chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Injection site haematoma, Oedema peripheral, Pain in extremity
Clinical narrative: This case is 1 of a cluster of 5 (previously reported as 6 unidentified) identified patients' who experienced similar adverse events following vaccination with ADACEL. The events for the first patient was captured in case 2010-04334, second patient in 2010-04836, third patient in 2010-04837 and fourth patient in 2010-04838. Initial report received from a health care professional on 07 September 2010. A 46-year-old female patient received on 04 August 2010 an injection (route and site not provided) of ADACEL, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082AA. The patient developed severe fever of 103+ (fever lasted for 3 days), chills, arm at injection site bruised and a red, painful, swollen and sore arm. The arm soreness and swelling lasted for 10 days. The outcome was reported as recovered. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: This case is 1 of a cluster of 5 (previously reported as 6 unidentified) identified patients' who experienced similar adverse events following vaccination with ADACEL. The events for the first patient was captured in case 2010-04334, second patient in 2010-04836, third patient in 2010-04837 and fourth patient in 2010-04838. Initial report received from a health care professional on 07 September 2010. A 46-year-old female patient received on 04 August 2010 an injection (route and site not provided) of ADACEL, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082AA. The patient developed severe fever of 103+ (fever lasted for 3 days), chills, arm at injection site bruised and a red, painful, swollen and sore arm. The arm soreness and swelling lasted for 10 days. The outcome was reported as recovered. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Malaise, Myalgia, Neck pain, Pyrexia
Clinical narrative: This is a cluster of several unidentified patients who experienced similar adverse events following vaccination with ADACEL. Initial report received from a physician on 04 September 2010. An unknown amount of patients (reported as several) received on unknown dates an injection (routes and sites not provided) of ADACEL, sanofi pasteur Inc. lot number U3110BA and sanofi pasteur Ltd. lot number C3349. The patients who recently received the Tdap from lot number U3110BA experienced significant side effects. Several patients complained of myalgia, malaise, soreness in the neck, fever, and redness over the site of injection. Some patients felt more ill than others. The outcomes for the patients were not reported. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a health care professional on 30 August 2010. A female patient (age not reported) received on an unknown date an injection of ADACEL, lot number not reported. The patient was seen in a "grocery store" and stated receiving ADACEL vaccine, she had a reaction. The patient was asked to return to the health center for follow-up and has not returned. Unable to provided further information about this patient or situation. The outcome was reported as unknown. This case is linked to 2010-04634, 2010-04635, 2010-04637 and 2010-04638 but is not part of the cluster (no lot number reported). Documents held by sender: None.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Influenza, Pain in extremity, Pyrexia
Clinical narrative: This case is 1 of a cluster of 5 (previously reported as 6 unidentified) identified patients who experienced similar adverse events following vaccination with ADACEL. The events for the first patient was captured in case 2010-04334, third patient in 2010-04837, fourth patient in 2010-04838 and fifth patient in 2010-04839. Initial report received from a health care professional on 07 September 2010. A 39-year-old female patient received on 04 August 2010 an injection (route and site not reported) of ADACEL, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082AA. The patient developed flu symptoms, fever, chills and arm pain. The outcome was reported as recovered. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza, Pain in extremity
Clinical narrative: This case is 1 of a cluster of 5 (previously reported as 6 unidentified) identified patients who experienced similar adverse events following vaccination with ADACEL. The events for the first patient was captured in case 2010-04334, second patient in 2010-04836, third patient in 2010-04837 and fifth patient in 2010-04839. Initial report received from a health care professional on 07 September 2010. A 45-year-old female patient received on 04 August 2010 an injection (route and site not reported) of ADACEL, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082AA. The patient developed flu symptoms and arm pain. The outcome was reported as recovered. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Neck pain, Pain in extremity, Painful respiration
Clinical narrative: This case is 1 of a cluster of 4 patients' who experienced similar adverse events following vaccination with ADACEL. The event for the first case was captured in case number 2010-04634, the third case in 2010-04637 and the fourth case in 2010-04638. Initial report received from a health care professional on 30 August 2010. A 48-year-old female patient received on 20 August 2010 a left arm injection (route not provided) of ADACEL, sanofi pasteur Ltd. lot number C3256 and sanofi pasteur Inc. lot number U3035CA. The patient called to report she had sore arm, bruised to shoulder, sore when breathing hard, and neck was hurting. The patient was asked to return but has not returned to facility. No further information can be provided for this patient. The outcome was reported as unknown. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Chills, Cough, Pyrexia, Rash erythematous
Clinical narrative: Case received from a healthcare professional through the MIS on 08 October 2010 under the local reference number 10-0699. A 34-year-old female patient, with no reported medical history, had received her dose of ADACEL, batch number C3517BA, on 06 October 2010. On 06 October 2010, 15 minutes post-vaccination, the patient experienced heaviness and tightness in her chest. Later that evening, she developed a red rash on her upper arm. She also presented with fever, chills and cough. The following evening, she still had fever. Twenty-four hours later, the patient's symptoms resolved and she was fine. Documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza, Injection site haematoma, Injection site nodule, Myalgia, Pyrexia
Clinical narrative: This case is a cluster of 6 unidentified patients who experienced similar adverse events following vaccination with ADACEL. Initial report received from a consumer on 11 August 2010. A group of 6 unidentified patients received an injection of ADACEL on 04 August 2010, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082AA. All 6 patients experienced varied fever temperatures, "flu-like symptoms", pain at site, reddened arm, swollen arm, and lump at injection site the night of 04 August 2010. The outcome was not reported. This case is 1 of a cluster of 5 (previously reported as 6 unidentified) identified patients who experienced similar adverse events following vaccination with ADACEL. The events for the second patient was captured in case 2010-04836, third patient in 2010-04837, fourth patient in 2010-04838 and fifth patient in 2010-04839. A 38-year-old female patient (age reported as 39 and birth date of 17 November 1971 calculates to an age of 38) received on 04 August 2010 an injection (route and site not provided) of ADACEL, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082AA. The patient developed flu symptoms, fever, knot and bruise at injection site and muscle pain for one week to 10 days. The outcome was reported as recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Initial report received from a health care professional on 16 August 2010. A 21-year-old male patient, with no illness at the time of vaccination, received on 16 August 2010 a .5 milliliter (ml) "ID" left forearm injection of ADACEL, lot number C3489AA, and complained of pain at the site immediately. The outcome was reported as unknown. Follow-up information was received on 16 September 2010 from a healthcare professional. The patient recovered on an unspecified date. The reporter stated there was no additional information at this time. Follow-up information was received from the healthcare professional on 25 October 2010. The reporter confirmed that ADACEL was administered intradermally in the left forearm. No additional information was provided. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Contusion, Drug exposure during pregnancy, Pain in extremity
Clinical narrative: Initial report received from a consumer on 17 August 2010. A 26-year-old pregnant female, with an allergy to tape, received on 07 April 2010 an intramuscular (IM) injection (dose 1) of ADACEL (lot number unknown) and an IM injection (dose 1) of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown). The patient denies any medical conditions and was taking prenatal vitamins. Her date of last menstrual period was 20 January 2010 with an estimated date of delivery on 11 October 2010. The patient stated that her arm was bruised and very sore for approximately 4 weeks following receipt of the vaccine. The outcome was reported as recovered. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Dizziness, Dry mouth, Pain
Clinical narrative: This is 1 of a cluster of 2 patients who experienced similar events following vaccination with ADACEL. The event for the first patient was captured in case number 2010-03334. Initial report was received from a health care profession on 09 June 2010. An unidentified patient, with medical history not provided, received an intramuscular injection on 01 June 2010 of ADACEL, lot number U3446AA, and on 02 June 2010 developed a temperature up to 100.5 with body aches, chills, lightheadedness and dry mouth. The patient had no illness at the time of vaccination and received no vaccinations within 4 weeks prior to the ADACEL vaccine. The outcome was reported as recovered. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Computerised tomogram head, Computerised tomogram normal, Full blood count, Headache
Clinical narrative: Initial case was received on 17 June 2010 from a healthcare professional. A 49 year old female patient received a left deltoid intramuscular injection of ADACEL (lot number C3352AA) in the a.m. on 10 June 2010. In the p.m. on 10 June 2010 the patient experienced a headache, chills, photophobia, stiff neck and myalgia. She was evaluated and treated in the emergency department (ED). No ED report was provided. She was evaluated by a family practitioner on 11 June 2010 (no report provided). On 17 June 2010 she was seen by a nurse practitioner. Blood work was ordered including a CBC and comprehensive metabolic panel (results not provided). The patient had no illness at the time of vaccination. Her medical history included a herniated disk, sinus arrhythmia with palpitations and allergies to "MS04", Sulfa drugs and VIDCODIN. She was not pregnant. Concomitant medications included multivitamins, glucosamine, calcium and OPC3. At the time of this report, it was unknown if the patient had recovered. Follow-up information was received 02 August 2010 from a health care professional. The patient had not received any other vaccines within four weeks of ADACEL. A CT of the head was negative and patient declined a neurological follow-up. No treatment was required. All signs and symptoms had resolved as of 26 July 2010, for all but a mild headache. According to the reporter, the patient recovered on 26 July 2010. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test, Musculoskeletal stiffness, Myalgia, Photophobia
Clinical narrative: Initial case was received on 17 June 2010 from a healthcare professional. A 49 year old female patient received a left deltoid intramuscular injection of ADACEL (lot number C3352AA) in the a.m. on 10 June 2010. In the p.m. on 10 June 2010 the patient experienced a headache, chills, photophobia, stiff neck and myalgia. She was evaluated and treated in the emergency department (ED). No ED report was provided. She was evaluated by a family practitioner on 11 June 2010 (no report provided). On 17 June 2010 she was seen by a nurse practitioner. Blood work was ordered including a CBC and comprehensive metabolic panel (results not provided). The patient had no illness at the time of vaccination. Her medical history included a herniated disk, sinus arrhythmia with palpitations and allergies to "MS04", Sulfa drugs and VIDCODIN. She was not pregnant. Concomitant medications included multivitamins, glucosamine, calcium and OPC3. At the time of this report, it was unknown if the patient had recovered. Follow-up information was received 02 August 2010 from a health care professional. The patient had not received any other vaccines within four weeks of ADACEL. A CT of the head was negative and patient declined a neurological follow-up. No treatment was required. All signs and symptoms had resolved as of 26 July 2010, for all but a mild headache. According to the reporter, the patient recovered on 26 July 2010. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received 25 August 2010 from a health care professional. A female patient who was reported to have been greater than 65 years of age, and who also was physician, had received ADACEL during August 2010 (lot number, route, site and date of administration not reported) and eight days later, she developed induration larger than a silver dollar at the the injection site - deltoid muscle. The area was hot to touch, itchy and swollen. The reporter further stated that, "more recently" another area below the injection site had become red and warm to touch. The patient (physician) began taking antibiotics on an unspecified date and at the time of the report, she had not recovered. The reporter refused to provide any further information pertaining to the event or their contact information. The reporter stated she would file a VAERS report online if the patient (physician) agreed. No further information was provided at the time of the report. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Initial report was received 25 August 2010 from a health care professional. A female patient who was reported to have been greater than 65 years of age, and who also was physician, had received ADACEL during August 2010 (lot number, route, site and date of administration not reported) and eight days later, she developed induration larger than a silver dollar at the the injection site - deltoid muscle. The area was hot to touch, itchy and swollen. The reporter further stated that, "more recently" another area below the injection site had become red and warm to touch. The patient (physician) began taking antibiotics on an unspecified date and at the time of the report, she had not recovered. The reporter refused to provide any further information pertaining to the event or their contact information. The reporter stated she would file a VAERS report online if the patient (physician) agreed. No further information was provided at the time of the report. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Cluster of two female patients who each developed redness, pain, and "knots" at the injection site following the administration of ADACEL (lot number unknown). Initial report received on 05 August 2010 from a health professional (nurse). Two unidentified post-partum female patients, whose medical histories were not reported, each received a dose of ADACEL (lot number unknown) on an unspecified date. The patients each developed redness, pain, and "knots" at the injection site. Their outcomes were not reported. No other information was provided.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: This case is 1 of a cluster of 3 patients who experienced similar adverse events following vaccination with MENACTRA. Initial reported received from a health care professional on 25 May 2010. An 11-year-old child, with a history of asthma, received the following injections on 17 May 2010: A right deltoid injection of MENACTRA, lot number U3357BA, a left deltoid injection of ADACEL, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082BA, and VARIVAX (Merck), lot number 00262. The patient developed a very swollen and itchy unidentified location that looked like a big hard ball. The swelling was reported as improved, however, the area still was a little itchy and red. The outcome for the events was reported as not recovered. Follow-up information was received from the health care professional on 21 June 2010. MENACTRA and ADACEL were administered intramuscularly, and the events occurred in the right arm. The patient did not require treatment, and was not seen by a physician. Improvement was noted at the time of a telephone call with the patient's mother, and the events subsequently resolved. The reporter for this case is the same as for cases 2010-02943 and 2010-02944. Documents held by sender: None.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Headache
Clinical narrative: Initial report received from a health care professional on 27 May 2010. A 56-year-old male patient, with no medical history reported, received an injection (route and site not provided) on 03 May 2010 of ADACEL, lot number C3438 AA, and received a second injection (route and site not provided) on 24 May 2010 of Diphtheria, Tetanus and Acellular Pertussis vaccine, manufacturer and lot number unknown, and on 26 May 2010 experienced diarrhea, headache, dizziness and stomach ache. The patient received the first vaccination at an office and then received the second vaccination at his work because he had forgotten he had already had the vaccine. The outcome was not reported. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Cheilitis, Lip exfoliation
Clinical narrative: Initial report received from a health care professional on 06 April 2011. A 40-year-old female patient received on 22 March 2011 at right deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number C3661 and sanofi pasteur Inc. lot number U3554CA. The patient has no medical history and no concomitant medications. The patient had no illness at the time of vaccination. On 23 March 2011, the patient developed peeling and red lips "like when a child is licking his lips and they peel". She had no other complaints. The patient was to see her physician. The outcome was reported as not recovered. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin hypopigmentation, Urticaria
Clinical narrative: Initial report received from a health care professional on 12 April 2011. A female patient received on an unknown date an injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. lot number C3637 and sanofi pasteur Inc. lot number U3491BA. The patient developed hives. No further information was provided. The outcome was not reported. Follow-up information was received from the healthcare professional on 09 May 2011. The patient was 14 years old at the time of vaccination, and received ADACEL in the left deltoid on 15 Marcy 2011 in a school base clinic. She had no illness at the time of vaccination, and denied any history of allergies. She had no history of changes in soaps or detergents, however did have a dog which she allowed to sleep in bed with her. The event began on 20 March 2011, 5 days post-vaccination, with the patient complaining of red itchy areas on the face with no associated pain. Medications included cortisone and BENADRYL. Per the reporter, the patient had "heavy use" of cortisone cream, and had hypopigmented areas on the face and forearms. The patient was instructed to stop cortisone use, use AQUAPHOR, sunblock, AVEENO or CETAPHIL; remove dog from bed; wash all bedding thoroughly; and follow-up in 1-2 weeks. The assessment was possible dermatitis vs eczema, "unlikely secondary to Tdap given 1 month ago". The events subsequently resolved on an unspecified date. Documents held by sender: None.
Age: 89.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Initial report was received from a health care professional on 25 April 2011. An 89-year-old male patient had received on 15 April 2011 a dose of ADACEL (lot number, route and site of administration not reported) and an unspecified amount of time after vaccination experienced bilateral lower limb swelling and itching. According to the reporter the patient symptoms were "getting better" but had not resolved. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Vaccination site erythema
Clinical narrative: Injection site mass. Vaccination site erythema.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Induration, Injection site haemorrhage, Lymphadenitis, Oedema peripheral
Clinical narrative: Initial report was received from a health care professional on 29 March 2011. A 54 year-old female patient with a history of hypertension, allergic rhinitis and an allergy to sulfa had received a first dose intramuscular left deltoid injection of ADACEL, lot number U3874AA (sanofi pasteur Ltd. lot number C3823) on 25 March 2011 and an unspecified amount of time later developed pain down her arm and a large lump in her armpit region measuring 2 1/2 inches in length. The patient was evaluated by a physician on 29 March 2011. Treatments were not reported. Concomitant medications included Kozar and Hydrochloriothiazide. The patient received no other vaccines on 25 March 2011. Illness at time of vaccination, vaccines given within four weeks prior of suspect vaccine and adverse event following prior vaccinations were all denied. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information received on 25 April 2011 from a health care professional. Additional medical history includes nausea when taking Sulfanilamides. Other concomitant medications that were listed included: NASALCROM for the eyes, Hydrochlorothiazide, COZAAR (previously reported as Kozar), RHINOCORT AQUA and EFFEXOR XR. Start dates for all concomitant medications were reported as 25 March 2011; and Indications were not provided. The patient was evaluated by a physician on 29 March 2011 at 8:15 am (4 days post-vaccination). Vital signs that day included blood pressure 149/84, temperature 98.3 degrees Fahrenheit and pulse 96 beats/minute. The patient had received the ADACEL vaccination the Friday before on 25 March 2011 and subsequently developed pain over the left arm with some radiation down her arm, but then noted swelling over the left axilla (anterior). Onset date was not provided. On the 29th the swelling had worsened, but there was not much pain, and no redness or fever. The left arm pain had resolved. Physical exam that day revealed no apparent distress, but left upper arm was positive for mild ecchymosis over the site of injection with no induration or erythema. The left anterior axilla had a 2.5 x 2 cm firm mass with no erythema or fluctuance. There were no signs of infection. The patient was prescribed warm compresses and Ibuprofen as needed. Final clinical assessment was suspect prominent lymphadenitis reaction. The patient was instructed to follow-up if symptoms worsened or if any redness occurred. At the time of this report, the patient had recovered (date not reported). Documents held by sender: Office visit doctor note.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Initial report was received from a health care professional on 29 March 2011. A 54 year-old female patient with a history of hypertension, allergic rhinitis and an allergy to sulfa had received a first dose intramuscular left deltoid injection of ADACEL, lot number U3874AA (sanofi pasteur Ltd. lot number C3823) on 25 March 2011 and an unspecified amount of time later developed pain down her arm and a large lump in her armpit region measuring 2 1/2 inches in length. The patient was evaluated by a physician on 29 March 2011. Treatments were not reported. Concomitant medications included Kozar and Hydrochloriothiazide. The patient received no other vaccines on 25 March 2011. Illness at time of vaccination, vaccines given within four weeks prior of suspect vaccine and adverse event following prior vaccinations were all denied. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information received on 25 April 2011 from a health care professional. Additional medical history includes nausea when taking Sulfanilamides. Other concomitant medications that were listed included: NASALCROM for the eyes, Hydrochlorothiazide, COZAAR (previously reported as Kozar), RHINOCORT AQUA and EFFEXOR XR. Start dates for all concomitant medications were reported as 25 March 2011; and Indications were not provided. The patient was evaluated by a physician on 29 March 2011 at 8:15 am (4 days post-vaccination). Vital signs that day included blood pressure 149/84, temperature 98.3 degrees Fahrenheit and pulse 96 beats/minute. The patient had received the ADACEL vaccination the Friday before on 25 March 2011 and subsequently developed pain over the left arm with some radiation down her arm, but then noted swelling over the left axilla (anterior). Onset date was not provided. On the 29th the swelling had worsened, but there was not much pain, and no redness or fever. The left arm pain had resolved. Physical exam that day revealed no apparent distress, but left upper arm was positive for mild ecchymosis over the site of injection with no induration or erythema. The left anterior axilla had a 2.5 x 2 cm firm mass with no erythema or fluctuance. There were no signs of infection. The patient was prescribed warm compresses and Ibuprofen as needed. Final clinical assessment was suspect prominent lymphadenitis reaction. The patient was instructed to follow-up if symptoms worsened or if any redness occurred. At the time of this report, the patient had recovered (date not reported). Documents held by sender: Office visit doctor note.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Migraine, Musculoskeletal stiffness
Clinical narrative: Initial report received from a health care professional on 30 March 2011. A 30-year-old female patient with no concurrent illnesses, had received an intramuscular right deltoid injection of ADACEL (lot number U3554CA, Sanofi pasteur Ltd. lot number C3661) on 28 March 2011, and 2 hours after receiving the vaccinations she reported having a headache that progressed to a migraine, and neck stiffness that required a doctor visit. Results of doctor visit were not provided. No relevant diagnostic tests/laboratory data were performed. The patient had not received any other vaccinations within 4 weeks prior to 28 March 2011; and her pre-existing medical history and use of other medications were unknown. It was also unknown if the patient had experienced any adverse events with prior vaccinations. A the time of this report, the patient had not recovered. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Live birth, Ultrasound foetal, Ultrasound scan normal
Clinical narrative: Initial report received from a health care professional on 24 May 2010. A neonate, with no medical history reported, received transplacental ADACEL at the end of July 2009 when the mother was vaccinated with ADACEL, lot number unknown. The mother had no health risks, no pregnancy complications and was healthy during pregnancy. A prenatal ultrasound was normal and Alphafetoprotein (AFP) testing was negative (dates not provided). The neonate experienced complication of shoulder dystocia during labor and/or delivery. The patient was delivered live vaginally on 26 March 2010 with no congenital anomaly and weighing 8.5 pounds (3.8 kilograms) with a one minute Apgar score of 8 and a 5 minute Apgar score of 9. The reporter for this case is the same as for case number 2009- 03908 (mother case, no adverse event). Follow-up information was received on 14 July 2010 from a healthcare professional. The neonate recovered from the previously reported shoulder dystocia on an unspecified date. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Cognitive disorder, Computerised tomogram normal, Diplopia, Fatigue
Clinical narrative: Initial report received on 20 April 2011 from a consumer, who is the patient. A 55 year old female patient, with an allergy to thimerosal, received a left deltoid intramuscular injection of ADACEL (lot number unknown) on 10 January 2011. The patient had no illness at the time of vaccination. Concomitant medication included Levothyroid. She had received previous tetanus vaccines. On the night of vaccination (10 January 2011), the patient experienced fatigue. One week later, she had a rapid heart beat. One week after that, she had "an electric sensation in her head which transformed into migraine headaches". She continued to have these headaches, balance problems, cognitive problems, and double vision at times. On an unspecified date, the patient consulted a physician. Diagnostic tests included MRIs, CAT Scans, labs, and other tests that showed nothing. At the time of the report, the patient had not recovered.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Heart rate increased, Laboratory test normal, Migraine, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Initial report received on 20 April 2011 from a consumer, who is the patient. A 55 year old female patient, with an allergy to thimerosal, received a left deltoid intramuscular injection of ADACEL (lot number unknown) on 10 January 2011. The patient had no illness at the time of vaccination. Concomitant medication included Levothyroid. She had received previous tetanus vaccines. On the night of vaccination (10 January 2011), the patient experienced fatigue. One week later, she had a rapid heart beat. One week after that, she had "an electric sensation in her head which transformed into migraine headaches". She continued to have these headaches, balance problems, cognitive problems, and double vision at times. On an unspecified date, the patient consulted a physician. Diagnostic tests included MRIs, CAT Scans, labs, and other tests that showed nothing. At the time of the report, the patient had not recovered.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Muscle tightness, Restless legs syndrome, Tinnitus
Clinical narrative: Initial report was received on 21 January 2011 from a consumer who is also the patient. A 49 year-old female patient with a history of asthma, GERD and an allergy to Amytriptyline had received a first dose intramuscular right arm injection of ADACEL, lot number C3487AA on 30 November 2010 and later that night, experienced a mild headache, tense muscles, restless legs and ringing in the left ear. The patient had also received the "Flu vaccine" (manufacturer, lot number, route and site of administration were not reported) in October 2010. Concomitant medications were NEXIUM and SYNTHROID. The patient was evaluated by a physician however treatments were not reported. No further information was available at the time of the report. The reporter stated that "all symptoms except for the ringing in the ear have resolved". Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Eye pain, Headache, Pain in extremity
Clinical narrative: Initial report was received from a consumer, who is also the patient on 27 December 2010. A 59 year-old female patient with no reported past medical history had received ADACEL (lot number, route and site of administration not reported) on 22 December 2010 and an unspecified amount of time later, experienced "severe eye pain - pain from eyes radiating through head with any eye movement", headache, arm pain and hand pain. The patient was not evaluated by a physician. Treatments included TYLENOL with some relief. The patient reports a decrease in eye and head pain but not totally gone. She also stated she is "getting better but very slowly". The patient's outcome was reported as unknown. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity, Pain in jaw, Paraesthesia
Clinical narrative: Initial report received from a consumer on 20 October 2010. A female patient (birth date declined) received on 19 October 2010 a right deltoid injection (route not reported) of ADACEL, lot number unknown. On 20 October 2010 the patient woke up with severe bilateral jaw pain, face tingling as though NOVOCAIN wore off, severe arm pain, and bilateral stiff neck. The patient had called her physician. The patient declined to give any further information. The outcome was reported as not recovered. Documents held by sender: None.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety
Clinical narrative: Case received from a consumer through the MIS on 30 September 2010 under the local reference number 10-0632. A 39-year-old female patient, with a medical history of autoimmune disease, had received her intramuscular dose of ADACEL (batch number and anatomical site of administration not reported) on 25 August 2010. The patient had had no illness at time of vaccination. She had no previous history of adverse event following vaccination and no other vaccine received within 4 weeks prior to 25 August 2010. The patient had had no other medication. On 03 September 2010, i.e. 9 days post-vaccination, the patient felt anxious. Her anxiety level increased little by little to a high level and had remained constant. The patient's symptoms were not resolved at the time of the report. Documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Feeling cold, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial case received. A male patient received on an unspecified date, a dose 3 injection of ADACEL (lot number not reported) six weeks after dose 2. Within 24 hours the patient experienced pain in hand and arm, nausea and the site of the injection on an unspecified arm was swollen 4 and 1/2 inches "around", red and hot to touch. He also experienced a sensation of being cold and was dizzy. The two prior doses of ADACEL (dates not reported) were given 4 weeks apart and no reactions occurred following the first and second dose. The patient had no illness at the time of the vaccination and did not receive any other vaccinations within 4 weeks. He had no pre-existing medical conditions, no allergies and no concomitant medications. It was unknown if the patient  recovered. Documents held by sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pain in extremity
Clinical narrative: Initial case received. A male patient received on an unspecified date, a dose 3 injection of ADACEL (lot number not reported) six weeks after dose 2. Within 24 hours the patient experienced pain in hand and arm, nausea and the site of the injection on an unspecified arm was swollen 4 and 1/2 inches "around", red and hot to touch. He also experienced a sensation of being cold and was dizzy. The two prior doses of ADACEL (dates not reported) were given 4 weeks apart and no reactions occurred following the first and second dose. The patient had no illness at the time of the vaccination and did not receive any other vaccinations within 4 weeks. He had no pre-existing medical conditions, no allergies and no concomitant medications. It was unknown if the patient  recovered. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site mass
Clinical narrative: Initial information received on 30 July 2010 from a consumer, who is the parent of the patient. A 13 year old female with no past medical history, no known allergies, was not on any concurrent medications and had no reported illness at time of vaccination, had received a "subcutaneous" left deltoid injection of ADACEL (lot number and needle length were unknown) on 27 July 2010 and a right deltoid injection of VARIVAX vaccination (lot number not known) in July of 2010. The patient then developed a "two inch red area with hematoma and a hard lump" at the site. The reporter plans to notify their physician on 30 July 2010. No further information was provided at the time of the report. Follow-up information was received 26 August 2010 from a consumer, who is the patient's parent. According to the reporter, the redness and hematoma completely resolved in approximately four to five days after vaccine administration. An outcome was not reported for the hard lump at the injection site. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: This is a cluster of 2 unidentified patients who experienced similar adverse events following vaccination with ADACEL. Initial report received from a health care professional on 06 July 2011. A group of 2 unidentified patients, with a history of allergies to seafood, received an injection (route and site not reported) of ADACEL, Sanofi Pasteur lot number not reported, on an unknown date. The patient's had mild to moderate reactions. The outcome was not reported. Documents held by sender: None
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Cardiac monitoring, Cardiac stress test, Feeling abnormal, Headache
Clinical narrative: Initial report received on 01 October 2010 from a consumer, who is the patient. A 50-year-old male patient, who had no concurrent illnesses, had received a first left deltoid injection of ADACEL vaccine (lot number unknown) on the morning on 24 September 2010. That evening, the patient developed nausea, headache, and palpitations. He returned to the physician's office three days later with complaint of continued palpitations and blood work was completed (results not reported). The palpitations continued, and two days later on 29 September 2010, the patient was sent to the emergency room and placed on a heart monitor. Palpitations continued, and on 30 September 2010 a stress test was completed (results not reported) and the patient was placed on 24 hours heart monitor. The patient stated he feels like he is speeding. Current medical conditions include allergy to caffeine, MSG (monosodium glutamate), trees, grasses and mold. Concomitant medications include PROVENTIL and FLOVENT inhalers. The patient was to be evaluated by a cardiologist on 01 October 2010 (results not reported). The patient has not recovered. Documents held by sender: None. Corrective version created on 15 October 2010 to follow the new HAs' recommendation to have all the seriousness criteria completed by "yes" or "no". Follow-up information was received from a health care professional on 29 October 2010 reported that the patient was vaccinated at a private doctor's office and that this event was not previously reported. Documents held by sender: None.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Palpitations
Clinical narrative: Initial report received on 01 October 2010 from a consumer, who is the patient. A 50-year-old male patient, who had no concurrent illnesses, had received a first left deltoid injection of ADACEL vaccine (lot number unknown) on the morning on 24 September 2010. That evening, the patient developed nausea, headache, and palpitations. He returned to the physician's office three days later with complaint of continued palpitations and blood work was completed (results not reported). The palpitations continued, and two days later on 29 September 2010, the patient was sent to the emergency room and placed on a heart monitor. Palpitations continued, and on 30 September 2010 a stress test was completed (results not reported) and the patient was placed on 24 hours heart monitor. The patient stated he feels like he is speeding. Current medical conditions include allergy to caffeine, MSG (monosodium glutamate), trees, grasses and mold. Concomitant medications include PROVENTIL and FLOVENT inhalers. The patient was to be evaluated by a cardiologist on 01 October 2010 (results not reported). The patient has not recovered. Documents held by sender: None. Corrective version created on 15 October 2010 to follow the new HAs' recommendation to have all the seriousness criteria completed by "yes" or "no". Follow-up information was received from a health care professional on 29 October 2010 reported that the patient was vaccinated at a private doctor's office and that this event was not previously reported. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Gastrointestinal surgery, Intestinal resection, Intussusception, Lethargy, Pathology test
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Vitello-intestinal duct remnant, Vomiting
Clinical narrative: Initial report received on 29 June 2011 from another manufacturer, report # WAES 1106USA03180. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31 January 2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot# C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot# E234419) IM to the left leg. On 01 February 2011 the patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5 Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29 April 2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31 January 2011 to 11 April 2011. Impression: intussusception. On 11 February 2011, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04 April 2011 due to diarrhea and diaper rash. On 11 April 2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with NYSTATIN, aquaphor and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available". Note: The lot number (C3808AB) provided for TRIHIBIT from the other manufacturer was invalid for the product but matches PENTACEL instead. Documents held by sender: None.