chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema
Clinical narrative: Initial report received from a consumer on 11 November 2013. A 59 year old male patient, history and concomitant medications were reported as none, had received a intradermal dose of FLUZONE ID vaccine (dose and lot number were not reported) in left arm on 27 September 2013. It was reported that, a few days after patient noticed that he had a pea size area of redness on the left deltoid area. It has been approximately 45 days and the redness remains. No other symptoms were reported. Lab data reported as none. Corrective treatment was not reported. At the time of this report, the patient was recovered from the post vaccination reaction. Documents held by sender: none. Follow up information received from a consumer on 23 December 2013. The patient had received FLUZONE ID vaccine (lot number: UT4720AA, expiry date: 3 April 2014) on 27 September 2013. It was reported that the patient had mosquito bite like red bump at the injection site commonly seen for about a week or so after vaccination. The patient had not received any corrective treatment. At the time of this report, the patient had not recovered from events.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a consumer on 11 November 2013. A 59 year old male patient, history and concomitant medications were reported as none, had received a intradermal dose of FLUZONE ID vaccine (dose and lot number were not reported) in left arm on 27 September 2013. It was reported that, a few days after patient noticed that he had a pea size area of redness on the left deltoid area. It has been approximately 45 days and the redness remains. No other symptoms were reported. Lab data reported as none. Corrective treatment was not reported. At the time of this report, the patient was recovered from the post vaccination reaction. Documents held by sender: none. Follow up information received from a consumer on 23 December 2013. The patient had received FLUZONE ID vaccine (lot number: UT4720AA, expiry date: 3 April 2014) on 27 September 2013. It was reported that the patient had mosquito bite like red bump at the injection site commonly seen for about a week or so after vaccination. The patient had not received any corrective treatment. At the time of this report, the patient had not recovered from events.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site induration, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Initial report received from healthcare professional on 24 October 2013. A 51-year-old female patient whose medical history and concomitant medications were not reported, received FLUZONE ID (lot number UT4719BA and expiration date 02-APR-2014) intradermal in left deltoid (does number not reported) on 19 October 2013. On 22 October 2013, patient had arm pain, pain and swelling after injections,. When she abducts the arm the area around the injection site pulls. Swelling and pain has bone down but still pulls with movement. Patient had mild swelling of left deltoid and slight indurated area. Laboratory investigation and corrective treatment were not reported. As of this report, the patient had not recovered from the events. Documents held by sender: none
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Initial report received from healthcare professional on 24 October 2013. A 51-year-old female patient whose medical history and concomitant medications were not reported, received FLUZONE ID (lot number UT4719BA and expiration date 02-APR-2014) intradermal in left deltoid (does number not reported) on 19 October 2013. On 22 October 2013, patient had arm pain, pain and swelling after injections,. When she abducts the arm the area around the injection site pulls. Swelling and pain has bone down but still pulls with movement. Patient had mild swelling of left deltoid and slight indurated area. Laboratory investigation and corrective treatment were not reported. As of this report, the patient had not recovered from the events. Documents held by sender: none
Age: 17.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 05 November 2013. A 17-year-old patient received FLUZONE ID. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 16.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 08 November 2013. On unspecified date a 16-months-old patient had received a dose of FLUZONE ID. Intradermal vaccines have not been administered in persons less than 18 or 65 and over years of age. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Age: 74.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 01 November 2013. The 74-year-old patient had received FLUZONE ID (route, site not provided). Reporter stated that FLUZONE ID administered to 74 year old patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial case received from a health care professional on 15 November 2013. A 52 years old patient had medical history of reflux disease and had allergies to penicillin, sulfa drugs, peanuts, walnuts, pine nuts, shellfish, received a dose of FLUZONE ID intradermally in right deltoid on 11 November 2013 (Batch number UT4719BA). Patient had not reported concomitant medication. It was reported that on 11 November 2013 patient had experienced pain, redness and swelling at injected site. No corrective treatment was reported. At the time of report the outcome of event was not recovered.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Initial information received from a consumer on 15 November 2013. A 53-year-old female patient with no medical history had received a dose of FLUZONE ID (batch number and site of administration not reported) on 12 September 2013. On 13 September 2013, patient had developed injection site reaction of swelling and a small area of induration. It was reported, that small area of induration persists 2 months later. No lab investigations were performed. At the time of this report, the outcome was unknown. List of documents held by sender: none. Follow up information received from non-healthcare professional on 05 August 2014. The patient had no illness at time of vaccination. Reporter's details were updated.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia, Injection site reaction, Skin tightness
Clinical narrative: Initial report received from healthcare professional on 12 November 2013. A 53-years-old male patient had received first dose of FLUZONE ID (lot number UT4721BA, intradermal in the left deltoid) on 04 October 2013. The patient had no illness at the time of vaccination and does not have any pre-existing allergies, birth defects. On 04 October 2013, after vaccination the patient had experienced numbness at the injection site and pulling of skin. The corrective treatment and laboratory details were not reported. At the time of this report the patient was not recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial information reported on 06-Nov-2013: This case involves female patient who experienced silver dollar size redness and swelling at the injection site. On unknown date patient received FLUZONE ID (Lot UT4726AA). Patient developed silver dollar size redness and swelling at the injection site. One patient experienced pain for 4 days at the injection site. No further relevant information reported. Follow up information received on 25 February 2014. The expiry date 24 April 2014 of the product was updated previously it was missed.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: Initial information regarding unsolicited case received from nurse on 07-Nov-2013: This case involves four patients (demographic detail unknown). The patient's past medical history and concomitant medications were unknown. On an unknown date in November 2013, the patients received FLUZONE ID (Lot# UT4725AA and expiration date unknown) through intradermal route. The patient reported inflamed reddened area at the injection site, and fever. The outcomes of the events were recovered. No further relevant information provided. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Paraesthesia
Clinical narrative: Initial information regarding unsolicited case received from pharmacist on 06-Nov-2013: The case involves female patient. The patient's past medical history and concomitant medications were unknown. On 06-Nov-2013, the patient received FLUZONE ID (Lot# and expiration date unknown). The patient received FLUZONE ID and within the 15 minutes after vaccination patient experienced pain, redness, swelling at injection site and later in evening began feeling arm tingling and malaise. The outcomes of the events were unknown. No further relevant information provided. List of documents held by sender: none.
Age: 1.5
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial misuse report received on 11 October 2013 from a medical assistant. A 18 months old unknown patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient received the (FLUZONE) ID. As of unknown date, patient used FLUZONE ID vaccine had been administered to an individual whose age falls outside the products indication. Consider reimmunizing the person with an influenza vaccine appropriate for the person age. List of documents held by sender: none.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initial information regarding unsolicited case received from nurse on 08-Nov-2013: This case involves 49-year-old male patient. The patient's past medical history and concomitant medications were unknown. On 01-Nov-2013, the patient received FLUZONE ID (Lot# UT4719AA and expiration date unknown) intradermal left deltoid. Within 24 hours began experiencing stiff, sore arm and swollen side of neck. Stiff sore arm resolved but patient continues to have swollen neck. No further relevant information provided. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initial report received from a reporter on 08-November-2013. A 44-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Lot number UT4719AA) via intradermal route at left deltoid, on 18-September-2013. On 19-September-2013, within 24 hours after receiving vaccine the patient experienced stiff, sore arm and swollen side of neck. Corrective treatment was not reported. At the time of report events stiff sore arm were resolved and event swollen neck was ongoing. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Initial report received from a patient on 08-November-2013. A 55-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Lot number unknown) via intradermal route at right arm between elbow and shoulder on 06-November-2013. On 07-November-2013, the patient experienced a red mark at the injection site about the size of 3 1/2 dollars between the elbow and the top of the arm not the deltoid where the muscle is. She also has pain under the right arm. Corrective treatment was not reported. At the time of this report the outcome of events was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Initial report received from health care professional on 08 November 2013. Over 30 out of 50 patients whose age, gender, medical history and concomitant medications were not reported, got FLUZONE ID (Lot # UT4719AA) intradermally are complaining of redness at the site and knots at the injection sites 1 week later. Corrective treatment was not reported. At the time of this report the outcome of adverse event was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Induration, Injection site induration, Pain, Paraesthesia, Skin warm
Clinical narrative: Initial report received from a healthcare professional on 18 September 2013. On 9-Sep-2013 unknown age and gender patient received dose of FLUZONE ID (Lot: UT4725AA) intradermal. Patient had painful experience since 09-Sep-2013. Patient experienced hot and hard with pain and that spread to patient's armpit until yesterday (16-Sep-2013). On 17-Sep-2013, injection site was hard. Patient reported that this intradermal injection felt like a whole bunch of needles pricking me at one time instead of one needle and caused a welt that spread. Events were resolved at the time of report. Documents held by sender: none. Follow-up information received from a health care professional on 15-September-2014: The patient received FLUZONE ID in the left deltoid, at the clinic. The patient did not visit the clinic for assessment. No medical history and concomitant medications were mentioned on the records.
Sex: U
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Initial report received from a healthcare professional on 18 September 2013. On 9-Sep-2013 unknown age and gender patient received dose of FLUZONE ID (Lot: UT4725AA) intradermal. Patient had painful experience since 09-Sep-2013. Patient experienced hot and hard with pain and that spread to patient's armpit until yesterday (16-Sep-2013). On 17-Sep-2013, injection site was hard. Patient reported that this intradermal injection felt like a whole bunch of needles pricking me at one time instead of one needle and caused a welt that spread. Events were resolved at the time of report. Documents held by sender: none. Follow-up information received from a health care professional on 15-September-2014: The patient received FLUZONE ID in the left deltoid, at the clinic. The patient did not visit the clinic for assessment. No medical history and concomitant medications were mentioned on the records.
Age: 76.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial medication error report received on 04 October 2013 from a nurse. A 76 years old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (route was intradermal), lot number and site of vaccination was not reported on an unspecified date. The dose was given intradermal to a patient 2 weeks ago and they are just realizing it now. The safety and immunogenicity of FLUZONE ID vaccine have not been established in persons <18 or 65 and over years of age. List of documents held by sender: none.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received on 07 October 2013 from a health care professional. A 66 year old patient, whose medical history and concomitant medications were not reported, received a intradermal dose of FLUZONE ID (lot number and expiry date was not reported). It was reported that the patient whose age was 66 years, which falls outside the products indication was given the vaccine. No reaction was reported. List of documents held by sender: none.
Age: 12.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial misuse report received on 14 October 2013 from a health care professional. A 12 years old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that FLUZONE ID was given to the patient of 12 years. List of documents held by sender: none.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 02-October-2013. The 70-year-old patient had received FLUZONE ID. No adverse event was reported. List of documents held by sender: none.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 10-Oct-2013. A 66-years-old patient administered with FLUZONE ID. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 8.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse practitioner (NP) on 02-Oct-2013: The 06-years-old patient had received FLUZONE ID (dose unknown). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received on 07 October 2013 from a health care professional. A patient, whose medical history and concomitant medications were not reported, received a intradermal dose of FLUZONE ID (lot number and expiry date was not reported). It was reported that the patient whose age falls outside the products indication was given this vaccine. No reaction was reported. List of documents held by sender: none.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial medication error report received on 04 October 2013 from a nurse. A 65 years old unknown patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (route, lot number and site of vaccination was not reported) on an unspecified date. We administered to a 65 year old patient. List of documents held by sender: none.
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 02-Oct-2013: The 67-years-old patient had received FLUZONE ID (dose unknown). No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial medication error report received on 04 October 2013 from a nurse. A 11 years old unknown patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (route, lot number and site of vaccination was not reported) on an unspecified date. Drug was given to an 11 year old. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 14 October 2013. The over 65 year old patient had received FLUZONE ID. The safety and immunogenicity of FLUZONE ID have not been established in persons <18 or 65 and over years of age. If FLUZONE ID vaccine has been administered to an individual whose age falls outside the products indication, consider reimmunizing the persons with and influenza vaccine appropriate for the person's age or underlying condition. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 82.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received on 09-Oct-2013 from a health care professional. An 82-year-old patient (whose gender unknown), medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that an 82-year-old patient have received the FLUZONE ID. As of 09-Oct-2013, patient did not have any adverse events. List of documents held by sender: none.
Age: 18.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse practitioner (NP) on 02-Oct-2013: The under 18-years-old patient had received FLUZONE ID (dose unknown). No adverse event was reported. List of documents held by sender: none.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 01 October 2013. The patient over 65-years-old received FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 01 October 2013. The patient over 64-years-old received FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 16.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 03-October-2013. The 16-year-old patient had received FLUZONE ID. No adverse event was reported. List of documents held by sender: none.
Age: 12.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial medication error report received on 10-OCT-2013 from a nurse. A 12 year old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number, route and site of vaccination was not reported) on an unspecified date. Nurse stated reported that FLUZONE was administered to 12 years old patient. List of documents held by sender: none.
Age: 12.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 14-October-2013. The 12-year-old patient had received FLUZONE ID. No adverse event was reported. List of documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Initial report received from a healthcare professional on 04-November 2013. A 12 week pregnant female patient whose age, medical history was not reported, received a dose of FLUZONE ID (lot number: UT4726AA, expiry date and site of administration was unknown) via intradermal route on 04 November 2013. List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Cold sweat, Nausea, Rash erythematous, Rash pruritic
Clinical narrative: Initial report received from a healthcare professional on 05 November 2013. A 27 year old female received a dose of FLUZONE ID at left deltoid intradermal on 31-Oct-2013. After four days (04 November 2013), patient experienced symptoms of low grade temp, nausea, cold sweats, and a red, raised rash has developed on her arms, axillary area, inside of the thighs, and at the knees. Patient mentioned that rash was itchy. Event was not resolved at the time of report. List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Neck pain, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 05-Nov-2013. A 62 year old female received FLUZONE ID (batch number: UT4722BA, expiry date: unknown) intradermal in left deltoid on 09 October 2013. The patient's medical history and concomitant medications were not reported. Within a few days of vaccination the patient experienced redness around injection site, pain up near the neck and radiating down into the arm a few days after vaccine and the arm has been aching ever since and a nodule at the injection site. At the time of this report the outcome of the events were not resolved. Documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Initial report received from a healthcare professional on 09 January 2014. A 25-year-old female patient had received first dose of FLUZONE ID, (batch number UT4721BA) intradermally in left arm on 08 January 2014. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions includes epilepsy, seizure free 21 years. On 09 January 2014, one day after vaccination, the patient reported of pins and needles feeling going down her left arm and her arm was red and swollen at the injection site, about the size of a small pancake. Pharmacist advised her to take a BENADRYL and if no improvement to go to urgent care. Laboratory tests were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site scar, Injection site warmth
Clinical narrative: Initial report received from a health care professional on 27 December 2013. A 65-year-old female patient whose medical history, concomitant medications and allergies and illness at the time of vaccination were unknown, had received FLUZONE ID intradermal in right forearm (batch number, dose, dose number were unknown) on 23 September 2013. On unspecified date, during a visit for another reason i.e. on 18 December 2013, 2 weeks after the ID vaccine patient developed redness, warmth, itchy feeling and pain at injection site. Patient has a "scar" at the injection site. Corrective treatment and laboratory investigations were not reported. The outcome of the event was unknown. Documents held by sender: none. Follow-up information received from the healthcare professional on 07-Feb-2014. The patient had hypertension and diabetes mellitus. The patient does not have any acute illness at the time of vaccination and had not received any other vaccine. The patient does not have any laboratory details. The patient had not gone to emergency room. At the time of this report the patient was recovered but still sores is seen.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Initial report received from healthcare professional on 12 December 2013. A 59-year-old female patient, whose medical history and concomitant medications were not reported, received FLUZONE ID (lot number, expiration date and route were unknown) in right deltoid on 22 September 2013. On 22 September 2013, patient experienced severe pain when she received the vaccine. Sore for a couple of day, arm sore. Now almost 2 months, still feels throbbing in her arm intermittently. No pain now but achy throbbing feeling at the insertion site and travels down her arm. Laboratory investigation and corrective treatment were not reported. As of this report, the patient was not recovered from the events. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Infection, Injection site erythema, Injection site swelling
Clinical narrative: Initial report received on 11 December 2013 from consumer. A 56 year old female patient whose medical history and concomitant medications included as antibiotics, received a dose of FLUZONE ID (route was intradermal, lot # UT4721AA, expiration date unknown and site was left deltoid) on 16 September 2013. Reporter stated that on 16 September 2013 patient developed bump at injection site immediately after vaccine, and site redness. Also stated that bump at site has persisted since vaccination, now bump is red for the last 10 days, patient started abx for infection and on 16 September 2013 bump has turned red. Event was not recovered at the time of report. List of documents held by sender: none. Additional information received on 20 December 2013 from consumer: Concomitant medication added as antibiotics.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Initial report received from a healthcare professional on 05 December 2013. This is a summary case of 30-35 patients of unspecified demographics. Some 30-35 patients had received an intradermal dose of FLUZONE ID vaccine, batch number: UT4277AA (dose number and anatomical site of vaccination was not reported) on an unspecified date in October 2013. On an unspecified date in October 2013 after vaccination, the patients developed welts at injection site. The welts at the vaccination site had resolved in 2-3 days without any medical intervention. Laboratory investigations were not reported. Documents held by sender: none. Follow-up information received from a healthcare professional on 21 January 2014. The patient had received previously 10 doses of FLUZONE ID (Lot number, route and site of vaccination unknown) on an unspecified date.
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Initial report received from a non-healthcare professional on 27-Nov-2013. A 48-year-old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number: UT4719BA) on right deltoid via intradermal route on 10-Oct-2013. On 12-Oct-2013 patient developed redness with nodule at injection site and lasted 3 days. On 15-Oct-2013 the red area turned white. As of 27-Nov-2013 the nodule persists and was painful per patient. Patient stated to reporter she did bump the area and caused bruising at the site as well and no surrounding redness. Patient did not treated herself symptomatically. The events were not resolved. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial information was received from healthcare professional on 20 November 2013. This case concerns 50-100 patients (age and gender not reported) whose medical history and concomitant medication was not reported had received FLUZONE ID (batch number: UT4722AA and UT4721AA) on deltoid on 07 October 2013. The patients experienced more complaints of soreness overall. The patient was more pronounced scaling at 1-10, average complaint of 4/7. One patient had redness, warmth and discomfort with touch, swollen to 1/2 inch. This patient was injected near her old smallpox scar that she received as a child. Another person was treated for anaphylaxis. Pain was from arm to wrist, headache, breathing difficulty. The patient went to emergency room for steroids and was released; was doing well. No laboratory details were reported. The corrective treatment was not reported. The list of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial case was received from a health care professional on 22 November 2013. A 6 patients both male and female (age unknown) had no medical history reported, received a dose FLUZONE ID 20 November 2013 (batch number U4728AB). Patient had not reported concomitant medication. It was reported that on 21 November 2013 patients reported that they had redness, swelling, itchiness at injection site. Patient had received ibuprofen and BENADRYL as a corrective treatment (route, site and dose not reported). At the time of report the outcome of event was unknown.
Sex: U
Vaccine: FLU3
Symptoms: Injection site swelling, Rash generalised
Clinical narrative: Initial report received from a reporter on 19-November-2013. An eight patients, whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID via intradermal route (lot number and site of vaccination not reported) on 2013. On 2013, patients experienced swelling at the injection site, the size of a softball and widespread rash over their body. Corrective treatment was not reported. At the time of this report the outcome of events was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Initial report received from a health care professional on 19-November-2013. Five adult patients, whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID via intradermal route (lot number and site of vaccination not reported). They experienced 10 cm x 5 cm bruising at injection site, painful. Corrective treatment was not reported. At the time of this report the outcome of events was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Erythema, Skin warm, Swelling
Clinical narrative: Initial report received from a nurse on 20 November 2013. A adult female patient whose medical history and concomitant medications were not reported, received FLUZONE ID (Lot # UT4722AA and expiration date 10-Apr-2014; Lot # UT4721AA and expiration date 08-Apr-2014) at deltoid. The patient had experienced redness, warmth, and discomfort with touch, swollen to 1/2 inch. This patient was injected near her old smallpox scar that she received as a child. The patient was recovered at the time of this report. List of documents held by sender: none.
Age: 12.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 11 November 2013. A 12-year-old had received a dose of FLUZONE ID. No adverse event was reported. List of documents held by sender: none.
Age: 10.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 11 November 2013. A 10-year-old had received a dose of FLUZONE ID. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 14 November 2013. On unspecified date FLUZONE ID was administered to an 11 year old patient. Wrong vaccine was administered. No adverse event was reported. List of documents held by sender: none.
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Unevaluable event
Clinical narrative: Initial misuse report received from a nurse on 06 November 2013. The 64-years-old patient had received FLUZONE ID (dose, site not reported). (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a 79 year old male patient reporting on himself. In November 2014 the patient was vaccinated with a dose of ZOSTAVAX, in the arm, (lot # K010732 and expiration date 31-OCT-2015), (dose and route not reported). During December 2014 the patient developed herpes zoster. The patient sought medical attention and he stated he was preparing to receive treatment. At the time of the report the outcome of herpes zoster was reported as not recovered. The reporter considered herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 79 year old male patient reporting on himself. In November 2014 the patient was vaccinated with a dose of ZOSTAVAX, in the arm, (lot # K010732 and expiration date 31-OCT-2015), (dose and route not reported). During December 2014 the patient developed herpes zoster. The patient sought medical attention and he stated he was preparing to receive treatment. At the time of the report the outcome of herpes zoster was reported as not recovered. The reporter considered herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 8-year-old male patient who received KNIRIX (batch number 23MJ7, expiry date 22nd October 2015. On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: Inadvertently gave KINRIX instead of BOOSTRIX for a 8 years old first dose of DTP.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 4-year-old female patient who received INFANRIX (batch number AC14B157CA, expiry date 13th September 2014. On 11 November 2014, the patient received INFANTIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: Patient received expired dose vaccine.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case reported by a other health professional and described the occurrence of wrong vaccine administered in a 13-year-old male patient who received HAVRIX 1440 (batch number Y4R59, expiry date 7th March 2016). On an unknown date, the patient received HVRIX 1440. On an unknown date, an unknown time after receiving HAVRIX 1440, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: 13 years old patient inadvertently administered HAVRIX 1440.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a 37-year-old female patient who received ENGERIX B adult (batch number AHBVC095CA, expiry date 17th May 2014). On 13th November 2014, the patient received the 1st dose of ENGERIX B adult (unknown). On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received on 14 November 2014: The expired dose was inadvertently administered. No adverse event was reported.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse refers to a 13 year old patient of unknown gender. On 14-NOV-2014 the 13 years old patient (inappropriate age) was vaccinated with PROQQUAD, lot# and expiry date unknown, standard dose, subcutaneous; which was coded as "Inappropriate schedule of vaccine administered". No adverse effects were reported. Additional information has been requested.
Age: 37.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 37 year old patient. Medical history and concurrent conditions were not reported, who on 21-DEC-2013 was vaccinated with a 0.5 ml dose of GARDASIL intramuscular, lot # H015863 and expiration date:24-FEB-2015. No concomitant medication was reported. No adverse effects were noted. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site redness - anterior part of right forearm 80% above the elbow. Injection site minimal swelling and itching.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth, Paraesthesia
Clinical narrative: This spontaneous report as received from a 62 year old female nurse via company representative refers to herself. The reporter stated that she was sensitive to any unspecified injections. On 24-OCT-2014 the patient was vaccinated with ZOSTAVAX (subcutaneous, dose/frequency was reported as normal dose/one time injection in left deltoid area) for prevention of shingles. Concomitant therapies included unspecified blood pressure medication and CLARITIN (dose and frequency unknown). On 24-OCT-2014, the patient experienced tingling on the day of injection in her left arm and fingers in her left hand. After approximately 10-12 hours later the patient experienced tingling on the left side of her face. Finally the patient also experienced hot and itchy sensation at the injection site in her left deltoid area for about 3-4 weeks. BENADRYL 50 mg was given as the treatment for the events. The outcome of the events was unknown. The causal relationship between the events and ZOSTAVAX was not reported. No further adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 17-DEC-2014, the patient was vaccinated with a dose of RECOMBIVAX HB (lot # reported as L5MN2 exp date 02-SEP-2016) instead of GARDASIL in error. The patient received the first dose of GARDASIL on 04-NOV-2014 and did not receive her second dose of GARDASIL at this time due to the error. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-DEC-2014, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (lot # reported as L5MN2 exp date 02-SEP-2016) instead of GARDASIL in error (wrong drug administered). The patient received the first dose of GARDASIL on 30-OCT-2014 and did not receive her second dose of GARDASIL at this time due to the error. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was administered with an improperly stored dose of GARDASIL, 0.5 ml, intramuscular (strength, dose number, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse events were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with an improperly storage doses of GARDASIL. (Dose, route, lot # and expiration date not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not expected. On an unknown date the patient was administered with an improperly stored dose of GARDASIL, 0.5 ml, intramuscular (strength, dose number, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse events were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot#, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot#, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Drug administered to patient of inappropriate age, Hepatitis B antibody negative
Clinical narrative: This spontaneous report has been received from a physician and refers to a 19 year old female patient with asthma and without drug reactions or allergies. The patient's medical history included attention deficit/hyperactivity disorder. The patient received three unspecified Hepatitis B vaccines (manufacturer unknown) when she was "younger" and on 21-APR-2014 the patient had titers drawn for the hepatitis B and the results showed that the patient was not immune (related case # 1501USA006194). So the patient was administered RECOMBIVAX HB on the following dates: 0.5ml (physician confirmed that the patient was administered 0.5ml) of RECOMBIVAX HB (lot# J007946 and expiration date 24-MAR-2016) intramuscular on 22-APR-2014, an unspecified dose of RECOMBIVAX HB (lot# J007946 and expiration date 24-MAR-2016) intramuscular on 26-JUN-2014 (the second vaccine should be given on 22-MAY-2014) and the "pediatric version" (unspecified dose) of RECOMBIVAX HB (lot# K008334 and expiration date 09-JUN-2016) intramuscular on 29-DEC-2014 (the third vaccine should be given on 22-OCT-2014 and should be given as adult formulation, other than "pediatric version"). Concomitant therapies included methylphenidate. Additional information is not expected as the physician is not allowed to be contacted.