chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 16 August 2013. An 83-year-old female patient had received an intramuscular dose of ADACEL vaccine (batch number- C4432AB) in the left deltoid on 09 August 2013. The patient had no illness at time of vaccination. The patient had medical history of HTN (hypertension), diabetes and thyroid disorder. The patient's concomitant medications were not reported. On 14 August 2013, 5 days after vaccination, the patient developed redness and swelling from left shoulder to the elbow and the area was hot to touch. Corrective treatments were not reported and laboratory tests were not done. At the time of this report, the patient had not recovered from the event. Documents held by sender: none. Follow-up information received from a healthcare professional on 16 October 2013: The patient's address was upgraded.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin induration, Skin warm, Swelling
Clinical narrative: Initial report received from a healthcare professional on 09 August 2013. A 54-year-old female patient had received an intramuscular dose of ADACEL vaccine (batch number: U4655AA, expiry date: 12/13/2015) in the right deltoid on 07 August 2013. The patient's medical history included anxiety, polyps, bursitis, depression, emphysema, chronic bronchitis, "onychimosis", migraine, scholiosis, tendonitis and spondylosis. The patient had no known drug allergies (NKDA). The patient had received Cortisone shot within a day of the vaccine, not related to the injection site. On 08 August 2013, the patient developed golf ball sized raised area, with itching, swelling that became red, hot, indurated and tender to touch. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. At the time of this report, the patient had not recovered from the events. List of documents, held by sender: None.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Initial report received from a healthcare professional on 09 August 2013. A 54-year-old female patient had received an intramuscular dose of ADACEL vaccine (batch number: U4655AA, expiry date: 12/13/2015) in the right deltoid on 07 August 2013. The patient's medical history included anxiety, polyps, bursitis, depression, emphysema, chronic bronchitis, "onychimosis", migraine, scholiosis, tendonitis and spondylosis. The patient had no known drug allergies (NKDA). The patient had received Cortisone shot within a day of the vaccine, not related to the injection site. On 08 August 2013, the patient developed golf ball sized raised area, with itching, swelling that became red, hot, indurated and tender to touch. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. At the time of this report, the patient had not recovered from the events. List of documents, held by sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Underdose
Clinical narrative: Initial report received from healthcare professional via other company (Novartis Pharmaceutical Corporation) on 13 September 2013. A male patient whose date of birth, at the time of event, medical history and concomitant medications were not reported, had received a dose of Tdap-ADACEL vaccine (batch number, route and anatomical site of administration were not reported) on an unspecified date. It was reported that, a part of a dose of Tdap was lost during administration and a partial dose was administered to the patient; thus vaccine underdose. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 22 July 2013. This is an invalid case as individual patient identifiers are not reported. A cluster of 4 male and female patients, whose date of birth, age and medical history were reported as "n/a" (not available) and concomitant medications were not reported, had received a dose of ADACEL vaccine (lot number: U4618AA, expiry date: 23 October 2015, dose in series, route and site of administration was reported as "n/a") on 15 July 2013. On 15 July 2013, after vaccination, 4 patients experienced redness and swelling at injection site. The reporter did not have chart, further information on reaction or demographics of patients and did not know if patients had been treated. Relevant laboratory tests were not reported. The patients required ER/Doctor visit. At the time of this report, the outcome of event was unknown. Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 31 July 2013. A 61-year-old female patient, had received an intramuscular first dose of ADACEL vaccine (lot number: C4365AA) in left deltoid on 25 July 2013. The patient had a medical history of diabetes. The patient had no known allergies and no illness at time of vaccination. Concomitant medications were not reported. On 26 July 2013, one day after vaccination, the patient developed 6 x 8 cm red and warm area at the injection site. Laboratory investigations and corrective medications were not reported. On 31 July 2013, there was no improvement in the patient and the patient visited a physician who verified the measurements. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 12 July 2013. It was reported that a patient (No information was provided regarding the patient) was administered a dose of ADACEL instead of administering Varicella vaccine. The patient had received first dose of ADACEL vaccine before 18 months. No adverse event was reported. List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Initial misuse report received from a healthcare professional on 19 JUNE 2013. It was reported that a 16-year-old male patient was given a dose of ADACEL on 17 JUNE (year not specified) and he had also received a dose of TDap on 04 APRIL 2012. No adverse event was reported. Documents held by sender: none.
Age: 6.0
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 AUGUST 2013. A 6-year-old patient was inadvertently administered ADACEL as fifth dose in DTap series. No adverse event was reported. Documents held by sender: none
Age: 1.0
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 AUGUST 2013. An 01-year-old patient received a dose of ADACEL in error. The patient had previously received three doses of DTap on unspecified dates. No adverse event was reported. Documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Lymphadenopathy, Swelling
Clinical narrative: Initial information received from a healthcare professional on 23 SEPTEMBER 2013. A 12-year-old male patient had received first dose of MENACTRA (batch number: U4648AA, expiry date: 25 APRIL 2015, route of administration not reported) in the left deltoid and first dose of ADACEL (batch number C4456AA, expiry date: 10 DECEMBER 2015, route of administration not reported) in the left deltoid, on 21 SEPTEMBER 2013. The patient had no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects or medical conditions. The patient had not received any other vaccinations within 4 weeks of the present vaccination given on 21 SEPTEMBER 2013. On 21 SEPTEMBER 2013, the same day after vaccination, the patient had enlarged lymph nodes less than 3 centimeter, in the left axilla. The patient also had minimal swelling, less than 1 centimeter round area with minimal redness. There were no other symptoms. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 12 NOVEMBER 2013. The patient had no medical history and no illness at the tine of vaccination. On an unspecified date, the patient recovered.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 15 JULY 2013. A 77-year-old female patient, with allergy to PCN (Penicillin) , no illness at the time vaccination and whose concomitant medications were not reported, had received an intramuscular dose of ADACEL (batch number and anatomical site of administration were not reported) on 10 JULY 2013. On 12 JULY 2013, the patient presented with injection site reaction which was red, itchy, tender to touch and swollen measuring 7 inches from side to side, 3 inches from top to bottom. No laboratory tests were done. The corrective treatment was not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Initial report received from a  healthcare professional on 02 AUGUST 2013. A 16-year-old male patient had received an intramuscular dose of ADACEL (batch number: C3070AA, expiry date 02/27/2011, dose number was not reported) in the right deltoid, as intramuscular dose of MENACTRA (batch number: U4583AA, expiry date 11/04/2014, dose number was not reported) in the right deltoid and GARDASIL (manufacturer Merck, batch number, dose number, route and site of administration were not reported) all vaccines on an unspecified date. The patient had no known drug allergies. Patient's medical history was not reported. On an unspecified date, one week following vaccination the patient had swelling of hands and fee. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of event was unknown. List of documents held by the sender: none.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Initial report received from a healthcare professional on 28 AUGUST 2013. A 34-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of ADACEL (lot number: U4655AA, expiry date: 12/13/2015 and exact dose number was not reported) intramuscularly in the left deltoid on 20 AUGUST 2013. As per the reporter, the patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects were not reported. On 26 AUGUST 2013, the patient had experienced local site reactions of redness, swelling, warm to touch at injection site of left arm. Corrective treatments and laboratory investigations were not reported. At the time of the report, outcome of the event was unknown. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Abdominal discomfort, Abdominal pain, Blood test normal, Crying, Poor quality sleep
Clinical narrative: Initial report received from a non-healthcare professional (patient's parent) on 23 SEPTEMBER 2013.  A 2-year-old male patient had received a fourth dose of DTap (lot number was not available, route of administration was not reported) in the thigh on 16 SEPTEMBER 2013. The patient had previously experienced "crying for days" after receiving DTap, RV, HIB and IPOL at two, four and six months of age and had intussusception". The patient was hospitalized. The patient had no illness at the time of vaccination. The patient had no known allergies. He was concomitantly on "Lebsen drops" twice daily. Prevacid 5mg twice daily, "Genulac" 10mg twice daily, Probiotics, Ter-Fair Biotic for children (Klare labs) and Betaine Hydrochloride.  On an unspecified date, 48 hours after vaccination, the patient began to cry, was holding stomach and had crampy pain in abdomen. The patient was not sleeping well. On an unspecified date, the patient had done blood work with normal result (list of labs were not available). Corrective treatments were not reported. At the time of this report, the patient was recovering from the event of abdominal pain. The outcome of event crying was unknown and the patient was not still sleeping well. Documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 26 AUGUST 2013. A 49-year-old female patient had received intramuscular first dose of ADACEL (batch number: C4385AA and expiry date: 17 SEPTEMBER 2015) in the left deltoid on 14 AUGUST 2013. The patient had no illness at the time of vaccination and no known allergies. The patient was diabetic. Concomitant medications were not reported. On 17 AUGUST 2013, the patient developed pain on left arm radiating to shoulder, neck area and to bottom of the shoulder blades. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none. Follow up information received on 04 NOVEMBER 2013. Concomitant medications included Metformin hydrochloride 500 mg,   Glimepiride 1 mg; Simvastatin 20 mg and Lisinopril 5 mg. The outcome of the patient was reported as unknown.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction
Clinical narrative: Initial report received from a healthcare professional on 22 AUGUST 2013. An 11-year-old female patient whose medical history and concomitant medications were not reported, had received a dose of ADACEL (batch number, dose in series, route and site of administration was not reported) on an unspecified date. On an unspecified date, the patient developed unspecified local side effects that were worse than usual. Laboratory investigations and the corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.
Age: 1.5
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 1 JULY 2013. It was reported that ADACEL was given to an 18-month old patient as the 4th dose in the series. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Local reaction
Clinical narrative: Initial report received from a healthcare professional on 22 AUGUST 2013.  This case concerns one among the  two 11-year-old male patients, whose medical history and concomitant medications were not reported, had received a dose of ADACEL (batch number, dose in series, route and site of administration was not reported) on an unspecified date. On an unspecified date, the patient developed unspecified local side effects and was worse than usual. Laboratory investigations and the corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none
Age: 14.0
Sex: M
Vaccine: FLUX, MEN, TDAP
Symptoms: Allergy test, Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: This case is  linked to case number 2013-08940 (same patient different adverse events). Initial report received from non-health care professional (patient's parent) on 15 August 2013. A 14-year-old male patient had received intramuscular dose 1 of ADACEL (batch number C3976AA, expiry date : 30 March 2014) in the left deltoid, intramuscular dose 1 of meningococcal vaccine (manufacturer unknown, lot number: not reported) in the right deltoid and dose 1 of FLUMIST (other manufacturer product, lot number, route and anatomical site of administration were not reported) all on 14 November 2012. The patient had no illness at time of vaccination. the patient had possible allergy to gelatin. The patient's concomitant medications were not reported. At the age of 2 year, the patient had received tetanus vaccine and had developed swollen leg. On 15 November 2012, 1 day after vaccination, the patient developed swelling in the left arm site of 6x8 inches. The corrective treatments received on 23 October 2013. The patient had received meningococcal vaccine in right deltoid, ADACEL in left deltoid. The patient had thiomersal allergy in past. After 24 hours of vaccination, the patient experienced redness, swelling, fever and aches. The patient had done subsequent tests for gelatin. Documents held by sender: none  Follow up information received on 23 October 2013. Subsequent tests have done for gelatin.
Age: 14.0
Sex: M
Vaccine: FLUX, MEN, TDAP
Symptoms: Swelling
Clinical narrative: This case is  linked to case number 2013-08940 (same patient different adverse events). Initial report received from non-health care professional (patient's parent) on 15 August 2013. A 14-year-old male patient had received intramuscular dose 1 of ADACEL (batch number C3976AA, expiry date : 30 March 2014) in the left deltoid, intramuscular dose 1 of meningococcal vaccine (manufacturer unknown, lot number: not reported) in the right deltoid and dose 1 of FLUMIST (other manufacturer product, lot number, route and anatomical site of administration were not reported) all on 14 November 2012. The patient had no illness at time of vaccination. the patient had possible allergy to gelatin. The patient's concomitant medications were not reported. At the age of 2 year, the patient had received tetanus vaccine and had developed swollen leg. On 15 November 2012, 1 day after vaccination, the patient developed swelling in the left arm site of 6x8 inches. The corrective treatments received on 23 October 2013. The patient had received meningococcal vaccine in right deltoid, ADACEL in left deltoid. The patient had thiomersal allergy in past. After 24 hours of vaccination, the patient experienced redness, swelling, fever and aches. The patient had done subsequent tests for gelatin. Documents held by sender: none  Follow up information received on 23 October 2013. Subsequent tests have done for gelatin.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Vaccination site swelling
Clinical narrative: This case is part of 2 cluster cases and is linked to case number 2013-09274 (same reporter, events after receiving ADACEL (lot number: C4432AB) and MENATRCA (lot number: U4648AA). Initial report received from a healthcare professional on 16 AUGUST 2013. A patient whose gender, and age at the time of event was not reported, had received intramuscular first dose of ADACEL (batch number: C4432AB) in the left deltoid and intramuscular first dose of MENTACTRA (batch number: U4648AA, side: right, anatomical site of vaccination was not reported) on 13 AUGUST 2013. The patient had no known drug allergies or illness at the time of vaccination. The patient's concomitant medications were not reported. On 13 AUGUST 2013, the patient developed redness and swelling on left deltoid at vaccination site. The corrective treatments and laboratory investigations were not reported. On an unspecified date, the patient had recovered from the events. Documents held by sender: none. Follow up information received on 11 NOVEMBER 2013. A 11 year old female patient (birth date 28 FEBRUARY 2002), had received a intramuscular dose of ADACEL on left arm deltoid region and a intramuscular dose of MENACTRA on right arm. It was reported that on 13 AUGUST 2013 the patient experienced right and left upper arm pale pink, warm and slight tender. The patient had the vital signs included temperature 97.6 degree Fahrenheit and weight 104 lbs, physical examinations included right upper extremity; upper out arm pale pink, warm and slight tender and left upper extremity; upper out arm pale pink, warm and slight tender. The patient had the corrective treatments included Ibuprofen PRN for pain, cool compression PRN for pain, warm compress PRN for muscle spasm, monitored for increased redness, tenderness or streaking. After the discussion the event was not an allergic reaction, but the body's response to the vaccination, as it was starting to build immunity and the swelling which was already improved within 24 hours, it should resolve over the  next 7-10 days. The event cessation date was 15 AUGUST 2013.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 JULY 2013. A patient (no information was provided regarding the patient) had received a dose of ADACEL that was 2 days expired. No adverse event was reported. Documents held by sender: none
Age: 1.3
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 17 JULY 2013. ADACEL. ADACDEL was administered to a 15 month old patient. No adverse event was reported. Documents held by sender: None.
Age: 5.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 30 July 2013. A 5-year-old patient was administered ADACEL vaccine instead of DAPTACEL for the fifth dose in DTaP series. No adverse event was reported. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 29 JULY 2013. It was reported that, a 5-year-old male patient had received ADACEL instead of DAPTTACEL. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Initial information received from a healthcare professional on 06 AUGUST 2013. This is a invalid case as individual patient identifiers were missing. Cluster of  several patients whose age, gender, medical history and concomitant medications were not reported,  had received a dose of ADACEL (lot number, dose number, route and site of vaccination were not reported) on unspecified date. On an unspecified date, several patients developed swollen painful days after receiving ADACEL. Laboratory details and corrective treatments were not reported. At the time of this report, the outcome of events was not reported. Documents held by sender: none
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Initial report received from a consumer on 25 JULY 2013. A 40-year-old female patient had received a first intramuscular dose of ADACEL (batch number unknown) in the left deltoid on 18  JULY 2013. The patient had a medical history of allergy to codeine. Concomitant medications were not reported. The patient had no illness at the time of vaccination. On 18 JULY 2013, i.e. the same day after vaccination, the patient developed quarter sized painful and warm knot at the injection site without redness. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Follow-up information received from a healthcare professional on 09 SEPTEMBER 2013. The patient received ADACEL , batch number: "432TJ" (date of expiration 21 AUGUST 2015). The patient has no illness at the time of vaccination. The patient outcome was not recovered. Documents held by sender: none
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 29 JULY 2013. A 22-year old female patient had received an intramuscular dose 2 of ADACEL  (batch number: U4426AA) in left deltoid on 22 JULY 2013. The patient had no illness at the time of vaccination and had a history of PCN (penicillin) allergy. Concomitant medications were not reported. The patient had received first dose of ADACEL (lot number, route and site of vacinnation was not reported) on an unspecified date in 2009 previously. The patient's health during pregnancy and specific risk factors were not reported. Patient had not received any treatment for infertility. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 05 JANUARY 2013. The estimated date of delivery was 12 OCTOBER 2013. On 22 JULY 2013 after vaccination, the patient developed throbbing from the left shoulder to fingers and the conditioned worsened at night and the patient felt numbness in the left fingers. There was no redness or swelling at the injection site and no other symptoms were reported. Laboratory investigations and corrective treatment was not reported. At the time of this report, patient had not recovered from the events. Documents held by sender: none
Sex: U
Vaccine: TDAP
Symptoms: Adverse reaction, Syringe issue
Clinical narrative: Initial report received from a healthcare professional on 30 JULY 2013. This is an invalid case as individual patient identifiers and specific adverse reactions were not reported. Several patients whose age, gender, medical history and concomitant medications were not reported, had received a dose of ADACEL (batch number, route, dose and anatomical site of administration were not reported) on an unspecified date. As per reporter; "since they changed back to ADACEL syringes they had a lot of patients with reactions' (type of reaction was not specified). Corrective treatment and laboratory investigations were not reported. Outcome of the event was not reported. Documents held by sender: none
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 08 JULY 2013. It was reported that the vaccine administrator did not see the immunization chart and administered a dose of ADACEL vaccine to a female patient who had already received a dose in MAY 2008. No other information was provided regarding the patient. No adverse event was reported. Documents held by sender: none
Age: 2.0
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 08 JULY 2013. A 2-year-old patient was administered a dose of ADACEL. No adverse event was reported. Documents held by sender: none
Age: 41.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site pruritus, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 23 JULY 2013. A 41-year-old female patient, who had no significant medical history or illness at the time of vaccination had received a subcutaneous dose of MENACTRA (batch number: U4428AA) in the left arm, an intramuscular first dose of ADACEL (batch number U4667AA) in the left deltoid and an intradermal dose of TUBERSOL (batch number C4283AA) in the left forearm all on 12 JULY 2013. The patient's concomitant drugs were not reported. It was reported that the patient received a subcutaneous dose of MENACTRA instead of an intramuscular dose thus the patient received the vaccine by wrong route. On 14 JULY 2013, 2 days after vaccination, the patient developed 25 mm red, itchy and painful area at injection site and the left arm was sore. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient was 97% back to normal however had not recovered completely. Follow up information received from a healthcare professional on 12 SEPTEMBER 2013. It was reported that the patient had received several previous doses of TUBERSOL 5 TU on unspecified dates in past. The patient had received dose 1 of MENACTRA on 12 JULY 2013. No laboratory tests done. On contacting the patient on 25 JULY 2013, it was reported that there was no soreness or redness at the injection site. It was determined that any adverse reaction had resolved and no further evaluation was necessary. The patient had recovered from all the events on an unspecified date. Documents held by sender: none
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Initial report received from a healthcare professional on 03 JULY 2013. A 35-year-old male patient (born on 18 JUNE 1978, age not reported), had received an intramuscular dose of ADACEL (batch number: C4365AA, expiry date: 06/25/2015) in left deltoid on 21 JUNE 2013. The patient had no illness at time of vaccination and had no drug allergies. Concomitant medications were not reported. On an unspecified date 1 to 2 days after vaccination, the patient developed blisters and redness at injection site. Laboratory tests and corrective treatments were not reported.  At the time of this report, the outcome of events was unknown. Documents held by sender were none. Follow up information received from a healthcare professional on 19 AUGUST 2013. The patient outcome was recovered.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Initial report received from healthcare professional on 03 JULY 2013. A 50-year-old male patient (born on 17 DECEMBER 1962), had received an intramuscular dose of ADACEL (lot number: C4365AA, dose number not reported) in left deltoid on 28 JUNE 2013. The patient had no pre-existing physician diagnosed drug allergies, as per the reporter, the patient had no illness at time of vaccination. On an unspecified date after 1 to 2 days of vaccination, the patient had developed blisters and redness at injection site. Laboratory tests and corrective treatments were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender were none
Sex: U
Vaccine: DTAPIPVHIB, FLU3, HIBV, IPV, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 14 June 2013. This case is invalid as individual patient identifiers were not reported. In a VFC audit it was found that the storage temperature of vaccines as 1 degree Celsius and 2 other gauges had other readings starting from 24 December 2013 where IPOL, FLUZONE SV 2012-2013, ActHIB, MENACTRA, ADACEL and PENTACEL vaccines were stored. All products were unstable as of 24 December 2012. No adverse event was reported. Documents held by sender: none
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: Initial report received from a non-healthcare professional (patient's son) on 11 JULY 2013. A female patient whose age, medical history and concomitant medications were not reported, had received a dose of ADACEL (lot number, route and anatomical site of administration were not reported) on 06 JULY 2013, morning. On an unspecified date, after vaccination, the patient developed fever of 101.6 F, fatigue, redness and swelling from elbow to shoulder. Relevant laboratory tests were not reported. The patient took Benadryl every 6 hours as corrective treatment on unspecified dates. At the time of this report, the outcome of events was not reported. Documents held by sender: none
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Initial report received from a healthcare professional on 25 JUNE 2013. A 61-year-old male patient had received an intramuscular dose of ADACEL (batch number: C4365AA, dose number and site of administration not reported) left side (site was not specified) on 12 JUNE 2013. The patient had no illness at the time of vaccination. The patient had medical history of DM (diabetes mellitus), HTN (hypertension) and Hyperlipidemia. On 13 JUNE 2013, one day after vaccination, the patient experienced swollen, stiff and painful hands. Laboratory tests were not done and corrective treatments were not reported. The patient required ER/doctor visit as he felt that it was getting worse. As of 25 JUNE 2013, the patient had not recovered from the events. List of documents held by sender: none
Age: 16.0
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 JUNE 2013. A 16-year-old patient had received a dose of ADACEL on 24 APRIL 2012 and then again on 17 JUNE 2013 not realizing had received dose in 2012. No adverse event was reported. Documents held by sender: none
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 17 JUNE 2013. A patient received 0.1 ml of ADACEL intradermally instead of  TUBERSOL (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 1.4
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 27 JUNE 2013. It was reported that a 16-month-old patient was administered ADACEL instead of DAPTACEL. No adverse event was reported. Documents held by sender: none
Age: 10.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 28 MAY 2013. It was reported that ADACEL was given to a patient at an age of 10 years. No adverse event was reported. Documents held by sender: none
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 03-SEP-2013. The 9-year-old patient had received ADACEL behind on Dtap vaccination. No adverse event was reported. List of documents held by sender: none
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: A 26-year-old female patient had received second dose of ADACEL (lot number C4432AB, route of administration was not reported) in left deltoid on 12 JUNE 2013.  The patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On 13 JUNE 2013, one day after vaccination, the patient developed redness, warm to touch and raised area 4 cm at the vaccination site. The patient was advised warm compress. The patient received Benadryl and Advil as corrective treatments on unspecified dates. No laboratory investigations were done. At the time of this report, the patient had not recovered from the events. Follow-up information received from a healthcare professional on 18 JULY 2013. The patient received ADACEL intramuscularly. Documents held by sender: none
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Muscle tightness
Clinical narrative: Initial report received from a healthcare professional on 05-Nov-2013. A 42 year-old female received ADACEL (batch number: unknown, expiry date: unknown) intramuscularly in 2009. The patient's medical history and concomitant medications were not reported. In 2009, within 24 hours of vaccination the patient felt her jaw was tight and had joint pain throughout her body. At the time of this report the outcome of the events were resolved. Documents held by sender: none.
Age: 87.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This case is linked with AER# 2013-06986 (same reporter). Initial report received from a healthcare professional on 14 June 2013. An 87-year-old female patient had received second dose of ADACEL, (lot number-C4313AA, expiry date-03/22/2015, route of administration was not reported) in left deltoid on 06 June 2013. The patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On 12 June 2013, the patient presented redness, raised and warm to toch. The patient used warm compress as corrective treatment and had not used antibiotics. The patient was advised to take BENADRYL and ADVIL (details not reported). No laboratory investigations were performed. At the time of this report, the patient was not recovered from the events. Follow up information received from a healthcare professional on 18 July 2013. The patient had received vaccine intramuscularly. Documents held by sender: none.
Age: 0.4
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 23 May 2013. A 05-month-old patient was inadvertently administered ADACEL instead of DTaP as second dose in Dtap vaccine series. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 03 May 2013. It was reported that ADACEL was exposed to temperature excursion (20 degree Fahrenheit) for 4-5 days. No information was provided regarding the patients. No adverse event was reported. Documents held by sender: none.
Age: 1.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional 27 June 2013. A 13-month-old patient had received a dose of ADACEL vaccine instead of DTaP vaccine. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 29 May 2013. An expired dose of ADACEL was given to a patient (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case is linked to case number 2013-07378 (same reporter, same vaccine). Initial misuse report received from a healthcare professional on 22 May 2013. A child had received ADACEL vaccine on 29 April 2013 that had expired on 28 January 2013. No adverse event was reported. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 05 September 2013. A 77-years-old female patient received ADACEL. This vaccine is only approved up to age 64 years patient. No other information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 15.0
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 June 2013. A 15-year-old patient had received a dose of ADACEL in September 2010 and then received again last week. No adverse event was reported. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Initial report received from a health care professional on 15 October 2013. A 49-year-old female patient, with the history of diabetes mellitus, hypertension, had received a dose of ADACEL vaccine (lot number: U4688B) in left deltoid region on 11 October 2013. It was reported that, on the same day after vaccination the patient experienced swollen lymph nodes, supraclavicular and axillary lymph nodes and pain. Corrective treatment was not reported. At the time of this report, the event was ongoing at the time of report. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Vaccination site warmth
Clinical narrative: This is a case is a part of 2 cluster cases and is linked to case 2013-07001 (reported by same reporter, events after ADACEL batch number- C4344AB). Initial report received from a healthcare professional on 18 June 2013. This case is invalid as individual patient identifiers were missing. A cluster of three patients of unspecified demographics had received an intramuscular dose of ADACEL (batch number- C4344AB, expiry date-06/04/2015, anatomical site of vaccination was not reported) on an unspecified date. Patients had no illness at the time of vaccination. Medical history and concomitant medications were not reported. On unspecified date after vaccination, 3 patients presented redness, warm to touch and lump at the vaccination site. No laboratory investigations were done. As corrective treatment, the patients received BENADRYL, TYLENOL and Ice packs on unspecified dates. On unspecified date, the patients had recovered from events. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 22 May 2013. A 0.5 ml dose of ADACEL was administered to a patient intradermally (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pruritus, Pain in extremity, Peripheral swelling
Clinical narrative: Initial report received from a consumer (The patient) on 13 June 2013. A 45-year-old female patient had received an intramuscular first dose of ADACEL vaccine (batch number- unknown) in left deltoid on an unspecified date in 2010. The patient's medical history and concomitant medications were not reported. Three day after vaccination, It was reported that the patient's left arm was swollen with swollen with redness, pain and itchy at injection site. Laboratory investigations and corrective treatment was not reported. At the time of this report, outcome was recovered on an unspecified date. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Initial case was received from a health care professional on 09 October 2013. An patient (Age and gender unknown) had medical history of allergies to latex reported, received a dose reported and Batch number 25355 which is not a Sanofi batch number). Patient had not reported concomitant medication. It was reported that on an unspecified date patient had swelling of hands and feet and hives. No corrective treatment was reported. At the time of report the outcome of event was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K000456 and expiry date: 15-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report receive from a healthcare professional on 17 May 2013. It was reported that 2 doses of ADACEL were administered to a patient a day apart (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Ths spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 21-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J006831 and expiry date: 14-SEP-2014) which was improperly strored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information has been received concerning a female patient of unknown age. Patient's concurrent conditions, medical history and allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). Concomitant medications were not provided. On an unknown date the patient sustained a reaction to her left arm after receiving the vaccine. The outcome of the event was not reported. The causality was not provided. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 28 May 2013. A 01-month-old patient had inadvertently received ADACEL that was supposed to be administered to another patient. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 14-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J008433 and expiry date: 11-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 01 MAY 2013. It was reported that the patient who had received first dose of ADACEL on 15 DECEMBER 2006, received second dose on 01 MAY 2013. No adverse event was reported. Documents held by sender: none
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 18-JUL-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J000141 and expiry date: 04-JUL-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20 May 2013. A patient received a dose of ADACEL and Td vaccine (unknown manufacturer) in the same visit in April (year not specified). No information was provided regarding the patient. No adverse event was reported. Documents held by sender: None.