chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Eye irritation
Clinical narrative: This spontaneous report as received from a unknown age pharmacist refers to himself. Pharmacist stated on 09-APR-2013 while pulling the syringe back before administering ZOSTAVAX he thought a drop of ZOSTAVAX may have splashed in his right eye. Pharmacist stated he was wearing eye glasses at the time and was unsure if it was sweat or the vaccine. However, pharmacist confirmed the client got the full recommended dose of the ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. No immediate symptoms but pharmacist stated now he may had some burning in his right eye. Pharmacist stated he did not flush his eye at time of occurrence. The pharmacist did not seek medical attention. The outcome and action taken were not provided. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. On 08-APR-2013 the patient was vaccinated with an expired dose of ROTATEQ (lot # 0886AA, exp: 23-NOV-2012), 2 ml orally (third dose in series). Medical assistant reported that the first 2 ml dose of ROTATEQ was given orally on 11-OCT-2012 and second 2 ml doe of ROTATEQ was given orally on 08-JAN-2013. No adverse effect reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Chest discomfort, Dizziness, Facial pain, Headache
Clinical narrative: Headache, facial pain after 1.30 hrs. Itching - 6 hrs lips swelling, headache, abd pain, dizziness, chest heavy - 18 hours. No reaction at injection site.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Pruritus
Clinical narrative: Headache, facial pain after 1.30 hrs. Itching - 6 hrs lips swelling, headache, abd pain, dizziness, chest heavy - 18 hours. No reaction at injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. The reporter stated that, he heard that a patient who was administered with ZOSTAVAX may have developed cellulitis (date unspecified). The patient sought an unspecified medical attention. It was unspecified if any treatment was provided or if any lab test were performed. The outcome of cellulitis was unknown. The relatedness for cellulitis was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning to a patient of unknown age and gender. On 27-FEB-2013 the patient was vaccinated with a dose of M-M-R II (lot number H013041, expiration date 17-JUL-2014) (dose and route not reported). The vaccine administered was improperly stored, was exposed to 66F since 21-JAN-2013. No adverse effect reported. This case is linked to the following MARRS cases: 1304USA007561, 1304USA008124, 1304USA008125, 1304USA008126, 1304USA008128. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Malaise, Nausea, Rash generalised
Clinical narrative: Pt reports she broke out in a rash all over and felt nauseated, she states she stayed home from school the next day due to still not feeling well.  Pt is in school today with no symptoms.
Age: 39.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site rash, Pain, Rash
Clinical narrative: CLIENT EXPERIENCED PAIN AND RASH COVERING CHEST AND LEFT ARM OF INJECTION SITE.  CLIENT WAS TOLD TO TAKE IBUPROFEN AND BENADRYL AS NEEDED.  RECOVERED AFTER TWO DAYS.
Age: 53.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site pain
Clinical narrative: Pain for injection site up arm to neck started appr 1 hr after injection. In am 4/17 severe headache not responding to Tylenol.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Mucosal dryness, Syncope
Clinical narrative: Pt received Meningitis injection and fainted following administration. Pt stated hadn't eaten since night before and is afraid of shots. Pt had dry mucous membranes. Pt was laid on floor, pt awoke. Juice and crackers given. Pt was sat up and then stood without difficulty. Vital signs were stable. Pt ate sandwich and stated he was feeling much better. Pt ambulated without difficulty under care of mother.  4/17/13: Spoke with Dad, stated pt took nap yesterday afternoon and then felt better. Pt attended baseball practice last night. Pt attended school this morning and stated he was feeling fine. No further treatment needed.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site haematoma, Injection site oedema
Clinical narrative: Erythema of right thigh as well as mild edema and hematoma present.
Age: 1.06
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Condition aggravated, Cough, Croup infectious, Respiratory tract infection, Urticaria
Clinical narrative: Hives the next day, then vomiting x 2-3 days 2 days after shots. Also had "viral" symptoms including congestion, croupy cough.
Age: 1.06
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Viral infection, Vomiting
Clinical narrative: Hives the next day, then vomiting x 2-3 days 2 days after shots. Also had "viral" symptoms including congestion, croupy cough.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Erythema
Clinical narrative: Approximately 8-10 hours after vaccination, patient developed erythema that enlarged to approximately 5 cm in diameter over the next 24 hours.  Area was approximately 4-5 cm lower than injection site and on the anterior portion of the arm.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: My son had fever the night of 4/14/13 thru the evening of 4/16/13, for about 48 hours, approximately 10 days after the shot was given. He also had a large swelling at the site of the vaccination along with redness.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site swelling, Oedema peripheral, Pruritus
Clinical narrative: On 4/1/13, the patient stated her arm was red, swollen, & itchy.  Patient presented to the ER on 4/8/13 with same complaints. Area of inject site noted to be "softball sized."  Patient was given hydroxyzine and oral antibiotics, as the ER physician thought that it was an allergic reaction and/or cellulitis.
Age: 0.48
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Irritability, Pyrexia, Rash generalised
Clinical narrative: Child got 6 month shots and had fever to 101 and a generalized rash with fussy.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Site of injection swell up - patient BENADRYL. The site is back down to normal.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Cogwheel rigidity, Gait disturbance, Masked facies, Muscle rigidity
Clinical narrative: Unsteady gait, weakness, rigidity, tremors, mild cog wheeling, mask like facies.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Neutrophil count increased, Tremor, White blood cell count increased
Clinical narrative: Unsteady gait, weakness, rigidity, tremors, mild cog wheeling, mask like facies.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt awoke with redness, swelling and warmth of the arm where injection was given. Had fevers and chills that same night. No temp. taken.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Left shoulder pain and arm decreased ROM/weakness.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, IPV, PPV, RV5
Symptoms: Diarrhoea
Clinical narrative: Persistent severe diarrhea that lasted 8 days.
Age: 30.0
Sex: M
Vaccine: TTOX
Symptoms: Oropharyngeal pain
Clinical narrative: Donor states that one hour after the immunization he had a sore throat. Denies any other s/s and state that it was gone by the morning.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Amnesia, Chills, Confusional state, Fatigue, Injection site swelling
Clinical narrative: Swelling at the site of (R) injection and fatigue and chills. So tired and husband noticed personality changes, memory loss and confusion and she slept deeply for several hours and got better in 18 hours.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Personality change, Somnolence
Clinical narrative: Swelling at the site of (R) injection and fatigue and chills. So tired and husband noticed personality changes, memory loss and confusion and she slept deeply for several hours and got better in 18 hours.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: (L) arm with 10x11 cm area erythema with induration and tenderness in upper arm. (and bruise in lower arm).
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Localized adverse reaction at site of immunization. No difficulty breathing. Area of reaction is hot, with erythema, indurated 9.0 cm x 9.5 cm on (R) deltoid. Area is sore and itchy. Feels sleepy. Ice applied. Verbalized relief.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local reaction, Somnolence
Clinical narrative: Localized adverse reaction at site of immunization. No difficulty breathing. Area of reaction is hot, with erythema, indurated 9.0 cm x 9.5 cm on (R) deltoid. Area is sore and itchy. Feels sleepy. Ice applied. Verbalized relief.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: About 5 hr after IZ started with tenderness, sl swelling to injection site. Today approximately 10 cm raised, pink, tender injection site reaction. No s/s secondary infection.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, pain and fever 24 hours post inj. No treatment given. Referred to physician for evaluation (his PCP).
Age: 1.04
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Generalised erythema, Rash generalised
Clinical narrative: Generalized erythematous diffuse exanthem.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Gait disturbance, Hypoaesthesia, Motor dysfunction, Nerve conduction studies
Clinical narrative: Intense pain and numbness in both feet and hands, impaired walking, motor control and balance, rapid weight loss. Continuing. Treatment: Physical therapy.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Weight decreased
Clinical narrative: Intense pain and numbness in both feet and hands, impaired walking, motor control and balance, rapid weight loss. Continuing. Treatment: Physical therapy.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling soon after at site of injection yesterday. This a.m. mom noticed left arm swollen and pink at exam moderate edema, non-pithing and pink erythema, warm to touch, mildly tender from (L) elbow to (L) superior shoulder, 21 cm circumferential T 100.3. 4/4/13 improving gradually. 4/9/13 completely resolved.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warmth over right deltoid where PREVNAR 13 vaccine was given yesterday.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever x 2 day, red raised rash x 4 days.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count normal, Headache, Metabolic function test normal, Urine analysis normal, Vomiting
Clinical narrative: Headache started approximately 1 hr after Tdap. Vomiting started approximately 12 hours post injection.
Age: 10.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Positive redness/swelling (L) SQ site ((L) arm).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at site with lingering symptoms since 3/12/13 when injection given.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from a health care worker refers to a 37 year old female patient with no drug reactions or allergies. Pertinent medical history was none. On 20-FEB-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot number was reported as H04196, expiry date was 19-MAR-2014, dose was not reported), subcutaneously. Concomitant medical history was none. On 22-FEB-2013, the patient was seen in an unspecified emergency room due to severe pain in the injection site and fever. No laboratory test was performed. The patient was diagnosed with cellulitis at the injection site and was prescribed BENADRYL, BACTRIM and VINCODIN and was sent home. Patient sought medical attention and again on the 22-MAR-2013, the patient was seen in the physician's office and was prescribed KEFLEX and prednisone. Approximately on an unknown date in 2013, the event of cellulitis at the injection site was recovered/resolved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Adverse drug reaction, Arthralgia, Blood test abnormal, Dry mouth, Electroencephalogram
Clinical narrative: This spontaneous report was received from an approximately 66 year old female patient with arthritis regarding herself. The patient had no drug reactions or allergies. On an unknown date in March 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). The patient was given pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot number, expiry date, dose and route unspecified) around the same time as the ZOSTAVAX (approximately in March 2011), but indicated that the vaccines were not given concomitantly. Concomitant therapy included LIPITOR. On an unknown date, the patient experienced a burning sensation in her joints shortly after receiving ZOSTAVAX, recommended by her primary care physician. She was treated with NEURONTIN by her rheumatologist which did not helped in her pain. On an unknown date in November or December 2012, her neurologist prescribed nortriptyline and her symptoms were reduced. On an unknown date in February (reported as February or March) 2012, and in the spring or summer of 2012, a physician tried treating the patient with OXYCONTIN, VOCODIN, TYLENOL with codeine, CYMBALTA and LYRICA (manufacturer unknown). None of these relieved the burning sensation, which kept her awake at night. A homeopathic practitioner diagnosed her with a possible allergic reaction to ZOSTAVAX. On an unknown date in March 2012, she stopped LIPITOR. On an unknown date electroencephalography (EEG) was performed and the result was unknown. On an unknown date, a  blood work was performed which indicated that she should go back on the LIPITOR. She stopped taking it for 4 days. She indicated that she thinks there may be a connection from when she was on LIPITOR and the severity of her burning sensation. She also stated that on Nortriptyline, she experienced dry mouth and weight gain. The patient had not recovered from neuropathy as none of the treatments relieved the symptoms. Outcome of other events was unknown. It was reported that the allergic reaction to be possibly related to ZOSTAVAX and the relatedness was unknown for pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The relatedness for all the other events was unknown for ZOSTAVAX and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Hypersensitivity, Insomnia, Neuropathy peripheral, Weight increased
Clinical narrative: This spontaneous report was received from an approximately 66 year old female patient with arthritis regarding herself. The patient had no drug reactions or allergies. On an unknown date in March 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). The patient was given pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot number, expiry date, dose and route unspecified) around the same time as the ZOSTAVAX (approximately in March 2011), but indicated that the vaccines were not given concomitantly. Concomitant therapy included LIPITOR. On an unknown date, the patient experienced a burning sensation in her joints shortly after receiving ZOSTAVAX, recommended by her primary care physician. She was treated with NEURONTIN by her rheumatologist which did not helped in her pain. On an unknown date in November or December 2012, her neurologist prescribed nortriptyline and her symptoms were reduced. On an unknown date in February (reported as February or March) 2012, and in the spring or summer of 2012, a physician tried treating the patient with OXYCONTIN, VOCODIN, TYLENOL with codeine, CYMBALTA and LYRICA (manufacturer unknown). None of these relieved the burning sensation, which kept her awake at night. A homeopathic practitioner diagnosed her with a possible allergic reaction to ZOSTAVAX. On an unknown date in March 2012, she stopped LIPITOR. On an unknown date electroencephalography (EEG) was performed and the result was unknown. On an unknown date, a  blood work was performed which indicated that she should go back on the LIPITOR. She stopped taking it for 4 days. She indicated that she thinks there may be a connection from when she was on LIPITOR and the severity of her burning sensation. She also stated that on Nortriptyline, she experienced dry mouth and weight gain. The patient had not recovered from neuropathy as none of the treatments relieved the symptoms. Outcome of other events was unknown. It was reported that the allergic reaction to be possibly related to ZOSTAVAX and the relatedness was unknown for pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The relatedness for all the other events was unknown for ZOSTAVAX and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning to a patient of unknown age and gender. On 20-FEB-2013 the patient was vaccinated with a dose of MMR II (lot number H013041, expiration date 17-JUL-2014) (dose and route not reported). The vaccine administered was improperly stored, was exposed to 66F since 21-JAN-2013. No adverse effect reported. This case is linked to the following MARRS cases: 1304USA007561, 1304USA008125, 1304USA008126, 1304USA008127, 1304USA008128. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning to a patient of unknown age and gender. On 12-MAR-2013 the patient was vaccinated with a dose of M-M-R II (lot number H013041, expiration date 17-JUL-2014) (dose and route not reported). The vaccine administered was improperly stored, was exposed to 66F since 21-JAN-2013. No adverse effect reported. This case is linked to the following MARRS cases: 1304USA007561, 1304USA008124, 1304USA008125, 1304USA008126, 1304USA008127. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: The author of a literature article reported that children receiving a HSCT from January 2010 thru October 2012 were prospectively followed. Three doses of Hep B, PCV 13, and PENTACEL were given per guidelines two months apart. Pre and post vaccine-specific antibodies and T&B cell studies were performed at 6 and 12 months post-HSCT. Time to immunization post HSCT was a median of 197 days. 2/12 subjects were chronic graft versus host disease (HVHD). One of these patients did not respond to vaccination. The author concluded that hepatitis, tetanus, and pneumococcal vaccination was immunogenic in a majority of subjects when given 6 months post HSCT. The patient outcome was not reported. 17-APR-2013: This is a correct report to add observed study type. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a 26 year old female patient. On an unknown date in 2009, when the patient was 26 years of age, the patient was vaccinated with GARDASIL dose 1. Lot number, route of administration and anatomical location were not reported. On an unknown date, the patient became pregnant and missed dose 2 and 3 of GARDASIL. In the summer of 2012, when the patient was 29 years of age, the patient was vaccinated with GARDASIL dose 2, 3 and 4. For dose 2, 3 and 4, no information was reported regarding the lot number, anatomical location and route of administration. The patient had experienced no adverse event, but was worried about her health as she received 4 doses of GARDASIL. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pt pain describes gradually increasing pain 2-3 hrs after PNEUMOVAX to injection site.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Emotional distress, Fatigue, Somnolence, Thyroid function test normal
Clinical narrative: My daughter has experienced substantial hair loss since having the GARDASIL series of immunizations. She has always had a thick beautiful head of hair and now at the age of 19 she has areas of the scalp with very little hair. It is devastating to her emotional well being. She has also experienced extreme fatigue. She never seems to get enough sleep and spends a lot of time in bed.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning to a patient of unknown age and gender. On 06-FEB-2013 the patient was vaccinated with a dose of MMR II (lot number H013041, expiration date 17-JUL-2014) (dose and route not reported). The vaccine administered was improperly stored, was exposed to 66F since 21-JAN-2013. No adverse effect reported. This case is linked to the following MARRS cases: 1304USA008124, 1304USA008126, 1304USA008127, 1304USA008128. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning to a patient of unknown age and gender. On 20-FEB-2013 the patient was vaccinated with a dose of M-M-R II (lot number H013041, expiration date 17-JUL-2014) (dose and route not reported). The vaccine administered was improperly stored, was exposed to 66F since 21-JAN-2013. No adverse effect reported. This case is linked to the following MARRS cases: 1304USA007561, 1304USA008124, 1304USA008126, 1304USA008127, 1304USA008128. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Fever on day of vaccination to hive rash on trunk and back day after vaccination. No anaphylaxis reaction/no shock, vital signs stable.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 year old male patient with high blood pressure. On 10-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # J000435, expiry date: 10-APR-2014) subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown). On 10-APR-2013, the patient experienced numbness and tingling in his left hand fourth and fifth fingers. The patient went for an office visit. No treatments were given. No lab tests were performed. At the time of reporting the patient had not recovered from numbness and tingling in his left hand fourth and fifth fingers. Causality assessment was not provided. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site necrosis, Injection site reaction, Skin disorder
Clinical narrative: Hypopigmented area just above the knee with fat necrosis under the skin causing dimpling.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Demyelination, Hypoaesthesia, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Numbness (L) face, arm, side, & leg.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Demyelination, Hypoaesthesia, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Numbness (L) face, arm, side, & leg.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a 70 year old female patient. Patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route and duration were unspecified) on an unknown date "sometime in the past" and developed shingles around 15-MAR-2013. Patient had sought medical attention via pharmacy visit and unspecified treatment was given for the event. The outcome of shingles and drug relationship were unknown. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Erythema
Clinical narrative: Patient presents to clinic on 4-18-13 with red area to (R) arm - approximately 1" x 4" that appeared on 4-15-13. Pt denies nausea, trouble breathing or fever, has not used any OTC medicines. Referred to MD of choice if worsen or persists.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: With 1-2 hours of Dtap vaccine in (L) upper thigh, redness warm and swelling began and seemed to spread down entire (L) thigh to (L) knee. The area was warm and tender. KEFLEX prescribed on day 9 with no improvement after 3 days of antibiotic. Swelling, redness and tenderness began to go down and only mild bruising on day 28.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Patient was recently adopted, she has HIV and was here to receive vaccines. Per our infectious disease dept, she was supposed to receive Tdap, flu, PREVNAR and MMR. The nurse gave KINRIX instead. Patient had no known adverse reaction to this vaccine.
Age: 72.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: No effects - reporting only. 4-17-13 I diluted the ZOSTAVAX vaccine w/ BOOSTRIX by mistake and gave injection Sub Q. I informed patient immediately and began making calls Merck Glaxo CDC FDA.
Age: 77.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: No effects- reporting only. 4-17-13 I diluted the ZOSTAVAX vaccine w/Tdap (BOOSTRIX) by mistake and gave injection sub q. I informed patient immediately and began called for advise. Merck Glaxo CDC FDA.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood creatine phosphokinase normal, Full blood count normal, Injection site joint pain, Injection site pain, Red blood cell sedimentation rate normal
Clinical narrative: "Immense" pain at time of Tdap injection and patient with continued left shoulder joint pain 25 days later.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity, Product quality issue
Clinical narrative: "Immense" pain at time of Tdap injection and patient with continued left shoulder joint pain 25 days later.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Localized red/swollen area 3cm x 5cm.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Felt like I was going to pass out and threw up.  My neck hurts and had a low grade fever. Nauseous and have a headache. There is a rash where the injection was given. The rash is itchy, swollen, and hot.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site warmth, Nausea, Neck pain, Pyrexia, Vomiting
Clinical narrative: Felt like I was going to pass out and threw up.  My neck hurts and had a low grade fever. Nauseous and have a headache. There is a rash where the injection was given. The rash is itchy, swollen, and hot.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Paraesthesia, Vaccination site rash
Clinical narrative: The patient developed a rash 2 inches around in the vaccine site.  The patient also reports tingling from shoulder to elbow for approximately 1 week.  The patient could not straighten arm due to pain.  Patient can still feel pain upon movement.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Axillary pain, Chest pain, Injection site swelling, Injection site warmth, Nipple pain
Clinical narrative: L DELTOID AROUND VACCINE SWOLLEN AND HOT TO TOUCH; AXILLARY REGION VERY TENDER TO TOUCH, NO SUPERFICIAL AXILLARY LYMPH NODES, UNABLE TO PRESS DEEPLY DUE TO PAIN LEVEL. PAIN RADIATING TO CHEST - NIPPLE REGION.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Tenderness
Clinical narrative: L DELTOID AROUND VACCINE SWOLLEN AND HOT TO TOUCH; AXILLARY REGION VERY TENDER TO TOUCH, NO SUPERFICIAL AXILLARY LYMPH NODES, UNABLE TO PRESS DEEPLY DUE TO PAIN LEVEL. PAIN RADIATING TO CHEST - NIPPLE REGION.
Age: 18.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Red area down to elbow that is warm to touch and slightly swollen.
Age: 24.0
Sex: M
Vaccine: HPV4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Little red bumps that were very itchy the day after recieving HPV vaccine.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Heart rate increased, Pyrexia
Clinical narrative: Began running fever at 11:00 AM. Was up to 102.8 by 7 PM. Had febrile seizure. Seen at ED. Given TYLENOL/MOTRIN and monitored for elevated HR. Temp 102 (ax actual) at 9:35 AM on 4-18-13.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site swelling
Clinical narrative: Swollen leg at injection site, 24 hrs. after. Dr advised pts mother to give BENADRYL 3/4 tsp q6hrs. and cool compresses. Pt doing well and no symptoms next day.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy, hives to (R) forearm, more than 20 minutes after vaccine administration. CLARITIN 10mg oral given. Temp 98.8 degrees temporal Pulse: 60 Resp: 16 B/P: 108/62 sitting.
Age: 26.0
Sex: U
Vaccine: ANTH, YF
Symptoms: Angioedema, Dysphagia
Clinical narrative: Patient developed symptoms of angioedema within 30 min of being vaccinated. No documentation found in the medical record system.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt presents after injection with pain, redness, swelling at site. T - 99.1 degrees, P - 68, R - 16, BP - 158/72. 2 inch diameter, erythema to post. Upper (R) arm (center hard core.) MD advised and recommended ice, ibuprofen, BENADRYL. MD did not see pt. Pt scheduled OV today but canceled. Will f/u with clinic staff.
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth, Vomiting
Clinical narrative: Pt was given the Dtap injection in the left thigh on 4/2/13. Patient's mom brought him in on 4/3/13 complaining of emesis x 3-4 from 12 pm to time of visit with erythema and increased warmth at injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an office receptionist 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 ZOSTAVAX (lot#, expiration date and route unknown). On an unknown date the patient experienced developed shingles. The outcome of the reported event was unknown. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. On 06-APR-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVX (lot# and expiration date not provided), subcutaneous at an unspecified pharmacy. The patient visited the physician's office on 12-APR-2013 (also reported as today) with a rash on her neck. The rash was red but did not look like a "herpes rash" according to the physician. Physician said that rash appeared to be non-specific eczema. Physician stated that the patient would be calling with more information. The outcome of non-specific eczema is unknown. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a female consumer refers to her daughter of unknown age. The patient was vaccinated with a first and second dose of GARDASIL (Lot#, dose and route not reported) on unknown dates. The patient did not receive the third dose at the time specified in the PI. No adverse effect reported. It was not known if the patient sought medical attention. This is one of several reports received from a same reporter. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age and gender. On 11-APR-2013 the patient was vaccinated with expired ZOSTAVAX (lot # 672606/1655AA, expiration date 21-JAN-2013 and route not reported). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. On 09-APR-2013, the patient was vaccinated with an expired dose of GARDASIL (Lot # 665607/1333Y, expiration date 25-JUN-2012) (route not reported). No adverse effect was reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash, Somnolence, Vomiting
Clinical narrative: Vomiting, fever, cough and excessive sleepiness. 10 days after injection, rash 14 days after injection. RX given acetaminophen 1.2 ml infant drops q6h po PRN for fever, clear liquids.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 15-APR-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 672558/1600AA, expired date 13-JAN-2013). No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a female consumer refers to her daughter of unknown age. The patient was vaccinated with a first and second dose of GARDASIL (Lot #, dose and route not reported) on unknown dates. The patient did not receive the third dose at the time of specified in the PI. No adverse effect reported. It was not known if the patient sought medical attention. This is one of several reports received from a same reporter. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 23 year old patient. on 15-APR-2013 the patient was vaccinated with the first dose of GARDASIL (lot # 668261/1397AA; expired date 09-APR-2013) (0.5 ml once, intramuscular) for HPV prevention. No adverse effects reported. The action taken and outcome were unknown. The causality was not provided at the time of report. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: This spontaneous report as received from a physician via a nurse refers to a 13 month old male patient. There was no relevant medical history and no concomitant medication was taken. On 25-MAR-2013 the patient was vaccinated with M-M-R II lot # H011885 dose 1, 0.5 ml, subcutaneous. On 02-APR-2013, the patient experienced fever. On 04-APR-2013, the patient experienced erythema maculopapular rash. The outcome of erythema maculopapular rash and fever was unknown. The action taken regarding M-M-R II  was unknown. The reporter causality was unknown. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Breast pain, Nipple pain, Psoriasis
Clinical narrative: This spontaneous report as received from a 72 year old patient regarding himself. Patient has an allergy to opaque dye. The patient's medical history included kidney cancer surgery, kidney stones and slow stream. On 14-JAN-2013,the patient was vaccinated with ZOSTAVAX (Lot number, expiry date and route were not reported), 0.65 milliliter (ml). Other suspect therapies included finasteride (manufacturer unknown). Concomitant therapies included tamsulosin hydrochloride (reported as TAMSULOSIN) and CRESTOR. Approximately on 19-JAN-2013 (reported as 5-8 days after vaccination), the patient experienced penile psoriasis, nipple pain and breast pain. The patient stated that he was in extreme pain that was affecting his daily life from these adverse experiences. In addition, the patient had been taking finasteride (manufacturer unknown) when he had received the ZOSTAVAX shot. However, he was directed by this physician to stop taking this medication a week after having the shot because the physician thought that this is what was causing the breast pain. Though, after stopping therapy on this drug approximately on an unknown date in January 2013, it did not alleviate the breast pain. Patient sought medical attention (saw the physician) and was treated with SORIATANE for the event penile psoriasis. The events breast pain, penile psoriasis and nipple pain was reported as not recovered/not resolved. The reporter considered breast pain to be related to finasteride (manufacturer unknown). Legal issue was involved and the adverse event was seen sent to Legal team. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On an unknown date in 2013 the patients might have been vaccinated with M-M-R II 0.5 ml that was improperly stored. Lot numbers were not provided. The vaccines were exposed to 47 F for 48 hours in March 2013. No adverse effect was reported. The reporter considered an unknown number of patients might have received improperly stored MMR vaccines and no adverse effect to be not related to M-M-R II. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a pediatric patient of unknown age. On an unknown date in April-2013, the patient was inadvertently vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 15-APR-2013 the patient was vaccinated with dose 3 of GARDASIL (lot # was not reported). The reporter reported that the patient received her first 2 doses of GARDASIL (lot # was not reported) "seven years ago". No adverse effect reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Papule, Rash erythematous, Urticaria
Clinical narrative: Same day nurse notes:  After patient left room, about 10 minutes, parents returned to nurse station to show how the patient's face looked like.  Patient had few bumps, red and raised on his face.  Nurse assessment did not show any other bumps on his body or area of injections.  Patient denied itching.  No trouble breathing.  Patient was assessed by Dr. Same day provider notes:  Provider called for evaluation after vaccination on 3/29/13.  Patient was seen and evaluated soon after nurse visit for vaccinations.  Patient was feeling well but started to develop hives and red bumps on face.  Bumps raised wheals and papules.  Evaluation was performed.  Patient was in no respiratory distress.  No signs of lip swelling or edema.  Lungs were clear.  Patient was instructed to go home with careful observation.  Benadryl for the symptoms and go to hospital if he develops worsening symptoms such as respiratory distress. Third day after, nurse notes:  Talked to patient's father and stated is doing pretty good, after getting home and giving Tylenol to patient, bumps disappeared. (Disappeared same day of immunization administration.  Patient's dad said he gave Tylenol.) NIPINFO response: Hello, Thank you for your question. Unfortunately, we do not diagnose clinical scenarios. Contraindications to further vaccine doses include a severe anaphylactic reaction to a previous vaccine dose or its components. This does not appear to be the case here. Rashes at the injection site are common after inactivated vaccines within 1 or 2 days after vaccination. If there is concern of an allergic reaction, we recommend follow up with a pediatric allergist. Also consider checking for latex allergy in this patient. Whether or not a provider believes that a vaccine(s) caused a reaction, we still recommend that you make a report to VAERS. . Thanks.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Biopsy brain, Brain oedema, Cytomegalovirus test negative, Demyelination
Clinical narrative: Pt is a 49 y/o male who presented to facility for his yearly flu shot on 11/16/2012. He had received a flu shot in the previous year without incident. He presented to his PCP on 1/18/2013 with a chief complaint of visual field deficits and headache for the past 5 days. His PCP referred him to an emergent visit with the ophthalmology department. He was referred from there to the emergency department with concern for a neurological process versus an ophthalmologic one. In the ED he was extensively worked up for neurological processes and found to be negative for HIV, CMV, meningitis, MS and at this time was not experiencing nausea, vomiting, or gait disturbances. He also received a gadolinium-enhanced MRI at this time. The MRI revealed a hypodense lesion in posterior limb of the right internal capsule surrounded by slight edema, suspicious for glioma or possible cerebrovascular accident. He was admitted to the hospital for further management on 1/18 and was continually followed by neurology through to his discharge on 2/6. After further investigation it was also discovered that he had recently had symptoms consistent with an upper respiratory viral illness prior to the onset of his neurologic symptoms. The timeline of this illness is unclear per the notes but is described as "flu-like symptoms" and were present before the onset of his neurological symtoms. During his hospitalization he experienced progressive loss of his visual field as well as neurologic decompensation presenting as left-sided hemiplegia and facial droop as well as gait disturbance. On 1/25 the lesion was biopsied and he was started on dexamethasone. This biopsy revealed a demyelinating process and neurology determined that this was likely a tumefactive demyelinating lesion, more specifically acute disseminated encephalomyelitis (ADEM). This is an exceptionally rare side effect of vaccinations but it has been reported in the literature and has been associated with previous influenza vaccinations. Given the timeline of onset after administration of the vaccine, it is difficult to determine whether the vaccine or the possible viral illness was the cause of the ADEM. In correspondence between doctors it was stated that this could be related to the influenza vaccine given in November. Based on an assessment with the Naranjo scale this would be classified as a possible adverse event associated with the administration of the influenza vaccine. Pt was initially treated with dexamethasone but was switched over to a 5 day course of intravenous methylprednisolone after diagnosis of a demyelinating disorder. This was followed up with prednisone taper and aggressive physical therapy. He continues to improve per the notes and has progressed to being able to walk with a cane.