chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Developed erythema, swelling and hives (localized to injection site) 1 day after injection. No tenderness. Treatment with BENADRYL.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Mother refers that the infant presented diarrhea (stools with blood) for 3 instances.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Nausea, Rash generalised, Rash vesicular
Clinical narrative: Varicella adm 1-15-16. Client reports that developed chicken pox blister-like rash to all over body. Denies any fever since vaccine. C/O nausea and headache 2 days ago. Went to Dr and was prescribed acyclovir: (client had never been vaccinated as child).
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Rash on abdomen, back and upper legs. Developed rash 4-5 days after vaccinations. Rash described as red raised welts.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. On 21-JAN-2016, the patient was inadvertently vaccinated with VARIVAX (Merck) injection, lot # K005182 and expiration date on 10-APR-2016, instead of ZOSTAVAX (Merck) (route, dose, frequency and strength were not reported). No concomitant medications were reported. No adverse events were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Neuropathy peripheral
Clinical narrative: AXILLARY NEUROPATHY (PATIENT STATEMENT)am now far enough along in the progression of this injury where my neurologist is recommending nerve transposition.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Abdominal pain, Seizure, Tonic posturing, Vomiting
Clinical narrative: Seizure (tonic positioning) lasting approx 3-5 seconds, followed by intense middle abdomen pain, causing vomiting x1.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient is having arm/ shoulder pain. He is unable to lift his arm over his head.
Age: 23.0
Sex: F
Vaccine: FLUX, MEN, TDAP, TYP, FLUX, MEN, TDAP, TYP
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Nauseous, Chills, Body Aches, Headache, Fever. Went to ER next day (01/21/2016 9:00 AM) received 2 IV, Motrin, Tylenol, and Zofran. Left hospital with 101 F fever.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema, Blood culture, Differential white blood cell count, Faeces discoloured, Full blood count
Clinical narrative: Patient began having vomiting and dark colored stool. He was sent for a KUB which showed distended small bowel and subsequently barium enema was ordered.  The patient was found to have an intussusception.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intestinal dilatation, Intussusception, Metabolic function test, Platelet count, Urinary system X-ray
Clinical narrative: Patient began having vomiting and dark colored stool. He was sent for a KUB which showed distended small bowel and subsequently barium enema was ordered.  The patient was found to have an intussusception.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Patient began having vomiting and dark colored stool. He was sent for a KUB which showed distended small bowel and subsequently barium enema was ordered.  The patient was found to have an intussusception.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Pt states that arm is hurting from the shoulder all the way down to the wrist. Upon examining arm pt has no redness no marks of any kind. Pt has brought this up to primary care as well but no concern was expressed.
Age: 47.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection sight of vaccination swollen, hard, red, and tender in an area about 6 inches in diameter. Severe fatigue lasting 2 weeks or so. Nausea for 2 weeks, off and on.
Age: 47.0
Sex: M
Vaccine: DTAP
Symptoms: Nausea
Clinical narrative: Injection sight of vaccination swollen, hard, red, and tender in an area about 6 inches in diameter. Severe fatigue lasting 2 weeks or so. Nausea for 2 weeks, off and on.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Localizes softball size pain, swelling, redness, and heat.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swelled up and turned red and started itching. The next day there was a hard lump at the site and the redness spread further outward from the site. Arm was painful and hurt to lift it over then next six days.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Injection site swelled up and turned red and started itching. The next day there was a hard lump at the site and the redness spread further outward from the site. Arm was painful and hurt to lift it over then next six days.
Age: 48.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenopia, Cough, Eye movement disorder, Fatigue, Injection site erythema
Clinical narrative: Significant swelling at injection site, and in the opposite arm. Redness and hardness from the elbow to the shoulder of the arm that had the injection. 2 days after injection vision became blurry. 3 days after injection eyes were not focusing and my wife could see that both eyes were not looking in the same direction. 5 days after injection the eye blurriness stopped, although I had eye fatigue for a couple weeks. Severe fatigue and nausea from the day after injection was almost constant for 1 month. On August 12, one week after injection I had a fever of 100.5, and fatigue, and nausea. Doctor was called, and I was seen and tests were run. I was given an antibiotic for my sypmtoms (cough, nasal drainage, fever). After 3 days the fever subsided, and the fatigue and nausea persisted for about 3-5 weeks from the time of injection. About once a month, a rash appears on or around injection site of both arms since the injection of DTap acel. Severe fatigue still occurs for several weeks, followed by 1-2 weeks of more "normal" energy levels. Then, fatigue again continues with a slight rash on arms. This pattern has continued from the 2nd dose of DTaP on August 5, 2015 until present (January 2016).
Age: 48.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Laboratory test, Nausea
Clinical narrative: Significant swelling at injection site, and in the opposite arm. Redness and hardness from the elbow to the shoulder of the arm that had the injection. 2 days after injection vision became blurry. 3 days after injection eyes were not focusing and my wife could see that both eyes were not looking in the same direction. 5 days after injection the eye blurriness stopped, although I had eye fatigue for a couple weeks. Severe fatigue and nausea from the day after injection was almost constant for 1 month. On August 12, one week after injection I had a fever of 100.5, and fatigue, and nausea. Doctor was called, and I was seen and tests were run. I was given an antibiotic for my sypmtoms (cough, nasal drainage, fever). After 3 days the fever subsided, and the fatigue and nausea persisted for about 3-5 weeks from the time of injection. About once a month, a rash appears on or around injection site of both arms since the injection of DTap acel. Severe fatigue still occurs for several weeks, followed by 1-2 weeks of more "normal" energy levels. Then, fatigue again continues with a slight rash on arms. This pattern has continued from the 2nd dose of DTaP on August 5, 2015 until present (January 2016).
Age: 48.0
Sex: M
Vaccine: DTAP
Symptoms: Peripheral swelling, Pyrexia, Rash, Rhinorrhoea, Vision blurred
Clinical narrative: Significant swelling at injection site, and in the opposite arm. Redness and hardness from the elbow to the shoulder of the arm that had the injection. 2 days after injection vision became blurry. 3 days after injection eyes were not focusing and my wife could see that both eyes were not looking in the same direction. 5 days after injection the eye blurriness stopped, although I had eye fatigue for a couple weeks. Severe fatigue and nausea from the day after injection was almost constant for 1 month. On August 12, one week after injection I had a fever of 100.5, and fatigue, and nausea. Doctor was called, and I was seen and tests were run. I was given an antibiotic for my sypmtoms (cough, nasal drainage, fever). After 3 days the fever subsided, and the fatigue and nausea persisted for about 3-5 weeks from the time of injection. About once a month, a rash appears on or around injection site of both arms since the injection of DTap acel. Severe fatigue still occurs for several weeks, followed by 1-2 weeks of more "normal" energy levels. Then, fatigue again continues with a slight rash on arms. This pattern has continued from the 2nd dose of DTaP on August 5, 2015 until present (January 2016).
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Urticaria
Clinical narrative: Rash with hives on thigh, r/l ankle and now neck.  No redness or rash on injection site. She has not had any exposures to anything new except the HPV 9.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse event, pt pregnancy diagnosed after vaccine given. Pregnant at the time of the vaccination.
Age: 28.0
Sex: M
Vaccine: ANTH, RAB
Symptoms: Ataxia, Diplopia
Clinical narrative: Diplopia, ataxia.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Increased pain in arm after vaccine that progressed over the course of 3 weeks and now starting to improve.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: started to have soreness of the arm after the vaccine and then the pain progressed over the course of 2 weeks and now cannot lift her right arm.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Dysphemia, Obsessive-compulsive disorder, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Streptococcus test, Tic
Clinical narrative: STUTTERING, Facial tics, OCD, PANDAS.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Blood culture, C-reactive protein, Chest X-ray, Chills, Culture urine
Clinical narrative: Fever, chills.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Mononucleosis heterophile test, Pyrexia
Clinical narrative: Fever, chills.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate, Urine analysis
Clinical narrative: Fever, chills.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Condition aggravated, Dizziness, Immediate post-injection reaction, Loss of consciousness, Petit mal epilepsy
Clinical narrative: Right after adminstration, patient started feeling light headed and passed out and had a blank seizure which lasted for about a few seconds. He had 2 back to back within one minute.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Endotracheal intubation, Intensive care, Paralysis
Clinical narrative: Paralytic stroke like symptoms - required Intensive Care with airway intubation. Neurologist questioning if this is related to the flu vaccine.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy, HIV test, Laboratory test, Vaginal haemorrhage
Clinical narrative: Information has been received from a medical assistant referring to a 25 year old female patient with none drug reactions/allergies. The patient's medical history included 8 previous pregnancies with 4 elective abortions and 2 miscarriages. The patient became pregnant again with last menstrual period (LMP) of 17-DEC-2015 and expected delivery of date (EDD) of 22-SEP-2016. On 14-JAN-2016 the pregnant patient was vaccinated with GARDASIL (lot # K010215, expiration date: 05-MAY-2017, 0.5 ml, intramuscular). On the same day, HIV testing and obstetric panel were performed (result not provided). On 17-JAN-2016, the patient went to an unspecified emergency room, complaining of vaginal bleeding where she received a diagnosis of "impression: spontaneous abortion." The outcome of abortion spontaneous was reported as recovering/resolving. The causality was not reported. Upon internal review, spontaneous abortion was considered to be medically significant. Additional information has been requested.
Age: 0.84
Sex: M
Vaccine: FLU3, HEP
Symptoms: Rash
Clinical narrative: Mother noticed rash on trunk/back 1/25/16. Flu shot given 1/20/16. Rash worsened since 1/25/16.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Malaise, Pyrexia, Skin warm
Clinical narrative: Large area redness/heat/swelling plus fever/chills/malaise within 48 hrs after shots. Systemic symptoms gone after 4th day (1/24/16) but locally no better so started KEFLEX.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: Large area redness/heat/swelling plus fever/chills/malaise within 48 hrs after shots. Systemic symptoms gone after 4th day (1/24/16) but locally no better so started KEFLEX.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients. Patients' pertinent medical history and concurrent conditions were not reported. On multiple unspecified dates ranging from 12-JAN-2016 through 19-JAN-2016, improperly stored VARIVAX (Merck) were administered to multiple unspecified patients, lot # L028275 and expiration date 28-JUL-2017 (strength, dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported and no product quality complaint was involved. The nurse reported the temperature excursion. Temperature: every day cycles lasting up to 6 minutes each ranging temperature from -13.6 C degree to -14.5 C degree. Time frame: total 54 minutes cumulative Outcome of the excursion: VARIVAX (Merck) was supported until expiry. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Angina pectoris, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: The day of vaccine given Ampicillin and Tramadol/acetaminophen for sore throat and earache. Right  away by the afternoon problems began. Felt very weak so went to bed. Right away paralyzed, lots of pain, headache, all joints very sensitive. Massaged arm until sensation came back. Symptoms continued, had fever 100 degrees-102 degrees before going to ER. On 1/10 went to ER. On ER they ran scan/x-rays. The discharge summary mentions angina, gallstone, tension headache. In the ER they gave her 2 aspirins for heart, TYLENOL X - 500mg, also received metoclopramide and acetaminophen and nitroglycerin. Came home rested because would get dizzy. Went to the doctor on 1/18 as follow-up to ER. By then felt better and was able to move more. Today still dizzy, tired a lot but on her way to recovery.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hyperaesthesia, Pain, Paralysis, Pyrexia, Scan
Clinical narrative: The day of vaccine given Ampicillin and Tramadol/acetaminophen for sore throat and earache. Right  away by the afternoon problems began. Felt very weak so went to bed. Right away paralyzed, lots of pain, headache, all joints very sensitive. Massaged arm until sensation came back. Symptoms continued, had fever 100 degrees-102 degrees before going to ER. On 1/10 went to ER. On ER they ran scan/x-rays. The discharge summary mentions angina, gallstone, tension headache. In the ER they gave her 2 aspirins for heart, TYLENOL X - 500mg, also received metoclopramide and acetaminophen and nitroglycerin. Came home rested because would get dizzy. Went to the doctor on 1/18 as follow-up to ER. By then felt better and was able to move more. Today still dizzy, tired a lot but on her way to recovery.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Tension headache, X-ray
Clinical narrative: The day of vaccine given Ampicillin and Tramadol/acetaminophen for sore throat and earache. Right  away by the afternoon problems began. Felt very weak so went to bed. Right away paralyzed, lots of pain, headache, all joints very sensitive. Massaged arm until sensation came back. Symptoms continued, had fever 100 degrees-102 degrees before going to ER. On 1/10 went to ER. On ER they ran scan/x-rays. The discharge summary mentions angina, gallstone, tension headache. In the ER they gave her 2 aspirins for heart, TYLENOL X - 500mg, also received metoclopramide and acetaminophen and nitroglycerin. Came home rested because would get dizzy. Went to the doctor on 1/18 as follow-up to ER. By then felt better and was able to move more. Today still dizzy, tired a lot but on her way to recovery.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Tenderness
Clinical narrative: Redness, tenderness.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Joint injury, Mobility decreased, Pain, Vaccination complication
Clinical narrative: Patient states given flu shot too high in arm, has been to 3 doctors with no diagnosis. Orthopedic doctor states she has "SIRVA". Patient can't move arm higher than 3 inch above wrist, has trouble putting on clothes but is able to move it. Says in pain every day.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On unspecified date in 2014, the patient was vaccinated with the first dose of GARDASIL (Lot #, expiration date and route of administration were not reported), the second dose was administered on unspecified date in 2015 (Lot #, expiration date and route of administration were not reported) and the third on unspecified date in 2016 (Lot #, expiration date and route of administration were not reported). The adverse event reported was that the vaccination was given other than prescribed in the prescribing information. The patient sought medical attention as there was an office visit. Additional information is not expected as the reporter did not wish further contact.
Age: 10.0
Sex: F
Vaccine: RAB
Symptoms: Eye swelling, Rash pruritic, Throat irritation, Wheezing
Clinical narrative: On 1/16/16 parent brought pt to ER for itchy rash that she had x 24 hours. Also stated c/o scratchy throat and wheeze - resolved with 1 dose albuterol before going to hospital. Swelling noted around 1 eye given BENADRYL and started on ZYRTEC.
Age: 71.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema
Clinical narrative: Received PNEUMOVAX 23 1/14/16. Pt reports developed redness the day after vaccine. Seen by PCP 1/20/16 left upper arm with 8 cm diameter redness around lower half of forearm (about 2/3 circumference of arm). Warm compress and MOTRIN recommended.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Rash
Clinical narrative: Tdap given 1/20/16. Developed rash about 3 days after. Pt. seen by doctor 1/27/16. Localized redness around injection site that is resolving. Recommendation to apply heat or ice and return as needed.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pruritus, Limb discomfort
Clinical narrative: Right arm rec'd shot got hard, red, and itchy 5 days after pt. rec'd shot for PREVNAR 13. Redness and discomfort (L) arm flu shot for 2 days.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Paraesthesia, Rash
Clinical narrative: Patient had complaint of left thigh feeling sore (immunization given in left deltoid) then mother looked at thigh and noted U shaped rash 10 cm x 6-8 cm, states with touch like pin prickling and now 30 hours later sharp pain. Will be seeing provider today.
Age: 0.24
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an office manager (health professional) via a field representative regarding a 12 week old patient of unknown gender. No historical or concurrent conditions were reported. On 28-DEC-2015, the patient was vaccinated with first dose of oral ROTATEQ (lot # unspecified). On 18-JAN-2016, the patient was inadvertently vaccinated with another dose ROTATEQ. No concomitant medications were reported. No symptoms were reported. No product quality complaint (PQC) was reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concomitant medications, concurrent conditions and medical history was not reported. On 26-JAN-2016 the patient received an expired dose of M-M-R II (lot # K000998 with expiration date 22-JAN-2016, dose 0.5 ml) subcutaneously. No adverse effects were reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Generalised erythema, Heart rate increased, Hyperhidrosis, Skin warm
Clinical narrative: Case number PHHY2014US156125 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 543701) website on 28 Nov 2014. This report refers to a 23 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 15 Sep 2014. On 15 Sep 2014, she experienced difficulty in breathing, fast heartbeat, sweating and her whole body turned red and hot. The outcome was reported as complete recovery. The seriousness of the events was not reported, but the events difficulty in breathing and fast heart beat were upgraded based on the information available in the source documents. The causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2014US156156 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 543962) website on 28 Nov 2014. This report refers to a 55 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 11 Sep 2014. On 12 Sep 2014, she experienced hives all over and itching. The outcome was reported as condition unchanged. The seriousness of the events was not reported, but the event hives was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Breast swelling, Burning sensation, Fatigue, Hypersensitivity
Clinical narrative: Case number PHHY2014US157991 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 544267) website on 28 Nov 2014. This report refers to a 47 years old female patient. She was healthy and did not receive any other vaccine for several years. Her current conditions were not reported. Her concomitant medications included acyclovir 400 mg daily, CELEXA 10 mg daily and XANAX 0.5 mg as needed. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 15 Sep 2014. On 16 Sep 2014, her armpit lymph nodes in the injected arm were swollen to the size of a tennis ball and she had burning sensation, pain and joint pain. By next day, she had more swelling in armpit which extended to her chest and breast and then up to her clavicle, neck and throat. She had even more pain and extreme exhaustion. Her vaccination site then turned red and became swollen. She ended up in urgent care on an unknown date in Sep 2014 and was put on antihistamine, PEPCID, steroids and ibuprofen. She was told that she has having a severe allergic reaction to the flu vaccine and was advised to never take it again. The final outcome was reported as condition unchanged. The seriousness of events was not reported, but the event allergic reaction to the flu vaccine and lymphadenopathy were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Local swelling, Lymphadenopathy, Pain, Pharyngeal oedema
Clinical narrative: Case number PHHY2014US157991 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 544267) website on 28 Nov 2014. This report refers to a 47 years old female patient. She was healthy and did not receive any other vaccine for several years. Her current conditions were not reported. Her concomitant medications included acyclovir 400 mg daily, CELEXA 10 mg daily and XANAX 0.5 mg as needed. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 15 Sep 2014. On 16 Sep 2014, her armpit lymph nodes in the injected arm were swollen to the size of a tennis ball and she had burning sensation, pain and joint pain. By next day, she had more swelling in armpit which extended to her chest and breast and then up to her clavicle, neck and throat. She had even more pain and extreme exhaustion. Her vaccination site then turned red and became swollen. She ended up in urgent care on an unknown date in Sep 2014 and was put on antihistamine, PEPCID, steroids and ibuprofen. She was told that she has having a severe allergic reaction to the flu vaccine and was advised to never take it again. The final outcome was reported as condition unchanged. The seriousness of events was not reported, but the event allergic reaction to the flu vaccine and lymphadenopathy were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling, Vaccination site swelling
Clinical narrative: Case number PHHY2014US157991 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 544267) website on 28 Nov 2014. This report refers to a 47 years old female patient. She was healthy and did not receive any other vaccine for several years. Her current conditions were not reported. Her concomitant medications included acyclovir 400 mg daily, CELEXA 10 mg daily and XANAX 0.5 mg as needed. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 15 Sep 2014. On 16 Sep 2014, her armpit lymph nodes in the injected arm were swollen to the size of a tennis ball and she had burning sensation, pain and joint pain. By next day, she had more swelling in armpit which extended to her chest and breast and then up to her clavicle, neck and throat. She had even more pain and extreme exhaustion. Her vaccination site then turned red and became swollen. She ended up in urgent care on an unknown date in Sep 2014 and was put on antihistamine, PEPCID, steroids and ibuprofen. She was told that she has having a severe allergic reaction to the flu vaccine and was advised to never take it again. The final outcome was reported as condition unchanged. The seriousness of events was not reported, but the event allergic reaction to the flu vaccine and lymphadenopathy were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Diarrhoea, Dysphonia, Electrocardiogram, Foreign body sensation in eyes
Clinical narrative: Case number PHHY2014US156049, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544536) website on 28 Nov 2014. This report refers to a 65-year-old female patient. Historical conditions and were current illness none. Concomitant medications included Alendronate, calcium, ascorbyl palmitate and Vitamin E. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 18 Sep 2014. On the same day after vaccination, she experienced gritty eyes, swollen throat, hoarseness, occasional cough, vomiting and diarrhea. She went to clinic. She was given sodium chloride (NS) 0.9 percent injection, SOLU-MEDROL 125 mg injection and BENADRYL 50 mg/ml injection solution intravenously. She underwent ECG epic order and group A strep rapid AG test (no results reported). The outcome of the events was condition unchanged. Seriousness was not reported. The case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal oedema, Streptococcus test, Vomiting
Clinical narrative: Case number PHHY2014US156049, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544536) website on 28 Nov 2014. This report refers to a 65-year-old female patient. Historical conditions and were current illness none. Concomitant medications included Alendronate, calcium, ascorbyl palmitate and Vitamin E. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 18 Sep 2014. On the same day after vaccination, she experienced gritty eyes, swollen throat, hoarseness, occasional cough, vomiting and diarrhea. She went to clinic. She was given sodium chloride (NS) 0.9 percent injection, SOLU-MEDROL 125 mg injection and BENADRYL 50 mg/ml injection solution intravenously. She underwent ECG epic order and group A strep rapid AG test (no results reported). The outcome of the events was condition unchanged. Seriousness was not reported. The case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Dizziness, Nausea, Peripheral swelling, Pruritus, Streptococcus test negative
Clinical narrative: Case number PHHY2014US156130, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544565) website on 28 Nov 2014. This report refers to a 15-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included human papilloma vaccine (manufacturer and batch number: not reported) and influenza vaccine (manufacturer and batch number: not reported). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), along with GARDASIL (batch number: not reported) on 19 Sep 2014. On 20 Sep 2014, she experienced itching, swelling of feet and hands, nausea, vomiting, dizzy, and hives all over body face, hand and feet. She was sent to emergency room. The patient underwent streptococcus test which was negative. The outcome of the events was condition unchanged. Seriousness was not reported. The case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Urticaria, Vomiting
Clinical narrative: Case number PHHY2014US156130, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544565) website on 28 Nov 2014. This report refers to a 15-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included human papilloma vaccine (manufacturer and batch number: not reported) and influenza vaccine (manufacturer and batch number: not reported). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), along with GARDASIL (batch number: not reported) on 19 Sep 2014. On 20 Sep 2014, she experienced itching, swelling of feet and hands, nausea, vomiting, dizzy, and hives all over body face, hand and feet. She was sent to emergency room. The patient underwent streptococcus test which was negative. The outcome of the events was condition unchanged. Seriousness was not reported. The case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Lip swelling, Ocular hyperaemia, Wheezing
Clinical narrative: Case number PHHY2014US156213, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544687) website on 28 Nov 2014. This report refers to a 38-year-old male patient. Concurrent conditions included cold with no fever. No concomitant medication was reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 22 Sep 2014. On the same day after vaccination he experienced, wheezing, swollen lips and red eyes. The outcome of the events was condition unchanged. Seriousness was not reported. The case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Dyspnoea, Headache, Heart rate increased, Myalgia
Clinical narrative: Case number PHHY2014US158299, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544904) website on 28 Nov 2014. This report refers to a 30-year-old female patient. Her current conditions included environmental allergies (trees, grasses, molds, etc.,), asthma and thyroid disease. Concomitant drugs included SYNTHROID, Albuterol, ZYRTEC and BENADRYL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 23 Sep 2014. On the same date, after vaccination she experienced sudden shortness of breath, hoarseness, constricting of throat, wheezing and increased heart rate. On 24 Sep 2014 around 02:00 am, she experienced a severe headache and severe muscle pain. She treated her events in the same way as she treated her allergic reaction with OTC anti-histamines and Albuterol, to help her shortness of breath. The outcome of the events reported as recovered. The events reported as non-serious. Seriousness assessment of the events (shortness of breath, hoarseness, constricting of throat, wheezing and increased heart rate) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Throat tightness, Wheezing
Clinical narrative: Case number PHHY2014US158299, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544904) website on 28 Nov 2014. This report refers to a 30-year-old female patient. Her current conditions included environmental allergies (trees, grasses, molds, etc.,), asthma and thyroid disease. Concomitant drugs included SYNTHROID, Albuterol, ZYRTEC and BENADRYL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 23 Sep 2014. On the same date, after vaccination she experienced sudden shortness of breath, hoarseness, constricting of throat, wheezing and increased heart rate. On 24 Sep 2014 around 02:00 am, she experienced a severe headache and severe muscle pain. She treated her events in the same way as she treated her allergic reaction with OTC anti-histamines and Albuterol, to help her shortness of breath. The outcome of the events reported as recovered. The events reported as non-serious. Seriousness assessment of the events (shortness of breath, hoarseness, constricting of throat, wheezing and increased heart rate) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2014US159810 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System (VAERS ID: 545616) website on 28 Nov 2014. This report refers to a 27 year old female patient. Her current conditions included asthma and rheumatoid arthritis. Her concomitant medications included PROAIR, FLOVENT, CLARITIN-D and trazodone. On 27 Sep 2014, she was vaccination with seasonal influenza vaccine (manufacturer and batch number: not reported) into her arm. On the same day, after the vaccination, the patient developed hives on her arms and legs. The outcome of the event was unknown. The event was reported as non serious but the seriousness of hives was upgraded based on the information available in the source documents. The causality of the event was not reported.
Age: 1.0
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2014US159811 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System (VAERS ID: 545653) website on 28 Nov 2014. This report refers to an year old female patient. Her current conditions included common cold and medical history included acid reflux. Her concomitant medications included MOTRIN. On 18 Sep 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), with measles, mumps and rubella vaccine (other manufacturer, batch number: not reported) and with varicella zoster vaccine (other manufacturer, batch number: not reported). On 29 Sep 2014, she developed a full body rash including her face, trunk and extremities. The outcome of the event was unknown. The event was reported as non serious but the seriousness of full body rash was upgraded based on the information available in the source documents. The causality of the event was not reported.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Pruritus, Pyrexia, Rash, Rash erythematous
Clinical narrative: Case number PHHY2014US159812 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System (VAERS ID: 545616) website on 28 Nov 2014. This report refers to a 67 year old female patient. Her past medical history was not reported. Her concomitant medications included simvastatin at a dose of 20 mg, amlodipine besylate at a dose of 5 mg, triamterene/hydrochlorothiazide at a dose of 37.5-25 mg and omeprazole at a dose of 20 mg. Her vaccination history included a dose of pneumococcal vaccine (other manufacturer, batch number: not reported) on 23 Oct 2013. On 25 Sep 2014, she was vaccinated with seasonal influenza vaccine (manufacturer, batch number: not reported) into her upper arm and with pneumococcal vaccine (other manufacturer, batch number: not reported) into her upper arm. On the same day after vaccination, her upper arm was very sore at the site of vaccination and she was feverish. The following day, she could barely lift her arm. Two days after vaccination, she had a red rash over her chest, back, neck and arm. Third day after the vaccination, she started itching and the fourth day after vaccination, her rash was gone but her arm was sore but usable. The patient completely recovered from the rash and the outcome of all the other events was condition improving. The events were reported as non serious but the seriousness of erythematous rash over her chest, neck and arm was upgraded based on the information available in the source documents. The causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vaccination site pain
Clinical narrative: Case number PHHY2014US159812 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System (VAERS ID: 545616) website on 28 Nov 2014. This report refers to a 67 year old female patient. Her past medical history was not reported. Her concomitant medications included simvastatin at a dose of 20 mg, amlodipine besylate at a dose of 5 mg, triamterene/hydrochlorothiazide at a dose of 37.5-25 mg and omeprazole at a dose of 20 mg. Her vaccination history included a dose of pneumococcal vaccine (other manufacturer, batch number: not reported) on 23 Oct 2013. On 25 Sep 2014, she was vaccinated with seasonal influenza vaccine (manufacturer, batch number: not reported) into her upper arm and with pneumococcal vaccine (other manufacturer, batch number: not reported) into her upper arm. On the same day after vaccination, her upper arm was very sore at the site of vaccination and she was feverish. The following day, she could barely lift her arm. Two days after vaccination, she had a red rash over her chest, back, neck and arm. Third day after the vaccination, she started itching and the fourth day after vaccination, her rash was gone but her arm was sore but usable. The patient completely recovered from the rash and the outcome of all the other events was condition improving. The events were reported as non serious but the seriousness of erythematous rash over her chest, neck and arm was upgraded based on the information available in the source documents. The causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine, Blood test normal, Laboratory test normal, Thyroid function test normal, Urticaria
Clinical narrative: Case number PHHY2014US155934, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 546264) website on 28 Nov 2014. This report refers to a 37-year-old female patient. She had no current illness and no known allergies to medicine. Her vaccination history included flu shots. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly into right arm on 16 Sep 2014. On 17 Sep 2014, she developed hives on her abdomen. By 20 Sep 2014, she was almost covered in hives from her breast to hips including sides and back of the same location. She consulted doctor on 22 Sep 2014 and was given prednisone. The hives faded through the week and the treatment with prednisone was stopped on 28 Sep 2014. The very next day the hives began to appear again and progressively got worsen. All laboratory tests and blood results were negative for infection, lupus and thyroid. As per doctor all results were negative leaving him to believe it was an allergy to something in the vaccine. Final outcome of the events was reported as condition unchanged. Seriousness and causality of the events was not reported. Seriousness assessment of generalized urticarial was upgraded based on the NVS-IMS list.
Age: 22.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2014US156488, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546740) website on 28 Nov 2014. This report refers to 22-year-old female patient. Medical history was not reported. Concomitant medication included MOTRIN. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) along with and DTAP (batch number: unknown, other manufacturer) on an 18 Sep 2014. On 30 Sep 2014, the patient experienced hives all over body and was treated with BENADRYL. Outcome of the event was reported as recovered. Seriousness and causality of the event was not reported. Seriousness assessment of generalized urticarial was upgraded based on the NVS-IMS list.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, Wheezing
Clinical narrative: Case number PHHY2014US169751 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS ID: 546791) website on 29 Dec 2014. This report refers to a 43 years old female patient. Past medical history included asthma and allergies. Concomitant medications included SYMBICORT, ALLEGRA, TYLENOL, ATROVENT and XOPENEX. She was vaccinated with AGRIFLU (batch number: 015011A) intramuscularly in the right arm on 24 Sep 2014. On 25 Sep 2014, she experienced hives and wheezing. She went to emergency room. The outcome of the event was reported as complete recovery. The event was reported as serious (life threatening). The causality of the event was not reported.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphagia, Dyspnoea, Heart rate increased, Hot flush, Pharyngeal oedema
Clinical narrative: Case number PHHY2014US159261, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546877) website on 28 Nov 2014. This report refers to a 54-year-old female patient. Medical history included systemic lupus. Concomitant medication included SYNTHROID, cortisone and prednisone. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 26 Sep 2014. On the same day, after vaccination, the patient experienced difficulty swallowing, some difficulty breathing, hot flash, rash on the face, fast heartbeat, swelling of the face and throat. These symptoms resolved after about 30 minutes to an hour. These events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of swelling of throat was upgraded based on the NVS-IME list; swelling face, difficulty swallowing, difficulty breathing, hot flash, rash on face was upgraded based on information in the source documents.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Swelling face
Clinical narrative: Case number PHHY2014US159261, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546877) website on 28 Nov 2014. This report refers to a 54-year-old female patient. Medical history included systemic lupus. Concomitant medication included SYNTHROID, cortisone and prednisone. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 26 Sep 2014. On the same day, after vaccination, the patient experienced difficulty swallowing, some difficulty breathing, hot flash, rash on the face, fast heartbeat, swelling of the face and throat. These symptoms resolved after about 30 minutes to an hour. These events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of swelling of throat was upgraded based on the NVS-IME list; swelling face, difficulty swallowing, difficulty breathing, hot flash, rash on face was upgraded based on information in the source documents.