chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Dyspnoea, Headache, Pyrexia
Clinical narrative: Minor tightness of breath, dry cough, headache, leg joint ache, fever 101 degrees @ 2:00 AM.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient received the flu immunization in the left thigh on 10/08/14 in the AM. In the PM there was a small bump. Today his leg is red, swollen, hard and warm to the touch. No breathing difficulties.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain in left arm shooting down arm. Tingling. Shoulder pain that hasn't resolved as of 10/09/2014.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Aggression, Clumsiness, Drooling, Fine motor delay, Gait disturbance
Clinical narrative: Regression on development including speech (sounds, words, mouth movements), motor (clumsy, tripping), and fine motor (grasping, hand movement and control, etc.). Began drooling immensely. Increased aggression and tantrums.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Motor developmental delay, Speech disorder developmental
Clinical narrative: Regression on development including speech (sounds, words, mouth movements), motor (clumsy, tripping), and fine motor (grasping, hand movement and control, etc.). Began drooling immensely. Increased aggression and tantrums.
Age: 0.75
Sex: F
Vaccine: FLUX, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Redness at injection site exceeding 2 inches in diameter, fever 100.4 degrees F, pain at injection site, inflammation at injection site not relieved by otc anti-inflammatory's, injection site hard and hot to the touch. Received PCV-13, Influenza Inactivated, HIB.
Age: 0.75
Sex: F
Vaccine: FLUX, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Redness at injection site exceeding 2 inches in diameter, fever 100.4 degrees F, pain at injection site, inflammation at injection site not relieved by otc anti-inflammatory's, injection site hard and hot to the touch. Received PCV-13, Influenza Inactivated, HIB.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Patient called to report that his arm hurts more, he feels like he has a fever and the left side of his face feels tingly.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Increased upper airway secretion, Laboratory test, Pyrexia, Vomiting
Clinical narrative: Vomiting; felt feverish; excess phlegm in the throat. IV fluid bolus, ondansetron, lab.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Productive cough, Pyrexia
Clinical narrative: Literally, one minute fine, next miserable. Sudden on-set of uncontrolled sneezing.  Rapid onset of copious amounts of nasal mucus.  Sudden on-set of uncontrolled coughing, wheezing, "wet" cough.  Tight chest, fluid in the chest. Took Claritin D (24 hour) - minimal effect.  Mild fever (100 degrees).  5 hours later still trouble breathing, sinuses clogged, chest still "heavy", coughing - but better!  NOTE: had already taken daily anti-histamine.  Working in home office.  Windows closed.  No environmental change, just one minute fine, the next horrible respiratory reaction.  Only thing different this day - flu vaccination. No history of vaccine reaction (I get them every year at this time).
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Respiratory tract congestion, Rhinorrhoea, Sinus congestion, Sneezing, Wheezing
Clinical narrative: Literally, one minute fine, next miserable. Sudden on-set of uncontrolled sneezing.  Rapid onset of copious amounts of nasal mucus.  Sudden on-set of uncontrolled coughing, wheezing, "wet" cough.  Tight chest, fluid in the chest. Took Claritin D (24 hour) - minimal effect.  Mild fever (100 degrees).  5 hours later still trouble breathing, sinuses clogged, chest still "heavy", coughing - but better!  NOTE: had already taken daily anti-histamine.  Working in home office.  Windows closed.  No environmental change, just one minute fine, the next horrible respiratory reaction.  Only thing different this day - flu vaccination. No history of vaccine reaction (I get them every year at this time).
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Pain in extremity, Urticaria
Clinical narrative: Swelling spreading into elbow, pain that is growing down my arm into my hand, hives developed overnight after vaccine.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, X-ray limb
Clinical narrative: Pt's arm felt sore that afternoon and the pain has persisted since. She c/o of pain from deltoid/shoulder radiating to wrist. +numbness in fingertips intermittently which she notes is new.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever - 100 - 101;  aching; injection site is swollen and red and the area is getting larger since Wednesday, 10/1/14. Patient went to a walk-in clinic and was told by on call physician that the reaction was common.  She saw another physician whom prescribed her Bactrim ds (1 tablet by mouth twice daily for 10 days.)
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness at injection site and warmth at injection site, also mild pain/soreness at injection site.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Epistaxis, Inappropriate schedule of drug administration, Injection site pruritus
Clinical narrative: Case number PHEH2014US016691 is an initial spontaneous report received from the physician assistant on 19 Aug 2014 with a follow up report received from the physician assistant on 30 Sep 2014. This report refers to a 13 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with one dose of MENVEO (batch number: X12004/A12004) intramuscularly on 04 May 2014 and with another dose of MENVEO (batch number: A12004) at a dose of 0.5 ml, intramuscularly into her right deltoid on 19 Aug 2014 at 12:00 PM respectively (inappropriate schedule of vaccine administered). On 19 Aug 2014, she was also vaccinated with BOOSTRIX (other manufacturer, batch number: T25EG) at a dose of 0.5 ml, intramuscularly into her left deltoid. It was reported that she initially experienced itching at the injection site, diarrhoea, upset stomach and was sleepy after vaccination which caused her to rest her head. She also had an episode of nose bleed. On an unspecified date, she was hospitalized for an unspecified duration and she completely recovered from the events. She was seen by a PCP after a week which coincided with her yearly visit and no adverse events were noted during the visit. The reporter spoke to the patient's father after a few days and the patient was reported to be fine. The events were reported as serious (hospitalization) and causality of the events was not reported. Follow up report was received from the physician assistant on 30 Sep 2014: Updated the date of vaccination of initial dose of MENVEO, the anatomical site of vaccine administration and time of vaccination of the latter dose of MENVEO, co-suspect vaccination, events (diarrhoea, upset stomach and nose bleed), seriousness and causality of the events, outcome of the events and reporter's comments.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Somnolence
Clinical narrative: Case number PHEH2014US016691 is an initial spontaneous report received from the physician assistant on 19 Aug 2014 with a follow up report received from the physician assistant on 30 Sep 2014. This report refers to a 13 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with one dose of MENVEO (batch number: X12004/A12004) intramuscularly on 04 May 2014 and with another dose of MENVEO (batch number: A12004) at a dose of 0.5 ml, intramuscularly into her right deltoid on 19 Aug 2014 at 12:00 PM respectively (inappropriate schedule of vaccine administered). On 19 Aug 2014, she was also vaccinated with BOOSTRIX (other manufacturer, batch number: T25EG) at a dose of 0.5 ml, intramuscularly into her left deltoid. It was reported that she initially experienced itching at the injection site, diarrhoea, upset stomach and was sleepy after vaccination which caused her to rest her head. She also had an episode of nose bleed. On an unspecified date, she was hospitalized for an unspecified duration and she completely recovered from the events. She was seen by a PCP after a week which coincided with her yearly visit and no adverse events were noted during the visit. The reporter spoke to the patient's father after a few days and the patient was reported to be fine. The events were reported as serious (hospitalization) and causality of the events was not reported. Follow up report was received from the physician assistant on 30 Sep 2014: Updated the date of vaccination of initial dose of MENVEO, the anatomical site of vaccine administration and time of vaccination of the latter dose of MENVEO, co-suspect vaccination, events (diarrhoea, upset stomach and nose bleed), seriousness and causality of the events, outcome of the events and reporter's comments.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Local swelling, Skin warm
Clinical narrative: ARM SWOLLEN SHOULDER TO ELBOW, RED, HOT MD DIAGNOSED AS CELLULITIS.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Musculoskeletal stiffness
Clinical narrative: ARM SWOLLEN SHOULDER TO ELBOW, RED, HOT MD DIAGNOSED AS CELLULITIS.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: FEVER 102 DEGREES. RIGHT ARM AFFECTED - INJECTION SITE WAS HOT TO THE TOUCH AND SWOLLEN WITH SEVERE REDNESS LASTING 4 DAYS.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: Blisters at the site with f
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Bruise a little larger than a quarter size.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHEH2014US019976 is an initial spontaneous report from the physician received on 02 Oct 2014. This report refers to a male patient of an unknown age. His vaccination history included MMR vaccine (other manufacturer and batch number: not reported) and had an anaphylactic reaction to it and he also received varicella vaccine (other manufacturer and batch number: not reported) and had allergic reaction to it. His current condition included asthma. He was allergic to peanuts. He was vaccinated with flu shot (manufacturer and batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on an unknown date (06 years of age at the time of vaccination). On an unknown date, after vaccination he had an anaphylaxis. The outcome of the event was unknown. The seriousness and causality of the event were not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Dizziness, Feeling abnormal, Feeling of body temperature change, Hypoglycaemia
Clinical narrative: This case was reported by a physician and described the occurrence of nearly passed out in a 36-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, 45 min after receiving FLUVIRAL, the patient experienced nearly passed out (serious criteria GSK medically significant and clinically significant/intervention required), lightheaded, feel thirsty, feeling hot and cold and seeing spots. On an unknown date, the patient experienced product complaint. On 27th September 2014, the outcome of the nearly passed out, lightheaded, feel thirsty, feeling hot and cold and seeing spots were recovered/resolved. On an unknown date, the outcome of the product complaint was not reported. The reporter considered the nearly passed out, lightheaded, feel thirsty, feeling hot and cold and seeing spots to be probably related to FLUVIRAL. Additional details received: The patient did not have breakfast on 26th September 2014 morning. She received FLUVIRAL at 8:30. She felt lightheaded as if she was going to pass out at 9:15. She drank some water and sat down, but continued to teach. After the class, she had some popcorn, drank more water and felt better. Then she felt thirsty, and hot and then cold. She was seeing spots at 10 and sat down again. She had a coke at 10:45. She felt a lot better after lunch but not quite herself throughout the day. On 27th September 2014 morning, after her normal breakfast of a protein shake, she felt normal again. She indicated that she didn't think she got the flu vaccine because her arm was not sore (she didn't have to sleep on her left side, which she always does after receiving a flu vaccine, because she is left-handed and always gets her flu vaccine on her right arm). The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.                     Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Product quality issue, Thirst, Visual impairment, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of nearly passed out in a 36-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, 45 min after receiving FLUVIRAL, the patient experienced nearly passed out (serious criteria GSK medically significant and clinically significant/intervention required), lightheaded, feel thirsty, feeling hot and cold and seeing spots. On an unknown date, the patient experienced product complaint. On 27th September 2014, the outcome of the nearly passed out, lightheaded, feel thirsty, feeling hot and cold and seeing spots were recovered/resolved. On an unknown date, the outcome of the product complaint was not reported. The reporter considered the nearly passed out, lightheaded, feel thirsty, feeling hot and cold and seeing spots to be probably related to FLUVIRAL. Additional details received: The patient did not have breakfast on 26th September 2014 morning. She received FLUVIRAL at 8:30. She felt lightheaded as if she was going to pass out at 9:15. She drank some water and sat down, but continued to teach. After the class, she had some popcorn, drank more water and felt better. Then she felt thirsty, and hot and then cold. She was seeing spots at 10 and sat down again. She had a coke at 10:45. She felt a lot better after lunch but not quite herself throughout the day. On 27th September 2014 morning, after her normal breakfast of a protein shake, she felt normal again. She indicated that she didn't think she got the flu vaccine because her arm was not sore (she didn't have to sleep on her left side, which she always does after receiving a flu vaccine, because she is left-handed and always gets her flu vaccine on her right arm). The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.                     Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Hyperhidrosis, Hypoglycaemia, Nausea
Clinical narrative: This case was reported by a physician and described the occurrence of hypoglycemia in a adult female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, less than a day after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria clinically significant/intervention required), seizures (serious criteria GSK medically significant and clinically significant/intervention required), nausea, lightheaded, sweating, shaky and product complaint. On an unknown date, the outcome of the hypoglycemia, seizures, nausea, lightheaded, sweating, shaky and product complaint were unknown. The reporter considered the hypoglycemia, seizures, nausea, lightheaded, sweating and shaky to be probably related to FLUVIRAL. Additional details received: Despite several attempts, the subject could not be contacted. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Sex: F
Vaccine: FLU3
Symptoms: Product quality issue, Tremor, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of hypoglycemia in a adult female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, less than a day after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria clinically significant/intervention required), seizures (serious criteria GSK medically significant and clinically significant/intervention required), nausea, lightheaded, sweating, shaky and product complaint. On an unknown date, the outcome of the hypoglycemia, seizures, nausea, lightheaded, sweating, shaky and product complaint were unknown. The reporter considered the hypoglycemia, seizures, nausea, lightheaded, sweating and shaky to be probably related to FLUVIRAL. Additional details received: Despite several attempts, the subject could not be contacted. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Hypoglycaemia, Nausea, Product quality issue
Clinical narrative: This case was reported by a physician and described the occurrence of hypoglycemia in a adult female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, less than a day after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria clinically significant/intervention required), lightheaded, nausea, sweating and shaky. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the hypoglycemia, lightheaded, nausea, sweating, shaky and product complaint were unknown. The reporter considered the hypoglycemia, lightheaded, nausea, sweating and shaky to be probably related to FLUVIRAL. Additional details received: The only information received about this subject was that she had had lunch before the vaccination. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of hypoglycemia in a adult female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, less than a day after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria clinically significant/intervention required), lightheaded, nausea, sweating and shaky. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the hypoglycemia, lightheaded, nausea, sweating, shaky and product complaint were unknown. The reporter considered the hypoglycemia, lightheaded, nausea, sweating and shaky to be probably related to FLUVIRAL. Additional details received: The only information received about this subject was that she had had lunch before the vaccination. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 1.89
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Decreased appetite, Decreased interest, Diarrhoea, Feeling abnormal
Clinical narrative: Diarrhea following vaccine - immediate...till present. Low grade fever - climbed to 102 for few days. Very swollen glands. Change in behavior - foggy - lethargic - lack of interest. Not sleeping - (twitching in sleep). Loss of appetite - (lost more than 1 pound in 4 days). Full body measles rash (4 days) puffy cheeks/eyes, eyes photosensitive to sun, bright light. 1 month plus.
Age: 1.89
Sex: M
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Insomnia, Lethargy, Lymphadenopathy, Measles
Clinical narrative: Diarrhea following vaccine - immediate...till present. Low grade fever - climbed to 102 for few days. Very swollen glands. Change in behavior - foggy - lethargic - lack of interest. Not sleeping - (twitching in sleep). Loss of appetite - (lost more than 1 pound in 4 days). Full body measles rash (4 days) puffy cheeks/eyes, eyes photosensitive to sun, bright light. 1 month plus.
Age: 1.89
Sex: M
Vaccine: MMR
Symptoms: Morbillivirus test positive, Muscle twitching, Photophobia, Pyrexia, Swelling face
Clinical narrative: Diarrhea following vaccine - immediate...till present. Low grade fever - climbed to 102 for few days. Very swollen glands. Change in behavior - foggy - lethargic - lack of interest. Not sleeping - (twitching in sleep). Loss of appetite - (lost more than 1 pound in 4 days). Full body measles rash (4 days) puffy cheeks/eyes, eyes photosensitive to sun, bright light. 1 month plus.
Age: 1.89
Sex: M
Vaccine: MMR
Symptoms: Weight decreased
Clinical narrative: Diarrhea following vaccine - immediate...till present. Low grade fever - climbed to 102 for few days. Very swollen glands. Change in behavior - foggy - lethargic - lack of interest. Not sleeping - (twitching in sleep). Loss of appetite - (lost more than 1 pound in 4 days). Full body measles rash (4 days) puffy cheeks/eyes, eyes photosensitive to sun, bright light. 1 month plus.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Aphasia, Cold sweat, Headache, Hypoglycaemia
Clinical narrative: This case was reported by a physician and described the occurrence of possibly passed out in a 54-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, less than a day after receiving FLUVIRAL, the patient experienced possibly passed out (serious criteria GSK medically significant and clinically significant/intervention required), cold sweat, heart racing, feeling like passing out, incoherent speech, difficulty finding words and headache. On an unknown date, the patient experienced product complaint. On 26th September 2014, the outcome of the possibly passed out, cold sweat, heart racing, feeling like passing out, incoherent speech and difficulty finding words were recovered/resolved. On an unknown date, the outcome of the headache and product complaint were unknown. The reporter considered the possibly passed out, cold sweat, heart racing, feeling like passing out, incoherent speech, difficulty finding words and headache to be probably related to FLUVIRAL. Additional details received: The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06 October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Incoherent, Palpitations, Product quality issue, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of possibly passed out in a 54-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, less than a day after receiving FLUVIRAL, the patient experienced possibly passed out (serious criteria GSK medically significant and clinically significant/intervention required), cold sweat, heart racing, feeling like passing out, incoherent speech, difficulty finding words and headache. On an unknown date, the patient experienced product complaint. On 26th September 2014, the outcome of the possibly passed out, cold sweat, heart racing, feeling like passing out, incoherent speech and difficulty finding words were recovered/resolved. On an unknown date, the outcome of the headache and product complaint were unknown. The reporter considered the possibly passed out, cold sweat, heart racing, feeling like passing out, incoherent speech, difficulty finding words and headache to be probably related to FLUVIRAL. Additional details received: The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06 October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Convulsion, Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: After about 5 minutes after Tdap (ADACEL) (Rt) deltoid (IM) pt started with light headache, then jerky contraction of his extremities and body with eyes staring at the ceiling then pt returns to normal status, his VS stable.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dyskinesia, Headache, Staring
Clinical narrative: After about 5 minutes after Tdap (ADACEL) (Rt) deltoid (IM) pt started with light headache, then jerky contraction of his extremities and body with eyes staring at the ceiling then pt returns to normal status, his VS stable.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain that lasted for almost 3 weeks.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Soreness came on in a couple of hours in left deltoid. The intensity vacillates from mild to severe pain. Restricting my use of the arm. This has been 33 days and counting.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Ear discomfort, Hypoaesthesia, Migraine, Paraesthesia
Clinical narrative: Complained of tingling/numbness left side of face and felt as if something was penetrating her left ear canal. Sent to urgent care.
Age: 31.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Parotid gland enlargement
Clinical narrative: Developed rt sided parotid swelling secondary to administration of MMR vaccine 1st MMR - 8/25/14 2nd MMR - 9/23/14.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Erythema, Injection site pain, Local swelling, Skin warm
Clinical narrative: Childs left arm was swollen, red and warm. Child had pain from deltoid to elbow. Tx: BENADRYL warm and cold compress PRN ASAP PRN.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Day of shot -> fever, sore throat, cough, and congestion.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythematous induration on the left deltoid area with tenderness distinct margins no axillary lymph node involvement no fever - no vomiting no respiratory distress. Treated with 10 day course of AUGMENTIN orally.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Severe pain, swelling, red itchy body ache.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Diarrhoea, Headache, Hyperhidrosis, Pain
Clinical narrative: Headache, diarrhea, hot and cold sweats body aches.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Heart rate increased, Vomiting
Clinical narrative: Shot at 12:30 6 pm - Fast heartrate 8 pm - vomiting and felt bad (possibly fever) took 24 hours to feel normal again.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: The morning after the pt. received the vaccine, she said she had a headache. Over the next 2 days, the injection site became more and more sore and hot. Eventually an area of redness/irritation had formed approximately 4 inches in diameter. As of today, the pt. says the soreness is gone and the itching seems to be going away. 10/5/14 at 7:10 pm.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Skin irritation
Clinical narrative: The morning after the pt. received the vaccine, she said she had a headache. Over the next 2 days, the injection site became more and more sore and hot. Eventually an area of redness/irritation had formed approximately 4 inches in diameter. As of today, the pt. says the soreness is gone and the itching seems to be going away. 10/5/14 at 7:10 pm.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever - 105.2 degrees F. Pt reports (+) chills, cough, headache, pain at injection site started about 5 hours ago. Pt. treated with TYLENOL 1000 mg and ibuprofen 800 mg.
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pain, Vomiting
Clinical narrative: 4 hours after vaccination pt experienced body chills/aches, vomiting, and diarrhea. Symptoms had passed by 10/3/14 AM when he called us.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Haematemesis, Syncope
Clinical narrative: Pt was administered the flu shot at a flu clinic and experienced syncope and vomiting blood within 5 minutes.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash on arm that influenza vaccine about 8 cm in circumference. Received at school on 10/7/14.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Cellulitis, Dehydration, Nausea, Pain
Clinical narrative: 2 days following vaccines (FLUVIRIN, PNEUMOVAX, ZOSTAVAX) developed cellulitis of vaccinated arm - all 3 vaccines in left arm per request. Seen in ER 10/4/14 - Rx's for antibiotics/anti nausea/pain given - also received IV fluids due to nausea/dehydration.
Age: 28.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site anaesthesia, Pain in extremity, Sensation of foreign body
Clinical narrative: Pain with foreign body sensation to arm. Fluctuance to injection site with numbness 14 days s/p vaccination. Will R/O abscess.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Fatigue, Injection site swelling, Pain, Skin warm
Clinical narrative: Symptoms included swelling at the site, arm warm to touch, felt tired, extremely painful. Went to emergency room on 10/5/14. Patient stated she had a cellulitis.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Feeling cold, Malaise, Swelling face, Tremor
Clinical narrative: Pt. states had flu shot and never had one before. States became sick at 6 pm - was shaky, cold and didn't feel good no fever. Went to ER and was given Ibuprofen. This morning had swelling under eyes otherwise states "fine now".
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Arm turned red and warm -> large area about 4 inches. Starting to fade as of 10/9/14. Pt went to the doctor, was told to wait.
Age: 21.0
Sex: M
Vaccine: FLUC3
Symptoms: Syncope
Clinical narrative: Syncope ... lasted 5-10 seconds. Symptomatic treatment for 5 minutes. No medical treatment sought.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient received FLUVIRIN on 10/1/14 in left upper arm. Pt. claims on 10/9/14 her arm is in excruciating pain and shoots into her neck. Told patient contact MD, take MOTRIN and use ice on arm.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient received FLUVIRIN on 10/1/14 in left upper arm. Pt. claims on 10/9/14 her arm is in excruciating pain and shoots into her neck. Told patient contact MD, take MOTRIN and use ice on arm.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Red, itchy.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Approximately 5 mins later, pt complained of pain in legs and could not move legs. Medics were called and about 10 mins later pt felt all fine and refused hospital.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Injection site erythema, Local swelling
Clinical narrative: Left arm swelling, redness from deltoid to elbow and cough. Primary care provider believes it was the influenza vaccine that caused reaction.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dysstasia, Fatigue, Gait disturbance, Headache
Clinical narrative: Muscle aches, muscle weakness - hard time getting up/walking. Fatigue. Headaches. Shivering/chills. Facial swelling.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Myalgia, Swelling face
Clinical narrative: Muscle aches, muscle weakness - hard time getting up/walking. Fatigue. Headaches. Shivering/chills. Facial swelling.
Age: 3.0
Sex: F
Vaccine: FLU3, HEPA, MMR
Symptoms: Wrong drug administered
Clinical narrative: Pt. and sibling both given immunizations, tray with immunizations labeled, but given to wrong patient.
Age: 2.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Pt. and sibling both given immunizations. Tray with immunizations labeled correctly, but given to wrong patient.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and urticaria pruritus.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received 1.0ml of influenza vaccine. Progress call to parent on 9/19/14 - no fever and no sore arm, redness or swelling at site.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN4, IPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Hive around injection site of PROQUAD - 48 hrs after vaccine was given, rx: BENADRYL mother observer - to return to office if worsens.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: Nausea.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Allergy to vaccine, Erythema, Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: On 9/15/14, pt received PNEUMOVAX 23 in right upper arm and FLUZONE HD in left upper arm. Right arm was sore the next day. On Wednesday 9/17 I was called for advice. The patients right arm was red and warm to the touch from below the injection site to his elbow but not painful. He was advised to contact his physician. After showering, he noticed redness between his legs both front and back. He called his doctor and drove to the office. Approximately 3-4 hours after I saw him, the redness spread to both thighs. At the office the doctor observed him front and back and also noted redness on left lower arm between elbow and wrist. The physician told the patient he was allergic to something in the vaccine. He was also told not to have these vaccines again. (His wife also received both vaccines without incident). The patient was told to take BENADRYL and was given an rx for a MEDROL Dosepak. He took BENADRYL the night of 9/17/14 and began the methylprednisolone Dosepak on the 18th. His rash was mostly resolved by 9/21, with slight redness in the perineum. He was able to on vacation then next week, although feeling a bit tired.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: On 9/15/14, pt received PNEUMOVAX 23 in right upper arm and FLUZONE HD in left upper arm. Right arm was sore the next day. On Wednesday 9/17 I was called for advice. The patients right arm was red and warm to the touch from below the injection site to his elbow but not painful. He was advised to contact his physician. After showering, he noticed redness between his legs both front and back. He called his doctor and drove to the office. Approximately 3-4 hours after I saw him, the redness spread to both thighs. At the office the doctor observed him front and back and also noted redness on left lower arm between elbow and wrist. The physician told the patient he was allergic to something in the vaccine. He was also told not to have these vaccines again. (His wife also received both vaccines without incident). The patient was told to take BENADRYL and was given an rx for a MEDROL Dosepak. He took BENADRYL the night of 9/17/14 and began the methylprednisolone Dosepak on the 18th. His rash was mostly resolved by 9/21, with slight redness in the perineum. He was able to on vacation then next week, although feeling a bit tired.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Local swelling, Rash
Clinical narrative: On 9/15/14, pt received PNEUMOVAX 23 in right upper arm and FLUZONE HD in left upper arm. Right arm was sore the next day. On Wednesday 9/17 I was called for advice. The patients right arm was red and warm to the touch from below the injection site to his elbow but not painful. He was advised to contact his physician. After showering, he noticed redness between his legs both front and back. He called his doctor and drove to the office. Approximately 3-4 hours after I saw him, the redness spread to both thighs. At the office the doctor observed him front and back and also noted redness on left lower arm between elbow and wrist. The physician told the patient he was allergic to something in the vaccine. He was also told not to have these vaccines again. (His wife also received both vaccines without incident). The patient was told to take BENADRYL and was given an rx for a MEDROL Dosepak. He took BENADRYL the night of 9/17/14 and began the methylprednisolone Dosepak on the 18th. His rash was mostly resolved by 9/21, with slight redness in the perineum. He was able to on vacation then next week, although feeling a bit tired.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Skin warm
Clinical narrative: On 9/15/14, pt received PNEUMOVAX 23 in right upper arm and FLUZONE HD in left upper arm. Right arm was sore the next day. On Wednesday 9/17 I was called for advice. The patients right arm was red and warm to the touch from below the injection site to his elbow but not painful. He was advised to contact his physician. After showering, he noticed redness between his legs both front and back. He called his doctor and drove to the office. Approximately 3-4 hours after I saw him, the redness spread to both thighs. At the office the doctor observed him front and back and also noted redness on left lower arm between elbow and wrist. The physician told the patient he was allergic to something in the vaccine. He was also told not to have these vaccines again. (His wife also received both vaccines without incident). The patient was told to take BENADRYL and was given an rx for a MEDROL Dosepak. He took BENADRYL the night of 9/17/14 and began the methylprednisolone Dosepak on the 18th. His rash was mostly resolved by 9/21, with slight redness in the perineum. He was able to on vacation then next week, although feeling a bit tired.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site pain
Clinical narrative: Patient received ZOSTAVAX 9/27/14, had symptoms of pain and redness 9/29/14 at injection site. Was told by urgent care that it was infected and given antibiotics for 1 wk course.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Myalgia
Clinical narrative: Muscle ache/soreness at site, red "welts" by bedtime 10/6/14 all welts gone no further symptoms.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Pain, Pyrexia, Urticaria, White blood cell count increased
Clinical narrative: Pain, redness, hives, fever. Right deltoid, antibiotics administreed for possible cellulitis. Ceftriaxone and Doxycycline.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Hypoaesthesia, Paraesthesia, Rash, Rash erythematous
Clinical narrative: The next day after receiving the flu vaccine, she noticed a bright red rash to her upper chest, numbness and tingling to her face, itchy eyes. No fever, no hives, no swelling, no shortness of breath/ difficulty breathing, no increased HR. She took BENADRYL and rash and itching subsided. Ibuprofen 40 mg x one day given by NP. She reported similar reactions in previous years. She was referred to PMD for follow-up.
Age: 0.08
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient came to office to receive 2nd hepatitis B vaccine and influenza vaccine was administered instead. CDC contacted. Mom states no adverse reactions.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Erythema, Local swelling, Lymphadenopathy
Clinical narrative: Red swollen arm and lymph nodes. cellulitis
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Headache, Insomnia, Ocular hyperaemia, Pain
Clinical narrative: Next day: 10/06/14 Body ache, chills, severe headache, insomnia, severe puffy eyes (eyelids completely covered eyes), eye redness, yellow crust discharge - Patient went to acute care. Patient came back to Pharmacy on 10/8/14. Symptoms gone and she reported no more ADR's.