chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Chest discomfort, Lip swelling, Throat irritation
Clinical narrative: VIVOTIF oral vaccine given at home eve of 2/28/13 as directed. VIVOTIF not prescribed at facility - it was prescribed at an outside travel clinic. Mother called facility A.M. of 3/1/13 to report that patient had swollen lips, was c/o chest tightness and throat discomfort. Mom instructed to give child BENADRYL (total 50mg given). Child was seen at facility in A.M. of 3/1/13. Chest & throat discomfort resolved following po BENADRYL. Patient did present with swollen facial lips in clinic.
Age: 13.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Lip swelling, Pharyngeal oedema, Rash, Skin test negative, Urticaria
Clinical narrative: VIVOTIF oral vaccine given at home eve of 2/28/13 as directed. VIVOTIF not prescribed at facility - it was prescribed at an outside travel clinic. Mother called facility A.M. of 3/1/13 to report that patient had swollen lips, was c/o chest tightness and throat discomfort. Mom instructed to give child BENADRYL (total 50mg given). Child was seen at facility in A.M. of 3/1/13. Chest & throat discomfort resolved following po BENADRYL. Patient did present with swollen facial lips in clinic.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Erythema left upper arm (7 cm x 8 cm). Swelling, warmth. Headache, nausea. Low grade fever, pain to left upper arm.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Erythema left upper arm (7 cm x 8 cm). Swelling, warmth. Headache, nausea. Low grade fever, pain to left upper arm.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Vision blurred
Clinical narrative: Pt reported dizziness and blurred vision after shot. Called Nurse to recheck and follow up. See Nurse comments.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient in his 70's with history of lower back pain from degenerative disc disease. The physician had two patients who experienced a vaccine failure of ZOSTAVAX. Other case reported (MARRS # 1303USA001545). On approximately 7-FEB-2013 "about three weeks ago" the patient received ZOSTAVAX 0.65ml subcutaneously (lot# and exp date were unspecified). On 14-FEB-2013 one week after injection, the patient started to experience lower back pain and went to Emergency department of unspecified hospital. At the emergency room (ER), the patient received unspecified steroid therapy, (product, dosage and manufacturer unspecified) that the patient decided not to take. On 21-FEB-2013 two weeks after injection the patient presented at physician's office and was diagnosed with Shingles. The relatedness of shingles is unknown. The outcome of shingles is unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age. On 29-OCT-2012, the patient was inadvertently vaccinated with an expired dose of GARDASIL (lot # 0992Z; exp. date: 14-OCT-2012) (dose and route not reported). No adverse effects reported. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal test negative, Injection site erythema, Injection site rash, Laboratory test normal
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter a 17 year old female patient. In 2008, the patient was vaccinated with the first dose of GARDASIL (injection) (lot#, dose and route not reported). On an unspecified date, the patient within a few days got a red rash around the injection site. The patient went to see an allergies and several test (unspecified) were completed including a yeast test. All the test results were negative. The outcome of red rash around the injection site was unknown. The relatedness of the event with GARDASIL was not provide. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report as received from a company representative refers to a female patient of unknown age with history of lower back pain and unspecified nerve pain. The primary reporter stated that a physician had two patients who experienced a vaccine failure of ZOSTAVAX. Other case (MARRS # 1303USA000448). On 21-FEB-2013 "about three weeks ago" The female patient received ZOSTAVAX 19400 PFU, 0.65ml subcutaneously (lot# and exp date were unspecified). On 21-FEB-2013 two weeks after ZOSTAVAX injection, the patient developed outbreak on her thigh and was diagnosed with shingles. It was reported that vaccine failure and shingles did not cause hospitalization or prolonged and were not life threatening. The relatedness of shingles was unknown. The outcome of vaccine failure and shingles was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Labia enlarged
Clinical narrative: This spontaneous report as received from a physician regarding a 12 year old female patient. The patient's medical history included that patient's father has an unusually large penis and scrotum. On an unknown date the patient was vaccinated with GARDASIL (lot # and expiration date unspecified), 0.5 ml, 3 doses, (route unspecified) for prevent Human papillomavirus (HPV). Patient's mother reported that she wanted to know if GARDASIL could have enlarged her daughter's labia, because the patient experienced this after having completed the GARDASIL series. In the message, the mother also wanted to let the doctor know that the patient's father has an unusually large penis and scrotum and she wanted to know if this is something that could be genetically related to the enlarged labia of her daughter. At the time of the report the outcome of the enlarged labia was unknown. It was reported that there was no hospitalization and no treatment given for the enlarged labia. Lab diagnostics studies were not performed. Patient sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old female patient. On 10-NOV-2012, the patient was vaccinated with the first dose of GARDASIL (lot # and dose not reported). On 07-DEC-2012, the patient was vaccinated with the second dose of GARDASIL (Subcutaneous injection) (lot # and dose not reported). No adverse effects were reported. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Dyspnoea, Herpes zoster, Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a 54 year old female patient with penicillin allergy and no pertinent medical history and no drug reactions or allergies refers to herself. On 07-DEC-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H011331, exp date 20-SEP-2013) in the upper left arm for shingles vaccination immediately within hours the injection site became swollen from dime to quarter size, red with bumps and circular rash. Within the next two weeks she had a breakout on stomach and cheeks. The patient contacted her physician and was told she had a mild case of Shingles. She has continued to experience nerve tingling, shortness of breath and breakouts in different areas of her body. The patient also got warm and tingling sensations. The patient was now getting back spas and having discomfort when walking. The patient's mother also reported that her daughter was administered ZOSTAVAX and had experienced a rash on her face and back and was experiencing a tingly feeling. No lab diagnostics studies were performed. Topical cream, methocarbamol, ibuprofen (manufacturer and dose not specified) was given for the patient. At the time of the report, the outcome of the events was reported as not recovered. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Paraesthesia, Rash, Skin warm
Clinical narrative: This spontaneous report as received from a 54 year old female patient with penicillin allergy and no pertinent medical history and no drug reactions or allergies refers to herself. On 07-DEC-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H011331, exp date 20-SEP-2013) in the upper left arm for shingles vaccination immediately within hours the injection site became swollen from dime to quarter size, red with bumps and circular rash. Within the next two weeks she had a breakout on stomach and cheeks. The patient contacted her physician and was told she had a mild case of Shingles. She has continued to experience nerve tingling, shortness of breath and breakouts in different areas of her body. The patient also got warm and tingling sensations. The patient was now getting back spas and having discomfort when walking. The patient's mother also reported that her daughter was administered ZOSTAVAX and had experienced a rash on her face and back and was experiencing a tingly feeling. No lab diagnostics studies were performed. Topical cream, methocarbamol, ibuprofen (manufacturer and dose not specified) was given for the patient. At the time of the report, the outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) for prophylaxis of chickenpox (dose, route, site of administration and lot # not reported). On an unknown date the patient developed shingles. It was unknown if the patient sought medical attention. The outcome of shingles is unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician who stated that an unspecified amount of MMR II that was unsupported due to a temperature excursion, may have been administered to an unspecified number of patients. The temperature excursion occurred in December of 2012 and an unknown number of patients may had been affected. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Generalized macular papular rash in the trunk region 6 hours after administration of KINRIX & PROQUAD and Influenza.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Pt states redness, warm and inflamed at injection site.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Fall, Headache, Hip fracture, Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a 89 year old female patient regarding herself. The patient has high blood pressure and kidney problems. The patient's medical history included shingles (reported as 5 years ago). On an unknown date in 2010 (reported as 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient stated that she fell and broke her hip, but could not be real specific about whether she broke her hip before or after getting ZOSTAVAX. The patient stated that she still had tremendous pain and scratching in her head, her left eye and forehead. Her physician diagnosed her with having PHN (post herpetic neuralgia). She had tried many forms of pain management as a treatment and nothing had worked. She also stated that gabapentin (manufacturer unspecified) did not work for her. At the time of this report the patient had not recovered from the reported events. The patient sought medical attention (was seen by HCP). Upon internal review the event of she fell and broke her hip was considered to be medically significant. Additional information is not expected.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a 89 year old female patient regarding herself. The patient has high blood pressure and kidney problems. The patient's medical history included shingles (reported as 5 years ago). On an unknown date in 2010 (reported as 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient stated that she fell and broke her hip, but could not be real specific about whether she broke her hip before or after getting ZOSTAVAX. The patient stated that she still had tremendous pain and scratching in her head, her left eye and forehead. Her physician diagnosed her with having PHN (post herpetic neuralgia). She had tried many forms of pain management as a treatment and nothing had worked. She also stated that gabapentin (manufacturer unspecified) did not work for her. At the time of this report the patient had not recovered from the reported events. The patient sought medical attention (was seen by HCP). Upon internal review the event of she fell and broke her hip was considered to be medically significant. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Joint effusion, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: Mother of pt report that several days after her shot - she developed pain in her knee generally in Rt knee pain. Also developed ? arthralgia origin undetermined. Has improved. Some occasional pain in joints.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcus test negative, X-ray limb abnormal
Clinical narrative: Mother of pt report that several days after her shot - she developed pain in her knee generally in Rt knee pain. Also developed ? arthralgia origin undetermined. Has improved. Some occasional pain in joints.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 41 year old female patient. On an unknown date a pharmacist administered to the patient ZOSTAVAX, 19400 PUF, 0.65 ml (lot number no reported) subcutaneous in the abdomen. There are no adverse events reported at this time. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age with no known allergies. On 29-AUG-2012 at 15:48 PM, the patient was vaccinated with the first dose of PNEUMOVAX23 IM, lot # H013581 the right deltoid (dose not reported). On 29-AUG-2012, the patient experienced local reaction - pain, swelling and redness. During the call the evaluate it was stated that signs and symptoms were improving. The outcome of the adverse events was reported as recovered/resolved on an unknown date. This is one of several reports from the same source (MARRS # 1211USA001592, 1211USA001593, 1210USA013157, 1302USA012880). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients. On unknown dates the patient was vaccinated with ZOSTAVAX 0.5 ml (lot # not reported). The patients had developed shingles at an unspecified amount of time after receiving vaccination. The patients visited physician's office for medical attention. The outcome of shingles was unknown. VZV packet faxed to physician. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cancer
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 19 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (strength, dose and frequency not provided). The patient was diagnosed with ovarian cancer while on GARDASIL. The patient was not given treatment for AE. The patient had not sought medical attention. The outcome of ovarian cancer was unknown. Therapy was not discontinued (also reported that the therapy was not reintroduced). Ovarian cancer was considered to be an other important clinical event. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: This spontaneous report as received from a 74 year old female patient with high cholesterol and thyroid refers to herself. The patient had no drug reactions/allergies. In 2010 the patient was vaccinated with ZOSTAVAX (subcutaneous, 1 time vaccine, lot # was unknown). Concomitant therapies included acyclovir, prednisone and "symbastin(20 mg per day)". In March 2011 the patient got shingles in her left eye. The outcome of event was unknown. The patient sought medical attention and received treatment of timelaw pressure drop for eye. No lab diagnosis studies performed. Additional information has been requested.
Age: 1.79
Sex: U
Vaccine: DTAP, HIBV, PNC
Symptoms: Abasia, White blood cell count increased
Clinical narrative: Patient received DTaP #4, Hib #4, PREVNAR #4 on 3/4/13 and after vaccinations pt is not able to walk.
Age: 0.62
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was to receive Hep B vaccine (2nd dose) but received Hep A vaccine, Nurse pulled wrong vaccine by mistake.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to her 6 year old grandson. On an unknown date the patient was vaccinated with the second dose of VARIVAX 0.5 ml, subcutaneous. Lot# was unspecified. On an unknown date, after receiving VARIVAX (merck) the patient developed "chicken pox some time after receiving the vaccine but it was a mild case." Within a year, he also ended up having a small patch of shingles on an unspecified area of his arm. There was not any lab study. The patient was recovered from events on unspecified date. The patient just sought medical attention from the reporting nurse. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Dyspnoea, Nausea
Clinical narrative: Shortness of breath, stomach cramps, diarrhea/nausea.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 04-MAR-2013, the patient was vaccinated with an expired dose of ZOSTAVAX, (lot number reported as 1599AA, expiry date 13-JAN-2013). No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that the patient received ZOSTAVAX (lot#H017447, expiration date 20-DEC-2013, route of administration not reported) on 13-FEB-2013 that was reconstituted with expired sterile diluent (lot#6008Y, expiration date September 2011). ZOSTAVAX was not expired only the sterile diluent used to reconstitute the ZOSTAVAX. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a consumer refers to multiple patients of unknown age and gender. On an unknown date, the patients was vaccinated with ZOSTAVAX(dose, route, frequency and lot not reported). On an unknown date, people suffering horrible side effects. The outcome of the event was unknown. The reporter considered the event to be related to ZOSTAVAX. This is one report of several reports from the same source (MARRS#1302USA009042). Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old female patient. On 19-MAR-2012 the patient was vaccinated with dose 3, GARDASIL (lot#, expiration date and route not reported). On 21-OCT-2011, the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). On 16-JAN-2012, the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date and route not reported). No adverse effect was observed or reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Menorrhagia, Polymenorrhoea
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL, .5 ml for prophylaxis. The dose number, lot number, expiry date, route of administration and anatomical location were not reported. On an unknown date the patient experienced more frequent periods, the patient menstruated every two weeks. Prior to the vaccination with GARDASIL, the patient menstruated on a monthly basis. Furthermore the patient experienced that her periods were heavier, requiring more tampons, and the patients experienced more cramping. The outcome of more frequent periods, heavier period sand more cramping is unknown. The relatedness was not reported for any of the events for GARDASIL. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Lymphadenopathy, Mobility decreased, Neck pain, Pain
Clinical narrative: Swollen lymph nodes in right armpit and left side of neck, pain when lifting right arm, unable to turn head due to pain in neck.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Patient has had a number seizures since receiving this vaccine.  He never had seizures or medical problems before the vaccine.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever, followed by severe arm pain and redness at injection site.  Arm pain increased in 72 hrs followed by erythema at site and streaking on arm into axillary surface.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning an unspecified number of patients who on unknown dates received an unspecified number of doses of VARIVAX (merck) that were possible stored improperly. The electronic freezer temperature monitor was unable to produce freeze temperature range. No adverse events were reported. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 month old patient. On 28-FEB-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (route and lot # not reported). No symptoms were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Client reported itching approximately 15-20 minutes after Tdap vaccine. Hives appeared on trunk & arms. No facial swelling, no SOB. Gave client BENADRYL 25 mg PO. Client showed improvement 30 minutes later. Cetirizine 10 mg daily. To ER for T sxs or severe sxs.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Erythema, Immediate post-injection reaction, Injection site discolouration, Injection site warmth
Clinical narrative: Crying incontrollable, both legs turned purple, Hot to touch, feet turned red. Immediately after last shot given (PCV13), mild inspiration stridor, noted by Dr., which was ordered SOLUMEDROL 10 mg IM x 1 O2 100%, HR 137 via toe.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Stridor
Clinical narrative: Crying incontrollable, both legs turned purple, Hot to touch, feet turned red. Immediately after last shot given (PCV13), mild inspiration stridor, noted by Dr., which was ordered SOLUMEDROL 10 mg IM x 1 O2 100%, HR 137 via toe.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: Patient's mother said everything was fine, he didn't get any symptoms or got sick.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain
Clinical narrative: Having pain on the lt side of the body after getting Tdap and flu shot.
Age: 35.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: SPLOTCHY RASH FROM LEFT SIDE STERNUM TO AXILLA ALONG T4 DERMATOME.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Computerised tomogram abnormal, Computerised tomogram thorax abnormal, Eosinophil count increased, Leukocytoclastic vasculitis
Clinical narrative: Pt with onset of urticarial lesions on the evening of the injection. Initially responded slightly to antihistamines and oral steroids. Symptoms returned after cessation of steroids. Later developed respiratory symptoms and continued skin symptoms. Skin biopsy showed likely leukocytoclastic vasculitis. Chest CT with ground glass appearance. Acute elevation of peripheral eosinophil counts. Responded well to oral steroids. Skin lesions resolved. Follow up chest CT with near complete resolution of previous radiographic findings. Clinically returned to baseline health.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory disorder, Skin disorder, Skin lesion, Urticaria
Clinical narrative: Pt with onset of urticarial lesions on the evening of the injection. Initially responded slightly to antihistamines and oral steroids. Symptoms returned after cessation of steroids. Later developed respiratory symptoms and continued skin symptoms. Skin biopsy showed likely leukocytoclastic vasculitis. Chest CT with ground glass appearance. Acute elevation of peripheral eosinophil counts. Responded well to oral steroids. Skin lesions resolved. Follow up chest CT with near complete resolution of previous radiographic findings. Clinically returned to baseline health.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Burning sensation, Guillain-Barre syndrome, Influenza like illness, Skin reaction
Clinical narrative: Flu like symptoms, severe skin reaction, severe burning sensation on top and back of head.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chills, Pyrexia
Clinical narrative: Severe stomach cramping, mild fever, chills, joint aching, severe back pain.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: States she has had pain in entire R arm for several months ever since flu vaccine. Pain is worse at night. Has improved w time. No prior hx of this type of reaction to flu vaccine. No swelling. Has been having paresthesias in R hand since then as well. Heat helps. Tried Advil which helps.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Blood creatine phosphokinase increased, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: PT administered 1st dose of Anthrax & c/o pain/numbness in left arm.  Pt rated pain 8/10 and received 30mg Toradol.  Pt still has pain with lateral abduction above shoulder; pain with resistance to triceps and pain with resistance to downward pressure to outstretched left arm at 45 degrees from anterior.  Naproxen 500mg PO.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Pallor, Unresponsive to stimuli
Clinical narrative: Client seated next to nurse, HPV #2 given in left arm, IM. After injection, client stated that she thought she was going to faint. While seated, she began to fall back and was caught in arms of nurse giving injection. Mother was told that nurse would ease client to the floor, at which time client sat up and said, "did I go to sleep?". Client was unresponsive from 3-5 seconds. Cool packs applied to back and neck for about 10 minutes. Client very pale and stated she was hungry. She ate an apple and the color returned to her face. Client observed for 15 more minutes.
Age: 0.28
Sex: M
Vaccine: DTP, OPV
Symptoms: Convulsion, Crying, Disability, Head circumference abnormal, Nervous system disorder
Clinical narrative: Fever over 103 degrees F. Very unusual crying and seizing for 5 hours. Head/skull doubled in size (from normal size) within one week. In shock for several days after the whole-cell DPT vaccine of January 7, 1987. Was never a normal baby or human being after administration of this vaccine.
Age: 0.28
Sex: M
Vaccine: DTP, OPV
Symptoms: Pyrexia, Shock
Clinical narrative: Fever over 103 degrees F. Very unusual crying and seizing for 5 hours. Head/skull doubled in size (from normal size) within one week. In shock for several days after the whole-cell DPT vaccine of January 7, 1987. Was never a normal baby or human being after administration of this vaccine.
Age: 43.0
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: The morning after vaccine noted reddened rash on both arm. The Lt arm rash was a little worst Client did not do any treatment or call her MD. Rash is slowly clearing as of 3/6/12.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Computerised tomogram, Dizziness, Electrocardiogram normal, Electromyogram abnormal
Clinical narrative: Friday night feet started going numb as walking, Sat am couldn't bear weight on legs, progressively became worse, then Sunday hands went numb.  Mon AM - went to chiropractor, then after adjusting was encourgaged to go to hospital if get worse.  At work that day became worse, dizzy, dilated pupils.  Went to urgent care - EKG was normal.  Transfered to ER, did full workup and admitted to hospital, neurologist diagnosed Guillain-Barre on Tuesday night after EMG tests.  Started on IVIG Tuesday night, received another dose on Wednesday, Thursday had horrid headache - determined reaction to IVIG.  Neurology noted improvement on Friday and cleared to go home.  Did not receive more than 2 doses of IVIG.  Did not require plasmapheresis.  Sent home on Friday and slowly recovering at home.  Numbness is resolving.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Immunoglobulin therapy, Mydriasis
Clinical narrative: Friday night feet started going numb as walking, Sat am couldn't bear weight on legs, progressively became worse, then Sunday hands went numb.  Mon AM - went to chiropractor, then after adjusting was encourgaged to go to hospital if get worse.  At work that day became worse, dizzy, dilated pupils.  Went to urgent care - EKG was normal.  Transfered to ER, did full workup and admitted to hospital, neurologist diagnosed Guillain-Barre on Tuesday night after EMG tests.  Started on IVIG Tuesday night, received another dose on Wednesday, Thursday had horrid headache - determined reaction to IVIG.  Neurology noted improvement on Friday and cleared to go home.  Did not receive more than 2 doses of IVIG.  Did not require plasmapheresis.  Sent home on Friday and slowly recovering at home.  Numbness is resolving.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Weight bearing difficulty
Clinical narrative: Friday night feet started going numb as walking, Sat am couldn't bear weight on legs, progressively became worse, then Sunday hands went numb.  Mon AM - went to chiropractor, then after adjusting was encourgaged to go to hospital if get worse.  At work that day became worse, dizzy, dilated pupils.  Went to urgent care - EKG was normal.  Transfered to ER, did full workup and admitted to hospital, neurologist diagnosed Guillain-Barre on Tuesday night after EMG tests.  Started on IVIG Tuesday night, received another dose on Wednesday, Thursday had horrid headache - determined reaction to IVIG.  Neurology noted improvement on Friday and cleared to go home.  Did not receive more than 2 doses of IVIG.  Did not require plasmapheresis.  Sent home on Friday and slowly recovering at home.  Numbness is resolving.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe pain in the left arm just below injection site with substantial swelling in the bicep area down to the left elbow. Also large area reddened.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Electrocardiogram abnormal, Intensive care, Myopericarditis
Clinical narrative: Shortness of breath x 12hrs, chest pain x 5-6 hrs.  Transferred to Hospital where he was asymptomatic.  Troponin peaked at 12 with EKG changes suggestive of pericarditis.  Diagnosed with myopericarditis likely secondary to smallpox vaccine.  Admitted to ICU, then evacuated to another hospital the following morning on first available flight.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin increased
Clinical narrative: Shortness of breath x 12hrs, chest pain x 5-6 hrs.  Transferred to Hospital where he was asymptomatic.  Troponin peaked at 12 with EKG changes suggestive of pericarditis.  Diagnosed with myopericarditis likely secondary to smallpox vaccine.  Admitted to ICU, then evacuated to another hospital the following morning on first available flight.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Asthenia, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, C-reactive protein normal, Chest X-ray normal
Clinical narrative: Shortness of breath x 12hrs, chest pain x 5-6 hrs.  Transferred to Hospital where he was asymptomatic.  Troponin peaked at 12 with EKG changes suggestive of pericarditis.  Diagnosed with myopericarditis likely secondary to smallpox vaccine.  Admitted to ICU, then evacuated to another hospital the following morning on first available flight.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest discomfort, Chest pain, Chills, Dyspnoea, Echocardiogram normal
Clinical narrative: Shortness of breath x 12hrs, chest pain x 5-6 hrs.  Transferred to Hospital where he was asymptomatic.  Troponin peaked at 12 with EKG changes suggestive of pericarditis.  Diagnosed with myopericarditis likely secondary to smallpox vaccine.  Admitted to ICU, then evacuated to another hospital the following morning on first available flight.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram T wave inversion, Fatigue, Haematocrit decreased
Clinical narrative: Shortness of breath x 12hrs, chest pain x 5-6 hrs.  Transferred to Hospital where he was asymptomatic.  Troponin peaked at 12 with EKG changes suggestive of pericarditis.  Diagnosed with myopericarditis likely secondary to smallpox vaccine.  Admitted to ICU, then evacuated to another hospital the following morning on first available flight.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Haemoglobin decreased, Myocarditis, Pericardial effusion, Platelet count normal, Red blood cell count decreased
Clinical narrative: Shortness of breath x 12hrs, chest pain x 5-6 hrs.  Transferred to Hospital where he was asymptomatic.  Troponin peaked at 12 with EKG changes suggestive of pericarditis.  Diagnosed with myopericarditis likely secondary to smallpox vaccine.  Admitted to ICU, then evacuated to another hospital the following morning on first available flight.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin I increased, Troponin T normal, White blood cell count increased
Clinical narrative: Shortness of breath x 12hrs, chest pain x 5-6 hrs.  Transferred to Hospital where he was asymptomatic.  Troponin peaked at 12 with EKG changes suggestive of pericarditis.  Diagnosed with myopericarditis likely secondary to smallpox vaccine.  Admitted to ICU, then evacuated to another hospital the following morning on first available flight.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase normal, Chest pain, Chills, Dyspnoea
Clinical narrative: Shortness of breath x 12hrs, chest pain x 5-6 hrs.  Transferred to Hospital where he was asymptomatic.  Troponin peaked at 12 with EKG changes suggestive of pericarditis.  Diagnosed with myopericarditis likely secondary to smallpox vaccine.  Admitted to ICU, then evacuated to another hospital the following morning on first available flight.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram ST segment elevation, Troponin I increased
Clinical narrative: Shortness of breath x 12hrs, chest pain x 5-6 hrs.  Transferred to Hospital where he was asymptomatic.  Troponin peaked at 12 with EKG changes suggestive of pericarditis.  Diagnosed with myopericarditis likely secondary to smallpox vaccine.  Admitted to ICU, then evacuated to another hospital the following morning on first available flight.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
Clinical narrative: Shortness of breath x 12hrs, chest pain x 5-6 hrs.  Transferred to Hospital where he was asymptomatic.  Troponin peaked at 12 with EKG changes suggestive of pericarditis.  Diagnosed with myopericarditis likely secondary to smallpox vaccine.  Admitted to ICU, then evacuated to another hospital the following morning on first available flight.
Age: 70.0
Sex: M
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Very sore area where shot was administered. Left arm and shoulder. Could not put any pressure on shoulder, sleep on it, or move left arm very well.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Became very tired, dizzy, and muscle aches. Sight of injection was very sore, swollen and increase red area on arm.  Took Motrin and sent to bed and slept all night and the next day.  Slight temperature the next day and continued feeling of tiredness and muscle aching.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Became very tired, dizzy, and muscle aches. Sight of injection was very sore, swollen and increase red area on arm.  Took Motrin and sent to bed and slept all night and the next day.  Slight temperature the next day and continued feeling of tiredness and muscle aching.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Bone pain, Pain, Pain in extremity
Clinical narrative: Patient is complaining about pain in the administered arm since the day after it was given. The pain is there when he moves his arm but not when there is no movement, and it feels like it is in the bone. The pain started 1/14/2013 to date 03/06/2013. Patient does not have a primary care physician and has not been evaluated professionaly.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: It's been over a month and the injection site is still sore and bothering me.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chills, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging
Clinical narrative: Pain and later swelling at injection site.  Later fever and chills around 10:00 PM.  Very intense back pain began around midnight lasting a few hours disrupting sleep, improved by 4:00 Am on 03-06-2013, finally allowing sleep.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pain and later swelling at injection site.  Later fever and chills around 10:00 PM.  Very intense back pain began around midnight lasting a few hours disrupting sleep, improved by 4:00 Am on 03-06-2013, finally allowing sleep.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Constant pain at the site of vaccine (left arm). The pain varies each day.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Throat tightness
Clinical narrative: This spontaneous report as received from an office medical assistant via company representative referring a 40 year old female patient, who on 27-FEB-2013, was vaccinated with a dose of M-M-R II, (dose, route of administration and lot # not reported). Office medical assistant informed the company representative that on 27-FEB-2013, the patient started itching and then her throat started to close up after receiving a dose of M-M-R II from another clinic location. Reporter stated that the patient went to their practice for an office visit and they assessed and corrected the situation and the events improved. The patient said that she had a similar type of response at a past (unspecified) time with PNEUMOVAX23. Started itching and then her throat started to close up were considered serious events due to a potentially life threatening by the reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a physician refers to an approximately 63 year old female patient. On 20-FEB-2013, the patient was vaccinated with ZOSTAVAX (Lot #, dose, route and indication were not reported). Physician reported that a patient was vaccinated with ZOSTAVAX and three days after vaccination, on 23-FEB-2013, the patient developed shingles and developed pain on her right torso along a dermatoma. The patient sought medical attention in office. The patient was treated with LIDODERM PATCH, VICODIN and NSAID. The outcome of shingles and pain on her right torso along a dermatoma was unknown. The relation between medication and events was unknown. The relation between medication and events was unknown. Additional information has been requested.
Age: 0.32
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX vaccine was given to pt. at 3 mos of age and indicated for 4-6 yrs.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# not reported). On an unknown date while on ZOSTAVAX, the unspecified patient developed shingles. The outcome of the event was unknown. The relatedness for the event with the therapy was not provided. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Faecal volume increased, Pyrexia
Clinical narrative: Diarrhea developed 1 day after immunizations given. Large volume watery stools with no vomiting. Fever to 101 x 24 hours. Not dehydrated.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Local swelling, Rash
Clinical narrative: No fever, localized redness & swelling with "dots" around area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Localized reaction, red & swollen. No fever.
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, Mumps antibody test negative, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a female patient who is a staff member, of unknown age. On an unknown date many years ago the patient was vaccinated with dose 1 M-M-R II (lot#, expiration date and route not reported). Patient did not have documentation of receiving first dose of M-M-R II. Approximately on an unknown date in 2013 (reported as couple weeks ago) the staff members titer levels were measured and she was found to have a negative mumps titer. Pharmacist reported that dose 2 of M-M-R II (lot#, expiration date 12-AUG-2012 and route not reported) was administered to her because of the negative mumps titer but the dose of M-M-R II was expired. No symptoms reported. No other details. Outcome of the reported event was unknown. No treatment was given for the event. Patient sought an unspecified medical attention. Causality was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Ear pain, Eczema, Headache, Insomnia
Clinical narrative: This spontaneous report as received from a consumer refers to a 61 years old female patient with drug allergy to CYRPON. On 06-DEC-2012 the patient was subcutaneously vaccinated with ZOSTAVAX (dose and lot number not reported). No other co-suspect products were reported. Concomitant therapies included FLONASE, ZYRTEC and ZANTAC. On 06-DEC-2012, the patient had gotten eczema, nasal wheezing, headache, throat closing, dizziness, stabbing pain in left ear and insomnia. On 06-DEC-2012, she had gotten hives, but this she stated was not shingles and she also had swollen lymph nodes. PULMICORT inhaler, steroid creme were given as treatment for the adverse events. There were no laboratory diagnostics studies performed. She was referred to her doctor. The outcome of eczema, nasal wheezing, headache, swollen lymph nodes, hives, insomnia, stabbing pain in left ear, dizziness, throat closing and eczema was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Throat tightness, Urticaria, Wheezing
Clinical narrative: This spontaneous report as received from a consumer refers to a 61 years old female patient with drug allergy to CYRPON. On 06-DEC-2012 the patient was subcutaneously vaccinated with ZOSTAVAX (dose and lot number not reported). No other co-suspect products were reported. Concomitant therapies included FLONASE, ZYRTEC and ZANTAC. On 06-DEC-2012, the patient had gotten eczema, nasal wheezing, headache, throat closing, dizziness, stabbing pain in left ear and insomnia. On 06-DEC-2012, she had gotten hives, but this she stated was not shingles and she also had swollen lymph nodes. PULMICORT inhaler, steroid creme were given as treatment for the adverse events. There were no laboratory diagnostics studies performed. She was referred to her doctor. The outcome of eczema, nasal wheezing, headache, swollen lymph nodes, hives, insomnia, stabbing pain in left ear, dizziness, throat closing and eczema was unknown. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site streaking, Injection site warmth
Clinical narrative: Pt received Dtap (L) deltoid on 2/25/13. Patient c/o redness / swelling / itching that worsened on 2/27/13. On exam 2/27/13 skin on (L) upper arm with large area of warmth, erythema with puncture seen at upper pole, approx 10 x 8 cm nontender minimal streaking (border down) Dx cellulitis Rx clindamycin 150 mg TID x 10 days. Reexamined 3/1/13 with faint area of erythema, no extension of redness, no induration or tenderness.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pruritus, Swelling
Clinical narrative: Pt received Dtap (L) deltoid on 2/25/13. Patient c/o redness / swelling / itching that worsened on 2/27/13. On exam 2/27/13 skin on (L) upper arm with large area of warmth, erythema with puncture seen at upper pole, approx 10 x 8 cm nontender minimal streaking (border down) Dx cellulitis Rx clindamycin 150 mg TID x 10 days. Reexamined 3/1/13 with faint area of erythema, no extension of redness, no induration or tenderness.