chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU(H1N1), VARZOS
Symptoms: Anaemia, Arthralgia, Asthenia, Blood potassium decreased, C-reactive protein increased
Clinical narrative: 2010. A 60-year-old female patient received an intramuscular left deltoid injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UT068HH, not a valid sanofi pasteur lot number) and ZOSTAVAX (Merck, lot number 0961Y) on 11 March 2010. The patient had a history of migraine, chronic fatigue syndrome, fibromyalgia, insomnia, recurrent urinary tract infections, right knee arthroplasty (2008), hysterectomy (20 years ago), and vaginal reconstruction (3 years ago). Drug allergies included Sulfa, BACTRIM, Codeine, Erythromycin, CIPRO, and DILAUDID. Concomitant medications included ATIVAN, CALAN-CR, HIPREX, NEXIUM, TOPAMAX, and Trazodone. The patient denied any previous events following receipt of vaccines, and denied acute illness at the time of vaccination. On 12 March 2010, one day post-vaccination, the patient presented to the emergency room with fever (reported as 103 degrees), severe pain in both legs, generalized weakness, and body aches. The pain was initially in the right knee, but quickly spread to her hands, back, shoulders, groin, knees, and neck. It was described as 10/10, acute, and sharp. She also complained of some nausea, and a headache beginning 11 March 2010. She was treated in the emergency room with Morphine with partial relief. Physical exam was essentially negative. Diagnostic data showed an elevated C-reactive protein (21.3). She was admitted to the hospital with a diagnosis of fever, myalgia, and arthralgia, which the physician noted was "due to vaccination yesterday". On 13 March 2010 the patient underwent an orthopedic consult, during which 45ml of fluid was aspirated from a right knee effusion. The patient was started on ANCEF due to the cloudiness of the fluid; however, subsequent cultures revealed no growth x 2 days, and antibiotics were discontinued. She was also started on "round-the-clock" MOTRIN. During hospitalization she was noted to have mild anemia and mild hypokalemia; potassium was replaced during hospitalization. Her blood pressure was also low, and CALAN dosage was decreased. On 15 March 2010 she was discharged from the hospital, and at that time it was noted that she was "doing better and her joint aches and pains are also resolved".
Age: 60.0
Sex: F
Vaccine: FLU(H1N1), VARZOS
Symptoms: Culture negative, Evans syndrome, Groin pain, Haemoglobin decreased, Headache
Clinical narrative: 2010. A 60-year-old female patient received an intramuscular left deltoid injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UT068HH, not a valid sanofi pasteur lot number) and ZOSTAVAX (Merck, lot number 0961Y) on 11 March 2010. The patient had a history of migraine, chronic fatigue syndrome, fibromyalgia, insomnia, recurrent urinary tract infections, right knee arthroplasty (2008), hysterectomy (20 years ago), and vaginal reconstruction (3 years ago). Drug allergies included Sulfa, BACTRIM, Codeine, Erythromycin, CIPRO, and DILAUDID. Concomitant medications included ATIVAN, CALAN-CR, HIPREX, NEXIUM, TOPAMAX, and Trazodone. The patient denied any previous events following receipt of vaccines, and denied acute illness at the time of vaccination. On 12 March 2010, one day post-vaccination, the patient presented to the emergency room with fever (reported as 103 degrees), severe pain in both legs, generalized weakness, and body aches. The pain was initially in the right knee, but quickly spread to her hands, back, shoulders, groin, knees, and neck. It was described as 10/10, acute, and sharp. She also complained of some nausea, and a headache beginning 11 March 2010. She was treated in the emergency room with Morphine with partial relief. Physical exam was essentially negative. Diagnostic data showed an elevated C-reactive protein (21.3). She was admitted to the hospital with a diagnosis of fever, myalgia, and arthralgia, which the physician noted was "due to vaccination yesterday". On 13 March 2010 the patient underwent an orthopedic consult, during which 45ml of fluid was aspirated from a right knee effusion. The patient was started on ANCEF due to the cloudiness of the fluid; however, subsequent cultures revealed no growth x 2 days, and antibiotics were discontinued. She was also started on "round-the-clock" MOTRIN. During hospitalization she was noted to have mild anemia and mild hypokalemia; potassium was replaced during hospitalization. Her blood pressure was also low, and CALAN dosage was decreased. On 15 March 2010 she was discharged from the hospital, and at that time it was noted that she was "doing better and her joint aches and pains are also resolved".
Age: 60.0
Sex: F
Vaccine: FLU(H1N1), VARZOS
Symptoms: Hypokalaemia, Hypotension, Joint effusion, Musculoskeletal pain, Myalgia
Clinical narrative: 2010. A 60-year-old female patient received an intramuscular left deltoid injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UT068HH, not a valid sanofi pasteur lot number) and ZOSTAVAX (Merck, lot number 0961Y) on 11 March 2010. The patient had a history of migraine, chronic fatigue syndrome, fibromyalgia, insomnia, recurrent urinary tract infections, right knee arthroplasty (2008), hysterectomy (20 years ago), and vaginal reconstruction (3 years ago). Drug allergies included Sulfa, BACTRIM, Codeine, Erythromycin, CIPRO, and DILAUDID. Concomitant medications included ATIVAN, CALAN-CR, HIPREX, NEXIUM, TOPAMAX, and Trazodone. The patient denied any previous events following receipt of vaccines, and denied acute illness at the time of vaccination. On 12 March 2010, one day post-vaccination, the patient presented to the emergency room with fever (reported as 103 degrees), severe pain in both legs, generalized weakness, and body aches. The pain was initially in the right knee, but quickly spread to her hands, back, shoulders, groin, knees, and neck. It was described as 10/10, acute, and sharp. She also complained of some nausea, and a headache beginning 11 March 2010. She was treated in the emergency room with Morphine with partial relief. Physical exam was essentially negative. Diagnostic data showed an elevated C-reactive protein (21.3). She was admitted to the hospital with a diagnosis of fever, myalgia, and arthralgia, which the physician noted was "due to vaccination yesterday". On 13 March 2010 the patient underwent an orthopedic consult, during which 45ml of fluid was aspirated from a right knee effusion. The patient was started on ANCEF due to the cloudiness of the fluid; however, subsequent cultures revealed no growth x 2 days, and antibiotics were discontinued. She was also started on "round-the-clock" MOTRIN. During hospitalization she was noted to have mild anemia and mild hypokalemia; potassium was replaced during hospitalization. Her blood pressure was also low, and CALAN dosage was decreased. On 15 March 2010 she was discharged from the hospital, and at that time it was noted that she was "doing better and her joint aches and pains are also resolved".
Age: 60.0
Sex: F
Vaccine: FLU(H1N1), VARZOS
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: 2010. A 60-year-old female patient received an intramuscular left deltoid injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UT068HH, not a valid sanofi pasteur lot number) and ZOSTAVAX (Merck, lot number 0961Y) on 11 March 2010. The patient had a history of migraine, chronic fatigue syndrome, fibromyalgia, insomnia, recurrent urinary tract infections, right knee arthroplasty (2008), hysterectomy (20 years ago), and vaginal reconstruction (3 years ago). Drug allergies included Sulfa, BACTRIM, Codeine, Erythromycin, CIPRO, and DILAUDID. Concomitant medications included ATIVAN, CALAN-CR, HIPREX, NEXIUM, TOPAMAX, and Trazodone. The patient denied any previous events following receipt of vaccines, and denied acute illness at the time of vaccination. On 12 March 2010, one day post-vaccination, the patient presented to the emergency room with fever (reported as 103 degrees), severe pain in both legs, generalized weakness, and body aches. The pain was initially in the right knee, but quickly spread to her hands, back, shoulders, groin, knees, and neck. It was described as 10/10, acute, and sharp. She also complained of some nausea, and a headache beginning 11 March 2010. She was treated in the emergency room with Morphine with partial relief. Physical exam was essentially negative. Diagnostic data showed an elevated C-reactive protein (21.3). She was admitted to the hospital with a diagnosis of fever, myalgia, and arthralgia, which the physician noted was "due to vaccination yesterday". On 13 March 2010 the patient underwent an orthopedic consult, during which 45ml of fluid was aspirated from a right knee effusion. The patient was started on ANCEF due to the cloudiness of the fluid; however, subsequent cultures revealed no growth x 2 days, and antibiotics were discontinued. She was also started on "round-the-clock" MOTRIN. During hospitalization she was noted to have mild anemia and mild hypokalemia; potassium was replaced during hospitalization. Her blood pressure was also low, and CALAN dosage was decreased. On 15 March 2010 she was discharged from the hospital, and at that time it was noted that she was "doing better and her joint aches and pains are also resolved".
Age: 46.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Ear pruritus, Hypoaesthesia, Myelitis transverse
Clinical narrative: Initial case was received on 25 March 2010 from a healthcare professional. A 46 year old female patient received an injection (route and site not reported) of Influenza A H1N1 2009 Monovalent Vaccine - Preservative (lot number UP073AA) on 18 January 2010. Approximately one month later, on approximately 25 February 2010, the patient experienced left ear itching which then progressed to numbness in ear that spread to neck, shoulder, feet, legs and abdomen. The preliminary diagnosis was transverse myelitis. The patient is being treated daily with 1000 mg intravenous (IV) prednisolone. The patient had no illness at the time of the vaccination and no vaccinations within the 4 weeks prior. She had no adverse event following prior vaccinations. She had no known allergies and no pre-existing medical conditions. Concomitant medications were not reported. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: DTAP, FLU(H1N1), FLUN3, HEPA, MNQ
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: TIGHTNESS in his chest and shortness in of breath.
Age: 73.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Right upper arm very sore, difficult to move, can't lay on the arm. Pain is on and off. It wakes me up if I'm sleeping.
Age: 1.02
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Temperature of 99 and rash noted on body morning after vaccine. Mother called health department Monday morning with complaint of fever gone but rash continued to spread over child's entire body. Did not appear to bother child as far as itching.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Guillain-Barre syndrome, Malaise, Mobility decreased, Sensation of heaviness
Clinical narrative: Started getting sick around Thanksgiving my feet started getting numb and I started to fall (at least 3 times) My legs wouldn't work. My son had to carry me so I could get around. I got a wheelchair in order to get to the Doctor's office. Dr. did tests and I was hospitalized. My Left big toe went black. I need rehab and I can't be left alone. My arms are heavy and they don't always work either. My fingers get numb alot. My doctor told me I had Guillian-Barre Syndrome. I had no idea what that was.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration, Wheelchair user
Clinical narrative: Started getting sick around Thanksgiving my feet started getting numb and I started to fall (at least 3 times) My legs wouldn't work. My son had to carry me so I could get around. I got a wheelchair in order to get to the Doctor's office. Dr. did tests and I was hospitalized. My Left big toe went black. I need rehab and I can't be left alone. My arms are heavy and they don't always work either. My fingers get numb alot. My doctor told me I had Guillian-Barre Syndrome. I had no idea what that was.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Burning sensation, Condition aggravated, Dizziness, Dysgraphia, Erythema
Clinical narrative: C/O pain, redness and swelling at site of injection that eventually spread down her entire right arm  Couldn't write with her right hand at school next day. Arm in pain swollen from shoulder to fingers could not make a fist or lift arm from Mar. 30 10 until Apr. 6 remain swollen tender to touch with a burning sensation site still swollen & sore ran fever & dizzy.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Grip strength decreased, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: C/O pain, redness and swelling at site of injection that eventually spread down her entire right arm  Couldn't write with her right hand at school next day. Arm in pain swollen from shoulder to fingers could not make a fist or lift arm from Mar. 30 10 until Apr. 6 remain swollen tender to touch with a burning sensation site still swollen & sore ran fever & dizzy.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: C/O pain, redness and swelling at site of injection that eventually spread down her entire right arm  Couldn't write with her right hand at school next day. Arm in pain swollen from shoulder to fingers could not make a fist or lift arm from Mar. 30 10 until Apr. 6 remain swollen tender to touch with a burning sensation site still swollen & sore ran fever & dizzy.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe swelling, redness & pain around the injection site of immunization area; muscle pain & body soreness; fever & general discomfort; tiredness and general overall need for sleep lasting next several days
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Severe swelling, redness & pain around the injection site of immunization area; muscle pain & body soreness; fever & general discomfort; tiredness and general overall need for sleep lasting next several days
Age: 61.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Rash on right and right side of stomach. No itching just rash.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Snoring, Vaccine positive rechallenge
Clinical narrative: Patient had nasal H1N1 vaccination in 12/09 and had acute onset of snoring afterwards. Had second nasal spray in 2/10 and had again acute onset of snoring afterwards. Both lasted for greater than a month.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Inappropriate schedule of drug administration, Pain, Pyrexia
Clinical narrative: Fever of 103 F (axillary), headache, bodyaches.
Age: 57.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Ear pain, Emotional distress, Headache, Immunoglobulin therapy, Laboratory test
Clinical narrative: LT SIDE OF HEAD STARTED HURTING, SOME THROBBING IN LT EAR. THEN LATER IN DAY VISION TO LT EYE BECAME DIM. WENT TO A CLINIC. DR SENT ME TO A RETINAL SPECIALIST, THEN THAT DR SENT ME TO A NEUROLOGIST WHO SPECIALIZES IN MULTIPLE SCLEROSIS. HE TOLD ME I HAD OPTIC NEURITIS. HAD TO BE TREATED WITH 5 DAYS OF IV MEDS. THEN WORKED ME UP FOR MS. I AM STILL BEING TREATED BY THOSE DOCTORS TO THIS DAY. THEY ALSO SENT ME TO A IMMUNOLOGISTS BECAUSE I NOW NEED IGG. I HAVE NO HX OF ANY ILLNESSES NOR DOES MY FAMILY. I AM A REGISTERED NURSE. THIS PROBLEM (POOR VISION) NEUROPATHY AROUND MY LEFT EYE THE CHANCE OF A RELAPSE, THE MONEY IT HAS COST ME, HAS BEEN FINANCIALLY AND EMOTIONALLY DRAINING NOT TO MENTION THE FACT THAT I NOW HAVE TO HAVE THE SCAR OF BEING TAGGED AS A "OPTIC NEURITIS" PATIENT
Age: 57.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Optic neuritis, Pain, Visual impairment
Clinical narrative: LT SIDE OF HEAD STARTED HURTING, SOME THROBBING IN LT EAR. THEN LATER IN DAY VISION TO LT EYE BECAME DIM. WENT TO A CLINIC. DR SENT ME TO A RETINAL SPECIALIST, THEN THAT DR SENT ME TO A NEUROLOGIST WHO SPECIALIZES IN MULTIPLE SCLEROSIS. HE TOLD ME I HAD OPTIC NEURITIS. HAD TO BE TREATED WITH 5 DAYS OF IV MEDS. THEN WORKED ME UP FOR MS. I AM STILL BEING TREATED BY THOSE DOCTORS TO THIS DAY. THEY ALSO SENT ME TO A IMMUNOLOGISTS BECAUSE I NOW NEED IGG. I HAVE NO HX OF ANY ILLNESSES NOR DOES MY FAMILY. I AM A REGISTERED NURSE. THIS PROBLEM (POOR VISION) NEUROPATHY AROUND MY LEFT EYE THE CHANCE OF A RELAPSE, THE MONEY IT HAS COST ME, HAS BEEN FINANCIALLY AND EMOTIONALLY DRAINING NOT TO MENTION THE FACT THAT I NOW HAVE TO HAVE THE SCAR OF BEING TAGGED AS A "OPTIC NEURITIS" PATIENT
Age: 54.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Swelling face
Clinical narrative: SWOLLEN FACE ON LEFT SIDE, DIZZINESS, WEAKNESS, HIVES, CHEST PAINS SHORT OF BREATH.
Age: 54.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Urticaria
Clinical narrative: SWOLLEN FACE ON LEFT SIDE, DIZZINESS, WEAKNESS, HIVES, CHEST PAINS SHORT OF BREATH.
Age: 54.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Dyspnoea, Swelling face
Clinical narrative: SWOLLEN FACE ON LEFT SIDE, DIZZINESS, WEAKNESS, HIVES, CHEST PAINS SHORT OF BREATH.
Age: 0.21
Sex: F
Vaccine: DTAPIPV
Symptoms: Gaze palsy, Lethargy, Social avoidant behaviour, Unresponsive to stimuli
Clinical narrative: Child appeared "glazed over", exhibited lethargic behavior, lack of eye contact, lack of (normal) response to voices, stopped making (verbal) sounds.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Swollen, red rash at site of injection. Severe pain at site of injection, radiating up the left arm and to neck. Also pain at side of body. Slight fever rash & pain lasted for one week.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Swollen, red rash at site of injection. Severe pain at site of injection, radiating up the left arm and to neck. Also pain at side of body. Slight fever rash & pain lasted for one week.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Local swelling redness, raised area where shot was given, red area spreading 3 1/2 inches in diameter consistent with allergic reaction or adverse reaction.
Age: 1.53
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Localized reaction to GSK DTaP in LAT. Resulted in raised red, swollen, hot area.
Sex: U
Vaccine: DTAPIPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of fever in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). In February 2010 the subject received 1st dose of KINRIX in an unknown arm. In February 2010, at an unspecified time after vaccination with KINRIX, the subject experienced fever over 103 degrees and a swollen arm from the shoulder to the wrist. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with KINRIX. Information received via QA indicated that they have not received any other product complaints for this lot number of KINRIX. No product was available for return to GlaxoSmithKline. Quality assurance (QA) results received on 02 March 2010, concluded that based on the fact that no precise technical problem was reported, no technical investigation has been accordingly; GlaxoSmithKline Biologicals considers this complaint as not verified. This is one of two reports made by the healthcare professional, for the other case see A0846121A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of fever in a subject of unspecified age and gender who was vaccinated with KINRIX, GlaxoSmithKline for prophylaxis. In February 2010 the subject received 1st dose of KINRIX in and unknown arm. In February 2010, at an unspecified time after vaccination with KINRIX, the subject experienced fever over 103 degrees. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the even was probably related to vaccination with KINRIX. Information received via QA indicated that they have not received any other product complaints for this lot number of KINRIX. No product was available for return to GlaxoSmithKline. Quality assurance results received on 02 March 2010, concluded that based on the fact that no precise technical problem was reported, no technical investigation has been performed accordingly; GlaxoSmithKline Biologicals considers this complaint as not verified. This is second of two reports made by the healthcare professional, for the other case see A0846107A.
Age: 0.21
Sex: F
Vaccine: DTAP, IPV, PNC, RV1
Symptoms: Intussusception, No reaction on previous exposure to drug, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). There were no reported concomitant medications or relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included DTPA (non-GSK) (Sanofi) given on 8 July 2009; PREVNAR (non-GSK) (Wyeth) given on 8 July 2009; IPOL (non-GSK) (Sanofi) given on 8 July 2009. On 8 July 2009 the subject received 1st dose of ROTARIX (1 ml, oral). The lot number was reported as A410A733A. On 15 July 2009, 7 days after vaccination with ROTARIX, the subject experienced intussusception and "severe" vomiting. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The healthcare professional considered the events were probably related to vaccination with ROTARIX.  Follow-up information received on 21 August 2009 indicated that the events began on 15 July 2009 and resolved by the following day, 16 July 2009. The subject received an enema for treatment and symptoms resolved. In the reporter's opinion, the events were probably related to treatment with ROTARIX. The child did not received bowel resection. Follow-up information specifically regarding intussusception was requested but not provided.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Body temperature normal, Irritability, Pyrexia, Screaming
Clinical narrative: This case was reported by a physician and descried the occurrence of fussy in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccines given on 2 July 2009. On 2 July 2009 at 16:00 the subject received 1st dose of ROTARIX (oral). On 2 July 2009, less than one day after vaccination with ROTARIX, the subject experienced fussy, clarified as screaming. She also had a fever of 99.6. The subject was treated with unknown medication. At the time of reporting the fever was resolved. The event of fussy was unresolved, and the outcome of screaming was unknown. The vaccination course with ROTARIX was discontinued.
Age: 0.21
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a physician and described the occurrence of diarrhea in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included gastro esophageal reflux. Concurrent medications included Zantac. On 26 June 2009 the subject received 1st dose of ROTARIX (oral). On 27 May 2009, 1 day after vaccination with ROTARIX, the subject experienced diarrhea. At the time of reporting the event was unresolved.
Age: 0.3
Sex: F
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a physician, via a GSK representative and described the occurrence of vomiting in a 3-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline for prophylaxis. On an unspecified date the subject received 1st dose of ROTARIX (1 ml, oral). Four days after vaccination with ROTARIX, the subject experienced vomiting. At the time of reporting the outcome of the event was unspecified. The vaccination series with ROTARIX was delayed.
Age: 0.2
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced diarrhea. At the time of reporting the outcome of the event was unspecified. Please see case A0798921A for an additional case of diarrhea with ROTARIX reported by the consumer.
Age: 0.2
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK); non-GSK manufacturer given on an unspecified date; PNEUMOCOCCAL vaccines (non-GSK) manufacturer given on an unspecified date. On an unspecified date the subject received unspecified dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced diarrhea. At the time of reporting the outcome of the event was unspecified. Please see case A0798920A for an additional case of diarrhea with ROTARIX reported by the consumer.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included PEDIARIX; GlaxoSmithKline given on 20 July 2009; haemophilus influenzae type b vaccine (non-gsk); Sanofi Pasteur MSD given on 20 July 2009; PREVENAR; Wyeth labs given on 20 July 2009. There were no concurrent medications. On 20 July 2009 at 11:45 the subject received 2nd dose of ROTARIX (1 ml, oral). On 20 July 2009, 10 to 15 minutes after vaccination with ROTARIX, the subject experienced vomiting. At the time of reporting the outcome of the event was unspecified.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RV1
Symptoms: Body temperature normal, Pyrexia, Screaming, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of screaming in a 2-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline for prophylaxis. A physician or other health care professional has not verified this report. Concurrent vaccination included HIB; manufacturer unspecified; unknown; unknown given on 11 November 2009; DTAP; manufacturer unspecified; unknown; unknown given on 11 November 2009; HEPATITIS B; manufacturer unspecified; unknown; unknown given on 11 November 2009; PCV; non GSK manufacturer; unknown; unknown given on 11 November 2009; and POLIO; manufacturer unspecified; unknown; unknown given on 11 November 2009. On 11 November 2009 at 11:00 the subject received 1st dose of ROTARIX (oral). On 11 November 2009 around 14:00, about three hours after vaccination with ROTARIX, the subject experienced vomiting. On 11 November 2009 at 14:30, three and half hours after vaccination with ROTARIX, the subject experienced screaming. On 11 November 2009 at an unspecified time, less than one day after vaccination with ROTARIX, the subject experienced fever. Relevant test results included body temperature at 99.5 on 11 November 2009. The subject's father requested information on when he might expect his two month old that had received ROTARIX on 11 November 2009 to stop screaming. The father stated the subject received several other vaccines. The father reported the rotavirus vaccine was ROTARIX, and the others were given intramuscular (two in the right thigh and one in the left). The father did not have the lot numbers or manufacturers for the vaccines. The father reported contacting the clinic after they arrived home, but the clinic had closed. The father also reported he contacted the nurse line at the hospital, but at the time of reporting had not received a call back yet. The father had purchased some children's TYLENOL but he had not given it at the time of reporting. At the time of reporting the screaming and fever were unresolved, and vomiting was resolved
Sex: U
Vaccine: RV1, RV1
Symptoms: Vomiting projectile
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of projectile vomiting in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date at an unknown time, the subject received an unspecified dose of ROTARIX (1 injection, oral). At an unspecified time after vaccination with ROTARIX, the subject experienced projectile vomiting. The healthcare professional reported that the subject experienced projectile vomiting after getting ROTARIX. At the time of reporting the outcome of the projectile vomiting was unknown.
Sex: F
Vaccine: RV1
Symptoms: Dyspnoea, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: This case was reported by a consumer via another manufacturer and described the occurrence of swelling of lip and face in a female subject of unspecified ago who was vaccinated with ROTARIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of ROTARIX (unknown).  At an unspecified time after vaccination with ROTARIX, the subject experienced swelling of lip and face, swelling of tongue, swelling of cheek (s) and difficulty breathing.  A Merck representative learned of the adverse event on 10 November 2009.  The representative was with the subject's mother at the time of reporting and put the reporter on the phone to report the adverse event.  The subject's mother reported that her daughter experienced swelling in her lip, face, tongue, and cheeks after receiving ROTARIX.  The subject also experienced breathing difficulties after the vaccination.  No further information was given at the time of reporting.  At the time of reporting the outcome of the events were unspecified.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Abdominal pain upper, Flatulence, Incorrect route of drug administration, Irritability
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of gassiness in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilius influenza type b vaccine (Hib; manufacturer unspecified; unknown; unknown) given on 5 October 2009; PEDIARIX (GlaxoSmithKline; unknown; unknown) given on 5 October 2009; and PREVNAR (non-gsk) (Wyeth Labs; unknown; unknown) given on 5 October 2009. On 5 October 2009 at an unspecified time, the subject received 1st dose of ROTARIX (intramuscular, right thigh) and experienced inappropriate route of vaccination. On an unspecified date, an unspecified time after vaccination with ROTARIX, the subject experienced gassiness, stomach pain, and fussiness. The nurse reported that ROTARIX was administered intramuscularly instead of orally. The subject was seen nine days after maladministration and the subject continued to have fussiness and stomach pain (gassiness). No further information was provided at the time of reporting. At the time of reporting the outcome of the events was unspecified.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, PNC
Symptoms: Feeling hot, Oedema peripheral, Pyrexia
Clinical narrative: Patients mother called after taking the child home and stated patients left leg was very swollen and hot to the touch.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, PNC
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patients mother called after taking the child home and stated patients left leg was very swollen and hot to the touch.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Asthenia, Back pain, Chest discomfort, Chills, Confusional state
Clinical narrative: Chills or shivering; fatigue; general body discomfort; headache; mild fever; mild bruising; pain; redness; swelling or tenderness at the injection site; mild tiredness or weakness; muscle aches; sore throat; or stuffy nose; chest pain; rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face lips, or tongue; unusual hoarseness; kidney pain and infection.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Discomfort, Dysphonia, Erythema, Fatigue, Headache
Clinical narrative: Chills or shivering; fatigue; general body discomfort; headache; mild fever; mild bruising; pain; redness; swelling or tenderness at the injection site; mild tiredness or weakness; muscle aches; sore throat; or stuffy nose; chest pain; rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face lips, or tongue; unusual hoarseness; kidney pain and infection.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Kidney infection, Myalgia, Nasal congestion, Pain, Pruritus generalised
Clinical narrative: Chills or shivering; fatigue; general body discomfort; headache; mild fever; mild bruising; pain; redness; swelling or tenderness at the injection site; mild tiredness or weakness; muscle aches; sore throat; or stuffy nose; chest pain; rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face lips, or tongue; unusual hoarseness; kidney pain and infection.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Tenderness
Clinical narrative: Chills or shivering; fatigue; general body discomfort; headache; mild fever; mild bruising; pain; redness; swelling or tenderness at the injection site; mild tiredness or weakness; muscle aches; sore throat; or stuffy nose; chest pain; rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face lips, or tongue; unusual hoarseness; kidney pain and infection.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Asthenia, Chest discomfort, Chest pain, Chills, Contusion
Clinical narrative: Chills or shivering; fatigue; general body discomfort; headache; mild fever; mild bruising; pain; redness; swelling or tenderness at the injection site; mild tiredness or weakness; muscle aches; sore throat; or stuffy nose; chest pain; rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face lips, or tongue; unusual hoarseness; kidney pain and infection.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Discomfort, Dysphonia, Dyspnoea, Erythema, Fatigue
Clinical narrative: Chills or shivering; fatigue; general body discomfort; headache; mild fever; mild bruising; pain; redness; swelling or tenderness at the injection site; mild tiredness or weakness; muscle aches; sore throat; or stuffy nose; chest pain; rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face lips, or tongue; unusual hoarseness; kidney pain and infection.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Headache, Injection site pain, Injection site swelling, Kidney infection, Lip swelling
Clinical narrative: Chills or shivering; fatigue; general body discomfort; headache; mild fever; mild bruising; pain; redness; swelling or tenderness at the injection site; mild tiredness or weakness; muscle aches; sore throat; or stuffy nose; chest pain; rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face lips, or tongue; unusual hoarseness; kidney pain and infection.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Myalgia, Nasal congestion, Oedema mouth, Oropharyngeal pain, Pain
Clinical narrative: Chills or shivering; fatigue; general body discomfort; headache; mild fever; mild bruising; pain; redness; swelling or tenderness at the injection site; mild tiredness or weakness; muscle aches; sore throat; or stuffy nose; chest pain; rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face lips, or tongue; unusual hoarseness; kidney pain and infection.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pruritus, Pyrexia, Rash, Renal pain, Swelling face
Clinical narrative: Chills or shivering; fatigue; general body discomfort; headache; mild fever; mild bruising; pain; redness; swelling or tenderness at the injection site; mild tiredness or weakness; muscle aches; sore throat; or stuffy nose; chest pain; rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face lips, or tongue; unusual hoarseness; kidney pain and infection.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Chills or shivering; fatigue; general body discomfort; headache; mild fever; mild bruising; pain; redness; swelling or tenderness at the injection site; mild tiredness or weakness; muscle aches; sore throat; or stuffy nose; chest pain; rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face lips, or tongue; unusual hoarseness; kidney pain and infection.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Blood test, Feeling cold, Feeling hot, Hypoaesthesia, Lumbar puncture
Clinical narrative: This is a 59-year old male with no significant past medical history who presented with complaint of muscle weakness, dysphagia, and dysphonia. The weakness began in 10/2009 with painful calves -which he initially attributed to over-working his muscles while exercising-, then progressed to his upper extremities. He reports receiving his flu shot early in October, and that the weakness became worse after the injection. He was hospitalized at an outside facility in 10/2009, 11/2009, and 1/2010 with the same problem of muscle weakness and rash. On his initial admission, approximately 2 weeks after onset of symptoms, his working diagnosis was GUILLAIN-BARRE Syndrome, although his CSF evaluation was inconsistent with GUILLAIN-BARRE Syndrome. There was some speculation after the CSF evaluation that there had not been adequate time for the markers of GUILLAIN-BARRE to develop. After that discharge, he underwent a muscle biopsy, which was reported to be consistent with myositis. His wife reports that on his 11/2009 admission, he had a CK level that was ~ 22,000. He was also noted at that time to have an increasing rash surrounding his neck in a possible shawl sign. After his muscle biopsy, his working diagnosis was changed to dermatomyositis. He appeared to be improving on oral steroids until mid- to late-January when he reported increased difficulty swallowing and increased weakness. At that time, he was admitted again to an outside hospital for IV steroids. He was later transferred to our facility for increased access to specialists and sub-specialists and later management of his dysphagia. For his increasing dysphagia, he was initially started on IV Methylprednisolone, which was later changed to oral prednisone. He, also, received 3 days of IVIG with no improvement or changes in his dysphagia. Prior to discharge, he was started on Cyclophosphamide 100mg orally daily. He was, also, discharged on high dose prednisone and continues with the diagnosis of dermatomyositis secondary to flu vaccine.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Muscle spasms, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging brain, Paraesthesia
Clinical narrative: This is a 59-year old male with no significant past medical history who presented with complaint of muscle weakness, dysphagia, and dysphonia. The weakness began in 10/2009 with painful calves -which he initially attributed to over-working his muscles while exercising-, then progressed to his upper extremities. He reports receiving his flu shot early in October, and that the weakness became worse after the injection. He was hospitalized at an outside facility in 10/2009, 11/2009, and 1/2010 with the same problem of muscle weakness and rash. On his initial admission, approximately 2 weeks after onset of symptoms, his working diagnosis was GUILLAIN-BARRE Syndrome, although his CSF evaluation was inconsistent with GUILLAIN-BARRE Syndrome. There was some speculation after the CSF evaluation that there had not been adequate time for the markers of GUILLAIN-BARRE to develop. After that discharge, he underwent a muscle biopsy, which was reported to be consistent with myositis. His wife reports that on his 11/2009 admission, he had a CK level that was ~ 22,000. He was also noted at that time to have an increasing rash surrounding his neck in a possible shawl sign. After his muscle biopsy, his working diagnosis was changed to dermatomyositis. He appeared to be improving on oral steroids until mid- to late-January when he reported increased difficulty swallowing and increased weakness. At that time, he was admitted again to an outside hospital for IV steroids. He was later transferred to our facility for increased access to specialists and sub-specialists and later management of his dysphagia. For his increasing dysphagia, he was initially started on IV Methylprednisolone, which was later changed to oral prednisone. He, also, received 3 days of IVIG with no improvement or changes in his dysphagia. Prior to discharge, he was started on Cyclophosphamide 100mg orally daily. He was, also, discharged on high dose prednisone and continues with the diagnosis of dermatomyositis secondary to flu vaccine.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Sensory disturbance
Clinical narrative: This is a 59-year old male with no significant past medical history who presented with complaint of muscle weakness, dysphagia, and dysphonia. The weakness began in 10/2009 with painful calves -which he initially attributed to over-working his muscles while exercising-, then progressed to his upper extremities. He reports receiving his flu shot early in October, and that the weakness became worse after the injection. He was hospitalized at an outside facility in 10/2009, 11/2009, and 1/2010 with the same problem of muscle weakness and rash. On his initial admission, approximately 2 weeks after onset of symptoms, his working diagnosis was GUILLAIN-BARRE Syndrome, although his CSF evaluation was inconsistent with GUILLAIN-BARRE Syndrome. There was some speculation after the CSF evaluation that there had not been adequate time for the markers of GUILLAIN-BARRE to develop. After that discharge, he underwent a muscle biopsy, which was reported to be consistent with myositis. His wife reports that on his 11/2009 admission, he had a CK level that was ~ 22,000. He was also noted at that time to have an increasing rash surrounding his neck in a possible shawl sign. After his muscle biopsy, his working diagnosis was changed to dermatomyositis. He appeared to be improving on oral steroids until mid- to late-January when he reported increased difficulty swallowing and increased weakness. At that time, he was admitted again to an outside hospital for IV steroids. He was later transferred to our facility for increased access to specialists and sub-specialists and later management of his dysphagia. For his increasing dysphagia, he was initially started on IV Methylprednisolone, which was later changed to oral prednisone. He, also, received 3 days of IVIG with no improvement or changes in his dysphagia. Prior to discharge, he was started on Cyclophosphamide 100mg orally daily. He was, also, discharged on high dose prednisone and continues with the diagnosis of dermatomyositis secondary to flu vaccine.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Biopsy muscle abnormal, CSF test abnormal, Dermatomyositis, Dysphagia, Dysphonia
Clinical narrative: This is a 59-year old male with no significant past medical history who presented with complaint of muscle weakness, dysphagia, and dysphonia. The weakness began in 10/2009 with painful calves -which he initially attributed to over-working his muscles while exercising-, then progressed to his upper extremities. He reports receiving his flu shot early in October, and that the weakness became worse after the injection. He was hospitalized at an outside facility in 10/2009, 11/2009, and 1/2010 with the same problem of muscle weakness and rash. On his initial admission, approximately 2 weeks after onset of symptoms, his working diagnosis was GUILLAIN-BARRE Syndrome, although his CSF evaluation was inconsistent with GUILLAIN-BARRE Syndrome. There was some speculation after the CSF evaluation that there had not been adequate time for the markers of GUILLAIN-BARRE to develop. After that discharge, he underwent a muscle biopsy, which was reported to be consistent with myositis. His wife reports that on his 11/2009 admission, he had a CK level that was ~ 22,000. He was also noted at that time to have an increasing rash surrounding his neck in a possible shawl sign. After his muscle biopsy, his working diagnosis was changed to dermatomyositis. He appeared to be improving on oral steroids until mid- to late-January when he reported increased difficulty swallowing and increased weakness. At that time, he was admitted again to an outside hospital for IV steroids. He was later transferred to our facility for increased access to specialists and sub-specialists and later management of his dysphagia. For his increasing dysphagia, he was initially started on IV Methylprednisolone, which was later changed to oral prednisone. He, also, received 3 days of IVIG with no improvement or changes in his dysphagia. Prior to discharge, he was started on Cyclophosphamide 100mg orally daily. He was, also, discharged on high dose prednisone and continues with the diagnosis of dermatomyositis secondary to flu vaccine.