chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 11-APR-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMRV
Symptoms: Diarrhoea, Rash, Rash erythematous
Clinical narrative: Red dots on stomach and back, started 5/23/2014, had diarrhea for 2 days, Temp of 99.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Nasal congestion, Rash, Skin warm
Clinical narrative: 5/22/14 late AM received PNEUMOVAX vaccine. Was starting a call at time. By evening injection site was very sore and lasted until Sat night. Friday evening started rash - red, hot about 5 inches long by 3 inches wide - lasted 1-2 days. Remained afebrile. 5/27 - arm better now. Has heavy cold - nasal congestion.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dizziness, Electrocardiogram, Injection site erythema, Injection site pain
Clinical narrative: Dizzy, tachycardia, palpitations - HR 120-137. Sinus, joint pain, localized site erythema and pain.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations, Sinus headache, Tachycardia
Clinical narrative: Dizzy, tachycardia, palpitations - HR 120-137. Sinus, joint pain, localized site erythema and pain.
Age: 28.0
Sex: F
Vaccine: HEP, MMR, MNQ
Symptoms: Paraesthesia oral, Pruritus, Urticaria
Clinical narrative: MCV4, HepB and MMR administered. Pt voiced prior to vaccines vague hx of childhood immunizations. Pt stated mother denied reactions then voiced rash after 1 childhood vaccine. Vaccines administered minutes apart. Last vaccine MMR given to (R) arm. Approx 2 min after pt. voiced itching with hives noted to neck and below hairline to back of neck. Pt voiced lips tingling. Pt. walked to ER. Continued hives noted and anaphylaxis protocol per policy followed per ER Dr.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. No relevant medical history of the patients was reported. On 19-MAY-2014 the unspecified patients were vaccinated with 5 doses of PEDVAXHIB, intramuscularly (strength, dose, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that these vaccine doses had reached a low temperature of 32.9 Fahrenheit for 9.5 hours and were supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This case is linked to Case # 1405USA014111, Case # 1405USA014112, Case # 1405USA014113 via the same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. No relevant medical history of the patients was reported. On 19-MAY-2014, unspecified patients were vaccinated with 3 doses of ROTATEQ (strength, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that on an unknown date, these vaccine doses had reached a low temperature of 32.9 Fahrenheit for 9.5 hours and were supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This case is linked to Case # 1405USA011843, Case # 1405USA014111, Case # 1405USA014113 via the same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. No relevant medical history of the patients was reported. On 19-MAY-2014, the patients were vaccinated with 2 doses of VAQTA (strength, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that on an unknown date, these vaccine doses had reached a low temperature of 32.9 Fahrenheit for 9.5 hours and were supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This case is linked to Case # 1405USA011843, Case # 1405USA014112, Case # 1405USA014113 via the same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified numbers of patients. On an unspecified date, the patients were vaccinated with (unspecified number) VARIVAX (Merck) lot # J001181 (expiration date 31-JAN-2015), J009899 (expiration date 12-AUG-2015), J004159 (expiration date 08-APR-2015); route of administration - subcutaneous, dosage and indication were not provided. It was reported that since 05-MAR-2014 VARIVAX (Merck) was exposed to temperature above 5F. Some of the temperatures went above 8F to an unspecified temperature on unspecified dates during 43 days time-frame. Reporter stated the VARIVAX (Merck) was exposed to 16F for 44 days time-frame. Additionally, there was a 14 hour time-frame that the product was exposed to 16F. Excursion supported. These potentially improperly stored vaccines were given to an unspecified number of patients on unspecified dates. No known adverse effects were reported. Lot number J009899 is not valid for VARIVAX (Merck). This is one of several reports from the same source. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 11 month old patient (gender unknown). On an unknown date, the patient was vaccinated with VARIVAX subcutaneous (dose not reported). It was reported that a patient was administered the first dose of VARIVAX (Merck) at 11 months old. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. No relevant medical history of the patients was reported. On 19-MAY-2014, the patients were vaccinated with 2 doses of RECOMBIVAX HB (strength, route of administration, lot number and expiration dates were not reported). Thimerosal status was not provided. No concomitant medications were reported. It was reported that on an unknown date, these vaccine doses had reached a low temperature of 32.9 Fahrenheit for 9.5 hours and were supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This case is linked to Case # 1405USA011843, Case # 1405USA014111, Case # 1405USA014112 via the same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified numbers of patients. On an unspecified date, the patients were vaccinated with (unspecified number) PROQUAD (Merck) lot # K001853 (expiration date 06-AUG-2015), J006869 (expiration date 14-DEC-2014), J000134 (expiration date 04-JUL-2014); dosage, indication and route of administration were not provided. It was reported that since 05-MAR-2014 PROQUAD (Merck) was exposed to temperature above 5F. Some of the temperatures went above 8F to an unspecified temperature on unspecified dates during 43 days time-frame. Reporter stated the PROQUAD (Merck) was exposed to 16F for 44 days time-frame. Additionally, there was a 14 hour time-frame. Additionally, there was a 14 hour time-frame that the product was exposed to 16F. These potentially improperly stored vaccines were given to an unspecified number of patients on unspecified dates. No known adverse effects were reported. This is one of several reports from the same source.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Tunnel vision, Visual impairment
Clinical narrative: Child had tunnel vision and vision was black, no LOC, could hear mom talking, room temp 72 degrees F. Pt given water and chocolate in office.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling, Vaccination complication
Clinical narrative: Mild reaction to injection noted 1 day after injection: redness, swelling, itching and soreness. Recommended BENADRYL PRN.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Cellulitis, Erythema, Induration, Livedo reticularis
Clinical narrative: Vesicles or blisters, surrounded by indurated erythema 5 cm, dusky cutis marmorata of > 10 cm. Because of the spreading erythema and tenderness treated with TMP-SMX for cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Tenderness
Clinical narrative: Vesicles or blisters, surrounded by indurated erythema 5 cm, dusky cutis marmorata of > 10 cm. Because of the spreading erythema and tenderness treated with TMP-SMX for cellulitis.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt described her arm as "my deltoid was red and very painful". Pt reported swelling and pain approx 24 hours after injection. (L) arm involvement starting at top of shoulder to bicep/deltoid area. Pt treated with ice and alternating with MOTRIN and TYLENOL. Pt offered prednisone but declined.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site rash
Clinical narrative: Pt has a raised rash approximately 2" x 4" at the administration site. Pt saw MD and was placed on cephalexin 250mg PO qid.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 04-APR-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 14-MAR-2013, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 12-MAY-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008982). Additional information has been requested.
Age: 1.64
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Abnormal behaviour, Convulsion, Pyrexia
Clinical narrative: High fever, seizure once, went to ER. Behavior changes for 1-2 weeks.
Age: 61.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Dry skin, Injection site pain, Joint range of motion decreased, Local swelling, Mobility decreased
Clinical narrative: MD received a call from patient 1/2hr after receiving PNEUMOVAX in (R) deltoid that he is experiencing increasing pain in that area that is now excruciating. Describes dry, pins and needles in hand and fingers. Having trouble lifting arm. No rash, redness or swelling. No breathing problems and notes good color in tips of fingers. Provider advised pt to take hydrocodone for pain, and go to ED if symptoms worsen. Arm swelling occurred the next day. Pt to ice pack arm and go to ED if symptoms worsen. Range of motion in (R) shoulder reported decreased 2 days later. Symptoms fully resolved 9 days later.
Age: 61.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Paraesthesia
Clinical narrative: MD received a call from patient 1/2hr after receiving PNEUMOVAX in (R) deltoid that he is experiencing increasing pain in that area that is now excruciating. Describes dry, pins and needles in hand and fingers. Having trouble lifting arm. No rash, redness or swelling. No breathing problems and notes good color in tips of fingers. Provider advised pt to take hydrocodone for pain, and go to ED if symptoms worsen. Arm swelling occurred the next day. Pt to ice pack arm and go to ED if symptoms worsen. Range of motion in (R) shoulder reported decreased 2 days later. Symptoms fully resolved 9 days later.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: Fever, malaise, nausea.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 62.0
Sex: M
Vaccine: TTOX
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 64.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site warmth
Clinical narrative: (R) deltoid very red, hot to touch difficulty moving arm. Received BACTRIM, tried MOTRIN and cold packs.
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 a several unspecified patients of unknown age. On 21-MAY-2014, several patients received M-M-R II (lot # J006955, expiration date: 07-JUN-2015) 0.5 ml, subcutaneous. They received M-M-R II post not support excursion date 21-MAY-2014 (dose stored at 17 Celsius degree for 21.5 hours). No patients have expressed any adverse effects. None of patients sought medical attention. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient of unknown gender. The reporter stated that on 20-MAY-2014 the patient was vaccinated with a dose of M-M-R II (dose, route and lot# not provided, expiration date 17-MAY-2014). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Red and slightly warm to the touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 80.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, erythema and tenderness in right deltoid area.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Seizure like phenomena
Clinical narrative: Seizure-like movements. Called 911 and patient was taken to the ER.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Pruritus, Rash
Clinical narrative: Pt developed stomache ache 1-2 days after injection and a rash from her shoulder to her elbow with itching 3-4 days after her inj. that lasted about 5 days.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The evening of the day the pt received vaccine she developed approximately 5cm swelling, aching at site of injection and a warm, red "patch" developed. No fever. The swelling worsened over 2 days and red patch grew to encompass the entire back side of arm from injection site to elbow. She sought out MD on Saturday and took BENADRYL. By May 5th when the student came back to see nurse, the swelling had mostly resolved as did the redness and pain.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red at injection site - Hot to touch. Swelling went down after BENADRYL dose.
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Dysphonia, Flushing, Injection site pain, Lymph node pain
Clinical narrative: General malaise, facial flushing, hoarse voice, anterior cervical adenopathy 24 hours after vaccine x 24 hours then sinus headache, left deltoid tenderness, anterior cervical nodes less tender, rx with TYLENOL. Thursday after MMR, general arthralgia and recurrent facial flushing x 24 hours. General malaise and all symptoms resolved 6 days after onset.
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Malaise, Rubella antibody negative, Sinus headache
Clinical narrative: General malaise, facial flushing, hoarse voice, anterior cervical adenopathy 24 hours after vaccine x 24 hours then sinus headache, left deltoid tenderness, anterior cervical nodes less tender, rx with TYLENOL. Thursday after MMR, general arthralgia and recurrent facial flushing x 24 hours. General malaise and all symptoms resolved 6 days after onset.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Dyskinesia, Injection site erythema
Clinical narrative: Pt had 2 month physical/immunes on 5/15/14. She napped that afternoon, woke from nap and cried inconsolably for over an hour. Dose of TYLENOL given at home with minimal relief; immune site without drainage or swelling, were pink also reported to have had "jerky" movements, none sustained no stiffness, no eye rolling, head turning or staring, lasted only seconds. No issues reported after 5/15/14.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via Company Representative refers to a 69 year old female patient. Medical history and concurrent conditions were not reported. On either 17-MAY-2014 or 18-MAY-2014, the patient was vaccinated with ZOSTAVAX Lot # J014566; expiration date 18-FEB-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. On an unspecified dater after this, the patient experienced "a 2-3 inches in diameter area at the injection site, that was red, itchy, painful, swollen, and arm". The patient was given an unspecified antihistamine (manufacturer unspecified). The present status of the patient was unspecified. No lab diagnostics studies were performed. No lab diagnostics studies were performed. It was reported that patient sought medical attention calling the pharmacist. This is one of two reports received from the same reporter (MARRS # 1405USA011320). Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via Company Representative refers to a 75 year old female patient. Medical history and concurrent conditions were not reported. On either 17-MAY-2014 or 18-MAY-2014, the patient was vaccinated with ZOSTAVAX Lot # J014566; expiration date 18-FEB-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. On an unspecified date after this 9approximately in May 2014), the patient experienced "a 2-3 inches in diameter area at the injection site, that was red, itchy, painful, swollen, and warm". The patient was given an unspecified antihistamine (manufacturer unspecified). The present status of the patient was unspecified. The present status of the patient was unspecified. No lab diagnostics studies were performed. It was reported that patient sought medical attention calling the pharmacist. This is one of two reports received form the same reporter (MARRS# 1405USA011320). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, route and lot # not reported) where it was a very long time between doses. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. In approximately May 2013, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly. On approximately 12-MAR-2014, the patient received the second 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly and on 21-MAY-2014, 10 weeks after second dose, the patient received the third 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Malaise, Rash vesicular
Clinical narrative: This spontaneous report as received from a female nurse of unknown age via a field representative refers to herself. The patient's medical history and concurrent conditions were not reported. On 14-FEB-2014 the patient was vaccinated with ZOSTAVAX (lot # not provided) 1 injection, subcutaneous. On 14-FEB-2014 the patient experienced zoster type rash at the injection site after being administered with the ZOSTAVAX, and she did not "feel well" for several days after receiving the vaccine. The patient sought unspecified medical attentions. No treatment was given for the events. After a few weeks, the patient began feeling "normal" again. The outcome of the events was reported as recovered. The relationship between ZOSTAVAX and events was not reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a currently 67 year old male patient with no drug reactions or allergies. On 10-APR-2014, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J001694, expiration date 08-MAY-2014) subcutaneously. Concomitant therapy included unspecified blood pressure medications. The pharmacist reported that in approximately MAY-2014, "s month and a half' after receiving ZOSTAVAX, the patient was diagnosed with shingles. The patient reported to the pharmacist that he came down with some rash on his back on an unspecified date and went to see a physician and patient was diagnosed with shingles. The patient received unspecified treatment for the adverse event. The outcome of shingles was reported as recovering/resolving. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 57 year old female patient. On 08-MAY-2014 the patient was vaccinated with ZOSTAVAX 0.5 ml/one shot dose (route not reported) lot # J011828 and expiration date 26-DEC-2014 in the left arm. There was no pertinent medical history. There were no allergies or drug reactions reported. There was no concomitant medication. On 12-MAY-2014, the patient developed a large open blister at the ZOSTAVAX injection site on their left arm. The patient stated that it was hot all around (the blister). The patient sought medical attention and was given SILVADENE and unspecified antibiotics for treatment. At the time of the report the outcome of the events was reported as not recovered. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 8 year old female patient. On 19-JUL-2013, the patient was vaccinated by a staff error with a 0.5 ml dose of GARDASIL (lot # J003727, expiration date 07-NOV-2015) intramuscularly in the left deltoid. No adverse effects were reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiform.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. On 19-MAY-2014 the patients were vaccinated with a dose of GARDASIL 120Y (dose, strength and route were not reported, lot # J006236, expiration date 25-FEB-2016) that was exposed to 24F for 74 hours (date of exposure unspecified). The GARDASIL was not supported by in-house temperature stability data. The reporter did not specify which dose this was for either patient in the GARDASIL series. No adverse symptoms were reported. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash and pruritic at site of injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site movement impairment, Injection site pain, Injection site swelling
Clinical narrative: Within 1 day of DTaP, MMR in right thigh entire anterior thigh was red swollen hot and painful limiting ambulation. 2 days after vaccination improving but exam shows 11 x 15 cm area of heat, induration, redness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Within 1 day of DTaP, MMR in right thigh entire anterior thigh was red swollen hot and painful limiting ambulation. 2 days after vaccination improving but exam shows 11 x 15 cm area of heat, induration, redness.
Age: 31.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Initial report was received on 10 January 2014 from a healthcare provider. A 31 year old male patient received an 0.5 mL influenza quadrival A-B vaccine, lot number U4780AA intramuscularly into the left deltoid and ADACEL, lot number C4251AA intramuscularly into the left deltoid on 22 November 2013. A few days later the patient was seen at another clinic and experienced headaches and numbness of his great toe. On 09 December 2013 he was seen again with "rapid progressive numbness starting on his toe then spread to global numbness on toes, hands and tongues". Sometime between 01 December and 19 December 2013 he was seen by neurology and was hospitalized for an unknown period of time. On 19 December 2013 he called the reporter's office because he wanted a referral for rehab after being discharged from the hospital with a diagnosis of Guillain barre. Records were requested. The report stated that he is 80% recovered. Exact dates of hospitalization are unknown at this time. Concomitant medications and the patient medical history were not reported. Laboratory tests and diagnostic tests were not reported. No further details were available at the time of this report. The patient's outcome was recovering. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Initial report was received on 10 January 2014 from a healthcare provider. A 31 year old male patient received an 0.5 mL influenza quadrival A-B vaccine, lot number U4780AA intramuscularly into the left deltoid and ADACEL, lot number C4251AA intramuscularly into the left deltoid on 22 November 2013. A few days later the patient was seen at another clinic and experienced headaches and numbness of his great toe. On 09 December 2013 he was seen again with "rapid progressive numbness starting on his toe then spread to global numbness on toes, hands and tongues". Sometime between 01 December and 19 December 2013 he was seen by neurology and was hospitalized for an unknown period of time. On 19 December 2013 he called the reporter's office because he wanted a referral for rehab after being discharged from the hospital with a diagnosis of Guillain barre. Records were requested. The report stated that he is 80% recovered. Exact dates of hospitalization are unknown at this time. Concomitant medications and the patient medical history were not reported. Laboratory tests and diagnostic tests were not reported. No further details were available at the time of this report. The patient's outcome was recovering. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Nuclear magnetic resonance imaging normal, Sleep study normal
Clinical narrative: Tonic-clonic seizures.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blister, Herpes zoster, Pruritus, Rash
Clinical narrative: Blisters, rash and itching on left buttock.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Initial report was received from a consumer on 24 May 2013. This is a cluster of 2 unidentified  patients who experienced cellulitis following administration of ADACEL, lot number C4418BA. This case is invalid (no patient identifiers). Two unidentified patients (gender, date of birth and ages not reported) had received an injection of ADACEL, lot number C4418BA (route, site and date of administration not reported) and an unspecified amount of time later developed cellulitis. Treatment included antibiotics. Outcome was unknown. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Clumsiness, Electromyogram abnormal, Grip strength decreased, Mobility decreased
Clinical narrative: Initial report received from literature on 22 May 2014. The aforementioned information obtained from the literature abstract: This case report describes the course of a 26-year-old male who developed a dense motor palsy of the radial nerve after receiving a seasonal influenza vaccination. The palsy developed within 12 to 16 hours of inoculation and demonstrated no clinical recovery until 5 months post injury. Electro-myographic and nerve conduction studies obtained at six weeks post injury were consistent with complete motor denervation. Sensory function was preserved. The injury was successfully treated non-operatively with physical therapy and wrist splinting, and the palsy gradually resolved over the next several months.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Motor dysfunction, Muscular weakness, Musculoskeletal pain, Nerve conduction studies abnormal, Night sweats
Clinical narrative: Initial report received from literature on 22 May 2014. The aforementioned information obtained from the literature abstract: This case report describes the course of a 26-year-old male who developed a dense motor palsy of the radial nerve after receiving a seasonal influenza vaccination. The palsy developed within 12 to 16 hours of inoculation and demonstrated no clinical recovery until 5 months post injury. Electro-myographic and nerve conduction studies obtained at six weeks post injury were consistent with complete motor denervation. Sensory function was preserved. The injury was successfully treated non-operatively with physical therapy and wrist splinting, and the palsy gradually resolved over the next several months.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity, Pyrexia, Radial nerve palsy
Clinical narrative: Initial report received from literature on 22 May 2014. The aforementioned information obtained from the literature abstract: This case report describes the course of a 26-year-old male who developed a dense motor palsy of the radial nerve after receiving a seasonal influenza vaccination. The palsy developed within 12 to 16 hours of inoculation and demonstrated no clinical recovery until 5 months post injury. Electro-myographic and nerve conduction studies obtained at six weeks post injury were consistent with complete motor denervation. Sensory function was preserved. The injury was successfully treated non-operatively with physical therapy and wrist splinting, and the palsy gradually resolved over the next several months.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Electromyogram abnormal, Injury, Nerve conduction studies abnormal, Radial nerve palsy, Splint application
Clinical narrative: Initial report received from literature on 22 May 2014. The aforementioned information obtained from the literature abstract: This case report describes the course of a 26-year-old male who developed a dense motor palsy of the radial nerve after receiving a seasonal influenza vaccination. The palsy developed within 12 to 16 hours of inoculation and demonstrated no clinical recovery until 5 months post injury. Electro-myographic and nerve conduction studies obtained at six weeks post injury were consistent with complete motor denervation. Sensory function was preserved. The injury was successfully treated non-operatively with physical therapy and wrist splinting, and the palsy gradually resolved over the next several months.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: RASH, SORE THROAT, NOT FEELING WELL, SLIGHT FEVER; LASTED A FEW DAYS.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Cellulitis, Herpes zoster, Hypertension, Oedema
Clinical narrative: This spontaneous report as received from a 59 year old male patient refers to himself with no medical history or drug reactions or allergies. On 04-JAN-2014 the patient was vaccinated with ZOSTAVAX (in the arm, dose number, frequency, lot number was not reported). No concomitant medications were included. In January 2014, reported as sometime near the end of January 2014, the patient developed shingles after receiving ZOSTAVAX. Since then he had experienced scarring, cellulitis, high blood pressure, edema and an autoimmune deficiency. In 2014, the patient was admitted to a hospital (name unspecified) for three days while he received unspecified treatment. Lab diagnostics studies were performed but unspecified by the reporter. The outcome of shingles, autoimmune deficiency, edema, high blood pressure, cellulitis and scarring was reported as not recovered/not resolved. the relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Scar
Clinical narrative: This spontaneous report as received from a 59 year old male patient refers to himself with no medical history or drug reactions or allergies. On 04-JAN-2014 the patient was vaccinated with ZOSTAVAX (in the arm, dose number, frequency, lot number was not reported). No concomitant medications were included. In January 2014, reported as sometime near the end of January 2014, the patient developed shingles after receiving ZOSTAVAX. Since then he had experienced scarring, cellulitis, high blood pressure, edema and an autoimmune deficiency. In 2014, the patient was admitted to a hospital (name unspecified) for three days while he received unspecified treatment. Lab diagnostics studies were performed but unspecified by the reporter. The outcome of shingles, autoimmune deficiency, edema, high blood pressure, cellulitis and scarring was reported as not recovered/not resolved. the relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Syncope after HPV vaccine given. Patient was alert after falling from chair to floor. She was monitored for 1 hour after episode occurred. She was given orange juice and a snack.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Low Grade fever of 100.8 degrees F.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Induration, Injection site erythema, Injection site oedema, Local swelling, Pain
Clinical narrative: Erythema and edema to left arm between the shoulder and elbow. Arm is swollen and firm to touch. Mild pain and mild itching. Benadryl and ice used.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus
Clinical narrative: Erythema and edema to left arm between the shoulder and elbow. Arm is swollen and firm to touch. Mild pain and mild itching. Benadryl and ice used.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Dysgeusia, Headache, Injection site pain, Toothache
Clinical narrative: Headache, joint pain, tooth pain, metal taste in mouth, soreness at injection site.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Redness on arm, area warm to the touch. Growing area of redness, firm, size of a golf ball.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Aphagia, Choking, Cytogenetic analysis, Depressed level of consciousness, Dysphagia
Clinical narrative: 10/30/13 - Unable to stand/support weight. 10/31/13 - Topples over when sitting. 11-10-13 - Unable to support head, torso, progressive dystonia, hypotonic torso, arrested speech, choking when eating, hyperirritability. 3 spinal taps, mult. hospitalizations, G-button placement for FTT.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Dysstasia, Dystonia, Electroencephalogram, Failure to thrive, Feeding disorder of infancy or early childhood
Clinical narrative: 10/30/13 - Unable to stand/support weight. 10/31/13 - Topples over when sitting. 11-10-13 - Unable to support head, torso, progressive dystonia, hypotonic torso, arrested speech, choking when eating, hyperirritability. 3 spinal taps, mult. hospitalizations, G-button placement for FTT.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Gastrooesophageal reflux disease, Gastrostomy, Grip strength decreased, Hepatic enzyme increased, Hypotonia
Clinical narrative: 10/30/13 - Unable to stand/support weight. 10/31/13 - Topples over when sitting. 11-10-13 - Unable to support head, torso, progressive dystonia, hypotonic torso, arrested speech, choking when eating, hyperirritability. 3 spinal taps, mult. hospitalizations, G-button placement for FTT.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Interferon alpha level increased, Irritability, Laboratory test abnormal, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: 10/30/13 - Unable to stand/support weight. 10/31/13 - Topples over when sitting. 11-10-13 - Unable to support head, torso, progressive dystonia, hypotonic torso, arrested speech, choking when eating, hyperirritability. 3 spinal taps, mult. hospitalizations, G-button placement for FTT.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Posture abnormal, Speech disorder, Weight bearing difficulty
Clinical narrative: 10/30/13 - Unable to stand/support weight. 10/31/13 - Topples over when sitting. 11-10-13 - Unable to support head, torso, progressive dystonia, hypotonic torso, arrested speech, choking when eating, hyperirritability. 3 spinal taps, mult. hospitalizations, G-button placement for FTT.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Lumbar puncture, Myelitis transverse, Neurological symptom, Nuclear magnetic resonance imaging
Clinical narrative: When woke up in AM of 10-29-13, right arm was very sore and painful, right arm was difficult to raise, appeared to have stroke-like symptoms - symptoms got worse and hospitalization was needed - was first time receiving Flu vaccine. Diagnosis - Transverse Myelitis.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: When woke up in AM of 10-29-13, right arm was very sore and painful, right arm was difficult to raise, appeared to have stroke-like symptoms - symptoms got worse and hospitalization was needed - was first time receiving Flu vaccine. Diagnosis - Transverse Myelitis.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Local swelling, Pain in extremity
Clinical narrative: Swollen right arm, painful, could not lift it. Went to ER got abx.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Body temperature increased, Bruxism, Chills, Dyspnoea, Feeling hot
Clinical narrative: Difficulty breathing, feeling very hot, elevated body temperature, chills, clenching, nausea.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Nausea
Clinical narrative: Difficulty breathing, feeling very hot, elevated body temperature, chills, clenching, nausea.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Eczema, Skin reaction
Clinical narrative: Severe skin reaction. We were told it was eczema but she never had it before the shots. She has severe outbreaks constantly. She is now 24 and still has reactions to everything.
Age: 1.52
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Chicken pox rash and fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Rash, Rash erythematous, Swelling face
Clinical narrative: Next morning got a couple of big bumps on forehead by the end of the day 1 big bump formed, it hurt when touched. By 5/27 had more bumps on nose/cheeks like acne; they were red. Nothing burst now they are less and getting smaller.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 13 month old patient of unknown gender. On an unknown date in April 2014, betweeb 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Discomfort, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Mother called in the office due to inconsolable crying after vaccination (over 3 hours). Advised mother to bring the patient in to the office.  Patient was seen at the office @ 5:30 pm. General appearance: ill-appearing, uncomfortable due to pain, tearful, irritable 6/10, crying.  Skin: site of injection: Right 2 injection sites no swolling or iduration, Left 2 injection sites (Dtap/IPV from the record) remarkable swolling and tenderness, size 5x3cm. Tylenol infant 1.25ml given at 0545PM. Instruction for Tylenol given as well. Advised mother to continue Tylenol every 4 hours for 24 hours. Call to the office if patient's symptom is not resolved or other symptoms appears next 24 hours.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pain, Tearfulness
Clinical narrative: Mother called in the office due to inconsolable crying after vaccination (over 3 hours). Advised mother to bring the patient in to the office.  Patient was seen at the office @ 5:30 pm. General appearance: ill-appearing, uncomfortable due to pain, tearful, irritable 6/10, crying.  Skin: site of injection: Right 2 injection sites no swolling or iduration, Left 2 injection sites (Dtap/IPV from the record) remarkable swolling and tenderness, size 5x3cm. Tylenol infant 1.25ml given at 0545PM. Instruction for Tylenol given as well. Advised mother to continue Tylenol every 4 hours for 24 hours. Call to the office if patient's symptom is not resolved or other symptoms appears next 24 hours.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Chapped lips, Headache, Lip dry, Nausea, Pyrexia
Clinical narrative: Pt c/o headache and low-grade fever last night, but reports headache resolved either the same night or early this am (pt wasn't sure). As of 10:30 a.m. this am, pt c/o slight nausea; dry, chapped lips; and low-grade fever. Reports taking Tylenol at 10:10 am right before reporting reaction. He never took his temp to verify low-grade fever.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: This spontaneous report as received from a physician via sales representative refers to 3 patients of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date after the patients were vaccinated with (Oka-Merck) PROQUAD, route subcutaneous the patients developed large red raised welts in the area of the injection site. The physician also reported to the representative that the three patients also received KNIRIX, along with PROQUAD was administered. The outcome of large red raised welts in the area of the injection site is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has ben requested.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 11 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.