chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Abnormal behaviour, Delirium, Pyrexia, Unresponsive to stimuli, Viral infection
Clinical narrative: Case number PHHY2014US000863 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 507361) website on 06 Jan 2014. This report refers to a 76-year-old female patient. Her medical history was not reported. This poly-medicated patient was vaccinated with FLUVIRIN (batch number: 1307801) intramuscularly on 23 Jul 2013. On 25 Oct 2013, at 3.30 pm, she had a 103.5 fever and was delirious. She was behaving as if she was out of her head and could not respond. Following these events, she was sent to the hospital. Hospital suspected that she must have some kind of virus and gave her antibiotics. The event outcome was reported as condition unchanged as of 11 Oct 2013. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Walking aid user
Clinical narrative: Case number PHHY2014US000854 is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (reference number: 507824) website on 06 Jan 2014. This report refers to a 78 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13402P) in the left arm on 08 Oct 2013. On 09 Oct 2013, she experienced trouble during walking and getting up and she needed a walker. It was reported that the symptoms were similar to paralysis. She did not visit any physician. On the day of reporting she was feeling better and the symptoms lasted for six days. The outcome of the events was reported as condition unchanged as of 15 Oct 2013. The causality and seriousness of the events were not reported.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Rash erythematous, Rash pruritic
Clinical narrative: Area where shot was given, turned very red, and swollen. Area grew to about 3 inches in size. Red itchy spots appeared on upper arms - I went to private doctor was given shot it took about four weeks for soreness, redness and itchiness to go away.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia, Biopsy, Madarosis
Clinical narrative: 80% loss of hair - with possible no regrowth. Had biopsy - no history of hair loss. Also loss of eyebrows and body hair - now wear a wig!
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red rash on arm where vaccine was given. See photo attached. Taken 1/2/2014.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a female patient in her 70's. On an unknown date in July 2008 the patient was vaccinated with ZOSTAVAX (lot# not provided) (dose not reported) for prevention of shingles. On an unknown date in December 2013the patient developed shingles after receiving ZOSTAVAX. The company representative reported that the physician stated to her that this was the second ZOSTAVAX failure that he had seen. The patient sought medical attention-visited the office. There was no PQC involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Autopsy, Death, Headache
Clinical narrative: This spontaneous report as received from nurse refers to a 14 year old female patient with attention deficit disorder and anxiety and with no drug reaction or allergies. On 14-JUL-2011 the patient was vaccinated with first dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided), on 25-JUL-2012 patient received second dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided) and on 21-NOV-2013 patient received third dose of recalled GARDASIL (lot number: J007354, expiration date 20-FEB-2016) (dose and route of administration were not provided). Secondary suspect therapy included FLUMIST which was given on 21-NOV-2013. Concomitant therapies included ADDERALL XR and CELEXA. It was reported that patient complained of headache on 04-JAN-2014 and she went to bed early that night. It was reported that "she never woke up". Patient died on 04-JAN-2014. Nurse has not been informed of the autopsy result so she could not determinate cause of death. Lab diagnostic studies were not performed. It was also reported that approximately 27 doses of the recalled lot of GARDASIL were also administered at reporter's facility but she has not heard of any other adverse effects. The outcome of headache was unknown. The relatedness between death, headache and GARDASIL was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. On 06-JAN-2014 the patient was vaccinated with ZOSTAVAX (expiry date: 28-SEP-2013), dose: 0.65 ml, subcutaneous. On 06-JAN-2013 the pharmacist reported that patient was administered expired dose of ZOSTAVAX. On an unknown date the patient experienced administered expired dose. She stated that the carton expiration date is: 21-JUN-2014 but that on the vial of ZOSTAVAX the expiration date was: 28-SEP-2013. She stated that the carton was unopened when she received it. No adverse effects reported. There was a product quality complaint involved. The outcome of the medication error was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose, sore throat, cold-like symptoms.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Muscle disorder, Pain
Clinical narrative: By 4:00 pm, I was in excruciating pain from head to toe.  Muscles in legs were most affected--couldn't walk at times.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Fifteen minutes after recieving Fluzone vaccine patient began developing hives on face and trunk of body. No difficulty breathing or swelling of mouth or tongue. Doctor called and patient given 7.5mL of Benadryl and watched for another 30 minutes. Hives went down and patient evaluated again by doctor. Patient watched for another 15 minutes and then released to go home.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a adult female patient of unknown age. On an unknown date the patient was vaccinated with 3-dose series of RECOMBIVAX HB for required. The patient was "tested in the past couple of weeks" for hepatitis B surface antibodies (in approximately 2013). The "test" came back "negative". There was no treatment given for the event. The outcome of hepatitis b surface antibodies negative was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician via field representative refers to female patient who was more than a 70 years old. On an unknown date approximately in 2007 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot #and expiry date unspecified). The physician reported that an anonymous patient developed rash and shingles (date unspecified) after receiving ZOSTAVAX. The patient sought medical attention by seeing the doctor. The events were reported to be not recovered. Reports causality was not provided. No product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to an unspecified number of patients. No specific (individual) patient information was provided. It was reported that an unspecified number of patients had received their second dos of GARDASIL four weeks after receiving the first dose. No lot number or dates of administration was provided. No adverse effects were reported. No further information was available. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiry date unspecified). The pharmacist reported that on occasion after reconstituting ZOSTAVAX, the amount of reconstituted vaccine was only equivalent to 0.63 milliliter as opposed to 0.65 ml. The pharmacist had administered the lesser dose of ZOSTAVAX to an unspecified n umber of unspecified patients on unspecified dates. No adverse effect reported. The pharmacist enquired if the patients received a full dose. No further information available. Product quality complaint was reported. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Atypical pneumonia, Chest X-ray, Cough, Pyrexia
Clinical narrative: This spontaneous report as received from a other health professional refers to a 9 year old female patient. No pertinent medical history and no drug reaction/allergies. On 15-NOV-2013 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular ("without any issues"). On 16-DEC-2013 the patient was vaccinated with GARDASIL lot # J008423 dose 2, 0.5 ml, intramuscular. No concomitant medication. At an unknown date, post administration of second dose, the patient developed a cough. The nurse stated that the patient had a fever of 100F and the cough became "non productive". The nurse stated that the grandmother tried unspecified cough medicine at home. The nurse stated the patient is now in office with unspecified physician diagnosing condition as "atypical pneumonia". A chest X ray was performed, but the result was not specified. The outcome of atypical pneumonia is unknown. The causal relationship was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody, No adverse event
Clinical narrative: This spontaneous report as received from a pediatric patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (strength: 5microgram/0.5 milliliter (mcg/ml) at the dose of 5/0.5 mcg/ml (route, lot# and expiry unspecified). The physician reported that a patient might have received 3 pediatric doses of RECOMBIVAX HB and failed to seroconvert; antibodies were low. The doctor stated that she needed to review her records to make sure all 3 doses were administered to the patient. No adverse effects reported. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Pt states itching all over body as of 1/5/14 - no signs of hives or rash. Pt wasn't sure if it was b/c of ZOSTAVAX or flu shot.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old patient of unknown gender. On 09-JAN-2014 the patient received first dose of PNEUMOVAX23 (lot # 2017AE; exp date: 22-AUG-2103) 0.5 ml, intramuscular (site of administration was not reported) and it was expired. No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 18 year old female patient. There was no pertinent medical history and no drug reactions or allergies. In May 2007, the reporter was starting to inject the patient with GARDASIL, Lot # J006587 expiry date 04-DEC-2015, third dose (dose and route not reported) and she noticed the pre-filled syringe was leaking. A PQC was filed. There was no concomitant medication. No adverse event symptoms were reported. Another GARDASIL unit was opened and injected into the patient without issue (lot, dose and route not reported). The patient did not seek for medical attention. No lab diagnostics performed. The outcome of the events was not reported. This is one of two reports from the same source (MARRS case 1401USA004004). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure to product, No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report as received from a Medical Assistant regarding herself as a female patient of unknown. Medical history, drug reactions/allergies and concomitant medications were not reported. In May 2007, the reporter was starting to inject a patient with GARDASIL, Lot # J006587 expiry date 04-DEC-2015, and she noticed the pre-filled syringe was leaking onto her hands. No adverse event symptoms were reported. A PQC was filed. The outcome of the events was not reported. This is one of two reports from the same source (MARRS case 1401USA001288). Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Erythema, Feeling hot, Local swelling, Pneumonia
Clinical narrative: This spontaneous report was received from a physician refers to a 72 year old female patient. The patient had a history of allergic to ibuprofen, ampicillin and also allergic to flu vaccines due to the egg content of the product. On 31-DEC-2013, the patient was vaccinated with PNEUMOVAX23 (dose and frequency was not reported). Concomitant medications included VESICARE, latanoprost (eye drops) and Trimethoprim. On 31-DEC-2013, the patient experienced redness, swelling and heat in her arm after receiving a PNEUMOVAX23 shot. The patient sought medical attention and was prescribed with cold compresses and BENADRYL. The patient had routine blood work with normal results that were taken after the vaccination. On an unknown date, within the last 10 years, the patient experienced pneumonia. The physician reported that the reaction was not near the injection site the reaction goes from her elbow up. The physician also reported that the patient began feeling the reaction begin during the car ride home after receiving the shot of PNEUMOVAX23. The physician stated that the patient was receiving pneumonia vaccines 20-30 years ago once approximately every 10 years with no adverse reaction until this last dose on 31-DEC-2013. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a unknown patient of unknown age and sex. On an unknown day in August 2012 the patient received the first dose of GARDASIL (lot #, expiration date, dose, frequency, route of administration were not reported) and then received second dose of GARDASIL on an unknown day in November 2013. Third dose has not been administered yet. No symptoms were reported. Additional information has been requested. This is one of several reports received from the same source.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from the MedWatch program from a 62 year old female consumer who is an attorney, regarding herself. Her history included chicken pox and prednisone (1996). She currently takes COUMADIN (unknown indication). She had her COUMADIN level checked 03JAN2014, prior to receiving ZOSTAVAX, and was told it was okay and she could go ahead with the vaccine. Other reported medications included diphenhydramine 25mg occasionally to help her sleep, albuterol "occasionally" and FLOVENT "sometimes when her colleagues have colds to keep her airways open" (unclear if taken concomitantly). On 03JAN2014 the patient received ZOSTAVAX via a subcutaneous injection into her deltoid muscle. The pharmacist applied a band aid following the injection, but was unable to pinpoint the injection site. On 04JAN2014, the patient removed the band aid from her arm and she noticed "two oozing blisters" with a pink color around the site. She believes that one of the blisters is at the site of ZOSTAVAX administration and the second blister is on the opposite side of the injection site. She thinks that it is possible that the needle went through one side to the other. She contacted her physician by phone and he suggested she start VALTREX. As of the phone call, the consumer did not start VALTREX and the two blisters were continuing to ooze. In a follow-up phone call the patient provided the lot number and expiration date of the ZOSTAVAX. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 year old female patient. The patient's medical history included supraventricular tachycardia cardiac. Patient had no drug reactions/allergies. On 23-DEC-2003 the patient was vaccinated with VARIVAX dose 1 (dosing information, route of administration and lot # were not provided). On 23-DEC-2013 the patient was vaccinated with VARIVAX lot # J006161 (expiry date 20-MAY-2015) dose 2, 0.5 ml, subcutaneous. No concomitant medication was used. The patient's parents reported that the next day (24-DEC-2103) "18 hours later" a large vesicle was formed over the injections site. The physician documented that the vesicle was 4 cm in diameter and was full of clear fluid. The patient was recommended (Ibuprofen) and "compresses" for comfort. It was also reported that no treatment was given. The patient was seen in the office for a follow up visit on 27-dec-2013. And the vesicle was draining clear liquid and was beginning to crust. The nurse stated that the lesion "looked exactly like a chickenpox lesion". The outcome of the event was reported as recovering/resolving. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old female patient. Without pertinent medical history, drug reactions or allergies. On 20-NOV-2013, the patient was vaccinated with a dose of GARDASIL Lot No. J007354; Expiration date: 20-FEB-2016, 0.5 ml, intramuscular for prevention of human papilloma virus (HPV). Secondary therapy was not reported. There was no concomitant medication. The physician reported that the patient initially experienced swelling (approximately in November 2013) and a lump after receiving GARDASIL. On 28-DEC-2013, the patient was seen in the office and ha a palpable, non-tender lump that was "marble sized, approximately 1-2 cm, in size" at the injection site. The outcome of the events was unknown. The patient did not receive treatment for the events. No Lab diagnostics studies were performed. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Headache, Sensation of pressure
Clinical narrative: Pt returned 1/9/14 to Health dept stating she has had a headache and pressure in her nose since two hours post receiving vaccine. She denies taking any medication for the headache or "pressure in her nose".  Pt denies calling her personal Doctor with these issues.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Injected limb mobility decreased, Joint range of motion decreased, Oropharyngeal pain, Sinus operation
Clinical narrative: After receiving the Flu vaccine, 5 days later onset of sore throat, dry cough, nasal drain.  10 days later vaccine site sore to touch with touchable nodule, which lasted till mid-December.  From mid-December to current ROM for left arm has decreased, difficulty raising arm or lifting objects.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site nodule, Vaccination site pain
Clinical narrative: After receiving the Flu vaccine, 5 days later onset of sore throat, dry cough, nasal drain.  10 days later vaccine site sore to touch with touchable nodule, which lasted till mid-December.  From mid-December to current ROM for left arm has decreased, difficulty raising arm or lifting objects.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site pruritus, Pyrexia
Clinical narrative: Headache, fever, itchy at site of injection.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Electrocardiogram, Syncope
Clinical narrative: Was informed by parent that child was walking to main hospital building and fainted. Rapid Response Team at hospital call and child taken to ER for evaluation.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Acute respiratory distress syndrome, Death, Pneumonia, Rash generalised, Varicella
Clinical narrative: Generalized varicella rash.  Pt admitted to hospital 05/05/2013.  Treated with Acyclovir. Developed pneumonia and ARDs.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a health professional regarding a patient (demographics unknown), who on an unknown date, was vaccinated with VARIVAX (Merck) lot # J003221, expiration 15-MAR-2015, that had been improperly stored. The outcome of improperly stored vaccination is unknown. This is a corrected report. On 30-OCT-2013, information has been received from the registered nurse, who stated that the doses of VARIVAX (Merck), Lot # J003221, expiration date on 15-MAR-2015 were exposed to unknown temperatures for 5 hours during interoffice transport. All vaccines were unsupported and were possibly administered to patients. No adverse symptoms reported. Nurse was unable to provide further temperature excursion details or dates of administration. All patients were revaccinated. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a recalled dose of GARDASIL (dose and route was  not provided) (lot # J007354, expiration date 20-FEB-2016). On an unknown date, the patient experienced adverse effect. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, Crying, Culture urine negative, Irritability
Clinical narrative: High pitch cry, fever and irritability 12-24 hr after vaccines. Admitted to hospital to r/o sepsis. Doing better the next day. Possible discharge after 48 hr.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Mobility decreased, Pyrexia, White blood cell count increased
Clinical narrative: High pitch cry, fever and irritability 12-24 hr after vaccines. Admitted to hospital to r/o sepsis. Doing better the next day. Possible discharge after 48 hr.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Pain, Rash
Clinical narrative: Rash approx. 4" in diameter around area. Hard and sore.
Sex: M
Vaccine: FLU4
Symptoms: Nervous system disorder
Clinical narrative: Initial report received from a healthcare professional on 03 January 2014. A male patient, whose age, medical history and concomitant medications were not reported, had received FLUZONE QUADRIVALENT batch number; dose, route and anatomical site of administration were not reported on unspecified date. On unspecified date, in evening after vaccination the patient experienced neurological event and was hospitalized. Corrective treatments and laboratory investigations were not reported. The outcome of event was not reported. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, bruising, warm to touch at injection site. Treatment recommended: BENADRYL PO. Lasted 6 days.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient states he went home and fainted from sitting position about 45 minutes after his immunization. Wife revived him after about 10 seconds by calling his name.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Head injury, Loss of consciousness, Myalgia, Pallor, Syncope
Clinical narrative: Patient was given vaccination, was fine after the vaccination, then complained of muscle soreness. Patient then went  pale and fainted, hitting his head on pharmacy counter. Regained consciousness and was A and O x 3. Left with paramedics for precautionary reasons.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Back pain, Chills, Diarrhoea, Dizziness
Clinical narrative: 12-26-13 Facial rash and itching. 12-28-13 Body aches, leg muscle pain. 12-29-13 Headache, nausea, photosensitivity, dizzy. 12-30-13 Stomach cramps. 1-1-14 Back pain, chills, diarrhea.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Myalgia, Nausea, Pain, Photosensitivity reaction
Clinical narrative: 12-26-13 Facial rash and itching. 12-28-13 Body aches, leg muscle pain. 12-29-13 Headache, nausea, photosensitivity, dizzy. 12-30-13 Stomach cramps. 1-1-14 Back pain, chills, diarrhea.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: 12-26-13 Facial rash and itching. 12-28-13 Body aches, leg muscle pain. 12-29-13 Headache, nausea, photosensitivity, dizzy. 12-30-13 Stomach cramps. 1-1-14 Back pain, chills, diarrhea.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: Shot given at 5:30 am. Within 2 hrs dizzy/light headed, nausea. Also - aching/chills for 8 hrs. Sleep was fitfall, leaving me exhausted. Stayed in bed all the next day (New Years) trying to get enough fluids, was hard. Duration 48 - 60 hrs 4 days later I'm back to my energy level, at all. Other symptoms have gone.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Poor quality sleep
Clinical narrative: Shot given at 5:30 am. Within 2 hrs dizzy/light headed, nausea. Also - aching/chills for 8 hrs. Sleep was fitfall, leaving me exhausted. Stayed in bed all the next day (New Years) trying to get enough fluids, was hard. Duration 48 - 60 hrs 4 days later I'm back to my energy level, at all. Other symptoms have gone.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Pain in jaw, Trigeminal neuralgia
Clinical narrative: Got shot on Monday. Next Sunday night got unbearable jaw pain. Got Dr. appt. on Tues. Sent me for MRI and to a neurologist who checked it out as trigeminal neuralgia. Tried Gabapentin. Did not stop it. Am on Nortriptyline 25mg 1 morning and 2 at bedtime. Is some better in summer, sometimes not. Is on same side as shot was administered. 3 doctors said "No, it's a dead virus" but it is not and I feel it is from the shot.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Vaccine induced varicella rash.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: 24 hours after receiving MCV4 in LA pt. was experiencing nausea, vomiting, swelling at site, hot to touch, redness.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Asthenia, Erythema, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: Immediately had major pain and burning at immunization site. Nurse said it would subside. Got home and couldn't move arm without excrutiating pain. Arm had swollen to three X its normal size. It was red, had fever in it and streaking. If I walked or moved it I would scream out with pain. Called physicians ofc and was told to use ice. Have photos I took during the 7 days of the above. I am now seeing a PT due to the above problems. During this period, I have had weakness, and spent days in bed due to the pain. I have not regained full use of this arm and pain is still there. The strength I had in this arm is so weak that I cannot lift my purse, vacuum floors or do anything that requires any physical work fully without pain.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site nodule, Injection site pain, Injection site streaking, Injection site swelling, Local swelling
Clinical narrative: Immediately had major pain and burning at immunization site. Nurse said it would subside. Got home and couldn't move arm without excrutiating pain. Arm had swollen to three X its normal size. It was red, had fever in it and streaking. If I walked or moved it I would scream out with pain. Called physicians ofc and was told to use ice. Have photos I took during the 7 days of the above. I am now seeing a PT due to the above problems. During this period, I have had weakness, and spent days in bed due to the pain. I have not regained full use of this arm and pain is still there. The strength I had in this arm is so weak that I cannot lift my purse, vacuum floors or do anything that requires any physical work fully without pain.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscular weakness, Pain, Skin warm
Clinical narrative: Immediately had major pain and burning at immunization site. Nurse said it would subside. Got home and couldn't move arm without excrutiating pain. Arm had swollen to three X its normal size. It was red, had fever in it and streaking. If I walked or moved it I would scream out with pain. Called physicians ofc and was told to use ice. Have photos I took during the 7 days of the above. I am now seeing a PT due to the above problems. During this period, I have had weakness, and spent days in bed due to the pain. I have not regained full use of this arm and pain is still there. The strength I had in this arm is so weak that I cannot lift my purse, vacuum floors or do anything that requires any physical work fully without pain.
Age: 49.0
Sex: F
Vaccine: FLU4, PNC10
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Erythema at the site, local swelling to the site, pain that started approx 4 hours after vaccine was given. Patient treated herself with NSAIDs and warm compresses with little relief.
Age: 0.15
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Blood test normal, Depressed level of consciousness, Urine analysis normal
Clinical narrative: Parents tried to wake up baby to feed and would not arouse. EMS called and taken to a hospital.  Baby was awake and alert when EMS arrived and remained so during hospital observation.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Balance disorder, Dizziness, Fall, Feeling cold, Gait disturbance
Clinical narrative: Went to bathroom to urinate and felt dizzy until I lost balance and stumbled/fell on bathroom floor. Approximately 2 to 5 minutes later I again felt dizzy and heard loud noises/echoes inundating my ears and subsequently fainted for an unknown amount of time. I awoke sweaty and cold on the floor.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Syncope, Tinnitus
Clinical narrative: Went to bathroom to urinate and felt dizzy until I lost balance and stumbled/fell on bathroom floor. Approximately 2 to 5 minutes later I again felt dizzy and heard loud noises/echoes inundating my ears and subsequently fainted for an unknown amount of time. I awoke sweaty and cold on the floor.
Sex: F
Vaccine: FLUX
Symptoms: Fall, Headache, Heart rate decreased, Injection site erythema, Injection site urticaria
Clinical narrative: This case was reported by a consumer via a market research program project number ADVAIR00165, and described the occurrence of pink around injection site in a female subject of unspecified age who was vaccinated with influenza (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medications included albuterol (unknown manufacturer). On 11 September 2013 the subject received a dose of influenza (details unknown). On 12 September 2013, 1 day after vaccination with influenza, the subject experienced pink around injection site and injection site hives and less than a week after vaccination with influenza, the subject experienced headache. The subject reported that she received her flu shot on Wednesday [11 September 2013] and for the "first time event had a reaction". She informed that she asked her mother to check if it was okay yesterday [12 September 2013] and her mother said it was 'a bit pink' (pink around injection site). She reported that she looked at it last night [12 September 2013] and "had a silver dollar size hive with a smaller one above it" (injection site hives). She noted, "Obviously, it didn't bother me, but sure startled me when I did look. Might explain my headache too!" At the time of reporting the outcome of the events was unspecified. Follow-up information received from a consumer via a market research program project number ADVAIR00165. The subject noted online the following: "I checked several times a day. If it goes below 90, I deep breathe and some sort of exercise (mild) in order to speed up the heart as my PVC's [premature ventricular contraction] happen when my pulse drops below 90 also. Seems to be the magic number. Still waiting on heart scans to try to pinpoint problem." (decreased heart rate, PVC) Follow-up information was received on 2 January 2014 from the patient. On 24 December 2013, the subject experienced lumbar compression fracture, back fracture (broke my back) and fell. This case was upgraded to medically serious by GSK. The subject stated that on 24 December 2013, she was trying to help her mother up, which caused the subject to fall and fracture her back. On 30 December 2013, the subject went to the doctor to have x-rays performed. The x-rays revealed a compression fracture of at least L1 (lumbar compression fracture). The subject had plans to return to the doctor's office on 6 January 2014. At the time of reporting, the outcome of lumbar compression fracture, back fracture and fell was unknown.
Sex: F
Vaccine: FLUX
Symptoms: Scan, Spinal X-ray abnormal, Spinal compression fracture, Ventricular extrasystoles
Clinical narrative: This case was reported by a consumer via a market research program project number ADVAIR00165, and described the occurrence of pink around injection site in a female subject of unspecified age who was vaccinated with influenza (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medications included albuterol (unknown manufacturer). On 11 September 2013 the subject received a dose of influenza (details unknown). On 12 September 2013, 1 day after vaccination with influenza, the subject experienced pink around injection site and injection site hives and less than a week after vaccination with influenza, the subject experienced headache. The subject reported that she received her flu shot on Wednesday [11 September 2013] and for the "first time event had a reaction". She informed that she asked her mother to check if it was okay yesterday [12 September 2013] and her mother said it was 'a bit pink' (pink around injection site). She reported that she looked at it last night [12 September 2013] and "had a silver dollar size hive with a smaller one above it" (injection site hives). She noted, "Obviously, it didn't bother me, but sure startled me when I did look. Might explain my headache too!" At the time of reporting the outcome of the events was unspecified. Follow-up information received from a consumer via a market research program project number ADVAIR00165. The subject noted online the following: "I checked several times a day. If it goes below 90, I deep breathe and some sort of exercise (mild) in order to speed up the heart as my PVC's [premature ventricular contraction] happen when my pulse drops below 90 also. Seems to be the magic number. Still waiting on heart scans to try to pinpoint problem." (decreased heart rate, PVC) Follow-up information was received on 2 January 2014 from the patient. On 24 December 2013, the subject experienced lumbar compression fracture, back fracture (broke my back) and fell. This case was upgraded to medically serious by GSK. The subject stated that on 24 December 2013, she was trying to help her mother up, which caused the subject to fall and fracture her back. On 30 December 2013, the subject went to the doctor to have x-rays performed. The x-rays revealed a compression fracture of at least L1 (lumbar compression fracture). The subject had plans to return to the doctor's office on 6 January 2014. At the time of reporting, the outcome of lumbar compression fracture, back fracture and fell was unknown.
Age: 0.37
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Large, hard lump began to develop at injection site.  Hot to touch.  Remained swollen and hard for two months. At 2 1/2 months later, there is still a small hard lump at injection site.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations
Clinical narrative: Heart palpations for an hour and a half. Just waiting and drinking lots of water.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV5
Symptoms: Chest X-ray abnormal, Crepitations, Diarrhoea, Dyspnoea, Gastroenteritis viral
Clinical narrative: Patient received KINRIX (Dtap, IPV) in error on 11/27/13. Returned to office 12/5/13. Diagnosed w/AGE, viral. Symptoms = vomit x 1, slightly loose back at office on 12/20/13. Diagnosed w/(+) RSV/Bronchiolitis. Hospitalized 12/21/13-1/1/14. Respiratory symptoms include crackles, rales, substernal refractions, tachypnea, low O2 sats. Back to office on 1/8/14 w/same symptoms, only worse. CX Ray indicates perihilar interstitial infiltrates increased WOB. Child referred to pulmonology. Child now re-hospitalized at clinic.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV5
Symptoms: Laboratory test, Lung infiltration, Oxygen saturation decreased, Rales, Respiratory syncytial virus bronchiolitis
Clinical narrative: Patient received KINRIX (Dtap, IPV) in error on 11/27/13. Returned to office 12/5/13. Diagnosed w/AGE, viral. Symptoms = vomit x 1, slightly loose back at office on 12/20/13. Diagnosed w/(+) RSV/Bronchiolitis. Hospitalized 12/21/13-1/1/14. Respiratory symptoms include crackles, rales, substernal refractions, tachypnea, low O2 sats. Back to office on 1/8/14 w/same symptoms, only worse. CX Ray indicates perihilar interstitial infiltrates increased WOB. Child referred to pulmonology. Child now re-hospitalized at clinic.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV5
Symptoms: Tachypnoea, Use of accessory respiratory muscles, Vomiting, Wrong drug administered
Clinical narrative: Patient received KINRIX (Dtap, IPV) in error on 11/27/13. Returned to office 12/5/13. Diagnosed w/AGE, viral. Symptoms = vomit x 1, slightly loose back at office on 12/20/13. Diagnosed w/(+) RSV/Bronchiolitis. Hospitalized 12/21/13-1/1/14. Respiratory symptoms include crackles, rales, substernal refractions, tachypnea, low O2 sats. Back to office on 1/8/14 w/same symptoms, only worse. CX Ray indicates perihilar interstitial infiltrates increased WOB. Child referred to pulmonology. Child now re-hospitalized at clinic.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV5
Symptoms: Bronchiolitis, Drug administered at inappropriate site, Drug administered to patient of inappropriate age, Interstitial lung disease, Respiratory syncytial virus infection
Clinical narrative: Patient received KINRIX (Dtap, IPV) in error on 11/27/13. Returned to office 12/5/13. Diagnosed w/AGE, viral. Symptoms = vomit x 1, slightly loose back at office on 12/20/13. Diagnosed w/(+) RSV/Bronchiolitis. Hospitalized 12/21/13-1/1/14. Respiratory symptoms include crackles, rales, substernal refractions, tachypnea, low O2 sats. Back to office on 1/8/14 w/same symptoms, only worse. CX Ray indicates perihilar interstitial infiltrates increased WOB. Child referred to pulmonology. Child now re-hospitalized at clinic.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Cold sweat, Drooling, Dyskinesia, Fall, Gaze palsy
Clinical narrative: After pt received HPV he was sitting on bed and fell backwards and eyes rolled back, head and body jerking and drooling from (R) side of mouth. Episode lasted 10 - 15 seconds. Pt did not respond during that time when pt was finally able to respond he wasn't sure what happened pt was pale and clammy. Dr assessed pt and kept pt in office x 1 hr 10 minutes.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: After pt received HPV he was sitting on bed and fell backwards and eyes rolled back, head and body jerking and drooling from (R) side of mouth. Episode lasted 10 - 15 seconds. Pt did not respond during that time when pt was finally able to respond he wasn't sure what happened pt was pale and clammy. Dr assessed pt and kept pt in office x 1 hr 10 minutes.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness, Laboratory test normal, Optic nerve injury, Scotoma, Swelling
Clinical narrative: Patient had swelling on the right eye nerve then moved to the left eye nerve causing blind spots and loss of vision. The swelling stayed for about 4 months then went away. The swelling left permanent optic nerve damage resulting in significant permanent vision loss. 3 eye doctors told him there was no treatment or cure.
Age: 0.92
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Pts mother called two hours after second dose of flu shot was administered; pt has fever.
Sex: F
Vaccine: UNK
Symptoms: Local reaction, Local swelling, Skin warm
Clinical narrative: Local reaction at (L) upper arm laterally with swelling (3 x 4 cm) NT, mild warm. No erythema. Rx - cold compress and pain meds as needed.
Age: 4.0
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction with swelling, erythema and warmth on (R) upper arm 3 x 4 cm at the site of varicella vaccine administered.
Age: 61.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest pain, Dyspnoea, Muscular weakness, Myalgia, Palpitations
Clinical narrative: Muscle soreness that spread across chest and other arm. Chest pain. Heart racing, difficulty breathing (labored). Muscle weakness.
Age: 61.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Adverse reaction, Hypersensitivity
Clinical narrative: Muscle soreness that spread across chest and other arm. Chest pain. Heart racing, difficulty breathing (labored). Muscle weakness.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Antibody test negative, Myelitis transverse, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Transverse Myelitis.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Arm where vaccine administerd sore, red and warm to touch.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Pain, redness and warmth at vaccination site.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, redness and warmth at injection site.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, redness and warmth at injection site.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Disorientation, Dizziness, Faecal incontinence, Fall
Clinical narrative: Pt had a queasy / nausea feeling in his stomach all day yesterday. During the evening, pt was attending a meeting.   Pt became dizzy, started to sweat - pt arose to walk to the mens room - pt became so lightheaded and fell. Denies LOC or hitting his head.   Pt experienced bowel incontinence of loose stools during this disorientation episode.  Started vomiting and was lightheaded.   Pt was certain his blood sugar must be low.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Pt had a queasy / nausea feeling in his stomach all day yesterday. During the evening, pt was attending a meeting.   Pt became dizzy, started to sweat - pt arose to walk to the mens room - pt became so lightheaded and fell. Denies LOC or hitting his head.   Pt experienced bowel incontinence of loose stools during this disorientation episode.  Started vomiting and was lightheaded.   Pt was certain his blood sugar must be low.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient today reported right arm pain and loss of mobility from shortly after vaccination to present. No treatment sought or provided at this time.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Client spiked a fever of 101.3 Mother gave Ibuprofen to reduce temp. Advised to see PCP. 2nd Phone conversation @ 1:45pm Temp now reduced, mother states her son had previous Sx's last year but not associated with Flu vaccine. been slightly ill since returning to school this year. Advised to still seek PCP for evaluation.
Age: 26.0
Sex: M
Vaccine: FLUX
Symptoms: Oedema peripheral
Clinical narrative: Tennis ball size swelling in armpit on same side as influenza vaccination.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Rash generalised
Clinical narrative: Rash/bumps on body, no temps, was advised during conversation with mom at 1;45pm regarding her sons Sx's (see VAERS report number E-77414). Advised she should take her daughter to PCP for further evaluation today. Mom did note daughter had previous rash unrelated to vaccination. seen a dermatologist previously.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: MD was aware age outside of recommended age. Patient presented on 1-10-14 with an injection site reaction covering 3/4's of upper right arm. Arm had erythema, pain, swelling, and warmth. Patient was instructed to see MD if area didn't improve over next 12-24 hours (and go to ER if area got worse). Patient sought medical attention 1/10/14 and is recovering in hospital.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Feeling abnormal, Headache, Herpes zoster, Hyperacusis
Clinical narrative: Fri Jan 10, 2014 12:45 PM Patient, 60 year old. She is calling regarding: had shingles vaccine two days ago. Her left arm is red and swollen from elbow to shoulder and painful. She applied ice, hot to touch. Has body aches and feeling really bad. 149/72 pulse 83. Consulting Nurse spoke to patient directly. She began having headache yesterday morning, neck is supple. Pain is up in forehead between her eyes, no visual changes. Light and noise bothers her head. Never had migraines, not having nausea. She has small little blisters where vaccine given about size of silver dollar, large blister just smaller than a dime. Painful to touch. Current Temp 102.3 and thermometer has not beeped to completion of measuring. The above was copied from a Consulting Nurse encounter today. Pt is currently being cared for by Dr. at Emergency Room.  Dr. called the injection room and spoke to myself and LPN regarding this reaction. Dr. was advised this reaction can occur but it's very rare, pt needs to stay away from pregnant women, infants, anyone immunocompromised etc until blisters crust over and dry up. Dr. states he will treat the pt as though she has shingles.