknown. The company representative did not believe that the patient went to the hospital following the events and she thought that it would be okay to follow up with the physician for more information. Follow-up (24FEB2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Fatigue, Feeling abnormal, Hypotonia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional, reporting on behalf of a physician. A female patient of an unspecified age and ethnicity received the first dose of PREVNAR13, intramuscular on 15OCT2014 at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date in OCT2014, the patient experienced not feeling right, not feeling well since, felt sick, felt very  heavy, she could not move her body, had to stay in bed, needed help to get around, limp, no energy to do anything, hadn't been herself, fatigue and loss of appetite. The clinical outcome of the reported events was unknown. It was reported that the  patient wanted to know if the events could be side effects of PREVNAR13. Follow-up (27OCT2014): new information received from the contactable healthcare professional includes: reaction data (added event: could not move her body). Follow-up (20OCT2014): New information received from the same contactable healthcare professional on behalf of a physician via a sales representative includes: suspect product data (changed from PREVNAR to PREVNAR13, and reaction date (added events: fatigue and loss of appetite). Follow-up (16DEC2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable healthcare professional, reporting on behalf of a physician. A female patient of an unspecified age and ethnicity received the first dose of PREVNAR13, intramuscular on 15OCT2014 at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date in OCT2014, the patient experienced not feeling right, not feeling well since, felt sick, felt very  heavy, she could not move her body, had to stay in bed, needed help to get around, limp, no energy to do anything, hadn't been herself, fatigue and loss of appetite. The clinical outcome of the reported events was unknown. It was reported that the  patient wanted to know if the events could be side effects of PREVNAR13. Follow-up (27OCT2014): new information received from the contactable healthcare professional includes: reaction data (added event: could not move her body). Follow-up (20OCT2014): New information received from the same contactable healthcare professional on behalf of a physician via a sales representative includes: suspect product data (changed from PREVNAR to PREVNAR13, and reaction date (added events: fatigue and loss of appetite). Follow-up (16DEC2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Skin discolouration, Skin warm, Swelling
Clinical narrative: This is a spontaneous report from a contactable registered nurse via a sales representative. This report is in addition to original Reportum, 1HZFXE5S to report an adverse event. A 71-year-old female patient of an unspecified ethnicity received PREVNAR 13, (with lot number, NDC number, expiration date not provided) 0.5 ml single IM in the deltoid (unknown which) on 24Nov2014, administered in the clinic office. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced redness, swelling, warm to touch, discoloration like a bruise on an unspecified date, and unknown if occurred immediately or the next day. The reporter did not know if the redness, swelling, warm to touch, and discoloration has resolved. Follow-up (23JAN2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Hypersomnia, Injection site rash, Myalgia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist mentioned that an elderly female patient (over 65 years) of unknown ethnicity received on unspecified date the first single dose of PREVNAR13 in the arm. The patient had never received a pneumococcal vaccine. On unknown date, the patient experienced fever of 100-101 F, headache, rash in the arm at the injection site which continued to spread, fatigue, she slept 24 hour and a lot of muscle ache. She went to the emergency room and was given Prednisone for the rash and she is doing fine. The pharmacist also asked if PREVNAR 13 contained Thimerosal. The pharmacist mentioned that they have given lots of shots of  PREVNAR13 over the  years, however never had an problem like this. The pharmacist considered that the events were due to PREVNAR13. Outcome was recovered. Follow-up (02DEC2014): New information from the same contactable pharmacist includes: age group, dose number, new events (headache and fatigue), event term updated (from rash to rash at the injection site), reaction details, treatment and outcome. Follow-up (30JAN2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist mentioned that an elderly female patient (over 65 years) of unknown ethnicity received on unspecified date the first single dose of PREVNAR13 in the arm. The patient had never received a pneumococcal vaccine. On unknown date, the patient experienced fever of 100-101 F, headache, rash in the arm at the injection site which continued to spread, fatigue, she slept 24 hour and a lot of muscle ache. She went to the emergency room and was given Prednisone for the rash and she is doing fine. The pharmacist also asked if PREVNAR 13 contained Thimerosal. The pharmacist mentioned that they have given lots of shots of  PREVNAR13 over the  years, however never had an problem like this. The pharmacist considered that the events were due to PREVNAR13. Outcome was recovered. Follow-up (02DEC2014): New information from the same contactable pharmacist includes: age group, dose number, new events (headache and fatigue), event term updated (from rash to rash at the injection site), reaction details, treatment and outcome. Follow-up (30JAN2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable physician. A 65-year-old male patient received first dose of PREVNAR 13 (lot number J49845, expiration date Mar2016, NDC number 0005-1971-02) on 26Nov2014 at 0.5 ml single dose via intramuscular route. Concomitant medications included unspecified blood pressure medication and unspecified diabetic medication. Medical history included diabetes and hypertension. On unspecified date in Nov2014 the patient experienced induration, erythema and tenderness around the injection site. On 01Dec2014 the patient also had rotating circumference around upper arm about 75%. The physician reported that patient took ibuprofen for symptoms, that were worse over the weekend before this report (Nov2014) but have improved. Outcome of the events was unknown. Follow-up (23Jan2015): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site nodule, Peripheral swelling, Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A 76 year old male patient received PREVNAR13, exp date 21MAR2016, NDC: 00051971-2) intramuscular at 0.5 ml, single dose on 17NOV2014. The reporter didn't know what was the lot number that could be J49845 or J49847. Patient medical history and concomitant medications were not reported. A few days after PREVNAR13 was given, patient had severe swelling and a rash on the arm in which the vaccine was given, and a knot at the site of the injection. Reporter saw patient at 5 to 7 days after the vaccine and it was still there. he was going to see the patient again on Monday 01DEC2014. Sales representative reported that no emergency room treatment was required for the adverse event however there was doctor visit as they wanted the doctor to look at the side effects. Sales representative reported that no other vaccine was administered besides PRENVAR13 on the same day and that the physician believes that the adverse events was caused due to  PREVNAR13. Follow-up (16MAR2015): Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable consumer through a non-clinical study program (marketing program no available), and then from a contactable other hcp. A 80 years old female consumer received PREVNAR 13, via an unspecified route of administration, in left arm, at 0.5 ml single, on an unspecified date about 2 weeks before the report. Ongoing medical history included blood pressure high and cholesterol high for about 2 years. Concomitant medications included oral ATACAND at 32 mg once a day, oral Baby Aspirin at 81 mg once a day, oral CRESTOR 5 mg once a day and oral hydrochlorothiazide 12 mg once a day. She did not receive any other vaccine on the same dale along with the suspect vaccine, she denied receiving any other vaccine within 4 weeks prior to the date she received the suspect vaccine. The consumer experienced on unknown date quick rash/reddish rash at site that moved to elbow (maybe a day after receiving the vaccine) which she said was ok but on an unspecified date at night she was waking up in the middle of the night, had pain in right and left wrist, pain in part of arm/tenderness and pain in left arm where shot given, pain in back, pain in neck and shoulders, some time it affected joints, right knee pain (that woke her up last night). The consumer stated she had experienced this maybe a couple of times a week. Consumer described her pain as like a toothache. Consumer said she did inform her doctors office of the rash and other symptoms and said she was told that it was normal, that some people got it and some did not and that the rash came with the shot. Consumer said that her husband got the vaccine too and did not get a rash. Consumer said the rash went away after 3 to 4 days. The consumer was not recovered from pain in right and left wrist, in shoulder, back, neck and knee. The outcome of the other reported events was unknown. The other hcp did not confirm occurrence of the events reported by the patient, and said that the patient did not provide information to him/her regarding the reported adverse events. Follow-up (20Nov2014): New information from the same contactable consumer includes: patient age, gender and ethnicity, vaccination details, medical history, concomitant medications, additional events and outcomes. Follow-up (09Dec2014): New information received from a contactable other HCP includes: the reporter did not confirm occurrence of the events reported by the patient. Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Middle insomnia, Musculoskeletal pain, Neck pain, Pain in extremity, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer through a non-clinical study program (marketing program no available), and then from a contactable other hcp. A 80 years old female consumer received PREVNAR 13, via an unspecified route of administration, in left arm, at 0.5 ml single, on an unspecified date about 2 weeks before the report. Ongoing medical history included blood pressure high and cholesterol high for about 2 years. Concomitant medications included oral ATACAND at 32 mg once a day, oral Baby Aspirin at 81 mg once a day, oral CRESTOR 5 mg once a day and oral hydrochlorothiazide 12 mg once a day. She did not receive any other vaccine on the same dale along with the suspect vaccine, she denied receiving any other vaccine within 4 weeks prior to the date she received the suspect vaccine. The consumer experienced on unknown date quick rash/reddish rash at site that moved to elbow (maybe a day after receiving the vaccine) which she said was ok but on an unspecified date at night she was waking up in the middle of the night, had pain in right and left wrist, pain in part of arm/tenderness and pain in left arm where shot given, pain in back, pain in neck and shoulders, some time it affected joints, right knee pain (that woke her up last night). The consumer stated she had experienced this maybe a couple of times a week. Consumer described her pain as like a toothache. Consumer said she did inform her doctors office of the rash and other symptoms and said she was told that it was normal, that some people got it and some did not and that the rash came with the shot. Consumer said that her husband got the vaccine too and did not get a rash. Consumer said the rash went away after 3 to 4 days. The consumer was not recovered from pain in right and left wrist, in shoulder, back, neck and knee. The outcome of the other reported events was unknown. The other hcp did not confirm occurrence of the events reported by the patient, and said that the patient did not provide information to him/her regarding the reported adverse events. Follow-up (20Nov2014): New information from the same contactable consumer includes: patient age, gender and ethnicity, vaccination details, medical history, concomitant medications, additional events and outcomes. Follow-up (09Dec2014): New information received from a contactable other HCP includes: the reporter did not confirm occurrence of the events reported by the patient. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test abnormal, Respiratory symptom
Clinical narrative: This is a spontaneous report from a contactable nurse through a company representative. This nurse reported similar events for two patients. This is the first of two reports. A patient of unspecified age, gender and ethnicity received PREVNAR13 on unknown date at 0.5 ml single. Exact dates of vaccination was not known, but the reporter stated it was over a three year period. Patient medical history and concomitant medication were unknown. On unknown date the patient had chronic respiratory symptoms. The patient was referred to an allergist and immunologist, who told that pneumococcal protection was low and required follow up with PNEUMOVAX23. After that this pneumococcal vaccine was given the patient had less chronic respiratory symptoms. Outcome of events was reported as unknown. Follow-up (13MAR2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: This is a spontaneous report from a contactable consumer via medical information. A 76-year-old female patient of an unspecified ethnicity received PREVNAR13 via an unspecified route of administration on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced rapid heart rate and shortness of breath while walking on steps and also while laying in bed. The outcomes of the events, rapid heart rate and shortness of breath were unknown.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 68-year-old female patient received PREVNAR13, lot number H86680, expiration date 30OCT2015, NDC number 00005-1971-022052) at 0.5 ml single dose intramuscular in the right arm on 18OCT2014. Medical history and concomitant medication were not reported. On 19OCT2014, the patient experienced a knot in her right arm. She also stated tat it was warm-to-the-touch and reddish in color. The patient stated she felt better every day. The pharmacist considered there was a reasonable possibility that the events were related to PREVNAR13 and commented that about 85% of patients vaccinated with PREVNAR13 experienced burns upon injection and pressure building up during the injection. Outcome was recovering. Follow-up (19DEC2014): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Increased upper airway secretion, Respiratory tract congestion, Vocal cord disorder
Clinical narrative: This is a spontaneous report from a contactable physician through Pfizer Medical Information. A 75 years old female patient received first dose of PREVNAR 13; lot number J49846, expiry date Feb2015) at 0.5 ml single, on 21Nov2014. Medical history was not provided. The patient was taking omeprazole 20 mg generally twice a day, atenolol at 200 mg once a day, LYRICA at 75 mg once a day and zolpidem occasionally at 10 mg at night. On 25Nov2014 in the evening the patient experienced congestion and increased throat secretions in the vocal cords. The physician reported that he did not see the patient. The physician mentioned that the height of the patient may be 5 feet and 5 inches but he was not sure. The physician reported that the consumer had just taken 1 shot of PREVNAR 13 injection till now. The events were not resolved at the time of the report. The physician did not think that the events were directly related to the suspect vaccine. Follow-up (06Jan2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 71-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced severe reaction at injection site - redness, swelling, and blisters. Therapeutic measures were taken as a result of the severe reaction at injection site - redness, swelling, and blisters and included treatment with an unspecified steroid. The clinical outcome of the events, severe reaction at injection site - redness, swelling, and blisters, was recovered on an unknown date. Follow-up (12Mar2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. An elderly female patient over the age of 65-years old of an unspecified ethnicity received PREVNAR 13 single dose on an unspecified date in 2014 reported as three weeks ago as a recommendation because of her age. The patient's medical history included that she received a "high dose" of flu vaccine and another vaccine and had a slight fever and arm was swollen after. The patient's concomitant medications were not reported. The patient experienced a slight fever and her arm was very swollen after she received the dose of PREVNAR 13. It was reported that the patient recovered from the fever and swelling on an unspecified date in 2014. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Drug administration error, Wound
Clinical narrative: This is a spontaneous report from a contactable nurse reporting on behalf of a doctor's office. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot J11488, Exp date Nov2015, NDC-0005-1971-02) intramuscular at 0.5 ml single dose for immunization. Patient medical history and concomitant medications were not reported. Reporter states that the injection could not go in. PREVNAR 13 was injected with the blue clip was removed. A new needle was applied and they were able to inject the dose. When the needle was on, the blue clips was removed and another needle applied, and injection provided. The reporter assents that the patient's skin was punctured when this event occurred. The reporter does not have the actual syringe, because the used product is in the sharps box. Follow-up (14Jan2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Rash, Scratch
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date in Nov2014 (mentioned as 2 days before the report) at a single dose, in arm. The patient medical history and concomitant medications were not reported. On an unknown date in Nov2014, the patient had a severe reaction and had broken out with a pretty bad rash and scratches on her arms. The injection site was bright red about 4 cam by 4 cm and itchy. The clinical outcome of all the reported events was unknown. The reporter mentioned that the patient received the Shingles and flu vaccines on an unspecified date (unknown if before or after PREVNAR 13) and she had a "more than normal" reaction to those as well. Follow-up (21Nov2014): New information from the same contactable pharmacist includes: vaccination partial date, anatomical locations of administration, additional events and other vaccinations details. Follow-up (18JAN2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Gingival swelling, Peripheral swelling
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative, and then from a contactable pharmacist. The physician reported the same event for 3 patients. This is the second of three reports. A female patient of unspecified age and ethnicity received PREVNAR 13 on unknown date, at 0.5 ml single, for immunization. Medical history and concomitant medications were not provided. On an unknown date she had swelling of the arm and gums swelled up (it was unknown if the patient received a treatment). Outcome of the events was unknown at the time of the report. Follow-up (18Apr2014): New information received from a contactable pharmacist includes: event "gums swelled up" added. Follow-up (22Apr2014): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Lip swelling
Clinical narrative: This is a spontaneous report from a contactable medical assistant (calling from physician's office) and from a contactable nurse, reporting on behalf of physician. A 65 year-old female consumer received injection of PREVNAR 13 (Lot#:H13995, Expiration Date: Mar2015) on 28Apr2014 at 0.5 ml single dose for immunization at private doctor's office. Relevant medical history included ongoing depression since an unknown date, the patient had not known drug allergies, she did not abuse of drug and alcohol, her father had died at 70 year-old due to pancreatic cancer, her mother had died at 96 year-old due to dementia. Patient concomitant medications included ongoing CYMBALTA since an unknown date at 60 mg daily for depression, IMITREX and pantoprazole. It was reported that on 05May2014 the consumer experienced swollen lips. This event did not result in emergency room or doctor visit. Relevant laboratory data was none. Therapeutic measures were taken in response to the reported event and included the administration of prednisone 50 mg oral tablet once daily for 5 days. The patient recovered from the reported event on 07May2014. Follow-up (28May2014): New information reported from a contactable nurse on behalf of physician includes: additional details on medical history and familiar history, additional concomitant medications, reaction data (event was changed from angioedema to swollen lips, outcome of this event), details on therapeutic measures, seriousness (event swollen lips was reported as non-serious). Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This is a spontaneous report from a nurse practitioner who reported for a patient, through a Pfizer Sales Representative. This patient (age, gender and race unknown) received PREVNAR 13 on 25Apr2014, single dose for immunization. Relevant medical history and concomitant medications were unknown. On unknown date in Apr2014 the patient was experiencing fever, swelling in arm at the site of injection and stiffness in neck due to which the patient was admitted to emergency department (ED) on 28Apr2014. Relevant laboratory data was unknown. Therapeutic measures taken in response to the reported events were not provided. Clinical outcome of the reported events was unknown at the time of the report. Follow-up (26JUN2014): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Skin discolouration, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A patient of unknown age, gender and received single dose of PREVNAR 13 on an unknown date, for immunization. Relevant medical history and relevant concomitant medications were unknown. After vaccination on unknown date the patient had redness, swelling and discoloration of skin. Relevant laboratory data was unknown, last action taken with PREVNAR 13, therapeutic measure taken in response to the events and clinical outcome of the reported events were unknown at the time of report. Follow-up (06Jun2014): Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable other health professional (medical assistant) who reported on behalf of a physician for a patient. A 58-year-old female patient received PREVNAR 13 single dose administered into her left deltoid via an unspecified route of administration on 20Mar2014 at 12:04 hours for immunization. The patient had no relevant medical history and was taking no concomitant medications. On 25Mar2014, the patient experienced redness and swelling in left shoulder which she mentioned was progressively worsened and redness and swelling spread to elbow, was warm to touch, redness on thumb, and burning sensations. No relevant laboratory data was reported. Therapeutic measures received, if any, were not reported. Clinical outcome of the events redness and swelling in left shoulder, redness and swelling spread to elbow, was warm to touch, redness on thumb, and burning sensations was unknown. Follow-up (28May2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: This is a spontaneous report from pharmacy technician for a consumer. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administered at single dose on unknown date. The patient medical history and concomitant medications were not reported. On unknown date, the patient developed swelling, redness, it rose a little bit, it was warm whenever you touch it and it was also itching. The outcome of the events was unknown. Follow-up (19Dec2014): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Dermatitis, Local reaction
Clinical narrative: This is a spontaneous report from a contactable nurse from a physician's office via a sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced local reaction on arm like a dermatitis on an unspecified date with outcome of unknown. Follow-up (24Feb2015): Follow up attempts completed. No further information expected.
Age: 0.8
Sex: M
Vaccine: PNC13
Symptoms: Cast application
Clinical narrative: This is a spontaneous report from a Study Program received from a contactable nurse practitioner. A 9 months old male patient of unspecified ethnicity received PREVNAR 13, via an unspecified route of administration, on unspecified date, at single dose. Relevant medical history and concomitant medications were unknown. On unspecified date the patient had cast on legs. Outcome of the reported event was unknown at the time of report. The nurse practitioner mentioned that the event was due to the PREVNAR 13 injection. Follow-up (29AUG2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Cough, Fatigue, Hypersensitivity, Injection site erythema, Rash
Clinical narrative: This is a spontaneous report from a contactable nurse. A female patient of unknown age, received a single dose of PREVNAR 13 (Lot H47688; Expiration date: May2015; NDC 0005197105) on 19Jun2014 and BENADRYL since unknown date, at an unknown dose and frequency. Relevant medical history and concomitant medications were unknown. On 19Jun2014, after vaccination and while being on diphenhydramine, the patient had allergic reaction, rash, fatigue, cough and baseball like red spot at site of injection. Relevant laboratory work was none. Last action taken with diphenhydramine was unknown. No therapeutic measures were taken in response to the events. Patient was still suffering from the reported events at the time of report. The nurse confirmed that allergic reaction was due to PREVNAR 13. Follow-up (20Aug2014): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test abnormal
Clinical narrative: This is a spontaneous report from a contactable nurse. A child patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. Prepneumococcal titers were low and the child needed a booster dose. The nurse asked what was the earliest age or how far apart from the 1 year vaccination the booster dose could be administered to the child. Follow-up (06Aug2014): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site inflammation, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. Medical history included diabetes. Concomitant medications were not reported. On an unspecified date the patient had inflammation at the site of injection, fever and malaise. The events were non-serious with outcome of unknown. Follow-up (03Dec2014): Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: M
Vaccine: FLUX, SMALL
Symptoms: Death, Eosinophilic myocarditis, Myocarditis
Clinical narrative: This unsolicited case was received from a literature via search on the VAERS database on 09-SEP-2015. This case is linked to cases: 2015SA141696 and U2003-00017 (same literature). Abstract: Background. Vaccines are among the safest medical products in use today. Hundreds of millions of vaccinations are administered each year. Serious adverse reactions are uncommon. However, temporally associated deaths can occur following vaccination. Our aim was to characterize main causes of death among reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous vaccine safety surveillance system. Methods. We searched VAERS for reports of death after any vaccination from 1 July 1997 through 31 December 2013. Available medical records, autopsy reports, and death certificates were reviewed to identify cause of death. Results. VAERS received 2149 death reports, most (n = 1469 [68.4 percent]) in children. Median age was 0.5 years (range 0-100 years); males accounted for 1226 (57 percent) reports. The total annual number of death reports generally decreased during the latter part of the study period. Most common causes of death among 1244 child reports with available death certificates/autopsy reports included sudden infant death syndrome (n = 544 [44 percent]), asphyxia (n = 74 [6.0 percent]), septicemia (n = 61 [4.9 percent]), and pneumonia (n = 57 [4.6 percent]). Among 526 adult reports, most common causes of death included diseases of the circulatory (n = 247 [46.9 percent]) and respiratory systems (n = 77 [14.6 percent]), certain infections and parasitic diseases (n = 62 [11.8 percent]), and malignant neoplasms (n = 20 [3.8 percent]). For child death reports, 79.4 percent received greater than 1 vaccine on the same day. Inactivated influenza vaccine given alone was most commonly associated with death reports in adults (51.4 percent). Conclusions. No concerning pattern was noted among death reports submitted to VAERS during 1997-2013. The main causes of death were consistent with the most common causes of death in the population. Keywords. Death, vaccines, epidemiology, surveillance, vaccine safety. This case involves a 26-year-old male patient who had received a dose of Smallpox Live Vaccine (dose, lot number and route were not reported, manufacturer: Unknown) and a dose of Influenza Vaccine (IIV3) (dose, lot number and route were not reported, manufacturer: Unknown) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date post-vaccination, the patient had died and cause of death was reported as eosinophilic myocarditis compatible with postvaccinal myocarditis. Lab tests and corrective treatments were not reported. At the time of this report, the outcome of the events reported as fatal. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Chest discomfort, Dyskinesia, Electroencephalogram normal, Eye movement disorder, Fall
Clinical narrative: Initial unsolicited report received from a healthcare professional (physician) on 16 September 2015. This case involves a 16-year-old female patient who was vaccinated with a [dose in series and route of vaccination were not reported] standard dose of MENACTRA (batch number and expiration date was unknown) in the left arm on 04 September 2015 and also received 0.5 ml intramuscular [dose in series not reported] dose of TRUMENBA (manufacturer Pfizer, batch number L13514 and expiration date 31 July 2016) in right arm on 04 September 2015. The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced psycho seizures, photosensitivity and was not being able to walk right now very well. On an unspecified date, patient was hospitalized. Lab data and corrective treatment was not reported. The outcome of event was unknown. It was unknown if patient had been discharged "Last date patient was seen in the hospital was 09 September 2015". The reporter assessed the causal relationship with both the suspect vaccine as unknown. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Headache, Hyperaesthesia, Hypoaesthesia, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Initial unsolicited report received from a healthcare professional (physician) on 16 September 2015. This case involves a 16-year-old female patient who was vaccinated with a [dose in series and route of vaccination were not reported] standard dose of MENACTRA (batch number and expiration date was unknown) in the left arm on 04 September 2015 and also received 0.5 ml intramuscular [dose in series not reported] dose of TRUMENBA (manufacturer Pfizer, batch number L13514 and expiration date 31 July 2016) in right arm on 04 September 2015. The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced psycho seizures, photosensitivity and was not being able to walk right now very well. On an unspecified date, patient was hospitalized. Lab data and corrective treatment was not reported. The outcome of event was unknown. It was unknown if patient had been discharged "Last date patient was seen in the hospital was 09 September 2015". The reporter assessed the causal relationship with both the suspect vaccine as unknown. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Pain, Pain in extremity, Paralysis, Photophobia, Tremor
Clinical narrative: Initial unsolicited report received from a healthcare professional (physician) on 16 September 2015. This case involves a 16-year-old female patient who was vaccinated with a [dose in series and route of vaccination were not reported] standard dose of MENACTRA (batch number and expiration date was unknown) in the left arm on 04 September 2015 and also received 0.5 ml intramuscular [dose in series not reported] dose of TRUMENBA (manufacturer Pfizer, batch number L13514 and expiration date 31 July 2016) in right arm on 04 September 2015. The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced psycho seizures, photosensitivity and was not being able to walk right now very well. On an unspecified date, patient was hospitalized. Lab data and corrective treatment was not reported. The outcome of event was unknown. It was unknown if patient had been discharged "Last date patient was seen in the hospital was 09 September 2015". The reporter assessed the causal relationship with both the suspect vaccine as unknown. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Gait disturbance, Photosensitivity reaction, Psychogenic seizure
Clinical narrative: Initial unsolicited report received from a healthcare professional (physician) on 16 September 2015. This case involves a 16-year-old female patient who was vaccinated with a [dose in series and route of vaccination were not reported] standard dose of MENACTRA (batch number and expiration date was unknown) in the left arm on 04 September 2015 and also received 0.5 ml intramuscular [dose in series not reported] dose of TRUMENBA (manufacturer Pfizer, batch number L13514 and expiration date 31 July 2016) in right arm on 04 September 2015. The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced psycho seizures, photosensitivity and was not being able to walk right now very well. On an unspecified date, patient was hospitalized. Lab data and corrective treatment was not reported. The outcome of event was unknown. It was unknown if patient had been discharged "Last date patient was seen in the hospital was 09 September 2015". The reporter assessed the causal relationship with both the suspect vaccine as unknown. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Gait disturbance, Photosensitivity reaction, Seizure
Clinical narrative: Initial unsolicited report received from a healthcare professional (physician) on 16 September 2015. This case involves a 16-year-old female patient who was vaccinated with a [dose in series and route of vaccination were not reported] standard dose of MENACTRA (batch number and expiration date was unknown) in the left arm on 04 September 2015 and also received 0.5 ml intramuscular [dose in series not reported] dose of TRUMENBA (manufacturer Pfizer, batch number L13514 and expiration date 31 July 2016) in right arm on 04 September 2015. The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced psycho seizures, photosensitivity and was not being able to walk right now very well. On an unspecified date, patient was hospitalized. Lab data and corrective treatment was not reported. The outcome of event was unknown. It was unknown if patient had been discharged "Last date patient was seen in the hospital was 09 September 2015". The reporter assessed the causal relationship with both the suspect vaccine as unknown. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Paraesthesia, Pruritus
Clinical narrative: Case number PHEH2015US017931, is an initial spontaneous report from a health care professional received on 11 Sep 2015. This report refers to a 61 years old female patient. Medical history and concomitant medications were not reported. Previous vaccinations with FLUVIRIN (batch number: not reported) were well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 15753P) intramuscularly on 10 Sep 2015. Within 15 minutes after vaccination the patient experienced flushing and itching on her face which later spread to her arms and hands. Her scalp was also itchy. Further her face and scalp were red and looked inflamed. The patient was treated with BENADRYL. Outcome of flushed face was condition unchanged and outcome of the other events were not reported. Seriousness and causality of the events were not reported. Seriousness assessment of inflammation, flushing, itching and redness was upgraded based on information in the source document.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Flushing, Inflammation, Pruritus generalised
Clinical narrative: Case number PHEH2015US017931, is an initial spontaneous report from a health care professional received on 11 Sep 2015. This report refers to a 61 years old female patient. Medical history and concomitant medications were not reported. Previous vaccinations with FLUVIRIN (batch number: not reported) were well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 15753P) intramuscularly on 10 Sep 2015. Within 15 minutes after vaccination the patient experienced flushing and itching on her face which later spread to her arms and hands. Her scalp was also itchy. Further her face and scalp were red and looked inflamed. The patient was treated with BENADRYL. Outcome of flushed face was condition unchanged and outcome of the other events were not reported. Seriousness and causality of the events were not reported. Seriousness assessment of inflammation, flushing, itching and redness was upgraded based on information in the source document.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Dehydration, Diarrhoea, Dyspnoea, Pallor
Clinical narrative: Vomiting diarrhea severe dehydration low grade fever unable to get air in pale severe sudden onset weakness.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: Vomiting diarrhea severe dehydration low grade fever unable to get air in pale severe sudden onset weakness.
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: The shot site was extremely sore but not red. Towards evening became extremely exhausted and ached all over!  At approximately 9:15 I got the chills and became light headed. Throughout night I got the sweats!  When woke 9/24/2015 was dizzy, chills, and had diarrhea and had no energy. I had a Low grade fever of 100.
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hyperhidrosis, Injection site pain, Pain, Pyrexia
Clinical narrative: The shot site was extremely sore but not red. Towards evening became extremely exhausted and ached all over!  At approximately 9:15 I got the chills and became light headed. Throughout night I got the sweats!  When woke 9/24/2015 was dizzy, chills, and had diarrhea and had no energy. I had a Low grade fever of 100.
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Chills, Diarrhoea, Dizziness, Hyperhidrosis
Clinical narrative: The shot site was extremely sore but not red. Towards evening became extremely exhausted and ached all over!  At approximately 9:15 I got the chills and became light headed. Throughout night I got the sweats!  When woke 9/24/2015 was dizzy, chills, and had diarrhea and had no energy. I had a Low grade fever of 100.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, warm, painful and slightly swollen.