chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis, erythema, swelling, warmth surrounding injection sites.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dysphagia, Malaise, Neck pain, Oropharyngeal pain
Clinical narrative: Vaccine was given on 3/14/13. Started feeling sick on 03/20/13. Her symptoms are throat hurting, hard to swallow, neck hurting, back hurting. Site of injection is fine. Denies any redness, swelling, and tenderness.
Age: 0.47
Sex: M
Vaccine: DTAPIPV, HIBV, PNC
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: KINRIX given to 5 month old. No adverse reactions.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Rash - varicella. Treatment recommended calamine, BENADRYL, oatmeal bath.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling & itching began 3-14-13 at about 9:00 am on posterior left upper arm.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pt had Hepatitis B vaccine #1 1cc 20mcg IM to (L) deltoid on 2/14/13. On 3/14/13 pt returned for #2 but complained of intermittent arm pain & numbness since 2/14/13.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site inflammation
Clinical narrative: On 3/21/13 at 8:05am, patient reported inflammation at the injection site.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Tdap given in (L) deltoid on 3/19/13. That night deltoid area where immunization was given developed some redness. The redness got bigger. Came to clinic 3/21 for evaluation. (L) deltoid area warm to touch with induration - measures 10.5cm across and 11.0cm up and down. Normal movement - tender to touch. Given ibuprofen.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Pt. states left arm nerve pain radiating down arm all the way to finger.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 year old female patient. The healthcare worker reported that on an unknown date the patient was vaccinated with GARDASIL (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The reporter said that on an unknown date the patient was administered GARDASIL and fainted. At the time of the report the outcome of faint was unknown. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Condition aggravated, Diarrhoea, Dyskinesia, Irritability, Mucous stools
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 month old female patient with milk protein allergy but this had not been confirmed. The patient's medical history included mucous in stools that looked like egg white, when the patient ws 3 weeks old (approximately in 23-JAN-2013). The pharmacist reported that on 05-MAR-2012 the patient was vaccinated with ROTATEQ, suspension 2, dose 1, oral. There were not concomitant medications. The pharmacist reported that on 06-MAR-2013 her daughter had been experiencing mucous in her stool. She has been irritable and screaming often. She also has been pulling her legs up to her chest. On 06-MAR-2013 a faecal occult blood test came back positive. The pharmacist reported that on 10-MAR-2013 her daughter had 5 loose stools. The pediatrician told the pharmacist to feed her daughter NUTRAMIGEN. At the time of the report, the outcome of faecal occult blood test positive, loose stools, pulling legs up to chest, irritability, screaming and mucous in stools was reported as not recovered/not resolved. The patient's mother sought medical attention by speaking to physician. The patient was treated with NUTRAMIGEN. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Occult blood positive, Screaming
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 month old female patient with milk protein allergy but this had not been confirmed. The patient's medical history included mucous in stools that looked like egg white, when the patient ws 3 weeks old (approximately in 23-JAN-2013). The pharmacist reported that on 05-MAR-2012 the patient was vaccinated with ROTATEQ, suspension 2, dose 1, oral. There were not concomitant medications. The pharmacist reported that on 06-MAR-2013 her daughter had been experiencing mucous in her stool. She has been irritable and screaming often. She also has been pulling her legs up to her chest. On 06-MAR-2013 a faecal occult blood test came back positive. The pharmacist reported that on 10-MAR-2013 her daughter had 5 loose stools. The pediatrician told the pharmacist to feed her daughter NUTRAMIGEN. At the time of the report, the outcome of faecal occult blood test positive, loose stools, pulling legs up to chest, irritability, screaming and mucous in stools was reported as not recovered/not resolved. The patient's mother sought medical attention by speaking to physician. The patient was treated with NUTRAMIGEN. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a Doctor of pharmacist refers to a 79 year old male patient with no drug reactions or allergies. On 18-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H0199996, expiration date 02-FEB-2014), subcutaneously. The pharmacist reported that almost immediately upon administration of the vaccine on 18-MAR-2013, the patient developed a raised, pale yellow, circular bump around the injection site. There were no lab diagnosis or studies performed. The outcome of raised, pale yellow, circular bump around the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no pertinent medical history or drug allergies. On 15-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot # H019035; expiry date: 17-JAN-2014), 0.65 ml, subcutaneous. Concomitant therapies included ELMIRON 100 mg (2 tablets twice a day). On 16-MAR-2013, the patient experienced a red place on the arm at the injection site that was a circle and wider area around the circle that was not quite as red, area was warm/hot to the touch, "tough and swollen", pain that came down the arm, itchy, and sores on the corners of the mouth. The pain had gone away and the redness had gotten a little better. The outcome of the red place on the arm at the injection site, area was warm/hot to the touch, "tough and swollen", itchy and sores on the corners of the mouth was reported as recovering. The patient was advised to take BENADRYL. Patient had sought medical attention via calling physician and visiting pharmacy. No lab tests were performed. Pharmacist was requesting a lot check. This is one of the reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Stomatitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no pertinent medical history or drug allergies. On 15-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot # H019035; expiry date: 17-JAN-2014), 0.65 ml, subcutaneous. Concomitant therapies included ELMIRON 100 mg (2 tablets twice a day). On 16-MAR-2013, the patient experienced a red place on the arm at the injection site that was a circle and wider area around the circle that was not quite as red, area was warm/hot to the touch, "tough and swollen", pain that came down the arm, itchy, and sores on the corners of the mouth. The pain had gone away and the redness had gotten a little better. The outcome of the red place on the arm at the injection site, area was warm/hot to the touch, "tough and swollen", itchy and sores on the corners of the mouth was reported as recovering. The patient was advised to take BENADRYL. Patient had sought medical attention via calling physician and visiting pharmacy. No lab tests were performed. Pharmacist was requesting a lot check. This is one of the reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from an immunization coordinator concerning a patient of unknown gender and age who on an unknown date may had been vaccinated with an improperly stored RECOMBIVAX HB vaccine. The immunization coordinator stated that the unit that had the temperature problems was in a remote area and they may not had administered any RECOMBIVAX HB, but she was unsure. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist referring a patient of unknown age and gender who on 14-MAR-2013 the patient was vaccinated with a expired dose of M-M-R II (lot# and expiration date not reported). No symptoms reported. 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 licensed practical nurse (L.P.N.) concerning to a patient of unknown age and gender. On 13-NOV-2007 the patient was vaccinated with the first GARDASIL (lot number and expiration date not reported) (dose, frequency and route not reported). No other co-suspects or concomitant medications were reported. It was reported that the patient was in the office now to receive her second dose. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with no pertinent medical history and no drug reactions/allergies. No other co-suspects were reported. There were no concomitant medications. On 11-MAR-2013 the patient was vaccinated with VARIVAX (merck) (lot# and route unknown). On 11-MAR-2013, the patient experienced redness at the injection site. No lab and no treatments given for the event. The patient had sought medical attention via her mother called the office. The outcome was reported as recovered on an unknown date. Action taken was not provided. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: FLUX, HEPA, HPV4, FLU3, HEPA, HPV4
Symptoms: Abdominal pain, Blood test, Diarrhoea, Diplopia, Dizziness
Clinical narrative: Per mom, few hours after Hep A & GARDASIL given, pt c/o HA & (L) upper quad abdominal pain that has become chronic. Also has occasional pain in (B) upper extremities that on occasion radiates down to that lower extremity. Symptom of this pt reported to nurse by mom during conversation on 3-21-13 by phone.
Age: 16.0
Sex: M
Vaccine: FLUX, HEPA, HPV4, FLU3, HEPA, HPV4
Symptoms: Electrocardiogram, Migraine, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: Per mom, few hours after Hep A & GARDASIL given, pt c/o HA & (L) upper quad abdominal pain that has become chronic. Also has occasional pain in (B) upper extremities that on occasion radiates down to that lower extremity. Symptom of this pt reported to nurse by mom during conversation on 3-21-13 by phone.
Age: 16.0
Sex: M
Vaccine: FLUX, HEPA, HPV4, FLU3, HEPA, HPV4
Symptoms: Abdominal pain upper, Headache, Pain in extremity
Clinical narrative: Per mom, few hours after Hep A & GARDASIL given, pt c/o HA & (L) upper quad abdominal pain that has become chronic. Also has occasional pain in (B) upper extremities that on occasion radiates down to that lower extremity. Symptom of this pt reported to nurse by mom during conversation on 3-21-13 by phone.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apnoea, Crying, Dyspnoea, Feeding disorder, Irritability
Clinical narrative: Intermittent gasping - see attached. Was seen this morning for a well-child check which is on the well child form. Received PREVNAR, PEDIARIX, ROTATEQ, and HIB. Mother left the office at approximately at 10:00-10:15 am. Mother said that when she got home and put the baby down for a nap. Did not give the baby TYLENOL nor did she feed the baby. Mother said that there were some periods of apnea that she noticed. She described the periods anywhere from 1-3 seconds, where the baby would have these periods of apnea and then take a big gasp there. She did not report any cyanotic episodes. I asked her if there were any prolonged periods of apnea, and she replied as a mother she'd felt called to pick up the baby instead of watching the baby for the apnea spells. She does have other children and they have not reacted to any vaccines. She has not vomited and has had good wet diapers. Mother has tried to feed the baby and it has not fed well. She comes into the office and she is crying which started approximately 20 minutes prior to the exam. Rather fussy baby. HR 186 on pulse ox of 98, by my count it was 130. AFOS. Both TM's clear. Mouth, moist. Neck, supple, FROM. HR regular w/o murmur. Lungs clear. Abdomen soft. After a full body search there was no rash. She did move all her extremities. I put them through the FROM. Baby did suck on her pacifier. There were some periods of calm but there were more periods of fussiness. Did discuss the situation with Dr., and it was decided to send the baby by ambulance to hospital. Report was made. Called EMS. The baby was put on a monitor. Sat was 98 at discharge. In the room I did note there were some periods, that the baby would, when crying, have a period of 1-2 seconds and then take a big breath, but this is when she was crying. I did not see any periods where she was quiet. There were no actual prolonged periods of apnea that I witnessed.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 73 year old male patient. On 14-MAR-2013 the patient was vaccinated with expired ZOSTAVAX lot # 671661/1253AA, expiration date was 01-NOV-2012, 0.65 ml, subcutaneous in the right arm. No adverse effects reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Borrelia test negative, CSF test normal, Headache, Intracranial pressure increased, Intraocular pressure increased
Clinical narrative: After intranasal flu vaccine, had EGD 1 wk later, prolonged lethargy, increasing to 16 hrs/day, headache, mild deficits of memory, severe headache. Developed idiopathic intracranial hypertension. OP = 39.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Lethargy, Memory impairment, Nuclear magnetic resonance imaging normal, Oesophagogastroduodenoscopy, Venogram normal
Clinical narrative: After intranasal flu vaccine, had EGD 1 wk later, prolonged lethargy, increasing to 16 hrs/day, headache, mild deficits of memory, severe headache. Developed idiopathic intracranial hypertension. OP = 39.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Vitamin A normal
Clinical narrative: After intranasal flu vaccine, had EGD 1 wk later, prolonged lethargy, increasing to 16 hrs/day, headache, mild deficits of memory, severe headache. Developed idiopathic intracranial hypertension. OP = 39.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Hypersomnia, Hypotension, Lethargy, Vitamin D decreased
Clinical narrative: Progressive lethargy - now sleeps approximately 14-16 hrs/day, worsens with greater activity. Also, hypotension.
Age: 1.48
Sex: F
Vaccine: DTAP
Symptoms: Blood glucose decreased, Flat affect, Hypotonia, Posture abnormal, Tremor
Clinical narrative: Received DTAP on 3/14/13 at well visit. 3/15/13 dad went to get baby out of bed at 7AM and she was limp - went to pick baby up and could not even keep head up. Baby had flat affect. Temp 97.7, Lt arm shaking slightly. Mom gave 2 juice boxes, called 911, to ER.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood bicarbonate normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: Swelling of the entire left arm with pain 1 day after receiving Tdap and MENACTRA vaccines. IV Nafcillin and clindamycin; BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood potassium increased, Blood sodium normal, Blood urea normal, Haemoglobin normal, Lymphocyte percentage
Clinical narrative: Swelling of the entire left arm with pain 1 day after receiving Tdap and MENACTRA vaccines. IV Nafcillin and clindamycin; BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Monocyte percentage increased, Neutrophil percentage, Oedema peripheral, Pain in extremity, Platelet count normal
Clinical narrative: Swelling of the entire left arm with pain 1 day after receiving Tdap and MENACTRA vaccines. IV Nafcillin and clindamycin; BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Red blood cell sedimentation rate increased, White blood cell count normal
Clinical narrative: Swelling of the entire left arm with pain 1 day after receiving Tdap and MENACTRA vaccines. IV Nafcillin and clindamycin; BENADRYL.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site discolouration, Injection site erythema, Injection site scab
Clinical narrative: "Bubble came off & turned to scab with redness & little white spots around it" " (R) arm muscle" -"upper arm."
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Nausea, Pyrexia, Vision blurred, Vomiting
Clinical narrative: Fever, chills, nausea, vomiting, blurred vision approx 7 hrs after vaccination.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Echocardiogram abnormal, Pericardial effusion, Pericarditis
Clinical narrative: On Wed Dec 5, 2012 I took my daughter to pharmacy to get a flu vaccine at 3:30 pm. The next morning at school her chest started hurting & it got worse throughout the day. The same thing happened the next day. The pain was worse with activity especially at dance class. We went to several Drs. The cardiologist diagnosed pericarditis. Treatment is rest, no activity and taking anti-inflammatory medicines (NAPROSYN & MOTRIN).
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site reaction, Oedema peripheral, Urticaria
Clinical narrative: Received phone call from mother on 3/15/13 at 4:30 pm. States she noticed patient had a small red welt approximately 2 in. away from injection site on (R) deltoid on 3/12/13. Noted that lower right arm swollen without redness, warmth or pain. Mother stated swelling noted just by looking at arm. Using ice to decrease swelling.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling hot, Headache, Injection site erythema
Clinical narrative: Pt. reports today that after getting pneumonia vaccine she developed redness & swelling at injection site extending to elbow up to face/eye. Denies mouth/tongue swelling or SOB. C/O chills & feeling "hot" but did not actually take a temp. Also c/o headache & neck ache. Pt. instructed to take BENADRYL 50mg q 6 hours x 3 doses & ice injection site.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Neck pain, Ocular hyperaemia
Clinical narrative: Pt. reports today that after getting pneumonia vaccine she developed redness & swelling at injection site extending to elbow up to face/eye. Denies mouth/tongue swelling or SOB. C/O chills & feeling "hot" but did not actually take a temp. Also c/o headache & neck ache. Pt. instructed to take BENADRYL 50mg q 6 hours x 3 doses & ice injection site.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old male patient. The patient's medical history included herpes zoster.The patient had a case of shingles, waited six weeks after symptoms stopped. Between 14th and 17th of February (in 2013) the patient was vaccinated with ZOSTAVAX (lot number was not reported) (0.65 ml, subcutaneous on unknown injection site). On 14-MAR-2013 the patient developed shingles again. The outcome was unknown. The action taken and causality were not provided at the time of report. The patient had an office visit for medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Ear pain, Lymphadenopathy, Oropharyngeal pain, Pyrexia, Tenderness
Clinical narrative: Sore throat (started 3/20/13 AM). Lt. side neck (glands) swollen & tender, 3/20/13 (start AM). Lt. earache (started 3/20/13 AM). Low grade fever (started 3/19/13 PM).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: After 15-30 minute after vaccines given, pt developed red splotchy rash (non papular, non macular). No oral/throat swelling. Brompheniramine 1 mg given (BENADRYL unavailable). Rash resolved within 15-25 min. Vitals remained stable / pulse ox 100 / no oral swelling or wheezing at discharge.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a healthcare worker referred to a 67 year old female patient with a history of having fever blisters and with drug reactions/allergies to penicillin. On 15-MAR-2013 the patient was vaccinated with ZOSTAVAX (1 vial, subcutaneous, lot#, dose/frequency were unspecified). Patient developed "fever blisters" on her lips on 16-MAR-2013 after receiving a dose of ZOSTAVAX. Patient had sought medical attention via seeing the physician. No lab diagnostics studies were performed and no treatment was given for the event. The outcome of "fever blisters on her lips"was reported as not recovered. Drug relationship was not provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Insomnia, Nausea, Weight decreased
Clinical narrative: This spontaneous report as received from a consumer's father refers to a 17 year old female patient. The patient's medical history included gastroesophageal reflux disease (GERD). The patient did not have any drug reactions/allergies. In early January the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular, lot # was unknown). Concomitant Medication was amitriptyline. Shortly after received GARDASIL the patient experienced anemia, insomnia, weight loss and nauseous. The outcome of events was reported as not recovered/not resolved. The relationship between events and GARDASIL was unknown. No lab diagnosis studies performed. No treatment was given for adverse event. The patient had sought medical attention via going to the Health Care Professional office. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse referring to an unspecified female patient (age unknown) who was vaccinated with a dose of ZOSTAVAX (lot # and expiration date and dose not reported) in 2008 who developed shingles recently. At the time of this report patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TYP, YF
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: On 3/6/13 YF vaccine given SQ in (R) tricep. Given info on YF vaccine - Advised to use med & take TYLENOL or ADVIL if needed. 3-12-13 Mother called informed sight was red & warm no other sign. 3-13-13 mother soon phoned us very red sight. Mother called & promised to take to MD so they could seen by his personal MD.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, C-reactive protein increased, Haematocrit normal, Haemoglobin normal, Joint swelling
Clinical narrative: Urticaria developed 36 hours post vaccination and continued as patient developed symmetric, multiple joint swelling and arthritis, fever, c/w serum sickness reaction. Responded well to 5 days ORAPRED 2 mg 1 BID and antihistamine. On 3/14/13 there was no residual rash / arthritis.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Platelet count increased, Polyarthritis, Pyrexia, Red blood cell sedimentation rate increased, Serum sickness
Clinical narrative: Urticaria developed 36 hours post vaccination and continued as patient developed symmetric, multiple joint swelling and arthritis, fever, c/w serum sickness reaction. Responded well to 5 days ORAPRED 2 mg 1 BID and antihistamine. On 3/14/13 there was no residual rash / arthritis.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, White blood cell count increased
Clinical narrative: Urticaria developed 36 hours post vaccination and continued as patient developed symmetric, multiple joint swelling and arthritis, fever, c/w serum sickness reaction. Responded well to 5 days ORAPRED 2 mg 1 BID and antihistamine. On 3/14/13 there was no residual rash / arthritis.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Exposure during pregnancy, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous prospective pregnancy report was received from a 29 year old female patient regarding herself. No medical history was reported. On 08-MAR-2013, the patient was vaccinated with (merck) VARIVAX (lot #,dose not reported) and the patient is currently pregnant. Other suspect therapies included rubella virus vaccine live (Manufacturer unknown), tetanus toxoid(Manufacturer unknown) and hepatitis b vaccine (recombinant) (Manufacturer unknown). The LMP and EDD is not known. The pregnancy outcome was pending. On 10-MAR-2013, the patient experienced red itchy bumps on her legs, arms and neck. Blood work was done last week(results not reported). The outcome of red itchy bumps on her legs, arms and neck was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dizziness, Dyspnoea, Presyncope, Swollen tongue
Clinical narrative: C/O tongue swelling, dyspnea and feeling faint with AVA #1. Workup with Allergy Clinic with diagnosis of vasovagal response.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Papule
Clinical narrative: This spontaneous report as received from nurse referring to an 81 year old male patient with muscular dystrophy, hypertension and atrial fibrillation, who on 25-FEB-2013, was vaccinated with a dose of ZOSTAVAX (lot # H021292, expiration date, 28-FEB-2014, dose and route not reported). The nurse reported that the patient developed shingles on 12-MAR-2013. He had a moderate case of shingles with papules on his ribs. The patient was treated with acyclovir. At the time of this report the patient had not recovered from shingles with papules on his ribs. The patient sought medical attention, contacted the physician. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: IPV, MMR, YF
Symptoms: Blood pressure increased, Chest discomfort, Chest pain, Electrocardiogram normal, Nervousness
Clinical narrative: Pt received above immunizations. Waited in waiting room and at 10 after injections began to complain of chest pain & pressure. VS taken EKG done pt transferred to hospital. Pt cleared at hospital and sent home. No further issues. Pt very nervous about receiving immus.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling right arm where shots was given.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from the patient's father. The patient was vaccinated with a dose of M-M-R II last week(on approximately 25-FEB-2013). The vaccine expired in November 2012. No adverse experience reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from nurse referring that "lots of patients" had developed shingles after vaccination with ZOSTAVAX (lot # and expiration date not reported) but no specific patient information was available. At the time of the report, the patients outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. Medical history and concomitant medication were not reported. On 26-FEB-2013 the patient was vaccinated with RECOMBIVAX HB (5/0.5 MCGR/ML) intramuscular (lotnumber unknown). On 14-MAR-2013, 17 days after onset of therapy the patient received the second dose on 14-MAR-2013 (Inappropriate schedule of vaccine administered). There was no adverse effect reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Injection site erythema, Injection site swelling, Neck pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with drug reactions/allergies to NSAIDs (nonsteroidal antiinflammatory drugs) and sulfonamides and hyperlipidemia. On 18-FEB-2013 the patient was vaccinated with ZOSTAVAX (single dose, lotnumber reported as H020844 exp date 02-FEB-2013) subcutaneous in the right upper arm as vaccination. Concomitant therapies included diphenhydramine and unspecified medication for hyperlipidemia. On 18-FEB-2013 the patient experienced redness and swelling at the injection sire after administration of ZOSTAVAX. The patient self-treated at home with BENADRYL. On 19-FEB-2013 the patient felt 'heaviness in her chest and soreness in the back of her neck the day after she received ZOSTAVAX. The patient tool nitroglycerin for these symptoms. No laboratory tests were performed. The outcome of heaviness in her chest, redness and swelling at the injection site and soreness in the back of her neck was reported as recovering. The relatedness for the adverse events was not reported for ZOSTAVAX. The patient sought medical attention, came in to pharmacy. Additional information is not expected.
Age: 32.0
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative, No adverse event, Rubella antibody test
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 32 year old male patient. The patient received a dose of M-M-R II on 04-JUN-2010 (lot and expiration date were unspecified) and had a negative Mumps titer (of 0.19) in early December of 2012 (titer for Measles and Rubella were acceptable). The patient was administered another dose of M-M-R II on 11-DEC-2012, but no titer tests had been done since then M-M-R II dose on 12/11/2012. The nurse stated that the patient might  have received M-M-R II as a child, but there were no vaccination records for the patient as a child. No adverse event reported, other than the negative Mumps titer. The outcome of negative mumps titer was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a patient who on an unknown date was vaccinated with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (dose,route and lot # not provided). The pharmacist stated that the patient had a negative or low titer for anti-HBs antibody following completion of the full hepatitis b vaccine (recombinant)(manufacturer unknown). The pharmacist did not know when the primary hepatitis b vaccine (recombinant)(manufacturer unknown) series was completed or when the negative or low titer result was reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 19-DEC-2012, the patient was vaccinated with the first dose of PENTACEL, but the office shortly after switched to LIQUID PEDVAXHIB, and therefore, the patient received the second 0.5 ml dose, intramuscular of LIQUID PEDVAXHIB on 29-JAN-2013 and the patient was in the office today (12-MAR-2013), to receive the third dose of LIQUID PEDVAXHIB. No concomitant medications reported. No adverse effect reported. Additional information is not expected.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Child was found unresponsive in crib on 3/21/13 am. Mom had fed at approx. 3 am and baby was fine. Found at 7 am face down in bassinet. 911 called. Pronounced dead at hospital.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: High fever - temperature began at 101.5 and went up to 103.6 F. High fever lasted for 3 days. Fever subsided after 4 days. Treated with doses of children's Advil and Tylenol.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Rash began and doctor said it was an immunization outbreak of Chicken Pox from the varicella vaccine.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Periarthritis
Clinical narrative: Shoulder pain and stiffness.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial test, Injection site erythema, Injection site swelling, Skin irritation, Skin lesion
Clinical narrative: Severe redness and swelling at injection site initiated at day 2 and continued for approximately 2 weeks before resolution. At day 12 a lesion appeared on her lower right extremity. Several more appeared and one grew to a rather large size, approx. 2&1/2 inches in diameter. As of current date (3/22/13) most lesions have resolved with some topical irritation remaining.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Viral test
Clinical narrative: Severe redness and swelling at injection site initiated at day 2 and continued for approximately 2 weeks before resolution. At day 12 a lesion appeared on her lower right extremity. Several more appeared and one grew to a rather large size, approx. 2&1/2 inches in diameter. As of current date (3/22/13) most lesions have resolved with some topical irritation remaining.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles like rash on back and arms.
Age: 40.0
Sex: M
Vaccine: MNQ
Symptoms: Eye irritation, Inflammation
Clinical narrative: Inflammation, irritation.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle aches and joint pain in both legs.
Age: 26.0
Sex: F
Vaccine: FLU3, MMR, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Patient became pale, dizzy, and diaphoretic.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PER, RVX
Symptoms: Crying, Screaming
Clinical narrative: Screaming high-pitched scream, inconsolable, non-stop until 9:35 PM.
Age: 1.19
Sex: M
Vaccine: FLU3
Symptoms: Cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Had cough, runny nose, congestion, low grade fever about 6 hours after flu shot on 01-09-2013.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Patient immediately vomited vaccine and contents of vaccine after administration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, pain and warm to touch to right deltoid.
Age: 20.0
Sex: F
Vaccine: HEPA, MNQ, YF
Symptoms: Dizziness, Loss of consciousness, Malaise, Pallor, Tremor
Clinical narrative: At 4:22PM Client appeared pale, said didn't feel good and felt like she was going to faint.  She was placed on the floor, started shaking and passed out. At 4:23 ammonia inhalent given, she woke and BP taken and was 100/60.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Back pain, Body temperature increased, Fatigue, Malaise
Clinical narrative: States feels tired, aches and pain in joints, nausea and low grade temp occasionally. A lot of pain in her neck, back and lower hip area.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Neck pain
Clinical narrative: States feels tired, aches and pain in joints, nausea and low grade temp occasionally. A lot of pain in her neck, back and lower hip area.
Age: 0.18
Sex: M
Vaccine: DTAP, RVX
Symptoms: Dyskinesia, Gastrooesophageal reflux disease, Infrequent bowel movements, Opisthotonus, Poor quality sleep
Clinical narrative: Ceased having BMs.  Called on Monday and Dr told me to try suppository.  After 8 hrs, patient had BM.  Waited another 4 days and had to use another suppository for BM.  After another 4 days, called and Dr told me to add Karo syrup to bottle on 4 and 5th day after no BM.  Patient had restless sleep/naps, arching of the back and thrashing.  Has since been diagnosed with silent reflux.  Mother tried homeopathic remedy (Nat Phos and arnica) and after 5 days reflux stopped and BMs were 2 times per day.  Stopped Nat Phos and arnica and reflux did not come back and BMs continued.  Had Hib and Prevnar shots and BMs ceased again. Put on Axid and Lactulose by Pedi and GI specialist.  After DTap and Rotovirus vaccines again, BMs ceased again and had to use multiple suppositories and doubled lactulose for patient to have BMs. Pedi recommended no more vaccines until child is older.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Redness and inflammation with warmth around skin. No signs of infection/cellulitis.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Patient states that last evening she developed red, raised bumps hives and rash on her neck and chest area.
Age: 14.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Syncope
Clinical narrative: Patient fainted for about 45 seconds.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: Devolped hives.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site pruritus, Skin warm, Swelling
Clinical narrative: Itching a shot site, swelling size of golf ball, red and warm to touch.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, edema, warmth in (L) upper arm. Improving with only Ibuprofen. Started about 1 wk after Tdap administered.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a physician through the patient's treating physician, refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (dose, frequency and route not reported). The reporting physician stated that on an unspecified date the patient developed seizures 1 month after receiving GARDASIL. It was unspecified if the patient sought medical attention and the patient received unspecified anti-seizure medications as treatment for seizures. At the time of the report the patient's outcome for seizures was unknown. Upon internal review the seizure was considered as other important medical event. Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash, Injection site urticaria, Urticaria
Clinical narrative: Rash/hives started around site of vaccine injection. The hives continued to spread to the rest of the body. Rash resolved with hydroxyzine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis, warmth, pain at injection site KEFLEX 500 mg po BID x 10 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Patient developed an erythematous macular rash around injection site on right thigh measuring 4cm x 4 cm with associated leg pain, & slight swelling, which is resolving upon seeing him 2 days later.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The pt said she received the vaccination in the afternoon (3:21 pm) and felt fine for the remainder of the day. Beginning the next day, she reported that the injection site was red, raised, warm, and painful. It continued to get worse. She was instructed to see a physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with headaches, muscle spasms and blood pressure. On 12-MAR-2013 the patient was vaccinated with ZOSTAVAX vial 19400 PFU (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). Concomitant medications included unspecified medications for headaches, muscle spasms and blood pressure. On 13-MAR-2013, the patient developed an itchy area "the size of a lemon" at the injection site after ZOSTAVAX was administered. At the time of the report the outcome of itchy area at the injection site was reported as not recovered/not resolved. The patient sought medial attention. There was not treatment given or laboratory tests performed. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chlamydia test, Exposure during pregnancy, Full blood count, Fungal infection, Glycosylated haemoglobin
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no known drug reactions or allergies and with no pertinent medical history who on 29-DEC-2011, presented to the family practice office symptomatic (specific symptoms unspecified0 and was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (Lot # 668670/0476AA). There was no concomitant medication. "The same day" on 29-DEC-2011 after GARDASIL vaccination, the patient had a pregnancy test that showed she was pregnant. The lab diagnostics studies performed also included chlamydia test, PAP, HIV screening. On 09-JAN-2012 the patient performed "full OB screen: CBC, rubella, RPR (syphilis screen), hepatitis B, hemoglobin A1C, blood type A positive" and no lab results provided. The nurse mentioned her gestation was 26 weeks and 1 day until now. Her LMP was on 13-NOV-2011. Expected date of delivery was on 19-AUG-2012. No further information was reported. Follow up information was received from a physician who reported that the 20 year old female patient with no medical history and no concurrent medical conditions and with no previous pregnancies, was vaccinated on 03-JAN-2013 (previously reported as 29-DEC-2011) with the first dose of GARDASIL (lot number 668670/0476AA). Estimated delivery date was reported as 19-AUG-2012. It was unknown that ultrasound, amniocentesis, MSAFP were done. On 22-AUG-2012, at 37 gestation week, the patient delivered normal full term female baby with no congenital anomaly. There were no other complications or abnormalities. Apgar score was 9, 9 for the baby. The baby's birth weight was 9lbs 8oz. There were no complications during pregnancy or during labor/delivery. Follow up information was received from a physician who reported that the patient had not medical history information and that she was vaccinated on 29-DEC-2011 (previously reported as 03-JAN-2012), with the first dose of GARDASIL. The patient used miconazole 2% vaginal cream QHS on 13-MAR-2012, for yeast infection. There were no complications during pregnancy; everything went fine and Estimated conception date was reported as 21-NOV-2011. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: HIV test, Hepatitis B, Laboratory test, Pregnancy test positive, Rubella antibody test
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no known drug reactions or allergies and with no pertinent medical history who on 29-DEC-2011, presented to the family practice office symptomatic (specific symptoms unspecified0 and was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (Lot # 668670/0476AA). There was no concomitant medication. "The same day" on 29-DEC-2011 after GARDASIL vaccination, the patient had a pregnancy test that showed she was pregnant. The lab diagnostics studies performed also included chlamydia test, PAP, HIV screening. On 09-JAN-2012 the patient performed "full OB screen: CBC, rubella, RPR (syphilis screen), hepatitis B, hemoglobin A1C, blood type A positive" and no lab results provided. The nurse mentioned her gestation was 26 weeks and 1 day until now. Her LMP was on 13-NOV-2011. Expected date of delivery was on 19-AUG-2012. No further information was reported. Follow up information was received from a physician who reported that the 20 year old female patient with no medical history and no concurrent medical conditions and with no previous pregnancies, was vaccinated on 03-JAN-2013 (previously reported as 29-DEC-2011) with the first dose of GARDASIL (lot number 668670/0476AA). Estimated delivery date was reported as 19-AUG-2012. It was unknown that ultrasound, amniocentesis, MSAFP were done. On 22-AUG-2012, at 37 gestation week, the patient delivered normal full term female baby with no congenital anomaly. There were no other complications or abnormalities. Apgar score was 9, 9 for the baby. The baby's birth weight was 9lbs 8oz. There were no complications during pregnancy or during labor/delivery. Follow up information was received from a physician who reported that the patient had not medical history information and that she was vaccinated on 29-DEC-2011 (previously reported as 03-JAN-2012), with the first dose of GARDASIL. The patient used miconazole 2% vaginal cream QHS on 13-MAR-2012, for yeast infection. There were no complications during pregnancy; everything went fine and Estimated conception date was reported as 21-NOV-2011. Additional information is not expected.