chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 15-JUN-2015 the patient was inadvertently vaccinated with a dose of improperly stored PROQUAD (Merck) (Lot# K018143; expiration date: 10-APR-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 16-MAR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 08JUN2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB and oral, ROTATEQ. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 08-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (unknown strength and route). Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports from the same reporter. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: MMR, TD, VARCEL
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 43 year old male patient with no drug reactions or allergies and no medical history. No concomitant medications or the patient's concurrent conditions were reported. On 19-JUN-2015, the patient was vaccinated with an unspecified dose of VARIVAX (Merck), (dose, lot number, expiration date, route of administration and injection site were not reported). Other suspect therapies administered on the same day included M-M-R II, (dose, lot number, expiration date, route of administration and injection site were not reported) and an unspecified Td (manufacturer unspecified) (dose, lot number, expiration date, route of administration and injection site were not reported). It was also reported that on the same day the patient received a Tuberculin Skin test. On 21-JUN-2015, the patient called the pharmacist to report that he had experienced a vesicular rash at the injection site of the VARIVAX (Merck) starting on the same day. It was also reported that the rash was not itchy, it was not red and there was no swelling at the injection site. The patient sought medical attention via calling the pharmacist. No laboratory diagnostic studies were reported. The outcome of vesicular rash at the injection site of the VARIVAX (Merck) was reported as not recovered at the time of the report. The relatedness between the event and VARIVAX (Merck) and M-M-R II was not reported. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 18 year old patient of unknown gender. Information regarding concurrent conditions and medical history was not provided. On 05-MAY-2015 the patient was vaccinated with PROQUAD (Merck), lot # reported as: K014799, exp. date unknown, 0.5 ml, subcutaneous (dose number and application site were not reported) (inappropriate schedule of drug administration). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-JAN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798, expiration date 12-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 21-MAY-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) Lot # K020760, expiry date 31-OCT-2016 (dose and route not reported). No adverse event was reported. This case of is one of the two report from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 23-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 02-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Tingling in her hands and fingers since 6/10/15.
Age: 2.0
Sex: M
Vaccine: HIBV, PPV
Symptoms: Cellulitis, Inappropriate schedule of drug administration, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from the authors in a literature article concerning a 2 year old male patient who was vaccinated with PCV (23-valent) (manufacturer unknown) and had received 13-valent PCV 1 and 2 years earlier. Concomitant vaccines included meningococcal vaccine (manufacturer unknown). The 2 year old boy with sickle cell disease type hemoglobin SS SCD (Hgb-SS) was initially vaccinated with PCV (23-valent) (manufacturer unknown). Then, 6 weeks later received a second dose of PCV (23-valent) (manufacturer unknown). Subsequently, he was brought to the emergency department with acute onset of fever and swelling of the left thigh that occurred 6 hours after administration of the PCV (23-valent) (manufacturer unknown). A physical examination revealed mild erythema and generalized edema, with warmth and tenderness to palpation of the left thigh and knee. The patient was febrile (38.9 degrees C), and the fever resolved with one dose of ibuprofen. Laboratory tests revealed a white blood cell count of 39.8 x 1000/mm3 that showed leukocytosis (11.0 x 1000/mm3 before immunization). He was admitted and treated empirically with ceftriaxone, and vancomycin was added for suspected cellulitis. The patient continued to improve during his hospitalization, and he was discharged 3 days later receiving clindamycin. His symptoms had completeLY resolved by the time of his 3 day post discharge follow-up visit. This is one of several reports from the same literature (1506USA012954, 1506USA013115, 1506USA013114 and 1506USA013112). Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HIBV, PPV
Symptoms: Injection site swelling, Injection site warmth, Leukocytosis, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from the authors in a literature article concerning a 2 year old male patient who was vaccinated with PCV (23-valent) (manufacturer unknown) and had received 13-valent PCV 1 and 2 years earlier. Concomitant vaccines included meningococcal vaccine (manufacturer unknown). The 2 year old boy with sickle cell disease type hemoglobin SS SCD (Hgb-SS) was initially vaccinated with PCV (23-valent) (manufacturer unknown). Then, 6 weeks later received a second dose of PCV (23-valent) (manufacturer unknown). Subsequently, he was brought to the emergency department with acute onset of fever and swelling of the left thigh that occurred 6 hours after administration of the PCV (23-valent) (manufacturer unknown). A physical examination revealed mild erythema and generalized edema, with warmth and tenderness to palpation of the left thigh and knee. The patient was febrile (38.9 degrees C), and the fever resolved with one dose of ibuprofen. Laboratory tests revealed a white blood cell count of 39.8 x 1000/mm3 that showed leukocytosis (11.0 x 1000/mm3 before immunization). He was admitted and treated empirically with ceftriaxone, and vancomycin was added for suspected cellulitis. The patient continued to improve during his hospitalization, and he was discharged 3 days later receiving clindamycin. His symptoms had completeLY resolved by the time of his 3 day post discharge follow-up visit. This is one of several reports from the same literature (1506USA012954, 1506USA013115, 1506USA013114 and 1506USA013112). Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt developed urticaria (hives) within minutes after SQ injection of VARIVAX & MMR. BENADRYL suspension 12.5 mg/5 mL 4 mL po given. Largely resolved 15 mins s/p administration. No throat/lip swelling, difficulty breathing, ER needed.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patients were administered improperly stored doses of PROQUAD (Merck) injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Leukocytosis, Pain in extremity, Peripheral swelling, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from the authors in a literature article concerning a 6 year old male patient who was vaccinated with PCV (23-valent) (manufacturer unknown). No concomitant vaccines were reported. The 6 year old boy with sickle cell disease type hemoglobin SC SCD was brought to the emergency department with left thigh pain and swelling 9 hours after PPSV23 (manufacturer unknown) administration. He was febrile (38.7 degrees C), with a WBC (white blood cell) count of 12.4 x 1000/mm3 that showed leukocytosis on admission (8.9 x 1000/mm3 before immunization). The patient was admitted and received penicillin and clindamycin. He was afebrile throughout his hospitalization and was discharged 4 days later when the swelling completely resolved. This is one of several reports from the same literature (1506USA012954, 1506USA013114, 1506USA013112 and 1506USA013113). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Leukocytosis, Oedema, Pain in extremity, Peripheral swelling, White blood cell count increased
Clinical narrative: Information has been received from the authors in a literature article concerning a 22 year old female patient who was vaccinated with PCV23 (manufacturer unknown) and had received PCV13 vaccine 4 months earlier. No concomitant vaccines were reported. The 22 year old female with sickle cell disease type hemoglobin SS SCD presented to the emergency department with painful swelling of the right arm 1 day after administration of PPSV23 (manufacturer unknown). She was afebrile, with a WBC (white blood cell) count of 13.6 x 1000/mm3 that showed leucocytosis (6.5 x 1000/mm3 before immunization). Patient also experienced oedema (unspecified). She received hydromorphone and hydration, and was discharged home from the emergency department. This is one of several reports from the same literature (1506USA012954, 1506USA013115, 1506USA013114 and 1506USA013113). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from the authors in a literature article concerning a 18 year old female patient who was vaccinated with PCV23 (manufacturer unknown) and had received PCV23 (manufacturer unknown) 5 years earlier. Concomitant vaccines included meningococcal vaccine. The 18 year old female with sickle cell disease type hemoglobin SS SCD presented to the adolescent clinic with severe pain and swelling of the left deltoid 1 day after administration of PPSV23. The area surrounding the injection site was mildly warm with red and edematous tenderness from midclavicular to upper humerus. The patient received ibuprofen for pain and was evaluated during the office visit. The patient was not admitted to the hospital. This is one of several reports from the same literature (1506USA012954, 1506USA013115, 1506USA013112 and 1506USA013113). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from the authors in a literature article concerning a 18 year old female patient who was vaccinated with PCV23 (manufacturer unknown) and had received PCV23 (manufacturer unknown) 5 years earlier. Concomitant vaccines included meningococcal vaccine. The 18 year old female with sickle cell disease type hemoglobin SS SCD presented to the adolescent clinic with severe pain and swelling of the left deltoid 1 day after administration of PPSV23. The area surrounding the injection site was mildly warm with red and edematous tenderness from midclavicular to upper humerus. The patient received ibuprofen for pain and was evaluated during the office visit. The patient was not admitted to the hospital. This is one of several reports from the same literature (1506USA012954, 1506USA013115, 1506USA013112 and 1506USA013113). Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: This spontaneous report was received from a physician refers to a 75 year old female patient. No pertinent medical history was reported. On an unknown date in 2013, the patient was vaccinated with ZOSTAVAX (dose, route, lot # were not reported). No co-suspect and concomitant therapies were reported. On 28-MAY-2015, the patient experienced herpes zoster. Action taken was not applicable. The outcome of herpes zoster was reported as recovered/resolved. The reporter considered herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-MAR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-MAR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (unknown strength and route). Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (unknown strength and route). Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. Information about pertinent medical history, concurrent condition and concomitant therapy was not reported. On an unspecified date in June 2013(reported as "about 2 years ago") the patient was vaccinated with ZOSTAVAX (strength, lot#, dosage, frequency and route unspecified). On an unspecified date in 2015(reported as "currently") the patient had a mild case of shingles. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 14-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 17-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 25-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 77 year old female patient with no concurrent and historical conditions and no allergies. On 09-JUN-2015 the patient was vaccinated with ZOSTAVAX (0.65 ml, once, subcutaneous, lot# and expiration date were not reported). There were no concomitant therapies. On 15-JUN-2015, the patient experienced redness, swelling, and itching similar to a bee sting at the injection site. The patient was seen at the pharmacy. There were no lad diagnostics studies performed. No treatment ws given for the events. The outcome of the events was not recovered. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 08JUN2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB and, oral, ROTATEQ. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 09JUN2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 18-JUN-2015 the patient was inadvertently vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L001326; expiration date: 13-JAN-2017) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 08JUN2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB and ROTATEQ. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes simplex
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old male patient with penicillin allergy. The patient's medical history included herpes simplex. On 21-APR-2015, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route of administration were not reported). The patient did not use any concomitants. On 25-APR-2015, the patient developed a herpes simplex outbreak. The event was treated with 1 dose of VALTREX on 25-APR-2015 and 1 dose of VALTREX on 26-APR-2015. No lab tests were performed. The outcome of herpes simplex was reported as recovered on unknown date in 2015 (reported as "date unspecified). The patient sought medical attention, he called pharmacy. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, as the reporter denied any further contact.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, MNQHIB, PNC13, RV1
Symptoms: Diarrhoea, Occult blood positive
Clinical narrative: 5 days after rotavirus vaccine patient has loose stools with hemocult positive blood.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 24-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Transient ischaemic attack
Clinical narrative: Signs of TIA which lead to hospital visit; rash at injection site appeared that night.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had redness and swelling around injection site.  The swelling was warm to the touch.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Chills, Dizziness, Headache, Neck pain
Clinical narrative: Patient's mom calling with son complaining of bad headache, stomach ache, chills, dizzy, neck pain.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash around neck, upper back, chest, lower stomach/abdomen areas. Also low-grade fever of 100.2F.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on back and stomach, abdomen areas. Fever 102.4F rectal.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Bone scan, Injection site erythema, Injection site rash, Pruritus, Swelling
Clinical narrative: Left arm with redness and small rash around injection site. Patient A/Ox3 denies S.O.B./ Numbness/ or additional swelling beyond injection site. Daughter wants to give Benadryl. Advise daughter only if her mother cannot tolerate the itching & as long as she is not allergic to it's components. Observe site, if itching increases in intensity & additional swelling occurs or her mother become short of breath, she is to take her mother to E.R. for further evaluation.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray
Clinical narrative: Left arm with redness and small rash around injection site. Patient A/Ox3 denies S.O.B./ Numbness/ or additional swelling beyond injection site. Daughter wants to give Benadryl. Advise daughter only if her mother cannot tolerate the itching & as long as she is not allergic to it's components. Observe site, if itching increases in intensity & additional swelling occurs or her mother become short of breath, she is to take her mother to E.R. for further evaluation.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Rash, Urticaria
Clinical narrative: THE PATIENT CALLED AND SAID HE BROKE INTO HIVES AND DEVELOPED RASHED ON HIS FACE, NECK AND SHOULDERS AND FELT LIKE HE HAD SOME ACHES AND PAINS SINCE LAST NIGHT.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Itchy rash on scalp, neck, shoulders, back of hands, forearms, knees, thighs, torso (striated rash on torso), top of feet.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Skin discolouration
Clinical narrative: 8cm x 6.5cm area of pinkness that is patchy and sore to touch. About 1-2cm below injection site and leg achiness.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 09JUN2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site swelling
Clinical narrative: Pt is pregnant. Swelling of injection site pt advised to call her physician.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Received immunization on 6/24/15. Redness and hardness under bandaid. This happened that day & continued til he came into pharmacy Friday. Swelling down to elbow 2 days after vaccine received.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: After receiving a PREVNAR vaccine, patient experienced redness, swelling, and low grade fever for 2 days. Got better.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Aphagia, Nausea, Pallor, Visual impairment
Clinical narrative: About one minute after vaccines completed, patient was pale and c/o nausea. Bucket given. RN got H2o. Patient unable to swallow and H2O just dribbled down face. Patient awake and responsive but stated he couldn't see. RN got MD. Patient placed on bed. BP 96/60. O2 > 90%. HR 58. Monitored patient. Mom at bedside also when he came more alert H2O offered again. BP taken several times until baseline which was 114/72 at 1408/
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain, Blood test, Dizziness, Fall, Loss of consciousness
Clinical narrative: Approximately 3-4 minutes after receiving MENACTRA and GARDASIL-9, patient was sitting up on exam table and felt nausea, abd pain and blacked out followed by falling onto ground. She then became conscious. BP stable. Pt was lying down for approximately 10 minutes, wanted to sit up but 5 min later, felt dizzy again. After lying down again approximately 10-15 min, pt recovered and symptoms resolved.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Nausea
Clinical narrative: Approximately 3-4 minutes after receiving MENACTRA and GARDASIL-9, patient was sitting up on exam table and felt nausea, abd pain and blacked out followed by falling onto ground. She then became conscious. BP stable. Pt was lying down for approximately 10 minutes, wanted to sit up but 5 min later, felt dizzy again. After lying down again approximately 10-15 min, pt recovered and symptoms resolved.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, fever (102 oral 101 oral) nausea x1 emesis inj. site/arm hurt. Felt better later afternoon 6-25-15.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Fatigue, Heart rate decreased
Clinical narrative: Trouble breathing, tired, low pulse rate.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles, Injection site warmth
Clinical narrative: (R) anterior thigh with 4-5 cm area of redness, warmth and mild edema within 24 hours of vaccination. Surface of area is irregular with many small flat vesicles filled with clear yellowish fluid. No drainage, no tenderness.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received on 18-JUN-2015 from a consumer refers to a 62 year old male patient with hypertension, hepatitis c, heart disease, "COD" (coronary artery disease) and iodine allergy. On 11-JUN-2015 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included TOPRAL, OMEPRAZOLE, RANITIDINE HYDROCHLORIDE and HYDROCODONE and VALIUM. The patient stated he has had redness at the injection site of a quarter that started the day after getting the vaccine. No further information was provided. The outcome of redness at the injection site is unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 10JUN2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pruritus
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding herself. Patient's pertinent medical history and concurrent conditions were not reported. Patient was reported as allergic to PREMARIN. On 05-JUN-2015 the patient was vaccinated with ZOSTAVAX once, in the upper arm (reported as to prevent shingles). Concomitant therapies included atenolol. On 07-JUN-2015 (reported as two days after receiving zoster vaccine live), patient experienced severe itching, red, and raised bumps greater than a fifty cent piece. Patient did not required medical attention. No treatment was given for the adverse events. No lab diagnostic studies were performed. Outcome of the events was reported as not recovered. Causality assessment of the events with respect to therapy with zoster vaccine live was not provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Immunisation, Induration, Injection site pruritus, Rash pustular
Clinical narrative: This spontaneous report as received on 19-JUN-2015 from a consumer refers to a female patient of unknown age with a history of receiving both doses of VARIVAX (Merck) as a child. On an unspecified date in 2014, she was told by her physician that she had no antibodies/varicella titers for the varicella virus in her body. She was pregnant at the time of the test. Her physician prescribed that she received a booster dose of VARIVAX (Merck) after her pregnancy. On an unspecified date in June 2015, the patient was vaccinated with a booster shot of VARIVAX (Merck). On 17-JUN-2015 the patient experienced an itching sensation at the injection site. On 18-JUN-2015 the patient developed a hard lump the size of a grapefruit on her arm. The patient reported she went to an unspecified urgent care clinic to receive an unknown treatment. On 19-JUN-2015 the patient developed pustules on her arm. No further information was provided. The outcome of antibody test negative, rash pustular, skin mass and injection site pruritus is unknown. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Upper extremity mass
Clinical narrative: This spontaneous report as received on 19-JUN-2015 from a consumer refers to a female patient of unknown age with a history of receiving both doses of VARIVAX (Merck) as a child. On an unspecified date in 2014, she was told by her physician that she had no antibodies/varicella titers for the varicella virus in her body. She was pregnant at the time of the test. Her physician prescribed that she received a booster dose of VARIVAX (Merck) after her pregnancy. On an unspecified date in June 2015, the patient was vaccinated with a booster shot of VARIVAX (Merck). On 17-JUN-2015 the patient experienced an itching sensation at the injection site. On 18-JUN-2015 the patient developed a hard lump the size of a grapefruit on her arm. The patient reported she went to an unspecified urgent care clinic to receive an unknown treatment. On 19-JUN-2015 the patient developed pustules on her arm. No further information was provided. The outcome of antibody test negative, rash pustular, skin mass and injection site pruritus is unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On 02-JUN-2015, the patient was vaccinated with VARIVAX (Merck) subcutaneous (dose, strength and lot number were not reported) that was improperly stored at -13.6 degrees C for 17 minutes on an unspecified date. It was unknown if this was the first or the second dose in the vaccine series of VARIVAX (Merck). No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to a 60 year old female patient. There was no medical history. On 11-JUN-2015 the patient was vaccinated with one shot of ZOSTAVAX (route not provided). On 14-JUN-2015, the patient experienced injection site swelling and redness and could not move the arm without pain. The patient went to an unspecified primary physician for medical attention. There was no intervention to prevent serious criteria, no significant disability or incapacity, no hospitalization or prolongation. The event was not considered life threatening. PQC not involved. The outcome of the events and the relatedness with ZOSTAVAX was unknown. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a currently 15 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unknown date in February 2015, the patient was vaccinated with the first dose of VAQTA (route, anatomical location, lot# and expiration date were not reported). On an unknown date in May 2015, just 3 months after initial dose, the patient was inadvertently vaccinated with the second dose of VAQTA (route, anatomical location, lot# and expiration date were not reported). There was no concomitant therapy reported. No adverse effect reported. Additional information is not expected since the physician declined to participate in the adverse event collection process.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature, Headache, Influenza, Musculoskeletal stiffness, Neck pain
Clinical narrative: This spontaneous report was received from a 22 year old female patient, regarding herself. Patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 16-JUN-2015 the patient received one shot (first in booster vaccination) with RECOMBIVAX HB. Concomitant medications were not reported. Patient reported that within 2 hours of receiving RECOMBIVAX HB, she experienced the onset of a sore throat, which progressed to Flu symptoms (Influenza) and respiratory problems (respiratory disorder), neck stiffness/soreness (musculoskeletal stiffness) and a headache. Patient sought medical attention on an unknown date and was seen by nurse int he office. No treatment was given for the adverse event, but the patient had been taking Ibuprofen. Nurse recorded patient's temperature, value of which was not provided. Outcome of the events were unknown. Causality assessment of the events with respect to therapy with RECOMBIVAX HB. Additional information is not expected as no reporter details were provided.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain, Respiratory disorder
Clinical narrative: This spontaneous report was received from a 22 year old female patient, regarding herself. Patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 16-JUN-2015 the patient received one shot (first in booster vaccination) with RECOMBIVAX HB. Concomitant medications were not reported. Patient reported that within 2 hours of receiving RECOMBIVAX HB, she experienced the onset of a sore throat, which progressed to Flu symptoms (Influenza) and respiratory problems (respiratory disorder), neck stiffness/soreness (musculoskeletal stiffness) and a headache. Patient sought medical attention on an unknown date and was seen by nurse int he office. No treatment was given for the adverse event, but the patient had been taking Ibuprofen. Nurse recorded patient's temperature, value of which was not provided. Outcome of the events were unknown. Causality assessment of the events with respect to therapy with RECOMBIVAX HB. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 10JUN2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse on 18-JUN-2015 concerning an unspecified number of unspecified patients who were administered an unspecified number of improperly stored doses of ROTATEQ, dosage not reported, orally (lot # K004921, expiration date 25-FEB-2016; and lot #K023534, expiration date 22-MAY-2016) on unspecified dates since 28-APR-2015. It was unspecified which unspecified patients received doses from which of the two lots of ROTATEQ. No adverse effects reported. No additional information provided. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Activities of daily living impaired, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: LEFT ARM - SWOLLEN, HOT, READ AND PAINFUL, PT WAS GIVEN PCV 23 AND TDAP IN THE SAME ARM. PAIN WAS SO SEVERE SHE HAD TO MIS WORK FOR 2 DAYS.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: REDNESS, ABOUT 4/10 PAIN AT INJECTION SITE.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Pain in extremity
Clinical narrative: (L) arm bruised at injection site, showed up at 2 days. Soreness since shot. 3-4 inch wide red ring around almost entire arm about 4 inches from site of injection. Noticed redness on 6/25, saw MD and advised will go away, no raised patches or rash, no fever.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Injection site reaction, Paraesthesia, Pruritus
Clinical narrative: Prickly, tingling sensation in skin, especially in hands & feet. Itching face, lips, forehead & scalp. Small red area on forehead, started with itching & tingling before rash appeared within a week of vaccination. Fatigue & sleepiness. Itching & red oval rash at injection site, persisting over a week.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Somnolence
Clinical narrative: Prickly, tingling sensation in skin, especially in hands & feet. Itching face, lips, forehead & scalp. Small red area on forehead, started with itching & tingling before rash appeared within a week of vaccination. Fatigue & sleepiness. Itching & red oval rash at injection site, persisting over a week.
Age: 72.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose of HAVRIX that expired (06/07/15) on 6/17/15.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Pt has intermittent low grade fever, dizzy spells and headache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site warm, red, swollen. Red area about inch to inch and half in diameter. Was noticed Thurs. around 8:30 pm. 6/27 warmth and swelling improved, but redness about the same reported by patient. Patient did not see doctor and now states it itches.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker regarding to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-MAY-2015, the patient was vaccinated with expired dose of RECOMBIVAX HB (lot # H017800, expiry date 01-JUN-2014) (dose and route were not reported). No adverse effects were reported. The outcome of the events was unknown. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to an unspecified number of patient of unknown demographics. Pertinent medical history, concurrent conditions and drug reactions/ allergies were not reported. On unspecified dates, the patients were administered with doses of ROTATEQ (lot # K016314, expiry date: 05-JUN-2016; lot # K023532, expiry date: 21-JUN-2016; lot # L000571, expiry date: 26-JUL-2016; L000434, expiry date: 10-JUL-2016) which was exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of the six reports received from the same source (MARRS # 1506USA014028, 1506USA014024, 1506USA014025, 1506USA014026 and 1506USA014027). Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to an unspecified number of patients of unknown demographics. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were administered with doses of VAQTA (lot # L004743, expiry date: 01-JUN-2017; lot # L001445, expiry date: 15-FEB-2016) which was exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of the six reports received from the same source (MARRS # 1506USA014028, 1506USA011037, 1506USA014024, 1506USA014025 and 1506USA014026). Additional information is not expected as the reporter did not wish further contact.