chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: House dust allergy, Hypersensitivity, Lip swelling, Pruritus, Pyrexia
Clinical narrative: Initial unsolicited case received from a healthcare professional from a local Department of Health on 04 and 05 February 2015. An 83-year-old female patient received an intramuscular left arm injection of FLUZONE (lot number UI197AA) on 30 September 2014 at 9:00 am. The patient denied pre-existing conditions or illness at time of vaccination. According to the patient's daughter, who reported the event to the healthcare professional, the patient developed a fever, cough, and shortness of breath on 01 October 2014 at 9:00 am (i.e. 24 hours post-vaccination). She was seen by her physician and prescribed an antibiotic which she had taken in the past. From November through February, the patient experienced 5 episodes of facial and lip swelling, hives, and severe itching. During each episode, the patient was treated in the emergency room with steroids, and was currently taking BENADRYL as needed. The patient's daughter had reported that "since flu vaccine mom appears to have a weakened immunity, highly sensitive to various things (peanuts, dust, fabric softener) which she had been exposed to in the past and never had a reaction". The patient was scheduled to see her physician on 06 February 2015. Outcome was unknown. Follow-up information received for this unsolicited case on 23 February 2015 from a healthcare professional. On 20 February 2015, the reporter spoke to the patient. No final diagnosis was made. The patient denied any illness at time of vaccination and any pre-existing physician-diagnosed allergies, birth defects and medical conditions. She had a full cardiac workup, X-ray, Doppler studies (results not provided). She did not have any allergy testing. The patient stated she was admitted to the hospital in October for 5 days (date provided: 30 October 2014, but unclear whether it was the admission or discharge date). She was also seen in the emergency room a few times since September. She was presently taking BENADRYL and PEPCID, and using cortisone cream PRN. She has never been seen by an allergist, and was under the care of an internist. Daughter had stated patient was initially prescribed an antibiotic, but patient denied taking any antibiotic. Patient was due to call the internist's office for an appointment. She was improving slowly. Documents held by sender: None. Follow-up information received from a physician on 13 April 2015 and on 14 April 2015. It was reported that patient was admitted on 30 October 2014 for chest pain and discharged on 03 November 2014. The reporter stated that he did not think the patient had any weakened immunity or other side effect from flu shot. The outcome of the event chest pain was unknown and patient was recovering from other events. Documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swelling face, Ultrasound Doppler, Urticaria, X-ray
Clinical narrative: Initial unsolicited case received from a healthcare professional from a local Department of Health on 04 and 05 February 2015. An 83-year-old female patient received an intramuscular left arm injection of FLUZONE (lot number UI197AA) on 30 September 2014 at 9:00 am. The patient denied pre-existing conditions or illness at time of vaccination. According to the patient's daughter, who reported the event to the healthcare professional, the patient developed a fever, cough, and shortness of breath on 01 October 2014 at 9:00 am (i.e. 24 hours post-vaccination). She was seen by her physician and prescribed an antibiotic which she had taken in the past. From November through February, the patient experienced 5 episodes of facial and lip swelling, hives, and severe itching. During each episode, the patient was treated in the emergency room with steroids, and was currently taking BENADRYL as needed. The patient's daughter had reported that "since flu vaccine mom appears to have a weakened immunity, highly sensitive to various things (peanuts, dust, fabric softener) which she had been exposed to in the past and never had a reaction". The patient was scheduled to see her physician on 06 February 2015. Outcome was unknown. Follow-up information received for this unsolicited case on 23 February 2015 from a healthcare professional. On 20 February 2015, the reporter spoke to the patient. No final diagnosis was made. The patient denied any illness at time of vaccination and any pre-existing physician-diagnosed allergies, birth defects and medical conditions. She had a full cardiac workup, X-ray, Doppler studies (results not provided). She did not have any allergy testing. The patient stated she was admitted to the hospital in October for 5 days (date provided: 30 October 2014, but unclear whether it was the admission or discharge date). She was also seen in the emergency room a few times since September. She was presently taking BENADRYL and PEPCID, and using cortisone cream PRN. She has never been seen by an allergist, and was under the care of an internist. Daughter had stated patient was initially prescribed an antibiotic, but patient denied taking any antibiotic. Patient was due to call the internist's office for an appointment. She was improving slowly. Documents held by sender: None. Follow-up information received from a physician on 13 April 2015 and on 14 April 2015. It was reported that patient was admitted on 30 October 2014 for chest pain and discharged on 03 November 2014. The reporter stated that he did not think the patient had any weakened immunity or other side effect from flu shot. The outcome of the event chest pain was unknown and patient was recovering from other events. Documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Chest X-ray, Chest pain, Differential white blood cell count, Dizziness
Clinical narrative: At noon of 4/13/15 dizzy, fever, tired, weak. Went to ER at 8:30pm because fever was over 102 degrees. At this time having tremors, severe headache and temperature over 103 degrees. Told to treat the symptoms, left ER at 11:50 pm. 4/14/15 in morning having chest tightness, shortness of breath, muscle cramps at 7 AM. Went back to ER, ran tests, EKG, Chest Xray, blood work. Fever returned around noon. Gave her motrin and prednisone. Left ER around 3:30 PM.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram, Full blood count, Lethargy, Migraine, Muscle spasms
Clinical narrative: At noon of 4/13/15 dizzy, fever, tired, weak. Went to ER at 8:30pm because fever was over 102 degrees. At this time having tremors, severe headache and temperature over 103 degrees. Told to treat the symptoms, left ER at 11:50 pm. 4/14/15 in morning having chest tightness, shortness of breath, muscle cramps at 7 AM. Went back to ER, ran tests, EKG, Chest Xray, blood work. Fever returned around noon. Gave her motrin and prednisone. Left ER around 3:30 PM.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Tremor
Clinical narrative: At noon of 4/13/15 dizzy, fever, tired, weak. Went to ER at 8:30pm because fever was over 102 degrees. At this time having tremors, severe headache and temperature over 103 degrees. Told to treat the symptoms, left ER at 11:50 pm. 4/14/15 in morning having chest tightness, shortness of breath, muscle cramps at 7 AM. Went back to ER, ran tests, EKG, Chest Xray, blood work. Fever returned around noon. Gave her motrin and prednisone. Left ER around 3:30 PM.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Blood test, Chest X-ray, Chest discomfort, Dizziness
Clinical narrative: At noon of 4/13/15 dizzy, fever, tired, weak. Went to ER at 8:30pm because fever was over 102 degrees. At this time having tremors, severe headache and temperature over 103 degrees. Told to treat the symptoms, left ER at 11:50 pm. 4/14/15 in morning having chest tightness, shortness of breath, muscle cramps at 7 AM. Went back to ER, ran tests, EKG, Chest Xray, blood work. Fever returned around noon. Gave her motrin and prednisone. Left ER around 3:30 PM.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Electrocardiogram, Fatigue, Headache, Muscle spasms
Clinical narrative: At noon of 4/13/15 dizzy, fever, tired, weak. Went to ER at 8:30pm because fever was over 102 degrees. At this time having tremors, severe headache and temperature over 103 degrees. Told to treat the symptoms, left ER at 11:50 pm. 4/14/15 in morning having chest tightness, shortness of breath, muscle cramps at 7 AM. Went back to ER, ran tests, EKG, Chest Xray, blood work. Fever returned around noon. Gave her motrin and prednisone. Left ER around 3:30 PM.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: On 4/1/15 AM patient experienced swelling 2-3 inches above elbow on administration arm (left arm). No sign or symptoms at administration site. Patient soaked arm in Epsom salt 2x and swelling went down. When patient notified us on 4/13/15 swelling is gone but area is still a little sore and sensitive.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 09-APR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 15-APR-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with doses of (Merck) VARIVAX, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 17-APR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 20-APR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Agitation, Hyperventilation
Clinical narrative: This spontaneous report as received from a mother reporting on her 5 year old son. On an unknown date, the patient was vaccinated with M-M-R II (dose, route, lot # not provided). On an unknown date, 4 weeks after vaccination, the patient started having repeated, unspecified time duration of deep breathing when he was at rest. Moreover he was experiencing unspecified time duration of being agitated. The patient did not seek medical attention. The outcome of the events and suspect product was not specified. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 01-APR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored dose of PROQUAD (Merck) (dose, dose number, frequency, route of administration, lot# and expiration date were not reported). No information on patients concomitant medication was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: Mom reports pt developed face paralysis (unknown side) 1 day after rcvng HPV. Was seen in ER 4/16/15 and dx Bell's Palsy with no noted correlation.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse via pharmaceutical companies refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX23, lot number, expiration date, dose and route of administration not reported. On an unknown ate, the patient experienced redness, pain and swelling at the injection site. The physician felt this was a more severe reaction than a normal local reaction. The reporter wanted to know whether the patient could receive PREVNAR 13. The outcome of redness, pain, and swelling at the injection site was unknown. The relatedness between the events and vaccination with PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Injection site rash
Clinical narrative: Pt was given Typhoid (left deltoid) and Hep A (rt deltoid) on 03/30/15. He had a growing rash that developed first on his rt deltoid on 04/13/15 and was seen in a local urgent care a few days later after OTC Benadryl and steroid cream weren't working. He received steroids that are helping. He had previously never had either vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: ITCHING THEN ABOUT 30 MINUTES LATER A RED RASH APPEARED ON MY ARMS, LEGS, CHEST AREA.   MY DOCTOR TOLD ME TO TAKE OVER THE COUNTER BENADRYL AND IF A BOOSTER WAS EVER OFFERED IN THE FUTURE NOT TO GET IT, AS THE REACTION COULD BE EVEN WORSE.
Age: 37.0
Sex: F
Vaccine: ANTH, MMR, TYP
Symptoms: Dyspnoea, Erythema, Fatigue, Injection site erythema, Injection site nodule
Clinical narrative: Migraine and fatigue on the day of vaccination. Reported on 23 April 2015, rash and redness to the right neck, swollen lymph nodes to the right neck. Prev Med nurse reported 80mm redness and nodule to the left upper arm near injection site. Small bumps to bilateral upper portion of face. Complain of difficulty of breathing for one night. Complain of itchy to the left arm.
Age: 37.0
Sex: F
Vaccine: ANTH, MMR, TYP
Symptoms: Lymphadenopathy, Migraine, Pruritus, Rash
Clinical narrative: Migraine and fatigue on the day of vaccination. Reported on 23 April 2015, rash and redness to the right neck, swollen lymph nodes to the right neck. Prev Med nurse reported 80mm redness and nodule to the left upper arm near injection site. Small bumps to bilateral upper portion of face. Complain of difficulty of breathing for one night. Complain of itchy to the left arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 13-APR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abnormal behaviour, Aggression, Crying, Injection site pain
Clinical narrative: Mom states child had behavioral changes after vaccines. She states child cried, very unreasonable and argumentative for 2 hours. After 2 hours the child fell asleep and when woke was fine and acted normal. Both injection sites were painful x 48hrs.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. This 77 years old female consumer received PREVENAR 13 on 19Mar2015, intramuscular, in left arm, at 0.5 ml single. Concomitant medications included KLOR-CON tablet once a day ongoing, atorvastatin tablet once a day for high blood pressure, aspirin small dose once a day ongoing, atenolol (Zydus Pharmacy) at 25 mg once a day for high blood pressure (she has been taking it for years) ongoing, vitamin D at 1000 mg, 1x/day ongoing, LEVOTHYROX 75mg, 0.5 tablet daily Monday through Saturday and 1 whole tablet on Sunday for low thyroid ongoing, chlorthalidone (manufacturer Mylan) 0.5 pill by mouth every other day and unspecified senior citizen vitamin once daily ongoing, and fish oil. Medical history included ongoing blood pressure high, fell and hurt left elbow (that bled for a week because of the blood thinner she took), 2 foot surgeries (she has titanium in both feet), hysterectomy, ongoing low thyroid and terrible headaches all her life until she took atenolol and she did not have them anymore. The patient stated that when she took a whole pill of chlorthalidone, it made her dizzy, so they decreased the dosage; this happened over 4 years ago; Doctor was aware of symptoms. On 19Mar2015 the vaccinated arm was mildly sore. On 26Mar2015, 8 days later she noticed a big, red 3.5 inch circle mark slightly painful and slightly swollen, but not tremendously painful. Both of these events involved admission to hospital. The patient was supposed to go back to doctor to get a different Pneumonia shot and was wondering if she should get it after experiencing the above symptoms. Doctor was not aware of her symptoms. The patient was recovered from the events at the time of report. Follow-up (27Mar2015): New information from a contactable consumer included vaccination date and onset date corrected to 19Mar2015, concomitant product fish oil. Follow-up (13Apr2015): Additional information received from the contactable consumer includes therapy duration of concomitant drugs and outcome. Case upgraded to serious due to hospitalization. Follow-up attempts are completed. No further information is expected.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Arthritis, Asthenia, Crying, Lyme disease
Clinical narrative: This is a spontaneous report based on information received by Pfizer from GlaxoSmithKline (Reference number: 492166-1325823943). A contactable consumer (consumer's father) reported for his female daughter as follows: "First of all, I suggest this email be recorded and sent to your legal department pursuant to the lawsuit which will be filed by my family/child (who at 12 months old) received a dose of PREVNAR as a vaccine to prevent Lymes disease. My child has not only had Lymes disease at a very young age, but continues to have it at age 15 and throughout her entire life with debilitating symptoms and many hospital visits. Your company removed this vaccine after a few short years and we know this to be responsible for our beautiful, otherwise healthy girl's, Lyme problems. Prior to contacting a high profile lawyer to handle our case on a pro-bono arrangement, we are giving your company the opportunity to settle this case in a clearly reasonable manner. It is unfortunate that you will probably fight this in court, but we are not going to stop fighting and letting the world know the true reasons this vaccine was taken off the market. This email is our first to you and your legal department and will be forwarded to our lawyer also, in the event that such a settlement is not immediately remedied, causing severe Lyme symptoms as well as arthritic conditions in an otherwise born healthy and beautiful baby girl. I expect an immediate response and my daughter is currently in the hospital again being treated with high doses of antibiotics. We know this is, and has been, the cause of her problems for years, but just found her 12 month old vaccination forms proving this vaccine was given to her by her pediatrician. We are tired of watching our daughter cry and suffer everyday from Lyme which she should have never been exposed to as a 12 month old child."
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 06-APR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mitral valve repair
Clinical narrative: This spontaneous report was received from a physician and refers to an approximately 38 year old male patient with no pertinent medical history and no drug reaction/allergy. Concomitant therapies included losartan potassium (manufacturer unknown), metoprolol and aspirin. On an unknown date, when he was a child, the patient was vaccinated with M-M-R II (therapy type: HSA, dose, route of administration, lot number and expiry date were not reported). On an unspecified date in 2003, the patient had a mitral valve repairment due to an unknown event. In approximately 2003, the patient was hospitalized in the reporting physician's hospital. the outcome of an unknown event that led to mitral valve repairment was not reported. On 17-FEB-2015, the patient's measles titers were drawn and were low. The patient sought medical attention (saw a physician). The outcome of low measles titer was not reported. The relatedness between the vaccination and the adverse events was not reported. Under internal review the an unknown event that led to mitral valve repairment was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, TDAP
Symptoms: Abdominal pain upper, Headache, Influenza A virus test negative, Influenza virus test negative, Malaise
Clinical narrative: Dad said patient went home from school 4-17-15 with a migraine in the morning. Received immunizations 4-17-15 at 1600. Mom said he started hot feeling well 4-17-15 around 1900, while they were out to eat. 4-18-15 woke up around 1000 with fever 104. Patient was seen in urgent care around 1200 with fever, headache, stomach ache. He was seen again 4-19-15 in the ER for fever at 2130. On 4-22-15 he was seen in the clinic for continues fevers. Continues to run fever off and on.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, TDAP
Symptoms: Mononucleosis heterophile test negative, Pyrexia, Streptococcus test negative, White blood cell count normal
Clinical narrative: Dad said patient went home from school 4-17-15 with a migraine in the morning. Received immunizations 4-17-15 at 1600. Mom said he started hot feeling well 4-17-15 around 1900, while they were out to eat. 4-18-15 woke up around 1000 with fever 104. Patient was seen in urgent care around 1200 with fever, headache, stomach ache. He was seen again 4-19-15 in the ER for fever at 2130. On 4-22-15 he was seen in the clinic for continues fevers. Continues to run fever off and on.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Erythema, Skin warm, Swelling
Clinical narrative: 5-6 cm area of swelling, erythema, warmth. Lasted 3 days. Then bruising lasting 5 weeks.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Myalgia
Clinical narrative: Severe joint and muscle pain in hip and lower back.  Continuous since date of onset.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: PT HAS ACQUIRED LARGE LOCALIZED REACTION MEASURING 3 BY 3 INCHES AT SITE OF ADMINISTRATION. PT HAS STATED THAT THE AREA FEELS VERY ITCHY, THE AREA IS TENDER. PT HAS TAKING ANTIHISTIMINE'S TO CONTROL SWELLING AT ITCHING.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Formication, Injection site reaction, Miliaria
Clinical narrative: Redness to skin, prickly heat at injection site, skin "crawling".
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Fatigue, Headache, Incorrect route of drug administration, Injection site warmth
Clinical narrative: Pain, redness, swelling, malaise, headache, sore throat, itching, hot at injection sight, fatigued, pain upon movement with some immobility, injection given sub q instead of IM.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Malaise, Mobility decreased, Oropharyngeal pain, Pain, Pruritus
Clinical narrative: Pain, redness, swelling, malaise, headache, sore throat, itching, hot at injection sight, fatigued, pain upon movement with some immobility, injection given sub q instead of IM.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Swelling
Clinical narrative: Pain, redness, swelling, malaise, headache, sore throat, itching, hot at injection sight, fatigued, pain upon movement with some immobility, injection given sub q instead of IM.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Pulmonary congestion
Clinical narrative: Based on Significant Correction performed on 03-FEB-2015, this case initially considered as non-serious was upgraded to serious as the modified event term 'Pulmonary Congestion' existed in IME List. Initial report received from healthcare professional on 4 December 2014. A 30-year-old male patient, whose concomitant medications were not reported, had received first dose of FLUZONE (batch number UI198AD, intramuscular and anatomical site of administration was not reported) having expiry date 30 June 2015 on 3 December 2014. The patient is allergic to penicillin and hydrocodone. It was reported that on 3 December 2014, on the same day after receiving FLUZONE vaccine, the patient experienced chest congestion. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: None. Follow-up information received from the healthcare professional on 03-Feb-2015. Patient was vaccinated with FLUZONE intramuscularly in left arm on 03-Dec-2014. Lab investigations were reported as unknown. Corrective treatments were reported as CRESTOR (10 mg) and Sertraline (100 mg). Patient appears fine now and no lasting adverse effects were reported. Documents held by sender: none. Addendum on 03-FEB-2015: Upon second medical examination of case at time of internal review a significant correction was performed to change the event coding for 'chest congestion' from respiratory tract congestion to pulmonary congestion. As the event was present in IME list, seriousness criteria and company assessment added to the case; however listedness remains the same.
Age: 46.0
Sex: F
Vaccine: IPV
Symptoms: Cough, Emphysema, Fatigue, Injection site erythema, Paranasal sinus hypersecretion
Clinical narrative: Based on the additional information received on 13 April 2015, this case initially considered as non-serious was upgraded to serious due to important medical events: upper respiratory infection, cough, fever, scratchy in throat, sinus disorder, fatigue and mild emphysema. Initial unsolicited report received from a nurse on 26 February 2015. A 46-year-old female patient had received first dose of 0.1 ml of IPOL (batch number, expiry date was not reported) via intradermal route in right forearm on 24 February 2015. Patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical condition was unknown and concomitant medications were not reported. On 24 February 2015 same day after vaccination, the patient developed redness at the injection site. The patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. On an unknown date the patient was recovered from the event (duration was reported as 15 minutes). Documents held by sender: none. Follow-up information received from health care professional on 13 April 2015. The patient was also administered with TUBERCULIN PPD (TB:PPD) (batch number: 720409, expiry date: 6 April 2015) via intradermal route in left forearm on 24 February 2015. The patient had a history of emphysema and hereditary history of asthma. On 24 February 2015, patient experienced hives. On 27 February 2015, the patient required doctor's visit in which patient was diagnosed with cough, sinus drainage, fever, fatigue, lungs hurt, feels scratchy in throat. The patient had not received any other vaccinations four weeks prior to this vaccination. Patient did not have any illness at the time of vaccination. The time at which vaccine administered and event occurred, patient details were updated. The state and country where vaccine administered was updated. The patient was prescribed with Azithromycin as corrective treatment. At the time of this report, on 25 February 2015, the patient was recovered from the hives. Outcome of the other events were unknown as patient did not present for the follow up however the nurse assumed that the patient was recovered. Document held by sender: None.
Age: 46.0
Sex: F
Vaccine: IPV
Symptoms: Pulmonary pain, Pyrexia, Sinus disorder, Throat irritation, Upper respiratory tract infection
Clinical narrative: Based on the additional information received on 13 April 2015, this case initially considered as non-serious was upgraded to serious due to important medical events: upper respiratory infection, cough, fever, scratchy in throat, sinus disorder, fatigue and mild emphysema. Initial unsolicited report received from a nurse on 26 February 2015. A 46-year-old female patient had received first dose of 0.1 ml of IPOL (batch number, expiry date was not reported) via intradermal route in right forearm on 24 February 2015. Patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical condition was unknown and concomitant medications were not reported. On 24 February 2015 same day after vaccination, the patient developed redness at the injection site. The patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. On an unknown date the patient was recovered from the event (duration was reported as 15 minutes). Documents held by sender: none. Follow-up information received from health care professional on 13 April 2015. The patient was also administered with TUBERCULIN PPD (TB:PPD) (batch number: 720409, expiry date: 6 April 2015) via intradermal route in left forearm on 24 February 2015. The patient had a history of emphysema and hereditary history of asthma. On 24 February 2015, patient experienced hives. On 27 February 2015, the patient required doctor's visit in which patient was diagnosed with cough, sinus drainage, fever, fatigue, lungs hurt, feels scratchy in throat. The patient had not received any other vaccinations four weeks prior to this vaccination. Patient did not have any illness at the time of vaccination. The time at which vaccine administered and event occurred, patient details were updated. The state and country where vaccine administered was updated. The patient was prescribed with Azithromycin as corrective treatment. At the time of this report, on 25 February 2015, the patient was recovered from the hives. Outcome of the other events were unknown as patient did not present for the follow up however the nurse assumed that the patient was recovered. Document held by sender: None.
Age: 46.0
Sex: F
Vaccine: IPV
Symptoms: Urticaria
Clinical narrative: Based on the additional information received on 13 April 2015, this case initially considered as non-serious was upgraded to serious due to important medical events: upper respiratory infection, cough, fever, scratchy in throat, sinus disorder, fatigue and mild emphysema. Initial unsolicited report received from a nurse on 26 February 2015. A 46-year-old female patient had received first dose of 0.1 ml of IPOL (batch number, expiry date was not reported) via intradermal route in right forearm on 24 February 2015. Patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical condition was unknown and concomitant medications were not reported. On 24 February 2015 same day after vaccination, the patient developed redness at the injection site. The patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. On an unknown date the patient was recovered from the event (duration was reported as 15 minutes). Documents held by sender: none. Follow-up information received from health care professional on 13 April 2015. The patient was also administered with TUBERCULIN PPD (TB:PPD) (batch number: 720409, expiry date: 6 April 2015) via intradermal route in left forearm on 24 February 2015. The patient had a history of emphysema and hereditary history of asthma. On 24 February 2015, patient experienced hives. On 27 February 2015, the patient required doctor's visit in which patient was diagnosed with cough, sinus drainage, fever, fatigue, lungs hurt, feels scratchy in throat. The patient had not received any other vaccinations four weeks prior to this vaccination. Patient did not have any illness at the time of vaccination. The time at which vaccine administered and event occurred, patient details were updated. The state and country where vaccine administered was updated. The patient was prescribed with Azithromycin as corrective treatment. At the time of this report, on 25 February 2015, the patient was recovered from the hives. Outcome of the other events were unknown as patient did not present for the follow up however the nurse assumed that the patient was recovered. Document held by sender: None.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Nausea, Vomiting
Clinical narrative: Patient developed nausea/vomiting shortly after receiving vaccine.  He also spiked a temperature of 104.9.  He was given acetaminophen, which decreased his temp slightly, but it was still over 103 for a couple hours post developing the reaction.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Pain, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Rash, difficulty breathing, hives, pain, red bumps all over her body.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Feeling of despair, Nightmare
Clinical narrative: Triggered nightmares leading to severe state of the feeling of complete and total hopelessness.  I called my psychologist for this felt exactly like it did when I had a reaction to Venaflaxine in 2009 which lead to me being suicidal within 24 hours of use of that medication.  The complete despair I felt on the 20th was that same type of despair and hopelessness to the point that I started thinking about ending my life..but again, knew I was in trouble and got help.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blood test, Computerised tomogram, Crying, Headache
Clinical narrative: Patient began to experience a high pressure headache and vision disturbances.  Over the period of the following weeks, the condition worsened to the point that patient was unable to attend school.  Because of patient's deafness, anything related to her vision is especially concerning.  The headaches continued to get worse to the point of her crying in pain.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lumbar puncture, Neurological examination, Ophthalmological examination, Pain, Ultrasound scan
Clinical narrative: Patient began to experience a high pressure headache and vision disturbances.  Over the period of the following weeks, the condition worsened to the point that patient was unable to attend school.  Because of patient's deafness, anything related to her vision is especially concerning.  The headaches continued to get worse to the point of her crying in pain.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: Patient began to experience a high pressure headache and vision disturbances.  Over the period of the following weeks, the condition worsened to the point that patient was unable to attend school.  Because of patient's deafness, anything related to her vision is especially concerning.  The headaches continued to get worse to the point of her crying in pain.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown ages and gender. On unknown dates improperly stored doses of (Merck) VARIVAX (strength, lot#, dosage and frequency unspecified) were administered to the patients. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity, Paralysis
Clinical narrative: Initial unsolicited report received from a healthcare professional on 14-Apr-2014. A female patient, whose medical history and concomitant medications were not reported had received a dose of Tetanus toxoid (batch number, expiry date, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient became paralyzed for a 3-4 days and allergy. Upon internal review, the case is considered as serious due to important medical event (Paralysis). Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome for event paralyzed for 3-4 days was recovered and for allergy was unknown. Documents held by sender: none.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No concurrent or historic conditions were reported. On 15-APR-2015, the patient was vaccinated with ZOSTAVAX (lot # K016324, expiration date 24-DEC-2015) 0.65 ml, subcutaneous. In the morning of 17-APR-2015, 3 days after onset of therapy, the patient noticed swelling, redness and warmth at injection site and. The patient sought medical attention by contacting the pharmacist. The outcome of swelling, redness, warmth at the injection site was reported as not recovered/not resolved. The reporter did not assessed serious criteria for this case. No further information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 06-MAR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from an office manager referring to a 27 year old patient of unknown gender. Information regarding concurrent conditions and medical history was not provided. On 02-MAR-2015 the patient was 26 year old and was vaccinated with the first dose of GARDASIL intramuscularly (dose, lot # and application site were not reported). On 06-APR-2015, the patient was 27 years old and was vaccinated with the second dose of GARDASIL, intramuscularly (dose, lot # and application site were not reported (inappropriate schedule of drug administration). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain of skin, Product quality issue, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from an approximately 62 year old female consumer who was reporting on herself. The patient's medical history and concurrent conditions were not reported. The patient reported that she had drug reactions to pain killers which upset her stomach and many of them caused her hair fail out, including ibuprofen, ketoprofen or made her vomit, including codeine. In October 2014 (exact date not provided), the patient was vaccinated with a single dose of ZOSTAVAX, subcutaneous, lot # J01335, dose 0.65 ml, (injection site and expiration date were not reported). Concomitant therapies included simvastatin (manufacturer unknown). On 27-MAR-2015, the patient developed a "shingles-like rash and blisters". The patient stated that the rash and blisters were "very, very painful, red, and her skin felt like it was burning. Anything that touched her skin, it hurt". The patient sought medical attention via seeing an unspecified nurse. No lab diagnostic studies were performed. No treatment was given for the adverse events due to the patient's reaction to pain killers. The outcome of the events was reported as not recovered at the time of the report. Relatedness between the events and ZOSTAVAX was not reported. The patient believed that the batch she received "was defective" and requested a lot check. Additional information is not expected, because the patient did not give permission to contact her physician for further information.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin burning sensation
Clinical narrative: This spontaneous report was received from an approximately 62 year old female consumer who was reporting on herself. The patient's medical history and concurrent conditions were not reported. The patient reported that she had drug reactions to pain killers which upset her stomach and many of them caused her hair fail out, including ibuprofen, ketoprofen or made her vomit, including codeine. In October 2014 (exact date not provided), the patient was vaccinated with a single dose of ZOSTAVAX, subcutaneous, lot # J01335, dose 0.65 ml, (injection site and expiration date were not reported). Concomitant therapies included simvastatin (manufacturer unknown). On 27-MAR-2015, the patient developed a "shingles-like rash and blisters". The patient stated that the rash and blisters were "very, very painful, red, and her skin felt like it was burning. Anything that touched her skin, it hurt". The patient sought medical attention via seeing an unspecified nurse. No lab diagnostic studies were performed. No treatment was given for the adverse events due to the patient's reaction to pain killers. The outcome of the events was reported as not recovered at the time of the report. Relatedness between the events and ZOSTAVAX was not reported. The patient believed that the batch she received "was defective" and requested a lot check. Additional information is not expected, because the patient did not give permission to contact her physician for further information.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Asthenia, Chest discomfort, Chills, Cough
Clinical narrative: Cough, diarrhea, fever, headache, loss of appetite, muscle aches, sneezing, sore throat, vomiting, body aches, chills, difficulty breathing, earache, loss of voice, shivering, tightness in chest, unusual tiredness, weakness, difficulty swallowing.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Diarrhoea, Dysphagia, Dyspnoea, Ear pain
Clinical narrative: Cough, diarrhea, fever, headache, loss of appetite, muscle aches, sneezing, sore throat, vomiting, body aches, chills, difficulty breathing, earache, loss of voice, shivering, tightness in chest, unusual tiredness, weakness, difficulty swallowing.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: Cough, diarrhea, fever, headache, loss of appetite, muscle aches, sneezing, sore throat, vomiting, body aches, chills, difficulty breathing, earache, loss of voice, shivering, tightness in chest, unusual tiredness, weakness, difficulty swallowing.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Sneezing, Vomiting
Clinical narrative: Cough, diarrhea, fever, headache, loss of appetite, muscle aches, sneezing, sore throat, vomiting, body aches, chills, difficulty breathing, earache, loss of voice, shivering, tightness in chest, unusual tiredness, weakness, difficulty swallowing.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Chest scan, Foaming at mouth, Lip discolouration, Scan, Scan brain
Clinical narrative: My daughter convulsed, turned grey, lips turned purple, bubbles and foam were coming out of her mouth. She was unresponsive and transported to the hospital by ambulance. She was in the hospital for four days.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: My daughter convulsed, turned grey, lips turned purple, bubbles and foam were coming out of her mouth. She was unresponsive and transported to the hospital by ambulance. She was in the hospital for four days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypotonia, Opisthotonus
Clinical narrative: After shots were given, client asked to be picked up, mother did so, when mother picked her up she then went limp and bent backward. Mother states she awoke fast. Client was then offered water and crackers.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a 12 months old patient of unknown gender. There was no information regarding concurrent condition and historical medication. On 17-APR-2015, the patient was vaccinated with expired dose of PROQUAD (Merck), lot# J010159, expiration date-23-FEB-2015. No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.