chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from a nurse on 30 Sep 2016. This case is linked with 2016SA182127, 2016SA182128, 2016SA182129, 2016SA182130, 2016SA182131, 2016SA182132, 2016SA182133, 2016SA182134, 2016SA182135 (same reporter). This case involves a patient (age and sex not reported) who was vaccinated with a dose of Fluzone Intradermal (Batch number, expiry date, dose, route and site of administration were not reported) on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not provided. On an unspecified date, post vaccination; the patient experienced anaphylactic reaction. Lab data and corrective treatment was not reported. The outcome of the event was not reported. Upon internal review the case was considered as serious due to important medical event: anaphylactic reaction. List of documents held by sender: none. Sender's Comments: As with other vaccines, anaphylactic reaction is listed following INFLUENZA QUADRIVAL A-B VACCINE. This poorly documented cases as time to onset is unknown. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), information regarding any drug or food intake during the period between vaccination and reaction and allergy testing to identify the culprit allergen are needed to further assess this case. Based on the available information, a role of the vaccine cannot be ruled out.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 28-SEP-2016. This case is linked to case 2016SA182541 (same event, same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Adacel and a dose of Pentacel (batch number, expiry date, route and site of administration: not reported for both administration) on an unspecified date. Patient's medical history and concomitant medication was not reported. On an unspecified date, post vaccination patient was diagnosed with Pertussis. It was a case of vaccination failure as patient had received all pertussis immunizations. Laboratory data was reported. Corrective treatment was not reported. Outcome of the event was not reported. Upon internal review, the case was considered as serious due to important medical events diagnosed with pertussis and suspected vaccination failure. List of documents held by sender: none. Sender's Comments: Based on the information on unknown date patient received both vaccines PENTACEL and ADACEL and experienced pertussis on unknown date. Considering that the patient received all dose of pertussis, the patient should have been protected against pertussis. This case is therefore a suspected vaccination failure. The latency between the last dose of the vaccine administered and the occurrence of first symptoms is however not reported. However details regarding relevant medical history, date of vaccination for ADACEL and PENTACEL, date of occurrence of first symptoms, investigation reports confirming the diagnosis, age and gender of patient are needed for complete assessment of the case.
Age: 0.17
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HIBV, IPV, RV1
Symptoms: Breath holding, Crying, Erythema, Extra dose administered, Gastrooesophageal reflux disease
Clinical narrative: Initial unsolicited misuse report received from a consumer on 03 Oct 2016. This case involves a two-month-old male patient (reported as 8 week old) who was vaccinated with a dose of PENTACEL, dose of ACTHIB, dose of IPOL, dose of DAPTACEL and ROTARIX (manufacturer- Merck) (batch number, expiry date, route, dose not reported for all vaccines) on 29 Sep 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) included no known allergy and concomitant medications were not provided. Illness at time of vaccination was reported as none. On 01 Oct 2016, two days following the vaccination, the patient began having periods of crying fussy, holding breath, "looks like in pain and shock" face red. On 02 Oct 2016, the patient was taken to emergency room and diagnosed with acid reflux. It was a case of extra dose administered. Lab data and corrective treatment was not reported. The patient was not recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical event shock. List of documents held by sender: none. Sender's Comments: 2 month old patient experienced acid reflux, shock, holding breath and face red after vaccination with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE, HIB (PRP/T) VACCINE, IPV (VERO), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and ROTAVIRUS VACCINE. This case is suspected medication error case as patient was given extra doses of vaccines. Based on the information role of the vaccine can be excluded, because reported events can be due to extra doses administration or may be due to other etiology. However more details regarding relevant medical history, previous vaccination history, concomitant medication, concurrent condition at the time of vaccination are needed to complete assessment of the case.
Age: 0.17
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HIBV, IPV, RV1
Symptoms: Irritability, Pain, Shock
Clinical narrative: Initial unsolicited misuse report received from a consumer on 03 Oct 2016. This case involves a two-month-old male patient (reported as 8 week old) who was vaccinated with a dose of PENTACEL, dose of ACTHIB, dose of IPOL, dose of DAPTACEL and ROTARIX (manufacturer- Merck) (batch number, expiry date, route, dose not reported for all vaccines) on 29 Sep 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) included no known allergy and concomitant medications were not provided. Illness at time of vaccination was reported as none. On 01 Oct 2016, two days following the vaccination, the patient began having periods of crying fussy, holding breath, "looks like in pain and shock" face red. On 02 Oct 2016, the patient was taken to emergency room and diagnosed with acid reflux. It was a case of extra dose administered. Lab data and corrective treatment was not reported. The patient was not recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical event shock. List of documents held by sender: none. Sender's Comments: 2 month old patient experienced acid reflux, shock, holding breath and face red after vaccination with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE, HIB (PRP/T) VACCINE, IPV (VERO), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and ROTAVIRUS VACCINE. This case is suspected medication error case as patient was given extra doses of vaccines. Based on the information role of the vaccine can be excluded, because reported events can be due to extra doses administration or may be due to other etiology. However more details regarding relevant medical history, previous vaccination history, concomitant medication, concurrent condition at the time of vaccination are needed to complete assessment of the case.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Chills, Tremor
Clinical narrative: Initial unsolicited report received from a health care professional on 03-Oct-2016. This case involves a 80-year-old male patient, who was vaccinated with FLUZONE HD (batch number: UI666AA , expiry date: 13-Apr-2017) via intramuscular route (dose and dose in series not reported) in leg on 28-Sep-2016. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as DM Type II (diabetes mellitus II ), HTN (hypertension). It was also unknown that patient received any other vaccines within four week of suspect vaccine. Concomitant medications were not reported. On 28-Sep-2016, same day following the vaccination, the patient had shaking chills with accompanied abdominal pain. Lab test and corrective treatment was not reported. Patient recovered from abdominal pain on the same day after approximately two hours and chills by the next day. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pustular
Clinical narrative: Initial unsolicited report received from a pharmacist on 04-Oct--2016. This case involves a 68-year-old female patient, who was vaccinated with FLUZONE HD (batch number: UI672AA, expiry date: 17-Apr-2017) (route, dose and dose not reported) in right deltoid on 28-Sep-2016. Patient's illness at time of vaccination was reported as none. It was also reported that pre-existing physician diagnosed allergies: eggs and birth defects, medical conditions are none. It was also reported that patient had one dose of Fluzone last year. Concomitant medications were not reported. On 04-Oct-2016, six days following the vaccination, the patient experienced pustules on knees and hands. Lab test was none reported. Concomitant medication was not reported. Outcome of the events were reported as unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: Initial unsolicited report received from a nurse practitioner on 30 September 2016. This case is linked to 2016SA181982. (Same vaccine, same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number: UI658AA, expiry date: 30-Jun-2017 and batch number: UI657AB expiration date: 30-Jun-2017, dose, dose series, route and site of administration were not reported) on an unspecified date. It was reported that "the reporter did not have the number of patients who received which lot number". Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced upper arm redness, swelling, itching, rash, tenderness of vaccinated arm, generalized body aches, headache, neck pain, upset stomach, sore throat, fatigue and also experienced dizziness and couldn't lift the arm ("but did not know if patient was unable to move arm due to discomfort from moving arm or it was due to weakness or inability to move arm. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Initial unsolicited report received from a nurse practitioner on 30 September 2016. This case is linked to 2016SA181982. (Same vaccine, same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number: UI658AA, expiry date: 30-Jun-2017 and batch number: UI657AB expiration date: 30-Jun-2017, dose, dose series, route and site of administration were not reported) on an unspecified date. It was reported that "the reporter did not have the number of patients who received which lot number". Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced upper arm redness, swelling, itching, rash, tenderness of vaccinated arm, generalized body aches, headache, neck pain, upset stomach, sore throat, fatigue and also experienced dizziness and couldn't lift the arm ("but did not know if patient was unable to move arm due to discomfort from moving arm or it was due to weakness or inability to move arm. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Neck pain, Oropharyngeal pain, Pain
Clinical narrative: Initial unsolicited report received from a nurse practitioner on 30 September 2016. This case is linked to 2016SA181982. (Same vaccine, same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number: UI658AA, expiry date: 30-Jun-2017 and batch number: UI657AB expiration date: 30-Jun-2017, dose, dose series, route and site of administration were not reported) on an unspecified date. It was reported that "the reporter did not have the number of patients who received which lot number". Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced upper arm redness, swelling, itching, rash, tenderness of vaccinated arm, generalized body aches, headache, neck pain, upset stomach, sore throat, fatigue and also experienced dizziness and couldn't lift the arm ("but did not know if patient was unable to move arm due to discomfort from moving arm or it was due to weakness or inability to move arm. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Death, Influenza, Lung neoplasm malignant
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 03-Oct-2016. Manufacturer Report Number: 2016444837. This case involves a female patient (age not reported) who was vaccinated with FLU SHOT (manufacturer: unknown) (batch number, expiry date reported as unknown, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and Concomitant medications were not reported (reported as none provided). On an unknown date, following the vaccination, the patient got a touch of the flu and lung cancer. The patient's laboratory data (reported as none provided) and corrective treatment was not reported. The outcome of event: flu was not reported. It was reported that patient died 11-year ago and cause of death was lung cancer. List of documents held by sender: none. Sender's Comments: This is poorly documented consumer case where influenza was reported after administration of influenza vaccine and patient died due to lung cancer. However detail autopsy report, date of death, onset of lung cancer and administration date would be helpful to assess this case further. According to provided information no conclusion can be drawn. Reported Cause(s) of Death: lung cancer.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Initial unsolicited report received from a consumer via Pfizer (reference no 2016444890) on 03 Oct 2016. This case involves a female patient who was vaccinated with a dose of FLU SHOT (Batch number, expiration date, route of administration was not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient flu like symptoms. Relevant diagnostic tests/laboratory data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Adverse event, Foetal exposure during pregnancy, Rheumatoid arthritis, Seizure
Clinical narrative: This spontaneous report as received from the mother of the patient referring male patient of unknown age (also reported as her son). No medical history and concurrent conditions were reported. On an unknown date in October 1999 the patient's mother was vaccinated with a dose of VARIVAX injection (lot number and expiry date unknown) (dosing regimen and frequency unknown) (foetal exposure during pregnancy). It was reported that the mother was not taking any medications concomitantly. On an unknown date the patient experienced different problems (adverse event) and was diagnosed with general rheumatoid arthritis (medically significant) and seizure disorder (medically significant). It was also reported that it could not be confirmed if the patient (the son) received the vaccine. The outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX was unknown. There was no product quality complaint reported. Upon internal review seizure and rheumatoid arthritis were determined to be medically significant. This case is related to case number 1610USA004331 via mother child link. Additional information has been requested.
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous report as received from the mother of the patient referring male patient of unknown age (also reported as her son). No medical history and concurrent conditions were reported. On an unknown date in October 1999 the patient's mother was vaccinated with a dose of VARIVAX injection (lot number and expiry date unknown) (dosing regimen and frequency unknown) (foetal exposure during pregnancy). It was reported that the mother was not taking any medications concomitantly. On an unknown date the patient experienced different problems (adverse event) and was diagnosed with general rheumatoid arthritis (medically significant) and seizure disorder (medically significant). It was also reported that it could not be confirmed if the patient (the son) received the vaccine. The outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX was unknown. There was no product quality complaint reported. Upon internal review seizure and rheumatoid arthritis were determined to be medically significant. This case is related to case number 1610USA004331 via mother child link. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Adverse event, Foetal exposure during pregnancy, Rheumatoid arthritis, Seizure
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 44 year old female patient regarding herself. It was reported that the patient did not have any pertinent medical history or drug reactions and allergies. On an unknown date in October 1999 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection (lot number and expiry date unknown) (dosing regimen and frequency unknown). It was also reported that the patient was pregnant at the time of the vaccination (exposure during pregnancy) but she did not know it at the time of injection, the pregnancy was confirmed at an unspecified time after the (Oka/Merck) VARIVAX was administered. It was reported that the patient was not on any medication concomitantly. On an unknown date approximately in 1999 the patient became pregnant. The Last Menstrual Period was estimated to be on an unknown date in 1999 and Estimated Date of Delivery was not known. No adverse effects were reported. The patient delivered a male infant (delivery details unspecified). The pregnancy outcome was live birth. The baby experienced [rheumatoid arthritis, seizure, Foetal exposure during pregnancy and adverse event], (which was captured in Case # 1610USA000768). The outcome of the events was unknown. There was no product quality complaint reported. This case is related to case number 1610USA000768 via mother child link. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 44 year old female patient regarding herself. It was reported that the patient did not have any pertinent medical history or drug reactions and allergies. On an unknown date in October 1999 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection (lot number and expiry date unknown) (dosing regimen and frequency unknown). It was also reported that the patient was pregnant at the time of the vaccination (exposure during pregnancy) but she did not know it at the time of injection, the pregnancy was confirmed at an unspecified time after the (Oka/Merck) VARIVAX was administered. It was reported that the patient was not on any medication concomitantly. On an unknown date approximately in 1999 the patient became pregnant. The Last Menstrual Period was estimated to be on an unknown date in 1999 and Estimated Date of Delivery was not known. No adverse effects were reported. The patient delivered a male infant (delivery details unspecified). The pregnancy outcome was live birth. The baby experienced [rheumatoid arthritis, seizure, Foetal exposure during pregnancy and adverse event], (which was captured in Case # 1610USA000768). The outcome of the events was unknown. There was no product quality complaint reported. This case is related to case number 1610USA000768 via mother child link. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling, fevered area from upper arm to elbow.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Palpitations, Pyrexia
Clinical narrative: Fever, body aches, racing heart.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Wrong drug administered
Clinical narrative: Patient given a MMR instead of a MMRV.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # K018963, expiration date 15-OCT-2016; dose and route were unknown). No adverse effects were reported. The temperature excursion included 30 minutes at -11.6 Celsius degree, 2 hours and 30 minutes at -8.7 Celsius degree, 1 hour and 30 minutes at -9.2 Celsius degree, 1 hour and 15 minutes at -9.8 Celsius degree. Data logger was involved. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date, a dose of (wistar ra 27-3) M-M-R II was reconstituted with MECACTRA instead of the diluent (wrong solution used in drug reconstitution). Then the patient was vaccinated with (wistar ra 27-3) M-M-R II (dosage, route and lot # not specified). The reporter had no heard form the patient but was somewhat confident the patient had not had any adverse events after the administration. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Flushing, Hyperhidrosis, Injection site pain
Clinical narrative: Flushing, diaphoresis, severe pain to injection site, fatigue, diarrhea. Symptoms lasted <24 hours. Still has diarrhea.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: Pain to arm radiating throughout the arm causing limitation in range of motion with weakness. Reported to Occupational Health (OHD) on 10/12/2016. Requesting to continue palliative measures and declined physician evaluation at this time.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction, Rash macular, Urticaria
Clinical narrative: Patient woke up at 3:00 AM and noticed hives on face, neck, chest and bilateral arms. She also had a big red splotchy area at injection site.
Sex: U
Vaccine: FLU4
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Initial unsolicited report received from a nurse practitioner on 30 September 2016. This case is linked to 2016SA184281. (Same vaccine, same reporter). This case involves seven patients (age and gender not reported) who were vaccinated with dose of Fluzone QIV with two different lot numbers (Batch number: UI658AA and batch number: UI657AB expiration date 30 June 2017, route of administration were not reported) in the arm on an unspecified date. It was reported that did not have number of patient who received which lot number. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions not reported. Concomitant medication was not reported. On an unspecified date, following vaccination patients experienced upper arm redness, rash, swelling, itching, tenderness of vaccinated arm, generalized body aches, headache; neck pain; upset stomach; sore throat, and fatigue. Lab data and corrective treatment were not reported. Outcome of events reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Neck pain, Oropharyngeal pain
Clinical narrative: Initial unsolicited report received from a nurse practitioner on 30 September 2016. This case is linked to 2016SA184281. (Same vaccine, same reporter). This case involves seven patients (age and gender not reported) who were vaccinated with dose of Fluzone QIV with two different lot numbers (Batch number: UI658AA and batch number: UI657AB expiration date 30 June 2017, route of administration were not reported) in the arm on an unspecified date. It was reported that did not have number of patient who received which lot number. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions not reported. Concomitant medication was not reported. On an unspecified date, following vaccination patients experienced upper arm redness, rash, swelling, itching, tenderness of vaccinated arm, generalized body aches, headache; neck pain; upset stomach; sore throat, and fatigue. Lab data and corrective treatment were not reported. Outcome of events reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Initial unsolicited report received from a nurse practitioner on 30 September 2016. This case is linked to 2016SA184281. (Same vaccine, same reporter). This case involves seven patients (age and gender not reported) who were vaccinated with dose of Fluzone QIV with two different lot numbers (Batch number: UI658AA and batch number: UI657AB expiration date 30 June 2017, route of administration were not reported) in the arm on an unspecified date. It was reported that did not have number of patient who received which lot number. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions not reported. Concomitant medication was not reported. On an unspecified date, following vaccination patients experienced upper arm redness, rash, swelling, itching, tenderness of vaccinated arm, generalized body aches, headache; neck pain; upset stomach; sore throat, and fatigue. Lab data and corrective treatment were not reported. Outcome of events reported as unknown. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU4, PPV, FLU4, PPV
Symptoms: Burning sensation, Diarrhoea, Injection site erythema, Injection site pruritus, Nausea
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 Sep 2016. This case involves a 67 year old female patient who was vaccinated with a dose of FLUZONE HD, FLUZONE QIV both were administered intramuscularly and PNEUMOVAX 23 route unknown, (Batch number, expiry date, dose and site of administration was not reported for all vaccines) on 22 Sep 2016. The patient had a medical history of nickel allergy, diabetes (PMH) and hypertension the patient illness at the time of vaccination and any other vaccinations within four weeks of vaccinations were not reported. The patient concomitant medications were not reported. On an unspecified date reported as 2-3 days later following the vaccination the patient experienced nausea, vomiting, diarrhea, itchiness and burning of face and redness and itchiness at injection site. The patient was seen by the physician on an unknown date (reported as after evaluation "the physician said that the patient was fine). The patient's lab tests and corrective treatment was not reported. The outcome of the events were reported as unknown. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU4, PPV, FLU4, PPV
Symptoms: Pruritus, Vomiting
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 Sep 2016. This case involves a 67 year old female patient who was vaccinated with a dose of FLUZONE HD, FLUZONE QIV both were administered intramuscularly and PNEUMOVAX 23 route unknown, (Batch number, expiry date, dose and site of administration was not reported for all vaccines) on 22 Sep 2016. The patient had a medical history of nickel allergy, diabetes (PMH) and hypertension the patient illness at the time of vaccination and any other vaccinations within four weeks of vaccinations were not reported. The patient concomitant medications were not reported. On an unspecified date reported as 2-3 days later following the vaccination the patient experienced nausea, vomiting, diarrhea, itchiness and burning of face and redness and itchiness at injection site. The patient was seen by the physician on an unknown date (reported as after evaluation "the physician said that the patient was fine). The patient's lab tests and corrective treatment was not reported. The outcome of the events were reported as unknown. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU4, PPV, FLU4, PPV
Symptoms: Burning sensation, Diarrhoea, Fatigue, Rash, Rash erythematous
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 Sep 2016. This case involves a 67 year old female patient who was vaccinated with a dose of FLUZONE HD, FLUZONE QIV both were administered intramuscularly and PNEUMOVAX 23 route unknown, (Batch number, expiry date, dose and site of administration was not reported for all vaccines) on 22 Sep 2016. The patient had a medical history of nickel allergy, diabetes (PMH) and hypertension the patient illness at the time of vaccination and any other vaccinations within four weeks of vaccinations were not reported. The patient concomitant medications were not reported. On an unspecified date reported as 2-3 days later following the vaccination the patient experienced nausea, vomiting, diarrhea, itchiness and burning of face and redness and itchiness at injection site. The patient was seen by the physician on an unknown date (reported as after evaluation "the physician said that the patient was fine). The patient's lab tests and corrective treatment was not reported. The outcome of the events were reported as unknown. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU4, PPV, FLU4, PPV
Symptoms: Rash pruritic
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 Sep 2016. This case involves a 67 year old female patient who was vaccinated with a dose of FLUZONE HD, FLUZONE QIV both were administered intramuscularly and PNEUMOVAX 23 route unknown, (Batch number, expiry date, dose and site of administration was not reported for all vaccines) on 22 Sep 2016. The patient had a medical history of nickel allergy, diabetes (PMH) and hypertension the patient illness at the time of vaccination and any other vaccinations within four weeks of vaccinations were not reported. The patient concomitant medications were not reported. On an unspecified date reported as 2-3 days later following the vaccination the patient experienced nausea, vomiting, diarrhea, itchiness and burning of face and redness and itchiness at injection site. The patient was seen by the physician on an unknown date (reported as after evaluation "the physician said that the patient was fine). The patient's lab tests and corrective treatment was not reported. The outcome of the events were reported as unknown. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75-year-old female patient. The patient's pertinent medical history included unspecified pain. On 06-OCT-2016 (also reported as future date 16-OCT-2016), the patient was vaccinated with PNEUMOVAX 23 lot # L038522, expiry date 11-AUG-2017, in unspecified arm (dose and route were not reported) and unspecified influenza virus vaccine in the opposite arm. Concomitant therapies included unspecified prescription pain medication. Later, on the same day (also reported as future date 16-OCT-2016), she developed myalgia in the PNEUMOVAX 23 injection arm. The patient sought medical attention by pharmacist visit. The patient came back to the pharmacy on 07-OCT-2016, and stated that could not move her arm. The pharmacist inspected the arm and there was no redness, bumps or swelling at the injection site. The patient received unspecified treatment for the events. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not provided. The pharmacist considered the event of 'could not move her arm' as disability. This is one of two reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75-year-old female patient. The patient's pertinent medical history included unspecified pain. On 06-OCT-2016 (also reported as future date 16-OCT-2016), the patient was vaccinated with PNEUMOVAX 23 lot # L038522, expiry date 11-AUG-2017, in unspecified arm (dose and route were not reported) and unspecified influenza virus vaccine in the opposite arm. Concomitant therapies included unspecified prescription pain medication. Later, on the same day (also reported as future date 16-OCT-2016), she developed myalgia in the PNEUMOVAX 23 injection arm. The patient sought medical attention by pharmacist visit. The patient came back to the pharmacy on 07-OCT-2016, and stated that could not move her arm. The pharmacist inspected the arm and there was no redness, bumps or swelling at the injection site. The patient received unspecified treatment for the events. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not provided. The pharmacist considered the event of 'could not move her arm' as disability. This is one of two reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75-year-old female patient. The patient's pertinent medical history included unspecified pain. On 06-OCT-2016 (also reported as future date 16-OCT-2016), the patient was vaccinated with PNEUMOVAX 23 lot # L038522, expiry date 11-AUG-2017, in unspecified arm (dose and route were not reported) and unspecified influenza virus vaccine in the opposite arm. Concomitant therapies included unspecified prescription pain medication. Later, on the same day (also reported as future date 16-OCT-2016), she developed myalgia in the PNEUMOVAX 23 injection arm. The patient sought medical attention by pharmacist visit. The patient came back to the pharmacy on 07-OCT-2016, and stated that could not move her arm. The pharmacist inspected the arm and there was no redness, bumps or swelling at the injection site. The patient received unspecified treatment for the events. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not provided. The pharmacist considered the event of 'could not move her arm' as disability. This is one of two reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75-year-old female patient. The patient's pertinent medical history included unspecified pain. On 06-OCT-2016 (also reported as future date 16-OCT-2016), the patient was vaccinated with PNEUMOVAX 23 lot # L038522, expiry date 11-AUG-2017, in unspecified arm (dose and route were not reported) and unspecified influenza virus vaccine in the opposite arm. Concomitant therapies included unspecified prescription pain medication. Later, on the same day (also reported as future date 16-OCT-2016), she developed myalgia in the PNEUMOVAX 23 injection arm. The patient sought medical attention by pharmacist visit. The patient came back to the pharmacy on 07-OCT-2016, and stated that could not move her arm. The pharmacist inspected the arm and there was no redness, bumps or swelling at the injection site. The patient received unspecified treatment for the events. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not provided. The pharmacist considered the event of 'could not move her arm' as disability. This is one of two reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75-year-old female patient. The patient's pertinent medical history included unspecified pain. On 06-OCT-2016 (also reported as future date 16-OCT-2016), the patient was vaccinated with PNEUMOVAX 23 lot # L038522, expiry date 11-AUG-2017, in unspecified arm (dose and route were not reported) and unspecified influenza virus vaccine in the opposite arm. Concomitant therapies included unspecified prescription pain medication. Later, on the same day (also reported as future date 16-OCT-2016), she developed myalgia in the PNEUMOVAX 23 injection arm. The patient sought medical attention by pharmacist visit. The patient came back to the pharmacy on 07-OCT-2016, and stated that could not move her arm. The pharmacist inspected the arm and there was no redness, bumps or swelling at the injection site. The patient received unspecified treatment for the events. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not provided. The pharmacist considered the event of 'could not move her arm' as disability. This is one of two reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75-year-old female patient. The patient's pertinent medical history included unspecified pain. On 06-OCT-2016 (also reported as future date 16-OCT-2016), the patient was vaccinated with PNEUMOVAX 23 lot # L038522, expiry date 11-AUG-2017, in unspecified arm (dose and route were not reported) and unspecified influenza virus vaccine in the opposite arm. Concomitant therapies included unspecified prescription pain medication. Later, on the same day (also reported as future date 16-OCT-2016), she developed myalgia in the PNEUMOVAX 23 injection arm. The patient sought medical attention by pharmacist visit. The patient came back to the pharmacy on 07-OCT-2016, and stated that could not move her arm. The pharmacist inspected the arm and there was no redness, bumps or swelling at the injection site. The patient received unspecified treatment for the events. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not provided. The pharmacist considered the event of 'could not move her arm' as disability. This is one of two reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Disability, Mobility decreased
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75-year-old female patient. The patient's pertinent medical history included unspecified pain. On 06-OCT-2016 (also reported as future date 16-OCT-2016), the patient was vaccinated with PNEUMOVAX 23 lot # L038522, expiry date 11-AUG-2017, in unspecified arm (dose and route were not reported) and unspecified influenza virus vaccine in the opposite arm. Concomitant therapies included unspecified prescription pain medication. Later, on the same day (also reported as future date 16-OCT-2016), she developed myalgia in the PNEUMOVAX 23 injection arm. The patient sought medical attention by pharmacist visit. The patient came back to the pharmacy on 07-OCT-2016, and stated that could not move her arm. The pharmacist inspected the arm and there was no redness, bumps or swelling at the injection site. The patient received unspecified treatment for the events. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not provided. The pharmacist considered the event of 'could not move her arm' as disability. This is one of two reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 75 year old male patient. There was no pertinent medical history. Information about drug reactions/allergies was unknown. On 06-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 injection (dose, frequency and route not reported, lot # L038522, expiration date: 11-AUG-2017). Concomitant therapies included unspecified influenza virus vaccine in opposite arm on 06-OCT-2016. It was reported that the patient developed myalgia in the PNEUMOVAX 23 injection arm later on the same day and he could not move the arm. The patient came back to the pharmacy on 07-OCT-2016 and stated that he couldn't move the arm. There were no redness, bumps, or swelling at the injection site when he inspected the arm. Unspecified treatment was given for the event. There were no lab diagnostic studies performed. The patient sought medical attention by pharmacy visit. At the time of reporting, the patient was not recovered from the events. The causality was not reported. The pharmacist considered that "couldn't move the arm" was a significant disability or incapacity. This is one of the two reports from the same reporter (linked to MARRS# 1610USA003570). Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 75 year old male patient. There was no pertinent medical history. Information about drug reactions/allergies was unknown. On 06-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 injection (dose, frequency and route not reported, lot # L038522, expiration date: 11-AUG-2017). Concomitant therapies included unspecified influenza virus vaccine in opposite arm on 06-OCT-2016. It was reported that the patient developed myalgia in the PNEUMOVAX 23 injection arm later on the same day and he could not move the arm. The patient came back to the pharmacy on 07-OCT-2016 and stated that he couldn't move the arm. There were no redness, bumps, or swelling at the injection site when he inspected the arm. Unspecified treatment was given for the event. There were no lab diagnostic studies performed. The patient sought medical attention by pharmacy visit. At the time of reporting, the patient was not recovered from the events. The causality was not reported. The pharmacist considered that "couldn't move the arm" was a significant disability or incapacity. This is one of the two reports from the same reporter (linked to MARRS# 1610USA003570). Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 75 year old male patient. There was no pertinent medical history. Information about drug reactions/allergies was unknown. On 06-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 injection (dose, frequency and route not reported, lot # L038522, expiration date: 11-AUG-2017). Concomitant therapies included unspecified influenza virus vaccine in opposite arm on 06-OCT-2016. It was reported that the patient developed myalgia in the PNEUMOVAX 23 injection arm later on the same day and he could not move the arm. The patient came back to the pharmacy on 07-OCT-2016 and stated that he couldn't move the arm. There were no redness, bumps, or swelling at the injection site when he inspected the arm. Unspecified treatment was given for the event. There were no lab diagnostic studies performed. The patient sought medical attention by pharmacy visit. At the time of reporting, the patient was not recovered from the events. The causality was not reported. The pharmacist considered that "couldn't move the arm" was a significant disability or incapacity. This is one of the two reports from the same reporter (linked to MARRS# 1610USA003570). Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 75 year old male patient. There was no pertinent medical history. Information about drug reactions/allergies was unknown. On 06-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 injection (dose, frequency and route not reported, lot # L038522, expiration date: 11-AUG-2017). Concomitant therapies included unspecified influenza virus vaccine in opposite arm on 06-OCT-2016. It was reported that the patient developed myalgia in the PNEUMOVAX 23 injection arm later on the same day and he could not move the arm. The patient came back to the pharmacy on 07-OCT-2016 and stated that he couldn't move the arm. There were no redness, bumps, or swelling at the injection site when he inspected the arm. Unspecified treatment was given for the event. There were no lab diagnostic studies performed. The patient sought medical attention by pharmacy visit. At the time of reporting, the patient was not recovered from the events. The causality was not reported. The pharmacist considered that "couldn't move the arm" was a significant disability or incapacity. This is one of the two reports from the same reporter (linked to MARRS# 1610USA003570). Additional information has been requested.