chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: Patient received 0.1cc Td injection intradermally instead of a PPD test on 4/12/07.  On 4/13/07 the patient contacted Dr's office with a complaint of a local adverse reaction of erythema, induration and pain at the injection site.  On 5/24/07, the doctor's office confirmed that the patient recovered.
Age: 66.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Myalgia, Tenderness
Clinical narrative: Patient experienced injection site pain with arthralgia and myalgia after receiving a Td injection due to a cut.  At 48 hours after injection, the pain persisted with tenderness at the shoulder.  Patient could not abduct his arm due to pain.  On 04/30/07 patient was feeling better.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Injection site nodule, Skin warm
Clinical narrative: Patient received Td vaccine on 04/27/07; on 04/28/07 called the doctor's office and complained of swollen nodule at the injection site which progressed to become red and warm to the touch. Patient was recommended to take Benadryl. Patient called doctor's office on 05/01/07 to say that the redness went away and that there was just a slight nodule. Patient was told to call back in one week if the nodule does not completely dissipate.
Age: 37.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Erythema, Incorrect dose administered, Infection, Swelling
Clinical narrative: Large area of swelling/redness.  Diagnosed as infection and treated with antibiotics.  Patient inadvertently given a higher dose (1.0mL instead of 0.5mL).
Age: 25.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Erythema, Swelling
Clinical narrative: Mild/moderate reaction -- swelling and redness -- within normal limits.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Erythema, Swelling
Clinical narrative: Moderate swelling and redness -- within normal limits
Age: 38.0
Sex: F
Vaccine: HEP, TD
Symptoms: Erythema, Swelling
Clinical narrative: Moderate swelling and redness -- within normal limits
Age: 53.0
Sex: M
Vaccine: FLU3, JEV, RAB
Symptoms: Toothache
Clinical narrative: Right and front tooth pain and sensitivity to hot and cold.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Nausea, Pain in extremity
Clinical narrative: Patient experienced nausea and weakness within hours after receiving Td vaccine. Patient completely recovered within 48 hours. Patient received Td as booster shot and recalled experiencing pain in the arm after previous Td administration, over 10 years ago.
Age: 38.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Erythema, Swelling
Clinical narrative: Mild swelling and redness -- within normal limits
Age: 40.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Erythema, Swelling
Clinical narrative: Mild swelling and redness - within normal limits.
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Erythema
Clinical narrative: Mild redness; within normal limits.  No swelling.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Drug administered at inappropriate site, Incorrect dose administered, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Incorrect administration and dose of Td vaccine; 0.1mL given intradermally instead of PPD for Tb testing.  Patient experienced a reaction of swelling, redness and itchiness at the injection site.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Drug administered at inappropriate site, Incorrect dose administered, Wrong drug administered
Clinical narrative: Incorrect administration and dose of Td vaccine; 0.1 mL given intradermally instead of PPD for Tb testing. Patient experienced a reaction of swelling, redness and itchiness at the injection site.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Incorrect administration and dose of Td vaccine; 0.1mL given intradermally instead of PPD for Tb testing.  Patient experienced a reaction of swelling, redness and itchiness at the injection site.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Wrong drug administered
Clinical narrative: Td was mistakenly administered as a PPD test.  Patient experienced redness and induration at the injection site.
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Dyskinesia, Erythema, Headache, Pyrexia, Swelling face
Clinical narrative: Sore head, redness and puffiness in face, difficulty opening mouth, fever.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Malaise, Pain in extremity
Clinical narrative: Patient received Td vaccine on 7/2/07 for wound management.  On 7/4/07, patient experienced malaise, severe pain in arm that received vaccine that resulted in an inability to move her arm for more than 24 hours.
Age: 43.0
Sex: F
Vaccine: HEP, TD
Symptoms: Dizziness, Pyrexia
Clinical narrative: Patient received Td and Hepatitis B vaccines, as well as the PPD test, on 07/16/07 and on 07/17/07 experienced fever of 102.2 and dizziness.  Patient noted that she always gets dizzy when she gets a fever.  On 07/18/07 patient went to the doctor's office for a follow up visit, felt much better and fever was gone.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Patient was administered Td vaccine on 07/12/07.  On 07/14/07 patient experienced arm swelling, pain, redness.  Patient used cold compresses and Tylenol to relieve the pain.  Reaction took 5-6 days to resolve.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Cold compress therapy, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Patient was administered Td vaccine on 07/12/07. On 07/14/07 patient experienced arm swelling, pain, redness at the injection site. Patient used cold compresses and Tylenol to relieve the pain. Reaction took 10 days to resolve.
Age: 43.0
Sex: F
Vaccine: BCG, MMR, TD
Symptoms: Asthenia, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient received Td vaccine on 7/30/07, along with MMR and PPD.  Later on 7/30/07, patient experienced a fever and at the injection site experienced warmth, swelling, tenderness and weakness.  The patient returned to the health care center on 8/1/07 and then again on 8/7/07 with all the reactions listed above except for the fever.  The fever subsided within 24 hours of vaccination. Follow up received on 05/08/08. Lot number of MMR vaccine - 0282U. Lot number of TB test - unknown.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Abdominal distension, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: The patient received Td vaccination in her right hip area on 12/06/07.  Approximately 24 hours later, she developed a local site reaction consisting of pain and swelling at the injection site.  She also complained of swelling in her right upper thigh/lower abdominal area.  The doctor prescribed the antibiotic, cephalosporin.  Additional information received 12/21/07: The patient's adverse reactions have completely resolved.
Age: 21.0
Sex: F
Vaccine: HEPA, TD, TDAP
Symptoms: Erythema, Incorrect route of drug administration, Induration, Local reaction, Pain
Clinical narrative: The patient received Td vaccine intradermally in her left forearm by mistake on 12/10/07; she was supposed to have received PPD.  Two days later, on 12/12/07, the patient returned to the doctor's office to have her PPD test read; it was at this time that it was discovered that Td had been injected instead of the PPD. The patient had a local site reaction approximately the size of a silver dollar consisting of swelling, redness, hardness, and pain.  She has to systemic adverse reactions, and the patient was walking, talking, and acting normal.  The patient will be returning to the doctor's office to receive the PPD correctly in one week.  The local reaction will also be monitored at this time.  Follow up information received 01/02/2008: A representative from the practice stated that the patient had recovered from the local site reaction.
Age: 21.0
Sex: F
Vaccine: HEPA, TD, TDAP
Symptoms: Swelling
Clinical narrative: The patient received Td vaccine intradermally in her left forearm by mistake on 12/10/07; she was supposed to have received PPD.  Two days later, on 12/12/07, the patient returned to the doctor's office to have her PPD test read; it was at this time that it was discovered that Td had been injected instead of the PPD. The patient had a local site reaction approximately the size of a silver dollar consisting of swelling, redness, hardness, and pain.  She has to systemic adverse reactions, and the patient was walking, talking, and acting normal.  The patient will be returning to the doctor's office to receive the PPD correctly in one week.  The local reaction will also be monitored at this time.  Follow up information received 01/02/2008: A representative from the practice stated that the patient had recovered from the local site reaction.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypoaesthesia oral, Injection site pain, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shortness of breath in a female subject aged between 40 and 49 years old who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 5 October 2007 at 16:00 the subject received 1st dose of Flulaval (.05 ml, unknown).  Within one hour after vaccination with Flulaval, on 05 October 2007, the subject experienced shortness of breath, tongue numbness and injection site tenderness.  The subject was seen in the emergency room but was not admitted to the hospital.  The reporter did not believe that the patient had received any previous influenza vaccinations.  The reporter also noted that she considered this to be a pharmaceutical product complaint.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue, Malaise, Myalgia, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of malaise in a 48-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. The subject had received influenza vaccine in previous years with no subsequent adverse events and also had no adverse events following receipt of other prior vaccinations. The subject received no concurrent vaccinations or medications on 2 October 2007. On 2 October 2007 the subject received unspecified dose of Flulaval ( .5 ml, unknown, left arm). On "the evening of" 4 October 2007. 2 days after vaccination with Flulaval, the subject experienced malaise, fatigue, myalgia and body feeling warm. The subject was seen by her personal physician who wrote an order that  she was sick on 03 October 2007 and 04 October 2007 and could return to work on 05 October 2007. At the time of reporting the events were resolved. Follow-up information received on 24 October 2007 indicated that the events actually began on the same day of Flulaval administration. The time to onset was not specified. The events completely resolved by 04 October 2007. In the reporter's opinion, the events were possibly related to treatment with Flulaval. The subject saw her primary care physician and was given a prescription, but it was felt that the symptoms may have been related to the vaccine.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pharmaceutical product complaint, Tenderness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arms continued to be tender.  Pharmaceutical product complaint was also identified.  It was unknown if the subjects had previously received any influenza injections.  Also any previous reactions following vaccinations are also unknown.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The reporter noted that this occurred in six patients.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness, Oedema peripheral, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 29 year old female who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml in an unknown arm.  On 5 October 2007, the same day of vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arm continued to be tender.  Pharmaceutical product complaint was also identified.  These events resolved by 08 October 2007 and were not considered to be related to treatment with Flulaval.  On follow-up, swollen arm an stiffness of the arm lasting two days was reported.  Onset of these events was not specified.  The reporter noted that this occurred in six patients.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pharmaceutical product complaint, Tenderness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arms continued to be tender.  Pharmaceutical product complaint was also identified.  It was unknown if the subjects had previously received influenza injections.  Also any previous reactions following vaccinations was also unknown.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The reporter noted that this occurred in six patients.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arms continued to be tender.  Pharmaceutical product complaint was also identified.  It was unknown if the subjects had previously received any influenza injections.  Also any previous reactions following vaccinations was also unknown.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The reporter noted that this occurred in six patients.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of an allergic reaction in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 10 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  On 10 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced a severe allergic reaction.  At the time of reporting the outcome of the event was unspecified.  No further details were reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: This case was reported by a vaccine distributor and described the occurrence of welt form on the injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline) for Prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unspecified time after vaccination with Flulaval, the subject developed a welt at the injection site. The welt was about two inches across, and looked very similar to a bug bite. At the time of reporting the outcome of the event was unspecified.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Feeling hot, Hyperhidrosis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of body feeling warm in a 31-year-old male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 4 October 2007 the subject received 1st dose of Flulaval at 0.5 ml in the left arm.  In the evening of 4 October 2007, less than one day after vaccination with Flulaval, the subject experienced body feeling warm, sweating and joint pain.  On 5 October 2007, the events were resolved.  The healthcare professional considered the events were possibly related to vaccination with Flulaval.  Follow-up was received from the healthcare professional.  The subject had no relevant medical history.
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Hypoaesthesia oral, Pain
Clinical narrative: This case was reported by a healthcare professional (distributor) and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unspecified time after vaccination with Flulaval, the subject experienced allergic reaction, shortness of breath body pain and tongue numbness. The subject required medical attention in the emergency room. At the time of reporting the outcome of the events was unspecified. The reporter did not know if the patient had previously received any influenza vaccinations. It was also unknown if the subject had any adverse events following previous vaccinations.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional (distributor) and described the occurrence of injection site tenderness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, the subject experienced injection site tenderness.  At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional (distributor) and described the occurrence of injection site tenderness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unspecified time after vaccination with Flulaval, the subject experienced injection site tenderness. At the time of reporting the outcome of the event was unspecified. The reporter did not know if the patient had previously received any influenza vaccinations. It was also unknown if the subject had any adverse events following previous vaccinations.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Throat tightness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of the throat feeling tight in a 24-year-old female subject who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Concurrent medications included unknown (Depo), Sertraline hydrochloride (Zoloft), Guaiphenesin (Mucinex) and Clartin-D (Claritin D). On 11 October 2007 at 15:30 the subject received unspecified dose of Flulaval, the subject expereinced a slight sensation of  throat tightness and swelling. The events were resolved by 15 October 2007. Causality was not known.
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of the use of expired vaccine in an adult female subject who was vaccinated with influenza trivalent (Flulaval, GlaxoSmithKline), influenza virus vaccine (flu vaccine) for prophylaxis. Concurrent medications included Diphenydramine hydrochloride (Benadryl). On either 15 October 2007 or 16 October 2007, the subject received unspecified dose of Flulaval at 0.5 ml. Following vaccination with Flulaval it was noted that the drug administered was last years vaccine which was expired. No adverse events were reported. It was also noted at the time of reporting that the subject received flu vaccine in the past (unknown manufacturer) and experienced shortness of breath and rash. The reporter stated that she had no further details on this past experience.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Expired drug administered, Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of the use of expired vaccine in a 41 year old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  Concurrent medications included Lexapro.  On 15 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  On 16 October 2007, 1 day after vaccination with Flulaval, the subject experienced injection site redness described as localized erythema.  An unknown amount of time after vaccination with Flulaval, it was noted that the drug used was last year's vaccine and was expired.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the event of injection site redness to be probably related to vaccination with Flulaval.
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 16 October 2007 the subject received 1st dose of Flulaval (.5 ml, unknown).  On 16 October 2007, less than one day after vaccination with Flulaval, the subject experienced swelling injection site and injection site warmth.  The subject questioned the possibility of a wrong route of administration.  She believed that she was vaccinated subcutaneously due to the swelling and heat at the injection site.  At the time of reporting the outcome of the events were unspecified.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Feeling hot, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of neck tingling in a male subject aged between 30 and 39 years old who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject received no vaccines other than Flulaval on 17 October 2007.  On 17 October 2007 at 11:30 the subject received unspecified dose of Flulaval (0.5 mL; unknown, left arm).  On 17 October 2007 at 12:35 p.m., within 65 minutes of vaccination with Flulaval, the subject returned to report a "strange sensation" described as tingling of the neck on the left side, and a sensation of warmth running down the left leg.  The site of vaccination reportedly looked "normal".  At the time of reporting the events were unresolved.  The reporting health care professional is employed by an agency that provides influenza vaccines to clients at the clients' sites; the vaccine that is the subject of this report was administered at an attorney's office.  Follow-up was received by the healthcare professional on 02 November 2007.  At the time of reporting, the subject was 31 years of age.  The subject had previously received influenza vaccines and had not experienced any reactions following prior influenza vaccinations.  The subject had no history of adverse events following previous vaccinations.  Medical history included a possible shellfish allergy.  The healthcare professional reported that, after considerable interviewing, the subject noted that he has experienced these same sensations (tingling of the neck on the left side, and a sensation of warmth running down the left leg) in the past after eating shellfish.  The events resolved on 17 October 2007.  The healthcare professional considered the events to be related to vaccination with Flulaval.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 42-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 17 October 2007, the subject received a 0.5 ml dose of Flulaval "below the deltoid" in an unspecified arm.  On 18 October 2007, approximately one day after vaccination with Flulaval, the subject experienced injection site redness.  At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received an unspecified dose of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, the subject experienced injection site redness.  At the time of reporting the outcome of the event was unspecified.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: This case was reported by a physician and described the occurrence of accidental exposure while preparing drug for administration in a 51-year-old male subject who was to receive Flulaval (GlaxoSmithKline) for prophylaxis.  The reporter is also the subject.  On 23 October 2007 at approximately 11:10 the subject was ready to have an unspecified dose of Flulaval administered.  The Flulaval was accidentally splattered into eye and he experienced accidental exposure to the Flulaval as the vaccine was getting ready to be administered.  He also experienced some burning of his right eye.  The subject washed out his eye with water and applied ophthalmic tear drops.  The subject will possibly seek medical attention with an ophthalmologist.  At the time of reporting the outcome of the events was unspecified.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 32-year-old female subject who was vaccinated with Flulaval for prophylaxis. The healthcare professional is the subject. The subject reported that she had received influenza virus vaccine in previous years and experience transient low-grade fever and aches. Concurrent medications included Yaz. On 22 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm). On 23 October 2007, within 24 hours after vaccination with Flulaval, the subject experienced injection site redness, injection site soreness, and injection site warmth. The subject was seen by a physician. The subject stated that she did not experience the fever and aches that she had experienced with previous influenza vaccinations. At the time of reporting the events were unresolved. The subject also reported a product complaint because she is concerned over the potential for a contaminated or defective product. The healthcare professional considered the events were probably related to vaccination with Flulaval.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 50-year-old male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 11 October 2007 the subject received 1st dose of Flulaval (.5 ml, unknown, right arm).  On 21 October 2007, 10 days after vaccination with Flulaval, the subject experienced injection site pain.  At the time of reporting the event was unresolved.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a large, red ring around the injection site in a 43-year-old female subject who was vaccinated with Flulaval for prophylaxis. There were no concurrent medication. On 24 October 2007 at 14:05 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm. on 24 October 2007, 1 hour after vaccination with Flulaval, the subject experienced a red ring at the injection site that was reportedly the size of a silver dollar. The following morning, on 25 October 2007, the subject developed a rash on the chest area. The subject experienced both a local and a systemic reaction to the vaccine. The subject was treated with Benadryl and Tylenol. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Flulaval.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a large, raised knot at the injection site in a 34-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  On 24 October 2007 at 14:00 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm.  On 24 October 2007, 30 minutes after vaccination with Flulaval, the subject developed a large, raised knot (the size of a fist) at the injection site.  The injection site was also warm to the touch and red.  The subject was treated with Benadryl and Tylenol.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Induration, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red induration in a 46-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  On 24 October 2007 at 14:15 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm.  On 24 October 2007, immediately after vaccination with Flulaval, the subject experienced red induration and injection site hot to the touch.  The subject was treated with Tylenol.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 46-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history included allergy to mites, allergy to molds, latex allergy, shellfish allergy and tetracycline allergy since approximately 1985.  The healthcare professional reported that the subject receives allergy injections which have caused injection site reactions in the past.  Concurrent medications included Claritin and allergy injections.  The administration site for the allergy injections was not provided.  No other immunizations were administered on 24 October 2007.  The subject received influenza virus vaccine in previous years, however, it was not reported whether adverse events occurred following receipt of prior influenza virus vaccinations.  On the morning of 24 October 2007 the subject received 1st dose of Flulaval (.5 ml, intramuscular, unknown deltoid).  In October 2007, on or after 24 October 2007 and on or before 26 October 2007, less than one week after vaccination with Flulaval, the subject experienced injection site redness, warmness to touch at injection site and injection site discomfort.  The reporter stated that the subject refused treatment for this reaction.  At the time of reporting the events were unresolved.  Follow-up received on 27 November 2007 via the nurse.  She reported that on 26 October 2007, two days following vaccination with Flulaval, the subject experienced injection site redness, warmness to touch at the injection site and injection site discomfort.  The events resolved after approximately one week around 01 or 02 November 2007.  The reporter considered that the events were not serious.  The reporter considered that the events were related to the use of Flulaval.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure, Dysgeusia, Fatigue, Nasal congestion, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of body pain in a 52-year-old female subject who was inadvertently exposed to Flulaval for prophylaxis. The reporter is the subject. The subject reported that she had no relevant medical history. The subject had been previously vaccinated with influenza virus vaccine and did not experience any adverse events. The subject also had no adverse events following receipt of prior immunizations. There was no concurrent medications. On the dates of 23 October 2007 through 30 October 2007, the subject, a nurse was accidentally exposed to Flulaval. The nurse reported that when administering the Flulaval, once she withdrew the syringe from the vial, the solution sprayed in the air. The Nurse states the solution went up her nose and she could taste and smell the solution 6-12 hours after she administered the vaccine. The subject also reported that, 6 to 12 hours after the accidental exposure to Flulaval, she experienced body ache, nasal congestion and fatigue. The subject administered the Flulaval to over 100 individuals. The reporter considered the events to be a product complaint. At the time of reporting the outcome of the events was unspecified.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of body pain in a 52-year-old female subject who was inadvertently exposed to Flulaval for prophylaxis. The reporter is the subject. The subject reported that she had no relevant medical history. The subject had been previously vaccinated with influenza virus vaccine and did not experience any adverse events. The subject also had no adverse events following receipt of prior immunizations. There was no concurrent medications. On the dates of 23 October 2007 through 30 October 2007, the subject, a nurse was accidentally exposed to Flulaval. The nurse reported that when administering the Flulaval, once she withdrew the syringe from the vial, the solution sprayed in the air. The Nurse states the solution went up her nose and she could taste and smell the solution 6-12 hours after she administered the vaccine. The subject also reported that, 6 to 12 hours after the accidental exposure to Flulaval, she experienced body ache, nasal congestion and fatigue. The subject administered the Flulaval to over 100 individuals. The reporter considered the events to be a product complaint. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of bilateral rash in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions include breast cancer.  On 10 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  It was mentioned that the subject completed radiation (for the treatment of breast cancer) on 12 October 2007.  On 14 October 2007, 4 days after vaccination with Flulaval, the subject experienced bilateral rash. On 26 October 2007, the event was resolved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a red circle around the injection site in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 30 October 2007 the subject received a one time dose of Flulaval at 0.5 ml in the left arm.  On 30 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced an injection site reaction.  The subject developed a 1.5 inch circular, red, hot injection site reaction.  At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a red circle around the injection site in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 31 October 2007 the subject received a one time dose of Flulaval at 0.5 ml in the left arm.  On 31 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced an injection site reaction.  The subject developed a 3 inch circular, red, hot injection site reaction.  At the time of reporting the events were unresolved.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a red circle around the injection site in a 50  year old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 30 October 2007 the subject received a one time dose of Flulaval in the left arm.  On 30 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced an injection site reaction.  The subject developed a 1.5 inch circular, red, hot injection site reaction.  At the time of reporting the events were unresolved.
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Injection site reaction, Myalgia, Pain
Clinical narrative: This case was reported by a physician and described the occurrence of muscle soreness at injection site in an adult male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  In October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  In October 2007, the same day after vaccination with Flulaval, the subject experienced muscle soreness at injection site.  One day after vaccination with Flulaval, the subject experienced tiredness and achiness.  The subject experienced muscle soreness at injection site, tiredness and pain for approximately one day after the vaccination.  The subject was treated with Advil.  At the time of reporting, the events were unresolved.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Eye discharge, Ocular hyperaemia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of redness of eyes in a 37-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject had no relevant medical history.  There were no concurrent medications.  The subject received influenza virus vaccine in previous years with no subsequent adverse events and also had no adverse events following receipt of any prior immunizations.  On 2 November 2007 at 9:45 a.m., the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On 2 November 2007 at 11:45 a.m., 2 hours after vaccination with Flulaval, the subject stopped back by the pharmacy because she was experiencing problems following her vaccination, including redness of eyes, cough, chest tightness and white exudate in eyes.  The subject did say that the symptoms have not been getting worse.  At the time of reporting the events were unresolved.  The pharmacist considered the events were probably related to vaccination with Flulaval.  Follow-up was received on 27 November 2007 from the reporting pharmacist.  The onset of the adverse events was 2 November 2007, one hour after the receipt of Flulaval.  The events resolved on 04 November 2007.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in an elderly subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of Flulaval (unknown).  At an unknown time after vaccination with Flulaval, the subject experienced allergic reaction.  At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in an elderly subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unknown time after vaccination with Flulaval, the subject experienced allergic reaction. At the time of reporting the outcome of the event was unspecified.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, No reaction on previous exposure to drug, Periarthritis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of frozen shoulder in a 59-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history included diabetes and hypothyroidism.  The subject's concurrent conditions and concurrent medications were not reported.  The subject had received influenza virus vaccine in previous years with no subsequent adverse events.  The subject received no other immunizations on the date of receipt of Flulaval.  On 26 October 2007 the subject received unspecified dose of Flulaval (unknown, left arm).  On 27 October 2007, 1 day after vaccination with Flulaval, the subject experienced frozen shoulder, injection site pain and injection site soreness.  The subject was seen by an orthopedic doctor.  The subject was treated with Cortizone shot and physical therapy.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 2 November 2007 the subject received unspecified dose of Flulaval in an unknown arm.  Immediately after vaccination with Flulaval, the subject experienced an injection site reaction.  On 4 November 2007, the event was resolved.  Follow-up information was received on 11 December 2007 via a healthcare professional, who reported that the subject immediately developed a lump and redness at the injection site following vaccination of Flulaval.  The reporter stated that the events were resolved in two days with no further problems.
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a female subject of unspecified age who was vaccinated with Flulaval for prophylaxis. On 2 November 2007 the subject received unspecified dose of Flulaval in an unknown arm. Immediately after vaccination with Flulaval, the subject experienced an injection site reaction. On 4 November 2007, the event was resolved. Follow-up information was received on 11 December 2007 via a healthcare professional, who reported that the subject immediately developed a lump and redness at the injection site following vaccination with Flulaval. The reporter stated that the events were resolved in two days with no further problems.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of leg pain in a 72-year-old male subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject's medical history included arthritis, diabetes, high cholesterol and hypertension.  Concurrent medications included Caduet.  The subject received no other vaccinations on the date of receipt of Flulaval.  Information regarding receipt of previous immunization with Flulaval was not provided.  The subject had no adverse events following receipt of prior immunizations.  On 16 November 2007 at 2:21 p.m., the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On an unspecified date on or after 16 November 2007 and on or before 20 November 2007, less than one week after vaccination with Flulaval, the subject experienced left leg pain.  At the time of reporting the event was unresolved.  Follow-up information was received on 18 December 2007 via a pharmacist, who reported that the outcome of the event was unknown.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fatigue in a 15-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  No other vaccinations given on the same day as Flulaval.  No relevant medical history or concurrent medications.  On 24 November 2007 at 15:47 the subject inadvertently received unspecified dose of Flulaval (.5 ml, unknown, right arm) and experienced a vaccination error as she as supposed to received a pediatric vaccine.  On 01 December 2007, 7 days after vaccination with Flulaval, the subject experienced mild fatigue.  She was seen by a physician on 03 December 2007 because the fatigue persisted. No medications or treatment were prescribed during the visit.  Subject was told to follow up if her symptom changed.  At the time of reporting the fatigue was unresolved.  The healthcare professional considered the fatigue was probably related to vaccination with Flulaval.