chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Abdominal discomfort, Headache, Hypoaesthesia, Neck pain, Pain
Clinical narrative: This case was received from a health care professional on August 2009. A 51-year-old female patient, with a history of multiple food and drug allergies, received the following vaccines on 28 July 2009: ADACEL (lot number C32500AA) and PNEUMOVAX 23 (Merck, lot number 0310Y). She was also taking an ALBUTEROL rescue inhaler concomitantly. Two days post vaccination, on 30 July 2009, the patient experienced headache, neck pain, jaw pain, and a localized injection site reaction. Six days post-vaccination, on 03 August 2009, she complained of abdominal upset and numbness of the ankle, foot and leg. The patient sought medical attention for the event; no additional information was provided. Follow up information received on 29 September 2009 from a health care professional who stated that the patient did not have an illness at the time of vaccination. The patient received ADACEL intramuscularly in the right upper extremity and PNEUMOVAX 23 intramuscularly in the left upper extremity. The patient was reported as recovered.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Chills, Pyrexia
Clinical narrative: Initial report received on 08 July 2009 from a reporter.  A 70 year old female patient with a history of hypertension and hyperlipidemia and an allergy to Cephalexin received a first time dose of ADACEL (lot number C3246BA) intramuscularly in the right deltoid on 23 June 2009.  Concomitant therapy included SYNTHROID, Pravastatin and Co enzyme 10.  On 24 June 2009 the patient complained of abdominal cramps, fever, and chills.  By 30 June 2009 the patient's symptoms resolved.  Follow-up information was received 31 August 2009 from the patient's physician who reported that they had no additional information to provide.  List of Documents held by Sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis, Diarrhoea, Pyrexia, Rash
Clinical narrative: Initial information received on 05 August 2009 from a health care professional.  A cluster of four adult male and female patients received ADACEL (lot number C3248AA) in July.  Post vaccination (date not specified), the patients complained of rash, fever, diarrhea and one patient complained of cellulitis.  The patients were not recovered at the time of the report.  List of Documents held by Sender: none.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Initial report was received 20 July 2009 from a health care professional. The following case information pertains to one patient out of a cluster of two vaccines; the other patient has been captured in case 2009-03125. A 48-year-old female patient with a history of hyperlipidemia had received an intramuscular left deltoid injection of ADACEL, lot number C3250AA on 17 July 2009 and an unspecified amount of time later, she complained of an egg size bump that was warm to touch, and pain in her entire upper arm. The needle size utilized for vaccine administration had been 5/8 inch in length. The patient had not been evaluated by her physician; however her physician prescribed AUGMENTIN for the patient prn. The patient had been taking "VITORIN" and ZYRTEC prn concomitantly at the time of vaccination and she had no known allergies. She had not received any other vaccines concomitantly or within four weeks prior to receipt of ADACEL. At the time of the report, the patient had not recovered. Follow-up information received on 26 August 2009 from a health care professional. The patient was 49 years-old at the time of the adverse events. The ADACEL had been administered at 09:30 hours on 17 July 2009. The patient had received 875 mg of oral AUGMENTIN twice a day for seven days. The patient recovered; however the date of recovery was not reported. No further information is expected. The reporter for this case is the same as for case numbers 2009-03123 and 2009-03125. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Initial report received on 21 May 2009 from a health care professional.  A 63 year old female patient received ADACEL (lot number C3005) on 09 April 2009 in the left deltoid.  The patient later experienced severe cellulitis of the arm, noted as a probable vaccine reaction.  The patient made a full recovery.  No additional information was provided.  The reporter of this case is the same as case number 2009-02083.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Immediate post-injection reaction, Incorrect route of drug administration
Clinical narrative: This case was received from a health care professional in the on 11 August 2009.  This is a case of misuse (wrong route of administration).  A female patient, with no reported medical history, received a subcutaneous forearm injection of ADACEL (lot number not reported) on 10 August 2009.  Immediately after vaccination, the patient had a reaction and the arm turned red.  No additional information was reported.
Age: 22.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site papule, Injection site reaction, Wrong drug administered
Clinical narrative: A cluster of 2 adult patients who received MENACTRA, lot number U2846AA, instead of TUBERSOL and developed injection site reactions.  Initial report received on 14 August 2009 from a healthcare professional.  A 22 year old male patient, with no known allergies and no illness at the time of vaccination, received a 0.1 ml intradermal injection of MENACTRA (lot number U2846AA) and a dose of ADACEL (lot number UFA86DA) on 12 August 2009.  The patient was to receive TUBERSOL for a TB skin test, but inadvertently received MENACTRA instead.  Concomitant medication was ALLEGRA-D.  On 14 August 2009, the patient returned for the reading of the TB skin test, which was when it was discovered that the patient received MENACTRA instead of TUBERSOL.  At that time, the patient had a raised red papule at the injection site which looked like a positive TB skin test.  The patient's recovery status was unknown.  Follow-up information received on 23 October 2009 from a health care professional.  The ADACEL vaccine (lot number UF486DA, Sanofi Pasteur SA number C3099) administered on 12 August 2009 was a third, 0.5 mL dose that was administered intramuscularly in the left arm.  The MENACTRA vaccine administered on 12 August 2009 was administered intradermally in the right forearm.  The patient had received prior vaccination with MENACTRA on 15 June 2005 without any adverse events.  On 14 August 2009, the patient received a 0.1 mL intradermal PPD (trade name and manufacturer name not reported, lot number 111056) in the left forearm (result of that test was not provided).  The patient recovered from the raised red papule at the injection site on 14 August 2009.  Case 2009-03500 with the same reporter and same MENACTRA lot number was created for the other patient.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Hypokinesia, Injection site reaction, Pain in extremity
Clinical narrative: Initial information was received on 20 August 2009 from a health care professional.  A 15 year old female patient with a history of hypothyroidism (being treated with SYNTHROID), obese, hypertriglycerides, impaired fasting glucose experienced a reaction after she received ADACEL (lot number C2572AA) on 16 August 2007.  On 16 August 2007, 30 minutes post vaccination the patient developed severe pain in both legs and was unable to move her legs which lasted 15 minutes.  The patient was not seen by a health care professional but was given instruction over the phone.  No further information was provided.  Follow up information received on 02 October 2009 from a health care professional who reported that the patient did not have an illness at the time of vaccination.  The patient did not receive prior doses of ADACEL.  The lot number for GARDASIL which was administered was reported as 0188U.  Treatment was not provided for the patient's symptoms.  No further information was provided.  Follow-up information received on 09 November from a health care professional who reported that no additional information was available on this case.  List of Documents held by Sender: none.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Infection, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received on 21 August 2009 from a health care professional.  A 63-year-old male patient who was receiving wound management, had received a second intramuscular left deltoid injection of ADACEL, lot number UF551AA (lot number C3159) on 14 August 2009.  Five days post-vaccination, the patient developed redness, swelling, and warmth at the injection site.  The patient was evaluated by a physician and diagnosed with "infection."  No cultures were performed to confirm the infection.  The patient received corrective treatment with BENADRYL, ROCEPHIN and Doxycycline, and recovered on 12 August 2009, two days after the onset of the adverse events.  The reporter for this case is the same as for cases 2009-03624 and 2009-03625.  Documents held by sender:  None.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Injection site pain
Clinical narrative: A 25-year-old female patient, who had an active infection from an IUD that was being treated with CIPRO, had received an intramuscular left deltoid injection of ADACEL, lot number U2937BA (foreign lot number C3160) on 19 August 2009. The patient had received a tetanus vaccination 10 years ago. One day post-vaccination, the patient reported pain at the injection site and feeling a little warm. The patient had not taken her temperature. She was instructed to be seen for evaluation; however she did not do so. No treatment was prescribed, and no diagnostic tests or laboratory data were performed. At the time of this report it was unknown if the patient had recovered. The reporter for this case is the same as for cases 2009-03623 and 2009-03624. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain, Periarthritis, Pyrexia, Swelling
Clinical narrative: Initial report received on 28 August 2009 from a health professional.  A female patient, age not reported, received a first dose of ADACEL (lot number not reported) in the right deltoid on an unspecified date.  Medical history, concomitant medications, and illness at the time of vaccination were all unknown.  It was unknown if the patient had any vaccines within the four previous weeks and whether she had any previous adverse events following vaccination.  An unspecified amount of time after receiving ADACEL, the patient had fever and could not move her arm as high as usual.  The patient's recovery status was unknown.  No further information was available.  Follow-up information was received from a physician on 02 November 2009.  The patient received a left deltoid injection of ADACEL (Sanofi Pasteur Ltd lot number C3159, Sanofi Pasteur inc. lot number UF551AA), and within 24 hours of vaccination experienced pain and swelling.  She was treated with CELEBREX 200 mg for two weeks, and was then referred to an orthopedist on 15 October 2009.  Her prescription was changed to NAPROSYN 500 mg bid, and she began undergoing physical therapy.  An X-ray of the shoulder was normal, and she was diagnosed with a mild frozen shoulder.  At the time of the report, the patient still had persistent pain and limited range of motion.  Follow-up information received on 19 January 2010 from a physician.  The patient had received the vaccination on 24 August 2009.  The patient had a follow-up on 14 January 2010, and at that time the patient showed complete recovery of the left shoulder with no pain and full range of motion.  Per the reporter, the patient is considered to be recovered.  Documents held by sender:  None.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray normal
Clinical narrative: Initial report received on 28 August 2009 from a health professional.  A female patient, age not reported, received a first dose of ADACEL (lot number not reported) in the right deltoid on an unspecified date.  Medical history, concomitant medications, and illness at the time of vaccination were all unknown.  It was unknown if the patient had any vaccines within the four previous weeks and whether she had any previous adverse events following vaccination.  An unspecified amount of time after receiving ADACEL, the patient had fever and could not move her arm as high as usual.  The patient's recovery status was unknown.  No further information was available.  Follow-up information was received from a physician on 02 November 2009.  The patient received a left deltoid injection of ADACEL (Sanofi Pasteur Ltd lot number C3159, Sanofi Pasteur inc. lot number UF551AA), and within 24 hours of vaccination experienced pain and swelling.  She was treated with CELEBREX 200 mg for two weeks, and was then referred to an orthopedist on 15 October 2009.  Her prescription was changed to NAPROSYN 500 mg bid, and she began undergoing physical therapy.  An X-ray of the shoulder was normal, and she was diagnosed with a mild frozen shoulder.  At the time of the report, the patient still had persistent pain and limited range of motion.  Follow-up information received on 19 January 2010 from a physician.  The patient had received the vaccination on 24 August 2009.  The patient had a follow-up on 14 January 2010, and at that time the patient showed complete recovery of the left shoulder with no pain and full range of motion.  Per the reporter, the patient is considered to be recovered.  Documents held by sender:  None.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass
Clinical narrative: Initial report received on 08 September 2009 from a Healthcare Professional. A 26 year old female patient, whose medical history was not reported, received a left deltoid intramuscular injection of ADACEL (sanofi pasteur Inc. lot number UF551BA corresponding to sanofi pasteur Ltd. C3159) on 01 September 2009. Illness at the time of vaccination was not reported. Concomitant medications included CLARITIN and NYQUIL. On 04 September 2009, the patient developed a lump at the left deltoid injection site. Corrective treatment was not reported. At the time of the report (08 September 2009), the patient still had a pea-sized palpable lump which was not visible. The patient was reported to have recovered.
Sex: F
Vaccine: TDAP
Symptoms: Bone pain, Injection site reaction, Local reaction, Malaise, Pyrexia
Clinical narrative: Initial report received on 24 September 2009 from a Healthcare Professional.  An unidentified female patient, whose medical history were unknown, received a dose of ADACEL (lot number unknown) on an unspecified date (dosage, route and number of previous doses unknown).  Concomitant medications and illness at the time of vaccination were unknown.  On an unspecified date, the patient developed an 8 cm local reaction at the injection site, fever for 48 hours, malaise, and bone pain for 48 hours.  The patient's outcome was unknown.  The reporter declined to provide further information.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Drug administered at inappropriate site, Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: Initial case received from a health care professional on 29 September 2009.  This is a case involving a non-recommended site and route of administration.  A 47-year-old female patient, with a history of hypertension and overweight, experienced a red, tender area at the injection site after receiving a subcutaneous left buttock injection of ADACEL (C3355AA) on 24 September 2009.  It is recommended that ADACEL be given intramuscularly in the deltoid area.  According to the reporter, the vaccine was given intramuscularly, but the patient was very large, which resulted in a subcutaneous administration.  Approximately eight hours post-vaccination, the patient complained of her buttock being sore, with redness the size of a half-dollar noted at the injection site.  She was seen by her health care provider on 29 September 2009, at which time there was a 12-15 cm area of erythema which was tender.  The patient also complained of pain radiating to the abdomen.  At the time of the report, the events were ongoing. Follow up information received on 20 November 2009 from a health care professional. The patient did not require further treatment. The patient recovered. Follow up information was received from the health care professional on 23 November 2009.  The patient was treated with Ibuprofen, and the event recovered after a "few days".  No additional information was reported.  Documents held by sender:  None
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: Initial case received from a health care professional on 29 September 2009.  This is a case involving a non-recommended site and route of administration.  A 47-year-old female patient, with a history of hypertension and overweight, experienced a red, tender area at the injection site after receiving a subcutaneous left buttock injection of ADACEL (C3355AA) on 24 September 2009.  It is recommended that ADACEL be given intramuscularly in the deltoid area.  According to the reporter, the vaccine was given intramuscularly, but the patient was very large, which resulted in a subcutaneous administration.  Approximately eight hours post-vaccination, the patient complained of her buttock being sore, with redness the size of a half-dollar noted at the injection site.  She was seen by her health care provider on 29 September 2009, at which time there was a 12-15 cm area of erythema which was tender.  The patient also complained of pain radiating to the abdomen.  At the time of the report, the events were ongoing. Follow up information received on 20 November 2009 from a health care professional. The patient did not require further treatment. The patient recovered. Follow up information was received from the health care professional on 23 November 2009.  The patient was treated with Ibuprofen, and the event recovered after a "few days".  No additional information was reported.  Documents held by sender:  None
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Skin reaction
Clinical narrative: Initial report received on 30 September 2009 from a consumer, who is the patient's parent. An 11 year old male patient with no known allergies and no medical history, received a dose of ADACEL (lot number not reported) on 28 September 2009. On the same day, an unspecified amount of time later, the patient developed swelling, redness, and pain at the injection site. Two days later, the patient had pain and swelling under the armpit, he had swelling on the side of the body (same side as injection), and he stated that he "feels it moving when he walks". At the time of the report, the patient was to consult his health care provider later in the day. The patient's outcome was unknown. Follow-up information received on 21 October 2009 from a health care professional. On 28 September 2009, the patient had received ADACEL intramuscularly in the right upper extremity. The lot number for the ADACEL was reported to have been UF499AA (which corresponds to Sanofi Pasteur Ltd. lot number C3107). The patient had received five previous doses of DTaP on 26-AUG-1998, 14-ICT-1998, 18-DEC-1998, 21-JAN-2000, and 12 -May-2003 (no reaction to the fifth dose). On 30 September 2009, the patient was seen by the reporting physician and noted to have mild erythema of the right deltoid region and right axillae. The area was non-tender to palpation, was negative for induration, and full range of motion was noted for the right upper extremity. The diagnosis was localized shot reaction with no evidence of cellulitis. Corrective treatment was unspecified analgesics, warm compresses, and return for follow-up if symptoms worsened. At the time of the report the patient had not sought further follow-up for the reported events.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Initial report received on 30 September 2009 from a consumer, who is the patient's parent. An 11 year old male patient with no known allergies and no medical history, received a dose of ADACEL (lot number not reported) on 28 September 2009. On the same day, an unspecified amount of time later, the patient developed swelling, redness, and pain at the injection site. Two days later, the patient had pain and swelling under the armpit, he had swelling on the side of the body (same side as injection), and he stated that he "feels it moving when he walks". At the time of the report, the patient was to consult his health care provider later in the day. The patient's outcome was unknown. Follow-up information received on 21 October 2009 from a health care professional. On 28 September 2009, the patient had received ADACEL intramuscularly in the right upper extremity. The lot number for the ADACEL was reported to have been UF499AA (which corresponds to Sanofi Pasteur Ltd. lot number C3107). The patient had received five previous doses of DTaP on 26-AUG-1998, 14-ICT-1998, 18-DEC-1998, 21-JAN-2000, and 12 -May-2003 (no reaction to the fifth dose). On 30 September 2009, the patient was seen by the reporting physician and noted to have mild erythema of the right deltoid region and right axillae. The area was non-tender to palpation, was negative for induration, and full range of motion was noted for the right upper extremity. The diagnosis was localized shot reaction with no evidence of cellulitis. Corrective treatment was unspecified analgesics, warm compresses, and return for follow-up if symptoms worsened. At the time of the report the patient had not sought further follow-up for the reported events.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Local reaction, Lymphadenopathy
Clinical narrative: Initial non-serious report received from a health care professional on 12 October 2009. A cluster of several unidentified patients experienced large local reactions (not specified), and at least two unidentified patients experienced large local reactions (not specified) and enlarged lymph nodes of axilla after receiving ADACEL (lot numbers and route/site of administration not reported). The reporter indicated that all the patients were vaccinated within the last six months. No additional details were provided. Follow up information received on 30 October 2009 from a health care professional who provided information for a 28 year old male patient who developed pain and swelling at the injection site and left axilla pain three days after (08 October 2009) receiving ADACEL (lot number C3355AA) intramuscularly in the left arm on 05 October 2009. The patient did not have allergies, prior reactions with past immunizations, or receive any other vaccinations within 4 weeks of the administration of ADACEL. The patient recovered. The reporter stated that the cluster involves one other patient who remains unidentified. Follow-up information was received from the health care professional on 19 November 2009. According to the reporter, specific information for each patient was not available, as the events were "usually noted several weeks or months later". No additional information was provided. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site mass, Injection site swelling
Clinical narrative: Initial report received on 02 December 2009 from a health care professional. The case involves a 52-year-old female who is one of two cases on a cluster reported by the same reporter. The other patient's information is reported in case 2009-05288. A 52 year old female with no known allergies received in the left arm and injection (route not reported) of ADACEL (lot number not reported) on 06 November 2009. On 01 December 2009 (twenty five days after vaccination) the patient reported swelling and a lump at the injection site. The patient was seen in the doctor's office the following day. A lump, swelling and "purplish" discoloration was noted at the injection site. The patient had no reported illness at the time of vaccination. The patient's recovery status was reported as unknown. Follow-up information received on 08 January from a healthcare professional. The patient's recovery status was reported as recovered. List of documents held by sender: none
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site mass, Injection site swelling
Clinical narrative: Initial report received on 02 December 2009 from a health care professional. This case involves a 46-year-old female who is one of two cases in a cluster reported by the same reporter. The other patient's information is reported in 2009-05287. A 46 year old female with no known allergies received in the left arm an injection (route not reported) of ADACEL (lot number not reported) on 05 October 2009. On 20 October 2009, the patient was seen the the doctor's office for swelling, lump and "purplish" discoloration at the injection site. The exact date of onset was not reported. The patient had no reported illness at the time of vaccination. The patient's recovery status was reported as unknown. Follow-up information received on 08 January 2010 from a healthcare professional. The patient;s recovery status was reported as recovered.
Age: 47.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Burning sensation, Myalgia, Pain, Paraesthesia
Clinical narrative: Initial case received on 31 December 2009 from a health care professional. A 47 year old female patient received an intramuscular right deltoid injection of ADACEL (Lot number C3352AA) on 21 December 2009 and a left deltoid injection of FLUZONE SV on 21 December 2009. Concomitant medications included unspecified "birth control." She is allergic to sulfa. The patient had no illness at the time of the vaccination. Since vaccination on 21 December 2009, the patient has experienced a "dull constant muscular pain" and "occasional but frequent burning" and "tingling" in right arm in the bicep and deltoid area. Treatment medication of ibuprofen was not effective for pain control and the pain was reported to keep her up at night. As of this report the patient had not recovered. Follow-up information was received on 08 February 2010 from a healthcare professional. The patient received no other vaccinations within 4 weeks prior to date of 21 December 2009. The pain, burning and tingling in the right deltoid and bicep had improved. Unspecified treatment medication were prescribed. Follow-up information was received on 08 April 2010 from a healthcare professional. The patient last contacted the physician's office on 15 January 2010 and at that time her pain was improved, but present with any arm elevation. Treatment medications (previously unspecified) included gabpentin and Lortab at bedtime (HS) for pain and generic Lodine twice daily (BID). At the time of this report it was unknown if the patient fully recovered. Documents held by sender: none.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Local swelling, Lymphadenopathy
Clinical narrative: Initial information received on 05 February 2010 from a health care professional. A 42 year old female patient developed swelling of the axillary lymph node on the right side 3 days after he received an intramuscular right deltoid dose of ADACEL (lot number C3438AA) on 02 February 2009. The patient also noted swelling on the right side of the neck. The patient did not have any areas of redness. The patient was seen by a physician on 05 February 2010. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site pain, Pain in jaw
Clinical narrative: Initial information was received on 18 February 2010 from a health care professional. A female patient (age not provided) developed injection site pain on the day of vaccination after receiving ADACEL (lot unknown) in the left arm and MMR vaccine (manufacturer unknown) in the right arm on 08 February 2010. On 10 February 2010 the patient developed jaw pain on both sides of her jaw. The patient required a doctor's visit; date not provided. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Induration, Injection site induration, Night sweats, Oedema peripheral
Clinical narrative: Initial case received on 19 February 2010 from a physician. A 46 year old male patient received a left deltoid injection of ADACEL (sanofi pasteur Inc. lot number UF451BA, sanofi pasteur Ltd. lot number C3002) on 16 February 2010. On 17 February 2010, the patient experienced a 7 to 8 cm induration at the left deltoid with induration in the left axilla. The patient started night sweats and a low grade fever on 18 February 2010. The patient was seen in the physician's office on 18 February 2010. His medical history included gastroesophageal reflux disease (GERD) and he had no known allergies. The physician also stated that the patient experienced "swelling of the upper arm with 7-8 cm induration, and swelling of the axilla" with the areas being warm and tender. The patient was sweating profusely enough to "wet his clothes." At the time of this report the patient had not recovered. Documents held by sender: None.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm, Swelling, Tenderness
Clinical narrative: Initial case received on 19 February 2010 from a physician. A 46 year old male patient received a left deltoid injection of ADACEL (sanofi pasteur Inc. lot number UF451BA, sanofi pasteur Ltd. lot number C3002) on 16 February 2010. On 17 February 2010, the patient experienced a 7 to 8 cm induration at the left deltoid with induration in the left axilla. The patient started night sweats and a low grade fever on 18 February 2010. The patient was seen in the physician's office on 18 February 2010. His medical history included gastroesophageal reflux disease (GERD) and he had no known allergies. The physician also stated that the patient experienced "swelling of the upper arm with 7-8 cm induration, and swelling of the axilla" with the areas being warm and tender. The patient was sweating profusely enough to "wet his clothes." At the time of this report the patient had not recovered. Documents held by sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Neuralgia
Clinical narrative: Initial report was received from another manufacturer (doc number 45232482, service request number 1-3455878489) on 05 March 2010, who received the report from a health care professional who is also the patient's wife. A male patient (age not reported) had received an injection of ADACEL (manufacturer not specified; lot number, route, site and date of administration not reported), and an unspecified amount of time later, he experienced nerve pain in his arm. The reporter requested that they not be contacted for follow-up and no further information was provided at the time of the report. Documents held by sender: None.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Mass, Pruritus, Wrong drug administered
Clinical narrative: Initial report received on 07 April 2010 from a health care professional, who is also the patient. A 56 year old male patient, with no known allergies, inadvertently received a 0.1 ml intradermal injection of ADACEL (lot number not reported) in the forearm on 05 April 2010 instead of Tubersol. An unspecified amount of time later, on the same day, the patient developed a bump approximately the size of a dime that was surrounded by redness approximately the size of a half dollar. He also developed itchiness and burning which seemed to have resolved with the use of hydrocortisone cream. At the time of the report, the patient had not recovered; the bump and redness persisted.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Neck pain
Clinical narrative: Initial case received from a health care professional on 19 April 2010. This patient is one of a cluster of two patients who were experienced adverse events following receipt of ADACEL (lot number C3446AA). A 59-year-old female patient received an intramuscular left deltoid injection of ADACEL (lot number C3446AA) on an unknown date. She subsequently experienced neck pain and lower back pain. Outcome was unknown. Follow-up information was received on 17 May 2010 from a healthcare professional. The patient's date of birth was provided and her age was 56 year old (previously reported as 59 years old). Concomitant medications included LEXAPRO and LYRICA. She had no illness at the time of vaccination. Outcome was unknown. The event for the second patient in this cluster is captured in case number 2010-02296.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Initial case received from a health care professional on 19 April 2010. This patient is one of a cluster of two patients who were experienced adverse events following receipt of ADACEL (lot number C3446AA). A 46-year-old female patient received an intramuscular left deltoid injection of ADACEL (lot number C3446AA) on an unknown date. She subsequently experienced low grade fever, weakness, redness, and swelling in the left arm. Outcome was unknown. Follow-up information was received on 17 May 2010 from a healthcare professional. The patient had Lupus at the time of the vaccination. Her concomitant medications were Cozaar and "Plaquenel." She had recovered from the adverse events on an unspecified date. The event for the second patient in this cluster is captured in case number 2010-02295.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Rash maculo-papular
Clinical narrative: Initial case received from a health care professional on 20 April 2010. It involves a case of misuse (i.e. inappropriate age at vaccine administration). A 10-year-old boy received a right arm intramuscular injection of ADACEL (Sanofi Pasteur Inc lot number U3052BA, Sanofi Pasteur Ltd lot number C3311) and an intramuscular left arm injection of VAQTA (Merck, lot number 02647) on 19 April 2010. The morning after vaccination, the patient developed a macular-papular rash on the arms and trunk. The patient had no relevant medical history, was not taking any medications, and was not ill at the time of vaccination. At the time of the report, the event had not recovered.
Sex: U
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: This case is 1 of a cluster of 3 patients' who experienced similar adverse events following vaccination with ADACEL. The events for the other patient's were captured in case number 2010-02613 and 2010-02614. Initial report received from a health care professional on 05 May 2010. A patient, with an unknown medical history, had received an injection of ADACEL, Sanofi Pasteur Ltd number C3311 and Sanofi Pasteur Inc. Lot number U3052AA, and developed pain in the left arm and neck after vaccination. Other vaccinations within 4 weeks were reported as unknown. The outcome for the events was reported as unknown.
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case is 1 of a cluster of 3 patients' who experienced similar adverse events following vaccination with ADACEL. The events for the other two patient's were captured in case number 2010-02612 and 2010-02614. Initial report received from a health care professional on 05 May 2010. A patient, with an unknown medical history, had received an injection of ADACEL, sanofi pasteur Ltd. Lot number C3311 and sanofi pasteur Inc. Lot number U3052AA and developed redness and arm pain. Other vaccinations within 4 weeks were reported as unknown. The outcome for the events was reported as unknown. Documents held by sender none.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia, Influenza like illness, Myalgia
Clinical narrative: Initial report received from a health care provider on 07 May 2010.  A 39-year-old female patient, who denies any medical history and has no known allergies, had received an injection of ADACEL on 16 April 2010, lot number Sanofi Pasteur Ltd. C3170 and lot number Sanofi Pasteur Inc. U2936BA, developed muscle aches and flu like symptoms which started on 16 April 2010 for approximately 3 days and on the third day developed a metallic taste in her mouth that still persists.  The outcome for the events was reported as did not recover.  Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: Accidental exposure, Injection site erythema, Injection site induration
Clinical narrative: Initial report received from a health care provider on 11 May 2010. A 3-year-old male patient, with no medical history and no known allergies, had received an .1 milliliter intradermal injection to the right forearm of ADACEL on 07 May 2010, lot number Sanofi Pasteur Ltd. C3246AA, and developed redness and a raised hardened area. The patient inadvertently received ADACEL instead of purified protein derivative (PPD). The area of redness was read as a positive test yesterday (date not provided). The patient had no adverse event following prior vaccinations. The outcome for the event was reported as not recovered.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Initial report received from a health care provider on 13 May 2010. A 52-year-old female patient, with a history of hernia repair, hysterectomy and wound management due to a laceration, had received a subcutaneous injection to the left arm of ADACEL (Tdap), lot number C3158AA, on 10 May 2010 and developed on 12 May 2010 swelling, redness, and tenderness which extended down to left hand. The patient was treated with elevation with ice compresses. The patients concomitant medication was triamcinolone acetonide cream. As of 13 May 2010, the events were reported as not recovered. Follow-up information received on 18 May 2010 from a healthcare professional. The patient's swelling and redness in the left arm has decreased. On an unspecified date she also experienced a fever, which resolved. The patient was seen every day since 13 May 2010. She reported fatigue over the weekend and stated she slept all weekend. As of this report all events have not resolved. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swollen arm. Redness.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Initial report received from a health care provider on 18 May 2010.  A 43-year-old male patient, with a history of injection site soreness after previous tetanus vaccines and no known allergies, had received a right deltoid injection of ADACEL, invalid lot number UF5008A provided, and an injection of TUBERSOL, lot number, route and site not provided, both on 24 March 2010 and now 2 months later continues to have soreness of right deltoid which was the site of the vaccine injection.  The patient reported that the area was very sore and "can't lay on that side".  The patient has experienced only soreness of the arm that was vaccinated and reported no other symptoms or reactions.  The patient's concomitant medications were LISINOPRIL, JANUVIA, and AMARYL.  The outcome was reported as not recovered.  Documents held by sender:  None.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Myalgia, Pyrexia, Vomiting
Clinical narrative: Initial report received on 04 December 2009 from a consumer.  A female patient (age not provided) with no known allergies began vomiting, had a fever, muscle pain, and weakness eight hours after she received a first time intramuscular dose of ADACEL (lot number unknown) in August 2009.  The patient believed the manufacturer was Sanofi Pasteur.  The patient recovered from the events.  No further information was provided.  List of Documents held by Sender: none.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Heart rate increased, Throat irritation
Clinical narrative: Initial report received on 11 June 2009 from a consumer.  A 23 year old female patient with a history of hydrocodiene, peanuts, iodine, red eye allergies received ADACEL (lot number not known) in the right deltoid intramuscularly on an unknown date.  An hour and a half post vaccination, the patient reported that she had an increased heart rate, itching in her throat, and dizziness.  The patient's recovery status was unknown.  List of Documents held by Sender: none.
Age: 5.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Flushing, Swelling face, Urticaria, Wheezing
Clinical narrative: Information has been received from a physician concerning a 5 year old male patient with haemoglobin sc disease who on 14-MAY-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number 664653/1337Y). The physician reported that almost immediately following vaccination to the right upper extremity, the patient experienced difficulty breathing, wheezing, coughing, whole body urticaria and complained of sore neck. The patient was transferred to an unspecified hospital emergency room, treated with intravenous fluids, BENADRYL and corticosteroids and was observed for approximately eight hours before being discharged. The patient fully recovered as of 02-JUL-2010. Difficulty breathing, wheezing, coughing, whole body urticaria and sore neck were considered to be other important medical events by the physician. Difficulty breathing, wheezing, coughing, whole body urticaria and sore neck were considered to be immediately life-threatening. A lot check has been initiated. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cough, Dyspnoea, Immediate post-injection reaction, Neck pain, Urticaria
Clinical narrative: Information has been received from a physician concerning a 5 year old male patient with haemoglobin sc disease who on 14-MAY-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number 664653/1337Y). The physician reported that almost immediately following vaccination to the right upper extremity, the patient experienced difficulty breathing, wheezing, coughing, whole body urticaria and complained of sore neck. The patient was transferred to an unspecified hospital emergency room, treated with intravenous fluids, BENADRYL and corticosteroids and was observed for approximately eight hours before being discharged. The patient fully recovered as of 02-JUL-2010. Difficulty breathing, wheezing, coughing, whole body urticaria and sore neck were considered to be other important medical events by the physician. Difficulty breathing, wheezing, coughing, whole body urticaria and sore neck were considered to be immediately life-threatening. A lot check has been initiated. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Wheezing
Clinical narrative: Information has been received from a physician concerning a 5 year old male patient with haemoglobin sc disease who on 14-MAY-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number 664653/1337Y). The physician reported that almost immediately following vaccination to the right upper extremity, the patient experienced difficulty breathing, wheezing, coughing, whole body urticaria and complained of sore neck. The patient was transferred to an unspecified hospital emergency room, treated with intravenous fluids, BENADRYL and corticosteroids and was observed for approximately eight hours before being discharged. The patient fully recovered as of 02-JUL-2010. Difficulty breathing, wheezing, coughing, whole body urticaria and sore neck were considered to be other important medical events by the physician. Difficulty breathing, wheezing, coughing, whole body urticaria and sore neck were considered to be immediately life-threatening. A lot check has been initiated. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness
Clinical narrative: We were discussing family planning issues and her upcoming trip when I gave the nurse authorization to administer the Gardasil which she did in the left deltoid area. The patient did not report any immediate discomfort at the injection site. Approximately 3 minutes later, while still sitting chatting comfortably on the exam table, she suddenly reared back and pitched sideways off the table, impacting with her head on the floor, apparently unconscious. I opened the airway and stabilized the cervical spine and called for help as well as having the staff alert her mother who was, at that time, in the waiting room. I advised transport to an emergency room for cervical spine films. No seizure activity was seen. I estimate that she was unconscious for approximately 10 seconds. She was briefly confused but regained orientation quickly. She indicated that one of her lower incisors appear to be chipped; indeed, a small fragment of the tooth margin was recovered (less than 2 mm). The cervical spine was maintained in a stable position until 911 arrived and applied a rigid cervical collar and moved her to a backboard. She was able to move all 4 extremities without difficulty. Her mother indicated that she would like to have her proceed with the rest of the immunization series, but lying down next time..
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Confusional state, Fall, Loss of consciousness
Clinical narrative: We were discussing family planning issues and her upcoming trip when I gave the nurse authorization to administer the Gardasil which she did in the left deltoid area. The patient did not report any immediate discomfort at the injection site. Approximately 3 minutes later, while still sitting chatting comfortably on the exam table, she suddenly reared back and pitched sideways off the table, impacting with her head on the floor, apparently unconscious. I opened the airway and stabilized the cervical spine and called for help as well as having the staff alert her mother who was, at that time, in the waiting room. I advised transport to an emergency room for cervical spine films. No seizure activity was seen. I estimate that she was unconscious for approximately 10 seconds. She was briefly confused but regained orientation quickly. She indicated that one of her lower incisors appear to be chipped; indeed, a small fragment of the tooth margin was recovered (less than 2 mm). The cervical spine was maintained in a stable position until 911 arrived and applied a rigid cervical collar and moved her to a backboard. She was able to move all 4 extremities without difficulty. Her mother indicated that she would like to have her proceed with the rest of the immunization series, but lying down next time..
Age: 27.0
Sex: M
Vaccine: HEPA, MNQ, TYP, YF, HEPA, MNQ, TYP, YF
Symptoms: Headache, Meningitis viral, Neck pain, Photophobia, Pyrexia
Clinical narrative: Vaccines given on 6/8/2010 prior to travel to foreign countries. Developed headache, fever, stiff neck, photophobia. 6/18/2010 admitted to hospital. 6/19/2010 treated with VANCOMYCIN, Ceftriaxone. CT scan of head negative, CSF fluid culture negative, blood culture negative. Viral meningitis discharged 6/22/2010.
Age: 27.0
Sex: M
Vaccine: HEPA, MNQ, TYP, YF, HEPA, MNQ, TYP, YF
Symptoms: Blood culture negative, CSF glucose normal, CSF lymphocyte count normal, CSF test normal, CSF white blood cell count increased
Clinical narrative: Vaccines given on 6/8/2010 prior to travel to foreign countries. Developed headache, fever, stiff neck, photophobia. 6/18/2010 admitted to hospital. 6/19/2010 treated with VANCOMYCIN, Ceftriaxone. CT scan of head negative, CSF fluid culture negative, blood culture negative. Viral meningitis discharged 6/22/2010.
Age: 27.0
Sex: M
Vaccine: HEPA, MNQ, TYP, YF, HEPA, MNQ, TYP, YF
Symptoms: Computerised tomogram head, Computerised tomogram normal, Gram stain, HIV test negative, Headache
Clinical narrative: Vaccines given on 6/8/2010 prior to travel to foreign countries. Developed headache, fever, stiff neck, photophobia. 6/18/2010 admitted to hospital. 6/19/2010 treated with VANCOMYCIN, Ceftriaxone. CT scan of head negative, CSF fluid culture negative, blood culture negative. Viral meningitis discharged 6/22/2010.