chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Received TC from patient's mother this pm. She reports that patient has reddened warm non-painful area on upper Rt arm. Area is slightly larger than a quarter. First noticed within last 24 hours. Had rec'd vaccines on 2/6/15 here at HD. Reviewed shot record from that day and appears from Mom's report that it is in area where Varivax was given (Mom says it is "behind" area of deltoid muscle on upper Rt arm). Reviewed package insert and reassured Mom that this can be a normal rx to Varivax. Is applying cool compresses to area. Instructed Mom to monitor size of area over next 24 hours. If it becomes larger, painful, or dgtr begins running temp to call us or PMD. Mom was receptive to instructions and daughter does have PMD in area if she needs. Completed VAERS report electronically.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling progressed to where the whole upper arm was deep red by 8PM on 2/18/15.  By 8AM on 2/19/15, the redness had spread and his right arm was swollen to twice the size of his left arm.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abasia, Computerised tomogram, Dysphagia, Echocardiogram, Grip strength decreased
Clinical narrative: Numbing and tingling of the four extremities, difficulty swallowing, unable to hold objects, unable to walk.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Nerve conduction studies, Paraesthesia
Clinical narrative: Numbing and tingling of the four extremities, difficulty swallowing, unable to hold objects, unable to walk.
Age: 1.57
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Decreased appetite, Fear of falling, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Fever, redness and swelling at injection sites, fussy, irritable, fear of falling, decreased eating (although still takes 1/2 bottles), but have to go back to tube feeds for enough calories through her G-tube and to prevent dehydration. Here I am filling out ANOTHER VAERS form for each of the little twin girls we have had in our home through foster care since they were released from the hospital weeks after they were born. We are in the early stages of the adoption process. Due to the severe adverse reactions each girl experienced in April 2014, we were able to obtain a court order to suspend any further vaccinations for 6 months. After this court order was issued, the girls each had to have G-tubes surgically placed due to the severe side effects of previous vaccinations given. Their G-tube surgeries were in June 2014. In January 2015, the PCP and the dept. decided since the court order was no longer valid (past the proposed 6 month time period) that the girls needed to get caught up on ALL their vaccines (with the exception of the live virus vaccines - as we currently have a child doing chemo and his PCP recommended that NO family members get ANY vaccines while he is undergoing chemo). During this time, the girls have progressed tremendously and were not being tube fed all the time. We were working towards bolus feeds along with oral eating via table meals and bottles with their high calorie formula. I went to another licensed medical doctor for a 2nd opinion on January 19, 2015 concerning getting any more vaccines due to their previous documented reactions. After examining each girl and thoroughly going over all the documentation from previous appointments with their PCP, my own documentation and their O/T, he made strong recommendations that it would NOT be in their best interest to get any more vaccines. He then filled out a permanent MEDICAL EXEMPTION form so they would not receive any further vaccines due to their previous adverse reactions that seemed to be getting worse each time they received a vaccination.
Age: 1.57
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever, redness and swelling at injection sites, fussy, irritable, fear of falling, decreased eating (although still takes 1/2 bottles), but have to go back to tube feeds for enough calories through her G-tube and to prevent dehydration. Here I am filling out ANOTHER VAERS form for each of the little twin girls we have had in our home through foster care since they were released from the hospital weeks after they were born. We are in the early stages of the adoption process. Due to the severe adverse reactions each girl experienced in April 2014, we were able to obtain a court order to suspend any further vaccinations for 6 months. After this court order was issued, the girls each had to have G-tubes surgically placed due to the severe side effects of previous vaccinations given. Their G-tube surgeries were in June 2014. In January 2015, the PCP and the dept. decided since the court order was no longer valid (past the proposed 6 month time period) that the girls needed to get caught up on ALL their vaccines (with the exception of the live virus vaccines - as we currently have a child doing chemo and his PCP recommended that NO family members get ANY vaccines while he is undergoing chemo). During this time, the girls have progressed tremendously and were not being tube fed all the time. We were working towards bolus feeds along with oral eating via table meals and bottles with their high calorie formula. I went to another licensed medical doctor for a 2nd opinion on January 19, 2015 concerning getting any more vaccines due to their previous documented reactions. After examining each girl and thoroughly going over all the documentation from previous appointments with their PCP, my own documentation and their O/T, he made strong recommendations that it would NOT be in their best interest to get any more vaccines. He then filled out a permanent MEDICAL EXEMPTION form so they would not receive any further vaccines due to their previous adverse reactions that seemed to be getting worse each time they received a vaccination.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Appendix cancer, Fatigue, Surgery
Clinical narrative: Case number PHEH2015US002659 is an initial spontaneous report from a consumer (patient) received on 04 Feb 2015. This report refers to a 55-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 004071A) intramuscularly in Oct 2013. On 12 Oct 2013, he experienced severe fatigue and a pulsating pain in his abdomen. It was diagnosed as appendix cancer and a surgery was performed to treat it. The outcome of the events reported as not recovered as of 04 Feb 2015. The seriousness and causality of the events were not reported.
Sex: U
Vaccine: RVX
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Gastrointestinal disorder, Rotavirus test positive, Vaccination failure
Clinical narrative: This case was reported in a literature article. On an unknown date, unknown after receiving Rotavirus vaccine and 14 days after receiving Rotavirus vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included diarrhea rotavirus with serious criteria of GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional events(s) included diarrhea rotavirus (unknown). It was unknown if the investigator considered the diarrhea rotavirus to be related to Rotavirus vaccine. Relevant Tests: An enzyme immune-assay of a stool sample was positive for rotavirus antigen. Additional information received: This case was reported in a literature article and it described the occurrence of a vaccine failure in a child of unspecified gender and at least 8 months old, who had received ROTARIX (GlaxoSmithKline). The patient had been enrolled in a study that excluded children with a severely immunocompromising condition. No further information on the patient's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the patient received at least 3 doses of ROTARIX (oral, dosages unknown; batch numbers not provided). On an unspecified date either between January and June 2010 or between January and June 2011, at least 14 days after the administration of the last dose of the vaccine, the patient developed acute gastrointestinal symptoms defined by the authors as at least 3 looser-than-normal stools in a 24-hour period during the illness and onset of the diarrhoea within 10 days of presentation to hospital. It was unknown if the patient was admitted. An enzyme immune-assay of a stool sample was positive for rotavirus antigen. Treatment was unknown. The outcome of the event was unspecified. The authors did not comment on any causal relationship between the vaccine and the event. The authors concluded that "This evaluation demonstrates that monovalent rotavirus vaccine was highly effective in children against severe rotavirus disease during at least the first 2 years of life, and confirms the high effectiveness of the pentavalent rotavirus vaccine". This case is 1 of the 2 valid cases reported in the same literature article (see case US2014GSK051982).
Age: 0.31
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Crying, Emotional distress, Loss of consciousness, Malaise, Muscle twitching
Clinical narrative: Baby was fine for two hours after shots, then began screaming and crying. My son was inconsolable as if he were on fire. The screaming went on for many hours in which I gave him Tylenol, eventually he became malaised and passed out. He was groggy for the next few days.  Later that month I began to notice he was having staring spells that I could not break him out of, that would last a minimum of 1 minute. I am, certain that they were indeed seizures. He also experienced muscle twitching. Thankfully after a few months they have appeared to subsided, but I am still uncertain of the long term effects of the shot on my son.
Age: 0.31
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Screaming, Seizure, Somnolence, Staring
Clinical narrative: Baby was fine for two hours after shots, then began screaming and crying. My son was inconsolable as if he were on fire. The screaming went on for many hours in which I gave him Tylenol, eventually he became malaised and passed out. He was groggy for the next few days.  Later that month I began to notice he was having staring spells that I could not break him out of, that would last a minimum of 1 minute. I am, certain that they were indeed seizures. He also experienced muscle twitching. Thankfully after a few months they have appeared to subsided, but I am still uncertain of the long term effects of the shot on my son.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Electrocardiogram normal, Fatigue, Headache, Injection site erythema
Clinical narrative: Headache, fatigue, mild but constant left sided chest pain and nausea. Increased redness and local swelling at the injection site with warmth and then pain and tenderness in to her left trapezius and in to her neck and left anterior chest.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Neck pain
Clinical narrative: Headache, fatigue, mild but constant left sided chest pain and nausea. Increased redness and local swelling at the injection site with warmth and then pain and tenderness in to her left trapezius and in to her neck and left anterior chest.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Headache, fatigue, mild but constant left sided chest pain and nausea. Increased redness and local swelling at the injection site with warmth and then pain and tenderness in to her left trapezius and in to her neck and left anterior chest.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain, Pyrexia, Sickle cell anaemia, Sickle cell anaemia with crisis
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner (NP) based on information received by Pfizer from Novartis Pharmaceuticals Corporation (Novartis Reference# PHEH2012US000906-OS). A 52-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13, via an unspecified route of administration, on 28Oct2014. The patient's medical history was not reported. The patient's concomitant medications were not reported. The nurse reported the following: "patient received PREVNAR on 28Oct2014 and experienced generalized pain, nausea, vomiting, fever. The patient was then hospitalized with sickle cell disease with vaso-occlusive crisis." The patient's clinical outcome was not provided.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner (NP) based on information received by Pfizer from Novartis Pharmaceuticals Corporation (Novartis Reference# PHEH2012US000906-OS). A 52-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13, via an unspecified route of administration, on 28Oct2014. The patient's medical history was not reported. The patient's concomitant medications were not reported. The nurse reported the following: "patient received PREVNAR on 28Oct2014 and experienced generalized pain, nausea, vomiting, fever. The patient was then hospitalized with sickle cell disease with vaso-occlusive crisis." The patient's clinical outcome was not provided.
Sex: F
Vaccine: FLU3
Symptoms: Encephalitis
Clinical narrative: Initial information received for this unsolicited case on 12 February 2015 from a consumer who is the patient's daughter-in-law. An unidentified female patient was vaccinated on an unreported date with FLUZONE (Sanofi Pasteur), batch, route and site of administration not reported and at an unspecified time later she experienced encephalitis which required several hospitalizations. The patient's concomitant medications and medical history were not reported. Laboratory tests and hospitalization dates were not reported. The reporter refused to provide further information about the patient or event. The patient outcome is unknown. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, C-reactive protein increased, Chills, Dizziness, Malaise
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 34 years old female patient received first dose of PREVNAR 13 (lot number J90092, expiry date May2016) on 30Jan2015 around 10:27 A.M., at 0.5 ml single, intramuscular. There were no concomitant vaccines administered on same date or within 8 weeks. Concomitant medications included dicyclomine at 10 mg twice a day, mirtazapine, at 15 mg once a day (at bedtime), clonazepam at 0.5 mg twice a day, flunisolide nasal spray (two sprays twice a day) and sertraline tablet at 200 mg daily (2 tablets daily). The patient was asplenic (she had surgery to remove her spleen years ago) and she had ongoing chronic sinusitis and ongoing depression. On 30Jan2015 in the evening, the patient felt sick and went to the emergency room. Symptoms at that time included progressive fever, malaise, weakness, chills, and light headedness. White blood cell count on 30Jan2015 was 34900. The patient was admitted to the hospital on 30Jan2015 and started antibiotics until 03Feb2015. White blood cell count on 31Jan2015 was 12200. C-reactive protein was 3.33 on unknown date and sedimentation rate was 8 on unknown date. The patient was discharged on 03Feb2015. The event "white count was 34900" was resolving at the time of the report. Other events outcome was unknown at the time of the report.
Age: 34.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Red blood cell sedimentation rate normal, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 34 years old female patient received first dose of PREVNAR 13 (lot number J90092, expiry date May2016) on 30Jan2015 around 10:27 A.M., at 0.5 ml single, intramuscular. There were no concomitant vaccines administered on same date or within 8 weeks. Concomitant medications included dicyclomine at 10 mg twice a day, mirtazapine, at 15 mg once a day (at bedtime), clonazepam at 0.5 mg twice a day, flunisolide nasal spray (two sprays twice a day) and sertraline tablet at 200 mg daily (2 tablets daily). The patient was asplenic (she had surgery to remove her spleen years ago) and she had ongoing chronic sinusitis and ongoing depression. On 30Jan2015 in the evening, the patient felt sick and went to the emergency room. Symptoms at that time included progressive fever, malaise, weakness, chills, and light headedness. White blood cell count on 30Jan2015 was 34900. The patient was admitted to the hospital on 30Jan2015 and started antibiotics until 03Feb2015. White blood cell count on 31Jan2015 was 12200. C-reactive protein was 3.33 on unknown date and sedimentation rate was 8 on unknown date. The patient was discharged on 03Feb2015. The event "white count was 34900" was resolving at the time of the report. Other events outcome was unknown at the time of the report.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Abasia, Allergy test positive, Balance disorder, Crying, Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable mother reporting on her daughter. This consumer reported similar events for two patients. This is the first of two reports. A female patient of unknown age (the older daughter) received PREVNAR 13 (lot E23419) 0.5ml single dose, intramuscular in right thigh at 12 months on 23May2011. The patient received the same vaccine also at 2 months, 4 months and 6 months of age and with each vaccine the patient had an allergic reaction. The patient also received on the same date the following vaccines DTAP, HIB, hepatitis a vaccine, MMR and varicella vaccines all at 1 DF. After receiving the vaccine she had multiple side effects, some starting early on and others starting later on unknown date in May2011. Reporter stated that the initial side effect reaction was almost instant. The vaccine side effects lasted weeks in durations. The patient experienced unable to walk, unable to stand, equilibrium was out of wack, high fever of 104, puffed like marshmallow, red rash, vomiting, diarrhea, fainting, dizzy, not able to breathe, hives, swollen lymph nodes, facial pain, head pain, screaming and crying out of control for hours, speech delay. Now she had developed several food allergies, including peanuts, eggs and soy. At the time of the events, she weighed less than 18 pounds. The outcome of the events was unknown.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Dizziness, Dyspnoea, Dysstasia, Facial pain, Food allergy
Clinical narrative: This is a spontaneous report from a contactable mother reporting on her daughter. This consumer reported similar events for two patients. This is the first of two reports. A female patient of unknown age (the older daughter) received PREVNAR 13 (lot E23419) 0.5ml single dose, intramuscular in right thigh at 12 months on 23May2011. The patient received the same vaccine also at 2 months, 4 months and 6 months of age and with each vaccine the patient had an allergic reaction. The patient also received on the same date the following vaccines DTAP, HIB, hepatitis a vaccine, MMR and varicella vaccines all at 1 DF. After receiving the vaccine she had multiple side effects, some starting early on and others starting later on unknown date in May2011. Reporter stated that the initial side effect reaction was almost instant. The vaccine side effects lasted weeks in durations. The patient experienced unable to walk, unable to stand, equilibrium was out of wack, high fever of 104, puffed like marshmallow, red rash, vomiting, diarrhea, fainting, dizzy, not able to breathe, hives, swollen lymph nodes, facial pain, head pain, screaming and crying out of control for hours, speech delay. Now she had developed several food allergies, including peanuts, eggs and soy. At the time of the events, she weighed less than 18 pounds. The outcome of the events was unknown.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Headache, Hypersensitivity, Lymphadenopathy, Pyrexia, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable mother reporting on her daughter. This consumer reported similar events for two patients. This is the first of two reports. A female patient of unknown age (the older daughter) received PREVNAR 13 (lot E23419) 0.5ml single dose, intramuscular in right thigh at 12 months on 23May2011. The patient received the same vaccine also at 2 months, 4 months and 6 months of age and with each vaccine the patient had an allergic reaction. The patient also received on the same date the following vaccines DTAP, HIB, hepatitis a vaccine, MMR and varicella vaccines all at 1 DF. After receiving the vaccine she had multiple side effects, some starting early on and others starting later on unknown date in May2011. Reporter stated that the initial side effect reaction was almost instant. The vaccine side effects lasted weeks in durations. The patient experienced unable to walk, unable to stand, equilibrium was out of wack, high fever of 104, puffed like marshmallow, red rash, vomiting, diarrhea, fainting, dizzy, not able to breathe, hives, swollen lymph nodes, facial pain, head pain, screaming and crying out of control for hours, speech delay. Now she had developed several food allergies, including peanuts, eggs and soy. At the time of the events, she weighed less than 18 pounds. The outcome of the events was unknown.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Screaming, Speech disorder developmental, Swelling, Syncope, Urticaria
Clinical narrative: This is a spontaneous report from a contactable mother reporting on her daughter. This consumer reported similar events for two patients. This is the first of two reports. A female patient of unknown age (the older daughter) received PREVNAR 13 (lot E23419) 0.5ml single dose, intramuscular in right thigh at 12 months on 23May2011. The patient received the same vaccine also at 2 months, 4 months and 6 months of age and with each vaccine the patient had an allergic reaction. The patient also received on the same date the following vaccines DTAP, HIB, hepatitis a vaccine, MMR and varicella vaccines all at 1 DF. After receiving the vaccine she had multiple side effects, some starting early on and others starting later on unknown date in May2011. Reporter stated that the initial side effect reaction was almost instant. The vaccine side effects lasted weeks in durations. The patient experienced unable to walk, unable to stand, equilibrium was out of wack, high fever of 104, puffed like marshmallow, red rash, vomiting, diarrhea, fainting, dizzy, not able to breathe, hives, swollen lymph nodes, facial pain, head pain, screaming and crying out of control for hours, speech delay. Now she had developed several food allergies, including peanuts, eggs and soy. At the time of the events, she weighed less than 18 pounds. The outcome of the events was unknown.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable mother reporting on her daughter. This consumer reported similar events for two patients. This is the first of two reports. A female patient of unknown age (the older daughter) received PREVNAR 13 (lot E23419) 0.5ml single dose, intramuscular in right thigh at 12 months on 23May2011. The patient received the same vaccine also at 2 months, 4 months and 6 months of age and with each vaccine the patient had an allergic reaction. The patient also received on the same date the following vaccines DTAP, HIB, hepatitis a vaccine, MMR and varicella vaccines all at 1 DF. After receiving the vaccine she had multiple side effects, some starting early on and others starting later on unknown date in May2011. Reporter stated that the initial side effect reaction was almost instant. The vaccine side effects lasted weeks in durations. The patient experienced unable to walk, unable to stand, equilibrium was out of wack, high fever of 104, puffed like marshmallow, red rash, vomiting, diarrhea, fainting, dizzy, not able to breathe, hives, swollen lymph nodes, facial pain, head pain, screaming and crying out of control for hours, speech delay. Now she had developed several food allergies, including peanuts, eggs and soy. At the time of the events, she weighed less than 18 pounds. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache
Clinical narrative: Severe frontal headache started 15 min after vaccine and worsened. No associated symptoms.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients. Patients medical history and current condition was not reported. Since an unknown date the patients were vaccinated with improperly stored ROTATEQ oral liquid (unknown dose and frequency) (Lot number and expiry date not reported) and sterile diluents. No adverse effects reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial pregnancy report received from a healthcare professional on 08 May 2013. A 24-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose 1 of ADACEL vaccine lot number: C4366AA in right deltoid on 08 May 2013. The patient was pregnant during vaccination. The patient's last menstrual period was reported as 21 September 2012 and the expected date of delivery is 03 July 2013. List of documents held by the sender: none.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Crying, Erythema, Exophthalmos, Hypoaesthesia, Inappropriate affect
Clinical narrative: Numbness with tingling in face and arm within fifteen minutes vaccine being given. This was the of second shot in the series of three. The numbness lasted a total of thirty to sixty minutes.  02/18/2015 6:00 PM Sudden severe fit of uncontrollable laughing and crying. During the fit unable to stop even to breathe, eyes bugged out, threw himself backwards, his face was red and swollen. The fit lasted a between five and ten minutes, as soon as the fit stopped his face became numb with tingling sensation.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Paraesthesia, Seizure, Swelling face
Clinical narrative: Numbness with tingling in face and arm within fifteen minutes vaccine being given. This was the of second shot in the series of three. The numbness lasted a total of thirty to sixty minutes.  02/18/2015 6:00 PM Sudden severe fit of uncontrollable laughing and crying. During the fit unable to stop even to breathe, eyes bugged out, threw himself backwards, his face was red and swollen. The fit lasted a between five and ten minutes, as soon as the fit stopped his face became numb with tingling sensation.
Age: 34.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Headache, Insomnia, Nausea, Pain in extremity
Clinical narrative: Shortly after receiving immunization developed a sore arm. Arm soreness with tingling in wrist and hand occured as day progressed. At approximately 5:00 PM patient developed a headache, nausea, and dizziness. Patient reports difficulty sleeping that night. Patient reports taking Ibuprofen that evening.
Age: 34.0
Sex: F
Vaccine: HEPAB
Symptoms: Paraesthesia
Clinical narrative: Shortly after receiving immunization developed a sore arm. Arm soreness with tingling in wrist and hand occured as day progressed. At approximately 5:00 PM patient developed a headache, nausea, and dizziness. Patient reports difficulty sleeping that night. Patient reports taking Ibuprofen that evening.
Age: 7.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site rash
Clinical narrative: MOM DESCRIBED IT AS RASHES FROM HIS SHOULDER TO HIS ELBOW, LEFT SIDED.  MOM OFFERED BENADRYL, RASHES SUBSIDED NEXT DAY.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Erythema, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Left arm redness, stiffness, pain, warmth, left shoulder pain, spreading towards left side of neck and left upper back.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Left arm redness, stiffness, pain, warmth, left shoulder pain, spreading towards left side of neck and left upper back.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash on right arm.  Injection given on left arm.
Age: 1.24
Sex: M
Vaccine: HEPA, MMR
Symptoms: Cough, Malaise, Pyrexia, Rash maculo-papular, Respiratory tract congestion
Clinical narrative: Fever x 3 days (up to 103.2), Congestion, rhinorrhea, cough, malaise.  Developed rash 2/2/2015 - diffuse maculopapular - that lasted for 1 week.
Age: 1.24
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rhinorrhoea
Clinical narrative: Fever x 3 days (up to 103.2), Congestion, rhinorrhea, cough, malaise.  Developed rash 2/2/2015 - diffuse maculopapular - that lasted for 1 week.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left knee stiffness, pain and swelling. The next day right knee stiffness pain and swelling which persisted for 2-3 days; left ankle stiffness and  pain, right and left wrist stiffness and pain which persisted for 4 days. 02/19/2015 right hand and fingers stiffness, pain and swelling still occurring.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Peripheral swelling
Clinical narrative: Left knee stiffness, pain and swelling. The next day right knee stiffness pain and swelling which persisted for 2-3 days; left ankle stiffness and  pain, right and left wrist stiffness and pain which persisted for 4 days. 02/19/2015 right hand and fingers stiffness, pain and swelling still occurring.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV1
Symptoms: Blood glucose normal, Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Erythema of eyelid, Eyelid oedema, Eyelids pruritus, Lymphadenopathy
Clinical narrative: Itching, redness, swelling of left anterior shoulder, left upper back, left upper eyelid, right supraclavicluar lymph node enlargement.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Swelling
Clinical narrative: Itching, redness, swelling of left anterior shoulder, left upper back, left upper eyelid, right supraclavicluar lymph node enlargement.
Age: 35.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, ANTH, JEV1, SMALL
Symptoms: Arthralgia, Blood albumin decreased, Blood lactate dehydrogenase increased, Liver function test abnormal, Myalgia
Clinical narrative: Febrile illness (103-104 fever spikes), myalgias, arthralgias, testicular swelling/pain x 3 weeks.
Age: 35.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, ANTH, JEV1, SMALL
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Serum ferritin increased, Testicular pain, Testicular swelling
Clinical narrative: Febrile illness (103-104 fever spikes), myalgias, arthralgias, testicular swelling/pain x 3 weeks.
Age: 35.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, ANTH, JEV1, SMALL
Symptoms: Ultrasound testes normal, White blood cell count increased
Clinical narrative: Febrile illness (103-104 fever spikes), myalgias, arthralgias, testicular swelling/pain x 3 weeks.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash macular
Clinical narrative: Generalized, red, lacy, macular, rash on her body. It was on her face, trunk and back. While examining her, the rash dissipated and went away. Heart and lung sounds were normal, no wheezing or increased work of breathing noted. RN was asked to give 1 mg/kg/dose of Benadryl. Parents were asked to call back if the child has any rash, or other reaction tonight or at any point over the next few days.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Atrial fibrillation, Blood pressure increased, Dizziness, Erythema, Feeling cold
Clinical narrative: Arm became red and hard with swelling.  As the evening progress, I became nauseated, dizzy light headed, sweaty and then cold and shaky. Passed out and was taken to ER by friend.  My heart was in Afib and my BP was elevated by time I arrived at ER.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Induration, Loss of consciousness, Nausea, Peripheral swelling
Clinical narrative: Arm became red and hard with swelling.  As the evening progress, I became nauseated, dizzy light headed, sweaty and then cold and shaky. Passed out and was taken to ER by friend.  My heart was in Afib and my BP was elevated by time I arrived at ER.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Arm became red and hard with swelling.  As the evening progress, I became nauseated, dizzy light headed, sweaty and then cold and shaky. Passed out and was taken to ER by friend.  My heart was in Afib and my BP was elevated by time I arrived at ER.
Sex: M
Vaccine: HEP
Symptoms: Dysphonia, Dyspnoea, Heart rate increased, Pyrexia, Urticaria
Clinical narrative: Baby had difficulty breathing, a fast heartbeat, a low fever, small hives on face and back, and wheezing/hoarseness.
Sex: M
Vaccine: HEP
Symptoms: Wheezing
Clinical narrative: Baby had difficulty breathing, a fast heartbeat, a low fever, small hives on face and back, and wheezing/hoarseness.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: A rash devoloped at the injection site and spread radially outward until stopping at elbow and shoulder.  Pt said rash was extremely itchy.  Pt took Benadryl to help with the pruritis.  Benadryl helped.  Rash started to resolve on the third day and appears to be getting better at this time, 5th day from injection time.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Fever ranging from 99 to 101, severe  joint pain, body aches. This lasted until 02/19/15.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema
Clinical narrative: Redness at Injection site.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Contusion, Erythema, Induration, Tenderness
Clinical narrative: Erythematous area approximately 6.5 cm X 5 cm indurated.  Slightly painful to touch, SI bruise.
Age: 68.0
Sex: F
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: PT GOT RASH ON HER UPPER CHEST AND BACK. SHE USED BENADRYL CREAM AND TOOK BENADRYL CAPSULES.
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: HIV test, Rash erythematous, Rash vesicular, Viral test
Clinical narrative: Erythromatous vesicular rash in clusters on L shoulder, chest, back and posterior neck.  No pustules. No pruritis or pain.  Smallpox site on L arm is healing well with a scab in place.  Started 12 days after vaccine was administered.  He reports good wound care of site.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5, DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Erythema, Swelling face, Urticaria
Clinical narrative: 6 hrs after vaccine administration face seemed a little swollen then awoke with hives all over.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5, DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Swelling face, Urticaria
Clinical narrative: 6 hrs after vaccine administration face seemed a little swollen then awoke with hives all over.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult subject of unspecified gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX QUADRIVALENT (unknown route and injection site). On an unspecified date, 2 days after vaccination with FLUARIX QUADRIVALENT, the subject experience swelling injection site, injection site warmth and injection site hives. At the time of reporting, the events were improved. The pharmacist considered the events were probably related to vaccination with FLUARIX QUADRIVALENT. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored ROTATEQ oral (dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers a patient of unknown age and gender. The patient medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with oral, ROTATEQ (lot # and expiration date were not provided). Concomitant medication information was not provided. On an unknown date, the patient received oral ROTATEQ that was improperly stored. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult subject of unspecified gender who was vaccinated with FLUARIX, (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX (unknown route and injection site). On an unspecified date, 2 days after vaccination with FLUARIX, the subject experienced swelling injection site, injection site warmth and injection site hives. At the time of reporting, the events were improved. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult subject of unspecified gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX QUADRIVALENT (unknown route and injection site). On an unspecified date, 2 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling injection site, injection site warmth and injection site hives. At the time of reporting, the events were improved. The pharmacist considered the events were probably related to vaccination with FLUARIX QUADRIVALENT. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: RVX
Symptoms: Diarrhoea, Gastrointestinal disorder, Rotavirus test negative
Clinical narrative: This case was reported in a literature article and described the occurrence of diarrhea in a child unk subject who received Rotavirus vaccine. On an unknown date, 14 days after receiving Rotavirus vaccine, the subject developed diarrhea (Non-serious). The outcome of diarrhea was unknown. It was unknown if the investigator considered the diarrhea to be related to Rotavirus vaccine. Relevant Tests: An enzyme immune-assay of a stool sample was negative for Rotavirus antigen. Additional information received: This case was reported in a literature article and it described the occurrence of diarrhoea in a child of unspecified gender and at least 8 months old, who had received an unspecified Rotavirus vaccine (manufacturer unknown). The patient had been enrolled in a post-marketing vaccine effectiveness study that excluded children with a severely immunocompromising condition. No further information on the patient's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the patient received 1 dose of an unspecified rotavirus vaccine (oral, dosage unknown; batch number not provided). On an unspecified date either between January and June 2010 or between January and June 2011, at least 14 days after the administration of the vaccine, the patient developed acute gastrointestinal symptoms defined by the authors as at least 3 looser-than-normal stools in a 24-hour period during the illness and the onset of the diarrhoea within 10 days of presentation to hospital. It was unknown if the patient was admitted. An enzyme immune-assay of a stool sample was negative for rotavirus antigen. Treatment was unknown. The outcome of the event was unspecified. The authors did not comment on any causal relationship between the vaccine and the event. The authors concluded that "This evaluation demonstrates that monovalent Rotavirus vaccine was highly effective in children against severe Rotavirus disease during at least the first 2 years of life, and confirms the high effectiveness of the pentavalent Rotavirus vaccine". This case is 1 of the 2 valid cases reported in the same literature article (see case US2014GSK051977).
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult subject of unspecified gender who was vaccinated with FLUARIX QUARDRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX QUADRIVALENT (unknown). On an unspecified date, 2 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling injection site, injection site warmth and injection site hives. At the time of reporting, the events were improved. The pharmacist considered the events were probably related to vaccination with FLUARIX QUADRIVALENT. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX quadrivalent (unknown route and injection site). On second day after vaccination with FLUARIX quadrivalent, the subject experienced swelling and warmth and injection site. The subject also experienced 3-4 hives at the injection site. Antibiotics were prescribed. At the time of reporting the events were improved. The pharmacist considered the events were probably related to vaccination with FLUARIX quadrivalent.
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer via pharmacist and lawyer and described the occurrence of unspecified adverse effect of drug or medicament in a female subject of unspecified age who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of FLUARIX QUADRIVALENT (unknown route and injection site). At an unspecified time after vaccination with FLUARIX QUADRIVALENT, the subject experienced an unspecified adverse effect. At the time of reporting, the outcome of the event was unspecified.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a female subject of unspecified age who was possibly vaccinated and FLULAVAL (GlaxoSmithKline) for prophylaxis during pregnancy. On an unspecified date the subject possibly received unspecified dose of FLULAVAL TETRA (unknown). Her last menstrual period was 10 January 2014 and estimated date of delivery was 17 October 2014. On an unknown date, at the time of vaccination with FLULAVAL TETRA, the subject experienced vaccine exposure during pregnancy during the 1st trimester. At the time of the report the subject was 4 weeks pregnant and the pregnancy was ongoing. Additional information received: Reporter called from doctor's office stating that they are unaware of patient referenced in safety follow-up form. They do not plan to fill out paperwork due to the fact that they are unable to identify patient. No further details to provide. The pregnancy was lost to follow up.
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt stated redness and swelling at injection site. Instructed to seek medical attention if symptoms worsen.
Age: 0.34
Sex: F
Vaccine: DTAP, RV5
Symptoms: Vomiting, Vomiting projectile
Clinical narrative: Patient has been vomiting up breast milk and it now is projectile vomiting. Pt started vomiting 2 days after vaccine. Then by day 7 after vaccine pt started projective vomiting with breast feed. pt holding down PEDIALYTE without vomiting.
Age: 10.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Erythema, Mass
Clinical narrative: Red, large lump under skin the day after vaccine. Lump got bigger the following day. Was give KEFLEX and BENADRYL.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Malaise, Pain, Pyrexia, Urticaria
Clinical narrative: Pt called stating after receiving TDAP, she felt ill with a fever of 101.0, body aches, diarrhea and hives (face). pt is feeling better now. Symptoms lasted 2 wks.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Amylase, Asthenopia, Blood creatine phosphokinase, Dizziness, Full blood count
Clinical narrative: Grandmother says boy felt dizzy and had heavy eyes.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Lipase, Metabolic function test, Urine analysis
Clinical narrative: Grandmother says boy felt dizzy and had heavy eyes.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Aspiration, Erythema, Induration, Mobility decreased, Pain
Clinical narrative: Approx 2 days after receiving vaccine pt states arm swelled up and become difficult to move. Pt was placed on antibx for another reason and swelling, improved. Pt came to clinic 2/9/15. Arm was hot to touch, red and had a 5cm x 4cm indurated area and painful. Pt was evaluated by MD and placed on additional antibiotics. Pt returned 2 days later. Erythema, redness decreased, however indurated area cont 5cm x 4cm. MD aspirated serous fluid. Sent for culture. No additional fluid except blood aspirated. Pt cont to antibiotics.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Approx 2 days after receiving vaccine pt states arm swelled up and become difficult to move. Pt was placed on antibx for another reason and swelling, improved. Pt came to clinic 2/9/15. Arm was hot to touch, red and had a 5cm x 4cm indurated area and painful. Pt was evaluated by MD and placed on additional antibiotics. Pt returned 2 days later. Erythema, redness decreased, however indurated area cont 5cm x 4cm. MD aspirated serous fluid. Sent for culture. No additional fluid except blood aspirated. Pt cont to antibiotics.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 10.5 x 7 cm area lat. proximal (R) upper arm sl. erythematous sl. swollen - not painful not causing LOM.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Influenza
Clinical narrative: None stated.
Age: 0.35
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: None at time of administration. MD and NP spoke to parent and made her aware of vaccine given in the wrong route.