chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal, Optic neuritis
Clinical narrative: This spontaneous report as received from a consumer refers to a 17 year old male patient (consumer's son). On 01-NOV-2013 the patient was vaccinated with GARDASIL (dose, route of administration and lot #batch# were not reported). No medical history and concomitant medication were reported. On 11-NOV-2013, the patient experienced pain, vision loss and nausea after receiving the GARDASIL. It was reported that the patient could open his eyelids but experienced pain when he tried to move his eyes. On an unknown date of November 2013, he was seen by an ophthalmologist, who diagnosed as optic neuritis and inflammation of the optic nerve for both eyes. He was referred to a neurologist. On an unknown date of November 2013, a vision field test was done and some loss of vision was noted. On 13-NOV-2013, the patient was taken to see a neurologist and an MRI was done and it showed inflammation. The patient then underwent a lumbar puncture to decrease the intracranial pressure (dates unspecified, November 2013). The patient sought medical attention (office visit). The patient was also given intravenous steroid therapy at the hospital (name of hospital not provided). It was reported that the patient was not admitted to the hospital but goes almost daily for treatments. The consumer also reported that as a consequence of the lumbar puncture, the patient experienced increased pain and nausea. The patient eye pain has increased since it was first noticed. The outcome of the reported events was reported as not recovered. It was also reported that both physicians have stated optic neuritis and inflammation of the optic nerve for both eyes have developed from receiving the GARDASIL. Upon internal review the event 'vision loss' was considered to be medically significant. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HPV4
Symptoms: Arthropathy, Smear cervix, Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a 45 year old female patient with polycystic ovarian syndrome regarding herself. No drug reactions were reported. The patient had mentioned that she was administered with GARDASIL (lot#, expiry not reported) 0.50mL, dose 1 on 15-AUG-2013 and dose number 2 on 21-OCT-2013. No concomitant medications were reported. The patient had confirmed that she had indeed received 2 shots. The patient would call her health care provider and get back on the dates of the injections. The patient's third shot was due in 15-FEB-2014. The patient had reported that GARDASIL had given her some wonderful side effects. She stated that the reason she was getting the vaccine, was because she was sure that she had human papillomavirus (HPV). She had a lesion on her thigh that she thought was caused by a type of HPV. Two of her physicians had told her that this lesion was either a skin tag or a mole. Before getting the shots, she has felt something moving around and all over her body. The patient could not pinpoint what that something would be and it was very painful at times. Immediately after getting the first injection (that night), her anxiety levels decreased and with each subsequent injection, her anxiety continued to go down. The injections relaxed her. The something that had been moving around in her body, had decreased in pain intensity and occurred less frequently. The patient had called back again to inform that she had the tell tale symptoms of HPV, such as an unspecified lesion. However she stated also that she had tremendous relief since getting the first 2 GARDASIL shots. Before the first injection, she had a feeling of stinging pain going through her body. After the first shot, the feeling left, but then resurfaced soon before getting the second dose. The patient said that GARDASIL should be given in higher doses because it might not be strong enough (details not specified). The patient also reported having a hip disability, onset date unknown. The patient had stated on another call, that each time she received a GARDASIL injection it seemed to suppress her HPV symptoms. The patient has suggested that the manufacturer should conduct a study for the vaccine to be used as a treatment for HPV. The patient had volunteered to be a part of this initiative and also suggested that for the study of the vaccine used as a course of treatment the vaccine should be given in higher doses and for a longer dosing regimen above the 3 shot series. A PAP test was performed (results not reported). Patient sought medical attention saw several physicians. The outcome of events hip disability was unknown. Reporter's causality was not provided. Upon internal review, the seriousness criterion of event hip disability was considered to be disability. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 05-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose detail and lot number unspecified). The pharmacist stated that the patient came to the pharmacy with a prescription for Medrol dose pack to treat an unspecified diagnosis. The patient had sought unspecified medical attention. The outcome of the patient was unknown. The relatedness of the event to ZOSTAVAX was not assessed. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 75 year old female patient with diabetes, osteopenia and macular degeneration and with no drug reactions/allergies. On 19-JUN-2003 the patient was vaccinated with the first dose of PNEUMOVAX23, 0.5 ml, intramuscular for vaccination (lot# and expiration date not reported). On 12-NOV-2013 the patient was vaccinated with the second dose of PNEUMOVAX23 (lot# J010654, expiration date: 17-OCT-2014), 0.5 ml, intramuscular. The healthcare worker reported that in November 2013 the patient developed "dry hives: and 11 centimeter by 16 centimeter erythematous, slightly raised, tender, warm area at the injections site after administered the second dose of PNEUMOVAX23. These adverse symptoms developed on an unspecified date. The nurse practitioner told the patient to use ice, Benadryl and Tylenol to treat these adverse symptoms. The outcome of the events was unknown. The patient had sought medical attention by going to see nurse practitioner. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Pruritus, Tenderness
Clinical narrative: This spontaneous report refers to a 70 year old female patient who wished to remain anonymous. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX in the left arm for preventions of shingles. Dose, route, lot and expiry date were not reported. Concomitant medications were none. The patient received the vaccine and had tenderness in her arm. She was injected on the left arm and it was swollen and itchy. The outcome of events was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Headache
Clinical narrative: This spontaneous report as received from a consumer refers to 11 year old female patient (consumer's daughter). The patient's medical history included severe fever on an unspecified date to an unspecified spinal meningitis vaccine when she was 4 months old. On 06-NOV-2013, the patient was vaccinated with GARDASIL (dose, route of administration, lot#/batch# were not reported). No concomitant medications reported. On 09-NOV-2013, the patient experienced severe backache which began 4 days after the administration of the vaccine. On 12-NOV-2013, the patient experienced severe headache. It was also reported that she had a reaction on an unspecified date to an unspecified spinal meningitis vaccine when she was 4 months old and required hospitalization in an unspecified hospital, for "a couple of days"  on an unspecified date. There was no diagnostics studies performed. The outcome of severe headache and severe backache was reported as not recovered/not resolved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Generalised erythema, Headache, Injection site pain, Injection site reaction, Migraine
Clinical narrative: This spontaneous report as received from a registered pharmacist via a company representative refers to a 66 year old female patient. The patient's concurrent condition included with allergy to Ceftin, Cephalosporins, Doxycycline, Codeine, Meperidine, Morphine and Sulfa drug allergy. The patient's history drug included flu shot taken on unspecified date on September 2013. On 13-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot number, expiry date and route not reported). On an unspecified date after vaccination (unspecified date between 13 and 14 November 2013), patient developed a painful arm (injections site are) with a 4 to 6 inch area of welts at the injection site, body aches (all over the body), itching  (all over the body) and redness (all over her body) and a bad headache (migraine like) following vaccination with ZOSTAVAX. The exact time frame development of the symptoms was unspecified, but the patient called the pharmacist on 14-NOV-2013 to report the adverse event. The pharmacist spoke with the patient on 16-NOV-2013 and the area of welts at the injections site had decreased (no information about the other symptoms). The patient received treatment with Ice packs and Benadryl. The patient sought medical attention, contacted pharmacist. The causality was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus generalised, Urticaria
Clinical narrative: This spontaneous report as received from a registered pharmacist via a company representative refers to a 66 year old female patient. The patient's concurrent condition included with allergy to Ceftin, Cephalosporins, Doxycycline, Codeine, Meperidine, Morphine and Sulfa drug allergy. The patient's history drug included flu shot taken on unspecified date on September 2013. On 13-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot number, expiry date and route not reported). On an unspecified date after vaccination (unspecified date between 13 and 14 November 2013), patient developed a painful arm (injections site are) with a 4 to 6 inch area of welts at the injection site, body aches (all over the body), itching  (all over the body) and redness (all over her body) and a bad headache (migraine like) following vaccination with ZOSTAVAX. The exact time frame development of the symptoms was unspecified, but the patient called the pharmacist on 14-NOV-2013 to report the adverse event. The pharmacist spoke with the patient on 16-NOV-2013 and the area of welts at the injections site had decreased (no information about the other symptoms). The patient received treatment with Ice packs and Benadryl. The patient sought medical attention, contacted pharmacist. The causality was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pruritus, Injection site rash, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient who was also a co-worker of the reporter. On 08-NOV-2013 the patient was vaccinated with ZOSTAVAX vial of unknown dose, lot and expiry date via unknown route, in the arm for preventions of shingles. The patient had experienced not feeling well, feeling tired and a rash, oblong shaped, on back of the arm, around injections site, that was itchy, after vaccination at a pharmacy. The reported did not have any physician's information. Pharmacist gave permission for VZV packet to be faxed. VZVIP packet faxed. No treatment was given. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous retrospective pregnancy report was received from a physician refers to a 22 years old female patient. On 25-APR-2012, the patient received the first 0.5 ml dose of GARDASIL (Lot# unspecified), intramuscularly, location unspecified. On 25-JUL-2012, the patient received the second 0.5ml dose of GARDASIL (Lot# unspecified), intramuscularly location unspecified. The patient became pregnant (LMP unknown), and was in office on 20-NOV-2013, for routine visit after delivering baby in October 2013. Patient wanted to receive the third 0.5ml dose of GARDASIL (Lot# unspecified), intramuscularly location unspecified on 20-NOV-2013. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an office manager, who is also the patient's grandmother, refers to her granddaughter of unknown age. On 22-NOV-2013 the patient was vaccinated with GARDASIL dose 3, 0.5 ml, intramuscular in the right arm (lot number and expiry date not provided). On 22-NOV-2013, the patient was administered 3rd dose of GARDASIL on 22-NOV-2013; second dose was administered on 21-OCT-2013. No adverse effects reported by patient. The outcome of was administered 3rd dose of GARDASIL on 22-nov-2013, second dose was administered on 21-oct-2013 and no adverse effects was unknown. The action taken with GARDASIL was not provided. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to 3 anonymous patients (demographics unknown). On an un unknown date in 2013, a few months ago, the 3 anonymous patients was vaccinated with ZOSTAVAX vial single dose of unknown lot and expiry date via unknown route in the arm for prevention of herpes zoster. All the patients had developed swelling under the arm below injection site after receiving the ZOSTAVAX. The outcome of swelling under the arms below injections site was reported as resolving. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Vomiting
Clinical narrative: Vomiting, chill.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via representative refers to unspecified number of patient of unknown demographics. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, lot and expiry date were unknown. The pharmacist stated that an unspecified physician noted the occurrence of ophthalmic zoster post-vaccination with ZOSTAVAX in an unspecified number of patients. The outcome of event was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a 72 year old female consumer refers to herself with arthritis, abalone (shell fish) and Penicillin, Citanest allergies. On 06-SEP-2011 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported), 1 time vaccine to prevent shingles. Concomitant therapies included aspirin) manufacturer unknown, reported as aspirin), Diltiazem Hydrochloride (manufacturer unknown, reported as diltiazem), Torsemide, TOPROL, Spironolactone, Coumadin (reported as CUOMADIN and Enalapril Maleate (manufacturer unknown, reported as enalapril). On 21-SEP-2013, the patient got shingles after getting the ZOSTAVAX, the outbreak was on her breast bone, in a band to her mid-back. She sought unspecified medical attention. Pain pill (no name given) and prednisone (manufacturer unknown, reported as prednizone) for 10 days were given for adverse event. None lab diagnostics studies were performed. The adverse event was improved on therapy and the outcome of shingles was recovering. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a 67 year old female (also reported as male) patient refers to herself. On 07-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified), injection, single dose vaccine (dose, route and location unspecified). Concomitant hormone therapy included with Provera. A few days later on 11-NOV-2013 the patient broke out with shingles pain and rash in the vicinity of her right arm and shoulder. Over the counter unspecified hydrocortisone cream was given for the adverse event. No medical attention had been sought by the patient. The patient had not yet contacted physician. At the time of report, the outcome of the event was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAC (lot# was not reported). On an unknown date the patient experienced developed a rash post vaccination. The patient sought medical attention. The outcome of developed a rash post vaccination was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to three female unspecified patients of unknown age. On an unknown date approximately October 2013, reported as within the last month, the three unspecified patients were vaccinated with ZOSTAVAX (dose, lot, expiry date and route were unknown). On an unknown date approximately October 2013, reported as within the last month, the patients developed redness and inflammation at the injections site after the vaccine was administered. No rashes developed in any of these cases. The outcome of events redness and inflammation at the injections site was unknown. All patients had contacted pharmacist to seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Intensive care, Malaise
Clinical narrative: This spontaneous report as received from a retired nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dosage, lot#/batch# were not reported). On an unknown date the patient became very sick and was hospitalized in ICU for 1-2 weeks. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age. On 15-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot number, expiry date and route not reported). On 17-NOV-2013, the patient (anonymous) developed a rash after receiving ZOSTAVAX. The outcome of rash was unknown. The causality was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a nurse practitioner via field representative refers to a male patient of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX and then developed a headache that had not gone away. The event outcome was unknown. The patient had visited the doctor to seek medical attention. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a 4 month old female patient. On 15-OCT-2013 the patient was vaccinated with a dose of VARIVAX (lot number reported as J003709; expiration date, dose and route of administration were not provided). The patient's mother reported that the patient was vaccinated at 4 months old. No adverse effect reported. The outcome of event is unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a registered pharmacist via a company representative refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot number, expiry date and route not reported). The pharmacist reported that on unspecified dated, an unknown number of patients experienced a rash like injections site reactions, which included bubbling after receipt of ZOSTAVAX. The outcome of rash like injections site reactions, which included bubbling was reported as recovered (date unspecified). The patient sought medical attention, called the pharmacy. The causality was not reported. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a couple of adult patients of unknown demographics. On an unknown date the patients were vaccinated with VARIVAX. It was reported that patients who received VARIVAX reported that their genital herpes improved for 1 year after vaccination with less outbreaks. The outcome of the event was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: 11/22 pt's (R) delt developed red edematous area size of 25 cent. Pt was given 5ml MOTRIN -- area hot to touch, 730 pm site of injection (R) deltoid area size of baseball according to mom. Mother applied cool compress and gave BENADRYL/MOTRIN. Pt afebrile after meds edema and redness decreased 11/23 - white line from site to shoulder noted with reddened circle at site - 9:30 AM - P.M. called.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 single dose injection for the prevention of pneumococcal disease. No concomitant medications were reported. On an unknown date the patient experienced swelling under the arms after administration of PNEUMOVAX23. The outcome of swelling under the arms was reported as recovering/resolving. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dyspnoea, Loss of consciousness
Clinical narrative: Client received zoster and Influenza at 2:00 pm. Went home, then to the lodge. Noticed slight SOB at 5:00 pm. Taken to Urgent Care; upon arrival; symptoms worsened and client lost consciousness. O2, EPI x 2 doses, and BENADRYL were given. Pt transferred via ambulance to hospital where steroids and PEPCID given. D/C from ER at approximately 10:00 pm. Nothing consumed at lodge. Had anaphylaxis approximately 12 years ago after contrast dye given. This reaction was delayed a few hours also.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from female registered nurse practitioner of unknown age referring to her. No medical history was reported. It was reported that a years ago patient received a 3 dose of series RECOMBIVAX HB (dosage, route of administration and lot#batch# number were not provided). Subsequently after the vaccination her hepatitis B titer was found negative. On an unknown date of 1997 she had another dose of Hepatitis B vaccine (manufacturer unknown) and a titer following vaccination was negative. It is not reported about the patients sought medical attention. The outcome of titer following the vaccination was negative was reported as not recovered/not resolved. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 64 year old patient. On 22-NOV-2013, the patient was vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous (lot number and expiry date not provided). On 22-NOV-2013, the patient was supposed to received VARIVAX instead of ZOSTAVAX. No adverse effects reported. The outcome of patient received VARIVAX instead of ZOSTAVAX and no adverse effects was unknown. The action taken with VARIVAX (Merck) was not provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Arthralgia, Chills, Dysstasia, Joint swelling
Clinical narrative: Chills, joint pain at first - then (L) knee increased pain with swelling - 2nd knee same a few hrs. later then that evening pain went (L) wrist - unable to walk stand or bear any wt w/in 28 hrs. getting shot. To ER - admitted w/sepsis dx.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Sepsis, Weight bearing difficulty
Clinical narrative: Chills, joint pain at first - then (L) knee increased pain with swelling - 2nd knee same a few hrs. later then that evening pain went (L) wrist - unable to walk stand or bear any wt w/in 28 hrs. getting shot. To ER - admitted w/sepsis dx.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMRV
Symptoms: Injection site rash, Urticaria
Clinical narrative: Rash - unilateral - left scapular rgn extending down left arm to left hand. Hives - no vesicles.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a physician refers to 11 year (also reported as 11 or 12) old patient. On 19-OCT-2013 the patient was vaccinated with GARDASIL dose second (also reported second or third dose) (lot #/batch #, route of administration, dosage were not reported). No concomitant medication was reported. On 01-NOV-2013, the patient experienced seizure. The physician was unable to clarify this information or provide any further details other than he thinks the patient may have been seen in the emergency room. The outcome of seizure was reported as recovered/resolved. Upon internal review the event seizure was considered to be medically significant. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Throat irritation, Throat tightness
Clinical narrative: (R) deltoid red, warm, itchy throat feels "full".
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Chills, Eye discharge, Eye irritation, Headache, Nasal congestion
Clinical narrative: Right eye was red, mucousy, and burning.  Right nostril was congested.  Right neck was sore.  Body aches, chills, low grade fever, headache.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Neck pain, Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: Right eye was red, mucousy, and burning.  Right nostril was congested.  Right neck was sore.  Body aches, chills, low grade fever, headache.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site swelling, Pyrexia
Clinical narrative: Fever, swollen arm at site of injection, trouble breathing.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Convulsion, Cytogenetic analysis normal, Electroencephalogram normal, Hypotonia, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient went limp but was breathing and conscious for approximately 3 minutes. After 4 months of testing and 29 repeated episodes over that time period, it has been determined that these are seizures.  The first episode was the day he received his 6 month vaccinations.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Flushing, Rash
Clinical narrative: Face and neck became hot and flushed--then face and neck broke out in a rash. The next day a rash appeared in the middle of back about waist level. There was about a 4 inch long rash on right rib cage. Cortisone cream and Benadryl tablets were taken to help with the itching. By 11/24/2013 symptoms were much improved. However, still have rash on back.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient developed a fever of 102 F, mother discovered this around 10:00 PM and gave him ibuprofen granuoles she had purchased abroad previous to July of 2013.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dry mouth, Dysgeusia, Erythema, Feeling abnormal, Flushing
Clinical narrative: Several minutes after vaccine given, individual c/o feeling weird and having "a strange taste in her mouth"; she also c/o some itchiness and her right arm feeling heavy.  Denied difficulty breathing, palpitations.  No other specific s/sx and reported sensitivities to many things and has previously reacted when taking other medications.  Denied difficulty breathing; declined medical evaluation at that time; took Benadryl 25mg by mouth; instructed to report worsening s/sx.  At around 1640, individual reported significant worsening of s/sx, "feeling really bad, continued strange taste in mouth, dry mouth, flushing/hot flashes and itching all over".  Left ear reddened, right ear not; no rash visualized elsewhere but due to worsening s/sx taken to ED for evaluation and treatment.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hot flush, Pruritus generalised, Sensation of heaviness
Clinical narrative: Several minutes after vaccine given, individual c/o feeling weird and having "a strange taste in her mouth"; she also c/o some itchiness and her right arm feeling heavy.  Denied difficulty breathing, palpitations.  No other specific s/sx and reported sensitivities to many things and has previously reacted when taking other medications.  Denied difficulty breathing; declined medical evaluation at that time; took Benadryl 25mg by mouth; instructed to report worsening s/sx.  At around 1640, individual reported significant worsening of s/sx, "feeling really bad, continued strange taste in mouth, dry mouth, flushing/hot flashes and itching all over".  Left ear reddened, right ear not; no rash visualized elsewhere but due to worsening s/sx taken to ED for evaluation and treatment.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Fever, Chills, Sweating.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Local swelling, Pain of skin
Clinical narrative: Entire upper arm became swollen, red and hot to the touch. It was very tender. This lasted for 5 days.  The site was raised about 1/2 inch. Very painful.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Entire upper arm became swollen, red and hot to the touch. It was very tender. This lasted for 5 days.  The site was raised about 1/2 inch. Very painful.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient experienced redness around site of injection, that redness continued to spread, we found out on 11/24/13 because she came in with a prescription for Bactrim. She was told to see if the spreading of redness subsided by 11/27/13 and to let her physician know if it didn't. She said it was painful.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: STIFFNESS THROUGHOUT THE LEFT SHOULDER. AS OF 11/26/13 THE CONDITION HAS WORSENED, TO THE POINT OF CONSTANT PAIN, CANT LIFT ARM VERY HIGH. TENDER AT INJECTION POINT.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, FLU3, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Mother of patient stated baby never had any reaction.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, X-ray limb
Clinical narrative: Pain at site of injection (left deltoid). Pain and stiffness left deltoid muscle and left shoulder.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration
Clinical narrative: 7 x 4 cm area of redness and induration non tender area marked.
Age: 29.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Activities of daily living impaired, Dizziness, Hyperhidrosis, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: 11/16 Left arm hurt in evening. 17/17 Left arm stiff and painful (AM), 10AM lightheaded fever. Pt took APAP and IBU not much improvement. 11/18 getting worse - fever out of control, didn't take temp, pain and swelling worse, missed work. 11/19 missed work drenched in sweat, saw MD. PNEUMOVAX recommendation and that both vaccines were given in same arm, MD is sending in KEFLEX Rx, and LORTAB Rx MD says we should report it as an incident.
Age: 29.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: 11/16 Left arm hurt in evening. 17/17 Left arm stiff and painful (AM), 10AM lightheaded fever. Pt took APAP and IBU not much improvement. 11/18 getting worse - fever out of control, didn't take temp, pain and swelling worse, missed work. 11/19 missed work drenched in sweat, saw MD. PNEUMOVAX recommendation and that both vaccines were given in same arm, MD is sending in KEFLEX Rx, and LORTAB Rx MD says we should report it as an incident.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Mother refers patient presented redness, swelling in right arm and warm to touch.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Immediate post-injection reaction, Pain, Pain in extremity, Pyrexia
Clinical narrative: (L) arm sore immediately. 1 hr later hurt to move it. 4-6 hrs later quarter size hives under chin. Today, low grade fever with aches and pain and HA.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: (L) arm sore immediately. 1 hr later hurt to move it. 4-6 hrs later quarter size hives under chin. Today, low grade fever with aches and pain and HA.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Pain, Swelling
Clinical narrative: Severe HA at least 24 hours. Soreness and swelling w/redness. Taking ibuprofen.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Extensive swelling of vaccinated limb, Injected limb mobility decreased
Clinical narrative: (L) arm swelled up to twice its normal size and unable to lift his arm up.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: My injection site arm encased in red rash. I have leukemia so I went to my doc for assistance. First time ever I had an adverse reaction to flu shot.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea, Rash, Urticaria
Clinical narrative: Noticed rash/hives on chest. SOB. Chest pain. Went to ED. Treated for anaphylaxis (epi, nebs, BENADRYL). Began to feel better on 11/18/13.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient states shot given in outer aspect of tricep and has been experiencing shooting from tips of finger into neck. No noticeable swelling or warmth around injection site. Patient advised to take Naproxen and follow-up with MD.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Local swelling, Pain
Clinical narrative: Pt received injection, "the morning of 11-15-13, by that evening the area was swollen, red and painful." Pt went to ER, but did not receive treatment, for the local reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a "few patients" (ages and genders not reported) who on an unknown date were vaccinated with a dose ZOSTAVAX (dose not reported). The pharmacist reported that the "few patients" had developed a red area (without pain, itching or rash) at the ZOSTAVAX injection site. Patients outcome of red area at injection site was not reported. Relationship between red area at injection site and therapy with ZOSTAVAX was not reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to 2 unspecified patients of unknown gender and age. On unknown dates the patients were vaccinated with ZOSTAVAX 19400 PFU, dosage not reported. On unknown dates after vaccination the patients developed a rash. It was reported that on unknown dates the patients came to the pharmacy with a prescription from unspecified physicians for VALTREX. The outcome of developed rash is unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Point of injection began swelling, became every hot, extremely sore/tender to touch. Called Dr., iced area, took BENADRYL, ibuprofen. Swelling increased for few hours, remained steady following day. By 11-3-13 arm was good.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Middle insomnia, Nausea, Pain
Clinical narrative: Flu vaccine 2pm on 10/1/13. Reported that she woke up in middle of that noc with temp to 103 degrees, severe chills, body aches and nausea. Temp 101 still the following day.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tendonitis
Clinical narrative: Pain in arm. Pt went to MD. She was diagnosed with tendonitis.
Age: 47.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness, swelling and warm at site of Tdap injection (L deltoid) afebrile (98.6).
Age: 0.68
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a 20 year old female patient with no pertinent medical history or drug reactions/allergies. On 01-JUL-1993, the patient was vaccinated with the first dose of RECOMBIVAX HB, 0.5 ml, intramuscular (lot Number and expiration date not reported). On 25-SEP-1993, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose, route, lot Number and expiration date not reported). On 26-FEB-1994, the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route, lot Number and expiration date not reported). There were no concomitant medications. The Register Nurse reported that the patient who completed the series as a child, showed negative titers for Hepatitis B antibody. No treatment was given to the patient. Hepatitis B antibody Titer laboratory test was performed which showed negative titers. The patient sought unspecified medical attention. The outcome of patient was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Mom states (L) at site, noted swelling et reddened. Day after injection increased swelling. Pt mom called PCP. Child taken to ER Dx with cellulitis. Given antibiotics.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Pain
Clinical narrative: Initial report was received from a healthcare professional on 15 November 2013. A 14-year-old male patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH906AE, on 11 November 2013 and 24 hours later complained of body aches and developed shingles. The patient had no illness at the time of vaccination and no past medical history. Outcome was not recovered. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Crying, Hyperhidrosis, Moaning, Nausea
Clinical narrative: Pt. was super anxious about vaccines and was crying after her 3rd (HPV). She started sweating (1 min) and looked pale and crying louder/moaning. C/O stomach ache and wanting to vomit. I had pt rest on my shoulder and gave her water and took her shirt off. Brought some cool compresses. Took BP 2 times. Had pt wait in office x 30 min. We were so worried that we forgot to give FLUMIST. Pt r/s appt OTP for 11/26/13.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: Pt. was super anxious about vaccines and was crying after her 3rd (HPV). She started sweating (1 min) and looked pale and crying louder/moaning. C/O stomach ache and wanting to vomit. I had pt rest on my shoulder and gave her water and took her shirt off. Brought some cool compresses. Took BP 2 times. Had pt wait in office x 30 min. We were so worried that we forgot to give FLUMIST. Pt r/s appt OTP for 11/26/13.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness over (L) upper arm.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Hypersomnia, Mobility decreased, Pyrexia
Clinical narrative: Severe chills; fever; total weakness unable to move any part of body within 8 hr. after receiving vaccine. Slept thru next day.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Local swelling, Nausea, Nodule
Clinical narrative: Swelling of arm and had knot on arm red rash, soreness itching, nausea. Diarrhea, headache went to ER and was given BENADRYL and also Cortisone by Dr.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Rash erythematous
Clinical narrative: Swelling of arm and had knot on arm red rash, soreness itching, nausea. Diarrhea, headache went to ER and was given BENADRYL and also Cortisone by Dr.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Erythema, Heart rate increased, Joint stiffness
Clinical narrative: Red face, fever, chills, rapid heartbeat, joint pain and stiffness, hives on left arm, swollen lymph nodes under left arm, muscle pain over entire body for 2 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Myalgia, Pyrexia, Urticaria
Clinical narrative: Red face, fever, chills, rapid heartbeat, joint pain and stiffness, hives on left arm, swollen lymph nodes under left arm, muscle pain over entire body for 2 days.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dyspnoea, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Dizziness. Sweating. Paleness. Weakness. Nausea. Shakiness. Labored breathing. Symptoms started immediately and lasted for 4 hours. Administered BENADRYL.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pallor, Tremor
Clinical narrative: Dizziness. Sweating. Paleness. Weakness. Nausea. Shakiness. Labored breathing. Symptoms started immediately and lasted for 4 hours. Administered BENADRYL.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Large (size of donut) red, hot to the touch, hard, swollen (4 days). Doctor almost had me come to urgent care.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site rash, Injection site reaction, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: 4 hours after pt got flu shot she got red itchy rash near injection site and it has since spread to both arms and chest and back and neck and flu shot was given on 10/22/13.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site scab
Clinical narrative: Patient came to pharmacy a month and 1/2 after administration saying her arm is still itchy at site of admin. Scratching so much she has scabs.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Tenderness, Tendonitis
Clinical narrative: Initially after the shot, my shoulder was tender and about 1 - 2 weeks after the shot, I started losing mobility and the shoulder was very painful. On Oct 31, I had an appointment with my primary care physician dr. She gave me a referral to a physical therapist in case my shoulder didn't get better. I started PT on Nov. 11 and continue with PT now for tendonitis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration
Clinical narrative: 11 mm x 9 mm induration upper left arm. Pt. to use ice and Ibuprofen as treatment.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site (L) deltoid. Redness size of half dollar. Circled area, applied ice and gave ibuprofen. Advised to ice on and off every 15 min for a couple of hours and take ibuprofen every 4 hours for inflammation. Following day (even though patient did not ice), redness reduced to (L) area of orig reaction in a small C shape.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain. Ice, TYLENOL, BENADRYL.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Pain and stiffness in left arm and shoulder. Has persisted without any relief to this point.  Treatments include X-ray, oral corticosteroids, massage, chiropractic therapy, physical therapy, MRI.
Age: 28.0
Sex: M
Vaccine: FLUC3
Symptoms: Oxygen saturation decreased, Paraesthesia, Pruritus generalised, Throat tightness, Urticaria
Clinical narrative: After recieved vaccination within three minutes, patient complained of itching and tingling throughout body, followed by tightening of the throat one minute later. Vital Signs are as follows: P105 O2 Sats 95% decreased to 91% on room air Blood Pressure 152/82. Hives noted to develop to upper extremities and the trunk of the body. Addministerd EPIPEN 0.3mg auto injector, high flow oxygen through non-rebreather mask, Oxygen saturation improved to 100%, Pulse remianed at 110 BPM. EMS was notified and arrived within ten minutes and transported patient to hospital.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Henoch-Schonlein purpura, Hypoaesthesia, Musculoskeletal pain, Pain in extremity
Clinical narrative: On 8/18 pt started getting back pains at T8 that spread down her spine to sacram.  Also had pain and numbness spreading to the left leg and part of right leg.  Also had pruritis with pain and diffuse petechiae on both upper later/posterior legs and shoulder/upper arms.  On 8/20 was admitted to observation.  Diagnosed with Menactra induced Henoch-Schonlein Purpura.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Petechiae, Platelet count normal, Prothrombin time normal, Pruritus
Clinical narrative: On 8/18 pt started getting back pains at T8 that spread down her spine to sacram.  Also had pain and numbness spreading to the left leg and part of right leg.  Also had pruritis with pain and diffuse petechiae on both upper later/posterior legs and shoulder/upper arms.  On 8/20 was admitted to observation.  Diagnosed with Menactra induced Henoch-Schonlein Purpura.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Patient received an expired immunization, exp date 11/19/2013. Clinical Supervisor also reported the event to Sanofi, they instructed to re-immunize the patient. Patient didn't exhibit signs of not feeling well.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Patient reporting extreme pain and achiness at injection site that shoots up to neck and down hand that has persisted almost 2 weeks post vaccination. No redness, swelling, or fever at injection site.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Customer called Pharmacist and reported her arm was still sore from her flu shot. She denied it being red or any other symptoms. The pharmacist advised her to take some Advil and call and report to us on Friday.
Age: 55.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Erythema, Local swelling
Clinical narrative: Arm turned red and swelled up.  cellulitis - 3 day hospital stay
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Low-grade fever, dizziness, muscle/joint aches, productive cough, sore throat, headache. Started with dizziness < 6 hours after vaccination. Has never been vaccinated for influenza before.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Productive cough, Pyrexia
Clinical narrative: Low-grade fever, dizziness, muscle/joint aches, productive cough, sore throat, headache. Started with dizziness < 6 hours after vaccination. Has never been vaccinated for influenza before.