chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Skin lesion, Type III immune complex mediated reaction
Clinical narrative: Initial report received from literature on 17 May 2014. A 39-years-old female patient, has not received any concomitant, received TDAP (batch number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. It was reported that within 24 hours of receiving TDAP vaccine, the patient noted several areas of pruritus and swelling on her distal lower extremities. During the next 24 hours these areas enlarged and developed into tender red nodules. The painful nodules persisted and she sought dermatologic medical attention. Correlation of the patients medical history, clinical symptoms, and lesion morphology were compatible with a diagnosis of Tdap vaccine-related erythema nodosum; however, the differential diagnosis also included an Arthus like phenomenon induced by immunization and erythema nodosum secondary to another etiology with immunization being associated by chance. Several circumstances favored Tdap vaccine-related erythema nodosum. Specifically, the patient had not been receiving any topical or systemic medications. Also, she had no recent streptococcal pharyngitis or systemic conditions such as Crohn's disease, sarcoidosis, or tuberculosis. Therefore, the temporal association between her recent Tdap vaccination and the development of the skin lesion suggested that the development of her erythema nodosum was related to her receiving Tdap vaccine. On cutaneous examination, 7 day after receiving Tdap vaccine, revealed tender erythematous nodules on her legs. There was a large, 12 by 8 cm, erythematous nodule on distal pretibial left leg. Multiple, individual and grouped, nodules were present on her right leg; they were located on the distal lateral thigh (4.0 by 2.5 cm), the proximal lateral calf (6.0 by 3.5 cm), the distal lateral calf (2.0 by 2.0 cm), and the distal lateral leg proximal to the ankle (each of 3 lesions measuring 2.5 by 2.5 cm). Symptomatic treatment was initiated oral ibuprofen 600 mg four times daily. Since a drug induced etiology was suspected, daily oral systemic therapy with an antihistamine and a corticosteroid, 180 mg of fexofenadine and prednisone (60 mg for 4 days, followed by 40 mg for 3 days, and followed by 20 mg for 2 days). Her symptoms began to improve and the nodules started to flatten within 3 days. One of the nodules proximal to her right ankle was smaller, yet palpable with mild erythema of the skin. All other nodules had completely flattened and there was macular hyperpigmentation at the sites. At the time of this report the patient was recovered from the event. Documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from health care professional on 09 June 2014. A 5-year-old patient (gender not reported) had received a dose of ADACEL instead of fifth dose DTaP vaccine series on an unspecified date. No adverse event was reported. List of documents held by sender: None.
Age: 8.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 10 June 2014. An 8-year-old patient received a dose of PENTACEL instead of  TDAP (No other information was provided regarding the patient). Thus inappropriate age at vaccine administration and wrong vaccine was administered but no adverse events reported. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity, Vaccination complication
Clinical narrative: This is a spontaneous report from non clinical study program IBCC (Inbound Call Center for HCPs) by a contactable physician. A patient of unspecified age and gender received, on an unknown date, PREVNAR 13 at single dose. Relevant medical history included allergy to egg products. Concomitant medications were unknown. Vaccines given on the same day and vaccines taken within the last four weeks were unknown. On an unknown date, the patient experienced an allergic reaction to PREVNAR 13. Relevant sibling information and lab data were unknown. At the time of the report the clinical outcome of above mentioned event was unknown. Follow-up (13Feb2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, subcutaneous on an unspecified date at 0.5 ml, single. The patient medical history and concomitant medications were not reported. It was reported that "She had a lady that had a serious allergic reaction when she gave PREVNAR 13 subcutaneously". Follow-up (13Mar2014): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased
Clinical narrative: This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on unspecified date at 0.5 ml, single. The patient medical history and concomitant medications were not reported. This physician reported "could hardly move are for one week". The outcome of the event was unknown. No follow-up attempts possible. No further information expected.
Age: 24.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative, with follow-up received from a contactable physician. A 24-year-old male patient of an unspecified ethnicity received the first dose of PREVNAR 13 (lot F65733, expiration date 01Aug2013), intramuscularly in the left deltoid, at 0.5 cc, once, on 07Dec2012 at 4 PM for cochlear implant. The patient had no prior medical history, no relevant drug history, no drug allergies and no family history. The patient had no adverse events following prior unspecified vaccination, had no vaccination within four weeks prior to 07Dec2012 and had no illness at the time of vaccination. Concomitant medication were not provided; the patient had no antipyretic prior to vaccination. The physician confirmed that, on 09Dec2012, the patient had experienced mild local redness (previously reported as local reaction to the shot). No treatment was required, no relevant tests, diagnostic tests or cultures were done, and the event did not result in an emergency room or doctor visit. The physician felt that the event, mild local redness, was related to PREVNAR 13. The pharmacist had reported that the patient should receive the 23-valent pneumococcal vaccine and asked if the patient could or could not have this vaccine, due to his previous local reaction. The patient recovered from the event on 12Dec2012. Follow-up (14Feb2013): New information received from a contactable Pharmacist via a sales representative includes: patient age group. Follow-up (26Mar2013): New information received from a contactable physician in response to the HCP follow-up letter includes: patient age, date of immunization, site of immunization and indication for PREVNAR 13, updated event details and clinical course, causality and outcome of event. Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Local reaction
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative, with follow-up received from a contactable physician. A 24-year-old male patient of an unspecified ethnicity received the first dose of PREVNAR 13 (lot F65733, expiration date 01Aug2013), intramuscularly in the left deltoid, at 0.5 cc, once, on 07Dec2012 at 4 PM for cochlear implant. The patient had no prior medical history, no relevant drug history, no drug allergies and no family history. The patient had no adverse events following prior unspecified vaccination, had no vaccination within four weeks prior to 07Dec2012 and had no illness at the time of vaccination. Concomitant medication were not provided; the patient had no antipyretic prior to vaccination. The physician confirmed that, on 09Dec2012, the patient had experienced mild local redness (previously reported as local reaction to the shot). No treatment was required, no relevant tests, diagnostic tests or cultures were done, and the event did not result in an emergency room or doctor visit. The physician felt that the event, mild local redness, was related to PREVNAR 13. The pharmacist had reported that the patient should receive the 23-valent pneumococcal vaccine and asked if the patient could or could not have this vaccine, due to his previous local reaction. The patient recovered from the event on 12Dec2012. Follow-up (14Feb2013): New information received from a contactable Pharmacist via a sales representative includes: patient age group. Follow-up (26Mar2013): New information received from a contactable physician in response to the HCP follow-up letter includes: patient age, date of immunization, site of immunization and indication for PREVNAR 13, updated event details and clinical course, causality and outcome of event. Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This is an initial spontaneous report from a Pfizer sales representative for a contactable physician who reported for a patient. This 70 year old, female patient received PREVNAR 13 on an unknown date at an unknown dose and frequency for an unknown indication. Relevant medical history and relevant concomitant medication was unknown. The patient experienced a hard red 2 inch long bump, pain and swelling at the site of injection while being on PREVNAR 13 on 18Nov2013. Relevant laboratory tests were unknown. Status of PREVNAR 13 therapy was unknown. Therapeutic measures taken in response to the events were unknown. Clinical outcome of the reported events was unknown. Follow-up (24Dec2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported similar adverse event fro two different patients. This is the first of two reports. A patient (age, gender and Ethnicity unknown) received PREVNAR 13 (Lot Number: H07344, Expiration Date: Apr2015, NDC Number: 0005197101) single dose, on an unspecified date. Relevant medical history and concomitant medications were unknown. Illness at the time of vaccination was unknown. Vaccines given on the same day and vaccines taken within the last four weeks were unknown. On an unspecified date, while on PREVNAR, the patient experienced rash and fever. Relevant sibling information was unknown. At time of this report, clinical outcome of the events was unknown. Follow-up (27Dec2013): Follow-up attempts completed. No further information expected.
Age: 0.2
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report by a non-contactable physician. A 2-month-old patient received PREVNAR 13 on unknown date for immunization. Relevant medical history concomitant medication was unknown. On unknown date, the patient developed fever at 103 degree within 24 hours of administering PRFEVNAR 13. At the time of the report the clinical outcome of above mentioned event was unknown. No follow-up attempts possible. No further information expected.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Blood test, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable medical assistant calling from physician's office. A 72-year-old male patient received PREVNAR 13 (Lot#: H34511, Exp Date: May2015) intramuscularly on 14Oct2013. Relevant medical history included chronic obstructive pulmonary disease, atrial fibrillation and smoking sensation. Relevant concomitant medication included FLUVIRIN on 14Oct2013. In Nov2013, the patient developed pain in arm. Relevant laboratory data included blood work in Oct2013 for which the results were unknown. No therapeutic measures were taken in response to the reported event. The patient was not recovered from the reported event at the time of report. The medical assistant was not sure if the reported event was due to the medication. Follow-up (17Jan2014): Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: This is a spontaneous report by a contactable nurse reporting for herself. A 49-year-old female nurse received PREVNAR 13 on 22Jul2013 at 9 AM, intramuscular injection on left deltoid muscle. Relevant medical history and concomitant medications were none. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 22Jul2013 she had swelling at the site of injection and redness extending from injection site. On 25Jul2013 she developed three spots of rash on her left arm. Relevant sibling information was unknown. Relevant sibling information was unknown. Relevant lab data was none. At the time of the report she had not recovered from above mentioned events. The nurse considered that there was a reasonable possibility that the events were related to PREVNAR 13. Follow-up (29-AUG-2013) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable Physician through a Pfizer Sales Representative. This patient (age, gender and race unknown) received PREVNAR 13 (lot G73024, exp.date Oct2014) on an unknown date, single dose. Relevant medical history and relevant concomitant medications were unknown. It was reported that on 06Sep2013, patient experienced soreness and swelling at the site of vaccination. Relevant laboratory data was unknown. Therapeutic measures taken in response to the reported event were unknown. The clinical outcome of the reported event was unkown, at the time of report. Follow-up (11Oct2013): Follow-up attempts completed. No further information expected.
Age: 0.29
Sex: F
Vaccine: HEP, PNC13
Symptoms: Hypersensitivity, Injection site induration, Injection site mass, Irritability, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 3-month-old female patient started to receive PREVNAR 13 (Lot# H00672, Exp. date Mar2015) at her right thigh on 05Sep2013. There was no relevant medical history. On 05Sep2013 patient was also administered with RECOMBIVAX HB at her left thigh at 0.5 ml. It was reported that on 05Sep2013 patient had allergic reaction, irritable, fever after two hours of vaccianiton, a small raised lesion and a hard mass underneath the skin on right thigh while being on PREVNAR 13. Nurse reported that the causality of these event could be due to PREVNAR 13. There were no relevant laboratory date done in response to the event. Therapeuric measure taken for the reported events was unknown. Patient was receovering from the reported events at the time of the report. Follow-up (17OCt2013): Follow-up attempts completed. No further infromation expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Physician, through a Pfizer Sales Representative. A female patient was administered with PREVNAR 13 single dose, unknown route on an unknown site at an unknown time for immunisation on an unknown date. Anatomical location of the administration of the vaccine was unknown. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. On an unknown date while on PREVNAR 13 unknown dose unknown frequency on an unknown site at an unknown time the patient had localized swelling at the site of injection. It was unknown if the patient had any siblings. Relevant lab data was unknown. At the time of report it was unknown if the patient was taking PREVNAR 13. At the time of report the clinical outcome of the above mentioned event was unknown. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck Inc, service requested number: 1-8394727844. A non-contactable pharmacist reported that a physician told her about a female patient of unknown age and ethnicity that developed a rash on her body after receiving PREVNAR 13, single dose. No follow up attempts possible. No further information expected.
Age: 39.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report from a contactable nurse and a contactable physician via a Pfizer Sales Representative. A 39-year-old (race unknown) female patient received PREVNANR 13 injection intramuscularly in the right arm at 0.5 ml single on unknown date. Relevant medical history included neutropenia, asthma and allergy to unspecified  diphtheria vaccines all since an unknown duration. Relevant concomitant medications included unspecified vaccines on 24Sep2013 on left arm influenza. On 24Sep2013, the patient experienced local reaction at the injection site, pain at the injection site, severe swelling at the injection site and redness at the injection site while on PREVNAR 13. Relevant laboratory data was unknown. Therapeutic measure taken in response to the events was CUBICIN intravenously on an unknown date in Sep2013 at an unknown dose and frequency. Clinical outcome of the events was unknown at the time of report. Follow-up (05Nov2013): New information received from the contactable physician includes: This physician confirmed the occurrence of the events. Follow-up (20NOV2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported same adverse event for different patients. This is first of the three reports. A patient (age, ethnicity and gender unknown) received PREVNAR 13 single dose, on an unspecified date. Relevant medical history and concomitant medications were unknown. It was reported that the patient experienced stinging during injecting PREVNAR 13. Therapeutic measures taken in response to the event were unknown. Clinical outcome of the event was unknown at time of this report. Follow-up (26Nov2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported same adverse event for different patients. This is second of the three reports. A patient (age, ethnicity and gender unknown) received PREVENAR 13 single dose, on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. It was reported that the patient experienced stinging during injecting of PREVENAR 13. Therapeutic measures taken in response to the event were unknown. Clinical outcome of event was unknown at time of this report. Follow-up (26Nov2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. The physician reported same adverse event for different patients. This is third of the three reports. A patient (age, ethnicity and gender unknown) received PREVNAR 13 single dose, on an unspecified date. Relevant medical history and concomitant medications were unknown. It was reported that the patient experienced stinging during injecting PREVNAR 13. Therapeutic measures taken in response to the event were unknown. Clinical outcome of event was unknown at time of this report. Follow-up (26Nov2013): Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: A 77 year old, female patient received PREVNAR 13 on 23Oct2013 at single dose to prevent pneumonia. Relevant medical history and concomitant medication was unknown. It was reported that the patient developed bad rashes all over the body since an unknown date in Oct2013. Relevant laboratory data was unknown. Therapeutic measures taken in response to the event included BENADRYL since an unknown date in Oct2013 (dose and frequency unknown). The patient had not recovered and the event was getting worse at the time of report. Follow-up (04Dec02013): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Rash maculo-papular
Clinical narrative: This is a spontaneous report from a non-contactable physician. A female patient of unknown age and race, received PREVNAR 13 on an unknown date at single dose. Relevant medical history and relevant concomitant medications were unknown. On an unknown date the patient experienced gigantic maculopapular rash. Relevant laboratory data was unknown. Therapeutic measures taken in response to the event were unknown. Clinical outcome of the event was unknown at the time of report. No follow up attempts possible. No further information expected.
Age: 60.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 60 year old female patient was administered with first dose of PREVNAR 13 in her right arm at 0.5 ml single dose on an unknown date. On the same day the patient received an influenza vaccine in her left arm. Relevant medical history was unknown. A short time after vaccination, the patient experienced significant redness in her right arm. She came back into the office the following day and showed significant swelling at the injection site. At the time of the report outcome of the above mentioned events was unknown. Follow-up (05Dec2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report by a contactable physician through a Pfizer sales representative reported one behalf of physician for an elderly patient who received PREVNAR 13 single dose intramuscular, on an unknown anatomical site for routine vaccination on an unknown date. Relevant medical history and relevant concomitant medications were unknown. Vaccines taken within the last four weeks were unknown. Vaccines given on the same day were unknown. On an unknown date the patient had severe swelling at the site of injection. Relevant sibling information was unknown. Relevant lab data was unknown. At the time of the report the clinical outcome of the above mentioned event was unknown. Follow-up (30-JUN-2013) Follow-up attempts completed. No further information expected.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from Pfizer Medical Information for a contactable reporter. A 2-month-old, female consumer received PREVNAR 13 in Mar2013. Relevant medical history included allergic to dairy products since an unknown duration. Relevant concomitant medications included DTAP/IPV/HIB, both in Mar2013. The patient experienced bad allergic reactions within 24 hours of administration of PREVNAR 13 in Mar2013. Relevant laboratory data was none. Therapeutic measures taken in response to the event were none. The patient recovered from the event. Follow-up - (20-JULY-2013) Follow-up attempts completed. No further information expected.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable reporter who reported on the behalf of a physician for a patient. This is first of the two reports reported by the same reporter. A 2-month-old female patient received PREVNAR 13 (Lot #G92622 and Expiration date: 12/2014), intramuscularly on left anterolateral thigh at a dose of 0.5ml on 07Jun2013 at 11:30 am. Relevant medical history was none. Concomitant medications included PENTACEL [Manufactured by Sanofi Pasteur], (Lot # C4484AA) intramuscularly on left anterolateral thigh on 07Jun2013 and ROTATEQ [Manufactured by Merck] (Lot # J003951) orally on 07Jun2013. The patient experienced fever and was fussy, both on 07Jun2013 at 9:30pm. Therapeutic measures taken in response to the reported event fever was TYLENOL in Jun2013 at a dose of 40mg in every 4 hours. The patient did not visit the emergency room or the doctor in response to the reported events, the patient was not hospitalized. The patient was recovered from the event fever since an unknown date in Jun2013 and clinical outcome of the reported event fussy was unknown at the time of the report. Follow-up (20-JUL-2013): Follow-up attempts completed. No further information expected.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report by a contactable nurse. A 12-month-old male patient received third dose of PREVNAR 13 on an unknown date at 13:30, on left arm. Relevant medical history and concomitant medication were none. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 27Jun2013 while on PREVNAR 13 after he was administered the third dose he experienced fever up to 104. Relevant lab data was none. At the time of the report he had not recovered from fever up to 104. Follow-up (07-AUG-2013) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site erythema
Clinical narrative: This is an initial spontaneous report by a contactable physician. This female Pfizer Sales representative reported on behalf of a male physician for patient who received PREVNAR 13 unknown dose intramuscular injection at an unknown time on arm as a single dose in Jun2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. In Jun2013 after taking PREVNAR 13 the patient experienced redness in arm which was about seven inches at the injection site which the physician explained was a definite allergic reaction. The patient did not require an emergency room or doctor visit. Relevant lab was unknown. At the time of the report the patient was not taking PREVNAR 13 as it was a single dose. At the time of the report the patient had recovered from the above mentioned events in 2013. Follow-up-(09-AUG-2013) Follow-up attempts completed. No further information expected.
Age: 0.51
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. A 6 months old, male patient received the third dose of PREVNAR 13 on 08Apr2013 (he received the first dose on 05Dec2012 and the second on 06Feb2013) single dose, as routine immunization. Relevant medical history was unknown. Relevant concomitant medication was none. The patient developed a rash at the bottom on 11Apr2013. Relevant laboratory data was none. Therapeutic measures taken in response to the event were LOTRIMIN. The patient recovered from the adverse event. The nurse also reported that on 08Apr2013 the patient was administered a third dose of DTaP and PEDIARIX. Follow-up (22-AUG-2013) Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a male patient who received KINRIX (batch number AC20B225BA, expiry date 23rd November 2014). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: patient was inadvertently administered an expired dose of KINRIX.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a infant patient who received ENGERIX B pediatric. On an unknown date, the patient received ENGERIX B pediatric at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse reported that approximately 38 infants were vaccinated at birth with ENGERIX that was stored out of recommended temperatures for approximately 1 month. Nurse did not have any further information at this time as they are still gathering info on these patients.
Sex: U
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable other HCP. A 4-months old infant received PREVNAR 13, 0.5 ml single dose, at 2 months on unknown date and experienced on the night that his hands and feet turned red. Follow-up (24-APR-2013): Follow-up attempts completed. No further information expected.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from contactable physician via sales representative. A 4-month-old patient (gender unknown) received PREVNAR 13 0.5 ml single dose, intramuscular, ROTATEQ and PENTACEL on unknown date. On unknown date the patient experienced on and off bright red hands and feet. Follow-up (26-APR-2013): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A female patient of unknown age and ethnicity received PREVNAR 13 administered in an arm and another unspecified vaccine, both received on an unknown date since the patient was to undergo a transplant. Relevant medical history included a sore on her finger for which she was treated. Concomitant medications were not reported. A day after the patient received the vaccines, she experienced significant swelling and pain in the same arm in which she had received the injection of PREVENAR 13. The symptoms resolved quickly after the patient took some BENADRYL. No additional information was reported. Follow-up (03-MAY-2013) Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported that a 57-year-old female patient, with a medical history of rheumatoid arthritis, had an allergic reaction following administration of pneumococcal vaccine (TRADE NAME UNKNOWN). At the time of reporting, no other information was provided.
Sex: F
Vaccine: PNC13
Symptoms: Dry skin, Erythema, Peripheral swelling, Pruritus
Clinical narrative: This is an initial spontaneous report by a contactable physician's assistant. This female Pfizer Sales representative reported on behalf of female physician's assistant who reported for a 65 year old female consumer was administered with one dose of PREVNAR 13 (Lot Number H013394, Expiration Date: 31Mar2014, NDC Number: 0006473900) unknown dose intramuscular injection single dose on left deltoid muscle on 08Apr2013. Vaccines given on the same day were none. Vaccines taken within the last four weeks were unknown. Previously the patient received on PREVNAR 13 unknown dose intramuscular injection single dose on left deltoid muscle at unknown time in 2007. Relevant medical history was unknown. Relevant concomitant medications were unknown. On 08Apr2013 after vaccine administering she reacted huge over her upper arm which she explained as cobblestone effect with skin with itching, redness, large amount of swelling and roughening of skin over whole dorsal side of upper arm. She visited the doctor due to cobblestone effect in skin with itching, redness, large amount of swelling and roughening of skin over whole dorsal side of upper arm. Therapeutic measures included unspecified antihistaminic in response to above mentioned events. Relevant lab data was unknown. At the time of the report the patient was not taking PREVNAR 13 as it was a single dose. At the time of the report she had recovered from above mentioned events in Apr2013. Follow-up (24-MAY-2013): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site inflammation, Injection site pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative and from a contactable Certified Medical Assistant (other healthcare professional) reporting on behalf of the physician. A 72-year-old, female patient received first dose of PREVNAR 13 (Lot G68911; Expiration date Oct2014) on 08Apr2013 at 04:00 PM, 0.5 ml single dose IM (deltoid left). Medical history included hypertension and allergy to contrast dye and Codeine. Relevant concomitant medications of the patient were none. No administration of any antipyretic prior to vaccination and no vaccinations within four weeks. After administration of PREVNAR 13, on an unspecified date in apr2013, the patient experienced chills, redness and inflammation (injection site reaction). On 08Apr2013 the patient experienced left arm swollen and rash and pain at site. She was given ice and prescribed Medrol dose pak to bring down the inflammation and help with the pain. No cultures or other diagnostic tests performed. Events did not result in an emergency room or doctor visit. Left arm swollen, rash and pain at site recovered all on 15Apr2013. Clinical outcome of the other events was unknown at the time of the report. Reporter assessed there was a reasonable possibility that the events were related to PREVNAR 13. Follow-up (24May2013): Follow-up attempts completed. No further information expected. Follow-up (03Jun2013): New information received from a contactable Certified Medical Assistant (other healthcare professional) reporting on behalf of the physician includes: PREVNAR 13 details (Lot #, expiration date, administered date, route, dose and dose number); events updated (left arm swollen, rash, pain at site added), treatment, reporter assessment, patient details (age, medical history). Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age, gender, and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced an unspecified allergic reaction after possibly receiving PREVNAR 13. The clinical outcome of the event, allergic reaction, was unknown. Follow-up (05-JUN-2013): Follow-up attempts completed. No further information expected.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report by a contactable nurse. A 4-year-old female child received PREVNAR 13 in the left thigh on an unknown date. Relevant medical history and concomitant medications were unknown. It was unknown if any vaccines were given on the same day. On unknown date, she experienced pain at site of injection, the site of injection got erythremic and site of injection developed a large redness. At the time of the report the clinical outcome of all the above mentioned events was unknown. Follow-up (07-JUN-2013) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This is an initial spontaneous report by a contactable physician. This Pfizer Sales Representative reported on behalf of a physician for an adult patient who began on PREVNAR 13 unknown dose intramuscular injection unknown frequency on upper arm for immunization for the prevention of pneumonia in Apr2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines taken on the same day were unknown. Vaccines taken within the last four weeks were unknown. In Apr2013 while on PREVNAR 13 unknown dose unknown frequency patient experienced moderate redness, pain and rash at the site of injection. Therapeutic measures taken in response to above mentioned evens included TYLENOL. Relevant lab data was unknown. At the time of the report it was unknown if patient was still administering PREVNAR 13. At the time of the report patient had recovered from above mentioned events in Apr2013. The physician considered there was a reasonable possibility that the above mentioned events were related to PREVNAR 13. Follow-up (12-JUN-2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This is an initial spontaneous report by a contactable Physician. This Pfizer Sales Representative reported on behalf of a physician for an adult patient who began on PREVNAR 13 unknown dose intramuscular injection unknown frequency on upper arm for immunization for the prevention of pneumonia in Apr2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines taken on the same day were unknown. Vaccines taken within the last four weeks were unknown. In Apr2013 while on PREVNAR 13 unknown dose unknown frequency patient experienced moderate redness, pain and rash at site the of injection. Therapeutic intervention taken in response to above mentioned events included TYLENOL. Relevant lab data was unknown. At the time of the report it was unknown if patient was still administering PREVNAR 13. At the time of the report patient had recovered from above mentioned events in Apr2013. The physician considered there was a reasonable possibility that the above mentioned events were related to PREVNAR 13. Follow-up (12-JUN-2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This is an initial spontaneous report by a contactable Physician. This Pfizer Sales Representative reported on behalf of a physician for an adult patient who began on PREVNAR 13 unknown dose intramuscular injection unknown frequency on upper arm. Vaccines taken on the same day were unknown. Vaccines taken within the last four weeks were unknown. In Apr2013 while on PREVNAR 13 unknown dose unknown frequency patient experienced moderate redness, pain and rash at the site of injection. Therapeutic intervention taken in response to above mentioned events included TYLENOL. Relevant sibling information was unknown. Relevant lab data was unknown. At the time of the report it was unknown if patient was still administering PREVNAR 13. At the time of the report patient had recovered from above mentioned events in Apr2013. The physician considered there was a reasonable possibility that the above mentioned events were related to PREVNAR 13. Follow-up (12-JUN_2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Feeling cold, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This is an initial spontaneous report by a contractible Physician. This Pfizer Sales Representative reported on behalf of a physician for an adult patient who began on PREVNAR 13 unknown dose intramuscular injection unknown frequency on upper arm for immunization  in APR 2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines taken on the same day or taken within the last four weeks were unknown. In APR 2013 while on PREVNAR 13 unknown dose unknown frequency patient experienced moderate redness, pain and swelling at the sit of injection, systemic reactions which she explained as vomiting, chills and fever. Therapeutic intervention taken in response to above mentioned events included TYLENOL. Relevant lab data was unknown. At the time of the report it was unknown if patient was still administering PREVNAR 13. At the time of the report patient had recovered from above mentioned events in APR 2013. The physician considered there was. a reasonable possibility that the above mentioned events were related to PREVNAR 13.  Follow-up (12-JUN-2013). Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: This is an initial spontaneous report by a contractible Physician. This Pfizer Sales Representative reported on behalf of a physician for an adult patient who began on PREVNAR 13 unknown dose intramuscular injection unknown frequency on upper arm for immunization  in APR 2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines taken on the same day or taken within the last four weeks were unknown. In APR 2013 while on PREVNAR 13 unknown dose unknown frequency patient experienced moderate redness, pain and swelling at the sit of injection, systemic reactions which she explained as vomiting, chills and fever. Therapeutic intervention taken in response to above mentioned events included TYLENOL. Relevant lab data was unknown. At the time of the report it was unknown if patient was still administering PREVNAR 13. At the time of the report patient had recovered from above mentioned events in APR 2013. The physician considered there was. a reasonable possibility that the above mentioned events were related to PREVNAR 13.  Follow-up (12-JUN-2013). Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Administration site induration, Administration site swelling, Ejection fraction decreased, Glycosylated haemoglobin increased, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A 53-year-old female patient received PREVNAR 13 (lot# F45137; expiration date 01Mar2014) at 0.5 ml single dose intramuscularly in left deltoid on 04Mar2013 at 9:31 for the prevention of pneumonia. The patient had received the following previous vaccinations: FLUZONE (on 02Oct2012 and 11Oct2011), influenza vaccine (in Oct 2012), and PNEUMOVAX (on Mar2013). Relevant medical history included diabetes, hypertension, hypothyroidism, leg swelling, GERD, hyperlipidemia and neck pain. In the past the patient showed allergy to TYLENOL with Codeine, and Minoxidil. She also had edema in her legs after treatment with Synthroid. Relevant concomitant medications included: PLAVIX, Alprazolam, Aspirin; TEGRETOL), Neurontin, KEPPRA, ALLEGRA, MICARDIS, Bd Insulin, Atorvastatin, LASIX; KLOR-CON, Nifedipine, NITROSTAT, NOVOLOG Flexpen, Levothyroxine, Folic Acid, and, Glucagon. After administration of PREVNAR 13, she experienced redness, swelling and hardness at the site of administration. Relevant therapeutic interventions included antibiotics in response to above mentioned events. The patient recovered from mentioned events in Apr2013. Follow-up (13Jun2013): Follow-up attempts completed. No further information expected. Follow-up (03Jul2013): New information received from the contactable nurse includes: patient's details, patient's medical history, vaccination details, previous vaccines administration, and concomitant medications.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Mammogram, Oedema peripheral, Ultrasound Doppler abnormal, Ultrasound thyroid abnormal
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A 53-year-old female patient received PREVNAR 13 (lot# F45137; expiration date 01Mar2014) at 0.5 ml single dose intramuscularly in left deltoid on 04Mar2013 at 9:31 for the prevention of pneumonia. The patient had received the following previous vaccinations: FLUZONE (on 02Oct2012 and 11Oct2011), influenza vaccine (in Oct 2012), and PNEUMOVAX (on Mar2013). Relevant medical history included diabetes, hypertension, hypothyroidism, leg swelling, GERD, hyperlipidemia and neck pain. In the past the patient showed allergy to TYLENOL with Codeine, and Minoxidil. She also had edema in her legs after treatment with Synthroid. Relevant concomitant medications included: PLAVIX, Alprazolam, Aspirin; TEGRETOL), Neurontin, KEPPRA, ALLEGRA, MICARDIS, Bd Insulin, Atorvastatin, LASIX; KLOR-CON, Nifedipine, NITROSTAT, NOVOLOG Flexpen, Levothyroxine, Folic Acid, and, Glucagon. After administration of PREVNAR 13, she experienced redness, swelling and hardness at the site of administration. Relevant therapeutic interventions included antibiotics in response to above mentioned events. The patient recovered from mentioned events in Apr2013. Follow-up (13Jun2013): Follow-up attempts completed. No further information expected. Follow-up (03Jul2013): New information received from the contactable nurse includes: patient's details, patient's medical history, vaccination details, previous vaccines administration, and concomitant medications.
Sex: U
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This consumer responded to a post on one of the parenting listserve. This consumer (age and gender unknown), with a medical history of sickle cell disease reported that he had had pneumonia about 4 times due to sickle cell disease. Due to recurrent pneumonia the patient was immunized with TRADE NAME UNKNOWN). After immunization, the patient had pain in the injected arm and could not even lift it. At the time of reporting, the outcome of the events was unknown. No follow-up attempts possible. No further information expected. Pfizer is the Marketing Authorization Holder for PREVNAR 13 has submitted the same report to the regulatory authorities.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer Sales Representative. An over 65-years-old female patient of unknown race received PREVNAR 13 on an unknown date in May2013 (elaborated as 4 days ago) at single dose once as pneumonia vaccine. Relevant medical history and concomitant medications were unknown. It was reported that on an unknown date in May2013 (4 days ago) patient experienced red sore which were swollen in touch, spot size of an orange at the site of injection and on 17May2013 patient experienced red sore which was swollen in touch spot 2-3 inches lower than the initial spot size of a lemon. Relevant lab details were unknown. Therapeutic measures taken in response to the reported events were unknown. The consumer had not recovered from the reported events at the time report. Follow-up (22-JUN-2013): Follow-up attempts completed. No further information expected.