chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: MMR
Symptoms: Injection site dryness, Injection site erythema, Injection site reaction, Skin exfoliation
Clinical narrative: Redness, drying, flaky area around injection site with diameter of approximately 1 inch.
Age: 1.03
Sex: F
Vaccine: IPV
Symptoms: Contusion, Coxsackie viral infection, Irritability, Platelet count decreased, Pyrexia
Clinical narrative: The baby began to act fussy and felt warm a few hours after her IPV (Polio Vaccination).  Upon taking her temperature, we realized she had 102.7 degree fever.  Administered Motrin and Tylenol throughout the evening after consulting with the doctor.  Fever spiked overnight to a little over 103 degrees.  Fever lasted 2 days.  On the third day she broke out in bumps on her feet, arms, and bottom.  An office visit then indicated that she had developed Coxsackie Virus.  The rash was visible about two weeks.  1-2 days after the rash cleared, excessive bruising occurred witch lasted another 1-2 weeks.  Her blood was tested.  Platelet levels came back on the lower end of the spectrum at 148.
Age: 1.03
Sex: F
Vaccine: IPV
Symptoms: Rash, Skin warm
Clinical narrative: The baby began to act fussy and felt warm a few hours after her IPV (Polio Vaccination).  Upon taking her temperature, we realized she had 102.7 degree fever.  Administered Motrin and Tylenol throughout the evening after consulting with the doctor.  Fever spiked overnight to a little over 103 degrees.  Fever lasted 2 days.  On the third day she broke out in bumps on her feet, arms, and bottom.  An office visit then indicated that she had developed Coxsackie Virus.  The rash was visible about two weeks.  1-2 days after the rash cleared, excessive bruising occurred witch lasted another 1-2 weeks.  Her blood was tested.  Platelet levels came back on the lower end of the spectrum at 148.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash macular
Clinical narrative: Blotchy red rash the entire length of the left arm.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count normal, Pyrexia
Clinical narrative: Fever 105.0.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Nasopharyngitis, Nausea, Oropharyngeal pain
Clinical narrative: 30 minutes after shot, patient became nauseated which lasted for two days, and received a sore throat on the third day. Minor cough accompanied by cold like symptoms.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Nausea, Oropharyngeal pain
Clinical narrative: Thirty minutes after shot, patient was nauseated which lasted for two days. On the third day, patient had a sore throat and cold like symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Grand mal convulsion, Hypersensitivity
Clinical narrative: Severe allergy attack. Had to use Epi Pen. Dr. advises go to E.R. but I've been there so many flippin' times (grand mal seizure 2 weeks ago) that I am using my Epi Pen unless it gets worse and I will go to hospital abt. 11/2 miles from here.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: There is a bumpy painful rash at the injection site - rash seems to be fading as days go.
Age: 0.01
Sex: M
Vaccine: HEP, HEP
Symptoms: Convulsion, Electrocardiogram abnormal, Erythema, Tremor, Unresponsive to stimuli
Clinical narrative: Mother reports patient had shaking, was unresponsive and turned red. Patient brought to the ER and was Dx with a Sz after EKG abnormalities.
Age: 0.01
Sex: M
Vaccine: HEP, HEP
Symptoms: Blood electrolytes, Blood glucose, Blood test, Central venous catheterisation, Dyspnoea
Clinical narrative: Mother reports patient had shaking, was unresponsive and turned red. Patient brought to the ER and was Dx with a Sz after EKG abnormalities.
Age: 0.01
Sex: M
Vaccine: HEP, HEP
Symptoms: Electroencephalogram abnormal, Foaming at mouth, Grand mal convulsion, Hypotonia, Muscle rigidity
Clinical narrative: Mother reports patient had shaking, was unresponsive and turned red. Patient brought to the ER and was Dx with a Sz after EKG abnormalities.
Age: 0.01
Sex: M
Vaccine: HEP, HEP
Symptoms: Tonic convulsion, Tremor, Urine analysis
Clinical narrative: Mother reports patient had shaking, was unresponsive and turned red. Patient brought to the ER and was Dx with a Sz after EKG abnormalities.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of injection site tenderness in a 36-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report during pregnancy. On 5 March 2014 the subject received a dose of BOOSTRIX (unknown). Her last menstrual period was in July 2013 and estimated delivery date was 01 May 2014. The pregnancy was by normal conception, she was not using contraception. No previous pregnancies. There was no evidence of a defect from prenatal testing, "three other tests"; details were not provided. On 5 March 2014, within hours of vaccination with BOOSTRIX, the subject experienced site tenderness/soreness and vaccine exposure during pregnancy. The subject was 33 weeks gestation, 3rd trimester at the time of vaccination. The subject reported a couple hours after vaccination she experienced tenderness and soreness at the injection site and went away after 24 hours. The tenderness and soreness at the injection reappeared on 12 March 2014. At the time of this report the tenderness and soreness continued, but was less severe than the previous time. At the time of the report injection site tenderness/soreness was improved. The pregnancy was ongoing. The case was closed and lost to follow up because the reporter wanted to remain anonymous and declined to provide information.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dizziness, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: Dark red throat and sinus, bad headache. In bed for a week with flu, 102.2 temp. spike for 1 1/2 days, severe dizzy, seizure like movements, trouble breathing, no bath, swelling.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pharyngeal erythema, Pyrexia, Seizure like phenomena, Sinus disorder
Clinical narrative: Dark red throat and sinus, bad headache. In bed for a week with flu, 102.2 temp. spike for 1 1/2 days, severe dizzy, seizure like movements, trouble breathing, no bath, swelling.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Dark red throat and sinus, bad headache. In bed for a week with flu, 102.2 temp. spike for 1 1/2 days, severe dizzy, seizure like movements, trouble breathing, no bath, swelling.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Laboratory test, Loss of control of legs, Myelitis transverse
Clinical narrative: Woke up in A.M. for church went to take shower - walked around bed and collapsed - legs wouldn't work - was paralyzed - husband called ambulance and sent to hospital and had numerous tests done. Pt. became paralyzed following vaccine - only thing it could be attributed to - nothing else changed - reporting now because per patient request - she doesn't think it was ever reported by MD. Patient diagnosed with transverse myelitis. Was not able to walk once episode occurred. After copious amounts of physical therapy she now needs the support of a cane to walk but still suffers pain and cannot participate many activities as she once did.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paralysis, Syncope, Walking aid user
Clinical narrative: Woke up in A.M. for church went to take shower - walked around bed and collapsed - legs wouldn't work - was paralyzed - husband called ambulance and sent to hospital and had numerous tests done. Pt. became paralyzed following vaccine - only thing it could be attributed to - nothing else changed - reporting now because per patient request - she doesn't think it was ever reported by MD. Patient diagnosed with transverse myelitis. Was not able to walk once episode occurred. After copious amounts of physical therapy she now needs the support of a cane to walk but still suffers pain and cannot participate many activities as she once did.
Age: 46.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site tenderness in a 46-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included FLUVIRIN (non-gsk) ; non-GSK manufacturer; unknown; unknown given on 18 November 2013. On 18 November 2013 the subject received a dose of BOOSTRIX (unknown). On 19 November 2013, 1 day after vaccination with BOOSTRIX, the subject experienced injection site tenderness and swelling injection site. The pharmacist reported that FLUVIRN was administered in the opposite arm from where the injection site tenderness and swelling injection site occurred. At the time of reporting the injection site tenderness and swelling injection site were worse. Follow-up information received on 08 January 2014 via healthcare provider who reported the symptoms started subsiding on 23 November 2013 and resolved on an unspecified date. The healthcare provider did not consider the events to be serious. No action was taken with BOOSTRIX. At the time of the report no other information was provided.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Local reaction, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red bump at injection site in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced local reaction of red itchy bumps at injection site (red bump at injection site and injection site pruritus). The reporter had very limited information, no other details were provided. At the time of reporting the outcome of the red itchy bumps at injection site was unspecified. This is the second of two reports made by the reporter, for the other case please see A1056647A. Follow up to the initial report received by GSK on 9 January 2013 and by the Safety Department on 14 February 2014. This complaint was associated with a product quality complaint. Follow up was received from the Quality Assurance Department on 14 February 2014. Based on results of the investigation by GSK Quality Assurance, the product complaint was assessed to be unsubstantiated.
Age: 11.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inflammation in the area of injection in an 11-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included seasonal influenza vaccine (non-gsk); Sanofi Pasteur; unknown; left deltoid given on 24 October 2013; BOOSTRIX; GlaxoSmithKline; unknown; unknown given on 14 January 2013. On 24 October 2013 the subject received 2nd dose of BOOSTRIX (.5 ml, unknown, right arm) and experienced extra dose administered. On 24 October 2013, 2 days after vaccination with BOOSTRIX, the subject experienced inflammation in the area of injection. The subject received a dose of BOOSTRIX on 14 January 2013 and accidentally received a 2nd dose on 24 October 2013. The subject returned to the office on 26 October 2013 with injection site reaction. The nurse reported the subject experienced a red inflamed area approximately one centimeter in size without blister secondary to BOOSTRIX. The subject received in the office an oral analgesic and topical antibiotic was administered on the area. At the time of reporting the inflammation in the area of injection was unresolved. The healthcare professional considered the inflammation in the area of injection was probably related to vaccination with BOOSTRIX. Follow up was received from healthcare professional on 28 January 2014. The healthcare professional documented that the diagnosis was "local reaction after Tdap". Per the reporter, the outcome of the events was resolved. The healthcare professional considered that the events were probably related to the BOOSTRIX. The reporter documented that a "2nd dose of Tdap given 9 months after a previous dose." A biopsy was not performed. Per the reporter, the symptoms did not recur following subsequent administration; however, the reporter also documented that the BOOSTRIX was not reintroduced. The healthcare professional documented that the subject had not experienced adverse events following previous vaccinations.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary mass, Local swelling, Tenderness
Clinical narrative: This case was reported by a physician and described the occurrence of lump under armpit in a 30-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject had no known drug allergies. On 17 June 2014, the subject received an unspecified dose of BOOSTRIX (route unknown, left arm). On 19 June 2014, 2 days after vaccination with BOOSTRIX, the subject experienced a tender swollen lump under armpit on the same arm the vaccination was given. At the time of reporting, the events were unresolved. The physician considered the events were probably related to vaccination with BOOSTRIX.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Pruritus
Clinical narrative: 15x12 cm area of redness on his right thigh. Zyrtec and Benadryl for itching.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Asthma, Condition aggravated, Cough, Discomfort, Feeling hot
Clinical narrative: Severe severe muscle aches. Don't remember ever aching as much. Could not sleep or find comfortable position.  Increased in severity throughout night but was about 80% better the next day. Skin was also very "sensitive" to touch. Don't recall photophobia but realize that I preferred the blinds closed. Also required asthma rescue meds twice. Developed occasional cough and with cough had head ache. Also several episodes of urinary urgency (not usual for me}.  Felt warm (temp with old battery oral thermometer only 90F. Right arm, site of two of the injections is still very tender but not red. Today the right arm is still very tender but the muscle aches have resolved.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Headache, Hyperaesthesia, Injection site pain, Insomnia, Micturition urgency
Clinical narrative: Severe severe muscle aches. Don't remember ever aching as much. Could not sleep or find comfortable position.  Increased in severity throughout night but was about 80% better the next day. Skin was also very "sensitive" to touch. Don't recall photophobia but realize that I preferred the blinds closed. Also required asthma rescue meds twice. Developed occasional cough and with cough had head ache. Also several episodes of urinary urgency (not usual for me}.  Felt warm (temp with old battery oral thermometer only 90F. Right arm, site of two of the injections is still very tender but not red. Today the right arm is still very tender but the muscle aches have resolved.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Myalgia
Clinical narrative: Severe severe muscle aches. Don't remember ever aching as much. Could not sleep or find comfortable position.  Increased in severity throughout night but was about 80% better the next day. Skin was also very "sensitive" to touch. Don't recall photophobia but realize that I preferred the blinds closed. Also required asthma rescue meds twice. Developed occasional cough and with cough had head ache. Also several episodes of urinary urgency (not usual for me}.  Felt warm (temp with old battery oral thermometer only 90F. Right arm, site of two of the injections is still very tender but not red. Today the right arm is still very tender but the muscle aches have resolved.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dyspnoea, Feeling abnormal, Heart rate increased, Throat irritation
Clinical narrative: Patient called on 10/10/2014 and informed us she experienced adverse reaction that started approximately 20 minutes after injection. She described increased HR, difficult breathing for 2.5 hours, burning throat, achy joints, mentally "foggy" for 3 days. she was treated at ER and was released.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Vomiting
Clinical narrative: Upset stomach and vomiting for 6 hours after flu shot.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Chills, Heart rate increased, Hyperhidrosis, Tremor
Clinical narrative: Increased blood pressure and heart rate.  Chills, sweating, shaking.  Patient called primary care physician who instructed him to take ibuprofen and rest.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: RED RASH ON THE ARM WHERE SHE RECEIVED THE IMMUNIZATION WITH SEVERE ITCHING.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Local swelling, Rash
Clinical narrative: RT ARM: FLU & ZOSTAVAX - SWELLING AND REDNESS FROM SHOULDER TO ELBOW, "BUMPY SKIN". LT ARM: PNEUMOVAX - SLIGHTLY RED AND SWELLING OF ARM, RED SPOTS.
Age: 0.56
Sex: F
Vaccine: 6VAX-F, RVX
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Mucus & blood in stool.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood pressure decreased, Blood test, Chills, Dizziness
Clinical narrative: I had the flu shot on Thursday and felt a little funny immediately afterward along with a headache. I started to lose control of my body temp but chalked it off as hot flashes although I have not hand any for a long while. I got home and my whole body ached. Took a Motrin and went right to bed. Woke up Friday 6:30 am and still had the headache that really never went away and my whole body hurt. Worked, complained about the headache and I felt funny but I was functional. I got home around 5:48 pm. The house was chilly and I was going to put my little heater on then my whole body locked up and my jaw locked too. I started shaking very hard I could not move for 28 minutes. Was so scared. When the muscles released I felt cold unbearably cold. Went to my room I got my thermal blanket out but it didn't help. I kept shaking and my teeth were chattering. I felt like I couldn't catch my breath. I knew I needed help but I couldn't move again. Then I woke up around 9pm. Didn't remember falling asleep. My hair was so wet like I got out of the shower and my clothes were soaked. I was so weak I couldn't move. When I was finally able to get up and go to the bathroom I had no muscle control and urinated in the hallway. By the time I got to the toilet I was vomiting. I was so weak. Walked to laundry room felt like I wanted to faint. Put on sweats and went back to bed and tried to stay warm. I woke up again around 9am and my muscles in my body felt exhausted and I still had that headache. By 6 pm Saturday my sister called. She said I was having a reaction to the flu shot. She is a pharmacist. She told me to go to the hospital. She called my neighbor who called 911. In the ambulance they were trying to take my BP. They kept saying something is wrong with the cuff my BP was only reading 77/35. When I got to the hospital at around 7:30pm they got a similar low reading and said they thought their cuff was bad too when my first reading of 77/35 after a few minutes got a reading of 98/58 and said that was much better. My BP kept dropping and they never paid attention to it. Spoke to the doctor and told her I was fine up to the flu shot. Explained about the headache and feeling funny right after the shot. She gave me Toradol, an antibiotic, and Benadryl and treated me for a UTI. She gave me a prescription for Cephalexin 500 mg 4x a day. Got home at 12:30am Sunday morning. Fever returned after hospital meds wore off 102.8, so did fatigue, nausea and vomiting.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Dyskinesia, Dyspnoea, Fear, Feeling abnormal, Feeling cold
Clinical narrative: I had the flu shot on Thursday and felt a little funny immediately afterward along with a headache. I started to lose control of my body temp but chalked it off as hot flashes although I have not hand any for a long while. I got home and my whole body ached. Took a Motrin and went right to bed. Woke up Friday 6:30 am and still had the headache that really never went away and my whole body hurt. Worked, complained about the headache and I felt funny but I was functional. I got home around 5:48 pm. The house was chilly and I was going to put my little heater on then my whole body locked up and my jaw locked too. I started shaking very hard I could not move for 28 minutes. Was so scared. When the muscles released I felt cold unbearably cold. Went to my room I got my thermal blanket out but it didn't help. I kept shaking and my teeth were chattering. I felt like I couldn't catch my breath. I knew I needed help but I couldn't move again. Then I woke up around 9pm. Didn't remember falling asleep. My hair was so wet like I got out of the shower and my clothes were soaked. I was so weak I couldn't move. When I was finally able to get up and go to the bathroom I had no muscle control and urinated in the hallway. By the time I got to the toilet I was vomiting. I was so weak. Walked to laundry room felt like I wanted to faint. Put on sweats and went back to bed and tried to stay warm. I woke up again around 9am and my muscles in my body felt exhausted and I still had that headache. By 6 pm Saturday my sister called. She said I was having a reaction to the flu shot. She is a pharmacist. She told me to go to the hospital. She called my neighbor who called 911. In the ambulance they were trying to take my BP. They kept saying something is wrong with the cuff my BP was only reading 77/35. When I got to the hospital at around 7:30pm they got a similar low reading and said they thought their cuff was bad too when my first reading of 77/35 after a few minutes got a reading of 98/58 and said that was much better. My BP kept dropping and they never paid attention to it. Spoke to the doctor and told her I was fine up to the flu shot. Explained about the headache and feeling funny right after the shot. She gave me Toradol, an antibiotic, and Benadryl and treated me for a UTI. She gave me a prescription for Cephalexin 500 mg 4x a day. Got home at 12:30am Sunday morning. Fever returned after hospital meds wore off 102.8, so did fatigue, nausea and vomiting.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling of body temperature change, Headache, Hot flush, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: I had the flu shot on Thursday and felt a little funny immediately afterward along with a headache. I started to lose control of my body temp but chalked it off as hot flashes although I have not hand any for a long while. I got home and my whole body ached. Took a Motrin and went right to bed. Woke up Friday 6:30 am and still had the headache that really never went away and my whole body hurt. Worked, complained about the headache and I felt funny but I was functional. I got home around 5:48 pm. The house was chilly and I was going to put my little heater on then my whole body locked up and my jaw locked too. I started shaking very hard I could not move for 28 minutes. Was so scared. When the muscles released I felt cold unbearably cold. Went to my room I got my thermal blanket out but it didn't help. I kept shaking and my teeth were chattering. I felt like I couldn't catch my breath. I knew I needed help but I couldn't move again. Then I woke up around 9pm. Didn't remember falling asleep. My hair was so wet like I got out of the shower and my clothes were soaked. I was so weak I couldn't move. When I was finally able to get up and go to the bathroom I had no muscle control and urinated in the hallway. By the time I got to the toilet I was vomiting. I was so weak. Walked to laundry room felt like I wanted to faint. Put on sweats and went back to bed and tried to stay warm. I woke up again around 9am and my muscles in my body felt exhausted and I still had that headache. By 6 pm Saturday my sister called. She said I was having a reaction to the flu shot. She is a pharmacist. She told me to go to the hospital. She called my neighbor who called 911. In the ambulance they were trying to take my BP. They kept saying something is wrong with the cuff my BP was only reading 77/35. When I got to the hospital at around 7:30pm they got a similar low reading and said they thought their cuff was bad too when my first reading of 77/35 after a few minutes got a reading of 98/58 and said that was much better. My BP kept dropping and they never paid attention to it. Spoke to the doctor and told her I was fine up to the flu shot. Explained about the headache and feeling funny right after the shot. She gave me Toradol, an antibiotic, and Benadryl and treated me for a UTI. She gave me a prescription for Cephalexin 500 mg 4x a day. Got home at 12:30am Sunday morning. Fever returned after hospital meds wore off 102.8, so did fatigue, nausea and vomiting.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Joint lock, Mobility decreased, Muscle fatigue, Pain, Trismus
Clinical narrative: I had the flu shot on Thursday and felt a little funny immediately afterward along with a headache. I started to lose control of my body temp but chalked it off as hot flashes although I have not hand any for a long while. I got home and my whole body ached. Took a Motrin and went right to bed. Woke up Friday 6:30 am and still had the headache that really never went away and my whole body hurt. Worked, complained about the headache and I felt funny but I was functional. I got home around 5:48 pm. The house was chilly and I was going to put my little heater on then my whole body locked up and my jaw locked too. I started shaking very hard I could not move for 28 minutes. Was so scared. When the muscles released I felt cold unbearably cold. Went to my room I got my thermal blanket out but it didn't help. I kept shaking and my teeth were chattering. I felt like I couldn't catch my breath. I knew I needed help but I couldn't move again. Then I woke up around 9pm. Didn't remember falling asleep. My hair was so wet like I got out of the shower and my clothes were soaked. I was so weak I couldn't move. When I was finally able to get up and go to the bathroom I had no muscle control and urinated in the hallway. By the time I got to the toilet I was vomiting. I was so weak. Walked to laundry room felt like I wanted to faint. Put on sweats and went back to bed and tried to stay warm. I woke up again around 9am and my muscles in my body felt exhausted and I still had that headache. By 6 pm Saturday my sister called. She said I was having a reaction to the flu shot. She is a pharmacist. She told me to go to the hospital. She called my neighbor who called 911. In the ambulance they were trying to take my BP. They kept saying something is wrong with the cuff my BP was only reading 77/35. When I got to the hospital at around 7:30pm they got a similar low reading and said they thought their cuff was bad too when my first reading of 77/35 after a few minutes got a reading of 98/58 and said that was much better. My BP kept dropping and they never paid attention to it. Spoke to the doctor and told her I was fine up to the flu shot. Explained about the headache and feeling funny right after the shot. She gave me Toradol, an antibiotic, and Benadryl and treated me for a UTI. She gave me a prescription for Cephalexin 500 mg 4x a day. Got home at 12:30am Sunday morning. Fever returned after hospital meds wore off 102.8, so did fatigue, nausea and vomiting.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Urinary incontinence, Urinary tract infection, Urine analysis, Vomiting
Clinical narrative: I had the flu shot on Thursday and felt a little funny immediately afterward along with a headache. I started to lose control of my body temp but chalked it off as hot flashes although I have not hand any for a long while. I got home and my whole body ached. Took a Motrin and went right to bed. Woke up Friday 6:30 am and still had the headache that really never went away and my whole body hurt. Worked, complained about the headache and I felt funny but I was functional. I got home around 5:48 pm. The house was chilly and I was going to put my little heater on then my whole body locked up and my jaw locked too. I started shaking very hard I could not move for 28 minutes. Was so scared. When the muscles released I felt cold unbearably cold. Went to my room I got my thermal blanket out but it didn't help. I kept shaking and my teeth were chattering. I felt like I couldn't catch my breath. I knew I needed help but I couldn't move again. Then I woke up around 9pm. Didn't remember falling asleep. My hair was so wet like I got out of the shower and my clothes were soaked. I was so weak I couldn't move. When I was finally able to get up and go to the bathroom I had no muscle control and urinated in the hallway. By the time I got to the toilet I was vomiting. I was so weak. Walked to laundry room felt like I wanted to faint. Put on sweats and went back to bed and tried to stay warm. I woke up again around 9am and my muscles in my body felt exhausted and I still had that headache. By 6 pm Saturday my sister called. She said I was having a reaction to the flu shot. She is a pharmacist. She told me to go to the hospital. She called my neighbor who called 911. In the ambulance they were trying to take my BP. They kept saying something is wrong with the cuff my BP was only reading 77/35. When I got to the hospital at around 7:30pm they got a similar low reading and said they thought their cuff was bad too when my first reading of 77/35 after a few minutes got a reading of 98/58 and said that was much better. My BP kept dropping and they never paid attention to it. Spoke to the doctor and told her I was fine up to the flu shot. Explained about the headache and feeling funny right after the shot. She gave me Toradol, an antibiotic, and Benadryl and treated me for a UTI. She gave me a prescription for Cephalexin 500 mg 4x a day. Got home at 12:30am Sunday morning. Fever returned after hospital meds wore off 102.8, so did fatigue, nausea and vomiting.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING ABOUT INJECTION SITE ABOUT THE SIZE OF A GOLF BALL AROUND. SLIGHTLY RAISED FROM SURFACE, WARM TO THE TOUCH, RED, TENDER TO THE TOUCH.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Convulsion, Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Immediately after recieving his shot, my son said he felt nausous and light-headed, and then had a seizure. It lasted several seconds.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dyskinesia, Headache, Staring
Clinical narrative: Immediately after recieving his shot, my son said he felt nausous and light-headed, and then had a seizure. It lasted several seconds.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Pruritus
Clinical narrative: PATIENT CAME IN TO THE PHARMACY ON SATURDAY AFTER RECEIVING THE VACCINE ON THURSDAY. SHE STATED THAT THE AREA WHERE SHE RECEIVED THE VACCINE WAS VERY SWOLLEN AND HARD. SHE WAS ALSO VERY ITCHY. SHE WENT TO URGENT CARE, AND THEY SAID SHE MAY BE ALLERGIC TO NEOMYCIN AND GAVE HER A TOPICAL STEROID.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Pain, Pain in extremity, Pruritus
Clinical narrative: First started itching and the next day started hurting.  The arm began to swell slightly and by Friday (10/10) it was hot and had a ring around it.  It hurt to lift arm.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: First started itching and the next day started hurting.  The arm began to swell slightly and by Friday (10/10) it was hot and had a ring around it.  It hurt to lift arm.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Vaccination was given in the right deltoid.  The patient reported her deltoid area started to swell about 6 hours later.  She also reported the area was swollen and very sore.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness at the site, slight swelling and itchiness.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction ... red, swollen and warm to touch area around injection site.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Injection site bruising, Injection site induration
Clinical narrative: Bruising at site of shot on left leg, and a hard spot where the vaccine was given.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Localized redness, swelling (around 50mm in diameter), and itching.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Rash/Hives on both arms not relieved by oral Benadryl, that spread to chest and torso by the next day. RPh advised visit to MD for evaluation and possible steroid.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 104 chills patient had taken aspirin.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Urticaria
Clinical narrative: Patient began breaking out in hives at around 3PM followed by total body chills and nausea, with no vomiting, lasting 8-12 hours. Post 8-12 hours all symptoms ceased.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Cellulitis, Chills, Headache, Hypersensitivity
Clinical narrative: Woke with fever and chills, extreme arm pain, could not move arm.  Took ibuprofen and called Dr. office at 6 am, told not usual reaction, come in if want to.  Went in, diagnosed "allergic reaction". Prescribed ibuprofen 800 MG. Continued to worsen, called again, still Dr. not concerned.  Second day headache and continued to worsen. Third day 9/18/2014 returned to dr. office, now diagnosed with Cellulitis. Given Cephalexin 500mg QID.  Dr. still not caring or concerned.  Missed 3 days of work and a paid weekend vacation.  Started to feel better on 9/19/14.  Symptoms lessened and cleared and finished med.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Woke with fever and chills, extreme arm pain, could not move arm.  Took ibuprofen and called Dr. office at 6 am, told not usual reaction, come in if want to.  Went in, diagnosed "allergic reaction". Prescribed ibuprofen 800 MG. Continued to worsen, called again, still Dr. not concerned.  Second day headache and continued to worsen. Third day 9/18/2014 returned to dr. office, now diagnosed with Cellulitis. Given Cephalexin 500mg QID.  Dr. still not caring or concerned.  Missed 3 days of work and a paid weekend vacation.  Started to feel better on 9/19/14.  Symptoms lessened and cleared and finished med.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red area at injection site.  Also warm to touch.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased
Clinical narrative: Decreased range of motion in left arm.
Age: 29.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Infection, Injection site erythema, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: Redness, swelling, and warmth of injection site; vomiting.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Dyspnoea, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: Difficulty breathing, muscle weakness, muscle soreness, cramps, palpitations (all over) chest pain.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations
Clinical narrative: Difficulty breathing, muscle weakness, muscle soreness, cramps, palpitations (all over) chest pain.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pain starting close to top of shoulder radiating down my left arm.  2 whole days of being unable to lift my arm up in the air.  Shooting pain down my arm so bad that I am having a hard time sleeping at night as well.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia, Dysphonia, Throat tightness, Wheezing
Clinical narrative: Sudden onset of wheezing, throat constriction, hoarse voice, trouble swallowing, dizziness.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Loss of consciousness, Malaise, Mobility decreased, Nausea
Clinical narrative: 2-3 minutes after vaccine was administered, pt. complained she doesn't feel well and passed out. She was breathing and conscious but was very weak and was not able to move. Her pulse was normal but kept saying she doesn't feel well. I called 911 after 10 minutes of no change in pt.'s condition. Pt's BP was normal. She complained of being nauseated and threw up. She was taken by paramedics to hospital.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 2-3 minutes after vaccine was administered, pt. complained she doesn't feel well and passed out. She was breathing and conscious but was very weak and was not able to move. Her pulse was normal but kept saying she doesn't feel well. I called 911 after 10 minutes of no change in pt.'s condition. Pt's BP was normal. She complained of being nauseated and threw up. She was taken by paramedics to hospital.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Unresponsive to stimuli
Clinical narrative: Patient became unresponsive approximately 5 minutes after administration of influenza vaccine. She did not fall, no movement of limbs. Eyes remained open, pupils equal and round. Unresponsiveness lasted for 15 seconds. Patient immediately became Alert & Oriented x 4. Verbal, c/o "a little" dizziness.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Feeling hot, Pain, Tremor
Clinical narrative: Rigors (shaking chills) for about 45 min; about an hour later I took naproxen 220 mg; 2 hours later I still felt hot and achy, checked my temp: 101.8 oral. I felt fine within about 24 hours.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: She went to her doctor's office first this morning. Observed her left arm and there was brusing the size of a nickel at the injection site. Two inches below the injection site, there was redness and swelling that was 2 x 3 inches.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient came to pharmacy with red, inflamed, warm size of half dollar reaction at site of injection. She did not feel bad and did not have a fever.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Patient came in on 10/06/2014 stating she had a rash on both wrists/arms that she thought resembled shingles. She stated they appeared on the evening of 10/03/2014 after she had received her vaccinations. She had a diagnosed case of shingles 4 weeks previously. She did not have any signs of shingles when she was vaccinated. She had been taking Benadryl 25mg OTC to treat rash.  I did not see any reaction at the vaccination sight, and recommended she go to her family doctor to be checked out.
Age: 43.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injected limb mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Excruciating radiating pain in right arm, muscle pain, loss of range of motion, pain while lifting arm or reaching, burning, stabbing pain.
Age: 43.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Excruciating radiating pain in right arm, muscle pain, loss of range of motion, pain while lifting arm or reaching, burning, stabbing pain.
Age: 72.0
Sex: M
Vaccine: FLUC3
Symptoms: Asthenia, Chills, Feeling hot, Pain in extremity
Clinical narrative: Chills followed by very hot.  Then very aching legs along with severe chills.  Finally on 2nd day, very weak.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site anaesthesia
Clinical narrative: Received flu shot high on left deltoid.  Felt intense pain immediately.  Pain in left shoulder since then which radiates into left elbow and hand at times. Also occasional numbness in elbow and pinky and ring finger of left arm.  Decreased range of motion, sometimes needing help with getting dressed.  Unable to lift arm above level of shoulder without pain.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Received flu shot high on left deltoid.  Felt intense pain immediately.  Pain in left shoulder since then which radiates into left elbow and hand at times. Also occasional numbness in elbow and pinky and ring finger of left arm.  Decreased range of motion, sometimes needing help with getting dressed.  Unable to lift arm above level of shoulder without pain.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Tremor
Clinical narrative: Pt had shaking episode after hugging nanny-- the whole episode lasted 45 seconds.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory disturbance, VIIth nerve paralysis
Clinical narrative: Decreased sensation on the right side of her face and right side facial paralysis.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Influenza like illness, Nausea, Pyrexia, Tremor
Clinical narrative: Weakness all over.  Flu like symptoms, fever, shakes, nausea for 24 hours. Too weak to move from bed.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Injected limb mobility decreased, Injection site joint inflammation, Muscular weakness
Clinical narrative: NUMBNESS IN LEFT ARM, MIN. MOVEMENT, WEAK MUSCLE, WENT TO DR 3 TIMES FOR PAIN, SHOT GIVEN TO HIGH ON ARM WHICH CAUSED INFLAMMATION IN JOINT AREA.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: NUMBNESS IN LEFT ARM, MIN. MOVEMENT, WEAK MUSCLE, WENT TO DR 3 TIMES FOR PAIN, SHOT GIVEN TO HIGH ON ARM WHICH CAUSED INFLAMMATION IN JOINT AREA.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Cellulitis, Chills, Erythema, Influenza like illness, Injected limb mobility decreased
Clinical narrative: 1. Limited/painful range of motion of arm; 2. Following day, fever, chills, body aches; arm quite swollen/red/aching/unable to lift/carry. 3: By day 3, general flu-like symptoms lessened, but arm remained red/swollen/achy. 4. Day 4 (Monday) sought medical dx--adverse reaction with cellulitis.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Local swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: 1. Limited/painful range of motion of arm; 2. Following day, fever, chills, body aches; arm quite swollen/red/aching/unable to lift/carry. 3: By day 3, general flu-like symptoms lessened, but arm remained red/swollen/achy. 4. Day 4 (Monday) sought medical dx--adverse reaction with cellulitis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Very sore injection site. Fever, chills that have lasted for 4 days.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site warmth, Local reaction, Pyrexia
Clinical narrative: Fever; local systemic reaction; hot to touch; skin pink/red in color.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site joint movement impairment, Injection site movement impairment, Ultrasound antenatal screen normal
Clinical narrative: This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of injection site arm stiffness in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) for prophylaxis during pregnancy. A physician or other health care professional has not verified this report. On 15 February 2014 the subject received a dose of BOOSTRIX (unknown details) and experienced vaccine exposure during the 3rd trimester of pregnancy. The gestational age at the time of vaccination was 34 weeks. The date of last menstrual period was reported as 21 June 2013. The estimated date of delivery was reported as 3 April 2014. On 15 February 2014, 6 to 8 hours after vaccination with BOOSTRIX, the subject experienced injection site arm stiffness (also described as "stiff shoulder"). Relevant test results included ultrasound examination in 2013: on 7 August, 4 September, 1 October, and 18 November. There was no evidence of defect from prenatal testing. At the time of reporting the event of injection site arm stiffness was resolved. Per the subject, the "stiffness resolved within 24 to 36 hours." At the time of reporting, the pregnancy was ongoing. The subject documented another case of vaccine exposure. See case A1062376B for details on the other case. Follow-up information was received on 18 March 2014 via consumer who reported she received BOOSTRIX injection 0.5ml ON 15February 2014 with authorization to contact her physician. No other information was provided. Follow-up information was received on 24 June 2014 via healthcare professional. The pregnancy was by normal conception, not by in-vitro fertilization. On 02 April 2014, at calculated 40 to 41 weeks gestation age, the subject gave birth to a male live infant who was considered full term. The infant was delivered by normal vaginal delivery, weight 7 pounds 10 ounces; length, head circumference and Apgar score were not provided. No other information was provided.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis, Product quality issue, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional (office manager) via sales representative and described the occurrence of pertussis in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 2 April 2012 the subject received a dose of BOOSTRIX (unknown details). At an unspecified time after vaccination with BOOSTRIX, the subject experienced pertussis and vaccination failure. This case was associated with a product complaint as the physician questioned the lot number. No further details were provided by the healthcare professional. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. The healthcare professional reported another case with BOOSTRIX. See case A1047577A for details on the other case. Quality Assurance results and safety statement was received 06 November 2013. A safety assessment was requested, an evaluation was performed and the conclusion shows that: considering the currently available data for batch number AC52B077AA (and family), it is unlikely that the reported events are linked to a manufacturing issue. No further investigation is required. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated.