chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Incorrect route of drug administration, Rash
Clinical narrative: This is a spontaneous report from a non-clinical study program for a contactable consumer reporting for his wife. A female patient of unspecified age and ethnicity received PREVNAR 13, subcutaneously in the middle of the arm, on unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. According to all the information available the patient should have been given the vaccine in the deltoid but in fact was given subcutaneously in the middle of the arm. On unspecified date the patient experienced rash with outcome of unknown. Follow-up (19Mar2015): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Diarrhoea, Myalgia
Clinical narrative: This is a spontaneous report from a contactable medical assistant who called on behalf of a physician. A 70-year-old female patient received PREVNAR 13 (lot H83180, expiration date 01Sep2015), on 21Aug2014, as a single dose to the upper deltoid of left arm for prevention of pneumococcal pneumonia, administered for the first time by a nurse. No other vaccine was given at that time. Medical history included hypertension and high cholesterol since 2007. Concomitant medication included lisinopril/hydrochlorothiazide/10/0.5 mg half a tablet per day for hypertension and pravastatin 20 mg three times daily. The patient experienced myalgia, arthralgia and diarrhea later in the day on 12Aug2014. The patient did not require any visits to the hospital or emergency. No investigations were done. The patient recovered from myalgia, arthralgia and diarrhea on unspecified dates. Per the reporter the events were related to the PREVNAR 13. Follow-up (12Mar2015): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Body temperature increased, Injection site erythema, Injection site warmth
Clinical narrative: This is a spontaneous report from a Medical Assistant who called on behalf of the Physician regarding a patient. A 64-year-old female patient was given the first dose of PREVNAR 13 (Lot J80525, exp 01Jan2016), intramuscularly in the upper deltoid, on 12Aug2014 at 0.5 mL, by a nurse in the doctor's office. Medical history included hypertension (2007), high cholesterol (2007), and glaucoma (2007). There were no concomitant vaccines or concomitant medication. The patient experienced red hot arm at the site of the injection, arthralgia and body temperature rose to 101 on "30Jan2015". The patient experienced the problems within 24 hours of injection and then for several days; and "he" reported a month later. This patient was experiencing this problem for the first time. The patient didn't require any visits to the hospital or emergency. The patient recovered from the events on an unspecified date. In the reporter's medical opinion, the events were related to PREVNAR 13. Follow-up (12Mar2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of an unspecified age, gender and ethnicity received the first dose of PREVNAR 13 intramuscular in the arm on an unspecified date at 0.5 ml single. The patient medical history and concomitant medications were not reported. The patient developed a large red area where shot was given (non-serious) on an unspecified date for one week. The patient recovered from the reported event on an unspecified date. Follow-up (06Mar2015): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Wrong technique in product usage process
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer Medical Information. This 71-year-old female patient received on 06Feb2015 PREVNAR 13 (lot number J77185, expiration date Apr2016, NDC 0005197105) at 0.5 ml single dose intramuscular. Relevant medical history was none. Concomitant medications were none. The pharmacist did not adequately shake PREVNAR 13 before administering it and patient said that it was painful when it was injected but then she felt fine later. Causality was not provided. Outcome was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This is an initial spontaneous report from a non-contactable Pharmacist. Pharmacist called to make a medical information inquiry. Pharmacist is reporting on behalf of a consumer who may be having a local reaction at a (PREVNAR 13) injection site. No further information obtained. The caller states that the vaccine was given on 29Nov2014. The patient reported to the pharmacy that a couple days after the injection, the injection site gets red, swollen and itchy. The pharmacist is concern that the patient may be having an allergic reaction. The package insert indicates that the site can be red and swollen but nothing about itching. The caller added that she did not know the details and the patient will come to the pharmacy for her to take a look at it and she could call later to report after seeing the patient. No follow-up attempts possible. No further information expected.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Pyrexia, Skin warm
Clinical narrative: This is a spontaneous report from a contactable physician. A 4-year-oldl male patient of an unspecified ethnicity received the fourth dose of PREVNAR 13 (lot number H86680, expiration date 30Oct2015) via an unspecified route of administration at 0.5 ml single dose in left arm, on 21Oct2014 at about 5 pm. Prior to PREVNAR 13, the patient received also bcg vaccine (manufacturer unknown) via an unspecified route of administration at 1 DF single dose for immunization. It was not on the same day visit day and interval was between the vaccines is not known. Medical history and concomitant medications were not reported. The physician said that the child received previous vaccinations with PREVNAR 13 and BCG vaccine in another country. The child had previous doses of PREVNAR 13 prior to 1 year old. The patient experienced developed fever and warm to the arm during the night between 21Oct2014 and 22Oct2014. The patient was taken to the Emergency room by his parents with a fever and arm hurting where he received the vaccine. The child was discharged from the ER and sent home with no problems. Outcome was recovering. The reporter queried whether there is a contraindication with giving the bcg vaccine and PREVNAR 13 in the same extremity (as previously received). Follow-up (22Oct2014): New information received from the same contactable physician includes: gender, vaccination date, new event (arm hurting where he received the vaccine), reaction details and outcome. Follow-up (04Dec2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Swelling face
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml, single. Concomitant medications were not reported. The patient had swelling in her left cheek, on an unspecified date, after having a shot of PREVNAR 13. The outcome of the event was unknown. The consumer asked if there were contraindications to administration in an immunosuppressed patient. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: This is a spontaneous report based on information received by Pfizer and Merck National Service Specialist (Service Request Number #1-12577085789) by a contactable nurse. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration at single dose on unknown. The patient medical history and concomitant medications were not reported. The patient experienced injection site reaction on an unspecified date with outcome of unknown. Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report from a contactable pharmacist. A 74-year-old female patient received PREVNAR 13 (Lot Number H86680; Expiration Dare Oct2014; NDC Number 00005-1971-02) single dose via intramuscular route of administration into the left arm on 16Oct2014. Relevant medical history was not reported. The patient was taking unspecified concomitant medications. The patient previously received PNEUMOVAX. The patient experienced warm to the touch, quite red, itched really bad, arm is a little swollen, and tender to touch on an unspecified date with outcome of not recovered. The reporter elaborated that the patient had some swelling of her upper arm. It was warm to touch and quite red, it had expanded about 6 inches in diameter in a week since having the shot. Reporter also indicated the patient said that her arm was a little swollen and the reporter said the area was not really large and that the site was a little swollen and tender to the touch and warm to the touch. The reporter indicated that it had probably gone six inches in diameter around the injection site that was quite red, reporter also indicated that the patient said it itched really bad. Per reporter, the patient said it (the reaction) gradually got worse over the week. She told him that it hadn't gotten any better yet, it had just been getting worse throughout the week. But it was kind of gradual. Per reporter, the patient said that after the first couple of days the site did not bother her and the reaction gradually got worse. The patient came into the pharmacy earlier this morning, 22Oct204, and showed the reporter her site. The reporter assessed the events as related to PREVNAR 13. The reporting pharmacist inquired "what are the possibilities of reactions to the vaccine and how long would it last?" The reporter also wanted to know more information on how often something like this happens and if it does happen, how often does it happen and what things should be done with this type of reaction. Follow-up (29Nov2014): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This spontaneous report from a contactable pharmacist. A 74-year-old female patient received PREVNAR 13 (Lot Number H86680; Expiration Dare Oct2014; NDC Number 00005-1971-02) single dose via intramuscular route of administration into the left arm on 16Oct2014. Relevant medical history was not reported. The patient was taking unspecified concomitant medications. The patient previously received PNEUMOVAX. The patient experienced warm to the touch, quite red, itched really bad, arm is a little swollen, and tender to touch on an unspecified date with outcome of not recovered. The reporter elaborated that the patient had some swelling of her upper arm. It was warm to touch and quite red, it had expanded about 6 inches in diameter in a week since having the shot. Reporter also indicated the patient said that her arm was a little swollen and the reporter said the area was not really large and that the site was a little swollen and tender to the touch and warm to the touch. The reporter indicated that it had probably gone six inches in diameter around the injection site that was quite red, reporter also indicated that the patient said it itched really bad. Per reporter, the patient said it (the reaction) gradually got worse over the week. She told him that it hadn't gotten any better yet, it had just been getting worse throughout the week. But it was kind of gradual. Per reporter, the patient said that after the first couple of days the site did not bother her and the reaction gradually got worse. The patient came into the pharmacy earlier this morning, 22Oct204, and showed the reporter her site. The reporter assessed the events as related to PREVNAR 13. The reporting pharmacist inquired "what are the possibilities of reactions to the vaccine and how long would it last?" The reporter also wanted to know more information on how often something like this happens and if it does happen, how often does it happen and what things should be done with this type of reaction. Follow-up (29Nov2014): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 75-year-old male patient of unknown ethnicity received PREVNAR 13 at 0.5 ml single dose on unspecified date. Medical history and concomitant medications were not reported.  On unknown date in 2014 (possibly in the week before this before) the patient experienced an allergic reaction and went to the emergency room. The physician reported that patient was now ok. Outcome was unknown. Follow-up (21Nov2014): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 71 years old female patient received first dose of PREVNAR 13 (lot number J23864, expiration date Nov2015; NDC: 00005-1971-02) at 0.5 single, on 23Oct2014, at approximately 1 P.M., in left upper arm, back part. On 07Oct2014 the patient received first dose of FLUCELVAX (lot number 016011A, expiration date Mar2015, NDC 62577061311) at 1 DF single, intramuscular, in left upper arm. Adverse event following prior vaccination: no per reporter. Medical history included rheumatoid arthritis. Concomitant medications included pravastatin oral tablet, for cholesterol, at 20 mg once daily, atenolol oral tablet, for blood pressure, at 100 mg twice daily, folic acid, 2 tablets of 1 mg once a day. On an unspecified date in Oct2014 the patient experienced injection site is painful and injection site warm. Furthermore the reporter stated that suspect injection received on 23Oct2014 may have been given subcutaneously. The events did not require an emergency room or doctor visit. The patient stated she had rheumatoid arthritis and had stronger reactions. Events "injection site warm" and "injection site painful" were persisting at time of report. Event suspect injection may have been given subcutaneously outcome was unknown at time of report. Follow-up (04Dec2014): Follow-up attempts completed. No further information expected.
Age: 0.11
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Erythema, Expired product administered, Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician (father of patient). A 6-weeks-old female patient of unknown ethnicity received PREVNAR 13 (lot number G57197, Exp date Sep2014) at 0.5 ml single dose and PEDIARIX at 1 DF single dose, both intramuscular on 16Oct2014. Medical history included sensorineural hearing loss and a treatment with Valacyclovir. Concomitant medications included Flu vaccine on unknown date. The patient was administered with an expired dose of PREVNAR 13. On an unspecified date in Oct2014, the patient experienced also localized redness and swelling that is painful to the touch. A treatment for the event was performed. The patient repeated vaccination on 14Nov2014 since the previously received product was expired. Outcome of the events was recovered. Follow-up (17Nov2014): New information from the same contactable physician included medical history, outcome of the events, concomitant medication. Follow-up (14Jan2015): Follow-up attempts completed. No further information expected.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Erythema, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer. A 83 years old female patient received single dose of PREVNAR 13 on 06Nov2014. The patient received PREVNAR 13 because of her age and as she had a history of pneumonia. Other medical history included some surgeries for back problem and allergies twice a month. Past vaccine history included PNEUMOVAX on unspecified date. Concomitant medications included diltiazem (unknown manufacturer) at 240 mg, 1x/day, DIOVAN at 320 mg, 1x/day, warfarin (unknown manufacturer) at 15 mg, weekly, LEVOXYL at 100 ug, 1x/day, SINGULAIR at 10 mg, 1x/day, LIPITOR at 40 mg, 1x/day. The consumer had no reaction to vaccination until 11Nov2014. On that day the consumer had as delayed reaction some arm pain at the injection site. In the morning of 14Nov2014 the arm on where she had injection was all reddened on the two large areas, her arm was quite red and hot/arm was all red and hot. The consumer reported there was something wrong with this batch of PREVNAR 13. The consumer was concerned as she was going for allergies twice a month and she wanted to know whether this was a normal reaction to vaccine or whether there was something wrong with the batch that was administered. The consumer underwent blood work on unspecified date and results were normal. The consumer did not recover from some arm pain at the injection site. Outcome of the other reported events was unknown.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer. A 83 years old female patient received single dose of PREVNAR 13 on 06Nov2014. The patient received PREVNAR 13 because of her age and as she had a history of pneumonia. Other medical history included some surgeries for back problem and allergies twice a month. Past vaccine history included PNEUMOVAX on unspecified date. Concomitant medications included diltiazem (unknown manufacturer) at 240 mg, 1x/day, DIOVAN at 320 mg, 1x/day, warfarin (unknown manufacturer) at 15 mg, weekly, LEVOXYL at 100 ug, 1x/day, SINGULAIR at 10 mg, 1x/day, LIPITOR at 40 mg, 1x/day. The consumer had no reaction to vaccination until 11Nov2014. On that day the consumer had as delayed reaction some arm pain at the injection site. In the morning of 14Nov2014 the arm on where she had injection was all reddened on the two large areas, her arm was quite red and hot/arm was all red and hot. The consumer reported there was something wrong with this batch of PREVNAR 13. The consumer was concerned as she was going for allergies twice a month and she wanted to know whether this was a normal reaction to vaccine or whether there was something wrong with the batch that was administered. The consumer underwent blood work on unspecified date and results were normal. The consumer did not recover from some arm pain at the injection site. Outcome of the other reported events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age ethnicity and gender started to receive PREVENAR 13, via an unspecified route of administration from an unspecified date to an unspecified date at 1 DF. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rash at injection site on an unspecified date with outcome of unknown. The action taken in response to the event for PREVENAR 13 was not applicable. Follow-up (19Dec2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity started to received PREVNAR13, via an unspecified route of administration in 2014 at a single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On unknown date in 2014, the patient experienced at the injection site started itching and she scratched it with outcome of unknown. It swelled up a little bit and its red on 2014 with outcome of unknown. The action taken in response to the events for PREVNAR13 was not applicable. Follow-up (31DEC2014): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist through a non-clinical study program. A 65 years old female patient received on 06Nov2014 PREVNAR 13 (lot number J90092, expiration date May2016, NDC number: 00005197105) at 0.5 ml single, intramuscular. Medical history and concomitant medications were not reported. On 06Nov2014 the patient experienced redness around the site (it site was about 6 inches long and 3 inches wide). The vaccination site was hot too since an unspecified date in Nov2014. The patient was not recovered from vaccination site redness, while vaccination site warmth outcome was unknown. Follow-up (10Jan2015): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist through a non-clinical study program. A 65 years old female patient received on 06Nov2014 PREVNAR 13 (lot number J90092, expiration date May2016, NDC number: 00005197105) at 0.5 ml single, intramuscular. Medical history and concomitant medications were not reported. On 06Nov2014 the patient experienced redness around the site (it site was about 6 inches long and 3 inches wide). The vaccination site was hot too since an unspecified date in Nov2014. The patient was not recovered from vaccination site redness, while vaccination site warmth outcome was unknown. Follow-up (10Jan2015): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist from a non-clinical-study program. A 65 years old female patient received the first dose of PREVNAR 13 (Lot J90092, Exp date May2016, NDC number: 00005197105) on 06Nov2014 intramuscular at 0.5 ml, single dose. Medical history and concomitant medications were not reported. On 06Nov2014 the injection site continued to grow, it was not raised but there was a lot of redness. The pharmacist confirms the site was red and states it was about 6 inches long and 3 inches wide. The pharmacist reported that on unspecified date in Nov2014 the site was warmth too. The outcome of the events was not recovered. Follow-up (10Jan2015): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist from a non-clinical-study program. A 65 years old female patient received the first dose of PREVNAR 13 (Lot J90092, Exp date May2016, NDC number: 00005197105) on 06Nov2014 intramuscular at 0.5 ml, single dose. Medical history and concomitant medications were not reported. On 06Nov2014 the injection site continued to grow, it was not raised but there was a lot of redness. The pharmacist confirms the site was red and states it was about 6 inches long and 3 inches wide. The pharmacist reported that on unspecified date in Nov2014 the site was warmth too. The outcome of the events was not recovered. Follow-up (10Jan2015): Follow-up attempts completed. No further information expected.
Age: 0.43
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable other health professional. A 5-month-old male patient received the first dose of PREVNAR13 0.5ml single dose via an unspecified route of administration on 05SEP2014. Relevant medical history and concomitant medications were not reported. The patient experienced hives on 05SEP2014, 8 hours after having received PREVNAR13. The hives had lasted up to a month, but resolved on an unspecified date. The reporter believed that the hives were due to PREVNAR13. A physician wanted to test the patient to see if it was a true allergic reaction to PREVNAR13 and the reporter wanted to know if there was any way that they could obtain samples of PREVNAR13 to use for testing purposes.  Follow-up (19FEB2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable nurse on behalf of the physician. A 71 years old female patient (75 kg weight, 158.75 cm height) received a single dose of PREVNAR13,( lot H45098, exp date 01MAY2015) intramuscular, in the right deltoid muscle on 25NOV2014 at 15.15 and TDAP in the left deltoid muscle intramuscular on 25NOV2014. Medical history included hyperlipidemia, depression, simple liver cyst right lobe stable on 3 US 2014, vaginal hysterectomy with bilateral salpingo-oophorectomy due to fibroids, basal cell removal left antecubital fossa, myringotomy tube2 in 2004, cataract surgery bilateral in 2011, hemorrhoids. She never smoked. She was allergic to erythromycin. Concomitant medications included ANUSOL-HC 2.5% rectal cream with applicator, for hemorrhoids twice daily for 10 days and then as needed,gabapentin 100 mg oral capsule twice daily, melatonin 5 mg oral tablet, nortriptyline 50 mg oral capsule once daily, PREMARIN 0.624 mg/g) vaginal cream with applicator, 0.5 g twice weekly (Monday and Thursday), simvastatin 40 mg oral tablet once daily (nightly). The vaccines were administered by the nurse at their facility. The nurse mentioned that she had no prior documentation whether the patient had experienced same adverse event before. On unknown date the patient had a reaction and redness at the site of the injection, the spot was square in shape and couple of inches in size. The patient was not  hospitalized. The patient denied fever. There was a 15,9 cm erythematous ring just inferior to the site of injection. on the right upper extreme, non-tender and slight swelling locally. The patient was evaluated for an itchy rash that came up after immunization with PREVNAR13, noted 6 days after vaccination. It has been gradually expanding for the past 2 days, itchy, mild localized swelling since yesterday, no swelling of lips/tongue, or shortness of breath. Patient also reported generalized dry skin at this time of year as normal for her. Patient reported reduced swelling and lessened redness. Now area red "swollen" x 2 days. PREVNAR13 local allergic reaction was reported. The patient received CLARITIN at 10 mg from 03DEC2014 and was still taking it as recommended by the physician. The patient has noticed improvement since she started taking loratadine. The patient was advised to take BENADRYL as needed, but she declined to this at this time, citing side effects. Lab data underwent by the patient included; blood pressure at 128/74, pulse at 84, respiratory rate at 16, BMI: 29.7. The nurse had no idea whether the reaction was due to PREVNAR13 or not. Follow-up (15DEC2014): New information from the same contactable nurse on behalf of the physician incldues: medical history, concomitant medications, additional events, treatment received and events details.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR13, via an unspecified route of administration on an unspecified date at single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced an allergic reaction to PREVNAR13. The clinical outcome of the event was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 75-year-old female patient received PREVNAR13, intramuscularly on 29NOV2014. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced itchiness at the injection site, swelling at the injection site, and redness at the injection site on an unspecified date. The outcomes of the events, itchiness at the injection site, swelling at the injection site, and redness at the injection site, were unknown. The causality was assessed as related for itchiness, swelling, and redness at the injection site. Follow-up (14JAN2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician via sales representative. A 78-year-old female patient received a single dose of PREVNAR13,, lot J49847, expiry date MAR2016, NDC 0005 1971 02), via an unspecified route of administration in the right deltoid, on 01DEC2014. Relevant medical history included hyperlipidemia and hypertension from an unknown date and unknown if ongoing. Concomitant medications included CARTIA XT, RALOXIFENE, ATORVASTATIN. The patient experienced redness and swelling below the injection site on an unspecified date in DEC2014. The outcome of the reported events was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report form a non-contactable consumer. A 76-year old male patient of an unspecified ethnicity received PREVNAR13, 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, 3 days after the vaccination, the patient experienced fatigue. The patient stated that he did not have this type of reaction with other vaccinations. He stated that with other vaccinations he usually had a local reaction. The clinical outcome of the event, fatigue was unknown. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 76-years-old male patient of an unspecified ethnicity received a single dose of PREVNAR13, via an unspecified route of administration on an unspecified date. The patient's medical history and concomitant medications were not reported. ON an unknown date, the patient experienced feeling kind of wiped out, fatigue The patient reported that he received the vaccine on Saturday and it had been 72 ours; he normally is a very energetic person. The clinical outcome for the event of taken feeling kind of wiped out, fatigue was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable consumer. A 69-year-old female patient received in DEC2014 first dose of PREVNAR13, via an unspecified route of administration in left arm, at single dose. The patient medical history and concomitant medications were not reported. The patient experienced rash all over the body, which started in DEC2014, within a few days of getting the shot. The rash was red, bumpy and itchy and it was worse at night. She went to the dermatologist who gave her a steroid cream that she has been using approximately 5 weeks. The rash was improving after 6 weeks and she needed to use less and less cream. Follow-up (13FEB2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable medical assistant and a contactable other HCP who reported for a patient. A 68 years old  male patient received PREVNAR13, (lot # J23867, expires: JAN2016) on 04DEC2014 at 16:08, at 0.5 ml single dose, intramuscular on left deltoid. Medical history included diabetes mellitus. Medical assistant mentioned that patient is taking several other medications. On 04DEC2014 directly after vaccination the patient started  having pain in his joints. The outcome of the event was not recovered. The physician consider the vaccine had no causal effect to the adverse event. Follow-up (26JAN2015): Additional information received from a contactable other HCP incldues route of administration and anatomical location of the vaccine. Assessment provided. Company Clinical Evaluation comment: The reported event might be compatible with the known adverse event  profile of PREVNAR13; a causal relationship therefore cannot be excluded.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 58-year-old female patient received PREVNAR 13 (Lot # G41025; expiration date 31Dec2014) intramuscular at 0.5 ml, single dose in the left arm on 19Dec2014. Patient medical history and concomitant medications were none. On 20Dec2014, the patient experienced swelling of LOA and area of injection LOA 3 cm erythema and induration with outcome of recovering. The events were treated with BENADRYL. The reporter considered the PREVNAR 13 had a causal effect to the adverse events. Follow-up (09Jan2015): New information obtained from a contactable nurse includes: Lot # and expiration date, time and anatomical location, onset date of the events, event description erythema indurated updated to erythema and induration, reporter's assessment. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A male patient of an unspecified age and ethnicity received the first dose of PREVNAR13, 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, the patient received the vaccine in the shoulder capsule instead of being injected into the deltoid. The patient went to the emergency room for pain in his shoulder, but reporter didn't indicate the patient was admitted. Therapeutic measures were taken as a result of the shoulder pain and included treatment with steroids. The clinical outcome of the events, the patient received the vaccine in the shoulder capsule instead of being injected into the deltoid and shoulder pain, was unknown. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from contactable consumer (Pfizer employee) who reported for her mother. A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose in the upper arm on an unspecified date in 2014. The patient medical history and concomitant medications were not reported. 2-3 hours after the administration of the vaccines, the patient could not move her arm forward to backward further mentioned that it was so sore and painful that she could not move her arm forward and backward. The patient had not taken any medication in response to the adverse event and further mentioned that she was fine. Follow-up (23Jan2015): Follow-up attempts completed. No further information expected.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer. An 81-year-old male patient received PREVNAR 13 (Lot # J90092, exp. Date 30May2016), via an unspecified route of administration at 0.5 ml, single in the left arm on 02Dec2014. Medical history included ongoing hypertension. Concomitant medication included VASOTEC 5 mg once a day for blood pressure. He received earlier inoculation for pneumonia at the age of 65 years. The patient experienced slight soreness at the site on 02Dec2014 with outcome of recovered, itchiness at the site on 07Dec2014 with outcome of recovered, redness at site on 08Dec2014 with outcome of recovering. Therapeutic measures were taken as a result of itchiness at the site. The patient described the events as follows: he experienced slight tenderness at the site of injection, which was his left deltoid on the day he received the vaccine that lasted about a day or 2. Also reports itchiness at the site 6 days after receiving it that cleared after taking an unknown name 1 percent anti itch medication. Then the site turned a significant reddened color that was about 3 x 3.5 inch in diameter with no discomfort, around the site. The redness was there a week and had lessened in color, but still there, color is more pinkish now. His primary physician gave him the ok to take the vaccine. Follow-up (25JAN2015): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Rash
Clinical narrative: This is a spontaneous report from a non-clinical study program from a contactable consumer reporting for herself. A 66-year-old female patient received a single dose of PREVNAR 13, via an unspecified route of administration in the right upper arm, on 04Dec2014, at her physician's office, a pulmonologist. Medical history included bronchitis and pneumonia from an unknown date and unknown if ongoing. The patient stated that immediately after the vaccination on 04Dec2014 she had pain at the site. On an unspecified date in Dec2014, she experienced rash. On 06Dec2014 she noticed itching at the site. On 10Dec2014 she observed that there was redness, a red mark, at the site, on the arm. She stated that she applied BENADRYL cream to the site for the itching and it has helped her. She stated that the pain was gone, but itching, rash and redness persisted. She had called her doctor, and she was waiting to hear back from the doctor. Follow-up (06Feb2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: This is a spontaneous report obtained from a contactable physician. A patient of unspecified age, gender and ethnicity, on an unknown date, PREVNAR13 0.5 ml, single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced reddish rash. The event lasted about a week after injection of the vaccine. Follow-up (06MAR2015): Follow-up attempts completed. No further information expected.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 87-year-old female patient received PREVNAR 13 (exp date May2016, NDC 0005 1971 05), intramuscular in right deltoid, on 13Jan2015, at 0.5 ml single. Relevant medical history and concomitant medications were not reported. On 14Jan2015 the patient experienced rash on hands and face, but no redness at the injection site. The patient went to her doctor on 19Jan2015 because of the rash and received a steroid shot. Outcome of the event was not recovered. Follow-up (27Feb2015): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 75-year-old female patient of an unspecified ethnicity received first dose of PREVNAR 13 (Lot: J53435 Expiration date: Nov2015; NDC:00005197101), on 14Jan2015 at 15:30 intramuscular on left deltoid at 0.5 ml, single. Concomitant medication included simvastatin for hyperlipidemia since more than 1 year at 40 mg daily at bed time and citalopram for depressive disorder since more than 1 year at 20 mg daily. The patient medical history and was not reported. On 15Jan2015, the patient experienced site swollen, site was very red and site was hard. The events were describes as follows: over the past two days, the injection site has been increasingly red, swollen, hard and it was the size of a half dollar. The events worsened. Events did not require emergency room or physician visit, no treatments given. The patient has recovered from the events on 22Jan2015. Follow-up (09Feb2015): New information received from the same contactable pharmacist includes: vaccination and events details, concomitant medications. Follow-up (10Mar2015): New information received from the same contactable pharmacist includes: reaction data (onset date) and outcome (recovered). Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable nurse via a representative. A 70 year old female patient received PRENVAR13 at 0.5 ml single, on an unknown date. Medical history included allergic reaction. Concomitant medications were not reported. On unspecified date the patient experienced localized rash. The reporting nurse asked if the suspect product contains thimerosal. The representative informed her that it does not contain thimerosal. Event outcome was not provided at time of report.
Age: 0.47
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13
Symptoms: Injection site urticaria, Rash erythematous
Clinical narrative: This spontaneous report from a contactable physician (allergist). A 5-month-old male patient received on 23Dec2013 first dose of PREVNAR 13 at 0.5 ml single dose in leg intramuscular. On the same date, the patient concomitantly received hepatitis B vaccine, IPV and DTAP. Vaccinations were provided at the pediatrician's office. Medical history was not provided. The patient was referred to allergist on 30Nov2014 and visited on 17Dec2014. Reaction was described as follows: while the patient was in the office, the hives appeared at vaccination site (leg) of PREVANR 13. The following day, on 24Dec2013, the patient developed a red rash on the neck. The patient was treated with BENADRYL on 23Dec2014 together with a steroid. The rash on the patient's neck did not last long and recovered on unspecified date. The reaction (hives) was not systemic and dissipated slowly by the end of the day (23Dec2013). The pediatrician is waiting to give the remaining dose of vaccine. Follow-up (19Feb2013): Follow-up attempts completed. No further information expected.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Chills
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his elderly father. An 87-year-old male patient received a single dose of PREVNAR 13 (Lot Number, and Expiration date not available), via an unspecified route of administration on 23Feb2015. Medical history included chronic obstructive pulmonary disease (COPD) at least ten years, congestive heart failure about two years, and mitral valve prolapse about two to three years ago. Concomitant medications included BUMEX, SPIRIVA, digoxin for congestive heart failure, metolazone 2.5 mg tablet once a day by mouth for congestive heart failure, CENTRUM 50 and over tablet once a day by mouth for supplement, fish oil capsule once a day by mouth for supplement. On 23Feb2015, the patient experienced chills with outcome of not recovered. Follow-up (13Mar2015): New information reported from another contactable consumer includes: reporter information. Follow-up attempts are completed. No further information is expected.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 92 years old female patient (weight 68 kg, height 157 cm) received PREVNAR13; lot number J77185, expiration date APR2016; NDC number 00005-1971-05) on 03OCT2014 at 0.5 ml single, intramuscular. Concomitant medication included high dosage of a flu shot (unspecified) that was received for immunization at PREVNAR13 vac time (not further specified). On unknown date, a couple days before the report, the patient began to e experience soreness, redness and warmth at PREVNAR13 vac injection site. The site was about 3 inches of redness and it was sore and warm to touch for about a week. The events redness and pain were not resolved, the event warm to the touch was resolved with sequel . Pharmacist stated that she was not the one who administered the vaccine. Causality among the events and PRENAR was not provided as related. Follow-up (19NOV2014): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: This is  a spontaneous report received from a cont actable physician via colleague. A patient of unspecified age ethnicity and gender received PREVNAR13, via an unspecified route of administration on unknown date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed a reaction (red and purple rash) on the upper arm that was injected and fever as well. The outcome of the event was unknown. Follow up:(25SEP2014): Follow-up attempts completed. No further information expected.
Age: 1.25
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician based on information received by Pfizer from Novartis Pharmaceuticals Corporation (Novartis reference #: PUS2014US106950). A 15 month-old female patient of an unspecified ethnicity  received PREVNAR13, MMR, and varicella virus vaccine, live all via unspecified routes of administration on 05AUG2014 at single doses to an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever. The clinical outcome of the event, fever, was unknown. Follow-up (12NOV2014): Follow-up attempts completed. No further information expected.
Age: 0.18
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Product deposit, Pyrexia
Clinical narrative: This is an initial spontaneous report by a contractible nurse. This female nurse reported on behalf of a 12 months old male patient who was administered PREVNAR12, lot number H45393, expiration date: 31MAY2015, 0.5ml injection on right upper leg on 30SEP2013. Relevant medical history included increasing head circumference and slow weight gain and it was unknown if these conditions were ongoing at the time of events onset. Relevant concomitant medications were unknown. Vaccines given on the day included VIVAX, MMR. Between 30SEP2013 and 08AUG2014 the patient was given three doses of pneumococcal 12-val conjugated vaccine (diptheria crm197 protein) as per the dosage regimen. The nurse mentioned that on 08AUG2014 pneumococcal 13-val conjugated vaccine (diphtheria crm197 protein) had sedimentation and was administered to the patient. The patient had fever of 102 degrees Celsius after administration of vaccine. Relevant lad date included unspecified blood work on 11AUG2014 and the results were unknown. At the time of report clinical outcome of the above mentioned events was unknown. The nurse suspected a causal relation between the drug and the adverse events. Follow-up (19SEP2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from contactable employee who reported on behalf of a consumer. This female consumer (age and race unknown) received PREVNAR13 on unknown date. Relevant medical history and concomitant medication were unknown. It was reported that on an unknown date consumer had tenderness at vaccination site. Relevant laboratory data was unknown, at the time of report. This may be a duplicate report in situations where another Marketing Authorization Holder of piperacillin has been submitted the same report to the regulatory authorities. Follow-up (12SEP2014): Follow-up attempts completed. No further information expected.