chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Electrocardiogram normal, Foreign body, Injection site erythema
Clinical narrative: Pt reports evening of 06/23/2011, arm felt very tight "like gripped in a vice" for 2-3 hours, then resolved w/arm movement. No further concerns until 6 days later 06/29/2011 while out of town Rt arm at injection site became very itchy and "pink, some minor skin breaks" after she kept itching it. She also felt her rt arm was "slightly" swollen above elbow, below deltoid. She also c/o of extreme dizziness, weak and faint. BENADRYL relieved itching and sx improved since returning, but still has occasional itching and feels Rt arm still slightly swollen above elbow only when compared to her Lt arm. Today on 07/07/2011 she reached above her head and looked up quickly and "got very woozy and blacked out" and fell against her washing machine. As soon as she looked back down, she regained herself. But now feeling dizzy, weak. She took her BP and pulse at home. BP reported as 96/62 - she says normally 120's/60-70's. Pulse 92. She denies any fevers, HA, chest pain or numbness, vision changes since vaccination. She reports no other vaccinations, no new medications, no new exposures to lotion, soaps, etc...known. Encouraged pt to contact her PMD today about sx and incident for further eval and recommendations. Pt told to call if new sx or concerns develop, otherwise I will FU with her on Mon. 07/11/11. Note: Injection site is still tender to touch but no rash/swelling. 07/11/11 1020 Phone call to patient for follow up. She spoke with provider on 07/08/11 and also had an EKG on 07/09/11. Provider visit told her EKG was normal. At office visit she reports BP was normal. She says provider diagnosed her with Benign paroxysmal positional vertigo and told her likely caused by a "stone in ear" and referred to tx. Not mentioned as a concern w/vaccination. Today, she is doing well. Taking movements slowly. Reports no further swelling in Rt arm - same as lt arm. RD is still tender to touch and has "itchy urge" every so often but doing well. Will continue follow up with provider as directed.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Loss of consciousness, Syncope
Clinical narrative: Pt reports evening of 06/23/2011, arm felt very tight "like gripped in a vice" for 2-3 hours, then resolved w/arm movement. No further concerns until 6 days later 06/29/2011 while out of town Rt arm at injection site became very itchy and "pink, some minor skin breaks" after she kept itching it. She also felt her rt arm was "slightly" swollen above elbow, below deltoid. She also c/o of extreme dizziness, weak and faint. BENADRYL relieved itching and sx improved since returning, but still has occasional itching and feels Rt arm still slightly swollen above elbow only when compared to her Lt arm. Today on 07/07/2011 she reached above her head and looked up quickly and "got very woozy and blacked out" and fell against her washing machine. As soon as she looked back down, she regained herself. But now feeling dizzy, weak. She took her BP and pulse at home. BP reported as 96/62 - she says normally 120's/60-70's. Pulse 92. She denies any fevers, HA, chest pain or numbness, vision changes since vaccination. She reports no other vaccinations, no new medications, no new exposures to lotion, soaps, etc...known. Encouraged pt to contact her PMD today about sx and incident for further eval and recommendations. Pt told to call if new sx or concerns develop, otherwise I will FU with her on Mon. 07/11/11. Note: Injection site is still tender to touch but no rash/swelling. 07/11/11 1020 Phone call to patient for follow up. She spoke with provider on 07/08/11 and also had an EKG on 07/09/11. Provider visit told her EKG was normal. At office visit she reports BP was normal. She says provider diagnosed her with Benign paroxysmal positional vertigo and told her likely caused by a "stone in ear" and referred to tx. Not mentioned as a concern w/vaccination. Today, she is doing well. Taking movements slowly. Reports no further swelling in Rt arm - same as lt arm. RD is still tender to touch and has "itchy urge" every so often but doing well. Will continue follow up with provider as directed.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Vertigo positional
Clinical narrative: Pt reports evening of 06/23/2011, arm felt very tight "like gripped in a vice" for 2-3 hours, then resolved w/arm movement. No further concerns until 6 days later 06/29/2011 while out of town Rt arm at injection site became very itchy and "pink, some minor skin breaks" after she kept itching it. She also felt her rt arm was "slightly" swollen above elbow, below deltoid. She also c/o of extreme dizziness, weak and faint. BENADRYL relieved itching and sx improved since returning, but still has occasional itching and feels Rt arm still slightly swollen above elbow only when compared to her Lt arm. Today on 07/07/2011 she reached above her head and looked up quickly and "got very woozy and blacked out" and fell against her washing machine. As soon as she looked back down, she regained herself. But now feeling dizzy, weak. She took her BP and pulse at home. BP reported as 96/62 - she says normally 120's/60-70's. Pulse 92. She denies any fevers, HA, chest pain or numbness, vision changes since vaccination. She reports no other vaccinations, no new medications, no new exposures to lotion, soaps, etc...known. Encouraged pt to contact her PMD today about sx and incident for further eval and recommendations. Pt told to call if new sx or concerns develop, otherwise I will FU with her on Mon. 07/11/11. Note: Injection site is still tender to touch but no rash/swelling. 07/11/11 1020 Phone call to patient for follow up. She spoke with provider on 07/08/11 and also had an EKG on 07/09/11. Provider visit told her EKG was normal. At office visit she reports BP was normal. She says provider diagnosed her with Benign paroxysmal positional vertigo and told her likely caused by a "stone in ear" and referred to tx. Not mentioned as a concern w/vaccination. Today, she is doing well. Taking movements slowly. Reports no further swelling in Rt arm - same as lt arm. RD is still tender to touch and has "itchy urge" every so often but doing well. Will continue follow up with provider as directed.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Arthritis, C-reactive protein normal, Full blood count normal, Inflammation, Injection site pain
Clinical narrative: Right shoulder pain 2nd to arthritis and inflammation from PNEUMOVAX vaccine.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Right shoulder pain 2nd to arthritis and inflammation from PNEUMOVAX vaccine.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS, FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large area of redness from (R) elbow up to right deltoid region. Very painful and swollen. Injection site is hard to the touch and very warm x 3 days.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS, FLU3
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Large area of redness from (R) elbow up to right deltoid region. Very painful and swollen. Injection site is hard to the touch and very warm x 3 days.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Initial report was received 11 January 2011 from a health care professional which involved a cluster of two unidentified patients. Two unidentified patients had received ADACEL, lot number 02969BA (lot number invalid) on an unspecified date (route and site of administration not reported), and an unspecified amount of time later, they developed cellulitis. According to the reporter, their supervisor reported these events to the CDC several months ago. No additional information was provided at the time of the report. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Abscess
Clinical narrative: Initial report was received 03 January 2011 from a health care professional. An unidentified patient had received an injection of ADACEL (lot number, route, site and date of administration not reported) and two days later, the patient developed an abscess which required hospitalization and treatment for four days. The reporter did not have any further information at the time of the report and the patient's outcome was unknown. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis
Clinical narrative: Initial report was received 26Aug2010 from a health care professional. This case is a cluster of 35 unidentified patients' who experienced similar adverse events following vaccination with ADACEL. A group of 35 unidentified patients' (ages ranged from 11 years to 64 years) received on an unknown date(s) an injection (route and site not reported) with ADACEL, lot number not reported. Following vaccination on an unknown date(s), the patients' experienced confirmed pertussis diagnosis. The outcome was not reported. Follow-up information was received from a health care professional on 28 September 2010 who clarified that there were 9 cases (previously reported as 35). The 9 cases occurred in children who had been fully and recently immunized. The vaccines were given out by local doctors participating in the Vaccines for Children Program. The State Health Division was contacted and did some research. The State Health Department did not find any patterns: no breakdown of the cold chain in any of the provider's offices, no concentration of cases at one provider. Follow-up information received from a health care professional on 25 October 2010 reported that this was not an adverse event. Follow-up information was received from a health care professional on 01 November 2010 reported that there were no cluster of 35 patient's with pertussis. The intent was to acquire information and not to report any adverse event. There were 35 cases of pertussis in which many of these patients never were vaccinated or were partially vaccinated. The reporter did not vaccinate these patients and does not have any lot numbers. The reporter had no further information at this time and does not want any further contact. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain, Sleep disorder
Clinical narrative: Initial report was received on 05 May 2011 from a health care professional. A 45 year-old female patient with no known allergies and no reported illnesses at the time of vaccination had received on 26 April 2011 ADACEL, lot number C3517AA (route and site of administration not reported). On 04 May 2011, the patient reported she started experiencing a stiff neck which kept her from sleeping through the night and she was unable to move her head due to the soreness of her neck. Treatments, laboratory data or relevant diagnostic tests were reported. She had no other vaccinations within four weeks of the suspect vaccine. The patient last Td vaccine was in 2007. The patient's outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Headache, Pain, Tremor
Clinical narrative: Initial report received from a health care professional on 09 May 2011. An unidentified patient (sex and birth date not reported) received on an unknown date an injection (route and site not reported) of ADACEL, sanofi pasteur lot number 4247AA (Not a valid lot number). The patient had an onset of headache, body aches, and hand tremors after the ADACEL, approximately 90 minutes after the vaccine. The patient's symptoms resolved. All further information was refused to be provided including to repeat the lot number. The outcome was reported as recovered. Documents held by sender: None.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Somnolence
Clinical narrative: Initial report received from the patients husband who is a pharmacist on 03 March 2011. A 74 year-old female patient with no reported medical history had received an intramuscular injection of ADACEL (lot number not reported) on an unspecified date in 2011. The patient subsequently developed redness and swelling at the injection site. She also complained of drowsiness and a flutter in her stomach. The patient was evaluated by a physician who prescribed antibiotics. Outcome was reported as not recovered. The reporter did not want to report this and would not provide any further information. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: This case is a cluster of ten unidentified patients who experienced similar adverse events following vaccination with ADACEL. Initial report received from a health care professional on 01 April 2011. A group of ten unidentified patients received from the same nurse a tricep injection (route not provided) of ADACEL, sanofi pasteur lot number C3838BA, on 28 March 2011. Ten employees out of 12 who received ADACEL had local reactions. One individual immediately reported to Employee Health (EH) after being injection complaining of itching at the site but no other complaints. As the week progressed the arm became very red, swollen and warm to touch. The injections were given in the tricep area rather than the deltoid. In all ten of those with reactions, all ten of them were administered in the tricep area rather than the deltoid. The reactions have ranged from small (no larger than a 50 cent piece) to engulfing the entire back of the arm and all ten had redness, warmth, and knots to varying degrees. Three individuals complained of flu like symptoms with headache, malaise, and low grade temperature (99.2 to 99.8). Two individuals have complained of neurologic type symptoms such as numbness in the shoulder and/or hand. Five patients have been sent to a physician for evaluation and treatment of the sites. There were two individuals given the vaccine that same day with the same nurse and same anatomical location but had no reaction. Two patients received the ADACEL vaccine with the same lot number on a different day and given by another EH staff in the deltoid and neither had a reaction. The outcomes were not reported. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: IPV, PPV, TDAP
Symptoms: Chills, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Initial report was received from a health care professional on 09 March 2011. A 48 year-old female patient with a past medical history of vertigo, hypertension (HTN) and an allergy to Darvocet-N-100, had received on 03 March 2011 at 3:15 pm the following vaccines: a right deltoid intramuscular injection of ADACEL, lot number U3872BA (sanofi pasteur Ltd. lot number C3827); a right deltoid intramuscular injection of IPOL, lot number E0330 and a first dose left deltoid intramuscular injection of PNEUMOVAX 23, Merck lot number 1021Z and 10 hours later on 04 March 2011 at 1:15 am, experienced a 101 fever, chills, nausea, vomiting and lightheadedness. The lightheadedness and nausea continued for six days. According to the reporter, the patient had received one dose of IPOL as a child and (illegible) as a child of ADACEL. Treatments were not reported. Concomitant medication was LISINOPRIL 30 mg daily. Relevant diagnostic tests/laboratory findings, other vaccines within four weeks prior to suspect vaccine, illness at the time of vaccination and adverse event following prior vaccination were reported as none. No further information was available at the time of the report. The patient's outcome was reported as recovered (date not reported). Follow-up information was received from a health care professional on 20 April 2011. The patient was not evaluated by a physician. She was prescribed Phenergan suppositories for the nausea. She had not received ADACEL previously but had received DECAVAC on 22 August 2005. The patient's outcome was reported as fully recovered on 03 April 2011. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Inflammation, Vaccination site nodule
Clinical narrative: Inflammation localized. Vaccination site nodule.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site nodule
Clinical narrative: Initial report received from a health care professional on 16 March 2011. An unidentified patient (no age, sex or birth date provided) received on 02 March 2011 a left arm subcutaneous injection of ADACEL, sanofi pasteur lot number C3540AA. The patient was given the injection subcutaneous instead of intramuscular. The patient now has a knot the size of a dime at the administration site on the left arm. The reported refused to provide any further information. No contact information provided. The outcome was reported as not recovered. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Initial report was received from a health care professional on 05 January 2011. A 49 year-old female patient with a past medical history of thyroid cancer and hypothyroid had received an intramuscular injection of ADACEL (lot number, site of administration not reported) in December 2010 (exact date not reported) and approximately 10 days later, reported she could not move her shoulder, had "a lot of pain" at the site and experienced injection site tenderness, slight swelling and redness. The patient was evaluated by a physician. Treatments were not reported. Concomitant medications included LEVOXYL (spelled LEVOXIL). No further information was available at the time of report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Chills, Drug exposure during pregnancy, Headache, Myalgia
Clinical narrative: Initial report was received 27 January 2011 from a health care professional. A pregnant female patient who at 22 weeks gestation had received an injection of ADACEL and FLUZONE (unspecified) vaccines on 26 January 2011 (lot numbers, routes and sites of administration were unknown) and six hours later, she developed joint and muscle aches, a headache, fever and chills. The events required a doctor's visit. Her dates of last menstrual period and expected delivery were not reported. Her past medical and obstetrical histories were unknown at the time of the report. At the time of the report, the patient had not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia
Clinical narrative: Initial report was received 27 January 2011 from a health care professional. A pregnant female patient who at 22 weeks gestation had received an injection of ADACEL and FLUZONE (unspecified) vaccines on 26 January 2011 (lot numbers, routes and sites of administration were unknown) and six hours later, she developed joint and muscle aches, a headache, fever and chills. The events required a doctor's visit. Her dates of last menstrual period and expected delivery were not reported. Her past medical and obstetrical histories were unknown at the time of the report. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Crying, Injection site swelling, Weight bearing difficulty
Clinical narrative: 6-22-11 - 1200 noon. Mom reported that 2 hours after vaccination was received, pt was inconsolably crying, (L) leg swelling & non wt bearing to (L) leg. Gave Ibuprofen & returned to our office at 1800 no swelling to leg noted; mildly favoring the (L) leg no fever, no crying. Recommended to continue Ibuprofen TID x 2d & F/U PRN.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Eye pain, Pain, Pain in jaw, Palpitations
Clinical narrative: Initial report was received from a health care professional on 21 March 2011. A 50 year-old female patient with a history of MVP, palpitations, tachycardia, hypothyroidism, hyperlipidemia and menopause had received an intramuscular left deltoid injection of ADACEL, lot number U3553CA (sanofi pasteur Ltd. lot number, C3677) and on 04 March 2011 at approximately 10:00 am, experienced "during cleaning" a racing heart and chest heaviness that lasted approximately 10 minutes. The patient also reported a low grade fever, generalized achiness that included her eyes and jaw stinging when she opened her mouth to eat. The low grade fever and generalized achiness that included her eyes that lasted approximately two days. According to the reporter, the patient was in a car accident "six days prior" (prior to what was not reported). Concomitant medications included SYNTHROID and Atenolol. Treatments were not reported. The patient received no other vaccines four weeks prior to or on 03 March 2011. The patient had no known illness at the time of vaccination and the reporter was not aware of any adverse events following prior vaccinations. No further information was available at the time of the report. The patient's outcome was reported as recovered on 18 March 2011. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Initial report was received from a health care professional on 21 March 2011. A 50 year-old female patient with a history of MVP, palpitations, tachycardia, hypothyroidism, hyperlipidemia and menopause had received an intramuscular left deltoid injection of ADACEL, lot number U3553CA (sanofi pasteur Ltd. lot number, C3677) and on 04 March 2011 at approximately 10:00 am, experienced "during cleaning" a racing heart and chest heaviness that lasted approximately 10 minutes. The patient also reported a low grade fever, generalized achiness that included her eyes and jaw stinging when she opened her mouth to eat. The low grade fever and generalized achiness that included her eyes that lasted approximately two days. According to the reporter, the patient was in a car accident "six days prior" (prior to what was not reported). Concomitant medications included SYNTHROID and Atenolol. Treatments were not reported. The patient received no other vaccines four weeks prior to or on 03 March 2011. The patient had no known illness at the time of vaccination and the reporter was not aware of any adverse events following prior vaccinations. No further information was available at the time of the report. The patient's outcome was reported as recovered on 18 March 2011. Documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation
Clinical narrative: Initial report received from a health care professional on 02 February 2011. An unidentified patient (age and sex not reported) received a bicep subcutaneous injection of ADACEL, manufacturer and lot number not provided. The patient received on an unknown date the vaccine shot below the deltoid in the bicep area and experienced an increased inflammatory response. The outcome was reported as unknown. Follow-up information was received from a health care professional on 17 May 2011. The patient was a 39 year-old female with no reported past medical history had received ADACEL, lot number U3491AA (sanofi pasteur Ltd. lot number C3637). Concomitant medication was reported as AUGMENTIN. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Feeling abnormal, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Initial report was received on 10 February 2011 from a health care professional. A 51-year-old female had received an intramuscular left deltoid injection of ADACEL, lot number U3491CA (sanofi pasteur Ltd. lot number C3637) on 14 December 2010 and the same day (also reported as 15 December 2010), felt "run down and feverish". The second day she reported she started to cough and had redness, pain scale of a three and was itchy at the site. The patient was evaluated by a physician and prescribed a medication for the cough but never took it. The symptoms subsided. Concomitant medications included Medroxyprogesterone and Estradiol. No further information was available at the time of the report. The patient's outcome was reported as recovered (date not reported). Follow-up information was received from a health care professional on 12 April 2011. The patient's adverse event began on 14 December 2011. Her past medical history was reported as none and she had no illness at the time of vaccination. The reporter states that the patient was called on 12 April 2011 and reported that she had no problems after the report. No further information was available at the time of the report. The patient's outcome remained as recovered. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Initial report was received on 10 February 2011 from a health care professional. A 51-year-old female had received an intramuscular left deltoid injection of ADACEL, lot number U3491CA (sanofi pasteur Ltd. lot number C3637) on 14 December 2010 and the same day (also reported as 15 December 2010), felt "run down and feverish". The second day she reported she started to cough and had redness, pain scale of a three and was itchy at the site. The patient was evaluated by a physician and prescribed a medication for the cough but never took it. The symptoms subsided. Concomitant medications included Medroxyprogesterone and Estradiol. No further information was available at the time of the report. The patient's outcome was reported as recovered (date not reported). Follow-up information was received from a health care professional on 12 April 2011. The patient's adverse event began on 14 December 2011. Her past medical history was reported as none and she had no illness at the time of vaccination. The reporter states that the patient was called on 12 April 2011 and reported that she had no problems after the report. No further information was available at the time of the report. The patient's outcome remained as recovered. Documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Pain, Pyrexia, White blood cell count increased
Clinical narrative: Initial report received from a health care professional on 10 February 2011. A 27-year-old male patient received on 06 February 2011 an injection (route and site not reported) of ADACEL, lot number unknown. The patient had no known allergies. Her concomitant medication was chloroquine. It was unknown if the patient was ill at the time of vaccination or if the patient had received any other vaccines within 4 weeks. On 10 February 2011 the patient developed a low grade fever, body aches, loose stools and a slightly increased white blood cell count. He was seen by a physician. No further information was available. The outcome was reported as unknown. Documents held by sender: None.
Age: 49.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Conjunctivitis, Eye discharge, Eye swelling, Ocular hyperaemia
Clinical narrative: Initial report received from a health care professional on 08 December 2010. A 49-year-old male patient received on 08 December 2010 a right deltoid intramuscular injection of FLUZONE, lot number U3823AA. The patient had a history of gastroesophageal reflux disease (GERD) and an allergy to penicillin. The patient had no illness at the time of vaccination, had no prior adverse events following vaccination and received no other vaccination within 4 weeks of the FLUZONE. The patient's concomitant medications included PROTONIX, VOLTAREN, and PRAVACHOL. On 08 December 2010, within 4 hours of the vaccine, the patient returned to the physician's office with conjunctivitis in both eyes. The patient had redness, drainage and swelling noted in both eyes. The patient was given KENALOG. The patient was monitored in the office and then sent home when stable. The outcome was reported as recovered. Follow-up information was received on 24 January 2011 from a health care professional. The patient had also received a left deltoid intramuscular injection of ADACEL, lot number C3539AA on 08 December 2010. The patient received the vaccinations at 9:31 AM and the adverse event onset time was 2:54 PM (previously reported as within four hours). No further information was available at the time of the report. The patient's outcome remained recovered. Documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypersensitivity, Inflammation, Nausea, Pyrexia
Clinical narrative: Allergic reaction, nausea, headache, fever, inflammation lcoalised, vaccination site rash, vaccination site induration, vaccination site pain.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site induration, Vaccination site rash
Clinical narrative: Allergic reaction, nausea, headache, fever, inflammation lcoalised, vaccination site rash, vaccination site induration, vaccination site pain.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Myalgia, Oropharyngeal pain
Clinical narrative: Initial report received from a health care professional on 04 November 2010. An 18-year-old female patient received inadvertently on 01 November 2010 a second injection (route and site not reported) of ADACEL, lot number not known. The patient received the first dose of ADACEL on 20 October 2010 for an injury. The patient's medical history and concomitant medications were not known. The patient received both doses for an injury that was not specified. On the 01 November 2010, the patient developed sore throat, chills and muscle aches. On 04 November 2010 she had reported the symptoms to her physician. The patient's medical records were not available. The outcome was reported as unknown. Documents held by sender: None
Age: 33.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Adverse event, Drug exposure during pregnancy
Clinical narrative: Initial report received from a nurse on 04 November 2010. A healthy pregnant female patient, who, per the patient, was approximately 5 weeks gestation had received an intramuscular left deltoid injection of FLUZONE (lot number U3726AA) on 25 October 2010. The date of the patient's last menstrual period and estimated date of delivery were unknown. The patient had not been evaluated by her OB/GYN at the time of this report. The patient had not experienced any adverse events. Follow-up information was received 13 December 2010 from a health care professional. The patient also received an intramuscular injection of ADACEL, lot number C3519AA on 25 October 2010, the same day she had received FLUZONE. Past obstetric history included two previous pregnancies; one which resulted in a full-term live birth with no congenital anomalies and one which resulted in a spontaneous abortion prior to 20 weeks gestation. The patient had no illness at the time of vaccination. According to the reporter, the patient experienced an adverse event; however, no additional information was provided pertaining to the event. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Dizziness, Migraine, Nausea, Vomiting
Clinical narrative: Initial case received from a nurse on 28 October 2010. A 29-year-old female patient received an intramuscular right deltoid injection of ADACEL (lot number C3518AA) on 26 October 2010. The patient had a history of asthma and migraine headaches, and had recently delivered a baby in June 2010. Allergies included penicillin and latex, and the patient was taking a multivitamin concomitantly. Approximately 30 minutes post-vaccination, the patient developed a migraine headache with accompanying nausea, vomiting, and dizziness. She was treated with 1 tablet of TYLENOL with codeine, and the event recovered 24 hours after vaccination. It was noted that the patient had not previously experienced vomiting or dizziness with migraines.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Skin test, Wrong drug administered
Clinical narrative: Initial report received from a health care professional on 28 October 2010. It involves a case of misuse, i.e. wrong vaccine administered. A 30-year-old female patient received an intradermal injection of ADACEL (lot number C3488BA) instead of TUBERSOL on 26 October 2010. The patient also received an intradermal injection of TUBERSOL (lot not reported) the same day. The patient was not taking any concomitant medications, was not ill at the time of vaccination, and had no pre-existing medical conditions. One day post-vaccination, the patient complained that the ADACEL injection site was warm, red, and hard. Treatment included ice and ibuprofen. The patient returned to her physician on 28 October 2010 to have her skin test read, and at that time the ADACEL site remained warm with a large reddened area. Per the reporter, the physician was planning to prescribe antibiotics to treat the event. At the time of the report, the event was still ongoing.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: Initial case was received on 28 October 2010 from a healthcare professional. A 59 year old female patient received on 15 September 2010 a left deltoid intramuscular injection of ADACEL (lot number C3491AA) and right deltoid intramuscular injection of FLUZONE (lot number U3619EA). In the PM of the day of the vaccines, the patient experienced a red, sore arm. She was seen in the doctor's office on 21 October 2010 and the dimensions were 11 and a half centimeters (cm) by 20 cm of erythema with "central induration". The patient was treated with BACTRIM which was ineffective. She was then treated with KEFLEX which "helped somewhat." She also used topical creams (not specified) on the area. The patient had no illness at the time of the vaccines. She had no known allergies. Pre-existing medical conditions included asthma and her concomitant medication was Albuterol. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Musculoskeletal stiffness, Swelling
Clinical narrative: This is a cluster of 9 unidentified patients who experienced similar adverse events following vaccination with INFLUENZA VACCINE. Initial report received from a health care professional on 22 October 2010. A group of 9 unidentified patients (identifiers not provided) received on 16 October 2010 an injection (routes and sites not provided) of INFLUENZA VACCINE, lot numbers not provided. The patients medical histories and concomitant medications were reported as unknown. It was unknown if the patients had any illness at the time of vaccination. On 17 October 2010, the 9 patients reported redness, swelling and non-specific arm stiffness. The FLUZONE was pre-drawn into "disp" syringes the day before. The outcomes were reported as unknown. Follow-up information was received from a health care professional on 13 December 2010. The patient was identified as a 76-year-old female patient who received on 16 October 2010 a left arm (tricep) injection of FLUZONE, lot number U3653AA, a left deltoid injection of ADACEL, lot number C3490AA and a right deltoid injection of PNEUMOVAX, Merck lot number 0882Z. The outcome remained reported as unknown. Documents held by sender: None.
Age: 36.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Initial report was received from a health care professional on 22 October 2010. A 37 year-old female patient, had received on 19 October 2010 a subcutaneous injection of ADACEL (lot number and site of administration not reported) and a Influenza vaccine (manufacturer, lot number, route and site of administration not reported). On 20 October the patient experienced a two inch by two inch area of redness, warmth and swelling. She also complained of itching and pain. The patient's past medical history, concomitant medications and treatments provided were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. The reporter for this case is the same as for 2010-06136. Documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Initial report was received from a health care professional on 22 October 2010. A 35 year-old male patient, had received on 19 October 2010 a subcutaneous injection of ADACEL (lot number and site of administration not reported) and a Influenza vaccine (manufacturer, lot number, route and site of administration not reported). On 20 October the patient experienced a two inch by two inch area of redness, warmth and swelling. He also complained of itching and pain. Th patient's past medical history, concomitant medications and treatments provided were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. The reporter for this case is the same as for 2010-06137. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Agitation, Injection site pain, Insomnia, Lethargy, Musculoskeletal pain
Clinical narrative: Case received from a healthcare professional on 14 October 2010 under the local reference number 10-0735. A 37-year-old female patient, with no illness at time of vaccination, no known allergies, no known medical conditions and no adverse event following prior vaccination, had received her dose of ADACEL, batch number C3491AA, in the left deltoid concomitantly with her dose of FLUVIRIN (other manufacturer, batch number 111784P1) in the left deltoid, on 08 October 2010. On an unspecified date post-vaccination, the patient experienced pain at the injection site. The patient also reported for past 1 week, had continued to experience pain at site and in shoulder, lethargy and "waking up at night". The outcome was not reported. Follow-up information was received on 01 November 2010 from a health care professional. The patient's had received an intramuscular right deltoid injection of ADACEL (previously reported as left deltoid) on 08 October 2010 at 13:00 and ten minutes later, experienced general lethargy and an inability to sleep regularly. She also reported "moderate-severe" pain at the injection site and surrounding shoulder area. The patient sought no medical assistance. No treatments were reported. No further information was provided at the time of the report. The patient's outcome was recovered on 13 October 2010. Documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Anxiety, Concussion, Injection site pain, Muscle spasms
Clinical narrative: Initial report received from a healthcare professional on 14 October 2010 under the reference 10-0724. A male patient (age not reported) with unknown medical history and unknown concomitant therapies had received an intramuscular dose of ADACEL (batch number not reported) on an unspecified date (route and anatomical site of injections were not reported). After the vaccination (onset date not reported), the patient's parent called to report patient's symptoms of pain at the injection site, arm pain, anxiety panic attacks, tearful, muscle spasms and behavioral changes. According to the reporter, a doctor visit was required. At the time of the report, the patient had not recovered. Follow-up information was received from the healthcare professional on 08 and 15 November 2010. According to the reporter, the patient had experienced a concussion after suffering an injury playing football. Upon re-evaluation, the physician felt that the patient's symptoms were related to the concussion, and not the vaccine. No additional information was reported. List of Documents held by Sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Panic attack, Sports injury, Tearfulness
Clinical narrative: Initial report received from a healthcare professional on 14 October 2010 under the reference 10-0724. A male patient (age not reported) with unknown medical history and unknown concomitant therapies had received an intramuscular dose of ADACEL (batch number not reported) on an unspecified date (route and anatomical site of injections were not reported). After the vaccination (onset date not reported), the patient's parent called to report patient's symptoms of pain at the injection site, arm pain, anxiety panic attacks, tearful, muscle spasms and behavioral changes. According to the reporter, a doctor visit was required. At the time of the report, the patient had not recovered. Follow-up information was received from the healthcare professional on 08 and 15 November 2010. According to the reporter, the patient had experienced a concussion after suffering an injury playing football. Upon re-evaluation, the physician felt that the patient's symptoms were related to the concussion, and not the vaccine. No additional information was reported. List of Documents held by Sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haemorrhage, Injection site pain, Injection site vesicles, Wound secretion
Clinical narrative: Case received from a Healthcare Professional on 12 October 2010 under the reference number 10-0706. A 32-year-old female patient, with no relevant medical history and no illness at the time of vaccination, had received an intramuscular dose of ADACEL (batch number C3491AA) in the left deltoid on 08 October 2010. The patient had received an intramuscular dose of FLUVIRIN (other manufacturer, batch number not reported) in the left deltoid on 23 September 2010. She had received concomitantly prenatals vitamins. The patient had no pre-existing physician-diagnosed allergies, birth defects or medical conditions. She did not experience adverse event following prior vaccination. On 09 October 2010, the left deltoid was sore. Two days post-vaccination, the patient noticed two open blister like areas on the left deltoid posterior to the injection site. "By sunday", blisters were oozing and bloody. The patient was seen by a physician who recommended hydrocortisone cream. The patient had not recovered at the time of reporting, symptoms improving slowly. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Skin lesion
Clinical narrative: Case received from a Healthcare Professional on 11 October 2010 under the local number 10-0700. Two patients (not identified), with no reported medical history and concomitant therapies, had received a dose of ADACEL (batch number C14B091AA was a not valid lot number for Sanofi Pasteur, route and site of administration not reported) on an unspecified date. Patients experienced lesion, swelling and redness at injection site on an unspecified date. Outcomes were not reported. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Drug exposure during pregnancy, Injection site erythema
Clinical narrative: Case of pregnancy follow-up received from a healthcare professional on 29 September 2010 under the reference numbers 10-0624 and P10-0065. A 29-year-old female patient, with no reported illness at time of vaccination, had received her dose of ADACEL, batch number C3476AA, on 20 September 2010. On an unspecified date post-vaccination, the patient experienced redness of skin at the injection site. The patient's date of last menstrual period was 27 August 2010. The estimated date of delivery was 05 June 2011. The outcome was unknown. Follow-up information was received 24 January 2011 from a health care professional who reported that this patient was no longer a patient at their office. The patient transferred her care November 2010. No further information was provided at the time of the report. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Rash
Clinical narrative: Initial case was received on 29 September 2010 from a healthcare professional. A 55 year old female patient received an injection of ADACEL in March 2008. On an unspecified date, the patient experienced shortness of breath and a rash on the chest. No pre-existing medical conditions, no known allergies and no concomitant medications were reported. No further information was provided. The patient recovered on an unspecified date. Follow-up information was received on 01 November 2010 from a healthcare professional. The reporter could not provide additional information. The patient was not seen in the reporter's clinic until 2010. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 17 September 2010. A group of 17 unidentified patients received on an unknown date an injection (sites and routes not provided) of ADACEL, lot numbers unknown. A pharmacy tech reported that 40 employees at a long term facility were given ADACEL. Days following the vaccine, fifteen patients had bad swelling, redness, itching, burning and local pain at injection site. Two patients were sent to the emergency room for cellulitis. The outcome was reported as unknown. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Initial report received from a health care professional on 17 September 2010. A group of 17 unidentified patients received on an unknown date an injection (sites and routes not provided) of ADACEL, lot numbers unknown. A pharmacy tech reported that 40 employees at a long term facility were given ADACEL. Days following the vaccine, fifteen patients had bad swelling, redness, itching, burning and local pain at injection site. Two patients were sent to the emergency room for cellulitis. The outcome was reported as unknown. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Initial case was received on 16 September 2010 from a healthcare professional. A nurse informed the reporter about a patient who reported that during administration of ADACEL (lot number not reported), if any vaccine leaks and gets on her skin, she experiences "numbness of the area." The reporter requested not to be contacted, since she has no further information regarding the patient or situation. Documents held by sender. None.
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Body temperature increased, Dizziness, Headache, Injection site reaction
Clinical narrative: Initial report was received from a health care professional on 16 September 2010. A female patient (age not reported) with an unknown past medical history, had received an intramuscular left deltoid injection of ADACEL, lot number C3488AA on 13 August 2010 and approximately six hours later, experienced a severe headache, temperature of 100.9, lethargy, dizziness, nausea, weakness, blurred vision and loss of sensation at vaccine injection site. No additional information was available at the time of this report. The patient's outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Nausea, Sensory loss, Vision blurred
Clinical narrative: Initial report was received from a health care professional on 16 September 2010. A female patient (age not reported) with an unknown past medical history, had received an intramuscular left deltoid injection of ADACEL, lot number C3488AA on 13 August 2010 and approximately six hours later, experienced a severe headache, temperature of 100.9, lethargy, dizziness, nausea, weakness, blurred vision and loss of sensation at vaccine injection site. No additional information was available at the time of this report. The patient's outcome was unknown. Documents held by sender: none.