chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: This is a spontaneous report by a contactable nurse and from a contactable physician. A 64-year-old female patient received on 21Jul2014 at 15:26, first dose of PREVNAR 13 (Batch. 0005-1971-01, Lot. H95098 and expiration date 31May2015) at single dose intramuscularly in left deltoid. Relevant medical history included allergic rhinitis, classic migraine, PVA septum, gastro-esophageal reflux disorder (GERD), sacral lumbar pain, malignant melanoma, hyperlipidemia, unspecified thyroid condition, nausea, venous stasis, osteopenia and vitamin D deficiency, all ongoing; patient was also allergic to penicillin and sulfa. Relevant concomitant medications were unknown. Vaccines given on the same day and within the last four weeks were none. No illness at the time of vaccination and no administration of any antipyretic reported. On 21Jul2014, she experienced a local reaction at the injection point described as erythema in an area of 4x6 cm at injection site which was warm and tenderness. No culture and others diagnosed tests done. Therapeutic measure taken in response to the above mentioned events included oral KEFLEX 500 mg, one three times a day for 10 days, since 23Jul2014. On 11Aug2014 patient recovered. Nurse considered causal relationship between the adverse events and PREVNAR 13 as unknown. Physician considered there was a reasonable possibility that the events were related to PREVNAR 13; relevant etiological factors to facilitate the assessment included: "Local reaction was early cellulitis; Afebrile 4 cm x 6 cm. No abscess / adenopathy". Follow-up (19Aug2014): New information received from a contactable physician includes: vaccine details, event details (onset, outcome), treatment, comment/assessment, medical history. Follow-up attempts completed. No further information expected. Follow-up (25Sep2014): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction
Clinical narrative: This is a spontaneous report by a contactable nurse and from a contactable physician. A 64-year-old female patient received on 21Jul2014 at 15:26, first dose of PREVNAR 13 (Batch. 0005-1971-01, Lot. H95098 and expiration date 31May2015) at single dose intramuscularly in left deltoid. Relevant medical history included allergic rhinitis, classic migraine, PVA septum, gastro-esophageal reflux disorder (GERD), sacral lumbar pain, malignant melanoma, hyperlipidemia, unspecified thyroid condition, nausea, venous stasis, osteopenia and vitamin D deficiency, all ongoing; patient was also allergic to penicillin and sulfa. Relevant concomitant medications were unknown. Vaccines given on the same day and within the last four weeks were none. No illness at the time of vaccination and no administration of any antipyretic reported. On 21Jul2014, she experienced a local reaction at the injection point described as erythema in an area of 4x6 cm at injection site which was warm and tenderness. No culture and others diagnosed tests done. Therapeutic measure taken in response to the above mentioned events included oral KEFLEX 500 mg, one three times a day for 10 days, since 23Jul2014. On 11Aug2014 patient recovered. Nurse considered causal relationship between the adverse events and PREVNAR 13 as unknown. Physician considered there was a reasonable possibility that the events were related to PREVNAR 13; relevant etiological factors to facilitate the assessment included: "Local reaction was early cellulitis; Afebrile 4 cm x 6 cm. No abscess / adenopathy". Follow-up (19Aug2014): New information received from a contactable physician includes: vaccine details, event details (onset, outcome), treatment, comment/assessment, medical history. Follow-up attempts completed. No further information expected. Follow-up (25Sep2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: This is a spontaneous report  from a sales representative on behalf of a physician who reported for a patient. This around 75-year-old female patient received PREVNAR13 (lot # H34460) via an unspecified route of administration in MAR2014. Relevant medical history and concomitant medication were unknown. It was reported that on an unknown date in MAR2014 PREVNAR13 was injected on left arm of patient after which her left arm was warm to touch and had redness radiating down her left arm. Therapeutic measure taken in response to the reported events was not provided. Clinical outcome of the reported events was unknown at the time of report. Follow-up (25APR2014): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional on behalf of a doctor reporting similar events for 4 patients. This is 3th of 4 reports. A patient of unknown age and gender received PREVNAR13 Lot number J80525, Exp date: APR2016, NDC number: 0005-1971-02), single dose, intramuscular on unknown date. On unknown date the patient's injection site was red, hot and swollen, experienced fever and injection site pain. The outcome of events was unknown. Follow-up (03MAR2015): This follow-up report is being submitted to amend previously reported information: call was from a contactable healthcare professional reporter who was calling on behalf of a doctor.
Sex: U
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable healthcare professional on behalf of a doctor reporting similar events for 4 patients. This is the second of 4 reports. A patient of unspecified age ethnicity and gender received PREVNAR13 (Lot number J80525, Expiration date APR2016), via an unspecified route of administration at single dose on unknown date. The patient medical history and concomitant medications were not reported. On unknown date the patient's injection site was red, hot and swollen, injection site obviously it hut, injection site had skin discoloration and also experienced fever. The outcome of events was unknown. Follow-up (03MAR2015). This follow-up report is being submitted to amend previously reported information: call was from a contactable healthcare professional reporter who was calling on behalf of a doctor.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional on behalf of a doctor reporting similar events for 4 patients. This is the second of 4 reports. A patient of unspecified age ethnicity and gender received PREVNAR13 (Lot number J80525, Expiration date APR2016), via an unspecified route of administration at single dose on unknown date. The patient medical history and concomitant medications were not reported. On unknown date the patient's injection site was red, hot and swollen, injection site obviously it hut, injection site had skin discoloration and also experienced fever. The outcome of events was unknown. Follow-up (03MAR2015). This follow-up report is being submitted to amend previously reported information: call was from a contactable healthcare professional reporter who was calling on behalf of a doctor.
Sex: U
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable healthcare professional reporting similar events for 4 patients. This is  the first of 4 reports. A patient of unknown age and gender received intramuscular PREVNAR13 Lot number: J80525, Expiration date: APR2016, NDC number: 0005-1971-02, single dose, on an unknown date. On unknown date the patient's injection site was red, hot and swollen, and had skin discoloration that was very large, also experienced fever and injection site pain. The outcome of events was unknown. Follow-up (03MAR2015): This follow-up report is being submitted to amend previously reported information: to amend the reporter information as the reporter was calling on behalf of a doctor.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional reporting similar events for 4 patients. This is  the first of 4 reports. A patient of unknown age and gender received intramuscular PREVNAR13 Lot number: J80525, Expiration date: APR2016, NDC number: 0005-1971-02, single dose, on an unknown date. On unknown date the patient's injection site was red, hot and swollen, and had skin discoloration that was very large, also experienced fever and injection site pain. The outcome of events was unknown. Follow-up (03MAR2015): This follow-up report is being submitted to amend previously reported information: to amend the reporter information as the reporter was calling on behalf of a doctor.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist from a non-clinical study program, Pfizer First Connect. A 67-year old female patient of an unspecified ethnicity received PREVNAR13; Lot number: J53435; Expiration Date: NOV2015), intramuscular on 23FEB2015 at 16:15 at 0.5 ml, single dose in the right deltoid muscle. The patient's medical history and concomitant medications were not reported. On 23FEB2016 at 16:15, the right arm of the patient instantly started to swell. On 23FEB2015 at 16:20, the site of the vaccination was hot and swollen to the touch. The events did not require treatment or hospitalization. The clinical outcome of the events, right arm of the patient instantly started to swell and site of the vaccination was hot and swollen to the touch, was unknown.
Age: 70.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable healthcare professional on behalf of a doctor reporting similar events for 4 patients. This is the 4th of 4 reports. A 70-year-old female patient received PREVNAR 13 (Lot# J80525, Exp date Apr2016, NDC number: 0005-1971-02), intramuscular in left deltoid, on 06Feb2015 at 8:55 am, at single dose. Relevant medical history included ongoing diabetes, ongoing hyperthyroidism, ongoing hyperlipidemia, ongoing hypertension and ongoing gastroesophageal reflux. Concomitant medications included RECOMBIVAX HB (manufacturer Merck) (Lot# K014190, Exp date 24Oct2016), intramuscular in right arm, on 06Feb2015, at unspecified dose and frequency; metformin tablet, via oral route, from/to an unspecified date, at 1DF daily, for unspecified indication; losartan potassium, oral, from/to an unspecified date, at 100 mg 1x/day, for unspecified indication; omeprazole capsule, oral, from/to an unspecified date, at 40 mg 2x/day (1 cap 2x/day), for unspecified indication; hydrochlorothiazide tablet, oral, from/to an unspecified date, at 25mg daily (1 tab daily), for unspecified indication; atorvastatin tablet, oral, from/to an unspecified date, at 20 mg daily (1 tab daily), for unspecified indication; multivitamins tablet, oral, from/to an unspecified date, at 1DF daily, for unspecified indication; AMBIEN, oral, from/to an unspecified date, at 5mg as needed, for unspecified indication. The patient experienced acute swelling in arm, local superficial swelling; arm pain; redness; 6 mm induration and mild erythema on 06Feb2015. The events required an emergency room or doctor visit, but the patient was not hospitalized. She had a follow-up visit on 10Feb2015 and reported to doctor that she had these symptoms for 4 days. Patient was seen again on 23Feb2015. The events acute swelling in arm, local superficial swelling and arm pain were recovering at the time of this report; event redness was not recovered; outcome of events 6 mm induration and mild erythema was unknown. Follow-up (03Mar2015): This follow-up report is being submitted to amend previously reported information: call was from a contactable healthcare professional reporter who was calling on behalf of a doctor.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Injection site reaction, Rash, Rash macular
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received PREVNAR13; (Lot number: J53435; Expiration date NOV2015), via an unspecified route of administration at 0.5 ml single dose on 16FEB2015. The patient medical history was not reported. Concomitant medication included ZYRTEC. It was reported that the patient received a flu shot in OCT2014. On 19FEB2015, three days after vaccination, the patient experienced an itchy rash on the arm, red arm with pain at injection site and a blotchy rash with itching. The patient also experienced a rash at the injection site reported as red, raised and itching. The patient applied hydrocortisone cream on the affected area. The pharmacist mentioned that patient wanted to know about active and inactive ingredients in this vaccine because patient was not sure whether she was allergic to something. The vaccination site redness, blotchy rash, and itching were reported as not recovered. It was reporter that the pain at the vaccination site was recovered on an unspecified date in FEB2015. The vaccination site rash was not recovered. The clinical outcome of the itchy rash on arm was unknown. Follow-up (23FEB2015): New information received from a contactable pharmacist includes: patient data (age and ethnicity), drug data (date of administration), reaction data (onset date, clinical outcome, added: blotchy rash, itching, vaccination site erythema, vaccination site pain and vaccination site rash).
Sex: F
Vaccine: PNC13
Symptoms: Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received PREVNAR13; (Lot number: J53435; Expiration date NOV2015), via an unspecified route of administration at 0.5 ml single dose on 16FEB2015. The patient medical history was not reported. Concomitant medication included ZYRTEC. It was reported that the patient received a flu shot in OCT2014. On 19FEB2015, three days after vaccination, the patient experienced an itchy rash on the arm, red arm with pain at injection site and a blotchy rash with itching. The patient also experienced a rash at the injection site reported as red, raised and itching. The patient applied hydrocortisone cream on the affected area. The pharmacist mentioned that patient wanted to know about active and inactive ingredients in this vaccine because patient was not sure whether she was allergic to something. The vaccination site redness, blotchy rash, and itching were reported as not recovered. It was reporter that the pain at the vaccination site was recovered on an unspecified date in FEB2015. The vaccination site rash was not recovered. The clinical outcome of the itchy rash on arm was unknown. Follow-up (23FEB2015): New information received from a contactable pharmacist includes: patient data (age and ethnicity), drug data (date of administration), reaction data (onset date, clinical outcome, added: blotchy rash, itching, vaccination site erythema, vaccination site pain and vaccination site rash).
Age: 95.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Confusional state, Gait disturbance, Lethargy
Clinical narrative: This is a spontaneous report from a contactable dentist calling on behalf of his mother. A 95-year-old female patient started to receive PREVNAR13 intramuscular on 18FEB2015 at 1DF, single and CORTISONE, via an injection in her hip from an unspecified date at unknown dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced she has been out of it, confused/seems very confused, lethargic and trouble walking on 19FEB2015. The patient underwent lab tests and procedures which included blood test: it was all fine on 17FEB2015. The action taken in response to the events for PREVNAR13 was not applicable and for cortisone acetate was unknown. The outcome of confused and lethargic was not recovered and trouble walking outcome of unknown. Follow-up (20FEB2015): New information received from the same contactable dentist includes: product data and reaction data.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm
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 at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient mentioned after she had inoculation her arm was red, it was itching and it was till in that way which was since couple of hours, it was warm. She put ice on it as she could not take aspirin so she took TYLENOL and the skin was coming about and later she tried BENADRYL did not react so much. She further mentioned the only thing she thought she should take was to take CORTISONE. The outcome of itching was not recovered and outcome for the others events was unknown. No follow-up attempts possible. No further information expected.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 73-year-old female patient received a single dose of PREVNAR 13 (Lot Number: J67647; Expiration Date: Mar2016; NDC Number: 00005197102), via an unspecified route of administration on 08Feb2015. Medical history included diabetic on an unknown date. Concomitant medications included JANUVIA, at 100 mg once a day. On 08Feb2015, the patient experienced swelling of the injection site, pain and tenderness. The reporting pharmacist stated that the swelling has gone but still pain in limitation to the use of arm. The clinical outcome for the event of injection site was recovered on an unknown date. The clinical outcome for the event of pain was not recovered. The clinical outcome for the event of tenderness was reported as unknown. The reporting pharmacist assessed the events of swelling of the injection site, pain and tenderness as related to the vaccine.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: This is a spontaneous report from a contactable nurse who reported from physician's office via a sales representative. This contactable nurse reported similar events for 3 different patients. This is one of 3 reports. An elderly patient (over 65 years of age) of an unspecified gender and ethnicity received, on an unspecified date (in early February), PREVNAR13; Lot: J67647) single dose, via an unspecified route of administration,. Relevant medical history and concomitant medications were unknown. The patient experienced redness and itching on an unspecified date. Clinical outcome of the events was unknown at time of this report.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 75-year-old female consumer received the first dose of PREVNAR13, in her right arm, on 17FEB2015. Medical history includes cataracts in both eyes, diagnosed about 3-4 months ago and for which she is due to have surgery next week (06MAR15), 3 transient ischemic attacks (TIA) in 2013, and high blood pressure. Concomitant medication include hydrochlorothiazide, valsartan 80-12.5 mg daily for high blood pressure, ASPIRIN, (unspecified manufacturer) 81 mg daily, and methotrexate 2.5 mg 4 tablets weekly. She also informed that she received a prescription for the shingles vaccine, but has not yet gotten it since she "does not feel well". The consumer reported she was prescribed PREVNAR13 by her physician during a physical yesterday (17FEB2015). She then received the vaccine on the same day at a pharmacy. Today (18FEB2015) her right arm is sore, after the shot and her arm has become increasingly sore today. Caller states her doctor is not aware of her experiences since receiving the shot. The consumer did not specify her clinical outcome.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Infection, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself on information received by Pfizer from Merck (manufacturer control number 1-13211237659). A female patient of unspecified ate and ethnicity received PREVNAR13, via an unspecified route of administration, on unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced high fever, chills for 6 weeks and developed infection in her nose with the "same strain". Outcome of the reported events was unknown at the time of this report.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling abnormal, Local reaction, Mass, Nodule
Clinical narrative: This is a spontaneous report from a contactable pharmacist via non-clinical-study program. A 68-year-old female patient received first dose of PREVNAR 13 (lot. J67648), intramuscular on left upper arm on 03Feb2015 at 0.5 single. The patient had a low thyroid, and it was unknown if she took thyroid medication. The patient went to the pharmacist to get a shot and stated that she had reactions to PREVNAR 13, described as follows: she had a welt/raised area, which was red and 3 inches long and 2 inches wide, she started to feel really bad, threw up 6 times and she ached all over. The pharmacist said she didn't see the welt, but there was a lump; it was a pink area and it felt like a knot, but she wasn't sure if the knot was there before. The events throwing up and aching all over only lasted about 24 hours. The outcome of welts was recovered and the outcome of the other events was not recovered. In reporter's opinion, the throwing up and body aches were just a coincidence: she said there was a virus going around and she's been seeing people who have been throwing up and having aches and it was not from the shot. Reporter thought the patient had a localized reaction from the shot but she thought the patient had something else, stating "it seemed like a little more than she saw, but nothing major". The patient got a different shot (unspecified) from reporter and didn't have the reaction.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Urticaria, Vomiting
Clinical narrative: This is a spontaneous report from a contactable pharmacist via non-clinical-study program. A 68-year-old female patient received first dose of PREVNAR 13 (lot. J67648), intramuscular on left upper arm on 03Feb2015 at 0.5 single. The patient had a low thyroid, and it was unknown if she took thyroid medication. The patient went to the pharmacist to get a shot and stated that she had reactions to PREVNAR 13, described as follows: she had a welt/raised area, which was red and 3 inches long and 2 inches wide, she started to feel really bad, threw up 6 times and she ached all over. The pharmacist said she didn't see the welt, but there was a lump; it was a pink area and it felt like a knot, but she wasn't sure if the knot was there before. The events throwing up and aching all over only lasted about 24 hours. The outcome of welts was recovered and the outcome of the other events was not recovered. In reporter's opinion, the throwing up and body aches were just a coincidence: she said there was a virus going around and she's been seeing people who have been throwing up and having aches and it was not from the shot. Reporter thought the patient had a localized reaction from the shot but she thought the patient had something else, stating "it seemed like a little more than she saw, but nothing major". The patient got a different shot (unspecified) from reporter and didn't have the reaction.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Fatigue
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 79-year-old female patient received PREVNAR 13 (Lot# J20343, Exp date May2016) intramuscular, on 12Feb2015, at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The pharmacist mentioned that no anti-pyretic drugs were used around the vaccination time. On 13Feb2015 in the morning the patient experienced severe fatigue and decreased appetite. In Feb2015 at 03:00 PM the patient didn't want to get out of her bed. The pharmacist mentioned that the patient had not taken any treatment for fatigue and decrease in appetite and did not undergo any laboratory test. Outcome of fatigue was not recovered, outcome of the other events was unknown. The pharmacist mentioned she was not sure that severe fatigue and decreased appetite were because of PREVNAR 13.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable HCP through a company representative. A 67 year old female received PREVNAR13 single dose intramuscular in the arm on unspecified date in FEB2015. The patient went to doctor, in 3 days later after she received the vaccine and was reported to have redness and swelling on the arm that she had the vaccine administered in. The HCP did not say which arm it was. The outcome of the events was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Vaccination complication
Clinical narrative: This is spontaneous report from a non clinical study program (IBCC (inbound Call Center for HCP's) for a contactable consumer. A retired consumer mentioned that he wanted know the ingredients of PRENVAR13 as he had the arm reactions from PREVNAR13 vaccination. Consumer mentioned that it was the first time he had reactions from the vaccination and he went to his Doctor's office and asked what components that reacted to him.
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist, calling on behalf of a physician. The pharmacist stated that a male patient of unspecified age and ethnicity received, on 13JAN2015, PREVNAR13 single dose. No vaccines were given on the same date along with suspect vaccine and no vaccine were given within 4 weeks prior to PREVNAR13. Relevant medical history and concomitant medications were unknown. After the injection, on 13JAN2015, the patient experienced arm pain. At time of this report, the patient did not recover from the event.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Poor quality sleep, Sleep apnoea syndrome
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting on herself. A female patient of unspecified age and ethnicity received on an unspecified date PRENVAR13, via an unspecified route of administration in the arm, at single dose. Relevant medical history ad concomitant medications were not reported. On an unspecified date arm and hand were very swollen right below lymph node. The patient mentioned that she tried to sleep and was waking. She further stopped breathing while sleeping that all she was going around. Outcome of the reported events was unknown at the time of this report. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a Physician who reported for 3 patients and from a nurse via a sales representative. This is the second of three reports. A patient of unspecified age, gender and ethnicity received a single dose of PREVNAR13 at single dose on unspecified date. Patient medical history and concomitant medications were not reported. On unknown date the patient experienced swelling of arm, redness and pain. The outcome of the events was unknown. One of the patients called back to the doctors office to report the side effects and took a picture to show the reaction and sent it to the office. According to the reporter there was a reasonable possibility that this events were related to the suspect product.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner via a Pfizer representative. A male patient received PREVNAR 13 (lot J49846, expiration date 01Feb2016) on 18Nov2014, at 3:53 PM, as 0.5 ml single dose, intramuscularly to the left deltoid. Medical history included liver transplant. Concomitant medication included an unspecified anti-rejection medication. The patient got a rash over the entire body that was itchy and red within a couple days after receiving the vaccine; onset date of rash was 19Nov2014. The patient visited the doctor due to the rash; there was no hospitalization for the events. Representative believed the patient was still experiencing the adverse event because he had to go back and get some more cream that was provided. As of the reporting on 18Feb2015, the outcome of rash was reported as recovered on an unspecified date. The physician reported that it was unknown if the Pfizer product had a causal effect to the adverse events. Follow-up (05FEB2015): Follow-up attempts completed. No further information expected. Follow up (18Feb2015): New information reported from a contactable physician includes: suspect product data (lot J49846, expiration date 01Feb2016; administered on 18Nov2014, at 3:53 PM to left deltoid), detailed event description (onset date of rash was 19Nov2014), outcome (rash recovered) and causality (unknown). Follow up attempts completed. No further information expected.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 89-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13, via an unspecified route of administration in the arm on 21Jan2015. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2015 the patient experienced a lot of redness in the area and a large portion of the upper arm was red. The patient was still experienced the reported events at the time of this report. Causality assessment was not provided.
Sex: F
Vaccine: PNC13
Symptoms: Dysgeusia, Ear disorder, Eye irritation, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer. This  consumer reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age and ethnicity received PREVNAR13 via an unspecified route of administration on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced numbness to the arm and neck and shoulder on one side, metallic taste in the mouth, eyes burning, and ears feeling like they are under water on an unspecified date. The outcomes of the events, numbness in the arm and neck and shoulder on one side, metallic taste in the mouth, eyes burning, and ears feeling like they are under water were unknown. Follow-up (26FEB2015): No follow up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a Physician who reported for 3 patients and from a nurse via a sales representative. This is the first of three reports.  A patient of unspecified age, gender and ethnicity received a single dose of PREVNAR13 at single dose on unspecified date. Patient medical history and concomitant mediations were not reported. On unknown date the patient experienced swelling of arm, redness and pain. The outcome of the events was unknown. One of the patients called back to the doctors office to report the side effects and took a picture to show the reaction and sent it to the office. According to the reporter there was a reasonable possibility that this events were related to the suspect product. Follow-up (06MAR2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via Company sales representative. A female patient of an unspecified age received PREVNAR 13 (Lot H65735, expiration date 07Jan2015) on 18Nov2014 at 11:42 am at 0.5 ml single in the left deltoid. Relevant medical history included ongoing rheumatoid arthritis, concomitant medication included methotrexate, six tablets weekly, for rheumatoid arthritis. No other vaccines were administered on 18Nov2014. On 19Nov2014 the patient experienced swelling arm, redness, pain. The patient recovered from the reported events on an unspecified date. The nurse mentioned that swelling of arms, redness and pain were due to PREVNAR 13.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Mobility decreased, Neck pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 72-year-old female patient of unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in the left arm, on 24Dec2014, at single dose. Relevant medical history and concomitant medications were not reported. Two days after vaccination the patient experienced redness in the same arm at the site of injection (without itching or pain) for 2-3 days. Four days after vaccination (2 days after redness happened) she experienced neck pain on the same side of the neck where the injection have been (left side) for about 2 weeks and she had trouble, like she could not turn her head all the way to the left. The patient mentioned that she routinely goes to an acupuncturist so she went. The patient recovered from the events.
Sex: U
Vaccine: PNC13
Symptoms: Skin exfoliation
Clinical narrative: This is a spontaneous report obtained from a contactable physician. A patient of unspecified age, gender and ethnicity received, on an unknown date, PREVNAR 13 single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced peeling of the skin around the injection site. Clinical outcome of the event was unknown at time of this report.
Sex: U
Vaccine: PNC
Symptoms: Hypersomnia, Irritability, Screaming
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age ethnicity and gender received third dose of PREVNAR 13 via intramuscular route of administration, in left thigh, at single dose, on unknown date. No illness was present at time of vaccination. The patient medical history was not reported. Concomitant medications were none. On an unspecified date, the patient experienced excessive sleeping/sleeping from 7 o'clock in evening to 7 o'clock in morning (but easily awakened), excessive cranky/very very fussy and screaming 3 hours after vaccination. The outcome of the events was unknown. Follow-up (18Feb2015): New information from a contactable physician includes: vaccine lot number, route of administration, anatomical location of vaccination, dose number, events details. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Cough, Feeling abnormal, Increased upper airway secretion, Influenza, Pain
Clinical narrative: This is a spontaneous report from a non-clinical study program. A contactable consumer (patient) reported a 65-year-old female patient started to receive XALATAN eye drops at 1 gtt daily for glaucoma on an unspecified ate "for many years"; in addition she received the pneumonia vaccine on 05DEC2014 at the pharmacy. The patient denied having any relevant medical history or taking any concomitant medications. On 12DEC2014, she got the flu after visiting the doctor's office. She was achy all over, in bed for four days, and experienced cough, runny nose/nose blowing, rattle in throat/phlegm in throat, congestion, sneezing and "getting weird". She also commented she was unable to read the small writing on the bottle/box of latanoprost, and was unable to get lot number, exp. date or NDC. The action taken with latanoprost was dose not changed, and with the pneumonia vaccine was permanently withdrawn on 05DEC2014. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Respiratory tract congestion, Rhinorrhoea, Sneezing
Clinical narrative: This is a spontaneous report from a non-clinical study program. A contactable consumer (patient) reported a 65-year-old female patient started to receive XALATAN eye drops at 1 gtt daily for glaucoma on an unspecified ate "for many years"; in addition she received the pneumonia vaccine on 05DEC2014 at the pharmacy. The patient denied having any relevant medical history or taking any concomitant medications. On 12DEC2014, she got the flu after visiting the doctor's office. She was achy all over, in bed for four days, and experienced cough, runny nose/nose blowing, rattle in throat/phlegm in throat, congestion, sneezing and "getting weird". She also commented she was unable to read the small writing on the bottle/box of latanoprost, and was unable to get lot number, exp. date or NDC. The action taken with latanoprost was dose not changed, and with the pneumonia vaccine was permanently withdrawn on 05DEC2014. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Malaise
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received a single dose of PREVNAR13; Lot Number: H86680; Expiration Date: OCT2015), intramuscularly in the deltoid muscle of the arm on 09DEC2014 at 1:00 PM, which was administered by the pharmacist. No vaccine was given on the same day; however other unspecified vaccines were given four weeks prior to the day of administration with PREVNAR13. The patient's medical history and concomitant medications were not reported. On the morning of 10DEC2014, the patient experienced weakness and sickness. The patient did not require an emergency room visit or doctor visit. The reporting pharmacist dd not know about the blood and laboratory test for the patient. The clinical outcome for the events of weakness and sickness was unknown. The causality was assessed by the reporting pharmacist who believed the events of weakness and sickness was due to the vaccine. The pharmacist did not know how the patient purchased the vaccine. The pharmacist did not want the physician to be contacted. Follow-up (11FEB2015): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Tenderness
Clinical narrative: This is a spontaneous report obtained from a contactable consumer who reported for her mother in law. A 76-year-old female patient received, on an unspecified date in 2014, PREVNAR13, 0.5 ml single dose. Relevant medical history included pacemaker insertion (cardiac). Concomitant medications were unknown. After the vaccination, the patient said her arm was extremely tendered for several days and she kept asking if she had a black and blue mark or not. She also had flu-like symptoms for 3 days after receiving the shot. She was not bad enough to be stuck in bed. Events recovered on an unknown date. She said she had the same reactions (pain in arm and flu-like symptoms) with influenza vaccine shot in October. Follow-up (13JAN2015, 13JAN2015, and 13JAN2015): New information received from   the same contactable consumer who reported for her mother in law includes: reporter, patient and event details. Follow-up (11MAR2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable Pharmacist who reported for patient. The Pharmacist mentioned that she had called earlier as well. A 67 year old female patient received PREVNAR13; lot H86212, expiry date 31OCT2015) on 11OCT2014, at 0.5 ml single. Medical history and concomitant medications were not provided. On 11OCT2014, the patient experienced pain in left arm, sore in left arm, could not lift her arm without pain and swelling at injection site. The Pharmacist mentioned that she administered the vaccine on 11OCT2014 and all the symptoms started on the evening of 11OCT2014. The swelling resolved on unknown date but the pain continued to worsen. Event "could not lift her arm without pain" outcome was unknown. The reporter thought that all those symptoms were due to administration of PREVNAR13. Follow up (13JAN2015): Follow-up activities closed. F/U response received from HCP. Follow up attempts completed. No further information expected.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Incorrect route of drug administration, Injection site discomfort, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a Non-Clinical Study Program (IBCC (Inbound Call Center for healthcare professionals)) from a contactable nurse who reported for the patient, her friend. A 73-year-old male patient received PREVNAR13, subcutaneously in the left deltoid muscle at a single dose on 09DEC2014. Medical history was not reported. Concomitant medications included simvastatin 20 mg per day. On 09DEC2014, the patient received PREVNAR13, which seemed to be given subcutaneously and when the nurse ran her finger over it felt like a pump like it went in subcutaneously rather than intramuscularly. It also seemed to bleed more and was more painful than normal. It  hurt him a lot. The discomfort at the site only lasted about a  day. The outcome of the events was recovered on an unknown date. Follow-up (29JAN2015): New information received from the same contactable nurse includes: outcome (recovered). Follow-up attempts completed. No further information expected.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Ear haemorrhage, Ear pain, Neck pain, Otorrhoea
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported for a patient. An 88-year old female patient of an unspecified ethnicity received PREVNAR13. (NDC number: 0005197105), intramuscular, on 06DEC2014 at 09:30 AM. She had a history of ear infections. There were no concomitant medications. No other vaccine was given on same date along or within four weeks with PREVNAR13. No adverse event was reported following prior vaccination in patient or siblings. The patient experienced severe pain in neck on 06DEC2014 12:30, She said that later on an unspecified date in DEC2014 she experienced severe pain in her left ear. Then, she had dark yellow liquid coming out when she put a Q-tip in her ear. She had a physician visit on 00DEC2014 and when her doctor looked in her left ear, she saw blood. The doctor advised her not to tough that ear for a while. No relevant test was reported. She was improved from the reported events at the time of the report. The reporter considered the event severe pain in neck as related to PREVNAR13, causality for events severe pain, dark yellow liquid coming out and blood in left ear was unknown. The physician did not confirm the occurrence of the events reported by the patient. Follow-up (29DEC2014): Additional information reported from a contactable physician includes physician not confirmed adverse event.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Injection site rash, Injection site warmth, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 65 year-old female consumer received on 03DEC2014, PREVNAR13, at 0.5 ml single, intramuscular on left arm. The consumer mentioned that she took a couple of drugs, one for pain and one to help symptoms of fibromyalgia (no further details provided). The consumer mentioned that her arm hurt on 03DEC2014 about 3 hour after shot and in the morning she could not even wash her hair and in afternoon the whole arm got stiffer. She further mentioned that when she went to bed last night she had 4 little rashes around the site. At the time of report the rash was big as her hand and she was little concerned. Investigation: none. The consumer mentioned that her arm was very sore and rash was big as her whole hand and it was hot. The patient also experienced swelling. Follow-up (23DEC2014): New information reported from the same contactable consumer includes: vaccination details, reaction data and  patient's clinical course. Follow-up (18FEB2015): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 65 year-old female consumer received on 03DEC2014, PREVNAR13, at 0.5 ml single, intramuscular on left arm. The consumer mentioned that she took a couple of drugs, one for pain and one to help symptoms of fibromyalgia (no further details provided). The consumer mentioned that her arm hurt on 03DEC2014 about 3 hour after shot and in the morning she could not even wash her hair and in afternoon the whole arm got stiffer. She further mentioned that when she went to bed last night she had 4 little rashes around the site. At the time of report the rash was big as her hand and she was little concerned. Investigation: none. The consumer mentioned that her arm was very sore and rash was big as her whole hand and it was hot. The patient also experienced swelling. Follow-up (23DEC2014): New information reported from the same contactable consumer includes: vaccination details, reaction data and  patient's clinical course. Follow-up (18FEB2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site extravasation
Clinical narrative: This is a spontaneous report from a contactable office staff (other HCP) from physician's office. A patient of unknown age and gender received on 11AUG2014, PREVNAR13 at single dose. Vaccines given on the same day and vaccines taken within the last four weeks wre unknown. Relevant medical history and concomitant medications were unknown. It was reported that on 11AUG2014, when PREVNAR13 vaccine was administered to the patient, the vaccine leaked out at injection site. Relevant lab tests and sibling information were unknown. At the time of the report the clinical outcome of above mentioned event was unknown. Follow-up (17OCT2014): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician through a sales representative. This physician reported the same reaction for two patients. This is the first of two reports. A patient of unknown age, gender and ethnicity received on an unknown date a single dose of PREVNAR13 in arm. Medical history and concomitant medications were not reported. On unspecified date in 2014, within last 3-4 weeks before this report, both patients had like a reaction on their arms that their arms swelled up and they had a large reaction from the shot. After a week, the patient visited the physician and a treatment was provided. Outcome was unknown. Follow-up (05-NOV-2014): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician through a sales representative. This physician reported the same reaction for two patients. This is the second of two reports. A patient of unknown age, gender and ethnicity received on an unknown date a single dose of PREVNAR13 in arm. Medical history and concomitant medications were not reported. On unspecified date in 2014, within last 3-4 weeks before this report, both patients had like a reaction on their arms that their arms swelled up and they had a large reaction from the shot. After a week, the patient visited the physician and a treatment was provided. Outcome was unknown. Follow-up (05-NOV-2014): Follow-up attempts completed. No further information expected.