chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 19-JAN-2015, the patient was vaccinated with expired dose of ZOSTAVAX (expiration date was 19-OCT-2014, lot number, dose and route of administration were not provided). No adverse events were reported. Additional information is not expected because the reporter did not wish follow up contact.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV, FLU4
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received PEDIARIX (batch number 2G437, expiry date 1st July 2016), (batch number 7537C, expiry date 14th July 2016) and (batch number 7J77Y, expiry date 4th July 2016). Co-suspect products included KINRIX (batch number A75B7, expiry date 3rd September 2016), (batch number 7537C, expiry date 14th July 2016) and (batch number EP2A3, expiry date 28th June 2015)and FLULAVAL quadrivalent (batch number 2G3J4, expiry date June 2015). On an unknown date, the patient received PEDIARIX. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received KINRIX. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received FLULAVAL quadrivalent. On an unknown date, an unknown time after receiving PEDIARIX, KINRIX and FLULAVAL quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of incorrect storage of drug was unknown. Additional information: Pediatric patients were vaccinated with PEDIARIX, KINRIX and FLULAVAL QIV after exposed to 27 deg F (several lots for each vaccine).
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 36-year-old female subject was enrolled in a study. The subject received BOOSTRIX (intramuscular) .5 ml on 5th August 2014. The subject received BOOSTRIX during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information: The last menstrual period, the due date and the number of gestational weeks were not reported. This is one of the 17 cases reported by the same reporter for the same vaccine.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 39-year-old female subject was enrolled in a study. The subject received BOOSTRIX (intramuscular) .5 ml on 19th August 2014. The subject received BOOSTRIX during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information: The last menstrual period, the due date and the number of gestational weeks were not reported. This is one of the 17 cases reported by the same reporter for the same vaccine.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Chills, Fatigue, Headache, Laboratory test normal
Clinical narrative: 11/4/14: Pt reports generalize malaise and chills. 11/12/14 pt reports to ED complaining of shaking chills, headache, achiness, rash/vesicles. All lab tests within normal limits. Extreme fatigue.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Rash
Clinical narrative: 11/4/14: Pt reports generalize malaise and chills. 11/12/14 pt reports to ED complaining of shaking chills, headache, achiness, rash/vesicles. All lab tests within normal limits. Extreme fatigue.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a male patient of unknown age. The patient's pertinent medical history and drug allergies were unspecified. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Dose/Frequency: 1 injection). Concomitant medications were unspecified. On an unknown date, the patient still had a mild case of shingles. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 06-AUG-2014, the patient was vaccinated with VAQTA (lot number, dose and frequency unspecified), intramuscular. Concomitant medications were not reported. On 15-JAN-2015 the patient received another dose of VAQTA. No known adverse effects were reported. The outcome of the events was unknown. The causality of the events with VAQTA was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a unspecified patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 14-JAN-2015, the patient was vaccinated with expired dose of ZOSTAVAX (dose, frequency and route were unspecified) (lot # J003723 and expiry date: 24-JUN-2014). No symptoms were reported. No product quality complaint was reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: A few of the vaccines were exposed inappropriate temperatures rendering them unstable. Some of these vaccines were inadvertently administered to children. Patient specific and lot specific information unavailable.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 81 year old female patient. No concurrent condition was reported. No historical medication was reported. Pharmacist reported that the patient was vaccinated with 2 doses of PNEUMOVAX 23 in her left arm within 48 hours. First dose was given on 17-JAN-2015 and second dose was given on 19-JAN-2015. No concomitant medication was reported. The patient experienced no adverse effect. No PQC was involved. The outcome of patient vaccinated 2 doses of PNEUMOVAX 23 in her left arm within 48 hours was unknown. No additional information was reported at time of call. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site pain, Pain in extremity
Clinical narrative: Initial information regarding unsolicited case reported by pharmacist on 20-Sep-2013: A 27-year-old patient (gender unknown) medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number UT4725AA) through intradermal route in right deltoid on 19-Sep-2013. On 20-Sep-2013, the patient reported burning sensation at injection site and arm pain in other arm, left. The pharmacist also reported that the patient indicated second trimester pregnancy. The outcomes of the events were unknown. List of documents held by sender: none.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Pruritus, Skin warm, Tenderness
Clinical narrative: Initial report received from healthcare professional on 27 September 2013. A 42-year-old male patient received FLUZONE ID (lot number U4720BA and expiration date unknown) intradermal (site and dose number not reported) on 16 September 2013. The patient had a medical history of smoking. The concomitant medication was not reported. On 17 September 2013, the patient developed an area of induration that measured 3"x1" which was reddened and warm to touch. The patient experienced some itching and slight tenderness on palpitation. Laboratory investigation and corrective treatment were not reported. As of this report, the patient had recovered from the events. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Initial report received from a non-healthcare professional on 25-Oct-2013. A 67-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number: unknown) on arm on 30 September 2013. On 30 September 2013, patient experienced pain and numbness in the entire arm four hours of post vaccination. The events were not resolved. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Initial report received from a non-healthcare professional (patient's parent on 25 October 2013). A female patient who medical history and concomitant medication were not reported, had received a dose of Flu (Manufacturer: Sanofi, lot number: unknown, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination, the patient experienced numbness in arm and it was hurt really badly. Laboratory investigations and corrective medications were unknown. At the time of this report, the outcome was unknown. Documents held by sender: None. Follow-up information received from non-healthcare professional on 05 December 2013. The patient was 67-year-old at the time of the event. The patient received FLUZONE HD vaccine in right upper arm, batch number: U4718AA in September 2013 at 01:30 PM. On an unspecified date, the patient had received Pneumonia vaccine from other manufacturer in left upper arm. On an unspecified date, the patient had received Pneumonia vaccine from other manufacturer in left upper arm. On 30 September 2013 at 05:00 PM, the patient had experienced the events. Patient still experiencing pain and has increased from "10" to 6"-8" depending on movement. Patient is treated in the first week of December. As of this report, the patient had not recovered from the events. No laboratory investigations were done.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site erythema, Pruritus generalised, Vaccination site rash
Clinical narrative: Initial pregnancy report received from healthcare professional on 07 October 2013. A 30-year and 2 months old female patient, concomitant medication were not reported, had received a dose of FLUZONE ID (batch number UT4721AA, intradermal in the left deltoid) on 03 October 2013. the patient had bee stings allergy, adhesive, barley, hazel nuts, marijuana allergies. The patient had fibromyalgia as medical history. It was reported that after vaccination on 03 October 2013, the patient had experienced redness extending from original area of vaccination by about 2 inches, rash initially spreading down arm from vaccination location progressing to itching over entire body and face. Corrective treatment and laboratory details were not reported. At the time of this report, the patient was recovered from adverse event. Documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Nasal congestion, Pyrexia, Respiratory tract congestion
Clinical narrative: Initial report received from a nurse on 31 October 2013. A 73 year old male patient whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Lot number U4764AA, intramuscularly and site of vaccination were not reported), on 24 October 2013. On 24 October 2013, 2 hours after receiving vaccine the patient developed shortness of breath, chest congestion, nasal congestion, fever 101 to 102 chills. It was reported that fever was gone in 12 hours, as was shortness of breath, congestion lasted until next day. At the time of this report the outcome of adverse event was recovered. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Contusion, Injection site pain, Injection site pruritus, Pain in extremity
Clinical narrative: Initial report received from a healthcare provider on 23 October 2013 (local reference number 13-0720). A 51 year old female patient whose medical history reported as none, received dose one of FLUZONE ID on left upper arm (batch no: UT4723AA) (route not reported) on 11 October 2013. On 11 October 2013, the patient had soreness, itching, pain at site, arm bruising, pain around wrist and pain radiating through the whole arm. Lab investigation included observation from diabetic specialist. Corrective treatment was not reported. At the time of this report, the outcome of event was unknown. Documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Rash
Clinical narrative: Initial report received form a healthcare professional. A female patient had received an intramuscular dose of ADACEL (batch number: C44188A) in the left deltoid on 21 October 2013. The patient had also received intramuscular dose of FLUZONE HD (batch number, dose in series and site of administration was unknown) on 10 October 2013. The patient illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown and concomitant medications were not reported. On an unspecified date, the patient developed pinpoint rash on the left arm and has had some joint pain worse than her usual arthritis pain. Laboratory tests and corrective treatment were not reported. At the time of this report the patient did not recover. List of documents held by sender: None
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial report received from a consumer on 31 October 2013. A 75-year-old female patient, received dose of FLUZONE HD intramuscular in left deltoid (batch number, dose not reported). The patient's allergies were none known; no illness at time of vaccination, no medical conditions, stated does take lisinopril for elevated blood pressure and simvastatin for elevated cholesterol. The patient received numerous standard flu vaccines. The patient felt pain at time of injection but ceased after received injection. Had no symptoms the day of injection. The patient stated day after injection began to experience pain of left arm at injection site and area just below injection site. Pain has worsened and affects arm movement. Stated feels most intense pain in left arm area at night or when first gets up in morning. The patient could barely move her arm in the morning. Stated soreness does ease up during the day. The patient has not seen HCP for pain but has been trying heating pad for comfort. Stated pain in arm continues to 31 October 2013, 3 weeks after vaccination. Did not have any other symptoms. Stated she has 2 female neighbors that also received FLUZONE HD at pharmacy and one of them had nausea, vomiting and diarrhea for several days. Stated other friend experienced pain in her arm which lasted one week after vaccination and then resolved. Caller stated did not want to provide any further information for her friend's reactions after vaccination. Lab investigation and corrective treatment were not reported. At the time of this report, the patient was not recovered. Documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Inflammation, Pain in extremity, Tendonitis, X-ray normal
Clinical narrative: Initial report received from a consumer on 31 October 2013. A 75-year-old female patient, received dose of FLUZONE HD intramuscular in left deltoid (batch number, dose not reported). The patient's allergies were none known; no illness at time of vaccination, no medical conditions, stated does take lisinopril for elevated blood pressure and simvastatin for elevated cholesterol. The patient received numerous standard flu vaccines. The patient felt pain at time of injection but ceased after received injection. Had no symptoms the day of injection. The patient stated day after injection began to experience pain of left arm at injection site and area just below injection site. Pain has worsened and affects arm movement. Stated feels most intense pain in left arm area at night or when first gets up in morning. The patient could barely move her arm in the morning. Stated soreness does ease up during the day. The patient has not seen HCP for pain but has been trying heating pad for comfort. Stated pain in arm continues to 31 October 2013, 3 weeks after vaccination. Did not have any other symptoms. Stated she has 2 female neighbors that also received FLUZONE HD at pharmacy and one of them had nausea, vomiting and diarrhea for several days. Stated other friend experienced pain in her arm which lasted one week after vaccination and then resolved. Caller stated did not want to provide any further information for her friend's reactions after vaccination. Lab investigation and corrective treatment were not reported. At the time of this report, the patient was not recovered. Documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial information received from a consumer on 18 November 2013. A 75-year-old female patient who received a dose of FLUZONE HD intramuscularly (batch number and site of administration not reported) on 09 October 2013. The patient had no illness at the time of vaccination. No known allergies and no medical conditions. She takes lisinopril for elevated blood pressure and simvastatin for elevated cholesterol. On 10 October 2013, the patient had painful and inflamed arm. Her X-ray was negative. The doctor diagnosed her with tendonitis and was given steroid shot which helped her. At the time of this report, the patient had not recovered. List of documents held by sender: none. Follow up information received from non-healthcare professional on 21 January 2013. The vaccine lot number was U4714AA and no medical confirmation was provided for the case.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Inflammation, Pain in extremity, Tendonitis, X-ray normal
Clinical narrative: Initial information received from a consumer on 18 November 2013. A 75-year-old female patient who received a dose of FLUZONE HD intramuscularly (batch number and site of administration not reported) on 09 October 2013. The patient had no illness at the time of vaccination. No known allergies and no medical conditions. She takes lisinopril for elevated blood pressure and simvastatin for elevated cholesterol. On 10 October 2013, the patient had painful and inflamed arm. Her X-ray was negative. The doctor diagnosed her with tendonitis and was given steroid shot which helped her. At the time of this report, the patient had not recovered. List of documents held by sender: none. Follow up information received from non-healthcare professional on 21 January 2013. The vaccine lot number was U4714AA and no medical confirmation was provided for the case.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial information received from a healthcare professional on 25 November 2013. A 31-year-old pregnant female patient whose medical history was not reported had received a first dose of FLUZONE HD intramuscularly (batch number U4782AA) on 24 September 2013. The patient's LMP was not provided. The expected delivery date was not reported. The patient's health during pregnancy, specify risk factors (eg: alcohol, tobacco or recreational drugs) was none. The patient did not experience any event. List of documents held by sender: none. Follow up information was received from health care professional on 25 November 2013. The cases were received on 21 March 2014. The patient had received FLUZONE HD on 24 November 2013 at that time the patient was 10 week pregnant. No adverse event was reported. The expiry date of vaccine was 6 March 2014.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Pain, Pain in extremity
Clinical narrative: Initial report received from a patient on 26 November 2013. A 50 year old female patient had received a dose of FLUZONE ID (Lot number unknown, on right deltoid by intradermal route) on 26 September 2013. Medical history includes hyperthyroidism and has had numerous intradermal flu vaccines over past 20 years without reaction. Concomitant medication included SYNTHROID. On 26 September 2013, after receiving vaccine the patient experienced pain at injection site. Then pain extended to entire length from shoulder to hand. Patient stated that arm aches and also feels throbbing at muscle area at location of injection site. Patient reported that aching and pain in arm continues until (26 November 2013). At the time of this report the outcome of adverse event was not recovered. Documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Initial report received from a healthcare professional on 05 December 2013. A 34-year-old female patient had received an intradermal dose of FLUZONE (Batch number: UT4722BA, expiry date: 11-APR-2014) in the left deltoid on 05 December 2013. The patient's pre-existing disease included: asthma, hypothyroidism and migraine. The patient had previously received the FLUZONE vaccine in 2008. On 05 December 2013, 60 minutes after vaccination, the patient developed numbness and tingling in the tongue. The patient recovered from the event without medical intervention. Laboratory investigations were not reported. List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site vesicles, Nausea, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 09 December 2013. This case is invalid as patient identifiers are missing. It was reported that 4 patient, whose age at the time of event, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (lot number, site and route of vaccination were not reported) on an unspecified date. On an unknown date, the patients developed the reactions being more severe than the average reaction. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was unknown. Document held by sender: None. Follow-up information received from a healthcare professional on 08 August 2014: This case is valid as patient identifiers were available. A 60-year-old male patient had received a dose of FLUZONE ID on 29 October 2013. On 31 October 2013, the patient experienced nausea, vomiting and rash at the injections site (blisters). The symptoms resolved a week later on an unspecified date.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial report received from a healthcare professional (pharmacist) on 07 January 2014: A 73-year-old female patient with no known allergies had received second dose of FLUZONE HD, (batch number U4782AA) intramuscularly in left deltoid on 31 December 2013. The patient had received previously a dose of FLUZONE HD, (batch number, route and site of administration unknown) on an unspecified date. The patient's illness at the time of vaccination was unknown. On 01 January 2014, there was a large bright red area below the injection site 1 inch below. By 02 January 2014, the red area got larger and redder and moved as far down as the elbow. It was painful in the beginning and now was not painful. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow-up information received from healthcare professional on 28 February 2014. It was reported that, on an unspecified date of January 2014, the outcome was recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis allergic, Erythema multiforme, Rash
Clinical narrative: This is a spontaneous report from a contactable other health professional (physician's assistant) received by Pfizer from GlaxoSmithKline (Manufacturer Report No. A1056364A). A 10-week-old male patient of unknown ethnicity received PREVENAR; DTAP vaccine, (manufactured by GlaxoSmithKline) administered via an unspecified route into the thigh; RECOMBIVAX HB; Rotavirus vaccine orally; Haemophilus Influenza Type B vaccine; and Poliomyelitis vaccine inactivated all on 17Aug2013. Relevant medical history included premature birth at 27 weeks (birth weight of 01kg). The patient was not receiving concomitant medications, had no known allergies, and had not experienced any adverse events with previous vaccinations (vaccination history was not reported). On 17Aug2013, less than one day after immunizations were received, the patient experienced anaphylaxis, hives, and fever. The patient also developed throat swelling, but the reporter stated it was unclear when throat swelling had started. The patient was hospitalized due to the events anaphylaxis, hives, fever, and throat swelling and the healthcare professional considered the events to be disabling, life threatening, and clinically significant (or requiring intervention). Immunization series with DTap was delayed. Relevant laboratory data was unknown. The events anaphylaxis, hives, fever, and throat swelling resolved on an unspecified date. The healthcare professional considered the events, hives, fever, and throat swelling as probably related to PREVENAR, DTAP; Hepatitis B vaccine; Haemophilus Influenza Type B vaccine; and Poliomyelitis vaccine inactivated. Follow-up (10Apr2014): Follow-up attempts completed. No further information expected.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pyrexia, Urticaria
Clinical narrative: This is a spontaneous report from a contactable other health professional (physician's assistant) received by Pfizer from GlaxoSmithKline (Manufacturer Report No. A1056364A). A 10-week-old male patient of unknown ethnicity received PREVENAR; DTAP vaccine, (manufactured by GlaxoSmithKline) administered via an unspecified route into the thigh; RECOMBIVAX HB; Rotavirus vaccine orally; Haemophilus Influenza Type B vaccine; and Poliomyelitis vaccine inactivated all on 17Aug2013. Relevant medical history included premature birth at 27 weeks (birth weight of 01kg). The patient was not receiving concomitant medications, had no known allergies, and had not experienced any adverse events with previous vaccinations (vaccination history was not reported). On 17Aug2013, less than one day after immunizations were received, the patient experienced anaphylaxis, hives, and fever. The patient also developed throat swelling, but the reporter stated it was unclear when throat swelling had started. The patient was hospitalized due to the events anaphylaxis, hives, fever, and throat swelling and the healthcare professional considered the events to be disabling, life threatening, and clinically significant (or requiring intervention). Immunization series with DTap was delayed. Relevant laboratory data was unknown. The events anaphylaxis, hives, fever, and throat swelling resolved on an unspecified date. The healthcare professional considered the events, hives, fever, and throat swelling as probably related to PREVENAR, DTAP; Hepatitis B vaccine; Haemophilus Influenza Type B vaccine; and Poliomyelitis vaccine inactivated. Follow-up (10Apr2014): Follow-up attempts completed. No further information expected.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Allergy to vaccine, Erythema multiforme, Rash
Clinical narrative: This is a spontaneous report from a contactable other health professional (physician's assistant) received by Pfizer from GlaxoSmithKline (Manufacturer Report No. A1056364A). A 10-week-old male patient of unknown ethnicity received PREVENAR; DTAP vaccine, (manufactured by GlaxoSmithKline) administered via an unspecified route into the thigh; RECOMBIVAX HB; Rotavirus vaccine orally; Haemophilus Influenza Type B vaccine; and Poliomyelitis vaccine inactivated all on 17Aug2013. Relevant medical history included premature birth at 27 weeks (birth weight of 01kg). The patient was not receiving concomitant medications, had no known allergies, and had not experienced any adverse events with previous vaccinations (vaccination history was not reported). On 17Aug2013, less than one day after immunizations were received, the patient experienced anaphylaxis, hives, and fever. The patient also developed throat swelling, but the reporter stated it was unclear when throat swelling had started. The patient was hospitalized due to the events anaphylaxis, hives, fever, and throat swelling and the healthcare professional considered the events to be disabling, life threatening, and clinically significant (or requiring intervention). Immunization series with DTap was delayed. Relevant laboratory data was unknown. The events anaphylaxis, hives, fever, and throat swelling resolved on an unspecified date. The healthcare professional considered the events, hives, fever, and throat swelling as probably related to PREVENAR, DTAP; Hepatitis B vaccine; Haemophilus Influenza Type B vaccine; and Poliomyelitis vaccine inactivated. Follow-up (10Apr2014): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Peripheral swelling
Clinical narrative: Initial report received from a consumer (the patient) via a third party administrator on 04 August 2014. A female patient (age not reported) had received a dose of influenza vaccine (manufacturer other, batch number, dose number, route and site of administration not reported) on an unspecified date. On an unspecified date, the patient felt that the symptoms that she was having in her arm was directly related to the vaccine. No information was provided regarding the adverse event. Complementary investigations and treatments were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none. Follow-up information received from non-healthcare professional on 8 September 2014. It was reported that, a 71-year-old patient received influenza vaccine on 17 January 2014. The patient was still having swelled arm and cannot stretch or reach or lean on it or reach behind back without pain. The patient did not receive any other vaccine within 4 weeks of vaccination.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Initial report received from healthcare professional on 08 Sep 2014. A 70-year-old male patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (lot number: U4997AA, expiry: 20 Mar 2015, dose, dose number not reported) in the left deltoid on 03 Sep 2014. The patient was previously vaccinated with FLUZONE HD in the year of 2013. The patient had a medical history of urticaria due to chemical exposure (formaldehyde) four years ago. It was reported that, on 04 Sep 2014, the patient developed urticaria after receiving the FLUZONE vaccine. Information regarding physician consultation was not reported. Lab investigation details and corrective treatments were not reported. The outcome of the event was reported as unknown. Documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from healthcare professional on 11 September 2014. A 72-year-old female patient, whose medical history and concomitant medications were not reported had received an intramuscular dose of FLUZONE HD vaccine (dose number not reported, lot number: U5016BA) in left deltoid on 09 September 2014. On 10 September 2014, a day post vaccination the patient developed an injection site reaction of redness, itching, pain and swelling. The patient did not seek any medical attention. Corrective treatment and relevant laboratory data were not reported. At the time of this report, the outcome was reported as unknown. Document Held by Sender: None.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blood test normal, Computerised tomogram head normal, Cough, Hyperaesthesia
Clinical narrative: Information has been received from a nurse referring to her 13 years old daughter. The patient's drug reaction included nausea to DITROPAN. On 14-JUL-2014, the patient was vaccinated with her first dose of GARDASIL (lot# J009788, expiration date 17-MAR-2016, dose 0.5 ml) intramuscularly. And the patient developed widespread hives and swelling of her knees and elbows on 21-JUL-2014. The patient was evaluated by a physician and was prescribed prednisone. Unspecified blood work was normal. The outcome of the events was not recovered. On 07-OCT-2014, the patient was administered her second dose of GARDASIL (lot# K009202, expiration date 17-DEC-2016, dose 0.5 ml) intramuscularly. On 10-OCT-2014, the patient developed a constant cough and the patient missed 10 days of school. The patient was evaluated at a local emergency room on two separate unspecified dates. The first emergency room evaluation revealed normal unspecified blood work, normal Computerised tomogram (CT) scan of the sinuses and the patient was prescribed an unspecified antibiotic. On the second emergency room visit, the patient was prescribed albuterol. The patient was then evaluated by an unspecified homeopathic provider and was given unspecified treatments while in the office. The nurse stated her daughter's cough resolved immediately on an unknown date in approximately October 2014. The patient then developed painful spasms of her back muscles and the skin of her back became sensitive to touch on an unknown date. An unspecified neurologist evaluated the patient and all testing, including an nuclear magnetic resonance imaging (MRI) of the back, were normal. The patient continued to experience back spasms and skin sensitivity. No further information was provided. The nurse was requesting a lot check for both lots, J009788 and K009202 for GARDASIL. The patient had sought for medical attention by emergency room visits. The reporter considered the event of constant cough as significant disability since the patient missed 10 days of school. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Laboratory test normal, Muscle spasms, Nuclear magnetic resonance imaging spinal normal, Pain
Clinical narrative: Information has been received from a nurse referring to her 13 years old daughter. The patient's drug reaction included nausea to DITROPAN. On 14-JUL-2014, the patient was vaccinated with her first dose of GARDASIL (lot# J009788, expiration date 17-MAR-2016, dose 0.5 ml) intramuscularly. And the patient developed widespread hives and swelling of her knees and elbows on 21-JUL-2014. The patient was evaluated by a physician and was prescribed prednisone. Unspecified blood work was normal. The outcome of the events was not recovered. On 07-OCT-2014, the patient was administered her second dose of GARDASIL (lot# K009202, expiration date 17-DEC-2016, dose 0.5 ml) intramuscularly. On 10-OCT-2014, the patient developed a constant cough and the patient missed 10 days of school. The patient was evaluated at a local emergency room on two separate unspecified dates. The first emergency room evaluation revealed normal unspecified blood work, normal Computerised tomogram (CT) scan of the sinuses and the patient was prescribed an unspecified antibiotic. On the second emergency room visit, the patient was prescribed albuterol. The patient was then evaluated by an unspecified homeopathic provider and was given unspecified treatments while in the office. The nurse stated her daughter's cough resolved immediately on an unknown date in approximately October 2014. The patient then developed painful spasms of her back muscles and the skin of her back became sensitive to touch on an unknown date. An unspecified neurologist evaluated the patient and all testing, including an nuclear magnetic resonance imaging (MRI) of the back, were normal. The patient continued to experience back spasms and skin sensitivity. No further information was provided. The nurse was requesting a lot check for both lots, J009788 and K009202 for GARDASIL. The patient had sought for medical attention by emergency room visits. The reporter considered the event of constant cough as significant disability since the patient missed 10 days of school. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse referring to her 13 years old daughter. The patient's drug reaction included nausea to DITROPAN. On 14-JUL-2014, the patient was vaccinated with her first dose of GARDASIL (lot# J009788, expiration date 17-MAR-2016, dose 0.5 ml) intramuscularly. And the patient developed widespread hives and swelling of her knees and elbows on 21-JUL-2014. The patient was evaluated by a physician and was prescribed prednisone. Unspecified blood work was normal. The outcome of the events was not recovered. On 07-OCT-2014, the patient was administered her second dose of GARDASIL (lot# K009202, expiration date 17-DEC-2016, dose 0.5 ml) intramuscularly. On 10-OCT-2014, the patient developed a constant cough and the patient missed 10 days of school. The patient was evaluated at a local emergency room on two separate unspecified dates. The first emergency room evaluation revealed normal unspecified blood work, normal Computerised tomogram (CT) scan of the sinuses and the patient was prescribed an unspecified antibiotic. On the second emergency room visit, the patient was prescribed albuterol. The patient was then evaluated by an unspecified homeopathic provider and was given unspecified treatments while in the office. The nurse stated her daughter's cough resolved immediately on an unknown date in approximately October 2014. The patient then developed painful spasms of her back muscles and the skin of her back became sensitive to touch on an unknown date. An unspecified neurologist evaluated the patient and all testing, including an nuclear magnetic resonance imaging (MRI) of the back, were normal. The patient continued to experience back spasms and skin sensitivity. No further information was provided. The nurse was requesting a lot check for both lots, J009788 and K009202 for GARDASIL. The patient had sought for medical attention by emergency room visits. The reporter considered the event of constant cough as significant disability since the patient missed 10 days of school. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Three red raised welts on R upper arm/lateral deltoid area. No distal erythema, deformity, edema, clubbing, or cyanosis in the R UE.
Age: 19.0
Sex: M
Vaccine: TYP
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, X-ray limb
Clinical narrative: RIGHT SHOULDER PAIN RADIATING DOWN ARM THROUGH FINGERS, PAIN RATED AS A 7/10 FOR 3 TO FOUR DAYS THEN WENT COMPLETELY NUMB. WENT TO HOSPITAL FOR TREATMENT, RECEIVED VOLTAREN, AND PANTOZOL.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: Fever 102.5. joint aches, dizzy, chills, site of injection very painful, swollen and red.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever 102.5. joint aches, dizzy, chills, site of injection very painful, swollen and red.
Age: 1.26
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Computerised tomogram, Febrile convulsion, Laboratory test
Clinical narrative: Patient had a febrile seizure and was taken to the ER.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Influenza, Pain, Pyrexia
Clinical narrative: 102 FEVER CHILLS ONLY- SOAKED IN COLD TUB AND TOOK MEDICATION FOR PAIN AND FEVER PER EMPLOYEE. FLU S/S PER EMPLOYEE.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Noticed redness and swelling, not unlike countless others who receive vaccine. Was told to use allergy cream and ice for swelling, it got better. Over a month later (1/22/15) pt states her arm still hurts and can't lie down on it.
Age: 24.0
Sex: M
Vaccine: YF
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: Anaphylaxis, Hives.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Seizure
Clinical narrative: This is a spontaneous report based on information received by Pfizer from GlaxoSmithKline (Manufacturer Report Number: A1025426A). This case was reported by a physician via sales representative and described the occurrence of seizure in a child subject around 2 months of age of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline), PEDIARIX, PREVENAR (non-gsk) and PEDVAXHIB (non-gsk). On an unspecified date, around 2 months of age, the subject received first dose of ROTARIX (oral), first dose of PEDIARIX (unknown details), first dose of PREVNAR (unknown details), first dose of PEDVAXHIB (unknown details). It was not specified as to which vaccination was co-suspect to the events. No dates of administration were provided. The physician reported that the subject "got their normal schedule of pediatric vaccines (2, 4 months schedule). On an unspecified date and an unspecified time after vaccination with the first dose of ROTARIX, PEDIARIX, PEDVAXHIB, and PREVNAR, the subject experienced a seizure. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow-up (16Aug2013): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous non-valid report as received via social media (Twitter) concerning "at least 9 girls per year". It was reported that "at least 9 girls per year are killed by the GARDASIL vaccine" (strength, dose, route of administration, lot# and expiry date unspecified) (dates of injections or adverse event not specified). Additional information is not expected as all available information has been provided and there is no patients and physician's contact information and we could not do follow up with them.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Chest X-ray abnormal, Malaise, Nasopharyngitis, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting on her daughter, from a non clinical study program, PREVNAR 13. A 4-year-old female patient of an unspecified ethnicity received three dose of PREVNAR and one dose of PREVNAR 13; all on unknown dates via unspecified routes of administration at single doses. It was reported that one dose of PREVNAR was given on an unknown date in Sep2009. The patient's medical history and concomitant medications were not reported. Since an unknown date in Sep2013, the patient was sick and diagnosed with a cold which was later determined to be pneumonia. The clinical course was as follows: The patient visited the emergency where she was diagnosed with pneumonia for which she was admitted to the hospital for one night in Sep2013. Since an unknown date in 2013, the reported events worsened while on unspecified antibiotics. Relevant laboratory data included x-ray on an unknown date in Sep2013 by which she was diagnosed with pneumonia. Therapeutic measures taken in response to the pneumonia included unspecified antibiotics and prednisone since an unknown date in 2013 at an unknown dose and frequency. The clinical outcome of the event, pneumonia, was not recovered. Follow-up (30Jan2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC
Symptoms: Injection site rash, Pneumonia, Rash
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Merck sales representative, manufacturer control number: 1-9309512235. A female patient of an unspecified age and ethnicity received a dose of PREVNAR on 23Oct2013. The patient's medical history and concomitant medications were not reported. The patient developed a severe rash at the injection site which disseminated to her chest and back and it was reported that the patient was diagnosed with pneumonia. Laboratory data was unknown. Therapeutic measures, if any, taken in response to the events were unknown. The clinical outcome of the events, pneumonia, injection site rash, and rash were all unknown. Follow-up (22Jan2014): Follow-up attempts completed. No further information expected.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Ear infection
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient's mother, based on information received by Pfizer from Merck and Co., Inc. (Service Request Number: 1-8751134863). A 1-year-old female patient of an unspecified ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the mother stated that "PREVNAR did not work" because her daughter kept getting ear infections after receiving the vaccine. The clinical outcome of the events, "PREVNAR did not work" and kept getting ear infections, was unknown. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC
Symptoms: Malaise, Pneumonia
Clinical narrative: This is a spontaneous report from a non-contactable consumer from a non clinical study program. A 24-month-old female patient of an unspecified ethnicity received four doses of PREVNAR; all via unspecified routes of administration on unspecified dates at single doses. The patient's medical history and concomitant medications were not reported. Since an unknown date in Feb2008, the patient was sick and diagnosed with pneumonia for which she went to the emergency room. The events occurred after she had received the four doses of PREVNAR. Relevant laboratory data was unknown. Therapeutic measures taken in response to the events were unknown. The clinical outcome of the event, pneumonia, was unknown. No follow up attempts possible. No further information expected.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth, Lymph node pain
Clinical narrative: On 1/22/2015 My vision was extremely blurred. I had pain, swelling, and fever in my arm at the injection sight just above left elbow which radiated to armpit. By 5:00 PM my vision was somewhat better. I went to bed on 1/22/2015 around 10:30 PM. I awoke just after midnight with severe throbbing pain in my arm both at injection site and radiating up my Left arm. By morning on 1/23/2015 around 8:00 AM I awoke to severe pain and fever in my arm and a marble sized lymph node that was swollen and tender in my armpit. The pain and swelling had my left arm pretty much immobilized. On both occasions, I contacted the pharmacy where immunization for shingles was given. I was instructed by pharmacist to keep a close watch on it and call back if it became worse. The pharmacist also called me back at random times to see if I was having further reaction. No plan for treatment was discussed at this time and was assumed to be a normal reaction.