chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Aphagia, Aphthous stomatitis, Biopsy, Blister, Blood test
Clinical narrative: This spontaneous report as received from a consumer's husband refers to a 62 years old female patient. It was reported that the patient had a healthy immune system and had no history of cold sores. On an unknown date, the patient was vaccinated with ZOSTAVAX, single dose injection. Other suspect therapies included AFLURIA and pertussis vaccine (unspecified) were administered within the same week as with ZOSTAVAX. No concomitants were reported. On 28-JAN-2014 (also reported as a few weeks later), the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. On an unknown date in 2014, the fever worsened and the patient developed symptoms of a Urinary tract infection (no UTI was confirmed) and severe discomfort in her throat, which included difficulty in swallowing. Patient visited to a walk-in clinic (unspecified), where she was prescribed LEVAQUIN. The patient then visited her physician. where she was examined. On an unknown date in 2014, the patient developed white tongue and canker sores in her mouth and she began to experience more severe problems in swallowing and was unable to eat or drink. The patient sought the attention of an Infectious Disease Specialist and on 04-FEB-2014; she went to the Emergency Room and was hospitalized on 04-FEB-2014. On an unknown date in 2014, lab diagnostics studies included blood, urine tests, endoscopy, cultures, biopsies were performed. She was diagnosed with unspecified herpes virus blisters in her throat. Patient received acyclovir by intravenous administration in hospital and CARAFATE to coat the ulcerations. BACTRIM and vancomycin were also given as treatment. She was discharged on 09-FEB-2014, and was reportedly able to eat and drink lightly, but was still uncomfortable. All the reported events were recovering/resolving. Causality assessment was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Culture, Dysphagia, Endoscopy, Headache, Herpes virus infection
Clinical narrative: This spontaneous report as received from a consumer's husband refers to a 62 years old female patient. It was reported that the patient had a healthy immune system and had no history of cold sores. On an unknown date, the patient was vaccinated with ZOSTAVAX, single dose injection. Other suspect therapies included AFLURIA and pertussis vaccine (unspecified) were administered within the same week as with ZOSTAVAX. No concomitants were reported. On 28-JAN-2014 (also reported as a few weeks later), the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. On an unknown date in 2014, the fever worsened and the patient developed symptoms of a Urinary tract infection (no UTI was confirmed) and severe discomfort in her throat, which included difficulty in swallowing. Patient visited to a walk-in clinic (unspecified), where she was prescribed LEVAQUIN. The patient then visited her physician. where she was examined. On an unknown date in 2014, the patient developed white tongue and canker sores in her mouth and she began to experience more severe problems in swallowing and was unable to eat or drink. The patient sought the attention of an Infectious Disease Specialist and on 04-FEB-2014; she went to the Emergency Room and was hospitalized on 04-FEB-2014. On an unknown date in 2014, lab diagnostics studies included blood, urine tests, endoscopy, cultures, biopsies were performed. She was diagnosed with unspecified herpes virus blisters in her throat. Patient received acyclovir by intravenous administration in hospital and CARAFATE to coat the ulcerations. BACTRIM and vancomycin were also given as treatment. She was discharged on 09-FEB-2014, and was reportedly able to eat and drink lightly, but was still uncomfortable. All the reported events were recovering/resolving. Causality assessment was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Mouth ulceration, Oropharyngeal discomfort, Pain, Pyrexia, Tongue discolouration
Clinical narrative: This spontaneous report as received from a consumer's husband refers to a 62 years old female patient. It was reported that the patient had a healthy immune system and had no history of cold sores. On an unknown date, the patient was vaccinated with ZOSTAVAX, single dose injection. Other suspect therapies included AFLURIA and pertussis vaccine (unspecified) were administered within the same week as with ZOSTAVAX. No concomitants were reported. On 28-JAN-2014 (also reported as a few weeks later), the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. On an unknown date in 2014, the fever worsened and the patient developed symptoms of a Urinary tract infection (no UTI was confirmed) and severe discomfort in her throat, which included difficulty in swallowing. Patient visited to a walk-in clinic (unspecified), where she was prescribed LEVAQUIN. The patient then visited her physician. where she was examined. On an unknown date in 2014, the patient developed white tongue and canker sores in her mouth and she began to experience more severe problems in swallowing and was unable to eat or drink. The patient sought the attention of an Infectious Disease Specialist and on 04-FEB-2014; she went to the Emergency Room and was hospitalized on 04-FEB-2014. On an unknown date in 2014, lab diagnostics studies included blood, urine tests, endoscopy, cultures, biopsies were performed. She was diagnosed with unspecified herpes virus blisters in her throat. Patient received acyclovir by intravenous administration in hospital and CARAFATE to coat the ulcerations. BACTRIM and vancomycin were also given as treatment. She was discharged on 09-FEB-2014, and was reportedly able to eat and drink lightly, but was still uncomfortable. All the reported events were recovering/resolving. Causality assessment was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Urinary tract infection, Urine analysis
Clinical narrative: This spontaneous report as received from a consumer's husband refers to a 62 years old female patient. It was reported that the patient had a healthy immune system and had no history of cold sores. On an unknown date, the patient was vaccinated with ZOSTAVAX, single dose injection. Other suspect therapies included AFLURIA and pertussis vaccine (unspecified) were administered within the same week as with ZOSTAVAX. No concomitants were reported. On 28-JAN-2014 (also reported as a few weeks later), the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. On an unknown date in 2014, the fever worsened and the patient developed symptoms of a Urinary tract infection (no UTI was confirmed) and severe discomfort in her throat, which included difficulty in swallowing. Patient visited to a walk-in clinic (unspecified), where she was prescribed LEVAQUIN. The patient then visited her physician. where she was examined. On an unknown date in 2014, the patient developed white tongue and canker sores in her mouth and she began to experience more severe problems in swallowing and was unable to eat or drink. The patient sought the attention of an Infectious Disease Specialist and on 04-FEB-2014; she went to the Emergency Room and was hospitalized on 04-FEB-2014. On an unknown date in 2014, lab diagnostics studies included blood, urine tests, endoscopy, cultures, biopsies were performed. She was diagnosed with unspecified herpes virus blisters in her throat. Patient received acyclovir by intravenous administration in hospital and CARAFATE to coat the ulcerations. BACTRIM and vancomycin were also given as treatment. She was discharged on 09-FEB-2014, and was reportedly able to eat and drink lightly, but was still uncomfortable. All the reported events were recovering/resolving. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous report was received from a medical assistant refers to a female patient of unknown age. The patient concurrent condition included blood pressure. On 20-NOV-2013, the patient was vaccinated with VARIVAX (merck) (dose, route and frequency was not reported) because the patient works in the medical field. Concomitant medication included water pill. On 11-FEB-2014, the patient visited the physician office and had blood work completed which showed her to be pregnant. The medical assistant stated that based on the last menstrual period, the patient was 5 weeks and 3 days pregnant. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age. It was reported the patient received 4 doses of PNEUMOVAX 23 (Injection, lot #, dose, route and duration were unspecified) or unspecified dates within a one year period of time. No adverse symptoms reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: This spontaneous report as received from a 67 year old female patient with diabetes refers to herself. There were no drug reactions/allergies. On 11-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route not reported). Concomitant therapies included glyburide. On the morning of 13-FEB-2014, the patient began to experience itching at the injection site and a lump at injection site. There was no treatment given for the events. No lab diagnostics studies performed. The patient did not seek medical attention. The outcome of the events was reported as not recovered. Additional information is not expected.
Age: 1.79
Sex: M
Vaccine: DTAP, FLU3, MMR
Symptoms: Eye swelling, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Approximately 30 minutes after child received MMR, DTaP, and Influenza vaccines he developed generalized pruritic, urticarial rash and eye swelling. Mom brought him back into the office and PO BENADRYL given with improvement of symptoms. Rx'd PO BENADRYL Q 4 hrs and PRELONE BID x 5 days.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from other health professional refers to multiple patients of unknown age and gender. On an unknown date the multiple patients was vaccinated with GARDASIL injection (strength, dose unit, route, lot# and expiry date unknown) that was exposed to a temperature of 31F for 720 hours. No adverse effect reported. The outcome of patients received a dose of GARDASIL that was exposed to a temperature of 31 F for 720 hours and no adverse effect reported was unknown. This case # 1402USA007528 is linked to case # 1402USA010413 via same reported link. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from other health professional refers to multiple patients of unknown age and gender. On an unknown date the multiple patients was vaccinated with PEDVAXHIB (strength, dose unit, route, lot# and expiry date unknown) that was exposed to a temperature of 31F for 720 hours. No adverse effect reported. The outcome of patients received a dose of PEDVAXHIB that was exposed to a temperature of 31 F for 720 hours and no adverse effect reported was unknown. This case #1402USA010413 is linked to case # 1402USA007528 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: This spontaneous report as received from registered nurse via company representative refers to multiple patients older than 50 year old with immunization. Patient's had no previous history of shingles and other medical histories. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml (lot# and expiry date unknown) subcutaneously. No concomitant medications were administered. Nurse reported that on an unknown date, unspecified numbers of patients have reported injection site reactions with ZOSTAVAX. She reported that the patients are experiencing swelling at injection site, and described them as big lumps with major discomfort and redness at injection site more often than not. She reports that the nurse stated that she received two calls from patients just today reporting injection site reactions. The nurse stated that no rashes are occurring. Nurse stated that some of the patients has been seen in the office in relation to the injection site reactions, that no patients have been diagnosed with cellulitis, and they have been managing symptoms with hot compresses and ibuprofen (manufacture unknown). No laboratory test was performed. The outcome of injection site reaction, redness at injection site and swelling at injection site was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a currently 56 year old female pharmacist with no drug reactions/allergies refers to herself. The patient's medical history included shingles in February of 2012 (exact date unspecified). There was no concomitant medication. The pharmacist reported that when she (the pharmacist) administers ZOSTAVAX to patients, she (the pharmacist) experienced reactivation of herpes and reactivation of shingles, about 7 to 10 days after administering ZOSTAVAX. The pharmacist reported that she had experienced reactivation of herpes about 6 times in the last two months and currently was experiencing reactivation of shingles (on her right hip). Lab diagnostics studies were not performed. The pharmacist did not seek medical attention. Valacyclovir hydrochloride was given as treatment for the event. The outcome of the event was not recovered. The pharmacist felt there was an association with the development of the herpes and the shingles and her (the pharmacist) administration of ZOSTAVAX to patients. The pharmacist never received a vaccination of ZOSTAVAX, but administered ZOSTAVAX to patients. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: Saw primary care on 2/14/14 c/o of fever 103 degrees. (R) upper arm, tender with swollen lymphatics, began hours after injections and lasted x 3 days.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site bruising, Injection site haemorrhage, Muscular weakness, Pain
Clinical narrative: Left arm has "never been the same" since vaccination, weakness and painful when raising. Bleeding from injection site at time of vaccination and 2" diameter bruise. Has not shared this info with primary care Dr. yet.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling, fever (99.5 - 101.5 degrees F) (at injection site).
Age: 56.0
Sex: M
Vaccine: TD
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Underdose
Clinical narrative: Pt came in to office for a Td injection employee misunderstood and gave the injection as a sub-q in the left forearm. Gave 0.1 ml.
Age: 64.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Blister
Clinical narrative: Clients son contacted this RN and reported that "on 2/14/14 his mother developed blister like rash on her face and belly. No fever, no malaise, no acute discomfort." No itchiness was reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Gaze palsy, Headache, Injection site pain, Pain in extremity
Clinical narrative: She began to have quick involuntary rolling of the eyes. Then later she cried her right leg was hurting. She also complained of her head hurting.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Screaming, Staring
Clinical narrative: She began to have quick involuntary rolling of the eyes. Then later she cried her right leg was hurting. She also complained of her head hurting.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Breast discomfort, Chest discomfort, Erythema, Local swelling, Pain
Clinical narrative: This is a 44-year-old female who presents to the emergency department today because of right arm pain redness. He was seen in primary care clinic yesterday and had a flu shot and a tetanus shot in her left arm and had Pneumovax placed in her right arm. At 8 PM last night her arm became more red swollen and painful. This discomfort when into her right breast as well. She states that she had a little bit of tingling in her mouth at that time and decided that she would take some Benadryl and use her EpiPen. They have 3 hours later she started feeling a little bit better. Saying she woke up and her arm was quite painful hurts to move. Still has some discomfort into her right upper chest wall. Prescribed Percocet, Keflex, Septra DS.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain in extremity, Paraesthesia oral
Clinical narrative: This is a 44-year-old female who presents to the emergency department today because of right arm pain redness. He was seen in primary care clinic yesterday and had a flu shot and a tetanus shot in her left arm and had Pneumovax placed in her right arm. At 8 PM last night her arm became more red swollen and painful. This discomfort when into her right breast as well. She states that she had a little bit of tingling in her mouth at that time and decided that she would take some Benadryl and use her EpiPen. They have 3 hours later she started feeling a little bit better. Saying she woke up and her arm was quite painful hurts to move. Still has some discomfort into her right upper chest wall. Prescribed Percocet, Keflex, Septra DS.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Rash erythematous
Clinical narrative: Rash on 75% body (small, raised, red bumps), dizziness, mild light-headedness. Lasted 1 day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to the touch. Tx. Cefazolin powder for injection 500 mg.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse who reported that improperly stored GARDASIL may have been administered (demographics and number of doses unspecified) since 20-JAN-2014 (case opened on 07-FEB-2014), no administration was reported during the call). No adverse event reported. GARDASIL was exposed to temperatures of 32.2 F for 17 hours. The product would not be adversely affected by this specific temperature excursion. Additional information is not expected.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Initial report was received from literature on 11 February 2014. The following is verbatim from the article abstract: Although influenza vaccines have saved millions of lives, some have been associated with extremely rare adverse effects such as Guillain-Barre syndrome, Bell's palsy, and optic neuritis. Despite the fact that olfactory loss after an influenza vaccination is noted in one case report, no quantitative olfactory testing was performed. Hence, it is unclear whether, in fact, olfactory dysfunction can be associated with such vaccinations. This study was designed to (1) identify patients from the Center who attributed their empirically determined chemosensory disturbances to influenza vaccinations and (2) determine whether influenza vaccinations add to the degree of olfactory or gustatory dysfunction due to other causes. Methods: A retrospective analysis of self-reported etiologies of 4554 consecutive patients presenting to the Center with complaints of chemosensory dysfunction was performed. Those who reported dysfunction secondary to influenza vaccinations were identified. Additionally, in a subset of 925 patients for whom detailed inoculation histories were available, it was determined whether the number of lifetime inoculations added to the deficits due to other causes. Results: Nine of the 4554 patients (0.19%) attributed olfactory disturbances to an influenza vaccination. None complained of taste dysfunction. All nine had abnormally low scores on the Smell Identification Test (p < 0.001), with three being anosmic and six microsmic. Seven had elevated phenyl ethyl alcohol detection thresholds (p < 0.05). Two cases exhibited mild-to-moderate loss of whole mouth taste function. Of the 925 patients, no association was evident between the number of lifetime vaccinations and the chemosensory test scores. In accord with previous studies, age and sex were significantly related to the test scores. Conclusion: A very small percentage of the 4554 patients evaluated (0.19%) attributed their chemosensory dysfunction to a prior influenza vaccination. No influences of the number of lifetime influenza vaccinations on the test scores were evident in the subset of 925 patients whose dysfunction was due to other causes.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Joint pain, lethargy, muscle ache, injection site redness, swelling, tenderness, - that enlarged - Rx KEFLEX 500 tid x 7d, OTC ZYTREC.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Joint pain, lethargy, muscle ache, injection site redness, swelling, tenderness, - that enlarged - Rx KEFLEX 500 tid x 7d, OTC ZYTREC.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Abasia, Abnormal behaviour, Computerised tomogram normal, Disorientation, Feeling abnormal
Clinical narrative: Was detained one hr. to monitor adverse signs, later could not walk. Went to work and 2 1/2 hrs later I suddenly felt strange/weird sights and disorientation - profuse sweating and co-workers said I was literally bouncing off walls. Drove later to emergency room. Triage nurse thought I was drunk/drinking.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Hyperhidrosis, Nervousness
Clinical narrative: Was detained one hr. to monitor adverse signs, later could not walk. Went to work and 2 1/2 hrs later I suddenly felt strange/weird sights and disorientation - profuse sweating and co-workers said I was literally bouncing off walls. Drove later to emergency room. Triage nurse thought I was drunk/drinking.
Sex: F
Vaccine: HPV4
Symptoms: Death, Neoplasm malignant
Clinical narrative: This spontaneous report as received from a Physician's Assistant via Field Representative refers to a female patient of unknown age. On an unknown date a mother stated that "one of her seven daughters" received the full series of GARDASIL (lot number, strength, dose, frequency were not reported). On an unknown date the patient died. According to the mother, her daughter had a type of gynecological cancer that was caused by the GARDASIL. Upon internal review the event of "a type of gynecological cancer" was determined to be medically significant. Additional information has been requested.  ***03/24/2014: Merck rep misunderstood report. Provider told story about someone else (not pt. in office) and death not involved".
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient states to still suffer pain from the distal portion of her deltoid area and the upper portion of her tricep on the injection arm. She states that it was painful during injection and administration, but it has improved over the past few months.
Age: 1.04
Sex: F
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Irritability, Laboratory test, Pyrexia, Urine analysis, Vomiting
Clinical narrative: Extreme irritability, fever 6 days post vaccination. Vomiting started on 02.14.14.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Injection site nodule, Local swelling, Rash, Skin warm
Clinical narrative: Thursday, 2/13/14 on lower left arm rash began, Started to travel up patient's arm. By Saturday morning patient had lower area about 7 inches long that was raised, inflamed, slightly swelled. Above that an injection site another area about 3 x 3 inches with nodule. Warm to touch no itching.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin irritation, Tenderness
Clinical narrative: Irregular large red area, itchiness, mild-moderate irritation/tenderness lasting 7 days and 2-11-14 - MD prescribed ATARAX, triamcinolone, possible steroid dose pak for future use.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash generalised, Urticaria
Clinical narrative: Received 4 vaccines on 2/3/14. Mom called Health Department on 2/4/14 to notify us patient has developed a head-to-toe rash on 2/4/14. Took pt to doctor on 2/6/14 et reported to have hives. Mom refused steroids for head-to-toe breakout. Mom reports child acted fine throughout et returned to normal 2/6/14. On 2/4/14 pt had rash on face. Has had since 10/2013 et doctors unable to diagnose. Going to dermatologist.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Receive varicella vaccine 2/18/14. After vaccine (15 min) pt stated she had a burning feeling around her mouth and itching on face. Pt had no difficulty breathing. There was no redness or swelling at injection site. When pt left problem had resolved. Pt was instructed to call 911 if problem occur again. 2/20/14 pt left message that shot site was raised and red and itching. No other problems. T.C. to pt to go to MD or ER. 2/21/14 T.C. from pt went to express care. Dx with cellulitis - taking Cipro bid "arm red and swollen advised her to if further problems occur.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: Receive varicella vaccine 2/18/14. After vaccine (15 min) pt stated she had a burning feeling around her mouth and itching on face. Pt had no difficulty breathing. There was no redness or swelling at injection site. When pt left problem had resolved. Pt was instructed to call 911 if problem occur again. 2/20/14 pt left message that shot site was raised and red and itching. No other problems. T.C. to pt to go to MD or ER. 2/21/14 T.C. from pt went to express care. Dx with cellulitis - taking Cipro bid "arm red and swollen advised her to if further problems occur.
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via sales representative and described the occurrence of injection site blisters in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 11 November 2013 the subject received unspecified dose of FLULAVAL (unknown details). On 11 November 2013, immediately after vaccination with FLULAVAL, the subject experienced injection site blisters (described as "blistering"). At the time of reporting the outcome of the event was unknown. The pharmacist reported other cases with FLULAVAL. See cases A1052877A and A1052879A for details.
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site atrophy, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist (subject) via sales representative and described the occurrence of injection site blisters in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2013 the subject received unspecified dose of FLULAVAL (unknown, unknown arm). In October 2013, immediately after vaccination with FLULAVAL, the subject experienced injection site blisters (described as "blistering") and indentation at injection site (described as "has 'crater' in arm"). At the time of reporting the outcome of the event of injection site blisters was unknown. The outcome of the indentation at injection site was unresolved. The pharmacist reported other cases with FLULAVAL. See cases A1052878A and A1052879A for details.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm soreness at injection site in a 21-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included arm soreness with previous flu vaccinations (Other). On 1 December 2013 the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 2 December 2013, 1 day after vaccination with FLULAVAL, the subject experienced arm soreness at injection site and unable to lift arm. The pharmacist reported the subject returned to the pharmacy noting that he has had continued arm soreness and inability to lift his arm since the day after received FLULAVAL on 01 December 2013. The subject had been applying ice and heat to arm, as well as taking ibuprofen. The pharmacist inquired about treatment recommendations. At the time of reporting the arm soreness at injection site and unable to lift arm were unresolved. Follow-up information received on 08 January 2014 via pharmacist who reported no action was taken with FLULAVAL. At the time of the report no other information was provided. The case was closed.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of arm soreness at injection site in a 63-year-old female subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included depression, high blood pressure and high cholesterol. Concurrent medications included SYNTHROID, Blood pressure medication, Anti-cholesterol medication, Vitamins and Antidepressant (unspecified). On 5 November 2013 at 17:30 the subject received a dose of Influenza vaccine unspecified (unknown, left arm). On an unspecified date in 2013, within months of vaccination with Influenza vaccine unspecified, the subject experienced arm soreness at injection site. The subject reported she received the flu vaccine a few weeks ago; brand name and manufacturer were unknown. She reported she did not know when she first started experiencing arm soreness, but that the soreness is not going away. At the time of reporting the event was unresolved. Follow up was received from consumer on 19 December 2013. The consumer (subject) confirmed that she was vaccinated with FLULAVAL (GlaxoSmithKline); previously the subject did not know which manufacturer or brand name.
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of injection site reaction in an unknown number of subjects of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2013 the subjects received a dose of FLULAVAL (.5 ml, unknown site, unknown arm). In 2013, immediately after vaccination with FLULAVAL, the subjects experienced injection site reaction. The nurse stated that an unknown number of subjects ("about a handful, maybe 5") told the nurse that they "felt like the vaccine was draining down their arm. The nurse also felt that the FLULAVAL vaccine was very thick like corn syrup." No product complaint was associated with this case. The nurse did not know if the subjects sought medical attention. At the time of reporting the outcome of the event was unspecified.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 67-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 24 October 2013 the subject received 1st dose of FLULAVAL (.5 ml, unknown route, left arm). The vaccine was administered "using 25 gauge, 1 inch needle." On 24 October 2013, less than one day after vaccination with FLULAVAL, the subject experienced injection site pain. The pharmacist described the local injection site pain as "starting 1 day after injection" but provided an onset date as the same date as the vaccination. The pharmacist also described the pain as "arm soreness", "achy", "annoying," and "dull." Per the pharmacist, the pain did not "improve over time, nor worsened but is low on the pain scale." The pain improves with activity. The pain "has lasted 3 weeks following administration of FLULAVAL." The pharmacist reported the immunization series was not discontinued. At the time of reporting the event was unresolved. The pharmacist considered the event was possibly related to vaccination with FLULAVAL. The pharmacist reported another case with FLULAVAL. See A1051253A for details on the other case.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of diarrhea in a 50-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 10 October 2013 the subject received a dose of FLULAVAL (unknown details). On 10 October 2013, within hours of vaccination with FLULAVAL, the subject experienced diarrhea. In October 2013, within a week of vaccination with FLULAVAL, the subject experienced injection site warmth, injection site inflammation and injection site swollen. The subject "received a FLULAVAL vaccination at the same time as her boyfriend. They went out to dinner afterwards and when they got home they started experiencing diarrhea." See case A1047929A for details on the male subject. At the time of reporting the outcome of the events injection site warmth, injection site inflammation, and injection site swollen were unspecified. At the time of reporting, the outcome of the event of diarrhea was unresolved. Per the pharmacist, the subject is "still experiencing diarrhea" "after 6-7 days." Per the pharmacist, the subject was "advised to seek medical attention but she has not yet seen a doctor" at the time of reporting. The pharmacist reported other cases with FLULAVAL, see A1047929A and A1046504A for details on the other cases.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a pharmacist and described the occurrence of diarrhea in a 54-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 10 October 2013 the subject received a dose of FLULAVAL (unknown details). On 10 October 2013, within hours of vaccination with FLULAVAL, the subject experienced diarrhea. The pharmacist reported that the subject "received a FLULAVAL vaccination at the same time as his girlfriend. They went out to dinner afterwards and when they got home they started experiencing diarrhea." See case A1047930A for details on the female subject. On 10 October 2013, the event was resolved. The pharmacist reported that "after one bout of diarrhea his symptoms resolved." The pharmacist reported other cases with FLULAVAL. See A1047930A and A1046504A for details on the other cases.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Pyrexia, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of influenza a virus test positive in a 3-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2013 the subject received a dose of FLULAVAL (unknown details). The nurse did not know the exact date of administration. The nurse did not report if the subject received the trivalent or the Quadrivalent formulation of FLULAVAL. On 20 October 2013, less than one month after vaccination with FLULAVAL, the subject experienced influenza a virus test positive, fever and vaccination failure. The subject experienced fever and went to the ER (emergency room). Per the nurse, the subject "was not experiencing any other symptoms except for a fever." No further details were available at the time of reporting. This case was assessed as medically serious by GSK. Relevant test results included a Rapid Antigen Test administered on 20 October 2013 and "tested positive for influenza A, but not influenza B." At the time of reporting the outcome of the events were unspecified. On case review, this case did not meet vaccination failure criteria and that event has been removed from the case. This case is no longer medically serious and has been down graded to non-serious.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Local reaction, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm pain at injection site in a 42-year-old male subject who was vaccinated with FLULAVAL trivalent 2013-2014. On 2 October 2013 the subject received a dose of FLULAVAL 2013-2014 season (unknown, unknown deltoid). At an unspecified time after vaccination with FLULAVAL 2013-2014 season, the subject experienced arm pain at injection site described as local reaction of "arm pain, arm soreness and stinging at injection site". At the time of reporting the events were unresolved. The pharmacist reported another case, please see A1050674A.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Underdose, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of intramuscular formulation administered by other route in an adult subject between 48 and 52 years of age of unknown gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2013 at 14:30 the subject received a dose of FLULAVAL (.1 dose, intradermal, unknown arm) and experienced intramuscular formulation administered by other route, wrong vaccine administered, and underdose. The FLULAVAL is indicated as a 0.5ml dose to be administered intramuscularly; however this subject received 0.1 dose "in the forearm". The nurse reported that "she accidentally gave" "a 0.1 dose of FLULAVAL as a PPD in the forearm, instead of intramuscularly." The nurse refused to provide any additional details. The nurse reported 2 other cases with FLULAVAL. See cases A1045207A and A1045210A for details on the other cases. Follow up was received from nurse on 1 November 2013. The nurse reported that this case had been reported to a Regulatory agency; however, a reference number was not provided. The nurse documented that on 7 October 2013 at 14:00 (previously 14:30), a female subject between 60-69 years old (previously an adult between 48 and 52 years of age of unknown gender) received a primary dose of FLULAVAL and experienced "marked pruritus for 10 minutes" and injection site redness (not previously reported). The nurse did not consider the events serious. The events were not life threatening, did not involve severe or permanent disability, did not involve hospitalization, did not involve congential defect, and did not jeopardize the subject or required intervention. The subject was evaluated by a physician within 15 minutes of the vaccination. On 10 October 2013, the nursing report documented that there were no adverse reactions at that date; however, the specific date of resolution was not reported. The nurse also provided follow up for the other 2 cases of A1045210A and A1045207A.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional (nurse, subject) and described the occurrence of injection site redness in a 50-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy. Concurrent medications included Vitamin D supplement. On 28 October 2013 at 08:20 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 28 October 2013, immediately after vaccination with FLULAVAL, the subject experienced injection site redness, injection site pruritus (described as "itchy"), and hardness injection site (described  as "hard area at injection site). On 28 October 2013, minutes after vaccination with FLULAVAL (described as "shortly after vaccination"), the subject experienced feeling lightheaded. At the time of reporting the events of injection site redness, injection site pruritus, and hardness injection site were unresolved. The feeling lightheaded improved within 5 to 10 minutes. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subject experienced injection site pain. The pharmacist stated that "the vaccine was administered at her pharmacy so she could not verify." At the time of reporting the outcome of the event was unspecified. The pharmacist reported another case with FLULAVAL. See A1051252A for details on the other case.
Sex: U
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a healthcare professional (quality assurance director for a network of clinics) and described the occurrence of flu-like symptoms in an unknown number of subjects of unspecified age and gender who were vaccinated with FLULAVAL (GlaxoSmithKline). In 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subject experienced flu-like symptoms. No further details were available for those subjects at the time of reporting. At the time of reporting the outcome of the event was unspecified. The reporter documented another case with FLULAVAL. See case A1046186A for details on the other case.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional (office manager) and described the occurrence of arm pain at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subject experienced arm pain at injection site. Per the office manager, the subject had "experienced 'extended arm pain' for many days following vaccination with FLULAVAL." No further details were available at the time of reporting. At the time of reporting the outcome of the event was unclear from the report and, therefore, unknown.
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered, Malaise, Off label use, Underdose
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of expired vaccine used in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline), influenza virus vaccine (unspecified). On 7 November 2013 at 22:00 the subject received a dose of FLULAVAL (.25 ml, unknown site, unknown deltoid) and experienced expired vaccine used, underdose and off label use. Per the nurse, all the vaccine was "a GSK flu vaccine from a multi-dose vial" so the reporter believed that the vaccine was "most likely FLULAVAL." Per the nurse, "a nurse in the facility inadvertently administered the expired vaccine." The vaccine expired May 2013. The subject had a "history of getting ill from the flu vaccination so they split the dose giving 0.25ml initially and then another 0.25ml at a later date." Per the nurse, the subject's body temperature had been monitored every 4 hours and "not noted any changes or any other adverse events." It was unclear from the report when the maladministration was discovered and when monitoring every 4 hours began. On an unspecified date the subject received a dose of Influenza vaccine (unspecified) (unknown details). At an unspecified time after vaccination with influenza vaccine (unspecified) and experienced unwell. Per the nurse, the subject had "a history of getting ill from the flu vaccination." At the time of reporting the outcome of the event was resolved.
Sex: M
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist via claims management company and described the occurrence of adverse event (s) in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 October 2013 the subject received a dose of FLULAVAL (unknown). On an unspecified date in 2013, within months of vaccination with FLULAVAL, the subject experienced adverse event (s). At the time of reporting the outcome of the event (s) was unspecified.
Sex: M
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via sales representative and described the occurrence of injection site blisters in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 11 November 2013 the subject received unspecified dose of FLULAVAL (unknown details). On 11 November 2013, immediately after vaccination with FLULAVAL, the subject experienced injection site blisters (described as "blistering"). At the time of reporting the outcome of the event was unknown. The pharmacist reported other cases with FLULAVAL. See cases A1052878A and A1052877A for details.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Local reaction, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm pain at injection site in about nine to ten subjects of unspecified age and gender who were vaccinated with FLULAVAL (GlaxoSmithKline). On unspecified dates in 2013 the subjects received a dose of FLULAVAL (unknown). At unspecified times after vaccination with FLULAVAL, the subjects experienced arm pain at injection site, described as local reactions of "arm pain, arm soreness, stinging at injection site and stinging at the time of the injection". At the time of reporting the events were unresolved. The pharmacist reported about nine to 10 subjects received the FLULAVAL vaccine and are still experiencing arm pain and arm soreness. Some of the subjects stated that they experienced stinging at the time of the injection, but that could have been from the alcohol swab, All of the subjects received the FLULAVAL vaccine last year and did not experience any adverse events. The pharmacist reported another case, please see A1050673A.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a 37-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 29 September 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, less than one month after vaccination with FLULAVAL (described as "right after vaccination"), the subject experienced injection site redness, injection site warmth and influenza. The pharmacist reported that the subject "became sick with the flu right after the vaccination" with FLULAVAL. At the time of reporting the outcome of the events were unspecified. The pharmacist reported other cases with FLULAVAL. See A1047929A and A1047930A for details on the other cases.