chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: Initial report received from a consumer on 14 December 2011. A 32-year-old female patient with no concurrent illnesses and no known allergies had received an intramuscular injection of ADACEL (lot number unknown) on 09 December 2011 and 4 days later was found to have a large, red, itchy welt that was hot to touch 4 inches below the injection site. She also had a headache and nausea. At the time of this report, the patient had not recovered. Follow-up information was received from a healthcare professional on 02 March 2012. The patient received an Intramuscular injection of ADACEL; Sanofi Pasteur Ltd. lot number C3989AA in left deltoid. On 14 December 2011, the patient was feeling unwell and fatigued. Upon exam it showed left fluid in upper arm with lightly erythematous patch approximately "2" diameter and warm to the touch; no swelling and no drainage. The patient was advice to follow-up with his physician; however, the patient has not been seen since 14 December 2011. The patient outcome was not reported. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lethargy, Pain in jaw
Clinical narrative: Initial report was received from a healthcare professional on 30 August 2011. A 60-year-old female patient had received an injection of ADACEL; lot number U4088CA (sanofi pasteur Ltd. lot number C3960) (route of administration not reported) in left deltoid on 15 August 2011. On an unspecified date one week after the injection, the patient developed lethargy, jaw pain, redness, pain in upper arm and swelling at the injection site. On 29 August 2011, the patient reported that the jaw pain is less but still has the redness and pain at the injection site. No further informational was available at the time of the report. The patient outcome was not reported. Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: This case is one of a cluster of three patients who experienced adverse events following administration of ADACEL (lot number U4090BA and sanofi pasteur Ltd. lot number C3961) and FLUZONE, lot number UH463AA. The events for the other patients were captured in case 2011-10183 and 2011-10184. Initial report was received on 14 October 2011 from a healthcare provider. A 59-year-old female patient (date of birth not reported) had received on 04 October 2011 and intramuscular injection of FLUZONE and ADACEL (site of administration not reported). On 12 October 2011, the patient experienced decreased range of motion and pain down her arm. The patient was prescribed ice, heat compresses, ibuprofen and TYLENOL. No further informational was available at the time of the report. The patient's outcome was reported as resolving. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 04 August 2011. A 54-year-old female patient received a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number C3935AA, on 27 July 2011. The patient had no known allergies (NKA) and denied any illnesses at the time of vaccination. Approximately 7 days later (August 2011), the patient developed a red raised area on the left deltoid which measured approximately 1/2 inch away from the injection site. The red area was 11.5 by 8 centimeters (cm) in size. The patient denied pain but stated she had slight burning sensation at times. The outcome was reported as not recovered. Follow-up information was received from the healthcare professional on 29 August 2011. The patient was seen on 04 August 2011 by a nurse practitioner, complaining of redness and a burning sensation in the left upper arm. She was treated with warm soaks and ibuprofen 400mg PO bid. The next day she noted that the burning sensation continued, but redness was decreased. She was advised to continue the warm soaks, and was prescribed prednisone 20mg PO x 2 days. On 09 August 2011 the left arm erythema was "almost completely resolved". Outcome was reported as recovered. Documents held by sender: None.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial report was received from a health care professional on 02 September 2011. A 24 year-old female patient with no reported past medical history had received on 21 July 2011 a left deltoid injection of ADACEL, lot number C3935AA and an unspecified amount of time later, experienced a sore arm and had pain when stretching or putting on clothes. The patient first reported this to the reporter on 10 August 2011. She called again on 02 September 2011 to report her sore arm was not improving and she continued to have pain with movement. Treatments were not reported. Concomitant medications included birth control pill. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Rash, Skin exfoliation
Clinical narrative: Initial report was received from a healthcare professional on 23 November 2011. A 12-year-old male patient had received an Intramuscular (IM) injection of ADACEL (sanofi pasteur Ltd. lot number C3947BA) in left deltoid on 22 September 2011. On 15 October 2011, the patient developed a reddening to his hands progressing to the skin peeling and a rash on the hands. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: A female patient had received an injection of ADACEL; sanofi pasteur Ltd. lot number C4008BA (route of administration not reported) in left deltoid on 10 January 2012. On an unspecified date following vaccination, the patient developed redness, swelling and pain in arm. It is unknown if the patient received any corrective treatment. No further information was available at the time of this report. The patient outcome was not reported.  Documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site rash, Pain in jaw
Clinical narrative: Initial report was received on 23 August 2011 from a health care professional. A female patient with no known allergies had received a first dose left deltoid injection of ADACEL, lot number U3561CA (sanofi pasteur ltd lot number C3726) (route and date of administration not reported) and five days after vaccination experienced a six inch in diameter rash at the injection site, headache, jaw pain and tiredness. The patient had no illness at the time of vaccination. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 20 March 2012. The patient received the ADACEL injection intramuscularly on 18 August 2011. The patient's rash occurred on post-vaccination day 5 and measured 6 inches in diameter at the site of injection. On day 4 the pain was resolving but on day 5 and measured 6 inches in diameter at the site of injection. On day 4 the pain was resolving but on day 5 the pain increased. The tiredness and headache was mild for two days. The headache resolved but the patient continued tired and jaw pain. The patient was treated with CLARIITN 10mg 1 tablet once daily (qd) for 7 days, cool compress to site, APAP 500 mg 1 tablet by mouth (po) every 4-6 as needed for pain (pp), AMICA 30c 1 tablet every 4 hours pp, AMICA topical as needed (prn). The patient was to follow-up if worse or not recovered within 14 days. The patient recovered without a permanent issue. The patient received no other vaccinations within four weeks of ADACEL. The patient's outcome was recovered. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Lymphadenopathy, Swelling, Ultrasound scan abnormal
Clinical narrative: Cluster of two adult female patients who each developed axillary pain following the administration of ADACEL (lot number C3837BA). Initial report received on 14 July 2011 from a health professional. A 37 year old female patient, with no known allergies and no medical history, received a first left deltoid intramuscular injection of ADACEL (lot number C3837BA) on 07 July 2011. The patient had no concomitant medications. She had no illnesses at the time of vaccination and had received no other vaccines within the four previous weeks. She had no adverse events following prior vaccination. Three days later, on 10 July 2011, the patient developed axillary pain and swelling. She was seen by a physician and sent for an ultrasound, which showed enlarged axillary lymph nodes. At the time of the report, the patient had not recovered. The events for the other patient are captured in case 2011-04670. Follow-up information was received from the healthcare professional on 01 September 2011. The pain and swelling was on the left side where injection was given, left deltoid. Treatment included RICE (rest/ice/compression/elevation) and acetaminophen prn. An ultrasound was performed of the left axilla. Symptoms lasted 7-8 days and then resolved. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 22 July 2011. A female patient (age not reported) received an intradermal injection of ADACEL, sanofi pasteur lot number not reported, one week ago. The patient inadvertently was administered ADACEL instead of PPD intradermal. The patient developed redness, swelling and a nodule at the injection site. The outcome was reported as unknown. Follow-up information was received 12 September 2011 from a health care professional. The lot number for ADACEL administered to the patient was C3976AA. The patient had no known illness at the time of vaccination. The event began within 24 hours after vaccination, and the swelling and redness resolved within two weeks. Outcome was recovered. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cyst, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: This case is 1 of a cluster of 2 patients' who experienced similar adverse events following vaccination with ADACEL. The event for the second patient was captured in case number 2011-06220. Initial report received from a health care profession on 03 August 2011. A female patient (age reported as in 30's and birth date reported as 15 December 1965) received a left deltoid intramuscular injection (dose 1) of ADACEL, sanofi pasteur Ltd. lot number C3927AA, on an unknown date (reported as one week ago). The patient's medical history was not reported. The patient had no other vaccines within 4 weeks of the ADACEL and had no known allergies. The patient complained of left deltoid redness and hotness at the injection site and one week later still has hard firm lump at the site. On patient examination, the patient had an induration (described as grape-size cyst) with no signs of inflammation (cold abscess?). On application of warm compresses (no antibiotic were used), the patient reported quick resolution of symptoms. The outcome was reported as recovered. Follow-up information was received from a health care professional on 19 September 2011. The patient had received the ADACEL vaccine on 26 July 2011 (previously reported as one week ago). She has a history of colon cancer "OEOD". No further information was available at the time of the report. The outcome remained recovered. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Urinary incontinence, Vomiting
Clinical narrative: Initial report was received from a healthcare professional on 29 September 2011. A 31-year-old female patient had received an Intramuscular (IM) injection of ADACEL; lot number U4104AA (sanofi pasteur Ltd. lot number C3962) in left deltoid and a Intradermal (ID) injection of APLISOL in right arm on 13 September 2011. On 14 September 2011, the patient developed symptoms of coughing spell leading to vomiting and urinary incontinence. No further information was available at the time of the report. The patient outcome was reported as unknown. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report was received 25 August and 26 August 2011 via a distributor (HSI item number 546-7789; Control # 41209), who received the report from a physician. The event for the other patient was capture in case number 2011-10008. A cluster of two unidentified patients had received an injection of ADACEL, lot number C3935AA (route, site and dates of administration not reported) and on 23 August 2011, both patients developed a 1/2 cm high raised red bump at the injection site. The events required a doctor's visit. Outcome was unknown. No additional information was provided at the time of the report. Follow-up information was received from a healthcare professional on 17 October 2-11. An 11-year-old male patient had received an injection of ADACEL in left deltoid on 22 August 2011. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: This case is one of a cluster of three patients who experienced adverse events following administration of ADACEL (lot number U4090BA and sanofi pasteur Ltd. lot number C3961) and FLUZONE, lot number UH463AA. The events for the other patients were captured in case 2011-10183 and 2011-10242. Initial report was received on 14 October 2011 from a healthcare provider. A 38-year-old female patient (date of birth not reported) had received on 29 September 2011 an intramuscular injection of FLUZONE and ADACEL (site of administration not reported). On 11 October 2011, the patient experienced decreased range of motion and pain down her arm. The patient was prescribed ice, heat alternating compresses, ibuprofen and TYLENOL. No further information was available at the time of the report. The patient's outcome was reported as resolving. Documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Initial report was received 31 August 2011 from a health care professional. A 50-year-old male patient had received a left deltoid injection of ADACEL, sanofi pasteur Inc lot number U4090AC (corresponding sanofi pasteur Ltd. lot number C3961) on 23 August 2011 and the next day he called the physician's office to report a sore arm with major swelling of the injection site and upper arm. He had no reported concurrent illness. Past medical history was not reported and he had no known allergies. Concomitant medications consisted of COREG DR, LIPITOR, AMBIEN, NARCO, Baby ASA and Vitamins. Relevant diagnostic test/laboratory data and the event outcome were unknown at the time of the report. Follow-up information was received on 17 October 2011 from a health care professional. The patient had received ADACEL intramuscularly (route previously not reported). Onset date for the patient's events was 23 August 2011 (previously not reported). No further information was available at the time of the report. The patient's outcome was reported as recovered "7-8 days". Documents held by sender: None.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Initial report was received 25 August and 26 August 2011 via a distributor (Item number 546-7789; Control # 41209), who received the report from a physician. A cluster of two unidentified patients had received an injection of ADACEL, lot number C3935AA (route, site and dates of administration not reported) and on 23 August 2011, both patients developed a 1/2 cm high raised red bump at the injection site. The events required a doctor's visit. Outcome was unknown. No additional information was provided at the time of the report. Follow-up information was received from a healthcare professional on 17 October 2011. The patient had received an injection of ADACEL in left deltoid on 16 August 2011. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Documents held by sender: None
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Initial report was received from a health care professional on 23 August 2011. A 34 year-old female patient with no known allergies, had received on 20 August 2011 a first dose intramuscular right deltoid injection of ADACEL, lot number U3979CA (sanofi pasteur ltd lot number C3915). On 23 August 2011, the patient experienced redness, swelling and a mass at the injection site. The patient was evaluated by a physician and treated with antibiotics and topical steroid cream. The patient had no illness at the time of vaccination. NO further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Tremor
Clinical narrative: Initial report received from a health care professional on 16 August 2011. A patient (age and sex not reported) received an injection (route and site not reported) of ADACEL, Sanofi Pasteur Ltd. lot number and date of vaccine not reported. The patient's medical history was not reported. A patient, post vaccination, developed dizziness, shakiness and fatigue. The reported stated that they do not report these and declined to provide information. The outcome was reported as unknown. Documents held by sender: None.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Initial report was received on 22 August 2011 from a health care professional. A 70 year-old female patient had received on 09 August 2011 an intramuscular left arm injection of ADACEL, lot number U3973DA (sanofi pasteur ltd. lot number C3914) and an unspecified amount of time later the same date, experienced pain at the left arm and redness at the site of vaccination. According to the report, the symptoms have been present for two weeks. The patient had an appointment to be evaluated. The patient had no illness at the time of vaccination. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a healthcare professional on 31 October 2011. The physician reported that he had explained to his patient that a reaction can take up to "two months" to go away. However, patient is doing well. No further informational was available at the time of the report. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Initial report was received 12 August 2011 from a health care professional. A "30 or so" year old male patient had received a left deltoid injection of ADACEL on 25 July 2011 and an unspecified amount of time later, he developed pain, soreness and decreased range of motion in the vaccinated arm. No redness, swelling or other symptoms were present. One week later, the patient felt the pain had not improved, but became worse and the patient could not sleep on their left side. The event required a doctor's visit. The patient was a healthy young man with normal body/muscle mass who exercised and worked out daily. The vaccine had been administered in the usual manner and the same needle length had been used as for other adult patients (needle size not reported). Outcome was not recovered. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site induration, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Initial report received from a consumer on 27 June 2011. A female patient received a right arm intramuscular injection of ADACEL, sanofi pasteur lot number not reported, on 24 June 2011. On an unknown date, the patient experienced swelling of the arm, hardened area around injection site, soreness of the arm, unable to lift arm and tingling of arm from shoulder to fingers. The patient also had "fever" for one day the day after receiving the vaccine. She continues to have arm soreness, decreased range of motion and arm tingling. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 09 August 2011. The lot number of the ADACEL was reported as sanofi pasteur Ltd. C3902 and sanofi pasteur Inc. lot number U3956BA. The patient was first seen on 27 June 2011 in Employee Health Services (EHS) with complaints of right arm swelling, and inability to lift arm. The patient was recommended to see a medical provider. On 29 June 2011, she was seen at an urgent care clinic and was given no lifting restrictions and range of motion exercise for a possible hematoma under the muscle with impingement. There was no diagnostic testing. On 13 July 2011, the patient provided a return to work release with no follow-up needed. No additional information available at this time. The outcome was reported as recovered. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Initial report received from a consumer on 27 June 2011. A female patient received a right arm intramuscular injection of ADACEL, sanofi pasteur lot number not reported, on 24 June 2011. On an unknown date, the patient experienced swelling of the arm, hardened area around injection site, soreness of the arm, unable to lift arm and tingling of arm from shoulder to fingers. The patient also had "fever" for one day the day after receiving the vaccine. She continues to have arm soreness, decreased range of motion and arm tingling. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 09 August 2011. The lot number of the ADACEL was reported as sanofi pasteur Ltd. C3902 and sanofi pasteur Inc. lot number U3956BA. The patient was first seen on 27 June 2011 in Employee Health Services (EHS) with complaints of right arm swelling, and inability to lift arm. The patient was recommended to see a medical provider. On 29 June 2011, she was seen at an urgent care clinic and was given no lifting restrictions and range of motion exercise for a possible hematoma under the muscle with impingement. There was no diagnostic testing. On 13 July 2011, the patient provided a return to work release with no follow-up needed. No additional information available at this time. The outcome was reported as recovered. Documents held by sender: None.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Nasal congestion, Productive cough, Respiratory tract congestion, Respiratory tract infection
Clinical narrative: Initial report received on 26 May 2011 from a consumer, who is the patient. A 36 year old female patient, with no known allergies and no medical history, received a first left deltoid intramuscular injection of ADACEL (lot number unknown) on 01 February 2011. The patient had no concomitant medications and no illness at the time of vaccination. She had received no other vaccines at the same time or in the previous four weeks. She had no adverse events following previous vaccinations. The patient reported that since the time that she received ADACEL, she had three respiratory infections with chest congestion, nasal congestion, and a productive cough that makes it difficult for her to catch her breath. The first respiratory infection was on approximately 24 February 2011, the second on approximately 17 March 2011, and the third on 18 May 2011. The patient had consulted an ENT physician. Corrective treatment was not reported. At the time of the report, the patient had not recovered.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site reaction, Pain, Urticaria
Clinical narrative: Initial report received from the patient's parent on 21 June 2011. An 11-year-old female patient had received a first dose of ADACEL (lot number C3540AA), and a first dose of MENACTRA (lot number U3518AA) on 18 January 2011 and 1 week post vaccinations the patient experienced the "usual" redness and soreness, but every so often for the "past 6 months" she has developed a welt below the right injection site lasting 3-4 hours, and then it goes away. The patient was evaluated by an allergist and dermatologist, but they were unable to determine the cause. It was noted the patient had received VARIVAX (Merck) in June 2010. No adverse event was reported with that vaccination. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Initial report was received from a health care professional on 27 June 2011 which involves the administration of the wrong vaccine. A female patient (date of birth not reported) had received ADACEL, lot number U3553CA (sanofi pasteur Ltd. lot number C3677) which was inadvertently administered intradermal for 'PPD instead of TUBERSOL" and at the time of the injection, the patient experienced redness and swelling at the injection site. The patient was evaluated by a physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Erythema, Injection site nodule, Injection site pain, Local swelling
Clinical narrative: Initial report was received 15 June 2011 from a health care professional which involved a case of misuse. This case also represents one of a cluster of three patients who experienced adverse events after receiving ADACEL, lot number C3898BA. The other two patients have been captured in case numbers 2011-03459 and 2011-03462. A 37-year-old female patient had received two intradermal left forearm injections of ADACEL, lot number C3898BA (instead of TUBERSOL) approximately one inch apart (the first injection was administered too deep0 on 13 May 2011 and 24 hours later, the patient developed a large red, swollen, blistered area. The event required a doctor's visit. AT the time of report, the blisters had resolved, but soreness and a knot remained at the site. Outcome was not recovered. Follow-up information was received from a health care professional on 19 July 2011. The dosage the patient received was 0.1 ml x 2. The patient was seen by a physician on 10 June 2011. The patient received treatment with BENADRYL as needed (PRN). The outcome remained not recovered. The reporter for this case is the same as case number 2011-03460. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Initial report was received 15 June 2011 from a health care professional which involved a case of misuse. This case also represents one of a cluster of three patients who experienced adverse events after receiving ADACEL, lot number C3898BA. The other two patients have been captured in case numbers 2011-03459 and 2011-03462. A 37-year-old female patient had received two intradermal left forearm injections of ADACEL, lot number C3898BA (instead of TUBERSOL) approximately one inch apart (the first injection was administered too deep0 on 13 May 2011 and 24 hours later, the patient developed a large red, swollen, blistered area. The event required a doctor's visit. AT the time of report, the blisters had resolved, but soreness and a knot remained at the site. Outcome was not recovered. Follow-up information was received from a health care professional on 19 July 2011. The dosage the patient received was 0.1 ml x 2. The patient was seen by a physician on 10 June 2011. The patient received treatment with BENADRYL as needed (PRN). The outcome remained not recovered. The reporter for this case is the same as case number 2011-03460. Documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Flushing, Paraesthesia
Clinical narrative: Initial report received from a health care professional, who reported the information to a liability specialist. This information was then reported to sanofi pasteur via other manufacturer on 01 July 2011. A 16-year-old male patient received an injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. batch number 8YO OVR660K, on an unknown date. The patient became dizzy, left arm tingling and face flushed. The patient was administered ammonia salts which revived him. The outcome was not reported. Follow-up information received from a health care professional on 05 August 2011. The patient received a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number C3899AA. On 20 June 2011, the patient developed the reaction of flushed, dizzy and tingling. The patient was treated with smelling salts and 911 was called. It was unknown if the patient was seen by a physician. The outcome was reported as unknown. No information was available. Follow-up information was received from the reporter on 01 September 2011. The patient outcome was noted as "recovered". No additional information was reported. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 30 June 2011. It pertains to 1 of a cluster of 2 patients whom the reporter noted had experienced adverse events following receipt of ADACEL. The event for the other patient is captured in 2011-03968. A male patient received an injection of ADACEL (lot number C3899AA). The following week, he returned to the office with "mild cellulitis". Outcome was not reported. Follow-up information was received from the healthcare professional on 11 August 2011. The patient was 61 years old, and had a history of left epididymitis, hyperlipidemia, splenic flexure syndrome, GERD, hyperplastic polyps colon, dysphagia, anal fissure healed, mild diverticulosis, IBS, chronic prostatitis (Koster), and hypertension (April 2008). Medication allergies included penicillin, ANUSOL, PREVACID, INDAPAMIDE, Amlodipine, and Clonidine. ADACEL was administered in the right arm in June 2011. One week post-vaccination, he developed soreness in the arm and redness at the injection site, which then increased and extended slightly down his arm. Upon exam, his right deltoid was slightly extended distally, with mild swelling, redness, and warmth. He was diagnosed with cellulitis, and treated with BACTRIM DS 1 tablet BID by mouth. He was instructed to return to the office if symptoms did not improve within 3 days. The event subsequently recovered on an unspecified date. Documents held by sender: Office note.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received from a health care professional on 29 2011 who is also the patient. A 51 year-old female patient with allergies to DEMEROL and horse serum had received a left arm injection of ADACEL, lot number C3921AA (route of administration not reported) on 24 June 2011 and by the evening of vaccination began to have soreness at the injection site. The next morning the patient experienced an itchy, swollen, red, hot to touch upper arm with hard spot the "size of palm" at the injection site and a sore arm. The patient reported that the arm soreness had been severe enough that she had been unable to sleep on her side. Concomitant medication included aspirin. Treatments were not reported. Illness at the time of vaccination and other vaccines with in four weeks of suspect were reported as none. The patient had no history of any medical conditions. No further information was provided at the time of the report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Initial report was received from a health care professional on 29 2011 who is also the patient. A 51 year-old female patient with allergies to DEMEROL and horse serum had received a left arm injection of ADACEL, lot number C3921AA (route of administration not reported) on 24 June 2011 and by the evening of vaccination began to have soreness at the injection site. The next morning the patient experienced an itchy, swollen, red, hot to touch upper arm with hard spot the "size of palm" at the injection site and a sore arm. The patient reported that the arm soreness had been severe enough that she had been unable to sleep on her side. Concomitant medication included aspirin. Treatments were not reported. Illness at the time of vaccination and other vaccines with in four weeks of suspect were reported as none. The patient had no history of any medical conditions. No further information was provided at the time of the report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Sensation of heaviness
Clinical narrative: Initial report was received from a patient on 26 September 2011. A 23-year-old female patient had received an Intramuscular (IM) injection of ADACEL (lot number not reported) in right arm on 19 September 2011. On an unspecified date, the patient right arm was aching and felt heavy when trying to lift it. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial report was received from a patient on 07 October 2011. A 70-year-old female patient had received ADAEL and FLUZONE HIGH-DOSE (lot numbers, route and site of administration not reported) on 02 October 2011. On an unspecified date, the patient arm was painful when "lifting weights" or moves her arm over her head. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Fibromyalgia
Clinical narrative: Initial report was received from a company representative on 11 October 2011. A female patient (age and date of birth not reported) had received an injection of ADACEL (lot number, route and site of administration not reported). On an unspecified date shortly after receiving the injection, the patient had a flare-up of her fibromyalgia. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Initial report received from Non-Health Care Professional on 30 April 2012. A female patient, whose medical history and concomitant medications were not reported, had received a intramuscular dose ADACEL in right deltoid (lot number - unknown) on 23 April 2012. It was reported that on 23 April 2012, the patient experienced pain in arm and fingers of right hand 6 hours post vaccination. The reporter stated that 8 days later the patient continued to had pain which was worsening, extends from arm to shoulder to back and from arm site down to finger of hand. The outcome of events was reported as not recovered. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from a Licensed practical nurse (LPN) concerning an 11 year old male patient. The patient was vaccination with a 0.5 ml dose of GARDASIL, on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The LPN reported that after getting the vaccination, at the end of May 2012, the patient was leaving the office and looked like he was going to faint. The patient was brought back into the office and the staff gave him a glass of water and had him lie down. No treatment information was reported. The adverse event improved after stopping therapy. Therapy with GARDASIL was not reintroduced. The patient sought unspecified medical attention. The patient's outcome was reported as recovered/resolved, "at the end of May". The relatedness for looked like he was going to faint is unknown for GARDASIL. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a 69 year old male consumer reporting on himself, with penicillin, erythromycin and sulfa drugs allergies and a history of heart attack (11 years ago), who on 26-JUL-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). Concomitant therapy included "a lot of medications, including heart medications". The consumer reported that "within a half-hour to an hour" of being administered the vaccine on 26-JUN-2012, he got a headache that was still present. No labs diagnostics studies were performed. No treatment was given for the experience. At the time of the report, the patient had not recovered. The patient did not seek medication attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Oral herpes
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with no pertinent medical history. The patient was vaccinated with her first dose of GARDASIL, lot # 658271/0558X, on 16-JUN-2009 (route, site and dose not reported). The patient was vaccinated with her second dose of GARDASIL, lot # 662404/0312Y, on 18-AUG-2009 (route, site and dose not reported). No other co-suspects were reported. There were no concomitant medications. On 14-JUL-2009 and on 28-JAN-2011, the patient experienced severe fever blisters. On 18-AUG-2009, therapy with GARDASIL was discontinued. The adverse event improved after stopping therapy. The patient was seen in the physician office. The patient was given ZOVIRAX and amoxicillin and AUGMENTIN as a treatment for the adverse event. The outcome of severe fever blister was reported as recovered/resolved. The relatedness for severe fever blister and severe fever blister was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a pharmacy student concerning a 15 month old female with no drug reaction/allergies and pertinent medical history who on 14-MAR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot# 671130/1220AA, Exp unknown), SQ. There was no concomitant medication. On 04-APR-2012 the patient experienced varicella like rash all over the body along with febrile illness. The patient came into the clinic. Acyclovir and TYLENOL were given for the adverse effects. No lab diagnostics study was performed. At the time of reporting, the patient's status was unknown. The reporter was requesting a lot check of this vaccine due to the patient having adverse experiences. A preliminary lot check investigation was performed. To date out investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Full blood count, Injection site cellulitis, Shift to the left, White blood cell count increased
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 54 year old male patient with diabetes type 2, obesity and hyperlipidaemia and no drug reactions or allergies who on 10-APR-2012, was vaccinated with a dose of PNEUMOVAX 23, 0.5ml, SC (lot number 672074/1502AA, expiration date 19-MAY-2015). It was reported that on 11-APR-2012, the patient was seen in the office because he was experiencing "flu-like symptoms" which included body aches, joint pain, cough and runny nose. The reporter stated that the patient came back to the office on 13-APR-2012, because he was experiencing pain at the injection site, the site was red and warm to the touch. It was reported that a physician diagnosed the patient with cellulitis and treated the patient with sulfamethoxazole and trimethoprim twice daily for 20 days. There were no lab diagnostics studies performed. The reporter stated that the patient was seen in the office on 16-APR-2012 and the physician noted that the patient improved by 50%. On an unknown date, the patient recovered from the adverse events. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Cellulitis, Cough, Influenza like illness, Injection site erythema
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 54 year old male patient with diabetes type 2, obesity and hyperlipidaemia and no drug reactions or allergies who on 10-APR-2012, was vaccinated with a dose of PNEUMOVAX 23, 0.5ml, SC (lot number 672074/1502AA, expiration date 19-MAY-2015). It was reported that on 11-APR-2012, the patient was seen in the office because he was experiencing "flu-like symptoms" which included body aches, joint pain, cough and runny nose. The reporter stated that the patient came back to the office on 13-APR-2012, because he was experiencing pain at the injection site, the site was red and warm to the touch. It was reported that a physician diagnosed the patient with cellulitis and treated the patient with sulfamethoxazole and trimethoprim twice daily for 20 days. There were no lab diagnostics studies performed. The reporter stated that the patient was seen in the office on 16-APR-2012 and the physician noted that the patient improved by 50%. On an unknown date, the patient recovered from the adverse events. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site warmth, Pain, Rhinorrhoea
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 54 year old male patient with diabetes type 2, obesity and hyperlipidaemia and no drug reactions or allergies who on 10-APR-2012, was vaccinated with a dose of PNEUMOVAX 23, 0.5ml, SC (lot number 672074/1502AA, expiration date 19-MAY-2015). It was reported that on 11-APR-2012, the patient was seen in the office because he was experiencing "flu-like symptoms" which included body aches, joint pain, cough and runny nose. The reporter stated that the patient came back to the office on 13-APR-2012, because he was experiencing pain at the injection site, the site was red and warm to the touch. It was reported that a physician diagnosed the patient with cellulitis and treated the patient with sulfamethoxazole and trimethoprim twice daily for 20 days. There were no lab diagnostics studies performed. The reporter stated that the patient was seen in the office on 16-APR-2012 and the physician noted that the patient improved by 50%. On an unknown date, the patient recovered from the adverse events. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Feeling abnormal, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: The first two days after the shot I felt not too well. On the second day I touched the site of the shot, just above my elbow, and found a quite warm swelling at least the size of a golf ball. My symptoms became progressively worse. I was very lethargic - almost like the onset of the flu - and felt generally quiet poorly. I had periods of dry mouth, of very moist mucous membranes, and at times a medicinal taste in my mouth. I was getting up to urinate at night very frequently. Near the end of the first week I had a dizzy spell, which may or may not have been related to the shot. The symptoms slowly abated. After eight days I felt relatively normal and the last of the redness at the shot site was gone. I attempted to speak with my physician at one point, but his nurse did not pass on my message clearly. By this time a regular appointment was just a few days off so I waited for that opportunity to discuss the situation with him. I did speak with the pharmacist several days after the shot and he suggested I might want to contact you.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Micturition urgency, Pollakiuria
Clinical narrative: The first two days after the shot I felt not too well. On the second day I touched the site of the shot, just above my elbow, and found a quite warm swelling at least the size of a golf ball. My symptoms became progressively worse. I was very lethargic - almost like the onset of the flu - and felt generally quiet poorly. I had periods of dry mouth, of very moist mucous membranes, and at times a medicinal taste in my mouth. I was getting up to urinate at night very frequently. Near the end of the first week I had a dizzy spell, which may or may not have been related to the shot. The symptoms slowly abated. After eight days I felt relatively normal and the last of the redness at the shot site was gone. I attempted to speak with my physician at one point, but his nurse did not pass on my message clearly. By this time a regular appointment was just a few days off so I waited for that opportunity to discuss the situation with him. I did speak with the pharmacist several days after the shot and he suggested I might want to contact you.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cough, Dizziness, Feeling abnormal, Influenza like illness, Injection site erythema
Clinical narrative: The first two days after the shot I felt not too well. On the second day I touched the site of the shot, just above my elbow, and found a quite warm swelling at least the size of a golf ball. My symptoms became progressively worse. I was very lethargic - almost like the onset of the flu - and felt generally quiet poorly. I had periods of dry mouth, of very moist mucous membranes, and at times a medicinal taste in my mouth. I was getting up to urinate at night very frequently. Near the end of the first week I had a dizzy spell, which may or may not have been related to the shot. The symptoms slowly abated. After eight days I felt relatively normal and the last of the redness at the shot site was gone. I attempted to speak with my physician at one point, but his nurse did not pass on my message clearly. By this time a regular appointment was just a few days off so I waited for that opportunity to discuss the situation with him. I did speak with the pharmacist several days after the shot and he suggested I might want to contact you.