chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Electrocardiogram, Feeling of body temperature change, Full blood count, Lipase, Liver function test
Clinical narrative: Patient stated she became lightheaded, then suddenly got a tingling sensation throughout her whole body, let her foot off the car's accelerator knowing something was wrong. States she blacked-out and didn't regain consciousness until after emergency responders were surrounding her. Patient was involved in a low speed single vehicle accident, was taken to ER and diagnosed with: MVA, facial contusion and vasovagal syncope. Discharged with treatment plan of supportive self/home care. Patient described temperature in car as not too hot or too cold.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Metabolic function test, Paraesthesia, Pregnancy test urine, Road traffic accident
Clinical narrative: Patient stated she became lightheaded, then suddenly got a tingling sensation throughout her whole body, let her foot off the car's accelerator knowing something was wrong. States she blacked-out and didn't regain consciousness until after emergency responders were surrounding her. Patient was involved in a low speed single vehicle accident, was taken to ER and diagnosed with: MVA, facial contusion and vasovagal syncope. Discharged with treatment plan of supportive self/home care. Patient described temperature in car as not too hot or too cold.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope, Urine analysis
Clinical narrative: Patient stated she became lightheaded, then suddenly got a tingling sensation throughout her whole body, let her foot off the car's accelerator knowing something was wrong. States she blacked-out and didn't regain consciousness until after emergency responders were surrounding her. Patient was involved in a low speed single vehicle accident, was taken to ER and diagnosed with: MVA, facial contusion and vasovagal syncope. Discharged with treatment plan of supportive self/home care. Patient described temperature in car as not too hot or too cold.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Dad reports swollen (L) deltoid, raised and red. They applied ice and ibu. Today area viewed, area red/pink. Measured 130mm x 100mm. Pt stated it felt like it was getting better. Area raised and slightly warm to the touch.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: MENVEO given 02-15-16. Left arm. IM. Patient and mother came to office 02-18-16 to report the site has been red, raised, hot to touch and itching since arriving home 02-15-16. Alternating TYLENOL/ibuprofen as needed. Tried some BENADRYL. Area is getting better, but still 3 inches by 3.75 inches - red, slightly raised. Cool now and much less itching.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Pallor
Clinical narrative: MMR, V, PREVNAR, Hep A administered each thigh. Band Aids applied. Within 5 minutes erythematous blanching reaction approx 4 cm. Improved when Band Aids removed, 6.25mg diphen.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema at injection site approx. 5 cm in diameter per MD, painful and warm getting larger per pt. Prescribed clindamycin and BACTRIM for precaution, pt doing well and no other complications.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Woke up with (L) arm red, itchy, painful, approx. 5-6 cm diameter.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site joint pain
Clinical narrative: Patient came into the pharmacy on 2/13/16 complaining of pain in the joint in his upper arm and shoulder related to the PREVNAR 13 injection.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 11-FEB-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 0.5 ml, intramuscular, lot # K007826 and expiration date 03-FEB-2016. Concomitant or co-suspect therapies were not provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a 19 year old female patient. The patient's medical history and concurrent conditions were not reported. On 14-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.18
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 14 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months female patient. Information about the patient's medical history and concurrent conditions was not reported. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 23-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were each vaccinated with a dose of RECOMBIVAX HB (lot # L035881, expiration date 26-JUN-2017, temperature: 49 Fahrenheit, no previous temperature excursion; route not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 15 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 26-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker (certified medical assistant), refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored VARIVAX (Merck) injection, lot # L036830, expiry date 24-SEP-2017, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. NO further information was provided. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 23-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 03-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARICELLA lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, male patient. The patient's medical history and concurrent conditions were not reported. On 22-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-FEB-2016, the patient was vaccinated with an expired dose of MMR II lot # K001230, expiry date 26-JAN-2016, 0.5 ml, subcutaneous. No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 14 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history or concurrent conditions was not reported. On 18-SEP-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, male patient. The patient's medical history and concurrent conditions were not reported. ON 03-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.09
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to a 13 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, male patient. The patient's medical history and concurrent conditions were not reported. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all schedule follow up information was received.
Age: 0.51
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product name confusion, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 6 month old infant patient of unknown gender. On 12-FEB-2016 the patient was vaccinate in error with GARDASIL 9 injection (lot # L016428; expiry: 30-JUL-2017) dose # 1. No concomitant medications were reported. On 12-FEB-2016, the nurse at the clinic where error occurred stated that, when she reached into the refrigerator to grab the vaccine that was intended for this patient, she saw the "H" of the "HPV" on the label of the GARDASIL 9 vial and grabbed GARDASIL 9 instead of the "Hib" vaccine that the patient was indicated to receive. The nurse stated that the "triple-check" that was usually done prior to administration was not done before this patient received the dose of GARDASIL 9. The nurse states that this patient has not demonstrated any adverse effects. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 15-FEB-2016 the patient was vaccinated with an expired dose of VARIVAX (Merck) (dose and route unknown, lot #: K002043, expiry date: 10-FEB-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 18-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (dose, lot # not reported). The nurse did not know if this was GARDASIL or GARDASIL 9. On 19-OCT-2015 the patient was vaccinated with a dose of GARDASIL 9. ON 21-OCT-2015, the patient was vaccinated with the second dose of GARDASIL 9 outside of the recommended series schedule. NO adverse symptoms reported. This is one of three reports from the same reporter. Additional information has been requested.
Age: 1.19
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 14 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.06
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 29-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 27-JUL-2012 the patient was vaccinated with the first dose of GARDASIL (dose and lot# not reported) (nurse did not know if this was GARDASIL or GARDASIL 9. On 17-NOV-2015 the patient was vaccinated with a dose of GARDASIL 9 (dose and lot# not reported) (confirmed not GARDASIL). The patient received GARDASIL 9 outside of the recommended series schedule. No adverse symptoms reported. The patient had not yet received a third dose. This is one of three reports from the same reporter. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 29-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all schedule follow up information was received.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 18-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (dose, lot # not reported). The nurse did not know if this was GARDASIL or GARDASIL 9. On 19-OCT-2015 the patient was vaccinated with a dose of GARDASIL 9. On 21-OCT-2015, the patient was vaccinated with the second dose of GARDASIL 9 (dose and lot# not reported) (confirmed not GARDASIL). The patient received GARDASIL 9 outside of the recommended series schedule. No adverse symptoms reported. This is one of three reports from the same reporter. Additional information has been requested.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 90 year old male patient with no pertinent medical history or known drug reactions or allergies. No information regarding the patient's concurrent conditions was provided. On an unknown date, reported as years ago, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot# and expiry date were not reported). The patient had no concomitant therapies. On an unknown date, reported as a few months ago, the patient developed shingles. He sought unspecified medical attention. The event was treated with unspecified antiviral medications. The outcome of the event was reported as recovering (it was also reported that the shingles had not yet resolved at the time of this report). The relatedness between ZOSTAVAX and the event was not provided. Additional information is not expected as the reporter declined any further contact.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 5 year old, female patient. The patient's medical history and concurrent conditions were not reported. On 28-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 25-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. 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 certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (lot# k010437, expiration dare 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.16
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 13 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 06-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report was received from a 72 year old female patient and refers to herself. The patient was allergic to aspirin and penicillin. The patient did not have pertinent medical history. The patient described herself as very healthy person. On an unspecified date in approximately 2012 (reported as four years ago), the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (dose, route of administration, lot # and expiration date were not provided). Concomitant therapies included unspecified vitamins. On 22-JAN-2016, the patient went to an unspecified emergency room because of a "little rash" on her belly. She was diagnosed with shingles and treated with an unspecified medication. She "had it so bad for three weeks" that she "could not even describe the pain". She further stated that she "would rather have a child than this pain" (referring to shingles pain). The patient also reported experiencing headaches (onset date was not reported). Since 22-JAN-2016, the patient had had an additional emergency room visit in an unspecified facility, three primary care physician visits and one visit to an unspecified dermatologist. In addition to the unspecified medication prescribed at the first emergency room visit, she had been prescribed unspecified doses of LYRICA, a lidocaine (manufacturer unknown) patch and an unspecified prescription cream "like cortisone (manufacturer unknown)". The patient stated she was still in pain and that if she was not "doing better" in a week or so, her primary care physician would send her to a pain management physician. The patient did not have lab diagnostics studies performed. The patient sought medical attention. The outcome of the events was reported as not recovered/not resolved at the time of the report. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 23-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 10-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.09
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 13 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, male patient. The patient's medical history and concurrent conditions were not reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 06-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 26-OCT-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. No medical history and concurrent condition were reported. On 08-FEB-2016, the patient was vaccinated with ZOSTAVAX (dose 0.65 ml, once, lot # L035285, Expiration date 15-DEC-2016) subcutaneously for shingles prevention. Concomitant medications included unspecified blood pressure medication and unspecified stomach medication. On an unknown date in February 2016 (reported as on an unspecified time after vaccination) the patient developed rash and swelling at the injection site. On 09-FEB-2016, the patient experienced vomiting. The patient sought medical attention and called pharmacist. The reporting pharmacist instructed the patient to take BENADRYL (unspecified manufacturer). The outcome of injection site rash, injection site swelling and vomiting was reported as not recovered. The reporter did not provided the causality between the events and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age and gender. On an unknown dates between 05-JAN-2016 and 15-JAN-2016, the patients were orally vaccinated with incorrectly stored doses of oral, ROTATEQ (dose, frequency, route of administration and indication were not reported, lot # L008996, expiration date 01-DEC-2016; L013203, expiration date 28-JAN-2017; L022447, expiration date 16-FEB-2017; reported as L035276, expiration date 09-JUn-2017). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 23-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age and gender. On an unknown dates between 05-JAN-2016 and 15-JAN-2016, the patients were vaccinated with incorrectly stored doses of GARDASIL 9 (dose, frequency, route of administration and indication were not reported, lot # L019291, expiration date 18-AUG-201; L020015, expiration date 16-AUG-2017). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 2 years old, male patient. The patient's medical history and concurrent conditions were not reported. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age and gender. On an unknown dates between 05-JAN-2016 and 15-JAN-2016, the patients were vaccinated with incorrectly stored doses of GARDASIL (dose, frequency, route of administration and indication were not reported, lot # K010215 with expiration date: 05-MAY-2017). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 patients of unknown age and gender. On 16-FEB-2016, the patients were vaccinated with incorrectly stored doses of PROQUAD (Merck) (dose, frequency, therapy type, route of administration and indication were not reported, lot # reported as L040143 with expiration date 13-MAR-2017). No adverse effects reported. Additional information is not expected, because the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to the patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. On an unspecified date, GARDASIL (lot # K011562, expiration date 08-APR-2017) was improperly stored to 32.7 degrees Fahrenheit for 90 minutes. Then on unspecified dates in 2016, since 04-JAN-2016, unspecified patients received the improperly stored doses of GARDASIL (dose and route of administration were unspecified). No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-FEB-2016, the patient was vaccinated with incorrectly stored doses of PROQUAD (Merck) (dose, frequency, therapy type, route of administration and indication were not reported, lot # L041626 with expiration date 20-APR-2017). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected, because the reporter did not wish to be contacted.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, male patient. The patient's medical history and concurrent conditions were not reported. On 23-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017  (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Erythema multiforme, Oedema, Pruritus, Rash, Urticaria
Clinical narrative: Skin rash, rash, erythema multiforme, urticarial pruritus and edema.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patients' medical history and concurrent conditions was not reported. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 04-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 13 months old, male patient. The patient's medical history and concurrent conditions were not reported. On 15-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 15-FEB-2016, the patient received an expired dose of PNEUMOVAX 23 (lot # K007826, expiration date: 03-FEB-2016, dose was not reported), intramuscularly. No known adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 13 months old, male patient. The patient's medical history and concurrent conditions were not reported. On 28-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVXA (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. The patient was vaccinated with GARDASIL (lot#, expiration date, dose and route not provided) on the following dates: the first dose on 10-JUL-2007, the second dose on 21-AUG-2008 (inappropriate schedule of vaccine administration), the third dose on 10-JAN-2010 (inappropriate schedule of vaccine administration). On 21-JAN-2016, the patient administered a dose of GARDASIL 9. No adverse effects were reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, male patient. The patient's medical history and concurrent conditions were not reported. On 23-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L001316 with expiration date 10-NOV-2016, dose and route were unknown) oral. No concomitant therapy was provided. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a 73 year old female patient. There was no information about concurrent condition and historical medication. On an unknown date in 2015, (as reported 31-JUN-2015) the patient was vaccinated with ZOSTAVAX, one shot/once, subcutaneous. No concomitant medication was reported. On an unknown date in 2015, (as reported 31-JUN-2015) the patient experienced redness, swelling and soreness around the injection site area. Patient did not seek any medical attention. The outcome of redness, swelling and soreness around the injection site area was reported as resolved as reported lasted a few days then went away. Causality between redness, swelling and soreness around the injection site area and ZOSTAVAX was unknown. Additional information has been requested.