chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Productive cough
Clinical narrative: This is a spontaneous report from a contactable physician who reported for himself. This 71-year-old male patient received PREVNAR 13 via intramuscular route of administration, in left deltoid, at the age of 70 years, on 19Oct2015, at 15:00, at 0.5 ml single. It was given 9 days too early. Medical history was not reported. No vaccines were given on same date along with suspect vaccine. Vaccination given within four weeks included influenza vaccine. He concomitantly received a lot of medications and took cardiac stuff like a beta blocker. The patient received PNEUMOVAX 23 after the age of 65-years, but prior to receiving PREVNAR 13. The patient experienced early pneumonia in Feb2016 with outcome of resolved in Mar2016. The primary infection site was in lungs. Clinical course was reported as follows: The patient stated that he received PREVNAR 13 and he became severely ill several months after the vaccine. No cultures were done but it might have been early pneumonia. He was given 10 days of LEVAQUIN as treatment. The patient was diagnosed with early pneumonia in early Feb2016. He was treated by a physician at an emergency care center. No admission to hospital was involved. A chest X-ray done at the emergency care center in Feb2016 showed either atelectasis or a little pneumonia. The patient had no fever, just had terrible cough and phlegm that would not stop. Phlegm was always clear. He had symptoms for 10 days before seeing the doctor. The cough lasted a month. After two weeks, he started to feel better and his symptoms gradually reduced. The physician did not feel the early pneumonia was related to PREVNAR 13. Follow up (23Jun2016): New information from the same contactable physician includes: vaccination time, route of administration, details about treatment received and lab data details. Follow-up attempts completed. No further information expected. Follow-up (14Jul2016): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13, TTOX
Symptoms: Cough, Extra dose administered, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer-Sponsored Program. A male patient of unspecified age and ethnicity received the second dose of PREVNAR 13 at single dose and the second dose of tetanus vaccine (unknown manufacturer), both via an unspecified route of administration on an unspecified date. Medical history included ongoing stage 6 kidney failure/kidney issues, he was trying to skip dialysis and to directly go to a transplant, he was hospitalized. The patient's concomitant medications were not reported. The second doses of PREVNAR 13 and of tetanus vaccines were given in error as documented by the doctors office, given 2 full strength PREVNAR 13 within a 35 day period, along with 2 tetanus vaccines full strength during the same time frame. On an unspecified date the patient experienced pneumonia and cough. Outcome of these events was unknown. Follow up (24May2016): New information reported from the same contactable consumer (patient's wife) includes: Patient gender, details on patient medical history, reaction data (new event of pneumonia and cough was reported). Follow-up (20JUL2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that her husband of unspecified age received PREVNAR 13 on an unspecified date, at 0.5 ml single. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine shot and then 2 months later he had to go to the hospital for pneumonia. Event outcome was unknown at time of report. No follow up attempts are possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable pharmacist based on information received by Pfizer from Merck and Co., Inc. 00101802. A 1-year-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and the patient's concomitant medications were not reported. The vaccine was not effective. No additional information provided. Follow-up (12OCT2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Injection site cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for 3 patients. This is the 2nd of 3 reports. 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's medical history and concomitant medications were not reported. The patient experienced significant cellulitis at the point of the shot, arm swelling, arm redness and soreness in arm on an unspecified date with outcome of unknown. The doctor attributed the significant cellulitis to PREVNAR 13. Follow-up (07JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Computerised tomogram thorax, Pneumonia, Prothrombin time abnormal
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer reporting  for herself. This 44 year-old female patient received pneumococcal vaccine via an unspecified route of administration on 20Apr2016 at 0.5 ml single, as inpatient in hospital. The patient medical history included blood clots and deep vein thrombosis (DVT), concomitant medications were not reported. The patient had received for immunization a pneumonia shot a long time before. After getting pneumococcal vaccine on 20Apr2016, on an unspecified date in 2016, she went in to see her doctor because she was having chest pain. On 10Aug2016 she underwent a heart CT scan because she had a history of blood clots and DVT. The level in clotting was not good and thought she may have had a pulmonary embolism. However then it was found that she did not have a pulmonary embolism, but was diagnosed with having pneumonia. Outcome was unknown. Follow-up (24DEC2016):  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: This spontaneous report from a contactable pharmacist. A 77-year-old female patient of an unspecified ethnicity received PREVNAR 13 on 25Feb2016, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2016, about a week after she received the vaccine, the patient experienced redness, itchiness, warm to the touch and a little sore. The patient had not yet been recovered. Follow-up (28-APR-2016): Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Prostatic specific antigen decreased
Clinical narrative: This is a spontaneous report from a contactable consumer and from a contactable physician. A 67-year-old male patient received PREVNAR 13, via an unspecified route in right shoulder of administration on 06Mar2016 at 15:00 single dose. Medical history included ongoing hypothyroidism diagnosed about 6 years before this report, ongoing prostatic specific antigen (PSA was 1.8) and urine flow/prostate. Concomitant medication included SYNTHROID, tablet orally at 56 ug daily for hypothyroidism, liothyronine orally at 20 ug daily for hypothyroidism and alfuzosin tablet at 10 mg daily for urine flow/prostate all ongoing. In 2008, at 59-year-old, the patient received influenza vaccine and experienced influenza and malaise. On 06Mar2016 the patient experienced soreness, like someone hit him in the arm both. The patient was recovering from the event. The physician confirmed that the patient provided to him/her information regarding the reported events with the use of the vaccine. The physician considered the vaccine had a causal effect to the adverse events. Follow-up (02May2016): New information reported from a contactable physician includes: confirmation that the patient provided to the physician information regarding the reported events with the use of the vaccine, causality assessment. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose. Relevant medical history was not reported. Concomitant medications included ALLEGRA, HCTZ and ZOLOFT. The patient experienced redness swelling and heat at site lasting a week on an unspecified date. The outcome of the events was recovered on an unspecified date. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Local swelling, Rash
Clinical narrative: This is a spontaneous report from a contactable other health care professional who reported for his/her nephew, via Pfizer sales representative. A patient of unspecified age, ethnicity and gender 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. On an unspecified date after receiving vaccination, the patient experienced a rash and a swollen area on leg. The final outcome of the events was not reported. Follow-up (05MAY2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Local swelling, Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a Company representative. A 71-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in the left arm on 02Mar2016 at 0.5 ml, single. Medical history included sensitive skin. The patient's concomitant medications were not reported. Within 24 hours patient had red rash and itching approximately 3 inches in diameter at injection site and local swelling. On the evening of 07Mar2016 the patient developed more extensive rash on that arm and hives like rash on her arms and anterior neck. Patient was prescribed antihistamines and low dose steroids for the symptoms. The outcome of the events was unknown. Follow-up (05May2016): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician via a Company representative. A 71-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in the left arm on 02Mar2016 at 0.5 ml, single. Medical history included sensitive skin. The patient's concomitant medications were not reported. Within 24 hours patient had red rash and itching approximately 3 inches in diameter at injection site and local swelling. On the evening of 07Mar2016 the patient developed more extensive rash on that arm and hives like rash on her arms and anterior neck. Patient was prescribed antihistamines and low dose steroids for the symptoms. The outcome of the events was unknown. Follow-up (05May2016): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report from a contactable physician via a Pfizer sales representative. A 89-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on unspecified date in the fall of 2015 at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. Within 24 hours of the injection in 2015 the patient experienced flu like symptoms with outcome of unknown. Follow-up (05May2016): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report from a contactable pharmacist. A 65-year-old male patient received PREVNAR 13, lot M73332, exp.date Jul2017, NDC number 0005-1971-05, via an unspecified route of administration on left deltoid on 02Mar2016 17:13 at 0.5ml single dose for immunisation. Medical history included ongoing osteoarthritis. There were no concomitant medications. The patient experienced a lot of pain way down his arm on 02Mar2015 and having difficulty holding up his arm on unknown date. It was also reported that the patient may have received injection higher up than recommended. The outcome of the event a lot of pain way down his arm was reported as not recovered while the outcome of the other event was reported as unknown. Follow-up (05May2016): Follow-up attempts completed. No further information expected.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Antibody test negative
Clinical narrative: This is a spontaneous report from a contactable Pfizer employee. A 1-year-old female patient received PREVNAR 13, on an unspecified date, in 2013, at 0.5 ml, single dose. Medical history included chronic ear infection. There were no concomitant medications. The patient had a blood work to confirm her antibodies and to determine that her vaccine did not build up the antibodies (in 2013), so she would need a booster shot. No hospitalization was required. Subsequently, a booster shot was administered. The outcome of the event was recovered at time of this report. Follow-up (23May2016): New information received from a contactable consumer includes: suspect drug details and reaction data. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable physician. A 71-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on left arm on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced within 2 hours, injection site was red and swollen 2 cm and itchy. 5 days later she had itchy rashes on arms and neck. The outcome was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sale representative. A patient of unspecified age ethnicity and gender received a single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient referred to emergency room with redness and swelling in arm, from shoulder down to the elbow, following a dose of pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date. The outcome of the events was unknown. The reporter stated that the events took place after use of product. No follow-up attempts possible. No further information expected.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from contactable consumer reporting for herself and from a contactable pharmacist. This 68-year-old female patient received PREVNAR 13 Batch/Lot M13067), intramuscular in left arm, in early afternoon on 05Nov2015, at a single dose. Relevant medical history and concomitant medications were not reported. The patient received pneumococcal vaccine the year before, with no adverse event. On 05Nov2015 the vaccine injection was very painful at the time of administration and the patient also experienced limited left arm movements (pain when moving her arm out to the side or opening a car door, no pain when moving her arm in front of her and up). Her orthopedic doctor advised her to take heavy doses of pain medicine or get a cortisone shot. The patient recovered from pain without any treatment on an unspecified date, she took ALEVE for limited left arm movements but she continued to experience it. Follow-up (08Apr2016): New information reported from the same contactable consumer includes: details on treatment and updated outcome for the event pain. Follow-up (17May2016): New information reported from the contactable pharmacist includes lot number and route of vaccine. Follow up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Cough, Fatigue, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer. A 78-year-old female patient of unspecified ethnicity received PREVNAR 13 via an unspecified route of administration, on unknown date 6 weeks before this report, at a single dose for immunization. Relevant medical history and concomitant medications were not reported. The patient experienced trouble raising her arms, cough and fatigue on unknown date. The outcome of the events was unknown. Follow-up (08-MAY-2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Blood creatinine increased
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 88 year-old female patient of unspecified ethnicity received PREVNAR 13 via an unspecified route of administration, on 09Feb2016 at 0.5 ml single for immunization. Relevant medical history and concomitant medications were not reported. The patient experienced creatinine level increased to 16- 17 on 14Mar2016. The outcome of the event was unknown. The physician confirmed that the event took place after received the vaccine. The physician asked if it could be a relationship between the event and product. Follow-up (11MAY2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a non-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. The patient medical history and concomitant medications were not reported. The patient experienced soreness for 3-4 months on an unspecified date with outcome of unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Impaired work ability, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer. This is the second report of the two cases. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on unknown date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced very sick and not able to go to work with outcome of unknown. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself and a contactable pharmacist. A 73-year-old male patient received PREVNAR 13 (Lot # M20640, exp. date Apr2017), intramuscular at 0.5 ml, single in the left deltoid on 16Dec2015 12:15. Medical history included prediabetes, adhesive capsulitis, blood cholesterol abnormal on ongoing. Concomitant medication included pravastatin 40 mg, 1x/day and COQ-10 200 mg softgel, 1x/day, both on ongoing for cholesterol. On 16Dec2015, the patient experienced persistent left deltoid pain with outcome of recovering. Also the patient reported that in Jan2016, he developed pain in left upper arm and shoulder and pain impeded arm movement. Therapeutic measures were taken as a result of these events and the outcome was reported as not recovered. Follow-up (22Mar2016): New information obtained from a contactable pharmacist includes: date of vaccine administration updated, route, dose, lot#, exp date and anatomical location, additional event (persistent left deltoid pain), onset and outcome. Follow-up (21MAY2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Skin warm, Swelling
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This Nurse reported similar events for 2 patients. This is 1st of two reports. An elderly patient (over 65) of an unspecified ethnicity and gender received PREVNAR 13 lot M35761 Exp date May2017, 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 a large circular swelling hot to the touch several days after injection on an unspecified date with outcome of unknown. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, Swelling
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative and a contactable Other HCP. This Nurse reported similar events for 2 patients. This is second of two reports. A female elderly patient (over 65) of an unspecified ethnicity received PREVNAR 13, (lot M35761 Exp date May2017), via an unspecified route of administration on an unspecified date at single dose. The patient years ago received a vaccine and passed out. She was told it was likely due to egg component. Concomitant medications were not reported. The patient experience a large circular swelling hot to the touch several days after injection on an unspecified date with outcome of unknown. Follow-up (28Mar2016): New information received from a contactable Other HCP included: gender, medical history. Follow-up(22May2016): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Erythema, Injection site rash, Injection site swelling, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse reporting for herself. A 60-years-old female patient received PREVNAR 13, intramuscular in the left arm in 2011 at 0.5, ml single. Medical history included well controlled asthma and hypersensitivity both from an unknown date and unknown if ongoing. Concomitant medication included DULERA, ZYRTEC both as needed. The patient previously took ADVAIR, inhaler for asthma and experienced intentional product misuse and drug ineffective. She started using an ADVAIR inhaler maybe 10-15 years ago for asthma. The ADVAIR inhaler 250/50 was prescribed to be used 1-2 puffs twice a day. She used it as needed. When she had the reaction, she started using it. It did not really help. The ADVAIR inhaler has been switched to DULERA used as needed. The patient experienced significant left arm swelling, left arm hot and red, chest got a little tight; red, itchy, raised rash; it was about 5-6 inches long at the site of injection all 2011 with outcome of recovered. Therapeutic measures were taken as a result of significant left arm swelling, red, itchy, raised rash and injection site rash included MEDROL dose pack. The left arm swelling was not just at the site. It went all the way down her arm. There was no bleeding. She was not wheezing. All the symptoms were gone. Her side effects started within 24 hours, after getting the injection. She went to the doctor's two days later. It took 2-3 days after starting the MEDROL dose pack for the side effect to resolve. Follow-up (20APR2016): Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse reporting for herself. A 60-years-old female patient received PREVNAR 13, intramuscular in the left arm in 2011 at 0.5, ml single. Medical history included well controlled asthma and hypersensitivity both from an unknown date and unknown if ongoing. Concomitant medication included DULERA, ZYRTEC both as needed. The patient previously took ADVAIR, inhaler for asthma and experienced intentional product misuse and drug ineffective. She started using an ADVAIR inhaler maybe 10-15 years ago for asthma. The ADVAIR inhaler 250/50 was prescribed to be used 1-2 puffs twice a day. She used it as needed. When she had the reaction, she started using it. It did not really help. The ADVAIR inhaler has been switched to DULERA used as needed. The patient experienced significant left arm swelling, left arm hot and red, chest got a little tight; red, itchy, raised rash; it was about 5-6 inches long at the site of injection all 2011 with outcome of recovered. Therapeutic measures were taken as a result of significant left arm swelling, red, itchy, raised rash and injection site rash included MEDROL dose pack. The left arm swelling was not just at the site. It went all the way down her arm. There was no bleeding. She was not wheezing. All the symptoms were gone. Her side effects started within 24 hours, after getting the injection. She went to the doctor's two days later. It took 2-3 days after starting the MEDROL dose pack for the side effect to resolve. Follow-up (20APR2016): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot# L99262, Exp date Feb2017, NDC 00005197102, UPC 300051971022), intramuscular, on 16Feb2016, at 0.5 ml single. No other medication was administered to the patient on the same day. Relevant medical history included high blood pressure/hypertension. Concomitant medications were not reported. The patient experienced swelling arm on an unspecified date with outcome of recovering. The reporting pharmacist did not know if the swelling of arm was related to PREVNAR 13. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Bronchitis
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A patient of unspecified age, ethnicity, and gender received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date (about 5-7 years prior to this report) at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced bronchitis. The clinical outcome of the event, bronchitis, was unknown. Pfizer is marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received PREVNAR 13 (Lot # N35763, NDC # 00005197102, Expiry Date May 2017), via an unspecified route of administration on 25Feb2016 at 0.5 ml, single. Medical history was not reported. Concomitant medication included amlodipine. The patient experienced pretty big welted rash on her left arm on which she received the injection and redness, both on 02Mar2016 with outcome of not recovered. No treatment was received in response to the events. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: This spontaneous report from a contactable medical assistant on behalf of the medical office. A 86 year-old Caucasian female patient received PREVNAR 13, lot number M51194, expiry date 01May2017) intramuscularly on the right deltoid on 01Mar2016 at 14:54 at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The patient experienced weakness, fatigue and arm pain on 01Mar2016. No swelling, heat or redness to the arm occurred. The patient did not recover from the events. The doctor did not express if the events were related to the PREVNAR 13. Follow (01MAY2016): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable medical assistant on behalf of the medical office. A 75-year-old female patient received PREVNAR 13 (Lot # M51194, Expiry Date 01May2017), intramuscular in the right deltoid on 26Feb2016 11:27 at 0.5 ml, single for immunisation. Medical history included ongoing asthma. Concomitant medications included ongoing PROAIR, ongoing ASMANEX and prednisone. The patient experienced weakness, tiredness, pain in her right arm, swelling of her right arm, tenderness at the injection site, all on 01Mar2016. The outcome of the events was unknown. The patient came into the medical office on 03Mar2016. The medical assistant assessed the events as related to pneumococcal 13-val conj vac (dipht crm197 protein). Follow (01MAY2016): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist via a Pfizer sales representative. A female patient of unknown age and ethnicity received PREVNAR 13 at 0.5 ml single dose. Medical history and concomitant medications were not reported. The patient experienced pain on an unspecified ate. The shot was more painful than her other immunizations. Outcome was not reported. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Bursitis
Clinical narrative: This is spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported the same event for two patients. This is first of two reports. A patient of unspecified age, gender and ethnicity received PREVNAR 13 via an unspecified route of administration, on unknown date, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced shoulder bursitis on unknown date, after the vaccination. The outcome of the event was unknown. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Bursitis
Clinical narrative: This is spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported the same event for two patients. This is the second of two reports. A patient of unspecified age, gender and ethnicity received PREVNAR 13 via an unspecified route of administration, on unknown date, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced shoulder bursitis on unknown date, after the vaccination. The outcome of the event was unknown. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC
Symptoms: Injection site mass
Clinical narrative: This is a spontaneous report from a contactable pharmacist based on information received by Pfizer from Merck & Co., Inc. (Manufacturer Control Number 00101450). A patient of unspecified age, ethnicity, and gender received PREVNAR, 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 developed a lump at the site of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection. The clinical outcome of the event, vaccination site mass, was not recovered. No follow up attempts possible. No further information expected.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report from a contactable medical assistant calling on behalf of the physician and from a contactable physician. A 61-year-old female patient received PREVNAR 13, (lot# L13063; Exp. 01Aug2016), intramuscularly in right arm on 21Feb2016 at 0.5 ml, single. Medical history included high blood pressure and blood cholesterol increased from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced a red hot to the touch itchy red injection site on 22Feb2016, her face and her legs were burning on 22Feb2016. Therapeutic measures were taken as a result of events included Dexamethasone. The events did not require emergency room or physician visit; the patient was not admitted to the hospital. The patient recovered from the events. The physician stated that the patient provided to him/her information regarding the reported adverse events with the use of the vaccine. The physician considered the vaccine had a causal of effect to the adverse events. Follow-up (22Mar2016): New information reported from a contactable physician includes: no hospitalization, emergency room or physician visit for the events, confirmation that the patient provided to the physician information regarding the reported adverse events with the use of the vaccine, causality assessment. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Cough, Sinus congestion
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 26Feb2016 at single dose. The patient medical history and concomitant medications were not reported. The patient experienced unusual sinus congestion and cough on an unspecified date with outcome of unknown. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Altered state of consciousness
Clinical narrative: This is a spontaneous report from a contactable consumer. An adult female patient (late 50s or early 60s) received PREVNAR 13 via an unspecified route of administration, on an unspecified date in Sep2015 at single dose for immunization. Relevant medical history and concomitant medication was not reported. The patient almost passed out on unknown date and she had to be picked up, taken to emergency room and she received BENADRYL shots. The patient was not admitted to the hospital. The outcome of the event was unknown. Follow-up (29MAY2016): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of PREVNAR 13 via an unspecified route of administration at single dose at top of right arm in Nov2015, administered at a pharmacy. Medical history included blood pressure measurement. Concomitant medication included Atenolol taken for years and ongoing at 25 mg for blood pressure. Other vaccinations within 4 weeks prior to suspected vaccine included: Flu shot. The patient experienced pain in arm, right arm (raise my arm in any direction I have severe pain) in Nov2015 which was reported as worsened and could not sleep on her right side. The event did not required an emergency room or doctor visit. The outcome of the event was not recovered. Follow-up (22Apr2016): New information obtained from a contactable consumer includes: updated verbatim of event. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist based on information received by Pfizer from Merck & Co, Inc. (Manufacturer control number: 1-14185936048). A 60-year-old female patient received PREVNAR 13 on an unspecified date, at single dose, for immunization. The patient history was not reported. The patient's concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced a 'bad reaction' for the next two weeks as she felt sick with a fever and did not feel well overall after she had a reaction to the diphtheria protein in pneumococcal 13-val conj vac (dipht crm197 protein). Events outcome was unknown. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Lymphocyte percentage increased, Neutrophil percentage decreased, White blood cell count decreased
Clinical narrative: This is a spontaneous report from a contactable pharmacist reporting for her husband. A 41-year-old male patient received PREVNAR 13, probably intramuscular in right upper arm at 0.5 ml single. Medical history included spleen operation (removal). Concomitant medications were none. The pharmacist reported that approximately three weeks after receiving PREVNAR 13, the patient (her husband) complained that his white blood cell count was 4.5 and his neutrophils count was 29.1. The patient experienced low white blood cell 4.5, neutrophils down to 29.1 and lymphocytes 56.6 on 29Jan2016. No therapeutic measures were taken as a result of the events. It was recommended to repeat blood test later. Additionally the patient complained that the arm, where he received the injection of PREVNAR 13, was sore for several days. The outcome of the events was unknown. The pharmacist didn't know if low white blood count was related to PREVNAR 13. Follow-up (29Feb2016): New information based on the information received by Pfizer from Merck (Service Request Number# 1-14186003814) includes: new event added and details provided. Follow-up (29APR2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Malaise
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age and ethnicity received PREVNAR, on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms and felt sick on Mar2016 with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Altered state of consciousness, Asthenia, Dyspnoea, Fatigue, Mobility decreased
Clinical narrative: The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 29Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from Pfizer-sponsored program Pfizer.com General Company information. A contactable consumer reported for herself. She was a 76-year-old female consumer and received PREVNAR 13, via an unspecified route of administration on 25Sep2015 at single dose. Medical history included hypertension from 1982 and ongoing, hypothyroidism from 1965 and ongoing, drug hypersensitivity, to sulfa from 1947 and ongoing. Concomitant medication included levothyroxine ongoing ar 1.12 mcg one per day for thyroid since she was in her 20s, EDARBI ongoing at 80 mg once a day for high blood pressure from about 2.5 years ago, nifedipine ongoing at 30mg twice a day for high blood pressure from about 4 years ago, TEKTURNA ongoing at 300 mg once a day, for high blood pressure from about 10 years ago and metoprolol ongoing at 50mg tablet; 1/2 tab per day for keeping heart from fluttering from about 5 years ago. The patient experienced on 26Sep2015 right arm so sore could not lift until next day and trouble breathing, on 27Sep2015 felt like was going to pass out and no energy this lasted for about 3 months after shot. She had real bad muscle pain all over body and felt like a rag doll, completely worn out and experienced itching. The patient recovered from pain in arm on 27Sep2015, recovered from the event muscle pain on unknown date in Feb2016. The outcome of the event worn out was recovering. The patient received BENADRYL and trouble breathing resolved. Follow-up (21Mar2016): additional information received from a contactable consumer includes date of vaccination. Events asthenia and itching added. Following (20May2016): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pain in extremity, Pruritus
Clinical narrative: The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 29Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from Pfizer-sponsored program Pfizer.com General Company information. A contactable consumer reported for herself. She was a 76-year-old female consumer and received PREVNAR 13, via an unspecified route of administration on 25Sep2015 at single dose. Medical history included hypertension from 1982 and ongoing, hypothyroidism from 1965 and ongoing, drug hypersensitivity, to sulfa from 1947 and ongoing. Concomitant medication included levothyroxine ongoing ar 1.12 mcg one per day for thyroid since she was in her 20s, EDARBI ongoing at 80 mg once a day for high blood pressure from about 2.5 years ago, nifedipine ongoing at 30mg twice a day for high blood pressure from about 4 years ago, TEKTURNA ongoing at 300 mg once a day, for high blood pressure from about 10 years ago and metoprolol ongoing at 50mg tablet; 1/2 tab per day for keeping heart from fluttering from about 5 years ago. The patient experienced on 26Sep2015 right arm so sore could not lift until next day and trouble breathing, on 27Sep2015 felt like was going to pass out and no energy this lasted for about 3 months after shot. She had real bad muscle pain all over body and felt like a rag doll, completely worn out and experienced itching. The patient recovered from pain in arm on 27Sep2015, recovered from the event muscle pain on unknown date in Feb2016. The outcome of the event worn out was recovering. The patient received BENADRYL and trouble breathing resolved. Follow-up (21Mar2016): additional information received from a contactable consumer includes date of vaccination. Events asthenia and itching added. Following (20May2016): Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Full blood count normal, Injection site pain, Insomnia, Lipids normal
Clinical narrative: This is a spontaneous report from a contactable certified medical assistant reporting on behalf of doctor. A 79-year-old female patient received PREVNAR 13 (Lot# M06899, exp date Mar2017, NDC 0005-1971-01), intramuscular, on 16Feb2016 at 11:45 am, at 0.5 ml single in right deltoid. Relevant medical history included ongoing hypertension, ongoing cataracts, ongoing hearing loss, ongoing deep vein thrombosis and ongoing hyperlipidemia. Concomitant medications included amlodipine (unspecified trade name), from an unspecified date and ongoing, at 10 mg daily, for hypertension; Aspirin, from an unspecified date and ongoing, at 325 mg daily, for pain; CENTRUM SILVER, from an unspecified date and ongoing, daily for vitamin supplementation; Glucosamine and chondroitin plus, at a 2 DF daily, for vitamin supplementation; hydrochlorothiazide, losartan, daily, for blood pressure high; ALEVE, at 220 mg daily, for inflammation and pain; Apple cider vinegar, at two tablespoons with 8 oz water daily; omega-3 fatty acids (unspecified trade name), at 300- 1000 mcq daily, simvastatin (unspecified trade name), at 20 mg 1x/day for weight loss and no control cholesterol and albuterol inhaler, at 90 ug as needed for asthma. The patient experienced unable to sleep on 16Feb2016 with outcome of recovered on 22Feb2016, arm was hot to touch on 17Feb2016 with outcome of recovered on 22Feb2016, entire arm was painful on 17Feb2016 with outcome of recovered on 22Feb2016, pain at injection site on 16Feb2016 with outcome of recovered on 22Feb2016, hard spot size of quarter on arm on 17Feb2016 with outcome of recovered on 22Feb2016, arm was hard to move on 17Feb2016 with outcome of recovered on 22Feb2016 and redness on 19Feb2016 with outcome of recovered. The patient underwent lab tests and procedures on 16Feb2016 which included: full blood count normal, lipid panel normal. the reporter considered the events related to pneumococcal 13-val conj vac (dipht crm 197 protein). Follow-up (03Mar2016): This follow-up report is being submitted to amend previously reported information: event "injection site mass" recoded to "vaccination site mass". Follow-up (27APR2016): Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: This is a spontaneous report from a contactable certified medical assistant reporting on behalf of doctor. A 79-year-old female patient received PREVNAR 13 (Lot# M06899, exp date Mar2017, NDC 0005-1971-01), intramuscular, on 16Feb2016 at 11:45 am, at 0.5 ml single in right deltoid. Relevant medical history included ongoing hypertension, ongoing cataracts, ongoing hearing loss, ongoing deep vein thrombosis and ongoing hyperlipidemia. Concomitant medications included amlodipine (unspecified trade name), from an unspecified date and ongoing, at 10 mg daily, for hypertension; Aspirin, from an unspecified date and ongoing, at 325 mg daily, for pain; CENTRUM SILVER, from an unspecified date and ongoing, daily for vitamin supplementation; Glucosamine and chondroitin plus, at a 2 DF daily, for vitamin supplementation; hydrochlorothiazide, losartan, daily, for blood pressure high; ALEVE, at 220 mg daily, for inflammation and pain; Apple cider vinegar, at two tablespoons with 8 oz water daily; omega-3 fatty acids (unspecified trade name), at 300- 1000 mcq daily, simvastatin (unspecified trade name), at 20 mg 1x/day for weight loss and no control cholesterol and albuterol inhaler, at 90 ug as needed for asthma. The patient experienced unable to sleep on 16Feb2016 with outcome of recovered on 22Feb2016, arm was hot to touch on 17Feb2016 with outcome of recovered on 22Feb2016, entire arm was painful on 17Feb2016 with outcome of recovered on 22Feb2016, pain at injection site on 16Feb2016 with outcome of recovered on 22Feb2016, hard spot size of quarter on arm on 17Feb2016 with outcome of recovered on 22Feb2016, arm was hard to move on 17Feb2016 with outcome of recovered on 22Feb2016 and redness on 19Feb2016 with outcome of recovered. The patient underwent lab tests and procedures on 16Feb2016 which included: full blood count normal, lipid panel normal. the reporter considered the events related to pneumococcal 13-val conj vac (dipht crm 197 protein). Follow-up (03Mar2016): This follow-up report is being submitted to amend previously reported information: event "injection site mass" recoded to "vaccination site mass". Follow-up (27APR2016): Follow-up attempts completed. No further information expected.