chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported he/she received my PREVNAR13 adult vaccine the day before this report at the Health Center. On the day of this report he/she had pain in t he arm that was injected. The site of injection was the upper left arm. He/she received the injection at 1PM on 29JAN2013. He/she had not other symptoms at this time.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swollen tongue, Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse. This  nurse reported that a 79-years-old, female patient received PREVNAR13, lot number G15075; expiration date MAY2014) on 14JAN2013 at 0.5 ml single dose due to Chronic Obstructive Pulmonary Disease (COPD). Relevant medical history included blood pressure problem and cholesterol problem since an unknown duration. Relevant concomitant medication included amlodipine at 10mg daily, nitroglycerine at 0.5 mg as needed, metoprolol at 50 mg two times a day, furosemide at 20 mg two times a day, aspirin at 81 mg daily, quinaprila t 50 mg two times a day, all since an unknown duration for blood pressure problem, simvastatin at 40 mg daily since an unknown duration for cholesterol problem and SPIRIVA at an unknown dose daily, VYTORIN at an unknown dose as needed, ADVAIR DISKUS at 500/50 mg four times a day, DUONEB at unknown dose (strength 0.5/2.5 mg/3 ml) four times a day, all since an unknown duration for Chronic Obstructive Pulmonary Disease (COPD). On 15JAN2013, when the patient woke up, her tongue was swollen, she had red hives and itching. Relevant laboratory data was unknown. Therapeutic measures taken in response to the events included visit to the emergency room on 21JAN2013 where she was administered VISTARIL at an unknown dose and frequency. She was also prescribed BENADRYL at 24 mg at an unknown frequency both on 15JAN2013 and prednisone at 20 mg for seven days followed by 10 mg for seven days on 21JAN2013, she was applying betamethasone cream at 0.05% two times a day since an unknown date. Clinical outcome of all the reported events was recovering as the nurse mentioned that she has improved a lot from the events but right now still had some red hive. It was also reported that the patient also visited a infectious disease specialist on 22JAN2013.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse through a sales representative. This nurse reported about a female patient of unknown age that received PREVNAR13, 0.5 ml single dose on an unknown date and experienced pain at the injection site. Follow-up (13-FEB-2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report based on information received by Pfizer from Merck (manufacturer report number 1-5810379005). A contactable physician reported that a patient (age, gender, and ethnicity unknown) received PREVNAR13, 0.5 ml, single dose, on an unspecified date. Relevant history and concomitant medications were unknown. The patient developed swelling in the arm at the injection site. At time of this report, clinical outcome of the event was unknown. Follow-up (25JAN2013): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a sales representative. A 72 year old female patient received PREVNAR13, single dose, on her arm in DEC2012. Relevant medical history included multiple sclerosis (ongoing at the time of event onset). It was unknown if she had any siblings. Concomitant medications were unknown. Vaccines given on the same day and taken within the last four weeks were unknown. In DEC2012, she developed redness and swelling at the site of injection. At the time of the report the clinical outcome of the events was unknown. Follow-up (22FEB2013) Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report by a contactable physician through a sales representative. A male patient (age unknown) received PREVNAR13 on an unknown date. Relevant medical history and concomitant medications were unknown. On unknown date, the patient experienced vomiting and the physician suspected that he might be having flu. The outcome of the event was unknown. Follow-up (14FEB2013): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Burns second degree, Scab
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner via a sales representative. A female patient of unspecified age and ethnicity received PREVNAR13 on unknown date in OCT2013, two weeks before reporting, at single dose. Medical history and concomitant medication were not reported. On unknown date the patient had 3 inch second degree burn with half inch thickness and was covering the scab. The nurse practitioner believed that the adverse event was due to PREVNAR13.
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting on  behalf of her mother. A 72-year-old female patient received PREVNAR13, intramuscular in the arm, on 31OCT2014, at 0.5 ml single. Relevant medical history included allergies to a lot of stuff for which the patient took something and acid reflux for which the patient took something. The reporter said that her mother was on other medications but she did not know the names of them. On 31OCT2013, the patient experienced extreme itching for 48 hours after receiving PREVNAR13. The patient completely recovered from the event on 02NOV2014.  Follow-up (26DEC2014): Follow-up attempts completed. No further information expected.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a pharmacist via a non-clinical-study program. An approximately 92 years old female patient received first dose of PREVNAR13; NDC number 000051974 05) on 22OCT2014, in her deltoid, at 0.5 ml single. No other medication was given on that day. Medical history was not reported. Concomitant medication included atenolol at 50 mg twice daily. The reporter stated that soreness of the arm is a possible side effect but the patient's arm had been swollen for about six days and she said it was getting worse. The patient was advised to see her physician, but the reporter was not aware if she followed through. Events were not resolved at the time of the report. Follow-up (19DEC2014): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Blood thyroid stimulating hormone decreased, Erythema, Hypersensitivity, Injection site pain, Muscle swelling
Clinical narrative: This is a spontaneous report from two contactable consumers (patient and patient's child) and from a contactable physician. A 72 years old female patient of an unspecified age and ethnicity received PREVNAR13, lot J50612) via intramuscular route of administration, in left deltoid muscle, on 21NOV2014 at 17:00, at 0.5 ml single. Medical history include  arterial hypertension since 28FEB2003, latent hypothyreose since 23NOV2007, chronic venous insufficiency. TSH in AUG2014 was 0.00765 IU/ml. Concomitant medication included METOHEXAL 95) at 1 DF daily, for arterial hypertension. The patient had local pain while injection since 21NOV2014 at 17:00 for  2 weeks. On 22NOV2014 at 06:00 the patient experienced painful to pressure, immediate  and visible swelling of the muscle for 2 weeks, with subsequent redness. The involved area was 15 cm in diameter oval. Redness lasted until 03DEC2014. There were nor hematoma discoloration, nether fever. After the pain subsided, a two weeks persistent itching developed, which stretched itself to the elbow and responded well to FENISTIL cream. The patient had itching  from 25NOV2014 (approximately at 06:00) to 06DEC2014. The immediate pain upon injection was only very short and was not documented as anything special by the physician. The adjective "painful upon palpation" referred to the redness and swelling which set in 12 hours after the injection". Since unknown date the patient had a hot hand-size area. The patient was treated with dimentidene cream for redness, itching, hot hand-size area. The patient also experienced an allergic reaction (substantial reatogenicity around the injection site) for 2 weeks. The patient was not hospitalized. At the time of report the patient was completely free of symptoms. Follow-up (15DEC2014): New information reported from the patient includes: updated patient date of birth, patient age, events details, events outcome, information that patient was not hospitalized. Follow-up (09JAN2015): New information from the contactable physician includes: vaccination details, medical history, concomitant medication, lab data, events clinical course, details and outcome. Follow-up (06MAR2015): Follow-up attempts completed. No further information expected. Follow-up (12MAR2015): New information from the contactable physician includes confirmation of events description and clinical course. Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus, Skin warm, Tenderness
Clinical narrative: This is a spontaneous report from two contactable consumers (patient and patient's child) and from a contactable physician. A 72 years old female patient of an unspecified age and ethnicity received PREVNAR13, lot J50612) via intramuscular route of administration, in left deltoid muscle, on 21NOV2014 at 17:00, at 0.5 ml single. Medical history include  arterial hypertension since 28FEB2003, latent hypothyreose since 23NOV2007, chronic venous insufficiency. TSH in AUG2014 was 0.00765 IU/ml. Concomitant medication included METOHEXAL 95) at 1 DF daily, for arterial hypertension. The patient had local pain while injection since 21NOV2014 at 17:00 for  2 weeks. On 22NOV2014 at 06:00 the patient experienced painful to pressure, immediate  and visible swelling of the muscle for 2 weeks, with subsequent redness. The involved area was 15 cm in diameter oval. Redness lasted until 03DEC2014. There were nor hematoma discoloration, nether fever. After the pain subsided, a two weeks persistent itching developed, which stretched itself to the elbow and responded well to FENISTIL cream. The patient had itching  from 25NOV2014 (approximately at 06:00) to 06DEC2014. The immediate pain upon injection was only very short and was not documented as anything special by the physician. The adjective "painful upon palpation" referred to the redness and swelling which set in 12 hours after the injection". Since unknown date the patient had a hot hand-size area. The patient was treated with dimentidene cream for redness, itching, hot hand-size area. The patient also experienced an allergic reaction (substantial reatogenicity around the injection site) for 2 weeks. The patient was not hospitalized. At the time of report the patient was completely free of symptoms. Follow-up (15DEC2014): New information reported from the patient includes: updated patient date of birth, patient age, events details, events outcome, information that patient was not hospitalized. Follow-up (09JAN2015): New information from the contactable physician includes: vaccination details, medical history, concomitant medication, lab data, events clinical course, details and outcome. Follow-up (06MAR2015): Follow-up attempts completed. No further information expected. Follow-up (12MAR2015): New information from the contactable physician includes confirmation of events description and clinical course. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Tinnitus, Vaccination complication
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for herself. This 64-year-old consumer got pneumonia before and was hospitalized and received PVD23 afterwards which brought her back to normal. She reported that after five years she got pneumonia again and now she went up to the pharmacy and the guy didn't look up and gave her PREVNAR13 and she had bad side effects as it included bacterial stuff. The consumer also mentioned that she could not have that stuff as she had horrible reaction after seven nights she got the shot and got sick after the very bad reaction. The consumer mentioned that PREVNAR13 was bacterial toxin stuff and she had ringing in her ears. The consumer mentioned the name of the product as PVC13 from PREVNAR. No follow-up attempts possible. No further information expected.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative and then from a contactable consumer (medical assistant). An 81-year-old female patient received on 18NOV2014 a single dose of PREVNAR13 in the arm. Relevant medical history included dementia, gerd, osteoporosis, high cholesterol, diabetes, all these conditions were ongoing. Concomitant medications included ARICEPT, BABY ASPIRIN, NAMENDA, lovastatin, escitalopram, multivitamins, metformin, JANUVIA, fluticasone, losartan. On unspecified date in NOV2014, after having received the vaccine, the patient arms were swollen and red (lots of swelling and redness in the entire injection area). The events were persisting at the time of the report. The physician considered there was a reasonable possibility that these events were related to PREVNAR13. Follow-up (25NOV2014): New information reported from a contactable consumer (medical assistant) includes: patient details (age and ethnicity) relevant medical history and concomitant medications, suspect product details (vaccination date, anatomical location of vaccination), reaction data (events verbatim was updated to arms swollen and red, updated onset date and outcome). Follow-up (18MAR2015): Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Flushing, Food allergy, Rash, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable consumer. A 79-year-old other ethnic group female patient started to receive PREVNAR13: Lot NumberJ49846, Expiration Date FEB2016, NDC 0005197102) single dose via an unspecified route of administration into the right deltoid on 19NOV2014 at 15:00 hours. Relevant medical history and concomitant medications were not reported. Past event included red cheeks after eating an olive in olive oil. The patient experienced cheeks were red on 19NOV2014 at 17:00 hours and hot, itchy rash to her chest on 19NOV2014 at 22:00 hours. Clinical course was a follows: At 17:00 hours on 19NOV 2014, patient's cheeks were red, but reporter noted that the patient had also eaten an olive in olive oil at this time and the patient had told the reporter that she'd had a similar reaction, red cheeks, after eating an olive in the past. On 19NOV2014 at 22:00 hours, the patient had a hot itchy rash on her chest. On 20NOV2014, patient took BENADRYL 25 mg at 09:00 hours and was seen by the reporter and was found to have flushed, red cheeks, but no rash to her chest. On 18NOV2014, patient got a steroid injection in her left hip at 10:00 hours. Name of steroid was not known by reporter. The reported stated that as of 20NOV2014, the patient was noted to have deep flush on her check bones, the rash was gone, but cheek bones were red. Outcome of the event hot itchy rash to her chest was resolved on an unspecified date and outcome of the event cheeks were red was unknown. Follow-up (14JAN2015): Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer. A 79-year-old other ethnic group female patient started to receive PREVNAR13: Lot NumberJ49846, Expiration Date FEB2016, NDC 0005197102) single dose via an unspecified route of administration into the right deltoid on 19NOV2014 at 15:00 hours. Relevant medical history and concomitant medications were not reported. Past event included red cheeks after eating an olive in olive oil. The patient experienced cheeks were red on 19NOV2014 at 17:00 hours and hot, itchy rash to her chest on 19NOV2014 at 22:00 hours. Clinical course was a follows: At 17:00 hours on 19NOV 2014, patient's cheeks were red, but reporter noted that the patient had also eaten an olive in olive oil at this time and the patient had told the reporter that she'd had a similar reaction, red cheeks, after eating an olive in the past. On 19NOV2014 at 22:00 hours, the patient had a hot itchy rash on her chest. On 20NOV2014, patient took BENADRYL 25 mg at 09:00 hours and was seen by the reporter and was found to have flushed, red cheeks, but no rash to her chest. On 18NOV2014, patient got a steroid injection in her left hip at 10:00 hours. Name of steroid was not known by reporter. The reported stated that as of 20NOV2014, the patient was noted to have deep flush on her check bones, the rash was gone, but cheek bones were red. Outcome of the event hot itchy rash to her chest was resolved on an unspecified date and outcome of the event cheeks were red was unknown. Follow-up (14JAN2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test abnormal, Respiratory symptom
Clinical narrative: This is a spontaneous report from a contactable nurse through a company representative. This nurse reported similar events for two patients. This is the second of two reports. A patient of unspecified age, gender and ethnicity received PREVNAR 13 on unknown date at single dose. Exact dates of vaccination are not known, but the reporter states it was over a three year period. Patient medical history and concomitant medication were not reported. On unknown date the patient had chronic respiratory symptoms. The patient was referred to an allergist and immunologist, who told that pneumococcal protection was low and required follow up with PNEUMOVAX 23. After that this pneumococcal vaccine was given the patient had less chronic respiratory symptoms. Outcome of events was reported as unknown. Follow-up (16Mar2015): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Local reaction, Streptococcal infection
Clinical narrative: This is a spontaneous report from a contactable medical assistant (Other HCP). A 64-year-old female patient received on 24Mar2014 at around 14:30 PREVNAR 13 (Lot Number: H79005, Expiration Date Sep2014, NDC number0005197102) at 0.5ml single dose intramuscular in right arm. Relevant medical history was none. Relevant concomitant medications included multivitamins that she was taking them during the onset of the events. Vaccines given on the same day and within the last four weeks were none. In the last week of Mar2014, after vaccination, she had a large local reaction on the site of injection which she mentioned as redness and swelling in her right arm due to which she was sent to emergency room in Mar2014 and they thought she had strep infection. Therapeutic measure in response to thought she had strep infection included unspecified antibiotic. Relevant lab data was none. At the time of report clinical outcome of "thought she had strep infection" was unknown. At the time of the report she had not recovered from other events. Follow-up (30MAY2014): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Nasopharyngitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (reporting for her mother) and a contactable physician. A 68-year-old female patient of unspecified ethnicity, received PREVNAR 13 (previously reported as PREVNAR 7)), via an unspecified route of administration on 03Apr2014. Medical history and concomitant medications were not reported. The patient received the vaccine on 03Apr2014, and experienced high fever for three days, cough and cold symptoms; onset date in Apr2014. The outcome of high fever for three days, cough and cold symptoms was unknown. Follow-up (22May2014): New information reported from a contactable consumer includes: suspect product data (suspect product was updated to PREVNAR 13). Follow-up (26Jun2014): New information received from the contactable physician includes: This physician confirmed the occurrence of the events. Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Local reaction, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. A 79-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on unknown date. Medical history included chemotherapy. The patient's concomitant medications were not reported. The patient experienced localized reaction on left arm and swelling on left arm on an unspecified date with outcome of unknown. Follow-up (19Dec2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Upper extremity mass
Clinical narrative: This is a spontaneous report from Non Clinical Study Program for a contactable consumer. This female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at a single dose on an unspecified date. The patient history and concomitant medications were not reported. The patient experienced huge lump in the back of her arm and her arm hurts on an unspecified date with outcome of unknown. The consumer mentioned that she had seen her dermatologist for skin cancer check up and she mentioned that her dermatologist told her that it was not a reaction as it was not red. She also mentioned that her dermatologist think that the injection might have been injected into the fatty tumor of the muscle. Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician who was also the prescribing physician. A 48-year-old female patient received PREVNAR 13 (lot. H86680; expiration date Oct2015; NDC# 0005197102), on 03Oct2014 at 0.5 ml, single as Preventive for Pneumonia. Medical history included ongoing diabetes from 2014 (since maybe six months) and ongoing high cholesterol since over a year. The patient had no other illness at the time of vaccination. Concomitant medication included losartan 25mg daily for preventive renal protection for diabetes, metformin 500mg (two tablets) twice a day for diabetes and pravastatin 10mg (one tablet) every evening for high cholesterol. On 08Oct2014 the patient had inflammation at the site of injection, fever and malaise. The events were non-serious with outcome was recovered. The physician mentioned that the adverse events did not require any kind of emergency visit. The physician believed that the inflammation at the site of injection and fever were caused by PREVNAR 13 vaccine. Follow-up (04DEC2014): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Full blood count normal, Headache, Injection site bruising, Injection site erythema, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable medical assistant. A 74-year-old female patient received on 08Aug2014 at 09:30 PREVNAR 13 (lot. G63300, expiration date 14Sep2014) in left arm, at 0.5 ml single to prevent pneumonia. Medical history included diabetes from 2007 due to which she was taking unspecified medication and hypothyroidism from 2008. Concomitant medication included SYNTHROID and metformin hydrochloride, JANUMET. On 09Aug2014 the patient experienced headache and on 10Aug2014 she experienced fever and rashes in left arm was red, warm, kind of bruise and little swollen and was all around and on top of the site were injection was given. The patient visited doctor's office on 13Aug2014 for the adverse events. She started taking unspecified antibiotics since 13Aug2014 for headache. The patient underwent lab tests which showed full blood count normal on 13Aug2014. The outcome of all the event was unknown. The medical assistance believed that the events were due to vaccine as the patient experienced the events after PREVNAR 13 vaccine administration and as she had rashes in left arm which was red, warm, kind of bruise and little swollen and was all around and on top of the site where injection was given. Follow-up (22Sep2014): New information from a contactable consumer included confirmation of lot Number and Expiration date. Follow-up (14Nov2014): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable medical assistant. A 74-year-old female patient received on 08Aug2014 at 09:30 PREVNAR 13 (lot. G63300, expiration date 14Sep2014) in left arm, at 0.5 ml single to prevent pneumonia. Medical history included diabetes from 2007 due to which she was taking unspecified medication and hypothyroidism from 2008. Concomitant medication included SYNTHROID and metformin hydrochloride, JANUMET. On 09Aug2014 the patient experienced headache and on 10Aug2014 she experienced fever and rashes in left arm was red, warm, kind of bruise and little swollen and was all around and on top of the site were injection was given. The patient visited doctor's office on 13Aug2014 for the adverse events. She started taking unspecified antibiotics since 13Aug2014 for headache. The patient underwent lab tests which showed full blood count normal on 13Aug2014. The outcome of all the event was unknown. The medical assistance believed that the events were due to vaccine as the patient experienced the events after PREVNAR 13 vaccine administration and as she had rashes in left arm which was red, warm, kind of bruise and little swollen and was all around and on top of the site where injection was given. Follow-up (22Sep2014): New information from a contactable consumer included confirmation of lot Number and Expiration date. Follow-up (14Nov2014): Follow-up attempts completed. No further information expected.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Condition aggravated, Irritability, Milk soy protein intolerance
Clinical narrative: This is a spontaneous report from a non-clinical-study program Pfizer.com Contact US Clinical Research from a contactable consumer, a contactable nurse and a contactable physician. A male patient (birth weight: 7 lbs 2 ounces) of an unspecified ethnicity, received a single dose of PREVNAR 13 IM, lot H47688, expiration date 31May2015 on 02Aug2014 at 2-month-old of age, and lot H866652, expiration date 31Dec2015 on 08Oct2014 at 2-month-old, but for immunization. The patient also received PEDIARIX (Batch/Lot # 54GM4, Expiration Date 30Aug2016) intramuscular in the right thigh, HIB vaccine (HIB, Batch/Lot # U7153AA, Expiration Date 20Mar2015) intramuscular in the left thigh, ROTARTIX (Batch/Lot # A41FB429A, Expiration Date 10Sep2015) oral, all on 02Aug2014 10:39 at 2 months of age for immunization. Medical history included ongoing severe milk soy protein intolerance (MSPI) since an unspecified date. Concomitant medications included PREVACID 2.5ml BID on 03Aug2014 and ongoing for reflux. Vaccination history included Hepatitis B at birth for immunization, purchased with private funds and administered by a nurse at the private doctor's office/hospital. Serotype not provided. On an unspecified date, the patient experienced severe MSPI. The clinical outcome of MSPI was not reported. Per the reporter, the patient was doing well until after his two month shots and believes that the soy from the PREVNAR 13 played a part. The patient experienced severe fussiness on 03Aug2014 recovered on 08Aug2014 and fussiness occurred on re-administration at 4 month vaccines on 08Oct2014. The patient recovered on 09Oct2014, without requiring treatment. The event fussiness did not resulted in an emergency room or doctor visit. The reported considered there was not a reasonable possibility that the event fussiness was related to the suspect product. The patient provided information to the reporter regarding the reported adverse event with the use of the product. The reporter could confirm the occurrence of the events reported by the patient. The reporter was willing to be contacted again by Pfizer for follow-up information on the reported adverse event. Follow-up (09Sep2014): New information reported from a contactable consumer includes: suspect product data (PREVNAR 7 vaccine); lot H47688 and expiration date 31 May2015). Follow-up (21Oct2014): New information reported from a contactable nurse includes on behalf of a physician in response to HCP letter: patient age and birth weight: suspect was PREVNAR 13 (not PREVNAR 7, data provided); suspects added; events added (fussiness); concomitant medications; vaccination history; reporter informed by patient about the event; reporter confirmed the events reported by the patient; reporter confirmed further contactability. Follow-up (10Nov2014): New information obtained from a contactable physician includes: confirmation of the reported events, details of vaccines. Follow-up attempts completed. No further information expected.
Age: 0.36
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is spontaneous report from a contactable reporter. The reporter reported about her 4 month old, daughter, who received second dose of PREVNAR 13 (lot number H13995) vaccine on 16Apr2014 at 0.5 ml single for immunization in the right thigh through intramuscular route at around 9:30 am. The consumer did not have any relevant medical history. Relevant drug history or allergies: No. Illness at time of vaccination: No. Adverse event following prior vaccinations: No. Birth weight: 7lbs 8ozs. Past drug history included first dose of PREVNAR 13 vaccine on 10Feb2014, first dose of HIB vaccine on 10Feb201a4 (in left thigh) and one dose of DTAP vaccine on 06Mar2014 (dose 1) and on 14May2014 for immunization. Relevant concomitant medications included one dose of HIB (lot number UH831AA) in left thigh, on 07Apr2014, for immunization. The reporter mentioned that her daughter developed high fever for 48 hours on 16Apr2014 few hours after taking the second dose of PREVNAR 13 vaccine. The patient did not have any other illness at the time of administration and was not hospitalized. The events resulted in an office visit. Relevant laboratory data were unknown. Therapeutic measures taken in response to the event included administration of TYLENOL. The consumer recovered from the events on 18Apr2014. The reporter stated that there was a reasonable possibility that the events are related to suspect product. Hib vaccine was received also on 13Jun2014. Next dose of PREVNAR 13 vaccine was scheduled for 22Sep2014. Follow-up (31Jul2014): New information from a contactable physician includes: suspect vaccine dose, lot number, updated administration date and anatomical location, vaccine history, concomitant vaccine lot number, events updated start and stop dates, treatment received, following vaccination scheduling and reporter causality assessment. Follow-up (25Sep2014): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site pruritus, Pyrexia, Vaccination site erythema, Vaccination site oedema
Clinical narrative: 9/7/15 Evening-itching at vaccine site. 9/8/15 Rash at vaccine site-office visit. Palm size 6-7 cm area of erythema with edema. 9/8/15 PM-after visit to office, temp 103 degrees F. 9/9/15 Severe, diffuse arthralgias and low grade fever. Erythema increasing ? 15 cm. 9/10/15 Decreasing arthralgias. 9/14/15 Erythema resolving. Skin still pruritic.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site rash
Clinical narrative: 9/7/15 Evening-itching at vaccine site. 9/8/15 Rash at vaccine site-office visit. Palm size 6-7 cm area of erythema with edema. 9/8/15 PM-after visit to office, temp 103 degrees F. 9/9/15 Severe, diffuse arthralgias and low grade fever. Erythema increasing ? 15 cm. 9/10/15 Decreasing arthralgias. 9/14/15 Erythema resolving. Skin still pruritic.
Sex: F
Vaccine: PPV
Symptoms: Cough, Pneumonia, Pyrexia, Wheezing
Clinical narrative: This is a spontaneous report from a contactable consumer. This female adult patient of unknown age and ethnicity received a single dose of PNEUMOVAX via an unspecified route of administration on an unspecified date 10 years ago and a "booster vaccine" of pneumococcal 13-valent conjugate vaccine (diphtheria crm 197 protein) (unknown manufacturer) single dose via an unspecified route of administration on an unspecified date 2 years ago. Relevant medical history and concomitant medications were not reported. On an unspecified date in Mar2014 (last week), the patient experienced cough, fever, and wheezing and was diagnosed with pneumonia. The reporting consumer (patient) inquired "Why would I get pneumonia when I received the pneumonia vaccine?" No other information was reported. No follow-up attempts needed. No further information expected. Follow-up (09May2014): Follow-up attempts completed. No further information expected.
Age: 0.51
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is an initial spontaneous report from a contactable nurse who reported for a patient. This 6 month old male patient received PREVNAR13 (lot # H41948, exp date: JUN2015) on 05MAR2014 then on 05MAY2014 thereafter on 09JUL2014. Relevant medical history included acid reflux since an unknown date. Relevant concomitant medication included omeprazole since an unknown date at 4.75 ml daily for acid reflux. It was reported that on 10JUL2014 after the patient was injected  PREVNAR13, the patient had a reaction site on his right lateral thigh which was 26x28 mm in size, red, warm and swollen. Relevant laboratory data was unknown. Therapeutic measures taken in response to the reported events were not provided. The clinical outcome of the reported events was unknown at the time of report. The causality of the events was unknown. Follow-up (21AUG2014): Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Headache
Clinical narrative: Case number PHHY2014US159773, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544320) website on 28 Nov 2014, with a follow up report received on 10 Aug 2015. This report refers to a 34-year-old female pregnant patient. Historical conditions, current illness and concomitant medication were none. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 17 Sep 2014. On the same day after vaccination, she experienced headache. The patient was a 6 months pregnant. The final outcome of the events was unknown. The events were reported as non-serious; Causality was not reported. No additional follow up received. This case was considered lost to follow up. Follow up report received on 10 Aug 2015: updated lost to follow up information.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Carpal tunnel syndrome, Condition aggravated, Exposure during pregnancy, Hypoaesthesia, Muscular weakness
Clinical narrative: Case number PHHY2014US163887 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 547610) website on 28 Nov 2014, with a follow up report on 10 Aug 2015. This report refers to a 36 year old pregnant female patient. Her estimated due date for delivery was in Mar 2015. Her current conditions included asthma, environmental allergies to dust, grass, trees, weed, mold, allergy to ciprofloxacin and meperidine and carpal tunnel syndrome. Her past medical history included fungal toe nail infection, oral allergy syndrome. Her concomitant medications included PROVENTIL HFA and Ventolin HFA (90 mcg/actuation inhaler) at a dose of 2 puffs as necessary, SINGULAIR at a dose of 10 mg tablet once daily as necessary, vitamin C at a dose of 250 mg and vitamin D3 with calcium orally. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 25 Aug 2014 and a seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscular into her upper left arm on 29 Sep 2014. On 29 Sep 2014, after the vaccination, she developed numbness, pain and weakness in her left arm decreasing over the next 3.5 days. Her carpal tunnel syndrome was worsened in her left arm. The outcome of the events was complete recovery. The events were reported as non serious and causality of the events was not reported. No adverse event was reported. No additional follow up received. This case was considered lost to follow up. Follow up report received on 10 Aug 2015: updated lost to follow up information.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US163887 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 547610) website on 28 Nov 2014, with a follow up report on 10 Aug 2015. This report refers to a 36 year old pregnant female patient. Her estimated due date for delivery was in Mar 2015. Her current conditions included asthma, environmental allergies to dust, grass, trees, weed, mold, allergy to ciprofloxacin and meperidine and carpal tunnel syndrome. Her past medical history included fungal toe nail infection, oral allergy syndrome. Her concomitant medications included PROVENTIL HFA and Ventolin HFA (90 mcg/actuation inhaler) at a dose of 2 puffs as necessary, SINGULAIR at a dose of 10 mg tablet once daily as necessary, vitamin C at a dose of 250 mg and vitamin D3 with calcium orally. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 25 Aug 2014 and a seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscular into her upper left arm on 29 Sep 2014. On 29 Sep 2014, after the vaccination, she developed numbness, pain and weakness in her left arm decreasing over the next 3.5 days. Her carpal tunnel syndrome was worsened in her left arm. The outcome of the events was complete recovery. The events were reported as non serious and causality of the events was not reported. No adverse event was reported. No additional follow up received. This case was considered lost to follow up. Follow up report received on 10 Aug 2015: updated lost to follow up information.
Age: 20.0
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Leukocytosis, Pyrexia
Clinical narrative: Case number PHHY2015US033272, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555414) website on 16 Mar 2015 and with follow up information received from the quality assurance department (QA reference numbers: 361994 and 361501) on 01 Apr 2015, with the follow-up information received from Quality Assurance Department (reference number: 361501) on 10 Apr 2015 with the follow-up information received from Quality Assurance Department (reference number: 361994) on 03 Jun 2015. This report refers to a 20-year-old female patient. Historical conditions included allergy to sulfa (hives) and asthma. Current conditions included post-diphenhydramine overdose. She was vaccinated with FLUCELVAX (batch number: none) intramuscularly into the right arm on 09 Nov 2014. On the same day after vaccination, the patient had experienced low-grade fever, pain, swelling, and redness at injection site. Further, the patient had tachycardia and leukocytosis. The patient was treated with analgesics-acetaminophen and ibuprofen. Patient's tachycardia and leukocytosis were treated with fluids and antibiotics. The events worsened initially, before getting resolved 2-3 days after the initial presentation. The events were reported as non-serious. Outcome of the events was reported as recovered. Causality of the events was not reported. As the batch number for the adverse event was unknown, the scope was narrowed to FLUCELVAX batches 161211 and 162181. Based on the review performed and the sterility assurance assessment detailed in child record 362018, the FLUCELVAX batches were manufactured in accordance with approved internal procedures and are in compliance with the cGMP requirements. No anomalies were noted during this review. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: unknown) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference numbers: 361994 and 361501) on 01 Apr 2015: Updated QA reference numbers. Follow-up information received from the Quality Assurance Department (reference number: 361501) on 10 Apr 2015: Updated FLUCELVAX vaccine batch review report. Follow-up information received from the Quality Assurance Department (reference number: 361994) on 03 Jun 2015: Updated FLUCELVAX batch review report.
Age: 20.0
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Tachycardia
Clinical narrative: Case number PHHY2015US033272, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555414) website on 16 Mar 2015 and with follow up information received from the quality assurance department (QA reference numbers: 361994 and 361501) on 01 Apr 2015, with the follow-up information received from Quality Assurance Department (reference number: 361501) on 10 Apr 2015 with the follow-up information received from Quality Assurance Department (reference number: 361994) on 03 Jun 2015. This report refers to a 20-year-old female patient. Historical conditions included allergy to sulfa (hives) and asthma. Current conditions included post-diphenhydramine overdose. She was vaccinated with FLUCELVAX (batch number: none) intramuscularly into the right arm on 09 Nov 2014. On the same day after vaccination, the patient had experienced low-grade fever, pain, swelling, and redness at injection site. Further, the patient had tachycardia and leukocytosis. The patient was treated with analgesics-acetaminophen and ibuprofen. Patient's tachycardia and leukocytosis were treated with fluids and antibiotics. The events worsened initially, before getting resolved 2-3 days after the initial presentation. The events were reported as non-serious. Outcome of the events was reported as recovered. Causality of the events was not reported. As the batch number for the adverse event was unknown, the scope was narrowed to FLUCELVAX batches 161211 and 162181. Based on the review performed and the sterility assurance assessment detailed in child record 362018, the FLUCELVAX batches were manufactured in accordance with approved internal procedures and are in compliance with the cGMP requirements. No anomalies were noted during this review. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: unknown) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference numbers: 361994 and 361501) on 01 Apr 2015: Updated QA reference numbers. Follow-up information received from the Quality Assurance Department (reference number: 361501) on 10 Apr 2015: Updated FLUCELVAX vaccine batch review report. Follow-up information received from the Quality Assurance Department (reference number: 361994) on 03 Jun 2015: Updated FLUCELVAX batch review report.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician and from a contactable other HCP. A 6-month-old female patient received the second dose of PREVNAR13; lot # H65735; Exp. date 01JULY2015; NDC number: 0005-1971-02), intramuscularly in the right thigh at 0.5 ml single dose on 11NOV2014; PEDIARIX (lot # 7377Y; Exp. date 04-JUL2016), intramuscularly in the left thigh on 11NOV2014; PEDVAXHIB (lot number KOOZ935; exp date 11DEC2016, intramuscularly in the right thigh at 0.6 ml on 11NOV2014; and ROTATEQ (lot number J015063, exp date 24OCT2015) orally at 2 ml on 11NOV2014, all give at 5:38 PM. The reporter mentioned that the patient had no medical history and she was taking no other medications concomitantly. The patient previously received the first dose of PREVNAR13 on an unknown date. On 12NOV2014, the patient experienced fever of 103.7 degree temperature rectally 21 hours after vaccination. Therapeutic measures were taken as a result of the event of fever of 103.7 degree temperature rectally and included treatment with TYLENOL and body temperature improved to 100.7 degrees rectally. The clinical outcome for the e vent of fever of 103.7 degree temperature rectally was recovered in NOV2014. The causality was assessed for the suspect, PREVNAR13, as not sure if related, but suspected as related to the event. Follow-up (07JAN2015): New information received from a contactable other HCP includes: Lot # and Expiration date, daily dose, time and anatomical location for vaccines administered, onset of the event changed to 12NOV2014 from 11NOV2014. Follow-up comments completed. No further information expected.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unknown date at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced bad allergy to PREVNAR 13. The clinical outcome of the event, bad allergy to PREVNAR 13 was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abdominal pain upper, Altered state of consciousness, Back pain, Burning sensation, Dizziness
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unknown date at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced bad allergy to PREVNAR 13. The clinical outcome of the event, bad allergy to PREVNAR 13 was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Insomnia, Loss of consciousness, Malaise, Nasopharyngitis, Pneumonia
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unknown date at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced bad allergy to PREVNAR 13. The clinical outcome of the event, bad allergy to PREVNAR 13 was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Reaction to excipient, Sleep disorder
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unknown date at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced bad allergy to PREVNAR 13. The clinical outcome of the event, bad allergy to PREVNAR 13 was unknown. No follow up attempts possible. No further information expected.