chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Computerised tomogram, Intestinal resection, Intussusception
Clinical narrative: This spontaneous report as received from a physician refers to a two and a half month old female patient. The patient was vaccinated with first dose of ROTATEQ (lot number not reported) orally on 29-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. A few weeks later, in approximately January 2013, the patient was diagnosed and treated for intussusception. The patient was operated on at medical center and part of the patient's bowel was removed because of the AE. The patient had done a CAT scan on an unspecified date. The patient was improved after the operation and recovered on an unspecified date. The relatedness for the event was unknown for ROTATEQ. The reporter felt the events was intervention to prevent serious criteria. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Fatigue, Musculoskeletal stiffness, Myalgia
Clinical narrative: Fatigue, muscle and joint pain, fever, painfully chills.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Fatigue, muscle and joint pain, fever, painfully chills.
Age: 52.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Chills, Headache, Immediate post-injection reaction, Oropharyngeal pain, Sinus congestion
Clinical narrative: Chills within moments after injection. Sore throat within one hour. Headache within three hours. Sinus congestion within six hours.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Autopsy, Death
Clinical narrative: No documentation of any problem. Have received word autopsy done - "child died of natural causes."
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Pt developed redness, mild edema at site of MMRV vaccine on 2/5/13. Approximately 2cm area of redness and induration at site on 2/6/13. Prescribed diphenhydramine and Triamcinolone cream.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 76 years old female patient. The patient's medical history included shingles rash. the patient was vaccinated with ZOSTAVAX in early November 2012. Patient route of administration and lot no. were not provided. No other co-suspects were reported. No concomitant medications were reported. The patient developed an itchy sensation on her back after receiving vaccination with ZOSTAVAX. It started gradually since receiving the vaccine. She explained that the sensation is in a patch of space on her back and is not indicated by any changes in the skin. The patch is located in the same location as a previous shingles rash she'd developed 2 years ago, prior to receiving the vaccine. The patient did not seek medical attention. Treatment included ice and OTC itch creams. The outcome of developed an itchy sensation on her back after receiving ZOSTAVAX is unknown. The relatedness for developed an itchy sensation on her back after receiving ZOSTAVAX is unknown for ZOSTAVAX. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Uterine dilation and evacuation
Clinical narrative: Had miscarriage.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Soreness in muscle at injection site persisting (at time of this filing, one month after vaccination).
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-01-16.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Convulsion, Epilepsy
Clinical narrative: Epilepsy NOS w/ intr epil 2012-12-23, clinician comment: known seizure disorder, well controlled with TEGRETOL, about two weeks after flu vaccine had a breakthrough seizure.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever NOS on 2013-01-16, clinician comment: Fever less than 24 hrs after vaccination, no focus, no sign of illness.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Nonspecif skin erupt NEC on 2012-12-27, clinician comment: rash was noted at injection sites as well as other places.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Asthenia, Joint swelling, Muscle tightness
Clinical narrative: Patient received 2 vaccinations on 1-29-2013. Hepatitis A in the right arm and MCV4 in the left arm. Pt stated weakness and swelling in her knee. She stated no injury or slipping or jarring her knee.  Went to therapy (02-1-2013) because there was previous injury to the knee and patient stated the muscle was tight and there was still swelling. He advised to contact PH to report.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Hyperhidrosis, Presyncope
Clinical narrative: After IM administration of Gardasil into patient left deltoid muscle patient stood up after sitting on exam table and proceeded to become near syncopal and extremely diaphoretic. Patient eased to floor with assistance. Patient did not loose loc. MD notified and b/p checked q15min x 1hour.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site streaking
Clinical narrative: Pt is experiencing red streaking from the site of injection toward chest.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Eosinophil count increased, Eosinophilia
Clinical narrative: Eosinophils on 2013-01-03, clinician comment: Possible that elevated eosinophil count related to vaccine. No clinic sequelae.
Age: 28.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Asthenia, Cardiac disorder, Dizziness, Dyspnoea, Lacrimation increased
Clinical narrative: Relates started with watering eyes for 2 weeks then into shortness of breath and ended up with heart issues, weakness, dizziness and hospitalization.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse to a patient of unknown age and gender. On 15-JAN-2013, the patient was vaccinated with a expired dose of M-M-R II (lot number was reported as 0104AA, expiry date was 12-JAN-2013 and dose and route was not reported). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 02-FEB-2013, pharmacist had attempted to vaccinate the patient with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported) and a large amount of the vaccine leaked out between the barrel of the syringe and the needle. The pharmacist also reported that the patient had reported an after hours adverse event. Action taken with the ZOSTAVAX was not applicable. The outcome of after hours adverse event was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 years old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with first dose of 0.5 ml GARDASIL (lot#0420AE, expired date:01-DEC-2014) intramuscularly on 04-FEB-2013. No other co-suspects were reported. There were no concomitant medications. On 05-FEB-2013 the patient experienced dizziness, headache and syncope. The patient had taken office visit for medical attention. No treatment information was given for the adverse events. The patient was recovered on 05-FEB-2013. The relatedness for syncope, dizziness and headache was unknown for GARDASIL. No lab diagnostics studies performed. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The nurse reported that a patient received the first dose of GARDASIL on 09-DEC-2009, the second dose of GARDASIL on 12-FEB-2010 and was in the office to receive the third dose of GARDASIL on 04-FEB-2013. It was unknown if the patient had sought medical attention. No adverse event reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site hypersensitivity
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 65-year-old female patient. On 08-OCT-2012 at 2:30 p.m. the patient was vaccinated with a dose of ZOSTAVAX (lot # H012578, expiration date not reported) in the left arm subcutaneously. No concomitant medications were reported. On 15-JAN-2013 call was placed to the registered nurse. The nurse stated that the patient was hypersensitive to injections. Approximately on 08-OCT-2012 (reported as the day after she received ZOSTAVAX) she had a 4 inch by 6 inch area that was red and inflamed. Approximately on 10-OCT-2012 (reported as the following day) she saw her physician as it had spread to her entire arm. She then went to the Emergency Room (ER). The patient had not followed up with her physician since that time. It was unknown if the patient had recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from an other health professional refers to plenty of patients of unknown age. The health care professional mentioned that plenty of patients had fainted from being administered a dose of GARDASIL on an unknown day. It was unknown if the patients sought medical attention. The outcome of fainted was unknown. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse to a female patient in her seventies(years). The patient was vaccinated with a dose of PNEUMOVAX23 (lot number unspecified) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced redness and swelling of arm at injection site. No treatment information was reported. The outcome of redness and swelling of arm at injection site was unknown. The relatedness for redness and swelling of arm at injection site was unknown for PNEUMOVAX23. It was unknown if the patient had sought medical attention. This is one of several reports received from same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 69 years old female patient with asthma, chronic obstructive pulmonary disease(COPD), hypothyroidism, cirrhosis of liver, chronic kidney disease and codeine allergy. The patient's medical history included liver disease and hepatitis C. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23 (lot number reported as H018441, exp:28-FEB-2014) intramuscularly into left arm on 14-JAN-2013. No other co-suspects were reported. Concomitant medications included SYNTHROID, NITROSTAT, INDERAL, PROAIR, vitamin D (unspecified), FLONASE and albuterol nebulizer. On an unspecified date of 2013 the patient experience redness and swelling of arm at injection site, pain and bruising of her left arm at injection site and headache. The patient had visited office for medical attention and was treated with ice packs to arm. At the time of the report, the outcome of the patient was unknown. The relatedness for the adverse events was unknown for Pneumovax23. No lab diagnostic studies performed. This is one of several reports received from same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot number reported as H018441, expired date; 28-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced redness and swelling of arm at injection site. No treatment information was reported. The outcome of redness and swelling of arm at injection site was unknown. The relatedness for redness and swelling of arm at injection site was unknown for PNEUMOVAX 23. It was unknown if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Pain
Clinical narrative: Ct was vaccinated on 1-5-13 at 2pm and claims that she has extreme pain at the injection site. She reported bruising and shooting pain. She reported this event on 1-21-13. She has only been taking ALEVE to relieve the pain but has not been seen or treated.
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Electrocardiogram normal, Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator on 31 January 2013. A male subject (date of birth not reported) with a reported past medical history of shellfish and iodine allergy had received on 15 April 2013 ACAM2000 (lot number, route, site and date of administration not reported) and Anthrax (lot number, route, site and date of administration not reported) and two days later, experienced a one time occurrence of mild chest pressure that lasted "only a couple minutes". No treatments were received. On 22 April 2010, a rapid Troponin I level was within normal limits and ECG was normal. The subject did not recall activity prior to the chest pressure. No further information was available at the time of the report. The subject's outcome was recovered. According to the investigator, the event of chest pressure was considered an other important event and possibly related to vaccination. Documents held by sender: none. Medical assessment: Insufficient information in the case was provided to make a complete assessment. Chest pressure may be a symptom of myopericarditis, a listed event in the reference safety information for ACAM2000, although laboratory investigations and the clinical course do not appear supportive and it is not clear. During the previous studies using ACAM2000, 2 similar events of chest pressure without the mention of potential etiology, were reported as serious adverse events following the use of ACAM2000, assessed as not related to the study vaccine in 1 case and unknown relatedness in another.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Erythema, Rash
Clinical narrative: Right side of face became bright red. Continuous rashes on chest. Chills almost every day. Rashes clear up but return since vaccination slight burning.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Headache, Insomnia, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Dysphagia, neck pain/stiffness difficulty raising arm, headache, muscle spasm (cen cal) insomnia.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain
Clinical narrative: Dysphagia, neck pain/stiffness difficulty raising arm, headache, muscle spasm (cen cal) insomnia.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: Large red indurated area anteriorly on site of vaccination that decreased in size over 3 days still > 4 cm on day 4. Reported to clinic similar reaction in another child from same lot.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Developed a large erythematous whelp at site of DTaP/IPV - IPV was from a new batch. Superficial reaction only. Reported to manufacturer. Similar reaction in another child from same IPV batch.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Dizziness, Electrocardiogram T wave amplitude decreased, Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator on 31 January 2013. A 26-year-old female subject had received the following vaccination on 17 January 2013: ACAM2000 (lot number, route and site not reported), anthrax vaccine (manufacturer, lot number, route and site not reported) and Typhoid vaccine (manufacturer, lot number, route and site not reported). The subject with a negative cardiac history reported 2 days of mild lightheadedness when standing at work, onset 4 days post vaccination. The subject reported adequate hydration and no cardiac symptoms or head injury. The events did not interfere with work and resolved with sitting. The subject reported experiencing similar symptoms only with an obvious illness in the past. The subject denied vertigo, chest pain, shortness of breath, vision changes, and recent history of head injury. There was not recurrence of symptoms. The subject did not seek care. The rapid and lab Troponin was normal (negative). On 24 January 2013, the results of the Troponin I test was < 0.10 ng/mL. Seven days post-vaccination on 24 January 2013, an electrocardiogram (ECG) was performed that revealed flat T waves. The subject was referred for this abnormality. According to the investigator, the preliminary ECG interpretation was no hallmark signs of myopericarditis, and low suspicion for myopericarditis at this time. The staff was advised that no referral or reporting of the adverse events was necessary unless lab Troponin returned elevated or ECG was worrisome. The subject's outcome was reported as not recovered (also reported as recovered on date of 22 January 2013). According to the investigator, the event of flat T waves on ECG was considered possibly related to vaccination. Documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site induration, Injection site mass, Injection site swelling, Pruritus
Clinical narrative: Tuesday nothing, Wednesday night itching, Thursday 80mm across, 60mm height red, warm circle appeared. Pt said it is itchy. Hard lump at injection site, swelling.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Tuesday nothing, Wednesday night itching, Thursday 80mm across, 60mm height red, warm circle appeared. Pt said it is itchy. Hard lump at injection site, swelling.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's palsy one day after receiving DTaP. Rx: Acyclovir, oral med - resolved in one week.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Cough, Dizziness, Electrocardiogram, Headache, Myopericarditis
Clinical narrative: This study case was received from the investigator on 28 January 2013. A male subject (date of birth not reported) had received the ACAM2000 (lot number, site, and date of vaccination not reported). An unreported amount of time later, the subject experienced transient elevated troponin. On 21 August 2010, the subject had blood drawn for Rapid Troponin I Levels and the result was within normal limits (negative). On the same day, 21 August 2010, the subject had blood drawn for central laboratory Troponin I levels and the result was 0.36 ng/mL (abnormal). Elevated troponin was also reported on 26 August 2010 with no values provided. The subject had normal follow-up troponin on 31 August 2010. The subject had an electrocardiogram reading on 31 August 2010, and the reason provided was "unable to interpret, rhythm strip only". On 21 August 2010, the subject reported a stuffy nose (treated with SUDAFED), sore throat, chest congestion, cough, headache, lightheadedness, and feverish. The subject had a past medical history of swollen or painful joints, frequent or severe headaches, cold or influenza. The subject took concomitant medication of SUDAFED for stuffy nose. The subject did not drink alcohol, smoked cigarettes and cigars within the past year, and had smokeless tobacco within the past year. In the subject's lifetime, he smoked at least 100 cigarettes and started smoking at age 18. He had an average of at least 3 cigarettes per day for 1 year and smoked half to one pack per day. The subject admitted to have quit smoking. The subject's outcome was not reported. According to the investigator, the event of Transient Elevated Troponin was considered a medically important event and possibly related to vaccination. According to the ACAM2000 Myopericarditis Adjudication Committee, the subject met the case definition for subclinical myopericarditis. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Troponin I increased
Clinical narrative: This study case was received from the investigator on 28 January 2013. A male subject (date of birth not reported) had received the ACAM2000 (lot number, site, and date of vaccination not reported). An unreported amount of time later, the subject experienced transient elevated troponin. On 21 August 2010, the subject had blood drawn for Rapid Troponin I Levels and the result was within normal limits (negative). On the same day, 21 August 2010, the subject had blood drawn for central laboratory Troponin I levels and the result was 0.36 ng/mL (abnormal). Elevated troponin was also reported on 26 August 2010 with no values provided. The subject had normal follow-up troponin on 31 August 2010. The subject had an electrocardiogram reading on 31 August 2010, and the reason provided was "unable to interpret, rhythm strip only". On 21 August 2010, the subject reported a stuffy nose (treated with SUDAFED), sore throat, chest congestion, cough, headache, lightheadedness, and feverish. The subject had a past medical history of swollen or painful joints, frequent or severe headaches, cold or influenza. The subject took concomitant medication of SUDAFED for stuffy nose. The subject did not drink alcohol, smoked cigarettes and cigars within the past year, and had smokeless tobacco within the past year. In the subject's lifetime, he smoked at least 100 cigarettes and started smoking at age 18. He had an average of at least 3 cigarettes per day for 1 year and smoked half to one pack per day. The subject admitted to have quit smoking. The subject's outcome was not reported. According to the investigator, the event of Transient Elevated Troponin was considered a medically important event and possibly related to vaccination. According to the ACAM2000 Myopericarditis Adjudication Committee, the subject met the case definition for subclinical myopericarditis. Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Residual soreness in deltoid muscle where injection given.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Blood test, Pruritus, Pyrexia, Rash
Clinical narrative: Mother stated on 2/4 - grandson started running a fever of 102, still running a 100ish with medicine. Has rash on buttocks, palms, genital area, legs, around mouth & in mouth. Client states itches. Saw Dr on 2/5/13. 2/06/13 Grandmother says Dr ran blood tests & consulted (infection disease doctor) & sent pictures to him. Grandmother also sent me pictures. She stated she is giving the child oatmeal baths, BENADRYL faithfully & TYLENOL for fever. 2/7/13 Spoke with grandmother again. She states he has been fever free since last night & "looks like rash is starting to clear up".
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Pyrexia, Rash, Secondary transmission
Clinical narrative: Mother stated on 2/4 - grandson started running a fever of 102, still running a 100ish with medicine. Has rash on buttocks, palms, genital area, legs, around mouth & in mouth. Client states itches. Saw Dr on 2/5/13. 2/06/13 Grandmother says Dr ran blood tests & consulted (infection disease doctor) & sent pictures to him. Grandmother also sent me pictures. She stated she is giving the child oatmeal baths, BENADRYL faithfully & TYLENOL for fever. 2/7/13 Spoke with grandmother again. She states he has been fever free since last night & "looks like rash is starting to clear up".
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Electrocardiogram normal, Myopericarditis, Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 24 January 2013. A male subject (age and date of birth not reported) had received the following vaccinations on 24 February 2012: ACAM2000 (lot number and site not reported) and anthrax vaccine (manufacturer, lot number, route and site not reported). Eight days post-vaccination on 03 March 2012, the subject experienced mild intermittent chest pressure in absence of any other symptoms that was not related to activity. Rapid and lab troponin and ECG were both normal on 05 March 2012. The subject was referred for care due to some suspicion of myopericarditis. The subject had an allergy to penicillin and Lasik surgery in July 2011. No further information was available at the time of the report. The subject's outcome was not recovered. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Age: 17.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Headache
Clinical narrative: Patient experienced dizziness & slight headache about 10 minutes after receiving vaccinations. He was given water & placed on exam table. After drinking water & resting his symptoms improved within 5-10 minutes. Mother advised to present to ER if any shortness of breath, increased dizziness, weakness, chills, fever, nausea, hives,  or increased heart rate.
Age: 1.47
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 24 January 2013 from the Investigator participating in the study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3612AA received on 06 January 2011, lot number C3783AA received on 03 March 2011 and lot number C3686AA received on 02 May 2011 and 1 dose of DAPTACEL; lot number C4003AA received on 17 April 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 07 October 2012, approximately six months after the last dose. On 07 October 2012, the subject developed a cough and paroxysmal cough on 13 October 2012 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 16 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 16 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 November 2012, the subject's cough and resolved. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.47
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 24 January 2013 from the Investigator participating in the study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3612AA received on 06 January 2011, lot number C3783AA received on 03 March 2011 and lot number C3686AA received on 02 May 2011 and 1 dose of DAPTACEL; lot number C4003AA received on 17 April 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 07 October 2012, approximately six months after the last dose. On 07 October 2012, the subject developed a cough and paroxysmal cough on 13 October 2012 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 16 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 16 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 November 2012, the subject's cough and resolved. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Electrocardiogram, Eye movement disorder
Clinical narrative: Case number PHEH2013US003168, is an initial spontaneous report received from a consumer on 05 Feb 2013: This report refers to an adult male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on 04 Feb 2013. On the same day after vaccination, the patient stated that his "eyes pulled in and downward, were crossed and were stuck that way". He ended up in emergency room with CAT scan of the brain and EKG with monitoring for a few hours just over 12 hours after vaccination. The test details were not reported. The patient is requesting compensation for medical expenses associated with the event. The outcome of the event, seriousness and causality assessment was not reported. No further information was provided.
Sex: F
Vaccine: MNQ
Symptoms: Pericarditis
Clinical narrative: Initial report received on 31 January 2013 from a manufacturer, which was reported by a healthcare professional, under (Manufacturer (MFR) report number: 1-6098105575). An adult female patient received an injection of MENACTRA, sanofi pasteur Inc. (also reported as manufacturer unspecified) (lot number, route, site, dose in series not reported) on an unspecified date in 2010. On an unspecified date, the patient developed Pericarditis (time frame development of the Pericarditis was unspecified) following vaccination. The patient was hospitalized for an unspecified time frame and reported to be recovered, exact date of recovery unspecified. The patient's past medical history was not reported. Laboratory or diagnostic testing or treatments were not reported. The reporter and physician were not involved when vaccine was administered or during the development of the pericarditis and did not wish to be contacted for follow-up. Treating physician associated with the pericarditis was unspecified. No other information was reported. The patient's outcome was reported as recovered on an unspecified date. Documents held by sender: None.
Age: 1.0
Sex: F
Vaccine: DTP
Symptoms: Hypoacusis
Clinical narrative: Initial case received 30 January 2013 from a healthcare professional, (physician) who is also the grandfather of the patient. A 1 year old female patient, date of birth not reported, with no reported medical history or concomitant medications, received a DPT vaccination, about thirty years ago, date not specified. The manufacturer, dose, route, site and batch number were not reported. The patient developed a hearing deficit "almost complete deafness" several weeks after vaccination, date not specified. Laboratory tests and treatment details were not reported. The reporter had no further details and refused to be contacted. The outcome was reported as not recovered. No further details were available at the time of this report. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site haematoma
Clinical narrative: Obtained vaccinations on 1-30-13. Noticed large amount of bruising to right arm starting around injection site to shoulder. Bruising resolving currently.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Erythema, Injection site erythema
Clinical narrative: Obtained varicella vaccine on 1-30-13. On 1-31-13 mother noticed moderate sized red area starting at injection site and going up 3 inches above injection site. Area remains red today.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Conjunctivitis, Cough, Myalgia, Rash papular, Rhinorrhoea
Clinical narrative: Conjunctivitis 48 degrees after vaccine - treated with breastmilk drops & homeopathic drops; cough, rhinorrhea, sneezing 4 d after vaccine - supportive care; erythematous papules rash 10d after rash. Myalgias 2 weeks after vaccine.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Sneezing
Clinical narrative: Conjunctivitis 48 degrees after vaccine - treated with breastmilk drops & homeopathic drops; cough, rhinorrhea, sneezing 4 d after vaccine - supportive care; erythematous papules rash 10d after rash. Myalgias 2 weeks after vaccine.
Age: 0.49
Sex: F
Vaccine: DT
Symptoms: Urticaria
Clinical narrative: Mom reports hive like rash on (L) thigh today (2-7-13). Dt given 2/4/13. Changed to Dt after reaction to PEDIARIX 10/15/12. At that event child had fever and cried for 7 hours.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Pt phoned office several hrs after injection c/o warmth to site & redness. Advised to ice site, ibuprofen 400mg every 8 days & BENADRYL every 40. Pt phoned office next AM c/o increased redness from arm pit to wrist. Came in for office visit. M prescribed prednisone 10 mg: 4 tabs for 2 days, 3 tabs fro 2 days, 2 tabs for 2 days 1 tab for 4days, 1/2 tab for 4 days.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pt was found to be pregnant.
Age: 38.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Inflammation, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: I received a flu shot at my local pharmacy a week and a half ago.  I received it in my left arm. Injection was give too high and I had pain immediately and an inflammatory response. It is two weeks and the pain contniues in the shoulder and arm area with limiting range of motion and pain.
Age: 38.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: I received a flu shot at my local pharmacy a week and a half ago.  I received it in my left arm. Injection was give too high and I had pain immediately and an inflammatory response. It is two weeks and the pain contniues in the shoulder and arm area with limiting range of motion and pain.
Age: 38.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: I received a flu shot at my local pharmacy a week and a half ago.  I received it in my left arm. Injection was give too high and I had pain immediately and an inflammatory response. It is two weeks and the pain contniues in the shoulder and arm area with limiting range of motion and pain.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dyskinesia
Clinical narrative: Patient had multiple jerking movements lasting for a few seconds.
Age: 52.0
Sex: F
Vaccine: IPV, TYP
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Fatigue, Headache, Injection site swelling, Malaise
Clinical narrative: Swelling at injection site, hives near injection site, malaise, fatigue, headache, stomach ache.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Swelling at injection site, hives near injection site, malaise, fatigue, headache, stomach ache.
Age: 31.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain, Pain in extremity
Clinical narrative: My arm was sore and hard to move immediately after the shot for about five days, however pain seemed to be decreasing.  Then pain came back a week later, and now it is sharp and stabbing whenever I lift my arm up and across my body (the motion used to remove my shirt).  Does not seem to be getting better.  Research online indicates this can happen when the shot is given high up on the shoulder, which mine was.
Age: 31.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site joint pain, Injection site pain, Pain
Clinical narrative: My arm was sore and hard to move immediately after the shot for about five days, however pain seemed to be decreasing.  Then pain came back a week later, and now it is sharp and stabbing whenever I lift my arm up and across my body (the motion used to remove my shirt).  Does not seem to be getting better.  Research online indicates this can happen when the shot is given high up on the shoulder, which mine was.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: 61Y F w/ PMHx of HTN and prior left sided umbilical hernia repair w/ mesh (2008 at hospital) who presented to ED today for evaluation of b/l "shaking"/paresthesias/numbness for 6 hours. Patient is excellent historian and accompanied by her husband. She reports having shingles vaccine on 10/31/12. On 11/9/12 she started having frequency/urgency and what she describes as bladder spasms without any dysuria, she called her PCP who gave her Rx for MACROBID which she took for 3 days. Urgency/frequency improved. A wk after that she began having sx again, PCP did urinalysis and UCx, which per her report grew 30k of unknown bacteria and was changed to ciprofloxacin. A couple of days later she went to hospital b/c of new onset rectal pressure described as baseball in rectum. There they performed abdominal CT scan which per patient was normal. She was told that could be allergic reaction to ciprofloxacin. She stopped taking medication. Since 11/9/12 she began having these sensation of b/l LE proximal "shaking" intermittently throughout the day. On further description was more of "creepy-crawly" description of b/l thighs w/ no visible shaking. This although intermittent has continued. She denied any weakness, no sensory changes, no bowel/bladder changes (retention or incontinence), no saddle anesthesia, no LBP, no neck pain, no diarrhea/no vomiting, some nausea on/off when had UTI initially. She was improving and went away for Thanksgiving. There she began having worsening of her bladder spasms, urinary freq/urgency again and perineal irritation. She got off plan and went to hospital where she had UTI w/u again as well as pelvic US which she was told were negative. She was given pyridium for 7 days. For the past 2 days she has been feeling b/l LE weakness and paresthesias, some anorexia, has mostly remained in bed. When getting up and walking has no objective weakness per report. Today at around 2 pm developed RUE tingling proximally which went down her arm in course of 30 mins and nor most notably numbness in all fingertips on volar aspect of her RUE. She denies any sx like this in the past, she has never had acute vision loss of eye pain in past, no vision changes, no slurred speech, no dysphagia, no word finding difficulty, no falls, no accidents, no neck pain, no lbp, no fevers, chills, no diarrhea, no sick contacts, no extra stress per her report, no fatigability, no worsening throughout the day or improvement throughout the day. Only medication is COZAAR which was increased from 25mg to 50mg b/c she was found HTN in ED visits. She reports weakness in b/l legs only when having the paresthesias.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Injection site swelling, Irritability, Pyrexia
Clinical narrative: Fever, swelling at injection sites, irritability.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt presented with large area of redness & swelling around injection site. Tissue hard to touch. Afebrile
Age: 5.0
Sex: M
Vaccine: FLUN3, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster in 2 dose varicella vaccine recipient.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Polymyalgia rheumatica
Clinical narrative: Fatigue and weakness of both shoulders and hips worse in the mornings. Later diagnosed as Poly Myalgia Rheumatica (PMR) and treated with Prednisone 5mgs BID with significant improvement.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: Pt complained of pain and soreness to right upper arm.  Small blister noted, area reddened and firm.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Flushing, Lip dry, Pruritus, Skin tightness, Swelling face
Clinical narrative: FLUSHING AND SWELLING OF FACE.  SENSATION OF FACIAL TIGHTNESS, DRY LIPS, ITCHY FACE.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster in zoster vaccine recipient.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Guillain-Barre syndrome
Clinical narrative: Started to fall, 4 times. Took to emergency room. In course of 4 days.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMR
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster in 2 dose varicella vaccine recipient.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Arm was sore day 1 as expected and then dissipated. About 2 weeks later, noticed pain upon raising arm, crossing arm over body, or pulling off t-shirt over head. Seems worse at night. Pain in upper arm near shoulder originating near injection site. Concerned how long this condition will continue. Not getting better.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dysstasia, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Progressively worsening muscle pain due to muscle weakness.  Started 3 to 4 days after administration.  Pain is to the point where patient has a hard time standing or moving.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: Progressively worsening muscle pain due to muscle weakness.  Started 3 to 4 days after administration.  Pain is to the point where patient has a hard time standing or moving.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Arm was sore first day and then soreness went away. Two weeks later noticed pain in upper left arm near injection site that radiated down but not as far as elbow. Painful to raise arm and to remove clothing by pulling off over head.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Antinuclear antibody positive, Arthralgia
Clinical narrative: Two small bald patches were noticed on this day.  They developed into many large bald patches, and now is almost completely bald.  She is currently taking topical steroids. She also complains of joint pain.  She is currently being treated by a Dermatologist and Rheumatologist.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Eyelid ptosis, Hyperaesthesia, Lacrimation increased, Tinnitus
Clinical narrative: Mild activation of previous Bell's Palsy on right side of face.  Droopy right eye, eye watering, tinnitus in right ear, sensitivity in right cheek facial nerve, symptoms continue but very mild.  Bell's Palsy first occurred in 2009.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Mild activation of previous Bell's Palsy on right side of face.  Droopy right eye, eye watering, tinnitus in right ear, sensitivity in right cheek facial nerve, symptoms continue but very mild.  Bell's Palsy first occurred in 2009.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Pt had a break out of Shingles.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test normal, Cardiac stress test normal, Chest X-ray normal, Chest pain, Dyspnoea
Clinical narrative: Could not breathe, chest pain, severe left leg pain and severe left arm pain.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Could not breathe, chest pain, severe left leg pain and severe left arm pain.
Age: 1.74
Sex: M
Vaccine: FLUX
Symptoms: Dehydration, Diarrhoea, Fluid intake reduced, Hypophagia, Lethargy
Clinical narrative: Throwing up, diarrhea, dehydrated, no food or liquid intake. Lethargic, would not wake up. Taken to urgent care, was given 400cc IV Fluid. Released to recover at home. Is starting to move about, but still not taking in much food or water.
Age: 1.74
Sex: M
Vaccine: FLUX
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Throwing up, diarrhea, dehydrated, no food or liquid intake. Lethargic, would not wake up. Taken to urgent care, was given 400cc IV Fluid. Released to recover at home. Is starting to move about, but still not taking in much food or water.
Age: 48.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Painful red swelling from right shoulder down to elbow, helped by Motrin and warm compress, but persisted.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Nasal congestion, Pain, Pyrexia
Clinical narrative: Stuffy, runny nose. Fever 100.2 degree. Body aches. Headache. Fatigue.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: Stuffy, runny nose. Fever 100.2 degree. Body aches. Headache. Fatigue.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: LEFT ARM REALLY HOT AND RED STARTED TO SWELL AND ALOT ITCHING. NO TEMP, SIZE 6.0 X 4.5. DR GAVE BENADRYL 25MG 1 EVERY 6 HRS FOR 5 DAYS.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: ON 1/29/13 PAPIENT CAME IN FOR HER WELL CHILD EXAM AND RECEIVED 2 SHOTS IN EACH UPPER ARM'S: HEP A #1 AND MENINGITIS SHOT. AND MOTHER WAS TO RETURN PATIENT BACK TO START THE RECOMMENDATIONS OF HPV AND TO FINISH THE VARICELLA SERIES SHOTS. MOTHER CALLED ON 1/31/2013 @ 4:43PM, SAYING PT'S LEFT ARM HURTS WHERE PT HAD THE A SHOT, IT IS ITCHY, RED, SWOLLEN, IT STARTED SINCE YESTERDAY SHE THOUGHT IT WAS IRRITATED, BUT TODAY WAS MORE. PER MEDICAL DOCTOR: MOTHER WAS TO HAVE PT USE COOL COMPRESSORS AND TYLENOL OR IBUPROFEN FOR PAIN AND TO SCHEDULE AN APPT FOR THE NEXT DAY.  On 2/1/2013: WHEN MOTHER BROUGHT IN PATIENT TO HER APPOINTMENT HER LEFT DELTOID WAS SWOLLEN AND SLIGHTLY TENDER A FEW HOURS AFTER THE SHOT AND WAS RESOLVING BY IT ITSELF, AT THAT TIME. THE MD MEASURED 6CM OF INDURATION OF THE LEFT DELTOID. NO RASH. DIAGNOSIS CODE: E949.6 VACCINE REACTION TO MENACTRA. PATIENT'S RECOMMENDATION WERE TO CONTINUE THE COOL COMPRESSES AND IF NEEDED TO TAKE THE TYLENOL FOR PAIN AND to CALL IF IT GET WORST.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients (children) of unknown gender (exact age was not reported). On 04-FEB-2013, the patients were vaccinated with improperly stored M-M-R-II. No other co-suspects and no concomitant medications were reported. No adverse effects were reported. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age. The patients were vaccinated with PNEUMOVAX23. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that 3 unspecified patients had swelling (2 patients had unspecified swelling and 1 patient had swelling the size of a baseball at the injection site shortly after administration of PNEUMOVAX23, sometime that week. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested. This case in linked to case 1302USA002092 (same reporter link).