chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 76 year-old female patient received the first dose of PREVNAR 13 intramuscular on 09Feb2015 at around 11:00 am at 0.5 ml single. Medical history included asthma and lung problems since she was 16 year-old, pneumothorax spontaneous from Jul1999 to an unknown date. The patient reported that before the vaccination she was in disgustingly good health and all the tests had normal results. Concomitant medications included ALBUTEROL, FLOVENT. On 09Feb2015 the patient experienced pain at injection site when the vaccine was injected, she had pain and soreness at the injection site, she had headache, tiredness, a terrible muscle pain all night and joint pain, the area where she got the vaccine was swollen, she did not sleep well in the night. The consumer stated that she has already called her doctor office and notified them of her side effects. She added that she has gotten the regular pneumonia vaccine in the past for immunisation and not had any issues with it. The patient was not recovered from pain, soreness and swelling at the injection site, muscle pain, joint pain, she was recovering from headache and tiredness, outcome of sleep difficulty and pain during the injection was unknown.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Laboratory test normal, Myalgia, Poor quality sleep
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 76 year-old female patient received the first dose of PREVNAR 13 intramuscular on 09Feb2015 at around 11:00 am at 0.5 ml single. Medical history included asthma and lung problems since she was 16 year-old, pneumothorax spontaneous from Jul1999 to an unknown date. The patient reported that before the vaccination she was in disgustingly good health and all the tests had normal results. Concomitant medications included ALBUTEROL, FLOVENT. On 09Feb2015 the patient experienced pain at injection site when the vaccine was injected, she had pain and soreness at the injection site, she had headache, tiredness, a terrible muscle pain all night and joint pain, the area where she got the vaccine was swollen, she did not sleep well in the night. The consumer stated that she has already called her doctor office and notified them of her side effects. She added that she has gotten the regular pneumonia vaccine in the past for immunisation and not had any issues with it. The patient was not recovered from pain, soreness and swelling at the injection site, muscle pain, joint pain, she was recovering from headache and tiredness, outcome of sleep difficulty and pain during the injection was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Diplopia, Vision blurred
Clinical narrative: This is a spontaneous report from a contactable nurse. A male patient of an unspecified age and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced blurred vision and diplopia on an unspecified date. The outcome of the reported events was unknown. Causality was not provided. No follow-up attempts possible. No further information expected.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician and from Pfizer Consumer Healthcare for a contactable Pfizer sales representative. This contactable physician reported different events with the same suspect product for four patients. This is the first of four reports. A 68-year-old male patient (weight 112 kg, height 173 cm) received PREVNAR 13 (lot number J67644, expiry date Mar2016) on 02Jan2015 at 09:00, intramuscular in left deltoid, at 0.5 ml single dose. The patient had no medical history. Concomitant medications were not provided. Past drug event included drug allergy due to erythromycin ethylsuccinate (EES), sulfa, SINGULAIR, and lisinopril. The patient experienced swollen arm and redness on 03Jan2015. The events required doctor visit on 16Jan2015. No other vaccinations were given within eight weeks prior to the events. Relevant tests were none. The patient was not recovered from the events at time of report. The Pfizer sales representative mentioned that the doctor believed that the reactions were experienced by the patient because of the PREVNAR 13. Follow-up (23Jan2015): New information from Pfizer Consumer Healthcare for a contactable Pfizer sales representative includes causality assessment. Follow-up (18Feb2015): New information reported from the contactable physician includes: past drug event. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report from a contactable consumer received via a sales representative. A female patient of an unspecified age and ethinicity received PREVNAR 13 , via an unspecified route of administration on an unspecified date for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced significant swelling in the arm on an unspecified date with outcome of unknown. Follow-up (18Feb2015): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arrhythmia, Blood test normal, Local reaction
Clinical narrative: This is a spontaneous report from a contactable physician who reported for herself. This 65-year-old female patient received the first single dose of PREVNAR 13 via an unspecified route of administration on 15Jan2015. The physician mentioned that she got the first PREVNAR 13 and a month later on 15Feb2015 she was scheduled to receive PNEUMOVAX 23. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 15Jan2015, the patient experienced some arrhythmia and sliding duration, no pain. The physician mentioned that she did undergo an unspecified blood test on an unspecified date in Jan2015 for which the results were normal. She suspected that the vaccine had caused the local reaction which she noticed in the night of 22Jan2015. Since the patient was not recovered from the reported events, she wanted to know whether it was safe for her to get the other scheduled PNEUMOVAX 23. The physician mentioned that she believed that PREVNAR 13 would have been shaken surely by her medical assistant who gave her the vaccine and further mentioned that she did not know whether she shook it. The physician just told her to prepare and give her the shot and the storage conditions were excellent at her facility. The vaccine was whitish in color. It was not frozen and she mentioned that if it was frozen she would have thrown it away. She also mentioned that she took no treatment for that local reaction and any other thing. She assessed some arrhythmia and local reaction as related to PREVNAR 13. Follow-up (19Feb2015): Follow-up attempts not possible. No follow-up information expected.
Sex: M
Vaccine: PNC13
Symptoms: Hypertension
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male patient of an unspecified age and ethnicity received the first dose of PREVNAR 13, intramuscular on an unknown date in 2014 at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date in 2014, after receiving the vaccine, the patient experienced an episode of high blood pressure. It was unknown if the patient had a history of fluctuations in blood pressure. Therapeutic measures taken, if any, were unknown. The clinical outcome of the event, an episode of high blood pressure, was unknown. No follow-up attempts possible. No further information expected.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: This is a spontaneous report by a contactable physician. A 60-year-old female patient received on 22Jan2015 first dose of PREVNAR 13 (lot number J67646, expiration date 22Mar2016, NDC number 0005197101) at 0.5 ml single dose in left arm intramuscular. No other vaccine was administered on the same date. Previously, the patient had never had a reaction to anything. She was not ill at the time. History included diabetes, hypertension, high cholesterol and gastroesophageal reflux disease (GERD), all ongoing. Concomitant medications included benazepril 20 mg for hypertension, insulin glargine at 25 DF daily for diabetes, insulin lispro at 5 DF before meals for diabetes, omeprazole 40 mg for GERD, amlodipine 5 mg for hypertension, simvastatin at 20 mg daily for high cholesterol, hydrochlorothiazide 25 mg daily for hypertension and metformin 1000 mg twice daily for diabetes. On 22Jan2015, the shot was administered and within a few hours the patient had a local and systemic reaction. It was reported also that the patient experienced on 22Jan2015 warmth, erythema, edema, chills, headache, myalgia, fatigue, difficulty moving arm and rash. Vaccination was given in the left upper arm where the local reaction took place. The raised rash was 2cm by 6cm and rectangle shaped. It was also very warm. Treatment included TYLENOL and ALEVE to manage her symptoms and warm compresses. The patient came into the clinic on 26Jan2015 for a follow-up visit and was improving. Outcome for all events was reported as improved.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Mobility decreased, Myalgia, Oedema, Rash
Clinical narrative: This is a spontaneous report by a contactable physician. A 60-year-old female patient received on 22Jan2015 first dose of PREVNAR 13 (lot number J67646, expiration date 22Mar2016, NDC number 0005197101) at 0.5 ml single dose in left arm intramuscular. No other vaccine was administered on the same date. Previously, the patient had never had a reaction to anything. She was not ill at the time. History included diabetes, hypertension, high cholesterol and gastroesophageal reflux disease (GERD), all ongoing. Concomitant medications included benazepril 20 mg for hypertension, insulin glargine at 25 DF daily for diabetes, insulin lispro at 5 DF before meals for diabetes, omeprazole 40 mg for GERD, amlodipine 5 mg for hypertension, simvastatin at 20 mg daily for high cholesterol, hydrochlorothiazide 25 mg daily for hypertension and metformin 1000 mg twice daily for diabetes. On 22Jan2015, the shot was administered and within a few hours the patient had a local and systemic reaction. It was reported also that the patient experienced on 22Jan2015 warmth, erythema, edema, chills, headache, myalgia, fatigue, difficulty moving arm and rash. Vaccination was given in the left upper arm where the local reaction took place. The raised rash was 2cm by 6cm and rectangle shaped. It was also very warm. Treatment included TYLENOL and ALEVE to manage her symptoms and warm compresses. The patient came into the clinic on 26Jan2015 for a follow-up visit and was improving. Outcome for all events was reported as improved.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site reaction
Clinical narrative: This is a spontaneous report by a contactable physician. A 60-year-old female patient received on 22Jan2015 first dose of PREVNAR 13 (lot number J67646, expiration date 22Mar2016, NDC number 0005197101) at 0.5 ml single dose in left arm intramuscular. No other vaccine was administered on the same date. Previously, the patient had never had a reaction to anything. She was not ill at the time. History included diabetes, hypertension, high cholesterol and gastroesophageal reflux disease (GERD), all ongoing. Concomitant medications included benazepril 20 mg for hypertension, insulin glargine at 25 DF daily for diabetes, insulin lispro at 5 DF before meals for diabetes, omeprazole 40 mg for GERD, amlodipine 5 mg for hypertension, simvastatin at 20 mg daily for high cholesterol, hydrochlorothiazide 25 mg daily for hypertension and metformin 1000 mg twice daily for diabetes. On 22Jan2015, the shot was administered and within a few hours the patient had a local and systemic reaction. It was reported also that the patient experienced on 22Jan2015 warmth, erythema, edema, chills, headache, myalgia, fatigue, difficulty moving arm and rash. Vaccination was given in the left upper arm where the local reaction took place. The raised rash was 2cm by 6cm and rectangle shaped. It was also very warm. Treatment included TYLENOL and ALEVE to manage her symptoms and warm compresses. The patient came into the clinic on 26Jan2015 for a follow-up visit and was improving. Outcome for all events was reported as improved.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Differential white blood cell count, Full blood count, Gait disturbance, Injection site erythema, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable Medical Assistant who reported on behalf of physician and from a contactable physician. A 64 years old female patient received PREVNAR 13 (Lot #: J67645, Exp date: 01Mar2016) on 16Dec2014 at 2.30 PM at 0.5 ml, single dose intramuscular in the right deltoid. Patient was vaccinated at private office and vaccine was purchased with private funds. The patient previously received a flu shot on unspecified date in Sep2014. Medical history included endocrine disease, hypothyroidism, hyperlipidemia, hypertension, thyroid tumor, hysterectomy and latex allergy. Patient had no smoking history, denied drug and alcohol use. Concomitant medication were not provided. No other vaccines were given same day nor in 4 weeks prior. On 16Dec2014 the patient experienced local swelling, arm was red and warm to touch localized to administration site. The patient experienced also aching (on a scale 0-10 she rated pain as 8). The patient reported to ER on Saturday 20Dec2014. Patient arrived ambulatory, gait was steady, she appeared comfortable, cooperative, alert, oriented to person, place and time, well-groomed, with arm, dry, normal in colour skin, mucous membranes pink, moist. Right upper extremity assessment findings included capillary refill less than 2 seconds, skin color red to right deltoid, skin temperature hot to touch, distal sensation intact, muscle tone normal, muscle strength 5, no edema present. The patient was not hospitalized. She was sent home, no treatment done per medical assistant. Medical assistant denied other symptoms on day of ER visit. IV therapy was indicated for hydration, established to the left hand using a 22 gauge catheter in one attempt. IV site was prepped with CHLORAPREP, saline lock was established, flushed with normal saline 10 ml. After procedure, there was no drainage at IV site, no swelling at IV site, no redness at IV site. IV was discontinued due to patient being discharged. The patient received prescription of oral acetaminophen at 650 mg, MOTRIN and PERCOCET. The patient received prednisone from 22Dec2014 to 24Dec2014. The patient recovered from the events on unknown date. Lab data included blood pressure at 158/94, pulse at 76, respiratory rate at 16, temperature at 97 (oral), pain: 8, O2 saturation at 98 in room air. On 20Dec2014 prothrombin time, basic metabolic panel and complete blood count with Auto Differential were measured. Follow-up (29Jan2015): Follow-up attempts completed. No further information expected. Follow-up (13Feb2015): New information from a contactable physician includes: medical history, vaccination time, concomitant medication, events clinical course, additional event, treatments received, lab data. Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Local swelling, Metabolic function test, Pain, Prothrombin time
Clinical narrative: This is a spontaneous report from a contactable Medical Assistant who reported on behalf of physician and from a contactable physician. A 64 years old female patient received PREVNAR 13 (Lot #: J67645, Exp date: 01Mar2016) on 16Dec2014 at 2.30 PM at 0.5 ml, single dose intramuscular in the right deltoid. Patient was vaccinated at private office and vaccine was purchased with private funds. The patient previously received a flu shot on unspecified date in Sep2014. Medical history included endocrine disease, hypothyroidism, hyperlipidemia, hypertension, thyroid tumor, hysterectomy and latex allergy. Patient had no smoking history, denied drug and alcohol use. Concomitant medication were not provided. No other vaccines were given same day nor in 4 weeks prior. On 16Dec2014 the patient experienced local swelling, arm was red and warm to touch localized to administration site. The patient experienced also aching (on a scale 0-10 she rated pain as 8). The patient reported to ER on Saturday 20Dec2014. Patient arrived ambulatory, gait was steady, she appeared comfortable, cooperative, alert, oriented to person, place and time, well-groomed, with arm, dry, normal in colour skin, mucous membranes pink, moist. Right upper extremity assessment findings included capillary refill less than 2 seconds, skin color red to right deltoid, skin temperature hot to touch, distal sensation intact, muscle tone normal, muscle strength 5, no edema present. The patient was not hospitalized. She was sent home, no treatment done per medical assistant. Medical assistant denied other symptoms on day of ER visit. IV therapy was indicated for hydration, established to the left hand using a 22 gauge catheter in one attempt. IV site was prepped with CHLORAPREP, saline lock was established, flushed with normal saline 10 ml. After procedure, there was no drainage at IV site, no swelling at IV site, no redness at IV site. IV was discontinued due to patient being discharged. The patient received prescription of oral acetaminophen at 650 mg, MOTRIN and PERCOCET. The patient received prednisone from 22Dec2014 to 24Dec2014. The patient recovered from the events on unknown date. Lab data included blood pressure at 158/94, pulse at 76, respiratory rate at 16, temperature at 97 (oral), pain: 8, O2 saturation at 98 in room air. On 20Dec2014 prothrombin time, basic metabolic panel and complete blood count with Auto Differential were measured. Follow-up (29Jan2015): Follow-up attempts completed. No further information expected. Follow-up (13Feb2015): New information from a contactable physician includes: medical history, vaccination time, concomitant medication, events clinical course, additional event, treatments received, lab data. Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Oral mucosal erythema, Oral pain
Clinical narrative: This is a spontaneous report obtained from a contactable nurse who reported for herself. A 67 year-old patient received, on 23Dec2014, PREVNAR 13 single dose. Relevant medical history was unknown. Concomitant medications included SYNTHROID and acetazolamide for Meniere's disease. On an unspecified date, the patient had a breakout in her mouth like a horse shoe red (in the middle of the back of her mouth, it was not on one side, it was all the way round other side just like the exact figure of the horse shoe and it was hurting). The patient's joints were not acting (her joints were little worse) and she had also pain in joints. The patient received ADVIL. The patient was recovering from pain mouth, while clinical outcome of the other events was unknown. Follow-up (04Mar2015): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer and from a contactable physician. A 65-year-old healthy female patient received PREVNAR 13 (Lot Number J498U2 or J49842, NDC number 0005-1971-01) at 0.5 ml single via intramuscular route into the left deltoid on 16Dec2014 at 10:00. Relevant medical history included tonsils out for surgery (when she was a teenager), cataract surgery (she was taking eye drop), high blood pressure, transient ischemic attack (TIA) stroke 10 years before this report, and pneumonia. Concomitant medications included ongoing atenolol at 50 mg since 2000, ongoing amlodipine at 5 mg since 2014, both for high blood pressure, and ongoing atorvastatin at 10 mg since 2005 for an unspecified indication. On 16Dec2014, 12 hours after the shot, the patient woke up at night and experienced excruciating pain of her arm (from her shoulder injection site to her finger tips). She got up and trying to shake her arm over the next 24 hours, she began to feel better but she was just shocked, she had such a painful reaction in whole arm. The reaction lasted for 2 weeks and included also 4 inch diameter swelling at injection site that was red and hard as a rock. After a few days a rash appeared and it began to itch. On 17Dec2014, the patient also developed extreme chills and her joint began to ache painfully that lasted for a few days. She was not aware of the side effects of PREVNAR 13. She thought she was coming down with the flu and after 48 hours she went on a website to look up adverse side effects and she had every single side effect. The patient did not receive treatment for the events. The patient recovered from the reported events on an unspecified date. She asked if this reaction was more likely in a person who had already had pneumonia and if the other pneumococcal vaccines currently on the market caused a similar reaction. Follow-up (28Jan2015): New information reported from a contactable physician includes: drug data (added suspect drug PREVNAR 13 with Lot Number J49842, Expiration Date 30Mar2016, dose of 0.5 ml, single, via IM route, anatomical location, start and stop time). Follow-up (18Feb2015): New information reported from the same contactable consumer includes: suspect product details (suspect product was confirmed PREVNAR 13, it was unknown if its lot number was J498U2 or J49842), additional details on concomitant medications (start date), reaction data (new events 4 inch diameter swelling at injection site that was red and hard as a rock, after a few days a rash appeared and it began to itch were added), reporter queries.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pain in extremity, Rash pruritic, Sleep disorder
Clinical narrative: This is a spontaneous report from a contactable consumer and from a contactable physician. A 65-year-old healthy female patient received PREVNAR 13 (Lot Number J498U2 or J49842, NDC number 0005-1971-01) at 0.5 ml single via intramuscular route into the left deltoid on 16Dec2014 at 10:00. Relevant medical history included tonsils out for surgery (when she was a teenager), cataract surgery (she was taking eye drop), high blood pressure, transient ischemic attack (TIA) stroke 10 years before this report, and pneumonia. Concomitant medications included ongoing atenolol at 50 mg since 2000, ongoing amlodipine at 5 mg since 2014, both for high blood pressure, and ongoing atorvastatin at 10 mg since 2005 for an unspecified indication. On 16Dec2014, 12 hours after the shot, the patient woke up at night and experienced excruciating pain of her arm (from her shoulder injection site to her finger tips). She got up and trying to shake her arm over the next 24 hours, she began to feel better but she was just shocked, she had such a painful reaction in whole arm. The reaction lasted for 2 weeks and included also 4 inch diameter swelling at injection site that was red and hard as a rock. After a few days a rash appeared and it began to itch. On 17Dec2014, the patient also developed extreme chills and her joint began to ache painfully that lasted for a few days. She was not aware of the side effects of PREVNAR 13. She thought she was coming down with the flu and after 48 hours she went on a website to look up adverse side effects and she had every single side effect. The patient did not receive treatment for the events. The patient recovered from the reported events on an unspecified date. She asked if this reaction was more likely in a person who had already had pneumonia and if the other pneumococcal vaccines currently on the market caused a similar reaction. Follow-up (28Jan2015): New information reported from a contactable physician includes: drug data (added suspect drug PREVNAR 13 with Lot Number J49842, Expiration Date 30Mar2016, dose of 0.5 ml, single, via IM route, anatomical location, start and stop time). Follow-up (18Feb2015): New information reported from the same contactable consumer includes: suspect product details (suspect product was confirmed PREVNAR 13, it was unknown if its lot number was J498U2 or J49842), additional details on concomitant medications (start date), reaction data (new events 4 inch diameter swelling at injection site that was red and hard as a rock, after a few days a rash appeared and it began to itch were added), reporter queries.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 79-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml single dose on 29Dec2014. Medical history included ongoing chronic lymphocytic leukaemia diagnosed with CLL 4 years ago, in 2010 or 2011, ongoing chronic obstructive pulmonary disease diagnosed with COPD maybe 30 years ago, ongoing arthritis. Concomitant medication included fluticasone propionate, ADVAIR on 250 puff twice a day, SPIRIVA one puff a day, ipratropium bromide, COMBIVENT if needed, SYNTHROID 125 mcg 5 days a week, fluticasone 2 nasal sprays in each nostril once a day, 50 mcg, PROTONIX 40 mg one a day as needed, takes it maybe twice a week, biotin 5000 mcg one daily, calcium citrate 1260 mg, vit D 1000 mg one daily, vitamin B1, folic acid 800 mg one daily, omega 3 oil 1000 mg one daily, coenzyme Q10 200 mg one daily, turmeric curcumin 1000 mg one daily, probiotics 10 billion one daily, CENTRUM SILVER. About 3 or 4 days after the administration of the vaccine she came down with all symptoms of cold, no fever, but a stuffy nose and sore throat and then waking up with the head cold symptoms. On 05Jan2014 or 06Jan2014, the patient experienced redness (red circle the size of a tennis ball)/round, red circle at site of injection. It was a little sensitive at beginning, but it just felt like a shot does. It is not sensitive now. She hadn't taken off her shirt in a while prior to a few days ago, so she does not know how long she had the red circle. Consumer states she had 2 colds in a row prior to getting the injection and because she has a form of leukemia known as CLL the doctor had recommended she get the injection. Consumer is not sure if the cold is a result of the shot or just coincidental. The outcome of redness (red circle the size of the tennis ball)/round, red circle at site of injection was not recovered, the outcome of cold was recovering and the outcome of the other events was unknown. Follow-up (08Jan2015): New information obtained from a contactable consumer includes: patient's age, medical history, concomitants medications, additional event (stuffy nose), date of vaccination, onset partial date of the events, outcome.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Arthritis, Condition aggravated
Clinical narrative: This is a spontaneous report from a non clinical study program (IBCC (Inbound Call Center for HCP's) for a contactable pharmacist. A 73-year-old male patient of unspecified ethnicity received PREVNAR13 (Lot # J49843), via an unspecified route of administration, on 19DEC2014, at single dose. Relevant medical history included arthritis in spine. Concomitant medications were not reported. On an unspecified date after the vaccination the patient noticed arthritis in his shoulder and other areas. Outcome of the reported event was unknown at the time of this report. The pharmacist said that she was not sure if arthritis in the patient's shoulder and  other areas was due to PREVNAR13. NDC#00005197102. Follow-up (06MAR2015): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Erythema, Feeling abnormal, Injection site pruritus, Injection site reaction
Clinical narrative: This is a  spontaneous report from a contactable consumer. This 74-year-old female patient received a single dose of pneumococcal vaccine via an unspecified route of administration in the left arm on 21JAN2015 around 11 AM. The patient medical history and concomitant medications were not reported. On 21JAN2015 within an hour after the vaccine was administered the patient experienced itchiness at injection site. In the evening her left arm had swelled, she stated she felt tightness in her left upper arm, rather than pain, a weird feeling. She stated that at time of reporting, her arm was not longer so swollen, but it as though the chemical had moved from the injection site. There was right redness, under her left arm, about an inch or two below her armpit, that was spread about 1 quarter inch across her chest from left to right and moved up toward her neck. She had a temperature of 99.7 degrees Fahrenheit around 8 PM on 21JAn2015. She had called the triage nurse and she was advised to take for increased body temperature ALEVE which sh did, she took 2 tablets by mouth. She believed that fever had gone, although she had not retake her temperature. She was concerned, and she asked if it would affect her heart and how long the reaction would last. The final outcome of the reported events was recovered. Follow-up attempts completed. No further information expected. Follow-up (20MAR2015): New information from contactable consumer includes event outcome. No follow up attempts possible. No further information expected.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a  spontaneous report from a contactable consumer. This 74-year-old female patient received a single dose of pneumococcal vaccine via an unspecified route of administration in the left arm on 21JAN2015 around 11 AM. The patient medical history and concomitant medications were not reported. On 21JAN2015 within an hour after the vaccine was administered the patient experienced itchiness at injection site. In the evening her left arm had swelled, she stated she felt tightness in her left upper arm, rather than pain, a weird feeling. She stated that at time of reporting, her arm was not longer so swollen, but it as though the chemical had moved from the injection site. There was right redness, under her left arm, about an inch or two below her armpit, that was spread about 1 quarter inch across her chest from left to right and moved up toward her neck. She had a temperature of 99.7 degrees Fahrenheit around 8 PM on 21JAn2015. She had called the triage nurse and she was advised to take for increased body temperature ALEVE which sh did, she took 2 tablets by mouth. She believed that fever had gone, although she had not retake her temperature. She was concerned, and she asked if it would affect her heart and how long the reaction would last. The final outcome of the reported events was recovered. Follow-up attempts completed. No further information expected. Follow-up (20MAR2015): New information from contactable consumer includes event outcome. No follow up attempts possible. No further information expected.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Influenza virus test negative, Injection site erythema, Investigation, Pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative and from a contactable nurse on behalf of the physician. This contactable physician reported different events with the same suspect product for four patients. This is the second of four reports. An 87 year-old female patient (weight 67 kg, height 165 cm) received PREVNAR 13 (lot number J80525, expiry date Apr2016) on 21Jan2015 around 15:00, intramuscular in right arm, at 0.5 ml single dose. The patient had a medical history of allergies to sulfa, amoxicillin, KEFLEX, NIASPAN, hydrochlorothiazide, VOLTAREN, amiodarone, AFRIN, doxycycline, clindamycin, clotrimazole. Concomitant medications were not provided, however it was reported that the patient was on like 20 unspecified medications. The patient went to the Emergency Room at night after the vaccination for body aches, hard chills and swelling, redness and hot in right arm, at the vaccination site, that developed on 21Jan2015 at 21:00, but was not hospitalized. Flu screen was negative on 21Jan2015. In response to the events she was given an antihistamine treatment. The patient recovered from the reported events on an unspecified date in 2015. The reporting physician stated he wanted to report this because this has happened all of a sudden and he was concerned. The Pfizer sales representative mentioned that the physician believed that the reactions were experienced by the patient because of the PREVNAR 13. Subsequently also the nurse confirmed that there was a reasonable possibility that the events were related to PREVNAR 13. Follow up (23Jan2015): New information reported from the same contactable physician via a Pfizer sales representative includes causality assessment. Follow-up (18Feb2015): New information reported from a contactable nurse on the behalf of the physician includes: details on patient medical history, reaction data (it was specified that swelling, redness and hot occurred at the injection site, updated events outcome), treatment given, nurse causality assessment. Follow-up attempts completed. No further information expected.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative and from a contactable nurse on behalf of the physician. This contactable physician reported different events with the same suspect product for four patients. This is the second of four reports. An 87 year-old female patient (weight 67 kg, height 165 cm) received PREVNAR 13 (lot number J80525, expiry date Apr2016) on 21Jan2015 around 15:00, intramuscular in right arm, at 0.5 ml single dose. The patient had a medical history of allergies to sulfa, amoxicillin, KEFLEX, NIASPAN, hydrochlorothiazide, VOLTAREN, amiodarone, AFRIN, doxycycline, clindamycin, clotrimazole. Concomitant medications were not provided, however it was reported that the patient was on like 20 unspecified medications. The patient went to the Emergency Room at night after the vaccination for body aches, hard chills and swelling, redness and hot in right arm, at the vaccination site, that developed on 21Jan2015 at 21:00, but was not hospitalized. Flu screen was negative on 21Jan2015. In response to the events she was given an antihistamine treatment. The patient recovered from the reported events on an unspecified date in 2015. The reporting physician stated he wanted to report this because this has happened all of a sudden and he was concerned. The Pfizer sales representative mentioned that the physician believed that the reactions were experienced by the patient because of the PREVNAR 13. Subsequently also the nurse confirmed that there was a reasonable possibility that the events were related to PREVNAR 13. Follow up (23Jan2015): New information reported from the same contactable physician via a Pfizer sales representative includes causality assessment. Follow-up (18Feb2015): New information reported from a contactable nurse on the behalf of the physician includes: details on patient medical history, reaction data (it was specified that swelling, redness and hot occurred at the injection site, updated events outcome), treatment given, nurse causality assessment. Follow-up attempts completed. No further information expected.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction
Clinical narrative: This is a spontaneous report from a contactable physician and from Pfizer Consumer Healthcare for a contactable Pfizer sales representative. This physician reported different events with the same suspect product for four patients. This is the fourth of four reports. A 90-year-old female received PREVNAR 13 (lot J67644, expiry date Mar2016) at 0.5 ml single, intramuscular, in left deltoid, on 15Jan2015 at 13:00. Medical history included allergy to ZOLOFT and ACE inhibitors. Concomitant medications were not provided. On an unspecified date 6 days after vaccination, the patient experienced a large local reaction. The patient was treated with antihistamines and antibiotic. Event outcome was unknown at time of report. The Pfizer sales representative mentioned that the doctor believed that the reactions were experienced by the patient because of the PREVNAR 13. Follow up (23Jan2015): New information from Pfizer Consumer Healthcare for a contactable Pfizer sales representative includes causality assessment. Follow up (18Feb2015): New information from a contactable Nurse on behalf of Physician includes: patient age and gender, past drug history, vaccination date, route and anatomical location of administration, event onset latency, treatments received. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Information regarding PREVNAR 13 was received from a physician regarding an unknown number of patients who experienced very painful injection sites. The patient received a dose on unspecified dates. Relevant medical history was not provided. Concomitant medications were not reported. The patients experienced very painful injection sites. Outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced pain during administration of the injection. The patient received a dose on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced pain during administration of the injection. As of 25 Oct 2010, it is unknown if patients have recovered from the pain during injection. The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Age: 0.2
Sex: U
Vaccine: PNC13
Symptoms: Laboratory test normal, Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a physician regarding 2 month old patients who experienced high fevers "around 104.0" within 48 hours of receiving PREVNAR 13 and PENTACEL for first immunization in the series at 2 month well baby visit. The patients received the first dose on unspecified dates. Relevant medical history was not provided. Additional suspect medication included PENTACEL. Concomitant medications were not reported. The patients experienced high fevers "around 104.0" within 48 hours of receiving PREVNAR 13 and PENTACEL for first immunization in the series at 2 month well baby visit. Outcome was unknown. No additional information was available at the time of this report. Laboratory test (results: negative septic workup) and body temperature (results: around 104.0) were done on an unspecified date. The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided.
Age: 0.8
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding her 9 month old male son who experienced loose stools for several days. The patient received the first dose on an unspecified date. Relevant medical history was not provided. Additional suspect medication included IPV and HepB vaccine. Concomitant medications were not reported. The patient experienced loose stools for several days. Outcome was recovered on an unknown date. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Information regarding PREVNAR13 was received from a healthcare professional regarding a patient who experienced redness around the injection site. The patient received a dose in 2010. Relevant medical history was not provided. Product was administered in 2010. Dose regiment was 1 dose 1 time per day. Concomitant medications  were not reported. The patient experienced redness around the injection site (injection site erythema) in 2010. As of 13 OCT 2010, it was unknown if the patient has recovered from the redness at the injection site. No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a 2 month old female patient who experienced nickel size red swelling on the leg, at the injection site. At 2 months of age, the patient received a dose on an unknown date in 2010. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced nickel size red swelling on the leg, at the injection site and nickel size red swelling on the leg, at the injection site on an unknown date in 2010. Treatments were not reported. The outcome was unknown. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 2 year old female patient who experienced hives. The patient received a dose on 14 Sep 2010. The patient's concurrent illness includes drug hypersensitivity (Penicillin). Concomitant medications were not reported. The patient experienced  hives on 14 Sep 2010. As of 16 Sep 2010, the outcome for hives was unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This is a spontaneous report from a contactable physician. A physician reported a 3-year-old male patient received PREVNAR13 on an unspecified date via an intramuscular route of administration in the left vastas lateralas. On 16JAN2011 the patient developed injection site swelling, painful, arm to the touch, and erythematous 5x10 cm. The patient was seen on 20JAN2011 with several local reaction to vaccine. At the time of this report, it is unknown if the patient recovered. No serious criteria were reported by the physician.
Sex: U
Vaccine: PNC13
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient (age, gender and origin unknown) received PREVNAR 13 on an unspecified date. Relevant medical history, concomitant medications and past product history were not reported. On an unknown date, following administration of the vaccination, the patient developed swelling of the lymph nodes. Treatment was not reported. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.
Age: 1.9
Sex: U
Vaccine: PNC13
Symptoms: Antibody test abnormal
Clinical narrative: This is a spontaneous report to Pfizer from Merck Research Laboratories, Service Request Number 1-398461704. A contactable nurse practitioner reported that a 22 month old patient received 3 doses of PREVNAR and 1 dose of PREVNSR13 and had an "abnormally low pneumococcal titer". The outcome of the event was not provided. No further AE information was provided.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Rash, Skin warm, Swelling
Clinical narrative: This is an initial spontaneous report by a medical assistant. This female medical assistant reported on behalf of a 4-year-old female patient who began on PREVNAR13 0.5 ml suspension for intramuscular injection unknown frequency on 23MAR2011. Relevant medical huistory was none. Relevant concomitant medicatons were none. On 24MAR2011 she experienced rashes, redness, swelling and ow grade fever of 99 which she mentioned it as warm to the touch. Therapeutic measures incldued BENADRYL in response to the rashes, redness, and swelling. Relevant lab data was none. At the time of the report it was unknown if she was taking PREVNAR13 At the tine of the report she had recovered from rashes, redness and swelling. At the tine of the report she was recovering from remaining event. Follow-up (13MAY2011): Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Flushing
Clinical narrative: This is a spontaneous report initially received from a contactable physician via a Pfizer Field Force Representative with follow-up from the nurse at the office. A 3-year-old male received the first dose of PREVNAR13 on 28MAR2011 via an intramuscular route of administration in the right thigh. There was no relevant medical history, no drug history, no drug allergies and no family history. No concomitant medications were noted. The patient was reported to be up-to-date on his vaccinations. The patient experienced facial flushing 30 minutes after vaccination. The patient returned to the physician's office 30 minutes after  vaccinations and was treated with BENADRYL. At the time of this report, the patient had recovered. The physician believes that there was a reasonable possibility that the event was related to PREVNAR13. Follow-up attempts completed. No further information expected. Follow-up (22APR2011): New information reported from a contactable nurse includes: gender of patient, dose details, onset of event, treatment outcome and causality assessment. Follow-up (19MAY2011): Follow-up attempts completed. No further information expected.
Age: 4.0
Sex: M
Vaccine: MMR, PNC13
Symptoms: Injection site induration, Injection site rash, Injection site urticaria, Injection site warmth
Clinical narrative: This medical assistant reported similar events for three patients. This is the third of three reports. This is a spontaneous report from a contactable medical assistant. A 4-year-old male patient received a dose of PREVNAR13 intramuscularly on the leg on 11APR2011. Relevant medical history was none. Relevant concomitant vaccine included measles, mumps, and rubella vaccine, varicella virus vaccine. Relevant past product history included PREVNAR at the age of 2 months. Vaccine taken within the last four weeks were none. On 12APR2011, the patient developed hardening of skin, hives, little bumps and warmth at the site of injection. Relevant lab data was unknown. At the time of the report the outcome of the events was unknown. Follow-up (27MAY2011): Follow-up attempts completed. No further information expected.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site rash, Injection site urticaria, Injection site warmth
Clinical narrative: This is the first of three reports. This is an initial spontaneous report received from a contactable medical assistant. A 4-year-old female patient intramuscularly received a dose of PREVNAR13 on the leg as routine vaccination on 12APR2011. The patient also concomitantly received a dose of measles, mumps, rubella and chicken pox vaccine on 12APR2011. There was no relevant medical history. Past vaccines included PREVNAR which was given when the baby was 2 month old. No vaccines were given within 4 weeks. On 13APR2011, the patient developed hardening of skin at the injection site, and also hives, little bumps and warmth at the site of injection. The events did not require an emergency room visit. Treatment was not provided. At the time of the report the clinical outcome of the above events was unknown. Follow-up (27MAY2011): Follow-up attempts completed. No further information expected.