chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Upper left arm started hurting; hurt to move arm; upper arm swollen and felt hard to the touch; used ice on arm first night; morning of the 27th I felt very weak, dizzy, and nauseous, with chills. Morning of the 28th the swelling of the upper arm was now in the tricep and red.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea
Clinical narrative: PT COMPLAINED OF NAUSEA ABOUT 20 MINUTES AFTER ADMINISTRATION OF PNEUMOVAX23 AND FLUZONE HD. SHE SAT DOWN TO EAT LUNCH AND BECAME NAUSEAUS. SHE LAID DOWN AND TOOK A NAP. WOKE UP FEELING BETTER WITH NO NAUSEA.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Muscle spasticity, Pain in extremity, Urticaria
Clinical narrative: Hives appeared above injection site of left thigh, spread up back and abdomen to the face. No tongue or throat swelling noted. Treated with benadryl. The next day pain in left leg and swelling from knee to hip noted twice the size of right leg. So far swelling lasting two days has not gone down yet.
Age: 50.0
Sex: F
Vaccine: FLUX, MMR
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHEH2016US027823, is an initial spontaneous report received from a nurse on 24 Oct 2016. This report refers to a 50 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer unknown, batch number and expiry: not reported) and MMR vaccine on an unknown date. After vaccination, on an unknown date, she experienced cellulitis at injection site. The outcome, seriousness and causality of the events were not reported. The seriousness of the event vaccination site cellulitis was upgraded (medically significant) based on the information available in the source document.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat tightness, Urticaria
Clinical narrative: Hives, itching, tightness in throat.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Product preparation error
Clinical narrative: No reaction but gave a sterile diluent instead of the meningitis diluent with the vaccine.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Screaming
Clinical narrative: HOURS OF SCREAMING FOR 2 DAYS AFTER 4 MONTH VACCINES.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Pharyngeal oedema, Tremor
Clinical narrative: "Swelling in bottom of throat, dizzy, weak, shaky".
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever and redness and swelling around the shot site, red sunburn looking rash warm to the touch, from elbow to shot site armpit area and back of his arm.
Sex: F
Vaccine: HPVX
Symptoms: Nervous system disorder, Seizure, Syncope
Clinical narrative: This spontaneous report as received from a physician, who learned of the events from one of her patients, via a company representative refers to a female high school student patient (the physician patient's family friend) of unknown age. The patient's pertinent medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was administered an unspecified dose of GARDASIL injection or GARDASIL 9 injection by an unspecified health care provider in the same town (dose in series, route of administration, lot # and expiration date were not reported). It could not be confirmed which of these vaccines the patient was administered. Concomitant medications were not reported. On an unknown date over a year ago and an unspecified time after vaccination, the patient was diagnosed with a neurological disorder. It could not be confirmed if the patient was diagnosed with encephalopathy or encephalitis. The patient also experienced symptoms of on-going fainting spells and seizures. The patient was taken to another city for unspecified treatment from an unspecified specialist for her condition. The outcome of the event was not recovered/not resolved at the time of reporting. The relatedness between the event and GARDASIL or GARDASIL 9 was not reported. Upon internal review, the event of encephalopathy or encephalitis was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 28-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10PK-0.5ml SD-PFS LLok w Tip" (lot # M005286, expiration date: 08-OCT-2017, dose and route were unspecified). No adverse effects were reported. This specified lot number was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 304 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHEH2016US027672, is an initial spontaneous report received from a nurse on 24 Oct 2016. This report refers to a female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, batch number: not reported) at an unknown dose on an unknown date. On an unknown date, the patient experienced cellulitis at injection site after injection. The outcome, seriousness and causality of the events were not reported. The seriousness assessment of vaccination site cellulitis was upgraded based on the information provided in the source document.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Case number PHEH2016US027671, is an initial spontaneous report received from a nurse on 24 Oct 2016. This report refers to a 50 years old female patient. Past vaccination history included influenza virus vaccine (manufacturer and batch number: not reported) and MMR vaccine received on an unknown date and she experienced cellulitis (see case: PHEH2016US027823). Concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number 1618701, Expiry: Apr 2017) at a dose of 0.5 ml intramuscularly on 18 Oct 2016. After vaccination, on 19 Oct 2016, she experienced cellulitis at injection site which started 24 hours later. Patient received treatment with KEFLEX and ice because the area was red and hot. It was reported that her mother also experienced the same reaction in the past to influenza vaccine (see case: PHEH2016US027672). The outcome of cellulitis at injection site was reported as condition improving; while it was not reported for other events. The event cellulitis at injection site was assessed as non serious by the nurse; while seriousness for other events was not reported. The seriousness of the events vaccination site cellulitis, vaccination site erythema and vaccination site warmth were upgraded (medically significant) based on the information available in the source document.
Age: 56.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Dizziness, Inflammation, Mobility decreased, Pain, Pyrexia
Clinical narrative: Got fever still do can't move right arm. Pain since got vaccine when I first got it I had dizzy spells. Lady at pharmacy made me wait 30 mins before I left. Doctor said I was inflammation in arm can't use arm arm to hot all the times good.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: The patient states that she has been experiencing constant dull pain in the arm that the FLUZONE HIGH DOSE was admiistered since the date of administration. She states that she is unable to fully rotate her arm. Her range of motion is limited. She states she took ibuprofen and used hot/cold compress but she is still in pain.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site pain
Clinical narrative: Patient called into the clinic 8 days after receiving flu shot stating that she was having soreness in the L deltoid. This nurse informed her to see her PCP for continuing discomfort.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Chills, Influenza, Myalgia, Vomiting
Clinical narrative: Severe flu symptoms.  Vomit, Stomach ache, chills, muscle pain.  Missed  1-1/2 days of work.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Peripheral swelling, Pyrexia
Clinical narrative: Local reaction. Arm feverish and swelling from shoulder to elbow.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Head injury, Loss of consciousness
Clinical narrative: Reported: After receiving HPV #3, patient began to walk toward elevator. Passed out and reportedly hit head on the carpet. Came to. Was put in a chair and given water, felt ok and wanted to leave went down elevator and began to feel dizzy again. Pt. brought to Exam Room 20 to lay down, water, cool compress and a lollipop given to pt. Was requested by mom to examine pt. Per Dr., pulse 70, pt. alert and interactive. Was advised to remain horizontal for 10 minutes, then sit up for 5 mins, then ok to leave if feeling better. Nurses were advised to check on pt. at intervals described.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Neck pain, Pain, Paraesthesia
Clinical narrative: Numbness and tingling in fingers and toes, sore neck, whole body aches. Suspicion for Guillain-Barre Syndrome.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Injection site erythema
Clinical narrative: Large reddened area around vaccine site on right arm radiating down upper arm and around posteriorly.  Patient complained of chills evening of vaccine date.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Rash on B neck; looks like 2 oval red patches, minimal itchiness at base of neck, but not at rash. She feels fine otherwise. Rash has not resolved yet.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Erythema, Infection, Malaise, Pain
Clinical narrative: Malaise, general ill feeling, aching, runny noise, cough, fever around 101, cough, redness and lumpy arm, described as "felt like real pneumonia infection". Took ASA for fever but did nothing so switched to Ibu but still did little. Took Benadryl on 10/27 and it helped with redness on arm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Rhinorrhoea
Clinical narrative: Malaise, general ill feeling, aching, runny noise, cough, fever around 101, cough, redness and lumpy arm, described as "felt like real pneumonia infection". Took ASA for fever but did nothing so switched to Ibu but still did little. Took Benadryl on 10/27 and it helped with redness on arm.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Fatigue, Pyrexia
Clinical narrative: TIGHTNESS IN CHEST, CHILLS, MILD FEVER, REALLY FATIGUED.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: RED (ABOUT 6 INCH DIAMETER), HOT, PAINFUL KNOT.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling cold, Headache, Nausea, Vomiting
Clinical narrative: States she was out to dinner and felt faint, tinnitus and vomited. Went home, felt cold, went to bed with 4 blankets. Next morning had a Headache and some nausea.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache, chills, body aches, fever of 101.2.  Lasted until about 08:00 PM.
Age: 24.0
Sex: F
Vaccine: MMR, TD
Symptoms: Contraindication to vaccination
Clinical narrative: LIVE VACCINE (MMR) GIVEN TO PREGNANT WOMAN.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, redness, swelling, itching for about an 1 1/2 around injection site. This was from the seasonal flu shot.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm red and swollen from shoulder to elbow. Talked with her provider and gave client Tylenol and applied heat for 2 days. School nurse observed on 10/24 and was still sl red and swollen she applied cool packs and stated looked improved by end of day.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: C-reactive protein increased, Cellulitis, Erysipelas, Injection site erythema, Injection site oedema
Clinical narrative: Patient's father noted worsening arm pain followed by fever (101-102.7). Following morning, erythema and edema noted on right arm (vaccine was administered to right deltoid).
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Leukocytosis, Pyrexia, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Patient's father noted worsening arm pain followed by fever (101-102.7). Following morning, erythema and edema noted on right arm (vaccine was administered to right deltoid).
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: X-ray abnormal
Clinical narrative: Patient's father noted worsening arm pain followed by fever (101-102.7). Following morning, erythema and edema noted on right arm (vaccine was administered to right deltoid).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Paresthesia of hands and feet.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Tremor, Vomiting
Clinical narrative: Patient experienced nausea and vomiting that night and next morning. Experienced shaking for 10 minutes around 4:30pm.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Flushing, Headache, Pruritus
Clinical narrative: 1.5 hours after vaccine, staff member became hot/flushed/dizzy. C/o HA, itching, episodes of flushing/dizziness.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dry mouth
Clinical narrative: Patient complaining of dry mouth.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Throat tightness
Clinical narrative: Throat not feeling right / fullness. Denies any other s/s. Reports Hx of anaphylaxis with other vaccines, but never with flu vaccine. Took one tablet of Benadryl 25 mg .
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A 72-year-old female patient of an unspecified race received, on 13Oct2016, PREVNAR 13 single dose and FLUZONE HD, both for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced local events on both arms like local pain, and redness. On the arm which patient received the shot of pneumococcal 13-val conj vac (dipht crm197 protein) hot area was also reported.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dyspnoea, Fatigue, Hypersensitivity, Immunoglobulin therapy
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (manufacturer reference number AR2016US00014709). This currently 61-year-old female patient reported that on an unspecified date in the past was extremely allergic to pneumococcal vaccine adding that she used to always get sick when  would get vaccines and was covered top to bottom in sores. The patient received pneumococcal vaccine for immunization at single dose. Outcome was not reported. No follow up attempts needed. No further information expected. Pfizer is the Marketing Authorization Holder of  pneumococcal 13-val conj vac (dipht crm197 protein) in the country of origin of the reporter. This report could be a duplicate in case another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) submitted the same report to the regulatory authorities. Follow-up (24Oct2016): This is a follow up report from a contactable consumer. A 56-year-old female patient received pneumococcal 13-val conj vaccine in Nov2011 at single dose; she had been hospitalized for rare pneumonia and was on low antibiotics (unspecified) and for these reasons she was vaccinated. Concomitant medication included fentanyl patch from 24Oct2011 (after surgery) until Apr2014. In Dec2011 the patient developed an allergic reaction to the pneumococcal vaccine and starting from May2012 she was treated with subcutaneous IgE. Since Jan2012 she was covered top to bottom in sores, due to which she was hospitalized soon after the first on her finger tips and treated with topical antibiotics and then with Z-PAK oral. On an unknown date she was  sick, and was hospitalized on the same date and treated with subcutaneous IgE, IgG human (HIZENTRA); IgE was helping her. Since an unknown date, she also experienced extreme fatigue and weakness, that were still present. If she was late on IgG, IgE subcutaneous treatments within 3 days she couldn't breathe. She got continual infections in skin with abrasions on back, shoulders, arms, legs, buttocks and sometimes face. The outcome of skin lesion was recovering; sickness, allergic reaction, fatigue and weakness not recovered; the outcome of breathing difficult and skin infection was unknown. Pfizer is the Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of origin of the reporter. This report could be a duplicate in case another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) submitted the same report to the regulatory authorities.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Skin abrasion, Skin infection, Skin ulcer
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (manufacturer reference number AR2016US00014709). This currently 61-year-old female patient reported that on an unspecified date in the past was extremely allergic to pneumococcal vaccine adding that she used to always get sick when  would get vaccines and was covered top to bottom in sores. The patient received pneumococcal vaccine for immunization at single dose. Outcome was not reported. No follow up attempts needed. No further information expected. Pfizer is the Marketing Authorization Holder of  pneumococcal 13-val conj vac (dipht crm197 protein) in the country of origin of the reporter. This report could be a duplicate in case another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) submitted the same report to the regulatory authorities. Follow-up (24Oct2016): This is a follow up report from a contactable consumer. A 56-year-old female patient received pneumococcal 13-val conj vaccine in Nov2011 at single dose; she had been hospitalized for rare pneumonia and was on low antibiotics (unspecified) and for these reasons she was vaccinated. Concomitant medication included fentanyl patch from 24Oct2011 (after surgery) until Apr2014. In Dec2011 the patient developed an allergic reaction to the pneumococcal vaccine and starting from May2012 she was treated with subcutaneous IgE. Since Jan2012 she was covered top to bottom in sores, due to which she was hospitalized soon after the first on her finger tips and treated with topical antibiotics and then with Z-PAK oral. On an unknown date she was  sick, and was hospitalized on the same date and treated with subcutaneous IgE, IgG human (HIZENTRA); IgE was helping her. Since an unknown date, she also experienced extreme fatigue and weakness, that were still present. If she was late on IgG, IgE subcutaneous treatments within 3 days she couldn't breathe. She got continual infections in skin with abrasions on back, shoulders, arms, legs, buttocks and sometimes face. The outcome of skin lesion was recovering; sickness, allergic reaction, fatigue and weakness not recovered; the outcome of breathing difficult and skin infection was unknown. Pfizer is the Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of origin of the reporter. This report could be a duplicate in case another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) submitted the same report to the regulatory authorities.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Rash macular, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter via a Pfizer sales representative. A 22-year-old female patient received the first dose of TRUMENBA, (lot M95612; expiry date Jul2017), via an unspecified route of administration at 0.5 ml, single in the left arm on 13Aug2016 at 11:40 am for immunisation. Medical history included possible allergy to KEFLEX. There were no concomitant medications. The patient experienced red splotchy hives all down both of her arms to about elbow, as well as under her neck and across her chest/hives on 13Aug2016 at 12:40 but the hives went away after an hour without any treatment. On 16Aug2016 in the area where shot was given that was a red bullseye from which she recovered on an unspecified date in 2016 without treatment and on an unspecified day in Aug2016 she had red hot on the neck, chest and arm for which was treated and recovered an unspecified date in 2016. Follow-up (25Oct2016): New information reported from the same contactable consumer includes: suspect vaccine details (lot, expiry date), updated events outcome, details on treatment. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A (over 65-year-old) female patient of an unspecified race received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient experienced diarrhea and red rash on an unspecified date with outcome of unknown for 3 days.
Sex: U
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a non-contactable nurse via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm redness on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Incisional drainage, Infection, Myalgia, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 71 year-old female patient of an unspecified race and ethnicity received PREVNAR 13, (NDC number: 0005197102, UPC number: 300051971022, lot N34936, expiry date Oct 2017) in the arm and FLUZONE QUADRIVALENT, (Sanofi Pasteur, lot UI684AD, expiry date 30Jun2017) in the opposite arm, both intramuscular on 20Oct2016 at 0.5 ml single for immunization.  The patient medical history and concomitant medications were not reported. On 20Oct2016 the patient started having pain in her arm and then the pain started in her body, muscles from her arm all the way up to her neck. She went to the emergency room where they discovered that there was an infection and they drained the infection. The patient was hospitalized due to the infection on 21Oct2016 and she was supposed to have surgery. Outcome was unknown. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events of pain in arm and muscle pain cannot be excluded based on the known adverse event profile and on the temporal relationship. Concerning the event infection, more information on the causative agent and clinical details is needed for a causality assessment. The Company moreover considers the administration of a concomitant vaccine an important confounder in the independent assessment of the causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Incisional drainage, Infection, Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 71 year-old female patient of an unspecified race and ethnicity received PREVNAR 13, (NDC number: 0005197102, UPC number: 300051971022, lot N34936, expiry date Oct 2017) in the arm and FLUZONE QUADRIVALENT, (Sanofi Pasteur, lot UI684AD, expiry date 30Jun2017) in the opposite arm, both intramuscular on 20Oct2016 at 0.5 ml single for immunization.  The patient medical history and concomitant medications were not reported. On 20Oct2016 the patient started having pain in her arm and then the pain started in her body, muscles from her arm all the way up to her neck. She went to the emergency room where they discovered that there was an infection and they drained the infection. The patient was hospitalized due to the infection on 21Oct2016 and she was supposed to have surgery. Outcome was unknown. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events of pain in arm and muscle pain cannot be excluded based on the known adverse event profile and on the temporal relationship. Concerning the event infection, more information on the causative agent and clinical details is needed for a causality assessment. The Company moreover considers the administration of a concomitant vaccine an important confounder in the independent assessment of the causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 72.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 72-year-old female patient received PREVNAR 13 (lot M51194, NDC number 00005197101, UPC number 300051971022, Expiry Date May 2017), on the right arm at 0.5 ml, single for prophylaxis and influenza vaccine FLUZONE, (lot UI63688, manufacturer Sanofi NDC number: 49281039988, UPC number: 34928139965, Expiry Date: 27Mar2017), on the left arm both on 23Sep2016 via intramuscular route for immunization. The patient medical history was not reported. There were no concomitant medications. On 24Sep2016 the patient experienced pain in arm that lasted for 4 weeks with outcome of not recovered and vaccination site pain on an unspecified date with outcome of recovered.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer, who is the patient. A female patient of an unspecified age, race, and ethnicity received the second dose of PREVNAR 13 and FLU vaccine; both via an unspecified routes of administration on 24Oct2016 at single doses for immunisation. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unknown date in 2015 for immunization. On 24Oct2016, it was realized the patient experienced inappropriate dose of vaccine administered. This was further elaborated as the patient received two doses of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein); one in 2015 and another on 24Oct2016. On 24Oct2016, the patient also experienced soreness in the arm. The clinical outcome of the events, inappropriate dose of vaccine administered and soreness in the arm, was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Face injury, Fall, Syncope
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is 1st of 2 reports (male and female). This physician reported for male patient that: A male patient of an unspecified age and ethnicity received TRUMENBA at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date after receiving TRUMENBA the patient experienced syncope events/fainted and, fell on his face. He was transported to the ER where he received follow-up care. The outcome of the events was unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available. Linked Report(s): US-PFIZER INC-2016497611 same reporter/drug, different patient/event; US-PFIZER INC-2016497611 same reporter/drug, different patient/event.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chills, Decreased appetite, Hyperhidrosis, Injection site pain, Malaise
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-year-old male patient of unspecified ethnicity received 1st dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation.  The patient's medical history was not reported. Concomitant medication included GARDASIL 9 the same unspecified date of Trumenba. The patient experienced malaise, fever chills, no appetite, sweating and tender at injection site on an unspecified date at 06:00 PM. The events lasted 48 hours. No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-year-old male patient of unspecified ethnicity received 1st dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation.  The patient's medical history was not reported. Concomitant medication included GARDASIL 9 the same unspecified date of Trumenba. The patient experienced malaise, fever chills, no appetite, sweating and tender at injection site on an unspecified date at 06:00 PM. The events lasted 48 hours. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Body temperature increased
Clinical narrative: This is a spontaneous report from a contactable calling on behalf of a doctor. A patient of an unspecified age and gender (a student) received  the first dose of TRUMENBA for immunization at 0.5ml single dose on unknown date via an unspecified route. Medical history and concomitant medication were unknown.  On unknown date the patient had a temperature of 103 Fahrenheit. The outcome of the event was unknown.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Fever (elevated temperature) of 100.1. Generalized aches.  Self medicated with 600 mg ibuprofen.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE REACTION, ARM WAS WARM TO THE TOUCH, SWOLLEN, RED, ITCHY.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Pain, Palpitations, Pyrexia
Clinical narrative: Fever, "Pounding" headache, Body aches, Arm administered in ached, Slight nausea, Palpitations.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Pyrexia
Clinical narrative: Fever and chills during night.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Skin discolouration
Clinical narrative: (09/23/16) PT DESCRIBED SORENESS AT SITE OF INJECTION AND BRUISING 5 DAYS AFTER INJECTION WITH FLUZONE HD. OBSERVED FOR A FEW MORE WEEKS, PAIN ALLEVIATED BUT SLIGHT DISCOLORATION UNDER SKIN. PT CONCERNED THAT THE LIGHT BROWN DISCOLORATION UNDER SKIN MAY POSSIBLY LEAVE A SCAR OR A MARK. HAS NOT SOUGHT MEDICAL ATTENTION.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction, arm was swollen, warm to the touch, itching.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chronic throat clearing, Dysphagia, Erythema, Headache, Musculoskeletal stiffness
Clinical narrative: Body aches, headache, stiff neck, reddened face, clearing throat often feeling like unable to swallow.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Body aches, headache, stiff neck, reddened face, clearing throat often feeling like unable to swallow.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Heat, Redness, Swelling of injection site. will see MD on 10-28-16 if no better.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Redness, Sore arm, warmth to area.
Age: 16.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling/numbness of bilateral lower extremities.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Redness, warmth, swelling, tenderness. Venous Doppler ordered, negative results. Antibiotics & steroid given if symptoms got worse.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: The next morning with a 1 inch erythematous, painful area around injection site that progressed by the afternoon to a very tender, very hot  Erythematous area from below shoulder to mid upper arm.  He feels tired, a little bit of a headache and dizzy when tries to run or play.  No fever.  No other rashes on body or abnormal bruising.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema, erythema at injection site has gotten worse in last 2 days, is taking cetirizine, ibuprofen, and topical hydrocortisone.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Headache, Injection site swelling
Clinical narrative: Headache, erythema and swelling to the right deltioid.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Nausea, Pallor, Vision blurred, Visual impairment
Clinical narrative: Child said he felt warm, had slight stomach nausea, severe blurry/distorted vision. Child lost all color in lips.  This all happened in the span of 5 minutes and went away just as quickly. Watched carefully and gave glass of water to drink. Fine for rest of day.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site reaction, Pyrexia, Swelling face
Clinical narrative: PATIENT WENT HOME AND HAD A SEVERE LOCALIZED REACTION IN THE ARM OF INJECTION RESULTING AND A MILD SYSTEMIC RECTION WITH SHLIGHT SWELLING IN FACE AND FEVER.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Skin induration
Clinical narrative: Mother stated pts arm was red and hard, this was his # 3 HPV-9.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported developing shingles 7 days after vaccine administration.  He has been treated with anti-viral ever since.  He reported forehead and near the eye were areas affected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: The imz s was raised and hot.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: Chills, muscle aches, subsequent nausea, sore throat, headache, increased heart rate (120 bpm), vomiting about 12 hours after shot.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: Chills, muscle aches, subsequent nausea, sore throat, headache, increased heart rate (120 bpm), vomiting about 12 hours after shot.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Eye swelling, Nasal congestion, Pyrexia, Respiratory tract congestion
Clinical narrative: Nasal and chest congestion followed by, eye swelling and high fever of 101 degree F starting at 11:00 PM on 10/25/16 and still continuing currently on 10/28/16. Baby seems to be aching and is fussy.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Pain
Clinical narrative: Experiencing extreme and sudden pain in my lower back spine on the waist area trying to stand up from a crouching position after I tied my shoes. This pain does not go away and is hurting whenever I exhibit any force to my waist. This means I cannot twist or bend forward or backward because it would exhibit force on my spine. I cannot easily get out of bed or shift from one position to another.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Activities of daily living impaired, Asthenia, Dizziness, Headache
Clinical narrative: Overall weakness, headache, upset stomach, itching rash on inside of both arms from wrists to elbows. Worse the next day, then light headedness for about 3 weeks. Still feels weak and unable to resume normal activities. Called doctor on second day after becoming ill. Took Zertec for itching. Went to see doctor 10/03/2016.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Overall weakness, headache, upset stomach, itching rash on inside of both arms from wrists to elbows. Worse the next day, then light headedness for about 3 weeks. Still feels weak and unable to resume normal activities. Called doctor on second day after becoming ill. Took Zertec for itching. Went to see doctor 10/03/2016.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt stopped by the pharmacy on 10/26 to complain about his right arm hurting and saying that he couldn't lift his arm.  However, when he was telling me that, he was raising his arm up and down.  He never notified us (the pharmacy) that his arm was hurting.  I had counseled him that his arm would may feel sore or hurt for a few days.  His shot was given per protocol mid deltoid region at a 90 degree angle.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Limb discomfort, Pain, Pain in extremity
Clinical narrative: I have had discomfort and pain in my left arm. The pain at times throb/burns at times and its painful when i move my arm certain ways. I can feel were i got my shot 2 months ago.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: Patient awoke approximately 7:15am-7:30am and started her usual morning routine.  At approximately 7:45am-7:50am she was sitting down having a cup coffee and suddenly became very dizzy.  She thought the symptoms would pass shortly but soon found herself "coming to" after her husband found her passed out for a short period of time.  Patient felt "off" the rest of the day, though reported feeling back to normal as of this morning.  Patient has a cardiac history (multiple stents placed) but denies any related symptoms or changes to medication.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itchy rash on left upper arm, 10x5 cm.
Age: 71.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Localized pain, swelling, and redness.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: On 10/28/16, she came into the pharmacy and stated her arm was still painful and had a red area that expanded down into her armpit and lymphnode area. She asked if the pain, which was not at the injection site, but on top of her shoulder, could be from the vaccine.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: Itching , and diffuse severe rash.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Body Aches, 100 F fever, vomiting.
Age: 93.0
Sex: M
Vaccine: PNC13
Symptoms: Dysphagia
Clinical narrative: Daughter returned to pharmacy drive thru window and stated that patient had trouble swallowing his hamburger at dinner. She reported no difficulty breathing, chest tightness, hives, rash, nor swelling of the mouth/throat. I advised daughter to take patient to the hospital if condition worsened or any of the side effected above happened.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Local reaction, Skin warm, Swelling
Clinical narrative: PATIENT HAD LOCALIZED REACTION REDNESS AND SWELLING, WARM TO THE TOUCH AND HARD TO THE TOUCH.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pain, Pruritus
Clinical narrative: Swelling, huge red spot at vaccine site, large lump-quarter size. Itchy with pain for 3-4 days. Redness & warm to touch with lump still at day 7 after onset.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site swelling
Clinical narrative: Swelling, huge red spot at vaccine site, large lump-quarter size. Itchy with pain for 3-4 days. Redness & warm to touch with lump still at day 7 after onset.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Eyelid oedema, Feeling hot, Flushing, Pain, Rash
Clinical narrative: My face had been growing increasingly hot and flushed since the vaccine on 10/21. However, it's not abnormal for me to feel a little under the weather after receiving my annual flu shot. When I went out into the sun on Sunday, 10/23, to let the dog out my face began to feel like it was on fire and when I blinked my eyelashes touching together was terribly painful.   When I got back inside and looked in the mirror I had a rash from the top of my chest, up my neck, on my chin and cheeks, up to the bottoms of my eyes where on the right side my eye was swollen above and below on the eyelid.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Skin burning sensation
Clinical narrative: My face had been growing increasingly hot and flushed since the vaccine on 10/21. However, it's not abnormal for me to feel a little under the weather after receiving my annual flu shot. When I went out into the sun on Sunday, 10/23, to let the dog out my face began to feel like it was on fire and when I blinked my eyelashes touching together was terribly painful.   When I got back inside and looked in the mirror I had a rash from the top of my chest, up my neck, on my chin and cheeks, up to the bottoms of my eyes where on the right side my eye was swollen above and below on the eyelid.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal distension, Diarrhoea, Flatulence, Pyrexia
Clinical narrative: Bloated and gassy all evening, diarrhea onset the next morning at about 5:30 AM - 8:00 AM, mild fever.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rashes occurred as well as hives all over the body.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Swelling
Clinical narrative: Redness on arm; hands numb/feet numb; swelling; right arm pain.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Are painful, warm to touch 1/2 hr after shot given, took ibuprofen.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Phone call from Mother on 10-18-16 reporting child's Lt. arm has hives, unknown duration. Reports red, not, raised from shoulder to elbow. ENP gave antibiotics and steroid.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed hives 24-48 hours after flu vaccine.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Decreased appetite, Dizziness, Nausea, Pyrexia
Clinical narrative: About 1 hour after vaccine administered developed fever (101.1), chills, dizziness, anorexia, nausea.
Age: 44.0
Sex: F
Vaccine: FLU3, HIBV, PPV
Symptoms: Headache, Injection site swelling, Injection site urticaria, Myalgia, Pain
Clinical narrative: Didn't feel well by the 21st mid day and began having muscle pain in upper back, shoulders, neck and couldn't' cough w/out head pain. On the 22nd noticed welt and swelling at injection site that went from the back of my arm to underneath of arm. Painful to even put on deodorant. Saw doctor who was worried about treating an possibly adding possible side effects.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Subcutaneous haematoma
Clinical narrative: Patient developed small hematoma under skin within seconds of received FLUZONE vaccination. Patient said she felt fine, no pain, no bleeding. Patient waiting in pharmacy approximately 15min. Nothing further. Told pt to put ice on when home.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Pt brought to office with redness and blistering to LT. RT. had redness with less, but still present blistering.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bone pain, Differential white blood cell count, Full blood count, Injection site pain, Platelet count
Clinical narrative: Inflammation and pain at the site of vacc, mild subjective fever with bone pain 9/10. Vaccine was applied 09/27/16. Pt came back next day 09/28/16. Ibuprofen 800mg 1 PO q6h PRN. QTY 90.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vaccination site inflammation
Clinical narrative: Inflammation and pain at the site of vacc, mild subjective fever with bone pain 9/10. Vaccine was applied 09/27/16. Pt came back next day 09/28/16. Ibuprofen 800mg 1 PO q6h PRN. QTY 90.
Age: 77.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient reported a small 1-2 inch rash on hip and interior of legs. Rash was itchy and began to subside after 1-2 weeks, patient stated.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Patient stated she had numbness in face, neck and arm after receiving her flu shot that lasted 24 hours and then resolved.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram head, Dizziness, Fatigue, Headache
Clinical narrative: 10/1/16 achy, slight fever, terrible headache, very dizzy and tired. Took DAYQUIL and Ibuprofen. Headaches became worse with vomiting and body aches. 10/14 Dr. Visit, 10/17 Blood work, 10/19 CT Scan of brain. As of 10/28 still queasy with continuous slight headache.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: 10/1/16 achy, slight fever, terrible headache, very dizzy and tired. Took DAYQUIL and Ibuprofen. Headaches became worse with vomiting and body aches. 10/14 Dr. Visit, 10/17 Blood work, 10/19 CT Scan of brain. As of 10/28 still queasy with continuous slight headache.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Injection site reaction, Oedema, Rash macular
Clinical narrative: Blotchy erythema around injection site. The injection site itself is without pustule or redness. There is some edema in the tissue without localization. No fluctuation. No streaking. No signs of infection.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Received vaccine in right arm-there was redness and swelling and warm to touch; treated with TYLENOL and ibuprofen.