chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Rash, Sensory loss
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 87 years old female patient. The patient was vaccinated with ZOSTAVAX (lot number, route, site not reported) on an unknown date. No other co-suspects or concomitant medications were reported. On an unknown date the patient experienced a rash, "but it was not a bad rash, and then the patient was admitted to the hospital with weakness in limbs" for an unspecified length of time. The nurse stated that the hospital was looking into if she had Guillain-Barre syndrome and also stated that the patient was losing feeling in her legs. No treatment information was reported. The events did not improve. All the events were considered medically significant by the reporter. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Diarrhoea, Palpitations, Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: Fever, vomiting, diarrhea, heart racing.
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pt called the pharmacy, said she felt horrible after the vaccination, mentioning burning in the injection site as well as swollen and pain. Advise pt that this might go away in couple of days will follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Local swelling
Clinical narrative: Topical reaction red, raised area - looked by d. area, (after shots). It was diagnosed by dr. as Shingles after 2 weeks. (as per pt); and Pt is on antiviral.
Age: 22.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, swelling around the injection area, pain.  Came back to us on 8/6.  Advised Zyrtec, Benadryl.  Some improvement.  Returned 8/7, minimal immprovement.  Given Medrol dose pack.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Arm became swollen and sore to the point where she could not raise it at all.  Had temp 100 degrees by 7pm.  Soreness, swelling and pain gradually diminished over the next 2 days.  No redness at injection site.
Age: 1.07
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Pruritus, Pyrexia, Rash, Rash erythematous, Screaming
Clinical narrative: Low fever, then rash started getting worse, raised red spots and rash around buttocks, arms, legs, feet, hands (varicella), constant screaming and itching at night; treated with children's Tylenol, Benadryl, and hydrocortisone cream.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Back pain, Blood test, Cardiac stress test, Chest X-ray
Clinical narrative: Chest pain, tightness, left arm pain, neck/ back pain, tingling, anxiety, feeling unwell, confusion.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Chest discomfort, Chest pain, Computerised tomogram, Confusional state, Electrocardiogram
Clinical narrative: Chest pain, tightness, left arm pain, neck/ back pain, tingling, anxiety, feeling unwell, confusion.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Malaise, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Chest pain, tightness, left arm pain, neck/ back pain, tingling, anxiety, feeling unwell, confusion.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Electromyogram, Headache, Hypoaesthesia, Muscle spasms, Nerve conduction studies abnormal
Clinical narrative: Leg cramps, paresthesia in hands, calves and feet, some numbness, muscle spasm in upper back, worsening of headaches, nerve irritation and excitability evident during nerve studies.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Neuralgia, Nuclear magnetic resonance imaging brain, Paraesthesia, X-ray
Clinical narrative: Leg cramps, paresthesia in hands, calves and feet, some numbness, muscle spasm in upper back, worsening of headaches, nerve irritation and excitability evident during nerve studies.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: HIVES ON ELBOWS, HANDS, AND FACE.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Mental status changes
Clinical narrative: Pt reports altered mental status lasting 72 hours where she did not get up from chair or really feel aware of surrounding.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Angioedema, Urticaria
Clinical narrative: Within 24 hours of receiving the ACAM2000 smallpox vaccine by itself at a clinic, pt developed urticaria of bilateral lower legs and tongue and facial angioedema. Pt was prescribed an unknown medication and all symptoms resolved within 6 hours of taking medication. Did not recur.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pruritus generalised, Rash
Clinical narrative: NAUSEA & RASH ON BOTH ARMS, ITCHING ALL OVER BODY.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Pruritus, Rash, Swelling
Clinical narrative: Red, swollen, itchy, rash, solid/hard skin at injection site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: Patient felt nauseous & lightheaded after vaccines, no loss of consciousness. Had patient lay down with legs elevated, blood pressures normal, felt normal after 10 minutes & walked out of office without difficulty.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Chills, Condition aggravated, Hereditary angioedema, Injection site erythema, Injection site swelling
Clinical narrative: Initial report received on 26 July 2012 by another manufacturer (reference number 2012DX000151) who had received the original report from a consumer. The following is verbatim from the report: "This spontaneous report was reported by a consumer and concerns a 34-year-old male who experienced skin injury and a possible allergic reaction to a tetanus shot characterized by chills, shaking, redness at the tetanus shot injection site, and fever. Additional information was received on 11 July 2011 from the consumer. On an unknown date, the patient was prescribed KALBITOR 30 mg subcutaneous (SC) as needed for treatment of Hereditary Angioedema (HAE). The patient was not taking concomitant medication and did not have a significant medical history. Additionally, he has no known allergies. On 03 March 2011, the first 30 mg dose of KALBITOR was received for treatment of an acute exacerbation of HAE. On 07 July 2012, the patient was working with bales of hay and experienced a skin injury when the wire in one bale poked his right knee. He was treated in an outpatient clinic with a tetanus vaccine and placed on BACTRIM to prevent a skin infection. 24 hours after receiving the vaccine, the patient experienced chills, fever, and shaking. He also noted slight redness at the vaccine injection site. The chills, fever, and shaking resolved within 24 hours (on 09 July 2012. On July 2012, the patient began experiencing swelling in his left arm (site of the tetanus shot), left knee and left foot. He returned to the outpatient clinic on 10 July 2012 and received a 30 mg dose of KALBITOR for this exacerbation of HAE. The patient believed the events following the vaccination were due to an allergic reaction to the tetanus shot. Additionally, he attributed the current HAE exacerbation to the tetanus shot since he usually does not have HAE exacerbation from injuries such as this one. At the time of the report, all the events had resolved. The tetanus vaccine was considered co-suspect for the events. Medical history details: None. Allergies: No known. Con Meds = None, Prev meds = "UNKNOWN." Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Joint swelling, Oedema peripheral, Pyrexia, Tremor
Clinical narrative: Initial report received on 26 July 2012 by another manufacturer (reference number 2012DX000151) who had received the original report from a consumer. The following is verbatim from the report: "This spontaneous report was reported by a consumer and concerns a 34-year-old male who experienced skin injury and a possible allergic reaction to a tetanus shot characterized by chills, shaking, redness at the tetanus shot injection site, and fever. Additional information was received on 11 July 2011 from the consumer. On an unknown date, the patient was prescribed KALBITOR 30 mg subcutaneous (SC) as needed for treatment of Hereditary Angioedema (HAE). The patient was not taking concomitant medication and did not have a significant medical history. Additionally, he has no known allergies. On 03 March 2011, the first 30 mg dose of KALBITOR was received for treatment of an acute exacerbation of HAE. On 07 July 2012, the patient was working with bales of hay and experienced a skin injury when the wire in one bale poked his right knee. He was treated in an outpatient clinic with a tetanus vaccine and placed on BACTRIM to prevent a skin infection. 24 hours after receiving the vaccine, the patient experienced chills, fever, and shaking. He also noted slight redness at the vaccine injection site. The chills, fever, and shaking resolved within 24 hours (on 09 July 2012. On July 2012, the patient began experiencing swelling in his left arm (site of the tetanus shot), left knee and left foot. He returned to the outpatient clinic on 10 July 2012 and received a 30 mg dose of KALBITOR for this exacerbation of HAE. The patient believed the events following the vaccination were due to an allergic reaction to the tetanus shot. Additionally, he attributed the current HAE exacerbation to the tetanus shot since he usually does not have HAE exacerbation from injuries such as this one. At the time of the report, all the events had resolved. The tetanus vaccine was considered co-suspect for the events. Medical history details: None. Allergies: No known. Con Meds = None, Prev meds = "UNKNOWN." Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 7/28, two day after the pt received the ZOSTAVAX vaccine, she came in complaining of swelling, redness and tenderness at the injection site. She tried an icepack and BENADRYL, but it became worse, so she went to the ER to have it looked at.
Age: 29.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Alopecia areata
Clinical narrative: Patient reports he developed alopecia areata after receiving first dose of Anthrax vaccine.  He presents to our immunization clinic for post-deployment Anthrax vaccine #4.  He is concerned his alopecia areata is due to the Anthrax series.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neck pain, Rash
Clinical narrative: Patient stated his neck began to hurt, and he developed a painful rash.  He went to his doctor on the following day and was diagnosed with shingles and was treated with valacyclovir.
Age: 12.0
Sex: M
Vaccine: HPVX, MEN, TDAP, VARCEL
Symptoms: Arthralgia, Back pain, Dry mouth, Dry throat, Fatigue
Clinical narrative: At first it was a complaint of arm & hand numb as well as sore & achy with fatigue.  By 08/07/12, it became sore throat, dry mouth & throat, fever up to 102.1 degrees, muscle pains in legs, arms, back, neck & jaw.  Joint pains in shoulders, hips, knees, back, neck & jaw. Very fatigued & thirsty. Left arm swollen from shoulder to elbow, sore & tingly, hot to the touch & firm. The injection points of the two vaccines he was given in the left arm are protruding outward.
Age: 12.0
Sex: M
Vaccine: HPVX, MEN, TDAP, VARCEL
Symptoms: Hypoaesthesia, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: At first it was a complaint of arm & hand numb as well as sore & achy with fatigue.  By 08/07/12, it became sore throat, dry mouth & throat, fever up to 102.1 degrees, muscle pains in legs, arms, back, neck & jaw.  Joint pains in shoulders, hips, knees, back, neck & jaw. Very fatigued & thirsty. Left arm swollen from shoulder to elbow, sore & tingly, hot to the touch & firm. The injection points of the two vaccines he was given in the left arm are protruding outward.
Age: 12.0
Sex: M
Vaccine: HPVX, MEN, TDAP, VARCEL
Symptoms: Injection site warmth, Myalgia, Neck pain, Oropharyngeal pain, Pain
Clinical narrative: At first it was a complaint of arm & hand numb as well as sore & achy with fatigue.  By 08/07/12, it became sore throat, dry mouth & throat, fever up to 102.1 degrees, muscle pains in legs, arms, back, neck & jaw.  Joint pains in shoulders, hips, knees, back, neck & jaw. Very fatigued & thirsty. Left arm swollen from shoulder to elbow, sore & tingly, hot to the touch & firm. The injection points of the two vaccines he was given in the left arm are protruding outward.
Age: 12.0
Sex: M
Vaccine: HPVX, MEN, TDAP, VARCEL
Symptoms: Paraesthesia, Pyrexia, Thirst
Clinical narrative: At first it was a complaint of arm & hand numb as well as sore & achy with fatigue.  By 08/07/12, it became sore throat, dry mouth & throat, fever up to 102.1 degrees, muscle pains in legs, arms, back, neck & jaw.  Joint pains in shoulders, hips, knees, back, neck & jaw. Very fatigued & thirsty. Left arm swollen from shoulder to elbow, sore & tingly, hot to the touch & firm. The injection points of the two vaccines he was given in the left arm are protruding outward.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Rash, Skin lesion, Urticaria
Clinical narrative: RASH STARTED AS DISCRETE RAISED LESIONS THAT COALESCED INTO LARGE RAISED WELTS.  PATIENT SELF TREATED WITH OTC BENADRYL, DID NOT SEEK MEDICAL ATTENTION LOCALLY.  RETURNED TO TRAVEL CLINIC AT 7 DAYS WITH A FEW LESIONS REMAINING BUT RESOLVING.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a healthcare professional (a nurse who also knew the subject) and described the occurrence of Guillain-Barre syndrome in a 47-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). In 1997 the subject received a dose of Influenza vaccine (details unknown). In 1997, less than one year after vaccination with Influenza vaccine, the subject experienced Guillain-Barre syndrome. According to the nurse, another person at a facility she knows received influenza vaccine (unknown manufacturer) and developed "GB syndrome" [Guillain-Barre syndrome] in 1997. She explained that she is now retired. The subject was hospitalised and the healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. The vaccination course with Influenza vaccine was discontinued. The healthcare professional considered the event was possibly related to vaccination with Influenza vaccine.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue, Myalgia
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of muscle pain in a 49 year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 19 October 2011 the subject received a dose of FLUARIX (.5 ml, unknown route). On 21 October 2011, 2 days after vaccination with FLUARIX, the subject experienced "severe" muscle pain and tiredness. The physician considered the events were disabling. The subject was unable to go to work. At the time of reporting the events were resolved. The physician considered the events were possibly related to vaccination with FLUARIX. The physician reported 2 subjects who experienced adverse events following vaccination with FLUARIX. This is case 2 of 2. See case ID A0950519A for details of the other report.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Pruritus, Urticaria
Clinical narrative: Rec'd PNEUMOVAX at 4:30 PM. C/O itchiness & hives at 5:39 pm. No cardio/pulm sx - (anxiety only) diffuse hives trunk & arms. Tx BENADRYL IM SOLUMEDROL IM BENADRYL & CLARITIN po at home.
Age: 1.63
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Skin warm
Clinical narrative: Area of erythema approximately 5cm in diameter, red, warm to touch nontender, no knot.
Age: 22.0
Sex: U
Vaccine: ANTH, SMALL
Symptoms: Local swelling, Mass, Paraesthesia
Clinical narrative: LLR following first AVA vaccine, given SQ. Symptoms: Disturbance of skin sensation, Swelling/mass/lump, localized superficial.
Age: 1.32
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 25 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; dose one received on 11 January 2010, dose two received on 15 March 2010, dose three received on 18 May 2010, and dose four received on 10 March 2011 (lot numbers, routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 11 January 2012, approximately 10 months after the last dose. On 04 February 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 07 February 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 February 2012 for five days. The subject was not hospitalized. At the time of final contact on 10 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 30 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.32
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 25 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; dose one received on 11 January 2010, dose two received on 15 March 2010, dose three received on 18 May 2010, and dose four received on 10 March 2011 (lot numbers, routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 11 January 2012, approximately 10 months after the last dose. On 04 February 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 07 February 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 February 2012 for five days. The subject was not hospitalized. At the time of final contact on 10 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 30 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.57
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 25 July 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3195AA received on 13 November 2009, lot number C3198AA received on 11 January 2010, lot number C3494AA received on 31 March 2010, and a dose of DAPTACEL, lot number C3449BA on 11 April 2011 (routes and sites of administration not reported). The subject developed a cough on 06 June 2012, approximately 13 months after the last dose. On 12 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 13 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 13 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 29 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required per protocol. Documents held by sender: None.
Age: 1.57
Sex: M
Vaccine: DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 25 July 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3195AA received on 13 November 2009, lot number C3198AA received on 11 January 2010, lot number C3494AA received on 31 March 2010, and a dose of DAPTACEL, lot number C3449BA on 11 April 2011 (routes and sites of administration not reported). The subject developed a cough on 06 June 2012, approximately 13 months after the last dose. On 12 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 13 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 13 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 29 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required per protocol. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue, Myalgia
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of muscle pain in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 12 October 2011 the subject received a dose of FLUARIX (.5 ml, unknown route). On 14 October 2011, 2 days after vaccination with FLUARIX, the subject experienced "severe" muscle pain and tiredness. The physician considered the events were disabling. The subject was unable to go to work. At the time of reporting the events were resolved. The physician considered the events were possibly related to vaccination with FLUARIX. The physician reported 2 subjects who experienced adverse events following vaccination with FLUARIX. This is case of 1 of 2. See case ID A0950526A for details of the other report.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule, Injection site pain, Injection site rash
Clinical narrative: Patient developed redness, inflammation and pain around the injection site on 8/2/12. She called her doctor on 8/3/12, and he recommended to use ice and TYLENOL. She applied ice and only had to take one TYLENOL. The rash was gone by 8/5/12. She still has a small knot on 8/7 at the injection site.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 25 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 3-year-old, male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3227AA received on 25 November 2008, lot number C3227AA received on 27 January 2009, lot number C3280AA received on 24 March 2009, lot number C3565AB received on 04 January 2010 (routes and sites of administration not reported). The subject developed cough on 29 June 2012, approximately 29 months after the last dose. On 02 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 02 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 02 July 2012 for 2 days. The subject was not hospitalized. At the time of final contact on 18 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. According to the investigator, this case was epidemiologically linked to another laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 25 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 3-year-old, male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3227AA received on 25 November 2008, lot number C3227AA received on 27 January 2009, lot number C3280AA received on 24 March 2009, lot number C3565AB received on 04 January 2010 (routes and sites of administration not reported). The subject developed cough on 29 June 2012, approximately 29 months after the last dose. On 02 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 02 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 02 July 2012 for 2 days. The subject was not hospitalized. At the time of final contact on 18 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. According to the investigator, this case was epidemiologically linked to another laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of injection arm pain in a 62-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to hydrocodone and smoker. Historic vaccination included pneumonia vaccine (non-gsk); manufacturer unspecified; unknown; unknown given on an unspecified date. Concurrent medications included ADVAIR and COMBIVENT. On 3 October 2011 at 15:15 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 10 October 2011, 7 days after vaccination with FLUARIX, the subject experienced injection arm pain, injection site movement impairment ("loss of range of motion, could not move him, complete loss of mobility"), not sleeping and inability to perform daily activities ("could not dress, cook"). The subject stated that 1 week after the vaccination she developed significant pain in her left arm and loss of motion. She denied any injection site immediate reaction from the vaccination. According to the subject, she continued to worsen to the point of complete loss of mobility in the injected arm. She stated she could not sleep, dress, cook or move her arm. The subject reported that she was only able to get 2 hours of sleep a night for 3 months. The subject saw her physician on 14 December 2011 and again on 12 January 2012 for "continued problems". An X-ray demonstrated no physical damage or tears in her arm. The subject had a magnetic resonance imaging (MRI) on 20 January 2012 and again no injury to the shoulder or arm was seen. The subject saw an orthopedist on 25 January 2012 who treated her with a cortisone injection, pain medications and range of motion exercises. According to the subject, the cortisone injections stopped the pain and the exercises have made a very small improvement in the range of motion. The subject noted that she is not certain if she will ever be able to have full range again like this on the internet and is angry over the loss of function and money". The subject indicated that she has not pursued legal action at this time, but may proceed for reimbursement. The subject stated she reported her events to the FDA. At the time of reporting, the injection site arm pain was resolved as of 25 January 2012 and the injection site movement impairment and not sleeping were improved. The outcome for inability to perform daily activities was unknown. Follow-up information was received via the consumer on 27 March 2012. It was reported that the subject still had ongoing issues following vaccination with FLUARIX. She noted pain in her arm described as severe pain with certain arm movements and "loss of range of motion". The subject noted still not having full use of her arm. She reported that her condition may require additional cortisone shots and therapy. This subject has received ADVAIR concurrently. For details concerning events associated with ADVAIR use, please see case A0912059A.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: A report has been received regarding a 61-year-old female with systemic lupus erythematous (SLE), prescribed BENLYSTA 10 mg/kg intravenously (IV) q28 days, who experienced congestion in chest and fever. The patient's medical history included asthma, fibromyalgia, acid reflux, restless leg syndrome, dyslipidemia, Sjogren's syndrome, SLE, depression, Vitamin D deficiency and transient ischemic attack 3 years ago. Concomitant medications include PLAQUENIL, CELLCEPT, NEURONTIN, PLAVIX, Vitamin D, lisinopril, LIPITOR, amitriptyline, SINGULAIR. NEXIUM, EVOXAC, SINEMET, EFFEXOR XR, multivitamin, ADVAIR HFA, PERCOCET. The patient's first dose of BENLYSTA was infused on 15Jun11 and she had 5 total infusions. On 24Oct11, 6 days after the BENLYSTA dose (840mg) was infused on 18Oct11, and 2 hours after receiving a flu shot. The patient notified her physician that she was experiencing congestion in her chest and a fever. The patient denied going to her health care provider (HCP) for treatment. Both events resolved on the same day. No action was taken with the administration of BENLYSTA. Follow-up information received on 28Dec11 included confirmation of BENLYSTA indication, total dose of BENLYSTA administered prior to AE, event onset and resolution dates, additional concomitant medications, medical and surgical histories. The information was incorporated into the above narrative. This case has been transferred from another company and may have been reported previously as 2011HGS-002895.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of itching in a 68-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 22 November 2011 at 10:30 the subject received a dose of FLUARIX (unknown route, left arm). On 22 November 2011, less than one day after vaccination with FLUARIX, the subject experienced itching on wrist and itching on arm. At the time of reporting the event was improved. The consumer also reported that her husband experienced adverse events following vaccination with FLUARIX (see case ID A0968632A for details).
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Right posterior upper arm with 5x3 cm area of warmth, 1/2 cm area of induration, mild edema non tender - will start Bactrim.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 55-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included ADD, bladder leaking and gastroesophageal reflux disease. It was reported that the subject has had unspecified left shoulder trouble. Concurrent medications included SANCTURA, RITALIN and PRILOSEC. On 30 September 2011 the subject received a dose of FLUARIX at 0.5 ml in the left arm. On 30 September 2011, less than one day after vaccination with FLUARIX, the subject experienced injection site pain (also reported as left upper arm soreness) and stiffness around the injection site. The events were described as local reactions. At the time of reporting (approximately one month following vaccination with FLUARIX) the events were unresolved.
Sex: U
Vaccine: FLU3
Symptoms: Arthritis, Bursitis, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of bursitis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). At an unspecified time after vaccination with FLUARIX, the subject experienced bursitis, injection site reaction and joint inflammation. The subject developed "bursitis at the vaccination site and the inflammation spread to joints". At the time of reporting the outcome of the events was unspecified. The healthcare professional reported eight patients, all of which received the same lot number of FLUARIX (unspecified lot number), developed bursitis at the vaccination site and inflammation spread to joints. This is two of eight. See A0956566A, A0956568A, A0956569A, A0956570A, A0956571A, A0956572A and A0956573A for details regarding the additional cases.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cough, Decreased appetite, Dizziness, Erythema, Nausea
Clinical narrative: Mother called 8/3/12 am to report swollen, painful, bright red area on (R) arm "about the size of a hand," Pt subsequent office visit 8/6/12 mother reported onset of dizziness - temp to 104 "off & on all weekend" with complaint of nausea, decreased appetite, sore throat & cough. Fever was still 101.6. Exam - normal including (-) strep test.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral, Oropharyngeal pain, Pain in extremity, Pyrexia, Streptococcus test negative
Clinical narrative: Mother called 8/3/12 am to report swollen, painful, bright red area on (R) arm "about the size of a hand," Pt subsequent office visit 8/6/12 mother reported onset of dizziness - temp to 104 "off & on all weekend" with complaint of nausea, decreased appetite, sore throat & cough. Fever was still 101.6. Exam - normal including (-) strep test.
Age: 1.76
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Febrile convulsion
Clinical narrative: 21 month old child who had only received his 2 month vaccines came to office on 7/23/12 to start to catch up on vaccines. Given 5 vaccines. 7 days later had febrile seizure.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt experienced significant swelling (3"), redness pain reported 3 days after immunization. Resolution without treatment within 7 days.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Rash reaction and fever, called pediatrician and they said this is common.
Age: 0.82
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Baseball size welt at injection site, heat at injection site, itchiness and pain at injection site. Hardness of skin under welt.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Baseball size welt at injection site, heat at injection site, itchiness and pain at injection site. Hardness of skin under welt.
Age: 20.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Abdominal discomfort, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Dizzy, achy muscles, upset stomach, headache, fever of 102 at 4:00 PM, chills at 7:00 PM.  Advil 600 mg helped a bit.
Age: 20.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Pyrexia
Clinical narrative: Dizzy, achy muscles, upset stomach, headache, fever of 102 at 4:00 PM, chills at 7:00 PM.  Advil 600 mg helped a bit.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Head injury, Headache, Syncope
Clinical narrative: WHILE STILL IN IMMUNIZATION ROOM PT STATED SHE FAINTED.  SHE WAS STANDING AT THE TIME AND SHE FELL INTO A CHAIR AND HER FATHER TRIED TO CATCH HER GRABBING HER BY THE UPPER ARMS.  REDNESS WAS VISIBLE ON HER UPPER ARMS.  FATHER WAS UNSUCCESSFUL IN CATCHING HER AND SHE HIT THE BACK OF HER HEAD ON THE DOOR KNOB BEFORE HITTING THE FLOOR.  SHE STATES SHE WAS NOT NAUSEATED OR DIZZY BUT THAT SHE SUDDENLY FAINTED. C/O BACK OF HER HEAD HURTING.  NO HEALTHCARE PERSONNEL WAS PRESENT TO WITNESS AS STEPPED OUT OF THE ROOM TO OBTAIN IMMUNIZATION RECORD PRINT-OUT FROM PRINTER.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 5.0
Sex: F
Vaccine: DTPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 8x8 raised red, warm area over R deltoid.  Slightly tender to touch.
Age: 1.04
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fever 103-104 degrees F lasting 24 hours, low grade fever 3 days after; would not eat except breastmilk for 3 days, extremely irritable for 4 days.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Generalized varicella-like rash.
Age: 1.31
Sex: M
Vaccine: MMR, PNC13
Symptoms: Febrile convulsion, Full blood count normal, Intensive care, Metabolic function test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: On 7th day after receiving MMR had prolonged seizure lasting 45 min. Admitted to PICU diagnosed as Complex Febrile seizure.
Age: 1.31
Sex: M
Vaccine: MMR, PNC13
Symptoms: Urine analysis normal
Clinical narrative: On 7th day after receiving MMR had prolonged seizure lasting 45 min. Admitted to PICU diagnosed as Complex Febrile seizure.
Sex: U
Vaccine: FLU3
Symptoms: Arthritis, Bursitis, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of bursitis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). At an unspecified time after vaccination with FLUARIX, the subject experienced bursitis, injection site reaction and joint inflammation. The subject developed "bursitis at the vaccination site and the inflammation spread to joints". At the time of reporting the outcome of the events was unspecified. The healthcare professional reported eight patients, all of which received the same lot number of FLUARIX (unspecified lot number), developed bursitis at the vaccination site and inflammation spread to joints. This is eight of eight. See A0956566A, A0956567A, A0956568A, A0956569A, A0956570A, A0956571A and A0956572A for details regarding the additional cases.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Pt received vaccines 8/1/2012. Came back to clinic 8/3/12 with mild erythema & redness to posterior left arm.
Age: 8.0
Sex: M
Vaccine: IPV, MMR, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: 8/7/12 Mom - called clinic to report patient has 104 degrees fever & is vomiting. Mom states "he & all my kids do this with every shot they get". Mom states is using TYLENOL & Ibuprofen to help with fever, giving fluids, etc. No plans to see PCP unless "it gets a lot worse". Denies any local site reaction. Advised mom to call if she contacts PCP or has concerns.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Severe pain - required narcotics moderate swelling, warmth, erythema fever 102.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Electrocardiogram, Syncope
Clinical narrative: 24 h after HPV vaccine given - patient had orthostatic syncope - awoke immediately on becoming horizontal.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site induration
Clinical narrative: Leg of inj had round 2.5cm hard spot.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain, Dizziness, Face injury, Fall, Haematoma
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM with the second dose of GARDASIL (lot # 670050/1229AA, Exp Date 12-NOV-2013) on 21-APR-2012. Other suspect therapies included HAVRIX on 21-APR-2012. No concomitant medications were reported. On 21-APR-2012 the patient experienced dizziness, black out (medically significant), hematoma-forehead, fall, facing face and abdominal pain. No treatment information was reported. The outcome of dizziness, black out, hematoma-forehead, fall, facing face and abdominal pain is unknown. Upon internal review black out was considered to be medical significant. The original reporting source was not provided. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM with the second dose of GARDASIL (lot # 670050/1229AA, Exp Date 12-NOV-2013) on 21-APR-2012. Other suspect therapies included HAVRIX on 21-APR-2012. No concomitant medications were reported. On 21-APR-2012 the patient experienced dizziness, black out (medically significant), hematoma-forehead, fall, facing face and abdominal pain. No treatment information was reported. The outcome of dizziness, black out, hematoma-forehead, fall, facing face and abdominal pain is unknown. Upon internal review black out was considered to be medical significant. The original reporting source was not provided. Additional information is not expected.
Sex: U
Vaccine: FLU3
Symptoms: Arthritis, Bursitis, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of bursitis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). At an unspecified time after vaccination with FLUARIX, the subject experienced bursitis, injection site reaction and joint inflammation. The subject developed "bursitis at the vaccination site and inflammation spread to joints". At the time of reporting the outcome of the events was unspecified. The healthcare professional reported eight patients, all of which received the same lot number of FLUARIX (unspecified lot number), developed bursitis at the vaccination site and inflammation spread to joints. This is seven of eight. See A0956566A, A0956567A, A0956568A, A0956569A, A0956570A, A0956571A and A0956573A and regarding the additional cases.
Sex: U
Vaccine: FLU3
Symptoms: Arthritis, Bursitis, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of bursitis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). At an unspecified time after vaccination with FLUARIX, the subject experienced bursitis, injection site reaction and joint inflammation. The subject developed "bursitis at the vaccination site and the inflammation spread to joints". At the time of reporting the outcome of the events was unspecified. The healthcare professional reported eight patients, all of which received the same lot number of FLUARIX (unspecified lot number), developed bursitis at the vaccination site and inflammation spread to joints. This is six of eight. See A0956566A, A0956567A, A0956568A, A0956569A, A0956570A, A0956572A and A0956573A for details regarding the additional cases.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Blood test normal, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a consumer (the subject's wife) and described the occurrence of itchy red rash in a 69-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure and penicillin allergy. Historic vaccination included influenza vaccine trivalent; GlaxoSmithKline; unknown; left arm given on 15 November 2010; seasonal influenza vaccine (non-gsk); Novartis; unknown; left arm given on 14 October 2009. The subject did not experience adverse events after prior flu shots. Concurrent medications included Blood pressure medication (Medication for high blood pressure). On 20 October 2011 at 11:00 the subject received a dose of FLUARIX (unknown route, right arm0. On 20 October 2011, less than one day after vaccination with FLUARIX, the subject experienced itchy red rash./ The rash was all over his body, but mostly concentrated at his spine. The reporter stated that the itching was constant, but moving to different locations. The subject consulted his primary care physician and was referred to a dermatologist. The reporter indicated that the dermatologist said "they had never seen anything like it". The primary care physician and an infectious disease physician performed unspecified blood work with negative results. The reporter stated that a second dermatologist performed a biopsy and the results indicated that the rash was due to the flu shot. At the time of reporting the event was worse. The consumer also reported that she had experienced adverse events following vaccination with FLUARIX (see case ID A0968637A for details).
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Third shot at the end of June. Went to the ER on July 3, 2012. Legs started going numb and tingly. Her arms and hands are all numb. It is hard to squeeze her hands. When walking it feels like her legs are noodles.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pruritus, Pyrexia, Rash macular, Vomiting
Clinical narrative: Red blotches all over. Sick to stomach, throwing up, fever. Itched terribly.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Peri injection erythema/edema itching left arm at site of varicella injection.
Age: 38.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: Headache; fluid filled vesicles around injection site; injection site itchy and hot to touch.