chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Dyspnoea, Rash
Clinical narrative: Initial unsolicited report received from Pfizer via health care professional on 06-Dec-2016. This case involves a (age was not reported) female patient who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose in series, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced rash, shortness of breath and also experienced allergy to vaccine. Relevant laboratory data and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Significant swelling and pain at the sight developed causing patient to seek help at the Urgent Care Center. Antibiotics were prescribed and a safety report was submitted.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Extreme Pain (9 out of 10) in vaccinated Arm. Unable to lift arm. Unable to sleep laying down. Had to try to sleep sitting up to support arm. Arm needed to be splinted. Required pain medication to function (First time ever after vaccination).
Sex: U
Vaccine: HEP
Symptoms: Drug dose omission, No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported. On unknown date, the patient was scheduled to be vaccinated with RECOMBIVAX HB intramuscular (lot # M033220 and expiration date 31-MAY-2018, dose was not provided). The nurse practitioner reported that on that day pressure in a vial of RECOMBIVAX HB was irregular upon withdrawing the vaccine into syringe causing medication to spray from the vial. As result the patient missed a dose. No adverse effects were reported. Product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concomitant medications, concurrent conditions or drug reactions and allergies was provided. On 17-NOV-2016, the patient was vaccinated with a dose of unspecified pneumococcal vaccine (dose, route, lot # and expiry date were not reported) for prophylaxis. The reporting pharmacist did not know if the pneumococcal vaccine was PREVNAR 13 or PNEUMOVAX23. On the next day, the patient was vaccinated with a dose of ZOSTAVAX (dose was not reported) lot # M013377, expiry date 25-MAY-2017, subcutaneously for prophylaxis. Concomitantly, on the same day, the patient was vaccinated with a dose of FLUZONE (dose, route, lot # and expiry date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus generalised
Clinical narrative: Patient reported generalized itching one hour post vaccine administration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abnormal behaviour, Pyrexia, Vomiting
Clinical narrative: Mother reports child not self soon after shot, started running a fever and throwing up later in the day and through the night.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Muscular weakness, Pain in extremity
Clinical narrative: Patient complaining of pain in upper arm, weakness raising arm both upwards and sideways and difficulty sleeping - patient states may be due to incorrect administration.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Leg swollen/rash.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Bradycardia, Hypoxia, Mental status changes, Shock
Clinical narrative: Delayed onset altered mental status, Bradycardia followed by shock/hypoxia. Successfully tx with Epi/Diphenhydramine/Methylprednisolone/IVF/O2.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Injection site erythema, Injection site nodule, Myalgia, Pain in extremity
Clinical narrative: The client noted redness and a knot the size of a thumb print at injection site. Denies feeling itchy at the site.  Each day has gotten progressively more red and hot. Denies fever.  States she has used cool compresses.  Notes soreness in the arm, muscle and bone.  Sent pictures of her arm from the last few days.  Shared with Lead Immunization RN and Medical Director. Contacted RN and relayed instructions rec'd from Medical Director.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to the multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M023382 with expiration date on 11-MAY-2018 and lot # M010483 with expiration date on 01-MAR-2018; dose and route of administration were unknown), for prophylaxis. The vaccines were exposed to temperature excursion of 5.5 degrees Fahrenheit for 4 hours and 45 minutes and 24.8 degrees Fahrenheit for 15 hours and 40 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Follow up information has been received on 22-NOV-2016. A message was left requiring a return call from the nurse and a request was made for the patients' identifiers and dates of vaccinations. All telephone attempts to obtain follow up information had been unsuccessful. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA003925: US-009507513-1610USA004869:, MERCK 1610USA004868:Mfr number.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to the multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M015926 with expiration date on 28-JUN-2017, dose and route of administration were not reported), for prophylaxis. The vaccines were exposed to temperature excursion of 5.5 degrees Fahrenheit for 4 hours and 45 minutes and 24.8 degrees Fahrenheit for 15 hours and 40 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.  Follow up information has been received on 22-NOV-2016. A message was left requiring a return call from the nurse and a request was made for the patients' identifiers and dates of vaccinations. All telephone attempts to obtain follow up information had been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA003925: US-009507513-1610USA004868: MERCK 1610USA004869:Mfr number.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Pneumonia, Respiratory distress, Respiratory tract congestion, X-ray
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 68 year old female patient. Medical history and current conditions were not reported. Concomitant medications were not reported. On 25-AUG-2016 the patient was vaccinated with PNEUMOVAX23 (dose, route, anatomical location and lot # were unknown) for prophylaxis. On 07-SEP-2016, the patient presented back to the office with cough and congestion that lasted for 6 days. On the 8-SEP-2016 she returned to office, feeling worse and was sent for an x-ray next day (data not showed). The doctor suspected pneumonia and the patient was diagnosed in the hospital or emergency room, and treated with unspecified antibiotic and the patient progressively got worse. On an unknown date in 2016, just a couple of days after that, the patient presented in the emergency room and ended up staying a week in the hospital, conflicting information reported as "02 sat of 84". The pneumonia was ruled out and doctor decided that it was a severe reaction, respiratory distress reaction to PNEUMOVAX 23. The patient was alive and was dismissed from the emergency room. The outcome of respiratory distress was unknown. The reporter considered the event respiratory distress to be related to the suspect therapy. Upon internal review, the event respiratory distress was determined to be medically significant. As of 09-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: MERCK 1611USA007545: Mfr number.
Sex: F
Vaccine: HPV9
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist, who was also the mother of the patient, refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient was vaccinated with GARDASIL 9 (route and site of administration, lot # and expiry date were not reported) for prophylaxis and received all 3 doses in total. All of the doses were not agitated in the vial prior to administration and were all clear in appearance (the prescribing information states that the product should be a white cloudy color after agitation). No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008739.
Sex: M
Vaccine: PPV
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report as received from a male patient of unknown age via Mylan refers to himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced pruritus generalised. The outcome of pruritus generalised was unknown. The relatedness between vaccination with PNEUMOVAX 23 and the event was not reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients was vaccinated with  VARIVAX (dosing details were not reported) for prophylaxis. The reporter stated that multiple unspecified patients with unspecified ages received VARIVAX (lots unknown, expiry date: unknown) on unspecified dates and did not receive a second dose (inappropriate schedule of drug administration). No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates between the year 2008 and January 2016, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route of administration, injection site, lot# and expiration date were not provided). Data logger was not involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old female patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 08-DEC-2016, the patient was vaccinated with GARDASIL 9 lot # M024261, expiry date: 30-JUL-2018 for prophylaxis under the assumption that it was the patient's third dose but after review of the patient's chart, it became evident that it was actually the fourth dose (extra dose administered). No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Sex: F
Vaccine: HIBV, PPV
Symptoms: Antibody test negative, C-reactive protein, Cough, Culture, Culture negative
Clinical narrative: This literature marketed report as received from the authors of a published article, concerns a 10 month old female patient. Her past medical history was significant for an admission at 3 months of age for community-acquired pneumonia. She had no other medical problems and was fully vaccinated for her age. Her parents denied any sick contacts and there was no family history of immunodeficiency. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (exact dose, route of administration, anatomical location, lot # and expiration date were nor provided). Other suspect vaccine received on an unknown date, included Haemophilus influenzae type B vaccine (manufacturer unknown) (formulation, dose, intervals and route of administration were not provided). On an unknown date, she presented with 5 days of fever and cough to the reporters' emergency department. The patient was diagnosed with an upper respiratory infection and discharged from the hospital without antibiotics. Vancomycin and ceftriaxone were initiated for presumed community acquired pneumonia complicated by empyema. The Gram stain of the pleural fluid revealed moderate white blood cells, moderate Gram-negative rods, and rare Gram-positive cocci. However, the pleural fluid culture initially remained negative. After 3 days of antibiotics, the patient continued to have high fevers, her inflammatory markers remained elevated, and she continued to require mechanical ventilation. On an unknown date, vancomycin was discontinued, and the patient was transitioned from piperacillin (+) tazobactam to ampicillin (+) sulbactam. The patient's leukocyte count and C-reactive protein (CRP) trended down during her hospitalization. Before discharge, the patient underwent an immunodeficiency workup. She had normal T-cell subsets, natural killer cells, and B cells. immunoglobulins were normal or elevated. An human immunodeficiency virus (HIV) screening test was negative. Her initial Haemophilus influenzae type B (manufacturer unknown) and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) antibody titers were just below the lower range of normal for a previously vaccinated child (vaccination failure). After 12 days of hospitalization, the patient was discharged from the hospital on oral amoxicillin (+) clavulanate to complete a 4-week course of antibiotics. The patient was scheduled to receive repeat vaccinations and have repeat titers drawn; however, she was lost to follow-up. The authors reviewed her laboratory findings with an immunologist who felt that the suspicion for an immunodeficiency was low. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and Haemophilus influenzae type B (manufacturer unknown). Additional information has been requested.
Sex: F
Vaccine: HIBV, PPV
Symptoms: Empyema, Gram stain positive, HIV test negative, Immunoglobulins increased, Inflammatory marker increased
Clinical narrative: This literature marketed report as received from the authors of a published article, concerns a 10 month old female patient. Her past medical history was significant for an admission at 3 months of age for community-acquired pneumonia. She had no other medical problems and was fully vaccinated for her age. Her parents denied any sick contacts and there was no family history of immunodeficiency. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (exact dose, route of administration, anatomical location, lot # and expiration date were nor provided). Other suspect vaccine received on an unknown date, included Haemophilus influenzae type B vaccine (manufacturer unknown) (formulation, dose, intervals and route of administration were not provided). On an unknown date, she presented with 5 days of fever and cough to the reporters' emergency department. The patient was diagnosed with an upper respiratory infection and discharged from the hospital without antibiotics. Vancomycin and ceftriaxone were initiated for presumed community acquired pneumonia complicated by empyema. The Gram stain of the pleural fluid revealed moderate white blood cells, moderate Gram-negative rods, and rare Gram-positive cocci. However, the pleural fluid culture initially remained negative. After 3 days of antibiotics, the patient continued to have high fevers, her inflammatory markers remained elevated, and she continued to require mechanical ventilation. On an unknown date, vancomycin was discontinued, and the patient was transitioned from piperacillin (+) tazobactam to ampicillin (+) sulbactam. The patient's leukocyte count and C-reactive protein (CRP) trended down during her hospitalization. Before discharge, the patient underwent an immunodeficiency workup. She had normal T-cell subsets, natural killer cells, and B cells. immunoglobulins were normal or elevated. An human immunodeficiency virus (HIV) screening test was negative. Her initial Haemophilus influenzae type B (manufacturer unknown) and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) antibody titers were just below the lower range of normal for a previously vaccinated child (vaccination failure). After 12 days of hospitalization, the patient was discharged from the hospital on oral amoxicillin (+) clavulanate to complete a 4-week course of antibiotics. The patient was scheduled to receive repeat vaccinations and have repeat titers drawn; however, she was lost to follow-up. The authors reviewed her laboratory findings with an immunologist who felt that the suspicion for an immunodeficiency was low. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and Haemophilus influenzae type B (manufacturer unknown). Additional information has been requested.
Sex: F
Vaccine: HIBV, PPV
Symptoms: Mechanical ventilation, Natural killer cell count, Pneumonia, Pyrexia, Upper respiratory tract infection
Clinical narrative: This literature marketed report as received from the authors of a published article, concerns a 10 month old female patient. Her past medical history was significant for an admission at 3 months of age for community-acquired pneumonia. She had no other medical problems and was fully vaccinated for her age. Her parents denied any sick contacts and there was no family history of immunodeficiency. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (exact dose, route of administration, anatomical location, lot # and expiration date were nor provided). Other suspect vaccine received on an unknown date, included Haemophilus influenzae type B vaccine (manufacturer unknown) (formulation, dose, intervals and route of administration were not provided). On an unknown date, she presented with 5 days of fever and cough to the reporters' emergency department. The patient was diagnosed with an upper respiratory infection and discharged from the hospital without antibiotics. Vancomycin and ceftriaxone were initiated for presumed community acquired pneumonia complicated by empyema. The Gram stain of the pleural fluid revealed moderate white blood cells, moderate Gram-negative rods, and rare Gram-positive cocci. However, the pleural fluid culture initially remained negative. After 3 days of antibiotics, the patient continued to have high fevers, her inflammatory markers remained elevated, and she continued to require mechanical ventilation. On an unknown date, vancomycin was discontinued, and the patient was transitioned from piperacillin (+) tazobactam to ampicillin (+) sulbactam. The patient's leukocyte count and C-reactive protein (CRP) trended down during her hospitalization. Before discharge, the patient underwent an immunodeficiency workup. She had normal T-cell subsets, natural killer cells, and B cells. immunoglobulins were normal or elevated. An human immunodeficiency virus (HIV) screening test was negative. Her initial Haemophilus influenzae type B (manufacturer unknown) and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) antibody titers were just below the lower range of normal for a previously vaccinated child (vaccination failure). After 12 days of hospitalization, the patient was discharged from the hospital on oral amoxicillin (+) clavulanate to complete a 4-week course of antibiotics. The patient was scheduled to receive repeat vaccinations and have repeat titers drawn; however, she was lost to follow-up. The authors reviewed her laboratory findings with an immunologist who felt that the suspicion for an immunodeficiency was low. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and Haemophilus influenzae type B (manufacturer unknown). Additional information has been requested.
Sex: F
Vaccine: HIBV, PPV
Symptoms: White blood cell count
Clinical narrative: This literature marketed report as received from the authors of a published article, concerns a 10 month old female patient. Her past medical history was significant for an admission at 3 months of age for community-acquired pneumonia. She had no other medical problems and was fully vaccinated for her age. Her parents denied any sick contacts and there was no family history of immunodeficiency. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (exact dose, route of administration, anatomical location, lot # and expiration date were nor provided). Other suspect vaccine received on an unknown date, included Haemophilus influenzae type B vaccine (manufacturer unknown) (formulation, dose, intervals and route of administration were not provided). On an unknown date, she presented with 5 days of fever and cough to the reporters' emergency department. The patient was diagnosed with an upper respiratory infection and discharged from the hospital without antibiotics. Vancomycin and ceftriaxone were initiated for presumed community acquired pneumonia complicated by empyema. The Gram stain of the pleural fluid revealed moderate white blood cells, moderate Gram-negative rods, and rare Gram-positive cocci. However, the pleural fluid culture initially remained negative. After 3 days of antibiotics, the patient continued to have high fevers, her inflammatory markers remained elevated, and she continued to require mechanical ventilation. On an unknown date, vancomycin was discontinued, and the patient was transitioned from piperacillin (+) tazobactam to ampicillin (+) sulbactam. The patient's leukocyte count and C-reactive protein (CRP) trended down during her hospitalization. Before discharge, the patient underwent an immunodeficiency workup. She had normal T-cell subsets, natural killer cells, and B cells. immunoglobulins were normal or elevated. An human immunodeficiency virus (HIV) screening test was negative. Her initial Haemophilus influenzae type B (manufacturer unknown) and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) antibody titers were just below the lower range of normal for a previously vaccinated child (vaccination failure). After 12 days of hospitalization, the patient was discharged from the hospital on oral amoxicillin (+) clavulanate to complete a 4-week course of antibiotics. The patient was scheduled to receive repeat vaccinations and have repeat titers drawn; however, she was lost to follow-up. The authors reviewed her laboratory findings with an immunologist who felt that the suspicion for an immunodeficiency was low. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and Haemophilus influenzae type B (manufacturer unknown). Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Complex partial seizures, Seizure, Seizure like phenomena
Clinical narrative: This spontaneous report as received from a medical assistant (patient's father) via a company representative refers to a male patient of unknown age (age was reported as "13 units not provided"). There was no information about the patient's concurrent conditions or medical history provided. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 injection (exact dose, interval, route of administration, anatomical location, lot # and expiration date were not provided). Concomitant therapy included ZOLOFT. The patient had started to experience "seizures or seizure-like activities" 1 week after his 2nd scheduled dose of GARDASIL 9 (date was unspecified). He completed the 3 shot series of suspect vaccine. The patient's physician summarized the patient's experienced as "on-going partial complex seizures". It was unknown if treatment was given for the event. The outcome of the event was reported as not recovered. Causality assessment was not provided. Upon internal review, the event of "on-going partial complex seizures" was considered to be medically significant. Additional information is not expected because there was no consent to contact the reporter.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Poor quality drug administered
Clinical narrative: This spontaneous report as received from a pharmacist, who was also the mother of the patient, refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient was vaccinated with GARDASIL 9 (route and site of administration, lot # and expiry date were not reported) for prophylaxis and received all 3 doses in total. All of the doses were not agitated in the vial prior to administration and were all clear in appearance (the prescribing information states that the product should be a white cloudy color after agitation). No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA000279.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Musculoskeletal pain, Periarthritis
Clinical narrative: Severe pain in shoulder, locked shoulder. 2 days with no improvement, I went back to the Dr. She said I was the 3rd person this week with the same reaction. Was given anti inflammation pills and pain medication.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PPV, RVX
Symptoms: Emotional distress, Haemoptysis, Pyrexia, Screaming
Clinical narrative: Inconsolable screaming so much that he coughed up a small amount of blood, 102 fever.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Joint range of motion decreased
Clinical narrative: Limited range of motion: can't raise my arm. Severe pain, tingling, numbness, pain to touch at the injection site, burning sensation.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray normal
Clinical narrative: Limited range of motion: can't raise my arm. Severe pain, tingling, numbness, pain to touch at the injection site, burning sensation.
Age: 27.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Influenza like illness, Pain in extremity, Peripheral swelling
Clinical narrative: Fever, flu-like symptoms, Left arm, red, swollen and painful.
Age: 27.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Sepsis
Clinical narrative: Fever, flu-like symptoms, Left arm, red, swollen and painful.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Malaise, Nausea, Pallor
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 18-year-old female patient received the second dose of TRUMENBA, on an unspecified date at single dose for immunisation.  Medical history included ongoing vitiligo.  The patient's concomitant medications were not reported.  The first dose of meningococcal group b rlp2086 was given on 30Aug2016 and no event occurred. The patient experienced severe chills, nausea and needed to sit down putting head between knees and looked pale/ill, on an unspecified date, after three hours of receiving 2nd vaccine dose.  The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported a similar event for two patients. This is first of two reports. A female patient of an unspecified age, race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported.  The patient complained that she had swelling at the injection site on an unspecified date. The patient was recovering. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2016573790 Same reporter/ product/ event, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported a similar event for two patients. This is the second of two reports. A female patient of an unspecified age, race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient complained that she had swelling at the injection site on an unspecified date. The patient was recovering. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016573776 Same reporter/ product/ event, different patient.
Age: 68.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 68-year-old patient of an unspecified gender started to receive PREVNAR 13  intramuscular on 01Dec2016 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On 02Dec2016, the patient experienced redness, swelling and warm to touch at the injection site. The clinical outcome of events redness, and swelling at the injection site is recovering and the outcome for event warm to touch at the injection site was unknown. The action taken in response to the event for PREVNAR 13 was not applicable. Therapeutic measures were taken as a result of redness, swelling and warm to touch at the injection site as BENADRYL was used.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner. This report was received via a Pfizer sales representative. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 07Dec2016 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 07Dec2016, the patient experienced 5cm reaction of redness and swelling at the injection site pretty quickly after receiving the vaccine. On 07Dec2016, the patient also experienced body aches. The clinical outcome of the events, redness at injection site, swelling of injection site, and body aches, was not recovered.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Myalgia, Nausea, Swelling, Tenderness
Clinical narrative: This is a spontaneous report from a contactable physician's assistant communicated to a Pfizer sales representative. A 17-year-old female patient of an unspecified race received TRUMENBA, intramuscular on an unspecified date at 0.5ml single dose for immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient experienced redness, swelling, tenderness at a location, muscle aches in back and nausea in Dec2016 with outcome of unknown.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 4-year-old female patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). Concomitant products included MMRV. On 25th October 2016, the patient received KINRIX (intramuscular) 0.5 ml. On 26th October 2016, 1 days after receiving KINRIX, the patient experienced injection site warmth, injection site pain, injection site induration, injection site swelling and injection site erythema. On 27th October 2016, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site warmth, injection site pain, injection site induration, injection site swelling, injection site erythema and injection site blisters were unknown. The reporter considered the injection site warmth, injection site pain, injection site induration, injection site swelling, injection site erythema and injection site blisters to be probably related to KINRIX. Additional details were provided as follows: This case was previously reported to Health department. On 25th October 2016, the patient received the MMRV vaccine as a concomitant medication on right arm (was manufactured by Merck) (batch number M015700, expiry date 26th December 2017). The reporter had a child that received the KINRIX vaccination in her left upper arm at 16:50 pm. The parents brought patient back to the physician's office two days after receiving the vaccination because the patient's left upper arm was red, hot, swollen, painful, hard, tender to the touch, and raised. On 27th October 2016, 2 days after receiving KINRIX, the patient developed injection site blisters. The physician was also notified of this situation. This case has been linked with cases US2016180183, US2016180270, US2016180271 and US2016180187 as reported by the same reporter. No further details were obtained.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 4-year-old female patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). Concomitant products included MMRV. On 25th October 2016, the patient received KINRIX (intramuscular) 0.5 ml. On 26th October 2016, 1 days after receiving KINRIX, the patient experienced injection site warmth, injection site pain, injection site induration, injection site swelling and injection site erythema. On 27th October 2016, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site warmth, injection site pain, injection site induration, injection site swelling, injection site erythema and injection site blisters were unknown. The reporter considered the injection site warmth, injection site pain, injection site induration, injection site swelling, injection site erythema and injection site blisters to be probably related to KINRIX. Additional details were provided as follows: This case was previously reported to Health department. On 25th October 2016, the patient received the MMRV vaccine as a concomitant medication on right arm (was manufactured by Merck) (batch number M015700, expiry date 26th December 2017). The reporter had a child that received the KINRIX vaccination in her left upper arm at 16:50 pm. The parents brought patient back to the physician's office two days after receiving the vaccination because the patient's left upper arm was red, hot, swollen, painful, hard, tender to the touch, and raised. On 27th October 2016, 2 days after receiving KINRIX, the patient developed injection site blisters. The physician was also notified of this situation. This case has been linked with cases US2016180183, US2016180270, US2016180271 and US2016180187 as reported by the same reporter. No further details were obtained.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Local swelling, Myalgia
Clinical narrative: After injection, pt could feel the pain spreading around the site, and reports an overall sore muscle pain with difficulty moving left arm that night (no redness). Next morning, she noticed redness and swelling that was band-like toward the back of the arm and below the site of injection. It began to feel better through the day but that night she realized the redness had moved down on her arm. When pt presented 3 days later, her arm was red, hot, swollen and blotchy (further down from the site of injection). The actual site looked normal, but pt says it was still a little sore underneath and she feels like the soreness was following her muscle down the arm. She states the pain today is not as sore as it previously was.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash macular, Skin warm
Clinical narrative: After injection, pt could feel the pain spreading around the site, and reports an overall sore muscle pain with difficulty moving left arm that night (no redness). Next morning, she noticed redness and swelling that was band-like toward the back of the arm and below the site of injection. It began to feel better through the day but that night she realized the redness had moved down on her arm. When pt presented 3 days later, her arm was red, hot, swollen and blotchy (further down from the site of injection). The actual site looked normal, but pt says it was still a little sore underneath and she feels like the soreness was following her muscle down the arm. She states the pain today is not as sore as it previously was.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called on 12/16/16 to report that her arm is red, swollen and warm all the way from her elbow to the injection site. Also there is redness on the opposite of her injection site on the same arm. Patient was advised to use ibuprofen and warm or cool compresses.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient described redness (1 to 1 1/2 inch area) at injection site of right arm, soreness and tender/warm to the touch.  She was worried that the site may be infected as the redness was expanding in area. Patient reported events about 48 hours after injection.  Patient was advised to monitor for 1 more day and if not improved she could go and see her physician.  She was told typical side effects would last 24 to 48 hours.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Lip haemorrhage, Lip injury
Clinical narrative: Pt fell on the sales floor in the store shortly after given a flu shot. She had bleeding from a cut lip.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Immune thrombocytopenic purpura, Mouth haemorrhage, Petechiae, Platelet count decreased
Clinical narrative: ITP: INITIAL ONSET: 3PM NOTICED EXCESSIVE BRUISING, 6PM PETECHIA ON BACK AND LEGS, 11PM MOUTH BLEEDING; 11/21/16 HOSPITAL ADMISSION WITH PLATELETS AT 0K.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Epistaxis, Immunoglobulin therapy, Mouth haemorrhage, Petechiae
Clinical narrative: 11/19/15@8A: EXCESSIVE BRUISING. 11/20/15@10A: MORE BRUISING AND PETECHIA. 11/20/15@8PM: AFTER HOUR CLINIC: LABS. 11/20/15@11PM: ER HOSPITAL ADMISSION - PLATELETS AT 1K. 11/21/15@2AM: HOSPITAL TRANSFER, MOUTH BLEEDING, BLOODY NOSE, MORE BRUISES. 11/21/15 PM: IVIG.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Platelet count decreased
Clinical narrative: 11/19/15@8A: EXCESSIVE BRUISING. 11/20/15@10A: MORE BRUISING AND PETECHIA. 11/20/15@8PM: AFTER HOUR CLINIC: LABS. 11/20/15@11PM: ER HOSPITAL ADMISSION - PLATELETS AT 1K. 11/21/15@2AM: HOSPITAL TRANSFER, MOUTH BLEEDING, BLOODY NOSE, MORE BRUISES. 11/21/15 PM: IVIG.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site pruritus, Muscle spasms, Pain in extremity
Clinical narrative: Patient stated that the reaction started as injection site redness and itching approximately 3 hours after receiving vaccine. The reaction then progressed to muscle spasms of the jaw, feet, and hands -- followed by shortness of breath and throat swelling -- followed by swelling of and pain in the legs, hands, and feet. The patient then went to the local clinic for evaluation and treatment of symptoms. The treating physician wanted to admit patient to the hospital but she was not willing. She was then sent home after symptoms had resolved.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pharyngeal oedema
Clinical narrative: Patient stated that the reaction started as injection site redness and itching approximately 3 hours after receiving vaccine. The reaction then progressed to muscle spasms of the jaw, feet, and hands -- followed by shortness of breath and throat swelling -- followed by swelling of and pain in the legs, hands, and feet. The patient then went to the local clinic for evaluation and treatment of symptoms. The treating physician wanted to admit patient to the hospital but she was not willing. She was then sent home after symptoms had resolved.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Eye pruritus, Rash generalised, Urticaria
Clinical narrative: He presented on 11/15/16 at 11:30pm with complaints of itchy eyes, no redness or swelling noted. Advised to take OTC BENADRYL. At 12:30pm he return with visible body rash and hives. He received treatment from his primary care physician.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blepharitis, Chills, Cold sweat, Diarrhoea, Eye pain
Clinical narrative: 7:00 to 9:00PM - Redness in eyes, inflammation and pain in eyelids. 9:00 to 10:00PM - Nausea, followed by 30 sec. of severe vomiting. 10:00 to 12:00PM - Chills, cold and "clammy" skin.  Eye pain subsided. 12:00 to 1:00AM - Chills subsided, followed by brief period of diarrhea.  Went to sleep, woke up with "shakiness" in legs, felt fine by late morning.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid pain, Nausea, Ocular hyperaemia, Tremor, Vomiting
Clinical narrative: 7:00 to 9:00PM - Redness in eyes, inflammation and pain in eyelids. 9:00 to 10:00PM - Nausea, followed by 30 sec. of severe vomiting. 10:00 to 12:00PM - Chills, cold and "clammy" skin.  Eye pain subsided. 12:00 to 1:00AM - Chills subsided, followed by brief period of diarrhea.  Went to sleep, woke up with "shakiness" in legs, felt fine by late morning.
Age: 1.42
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Fluid intake reduced, Hypophagia
Clinical narrative: "Really bad diarrhea ever since she had the flu shot today." Mom reports patient is not eating, difficulty drinking, appears to have "a little trouble breathing." Per mom, these are all changes since being seen in office today at 1315. Mom advised if patient is experiencing any change in respiratory status she should be taken to ER immediately.
Age: 84.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient states that she has redness, tenderness and itchiness at the injection site. These symptoms have not persisted for over 7 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX subcutaneous injection (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-SEP-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provided contact details to contact other registered nurse who could provide additional information about the patient. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA009079: US-009507513-1610USA009080: US-009507513-1610USA009085: US-009507513-1610USA009082: US-009507513-1610USA009083: US-009507513-1610USA009084: US-009507513-1610USA001984: US-009507513-1610USA009081:, MERCK 1610USA009078:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX subcutaneous injection (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-SEP-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provided contact details to contact other registered nurse nurse who could provide additional information about the patient. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments:  US-009507513-1610USA001984: US-009507513-1610USA009080: US-009507513-1610USA009085: US-009507513-1610USA009082: US-009507513-1610USA009083: US-009507513-1610USA009084: US-009507513-1610USA009078: US-009507513-1610USA009081:, MERCK 1610USA009079:Mfr number.